[Federal Register Volume 79, Number 139 (Monday, July 21, 2014)]
[Notices]
[Pages 42324-42326]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-16669]
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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.
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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 Access to published and unpublished pertinent scientific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