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Using multiple types of studies in systematic reviews of health care interventions--a systematic review.

ABSTRACT: BACKGROUND: A systematic review may evaluate different aspects of a health care intervention. To accommodate the evaluation of various research questions, the inclusion of more than one study design may be necessary. One aim of this study is to find and describe articles on methodological issues concerning the incorporation of multiple types of study designs in systematic reviews on health care interventions. Another aim is to evaluate methods studies that have assessed whether reported effects differ by study types. METHODS AND FINDINGS: We searched PubMed, the Cochrane Database of Systematic Reviews, and the Cochrane Methodology Register on 31 March 2012 and identified 42 articles that reported on the integration of single or multiple study designs in systematic reviews. We summarized the contents of the articles qualitatively and assessed theoretical and empirical evidence. We found that many examples of reviews incorporating multiple types of studies exist and that every study design can serve a specific purpose. The clinical questions of a systematic review determine the types of design that are necessary or sufficient to provide the best possible answers. In a second independent search, we identified 49 studies, 31 systematic reviews and 18 trials that compared the effect sizes between randomized and nonrandomized controlled trials, which were statistically different in 35%, and not different in 53%. Twelve percent of studies reported both, different and non-different effect sizes. CONCLUSIONS: Different study designs addressing the same question yielded varying results, with differences in about half of all examples. The risk of presenting uncertain results without knowing for sure the direction and magnitude of the effect holds true for both nonrandomized and randomized controlled trials. The integration of multiple study designs in systematic reviews is required if patients should be informed on the many facets of patient relevant issues of health care interventions.

SUBMITTER: Peinemann F

PROVIDER: S-EPMC3887134 | biostudies-literature | 2013

REPOSITORIES: biostudies-literature

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Using multiple types of studies in systematic reviews of health care interventions--a systematic review.

Peinemann Frank F Tushabe Doreen Allen DA Kleijnen Jos J

PloS one 20131226 12

<h4>Background</h4>A systematic review may evaluate different aspects of a health care intervention. To accommodate the evaluation of various research questions, the inclusion of more than one study design may be necessary. One aim of this study is to find and describe articles on methodological issues concerning the incorporation of multiple types of study designs in systematic reviews on health care interventions. Another aim is to evaluate methods studies that have assessed whether reported e ...[more]

PMID: 24416098

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Project description:BackgroundThe introduction of new medical technologies such as sensors has accelerated the process of collecting patient data for relevant clinical decisions, which has led to the introduction of a new technology known as digital biomarkers.ObjectiveThis study aims to assess the methodological quality and quality of evidence from meta-analyses of digital biomarker-based interventions.MethodsThis study follows the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guideline for reporting systematic reviews, including original English publications of systematic reviews reporting meta-analyses of clinical outcomes (efficacy and safety endpoints) of digital biomarker-based interventions compared with alternative interventions without digital biomarkers. Imaging or other technologies that do not measure objective physiological or behavioral data were excluded from this study. A literature search of PubMed and the Cochrane Library was conducted, limited to 2019-2020. The quality of the methodology and evidence synthesis of the meta-analyses were assessed using AMSTAR-2 (A Measurement Tool to Assess Systematic Reviews 2) and GRADE (Grading of Recommendations, Assessment, Development, and Evaluations), respectively. This study was funded by the National Research, Development and Innovation Fund of Hungary.ResultsA total of 25 studies with 91 reported outcomes were included in the final analysis; 1 (4%), 1 (4%), and 23 (92%) studies had high, low, and critically low methodologic quality, respectively. As many as 6 clinical outcomes (7%) had high-quality evidence and 80 outcomes (88%) had moderate-quality evidence; 5 outcomes (5%) were rated with a low level of certainty, mainly due to risk of bias (85/91, 93%), inconsistency (27/91, 30%), and imprecision (27/91, 30%). There is high-quality evidence of improvements in mortality, transplant risk, cardiac arrhythmia detection, and stroke incidence with cardiac devices, albeit with low reporting quality. High-quality reviews of pedometers reported moderate-quality evidence, including effects on physical activity and BMI. No reports with high-quality evidence and high methodological quality were found.ConclusionsResearchers in this field should consider the AMSTAR-2 criteria and GRADE to produce high-quality studies in the future. In addition, patients, clinicians, and policymakers are advised to consider the results of this study before making clinical decisions regarding digital biomarkers to be informed of the degree of certainty of the various interventions investigated in this study. The results of this study should be considered with its limitations, such as the narrow time frame.International registered report identifier (irrid)RR2-10.2196/28204.

