Dataset Information

Methods used to assess outcome consistency in clinical studies: A literature-based evaluation.

ABSTRACT: Evaluation studies of outcomes used in clinical research and their consistency are appearing more frequently in the literature, as a key part of the core outcome set (COS) development. Current guidance suggests such evaluation studies should use systematic review methodology as their default. We aimed to examine the methods used. We searched the Core Outcome Measures in Effectiveness Trials (COMET) database (up to May 2019) supplementing it with additional resources. We included evaluation studies of outcome consistency in clinical studies across health subjects and used a subset of A MeaSurement Tool to Assess systematic Reviews (AMSTAR) 2 (items 1-9) to assess their methods. Of 93 included evaluation studies of outcome consistency (90 full reports, three summaries), 91% (85/93) reported performing literature searches in at least one bibliographic database, and 79% (73/93) was labelled as a "systematic review". The evaluations varied in terms of satisfying AMSTAR 2 criteria, such that 81/93 (87%) had implemented PICO in the research question, whereas only 5/93 (6%) had included the exclusions list. None of the evaluation studies explained how inconsistency of outcomes was detected, however, 80/90 (88%) concluded inconsistency in individual outcomes (66%, 55/90) or outcome domains (20%, 18/90). Methods used in evaluation studies of outcome consistency in clinical studies differed considerably. Despite frequent being labelled as a "systematic review", adoption of systematic review methodology is selective. While the impact on COS development is unknown, authors of these studies should refrain from labelling them as "systematic review" and focus on ensuring that the methods used to generate the different outcomes and outcome domains are reported transparently.

SUBMITTER: Rogozinska E

PROVIDER: S-EPMC7343158 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Methods used to assess outcome consistency in clinical studies: A literature-based evaluation.

Rogozińska Ewelina E Gargon Elizabeth E Olmedo-Requena Rocío R Asour Amani A Cooper Natalie A M NAM Vale Claire L CL Van't Hooft Janneke J

PloS one 20200708 7

Evaluation studies of outcomes used in clinical research and their consistency are appearing more frequently in the literature, as a key part of the core outcome set (COS) development. Current guidance suggests such evaluation studies should use systematic review methodology as their default. We aimed to examine the methods used. We searched the Core Outcome Measures in Effectiveness Trials (COMET) database (up to May 2019) supplementing it with additional resources. We included evaluation studi ...[more]

PMID: 32639999

Similar Datasets

Project description:BACKGROUND:Pictorial blood loss assessment charts (PBACs) represent the most widely used method to assess menstrual blood loss (MBL) in clinical trials. The aims of this review were to: (1) determine the diagnostic accuracy of PBACs that have been validated against the reference alkaline hematin technique; (2) categorize the pitfalls of using obsolete and nonvalidated charts; (3) provide guidelines for development of a new PBAC or use of an existing chart to measure MBL in clinical trials; and (4) consider the feasibility of using pictorial charts in primary care. METHODS:A literature review was conducted using Embase and MEDLINE databases. The review identified reports of women with self-perceived or actual heavy menstrual bleeding (HMB), bleeding disorders, abnormal uterine bleeding, leiomyomata (uterine fibroids) or endometriosis, and women undergoing treatment for HMB, as well as those with normal menstrual periods. Data were reviewed from studies that focused on the development and validation of PBACs and from those that used derivative noncertified charts to assess HMB. RESULTS:Nine studies reported validation of PBAC scoring systems against the alkaline hematin technique. Across these studies, the sensitivity was 58-97%, the specificity was 7.5-95.5%, the positive and negative likelihood ratios were 1.1-13.8 and 0.14-0.56, respectively, and the diagnostic odds ratio was 2.6-52.4. The cut-off score above which the diagnosis of HMB was made ranged from 50 to 185. Several modifications of these PBACs were used in other studies; however, objective confirmation of their validity was not reported. Overall, there was widespread inconsistency of chart design, scoring systems, diagnostic cut-off limits and post-treatment outcome measures. CONCLUSIONS:PBACs are best suited to the controlled and specific environment of clinical studies, where clinical outcome parameters are defined. The current lack of standardization precludes widespread use of the PBAC in primary care. REVIEW REGISTRATION NUMBER:PROSPERO international prospective register of systematic reviews: CRD42016030083.

