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Table 1 SPIRIT Checklist

From: A study protocol to assess the feasibility of conducting an evaluation trial of the ADVANCE integrated intervention to address both substance use and intimate partner abuse perpetration to men in substance use treatment

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 the intended registry

Abstract, 2

Protocol version

3

Date and version identifier

3

Funding

4

Sources and types of financial, material, and other support

15

Roles and responsibilities

5a

Names, affiliations, and roles of protocol contributors

15

5b

Name and contact information for the trial sponsor

15

 

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

15

 

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)

14

Introduction

 

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of research question and justification for undertaking the trial, including summary of relevant studies (published and unpublished) examining benefits and harms for each intervention

2–3

 

6b

Explanation for choice of comparators

10

Objectives

7

Specific objectives or hypotheses

3, 10–11

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)

3

Methods: participants, interventions, and outcomes

 

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

3

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)

3, 6

Interventions

11a

Interventions for each group with sufficient detail to allow replication, including how and when they will be administered

9–10

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)

13

11c

Strategies to improve adherence to intervention protocols, and any procedures for monitoring adherence (e.g. drug tablet return, laboratory tests)

10

11d

Relevant concomitant care and interventions that are permitted or prohibited during the trial

10

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

11–13

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, 6–8

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

13–14

Recruitment

15

Strategies for achieving adequate participant enrolment to reach target sample size

10

Methods: assignment of interventions (for controlled trials)

 

Allocation:

   

 Sequence generation

16a

Method of generating the allocation sequence (e.g. computer-generated random numbers), and list of any factors for stratification. To reduce predictability of a random sequence, details of any planned restriction (e.g. blocking) should be provided in a separate document that is unavailable to those who enrol participants or assign interventions

8

 Allocation concealment mechanism

16b

Mechanism of implementing the allocation sequence (e.g. central telephone; sequentially numbered, opaque, sealed envelopes), describing any steps to conceal the sequence until interventions are assigned

8

 Implementation

16c

Who will generate the allocation sequence, who will enrol participants, and who will assign participants to interventions

8

Blinding (masking)

17a

Who will be blinded after assignment to interventions (e.g. trial participants, care providers, outcome assessors, data analysts), and how

8

 

17b

If blinded, circumstances under which unblinding is permissible, and procedure for revealing a participant’s allocated intervention during the trial

8

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

11–13

 

18b

Plans to promote participant retention and complete follow-up, including a list of any outcome data to be collected for participants who discontinue or deviate from intervention protocols

10

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

11–13

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

14

 

20b

Methods for any additional analyses (e.g. subgroup and adjusted analyses)

14

 

20c

Definition of analysis population relating to protocol non-adherence (e.g. as randomised analysis), and any statistical methods to handle missing data (e.g. multiple imputation)

14

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

13–14

 

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

13

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

13

Auditing

23

Frequency and procedures for auditing trial conduct, if any, and whether the process will be independent from investigators and the sponsor

13

Ethics and dissemination

 

Research ethics approval

24

Plans for seeking research ethics committee/institutional review board (REC/IRB) approval

15

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)

15

Consent or assent

26a

Who will obtain informed consent or assent from potential trial participants or authorised surrogates, and how (see Item 32)

6-8

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

14

Declaration of interests

28

Financial and other competing interests for principal investigators for the overall trial and each study site

15