Reviews Of Healthcare Interventions Research Articles

Systematic Reviews and Meta-analyses in Regional Anesthesia and Pain Medicine (Part I): Guidelines for Preparing the Review Protocol.

Comprehensive resources exist on how to plan a systematic review and meta-analysis. The objective of this article is to provide guidance to authors preparing their systematic review protocol in the fields of regional anesthesia and pain medicine. The focus is on systematic reviews of health care interventions, with or without an aggregate data meta-analysis. We describe and discuss elements of the systematic review methodology that review authors should prespecify, plan, and document in their protocol before commencing the review. Importantly, authors should explain their rationale for planning their systematic review and describe the PICO framework-participants (P), interventions (I), comparators (C), outcomes (O)-and related elements central to constructing their clinical question, framing an informative review title, determining the scope of the review, designing the search strategy, specifying the eligibility criteria, and identifying potential sources of heterogeneity. We highlight the importance of authors defining and prioritizing the primary outcome, defining eligibility criteria for selecting studies, and documenting sources of information and search strategies. The review protocol should also document methods used to evaluate risk of bias, quality (certainty) of the evidence, and heterogeneity of results. Furthermore, the authors should describe their plans for managing key data elements, the statistical construct used to estimate the intervention effect, methods of evidence synthesis and meta-analysis, and conditions when meta-analysis may not be possible, including the provision of practical solutions. Authors should provide enough detail in their protocol so that the readers could conduct the study themselves.

HPR59 Influence of Institute for Clinical and Economic Review (ICER) Reports in Formulary Decision Making

The Institute for Clinical and Economic Review (ICER) is a non-profit organization which conducts evidence-based reviews of health care interventions. The ICER Integrated Evidence Rating™ assesses the comparative clinical effectiveness and comparative value based on price expectation to arrive at an overall rating. This method for rating the clinical effectiveness is modeled on the “Evidence-Based Medicine (EBM) matrix.”

Effect of important modifiers on harmful effects in evidence synthesis practice of adverse events were insufficiently investigated: an empirical investigation

BackgroundSafety is important in the assessment of health interventions, while the results of adverse events are often susceptive to potential effect modifiers since the event risk tends to be rare. In this study, we investigated whether the potential impact of the important effect modifiers on harmful effects was analyzed in meta-analyses of adverse events.MethodsSystematic reviews of healthcare interventions, had adverse events as the exclusive outcomes, had at least one meta-analysis, and published between 1st January 2015, and 1st January 2020 were collected. An adverse event was defined as any untoward medical occurrence in a patient or subject in healthcare practice. Six effect modifiers that are the most important for harmful effects were identified by a group discussion. The proportions of eligible systematic reviews that investigated the potential impact of the six effect modifiers on harmful effects were summarized.ResultsWe identified 279 systematic reviews eligible for this study. Except for the modifier of interventions/controls (70.61%, 197/279), most of the systematic reviews failed to investigate the potential impact of treatment duration (21.15%, 59/279), dosage (24.73%, 69/279), age (11.47%, 32/279), risk of bias (6.45%, 18/279), and source of funding (1.08%, 3/279) on harmful effects. Systematic reviews with meta-analyses containing more studies were more likely to investigate the potential impacts of these modifiers on the effects, but the proportion was still low (2.3% to 33.3%). Systematic reviews that developed a protocol were significantly more likely to investigate the potential impact of all these effect modifiers (e.g. treatment duration: odds ratio = 5.08, 95% CI: 2.76 to 9.35) on the results.ConclusionsCurrent systematic reviews rarely investigated the potential impact of the important effect modifiers on harmful effects. Methodological guidelines for meta-analysis of adverse events should consider “effect modifier” as one of the domains to help systematic review authors better investigate harmful effects.

