Dataset Information

Outcomes Definitions and Statistical Tests in Oncology Studies: A Systematic Review of the Reporting Consistency.

ABSTRACT:

Background

Quality of reporting for Randomized Clinical Trials (RCTs) in oncology was analyzed in several systematic reviews, but, in this setting, there is paucity of data for the outcomes definitions and consistency of reporting for statistical tests in RCTs and Observational Studies (OBS). The objective of this review was to describe those two reporting aspects, for OBS and RCTs in oncology.

Methods

From a list of 19 medical journals, three were retained for analysis, after a random selection: British Medical Journal (BMJ), Annals of Oncology (AoO) and British Journal of Cancer (BJC). All original articles published between March 2009 and March 2014 were screened. Only studies whose main outcome was accompanied by a corresponding statistical test were included in the analysis. Studies based on censored data were excluded. Primary outcome was to assess quality of reporting for description of primary outcome measure in RCTs and of variables of interest in OBS. A logistic regression was performed to identify covariates of studies potentially associated with concordance of tests between Methods and Results parts.

Results

826 studies were included in the review, and 698 were OBS. Variables were described in Methods section for all OBS studies and primary endpoint was clearly detailed in Methods section for 109 RCTs (85.2%). 295 OBS (42.2%) and 43 RCTs (33.6%) had perfect agreement for reported statistical test between Methods and Results parts. In multivariable analysis, variable "number of included patients in study" was associated with test consistency: aOR (adjusted Odds Ratio) for third group compared to first group was equal to: aOR Grp3 = 0.52 [0.31-0.89] (P value = 0.009).

Conclusion

Variables in OBS and primary endpoint in RCTs are reported and described with a high frequency. However, statistical tests consistency between methods and Results sections of OBS is not always noted. Therefore, we encourage authors and peer reviewers to verify consistency of statistical tests in oncology studies.

SUBMITTER: Rivoirard R

PROVIDER: S-EPMC5055310 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Outcomes Definitions and Statistical Tests in Oncology Studies: A Systematic Review of the Reporting Consistency.

Rivoirard Romain R Duplay Vianney V Oriol Mathieu M Tinquaut Fabien F Chauvin Franck F Magne Nicolas N Bourmaud Aurelie A

PloS one 20161007 10

<h4>Background</h4>Quality of reporting for Randomized Clinical Trials (RCTs) in oncology was analyzed in several systematic reviews, but, in this setting, there is paucity of data for the outcomes definitions and consistency of reporting for statistical tests in RCTs and Observational Studies (OBS). The objective of this review was to describe those two reporting aspects, for OBS and RCTs in oncology.<h4>Methods</h4>From a list of 19 medical journals, three were retained for analysis, after a r ...[more]

PMID: 27716793

Similar Datasets

Project description:BACKGROUND:Despite more than 60 years of clinical trials, tuberculosis (TB) still causes a high global burden of mortality and morbidity. Treatment currently requires multiple drugs in combination, taken over a prolonged period. New drugs are needed to shorten treatment duration, prevent resistance and reduce adverse events. However, to improve on current methodology in drug development, a more complete understanding of the existing clinical evidence base is required. METHODS:A systematic review was undertaken to summarise outcomes reported in phase III trials of patients with newly diagnosed pulmonary TB. A systematic search of databases (PubMed, MEDLINE, EMBASE, CENTRAL and LILACs) was conducted on 30 November 2017 to retrieve relevant peer-reviewed articles. Reference lists of included studies were also searched. This systematic review considered all reported outcomes. RESULTS:Of 248 included studies, 229 considered "on-treatment" outcomes whilst 148 reported "off-treatment" outcomes. There was wide variation and ambiguity in the definition of reported outcomes, including their relationship to treatment and in the time points evaluated. Additional challenges were observed regarding the analysis approach taken (per protocol versus intention to treat) and the varying durations of "intensive" and "continuation" phases of treatment. Bacteriological outcomes were most frequently reported but radiological and clinical data were often included as an implicit or explicit component of the overall definition of outcome. CONCLUSIONS:Terminology used to define long-term outcomes in phase III trials is inconsistent, reflecting evolving differences in protocols and practices. For successful future cumulative meta-analysis, the findings of this review suggest that greater availability of individual patient data and the development of a core outcome set would be desirable. In the meantime, we propose a simple and logical approach which should facilitate combination of key evidence and inform improvements in the methodology of TB drug development and clinical trials.

Project description:BACKGROUND:Anxiety disorders and depression are frequent conditions in childhood and adolescence. eMental healthcare technologies may improve access to services, but their uptake within health systems is limited. OBJECTIVE:The objective of this review was to examine and describe how the implementation of eMental healthcare technologies for anxiety disorders and depression in children and adolescents has been studied. METHODS:We conducted a search of 5 electronic databases and gray literature. Eligible studies were those that assessed an eMental healthcare technology for treating or preventing anxiety or depression, included children or adolescents (<18 years), or their parents or healthcare providers and reported findings on technology implementation. The methodological quality of studies was evaluated using the Mixed Methods Appraisal Tool. Outcomes of interest were based on 8 implementation outcomes: acceptability (satisfaction with a technology), adoption (technology uptake and utilization), appropriateness ("fitness for purpose"), cost (financial impact of technology implementation), feasibility (extent to which a technology was successfully used), fidelity (implementation as intended), penetration ("spread" or "reach" of the technology), and sustainability (maintenance or integration of a technology within a healthcare service). For extracted implementation outcome data, we coded favorable ratings on measurement scales as "positive results" and unfavorable ratings on measurement scales as "negative results." Those studies that reported both positive and negative findings were coded as having "mixed results." RESULTS:A total of 46 studies met the inclusion criteria, the majority of which were rated as very good to excellent in methodological quality. These studies investigated eMental healthcare technologies for anxiety (n=23), depression (n=18), or both anxiety and depression (n=5). Studies of technologies for anxiety evaluated the following: (1) acceptability (78%) reported high levels of satisfaction, (2) adoption (43%) commonly reported positive results, and (3) feasibility (43%) reported mixed results. Studies of technologies for depression evaluated the following: (1) appropriateness (56%) reported moderate helpfulness and (2) acceptability (50%) described a mix of both positive and negative findings. Studies of technologies designed to aid anxiety and depression commonly reported mixed experiences with acceptability and adoption and positive findings for appropriateness of the technologies for treatment. Across all studies, cost, fidelity, and penetration and sustainability were the least measured implementation outcomes. CONCLUSIONS:Acceptability of eMental healthcare technology is high among users and is the most commonly investigated implementation outcome. Perceptions of the appropriateness and adoption of eMental healthcare technology were varied. Implementation research that identifies, evaluates, and reports on costs, sustainability, and fidelity to clinical guidelines is crucial for making high-quality eMental healthcare available to children and adolescents.

Dataset Information

Outcomes Definitions and Statistical Tests in Oncology Studies: A Systematic Review of the Reporting Consistency.

Background

Methods

Results

Conclusion

Publications

Outcomes Definitions and Statistical Tests in Oncology Studies: A Systematic Review of the Reporting Consistency.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets