Scientific Information Request on Behavioral Programs for Diabetes Mellitus, 42324-42326 [2014-16669]

Download as PDF 42324 Federal Register / Vol. 79, No. 139 / Monday, July 21, 2014 / Notices emcdonald on DSK67QTVN1PROD with NOTICES they were produced, including any code if applicable. The processes can be submitted in text document. In order for an entry to be eligible to win this Challenge, it must meet the following requirements: 1. Acceptable platforms—The tool must be designed for use with existing Web, mobile Web, electronic health record, or other platform. 2. Section 508 Compliance— Contestants must acknowledge that they understand that, as a prerequisite to any subsequent acquisition by FAR contract or other method, they are required to make their proposed solution compliant with Section 508 accessibility and usability requirements at their own expense. Any electronic information technology that is ultimately obtained by HHS for its use, development, or maintenance must meet Section 508 accessibility and usability standards. Past experience has demonstrated that it can be costly for solution-providers to ‘‘retrofit’’ solutions if remediation is later needed. The HHS Section 508 Evaluation Product Assessment Template, available at http://www. hhs.gov/od/vendors/index.html, provides a useful roadmap for developers to review. It is a simple, web-based checklist utilized by HHS officials to allow vendors to document how their products do or do not meet the various Section 508 requirements. 3. No HHS or OBMT logo—The app must not use HHS’ or OBMT’s logos or official seals in the Submission, and must not claim endorsement. 4. Functionality/Accuracy—A submission may be disqualified if it fails to function as expressed in the description provided by the user, or if it provides inaccurate or incomplete information. 5. Security—Submissions must be free of malware. Contestant agrees that OBMT may conduct testing on the app to determine whether malware or other security threats may be present. OBMT may disqualify the Submission if, in OBMT’s judgment, the app may damage government or others’ equipment or operating environment. Additional Information General Conditions: OBMT reserves the right to cancel, suspend, and/or modify the Contest, or any part of it, for any reason, at OBMT’s sole discretion. Intellectual Property • Each entrant retains full ownership and title in and to their submission. Entrants expressly reserve all intellectual property rights not expressly granted under the challenge agreement. VerDate Mar<15>2010 17:14 Jul 18, 2014 Jkt 232001 • By participating in the challenge, each entrant hereby irrevocably grants to OBMT a limited, non-exclusive, royalty-free, worldwide license and right to reproduce, publically perform, publically display, and use the submission for internal HHS business and to the extent necessary to administer the challenge, and to publically perform and publically display the Submission, including, without limitation, for advertising and promotional purposes relating to the challenge. Dated: July 11, 2014. E.J. Holland, Jr., Assistant Secretary for Administration, U.S. Department of Health and Human Services. [FR Doc. 2014–17065 Filed 7–18–14; 8:45 am] BILLING CODE 4151–17–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Scientific Information Request on Behavioral Programs for Diabetes Mellitus Agency for Healthcare Research and Quality (AHRQ), HHS. ACTION: Request for Scientific Information Submissions. AGENCY: The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review of Behavioral Programs for Diabetes Mellitus, which is currently being conducted by the Evidence-based Practice Centers for the AHRQ Effective Health Care Program. Access to published and unpublished pertinent scientific information will improve the quality of this review. AHRQ is conducting this systematic review pursuant to Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108–173, and Section 902(a) of the Public Health Service Act, 42 U.S.C. 299a(a). DATES: Submission Deadline on or before August 20, 2014. ADDRESSES: Online submissions: http:// effectivehealthcare.AHRQ.gov/ index.cfm/submit-scientificinformation-packets/. Please select the study for which you are submitting information from the list to upload your documents. Email submissions: SIPS@epc-src.org. SUMMARY: PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 Print submissions: Mailing Address: Portland VA Research Foundation Scientific Resource Center, ATTN: Scientific Information Packet Coordinator, PO Box 69539, Portland, OR 97239, Shipping Address (FedEx, UPS, etc.): Portland VA Research Foundation, Scientific Resource Center, ATTN: Scientific Information