Methodologic quality and risk-of-bias in systematic reviews of healthcare interventions: a review of methods

OBJECTIVE: To compare the characteristics of systematic reviews of healthcare interventions that assessed or did not methodologic quality/risk-of-bias of included studies. Additionally, to analyze methodologic features of those assessing the methodologic quality/risk-of-bias. METHODS: PubMed database was searched. From 25,571 systematic reviews retrieved, a random sample of 1,025 was screened. Frequencies were used to describe outcomes. Unadjusted and adjusted logistic regressions were performed to test the associations with methodologic quality/risk-of-bias results assessment. In a second analysis, systematic reviews that assessed methodologic quality/risk of bias were dichotomized according to the design of included studies (randomized clinical trials-only versus non-randomized studies of intervention or a combination of both). RESULTS: 303 systematic reviews were fully analyzed. Methodologic quality/risk of bias was assessed by 278 (92%). Methodologic quality/risk-of-bias assessment was associated with a higher number of databases searched (>4, P= 0.008), the presence of meta-analysis (P= 0.005), and the design of included studies (randomized clinical trials-only, P= 0.042). The chance of using a suitable tool and a tool designed for risk-of-bias assessment rather than methodologic quality was higher for randomized clinical trials-only systematic reviews (P< 0.05). The most used tool was Cochrane’s RoB Tool without a clear studies’ overall risk classification system. CONCLUSION: methodologic quality/risk-of-bias assessment was associated with included studies’ design (randomized clinical trials-only), a meta-analysis of data, and the number of databases searched (>4). The most used tool was Cochrane’s RoB Tool, with no clearly defined rating system. Methodologic quality/risk-of-bias assessment methods description, results, and impacts on meta-analysis, the certainty of evidence, and systematic reviews’ results are still to be consistently addressed.

Making sense of a systematic review

The article in last month’s issue explored the place of systematic reviews in informing health care decision making. This article describes the core components of a high-quality systematic review of health care interventions. These components include an assessment of the risk of bias for individual studies, evaluation of the overall certainty of the body of evidence for the main outcomes, meta-analysis and the interpretation of the data. An understanding of these differing elements is the key to recognising the potential and important limitations of any systematic review.

Involving the general practitioner during curative cancer treatment: a systematic review of health care interventions

ObjectiveThe role of primary care providers (PCP) in the cancer care continuum is expanding. In the post-treatment phase, this role is increasingly recognised by policy makers and healthcare professionals. During...

The impact of different inclusion decisions on the comprehensiveness and complexity of overviews of reviews of healthcare interventions

BackgroundOverviews of reviews (overviews) compile information from multiple systematic reviews (SRs) to provide a single synthesis of relevant evidence for decision-making. Overviews may identify multiple SRs that examine the same intervention for the same condition and include some, but not all, of the same primary studies. There is currently limited guidance on whether and how to include these overlapping SRs in overviews. Our objectives were to assess how different inclusion decisions in overviews of healthcare interventions affect their comprehensiveness and results, and document challenges encountered when making different inclusion decisions in overviews.MethodsWe used five inclusion decisions to conduct overviews across seven topic areas, resulting in 35 overviews. The inclusion decisions were (1) include all Cochrane and non-Cochrane SRs, (2) include only Cochrane SRs, or consider all Cochrane and non-Cochrane SRs but include only non-overlapping SRs, and in the case of overlapping SRs, select (3) the Cochrane SR, (4) the most recent SR (by publication or search date), or (5) the highest quality SR (assessed using AMSTAR). For each topic area and inclusion scenario, we documented the amount of outcome data lost and changed and the challenges involved.ResultsWhen conducting overviews, including only Cochrane SRs, instead of all SRs, often led to loss/change of outcome data (median 31% of outcomes lost/changed; range 0–100%). Considering all Cochrane and non-Cochrane SRs but including only non-overlapping SRs and selecting the Cochrane SR for groups of overlapping SRs (instead of the most recent or highest quality SRs) allowed the most outcome data to be recaptured (median 42% of lost/changed outcome recaptured; range 28–86%). Across all inclusion scenarios, challenges were encountered when extracting data from overlapping SRs.ConclusionsOverlapping SRs present a methodological challenge for overview authors. This study demonstrates that different inclusion decisions affect the comprehensiveness and results of overviews in different ways, depending in part on whether Cochrane SRs examine all intervention comparisons relevant to the overview. Study results were used to develop an evidence-based decision tool that provides practical guidance for overview authors.

