Behavioral Programs for Diabetes Mellitus

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Strength of the Body of Evidence We followed the Methods Guide 59 to evaluate the strength of evidence (SOE) for KQ 1 for all health outcomes (i.e., quality of life, development of micro- and macrovascular complications, all-cause mortality) and selected behavioral and clinical outcomes (i.e., glycemic control, adherence to diabetes self-management behaviors, change in body composition, change in physical activity or fitness, and change in dietary or nutrient intake). For KQ 2, we assessed SOE for HbA 1c which was the outcome reported by the most studies and thus the focus of this KQ. SOE assessments were based on evidence from trials. The body of evidence was graded by one reviewer, and reviewed by a second reviewer. Disagreements were resolved through discussion or by consulting with a third reviewer, as needed. We examined the five core domains most relevant to reviews of RCTs (anticipated to be the large majority of included studies): risk of bias, consistency, directness, precision, and reporting bias. We defined the risk of bias (low, medium, or high) on the basis of study design and methodological quality. We rated consistency (consistent, inconsistent, unknown [if there is only one study]) by assessing the direction and magnitude of the effects of the included studies. We assessed directness of the evidence (direct or indirect) on the basis of the use of surrogate outcomes or the need for indirect comparisons. We assessed precision (precise or imprecise) on the basis of the degree of certainty surrounding the effect estimate and based on sample size; for outcomes where clinically important thresholds were prespecified (i.e., HbA 1c , HRQL, behavioral outcomes with continuous data), we downgraded the SOE twice for imprecision when the 95% CI crossed thresholds both for and against behavioral programs. A precise estimate is one that allows for a clinically useful conclusion. Reporting bias (suspected or unsuspected) was evaluated with respect to publication bias, selective outcome reporting bias, and selective analysis reporting bias. For selective reporting and analysis biases, we evaluated the results across studies qualitatively on the basis of completeness of reporting for individual studies and reporting patterns across studies. We rated the body of evidence using four SOE grades which indicate our level of confidence that the evidence reflects the true effect for the major comparisons of interest: • High. Very confident that the estimate of effect lies close to the true effect for this outcome. The body of evidence has few or no deficiencies; the findings are stable, i.e., another study would not change the conclusions. • Moderate. We are moderately confident that the estimate of effect lies close to the true effect for this outcome. The body of evidence has some deficiencies; the findings are likely to be stable, but some doubt remains. • Low. We have limited confidence that the estimate of effect lies close to the true effect for this outcome. The body of evidence has major or numerous deficiencies (or both); additional evidence is needed before concluding either that the findings are stable or that the estimate of effect is close to the true effect. • Insufficient. We have no (or very little) evidence, we are unable to estimate an effect, or we have no confidence in the estimate of effect for this outcome (i.e., the 95% CI of the effect estimate includes values representing clinically important magnitudes favoring both behavioral programs and the comparator). We did not assess SOE for the KQs 3-6. KQ 4 assesses harms, which was a minor focus of this review. KQs 5 and 6 explore factors that may be associated with the effectiveness of behavioral programs; there is no precedent for SOE assessments for these types of questions. 22
Applicability We followed the Methods Guide to evaluate the applicability of the evidence to the delivery setting of interest (i.e., community health settings). 59 We considered important population characteristics, behavioral program characteristics, and delivery settings that may limit applicability of the findings. Factors that may limit the applicability include narrow eligibility criteria, components or delivery elements of behavioral programs that may not be feasible in some settings, and health system differences. Peer Review and Public Commentary Experts in behavioral medicine, diabetes education, clinical epidemiology, nutrition, physical education, psychology, and statistics fields, and individuals representing stakeholder and user communities were invited to provide external peer review of this report; AHRQ and an associate editor also provided comments. The draft report was posted on the AHRQ website for 4 weeks to elicit public comment. We addressed all reviewer comments, revising the text as appropriate, and documented everything in a disposition of comments report that will be made available 3 months after the Agency posts the final report on the AHRQ Effective Healthcare website. 23
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Evidence Report/Technology Assessme
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This report is based on research co
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Key Informants In designing the stu
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Peer Reviewers Prior to publication
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HbA 1c reduction were more often de
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KQ 6. Subgroups for Factors Moderat
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Figure 13. Behavioral programs for
Page 15 and 16: glycemia in reducing the incidence
Page 17 and 18: together with one or more additiona
Page 19 and 20: Figure A. Analytic framework for be
Page 21 and 22: Methods Literature Search Strategy
Page 23 and 24: With input from our Technical Exper
Page 25 and 26: participants had suboptimal baselin
Page 27 and 28: duration of diabetes ranged from 2.
