Table 1.
Main types of non-randomised feasibility studies submitted to the journal, where to find guidance and published examples
| Type of study | Equator website checklists and other helpful guidance | Published examples |
|---|---|---|
| Intervention development |
TIDieR http://www.equator-network.org/reporting-guidelines/tidier/ Maximising the impact of qualitative research in feasibility studies for randomised controlled trials: guidance for researchers (O’Cathain et al): https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-015-0026-y |
Thematic series on intervention development available at: https://www.biomedcentral.com/collections/interventiondevelopment |
| Patient-Reported Outcome Measures (PROMS) development |
CONSORT PRO (adapt alongside CONSORT extension to pilot trials) http://www.equator-network.org/reporting-guidelines/consort-pro/ COSMIN User Manual (comprehensive reference, useful risk of bias tool) https://cosmin.nl/wp-content/uploads/COSMIN-syst-review-for-PROMs-manual_version-1_feb-2018.pdf |
Thematic series on pilot and feasibility testing of patient-reported outcome measures available at: https://www.biomedcentral.com/collections/pilotfeasibilityPROMs |
| Piloting several components of the trial |
CONSORT extension to pilot trials (ignoring items not applicable) |
Aging, Community and Health—Community Partnership Program before-after study [25]: https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-016-0063-1 POWeR-RN non-randomised study with wait-list control [26] https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-017-0122-2#Sec16 |
| Implementation of research findings |
CONSORT extension to pilot trials (ignoring items not applicable) RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework for evaluating interventions Please note that when applying RE-AIM to pilot and feasibility studies, ‘potential effectiveness’ only should be addressed. |
Thematic series on implementation science and practice forthcoming at: https://www.biomedcentral.com/collections/implementationscience-pilotstudies GLA:D® Back before-after study [28]: https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-019-0448-z GenerationPMTO before-after study [29] https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-019-0476-8 |
| Feasibility studies in preparation for a cohort or other large scale study |
STROBE (ignoring items not applicable) http://www.equator-network.org/reporting-guidelines/strobe/ CONSORT extension to pilot trials (ignoring items not applicable) • Ensure there is adequate explanation as to why the study is a feasibility study, and state clear feasibility objectives • Ensure a formal sample size calculation is reported if hypothesis testing is carried out |
Community-based paediatric respiratory infection surveillance cohort study [31]: https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-018-0371-8 Prognosis of patients with apparent treatment-resistant hypertension [32]: https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-018-0232-5 |
| Feasibility studies that test preliminary hypotheses of association |
STROBE (ignoring items not applicable) http://www.equator-network.org/reporting-guidelines/strobe/ CONSORT extension to pilot trials (ignoring items not applicable) • Ensure there is adequate explanation as to why the study is a feasibility study, and state clear feasibility objectives • Ensure a formal sample size calculation is reported if hypothesis testing is carried out |
Is cognitive function in delirium associated with EEG frequency band connectivity (case-control study) [33]? https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-018-0388-z Are foetus mouth movements associated with sound stimulation in the womb [34]? https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-016-0053-3 |