Introduction on 'assessing the risk of bias of individual studies' in systematic review of health-care intervention programs revised by the Agency for Healthcare Research and Quality

This paper summarizes the Risk of Bias of Individual Studies in Systematic Reviews of Health Care Interventions revised by the Agency for Healthcare Research and Quality (AHRQ) and introduces how to use Revman software make risk of bias graph or risk of bias summary. AHRQ tool can be used to evaluate following study designs: RCTs, cohort study, case-control study (including nested case-control), case series study and cross-sectional study. The tool evaluates the risk of bias of individual studies from selection bias, performance bias, attrition bias, detection bias and reporting bias. Each of the bias domains contains different items, and each item is available for the assessment of one or more study designs. It is worth noting that the appropriate items should be selected for evaluation different study designs instead of using all items to directly assess the risk of bias. AHRQ tool can be used to evaluate risk of bias individual studies when systematic reviews of health care interventions is including different study designs. Moreover, the tool items are relatively easy to understand and the assessment process is not complicated. AHRQ recommends the use of high, medium and low risk classification methods to assess the overall risk of bias of individual studies. However, AHRQ gives no recommendations on how to determine the overall bias grade. It is expected that future research will give corresponding recommendations.

More than one-third of systematic reviews did not fully report the adverse events outcome

ObjectivesThe aim of the study was to assess the risk for adverse events reporting bias in systematic reviews of health care interventions registered to PROSPERO. Study Design and SettingThis study was a retrospective cohort study. Systematic review protocols in PROSPERO were screened and included if they focused on a health care intervention and listed an adverse event as either a primary or secondary outcome. The included systematic reviews were assessed to determine the completeness of reporting for the adverse event outcomes. Any discrepancies in reporting between protocol and review were recorded. ResultsOf 1,376 protocols for systematic reviews sifted, only 524 (38%) listed adverse events outcomes. One hundred eighty-six protocols were published in 2017 and 2018, of which 146 were included in our analysis. Among the included systematic reviews, 65% (95/146) fully reported the adverse event outcomes as intended by the protocol, 8% (12/146) entirely excluded the adverse event outcome, and the remaining 27% (39/146) either partially reported or changed the adverse event outcomes. ConclusionSixty-two percent of reviews did not mention adverse events in their protocol, and 35% of PROSPERO-registered systematic reviews had discrepant outcome reporting between the protocol and publication. The findings suggest a need for the encouraged use of harms reporting guidelines and further research into adverse events reporting bias.

Reporting guidelines on how to write a complete and transparent abstract for overviews of systematic reviews of health care interventions

ObjectiveAn overview of systematic reviews (OoSRs) is a study designed to offer a broad view of evidence from existing systematic reviews (SRs). The abstract is an important part of an OoSRs as it can determine whether reading the full text is of interest. The aim of this article is to offer guidelines to promote transparent and sufficient reporting in abstracts of OoSRs of health care interventions. Study Design and SettingThe items were developed by combining key features from abstracts of OoSRs, PRISMA for abstracts, and our published reporting guidelines for OoSRs. The initial version was distributed to experts to give feedback; pilot testing by a group of researchers followed. The refined checklist was applied by two reviewers independently in a sample of 40 abstracts. ResultsThe developed instrument “Preferred Reporting Items for OoSRs abstracts” (PRIO for abstracts) consists of six sections with 15 topics including 20 items in total. The mean inter-rater reliability was 0.87 (95% confidence interval: 0.82, 0.92). An explanation and at least one published example of good reporting per item are provided. ConclusionThis instrument will assist authors in writing transparent and informative abstracts for OoSRs and can be adopted by journals that publish OoSRs.

Assessing risk of bias in studies that evaluate health care interventions: recommendations in the misinformation age

Methods to assess the risk of bias in a way that is reliable, reproducible. and transparent to readers, have evolved over time. Viswanathan et al. recently provided updated recommendations for assessing risk of bias in systematic reviews of health care interventions. We comment on their recommendations and discuss new tools in development that we, as co-convenors and coordinators of the Cochrane Bias Methods Group, are leading, which complement the methods recommended.

Do systematic reviews on pediatric topics need special methodological considerations?