Packet Coordinator, 3710 SW U.S. Veterans Hospital Road, Mail Code: R&D 71, Portland, OR 97239 FOR FURTHER INFORMATION CONTACT: Ryan McKenna, Telephone: 503–220– 8262 ext. 58653 or Email: SIPS@epcsrc.org. SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and Quality has commissioned the Effective Health Care (EHC) Program Evidencebased Practice Centers to complete a review of the evidence for Behavioral Programs for Diabetes Mellitus. The EHC Program is dedicated to identifying as many studies as possible that are relevant to the questions for each of its reviews. In order to do so, we are supplementing the usual manual and electronic database searches of the literature by requesting information from the public (e.g., details of studies conducted). We are looking for studies that report on Behavioral Programs for Diabetes Mellitus, including those that describe adverse events. The entire research protocol, including the key questions, is also available online at: http://effectivehealthcare.AHRQ.gov/ search-for-guides-reviews-and-reports/ ?pageaction=displayproduct&productID =1917. This notice is to notify the public that the EHC Program would find the following information on Behavioral Programs for Diabetes Mellitus helpful: • A list of completed studies that your organization has sponsored for this indication. In the list, please indicate whether results are available on ClinicalTrials.gov along with the ClinicalTrials.gov trial number. • For completed studies that do not have results on ClinicalTrials.gov, please provide a summary, including the following elements: study number, study period, design, methodology, indication and diagnosis, proper use instructions, inclusion and exclusion criteria, primary and secondary outcomes, baseline characteristics, number of patients screened/eligible/ enrolled/lost to follow-up/withdrawn/ analyzed, effectiveness/efficacy, and safety results. • A list of ongoing studies that your organization has sponsored for this indication. In the list, please provide the ClinicalTrials.gov trial number or, if the E:\FR\FM\21JYN1.SGM 21JYN1 Federal Register / Vol. 79, No. 139 / Monday, July 21, 2014 / Notices trial is not registered, the protocol for the study including a study number, the study period, design, methodology, indication and diagnosis, proper use instructions, inclusion and exclusion criteria, and primary and secondary outcomes. • Description of whether the above studies constitute ALL Phase II and above clinical trials sponsored by your organization for this indication and an index outlining the relevant information in each submitted file. Your contribution will be very beneficial to the EHC Program. The contents of all submissions will be made available to the public upon request. Materials submitted must be publicly available or can be made public. Materials that are considered confidential; marketing materials; study types not included in the review; or information on indications not included in the review cannot be used by the EHC Program. This is a voluntary request for information, and all costs for complying with this request must be borne by the submitter. The draft of this review will be posted on AHRQ’s EHC Program Web site and available for public comment for a period of 4 weeks. If you would like to be notified when the draft is posted, please sign up for the email list at: http://effectivehealthcare.AHRQ.gov/ index.cfm/join-the-email-list1/. The systematic review will answer the following questions. This information is provided as background. AHRQ is not requesting that the public provide answers to these questions. The entire research protocol is also available online at: http://effective healthcare.AHRQ.gov/search-for-guidesreviews-and-reports/?pageaction= displayproduct&productID=1917. The Key Questions emcdonald on DSK67QTVN1PROD with NOTICES Question 1 For patients with Type 1 Diabetes Mellitus (T1DM), are behavioral programs implemented in a community health setting effective compared with usual or standard care, or active comparators in, a) improving behavioral, clinical, and health outcomes, b) improving diabetes-related health care utilization, and c) achieving program acceptability as measured by participant attrition rates? Question 2 For patients with T1DM, do behavioral programs implemented in the community health setting differ in effectiveness for behavioral, clinical, and health outcomes, their effect on diabetes-related health care utilization, VerDate Mar<15>2010 17:14 Jul 18, 2014 Jkt 232001 42325 or program acceptability, for subgroups of patients based on: Age (i.e., children and adolescents [≤18 years] and their families, young adults [19–30 years], adults [31–64 years], older adults [≥65 years]); race or ethnicity; socioeconomic status (e.g., family income, education level, literacy); time since diagnosis (i.e., ≤1 year vs. >1 year); and, level of glycemic control (e.g., HbA1c <7 vs. ≥7 percent)? PICOTS (Patients, Interventions, Comparators, Outcomes, Timing, and Setting) Criteria Question 3 Key Questions 1–4 For patients with T1DM, does the effectiveness of behavioral programs differ based on the: (a) Components; (b) intensity (i.e., program duration, frequency/periodicity of interactions); (b) delivery personnel (e.g., dietitian, exercise specialist, physician, nurse practitioner, certified diabetes educator, lay health worker); (c) method of communication (e.g., individual vs. group, face-to-face, interactive behavior change technology, social media); (d) degree of tailoring based on needs assessment (e.g., educational/behavioral deficits, age or other demographics, readiness to change); or (e) level and nature of community engagement? Population Question 4 For patients with T1DM, what are the associated harms (i.e., activity-related injury) of behavioral programs implemented in a community health setting compared with usual care, standard care, or active comparators? Question 5 Among behavioral programs targeted at adults with Type 2 Diabetes Mellitus (T2DM) implemented in a community health setting, what factors contribute to: (a) Their effectiveness for behavioral, clinical, and health outcomes; (b) their effect on diabetes-related health care utilization; and (c) program acceptability as measured by participant attrition rates? Factors include program components, program intensity, delivery personnel, methods of delivery and communication, degree of tailoring, and community engagement. Question 6 Do the factors that contribute to program effectiveness for patients with T2DM vary across the following subpopulations: Age (i.e., young adults [19–30 years], adults [31–64 years], older adults [≥65 years]); race or ethnicity; socioeconomic status (e.g., family income, education level, literacy); time since diagnosis (i.e., ≤1 year vs. >1 year); and, level of glycemic control (i.e., HbA1c <7 vs. ≥7 percent)? PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 PICOTS frameworks are presented below for the Key Questions that relate to Type 1 Diabetes Mellitus (T1DM) and Type 2 Diabetes Mellitus (T2DM). These frameworks will guide all the stages of the systematic review, including literature searching, study selection, and data abstraction. Patients with T1DM (any age) who have undergone basic diabetes education. Interventions • Multicomponent behavioral program that includes at least one of: Æ Diabetes self-management education; OR Æ Structured dietary intervention (related to any of weight loss, glycemic control, or reducing risk for complications) together with one or more additional components; OR Æ Structured exercise/physical activity intervention together with one or more additional components. Æ Additional components may include interventions related to: Diet or physical activity, behavioral change (including but not limited to: Goal setting, problem solving, motivational interviewing, coping skills training, cognitive behavioral therapy strategies), relaxation or stress reduction, blood glucose awareness, medication adherence, or self-monitoring for diabetic complications (foot, eye, and renal tests). • Repeated provision by one or more trained individuals • Duration of intervention: minimum 4 weeks Comparators • Usual or standard care or an active comparator (e.g., behavioral program or intervention) as reported for studies • Delivery methods (personnel, intensity, communication methods, etc.) as reported for studies Outcomes • Behavioral outcomes Æ Self-regulation of insulin based on diet, physical activity, and glucose monitoring results Æ Change in physical activity (e.g., volume of activity per week) or fitness (e.g., cardiorespiratory fitness, strength) E:\FR\FM\21JYN1.SGM 21JYN1 42326 • • • • • • Federal Register / Vol. 79, No. 139 / Monday, July 21, 2014 / Notices Æ Change in dietary or nutrient intake (i.e., energy intake, saturated fat consumption) Æ Adherence to treatment, including self-monitoring and medication Clinical outcomes Æ Glycemic control (Hemoglobin Alt) Æ Change in body composition (i.e., weight, Body Mass Index, waist circumference, % body fat) Æ Episodes of severe hypoglycemia Æ Treatment for hyperglycemia (ketoacidosis) Æ Control of blood pressure and lipids Æ Development or control of depression or anxiety Health outcomes Æ Quality of life (e.g., validated tools for health-related quality of life, life satisfaction, psychosocial adaptation to