Dataset Information

Methodological management of end-of-life decision data in intensive care studies: A systematic review of 178 randomized control trials published in seven major journals.

ABSTRACT:

Background

End-of-life (EOL) decisions are a serious ethical dilemma and are frequently carried out in intensive care units (ICUs). The aim of this systematic review was to investigated the different approaches used in ICUs and reported in randomized controlled trials (RCTs) to address EOL decisions and compare the impact of these different strategies regarding potential bias and mortality estimates.

Methods

We identified relevant RCTs published in the past 15 years via PubMed, EMBASE, and CINAHL. In addition, we searched The Cochrane Library and checked registries, including ClinicalTrials.gov to assess concordance between declared and published outcomes. Among the journals we screened were the 3 ICU specialty journals and the four general medicine journals with the highest impact factor. Only RCTs were selected in which in-ICU mortality was the primary or secondary outcome. The primary outcome was information regarding EOL decisions, and the secondary outcome was how EOL decisions were treated in the study analysis.

Results

A total of 178 relevant trials were identified. The details regarding the methodological aspects resulting from EOL decisions were reported in only 62 articles (35%). The manner in which EOL decisions were considered in the study analysis was very heterogeneous, often leading to a high risk of bias.

Conclusion

There is a heterogeneity regarding the management of data on EOL decisions in randomized control trials with mortality endpoints. Recommendations or rules are required regarding the inclusion of patients with potential EOL decisions in RCT analyses and how to manage such decisions from a methodological point of view.

Trial registration

PROSPERO website (CRD42013005724).

SUBMITTER: Kerever S

PROVIDER: S-EPMC6538318 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Methodological management of end-of-life decision data in intensive care studies: A systematic review of 178 randomized control trials published in seven major journals.

Kerever Sébastien S Jacquens Alice A Smail-Faugeron Violaine V Gayat Etienne E Resche-Rigon Matthieu M

PloS one 20190528 5

<h4>Background</h4>End-of-life (EOL) decisions are a serious ethical dilemma and are frequently carried out in intensive care units (ICUs). The aim of this systematic review was to investigated the different approaches used in ICUs and reported in randomized controlled trials (RCTs) to address EOL decisions and compare the impact of these different strategies regarding potential bias and mortality estimates.<h4>Methods</h4>We identified relevant RCTs published in the past 15 years via PubMed, EM ...[more]

PMID: 31136601

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Project description:ObjectivesTo evaluate the methodological quality of randomised controlled trial (RCT) abstracts in leading critical care nursing journals against the Consolidated Standards of Reporting Trials-Abstracts (CONSORT-A) checklist and to identify variables related with abstract reporting quality.DesignDescriptive methodological quality review.Data sourceWe searched the PubMed database and the websites of each included journal.Eligibility criteriaWe included RCT abstracts published between 2011 and 2021 in the first 11 Scopus-ranking (2021) critical care nursing journals that reported the results of RCTs in English that referred to the care of adult patients with acute/critical illness or their relatives and/or caregivers and conducted in ICUs.Data extraction and synthesisTwo independent investigators extracted the data using a prespecified 17-item checklist directly derived from CONSORT-A. For the primary outcome, each item was evaluated whether it was adequately reported or not and descriptive statistics were reported. An overall score was calculated by summing the results of all items and multivariate linear regression was conducted to detect potential predictors.ResultsSeventy-eight RCT abstracts were included in this review. The items with the highest CONSORT-A adherence were authors, objective, conclusion, participants, interventions and outcome. The randomisation item had the lowest CONSORT-A adherence, followed by trial registration, funding source, harms or side effects, recruitment, blinding and outcome results. The average CONSORT-A score was 8.5±1.5 points (of the maximum 17.5 points). Multivariate analysis indicated that the categorised word score and publication date were positively associated with the overall CONSORT-A score, while the first author's country being in Asia was negatively associated with the overall CONSORT-A score.ConclusionsThe 78 RCT abstracts showed poor overall adherence to CONSORT-A. The results indicate that the methodological reporting quality of RCT abstracts in critical care nursing journals requires improvement to facilitate assessment of the applicability and relevance of the results reported.

