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Table 1 SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and related documents

From: A mobile-based pregaming drinking prevention intervention for college students: study protocol for a randomized controlled trial

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

1

 Trial registration

2a

Trial identifier and registry name. If not yet registered, name of intended registry

3

2b

All items from the World Health Organization Trial Registration Data Set

2–3

 Protocol version

3

Date and version identifier

1

 Funding

4

Sources and types of financial, material, and other support

23

 Roles and responsibilities

5a

Names, affiliations, and roles of protocol contributors

1

5b

Name and contact information for the trial sponsor

23

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

23

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)

23

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of research question and justification for undertaking the trial, including summary of relevant studies (published and unpublished) examining benefits and harms for each intervention

4–9

6b

Explanation for choice of comparators

14–15

 Objectives

7

Specific objectives or hypotheses

8–9

 Trial design

8

Description of trial design including type of trial (eg, parallel group, crossover, factorial, single group), allocation ratio, and framework (eg, superiority, equivalence, noninferiority, exploratory)

 

9–10

Methods: participants, interventions, and outcomes

 Study setting

9

Description of study settings (eg, community clinic, academic hospital) and list of countries where data will be collected. Reference to where list of study sites can be obtained

8–10

 Eligibility criteria

10

Inclusion and exclusion criteria for participants. If applicable, eligibility criteria for study centres and individuals who will perform the interventions (eg, surgeons, psychotherapists)

10

 Interventions

11a

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

10–15

11b

Criteria for discontinuing or modifying allocated interventions for a given trial participant (eg, drug dose change in response to harms, participant request, or improving/worsening disease)

Not available

11c

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

Not available

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 (eg, systolic blood pressure), analysis metric (eg, change from baseline, final value, time to event), method of aggregation (eg, median, proportion), and time point for each outcome. Explanation of the clinical relevance of chosen efficacy and harm outcomes is strongly recommended

 

16–18

 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)

25

 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

9

 Recruitment

15

Strategies for achieving adequate participant enrolment to reach target sample size

9–10

Methods: Assignment of interventions (for controlled trials)

Allocation:

 Sequence generation

16a

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

10

 Allocation concealment mechanism

16b

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

Not available

 Implementation

16c

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

Not available

 Blinding (masking)

17a

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

Not available

17b

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

Not available

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 (eg, duplicate measurements, training of assessors) and a description of study instruments (eg, 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

12–14

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

10

 Data management

19

Plans for data entry, coding, security, and storage, including any related processes to promote data quality (eg, double data entry; range checks for data values). Reference to where details of data management procedures can be found, if not in the protocol

10–11

 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

15–16

20b

Methods for any additional analyses (eg, subgroup and adjusted analyses)

15–164

20c

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

 

15–16

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

Not available

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

Not available

 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

Not available

 Auditing

23

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

Not available

Ethics and dissemination

 Research ethics approval

24

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

10

 Protocol amendments

25

Plans for communicating important protocol modifications (eg, changes to eligibility criteria, outcomes, analyses) to relevant parties (eg, investigators, REC/IRBs, trial participants, trial registries, journals, regulators)

Not available

 Consent or assent

26a

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

10

26b

Additional consent provisions for collection and use of participant data and biological specimens in ancillary studies, if applicable

Not available

 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

9–10

 Declaration of interests

28

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

23

 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

23

 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

Not available

 Dissemination policy

31a

Plans for investigators and sponsor to communicate trial results to participants, healthcare professionals, the public, and other relevant groups (eg, via publication, reporting in results databases, or other data sharing arrangements), including any publication restrictions

Not available

31b

Authorship eligibility guidelines and any intended use of professional writers

Not available

31c

Plans, if any, for granting public access to the full protocol, participant-level dataset, and statistical code

23