Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 Sep 13;9(1):161.
doi: 10.1186/s40814-023-01389-w.

Use of guidelines, checklists, frameworks, and recommendations in behavioral intervention preliminary studies and associations with reporting comprehensiveness: a scoping bibliometric review

Affiliations

Use of guidelines, checklists, frameworks, and recommendations in behavioral intervention preliminary studies and associations with reporting comprehensiveness: a scoping bibliometric review

Christopher D Pfledderer et al. Pilot Feasibility Stud. .

Abstract

Background: Guidelines, checklists, frameworks, and recommendations (GCFRs) related to preliminary studies serve as essential resources to assist behavioral intervention researchers in reporting findings from preliminary studies, but their impact on preliminary study reporting comprehensiveness is unknown. The purpose of this study was to conduct a scoping bibliometric review of recently published preliminary behavioral-focused intervention studies to (1) examine the prevalence of GCFR usage and (2) determine the associations between GCFR usage and reporting feasibility-related characteristics.

Methods: A systematic search was conducted for preliminary studies of behavioral-focused interventions published between 2018 and 2020. Studies were limited to the top 25 journals publishing behavioral-focused interventions, text mined to identify usage of GCFRs, and categorized as either not citing GCFRs or citing ≥ 2 GCFRs (Citers). A random sample of non-Citers was text mined to identify studies which cited other preliminary studies that cited GCFRs (Indirect Citers) and those that did not (Never Citers). The presence/absence of feasibility-related characteristics was compared between Citers, Indirect Citers, and Never Citers via univariate logistic regression.

Results: Studies (n = 4143) were identified, and 1316 were text mined to identify GCFR usage (n = 167 Citers). A random sample of 200 studies not citing a GCFR were selected and categorized into Indirect Citers (n = 71) and Never Citers (n = 129). Compared to Never Citers, Citers had higher odds of reporting retention, acceptability, adverse events, compliance, cost, data collection feasibility, and treatment fidelity (ORrange = 2.62-14.15, p < 0.005). Citers also had higher odds of mentioning feasibility in purpose statements, providing progression criteria, framing feasibility as the primary outcome, and mentioning feasibility in conclusions (ORrange = 6.31-17.04, p < 0.005) and lower odds of mentioning efficacy in purpose statements, testing for efficacy, mentioning efficacy in conclusions, and suggesting future testing (ORrange = 0.13-0.54, p < 0.05). Indirect Citers had higher odds of reporting acceptability and treatment fidelity (ORrange = 2.12-2.39, p < 0.05) but lower odds of testing for efficacy (OR = 0.36, p < 0.05) compared to Never Citers.

Conclusion: The citation of GCFRs is associated with greater reporting of feasibility-related characteristics in preliminary studies of behavioral-focused interventions. Researchers are encouraged to use and cite literature that provides guidance on design, implementation, analysis, and reporting to improve the comprehensiveness of reporting for preliminary studies.

Keywords: Feasibility; Framework; Pilot; Preliminary studies; Reporting quality; Review.

PubMed Disclaimer

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) consort diagram

Similar articles

Cited by

References

    1. Beets MW, von Klinggraeff L, Weaver RG, Armstrong B, Burkart S. Small studies, big decisions: the role of pilot/feasibility studies in incremental science and premature scale-up of behavioral interventions. Pilot Feasibility Stud. 2021;7(1):1–9 - PMC - PubMed
    1. von Klinggraef L, Dugger R, Okely AD, Lubans D, Jago R, Burkart S, et al. Early-stage studies to larger-scale trials: investigators’ perspectives on scaling-up childhood obesity interventions (vol 8, 31, 2022). Pilot Feasibility Stud. 2022;8(1):1–3 - PMC - PubMed
    1. Rennie D. CONSORT revised - improving the reporting of randomized trials. JAMA. 2001;285(15):2006–7. doi: 10.1001/jama.285.15.2006. - DOI - PubMed
    1. Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, et al. Better reporting of interventions: Template for Intervention Description and Replication (TIDieR) checklist and guide. Bmj-Brit Med J. 2014;348:1–12 - PubMed
    1. Palmer W, Okonya O, Jellison S, Horn J, Harter Z, Wilkett M, et al. Intervention reporting of clinical trials published in high-impact cardiology journals: effect of the TIDieR checklist and guide. BMJ Evid-Based Med. 2021;26(3):91–7. doi: 10.1136/bmjebm-2019-111309. - DOI - PubMed

Publication types

LinkOut - more resources