Scientific Information Request on Pressure Ulcer Treatment Medical Devices, 74789-74790 [2011-30796]

Download as PDF Federal Register / Vol. 76, No. 231 / Thursday, December 1, 2011 / Notices Background The Patient Safety Act authorizes the listing of PSOs, which are entities or component organizations whose mission and primary activity is to conduct activities to improve patient safety and the quality of health care delivery. HHS issued the Patient Safety Rule to implement the Patient Safety Act. AHRQ administers the provisions of the Patient Safety Act and Patient Safety Rule (PDF file, 450 KB. PDF Help) relating to the listing and operation of PSOs. Section 3.108(d) of the Patient Safety Rule requires AHRQ to provide public notice when it removes an organization from the list of federally approved PSOs. AHRQ has accepted a notification from HealthWatch, Inc., PSO number P0010, which is a component entity of Quality Health Strategies, Inc., to voluntarily relinquish its status as a PSO. Accordingly, HealthWatch, Inc. was delisted effective at 12 Midnight ET (2400) on November 1, 2011. More information on PSOs can be obtained through AHRQ’s PSO Web site at http://www.pso.AHRQ.gov/ index.html. Dated: November 16, 2011. Carolyn M. Clancy, Director. BILLING CODE 4160–90–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Scientific Information Request on Pressure Ulcer Treatment Medical Devices 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 manufacturers of pressure ulcer treatment medical devices, such as (but not limited to): Ultrasonic wound care systems, negative pressure therapy units, turning & positioning systems, special mattresses, mattress covers, pillows, cushions, etc. Scientific information is being solicited to inform our Pressure Ulcer Treatment Strategies: A Comparative Effectiveness Review, which is currently being conducted by the Evidence-based Practice Centers for the AHRQ Effective Health Care Program. Access to published and emcdonald on DSK5VPTVN1PROD with NOTICES VerDate Mar<15>2010 17:34 Nov 30, 2011 Jkt 226001 In accordance with Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108–173, the Agency for Healthcare Research and Quality has commissioned the Effective Health Care (EHC) Program Evidence-based Practice Centers to complete a comparative effectiveness review of the evidence for pressure ulcer treatment strategies. 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 systematically requesting information (e.g., details of studies conducted) from medical device industry stakeholders through public information requests, including via the Federal Register and direct postal and/ or online solicitations. We are looking for studies that report on pressure ulcer treatment strategies, including those that describe adverse events, as specified in the key questions detailed below. The entire research protocol, including the key questions, is also available online at: http://effective healthcare.AHRQ.gov/index.cfm/search -for-guides-reviews-and-reports/ ?pageaction=displayproduct&productid =838#3870. SUPPLEMENTARY INFORMATION: [FR Doc. 2011–30798 Filed 11–30–11; 8:45 a.m.] SUMMARY: unpublished pertinent scientific information on these devices will improve the quality of this comparative effectiveness review. AHRQ is requesting this scientific information and conducting this comparative effectiveness review pursuant to Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108–173. DATES: Submission Deadline on or before January 3, 2012. ADDRESSES: Online submissions: http:// effectivehealthcare.AHRQ.gov/ index.cfm/submitscientific-informationpackets/. Please select the study for which you are submitting information from the list of current studies and complete the form to upload your documents. Email submissions: ehcsrc@ ohsu.edu (please do not send zipped files—they are automatically deleted for security reasons). Print submissions: Robin Paynter, Oregon Health and Science University, Oregon Evidence-based Practice Center, 3181 SW Sam Jackson Park Road, Mail Code: BICC, Portland, OR 97239–3098. FOR FURTHER INFORMATION CONTACT: Robin Paynter, Research Librarian, Telephone: (503) 494–0147 or Email: ehcsrc@ohsu.edu. PO 00000 Frm 00019 Fmt 4703 Sfmt 4703 74789 This notice is a request for industry stakeholders to submit the following: • A current product label, if applicable (preferably an electronic PDF file). • Information identifying published randomized controlled trials and observational studies relevant to the clinical outcomes. Please provide both a list of citations and reprints if possible. • Information identifying unpublished randomized controlled trials and observational studies relevant to the clinical outcomes. If possible, please provide a summary that includes 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 withdrawn/follow-up/ analyzed, and effectiveness/efficacy and safety results. • Registered ClinicalTrials.gov studies. Please provide a list including the ClinicalTrials.gov identifier, condition, and intervention. Your contribution is very beneficial to this program. AHRQ is not requesting and will not consider marketing material, health economics information, or information on other indications. This is a voluntary request for information, and all costs for complying with this request must be borne by the submitter. In addition to your scientific information please submit an index document outlining the relevant information in each file along with a statement regarding whether or not the submission comprises all of the complete information available. Please Note: The contents of all submissions, regardless of format, will be available to the public upon request unless prohibited by law. 