Changes to the National Registry of Evidence-Based Programs and Practices (NREPP), 13132-13155 [06-2313]

Download as PDF wwhite on PROD1PC65 with NOTICES 13132 Federal Register / Vol. 71, No. 49 / Tuesday, March 14, 2006 / Notices MSC 7844, Bethesda, MD 20892. (301) 435– 1119. mselmanoff@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Cellular/molecular Responses in Dendritic Cells, Macrophages, and T cells. Date: March 27, 2006. Time: 3 p.m. to 5 p.m. Agenda: To review and evaluate grant applications and/or proposals. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892. (Telephone Conference Call). Contact Person: Samuel C. Edwards, PhD, Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4200, MSC 7812, Bethesda, MD 20892. (301) 435– 1152. edwardss@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review Special Emphasis Panel; Atherosclerosis and Macrophages. Date: April 11, 2006. Time: 2 p.m. to 3 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892. (Telephone Conference Call). Contact Person: Olga A. Tjurmina, PhD, Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4030B, MSC 7814, Bethesda, MD 20892. (301) 451– 1375. ot3d@nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Atrial Fibrillation and Pacing. Date: April 12, 2006. Time: 2 p.m. to 3:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892. (Telephone Conference Call). Contact Person: Olga A. Tjurmina, PhD, Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4030B, MSC 7814, Bethesda, MD 20892. (301) 451– 1375. ot3d@nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Heart Failure Gene Therapy. Date: April 17, 2006. Time: 1 p.m. to 3 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892. (Telephone Conference Call). Contact Person: Rajiv Kumar, PhD, Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4122, MSC 7802, Bethesda, MD 20892. (301) 435– 1212. kumarra@csr.nih.gov. VerDate Aug<31>2005 19:18 Mar 13, 2006 Jkt 208001 Name of Committee: Center for Scientific Review Special Emphasis Panel; Health Services Organization and Delivery Member Conflict Special Emphasis Panel. Date: April 18, 2006. Time: 10:30 a.m. to 1:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892. (Telephone Conference Call). Contact Person: Gertrude K. McFarland, FAAN, RN, DNSC Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3156, MSC 7770, Bethesda, MD 20892. (301) 435–1784. mcfarlag@csr.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: March 6, 2006. Anna Snouffer, Acting Director, Office of Federal Advisory Committee Policy. [FR Doc. 06–2400 Filed 3–13–06; 8:45 am] BILLING CODE 4140–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Service Administration Changes to the National Registry of Evidence-Based Programs and Practices (NREPP) Substance Abuse and Mental Health Services Administration, HHS. ACTION: Notice. AGENCY: SUMMARY: The Substance Abuse and Mental Health Services Administration (SAMHSA) is committed to preventing the onset and reducing the progression of mental illness, substance abuse, and substance-related problems among all individuals, including youth. As part of this effort, SAMHSA has expanded and refined the agency’s National Registry of Evidence-based Programs and Practices (NREPP) based on a systematic analysis and consideration of public comments received in response to a previous Federal Register notice (70 FR 50381, Aug. 26, 2005). This Federal Register notice summarizes SAMHSA’s redesign of NREPP as a decision support tool for promoting a greater adoption of evidence-based interventions within typical community-based settings, and provides an opportunity for interested parties to become familiar with the new system. FOR FURTHER INFORMATION CONTACT: Kevin D. Hennessy, Ph.D., Science to PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 Service Coordinator/SAMHSA, 1 Choke Cherry Road, Room 8–1017, Rockville, MD 20857, (240) 276–2234. Charles G. Curie, Administrator, SAMHSA. Advancing Evidence-Based Practice Through Improved Decision Support Tools: Reconceptualizing NREPP Introduction The Substance Abuse and Mental Health Services Administration (SAMHSA) strives to provide communities with effective, highquality, and cost-efficient prevention and treatment services for mental and substance use disorders. To meet this goal, SAMHSA recognizes the needs of a wide range of decisionmakers at the local, state, and national levels to have readily available and timely information about scientifically established interventions to prevent and/or treat these disorders. SAMHSA, through its Science to Service Initiative, actively seeks to promote Federal collaboration (e.g., with the National Institutes of Health [NIH]) in translating research into practice. The ideal outcome of this Initiative is that individuals at risk for or directly experiencing mental and substance abuse use disorders will be more likely to receive appropriate preventive or treatment services, and that these services will be the most effective and the highest quality that the field has to offer. This report provides a summary of activities conducted during the past year to critically evaluate SAMHSA’s recent activities and future plans for the National Registry of Evidence-based Programs and Practices (NREPP). It outlines the major themes that emerged from a formal public comment process and links this feedback to new review procedures and Web-based decision support tools that will enhance access to evidence-based knowledge for multiple audiences. The report is presented in four sections: • Section I briefly states the background of NREPP and SAMHSA’s recent request for public comments. • Section II discusses the analysis of comments that was conducted and presents the key recommendations for NREPP based on this analysis. • Section III describes the new approach that SAMHSA is advancing for NREPP. • Section IV presents the specific dimensions of the NREPP system in its new framework as a decision support tool. E:\FR\FM\14MRN1.SGM 14MRN1 Federal Register / Vol. 71, No. 49 / Tuesday, March 14, 2006 / Notices • Section V describes future activities at SAMHSA to support NREPP. wwhite on PROD1PC65 with NOTICES I. Background: The National Registry of Evidence-Based Programs and Practices The National Registry of Evidencebased Programs and Practices was designed to represent a key component of the Science to Service Initiative. It was intended to serve as a voluntary rating and classification system to identify programs and practices with a strong scientific evidence base. An important reason for developing NREPP was to reduce the significant time lag between the generation of scientific knowledge and its application within communities.1 Quality treatment and prevention services depend on service providers’ ability to access evidencebased scientific knowledge, standardized protocols, practice guidelines, and other practical resources. The precursor of NREPP, the National Registry of Effective Prevention Programs, was developed by SAMHSA’s Center for Substance Abuse Prevention (CSAP) as a way to help professionals in the field become better consumers of substance abuse prevention programs. Through CSAP’s Model Program Initiative, over 1,100 programs were reviewed, and more than 150 were designated as Model, Effective, or Promising Programs. Over the past 2 years, SAMHSA convened a number of scientific panels to explore the expansion of the NREPP review system to include interventions in all domains of mental health and substance abuse prevention and treatment. In addition, SAMHSA committed itself to three guiding principles—transparency, timeliness, and accuracy of information—in the development of an evidence-based registry of programs and practices. During this process it was determined that, to provide the most transparent and accurate information to the public, evidence should be assessed at the level of outcomes targeted by an intervention, not at the more global level of interventions or programs. Based on this decision, SAMHSA’s current NREPP contractor conducted a series of pilot studies to explore the validity and feasibility of applying an outcomespecific, 16-criteria evidence rating system to an expanded array of 1 As cited by the Institute of Medicine (2001), studies have suggested it takes an average of 17 years for research evidence to diffuse to clinical practice. Source: Balas, E.A., & Boren, S.A. (2000). Managing clinical knowledge for health care improvement. In: J. Bemmel & A.T. McCray (Eds.), Yearbook of medical informatics 2000: Patientcentered systems. Stuttgart, Germany: Schattauer. VerDate Aug<31>2005 19:18 Mar 13, 2006 Jkt 208001 programs and practices. Through extensive dialogues with the prevention community, SAMHSA also explored ways to provide evidence-based reviews of population- and community-level interventions within NREPP. In an effort to augment the information gained through these activities, SAMHSA solicited formal public comments through a notice posted in the Federal Register on August 26, 2005. The notice asked for responses to the agency’s plans for NREPP, including (1) revisions to the scientific review process and review criteria; (2) the conveying of practical implementation information about NREPP programs and practices to those who might purchase, provide, or receive these interventions; and (3) the types of additional agency activities that may be needed to promote wider adoption of interventions on NREPP, as well as support innovative interventions seeking NREPP status. A brief summary of the public comments and key public recommendations is presented in Section II. The complete analysis of the public responses is included in the Appendix to this report. II. Public Responses to the Federal Register Notice Senior staff at SAMHSA engaged in a comprehensive review of comments received in response to the Federal Register notice. Particular attention was directed to comments from prominent state and Federal stakeholders, including providers and policymakers, who stand to be the most affected by whatever system is ultimately implemented. Efforts were taken to balance SAMHSA’s responsiveness to public feedback with the need to adhere to rigorous standards of scientific accuracy and to develop a system that will be fair and equitable to multiple stakeholder groups. Recommendations for NREPP In the more than 100 comments received as part of the public comment process, a number of recurring themes and recommendations were identified. While all specific and general recommendations for modification of the NREPP review process were carefully considered by SAMHSA, the following are those that were considered most essential to the development of an accurate, efficient, and equitable system that can meet the needs of multiple stakeholders: • Limit the system to interventions that have demonstrated behavioral change outcomes. it is inherently appealing to the funders, providers, and consumers of prevention and treatment PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 13133 services to know that an intervention has a measurable effect on the actual behavior of participants. As researchers at the University of Washington recommended, ‘‘the system should be reserved for policies, programs, and system-level changes that have produced changes in actual drug use or mental health outcomes.’’ • Rereview all existing programs. There was near consensus among the respondents to the notice that existing programs with Model, Effective, and Promising designations from the old reviews should be rereviewed under the new system. The Committee for Children pointed out that ‘‘a ‘grandfather’ system may give the impression to users, right or wrong, that these interventions aren’t as good as those that have undergone the new review process.’’ One individual suggested that programs and practices needed to be rated ‘‘according to a consistent set of criteria’’ so that ‘‘the adoption of an intervention by a provider can be made with confidence.’’ • Train and utilize panels of reviewers with specific expertise related to the intervention(s) under review. Respondents to the notice noted that it would be important for the NREPP review process to utilize external reviewers with relevant scientific and practical expertise related to the intervention being assessed. In addition, the pool of available reviewers should broadly include community-level and individual-level prevention as well as treatment perspectives. In order to promote transparency of the review process, the reviewer training protocols should be available for review by the public (e.g., posted on the NREPP Web site). • Provide more comprehensive and balanced descriptions of evidence-based practices, by emphasizing the important dimension of readiness for dissemination. The American Psychological Association (APA) Committee on Evidence-Based Practice recommended greater emphasis on the utility descriptors (i.e., those items describing materials and resources to support implementation), stating, ‘‘these are key outcomes for implementation and they are not adequately addressed in the description of NREPP provided to date. This underscores earlier concerns noted about the transition from efficacy to effectiveness.’’ The APA committee noted that generalizability of programs listed on NREPP will remain an issue until this ‘‘gap between efficacy and effectiveness’’ is explicitly addressed under a revised review system. • Avoid limiting flexibility and innovation; implement a system that is E:\FR\FM\14MRN1.SGM 14MRN1 wwhite on PROD1PC65 with NOTICES 13134 Federal Register / Vol. 71, No. 49 / Tuesday, March 14, 2006 / Notices fair and inclusive of programs and practices with limited funding, and establish policies that seek to prevent the misuse of information contained on NREPP. The National Association for Children of Alcoholics voiced this concern: ‘‘It has been intrinsically unfair that only grants [referring to NIH-funded efforts] have been able to establish ‘evidence’ while many programs appear very effective—often more effective in some circumstances than NREPP approved programs, but have not had the Federal support or other major grant support to evaluate them. The SAMHSA grant programs continue to reinforce the designation of NREPP programs in order to qualify for funding, and the states tend to strengthen this ‘stipulation’ to local programs,who then drop good (non-NREPP) work they have been doing or purchase and manipulate NREPP programs that make the grant possible. This is not always in the best interest of the client population to be served.’’ • Recognize multiple ‘‘streams of evidence’’ (e.g., researcher, practitioner, and consumer) and the need to provide information to a variety of stakeholders in a decision support context. A number of comments suggested that NREPP should be more inclusive of the practitioner and consumer perspective on what defines evidence. For example, one commenter noted: ‘‘The narrowed interpretation of evidence-based practice by SAMHSA focuses almost solely on the research evidence to the exclusion of clinical expertise and patient values.’’ Several comments noted that NREPP should be consistent with the Institute of Medicine’s definition of evidence-based practice, which reflects multiple ‘‘streams of evidence’’ that include research, clinical, and patient perspectives. • Provide a summary rating system that reflects the continuous nature of evidence quality. There was substantial disagreement among those responding to the notice concerning whether NREPP should include multiple categories of evidence quality. While a number of individuals and organizations argued for the use of categorical evidence ratings, there were many who suggested that NREPP should provide an average, numeric scale rating on specific evidence dimensions to better reflect the ‘‘continuous nature of evidence.’’ This approach would allow the user of the system to determine what level of evidence strength is required for their particular application of an intervention. • Recognize the importance of cultural diversity and provide complete descriptive information on the VerDate Aug<31>2005 19:18 Mar 13, 2006 Jkt 208001 populations for which interventions have been developed and applied. Most comments reflected the knowledge that cultural factors can play an important role in determining the effectiveness of interventions. The Oregon Office of Mental Health and Addiction Services noted, ‘‘SAMHSA should focus considerable effort on identifying and listing practices useful and applicable for diverse populations and rural areas. Providers and stakeholders from these groups have repeatedly expressed the concern they will be left behind if no practices have been identified which fit the need of their area. We need to take particular care to ensure that their fear is not realized.’’ • In addition to estimating the effect size of intervention outcomes, NREPP should include additional descriptive information about the practical impacts of programs and practices. In general, comments suggested that that effect size should not be used as an exclusionary criterion in NREPP. It was widely noted that effect size estimates for certain types of interventions (e.g., communitylevel or population-based) will tend to be of smaller magnitude, and that ‘‘professionals in the field have not reached consensus on how to use effect size.’’ Researchers at the University of Washington suggested the inclusion of information about the reach of an intervention, when available, as complementary information to effect sizes. Several comments also suggested that effect size is often confused with the clinical significance of an intervention and its impact on participants. • Acknowledge the need to develop additional mechanisms of Federal support for technical assistance and the development of a scientific evidence base within local prevention and treatment communities. Nearly one third of the comments directly addressed the need for SAMHSA to identify and/or provide additional technical assistance resources to communities to help them adapt and implement evidence-based practices. The Oregon Office of Mental Health and Addiction Services wrote, ‘‘The adoption of new practices by any entity is necessarily a complex and long-term process. Many providers will need technical support if adoption and implementation is to be accomplished effectively. Current resources are not adequate to meet this challenge.’’ In order to align NREPP with the important recommendations solicited through the public comment process, SAMHSA also recognized the importance of the following goals: PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 • Provide a user-friendly, searchable array of descriptive summary information as well as reviewer ratings of evidence quality. • Provide an efficient and costeffective system for the assessment and review of prospective programs and practices. Section III, Streamlined Review Procedures, provides a complete description of the modified and streamlined review process that SAMHSA will adopt in conducting evidence-based evaluations of mental health and substance abuse interventions. III. Streamlined Review Procedures The number and range of NREPP reviews are likely to expand significantly under the new review system, requiring that SAMHSA develop an efficient and cost-effective review process. The streamlined review procedures, protocols, and training materials will be made available on the NREPP Web site for access by all interested individuals and organizations. Reviews of interventions will be facilitated by doctoral-level Review Coordinators employed by the NREPP contractor. Each Review Coordinator will support two external reviewers who will assign numeric, criterion-based ratings on the dimensions of Strength of Evidence and Readiness for Dissemination. Review Coordinators will provide four important support and facilitative functions within the peer review process: (1) They will assess incoming applications for the thoroughness of documentation related to the intervention, including documentation of significant outcomes, and will convey summaries of this information to SAMHSA Center Directors for their use in prioritizing interventions for review; (2) they will serve as the primary liaison with the applicant to expedite the review of interventions; (3) they will collaborate with the NREPP applicant to draft the descriptive dimensions for the intervention summaries; and (4) they will provide summary materials and guidance to external reviewers to facilitate initial review and consensus discussions of intervention ratings. Interventions Qualifying for Review While NREPP will retain its open submission policy, the new review system emphasizes the important role of SAMHSA’s Center Directors and their staff (in consultation with key stakeholders) in setting intervention review priorities that will identify the particular content areas, types of E:\FR\FM\14MRN1.SGM 14MRN1 Federal Register / Vol. 71, No. 49 / Tuesday, March 14, 2006 / Notices intervention approaches, populations, or even types of research designs that will qualify for review under NREPP. Under the streamlined review procedures, the sole requirement for potential inclusion in the NREPP review process is for an intervention to have demonstrated one or more significant behavioral change outcomes. Centerspecific review priorities will be established and communicated to the field by posting them to the NREPP Web site at the beginning of each fiscal year.2 Review of Existing NREPP Programs and Practices It will be the prerogative of SAMHSA Center Directors to establish priorities for the review and interventions already on, and pending entry on, NREPP. As indicated above, these decisions may be linked to particular approaches, populations, or strategic objectives as identified by SAMHSA as priority areas. Until reviews of existing NREPP programs and practices are completed and posted to the new NREPP Web site, the current listing on the SAMHSA Model Programs Web site will remain intact. Notifications to Program/Practice Developers Upon the completion of NREPP reviews program/practice developers (or principal investigators of a researchbased intervention) will be notified in writing within 2 weeks of the review results. A complete summary, highlighting information from each of the descriptive and rating dimensions, will be provided for review. Program/ practice developers who disagree with the descriptive information or ratings contained in any of the dimensions will have an opportunity to discuss their concerns with the NREPP contractor during the 2-week period following receipt of the review outcome notification. These concerns must be expressed in writing to the contractor within this 2-week period. If no comments are received, the review is deemed completed, and the results may be posted to the NREPP Web site. If points of disagreement cannot be resolved by the end of this 2-week period, then written appeals for a rereview of the intervention may be considered on a case-by-case basis. wwhite on PROD1PC65 with NOTICES NREPP Technical Expert Panel SAMHSA will organize one or more expert panels to perform periodic (e.g., annual assessments of the evidence 2 Except for FY06 when priorities will be established and posted when the new system Web site is launched (i.e., within the third FY quarter). VerDate Aug<31>2005 19:18 Mar 13, 2006 Jkt 208001 review system and recommend enhancements to to the review procedures and/or standards for evidence-based science and practice. Panel membership will represent a balance of perspectives and expertise. The panels will be comprised of researchers with knowledge of evidence-based practices and initiatives, policymakers, program planners and funders, practitioners, and consumers. The modified NREPP system embodies a commitment by SAMHSA and its Science to Service Initiative to broaden the appeal and utility of the system to multiple audiences. While maintaining the focus on the documented outcomes achieved through a program or practice, NREPP also is being developed as a user-friendly decision support tool to present information along multiple dimensions of evidence. Under the new system, interventions will not receive single, overall ratings as was the case with the previous NREPP (e.g., Model, Effective, or Promising). Instead, an array of information from multiple evidence dimensions will be provided to allow different user audiences to both identify (through Web-searchable means) and prioritize the factors that are important to them in assessing the relative strengths of different evidence-based approaches to prevention or treatment services. Section IV presents in more detail the specific dimensions of descriptive information and ratings that NREPP will offer under this new framework. IV. NREPP Decision Support Tool Dimensions The NREPP system will support evidence-based decisionmaking by providing a wide array of information across multiple dimensions. Many of these are brief descriptive dimensions that will allow users to identify and search for key intervention attributes of interest. Descriptive dimensions would frequently include a brief, searchable keyword or attribute (e.g., ‘‘randomized control trial’’ under the Evaluation Design dimension) in addition to narrative text describing that dimension. Two dimensions, Strength of Evidence and Readiness for Dissemination, will consist of quantitative, criterion-based ratings by reviewers. These quantitative ratings will be accompanied by reviewer narratives summarizing the strengths and weaknesses or the intervention along each dimension. Considerations for Using NREPP as a Decision Support Tool It is essential for end-users to understand that the descriptive PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 13135 information and ratings provided by NREPP are only useful within a much broader context that incorporates a wide range of perspectives—including clinical, consumer, administrative, fiscal, organizational, and policy—into decisions regarding the identification, selection, and successful implementation of evidence-based services. In fact, an emerging body of literature on implementation science 3 suggests that a failure to carefully attend to this broader array of data and perspectives may well lead to disappointing or unsuccessful efforts to adopt evidence-based interventions. Because each NREPP user is likely to be seeking somewhat different information, and for varied purposes, it is unlikely that any single intervention included on NREPP will fulfill all of the specific requirements and unique circumstances of a given end-user. Appreciation of this basic premise of NREPP as a decision support tool to be utilized in a broader context will thus enable system users to make their own determinations regarding how best to assess and apply the information provided. The NREPP decision support dimensions include: • Descriptive Dimensions • Strength of Evidence Dimension Ratings • Readiness for Dissemination Dimension Ratings A complete description of these dimensions is provided in the sections below. Descriptive Dimensions • Intervention Name and Summary: Provides a brief summary of the intervention, including title, description of conceptual or theoretical foundations, and overall goals. Hyperlinks to graphic logic model(s), when available, could be accessed from this part of the summary. • Contract Information: Lists key contact information. Typically will include intervention developer’s title(s), affiliation, mailing address, telephone and fax numbers, e-mail address, and Web site address. • Outcome(s): A searchable listing of the behavioral outcomes that the intervention has targeted. • Effects and Impact: Provides a description and quantification of the effects observed for each outcome. 