BackgroundSystematic reviews are key tools to enable decision making by healthcare providers and policymakers. Despite the availability of the evidence based Preferred Reporting Items for Systematic reviews and Meta-Analysis (PRISMA-2009 and PRISMA-P 2015) statements that were developed to improve the transparency and quality of reporting of systematic reviews, uncertainty on how to deal with pediatric-specific methodological challenges of systematic reviews impairs decision-making in child health. In this paper, we identify methodological challenges specific to the design, conduct and reporting of pediatric systematic reviews, and propose a process to address these challenges.DiscussionOne fundamental decision at the outset of a systematic review is whether to focus on a pediatric population only, or to include both adult and pediatric populations. Both from the policy and patient care point of view, the appropriateness of interventions and comparators administered to pre-defined pediatric age subgroup is critical. Decisions need to be based on the biological plausibility of differences in treatment effects across the developmental trajectory in children. Synthesis of evidence from different trials is often impaired by the use of outcomes and measurement instruments that differ between trials and are neither relevant nor validated in the pediatric population. Other issues specific to pediatric systematic reviews include lack of pediatric-sensitive search strategies and inconsistent choices of pediatric age subgroups in meta-analyses. In addition to these methodological issues generic to all pediatric systematic reviews, special considerations are required for reviews of health care interventions’ safety and efficacy in neonatology, global health, comparative effectiveness interventions and individual participant data meta-analyses. To date, there is no standard approach available to overcome this problem. We propose to develop a consensus-based checklist of essential items which researchers should consider when they are planning (PRISMA-PC-Protocol for Children) or reporting (PRISMA-C-reporting for Children) a pediatric systematic review.SummaryAvailable guidelines including PRISMA do not cover the complexity associated with the conduct and reporting of systematic reviews in the pediatric population; they require additional and modified standards for reporting items. Such guidance will facilitate the translation of knowledge from the literature to bedside care and policy, thereby enhancing delivery of care and improving child health outcomes.

Using Multiple Types of Studies in Systematic Reviews of Health Care Interventions – A Systematic Review

BackgroundA 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 FindingsWe 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.ConclusionsDifferent 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.

Checklists of methodological issues for review authors to consider when including non-randomized studies in systematic reviews.

There is increasing interest from review authors about including non-randomized studies (NRS) in their systematic reviews of health care interventions. This series from the Ottawa Non-Randomized Studies Workshop consists of six papers identifying methodological issues when doing this. To format the guidance from the preceding papers on study design and bias, confounding and meta-analysis, selective reporting, and applicability/directness into checklists of issues for review authors to consider when including NRS in a systematic review. Checklists were devised providing frameworks to describe/assess: (1) study designs based on study design features; (2) risk of residual confounding and when to consider meta-analysing data from NRS; (3) risk of selective reporting based on the Cochrane framework for detecting selective outcome reporting in trials but extended to selective reporting of analyses; and (4) directness of evidence contributed by a study to aid integration of NRS findings into summary of findings tables. The checklists described will allow review groups to operationalize the inclusion of NRS in systematic reviews in a more consistent way. The next major step is extending the existing Cochrane Risk of Bias tool so that it can assess the risk of bias to NRS included in a review. Copyright © 2013 John Wiley & Sons, Ltd.

A Systematic Review of Health Care Interventions for Pain in Patients With Advanced Cancer

Poorly controlled pain is common in advanced cancer. The objective of this article was to synthesize the evidence on the effectiveness of pain-focused interventions in this population. We searched MEDLINE, CINAHL, PsycINFO, Cochrane, and DARE from 2000 through December 2011. We included prospective, controlled health care intervention studies in advanced cancer populations, focusing on pain. Nineteen studies met the inclusion criteria; most focused on nurse-led patient-centered interventions. In all, 9 (47%) of the 19 studies found a significant effect on pain. The most common intervention type was patient/caregiver education, in 17 (89%) of 19 studies, 7 of which demonstrated a significant decrease in pain. We found moderate strength of evidence that pain in advanced cancer can be improved using health care interventions, particularly nurse-led patient-centered interventions.