Page 29 and 30: Table B. Type 1 diabetes: summary o
Page 31 and 32: T2DM: Description and Risk of Bias
Page 33 and 34: Figure D. Plot of network meta-anal
Page 35 and 36: The positive findings for behaviora
Page 37 and 38: elated to the Human Development Ind
Page 39 and 40: Table D. Potential research needs b
Page 41 and 42: References 1. Renders CM, Valk GD,
Page 43 and 44: 37. Chodosh J, Morton SC, Mojica W,
Page 45 and 46: Introduction Background The high bu
Page 47 and 48: Factors other than blood glucose co
Page 49 and 50: may include interventions related t
Page 51 and 52: programs. The overarching boxes (co
Page 53 and 54: Figure 2. Analytic framework for be
Page 55 and 56: American Diabetes Association, Amer
Page 57 and 58: Table 1. Inclusion criteria for typ
Page 59 and 60: S1 in the Supplementary File). The
Page 61 and 62: clinically significant); we refer t
Page 63 and 64: Synthesis for T1DM (KQs 1-4) KQ 1:
Page 65: conducted for HbA 1c and body mass
Page 69 and 70: Type 1 Diabetes Mellitus This secti
Page 71 and 72: therapy, 90,99,108 motivational enh
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Page 75 and 76: followup (low SOE for both); there
Page 77 and 78: Figure 6. Behavioral programs for t
Page 79 and 80: similar results were found for yout
Page 81 and 82: HbA 1c : Comparative Effectiveness
Page 83 and 84: Two trials reported on adherence to
Page 85 and 86: Table 4. Other clinical and behavio
Page 87 and 88: Figure 14. Behavioral programs for
Page 89 and 90: Health-Related Quality of Life: Beh
Page 91 and 92: estimated effects were imprecise an
Page 93 and 94: Table 8. Type 1 diabetes: summary o
Page 95 and 96: Summary of Key Findings and Strengt
Page 97 and 98: studies 82,94,95,105,109,112 were n
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Page 103 and 104: Aerobic Fitness Test which estimate
Page 105 and 106: Key Points: Body Mass Index • Lif
Page 107 and 108: Table 12. Network meta-analysis for
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Discussion Key Findings and Discuss
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to be tempered by the findings of n
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compared with usual care. There was
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Our finding that single-topic, non-
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In their systematic review and meta
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For studies targeting adults, the m
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environmental contextual factors—
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assessors was also rarely reported,
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Tailoring programs to ethnic minori
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17. Centers for Disease Control and
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53. Medical Advisory Secretariat. B
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88. Ellis DA, Templin T, Naar-King
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122. Nansel TR, Iannotti RJ, Simons
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158. Cooper H, Booth K, Gill G. A t
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191. Koo BK, Han KA, Ahn HJ, et al.
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224. Sevick MA, Korytkowski M, Ston
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260. Yuan C, Lai CW, Chan LW, et al
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295. Ayling K, Brierley S, Johnson
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Appendix A. Operational Definitions
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the structured diet or physical act
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Appendix B. Literature Search Strat
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1. MeSH descriptor: [Diabetes Melli
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35. “blood glucose” N2 monitor*
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35. (behavio?r adj2 therap*).mp. 36
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52. exp animals/ not humans.sh. 53.
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57. "Follow-Up Studies"[Mesh] 58. "
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URL provided by Michelle Crain, AAD
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WHO ICTRP Trial Registry: WHO ICTRP
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Appendix D. Studies Excluded After
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Health. 2006;6:134. PMID: 16709243.
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November/December;24(9):450-6. PMID
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89. Dinneen SF, O'hara MC, Byrne M,
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119. Fitzpatrick SL, Jeffery R, Joh
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Aug;19(8):835-42. PMID: 8842601. Ex
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adherence and metabolic control. Di
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May;36(5):1297-303. PMID: 23223405.
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244. Korytkowski MT, Koerbel GL, Ko
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275. Maljanian R, Grey N, Staff I,
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306. Naccashian Z. The impact of di
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led structured program on blood glu
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Engineering. 2014;75(1-B E). PMID:
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395. Skoro-Kondza L, Tai SS, Gadelr
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426. Torbjornsen A, Jenum AK, Smast
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Americans with type 2 diabetes. J A
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patients. Diabetes Res Clin Pract.
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Table E1. Risk of bias for studies
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Weinger, 2011 L M NA M NA L NA L L
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Cramer, 2007 M M H M H L H H L M H
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Ridgeway, 1999 M M H M H L H H M L
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Appendix F. Description of Studies
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Author, Year & Country Comparison &
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Table F3. Description of studies an
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Appendix H. Strength of Evidence Ta
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Outcome # Trials (# Subjects); Tool
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Table H3. Behavioral programs compa
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16. Mayer-Davis EJ, Seid M, Crandel
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Table I1. Effectiveness of behavior
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Category Health Outcomes Outcomes A
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Table I2. Effectiveness of behavior
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Category Outcomes Timepoint Health
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Outcome Change in Body Composition
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Outcome Change in Physical Activity
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References for Appendix I 1. Adachi
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32. Rock CL, Flatt SW, Pakiz B, et
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follow-up study. Diabetes Res Clin
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98. Johnson ST, Bell GJ, Mccargar L
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Appendix J. Network Meta-Analysis R
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5 11-26h In person Group only NA -0
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9 11-26h In person Group only NA -0
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Behavioral Programs for Diabetes Mellitus

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