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Table 1 SPIRIT checklist

From: The feasibility of delivering the ADVANCE digital intervention to reduce intimate partner abuse by men receiving substance use treatment: protocol for a non-randomised multi-centre feasibility study and embedded process evaluation

Section/item Item No Description Addressed on page number
Administrative information    
 Title 1 Descriptive title identifying the study design, population, interventions and, if applicable, trial acronym Title page
 Trial registration 2a Trial identifier and registry name. If not yet registered, name of intended registry Abstract, 7
 Protocol version 3 Date and version identifier 27
 Funding 4 Sources and types of financial, material and other support 28
 Roles and responsibilities 5a Names, affiliations and roles of protocol contributors Title page, 28
5b Name and contact information for the trial sponsor 26
5c Role of study sponsor and funders, if any, in study design; collection, management, analysis and interpretation of data; writing of the report; and the decision to submit the report for publication, including whether they will have ultimate authority over any of these activities 27
5d Composition, roles and responsibilities of the coordinating centre, steering committee, endpoint adjudication committee, data management team and other individuals or groups overseeing the trial, if applicable (see Item 21a for data monitoring committee) 25
Background and rationale 6a Description of research question and justification for undertaking the trial, including summary of relevant studies (published and unpublished) examining benefits and harms for each intervention 5–7
Objectives 7 Specific objectives or hypotheses 7
Trial design 8 Description of trial design including type of trial (e.g. parallel group, crossover, factorial, single group), allocation ratio and framework (e.g. superiority, equivalence, noninferiority, exploratory) 7
Methods: Participants, interventions and outcome    
 Study setting 9 Description of study settings (e.g. community clinic, academic hospital) and list of countries where data will be collected. Reference to where list of study sites can be obtained 7–8
 Eligibility criteria 10 Inclusion and exclusion criteria for participants. If applicable, eligibility criteria for study centres and individuals who will perform the interventions (e.g. surgeons, psychotherapists) 8–10
 Interventions 11a Interventions for each group with sufficient detail to allow replication, including how and when they will be administered 13–15; Table 3; Fig. 2
11b Criteria for discontinuing or modifying allocated interventions for a given trial participant (e.g. drug dose change in response to harms, participant request or improving/worsening disease) 23–24
11c Strategies to improve adherence to intervention protocols, and any procedures for monitoring adherence (e.g. drug tablet return, laboratory tests) 24
11d Relevant concomitant care and interventions that are permitted or prohibited during the trial 15
 Outcomes 12 Primary, secondary and other outcomes, including the specific measurement variable (e.g. systolic blood pressure), analysis metric (e.g. change from baseline, final value, time to event), method of aggregation (e.g. median, proportion) and time point for each outcome. Explanation of the clinical relevance of chosen efficacy and harm outcomes is strongly recommended 17–22, Table 2
 Participant timeline 13 Time schedule of enrolment, interventions (including any run-ins and washouts), assessments and visits for participants. A schematic diagram is highly recommended (see figure) Fig. 1, Table 2
 Sample size 14 Estimated number of participants needed to achieve study objectives and how it was determined, including clinical and statistical assumptions supporting any sample size calculations 25
 Recruitment 15 Strategies for achieving adequate participant enrolment to reach target sample size 10–12, 24
Methods: Data collection, management and analysis    
 Data collection methods 18a Plans for assessment and collection of outcome, baseline, and other trial data, including any related processes to promote data quality (e.g. duplicate measurements, training of assessors) and a description of study instruments (e.g. questionnaires, laboratory tests) along with their reliability and validity, if known. Reference to where data collection forms can be found, if not in the protocol 11–12, 17–24
18b Plans to promote participant retention and complete follow-up, including list of any outcome data to be collected for participants who discontinue or deviate from intervention protocols 13, 15, 25
 Data management 19 Plans for data entry, coding, security and storage, including any related processes to promote data quality (e.g. double data entry; range checks for data values). Reference to where details of data management procedures can be found, if not in the protocol 24
 Statistical methods 20a Statistical methods for analysing primary and secondary outcomes. Reference to where other details of the statistical analysis plan can be found, if not in the protocol 25
20b Methods for any additional analyses (e.g. subgroup and adjusted analyses) 25–26
Methods: Monitoring    
 Data monitoring 21a Composition of data monitoring committee (DMC), summary of its role and reporting structure, statement of whether it is independent from the sponsor and competing interests, and reference to where further details about its charter can be found, if not in the protocol. Alternatively, an explanation of why a DMC is not needed 23–24.26
21b Description of any interim analyses and stopping guidelines, including who will have access to these interim results and make the final decision to terminate the trial 23–24
 Harms 22 Plans for collecting, assessing, reporting and managing solicited and spontaneously reported adverse events and other unintended effects of trial interventions or trial conduct 24
 Auditing 23 Frequency and procedures for auditing trial conduct, if any, and whether the process will be independent from investigators and the sponsor n/a
Ethics and dissemination    
 Research ethics approval 24 Plans for seeking research ethics committee/institutional review board (REC/IRB) approval 27
 Protocol amendments 25 Plans for communicating important protocol modifications (e.g. changes to eligibility criteria, outcomes, analyses) to relevant parties (e.g. investigators, REC/IRBs, trial participants, trial registries, journals, regulators) 27
 Consent or assent 26a Who will obtain informed consent or assent from potential trial participants or authorised surrogates and how (see Item 32) 10–12
26b Additional consent provisions for collection and use of participant data and biological specimens in ancillary studies, if applicable n/a
 Confidentiality 27 How personal information about potential and enrolled participants will be collected, shared and maintained in order to protect confidentiality before, during and after the trial 26–27
 Declaration of interests 28 Financial and other competing interests for principal investigators for the overall trial and each study site 29
 Access to data 29 Statement of who will have access to the final trial dataset and disclosure of contractual agreements that limit such access for investigators n/a
 Ancillary and post-trial care 30 Provisions, if any, for ancillary and post-trial care and for compensation to those who suffer harm from trial participation n/a
 Dissemination policy 31a Plans for investigators and sponsor to communicate trial results to participants, healthcare professionals, the public and other relevant groups (e.g. via publication, reporting in results databases or other data sharing arrangements), including any publication restrictions n/a
31b Authorship eligibility guidelines and any intended use of professional writers n/a
31c Plans, if any, for granting public access to the full protocol, participant-level dataset and statistical code n/a
 Informed consent materials 32 Model consent form and other related documentation given to participants and authorised surrogates On request