Project description:Importance:Multiple analyses in a clinical trial can increase the probability of inaccurately concluding that there is a statistically significant treatment effect. However, to date, it is unknown how many randomized clinical trials (RCTs) perform adjustments for multiple comparisons, the lack of which could lead to erroneous findings. Objectives:To assess the prevalence of multiplicity and whether appropriate multiplicity adjustments were performed among cardiovascular RCTs published in 6 medical journals with a high impact factor. Design, Setting, and Participants:In this cross-sectional study, cardiovascular RCTs were selected from all over the world, characterized as North America, Western Europe, multiregional, and rest of the world. Data were collected from past issues of 3 cardiovascular journals (Circulation, European Heart Journal, and Journal of the American College of Cardiology) and 3 general medicine journals (JAMA, The Lancet, and The New England Journal of Medicine) with high impact factors published between August 1, 2015, and July 31, 2018. Supplements and trial protocols of each of the included RCTs were also searched for multiplicity. Data were analyzed December 20 to 27, 2018. Exposures:Data from the selected RCTs were extracted and verified independently by 2 researchers using a structured data instrument. In case of disagreement, a third reviewer helped to achieve consensus. An RCT was considered to have multiple treatment groups if it had more than 2 arms; multiple outcomes were defined as having more than 1 primary outcome, and multiple analyses were defined as analysis of the same outcome variable in multiple ways. Multiplicity was examined only for the analysis of the primary end point. Main Outcomes and Measures:Outcomes of interest were percentages of primary analyses that performed multiplicity adjustment of primary end points. Results:Of 511 cardiovascular RCTs included in this analysis, 300 (58.7%) had some form of multiplicity; of these 300, only 85 (28.3%) adjusted for multiplicity. Intervention type and funding source had no statistically significant association with the reporting of multiplicity risk adjustment. Trials that assessed mortality vs nonmortality outcomes were more likely to contain a multiplicity risk in their primary analysis (66.3% [177 of 267] vs 50.4% [123 of 244]; P?<?.001), and larger trials vs smaller trials were less likely to make any adjustments for multiplicity (35.6% [52 of 146] vs 21.4% [33 of 154]; P?=?.001). Conclusions and Relevance:Findings from this study suggest that cardiovascular RCTs published in medical journals with high impact factors demonstrate infrequent adjustments to correct for multiple comparisons in the primary end point. These parameters may be improved by more standardized reporting.

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Project description:BackgroundMost researchers in Uzbekistan prefer to publish their reports in journals of their home country. Moreover, the proportion of healthcare practitioners who prefer to use these national sources of information also remains high. However, the quality of publications from national journals, in post-Soviet countries, has not been systematically evaluated until now. The primary objective of this study was to evaluate the quality of randomized controlled trials' (RCTs) reports published in medical journals from Uzbekistan. We supposed that reports had at least minimal quality to contribute to the higher quality of healthcare.MethodsTo evaluate the quality of RCTs, we selected two journals from the list of national medical journals for which background information was provided. We decided to select articles from journals that had the highest subscription rate and were likely to have the highest impact on clinical decisions. The journals were Medical Journal of Uzbekistan and Paediatrics. Only issues published in 2007-2017 were considered for evaluation. Two evaluators independently scored RCTs and controlled clinical trials (CCTs) reported in the journals. The 5-point scale developed by Jadad et al. was used to evaluate the quality of reports. Consensus-based decision was made about the final score of each report.ResultsWe reviewed 1311 studies in the two journals and found 380 clinical trials reports for the final evaluation. Our main finding was that none of the reports received a final score of more than 1, with an absolute agreement between evaluators. A median score of the studied reports was equal to 0, predicting a very low quality of controlled trials reported in the national journals (Wilcoxon signed-rank test p = 1.0; 95% CI = 0-0).ConclusionsWe believe that quality of reports about controlled trials, in Uzbekistan, can be considered insufficient to contribute to the higher quality of care and patients' safety. In the worst case, such condition can cause serious damage to the public health and lead to ineffective use of resources in the country. Therefore, the better reporting and organization of RCTs and CCTs should become a main goal of all stakeholders interested in the effective and safe healthcare in the country.