illness, patient satisfaction) Æ Development of micro- and macrovascular complications (i.e., retinopathy, nephropathy, neuropathy, cardiovascular outcomes) Æ Mortality (all-cause) Diabetes-related health care utilization Æ Hospital admissions Æ Length of stay in hospital Æ Emergency department admissions Æ Visits to specialist clinics Program acceptability as measured by participant attrition rates Harms from program as reported for studies Activity-related injury Timing Any length of followup emcdonald on DSK67QTVN1PROD with NOTICES Settings • Community health setting (i.e., ambulatory care clinics, outpatient clinics, primary care clinics, family physician clinics, Community Health Centers, Rural Health Centers) • United States or other high-income countries with a very high Human Development Index Key Questions 5–6 Population Adults (≥18 years) with T2DM who have undergone primary diabetes education 17:14 Jul 18, 2014 • Multicomponent behavioral programs that include at least one of: Æ Diabetes self-management education; OR Æ Structured dietary intervention (related to any of weight loss, glycemic control, or reducing risk for complications) together with one or more additional components; OR Æ Structured exercise/physical activity intervention together with one or more additional components. Æ Additional components may include interventions related to: diet or physical activity, behavioral change (including but not limited to: Goal setting, problem solving, motivational interviewing, coping skills training, cognitive behavioral therapy strategies), relaxation or stress reduction, blood glucose awareness, medication adherence, or self-monitoring for diabetic complications (foot, eye, and renal tests). • Repeated provision by one or more trained individuals • Duration of intervention: Minimum 4 weeks Jkt 232001 macrovascular complications (i.e., retinopathy, nephropathy, neuropathy, cardiovascular outcomes) Æ Mortality (all-cause) • Diabetes-related health care utilization Æ Hospital admissions Æ Length of stay in hospital Æ Emergency department admissions Æ Visits to specialist clinics • Program acceptability as measured by participant attrition rates Timing Any length of followup Study design Randomized controlled trials Settings • Community health setting (i.e., ambulatory care clinics, outpatient clinics, primary care clinics, family physician clinics, Community Health Centers, Rural Health Centers) • United States or other high-income country with a very high Human Development Index Language Comparators English • Usual or standard care or an active comparator (e.g., behavioral program or intervention) as reported for studies • Delivery methods (personnel, intensity, communication methods etc.) as reported for studies Dated: July 3, 2014. Richard Kronick, AHRQ Director. Outcomes Study Design Prospective comparative studies using a best evidence approach based on hierarchy of evidence: randomized controlled trials, nonrandomized controlled trials, prospective cohort studies, controlled before-after studies VerDate Mar<15>2010 Interventions • Behavioral outcomes Æ Change in physical activity (e.g., volume of activity per week) or fitness (e.g., cardiorespiratory fitness, strength) Æ Change in dietary or nutrient intake (i.e., energy intake, saturated fat consumption) Æ Adherence to medication • Clinical outcomes Æ Glycemic control (Hemoglobin Mc) Æ Change in body composition (i.e., weight, Body Mass Index, waist circumference, % body fat) Æ Control of blood pressure and lipids Æ Sleep apnea or sleep quality Æ Development or control of depression or anxiety • Health outcomes Æ Quality of life (e.g., validated tools for health-related quality of life, life satisfaction, psychosocial adaptation to illness, patient satisfaction) Æ Development of micro- and PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 [FR Doc. 2014–16669 Filed 7–18–14; 8:45 am] BILLING CODE 4160–90–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Statement of Organization, Functions, and Delegations of Authority Part E, Chapter E (Agency for Healthcare Research and Quality), of the Statement of Organization, Functions, and Delegations of Authority for the Department of Health and Human Services (61 FR 15955–58, April 10, 1996, most recently amended at 78 FR 38981, on June 28, 2013) is amended to reflect recent organizational changes. The specific amendments are as follows: I. Under Section E–10, Organization, delete all components and replace with the following: A. Office of the Director. B. Center for Delivery, Organization, and Markets. C. Center for Financing, Access, and Cost Trends. D. Center for Evidence and Practice Improvement. E:\FR\FM\21JYN1.SGM 21JYN1

