Table 5 Total number of documents identified containing a trial outcome reporting recommendation supporting each of the 132 candidate outcome reporting items in total, and number of documents with recommendations made that were specific to protocols, reports, both protocols and reports, and generally for trial documents

Category of “What” in general (recommendation not specific to any candidate item)

10

17

0

State the outcome

38

26

3

Specify the outcome as primary (or secondary)

30

35

3

If a primary outcome, provide a rationale for classifying the outcome as primary

3

3

1

Report if outcome is planned or unplanned^a

N/A

1

N/A

If a composite outcome, describe all individual components

0

1

0

If a composite outcome, provide citation to methodological paper(s), if applicable^a

1

0

0

Specify the outcome domain^b

5

6

0

Provide a rationale for the selected outcome domain^a,b

0

1

0

Classify the outcome and the outcome domain according to a standard outcome classification system or taxonomy^a,b

2

1

0

Specify if the outcome is an efficacy or harm outcome (adverse event). If a harm, see CONSORT for harms for specific guidance for trial reports

10

2

0

If outcome is patient-reported, refer to CONSORT-PRO or SPIRIT-PRO for specific guidance, as appropriate^c

0

0

0

Specify cut-off value for the outcome, if the outcome is continuous but defined and analysed as categorical, and justify cut-off value^a

2

1

0

Define clinical significance/meaningful change in terms of the outcome (e.g., minimal important difference, responder definition), including what would constitute a good or poor outcome

16

7

1

Justify the criteria used for defining meaningful change including what would constitute a good or poor outcome, such as from an outcome measurement interpretation guideline

2

2

0

Describe underlying basis for determining the criteria used for defining meaningful change^a

2

0

0

Category of “Why” in general (recommendation not specific to any candidate item)

10

4

0

Explain how the outcome relates to the hypothesis of the study

7

11

2

Explain how the outcome addresses the objective/research question of the study

10

4

0

Explain the mechanism (e.g., pathophysiological, pharmacological, etc.) or theoretical framework/model by which the experimental intervention is expected to cause change in the outcome in the target population

3

4

0

Specify if a relevant core outcome set is publicly available (e.g., via www.comet-initiative.org/), and if so, if the outcome is part of a core outcome set. If applicable, specify which core outcome set the outcome is part of

1

2

0

If a completely new outcome, justify why other outcomes are not appropriate or relevant for use in this trial

0

0

1

If there are other published definitions of the outcome beside the one that was used, explain why the chosen definition was used

0

0

0

Describe why the outcome is relevant to stakeholder groups (e.g., patients, clinicians, funders, etc.)

0

2

0

Report which stakeholders (e.g., patients, clinicians, funders, etc.) are actively involved in outcome selection, as per available guidance for the reporting of patient and public involvement

1

1

0

If applicable, describe discrepancies between the selected outcome and outcomes shown to be of interest to relevant stakeholder groups (e.g., through a core outcome set), and ways to reconcile discrepancies^a

0

2

0

Provide rationale for the choice of the specific type of outcome (e.g., why a patient-reported outcome instead of a clinician-reported outcome)

3

3

1

Category of “How” in general (recommendation not specific to any candidate item)

23

28

1

Describe the outcome measurement instrument (e.g., questionnaire, laboratory test). If applicable, include instrument scaling and scoring details (e.g., range and direction of scores)

23

19

0

Justify the selection of the outcome measurement instrument^a

9

6

0

If applicable, specify where outcome measurement instrument materials can be accessed. For trial protocols only: if materials are not publicly available, provide a copy^a

3

1

0

Specify if more than one language version of the outcome measure instrument used, and if yes, state how the translated versions were developed

3

0

0

If applicable, specify use of outcome measurement instrument in accordance with any user manual, and specify and justify deviations from user manual

9

1

0

If a new or untested outcome measurement instrument, describe an explicit framework (e.g., pathophysiological rationale) and/or supporting clinimetrics to support its use^a

