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Presentation approaches for enhancing interpretability of patient-reported outcomes (PROs) in meta-analysis: a protocol for a systematic survey of Cochrane reviews.

ABSTRACT: INTRODUCTION:Meta-analyses of clinical trials often provide sufficient information for decision-makers to evaluate whether chance can explain apparent differences between interventions. Interpretation of the magnitude and importance of treatment effects beyond statistical significance can, however, be challenging, particularly for patient-reported outcomes (PROs) measured using questionnaires with which clinicians have limited familiarity. The objectives of our study are to systematically evaluate Cochrane systematic review authors' approaches to calculation, reporting and interpretation of pooled estimates of patient-reported outcome measures (PROMs) in meta-analyses. METHODS AND ANALYSIS:We will conduct a methodological survey of a random sample of Cochrane systematic reviews published from 1 January 2015 to 1 April 2017 that report at least one statistically significant pooled result for at least one PRO in the abstract. Author pairs will independently review all titles, abstracts and full texts identified by the literature search, and they will extract data using a standardised data extraction form. We will extract the following: year of publication, number of included trials, number of included participants, clinical area, type of intervention(s) and control(s), type of meta-analysis and use of the Grading of Recommendations, Assessment, Development and Evaluation approach to rate the quality of evidence, as well as information regarding the characteristics of PROMs, calculation and presentation of PROM effect estimates and interpretation of PROM effect estimates. We will document and summarise the methods used for the analysis, reporting and interpretation of each summary effect measure. We will summarise categorical variables with frequencies and percentages and continuous outcomes as means and/or medians and associated measures of dispersion. ETHICS AND DISSEMINATION:Ethics approval for this study is not required. We will disseminate the results of this review in peer-reviewed publications and conference presentations.

SUBMITTER: Devji T

PROVIDER: S-EPMC5623559 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature

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Presentation approaches for enhancing interpretability of patient-reported outcomes (PROs) in meta-analysis: a protocol for a systematic survey of Cochrane reviews.

Devji Tahira T Johnston Bradley C BC Patrick Donald L DL Bhandari Mohit M Thabane Lehana L Guyatt Gordon H GH

BMJ open 20170927 9

<h4>Introduction</h4>Meta-analyses of clinical trials often provide sufficient information for decision-makers to evaluate whether chance can explain apparent differences between interventions. Interpretation of the magnitude and importance of treatment effects beyond statistical significance can, however, be challenging, particularly for patient-reported outcomes (PROs) measured using questionnaires with which clinicians have limited familiarity. The objectives of our study are to systematicall ...[more]

PMID: 28963296

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Project description:BackgroundIn contemporary medical research, randomised controlled trials are seen as the gold standard for establishing treatment effects where it is ethical and practical to conduct them. In palliative care such trials are often impractical, unethical, or extremely difficult, with multiple methodological problems. We review the utility of Cochrane reviews in informing palliative care practice.MethodsPublished reviews in palliative care registered with the Cochrane Pain, Palliative and Supportive Care Group as of December 2007 were obtained from the Cochrane Database of Systematic Reviews, issue 1, 2008. We reviewed the quality and quantity of primary studies available for each review, assessed the quality of the review process, and judged the strength of the evidence presented. There was no prior intention to perform any statistical analyses.Results25 published systematic reviews were identified. Numbers of included trials ranged from none to 54. Within each review, included trials were heterogeneous with respect to patients, interventions, and outcomes, and the number of patients contributing to any single analysis was generally much lower than the total included in the review. A variety of tools were used to assess trial quality; seven reviews did not use this information to exclude low quality studies, weight analyses, or perform sensitivity analysis for effect of low quality. Authors indicated that there were frequently major problems with the primary studies, individually or in aggregate. Our judgment was that the reviewing process was generally good in these reviews, and that conclusions were limited by the number, size, quality and validity of the primary studies.We judged the evidence about 23 of the 25 interventions to be weak. Two reviews had stronger evidence, but with limitations due to methodological heterogeneity or definition of outcomes. No review provided strong evidence of no effect.ConclusionCochrane reviews in palliative care are well performed, but fail to provide good evidence for clinical practice because the primary studies are few in number, small, clinically heterogeneous, and of poor quality and external validity. They are useful in highlighting the weakness of the evidence base and problems in performing trials in palliative care.