Agencies

[Federal Register Volume 79, Number 139 (Monday, July 21, 2014)]
[Notices]
[Pages 42324-42326]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-16669]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Scientific Information Request on Behavioral Programs for 
Diabetes Mellitus

AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.

ACTION: Request for Scientific Information Submissions.

-----------------------------------------------------------------------

SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is 
seeking scientific information submissions from the public. Scientific 
information is being solicited to inform our review of Behavioral 
Programs for Diabetes Mellitus, which is currently being conducted by 
the Evidence-based Practice Centers for the AHRQ Effective Health Care 
Program. Access to published and unpublished pertinent scientific 
information will improve the quality of this review. AHRQ is conducting 
this systematic review pursuant to Section 1013 of the Medicare 
Prescription Drug, Improvement, and Modernization Act of 2003, Public 
Law 108-173, and Section 902(a) of the Public Health Service Act, 42 
U.S.C. 299a(a).

DATES: Submission Deadline on or before August 20, 2014.

ADDRESSES: 
    Online submissions: http://effectivehealthcare.AHRQ.gov/index.cfm/submit-scientific-information-packets/. Please select the study for 
which you are submitting information from the list to upload your 
documents.

Email submissions: src.org">SIPS@epc-src.org.
Print submissions: Mailing Address: Portland VA Research Foundation 
Scientific Resource Center, ATTN: Scientific Information Packet 
Coordinator, PO Box 69539, Portland, OR 97239, Shipping Address (FedEx, 
UPS, etc.): Portland VA Research Foundation, Scientific Resource 
Center, ATTN: Scientific Information Packet Coordinator, 3710 SW U.S. 
Veterans Hospital Road, Mail Code: R&D 71, Portland, OR 97239

FOR FURTHER INFORMATION CONTACT: Ryan McKenna, Telephone: 503-220-8262 
ext. 58653 or Email: src.org">SIPS@epc-src.org.

SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and 
Quality has commissioned the Effective Health Care (EHC) Program 
Evidence-based Practice Centers to complete a review of the evidence 
for Behavioral Programs for Diabetes Mellitus.
    The EHC Program is dedicated to identifying as many studies as 
possible that are relevant to the questions for each of its reviews. In 
order to do so, we are supplementing the usual manual and electronic 
database searches of the literature by requesting information from the 
public (e.g., details of studies conducted). We are looking for studies 
that report on Behavioral Programs for Diabetes Mellitus, including 
those that describe adverse events. The entire research protocol, 
including the key questions, is also available online at: http://effectivehealthcare.AHRQ.gov/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=1917.
    This notice is to notify the public that the EHC Program would find 
the following information on Behavioral Programs for Diabetes Mellitus 
helpful:
     A list of completed studies that your organization has 
sponsored for this indication. In the list, please indicate whether 
results are available on ClinicalTrials.gov along with the 
ClinicalTrials.gov trial number.
     For completed studies that do not have results on 
ClinicalTrials.gov, please provide a summary, including the following 
elements: study number, study period, design, methodology, indication 
and diagnosis, proper use instructions, inclusion and exclusion 
criteria, primary and secondary outcomes, baseline characteristics, 
number of patients screened/eligible/enrolled/lost to follow-up/
withdrawn/analyzed, effectiveness/efficacy, and safety results.
     A list of ongoing studies that your organization has 
sponsored for this indication. In the list, please provide the 
ClinicalTrials.gov trial number or, if the

[[Page 42325]]

trial is not registered, the protocol for the study including a study 
number, the study period, design, methodology, indication and 
diagnosis, proper use instructions, inclusion and exclusion criteria, 
and primary and secondary outcomes.
     Description of whether the above studies constitute ALL 
Phase II and above clinical trials sponsored by your organization for 
this indication and an index outlining the relevant information in each 
submitted file.
    Your contribution will be very beneficial to the EHC Program. The 
contents of all submissions will be made available to the public upon 
request. Materials submitted must be publicly available or can be made 
public. Materials that are considered confidential; marketing 
materials; study types not included in the review; or information on 
indications not included in the review cannot be used by the EHC 
Program. This is a voluntary request for information, and all costs for 
complying with this request must be borne by the submitter.
    The draft of this review will be posted on AHRQ's EHC Program Web 
site and available for public comment for a period of 4 weeks. If you 
would like to be notified when the draft is posted, please sign up for 
the email list at: http://effectivehealthcare.AHRQ.gov/index.cfm/join-the-email-list1/.
    The systematic review will answer the following questions. This 
information is provided as background. AHRQ is not requesting that the 
public provide answers to these questions. The entire research protocol 
is also available online at: http://effectivehealthcare.AHRQ.gov/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=1917.

The Key Questions

Question 1

    For patients with Type 1 Diabetes Mellitus (T1DM), are behavioral 
programs implemented in a community health setting effective compared 
with usual or standard care, or active comparators in, a) improving 
behavioral, clinical, and health outcomes, b) improving diabetes-
related health care utilization, and c) achieving program acceptability 
as measured by participant attrition rates?

