Dataset Information

Methodological reporting in feasibility studies: a descriptive review of the nursing intervention research literature.

ABSTRACT:

Background

In reaction to weaknesses in feasibility studies reporting, the Consolidated Standards of Reporting Trials (CONSORT) statement published an extension for feasibility studies in 2016.

Aim

The aim of this study was to systematically review and appraise the reporting of feasibility studies in the nursing intervention research literature based on the CONSORT statement extension for feasibility studies.

Method

Papers published prior to January 2018 that described feasibility studies of nursing interventions were retrieved. Components of feasibility studies were coded, and code frequencies were analysed.

Results

The review included 186 papers. Although most papers (n = 142, 76.3%) included the label 'pilot' or 'feasibility' in their title, reporting for other components generally did not adhere to one or several CONSORT recommendations. Most papers reported objectives (n = 116, 62.4%), designs (n = 95, 51%), or rationales for sample size (n = 165, 88.7%) that were incongruent with the purpose of feasibility studies.

Discussion

This review results in two main implications for nursing research. First, we noted that the reporting of feasibility studies is weak. While all papers described feasibility studies, almost half focused exclusively on testing the effectiveness of an intervention. Second, we identified rationales for sample size along with key references that could offer guidance in reporting feasibility studies while being coherent with the CONSORT recommendations.

SUBMITTER: Mailhot T

PROVIDER: S-EPMC7932371 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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Publications

Methodological reporting in feasibility studies: a descriptive review of the nursing intervention research literature.

Mailhot Tanya T Goulet Marie-Hélène MH Maheu-Cadotte Marc-André MA Fontaine Guillaume G Lequin Pierre P Lavoie Patrick P

Journal of research in nursing : JRN 20191126 5

<h4>Background</h4>In reaction to weaknesses in feasibility studies reporting, the Consolidated Standards of Reporting Trials (CONSORT) statement published an extension for feasibility studies in 2016.<h4>Aim</h4>The aim of this study was to systematically review and appraise the reporting of feasibility studies in the nursing intervention research literature based on the CONSORT statement extension for feasibility studies.<h4>Method</h4>Papers published prior to January 2018 that described feas ...[more]

PMID: 34394661

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Project description:ObjectivePilot and feasibility studies are intended to ensure that subsequent randomised controlled trials (RCTs) are feasible, economical and rigorous, especially in a challenging research environment such as emergency medicine (EM). We aimed to evaluate the methodological quality in conducting and reporting randomised pilot and feasibility studies in the EM literature and propose recommendations to improve their quality.DesignMethodological systematic review.Data sources and eligibilityWe searched MEDLINE and Embase (2018-29 September 2023) for pilot or feasibility RCTs published as full texts in the five top-ranked and other first-quartile EM journals according to Scimago.Data extraction and analysisWe assessed their methodological features and reporting quality primarily based on the Consolidated Standards of Reporting Trials (CONSORT) extension.ResultsA total of 24 randomised trials identified as pilot (n=13), feasibility (n=3) or both (n=8) were included. At least one feasibility outcome was assessed in 9 trials (feasibility trials), while 15 others only focused on treatment efficacy (efficacy trials). Only three (12.5%) studies progressed to the main trials. Among 12 feasibility trials, 55.6% reported their outcomes with uncertainty estimates, and 33.3% had clear progression criteria. Efficacy trials tended to draw clinical implications on their results. Studies from the five top-ranked journals had better methodological and reporting quality than those from other first-quartile journals.ConclusionMain methodological concerns for pilot and feasibility studies in first-quartile EM literature include misconceptions, misuses and suboptimal design and reporting quality. These issues were more prominent in lower-ranked first-quartile journals. Our findings highlight the need for resources and training for researchers, journal editors and peer reviewers on the value, objectives and appropriate conduct of pilot and feasibility studies. The conceptual framework and standardised methodological components should be emphasised. EM journals should reinforce the reporting standards and support their publication. These actions can lead to more methodologically rigorous pilot and feasibility studies in EM.Prospero registration numberCRD42023468437.

Project description:IntroductionMethodological studies (ie, studies that evaluate the design, conduct, analysis or reporting of other studies in health research) address various facets of health research including, for instance, data collection techniques, differences in approaches to analyses, reporting quality, adherence to guidelines or publication bias. As a result, methodological studies can help to identify knowledge gaps in the methodology of health research and strategies for improvement in research practices. Differences in methodological study names and a lack of reporting guidance contribute to lack of comparability across studies and difficulties in identifying relevant previous methodological studies. This paper outlines the methods we will use to develop an evidence-based tool-the MethodologIcal STudy reportIng Checklist-to harmonise naming conventions and improve the reporting of methodological studies.Methods and analysisWe will search for methodological studies in the Cumulative Index to Nursing and Allied Health Literature, Cochrane Library, Embase, MEDLINE, Web of Science, check reference lists and contact experts in the field. We will extract and summarise data on the study names, design and reporting features of the included methodological studies. Consensus on study terms and recommended reporting items will be achieved via video conference meetings with a panel of experts including researchers who have published methodological studies.Ethics and disseminationThe consensus study has been exempt from ethics review by the Hamilton Integrated Research Ethics Board. The results of the review and the reporting guideline will be disseminated in stakeholder meetings, conferences, peer-reviewed publications, in requests to journal editors (to endorse or make the guideline a requirement for authors), and on the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) Network and reporting guideline websites.RegistrationWe have registered the development of the reporting guideline with the EQUATOR Network and publicly posted this project on the Open Science Framework (www.osf.io/9hgbq).