3 Fixsen, D.L., Naoom, S.F., Blase, K.A., Friedman, R.M., & Wallace, F. (2005). Implementation research: A synthesis of the literature. Tampa, Florida: University of South Florida, Louis de la Parte Florida mental Health Institute, The National Implementation Network (FMHI Publication #231). Rogers (1995). Diffusion of innovaations (5th Ed.) New York: The Free Press. E:\FR\FM\14MRN1.SGM 14MRN1 13136 Federal Register / Vol. 71, No. 49 / Tuesday, March 14, 2006 / Notices Includes information on the statistical significance of outcomes, the magnitude of changes reported including effect size and measures of clinical significance (if available), and the typical duration of behavioral changes produced by the intervention. • Relevant Populations and Settings: Identifies the populations and sample demographics that characterize existing evaluations. The settings in which different populations have been evaluated will be characterized along a dimension that ranges from highly controlled and selective (i.e., efficacy studies), to less controlled and more representative (i.e., effectiveness studies), to adoption in the most diverse and realistic public health and clinical settings (i.e., dissemination studies).4 • Costs: Provides a breakdown of intervention cost(s) per recipient/ participant or annual as appropriate (including capital costs, other direct costs [travel, etc.]). Start-up costs including staff training and development. A standardized template would be provided to applicants for estimating and summarizing the implementation and maintenance costs of an intervention. • Adverse Effects: Reported with regard to type and number, amounts of change reported, type of data collection, analyses used, intervention and comparison group, and subgroups. • Evaluation Design: Contains both a searchable index of specific experimental and quasi-experimental designs (e.g., pre-/posttest nonequivalent groups designs, regression-discontinuity designs, wwhite on PROD1PC65 with NOTICES 4 For more description of these types of studies and their role in supporting evidence-based services, see the report: Bridging science and service: A report by the National Advisory mental Health Council’s Clinical Treatment and Services Research Workgroup (https://www.nimh.nih.gov/ publicat/nimhbridge.pdf). VerDate Aug<31>2005 19:18 Mar 13, 2006 Jkt 208001 interrupted time series designs, etc.) 5 as well as a narrative description of the design (including intervention and comparison group descriptions) used to document intervention outcomes. • Replication(s): Coded as ‘‘None,’’ or will state the number of replications to date (only those that have been evaluated for outcomes). Replications will be additionally characterized as having been conducted in efficacy, effectiveness, or dissemination contexts. • Proprietary or Public Domain Intervention: Typically will be one or the other, but proprietary components or instruments used as part of an intervention will be identified. • Cultural Appropriateness: Coded as ‘‘Not Available’’ (N/A) if either no data or no implementation/training materials for particular culturally identified groups are available. When culturespecific data and/or implementation materials exist for one or more groups, the following two Yes/No questions will be provided for each group: • Was the intervention developed with participation by members of the culturally identified group? • Are intervention and training materials translated or adapted to members of the culturally identified group? • Implementation History: Provides information relevant to the sustainability of interventions. Provides descriptive information on (1) the number of sites that have implemented the intervention; (2) how many of those have been evaluated for outcomes; (3) the longest continuous length of implementation (in years); (4) the average or modal length of implementation; and (5) the approximate number of individuals who 5 Campbell, D.T., & Stanley, J.C. (1966). Experimental and quasi-experimental designs for research. Chicago: Rand McNally. PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 have received or participated in the intervention. Strength of Evidence Dimension Ratings Quantitative, reviewer-based ratings on this dimension will be provided within specific categories of research/ evaluation design. In this manner, users can search and select within those categories of research designs that are most relevant to their particular standards of evidence-based knowledge. The categories of research design that are accepted within the NREPP system are described below. Research Design Quality of evidence for an intervention depends on the strength of adequately implemented research design controls, including comparison conditions for quasi-experimental and randomized experimental designs (individual studies). Aggregation (e.g., meta-analysis and systematic research reviews) and/or replication across welldesigned series of quasi-experimental and randomized control studies provide the strongest evidence. The evidence pyramid presented below represents a typical hierarchy for classifying the strength of causal inferences that can be obtained by implementing various research designs with rigor.6 Designs at the lowest level of evidence pyramid (i.e., observational, pilot, or case studies), while acceptable as evidence in some knowledge development contexts, would not be included in the NREPP system. 6 Biglan, A., Mrazek, P., Carnine, D.W., & Flay, B. R. (2003). The integration of research and practice in the prevention of youth problem behaviors. American Psychologist, 58, 433–440. Chambless, D. L., & Hollon, S. (1998). Defining empirically supported therapies. Journal of Consulting and Clinical Psychology, 66, 7–18. Gray, J. A. (1997), Evidence-based healthcare: How to make health policy and management decisions. New York: Churchill Livingstone. E:\FR\FM\14MRN1.SGM 14MRN1 Federal Register / Vol. 71, No. 49 / Tuesday, March 14, 2006 / Notices 3. Intervention Fidelity 7 Each criterion would be rated on an ordinal scale ranging from 0 to 4. The endpoints and midpoints of the scale would be anchored to a narrative description of that rating. The remaining integer points of the scale (i.e., 1 and 3) would not be explicitly anchored, but could be used by reviewers to assign intermediate ratings at their discretion. 8 Marshall, M., Lockwood, A., Bradley, C., Adams, C., Joy, C., & Fenton, M. (2000). Unpublished rating scales: A major source of bias in randomised controlled trials of treatments for schizophrenia. British Journal of Psychiatry, 176, 249–252. VerDate Aug<31>2005 19:18 Mar 13, 2006 Jkt 208001 0 = Absence of evidence measure validity, or some evidence that the measure is not valid. 2 = Measure has face validity; absence of evidence that measure is not valid. 4 = Measure has one or more acceptable forms of criterion-related validity (correlation with appropriate, validated measures or objective criteria); OR, for objective measures of response, there are procedural checks to confirm data validity; absence of evidence that measure is not valid. The ‘‘experimental’’ intervention implemented in a study should have fidelity to the intervention proposed by the applicant. Instruments that have tested acceptable psychometric properties (e.g., interrater reliability, validity as shown by positive association with outcomes) provide the highest level of evidence. 0 = Absence of evidence or only narrative evidence that the applicant or provider believes the intervention was implemented with acceptable fidelity. PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 2 = There is evidence of acceptable fidelity in the form of judgment(s) by experts, systematic collection of data (e.g. dosage, time spent in training, adherence to guidelines or a manual), or a fidelity measure with unspecified or unknown psychometric properties. 4 = There is evidence of acceptable fidelity from a tested fidelity instrument shown to have reliability and validity. 4. Missing Data and Attrition Study results can be biased by participant attrition and other forms of missing data. Statistical methods as supported by theory and research can be employed to control for missing data and attrition that would bias results, but studies with no attrition needing adjustment provide the strongest evidence that results are not biased. 0 = Missing data and attrition were taken into account inadequately, OR there was too much to control for bias. 2 = Missing data and attrition were taken into account by simple estimates of data and observations, or by demonstrations of similarity between remaining participants and those lost to attrition. 4 = Attrition was taken into account by more sophisticated methods that E:\FR\FM\14MRN1.SGM 14MRN1 EN14MR06.000</GPH> ‘‘Acceptable’’ here means validity at a level that is conventionally accepted by experts in the field. 2. Validity Outcome measures should have acceptable validity to be interpretable. wwhite on PROD1PC65 with NOTICES 1. Reliability 7 Outcome measures should have acceptable reliability to be interpretable. ‘‘Acceptable’’ here means reliability at a level that is conventionally accepted by experts in the field.8 0 = Absence of evidence of reliability or evidence that some relevant types of reliability (e.g., test-retest, interrater, interitem) did not reach acceptable levels. 2 = All relevant types of reliability have been documented to be at acceptable levels in studies by the applicant. 4 = All relevant types of reliability have been documented to be at acceptable levels in studies by independent investigators. 13137 13138 Federal Register / Vol. 71, No. 49 / Tuesday, March 14, 2006 / Notices model missing data, observations, or participants; OR there was no attrition needing adjustment. 5. Potential Confounding Variables Often variables other than the intervention may account for the reported outcomes. The degree to which confounds are accounted for affects the strength of casual inference. 0 = Confounding variables or factors were as likely to account for the outcome(s) reported as were hypothesized causes. 2 = One or more potential confounding variables or factors were not completely addressed, but the intervention appears more likely than these confounding factors to account for the outcome(s) reported. 4 = All known potential confounding variables appear to have been completely addressed in order to allow causal inference between intervention and outcome(s) reported. adequate to support initial and ongoing implementation. 4 = Applicant provides training and support resources that are fully adequate to support initial and ongoing implementation (tested training curricula, mechanisms for ongoing supervision and consultation). 3. Quality Improvement (QI) Materials (e.g., Fidelity Measures, Outcome and Performance Measures, Manuals on How To Provide QI Feedback and Improve Practices) 0 = Applicant has limited or no materials. 2 = Applicant has materials that are partially adequate to support initial and ongoing implementation. 4 = Applicant provides resources that are fully adequate to support initial and ongoing implementation (tested quality fidelity and outcome measures, comprehensive and userfriendly QI materials). 6. Appropriateness of Analyses Appropriate analysis is necessary to make an inference that an intervention caused reported outcomes. 0 = Analyses were not appropriate for inferring relationships between intervention and outcome, OR the sample size was inadequate. 2 = Some analyses may not have been appropriate for inferring relationships between intervention and outcome, OR the sample size may have been inadequate. 4 = Analyses were appropriate for inferring relationships between intervention and outcome. Sample size and power were adequate. Scoring the Strength of Evidence and Readiness for Dissemination Dimensions The ratings for the decision support dimensions of Strength of Evidence and Readiness for Dissemination are calculated by averaging individual rating criteria that have been scored by reviewers according to a uniform fivepoint scale. For these two quantitative dimensions, the average score on each dimension (i.e., across criteria and reviewers) as well as average score for each rating criterion (across reviewers) will be provided on the Web site for each outcome targeted by the intervention.9 Readiness for Dissemination Dimension Ratings V. Future Activities: Implementing and Sustaining a Streamlined NREPP SAMHSA plans to initiate reviews using the new NREPP review process and procedures in summer 2006. The precise number and characteristics of new interventions that will be prioritized for the first series of reviews have yet to be determined. SAMHSA anticipates that many of the existing programs and practices currently listed on the SAMHSA Model Programs Web site will undergo an expedited set of reviews using the new system. Regardless, the current Model Programs Web site will remain intact until all relevant programs have been included in a new Web site, https://www.national registry.samhsa.gov wwhite on PROD1PC65 with NOTICES 1. Availability of Implementation Materials (e.g., Treatment Manuals, Brochures, Information for Administrators, etc.) 0 = Applicant has insufficient implementation materials. 2 = Applicant has provided a limited range of implementation materials, or a comprehensive range of materials of varying or limited quality. 4 = Applicant has provided a comrephensive range of standard implementation materials of apparent high quality. 2. Availability of Training and Support Resources 0 = Applicant has limited or no training and support resources. 2 = Applicant provides training and support resources that are partially VerDate Aug<31>2005 19:18 Mar 13, 2006 Jkt 208001 9 Note that it is unlikely that the Readiness for Dissemination dimension will vary by targeted outcome(s), insofar as the materials and resources are usually program specific as opposed to outcome specific. PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 The identification of collaborative mechanisms for supporting the continued development and refinement of NREPP will represent a SAMHSA priority in 2006. SAMHSA will explore means for providing adequate technical assistance resources to communities seeking to initiate and/or augment evidence-based practices. In addition, appropriate technical advisors and other scientific resources will be utilized to assure the continued evolution of NREPP as a state-of-the-art decision support tool. Appendix: Analysis of Public Comments in Response to Federal Register Notice Background and Overview The Substance Abuse and Mental Health Services Administration (SAMHSA), through its Science to Service initiative, develops tools and resources for providers of prevention and treatment services to facilitate evidence-based decisionmaking and practice. An important informational resource is the National Registry of Evidence-based Programs and Practices (NREPP). NREPP is a voluntary rating and classification system designed to provide the public with reliable information on the scientific basis and practicality of interventions designed to prevent and/or treat mental and addictive disorders. NREPP originated in SAMHSA’s Center for Substance Abuse Prevention (CSAP) in 1997 as a way to help professionals in the field become better consumers of prevention programs. The program was expanded in 2004 to include substance abuse treatment interventions within SAMHSA’s Center for Substance Abuse Treatment (CSAT) and mental health promotion and treatment interventions within the Center for Mental Health Services (CMHS). During the past 2 years, SAMHSA reviewed existing evidence rating systems and developed and pilot-tested a revised approach to the rating of specific outcomes achieved by programs and practices. This development effort led SAMHSA to propose 16 evidence rating criteria as well as a set of proposed utility descriptors to describe the potential of a given intervention to be ‘‘transported’’ to real-world settings and populations. Considering the prominence of NREPP within its Science-to-Service initiative and the potential impact of NREPP on the research and provider communities, SAMHSA announced a formal request for public comments in the Federal Register on August 26, 2005 (70 FR 165, 50381–50390) with a 60-day E:\FR\FM\14MRN1.SGM 14MRN1 Federal Register / Vol. 71, No. 49 / Tuesday, March 14, 2006 / Notices public comment period ending October 26, 2005. The notice outlined in some detail the proposed review system, including scientific criteria for evidence reviews, the screening and triage of NREPP applications, and the identification by SAMHSA of priority review areas. The notice invited general as well as specific comments and included 11 questions soliciting targeted feedback. By request of the SAMHSA Project Officer, MANILA Consulting Group coded and analyzed the responses received in response to the 11 questions posted in the Federal Register notice. The results of the analysts are presented below. wwhite on PROD1PC65 with NOTICES Method A total of 135 respondents submitted comments via e-mail, fax, and postal mail during the comment period. Of these 135 respondents, 109 (81%) answered at least some of the 11 questions posted in the Federal Register notice. Respondents The 135 respondents included 53 providers, 36 researchers, 4 consumers, 21 respondents with multiple roles, and ` 21 with unknown roles visa-a-vis NREPP. Respondents were labeled as having one or more of the following domains of interest: substance abuse prevention (N=68), substance abuse treatment (N=48), mental health promotion (N=22); and mental health treatment (N=20). The domain of interest was unknown for 33 respondents. The respondents represented 16 national organizations, 10 state organizations, and 14 local organizations; 90 were private citizens; and 5 were individuals with unknown affiliations. Fifty-one respondents (38%) were labeled ‘‘noteworthy’’ at the request of the SAMHSA Project Officer. Noteworthy respondents included those representing national or state governments or national organizations, and nationally known experts in substance abuse or mental health research or policy. Twenty-six responses were judged by the four MANILA coders and the SAMHSA Project Officer to contain no information relevant to the 11 questions in the notice. These responses, labeled ‘‘unanalyzable’’ for the purposes of this report, could be categorized as follows: • Mentioned topics related to SAMHSA but made no point relevant to the questions posted in the Federal Register notice (N=10); • Mentioned only topics unrelated to SAMHSA or incoherent text (N=7); • Asked general questions about NREPP and the Federal Register notice VerDate Aug<31>2005 19:18 Mar 13, 2006 Jkt 208001 (N=4);Wanted to submit a program for NREPP review (N=4); and • Wanted to submit a program for NREPP review (N=4); and • Responded to another Federal Register notice (N=1). Procedure Before coding began, responses were read to identify recurrent themes to include in the codebook (presented in Subpart A of this Appendix). Using this codebook, each submission was then assigned codes identifying respondent characteristics (name, location, domain of interest, affiliation/type of organization, functional role, and level of response) and the content or topical themes contained in the response. One pair of coders coded the respondent data, while another pair coded the content. Content coding was conducted by two doctoral-level psychologists with extensive training and experience in social science research and methodology. Each response could be assigned multiple codes for content. Coders compared their initial code assignments for all responses, discussed reasons for their code assignments when there were discrepancies, and then decided upon final code assignments. In many cases, coders initially assigned different codes but upon discussion agreed that both coders’ assignments were applicable. Coding assignments were ultimately unanimous for all text in all responses. Results The following discussion of key themes in the public comments is presented in order of the 11 questions from the Federal Register notice. Tables containing detailed frequencies of themes in the comments and other descriptive information are provided in Subpart B. Comments Addressing Question 1 Question 1. ‘‘SAMHSA is seeking to establish an objective, transparent, efficient, and scientifically defensible process for identifying effective, evidence-based interventions to prevent and/or treat mental and substance use disorders. Is the proposed NREPP system—including the suggested provisions for screening and triage of applications, as well as potential appeals by applicants—likely to accomplish these goals?’’ Respondents submitted a wide range of comments addressing Question 1. Highlights of these comments are presented below, organized by topic as follows: 1. Individual-Level Criteria 2. Population-, Policy-, and SystemLevel Criteria 3. Utility Descriptors PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 13139 4. Exclusion From NREPP Due to Lack of Funding 5. Potential Impact on Minority Populations 6. Potential Impact on Innovation 7. Provider Factors 8. Other Agencies’ Standards and Resources 9. Reliance on Intervention Developers To Submit Applications 10. Generalizability 11. Other Themes and Notable Comments 1. Individual-Level Criteria Number of respondents: 24 (22%). Recommendations made by respondents included adding cost feasibility as a 13th criterion (one respondent) and scoring all criteria equally (two respondents). Comments regarding specific criteria are presented in Subpart C. 2. Population-, Policy-, and SystemLevel Criteria Number of respondents: 29 (27%). Comments on specific criteria are presented in Subpart D. Highlights of comments on more general issues are presented below. Differences in Evaluation Approaches for Individual-Level and Population-, Policy-, and System-Level Outcomes Two respondents noted the proposed NREPP approach does not acknowledge key differences between evaluating individual-level outcomes and population-, policy-, and system-level outcomes. One of these respondents argued that NREPP is based on theories of change that operate only at the individual level of analysis, with the assumption that discrete causes lead to discrete effects, and therefore ‘‘many of the NREPP criteria appear to be insufficient or inappropriate for determining the validity of communitybased interventions and their contextdependent effects.’’ Unclear What Interventions Are of Interest to NREPP One organization, Community AntiDrug Coalitions of America, recommended that SAMHSA present a clear, operational definition of the types of interventions it wants to include in NREPP. Match Scale to Individual-Level Outcomes Twelve respondents, including the Society for Prevention Research and a group of researchers from a major university, recommended that the same scale be used for outcomes at the E:\FR\FM\14MRN1.SGM 14MRN1 13140 Federal Register / Vol. 71, No. 49 / Tuesday, March 14, 2006 / Notices individual level as for the population, policy, and system levels. Add Attrition Criterion The same group of university researchers suggested adding attrition as a 13th criterion to the rating criteria for studies of population outcomes. They noted, ‘‘Just as attention to attrition of individuals from conditions is essential in individual-level studies, attention to attrition of groups or communities from studies is essential in group-level studies. This is necessary in order to assess attrition as a possible threat to the validity of the claim that the population-, policy-, or system-level intervention produced observed outcomes.’’ Include Only Interventions That Change Behavior It was recommended that NREPP only include interventions proven to change behavior. A group of university researchers noted: As currently described, these outcomes refer to implementation of changes in policy or community service systems, not to changes in behavioral outcomes themselves. In fact, as currently described, the policy or system change would not be required to show any effects on behavior in order to be included in NREPP. This is a serious mistake. The NREPP system should be reserved for policies, programs, and system-level changes that have produced changes in actual drug use or mental health outcomes. wwhite on PROD1PC65 with NOTICES 3. Utility Descriptors Number of respondents: 15 (14%). Only one respondent, the Committee for Children, recommended specific changes to the utility descriptors. Their comments are presented in Subpart E of this Appendix. Seven other respondents recommended using utility descriptors in some way to score programs. The American Psychological Association (APA) Committee on Evidence-Based Practice recommended more emphasis on the utility descriptors ‘‘as these are key outcomes for implementation and they are not adequately addressed in the description of NREPP provided to date. This underscores earlier concerns noted about the transition from effectiveness to efficacy.’’ 4. Exclusion From NREPP Due To Lack of Funding Number of respondents: 28 (26%). The possibility that NREPP will exclude programs due to lack of funding was a concern voiced by several organizations, including the National Association for Children of Alcoholics, the APA Committee on Evidence-Based VerDate Aug<31>2005 19:18 Mar 13, 2006 Jkt 208001 Practice, the National Association of State Alcohol and Drug Abuse Directors, Community Anti-Drug Coalitions of America, and the California Association of Alcohol and Drug Program Executives. The National Association for Children of Alcoholics provided the following comment: NREPP should establish differing criteria for projects that collected data with [National Institutes of Health] grant funds and projects that collected data with no or very small amounts of funds. It has been intrinsically unfair that only grants have been able to establish ‘‘evidence’’ while many programs appear very effective—often more effective in some circumstances than NREPP approved programs—but have not had the Federal support or other major grant support to evaluate them. The SAMHSA grant programs continue to reinforce the designation of NREPP programs in order to qualify for funding, and the states tend to strengthen this ‘stipulation’ to local programs, who then drop good (non-NREPP) work they have been doing or purchase and manipulate NREPP programs that make the grant possible. This is not always in the best interest of the client population to be served. Another key concern was that funding for replication research is rarely available. Several respondents suggested that SAMHSA consider funding evaluation research, and many argued that the lack of funding resources could negatively impact minority populations or inhibit treatment innovation. The latter two themes were frequent enough to be coded and analyzed separately. Results are summarized in the following sections. 5. Potential Impact on Minority Populations Number of respondents: 13 (12%). Thirteen respondents noted that the proposed NREPP approach could negatively impact specific populations, including minority client populations. The Federation of Families for Children’s Mental Health suggested that NREPP would effectively promote certain practices ‘‘simply because the resources for promotion, training, evaluation are readily accessible * * * thus widening the expanse and disparities that currently exist.’’ Another frequently noted concern was that evidence-based practices are currently too narrowly defined, and thus as more funding sources begin to require evidence-based practices as a prerequisite for funding, some ethnic or racial minority organizations may be excluded from funding. One respondent also pointed to potential validity concerns, noting that ‘‘Very little clinical trial evidence is available for how to treat substance use disorders in specific populations who may constitute PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 most or all of those seen in particular agencies: HIV positive patients, native Americans, adolescents, Hispanics, or African Americans. Although it is unreasonable to expect all EBTs to be tested with all populations, the external validity of existing studies remains a serious concern.’’ For these reasons, many respondents surmised that the widespread application of interventions developed in research contexts that might tend to limit the inclusion of minority and/or underserved populations could ultimately result in decreased cultural competence among service providers. 6. Potential Impact on Innovation Number of respondents: 21 (19%). Twenty-one respondents cited concerns that the proposed NREPP approach could hamper innovation. CAADPE noted that its main concerns were ‘‘the focus on the premise that treatment will improve if confined to inteventions for which a certain type of research evidence is available’’ and ‘‘the issue of ‘branding,’ which could lead to some of our most innovative and effective small scale providers eliminated from funding considerations.’’ One respondent suggested that lists of evidence-based treatments could ‘‘ossify research and practice, and thus become self-fulfilling prophecies * * * stifling innovation and the validation of existing alternatives.’’ Several respondents observed that the potential for stifling innovation is even greater given that SAMHSA’s NREPP is not the only list of evidence-based practices used by funders. The APA Practice Organization recommended that NREPP focus on ‘‘developing and promoting a range of more accessible and less stigmatized services that are responsive to consumers’ needs and preference, and offer more extensive care opportunities.’’ 7. Provider Factors Number of respondents: 22 (20%). A number of respondents noted the proposed NREPP approach does not acknowledge provider effects on treatment outcomes. The APA Committee on Evidence-Based Practice wrote, ‘‘Relationship factors in a therapeutic process may be more important than specific interventions and may in fact be the largest determinant in psychotherapy outcome (see Lambert & Barley, 2002). How will NREPP address this concern and make this apparent to users?’’ Another respondent cited the Institute of Medicine’s definition of evidence- E:\FR\FM\14MRN1.SGM 14MRN1 Federal Register / Vol. 71, No. 49 / Tuesday, March 14, 2006 / Notices based practice as ‘‘the integration of the best research evidence with clinical expertise and client values,’’ noting that ‘‘The narrowed interpretation of evidence-based practice by SAMHSA focuses almost solely on the research evidence to the exclusion of clinical expertise and patient values.’’ Several respondents suggested that NREPP could place too much emphasis on highly prescriptive, annualized treatments. Counselors can become bored when they are not able ti ‘‘tinker’’ with or adapt treatments. In addition, making minor modifications may actually make treatments more effective with different population groups. 8. Other Agencies’ Standards and Resources Number of respondents: 27 (25%). Nineteen respondents suggested that, in developing NREPP, SAMHSA should consult other agencies’ standards and resources related to evidence-based practices—for example, the standards published by the APA, American Society for Addiction Medicine, and the Society for Prevention Research. One respondent suggested consulting with National Institutes of Health scientists about approaches for aggregating evidence; another recommended including in NREPP model programs identified by other agencies. One respondent submitted a bibliography of references for assessing the rigor of qualitative research. One respondent suggested that SAMHSA did not provide other institutions the opportunity to provide input on the development of NREPP prior to the request for public comments. wwhite on PROD1PC65 with NOTICES 9. Reliance on Intervention Developers To Submit Applications Number of respondents: 4 (4%). Four respondents cited problems with NREPP’s reliance on intervention developers to submit applications, and suggested that literature reviews instead be used to identify programs eligible for NREPP. One private citizen wrote, ‘‘If no one applies on behalf of a treatment method, is that one ignored? Why not simply start with the literature and identify treatment methods with adequate evidence of efficacy?’’ Another respondent observed that requiring an application creates a bias toward programs with advocates ‘‘either ideologically or because of a vested interest in sales, visibility, and profits. An alternative is to select interventions for NREPP consideration solely by monitoring the peer-reviewed published literature, and including them VerDate Aug<31>2005 19:18 Mar 13, 2006 Jkt 208001 regardless of whether or not the scientist responds or furthers the registration process.’’ The Society for Prevention Research suggested that SAMHSA convene a panel to periodically review available interventions that might not be submitted to NREPP because they ‘‘lack a champion.’’ 10. Generalizability Number of respondents: 48 (44%). Many respondents discussed the issue of generalizability of evidence, especially the concern that interventions proven to work in clinical trials do not always work in real-world settings. Several respondents pointed out the potential conflict between implementing an intervention with fidelity and having a adapt it for the setting. The APA Evidence-Based Practice Committee suggested that the proposed NREPP approach does not adequately distinguish between ‘‘efficacy’’ and ‘‘effectiveness,’’ and strongly recommended that SAMHSA look for ways to bridge the two. The Associations of Addiction Services recommended paying more attention to how and where treatments are replicated: ‘‘The highest level of evidence should be successful replication of the approach in multiple community treatment settings. Experience with [the National Institute on Drug Abuse] Clinical Trials Network suggests that an approach that shows meaningful outcome improvements in the ‘noisy’ setting of a publicly funded community treatment program is truly an approach worth promoting.’’ A few respondents suggested that NREPP score interventions according to their readiness and amenability to application in real-world settings. 11. Other Themes and Notable Comments Distinguishing Treatment and Prevention Number of respondents: 7 (6%). A few respondents called or evaluating treatment and prevention approaches differently. One respondent noted that some criteria appear to be more appropriate for treatment modalities than for preventive interventions, and recommended that SAMHSA ‘‘confer with research experts in those respective fields and separate out those criteria that are more relevant to only treatment or prevention.’’ Another respondent suggested that the criteria are more appropriate for prevention that treatment: PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 13141 The criteria and selection for the peer review panels should be separate for prevention and treatment programs. The criteria and models are different and the panels should not be an across the board effort, but rather representative of prevention and treatment experts specific to the program being evaluated. The plan is based as the notice states on 1,100 prevention programs with little experience with treatment programs/practices. Synthesizing Evidence Three respondents suggested using meta-analysis to synthesize evidence for outcomes. One recommended SAMHSA consult with National Institutes of Health experts in this area. Replications The Teaching-Family Association recommended considering replications when evaluating evidence. The Society for Prevention Research wrote that it is unclear how replications would be used in the proposed NREPP, and suggested averaging ratings across studies. Add Criteria The National Student Assistance Association Scientific Advisory Board and one other respondent suggested adding a cultural competence criterion. The Society for Prevention Research recommended adding a criterion to assess the clarity of causal inference. Range of Reviewer Perspectives The APA Practice Association noted the importance of having a ‘‘large and broad’’ reviewer pool: ‘‘A small group of reviewers representing a limited range of perspectives and constituencies would have an undue impact on the entire system. We are pleased that a nominations process is envisioned.’’ Cost Effectiveness One respondent called for incorporating program cost effectiveness into NREPP. In choosing what program to implement, end users often have to decide between diverse possibilities, such as attempting to pass a tax increase on beer or implementing additional classroom prevention curricula, each with competing claims about effectiveness. A cost-effectiveness framework may be the only way to compare these choices. Comments Addressing Question 2 Question 2. ‘‘SAMHSA’s NREPP priorities are reflected in the agency’s matrix of program priority areas. How might SAMHSA engage interested stakeholders on a periodic basis in helping the agency determine intervention priority areas for review by NREPP?’’ Number of respondents: 16 (15%). E:\FR\FM\14MRN1.SGM 14MRN1 13142 Federal Register / Vol. 71, No. 49 / Tuesday, March 14, 2006 / Notices Respondents recommended a number of approaches to engage stakeholders: • Conduct meetings, conferences, and seminars. • Send and solicit information via email or a Web site. • Send informational notices via newletters. • Survey stakeholders. • Work with the Addiction Technology Transfer Centers (ATTCs) to administer surveys. • Consult the National Prevention Network and the Society for Prevention Research, which ‘‘have forged a close working relationship to foster the integration of science and practice and * * * would be very helpful in answering this question.’’ Comments Addressing Question 3 Question 3. ‘‘There has been considerable discussion in the scientific literature on how to use statistical significance and various measures of effect size in assessing the effectiveness of interventions based upon both single and multiple studies (Schmidt & Hunter, 1995; Rosenthal, 1996; Mason, Schott, Chapman, & Tu, 2000; Rutledge & Loh, 2004). How should SAMHSA use statistical significance and measures of effect size in NREPP? Note that SAMHSA would appreciate receiving citations for published materials elaborating upon responders’ suggestions in this area.’’ Statistical Significance Number of respondents: 13 (12%). A group of university researchers recommended that for programs to be included in NREPP, they should be required to provide statistically significant results on drug use and/or mental health outcomes using twotailed tests of significance at p<.05. The APA Evidence-Based Practices Committee recommended further discussion and consideration by NREPP of the conceptual distinction between statistical and clinical significance. The County of Los Angeles Department of Health Services urged SAMHSA ‘‘not to place undue preference only on programs that offer statistically significant results. Studies of innovative approaches and of emerging populations may not have sample sizes large enough to support sophisticated statistical analyses, yet may offer valuable qualitative information on effective approaches.’’ wwhite on PROD1PC65 with NOTICES Effect Size Number of respondents: 24 (22%). Most of the respondents discussing effect size noted that interventions aimed at achieving population change were likely to have small effect sizes, even if they are very successful. Several VerDate Aug<31>2005 19:18 Mar 13, 2006 Jkt 208001 respondents recommended combining effect size with reach. A group of researchers from a major university noted: Effect sizes should be reported, but they should not be used as a criterion for inclusion or exclusion from NREPP. From a public health perspective, the impact of an intervention is a function of both its efficacy and its reach (Glasgow, Vogt, & Boles, 1999). An intervention with even a very modest effect size can have a substantial impact on public health if it reaches many people. Therefore, NREPP should report effect sizes for each statistically significant outcome reported and NREPP should also include and provide an assessment of the ‘‘reach’’ of that intervention. Specifically, the inclusion criteria for participation and the proportion of the recruited population that participated in the intervention study should be included in describing the likely ‘‘reach’’ of the program. Three respondents noted that professionals in the field have not reached consensus on how to use effect size. One noted, ‘‘Effect sizes may vary with the difficulty of the prevention goal and the methodological rigor of the analysis. Applying standards for ‘weak,’ ‘moderate,’ ‘strong’ or other labels fails to take into account differences in results that may be attributable to differences in goals or methods.’’ One respondent suggested considering other indicators of clinical effectiveness, such as use of the RCI (reliable change index; Jacobson & Truax, 1984). Other points made regarding effect size included the following: • Between-group effect sizes assume a standard comparison condition, which is rare in nonmedical interventions. Meta-analyses with baseline-follow-up effect sizes or a ‘‘network approach’’ to effect sizes are ways to overcome this problem. • Effect size is not the equivalent of client improvement and does not assess the significance of interventions for their clients. • Effect size alone is not sufficient to evaluate and rate programs; cost-benefit information or other practical information are also needed. Comments Addressing Question 4 Question 4. ‘‘SAMHSA’s proposal for NREPP would recognize as effective several categories of interventions, ranging from those with high-quality evidence and more replication to those with lower quality evidence and fewer replications. This would allow for the recognition of emerging as well as fully evidence-based interventions. Some view this as a desirable feature that reflects the continuous nature of evidence; provides important options for interventions recipients, providers, and funders when no or few fully evidence-based interventions are PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 available; and helps promote continued innovation in the development of evidencebased interventions. Others have argued that several distinct categories will confuse NREPP users. Please comment on SAMHSA’s proposal in this area.’’ Number of respondents: 35 (32%). Thirty-three respondents supported the use of multiple categories as outlined in Question 4; two respondents were opposed. Of those in favor of multiple categories, nine respondents wrote that this approach would reflect the process of emerging evidence and encourage knowledge sharing early in the process. The APA Evidence-Based Practice Committee argued that ‘‘Including all of these NREPP products is seen as a desirable feature that reflects the continuous nature of evidence. This may also be critical information for providing reasonable options for stakeholders when there are no or few evidence-based practices available.’’ The State Associations of Addiction Services pointed out that multiple categories would lessen the likelihood of misinterpreting information in NREPP, and the California Department of Alcohol and Drug Programs added that including multiple categories of intervention would give greater flexibility to programs using the list. Of the two respondents against multiple categories, one suggested that a clear designation of effectiveness is needed if NREPP is to be useful to the field. Additional Comments One respondent argued that only two categories should be used, effective and emergent: ‘‘While distinctions such as whether a program has had independent replications as opposed to developer replications may be of interest to researchers, the majority of those responsible for choosing and implementing programs may find this level of detail to be confusing rather than particularly helpful or relevant.’’ A group of university researchers recommended assigning scores to several categories of evidence quality: theoretical foundation, design adequacy, measure adequacy, fidelity, and analysis adequacy. Several other organizations suggesting adding a category for programs not yet shown to be evidence-based, but recommended for further study. One noted that categories of effectiveness should be the same for individual-level and population-, policy-, or system-level outcomes. One respondent proposed an approach in which SAMHSA would document the strength of evidence for E:\FR\FM\14MRN1.SGM 14MRN1 Federal Register / Vol. 71, No. 49 / Tuesday, March 14, 2006 / Notices each approach, and allow consumers to decide what is effective: Various authorities have established different and sometimes conflicting standards for when there is enough evidence to constitute an EBT. Part of the problem here is drawing a discrete line (EBT or not) on what is actually a continuous dimension. * * * To inform and demystify the dichotomous and somewhat arbitrary decision as to which treatments are evidencebased and which are not, it is useful to have a compilation of the strength of evidence for (or against) different approaches. * * * Why not just stick to your main emphasis on documenting the strength of evidence for each approach, and let others decide where they want to draw the line for what they regard to be ‘‘effective.’’ Another respondent argued that providing information on replications and having six potential categorizations for evidence-based practices could be too technical and confusing for some. Most consumers will be most interested in whether there is some body of evidence that the program they are considering works. One respondent, a private citizen, recommended that SAMHSA ask stakeholders what categories would be useful to them. Comments Addressing Question 5 Question 5. ‘‘SAMHSA recognizes the importance of considering the extent to which interventions have been tested with diverse populations and in diverse settings. Therefore, the agency anticipates incorporating this information into the Web site descriptions of interventions listed on NREPP. This may allow NREPP users to learn if interventions are applicable to their specific needs and situations, and may also help to identify areas where additional studies are needed to address the effectiveness of interventions with diverse populations and in diverse locations. SAMHSA is aware that more evidence is needed on these topics. Please comment on SAMHSA’s approach in this area. wwhite on PROD1PC65 with NOTICES Number of respondents: 27 (25%). Most respondents affirmed the importance of the issues raised in Question 5. Two respondents suggested that SAMHSA should facilitate research aimed at developing services for minority populations. Comments regarding what and how to report are noted below. What To Report Regarding what to report, respondents suggested tracking and reporting demographic changes; reporting the impact of interventions on different populations; and requiring programs that use NREPP interventions to report to SAMHSA on the impact on their client populations, as well as providers’ thoughts about the intervention’s VerDate Aug<31>2005 19:18 Mar 13, 2006 Jkt 208001 applicability to various client populations. The Oregon Office of Mental Health and Addiction Services suggested that SAMHSA ‘‘focus considerable effort on identifying and listing practices useful and applicable for diverse populations and rural areas. Providers and stakeholders from these groups have repeatedly expressed the concern they will be left behind if no practices have been identified which fit the need of their area. We need to take particular care to ensure that their fear is not realized.’’ The Committee for Children suggested reporting data for two separate dimensions: setting and population. Setting dimensions would include community data—size of community, community context (e.g., suburb, town), geographic location, community socioeconomic status—and agency data, which includes the type of agency (e.g., hospital, child care, school), characteristics (e.g., outpatient vs. inpatient, middle school vs. elementary school), size, and resources required for implementation. Population dimensions would include age, socioeconomic status, ethnicity, cultural identification, immigrant/acculturation status, race, and gender. How To Report Three respondents submitted suggestions for how to report on intervention effectiveness with diverse populations. The APA Evidence-Based Practices Committee suggested that SAMHSA develop ‘‘a comprehensive glossary that addresses definitions of different constituencies, populations, and settings.’’ The Family and Child Guidance Clinic and the Native American Health Center of Oakland both suggested that a panel of Native Americans be convened to decide which evidence-based programs and practices are effective for Native Americans, then submit a monograph describing these programs and practices. Comments Addressing Question 6 Question 6. ‘‘To promote consistent, reliable, and transparent standards to the public, SAMHSA proposes that all existing programs on NREPP meet the prevailing scientific criteria described in this proposal, and that this be accomplished through required rereviews of all programs currently on NREPP. SAMHSA has considered an alternative approach that would ‘‘grandfather’’ all existing NREPP programs under the new system, but would provide clear communication that these existing programs have not been assessed against the new NREPP scientific standards. Please comment on which approach you believe to be in the best interests of SAMHSA stakeholders.’’ PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 13143 Number of respondents: 32 (29%). Twenty-seven respondents proposed rereviewing existing programs under the revised NREPP criteria. Five respondents advocated grandfathering the programs into NREPP without review. Highlights of these viewpoints are provided below. Arguments for Rereview The Committee for Children wrote a grandfathering system ‘‘may give the impression to NREPP users, right or wrong, that ‘grandfathered’ interventions aren’t as good as those that have undergone the new review process.’’ Another respondent supported a single review process to assure programs that ‘‘all programs and practices are being rated according to a consistent set of criteria, and therefore that the adoption of an intervention by a provider can be made with confidence.’’ Two researchers (both SAMHSA Model Program affiliates) noted that grandfathering will ‘‘water down’’ the NREPP criteria, and recommended establishing a mechanism to remove programs from NREPP when the evidence warrants. A program developer called for a gradual transition from Model Program to rereview: I suggest that SAMHSA maintain the current Model Program designation and grant these programs status within the new NREPP for up to 3 years. During that time period the existing programs would be screened against the new review criteria and provided an opportunity to obtain additional research findings, if needed, in order to help achieve evidence-based status within the new NREPP. * * * Many current model programs have invested extensive time and financial resources to reference SAMHSA Model Program status is their informational, training, and curricula materials, under the auspices of their partnership agreements with the SAMHSA Model Program Dissemination Project. They did this in good faith. While the SAMHSA Model Program Project has been disbanded, it is reasonable to expect SAMHSA to honor their agreements with the model programs for a period of time during the transitional phase. During this transitional phase I recommend that the model program not be earmarked as not having been assessed against the new NREPP scientific standards, but rather that they have been found to be effective under the former NREP and are awaiting review under the new criteria.’’ Arguments for Grandfathering Those who argued for grandfathering previous Model Programs discussed the possible detrimental effects that not grandfathering would have. One respondent described taking away the E:\FR\FM\14MRN1.SGM 14MRN1 13144 Federal Register / Vol. 71, No. 49 / Tuesday, March 14, 2006 / Notices Model Program designation as ‘‘a breaking of faith that is just not acceptable. A subjective change in criteria does not justify harming programs that previously met the grade in all good faith * * * It also makes it hard for the end user to take the list seriously, especially if they have already expended considerable resources to replace a non-evidence-based program with one currently designated evidencebased.’’ Another respondent described the destabilizing effects and potential impact on credibility of programs: Imagine if the ‘‘model’’ you just selected this year at the cost of thousands of dollars (and redesigned your prevention delivery system upon) is somehow diminished or lessened in ‘‘scientific’’ credibility. Would you not begin to wonder if you could trust the next ‘‘model’’ to hold credibility? * * * There is a very real need to be careful about the criteria, and planning for a smooth and gentle segue for change * * * at the grassroots level if programs are rotating on and off of the registry system. One might well ask, how could a ‘‘model’’ program of today not worthy of some level of inclusion tomorrow? Yet another respondent pointed out that not grandfathering programs could pose financial problems for organizations offering model programs. Since some organizations may only receive funding for programs designated as ‘‘model programs,’’ they may not be able to offer the programs while awaiting rereview. Comments Addressing Question 7 Question 7. ‘‘What types of guidance, resources, and/or specific technical assistance activities are needed to promote greater adoption of NREPP interventions, and what direct and indirect methods should SAMHSA consider in advancing this goal?’’ wwhite on PROD1PC65 with NOTICES Venue, Channel, and Format for Promoting Adoption of NREPP Interventions Number of respondents: 7. Proposed strategies for promotion (venue, channel, and format) include the following: • Identify stakeholders and take the information to them (e.g., through conferences, journals, professional magazines, professional newsletters, physicians, churches, and PTAs). • Convene program developers and state administrators for regular meetings about programs and implementation. • Showcase NREPP programs at national, regional, and state conferences. • Develop fact sheets about NREPP programs (in collaboration with the program developers). VerDate Aug<31>2005 19:18 Mar 13, 2006 Jkt 208001 • Conduct training on NREPP programs through the Addiction Technology Transfer Centers (ATTCs). • Work with the Office of National Drug Control Policy’s National Media campaign. • On the NREPP Web site, offer downloadable information on programs as well as a way for consumers to contact the program developers for more information. (Note: SAMHSA’s Model Program Web site currently does provide program summaries and contact information for program developers). Technical Assistance for Promoting Adoption of NREPP Interventions Number of respondents: 30 (28%). Many respondents noted the importance of providing technical assistance to those looking to adopt NREPP-listed interventions. The Oregon Office of Mental Health and Addiction Services wrote, ‘‘The adoption of new practices by any entity is necessarily a complex and long-term process. Many providers will need technical support if adoption and implementation is to be accomplished effectively. Current resources are not adequate to meet this challenge.’’ Another respondent suggested that SAMHSA identify point people, either at the Federal level or through the CAPTs, who can ‘‘partner with developers to gain a clear understanding of their evidence-based interventions and become knowledgeable enough to accurately discuss them with community-based preventionists.’’ A group of university researchers agreed that substantial training and technical assistance are required for the effective implementation of preventive interventions. They recommended using SAMHSA’s Communities That Care, which has been shown to increase the adoption of tested and effective preventive interventions in communities, to increase adoption of NREPP interventions. The National Student Assistance Association Scientific Advisory Board recommended that SAMHSA use existing effective program and practice structures, such as Student Assistance Programs, for technical assistance, resources, and guidance. Guidance on Adopting NREPP Interventions Number of respondents: 10 (9%). Several respondents recommended that SAMHSA provide guidance to individuals and organizations looking to adopt NREPP interventions. The Center for Evidence-Based Interventions for Crime and Addiction wrote, ‘‘We do not PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 believe that just providing information about model programs on the Web will result in much diffusion of the innovation. NREPP must pay attention to training, dissemination, fidelity, and sustainability.’’ The Society for Prevention Research suggested that SAMHSA survey decisionmakers and practitioners to determine their perceptions of NREPP as well as about other factors influencing their decisions in order to determine how to encourage adoption of NREPP interventions. The APA Evidence-Based Practice Committee recommended that SAMHSA ‘‘anticipate misuses of NREPP so as to insure that funding bodies do not mistakenly assume that improving treatment comes from confining treatment to a list of recommended techniques.’’ Resources for Promoting NREPP Interventions Number of respondents: 27 (25%). Many respondents articulated ways that SAMHSA could support and promote NREPP interventions. One common suggestion was that SAMHSA should provide the funding for and/or help create the infrastructure that is required for program implementation. For example, the California-based Coalition of Alcohol and Drug Associations wrote: The existing treatment infrastructure cannot handle the expectation for data collection. It is currently unlikely that most community-based treatment programs could meet the standard to be listed on the registry. How can the infrastructure be strengthened? What funding streams is SAMHSA promoting to accomplish this? * * * The initiative promises technical assistance, but this is not substitute for missing infrastructure. The financial resources to support such efforts [have] always been absent, yet the expectations and demands continue to be placed upon underfunded community-based providers, driving some out of business and requiring others to reduce services. The Coalition of Alcohol and Drug Associations also asked how SAMHSA plans to protect providers from exploitation: ‘‘Already there are examples of large sums of money being asked for training materials on interventions developed with tax dollars. Consultants representing particular practices (especially those listed on RFAs or on SAMHSA lists) are charging fees of $3,000 per day. This is not something most nonprofits can afford.’’ Another respondent, a private citizen, suggested that SAMHSA fund Services to Science grants, ‘‘a category of funding which was originally designed by SAMHSA but [is] rarely utilized.’’ E:\FR\FM\14MRN1.SGM 14MRN1 Federal Register / Vol. 71, No. 49 / Tuesday, March 14, 2006 / Notices The State Associations of Addiction Services suggested that SAMHSA ‘‘consider new mechanisms for funding the development of the organizational capacity needed by providers to implement and sustain evidence-based practices. Such mechanisms might require new legislative authority and/or new funding.’’ Comments Addressing Question 8 Question 8. ‘‘SAMHSA is committed to consumer, family, and other nonscientist involvement in the NREPP process. The panels convened by SAMHSA and described earlier in this notice suggested that these stakeholders be included specifically to address issues of intervention utility and practicality. Please comment on how consumer, family, and other nonscientist stakeholders could be involved in NREPP.’’ wwhite on PROD1PC65 with NOTICES Development of NREPP Process Number of responses: 22 (20%). A number of respondents discussed the need to involve nonscientist stakeholder (primarily providers) in developing the NREPP process. Seven respondents said consumers should be involved in NREPP development. The Pennsylvania Department of Health pointed out that ‘‘the use of such approaches depends heavily on local, state, and national networks of community-based providers who need to be in a position to be an active participant in discussions related to the evaluation of interventions, practices, and programs.’’ The Oregon Office of Mental Health and Addiction Services argued that ‘‘Practices that are not readily acceptable by consumers and families may have limited usefulness, regardless of the evidence of technical adequacy. Consumers and families should be involved in advising SAMHSA at every level of design, development and implementation of NREPP. SAMHSA may wish to establish a specific consumer and family advisory group to provide advice on NREPP issues.’’ Community Anti-Drug Coalitions of America suggested that nonscientists should review publications and recommendations to ensure they are clear to nonresearchers. Role in NREPP Reviews Number of respondents: 21 (19%) Suggestions for NREPP reviews included the following: • Involve consumers and practitioners in reviewing programs. • Have practitioners assess the degree to which a program is implementable. • Have consumer groups rate programs’ utility. • Have clinicians review materials for clarity. VerDate Aug<31>2005 19:18 Mar 13, 2006 Jkt 208001 Comments Addressing Question 9 Question 9. ‘‘SAMHSA has identified NREPP as one source of evidence-based interventions for selection by potential agency grantees in meeting the requirements related to some of SAMHSA’s discretionary grants. What guidance, if any, should SAMHSA provide related to NREPP as a source of evidence-based interventions for use under the agency’s substance abuse and mental health block grants?’’ Technical Assistance Number of respondents: 11 (10%). A number of respondents suggested that SAMHSA provide training to users on the NREPP review process, as well as guidance on the appropriate use of NREPP and how to avoid misuse. For example, Student Assistance Programs (SAPs) and CAPTs could be used as technical assistance resources. One respondent wrote, ‘‘SAMHSA needs to make it clear that the NREPP ratings are established as recommendations for the field, rather than as demands upon agencies and programs—that it discourages thinking of NREPPapproved programs or practices as a finite list and encourages efforts that further refine and extend these programs and practices to new populations and settings.’’ Another respondent noted that government agencies responsible for block grant allocation may need protection fro mandates about using NREPP interventions that may not be affordable or appropriate for their client populations. Regulation A number of respondents provided recommendations related to regulation and funding priority tied to NREPP. Twelve respondents said block grant funds should not be restricted based on NREPP status. The Society for Prevention Research and several other organizations recommended giving priority to NREPP programs, while reserving some funds specifically for innovation. One respondent suggested that block grant funding should give priority to NREPP interventions. The Maryland Alcohol and Drug Abuse Administration argued that state authority should supersede Federal authority in block grant allocation. Another respondent recommended giving funding priority to systems that implement practices known to be effective, except where evidence-based practices have not yet been identified: ‘‘Although it is clear that funding cannot entirely be limited to existing evidence-based programs because of the chilling effect on innovation that such a stance would have, nevertheless, it PO 00000 Frm 00080 Fmt 4703 Sfmt 4703 13145 might be appropriate to require that a certain percentage of block grant dollars be committed to the dissemination and use of block grant monies, or to establish additional incentives for the adoption of such programs.’’ One respondent warned of the potential danger of unfunded mandates: ‘‘The worst case scenario is that best of practices could cost the most money but by law or regulation become an unfunded mandate for a governmentfunded or not-for-profit program.’’ The APA Practice Association noted that as NREPP is voluntary, ‘‘applicants should not be penalized for studying programs or interventions that are not on the NREPP.’’ Two organizations, the State Associations of Addiction Services and California Alcohol and Drug Programs, considered the revised NREPP approach to be too new to use as a block grant requirement. Comments Addressing Question 10 Question 10. ‘‘SAMHSA believes that NREPP should serve as an important, but not exclusive source, of evidence-based interventions to prevent and/or treat mental and substance use disorders. What steps should SAMHSA take to promote consideration of other sources (e.g., clinical expertise, consumer or recipient values) in stakeholders’ decisions regarding the selection, delivery and financing of mental health and substance abuse prevention and treatment services?’’ Number of respondents: 25 (23%). The following suggestions were noted: • Develop a directory of other sources of evidence-based practices. Some suggested providing links to these sources on the NREPP Web site. • Use an external advisory committee to identify other sources of evidencebased practices. • Include a disclaimer page that includes an introduction consistent with the issues raised in Question 10. Advertising or other promotional material created around NREPP could also include this information. • List other sources of evaluation research such as the Collaborative for Academic, Social, and Emotional Learning, the U.S. Department of Education, the Office of Juvenile Justice and Delinquency Prevention, and the National Institute of Mental Health. The National Association of State Alcohol/Drug Abuse directors wrote that its Exemplary Awards Program should ‘‘serve as an ‘incubator’ for programs that may wish to consider submitting into the NREPP process.’’ Comments Addressing Question 11 Question 11. ‘‘SAMHSA anticipates that once NREPP is in operation, various E:\FR\FM\14MRN1.SGM 14MRN1 13146 Federal Register / Vol. 71, No. 49 / Tuesday, March 14, 2006 / Notices stakeholders will make suggestions for improving the system. To consider this input in a respectful, deliberate, and orderly manner, SAMHSA anticipates annually reviewing these suggestions. These reviews would be conducted by a group of scientist and nonscientist stakeholders knowledgeable about evidence in behavioral health and the social sciences. Please comment on SAMHSA’s proposal in this area.’’ Number of respondents: 35 (32%). Many of the 35 responses stated that annual review of suggestions from stakeholders is important. Four respondents noted that feedback should be reviewed more frequently than once per year. Other themes included the following: • Use the annual review process as a mechanism for fostering innovation. • Use marketing strategies to encourage participation in the annual review process. • Solicit annual feedback from NREPP applicants whose programs have been labeled effective, as well as those whose programs have not been labeled effective. • Compare NREPP results to those in other similar systems. • Include a mechanism in NREPP for programs to be dropped from, or improve their status on, the registry (possible through the annual review). • Periodically conduct a metaanalysis of evaluation results (possible through the annual review). • To ensure the stability of NREPP, the criteria should be maintained without changes for a set period of time (e.g., 5 years). Comments Beyond the 11 Posted Questions Twenty-two respondents (20%) submitted comments on issues that were relevant but not specifically within the parameters of the 11 posted questions. These are summarized below. Programs Versus Practices wwhite on PROD1PC65 with NOTICES Fourteen respondents (13%) objected to using the terms ‘‘programs’’ and ‘‘practices’’ as if they were interchangeable. One private citizen who submitted comments wrote: It is important to distinguish between the value of rating practices and the value of rating programs. although it makes sense for reviewers to rate the quality/strength of evidence regarding a treatment practice, it is a much different proposition to rate the effectiveness of a program. The effectiveness of a treatment program is a function, among other things, of the treatment practices it employs, the ancillary services (e.g., employment counseling) it provides, the qualities and behaviors of its treatment providers * * * One could imagine a very ineffective program using evidence-based VerDate Aug<31>2005 19:18 Mar 13, 2006 Jkt 208001 practices (e.g., one having disengaged or poorly trained counselors), and a very effective program that used other than evidence-based practices (e.g., one with committed, empathic counselors using practices that had not yet been subjected to research. Furthermore, given the multiple elements that contribute to a program’s overall effectiveness, its effectiveness could change rapidly (e.g., when a charismatic program leader leaves, when there is significant counselor turnover, when funding source/amount changes, etc.). Thus, it makes much less sense to rate the effectiveness of individual programs than it does to rate the strength of evidence supporting specific treatment practices. Terminology The APA Evidence-Based Practices Committee suggested using a site glossary to define diagnostic terminology and client populations and communities. Standard Outcomes One respondent recommended including a standard set of outcomes to be evaluated. Effect of Including Mental Health Interventions One national organization expressed a concern that included mental health interventions will detract from the focus on substance abuse: The proposed expansion of NREPP to include substance abuse treatment and mental health will dramatically dilute the focus of substance abuse prevention. The resources NREPP require will necessarily be diluted across a broader range of issues and inevitably detract from a focused mission of supporting efforts to prevent substance abuse. Reporting the Date of Reviews One respondent recommended that SAMHSA document and report the date on which a review was conducted. This will allow users to know how much time has passed since the review and prompt them to search for more recent evidence if needed. Rationale for Revising NREPP One respondent questioned if SAMHSA had sufficiently evaluated the existing system before deciding to revise it. Subpart A.—Federal Register Notice Comment Codebook Comment ID Number: Coded by: Date coded: Coded by: (each item is coded by two individual coders) Date coded: Entered by: Date entered: PO 00000 Frm 00081 Fmt 4703 Sfmt 4703 1. Respondent Category 1.1 Commenter Name 1.1.1 First 1.1.2 MI 1.1.3 Last 1.2 Location 1.2.1 City 1.2.2 State 1.2.3 ZIP code 1.2.4 Unknown 1.3 Domain Interest 1.3.1 SAP 1.3.2 SAT 1.3.3 MHP 1.3.5 Unknown 1.4 Affiliation 1.4.1 Private 1.4.2 Organization 1.4.2.1 National 1.4.2.2 State 1.4.2.3 Local 1.4.2.4 Unknown 1.5 Functional Role 1.5.1 Provider 1.5.2 Researcher 1.5.3 Consumer 1.5.4 Multiple 1.5.5 Unknown 1.6 Response Level 1.6.1 Nonresponsive 1.6.2 Routine 1.6.3 Noteworthy (responder or comment content) 2. Topical Themes 2.1 Will the proposed NREPP system identify effective interventions 2.1.1 General, not criteria specific 2.1.2 Individual-level outcome criteria 2.1.3 Population/policy/system-level outcome criteria 2.1.4 Utility descriptors 2.1.5 Exclusion due to lack of funding 2.1.6 Negative impact on minority populations 2.1.7 Negative impact on program innovation 2.1.8 Lack of acknowledgment of provider factors 2.1.9 Use of other agencies’ standards and resources 2.1.10 Reliance on developers for submitting applications 2.1.11 Generalizability issues 2.2 How can stakeholders be engaged to identify priority review areas 2.2.1 Identification (of priority areas) 2.2.2 Engagement (of stakeholders) 2.3 How should statistical significance and effect size be used to judge effectiveness 2.3.1 Statistical significance 2.3.2 Effect size 2.3.3 General, NEC 2.4 Should NREPP use multiple categories of effectiveness 2.4.1 General, not outcome specific 2.4.1 Pro 2.4.2 Con 2.4.2 Individual-level outcome rating categories 2.4.2.1 Pro 2.4.2.2 Con 2.4.3 Population/policy/system-level outcome rating categories 2.4.3.1 Pro 2.4.3.2 Con E:\FR\FM\14MRN1.SGM 14MRN1 13147 Federal Register / Vol. 71, No. 49 / Tuesday, March 14, 2006 / Notices 2.5 How can NREPP best provide information on population-specific needs and situations 2.5.1 General comment 2.5.2 Venue (e.g., organized events/ meetings, national or regional organizations) 2.5.3 Channel (distribution mechanisms, e.g., listservs, clearinghouses, etc.) 2.5.4 Format (media type, document type, e.g., fact sheets, white papers, policy publications, etc.) 2.6 Should current NREPP programs be ‘‘grandfathered’’ or rereviewed 2.6.1 Grandfathered 2.6.2 Rereviewed 2.6.3 General, NEC 2.7 How should SAMHSA promote greater adoption of NREPP interventions 2.7.1 General comment 2.7.2 Venue 2.7.3 Channel 2.7.4 Format 2.7.5 Technical assistance 2.7.6 Guidance 2.7.7 Resources 2.8 How should nonscientist stakeholders be involved in the NREPP process 2.8.1 General comment 2.8.2 Venue, channel, format 2.8.3 Potential stakeholders 2.8.4 Involvement in the development of the NREPP process 2.8.5 Involvement in program reviews 2.9 What relationship should exist between NREPP and SAMHSA block grants 2.9.1 Technical assistance provision 2.9.2 Funding support 2.9.3 Regulatory (required to use) 2.10 What additional sources of information should be considered regarding SAMHSA services 2.10.1 Steps SAMHSA should take 2.10.2 Source 2.11 How should an annual review of NREPP procedures and practices be conducted 2.12 Other issues 2.12.1 Program vs. practice Subpart B.—Comments on SAMHSA’s Federal Register Notice: Frequencies and Percentages TABLE 1.—CHARACTERISTICS OF RESPONDENTS [N=135] n Percent Domain interest (not mutually exclusive) Substance abuse prevention ................................................................................................................................................... Substance abuse treatment ..................................................................................................................................................... Mental health promotion .......................................................................................................................................................... Mental health treatment ........................................................................................................................................................... Unknown .................................................................................................................................................................................. 68 48 22 20 33 50.4 35.6 16.3 14.8 24.4 90 16 10 14 5 66.7 11.9 7.4 10.4 3.7 53 36 4 21 21 39.3 26.7 3.0 15.6 15.6 51 58 26 37.8 43.0 19.3 10 125 7.4 92.6 Affiliation Private ...................................................................................................................................................................................... National organization ............................................................................................................................................................... State organization .................................................................................................................................................................... Local organization .................................................................................................................................................................... Unknown organization ............................................................................................................................................................. Functional role Provider .................................................................................................................................................................................... Researcher .............................................................................................................................................................................. Consumer ................................................................................................................................................................................ Multiple roles ............................................................................................................................................................................ Unknown .................................................................................................................................................................................. Respondent clout Noteworthy ............................................................................................................................................................................... Responsive .............................................................................................................................................................................. Unanalyzable ........................................................................................................................................................................... Current program status Affiliated with a current program ............................................................................................................................................. No known affiliation with a current program ............................................................................................................................ TABLE 2.—COMMENTS REGARDING THE PROPOSED NREPP SYSTEM ACCOMPLISHING ITS GOALS [Question 1] National org. n wwhite on PROD1PC65 with NOTICES State org. %1 n Local org. % n Unknown org. % n % Private n % ‘‘Noteworthy’’ respondents General, not criteria specific 2 ................ Individual-level outcome criteria ......... VerDate Aug<31>2005 19:18 Mar 13, 2006 11 78.6 4 50.0 2 100 2 66.7 16 84.2 1 7.1 1 12.5 0 0.0 1 33.3 14 73.7 Jkt 208001 PO 00000 Frm 00082 Fmt 4703 Sfmt 4703 E:\FR\FM\14MRN1.SGM 14MRN1 13148 Federal Register / Vol. 71, No. 49 / Tuesday, March 14, 2006 / Notices TABLE 2.—COMMENTS REGARDING THE PROPOSED NREPP SYSTEM ACCOMPLISHING ITS GOALS—Continued [Question 1] National org. %1 n Population-, policy-, or system-level outcome criteria .... Utility descriptors ...... Funding .................... Minority populatons .. Program innovation .. Provider factors ........ Use of other agencies’ standards and resources .............. Developers submitting applications .... Generalizability ......... State org. n Local org. % n Unknown org. % n Private % n % 2 4 7 1 4 4 14.3 28.6 50.0 7.1 28.6 28.6 4 1 3 0 4 4 50.0 12.5 37.5 0.0 50.0 50.0 1 0 1 1 2 1 50.0 0.0 50.0 50.0 100 50.0 1 0 0 0 0 1 33.3 0.0 0.0 0.0 0.0 33.3 14 3 3 2 2 4 73.7 15.8 15.8 10.5 10.5 21.1 4 28.6 2 25.0 0 0.0 0 0.0 12 63.2 1 7 7.1 50.0 0 5 0.0 62.5 0 2 0.0 100 0 0 0.0 0.0 2 5 10.5 26.3 ‘‘Responsive’’ respondents General, not criteria specific 2 ................ Individual-level outcome criteria ......... Population-, policy-, or system-level outcome criteria .... Utility descriptors ...... Funding .................... Minority populations Program innovation .. Provider factors ........ Use of other agencies’ standards and resource ................ Developers submitting applicaitons .... Generalizability ......... 1 All 0 0.0 0 0.0 4 40.0 2 100 18 43.9 0 0.0 0 0.0 1 10.0 0 0.0 6 14.6 0 0 0 0 0 0 0.0 0.0 0.0 0.0 0.0 0.0 0 0 0 0 0 0 0.0 0.0 0.0 0.0 0.0 0.0 2 0 5 2 3 4 20.0 0.0 50.0 20.0 30.0 40.0 0 0 0 0 0 0 0.0 0.0 0.0 0.0 0.0 0.0 5 7 9 7 6 4 12.2 17.1 22.0 17.1 14.6 9.8 0 0.0 0 0.0 3 30.0 0 0.0 6 14.6 0 0 0.0 0.0 0 0 0.0 0.0 0 7 0.0 70.0 0 1 0.0 50.0 1 21 2.4 51.2 percentages are calculated based on those providing comments. categories are not mutually exclusive. 2 These TABLE 3.—COMMENTS REGARDING HOW SAMHSA MIGHT ENGAGE INTERESTED STAKEHOLDERS TO DETERMINE INTERVENTION PRIORITY AREAS FOR REVIEW [Question 2] National org. State org. %1 n n Local org. % n Unknown org. % n Private % n % ‘‘Noteworthy’’ respondents Identification of priority areas 2 ........... Engagement of stakeholders ......... 3 42.9 0 0.0 0 0.0 0 0.0 2 100 5 71.4 1 100 1 100 0 0.0 1 50.0 wwhite on PROD1PC65 with NOTICES ‘‘Responsive’’ respondents Identification of priority areas 2 ........... Engagement of stakeholders ......... 1 All 0 0.0 0 0.0 1 50.0 0 0.0 1 33.3 0 0.0 0 0.0 2 100 0 0.0 3 100 percentages are calculated based on those providing comments. categories are not mutually exclusive. 2 These VerDate Aug<31>2005 19:18 Mar 13, 2006 Jkt 208001 PO 00000 Frm 00083 Fmt 4703 Sfmt 4703 E:\FR\FM\14MRN1.SGM 14MRN1 13149 Federal Register / Vol. 71, No. 49 / Tuesday, March 14, 2006 / Notices TABLE 4.—COMMENTS REGARDING STATISTICAL SIGNIFICANCE AND EFFECT SIZE [Question 3] National org. State org. %1 n n Local org. % n Unknown org. % n Private % n % ‘‘Noteworthy’’ respondents Statistical significance 2 .................. Effect size ................. General ..................... 1 2 2 25.0 50.0 50.0 0 3 0 0.0 100 0.0 1 1 0 50.0 50.0 0.0 0 1 0 0.0 100 0.0 11 13 2 84.6 100 15.4 0.0 100 0.0 0 0 0 0.0 0.0 0.0 0 6 1 0.0 85.7 14.3 ‘‘Responsive’’ respondents Statistical significance 2 .................. Effect size ................. General ..................... 1 All 0 0 0 0.0 0.0 0.0 0 0 0 0.0 0.0 0.0 0 3 0 percentages are calculated based on those providing comments. categories are not mutually exclusive. 2 These TABLE 4.—COMMENTS REGARDING STATISTICAL SIGNIFICANCE AND EFFECT SIZE [Question 3] National org. State org. %1 n n Local org. % n Unknown org. % n Private % n % ‘‘Noteworthy’’ respondents General, not outcome specific:. General comment 2 ............ Pro ..................... Con .................... Individual-level outcome rating categories: General comment ............... Pro ..................... Con .................... Population-, policy-, or system-level outcome rating categories: General comment ............... Pro ..................... Con .................... 2 10 0 20.0 100 0.0 0 3 0 0.0 100 0.0 0 1 0 0.0 100 0.0 0 0 0 0.0 0.0 0.0 3 12 1 20.0 80.0 6.7 0 1 0 0.0 10.0 0.0 0 0 0 0.0 0.0 0.0 0 0 0 0.0 0.0 0.0 0 0 0 0.0 0.0 0.0 0 0 0 0.0 0.0 0.0 0 0 0 0.0 0.0 0.0 0 1 0 0.0 33.3 0.0 0 0 0 0.0 0.0 0.0 0 0 0 0.0 0.0 0.0 0 0 0 0.0 0.0 0.0 wwhite on PROD1PC65 with NOTICES ‘‘Responsive’’ respondents General, not outcome specific:. General comment 2 ............ Pro ..................... Con .................... Individual-level outcome rating categories: General comment ............... Pro ..................... Con .................... Population-, policy-, or system-level outcome rating categories: General comment ............... VerDate Aug<31>2005 19:18 Mar 13, 2006 0 0 0 0.0 0.0 0.0 0 0 0 0.0 0.0 0.0 1 1 1 50.0 50.0 50.0 0 1 0 0.0 100 0.0 3 6 0 37.5 75.0 0.0 0 0 0 0.0 0.0 0.0 0 0 0 0.0 0.0 0.0 0 0 0 0.0 0.0 0.0 0 0 0 0.0 0.0 0.0 0 0 0 0.0 0.0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 Jkt 208001 PO 00000 Frm 00084 Fmt 4703 Sfmt 4703 E:\FR\FM\14MRN1.SGM 14MRN1 13150 Federal Register / Vol. 71, No. 49 / Tuesday, March 14, 2006 / Notices TABLE 4.—COMMENTS REGARDING STATISTICAL SIGNIFICANCE AND EFFECT SIZE—Continued [Question 3] National org. %1 n Pro ..................... Con .................... 1 All State org. 0 0 n 0.0 0.0 Local org. % 0 0 n 0.0 0.0 Unknown org. % 0 0 n 0.0 0.0 Private % 0 0 n 0.0 0.0 % 0 0 0.0 0.0 percentages are calculated based on those providing comments. categories are not mutually exclusive. 2 These TABLE 6.—COMMENTS REGARDING SAMHSA’S APPROACH FOR INCORPORATING INFORMATION ON THE EXTENT TO WHICH INTERVENTIONS HAVE BEEN TESTED WITH DIVERSE POPULATIONS AND IN DIVERSE SETTINGS [Question 5] National org. State org. %1 n n Local org. % n Unknown org. % n Private % n % ‘‘Noteworthy’’ respondents General comment 2 .. Venue ....................... Channel .................... Format ...................... 6 0 0 1 100 0.0 0.0 16.7 2 0 0 0 100 0.0 0.0 0.0 1 0 0 0 100 0.0 0.0 0.0 0 0 0 0 0.0 0.0 0.0 0.0 12 0 0 0 100 0.0 0.0 0.0 100 0.0 0.0 0.0 0 0 0 0 0.0 0.0 0.0 0.0 4 0 0 1 80.0 0.0 0.0 20.0 ‘‘Responsive’’ respondents ‘‘Responsive’’ respondents. General comment 2 .. Venue ....................... Channel .................... Format ...................... 1 All 0 0 0 0 0.0 0.0 0.0 0.0 0 0 0 0 0.0 0.0 0.0 0.0 1 0 0 0 percentages are calculated based on those providing comments. categories are not mutually exclusive. 2 These TABLE 7.—COMMENTS REGARDING WHETHER ALL EXISTING PROGRAMS ON NREPP SHOULD BE REREVIEWED OR ‘‘GRANDFATHERED’’ [Question 6] Noteworthy Responsive Percent of those providing comments n Percent of those providing comments n Comments from individuals affiliated with an existing NREPP program (8 individuals [3 Noteworthy, 5 Responsive] provided comments on this question) Rereview* ......................................................................................................................................... Grandfather ...................................................................................................................................... General comment ............................................................................................................................ 2 1 1 66.7 33.3 33.3 1 3 2 20.0 60.0 40.0 5 1 2 62.5 12.5 25.0 Comments from individuals not known to be affiliated with an existing NREPP program (29 individuals [21 Noteworthy, 8 Responsive] provided comments on this question) wwhite on PROD1PC65 with NOTICES Rereview .......................................................................................................................................... Grandfather ...................................................................................................................................... General comment ............................................................................................................................ 19 0 2 90.5 0.0 9.5 *Note: These categories are not mutually exclusive. There were instances of individuals who both commented specifically on whether to rereview or grandfather a program and also provided a general comment with regard to this question. VerDate Aug<31>2005 19:18 Mar 13, 2006 Jkt 208001 PO 00000 Frm 00085 Fmt 4703 Sfmt 4703 E:\FR\FM\14MRN1.SGM 14MRN1 13151 Federal Register / Vol. 71, No. 49 / Tuesday, March 14, 2006 / Notices TABLE 8.—COMMENTS REGARDING GUIDANCE, RESOURCES, AND/OR TECHNICAL ASSISTANCE TO PROMOTE GREATER ADOPTION OF NREPP INTERVENTIONS [Question 7] National org. State org. %1 n n Local org. % n Unknown org. % n Private % n % ‘‘Noteworthy’’ respondents General comment 2 .. Venue ....................... Channel .................... Format ...................... Technical assistance Guidance .................. Resources ................ 3 0 2 1 5 4 6 30.0 0.0 20.0 10.0 50.0 40.0 60.0 2 0 0 0 5 0 5 25.0 0.0 0.0 0.0 62.5 0.0 62.5 0 0 0 0 1 0 0 0.0 0.0 0.0 0.0 100 0.0 0.0 0 0 0 0 0 0 1 0.0 0.0 0.0 0.0 0.0 0.0 100 2 0 1 0 11 1 3 11.8 0.0 5.9 0.0 64.7 5.9 17.6 0.0 0.0 20.0 0.0 40.0 20.0 60.0 0 0 0 0 0 0 0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 3 2 3 1 6 4 9 16.7 11.1 16.7 5.6 33.3 22.2 50.0 ‘‘Responsive’’ respondents General comment 2 .. Venue ....................... Channel .................... Format ...................... Technical assistance Guidance .................. Resources ................ 1 All 0 0 0 0 0 0 0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0 0 0 0 0 0 0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0 0 1 0 2 1 3 percentages are calculated based on those providing comments. categories are not mutually exclusive. 2 These TABLE 9.—COMMENTS REGARDING HOW CONSUMER, FAMILY, AND OTHER NONSCIENTIST STAKEHOLDERS COULD BE INVOLVED IN NREPP [Question 8] National org. State org. %1 n n Local org. % n Unknown org. % n Private % n % ‘‘Noteworthy’’ respondents General comment 2 .. Venue, channel, format ........................ Potential stakeholders .................. Involvement in the development of the NREPP process .... Involvement in program reviews ........ 0 0.0 0 0.0 1 50.0 0 0.0 1 50.0 2 20.0 0 0.0 0 0.0 0 0.0 1 50.0 7 70.0 5 71.4 0 0.0 0 0.0 0 0.0 5 50.0 4 57.1 1 50.0 0 0.0 0 0.0 6 60.0 5 71.4 1 50.0 0 0.0 0 0.0 ‘‘Responsive’’ respondents General comment 2 .. Venue, channel, format ........................ Potential stakeholders .................. Involvement in the development of the NREPP process .... Involvement in program reviews ........ wwhite on PROD1PC65 with NOTICES 1 All 0 0.0 0 0.0 1 16.7 0 0.0 1 5.6 0 0.0 0 0.0 1 16.7 0 0.0 4 22.2 0 0.0 0 0.0 4 66.7 1 100 14 77.8 0 0.0 0 0.0 4 66.7 0 0.0 8 44.4 0 0.0 0 0.0 2 33.3 1 100 6 33.3 percentages are calculated based on those providing comments. categories are not mutually exclusive. 2 These VerDate Aug<31>2005 19:18 Mar 13, 2006 Jkt 208001 PO 00000 Frm 00086 Fmt 4703 Sfmt 4703 E:\FR\FM\14MRN1.SGM 14MRN1 13152 Federal Register / Vol. 71, No. 49 / Tuesday, March 14, 2006 / Notices TABLE 10.—COMMENTS REGARDING GUIDANCE SAMHSA SHOULD PROVIDE FOR USE UNDER THE AGENCY’S SUBSTANCE ABUSE AND MENTAL HEALTH BLOCK GRANTS [Question 9] National org. State org. %1 n n Local org. % n Unknown org. % n Private % n % ‘‘Noteworthy’’ respondents Technical assistance 2 .................... Funding support ....... Regulatory ................ 1 4 6 11.1 44.4 66.7 2 3 1 50.0 75.0 25.0 0 1 0 0.0 100 0.0 0 1 0 0.0 100 0.0 1 9 2 8.3 75.0 16.7 50.0 100 50.0 0 0 0 0.0 0.0 0.0 2 9 2 18.2 81.8 18.2 ‘‘Responsive’’ respondents Technical assistance 2 .................... Funding support ....... Regulatory ................ 1 All 0 0 0 0.0 0.0 0.0 0 0 0 0.0 0.0 0.0 1 2 1 percentages are calculated based on those providing comments. categories are not mutually exclusive. 2 These TABLE 11.—COMMENTS REGARDING STEPS SAMHSA SHOULD TAKE TO PROMOTE CONSIDERATION OF OTHER SOURCES OF EVIDENCE-BASED INTERVENTIONS [Questions 10] National org. State org. %1 n n Local org. % n Unknown org. % n Private % n % ‘‘Noteworthy’’ respondents Steps SAMHSA should take 2 ......... Source ...................... 4 1 80.0 20.0 1 0 100 0.0 0 1 0.0 100 0 1 0.0 100 12 0 100 0.0 100 0.0 0 0 0.0 0.0 2 2 66.7 66.7 ‘‘Responsive’’ respondents Steps SAMHSA should take 2 ......... Source ...................... 1 All 0 0 0.0 0.0 0 0 0.0 0.0 2 0 percentages are calculated based on those providing comments. categories are not mutually exclusive. 2 These TABLE 12.—COMMENTS REGARDING ANNUAL REVIEWS OF SUGGESTIONS FOR IMPROVING THE SYSTEM [Question 11] National org. n State org. % n Local org. % n Unknown org. % n Private % n % ‘‘Noteworthy’’ respondents General comment ..... 8 100 3 100 1 100 0 0.0 14 100 100 0 0.0 7 100 ‘‘Responsive’’ respondents General comment ..... 1 All 0 0.0 0 0.0 2 percentages are calculated based on those providing comments. TABLE 13.—ADDITIONAL COMMENTS NOT CLASSIFIED ELSEWHERE National org. n wwhite on PROD1PC65 with NOTICES State org. %1 n Local org. % n Unknown org. % n Private % n % ‘‘Noteworthy’’ respondents Other issues 2 ........... Defining terms .......... VerDate Aug<31>2005 19:18 Mar 13, 2006 4 5 Jkt 208001 66.7 83.3 PO 00000 1 3 Frm 00087 25.0 75.0 Fmt 4703 1 1 Sfmt 4703 50.0 50.0 E:\FR\FM\14MRN1.SGM 0 0 14MRN1 0.0 0.0 1 1 100 100 13153 Federal Register / Vol. 71, No. 49 / Tuesday, March 14, 2006 / Notices TABLE 13.—ADDITIONAL COMMENTS NOT CLASSIFIED ELSEWHERE—Continued National org. State org. %1 n n Local org. % n Unknown org. % n Private % n % ‘‘Responsive’’ respondents issues 2 Other ........... Defining terms .......... 1 All 0 0 0.0 0.0 0 0 0.0 0.0 1 2 50.0 100 0 0 0.0 0.0 5 2 71.4 28.6 percentages are calculated based on those providing comments. categories are not mutually exclusive. 2 These Subpart C.—Comments on Specific Evidence Rating Criteria Some of the respondents to SAMHSA’s August 2005 Federal Register notice submitted comments about specific evidence rating criteria. A summary and highlights of key comments about these criteria are presented below. Intervention Fidelity Two respondents commented on this criterion. One noted that it is difficult to monitor or confirm how treatment is delivered and how staff are trained in programs with complex approaches, such as community reinforcement or family training. Comparison Fidelity Eleven respondents commented on this criterion. Ten of the respondents, a group of researchers from a major university, wrote: The comparison fidelity evidence quality criterion assumes the implementation and fidelity monitoring of a ‘‘comparison condition.’’ In universal and selective prevention trials, this is not standard protocol. Rather, individuals or communities selected for comparison/control conditions receive standard prevention services available in the community. In such studies, it does not make sense to measure the ‘‘fidelity’’ of the comparison condition. However, as currently scored, this criterion will penalize prevention studies. I recommend the criterion and rating system be changed to reflect this difference between prevention and treatment research. wwhite on PROD1PC65 with NOTICES Nature of Comparison Condition Fourteen respondents provided comments on this criterion. One respondent, a director of research and evaluation for a prevention program noted: 19:18 Mar 13, 2006 Jkt 208001 Another service provider noted that studies that include the target intervention, comparison intervention, and attention control ‘‘would require funding at extremely high levels to have enough N in each group for statistical analysis. To conduct such a study in today’s economic climate is probably impractical.’’ A private citizen who submitted comments wrote: This is a critical criterion and should be weighted more heavily than many, if not all, of the other criteria. With the proposed system, if one were trying to ‘‘game the system,’’ it would be advantageous to choose a comparison intervention that was ineffective (and thus receive a low score on this criterion), so as to increase the likelihood of a significant treatment effect. Nevertheless, the practice being evaluated could have ‘‘strong evidence’’ by scoring highly on other criteria. A group of university researchers said that it is unclear how prevention practices being compared to existing prevention services would be scored using this criterion. Assurances to Participants One respondent questioned ‘‘whether such studies [without documented assurances to participants] should ever clear the bar for NREPP consideration. If investigators do not observe appropriate procedures to safeguard study participants’ interests, it is at least questionable whether their products should receive any degree of attention and support from SAMHSA.’’ Participant Expectations Many program participants are drawn from undeserved or marginalized populations, e.g. incarcerated youth, the mentally ill, linguistically isolated subgroups, or those suffering from Human Immunodeficiency Virus (HIV). For these populations, there may be no option to withhold active treatment only to the intervention group, due to legal requirements, health and safety considerations, or other ethical constraints. VerDate Aug<31>2005 The American Evaluation Association (AEA) duly notes this consideration in its 2003 commentary on scientifically based evaluation methods. Three respondents commented on this criterion. Two respondents listed potential problems with controlling expectations in school settings. For example, for an intervention to be implemented effectively by teachers, the teachers would have to be trained and therefore would be aware of the intervention they implement. PO 00000 Frm 00088 Fmt 4703 Sfmt 4703 Two respondents pointed out that expectations might be an active component of the intervention. One wrote that ‘‘trying to control [expectations] might reduce generalization of the eventual findings. In addition, given current ethical guidelines and human subjects policies, it is hard to see how one could ‘mask’ study conditions in many studies. In obtaining consent, one has to tell participants about the conditions to which they might be assigned and it is likely that participants will know to which condition they have been assigned.’’ Data Collector Bias Three respondents commented on this criterion. One noted, ‘‘Changes to this criterion should recognize the critical need to ensure the fidelity of psychosocial treatment interventions. Fidelity, in these cases, can only be ensured through staff awareness of the actions required of them. Masking conditions actually inhibits psychosocial treatment fidelity.’’ Selection Bias Three respondents commented on this criterion. One suggested that approaches other than random assignment, such as blocking variables of interest, should qualify for the highest score on this item. Another pointed out that random assignment to psychosocial interventions might not be possible due to ethical problems with nondisclosure. He suggested rewording the item to clarify that random assignment does not refer only to ‘‘blinding’’ participants to their treatment condition. Attrition Two respondents commented on this criterion. One pointed out that the criterion is unclear, and that ‘‘attrition needing adjustment’’ is not defined, nor is the difference between ‘‘crude’’ and ‘‘sophisticated’’ methods of adjusting for attrition. This respondent also pointed out that ‘‘sophisticated’’ does not necessarily mean better than ‘‘crude’’ (this comment also applied to the Missing Data criterion). E:\FR\FM\14MRN1.SGM 14MRN1 13154 Federal Register / Vol. 71, No. 49 / Tuesday, March 14, 2006 / Notices Theory-Driven Method Selection Eleven respondents commented on this criterion. A group of university researchers wrote: This is an important criterion. However, this criterion should recognize that a number of preventive interventions seek to address and reduce risk factors or enhance protective factors that research has shown are common shared predictors of a range of drug use, mental health, and other outcomes. It is important to explicitly recognize this fact in formulating and describing this criterion * * * Not all reviewers, especially those from treatment backgrounds, will be familiar with the concept of addressing shared predictors of broader outcomes in preventive trials in order to affect wide-ranging outcomes. This criterion needs to educate reviewers about this in the same way that the criterion currently warns against ‘‘dredging’’ for current significant results. Subpart D.—Criterion-Specific Themes for Population-, Policy-, and SystemLevel Outcomes Logic-Driven Selection of Measures A group of researchers from a major university suggested that this item and the parallel item for individual-level outcomes, Theory-Driven Measure Selection, should have the same label. Intervention Fidelity The seven respondents who commented on this criterion observed that interventions must be adapted for individual communities to be effective. The criterion as written does not account for this. wwhite on PROD1PC65 with NOTICES Nature of Comparison Condition One respondent stated that there is not consensus among evaluation researchers on this topic, and until there is, ‘‘we should reserve judgment on how best to define the nature of comparison conditions within community level interventions.’’ She also pointed out, ‘‘Since the collective behaviors of members in each community will vary * * * how can they possibly be compared to each other in a valid and reliable way.’’ Data Collector Bias A group of university researchers pointed out that the item assumes archival data are unbiased, while they may be biased by institutional practices. They suggested that the highest rating ‘‘be reserved for studies in which data collectors were masked to the population’s condition.’’ Another respondent, a national organization, wrote: The very nature of coalition work requires coalition members to be involved in its evaluation and research efforts. It is VerDate Aug<31>2005 19:18 Mar 13, 2006 Jkt 208001 culturally detrimental and unethical to work with coalitions in such a way that they are not involved in the evaluation process. Expecting the data collectors to be blind to the efforts of the community means that the researchers are outside the community and would have no understanding of the context in which the coalition works. Many evaluators and researchers view this as the absolute wrong way to work with coalitions. Criterion Seven [Data Collector Bias] runs counter to participatory research which is the standard in working with coalitions. Population Studied Eleven respondents commented on this criterion. One respondent stated that quasi-experimental time-series designs might be as internally valid as randomized control designs, and felt this should be reflected in the criterion. A group of university researchers advocated excluding single-group pre-/ posttest design studies from NREPP. They wrote, ‘‘A group randomized design with adequate numbers of groups in each condition holds the greatest potential for ruling out threats to internal validity in community-level studies. This criterion should be expanded to provide a rating of four for group randomized studies with adequate Ns.’’ Subpart E.—Comment for Children’s Suggestions for Utility Descriptors 1. Implementation Support Regarding the ease of acquiring materials is there centralized ordering for all materials? What implementation support materials are included in initial program cost, and are they adequate? Are basic program updates and replacement parts all easily available? Regarding start-up support, research suggests that there are several features that are important to the effectiveness and sustainability of programs. These include an active steering committee, administrator support, engagement of family members, and wholeschool implementation (for school-based programs). Do the basic program materials provided supply adequate guidance for effectively gaining these sources of support? On the other hand, some clients are not in the position to achieve all of these goals. Is it possible to effectively implement the program without them? Are needs assessment tools offered? This is important for determining whether implementation should take place at all. What is the nature of the start-up implementation support? What is the nature of the ongoing implementation support? Is client support differentiated for new and experienced clients? Do client support personnel have adequate PO 00000 Frm 00089 Fmt 4703 Sfmt 4703 training to answer sophisticated questions from the most highly experienced program implementers? Is there implementation support through a variety of media? What support is there for transfer of learning? For example, practice beyond specific lessons, opportunities for population served to demonstrate, and be reinforced for skills beyond specific lessons, support for staff awareness of skills, how to recognize skills, how to reinforce skills, examples typical in the daily setting, materials for engaging family members of the population served, materials for engaging staff outside the implementers of the program (e.g., residential housekeeping staff, school playground monitors), support for engaging community members outside the implementation setting, what training is required, what training is available beyond that which is required? 2. Quality Monitoring Are the tools supplied for quality monitoring user-friendly and inexpensive? How well are they adapted specifically to the program? What are their psychometric characteristics? 3. Unintended or Adverse Events No further comments. 4. Population Coverage Are the materials appropriate to the population to be served in regard to, for example: length of lessons, vocabulary, concepts and behavioral expectations, teaching strategies. 5. Cultural Relevance and Cultural Competence To what extent was cultural relevance addressed during the development of the program? Is there a theoretical basis to the program that addresses cultural relevance? Were stakeholders from a variety of relevant backgrounds engaged in the development process? How early in the development process were they involved? In what ways were they involved? Were professionals with multicultural expertise involved in the development process? How early in the development process were they involved? In what ways were they involved? 6. Staffing Since FTEs are often difficult to estimate and estimates many therefore be unreliable, the required time should be estimated for the following: Required training time, on-site start-up activities, implementer preparation time per week, lesson length × number of lessons per implementer, time required for other activities. E:\FR\FM\14MRN1.SGM 14MRN1 13155 Federal Register / Vol. 71, No. 49 / Tuesday, March 14, 2006 / Notices 7. Cost No further comments on this descriptor except to reiterate that cost considerations play into several of the other descriptors. ACTION: 8. Motivational Issues Affecting Implementation We suggest that consideration be given to examining what further motivational issues may impact whether the programs are implemented and sustained with fidelity. These include: appeal of materials and activities for the population to be served, appeal of materials and activities for the staff who will implement the programs, support of the program for the preexisting goals and programs of the site (e.g., schoolbased programs that support academics), how well the program otherwise integrates with existing goals, programs, and activities of the site (e.g., teachers are expected to direct student discussions, but not therapy), support offered for adapting the program to specific local populations, fit of materials to the typical structures of the setting (e.g., short enough lessons to fit within a class period, necessary equipment is usually available in the setting). [FR Doc. 06–2313 Filed 3–13–06; 8:45 am] BILLING CODE 4160–01–M DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR–5037–N–12] Notice of Submission of Proposed Information Collection to OMB; Deedin-Lieu of Foreclosure (Corporate Mortgagors or Mortgagors Owning More than One Property) Office of the Chief Information Officer, HUD. AGENCY: Notice. SUMMARY: The proposed information collection requirement described below has been submitted to the Office of Management and Budget (OMB) for review, as required by the Paperwork Reduction Act. The Department is soliciting public comments on the subject proposal. Mortgagee’s must obtain written consent from HUD’s National Servicing Center to accept a deed-in-lieu of foreclosure when the mortgagor is a corporate mortgagor or a mortgagor owning more than one property insured by the Department of Housing and Urban Development (HUD). Mortgagees must provide HUD with specific information, DATES: Comments Due Date: April 13, 2006. ADDRESSES: Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB approval Number (2502–0301) and should be sent to: HUD Desk Officer, Office of Management and Budget, New Executive Office Building, Washington, DC 20503; fax: 202–395–6974. FOR FURTHER INFORMATION CONTACT: Lillian Deitzer, Reports Management Officer, AYO, Department of Housing and Urban Development, 451 Seventh Street, SW., Washington, DC 20410; email Lillian Deitzer at Lillian_L_Deitzer@HUD.gov or telephone (202) 708–2374. This is not a toll-free number. Copies of available documents submitted to OMB may be obtained from Ms. Deitzer. SUPPLEMENTARY INFORMATION: This notice informs the public that the Department of Housing and Urban Development has submitted to OMB a request for approval of the information collection described below. This notice is soliciting comments from members of the public and affecting agencies concerning the proposed collection of information to: (1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) Evaluate the accuracy of the agency’s estimate of the burden of the proposed collection of information; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. This notice also lists the following information: Title of Proposal: Deed-in-Lieu of Foreclosure (Corporate Mortgagors or Mortgagors Owning More than One Property). OMB Approval Number: 2502–0301. Form Numbers: None. Description of the Need for the Information and Its Proposed Use: Mortgagee’s must obtain written consent from HUD’s National Servicing Center to accept a deed-in-lieu of foreclosure when the mortgagor is a corporate mortgagor or a mortgagor owning more than one property insured by the Department of Housing and Urban Development (HUD). Mortgagees must provide HUD with specific information. Frequency of Submission: On occasion. Number of respondents Annual responses 600 0.041 Reporting Burden: ............................................................................. DEPARTMENT OF THE INTERIOR Authority: Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. 35, as amended. wwhite on PROD1PC65 with NOTICES Total Estimated Burden Hours: 12.5. Status: Extension of a currently approved collection. Draft Conservation Agreement for the Yellow-Billed Loon (Gavia adamsii) Dated: March 9, 2006. Lillian L. Deitzer, Departmental Paperwork Reduction Act Officer, Office of the Chief Information Officer. [FR Doc. E6–3616 Filed 3–13–06; 8:45 am] BILLING CODE 4210–67–P VerDate Aug<31>2005 19:18 Mar 13, 2006 Jkt 208001 Fish and Wildlife Service U.S. Fish and Wildlife Service, Interior. ACTION: Notice of document availability for review and comment. AGENCY: SUMMARY: We, the U.S. Fish and Wildlife Service, announce the PO 00000 Frm 00090 Fmt 4703 Sfmt 4703 × Hours per response 0.5 = Burden hours 12.5 availability of the Draft Conservation Agreement for the Yellow-billed Loon (Gavia adamsii) for public review and comment. DATES: Comments on the draft conservation agreement must be received on or before April 13, 2006. ADDRESSES: Copies of the conservation agreement are available for inspection, by appointment, during normal business hours at the following location: U.S. Fish and Wildlife Service, Fairbanks Fish and Wildlife Field Office, 101 12th E:\FR\FM\14MRN1.SGM 14MRN1