Question 2

    For patients with T1DM, do behavioral programs implemented in the 
community health setting differ in effectiveness for behavioral, 
clinical, and health outcomes, their effect on diabetes-related health 
care utilization, or program acceptability, for subgroups of patients 
based on: Age (i.e., children and adolescents [<=18 years] and their 
families, young adults [19-30 years], adults [31-64 years], older 
adults [>=65 years]); race or ethnicity; socioeconomic status (e.g., 
family income, education level, literacy); time since diagnosis (i.e., 
<=1 year vs. >1 year); and, level of glycemic control (e.g., HbA1c <7 
vs. >=7 percent)?

Question 3

    For patients with T1DM, does the effectiveness of behavioral 
programs differ based on the: (a) Components; (b) intensity (i.e., 
program duration, frequency/periodicity of interactions); (b) delivery 
personnel (e.g., dietitian, exercise specialist, physician, nurse 
practitioner, certified diabetes educator, lay health worker); (c) 
method of communication (e.g., individual vs. group, face-to-face, 
interactive behavior change technology, social media); (d) degree of 
tailoring based on needs assessment (e.g., educational/behavioral 
deficits, age or other demographics, readiness to change); or (e) level 
and nature of community engagement?

Question 4

    For patients with T1DM, what are the associated harms (i.e., 
activity-related injury) of behavioral programs implemented in a 
community health setting compared with usual care, standard care, or 
active comparators?

Question 5

    Among behavioral programs targeted at adults with Type 2 Diabetes 
Mellitus (T2DM) implemented in a community health setting, what factors 
contribute to: (a) Their effectiveness for behavioral, clinical, and 
health outcomes; (b) their effect on diabetes-related health care 
utilization; and (c) program acceptability as measured by participant 
attrition rates? Factors include program components, program intensity, 
delivery personnel, methods of delivery and communication, degree of 
tailoring, and community engagement.

Question 6

    Do the factors that contribute to program effectiveness for 
patients with T2DM vary across the following subpopulations: Age (i.e., 
young adults [19-30 years], adults [31-64 years], older adults [>=65 
years]); race or ethnicity; socioeconomic status (e.g., family income, 
education level, literacy); time since diagnosis (i.e., <=1 year vs. >1 
year); and, level of glycemic control (i.e., HbA1c <7 vs. >=7 percent)?

PICOTS (Patients, Interventions, Comparators, Outcomes, Timing, and 
Setting) Criteria

    PICOTS frameworks are presented below for the Key Questions that 
relate to Type 1 Diabetes Mellitus (T1DM) and Type 2 Diabetes Mellitus 
(T2DM). These frameworks will guide all the stages of the systematic 
review, including literature searching, study selection, and data 
abstraction.

Key Questions 1-4

Population

    Patients with T1DM (any age) who have undergone basic diabetes 
education.

Interventions

 Multicomponent behavioral program that includes at least one 
of:
    [cir] Diabetes self-management education; OR
    [cir] Structured dietary intervention (related to any of weight 
loss, glycemic control, or reducing risk for complications) together 
with one or more additional components; OR
    [cir] Structured exercise/physical activity intervention together 
with one or more additional components.
    [cir] Additional components may include interventions related to: 
Diet or physical activity, behavioral change (including but not limited 
to: Goal setting, problem solving, motivational interviewing, coping 
skills training, cognitive behavioral therapy strategies), relaxation 
or stress reduction, blood glucose awareness, medication adherence, or 
self-monitoring for diabetic complications (foot, eye, and renal 
tests).
 Repeated provision by one or more trained individuals
 Duration of intervention: minimum 4 weeks

Comparators

 Usual or standard care or an active comparator (e.g., 
behavioral program or intervention) as reported for studies
 Delivery methods (personnel, intensity, communication methods, 
etc.) as reported for studies

Outcomes

 Behavioral outcomes
    [cir] Self-regulation of insulin based on diet, physical activity, 
and glucose monitoring results
    [cir] Change in physical activity (e.g., volume of activity per 
week) or fitness (e.g., cardiorespiratory fitness, strength)

[[Page 42326]]

