Table 1 Main types of non-randomised feasibility studies submitted to the journal, where to find guidance and published examples
From: Guidelines for reporting non-randomised pilot and feasibility studies
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://biomedcentral-pilotfeasibilitystudies.publicaciones.saludcastillayleon.es/articles/10.1186/s40814-015-0026-y | Thematic series on intervention development available at: https://biomedcentral-www.publicaciones.saludcastillayleon.es/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://biomedcentral-www.publicaciones.saludcastillayleon.es/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]: POWeR-RN non-randomised study with wait-list control [26] |
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: GLA:D® Back before-after study [28]: GenerationPMTO before-after study [29] |
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]: Prognosis of patients with apparent treatment-resistant hypertension [32]: |
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]? Are foetus mouth movements associated with sound stimulation in the womb [34]? |