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 Key Questions A preliminary set of KQs was posted on the Effective Health Care Program Web site of the Agency for Healthcare Research and Quality (AHRQ), and public comments were collected and evaluated. A Summary of the Public Comments Most of the public comments addressed specific patient or treatment characteristics and settings. Commenters suggested that the review E:\FR\FM\01DEN1.SGM 01DEN1 74790 Federal Register / Vol. 76, No. 231 / Thursday, December 1, 2011 / Notices should address combinations of treatments, co-morbid conditions, and ulcer characteristics that require an individualized approach to treatment. These comments led us to expand the potential range of treatments evaluated in the review. Because treatment goals for patients in hospice care differ widely from patients with pressure ulcers in other settings (wound healing may not be a goal of hospice care), we excluded hospice from the list of care settings to be reviewed. The final set of KQs is as follows: Final Key Questions Question 1 In adults with pressure ulcers, what is the comparative effectiveness of treatment strategies for improved health outcomes including but not limited to: Complete wound healing, healing time, reduced wound surface area, pain, and prevention of serious complications of infection? Question 1a Does the comparative effectiveness of treatment strategies differ according to features of the pressure ulcers, such as anatomic site or severity at baseline? Question 1b Does the comparative effectiveness of treatment strategies differ according to patient characteristics, including but not limited to: Age; race/ethnicity; body weight; specific medical co-morbidities; and known risk factors for pressure ulcers, such as functional ability, nutritional status, or incontinence? Question 1c Does the comparative effectiveness of treatment strategies differ according to patient care settings such as home, nursing facility, or hospital, or according to features of patient care settings, including but not limited to nurse/patient staffing ratio, staff education and training in wound care, the use of wound care teams, and home caregiver support and training? emcdonald on DSK5VPTVN1PROD with NOTICES Question 2 What are the harms of treatments for pressure ulcers? Question 2a Do the harms of treatment strategies differ according to features of the pressure ulcers, such as anatomic site or severity at baseline? Question 2b Do the harms of treatment strategies differ according to patient characteristics, including: Age, race/ ethnicity; body weight; specific medical VerDate Mar<15>2010 17:34 Nov 30, 2011 Jkt 226001 co-morbidities; and knows risk factors for pressure ulcers, such as functional ability, nutritional status, or incontinence? Question 2c DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0327] Do the harms of treatment strategies differ according to patient care settings such as home, nursing facility, or hospital, or according to features of patient care settings, including but not limited to nurse/patient staffing ratio, staff education and training in wound care, the use of wound care teams, and home caregiver support and training? The following PICOTS were identified for each KQ and include: Population Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Generic Clearance for the Collection of Qualitative Feedback on FDA Service Delivery AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Generic Clearance for the Collection of Qualitative Feedback on FDA Service Delivery’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. SUMMARY: • Adults ages 18 and older with pressure ulcers. Interventions • Various treatment strategies for pressure ulcers including but not limited to therapies that address the underlying contributing factors (e.g., support surfaces and nutritional supplements); therapies that address local wound care (e.g., absorbent wound dressings and biological agents); surgical repair; and adjunctive therapies (e.g., physical therapy). • Combined treatment modalities (co-interventions) will also be evaluated (such as comparing two treatments in combination with a single treatment). Comparators • Placebo or active control, usual care, or other interventions. Outcomes • For effectiveness: Complete wound healing, healing time, reduced wound surface area, pain, and prevention of serious complications of infection. • For harms of treatment: Pain, dermatologic complications, bleeding, and infection. Timing • Any duration of follow-up. Settings • Patient care settings, such as home, nursing facility, or hospital. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, (301) 796– 3794, Jonnalynn.Capezzuto@fda.hhs. gov. On May 26, 2011, the Agency submitted a proposed collection of information entitled ‘‘Generic Clearance for the Collection of Qualitative Feedback on FDA Service Delivery’’ to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0697. The approval expires on November 30, 2014. A copy of the supporting statement for this information collection is available on the Internet at http://www.reginfo.gov/ public/do/PRAMain. SUPPLEMENTARY INFORMATION: Dated: November 25, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–30877 Filed 11–30–11; 8:45 am] Dated: November 16, 2011. Carolyn M. Clancy, AHRQ, Director. BILLING CODE 4160–01–P [FR Doc. 2011–30796 Filed 11–30–11; 8:45 am] BILLING CODE 4160–90–M PO 00000 Frm 00020 Fmt 4703 Sfmt 9990 E:\FR\FM\01DEN1.SGM 01DEN1

