Drugs commonly associated with weight change: umbrella systematic review and meta-analysis (Protocol)

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Abstract

Background

Many drugs and treatments given to patients for various reasons affect their weight. This side effect is of great importance to patients and is also a concern for the treating physician because weight change may lead to the emergence or worsening of other health conditions.

Objective

The aim of this study is to summarize the evidence about commonly prescribed drugs and their association with weight change.

Methods/Design

Umbrella systematic review and meta-analysis of randomized controlled trials.

We will use an umbrella approach to identify eligible randomized controlled trials (RCTs). We will search for systematic reviews of RCTs that compare any of the drugs that have been associated with weight gain (obesogenic) or weight loss (leptogenic); these have been summarized by our experts’ panel in a predefined list. Two reviewers will independently determine RCT eligibility. Disagreement will be solved by consensus and arbitrated by a third reviewer. We will extract descriptive, methodological, and efficacy data in duplicate. Our primary continuous outcomes will be weight loss or gain expressed as a mean difference (MD) for weight (kg) or BMI (kg/m ²). We will calculate the MD considering the mean difference in weight or BMI between baseline and the last available follow-up in both study arms (drugs and placebo). Our primary dichotomous outcome, presented as a relative risk, will compare the ratio of the incidence of weight change in each trial arm. When possible, results will be pooled using classic random-effects meta-analyses and a summary estimate with 95% confidence interval will provided. We will use the I ² statistic and Cochran’s Q test to assess heterogeneity. The risk of bias will be assessed using the Cochrane risk of bias tool. Publication bias, if appropriate, will be evaluated, as well as overall strength of the evidence.

Discussion

This systematic review will offer the opportunity to generate a ranking of commonly prescribed drugs in terms of their effect on weight, allowing guideline developers and patient-physician dyad to choose between available therapies.

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Most cited references 8

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The impact of outcome reporting bias in randomised controlled trials on a cohort of systematic reviews.

Rebecca MD Smyth, Susanna Dodd, Carrol Gamble … (2009)

To examine the prevalence of outcome reporting bias-the selection for publication of a subset of the original recorded outcome variables on the basis of the results-and its impact on Cochrane reviews. A nine point classification system for missing outcome data in randomised trials was developed and applied to the trials assessed in a large, unselected cohort of Cochrane systematic reviews. Researchers who conducted the trials were contacted and the reason sought for the non-reporting of data. A sensitivity analysis was undertaken to assess the impact of outcome reporting bias on reviews that included a single meta-analysis of the review primary outcome. More than half (157/283 (55%)) the reviews did not include full data for the review primary outcome of interest from all eligible trials. The median amount of review outcome data missing for any reason was 10%, whereas 50% or more of the potential data were missing in 70 (25%) reviews. It was clear from the publications for 155 (6%) of the 2486 assessable trials that the researchers had measured and analysed the review primary outcome but did not report or only partially reported the results. For reports that did not mention the review primary outcome, our classification regarding the presence of outcome reporting bias was shown to have a sensitivity of 88% (95% CI 65% to 100%) and specificity of 80% (95% CI 69% to 90%) on the basis of responses from 62 trialists. A third of Cochrane reviews (96/283 (34%)) contained at least one trial with high suspicion of outcome reporting bias for the review primary outcome. In a sensitivity analysis undertaken for 81 reviews with a single meta-analysis of the primary outcome of interest, the treatment effect estimate was reduced by 20% or more in 19 (23%). Of the 42 meta-analyses with a statistically significant result only, eight (19%) became non-significant after adjustment for outcome reporting bias and 11 (26%) would have overestimated the treatment effect by 20% or more. Outcome reporting bias is an under-recognised problem that affects the conclusions in a substantial proportion of Cochrane reviews. Individuals conducting systematic reviews need to address explicitly the issue of missing outcome data for their review to be considered a reliable source of evidence. Extra care is required during data extraction, reviewers should identify when a trial reports that an outcome was measured but no results were reported or events observed, and contact with trialists should be encouraged.

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A case for clarity, consistency, and helpfulness: state-of-the-art clinical practice guidelines in endocrinology using the grading of recommendations, assessment, development, and evaluation system.

A Schünemann, Robert Vigersky, Regina Kunz … (2008)

The Endocrine Society, and a growing number of other organizations, have adopted the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system to develop clinical practice guidelines and grade the strength of recommendations and the quality of the evidence. Despite the use of GRADE in several of The Endocrine Society's clinical practice guidelines, endocrinologists have not had access to a context-specific discussion of this system and its merits. The authors are involved in the development of the GRADE standard and its application to The Endocrine Society clinical practice guidelines. Examples were extracted from these guidelines to illustrate how this grading system enhances the quality of practice guidelines. We summarized and described the components of the GRADE system, and discussed the features of GRADE that help bring clarity and consistency to guideline documents, making them more helpful to practicing clinicians and their patients with endocrine disorders. GRADE describes the quality of the evidence using four levels: very low, low, moderate, and high quality. Recommendations can be either strong ("we recommend") or weak ("we suggest"), and this strength reflects the confidence that guideline panel members have that patients who receive recommended care will be better off. The separation of the quality of the evidence from the strength of the recommendation recognizes the role that values and preferences, as well as clinical and social circumstances, play in formulating practice recommendations.

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Author and article information

Journal

Journal ID (nlm-ta): Syst Rev

Journal ID (iso-abbrev): Syst Rev

Title: Systematic Reviews

Publisher: BioMed Central

ISSN (Electronic): 2046-4053

Publication date Collection: 2012

Publication date (Electronic): 29 September 2012

Volume: 1

Page: 44

Affiliations

[1 ]Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, MN, USA

[2 ]Unidad de Conocimiento y Evidencia, Universidad Peruana Cayetano Heredia, Lima, Peru

[3 ]Division of Preventive, Occupational and Aerospace Medicine, Mayo Clinic, Rochester, MN, USA

[4 ]Division of Endocrinology, Diabetes, Metabolism, Nutrition, Mayo Clinic, Rochester, MN, USA

[5 ]Division of General Internal Medicine, Mayo Clinic, Rochester, MN, USA

[6 ]Mayo Clinic Libraries, Mayo Clinic, Rochester, MN, USA

[7 ]Mayo Clinic, The Knowledge and Evaluation Research Unit, 200 First Street SW, Rochester, MN, 55905, USA

Article

Publisher ID: 2046-4053-1-44

DOI: 10.1186/2046-4053-1-44

PMC ID: 3582551

PubMed ID: 23020969

SO-VID: 57378118-10b5-4a1f-9e97-597384f6376d

License:

This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

History

Date received : 30 May 2012

Date accepted : 24 September 2012

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Drugs commonly associated with weight change: umbrella systematic review and meta-analysis (Protocol)

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Abstract

Background

Objective

Methods/Design

Discussion

Related collections

Climate Change and Human Health

Most cited references 8

Intention-to-treat principle.

The impact of outcome reporting bias in randomised controlled trials on a cohort of systematic reviews.

A case for clarity, consistency, and helpfulness: state-of-the-art clinical practice guidelines in endocrinology using the grading of recommendations, assessment, development, and evaluation system.

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Cited by 6