0

2

0

If assessing multiple outcomes, specify any standardization of order of administration of the outcome measurement instrument(s)

1

0

0

If applicable, specify which outcome measurement instrument(s) is used at each assessment time point^a

2

0

0

Describe level at which the outcome is measured (i.e., cluster or individual)^a

0

2

0

Describe any additional resources/materials or processes necessary to perform outcome assessment, when relevant (e.g., language interpreter)

4

1

0

If applicable, specify the recall period for outcome assessment

3

0

0

Describe mode of outcome assessment (e.g., face to face, telephone, electronically)

8

5

1

Justify mode of outcome assessment (e.g., equivalence between different modes of administration)

1

0

0

Describe or provide reference to an empirical study that established validity of the outcome measure instrument for the mode of assessment used in this study^a

0

1

0

Describe or provide reference to an empirical study that establishes the validity of the outcome measurement instrument in individuals similar to the study sample

15

19

1

If outcome measurement instrument is known to have poor validity in individuals similar to the study sample, described how this discrepancy is accounted for^a

0

1

0

Describe or provide reference to an empirical study that established validity of the outcome measure instrument in the study setting

13

19

1

Describe or provide reference to an empirical study that established reliability of the outcome measure instrument in individuals similar to the study sample

8

14

1

Describe or provide reference to an empirical study that established reliability of the outcome measure instrument in individuals similar to the study setting

8

14

1

Describe or provide reference to an empirical study that establishes the responsiveness of the outcome measurement instrument in the study sample

3

0

0

Describe level of imprecision of outcome measurement instrument^a

0

1

0

Describe the feasibility of the outcome measurement instrument in the study sample

0

0

0

Describe the acceptability and burden of the outcome measurement instrument in the study sample

3

0

0

Describe any health risk(s) of the outcome assessment procedure^b

0

0

0

If applicable, describe any mathematical manipulation of the data necessary to perform during outcome assessment^a

0

1

0

Specify any monitoring of outcome data during the trial for the purpose of informing the clinical care of individual trial participants, and if applicable, describe how monitoring is managed in a standardized way

2

0

0

Category of “Who” in general (recommendation not specific to any candidate item)

0

0

0

Describe who assesses the outcome (e.g., nurse, parent) in each study group, and if applicable, how many assessors there are

12

10

0

Justify the choice of outcome assessor(s) (e.g., proxy versus healthcare provider)

2

0

0

Describe if there is an endpoint adjudication committee and if so, when the committee will perform the adjudication^a

4

0

0

Describe any processes to maximize outcome data quality (e.g., duplicate measurements)

8

9

0

Describe any trial-specific training required for outcome assessors to apply the outcome measurement instrument

9

5

0

Describe masking procedure(s) for outcome assessors, outcome data entry personnel, and/or outcome data analysts

6

10

1

Describe if outcome assessor(s) are masked to the intervention assignment

8

21

0

Specified any masking of members of the endpoint adjudication committee to the participant’s intervention group assignment^a

1

1

0

If applicable, justify why masking was not done, or explain why it was not possible, for outcome assessors, data entry personnel, and/or data analysts^a

1

3

0

State any strategies undertaken to reduce the potential for unmasking of outcome assessors, data entry personnel, and/or data analysts^a

4

0

0

If measured, describe success of masking of outcome assessors, outcome data entry personnel, and/or outcome data analysts to intervention assignment^a

N/A

5

N/A

Specify the name, affiliation, and contact details for the individual(s) responsible for the outcome content to identify the appropriate point of contact for resolution of any outcome-specific inquiries

3

0

0

Category of “Where” in general (recommendation not specific to any candidate item)

0

0

0

Describe setting of outcome assessment for each study group (e.g., community clinic, academic hospital)

6

9

0

Specify geographic location of outcome assessment for each study group (e.g., list of countries)

4

6

0

Justify suitability of the outcome assessment setting(s) for the study sample (e.g., measuring blood pressure in clinic vs. home)

0

0

0

Category of “When” in general (recommendation not specific to any candidate item)