Project description:BackgroundRandomized controlled trials (RCTs) are not always well reported, especially in terms of their methodological descriptions. This study aimed to investigate the adherence of methodological reporting complying with CONSORT and explore associated trial level variables in the Chinese nursing care field.MethodsIn June 2012, we identified RCTs published in five leading Chinese nursing journals and included trials with details of randomized methods. The quality of methodological reporting was measured through the methods section of the CONSORT checklist and the overall CONSORT methodological items score was calculated and expressed as a percentage. Meanwhile, we hypothesized that some general and methodological characteristics were associated with reporting quality and conducted a regression with these data to explore the correlation. The descriptive and regression statistics were calculated via SPSS 13.0.ResultsIn total, 680 RCTs were included. The overall CONSORT methodological items score was 6.34 ± 0.97 (Mean ± SD). No RCT reported descriptions and changes in "trial design," changes in "outcomes" and "implementation," or descriptions of the similarity of interventions for "blinding." Poor reporting was found in detailing the "settings of participants" (13.1%), "type of randomization sequence generation" (1.8%), calculation methods of "sample size" (0.4%), explanation of any interim analyses and stopping guidelines for "sample size" (0.3%), "allocation concealment mechanism" (0.3%), additional analyses in "statistical methods" (2.1%), and targeted subjects and methods of "blinding" (5.9%). More than 50% of trials described randomization sequence generation, the eligibility criteria of "participants," "interventions," and definitions of the "outcomes" and "statistical methods." The regression analysis found that publication year and ITT analysis were weakly associated with CONSORT score.ConclusionsThe completeness of methodological reporting of RCTs in the Chinese nursing care field is poor, especially with regard to the reporting of trial design, changes in outcomes, sample size calculation, allocation concealment, blinding, and statistical methods.

Project description:IntroductionMixed methods research intervention studies integrate quantitative evaluation approaches, such as randomized controlled trials and quasi-experimental designs, with qualitative research to evaluate the effectiveness, efficacy, or other results of an intervention or program. These types of studies, which have attracted growing attention in recent years, enhance the scope and rigor of the evaluation. While various frameworks that summarize the justifications for carrying out these types of studies and provide implementation guidance have been published in the last few years in the health sciences, we do not know whether such frameworks have been properly implemented in the social and educational sciences. This review examined the methodological features and reporting practices of mixed methods intervention studies aimed at increasing young people's interest in STEM.MethodsA systematic search was carried out in APA PsycNET, ERIC, ProQuest, Scopus, and Web of Science, and a hand search in 20 journals. We included peer-reviewed English-language articles that reported intervention studies with a quantitative component measuring outcomes specific to increasing secondary school students' interest in STEM fields, a qualitative component conducted before, during, or after the quantitative component, and evidence of integration of both components. Qualitative content analysis and ideal-type analysis were used to synthesize the findings.ResultsWe found 34 studies; the majority published in the last ten years. Several patterns of mixed methods application were described in these studies, illustrating the unique insights that can be gained by employing this methodology. The reporting quality of the included studies was generally adequate, especially regarding the justification for using a mixed methods intervention design and the integration of the quantitative and qualitative components. Nonetheless, a few reporting issues were observed, such as a lack of detail in the presentation of the mixed methods design, an inadequate description of the qualitative sampling and analysis techniques, and the absence of joint displays for representing integration.DiscussionAuthors must pay attention to these issues to ensure that the insights obtained by the use of mixed methods research are effectively communicated.

Project description:ObjectivesClinical practice guideline (CPG) developers conduct systematic summaries of research evidence, providing them great capacity and ability to identify research priorities. We systematically analysed the reporting form and content of research priorities in CPGs related to knee osteoarthritis (KOA) to provide a valuable reference for guideline developers and clinicians.DesignA methodological literature analysis was done and the characteristics of the reporting form and the content of the research priorities identified in KOA CPGs were summarised.Data sourcesSix databases (PubMed, Embase, China National Knowledge Infrastructure, VIP Database for Chinese Technical Periodicals, Wanfang and Chinese Biomedical Literature Database) were searched for CPGs published from 1 January 2017 to 4 December 2022. The official websites of 40 authoritative orthopaedic societies, rheumatology societies and guideline development organisations were additionally searched.Eligibility criteriaWe included all KOA CPGs published in English or Chinese from 1 January 2017 that included at least one recommendation for KOA. We excluded duplicate publications, older versions of CPGs as well as guidance documents for guideline development.Data extraction and synthesisReviewers worked in pairs and independently screened and extracted the data. Descriptive statistics were used, and absolute frequencies and proportions of related items were calculated.Results187 research priorities reported in 41 KOA CPGs were identified. 24 CPGs reported research priorities, of which 17 (41.5%) presented overall research priorities for the entire guideline rather than for specific recommendations. 110 (58.8%) research priorities were put forward due to lack of evidence. Meanwhile, more than 70% of the research priorities reflected the P (population) and I (intervention) structural elements, with 135 (72.2%) and 146 (78.1%), respectively. More than half of the research priorities (118, 63.8%) revolved around evaluating the efficacy of interventions. Research priorities primarily focused on physical activity (32, 17.3%), physical therapy (30, 16.2%), surgical therapy (27, 14.6%) and pharmacological treatment (26, 14.1%).ConclusionsResearch priorities reported in KOA CPGs mainly focused on evaluating non-pharmacological interventions. There exists considerable room for improvement for a comprehensive and standardised generation and reporting of research priorities in KOA CPGs.

Dataset Information

Methodological reporting in feasibility studies: a descriptive review of the nursing intervention research literature.

Background

Aim

Method

Results

Discussion

Publications

Methodological reporting in feasibility studies: a descriptive review of the nursing intervention research literature.

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