Agencies

[Federal Register Volume 71, Number 49 (Tuesday, March 14, 2006)]
[Notices]
[Pages 13132-13155]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-2313]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Service Administration


Changes to the National Registry of Evidence-Based Programs and 
Practices (NREPP)

AGENCY: Substance Abuse and Mental Health Services Administration, HHS.

ACTION:  Notice.

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SUMMARY: The Substance Abuse and Mental Health Services Administration 
(SAMHSA) is committed to preventing the onset and reducing the 
progression of mental illness, substance abuse, and substance-related 
problems among all individuals, including youth. As part of this 
effort, SAMHSA has expanded and refined the agency's National Registry 
of Evidence-based Programs and Practices (NREPP) based on a systematic 
analysis and consideration of public comments received in response to a 
previous Federal Register notice (70 FR 50381, Aug. 26, 2005).
    This Federal Register notice summarizes SAMHSA's redesign of NREPP 
as a decision support tool for promoting a greater adoption of 
evidence-based interventions within typical community-based settings, 
and provides an opportunity for interested parties to become familiar 
with the new system.

FOR FURTHER INFORMATION CONTACT: Kevin D. Hennessy, Ph.D., Science to 
Service Coordinator/SAMHSA, 1 Choke Cherry Road, Room 8-1017, 
Rockville, MD 20857, (240) 276-2234.

Charles G. Curie,
Administrator, SAMHSA.

Advancing Evidence-Based Practice Through Improved Decision Support 
Tools: Reconceptualizing NREPP

Introduction

    The Substance Abuse and Mental Health Services Administration 
(SAMHSA) strives to provide communities with effective, high-quality, 
and cost-efficient prevention and treatment services for mental and 
substance use disorders. To meet this goal, SAMHSA recognizes the needs 
of a wide range of decisionmakers at the local, state, and national 
levels to have readily available and timely information about 
scientifically established interventions to prevent and/or treat these 
disorders.
    SAMHSA, through its Science to Service Initiative, actively seeks 
to promote Federal collaboration (e.g., with the National Institutes of 
Health [NIH]) in translating research into practice. The ideal outcome 
of this Initiative is that individuals at risk for or directly 
experiencing mental and substance abuse use disorders will be more 
likely to receive appropriate preventive or treatment services, and 
that these services will be the most effective and the highest quality 
that the field has to offer.
    This report provides a summary of activities conducted during the 
past year to critically evaluate SAMHSA's recent activities and future 
plans for the National Registry of Evidence-based Programs and 
Practices (NREPP). It outlines the major themes that emerged from a 
formal public comment process and links this feedback to new review 
procedures and Web-based decision support tools that will enhance 
access to evidence-based knowledge for multiple audiences.
    The report is presented in four sections:
     Section I briefly states the background of NREPP and 
SAMHSA's recent request for public comments.
     Section II discusses the analysis of comments that was 
conducted and presents the key recommendations for NREPP based on this 
analysis.
     Section III describes the new approach that SAMHSA is 
advancing for NREPP.
     Section IV presents the specific dimensions of the NREPP 
system in its new framework as a decision support tool.

[[Page 13133]]

     Section V describes future activities at SAMHSA to support 
NREPP.

I. Background: The National Registry of Evidence-Based Programs and 
Practices

    The National Registry of Evidence-based Programs and Practices was 
designed to represent a key component of the Science to Service 
Initiative. It was intended to serve as a voluntary rating and 
classification system to identify programs and practices with a strong 
scientific evidence base. An important reason for developing NREPP was 
to reduce the significant time lag between the generation of scientific 
knowledge and its application within communities.\1\ Quality treatment 
and prevention services depend on service providers' ability to access 
evidence-based scientific knowledge, standardized protocols, practice 
guidelines, and other practical resources.
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    \1\ As cited by the Institute of Medicine (2001), studies have 
suggested it takes an average of 17 years for research evidence to 
diffuse to clinical practice. Source: Balas, E.A., & Boren, S.A. 
(2000). Managing clinical knowledge for health care improvement. In: 
J. Bemmel & A.T. McCray (Eds.), Yearbook of medical informatics 
2000: Patient-centered systems. Stuttgart, Germany: Schattauer.
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    The precursor of NREPP, the National Registry of Effective 
Prevention Programs, was developed by SAMHSA's Center for Substance 
Abuse Prevention (CSAP) as a way to help professionals in the field 
become better consumers of substance abuse prevention programs. Through 
CSAP's Model Program Initiative, over 1,100 programs were reviewed, and 
more than 150 were designated as Model, Effective, or Promising 
Programs.
    Over the past 2 years, SAMHSA convened a number of scientific 
panels to explore the expansion of the NREPP review system to include 
interventions in all domains of mental health and substance abuse 
prevention and treatment. In addition, SAMHSA committed itself to three 
guiding principles--transparency, timeliness, and accuracy of 
information--in the development of an evidence-based registry of 
programs and practices.
    During this process it was determined that, to provide the most 
transparent and accurate information to the public, evidence should be 
assessed at the level of outcomes targeted by an intervention, not at 
the more global level of interventions or programs. Based on this 
decision, SAMHSA's current NREPP contractor conducted a series of pilot 
studies to explore the validity and feasibility of applying an outcome-
specific, 16-criteria evidence rating system to an expanded array of 
programs and practices. Through extensive dialogues with the prevention 
community, SAMHSA also explored ways to provide evidence-based reviews 
of population- and community-level interventions within NREPP.
    In an effort to augment the information gained through these 
activities, SAMHSA solicited formal public comments through a notice 
posted in the Federal Register on August 26, 2005. The notice asked for 
responses to the agency's plans for NREPP, including (1) revisions to 
the scientific review process and review criteria; (2) the conveying of 
practical implementation information about NREPP programs and practices 
to those who might purchase, provide, or receive these interventions; 
and (3) the types of additional agency activities that may be needed to 
promote wider adoption of interventions on NREPP, as well as support 
innovative interventions seeking NREPP status. A brief summary of the 
public comments and key public recommendations is presented in Section 
II. The complete analysis of the public responses is included in the 
Appendix to this report.

II. Public Responses to the Federal Register Notice

    Senior staff at SAMHSA engaged in a comprehensive review of 
comments received in response to the Federal Register notice. 
Particular attention was directed to comments from prominent state and 
Federal stakeholders, including providers and policymakers, who stand 
to be the most affected by whatever system is ultimately implemented. 
Efforts were taken to balance SAMHSA's responsiveness to public 
feedback with the need to adhere to rigorous standards of scientific 
accuracy and to develop a system that will be fair and equitable to 
multiple stakeholder groups.

Recommendations for NREPP

    In the more than 100 comments received as part of the public 
comment process, a number of recurring themes and recommendations were 
identified. While all specific and general recommendations for 
modification of the NREPP review process were carefully considered by 
SAMHSA, the following are those that were considered most essential to 
the development of an accurate, efficient, and equitable system that 
can meet the needs of multiple stakeholders:
     Limit the system to interventions that have demonstrated 
behavioral change outcomes. it is inherently appealing to the funders, 
providers, and consumers of prevention and treatment services to know 
that an intervention has a measurable effect on the actual behavior of 
participants. As researchers at the University of Washington 
recommended, ``the system should be reserved for policies, programs, 
and system-level changes that have produced changes in actual drug use 
or mental health outcomes.''
     Rereview all existing programs. There was near consensus 
among the respondents to the notice that existing programs with Model, 
Effective, and Promising designations from the old reviews should be 
rereviewed under the new system. The Committee for Children pointed out 
that ``a `grandfather' system may give the impression to users, right 
or wrong, that these interventions aren't as good as those that have 
undergone the new review process.'' One individual suggested that 
programs and practices needed to be rated ``according to a consistent 
set of criteria'' so that ``the adoption of an intervention by a 
provider can be made with confidence.''
     Train and utilize panels of reviewers with specific 
expertise related to the intervention(s) under review. Respondents to 
the notice noted that it would be important for the NREPP review 
process to utilize external reviewers with relevant scientific and 
practical expertise related to the intervention being assessed. In 
addition, the pool of available reviewers should broadly include 
community-level and individual-level prevention as well as treatment 
perspectives. In order to promote transparency of the review process, 
the reviewer training protocols should be available for review by the 
public (e.g., posted on the NREPP Web site).
     Provide more comprehensive and balanced descriptions of 
evidence-based practices, by emphasizing the important dimension of 
readiness for dissemination. The American Psychological Association 
(APA) Committee on Evidence-Based Practice recommended greater emphasis 
on the utility descriptors (i.e., those items describing materials and 
resources to support implementation), stating, ``these are key outcomes 
for implementation and they are not adequately addressed in the 
description of NREPP provided to date. This underscores earlier 
concerns noted about the transition from efficacy to effectiveness.'' 
The APA committee noted that generalizability of programs listed on 
NREPP will remain an issue until this ``gap between efficacy and 
effectiveness'' is explicitly addressed under a revised review system.
     Avoid limiting flexibility and innovation; implement a 
system that is

