[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 Access to published and unpublished pertinent scientific 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