Project description:BackgroundThe approximately 1100 medical journals now active in China are publishing a rapidly increasing number of research reports, including many studies identified by their authors as randomized controlled trials. It has been noticed that these reports mostly present positive results, and their quality and authenticity have consequently been called into question. We investigated the adequacy of randomization of clinical trials published in recent years in China to determine how many of them met acceptable standards for allocating participants to treatment groups.MethodsThe China National Knowledge Infrastructure electronic database was searched for reports of randomized controlled trials on 20 common diseases published from January 1994 to June 2005. From this sample, a subset of trials that appeared to have used randomization methods was selected. Twenty-one investigators trained in the relevant knowledge, communication skills and quality control issues interviewed the original authors of these trials about the participant randomization methods and related quality-control features of their trials.ResultsFrom an initial sample of 37,313 articles identified in the China National Knowledge Infrastructure database, we found 3137 apparent randomized controlled trials. Of these, 1452 were studies of conventional medicine (published in 411 journals) and 1685 were studies of traditional Chinese medicine (published in 352 journals). Interviews with the authors of 2235 of these reports revealed that only 207 studies adhered to accepted methodology for randomization and could on those grounds be deemed authentic randomized controlled trials (6.8%, 95% confidence interval 5.9-7.7). There was no statistically significant difference in the rate of authenticity between randomized controlled trials of traditional interventions and those of conventional interventions. Randomized controlled trials conducted at hospitals affiliated to medical universities were more likely to be authentic than trials conducted at level 3 and level 2 hospitals (relative risk 1.58, 95% confidence interval 1.18-2.13, and relative risk 14.42, 95% confidence interval 9.40-22.10, respectively). The likelihood of authenticity was higher in level 3 hospitals than in level 2 hospitals (relative risk 9.32, 95% confidence interval 5.83-14.89). All randomized controlled trials of pre-market drug clinical trial were authentic by our criteria. Of the trials conducted at university-affiliated hospitals, 56.3% were authentic (95% confidence interval 32.0-81.0).ConclusionMost reports of randomized controlled trials published in some Chinese journals lacked an adequate description of randomization. Similarly, most so called 'randomized controlled trials' were not real randomized controlled trials owing to a lack of adequate understanding on the part of the authors of rigorous clinical trial design. All randomized controlled trials of pre-market drug clinical trial included in this research were authentic. Randomized controlled trials conducted by authors in high level hospitals, especially in hospitals affiliated to medical universities had a higher rate of authenticity. That so many non-randomized controlled trials were published as randomized controlled trials reflected the fact that peer review needs to be improved and a good practice guide for peer review including how to identify the authenticity of the study urgently needs to be developed.

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Project description:Objectives (1) To assess endorsement of trial registration in author instructions of urology-related journals and (2) to assess whether randomised controlled trials (RCTs) in the field of urology were effectively registered. Design Cross-sectional study of author instructions and published trials. Setting Journals publishing in the field of urology. Participants First, the authors analysed author instructions of 55 urology-related journals indexed in 'Journal Citation Reports 2009' (12/2010). The authors divided these journals in two groups: those requiring and those not mentioning trial registration as a precondition for publication. Second, the authors chose the five journals with the highest impact factor (IF) from each group. Intervention MEDLINE search to identify RCTs published in these 10 journals in 2009 (01/2011); search of the clinical trials meta-search interface of WHO (International Clinical Trials Registry Platform) for RCTs that lacked information about registration (01-03/2011). Two authors independently assessed the information. Outcome measures Proportion of journals providing advice about trial registration and proportion of trials registered. Results Of 55 journals analysed, 26 (47.3%) provided some editorial advice about trial registration. Journals with higher IFs were more likely to mention trial registration explicitly (p=0.015). Of 106 RCTs published in 2009, 63 were registered (59.4%) with a tendency to an increase after 2005 (83.3%, p=0.035). 71.4% (30/42) of the RCTs that were published in journals mentioning and requiring registration, and 51.6% (33/64) of the RCTs that were published in journals that did not mention trial registration explicitly were registered. This difference was statistically significant (p=0.04). Conclusions The existence of a statement about trial registration in author instructions resulted in a higher proportion of registered RCTs in those journals. Journals with higher IFs were more likely to mention trial registration.

