Dataset Information

Weight gain, overweight and obesity in solid organ transplantation--a study protocol for a systematic literature review.

ABSTRACT:

Background

Overweight and obesity, which have a substantial impact on health in the general population, have similar prevalence in solid organ transplant recipients but carry even more serious ramifications. As this group's use of immunosuppressive medication increases the risk for comorbidities, e.g. metabolic syndrome and cardiovascular disease, the prevention of additional risk factors is vital. This systematic review will be the first to summarize the issue of weight gain, overweight and obesity concurrently within and across solid organ transplantation. The three research questions relating to solid organ transplantation are the following: (1) What are the prevalence and evolution of overweight and obesity from pre- to post-transplant?; (2) Which pre- and post-transplant risk factors are associated with post-transplant weight gain, overweight or obesity? and (3) Which post-transplant patient outcomes and comorbidities are associated with pre- and post-transplant weight gain, overweight and obesity?

Methods/design

MEDLINE via PubMed, The Cochrane Library, Cumulative Index to Nursing and Allied Health (CINAHL), PsycINFO and Excerpta Medica DataBase (EMBASE) will be searched for original quantitative studies in adult liver, heart, lung or kidney transplant patients. Topics of interest will be the prevalence and evolution of overweight and obesity over time, risk factors associated with changes in weight or body mass index (BMI), overweight and obesity, and the relationship of weight or BMI with post-transplant outcomes and comorbidities. Screening of titles and abstracts, full-text reading and data extraction will be divided between three researchers. Researchers will cross-check one another's screening decisions for random samples of studies to adhere as closely as possible to the recommendations of The Cochrane Collaboration. For quality assessment, a purpose-adapted 19-item instrument will be used. Effect sizes will be calculated for relationships investigated in a minimum of five studies. Random effects meta-analysis with moderator analyses will be conducted if applicable.

Discussion

This systematic review will comprehensively synthesize the existing evidence concerning weight gain, overweight and obesity in solid organ transplantation in view of magnitude, influencing factors and associations with patient outcomes and comorbidities. The results can fuel the development of interventions to prevent weight gain in the solid organ transplant population.

Systematic review registration

PROSPERO CRD42014009151.

SUBMITTER: Beckmann S

PROVIDER: S-EPMC4320543 | biostudies-literature | 2015 Jan

REPOSITORIES: biostudies-literature

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Publications

Weight gain, overweight and obesity in solid organ transplantation--a study protocol for a systematic literature review.

Beckmann Sonja S Ivanović Nataša N Drent Gerda G Ruppar Todd T De Geest Sabina S

Systematic reviews 20150106

<h4>Background</h4>Overweight and obesity, which have a substantial impact on health in the general population, have similar prevalence in solid organ transplant recipients but carry even more serious ramifications. As this group's use of immunosuppressive medication increases the risk for comorbidities, e.g. metabolic syndrome and cardiovascular disease, the prevention of additional risk factors is vital. This systematic review will be the first to summarize the issue of weight gain, overweight ...[more]