0

1

0

Specify timing and frequency of outcome assessment(s) (e.g., time point for each outcome, time schedule of assessments)

32

28

3

Provided justification of timing and frequency of outcome assessment(s) (e.g., related to pathophysiological evidence for treatment response or complications occurrence and/or pragmatic justification)

5

4

0

Category of “Outcome data management and analyses” in general (recommendation not specific to any candidate item)

14

3

1

Data management and processes

Describe outcome data entry, coding, security and storage, including any related processes to promote outcome data quality (e.g., double entry, range checks from outcome data values). Reference to where details of data management procedures can be found, if not included

16

3

0

If applicable, specify who designs the electronic case report form, the name of the data management system, and if it is compliant with jurisdictional regulations^a

4

0

0

Analyses

Describe analysis metric for the outcome (e.g., change from baseline, final value, time to event)

14

3

0

Describe method of aggregation for the outcome data (e.g., mean, median, proportion)

10

5

0

Described relevant level of precision (e.g., standard deviation) of the outcome data^a

2

4

0

Describe unit of analysis of the outcome (i.e., cluster or individual)

2

8

0

If applicable, describe any transformations of the outcome data^a

2

2

0

Provide definition of analysis population relating to protocol non-adherence (e.g., as randomized analysis)

23

12

1

Justify definition of analysis population relating to protocol non-adherence (e.g., as randomized analysis)^a

1

0

0

Describe specific plans on how to present outcome data (including harms) (e.g., tables, graphs, etc.)^a

3

N/A

N/A

Describe time period(s) for which the outcome is analysed

24

3

0

If the outcome is assessed at several time points after randomization, state the pre-specified time point of primary interest^a

5

2

0

Describe statistical/analytical methods and significance test(s) for analysing the outcome data. This should include any analyses undertaken to address risk of type I error, particularly for trials with multiple outcomes and/or measurement time points. Reference to where other details of the statistical analysis plan can be found, if applicable

41

25

2

Justify statistical method(s) for the outcome analyses^a

2

3

0

State if outcome is part of any interim analyses^a

2

2

0

If interim analyses of the outcome are performed, describe the method to adjust for this in the final analysis^a

3

0

0

If applicable, describe methods for additional analyses, such as subgroup analyses and adjusted analyses

13

11

0

Identify statistical software for outcome analysis (e.g., SAS, R)^a

0

1

0

Describe how the outcome data are assessed for meeting assumptions for the statistical tests selected (e.g., normality, homogeneity of variance, etc.)^a

5

1

0

Specify alternative statistical methods to be used if the underlying assumptions (e.g., normality) do not hold^a

2

0

0

Describe how the statistical methods planned to evaluate the outcome are evaluated before implementation (e.g., through the use of simulations)^a

0

1

0

If applicable, describe any covariates/factors in the statistical model (e.g., adjusted analyses) used for analysing the outcome data

11

7

1

If applicable, justify inclusion and choice of covariates/factors

2

3

0

State and justify the criteria used to exclude any outcome data from the outcome analysis and reporting (e.g., unused data, spurious data)^a

12

2

0

If applicable, discuss the available power for secondary hypothesis testing for outcomes considered secondary^a

1

0

0

If intending to report the results of underpowered analyses, state an explicit strategy for their interpretation^a

1

N/A

N/A

Describe how any unplanned repeat measurements are handled when analysing the outcome data

0

2

0

Specify who analyses the outcome data (e.g., name and affiliation)

8

1

0

Results

Report the number of participants assessed for the outcome^a

N/A

5

N/A

For each group, specify the number of participants analysed for the outcome^a

N/A

19

N/A

Describe results for each group, and estimated effect size and its precision (such as 95% confidence interval). For binary outcomes, presentation of both absolute and relative effect sizes is recommended

N/A

36

N/A

Provide the results of planned outcome analyses (regardless of statistical significance)