Incomplete and Unreported: Failure to Report Results of Incomplete Studies Results in Publication Bias

Background: Clinical research that is incomplete and unreported can lead to bias in health care decisions. Selective reporting of outcomes in clinical research overestimates the benefits and safety of treatments and threatens the integrity of systematic reviews of health care interventions. The Common Rule does not require that results be made available from clinical studies to research subjects and the scientific community. Methods: We analyzed all closed studies (i.e., no longer recruiting) registered in the online database ClinicalTrials.gov as of May 2010 to identify the number, length, and characteristics of complete and incomplete (terminated, suspended, or withdrawn) studies. Random samples of terminated studies, which were defined as studies in which the recruitment or enrollment of participants has been halted prematurely and will not resume, were analyzed to identify the reasons for termination and availability of the results in ClinicalTrials.gov or in published articles. Results: We identified 3,554 (6.2%) terminated studies among 57,233 closed studies. Reasons for termination were unknown in 34% and safety-related in 11% of terminated studies. Industry-funded studies omitted termination reasons less often than National Institutes of Health (NIH)-funded studies (OR 0.3, 95%CI: 0.1, 0.9). Drug studies omitted termination reasons more often than all other intervention studies. (OR 2; 95% CI: 1.1, 3.7) and also cited safety as the termination reason (OR 8.6; 95%CI: 1.9, 36.8) more often than other intervention studies. Terminated studies lasted on average 2.2 ± 1.9 years, and results were available for 5% in ClinicalTrials.gov and for 8% in peer-reviewed journals. Conclusions: Existing clinical research policies should mandate registration of all clinical trials in ClinicalTrials.gov as a condition of studies approval by institutional review boards. Mandatory posting of the results in ClinicalTrials.gov for all terminated studies, along with the exact reasons for termination irrespective of study funding and market or publication status, would enhance comprehensive evidence analysis by clinicians and policymakers, as well as public trust in clinical research.

Priority setting for systematic review of health care interventions in Nigeria.

In an era of evidence based medicine and systematic review, this study seeks to identify priority systematic review topics that address common health problems in Nigeria. Firstly, a primary list of health problems was compiled from the National Health Management Information Systems and information from key informants (health professionals, researchers and NGOs) drawn from the six geo-political zones in Nigeria. Key steps included compilation and ranking of a comprehensive list of health problems into 4 categories: adult communicable, non-communicable, maternal and child health; searching the Cochrane Library and electronic databases for systematic reviews on identified priority problems, analysis of search outputs to identify gaps; listing and ranking of new priority systematic review topics using pre-determined criteria. Eighteen questions made the final list of priorities systematic reviews and 9 of them were related to malaria. There were 7 additional issues that the panelists identified as crucial cross-cutting issues that need to be addressed in systematic reviews. Identification and prioritization of systematic reviews relevant to health care in Nigeria will improve the opportunity to deliver evidence-based and equitable health care to the people. These topics are likely to be also important for health care decision in other resource-poor settings.

Quality assessment of systematic reviews of health care interventions using AMSTAR

Appraisal of the methodological quality of systematic reviews would reflect on their utility for the clinicians and policymakers. This study was done to assess the quality of systematic reviews published in five leading Indian medical journals using AMSTAR. 22 systematic reviews of healthcare interventions were identified. The scores ranged 0 to 10 (mean 3.77 and median 2.5), 9 reviews scored > 4/11. Most frequent yes and no scores were: publication status as an inclusion criterion (12 /22), respectively and duplicate study selection and data extraction (17 /22). Several suboptimal aspects of methodological quality were identified in the reviews evaluated.

The Cochrane Collaboration and Meta-Analysis of Clinical Data

The Cochrane Collaboration is an international not-for-profit and independent organization, dedicated to making up-to-date, accurate information about the effects of healthcare readily available worldwide. It produces and disseminates systematic reviews of healthcare interventions and promotes the search for evidence in the form of clinical trials and other studies of interventions.

Nottingham systematic review course

The course is hosted by the Cochrane Schizophrenia Group for those interested in undertaking reviews of randomised trials. The Cochrane Schizophrenia Group is part of the Cochrane Collaboration, an international, non-profit organisation that publishes systematic reviews of healthcare interventions. New reviewers are encouraged to attend this course. It is not specialty specific and will attract anyone wishing to do a Cochrane style review. This was a four day course that involved small group work, interactive tutorials, workshops, and practical computer sessions. The first two days were a gentle introduction to the Cochrane Collaboration, focusing on developing and writing a …