Project description:BackgroundThe COVID-19 pandemic catalyzed the adoption of home telemonitoring to cope with social distancing challenges. Recent research on home telemonitoring demonstrated benefits concerning the capacity, patient empowerment, and treatment commitment of health care systems. Moreover, for some diseases, it revealed significant improvement in clinical outcomes. Nevertheless, when policy makers and practitioners decide whether to scale-up a technology-based health intervention from a research study to mainstream care delivery, it is essential to assess other relevant domains, such as its feasibility to be expanded under real-world conditions. Therefore, scalability assessment is critical, and it encompasses multiple domains to ensure population-wide access to the benefits of the growing technological potential for home telemonitoring services in health care.ObjectiveThis systematic review aims to identify the domains and methods used in peer-reviewed research studies that assess the scalability of home telemonitoring-based interventions under real-world conditions.MethodsThe authors followed the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis) guidelines and used multiple databases (PubMed, Scopus, Web of Science, and EconLit). An integrative synthesis of the eligible studies was conducted to better explore each intervention and summarize relevant information concerning the target audience, intervention duration and setting, and type of technology. Each study design was classified based on the strength of its evidence. Lastly, the authors conducted narrative and thematic analyses to identify the domains, and qualitative and quantitative methods used to support scalability assessment.ResultsThis review evaluated 13 articles focusing on the potential of scaling up a home telemonitoring intervention. Most of the studies considered the following domains relevant for scalability assessment: problem (13), intervention (12), effectiveness (13), and costs and benefits (10). Although cost-effectiveness was the most common evaluation method, the authors identified seven additional cost analysis methods to evaluate the costs. Other domains were less considered, such as the sociopolitical context (2), workforce (4), and technological infrastructure (3). Researchers used different methodological approaches to assess the effectiveness, costs and benefits, fidelity, and acceptability.ConclusionsThis systematic review suggests that when assessing scalability, researchers select the domains specifically related to the intervention while ignoring others related to the contextual, technological, and environmental factors, which are also relevant. Additionally, studies report using different methods to evaluate the same domain, which makes comparison difficult. Future work should address research on the minimum required domains to assess the scalability of remote telemonitoring services and suggest methods that allow comparison among studies to provide better support to decision makers during large-scale implementation.

Project description:Background: The composition of the microbiome in human body sites plays an important role in health. The vaginal environment is colonized by several species of bacteria that have a major influence on reproductive health. The advancement of sequencing technologies has made the assessment of the composition of the microbiota possible through microbial DNA extraction and sequencing. Therefore, it is of a paramount importance to select a sensitive and reproducible DNA extraction method, that facilitates isolation of microbial DNA with a sufficient quantity and purity, from microbial species living in the vaginal environment. Here, we have evaluated four different DNA extraction protocols from self-collected vaginal swabs. Methods: Five healthy female volunteers were enrolled in the study. Each donor was asked to self-collect 4 samples using Copan ESwab. DNA was extracted using Qiagen DNeasy kit and three modified protocols of the MoBio PowerSoil kit ("DNeasy PowerSoil" after acquisition from Qiagen). DNA quantity and integrity was checked through Nanodrop and LabChip GX. DNA was further tested through quantitative real-time PCR (qPCR) and 16S sequencing. Vaginal microbiota diversities were determined using MiSeq-Illumina high-throughput sequencing of bacterial 16S rDNA V1-V3 fingerprint. Sequencing data were analyzed using QIIME pipeline. Results: Qiagen DNeasy protocol resulted in the highest DNA yield as compared to the modified protocols of MoBio Powersoil kit. The size of the DNA extracted using each protocol was ~40 kb. Qiagen DNeasy protocol gave the highest Genomic Quality Score (average ± standard deviation: 4.24 ± 0.36), followed by the different MoBio Powersoil protocols. A substantial variability in microbial DNA abundance was found across the protocols. The vaginal microbiota of the healthy volunteers was dominated by Lactobacillus species. MoBio Powersoil kit provided a significantly higher alpha diversity as compared to the Qiagen DNeasy kit, while beta diversity measures did not reveal any significant cluster changes, except when the Bray-Curtis method was applied. Conclusion: We were able to isolate microbial DNA from the vaginal swabs. Qiagen DNeasy method gave the highest DNA yield and quality but was not optimal in detecting microbial diversity. The modified MoBio PowerSoil protocols showed higher microbial diversities as compared to the standard protocol.

Dataset Information

Methods used to assess outcome consistency in clinical studies: A literature-based evaluation.

Publications

Methods used to assess outcome consistency in clinical studies: A literature-based evaluation.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets