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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://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)

http://www.equator-network.org/reporting-guidelines/consort-2010-statement-extension-to-randomised-pilot-and-feasibility-trials/

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)

http://www.equator-network.org/reporting-guidelines/consort-2010-statement-extension-to-randomised-pilot-and-feasibility-trials/

RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework for evaluating interventions

http://www.re-aim.org/

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)

http://www.equator-network.org/reporting-guidelines/consort-2010-statement-extension-to-randomised-pilot-and-feasibility-trials/

• 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)

http://www.equator-network.org/reporting-guidelines/consort-2010-statement-extension-to-randomised-pilot-and-feasibility-trials/

• 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