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Applying the PRECIS criteria to describe three effectiveness trials of weight loss in obese patients with comorbid conditions.

ABSTRACT: To characterize Practice-Based Opportunities for Weight Reduction (POWER) trials along the pragmatic-explanatory continuum.The POWER trials consist of three individual studies that target obesity treatment in primary care settings.Using the PRagmatic Explanatory Continuum Indicator Summary (PRECIS) criteria, nine reviewers independently scored each trial.Average and median ratings, inter-rater reliability, and relationships to additional ratings of the extent to which study designs were explanatory (i.e., efficacy) versus pragmatic (i.e., practical) and related to external validity were determined.One trial was consistently rated as being significantly more pragmatic than the others (R(2) =0.43, p< .001), although all three were in the moderate range on the PRECIS scales. Ratings varied across PRECIS dimensions, being most pragmatic on comparison condition and primary outcome. Raters, although undergoing training and using identical definitions, scored their own study as more pragmatic than the other studies/interventions.These results highlight the need for more comprehensive reporting on PRECIS and related criteria for research translation. The PRECIS criteria provide a richer understanding of the POWER studies. It is not clear whether the original criteria are sufficient to provide a comprehensive profile.

SUBMITTER: Glasgow RE

PROVIDER: S-EPMC3423177 | biostudies-other | 2012 Jun

REPOSITORIES: biostudies-other

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Applying the PRECIS criteria to describe three effectiveness trials of weight loss in obese patients with comorbid conditions.

Glasgow Russell E RE Gaglio Bridget B Bennett Gary G Jerome Gerald J GJ Yeh Hsin-Chieh HC Sarwer David B DB Appel Lawrence L Colditz Graham G Wadden Thomas A TA Wells Barbara B

Health services research 20111102 3 Pt 1

<h4>Objectives</h4>To characterize Practice-Based Opportunities for Weight Reduction (POWER) trials along the pragmatic-explanatory continuum.<h4>Settings</h4>The POWER trials consist of three individual studies that target obesity treatment in primary care settings.<h4>Design</h4>Using the PRagmatic Explanatory Continuum Indicator Summary (PRECIS) criteria, nine reviewers independently scored each trial.<h4>Methods</h4>Average and median ratings, inter-rater reliability, and relationships to ad ...[more]

PMID: 22092292

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Project description:Background. Differential gene expression in adipose tissue during diet-induced weight loss followed by a weight stability period is not well characterized. Markers of these processes may provide a deeper understanding of the underlying mechanisms. Objective. To identify differentially expressed genes in human adipose tissue during weight loss and weight maintenance after weight loss. Design. RNA from subcutaneous abdominal adipose tissue from nine obese subjects was obtained and analyzed at baseline, after weight reduction on a low calorie diet (LCD), and after a period of group therapy in order to maintain weight stability. Results. Subjects lost 18.8 + 5.4% of their body weight during the LCD and maintained this weight during group therapy. Insulin sensitivity (HOMA) improved after weight loss with no further improvement during weight maintenance. Cyclin-dependent kinase inhibitor 2B (CDKN2B) and JAZF zinc finger 1 (JAZF1), associated with type 2 diabetes, were downregulated. We could also confirm the downregulation of candidates for obesity and related traits, such as tenomodulin (TNMD) and matrix metallopeptidase 9 (MMP9), with weight loss. The expression of other candidates, such as cell death-inducing DFFA-like effector A (CIDEA) and stearoyl-CoA desaturase (SCD) were upregulated during weight loss but returned to baseline levels during weight maintenance. Conclusion. Genes in the adipose tissue are differentially expressed during weight loss and weight maintenance after weight loss. Genes that show sustained regulation may be of potential interest as markers of the beneficial effects of weight loss whereas others seem to be primarily involved in the process of weight loss itself. Nine participants were prescribed a low calorie diet (LCD) containing 1200 kcal/day for approximately three months (101 ± 26 days). Following the weight reduction phase the participants attended a six month follow-up period (167 ± 37 days). By protocol design, subjects were eligible to enter the study if they had lost at least 10% of their initial body weight during the LCD-period and maintained this weight (+5%) after group therapy. Subcutaneous adipose tissue samples were obtained at three time-points: (i) at baseline, (ii) after weight reduction when subjects were no longer losing weight, and (iii) after the group therapy weight maintenance phase.

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Applying the PRECIS criteria to describe three effectiveness trials of weight loss in obese patients with comorbid conditions.

Publications

Applying the PRECIS criteria to describe three effectiveness trials of weight loss in obese patients with comorbid conditions.

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