[[Page 13134]]

fair and inclusive of programs and practices with limited funding, and 
establish policies that seek to prevent the misuse of information 
contained on NREPP. The National Association for Children of Alcoholics 
voiced this concern: ``It has been intrinsically unfair that only 
grants [referring to NIH-funded efforts] have been able to establish 
`evidence' while many programs appear very effective--often more 
effective in some circumstances than NREPP approved programs, but have 
not had the Federal support or other major grant support to evaluate 
them. The SAMHSA grant programs continue to reinforce the designation 
of NREPP programs in order to qualify for funding, and the states tend 
to strengthen this `stipulation' to local programs,who then drop good 
(non-NREPP) work they have been doing or purchase and manipulate NREPP 
programs that make the grant possible. This is not always in the best 
interest of the client population to be served.''
     Recognize multiple ``streams of evidence'' (e.g., 
researcher, practitioner, and consumer) and the need to provide 
information to a variety of stakeholders in a decision support context. 
A number of comments suggested that NREPP should be more inclusive of 
the practitioner and consumer perspective on what defines evidence. For 
example, one commenter noted: ``The narrowed interpretation of 
evidence-based practice by SAMHSA focuses almost solely on the research 
evidence to the exclusion of clinical expertise and patient values.'' 
Several comments noted that NREPP should be consistent with the 
Institute of Medicine's definition of evidence-based practice, which 
reflects multiple ``streams of evidence'' that include research, 
clinical, and patient perspectives.
     Provide a summary rating system that reflects the 
continuous nature of evidence quality. There was substantial 
disagreement among those responding to the notice concerning whether 
NREPP should include multiple categories of evidence quality. While a 
number of individuals and organizations argued for the use of 
categorical evidence ratings, there were many who suggested that NREPP 
should provide an average, numeric scale rating on specific evidence 
dimensions to better reflect the ``continuous nature of evidence.'' 
This approach would allow the user of the system to determine what 
level of evidence strength is required for their particular application 
of an intervention.
     Recognize the importance of cultural diversity and provide 
complete descriptive information on the populations for which 
interventions have been developed and applied. Most comments reflected 
the knowledge that cultural factors can play an important role in 
determining the effectiveness of interventions. The Oregon Office of 
Mental Health and Addiction Services noted, ``SAMHSA should focus 
considerable effort on identifying and listing practices useful and 
applicable for diverse populations and rural areas. Providers and 
stakeholders from these groups have repeatedly expressed the concern 
they will be left behind if no practices have been identified which fit 
the need of their area. We need to take particular care to ensure that 
their fear is not realized.''
     In addition to estimating the effect size of intervention 
outcomes, NREPP should include additional descriptive information about 
the practical impacts of programs and practices. In general, comments 
suggested that that effect size should not be used as an exclusionary 
criterion in NREPP. It was widely noted that effect size estimates for 
certain types of interventions (e.g., community-level or population-
based) will tend to be of smaller magnitude, and that ``professionals 
in the field have not reached consensus on how to use effect size.'' 
Researchers at the University of Washington suggested the inclusion of 
information about the reach of an intervention, when available, as 
complementary information to effect sizes. Several comments also 
suggested that effect size is often confused with the clinical 
significance of an intervention and its impact on participants.
     Acknowledge the need to develop additional mechanisms of 
Federal support for technical assistance and the development of a 
scientific evidence base within local prevention and treatment 
communities. Nearly one third of the comments directly addressed the 
need for SAMHSA to identify and/or provide additional technical 
assistance resources to communities to help them adapt and implement 
evidence-based practices. The Oregon Office of Mental Health and 
Addiction Services wrote, ``The adoption of new practices by any entity 
is necessarily a complex and long-term process. Many providers will 
need technical support if adoption and implementation is to be 
accomplished effectively. Current resources are not adequate to meet 
this challenge.''
    In order to align NREPP with the important recommendations 
solicited through the public comment process, SAMHSA also recognized 
the importance of the following goals:
     Provide a user-friendly, searchable array of descriptive 
summary information as well as reviewer ratings of evidence quality.
     Provide an efficient and cost-effective system for the 
assessment and review of prospective programs and practices.
    Section III, Streamlined Review Procedures, provides a complete 
description of the modified and streamlined review process that SAMHSA 
will adopt in conducting evidence-based evaluations of mental health 
and substance abuse interventions.

III. Streamlined Review Procedures

    The number and range of NREPP reviews are likely to expand 
significantly under the new review system, requiring that SAMHSA 
develop an efficient and cost-effective review process. The streamlined 
review procedures, protocols, and training materials will be made 
available on the NREPP Web site for access by all interested 
individuals and organizations.
    Reviews of interventions will be facilitated by doctoral-level 
Review Coordinators employed by the NREPP contractor. Each Review 
Coordinator will support two external reviewers who will assign 
numeric, criterion-based ratings on the dimensions of Strength of 
Evidence and Readiness for Dissemination. Review Coordinators will 
provide four important support and facilitative functions within the 
peer review process: (1) They will assess incoming applications for the 
thoroughness of documentation related to the intervention, including 
documentation of significant outcomes, and will convey summaries of 
this information to SAMHSA Center Directors for their use in 
prioritizing interventions for review; (2) they will serve as the 
primary liaison with the applicant to expedite the review of 
interventions; (3) they will collaborate with the NREPP applicant to 
draft the descriptive dimensions for the intervention summaries; and 
(4) they will provide summary materials and guidance to external 
reviewers to facilitate initial review and consensus discussions of 
intervention ratings.

Interventions Qualifying for Review

    While NREPP will retain its open submission policy, the new review 
system emphasizes the important role of SAMHSA's Center Directors and 
their staff (in consultation with key stakeholders) in setting 
intervention review priorities that will identify the particular 
content areas, types of

[[Page 13135]]

intervention approaches, populations, or even types of research designs 
that will qualify for review under NREPP. Under the streamlined review 
procedures, the sole requirement for potential inclusion in the NREPP 
review process is for an intervention to have demonstrated one or more 
significant behavioral change outcomes. Center-specific review 
priorities will be established and communicated to the field by posting 
them to the NREPP Web site at the beginning of each fiscal year.\2\
---------------------------------------------------------------------------

    \2\ Except for FY06 when priorities will be established and 
posted when the new system Web site is launched (i.e., within the 
third FY quarter).
---------------------------------------------------------------------------

Review of Existing NREPP Programs and Practices

    It will be the prerogative of SAMHSA Center Directors to establish 
priorities for the review and interventions already on, and pending 
entry on, NREPP. As indicated above, these decisions may be linked to 
particular approaches, populations, or strategic objectives as 
identified by SAMHSA as priority areas. Until reviews of existing NREPP 
programs and practices are completed and posted to the new NREPP Web 
site, the current listing on the SAMHSA Model Programs Web site will 
remain intact.

Notifications to Program/Practice Developers

    Upon the completion of NREPP reviews program/practice developers 
(or principal investigators of a research-based intervention) will be 
notified in writing within 2 weeks of the review results. A complete 
summary, highlighting information from each of the descriptive and 
rating dimensions, will be provided for review. Program/practice 
developers who disagree with the descriptive information or ratings 
contained in any of the dimensions will have an opportunity to discuss 
their concerns with the NREPP contractor during the 2-week period 
following receipt of the review outcome notification. These concerns 
must be expressed in writing to the contractor within this 2-week 
period. If no comments are received, the review is deemed completed, 
and the results may be posted to the NREPP Web site. If points of 
disagreement cannot be resolved by the end of this 2-week period, then 
written appeals for a rereview of the intervention may be considered on 
a case-by-case basis.

NREPP Technical Expert Panel

    SAMHSA will organize one or more expert panels to perform periodic 
(e.g., annual assessments of the evidence review system and recommend 
enhancements to to the review procedures and/or standards for evidence-
based science and practice. Panel membership will represent a balance 
of perspectives and expertise. The panels will be comprised of 
researchers with knowledge of evidence-based practices and initiatives, 
policymakers, program planners and funders, practitioners, and 
consumers.
    The modified NREPP system embodies a commitment by SAMHSA and its 
Science to Service Initiative to broaden the appeal and utility of the 
system to multiple audiences. While maintaining the focus on the 
documented outcomes achieved through a program or practice, NREPP also 
is being developed as a user-friendly decision support tool to present 
information along multiple dimensions of evidence. Under the new 
system, interventions will not receive single, overall ratings as was 
the case with the previous NREPP (e.g., Model, Effective, or 
Promising). Instead, an array of information from multiple evidence 
dimensions will be provided to allow different user audiences to both 
identify (through Web-searchable means) and prioritize the factors that 
are important to them in assessing the relative strengths of different 
evidence-based approaches to prevention or treatment services.
    Section IV presents in more detail the specific dimensions of 
descriptive information and ratings that NREPP will offer under this 
new framework.

IV. NREPP Decision Support Tool Dimensions

    The NREPP system will support evidence-based decisionmaking by 
providing a wide array of information across multiple dimensions. Many 
of these are brief descriptive dimensions that will allow users to 
identify and search for key intervention attributes of interest. 
Descriptive dimensions would frequently include a brief, searchable 
keyword or attribute (e.g., ``randomized control trial'' under the 
Evaluation Design dimension) in addition to narrative text describing 
that dimension. Two dimensions, Strength of Evidence and Readiness for 
Dissemination, will consist of quantitative, criterion-based ratings by 
reviewers. These quantitative ratings will be accompanied by reviewer 
narratives summarizing the strengths and weaknesses or the intervention 
along each dimension.

Considerations for Using NREPP as a Decision Support Tool

    It is essential for end-users to understand that the descriptive 
information and ratings provided by NREPP are only useful within a much 
broader context that incorporates a wide range of perspectives--
including clinical, consumer, administrative, fiscal, organizational, 
and policy--into decisions regarding the identification, selection, and 
successful implementation of evidence-based services. In fact, an 
emerging body of literature on implementation science \3\ suggests that 
a failure to carefully attend to this broader array of data and 
perspectives may well lead to disappointing or unsuccessful efforts to 
adopt evidence-based interventions. Because each NREPP user is likely 
to be seeking somewhat different information, and for varied purposes, 
it is unlikely that any single intervention included on NREPP will 
fulfill all of the specific requirements and unique circumstances of a 
given end-user. Appreciation of this basic premise of NREPP as a 
decision support tool to be utilized in a broader context will thus 
enable system users to make their own determinations regarding how best 
to assess and apply the information provided.
---------------------------------------------------------------------------

    \3\ Fixsen, D.L., Naoom, S.F., Blase, K.A., Friedman, R.M., & 
Wallace, F. (2005). Implementation research: A synthesis of the 
literature. Tampa, Florida: University of South Florida, Louis de la 
Parte Florida mental Health Institute, The National Implementation 
Network (FMHI Publication 231).
    Rogers (1995). Diffusion of innovaations (5th Ed.) New York: The 
Free Press.
---------------------------------------------------------------------------

    The NREPP decision support dimensions include:
     Descriptive Dimensions
     Strength of Evidence Dimension Ratings
     Readiness for Dissemination Dimension Ratings
    A complete description of these dimensions is provided in the 
sections below.

Descriptive Dimensions

     Intervention Name and Summary: Provides a brief summary of 
the intervention, including title, description of conceptual or 
theoretical foundations, and overall goals. Hyperlinks to graphic logic 
model(s), when available, could be accessed from this part of the 
summary.
     Contract Information: Lists key contact information. 
Typically will include intervention developer's title(s), affiliation, 
mailing address, telephone and fax numbers, e-mail address, and Web 
site address.
     Outcome(s): A searchable listing of the behavioral 
outcomes that the intervention has targeted.
     Effects and Impact: Provides a description and 
quantification of the effects observed for each outcome.

[[Page 13136]]

Includes information on the statistical significance of outcomes, the 
magnitude of changes reported including effect size and measures of 
clinical significance (if available), and the typical duration of 
behavioral changes produced by the intervention.
     Relevant Populations and Settings: Identifies the 
populations and sample demographics that characterize existing 
evaluations. The settings in which different populations have been 
evaluated will be characterized along a dimension that ranges from 
highly controlled and selective (i.e., efficacy studies), to less 
controlled and more representative (i.e., effectiveness studies), to 
adoption in the most diverse and realistic public health and clinical 
settings (i.e., dissemination studies).\4\
---------------------------------------------------------------------------

    \4\ For more description of these types of studies and their 
role in supporting evidence-based services, see the report: Bridging 
science and service: A report by the National Advisory mental Health 
Council's Clinical Treatment and Services Research Workgroup (http:/
/www.nimh.nih.gov/publicat/nimhbridge.pdf).
---------------------------------------------------------------------------

     Costs: Provides a breakdown of intervention cost(s) per 
recipient/participant or annual as appropriate (including capital 
costs, other direct costs [travel, etc.]). Start-up costs including 
staff training and development. A standardized template would be 
provided to applicants for estimating and summarizing the 
implementation and maintenance costs of an intervention.
     Adverse Effects: Reported with regard to type and number, 
amounts of change reported, type of data collection, analyses used, 
intervention and comparison group, and subgroups.
     Evaluation Design: Contains both a searchable index of 
specific experimental and quasi-experimental designs (e.g., pre-/
posttest nonequivalent groups designs, regression-discontinuity 
designs, interrupted time series designs, etc.) \5\ as well as a 
narrative description of the design (including intervention and 
comparison group descriptions) used to document intervention outcomes.
---------------------------------------------------------------------------

    \5\ Campbell, D.T., & Stanley, J.C. (1966). Experimental and 
quasi-experimental designs for research. Chicago: Rand McNally.
---------------------------------------------------------------------------

     Replication(s): Coded as ``None,'' or will state the 
number of replications to date (only those that have been evaluated for 
outcomes). Replications will be additionally characterized as having 
been conducted in efficacy, effectiveness, or dissemination contexts.
     Proprietary or Public Domain Intervention: Typically will 
be one or the other, but proprietary components or instruments used as 
part of an intervention will be identified.
     Cultural Appropriateness: Coded as ``Not Available'' (N/A) 
if either no data or no implementation/training materials for 
particular culturally identified groups are available. When culture-
specific data and/or implementation materials exist for one or more 
groups, the following two Yes/No questions will be provided for each 
group:
     Was the intervention developed with participation by 
members of the culturally identified group?
     Are intervention and training materials translated or 
adapted to members of the culturally identified group?
     Implementation History: Provides information relevant to 
the sustainability of interventions. Provides descriptive information 
on (1) the number of sites that have implemented the intervention; (2) 
how many of those have been evaluated for outcomes; (3) the longest 
continuous length of implementation (in years); (4) the average or 
modal length of implementation; and (5) the approximate number of 
individuals who have received or participated in the intervention.

Strength of Evidence Dimension Ratings

    Quantitative, reviewer-based ratings on this dimension will be 
provided within specific categories of research/evaluation design. In 
this manner, users can search and select within those categories of 
research designs that are most relevant to their particular standards 
of evidence-based knowledge. The categories of research design that are 
accepted within the NREPP system are described below.

Research Design

    Quality of evidence for an intervention depends on the strength of 
adequately implemented research design controls, including comparison 
conditions for quasi-experimental and randomized experimental designs 
(individual studies). Aggregation (e.g., meta-analysis and systematic 
research reviews) and/or replication across well-designed series of 
quasi-experimental and randomized control studies provide the strongest 
evidence. The evidence pyramid presented below represents a typical 
hierarchy for classifying the strength of causal inferences that can be 
obtained by implementing various research designs with rigor.\6\ 
Designs at the lowest level of evidence pyramid (i.e., observational, 
pilot, or case studies), while acceptable as evidence in some knowledge 
development contexts, would not be included in the NREPP system.
---------------------------------------------------------------------------

    \6\ Biglan, A., Mrazek, P., Carnine, D.W., & Flay, B. R. (2003). 
The integration of research and practice in the prevention of youth 
problem behaviors. American Psychologist, 58, 433-440.
    Chambless, D. L., & Hollon, S. (1998). Defining empirically 
supported therapies. Journal of Consulting and Clinical Psychology, 
66, 7-18.
    Gray, J. A. (1997), Evidence-based healthcare: How to make 
health policy and management decisions. New York: Churchill 
Livingstone.

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[[Page 13137]]

[GRAPHIC] [TIFF OMITTED] TN14MR06.000

1. Reliability \7\
---------------------------------------------------------------------------

    \7\ Each criterion would be rated on an ordinal scale ranging 
from 0 to 4. The endpoints and midpoints of the scale would be 
anchored to a narrative description of that rating. The remaining 
integer points of the scale (i.e., 1 and 3) would not be explicitly 
anchored, but could be used by reviewers to assign intermediate 
ratings at their discretion.
---------------------------------------------------------------------------

    Outcome measures should have acceptable reliability to be 
interpretable. ``Acceptable'' here means reliability at a level that is 
conventionally accepted by experts in the field.\8\
---------------------------------------------------------------------------

    \8\ Marshall, M., Lockwood, A., Bradley, C., Adams, C., Joy, C., 
& Fenton, M. (2000). Unpublished rating scales: A major source of 
bias in randomised controlled trials of treatments for 
schizophrenia. British Journal of Psychiatry, 176, 249-252.
---------------------------------------------------------------------------

0 = Absence of evidence of reliability or evidence that some relevant 
types of reliability (e.g., test-retest, interrater, interitem) did not 
reach acceptable levels.
2 = All relevant types of reliability have been documented to be at 
acceptable levels in studies by the applicant.
4 = All relevant types of reliability have been documented to be at 
acceptable levels in studies by independent investigators.
2. Validity
    Outcome measures should have acceptable validity to be 
interpretable. ``Acceptable'' here means validity at a level that is 
conventionally accepted by experts in the field.

0 = Absence of evidence measure validity, or some evidence that the 
measure is not valid.
2 = Measure has face validity; absence of evidence that measure is not 
valid.
4 = Measure has one or more acceptable forms of criterion-related 
validity (correlation with appropriate, validated measures or objective 
criteria); OR, for objective measures of response, there are procedural 
checks to confirm data validity; absence of evidence that measure is 
not valid.
 3. Intervention Fidelity
    The ``experimental'' intervention implemented in a study should 
have fidelity to the intervention proposed by the applicant. 
Instruments that have tested acceptable psychometric properties (e.g., 
interrater reliability, validity as shown by positive association with 
outcomes) provide the highest level of evidence.

0 = Absence of evidence or only narrative evidence that the applicant 
or provider believes the intervention was implemented with acceptable 
fidelity.
2 = There is evidence of acceptable fidelity in the form of judgment(s) 
by experts, systematic collection of data (e.g. dosage, time spent in 
training, adherence to guidelines or a manual), or a fidelity measure 
with unspecified or unknown psychometric properties.
4 = There is evidence of acceptable fidelity from a tested fidelity 
instrument shown to have reliability and validity.
4. Missing Data and Attrition
    Study results can be biased by participant attrition and other 
forms of missing data. Statistical methods as supported by theory and 
research can be employed to control for missing data and attrition that 
would bias results, but studies with no attrition needing adjustment 
provide the strongest evidence that results are not biased.

0 = Missing data and attrition were taken into account inadequately, OR 
there was too much to control for bias.
2 = Missing data and attrition were taken into account by simple 
estimates of data and observations, or by demonstrations of similarity 
between remaining participants and those lost to attrition.
4 = Attrition was taken into account by more sophisticated methods that

[[Page 13138]]

model missing data, observations, or participants; OR there was no 
attrition needing adjustment.
5. Potential Confounding Variables
    Often variables other than the intervention may account for the 
reported outcomes. The degree to which confounds are accounted for 
affects the strength of casual inference.

0 = Confounding variables or factors were as likely to account for the 
outcome(s) reported as were hypothesized causes.
2 = One or more potential confounding variables or factors were not 
completely addressed, but the intervention appears more likely than 
these confounding factors to account for the outcome(s) reported.
4 = All known potential confounding variables appear to have been 
completely addressed in order to allow causal inference between 
intervention and outcome(s) reported.
6. Appropriateness of Analyses
    Appropriate analysis is necessary to make an inference that an 
intervention caused reported outcomes.

0 = Analyses were not appropriate for inferring relationships between 
intervention and outcome, OR the sample size was inadequate.
2 = Some analyses may not have been appropriate for inferring 
relationships between intervention and outcome, OR the sample size may 
have been inadequate.
4 = Analyses were appropriate for inferring relationships between 
intervention and outcome. Sample size and power were adequate.

Readiness for Dissemination Dimension Ratings

1. Availability of Implementation Materials (e.g., Treatment Manuals, 
Brochures, Information for Administrators, etc.)
0 = Applicant has insufficient implementation materials.
2 = Applicant has provided a limited range of implementation materials, 
or a comprehensive range of materials of varying or limited quality.
4 = Applicant has provided a comrephensive range of standard 
implementation materials of apparent high quality.
2. Availability of Training and Support Resources
0 = Applicant has limited or no training and support resources.
2 = Applicant provides training and support resources that are 
partially adequate to support initial and ongoing implementation.
4 = Applicant provides training and support resources that are fully 
adequate to support initial and ongoing implementation (tested training 
curricula, mechanisms for ongoing supervision and consultation).
3. Quality Improvement (QI) Materials (e.g., Fidelity Measures, Outcome 
and Performance Measures, Manuals on How To Provide QI Feedback and 
Improve Practices)
0 = Applicant has limited or no materials.
2 = Applicant has materials that are partially adequate to support 
initial and ongoing implementation.
4 = Applicant provides resources that are fully adequate to support 
initial and ongoing implementation (tested quality fidelity and outcome 
measures, comprehensive and user-friendly QI materials).