    [cir] Change in dietary or nutrient intake (i.e., energy intake, 
saturated fat consumption)
    [cir] Adherence to treatment, including self-monitoring and 
medication
 Clinical outcomes
    [cir] Glycemic control (Hemoglobin Alt)
    [cir] Change in body composition (i.e., weight, Body Mass Index, 
waist circumference, % body fat)
    [cir] Episodes of severe hypoglycemia
    [cir] Treatment for hyperglycemia (ketoacidosis)
    [cir] Control of blood pressure and lipids
    [cir] Development or control of depression or anxiety
 Health outcomes
    [cir] Quality of life (e.g., validated tools for health-related 
quality of life, life satisfaction, psychosocial adaptation to illness, 
patient satisfaction)
    [cir] Development of micro- and macrovascular complications (i.e., 
retinopathy, nephropathy, neuropathy, cardiovascular outcomes)
    [cir] Mortality (all-cause)
 Diabetes-related health care utilization
    [cir] Hospital admissions
    [cir] Length of stay in hospital
    [cir] Emergency department admissions
    [cir] Visits to specialist clinics
 Program acceptability as measured by participant attrition 
rates
 Harms from program as reported for studies
 Activity-related injury

Timing

Any length of followup

Study Design

Prospective comparative studies using a best evidence approach based on 
hierarchy of evidence: randomized controlled trials, nonrandomized 
controlled trials, prospective cohort studies, controlled before-after 
studies

Settings

 Community health setting (i.e., ambulatory care clinics, 
outpatient clinics, primary care clinics, family physician clinics, 
Community Health Centers, Rural Health Centers)
 United States or other high-income countries with a very high 
Human

Development Index

Key Questions 5-6

Population
Adults (>=18 years) with T2DM who have undergone primary diabetes 
education

Interventions

 Multicomponent behavioral programs that include at least one 
of:
    [cir] Diabetes self-management education; OR
    [cir] Structured dietary intervention (related to any of weight 
loss, glycemic control, or reducing risk for complications) together 
with one or more additional components; OR
    [cir] Structured exercise/physical activity intervention together 
with one or more additional components.
    [cir] Additional components may include interventions related to: 
diet or physical activity, behavioral change (including but not limited 
to: Goal setting, problem solving, motivational interviewing, coping 
skills training, cognitive behavioral therapy strategies), relaxation 
or stress reduction, blood glucose awareness, medication adherence, or 
self-monitoring for diabetic complications (foot, eye, and renal 
tests).
 Repeated provision by one or more trained individuals
 Duration of intervention: Minimum 4 weeks

Comparators

 Usual or standard care or an active comparator (e.g., 
behavioral program or intervention) as reported for studies
 Delivery methods (personnel, intensity, communication methods 
etc.) as reported for studies

Outcomes

 Behavioral outcomes
    [cir] Change in physical activity (e.g., volume of activity per 
week) or fitness (e.g., cardiorespiratory fitness, strength)
    [cir] Change in dietary or nutrient intake (i.e., energy intake, 
saturated fat consumption)
    [cir] Adherence to medication
 Clinical outcomes
    [cir] Glycemic control (Hemoglobin Mc)
    [cir] Change in body composition (i.e., weight, Body Mass Index, 
waist circumference, % body fat)
    [cir] Control of blood pressure and lipids
    [cir] Sleep apnea or sleep quality
    [cir] Development or control of depression or anxiety
 Health outcomes
    [cir] Quality of life (e.g., validated tools for health-related 
quality of life, life satisfaction, psychosocial adaptation to illness, 
patient satisfaction)
    [cir] Development of micro- and macrovascular complications (i.e., 
retinopathy, nephropathy, neuropathy, cardiovascular outcomes)
    [cir] Mortality (all-cause)
 Diabetes-related health care utilization
    [cir] Hospital admissions
    [cir] Length of stay in hospital
    [cir] Emergency department admissions
    [cir] Visits to specialist clinics
 Program acceptability as measured by participant attrition 
rates

Timing

Any length of followup

Study design

Randomized controlled trials

Settings

 Community health setting (i.e., ambulatory care clinics, 
outpatient clinics, primary care clinics, family physician clinics, 
Community Health Centers, Rural Health Centers)
 United States or other high-income country with a very high 
Human Development Index

Language

English

    Dated: July 3, 2014.
Richard Kronick,
AHRQ Director.
[FR Doc. 2014-16669 Filed 7-18-14; 8:45 am]
BILLING CODE 4160-90-M