Agencies

[Federal Register Volume 76, Number 231 (Thursday, December 1, 2011)]
[Notices]
[Pages 74789-74790]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-30796]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Scientific Information Request on Pressure Ulcer Treatment 
Medical Devices

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 manufacturers of 
pressure ulcer treatment medical devices, such as (but not limited to): 
Ultrasonic wound care systems, negative pressure therapy units, turning 
& positioning systems, special mattresses, mattress covers, pillows, 
cushions, etc. Scientific information is being solicited to inform our 
Pressure Ulcer Treatment Strategies: A Comparative Effectiveness 
Review, 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 on these 
devices will improve the quality of this comparative effectiveness 
review. AHRQ is requesting this scientific information and conducting 
this comparative effectiveness review pursuant to Section 1013 of the 
Medicare Prescription Drug, Improvement, and Modernization Act of 2003, 
Public Law 108-173.

DATES: Submission Deadline on or before January 3, 2012.

ADDRESSES: Online submissions: http://effectivehealthcare.AHRQ.gov/index.cfm/submitscientific-information-packets/. Please select the 
study for which you are submitting information from the list of current 
studies and complete the form to upload your documents. Email 
submissions: ehcsrc@ohsu.edu (please do not send zipped files--they are 
automatically deleted for security reasons).
    Print submissions: Robin Paynter, Oregon Health and Science 
University, Oregon Evidence-based Practice Center, 3181 SW Sam Jackson 
Park Road, Mail Code: BICC, Portland, OR 97239-3098.

FOR FURTHER INFORMATION CONTACT: Robin Paynter, Research Librarian, 
Telephone: (503) 494-0147 or Email: ehcsrc@ohsu.edu.

SUPPLEMENTARY INFORMATION: In accordance with Section 1013 of the 
Medicare Prescription Drug, Improvement, and Modernization Act of 2003, 
Public Law 108-173, the Agency for Healthcare Research and Quality has 
commissioned the Effective Health Care (EHC) Program Evidence-based 
Practice Centers to complete a comparative effectiveness review of the 
evidence for pressure ulcer treatment strategies.
    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 systematically requesting 
information (e.g., details of studies conducted) from medical device 
industry stakeholders through public information requests, including 
via the Federal Register and direct postal and/or online solicitations. 
We are looking for studies that report on pressure ulcer treatment 
strategies, including those that describe adverse events, as specified 
in the key questions detailed below. The entire research protocol, 
including the key questions, is also available online at: http://effectivehealthcare.AHRQ.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productid=838#3870.
    This notice is a request for industry stakeholders to submit the 
following:
     A current product label, if applicable (preferably an 
electronic PDF file).
     Information identifying published randomized controlled 
trials and observational studies relevant to the clinical outcomes. 
Please provide both a list of citations and reprints if possible.
     Information identifying unpublished randomized controlled 
trials and observational studies relevant to the clinical outcomes. If 
possible, please provide a summary that includes 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 withdrawn/follow-
up/analyzed, and effectiveness/efficacy and safety results.
     Registered ClinicalTrials.gov studies. Please provide a 
list including the ClinicalTrials.gov identifier, condition, and 
intervention.
    Your contribution is very beneficial to this program. AHRQ is not 
requesting and will not consider marketing material, health economics 
information, or information on other indications. This is a voluntary 
request for information, and all costs for complying with this request 
must be borne by the submitter. In addition to your scientific 
information please submit an index document outlining the relevant 
information in each file along with a statement regarding whether or 
not the submission comprises all of the complete information available.

