Table 1 Drafts of the initial proposed checklists for feasibility and pilot studies
Item no. (original CONSORT) | Feasibility studies | Pilot studies |
|---|---|---|
Abstract | ||
1a | Identification as feasibility study in title | Identification as pilot in the title; randomized in title if used |
1b | Summary of study design, methods, results, and conclusions | Summary of study design, methods, results, and conclusions |
Background | ||
2a | Scientific background and explanation of rationale for feasibility study | Scientific background and explanation of rationale for pilot study |
2b | Key aims and objectives of feasibility study | Key aims and objectives of pilot study |
2c | Description of type of trial planning for (e.g. drug development, health services, community intervention, cluster trial, etc.) | Description of type of trial planning for (e.g. drug development, health services, community intervention, cluster trial, etc.) |
Methods | ||
3a1 | Description of design of feasibility study covering all objectives (may have several components addressing different objectives which all need to be described); adequate descriptions of how each objective is to be addressed and any relevant thresholds for successful implementation of component(s) | Description of design of pilot study (should differ from that of main study because the aim is not to test effectiveness—thus, data collected and types of analysis may differ); how differs from main study; thresholds for success/proceeding to main trial |
3a2 | Description of criteria used to judge feasibility (often a threshold, for example for recruitment rates) | Description of criteria used to judge whether to proceed with main trial (often a threshold, for example for recruitment rates) |
3b | Important changes to methods, outcomes, eligibility criteria, etc. during the study, with reasons (changes are sometimes made during feasibility studies because lack of feasibility is identified early on in a study) | Important changes to methods, outcomes, eligibility criteria, etc. during the study, with reasons (changes are sometimes made during pilot studies because a difficulty with a particular aspect is identified fairly early on) |
4a | Specify how participants were selected for each component, how many refused, if volunteers; eligibility criteria if any | Eligibility criteria for participants, how many refused; if cluster trial pilot address issues around bias and contamination |
4b | Settings and locations where the data were collected | Settings and locations where the data were collected |
Description of how potential biases in the main trial are being explored in the feasibility study (potential biases: selection, detection, performance, attrition) | Description of how potential biases in the main trial are being explored in the pilot study (potential biases: selection, detection, performance, attrition) | |
5a | Detailed description of intervention to be tested in main trial, specifying assessor, administration, duration, quality control (e.g. calibration, training), etc. to be used in any feasibility assessments | Detailed description of intervention being assessed in pilot study, including assessor(s), control group if using, administration, duration, quality control (e.g. calibration, training), etc. as appropriate |
6a | Specify assessments or measurements to be made to address each objective, including how and when they were made (each component of the study should be addressed); include how feasibility of descriptive components will be addressed | Specify range of measurements to be taken including main outcome measure, secondary outcome measures, if can be identified, recruitment and consent rates, etc. |
6b | Details of qualitative analysis if appropriate, cost-effectiveness | Details of pre-trial modelling criteria |
7a | Appropriate justification for sample size for each component (unlikely to include a sample size calculation, more likely to be a pragmatic decision) | Appropriate justification for sample size (does not need to include a formal trial sample size calculation but may include other types of sample size calculations) |
8a | Details of administration of or qualitative work related to randomisation | Method used to generate random allocation sequence (if randomized pilot study); description of how it will be administered; details of any restrictions; who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions |
11a | If done, details of how blinding was considered and used | If done, who was blinded, e.g. after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how |
11b | If relevant, description of how the interventions are to be made similar and details of any testing done | If relevant, description of the similarity of interventions |
12a | Any statistical methods used in the analysis of each component (if relevant) | Statistical methods used to summarize and compare groups for primary and secondary outcomes; estimates of effect size with confidence intervals; no hypothesis testing is recommended |
12b | Methods for additional analyses not addressing key objectives, such as adjusted analyses and cost-effectiveness with justification | Methods for additional analyses not addressing key objectives, such as adjusted analyses and cost-effectiveness with justification |
Results | ||
13a | Description of participants and numbers for components being assessed with flow diagram if appropriate | Description of participants and numbers for components being assessed with flow diagram if appropriate; if randomisation used for each group, the numbers of participants who were randomly assigned, received intended treatment, and were assessed for the outcome(s) |
13b | Losses and exclusions for each component being tested, including reasons | Losses and exclusions including reasons; if randomisation used for each group |
14a | Dates defining the periods of recruitment and follow-up for each component | Dates defining the periods of recruitment and follow-up |
14b | Why recruitment to the study ended or was stopped prior to the planned end of study (if relevant) | Why recruitment to the study ended or was stopped prior to the planned end of study (if relevant) |
15 | Summary of people or samples used for each component tested | A table showing baseline demographic and clinical characteristics for participants in the study; if randomisation used for each group |
16 | For each component, number of participants (denominator) or samples included in each analysis or data summary | For study participants and each group if randomized, number of participants (denominator) included in each analysis or data summary; if randomized whether the analysis was by original assigned groups |
17a | For all components tested ensure results match objectives; if relevant estimated effect size and its precision (such as 95 % confidence interval); for binary outcomes, presentation of both absolute and relative effect sizes is recommended | For all parameters and outcomes tested ensure results match objectives; estimated effect size and its precision (such as 95 % confidence interval); for binary outcomes, presentation of both absolute and relative effect sizes is recommended |
18 | Results of any other analyses performed, including adjusted analyses, distinguishing pre-specified from exploratory | Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory |
19 | All important harms or unintended effects; detail and discussion; patient questionnaires used to assess safety, adverse events, harms, etc. | All important harms or unintended effects; detail and discussion; patient questionnaires used to assess safety, adverse events, harms, etc. |
Discussion | ||
20 | Limitations addressing sources of potential bias, changes to components, imprecision of estimates, multiplicity of analyses, etc. | Limitations addressing sources of potential bias, changes to components, imprecision of estimates, multiplicity of analyses etc. and changes to pilot study protocol |
21 | Generalisability of the findings to other studies; transferable information (external validity, applicability), etc. | Generalisability of pilot work to other studies; is larger trial needed; transferable information (external validity, applicability), etc. |
22a | Interpretation consistent with results for each component tested, balancing benefits and harms, and considering other relevant evidence | Interpretation consistent with results for pilot study, balancing benefits and harms, and considering other relevant evidence; will main trial go ahead; how it will be designed |
22b | Assessment of feasibility of each component | Changes to main study protocol |
23 | Not applicable | Registration number and name of trial registry |
24 | Research review committee approval, ethics approval and consent to participate | Research review committee approval, ethics approval and consent to participate; where the trial protocol can be accessed, if available |
25 | Sources of funding and other support | Sources of funding and other support |