PMID: 25563983

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Project description:BackgroundHigh gestational weight gain is a major public health concern as it independently predicts adverse maternal and infant outcomes. Past interventions have had only limited success in effectively managing pregnancy weight gain, especially among women with overweight and obesity. Well-designed interventions are needed that take an individualized approach and target unique barriers to promote healthy weight gain.ObjectiveThe primary aim of the study is to describe the study protocol for Healthy Mom Zone, an individually tailored, adaptive intervention for managing weight in pregnant women with overweight and obesity.MethodsThe Healthy Mom Zone Intervention, based on theories of planned behavior and self-regulation and a model of energy balance, includes components (eg, education, self-monitoring, physical activity/healthy eating behaviors) that are adapted over the intervention (ie, increase in intensity) to better regulate weight gain. Decision rules inform when to adapt the intervention. In this randomized controlled trial, women are randomized to the intervention or standard care control group. The intervention is delivered from approximately 8-36 weeks gestation and includes step-ups in dosages (ie, Step-up 1 = education + physical activity + healthy eating active learning [cooking/recipes]; Step-up 2 = Step-up 1 + portion size, physical activity; Step-up 3 = Step-up 1 + 2 + grocery store feedback, physical activity); 5 maximum adaptations. Study measures are obtained at pre- and postintervention as well as daily (eg, weight), weekly (eg, energy intake/expenditure), and monthly (eg, psychological) over the study period. Analyses will include linear mixed-effects models, generalized estimating equations, and dynamical modeling to understand between-group and within-individual effects of the intervention on weight gain.ResultsRecruitment of 31 pregnant women with overweight and obesity has occurred from January 2016 through July 2017. Baseline data have been collected for all participants. To date, 24 participants have completed the intervention and postintervention follow-up assessments, 3 are currently in progress, 1 dropped out, and 3 women had early miscarriages and are no longer active in the study. Of the 24 participants, 13 women have completed the intervention to date, of which 1 (8%, 1/13) received only the baseline intervention, 3 (23%, 3/13) received baseline + step-up 1, 6 (46%, 6/13) received baseline + step-up 1 + step-up 2, and 3 (23%, 3/13) received baseline + step-up 1 + step-up 2 +step-up 3. Data analysis is still ongoing through spring 2018.ConclusionsThis is one of the first intervention studies to use an individually tailored, adaptive design to manage weight gain in pregnancy. Results from this study will be useful in designing a larger randomized trial to examine efficacy of this intervention and developing strategies for clinical application.Registered report identifierRR1-10.2196/9220.

Project description:ObjectiveTo compare the clinical efficacy and bioequivalence of generic immunosuppressive drugs in patients with solid organ transplants.DesignSystematic review and meta-analysis of all studies comparing generic with innovator immunosuppressive drugs.Data sourcesMedline and Embase from 1980 to September 2014.Review methodsA literature search was performed for all studies comparing a generic to an innovator immunosuppressive drug in solid organ transplantation. Two reviewers independently extracted data and assessed quality of studies. Meta-analyses of prespecified outcomes were performed when deemed appropriate. Outcomes included patient survival, allograft survival, acute rejection, adverse events and bioequivalence.Results1679 citations were screened, of which 50 studies met eligibility criteria (17 randomized trials, 15 non-randomized interventional studies, and 18 observational studies). Generics were compared with Neoral (cyclosporine) (32 studies), Prograf (tacrolimus) (12 studies), and Cellcept (mycophenolate mofetil) (six studies). Pooled analysis of randomized controlled trials in patients with kidney transplants that reported bioequivalence criteria showed that Neoral (two studies) and Prograf (three studies) were not bioequivalent with generic preparations according to criteria of the European Medicines Agency. The single Cellcept trial also did not meet bioequivalence. Acute rejection was rare but did not differ between groups. For Neoral, the pooled Peto odds ratio was 1.23 (95% confidence interval 0.64 to 2.36) for kidney randomized controlled trials and 0.66 (0.40 to 1.08) for observational studies. For kidney observational studies, the pooled Peto odds ratios were 0.98 (0.37 to 2.60) for Prograf and 0.49 (0.09 to 2.56) for Cellcept. Meta-analyses for non-renal solid organ transplants were not performed because of a lack of data.There were insufficient data reported on patient or graft survival. Pooling of results was limited by inconsistent study methods and reporting of outcomes. Many studies did not report standard criteria used to determine bioequivalence. While rates of acute rejection seemed similar and were relatively rare, few studies were designed to properly compare clinical outcomes. Most studies had short follow-up times and included stable patients without a history of rejection.ConclusionsHigh quality data showing bioequivalence and clinical efficacy of generic immunosuppressive drugs in patients with transplants are lacking. Given the serious consequences of rejection and allograft failure, well designed studies on bioequivalence and safety of generic immunosuppression in transplant recipients are needed.

Dataset Information

Weight gain, overweight and obesity in solid organ transplantation--a study protocol for a systematic literature review.

Background

Methods/design

Discussion

Systematic review registration

Publications

Weight gain, overweight and obesity in solid organ transplantation--a study protocol for a systematic literature review.

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