    Please Note: The contents of all submissions, regardless of 
format, will be available to the public upon request unless 
prohibited by law.
    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 Key Questions

    A preliminary set of KQs was posted on the Effective Health Care 
Program Web site of the Agency for Healthcare Research and Quality 
(AHRQ), and public comments were collected and evaluated.

A Summary of the Public Comments

    Most of the public comments addressed specific patient or treatment 
characteristics and settings. Commenters suggested that the review

[[Page 74790]]

should address combinations of treatments, co-morbid conditions, and 
ulcer characteristics that require an individualized approach to 
treatment. These comments led us to expand the potential range of 
treatments evaluated in the review. Because treatment goals for 
patients in hospice care differ widely from patients with pressure 
ulcers in other settings (wound healing may not be a goal of hospice 
care), we excluded hospice from the list of care settings to be 
reviewed. The final set of KQs is as follows:

Final Key Questions

Question 1

    In adults with pressure ulcers, what is the comparative 
effectiveness of treatment strategies for improved health outcomes 
including but not limited to: Complete wound healing, healing time, 
reduced wound surface area, pain, and prevention of serious 
complications of infection?
Question 1a
    Does the comparative effectiveness of treatment strategies differ 
according to features of the pressure ulcers, such as anatomic site or 
severity at baseline?
Question 1b
    Does the comparative effectiveness of treatment strategies differ 
according to patient characteristics, including but not limited to: 
Age; race/ethnicity; body weight; specific medical co-morbidities; and 
known risk factors for pressure ulcers, such as functional ability, 
nutritional status, or incontinence?
Question 1c
    Does the comparative effectiveness of treatment strategies differ 
according to patient care settings such as home, nursing facility, or 
hospital, or according to features of patient care settings, including 
but not limited to nurse/patient staffing ratio, staff education and 
training in wound care, the use of wound care teams, and home caregiver 
support and training?

Question 2

    What are the harms of treatments for pressure ulcers?
Question 2a
    Do the harms of treatment strategies differ according to features 
of the pressure ulcers, such as anatomic site or severity at baseline?
Question 2b
    Do the harms of treatment strategies differ according to patient 
characteristics, including: Age, race/ethnicity; body weight; specific 
medical co-morbidities; and knows risk factors for pressure ulcers, 
such as functional ability, nutritional status, or incontinence?
Question 2c
    Do the harms of treatment strategies differ according to patient 
care settings such as home, nursing facility, or hospital, or according 
to features of patient care settings, including but not limited to 
nurse/patient staffing ratio, staff education and training in wound 
care, the use of wound care teams, and home caregiver support and 
training?
    The following PICOTS were identified for each KQ and include:
Population
     Adults ages 18 and older with pressure ulcers.
Interventions
     Various treatment strategies for pressure ulcers including 
but not limited to therapies that address the underlying contributing 
factors (e.g., support surfaces and nutritional supplements); therapies 
that address local wound care (e.g., absorbent wound dressings and 
biological agents); surgical repair; and adjunctive therapies (e.g., 
physical therapy).
     Combined treatment modalities (co-interventions) will also 
be evaluated (such as comparing two treatments in combination with a 
single treatment).
Comparators
     Placebo or active control, usual care, or other 
interventions.
Outcomes
     For effectiveness: Complete wound healing, healing time, 
reduced wound surface area, pain, and prevention of serious 
complications of infection.
     For harms of treatment: Pain, dermatologic complications, 
bleeding, and infection.
Timing
     Any duration of follow-up.
Settings
     Patient care settings, such as home, nursing facility, or 
hospital.

    Dated: November 16, 2011.
Carolyn M. Clancy,
AHRQ, Director.
[FR Doc. 2011-30796 Filed 11-30-11; 8:45 am]
BILLING CODE 4160-90-M