Project description:BackgroundEnrollment problems are common among randomized controlled trials conducted in the ICU. However, little is known about actual trial enrollment rates and influential factors. We set out to determine the overall enrollment rate in recent randomized controlled trials (RCTs) of patients with acute respiratory distress syndrome (ARDS), acute lung injury (ALI), or sepsis, and which factors influenced enrollment rate.MethodsWe conducted a systematic review by searching Pubmed using predefined terms for ARDS/ALI and sepsis to identify individually RCTs published among the seven highest impact general medicine and seven highest impact critical care journals between 2009 and 2019. Cluster randomized trials were excluded. Data were extracted by two independent reviewers using an electronic database management system. We conducted a random-effects meta-analysis of the eligible trials for the primary outcome of enrollment rate by time and site.ResultsOut of 457 articles identified, 94 trials met inclusion criteria. Trials most commonly evaluated pharmaceutical interventions (53%), were non-industry funded (78%), and required prospective informed consent (81%). The overall mean enrollment rate was 0.83 (95% confidence interval: 0.57-1.21) participants per month per site. Enrollment in ARDS/ALI and sepsis trials were 0.48 (95% CI 0.32-0.70) and 0.98 (95% CI 0.62-1.56) respectively. The enrollment rate was significantly higher for single-center trials (4.86; 95% CI 2.49-9.51) than multicenter trials (0.52; 95% CI 0.41-0.66). Of the 36 trials that enrolled < 95% of the target sample size, 8 (22%) reported slow enrollment as the reason.ConclusionsIn this systematic review and meta-analysis, recent ARDS/ALI and sepsis clinical trials had an overall enrollment rate of less than 1 participant per site per month. Novel approaches to improve critical care trial enrollment efficiency are needed to facilitate the translation of best evidence into practice.

Project description:ObjectivesPublished negative studies should have the same rigour of methodological quality as studies with positive findings. However, the methodological quality of negative versus positive studies is not known. The objective was to assess the reported methodological quality of positive versus negative studies published in Indian medical journals.DesignA systematic review (SR) was performed of all comparative studies published in Indian medical journals with a clinical science focus and impact factor >1 between 2011 and 2013. The methodological quality of randomised controlled trials (RCTs) was assessed using the Cochrane risk of bias tool, and the Newcastle-Ottawa scale for observational studies. The results were considered positive if the primary outcome was statistically significant and negative otherwise. When the primary outcome was not specified, we used data on the first outcome reported in the history followed by the results section. Differences in various methodological quality domains between positive versus negative studies were assessed by Fisher's exact test.ResultsSeven journals with 259 comparative studies were included in this SR. 24% (63/259) were RCTs, 24% (63/259) cohort studies, and 49% (128/259) case-control studies. 53% (137/259) of studies explicitly reported the primary outcome. Five studies did not report sufficient data to enable us to determine if results were positive or negative. Statistical significance was determined by p value in 78.3% (199/254), CI in 2.8% (7/254), both p value and CI in 11.8% (30/254), and only descriptive in 6.3% (16/254) of studies. The overall methodological quality was poor and no statistically significant differences between reporting of methodological quality were detected between studies with positive versus negative findings.ConclusionsThere was no difference in the reported methodological quality of positive versus negative studies. However, the uneven reporting of positive versus negative studies (72% vs 28%) indicates a publication bias in Indian medical journals with an impact factor of >1.

Dataset Information

Methodological management of end-of-life decision data in intensive care studies: A systematic review of 178 randomized control trials published in seven major journals.

Background

Methods

Results

Conclusion

Trial registration

Publications

Methodological management of end-of-life decision data in intensive care studies: A systematic review of 178 randomized control trials published in seven major journals.

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