N/A

23

N/A

Describe results of outcome data at each pre-specified time point^a

N/A

3

N/A

If a composite outcome, report results of its individual components^a

N/A

2

N/A

If applicable, separate pre-specified statistical analyses from post-hoc analyses that were not pre-specified^a

N/A

6

N/A

Report aggregated values of all outcome data (e.g., a table with mean, proportion, etc.) for each group^a

N/A

6

N/A

Describe results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory^a

N/A

6

N/A

If the outcome is used to make clinical decisions, provide an effect measure to quantify treatment effects (e.g., number needed to treat)^a

N/A

4

N/A

If the outcome data is part of a statistical analysis, state where the raw data are accessible (or will be accessible)^a

2

6

0

Report the statistical code used to complete each outcomes analyses (or where it is/will be accessible)^a

1

0

0

If someone other than a member in the study group interprets the outcome data, describe the person’s affiliations^a

3

0

0

Category of “Missing outcome data” in general (recommendation not specific to any candidate item)

2

1

0

Describe any plans to minimize missing outcome data

9

N/A

N/A

Describe plans on how reasons for missing outcome data will be recorded^a

3

N/A

N/A

Describe outcome data collection, assessment process, and analysis for participants who discontinue or deviate from the assigned intervention protocol

13

1

0

Describe methods to calculate missing outcome data rates and assess patterns of missing outcome data^a

1

0

0

For each group, describe how much outcome data are missing

N/A

14

N/A

For each group, describe any reason(s) for missing outcome data (e.g., missing study visits, lost to follow-up)

N/A

10

N/A

Describe statistical methods to handle missing outcome items or entire assessments (e.g., multiple imputation)

29

17

2

If applicable, describe any analyses conducted to assess the risk of bias posed by missing outcome data (e.g., comparison of baseline characteristics of participants with and without missing outcome data)

0

3

0

Provide justification for methods to handle missing outcome data. This should include: assumptions underlying the missing outcome data mechanism with justification (including analyses performed to support assumptions about the missingness mechanism); and how the assumed missingness mechanism and any relevant features of the outcome data would influence the choice of statistical method(s) to handle missing outcome data including sensitivity analyses

6

9

0

Category of “Interpretation” in general (recommendation not specific to any candidate item)

1

5

0

If there are elements in the clinical trial that would be different in a routine application setting (e.g., patient prompts/reminders, training sessions), discuss what impact the omission of these elements could have on outcomes if the intervention is applied outside the study setting^a

0

4

0

Report how the outcome results address the trial hypothesis, including the definition of clinically meaningful change, if applicable^a

N/A

1

N/A

Report how the outcome results addresses the research objective^a

N/A

1

N/A

Interpret outcome data in relation to clinical outcomes including survival data, where relevant

N/A

11

N/A

Discuss the possibility that the results are caused by type I or type II errors (e.g., multiple outcomes assessed, small sample size)^a

N/A

4

N/A

Describe other considerations or procedures that could affect the ability to interpret the outcome results

N/A

13

N/A

If applicable, discuss impact of missing outcome data on the interpretation of findings

N/A

4

N/A

If applicable, discuss limitations related to the lack of blinding of outcome assessors, outcome entry personnel, and/or outcome data analysts^a

N/A

3

N/A

If applicable, discuss any problems with statistical assumptions and/or data distributions for the outcome that could affect the validity of trial results^a

N/A

1

N/A

If a multi-centre trial, discuss any sources of variability in outcome assessment and the potential impact on trial result(s)^a

N/A

1

N/A

Interpret potential impact of imprecision on outcome results^a

N/A

3

N/A

Modifications (n = 3 items)

Category of “Modifications” in general (recommendation not specific to any candidate item)

0

0

0

Describe any changes to trial outcomes after the trial commenced (e.g., status of primary, definition), with reasons

1

23

1

Described any changes to trial outcomes since the trial was registered, with reasons^a

0

2

0

Described whether any changes made to the planned analysis of outcomes (including omissions) after the trial commenced, with reasons

3

5

5