Project description:BACKGROUND:Despite the growing reputation and subject coverage of the Cochrane Database of Systematic Reviews, many systematic reviews continue to be published solely in paper-based health care journals. This study was designed to determine why authors choose to publish their systematic reviews outside of the Cochrane Collaboration and if they might be interested in converting their reviews to Cochrane format for publication in the Cochrane Database of Systematic Reviews. METHODS:Cross-sectional survey of Australian primary authors of systematic reviews not published on the Cochrane Database of Systematic Reviews identified from the Database of Abstracts of Reviews of Effectiveness. RESULTS:We identified 88 systematic reviews from the Database of Abstracts of Reviews of Effectiveness with an Australian as the primary author. We surveyed 52 authors for whom valid contact information was available. The response rate was 88 per cent (46/52). Ten authors replied without completing the survey, leaving 36 valid surveys for analysis. The most frequently cited reasons for not undertaking a Cochrane review were: lack of time (78%), the need to undergo specific Cochrane training (46%), unwillingness to update reviews (36%), difficulties with the Cochrane process (26%) and the review topic already registered with the Cochrane Collaboration (21%). (Percentages based on completed responses to individual questions.) Nearly half the respondents would consider converting their review to Cochrane format. Dedicated time emerged as the most important factor in facilitating the potential conversion process. Other factors included navigating the Cochrane system, assistance with updating and financial support. Eighty-six per cent were willing to have their review converted to Cochrane format by another author. CONCLUSION:Time required to complete a Cochrane review and the need for specific training are the primary reasons why some authors publish systematic reviews outside of the Cochrane Collaboration. Encouragingly, almost half of the authors would consider converting their review to Cochrane format. Based on the current number of reviews in the Database of Abstracts of Reviews of Effectiveness, this could result in more than 700 additional Cochrane reviews. Ways of supporting these authors and how to provide dedicated time to convert systematic reviews needs further consideration.

Project description:BACKGROUND: Eczema is the most common inflammatory skin disease of childhood, characterized by an itchy red rash that usually involves the face and skin folds. There is currently no curative treatment for eczema, so the reduction of eczema incidence through disease prevention is a desirable goal. Potential interventions for preventing eczema include exclusive breastfeeding, hydrolysed protein formulas and soy formulas when bottle feeding, maternal antigen avoidance, omega oil supplementation, prebiotics and probiotics. OBJECTIVES: This overview of reviews aims to present the current body of data from Cochrane and non-Cochrane reviews to provide the most up-to-date evidence on the efficacy and safety of interventions to prevent eczema in infants and children at different risk levels for developing allergic disease. METHODS: Our pool of Cochrane and non-Cochrane reviews came from the 2010 United Kingdom National Health Service (NHS) Evidence Skin Disorders Annual Evidence Updates Mapping Exercise on Atopic Eczema. This group used a comprehensive search strategy last conducted in August 2010 to identify all systematic reviews on eczema prevention. We identified all reviews that met our pre-specified inclusion criteria, and data were extracted, analysed, compiled into tables and synthesized using quantitative and qualitative methods. MAIN RESULTS: Seven systematic reviews containing 39 relevant trials with 11 897 participants were included in this overview. Overall, there was no clear evidence that any of the main interventions reviewed reduced eczema incidence. In subgroup analyses of infants at high risk of allergic disease, an observational study found that exclusive breastfeeding for at least six months compared with introduction of solids at three to six months decreased the incidence of eczema by 60% (risk ratio (RR): 0.40; 95% confidence interval (CI): 0.21, 0.78), and a randomized controlled trial found that prebiotics compared with no prebiotics decreased incidence by 58% (RR: 0.42; 95% CI: 0.21, 0.84). However, each of these findings was based on the results of a single small trial, and no intervention reduced eczema incidence beyond the first two years of life. Although we pre-specified incidence of atopic eczema (i.e. eczema associated with immunoglobulin E (IgE) sensitization) as a primary outcome, data on whether participants diagnosed with eczema were truly atopic were largely lacking from systematic reviews. Similarly, data on atopy, measured using skin prick tests or specific IgE tests to allergens, were not reported in many reviews. No interventions were found to decrease atopy when reported. Adverse events data were generally lacking, but data from a trial of probiotics versus no probiotics showed significantly more spitting up in the first one (RR: 1.88; 95% CI: 1.03, 3.45) and two (RR: 1.69; 95% CI: 1.02, 2.80) months of life, but no overall increase in risk of gastrointestinal symptoms in the first year. AUTHORS#ENTITYSTARTX02019; CONCLUSIONS: Although there is currently no clear evidence showing that any of the interventions examined in this overview prevent eczema in participants not selected for risk of allergic disease, there is some evidence that exclusive breastfeeding for at least six months and prebiotics might reduce eczema incidence in high-risk participants. However, these conclusions are based on limited evidence with methodological shortcomings. Future research on prevention of eczema is needed and should examine different types of hydrolysed formulas, prebiotics and probiotics, as well as enhancement of the skin barrier and other novel approaches in infants at different risk levels for developing allergic disease.

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Presentation approaches for enhancing interpretability of patient-reported outcomes (PROs) in meta-analysis: a protocol for a systematic survey of Cochrane reviews.

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Presentation approaches for enhancing interpretability of patient-reported outcomes (PROs) in meta-analysis: a protocol for a systematic survey of Cochrane reviews.

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