Project description:A plethora of studies aiming to improve dietary, physical activity (PA), and weight-related (WR) outcomes among university students have been implemented and summarized in a series of systematic reviews, with unclear conclusions regarding their effectiveness. This overview aims to identify systematic reviews and meta-analyses of studies aiming to improve health outcomes in university students, to assess their methodological quality, to identify the different types of interventions used and outcomes assessed, and to estimate their overall effect. Four electronic databases were searched until 19 March, 2018 following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The identified reviews were described and their methodological quality was rated. The studies of reviews were investigated to identify the different types of interventions used and outcomes assessed. Effectiveness was assessed by measuring the overall number of improved outcomes out of the total number of outcomes reported. As a result, 8 reviews were identified targeting food sales (n = 2), dietary (n = 3), PA (n = 1), WR (n = 1), or all outcomes (n = 1). The methodological quality of the reviews was moderate (n = 5) to low (n = 3). In all, the reviews included 122 studies, of which 36 used an environmental, 51 a face-to-face, 30 an e-intervention, and 5 a combined approach. Environmental interventions improved a moderate number of food sales (32 of 61) and dietary intake (22 of 47) outcomes. Face-to-face interventions improved a high number of dietary cognitive outcomes (15 of 18), a moderate number of dietary intake (28 of 65) and WR (11 of 18) outcomes, and a low number of PA behavioral (22 of 69) and cognitive (2 of 14) outcomes. E-interventions improved a high number of dietary cognitive variables (11 of 16) but had a low effect (?33%) on the other types of outcomes. In conclusion, face-to-face and e-interventions improved cognitive variables toward diet or PA but were less effective in changing actual behaviors. Environmental interventions favorably changed food sales. Face-to-face and e-interventions moderately affected WR outcomes. Future research should focus on long-term studies.

Project description:BackgroundWe performed a systematic review to assess whether we can quantify the underreporting of adverse events (AEs) in the published medical literature documenting the results of clinical trials as compared with other nonpublished sources, and whether we can measure the impact this underreporting has on systematic reviews of adverse events.Methods and findingsStudies were identified from 15 databases (including MEDLINE and Embase) and by handsearching, reference checking, internet searches, and contacting experts. The last database searches were conducted in July 2016. There were 28 methodological evaluations that met the inclusion criteria. Of these, 9 studies compared the proportion of trials reporting adverse events by publication status. The median percentage of published documents with adverse events information was 46% compared to 95% in the corresponding unpublished documents. There was a similar pattern with unmatched studies, for which 43% of published studies contained adverse events information compared to 83% of unpublished studies. A total of 11 studies compared the numbers of adverse events in matched published and unpublished documents. The percentage of adverse events that would have been missed had each analysis relied only on the published versions varied between 43% and 100%, with a median of 64%. Within these 11 studies, 24 comparisons of named adverse events such as death, suicide, or respiratory adverse events were undertaken. In 18 of the 24 comparisons, the number of named adverse events was higher in unpublished than published documents. Additionally, 2 other studies demonstrated that there are substantially more types of adverse events reported in matched unpublished than published documents. There were 20 meta-analyses that reported the odds ratios (ORs) and/or risk ratios (RRs) for adverse events with and without unpublished data. Inclusion of unpublished data increased the precision of the pooled estimates (narrower 95% confidence intervals) in 15 of the 20 pooled analyses, but did not markedly change the direction or statistical significance of the risk in most cases. The main limitations of this review are that the included case examples represent only a small number amongst thousands of meta-analyses of harms and that the included studies may suffer from publication bias, whereby substantial differences between published and unpublished data are more likely to be published.ConclusionsThere is strong evidence that much of the information on adverse events remains unpublished and that the number and range of adverse events is higher in unpublished than in published versions of the same study. The inclusion of unpublished data can also reduce the imprecision of pooled effect estimates during meta-analysis of adverse events.

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Using multiple types of studies in systematic reviews of health care interventions--a systematic review.

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Using multiple types of studies in systematic reviews of health care interventions--a systematic review.

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