Scoring the Strength of Evidence and Readiness for Dissemination 
Dimensions

    The ratings for the decision support dimensions of Strength of 
Evidence and Readiness for Dissemination are calculated by averaging 
individual rating criteria that have been scored by reviewers according 
to a uniform five-point scale. For these two quantitative dimensions, 
the average score on each dimension (i.e., across criteria and 
reviewers) as well as average score for each rating criterion (across 
reviewers) will be provided on the Web site for each outcome targeted 
by the intervention.\9\
---------------------------------------------------------------------------

    \9\ Note that it is unlikely that the Readiness for 
Dissemination dimension will vary by targeted outcome(s), insofar as 
the materials and resources are usually program specific as opposed 
to outcome specific.
---------------------------------------------------------------------------

V. Future Activities: Implementing and Sustaining a Streamlined NREPP

    SAMHSA plans to initiate reviews using the new NREPP review process 
and procedures in summer 2006. The precise number and characteristics 
of new interventions that will be prioritized for the first series of 
reviews have yet to be determined. SAMHSA anticipates that many of the 
existing programs and practices currently listed on the SAMHSA Model 
Programs Web site will undergo an expedited set of reviews using the 
new system. Regardless, the current Model Programs Web site will remain 
intact until all relevant programs have been included in a new Web 
site, https://www.national registry.samhsa.gov
    The identification of collaborative mechanisms for supporting the 
continued development and refinement of NREPP will represent a SAMHSA 
priority in 2006. SAMHSA will explore means for providing adequate 
technical assistance resources to communities seeking to initiate and/
or augment evidence-based practices. In addition, appropriate technical 
advisors and other scientific resources will be utilized to assure the 
continued evolution of NREPP as a state-of-the-art decision support 
tool.

Appendix: Analysis of Public Comments in Response to Federal Register 
Notice

Background and Overview

    The Substance Abuse and Mental Health Services Administration 
(SAMHSA), through its Science to Service initiative, develops tools and 
resources for providers of prevention and treatment services to 
facilitate evidence-based decisionmaking and practice. An important 
informational resource is the National Registry of Evidence-based 
Programs and Practices (NREPP). NREPP is a voluntary rating and 
classification system designed to provide the public with reliable 
information on the scientific basis and practicality of interventions 
designed to prevent and/or treat mental and addictive disorders. NREPP 
originated in SAMHSA's Center for Substance Abuse Prevention (CSAP) in 
1997 as a way to help professionals in the field become better 
consumers of prevention programs. The program was expanded in 2004 to 
include substance abuse treatment interventions within SAMHSA's Center 
for Substance Abuse Treatment (CSAT) and mental health promotion and 
treatment interventions within the Center for Mental Health Services 
(CMHS).
    During the past 2 years, SAMHSA reviewed existing evidence rating 
systems and developed and pilot-tested a revised approach to the rating 
of specific outcomes achieved by programs and practices. This 
development effort led SAMHSA to propose 16 evidence rating criteria as 
well as a set of proposed utility descriptors to describe the potential 
of a given intervention to be ``transported'' to real-world settings 
and populations.
    Considering the prominence of NREPP within its Science-to-Service 
initiative and the potential impact of NREPP on the research and 
provider communities, SAMHSA announced a formal request for public 
comments in the Federal Register on August 26, 2005 (70 FR 165, 50381-
50390) with a 60-day

[[Page 13139]]

public comment period ending October 26, 2005. The notice outlined in 
some detail the proposed review system, including scientific criteria 
for evidence reviews, the screening and triage of NREPP applications, 
and the identification by SAMHSA of priority review areas. The notice 
invited general as well as specific comments and included 11 questions 
soliciting targeted feedback. By request of the SAMHSA Project Officer, 
MANILA Consulting Group coded and analyzed the responses received in 
response to the 11 questions posted in the Federal Register notice. The 
results of the analysts are presented below.

Method

    A total of 135 respondents submitted comments via e-mail, fax, and 
postal mail during the comment period. Of these 135 respondents, 109 
(81%) answered at least some of the 11 questions posted in the Federal 
Register notice.

Respondents

    The 135 respondents included 53 providers, 36 researchers, 4 
consumers, 21 respondents with multiple roles, and 21 with unknown 
roles visa-[agrave]-vis NREPP. Respondents were labeled as having one 
or more of the following domains of interest: substance abuse 
prevention (N=68), substance abuse treatment (N=48), mental health 
promotion (N=22); and mental health treatment (N=20). The domain of 
interest was unknown for 33 respondents. The respondents represented 16 
national organizations, 10 state organizations, and 14 local 
organizations; 90 were private citizens; and 5 were individuals with 
unknown affiliations. Fifty-one respondents (38%) were labeled 
``noteworthy'' at the request of the SAMHSA Project Officer. Noteworthy 
respondents included those representing national or state governments 
or national organizations, and nationally known experts in substance 
abuse or mental health research or policy.
    Twenty-six responses were judged by the four MANILA coders and the 
SAMHSA Project Officer to contain no information relevant to the 11 
questions in the notice. These responses, labeled ``unanalyzable'' for 
the purposes of this report, could be categorized as follows:
     Mentioned topics related to SAMHSA but made no point 
relevant to the questions posted in the Federal Register notice (N=10);
     Mentioned only topics unrelated to SAMHSA or incoherent 
text (N=7);
     Asked general questions about NREPP and the Federal 
Register notice (N=4);Wanted to submit a program for NREPP review 
(N=4); and
     Wanted to submit a program for NREPP review (N=4); and
     Responded to another Federal Register notice (N=1).

Procedure

    Before coding began, responses were read to identify recurrent 
themes to include in the codebook (presented in Subpart A of this 
Appendix). Using this codebook, each submission was then assigned codes 
identifying respondent characteristics (name, location, domain of 
interest, affiliation/type of organization, functional role, and level 
of response) and the content or topical themes contained in the 
response. One pair of coders coded the respondent data, while another 
pair coded the content. Content coding was conducted by two doctoral-
level psychologists with extensive training and experience in social 
science research and methodology.
    Each response could be assigned multiple codes for content. Coders 
compared their initial code assignments for all responses, discussed 
reasons for their code assignments when there were discrepancies, and 
then decided upon final code assignments. In many cases, coders 
initially assigned different codes but upon discussion agreed that both 
coders' assignments were applicable. Coding assignments were ultimately 
unanimous for all text in all responses.

Results

    The following discussion of key themes in the public comments is 
presented in order of the 11 questions from the Federal Register 
notice. Tables containing detailed frequencies of themes in the 
comments and other descriptive information are provided in Subpart B.

Comments Addressing Question 1

    Question 1. ``SAMHSA is seeking to establish an objective, 
transparent, efficient, and scientifically defensible process for 
identifying effective, evidence-based interventions to prevent and/
or treat mental and substance use disorders. Is the proposed NREPP 
system--including the suggested provisions for screening and triage 
of applications, as well as potential appeals by applicants--likely 
to accomplish these goals?''

    Respondents submitted a wide range of comments addressing Question 
1. Highlights of these comments are presented below, organized by topic 
as follows:
    1. Individual-Level Criteria
    2. Population-, Policy-, and System-Level Criteria
    3. Utility Descriptors
    4. Exclusion From NREPP Due to Lack of Funding
    5. Potential Impact on Minority Populations
    6. Potential Impact on Innovation
    7. Provider Factors
    8. Other Agencies' Standards and Resources
    9. Reliance on Intervention Developers To Submit Applications
    10. Generalizability
    11. Other Themes and Notable Comments

1. Individual-Level Criteria

Number of respondents: 24 (22%).

    Recommendations made by respondents included adding cost 
feasibility as a 13th criterion (one respondent) and scoring all 
criteria equally (two respondents). Comments regarding specific 
criteria are presented in Subpart C.

2. Population-, Policy-, and System-Level Criteria

Number of respondents: 29 (27%).

    Comments on specific criteria are presented in Subpart D. 
Highlights of comments on more general issues are presented below.
Differences in Evaluation Approaches for Individual-Level and 
Population-, Policy-, and System-Level Outcomes
    Two respondents noted the proposed NREPP approach does not 
acknowledge key differences between evaluating individual-level 
outcomes and population-, policy-, and system-level outcomes. One of 
these respondents argued that NREPP is based on theories of change that 
operate only at the individual level of analysis, with the assumption 
that discrete causes lead to discrete effects, and therefore ``many of 
the NREPP criteria appear to be insufficient or inappropriate for 
determining the validity of community-based interventions and their 
context-dependent effects.''
Unclear What Interventions Are of Interest to NREPP
    One organization, Community Anti-Drug Coalitions of America, 
recommended that SAMHSA present a clear, operational definition of the 
types of interventions it wants to include in NREPP.
Match Scale to Individual-Level Outcomes
    Twelve respondents, including the Society for Prevention Research 
and a group of researchers from a major university, recommended that 
the same scale be used for outcomes at the

[[Page 13140]]

individual level as for the population, policy, and system levels.
Add Attrition Criterion
    The same group of university researchers suggested adding attrition 
as a 13th criterion to the rating criteria for studies of population 
outcomes. They noted, ``Just as attention to attrition of individuals 
from conditions is essential in individual-level studies, attention to 
attrition of groups or communities from studies is essential in group-
level studies. This is necessary in order to assess attrition as a 
possible threat to the validity of the claim that the population-, 
policy-, or system-level intervention produced observed outcomes.''
Include Only Interventions That Change Behavior
    It was recommended that NREPP only include interventions proven to 
change behavior. A group of university researchers noted:

    As currently described, these outcomes refer to implementation 
of changes in policy or community service systems, not to changes in 
behavioral outcomes themselves. In fact, as currently described, the 
policy or system change would not be required to show any effects on 
behavior in order to be included in NREPP. This is a serious 
mistake. The NREPP system should be reserved for policies, programs, 
and system-level changes that have produced changes in actual drug 
use or mental health outcomes.

3. Utility Descriptors

Number of respondents: 15 (14%).

    Only one respondent, the Committee for Children, recommended 
specific changes to the utility descriptors. Their comments are 
presented in Subpart E of this Appendix.
    Seven other respondents recommended using utility descriptors in 
some way to score programs. The American Psychological Association 
(APA) Committee on Evidence-Based Practice recommended more emphasis on 
the utility descriptors ``as these are key outcomes for implementation 
and they are not adequately addressed in the description of NREPP 
provided to date. This underscores earlier concerns noted about the 
transition from effectiveness to efficacy.''

4. Exclusion From NREPP Due To Lack of Funding

Number of respondents: 28 (26%).

    The possibility that NREPP will exclude programs due to lack of 
funding was a concern voiced by several organizations, including the 
National Association for Children of Alcoholics, the APA Committee on 
Evidence-Based Practice, the National Association of State Alcohol and 
Drug Abuse Directors, Community Anti-Drug Coalitions of America, and 
the California Association of Alcohol and Drug Program Executives. The 
National Association for Children of Alcoholics provided the following 
comment:

    NREPP should establish differing criteria for projects that 
collected data with [National Institutes of Health] grant funds and 
projects that collected data with no or very small amounts of funds. 
It has been intrinsically unfair that only grants have been able to 
establish ``evidence'' while many programs appear very effective--
often more effective in some circumstances than NREPP approved 
programs--but have not had the Federal support or other major grant 
support to evaluate them. The SAMHSA grant programs continue to 
reinforce the designation of NREPP programs in order to qualify for 
funding, and the states tend to strengthen this `stipulation' to 
local programs, who then drop good (non-NREPP) work they have been 
doing or purchase and manipulate NREPP programs that make the grant 
possible. This is not always in the best interest of the client 
population to be served.

    Another key concern was that funding for replication research is 
rarely available. Several respondents suggested that SAMHSA consider 
funding evaluation research, and many argued that the lack of funding 
resources could negatively impact minority populations or inhibit 
treatment innovation. The latter two themes were frequent enough to be 
coded and analyzed separately. Results are summarized in the following 
sections.

5. Potential Impact on Minority Populations

Number of respondents: 13 (12%).

    Thirteen respondents noted that the proposed NREPP approach could 
negatively impact specific populations, including minority client 
populations. The Federation of Families for Children's Mental Health 
suggested that NREPP would effectively promote certain practices 
``simply because the resources for promotion, training, evaluation are 
readily accessible * * * thus widening the expanse and disparities that 
currently exist.''
    Another frequently noted concern was that evidence-based practices 
are currently too narrowly defined, and thus as more funding sources 
begin to require evidence-based practices as a prerequisite for 
funding, some ethnic or racial minority organizations may be excluded 
from funding. One respondent also pointed to potential validity 
concerns, noting that ``Very little clinical trial evidence is 
available for how to treat substance use disorders in specific 
populations who may constitute most or all of those seen in particular 
agencies: HIV positive patients, native Americans, adolescents, 
Hispanics, or African Americans. Although it is unreasonable to expect 
all EBTs to be tested with all populations, the external validity of 
existing studies remains a serious concern.'' For these reasons, many 
respondents surmised that the widespread application of interventions 
developed in research contexts that might tend to limit the inclusion 
of minority and/or underserved populations could ultimately result in 
decreased cultural competence among service providers.

6. Potential Impact on Innovation

Number of respondents: 21 (19%).

    Twenty-one respondents cited concerns that the proposed NREPP 
approach could hamper innovation. CAADPE noted that its main concerns 
were ``the focus on the premise that treatment will improve if confined 
to inteventions for which a certain type of research evidence is 
available'' and ``the issue of `branding,' which could lead to some of 
our most innovative and effective small scale providers eliminated from 
funding considerations.''
    One respondent suggested that lists of evidence-based treatments 
could ``ossify research and practice, and thus become self-fulfilling 
prophecies * * * stifling innovation and the validation of existing 
alternatives.'' Several respondents observed that the potential for 
stifling innovation is even greater given that SAMHSA's NREPP is not 
the only list of evidence-based practices used by funders.
    The APA Practice Organization recommended that NREPP focus on 
``developing and promoting a range of more accessible and less 
stigmatized services that are responsive to consumers' needs and 
preference, and offer more extensive care opportunities.''

7. Provider Factors

Number of respondents: 22 (20%).

    A number of respondents noted the proposed NREPP approach does not 
acknowledge provider effects on treatment outcomes. The APA Committee 
on Evidence-Based Practice wrote, ``Relationship factors in a 
therapeutic process may be more important than specific interventions 
and may in fact be the largest determinant in psychotherapy outcome 
(see Lambert & Barley, 2002). How will NREPP address this concern and 
make this apparent to users?''
    Another respondent cited the Institute of Medicine's definition of 
evidence-

[[Page 13141]]

based practice as ``the integration of the best research evidence with 
clinical expertise and client values,'' noting that ``The narrowed 
interpretation of evidence-based practice by SAMHSA focuses almost 
solely on the research evidence to the exclusion of clinical expertise 
and patient values.''
    Several respondents suggested that NREPP could place too much 
emphasis on highly prescriptive, annualized treatments. Counselors can 
become bored when they are not able ti ``tinker'' with or adapt 
treatments. In addition, making minor modifications may actually make 
treatments more effective with different population groups.

8. Other Agencies' Standards and Resources

Number of respondents: 27 (25%).

    Nineteen respondents suggested that, in developing NREPP, SAMHSA 
should consult other agencies' standards and resources related to 
evidence-based practices--for example, the standards published by the 
APA, American Society for Addiction Medicine, and the Society for 
Prevention Research. One respondent suggested consulting with National 
Institutes of Health scientists about approaches for aggregating 
evidence; another recommended including in NREPP model programs 
identified by other agencies. One respondent submitted a bibliography 
of references for assessing the rigor of qualitative research.
    One respondent suggested that SAMHSA did not provide other 
institutions the opportunity to provide input on the development of 
NREPP prior to the request for public comments.

9. Reliance on Intervention Developers To Submit Applications

Number of respondents: 4 (4%).

    Four respondents cited problems with NREPP's reliance on 
intervention developers to submit applications, and suggested that 
literature reviews instead be used to identify programs eligible for 
NREPP. One private citizen wrote, ``If no one applies on behalf of a 
treatment method, is that one ignored? Why not simply start with the 
literature and identify treatment methods with adequate evidence of 
efficacy?''
    Another respondent observed that requiring an application creates a 
bias toward programs with advocates ``either ideologically or because 
of a vested interest in sales, visibility, and profits. An alternative 
is to select interventions for NREPP consideration solely by monitoring 
the peer-reviewed published literature, and including them regardless 
of whether or not the scientist responds or furthers the registration 
process.''
    The Society for Prevention Research suggested that SAMHSA convene a 
panel to periodically review available interventions that might not be 
submitted to NREPP because they ``lack a champion.''

10. Generalizability

Number of respondents: 48 (44%).

    Many respondents discussed the issue of generalizability of 
evidence, especially the concern that interventions proven to work in 
clinical trials do not always work in real-world settings. Several 
respondents pointed out the potential conflict between implementing an 
intervention with fidelity and having a adapt it for the setting.
    The APA Evidence-Based Practice Committee suggested that the 
proposed NREPP approach does not adequately distinguish between 
``efficacy'' and ``effectiveness,'' and strongly recommended that 
SAMHSA look for ways to bridge the two.
    The Associations of Addiction Services recommended paying more 
attention to how and where treatments are replicated: ``The highest 
level of evidence should be successful replication of the approach in 
multiple community treatment settings. Experience with [the National 
Institute on Drug Abuse] Clinical Trials Network suggests that an 
approach that shows meaningful outcome improvements in the `noisy' 
setting of a publicly funded community treatment program is truly an 
approach worth promoting.''
    A few respondents suggested that NREPP score interventions 
according to their readiness and amenability to application in real-
world settings.

11. Other Themes and Notable Comments

Distinguishing Treatment and Prevention
Number of respondents: 7 (6%).

    A few respondents called or evaluating treatment and prevention 
approaches differently. One respondent noted that some criteria appear 
to be more appropriate for treatment modalities than for preventive 
interventions, and recommended that SAMHSA ``confer with research 
experts in those respective fields and separate out those criteria that 
are more relevant to only treatment or prevention.''
    Another respondent suggested that the criteria are more appropriate 
for prevention that treatment:

    The criteria and selection for the peer review panels should be 
separate for prevention and treatment programs. The criteria and 
models are different and the panels should not be an across the 
board effort, but rather representative of prevention and treatment 
experts specific to the program being evaluated. The plan is based 
as the notice states on 1,100 prevention programs with little 
experience with treatment programs/practices.
Synthesizing Evidence
    Three respondents suggested using meta-analysis to synthesize 
evidence for outcomes. One recommended SAMHSA consult with National 
Institutes of Health experts in this area.
Replications
    The Teaching-Family Association recommended considering 
replications when evaluating evidence. The Society for Prevention 
Research wrote that it is unclear how replications would be used in the 
proposed NREPP, and suggested averaging ratings across studies.
Add Criteria
    The National Student Assistance Association Scientific Advisory 
Board and one other respondent suggested adding a cultural competence 
criterion. The Society for Prevention Research recommended adding a 
criterion to assess the clarity of causal inference.
Range of Reviewer Perspectives
    The APA Practice Association noted the importance of having a 
``large and broad'' reviewer pool: ``A small group of reviewers 
representing a limited range of perspectives and constituencies would 
have an undue impact on the entire system. We are pleased that a 
nominations process is envisioned.''
Cost Effectiveness
    One respondent called for incorporating program cost effectiveness 
into NREPP. In choosing what program to implement, end users often have 
to decide between diverse possibilities, such as attempting to pass a 
tax increase on beer or implementing additional classroom prevention 
curricula, each with competing claims about effectiveness. A cost-
effectiveness framework may be the only way to compare these choices.

Comments Addressing Question 2

    Question 2. ``SAMHSA's NREPP priorities are reflected in the 
agency's matrix of program priority areas. How might SAMHSA engage 
interested stakeholders on a periodic basis in helping the agency 
determine intervention priority areas for review by NREPP?''

Number of respondents: 16 (15%).


[[Page 13142]]


    Respondents recommended a number of approaches to engage 
stakeholders:
     Conduct meetings, conferences, and seminars.
     Send and solicit information via e-mail or a Web site.
     Send informational notices via newletters.
     Survey stakeholders.
     Work with the Addiction Technology Transfer Centers 
(ATTCs) to administer surveys.
     Consult the National Prevention Network and the Society 
for Prevention Research, which ``have forged a close working 
relationship to foster the integration of science and practice and * * 
* would be very helpful in answering this question.''

Comments Addressing Question 3

    Question 3. ``There has been considerable discussion in the 
scientific literature on how to use statistical significance and 
various measures of effect size in assessing
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