Table 1 Recommendations for explicit reporting of information relating to adherence to treatment protocol

Single (one-off) intervention

Short-term intervention

Long-term intervention

1. Randomisation

Randomised^a

‘Crucial count for defining trial size and assessing whether a trial has been analysed by intention to treat’; necessary to determine whether all trial participants received treatment and were included in analysis.

2. Adherence to treatment protocol

a. Initiation

Initiated (or received) randomised intervention^a

Initiated randomised intervention^a

Initiated randomised intervention^a

Those not initiating randomised intervention

‘Knowing the number of participants who did not receive the intervention as allocated or did not complete treatment permits the reader to assess to what extent the estimated efficacy of therapy might be underestimated in comparison with ideal circumstances.’

b. Completion/persistence^b

Completed randomised intervention^a

Persisted with randomised intervention as required by treatment protocol^a

Those who did not complete/persist with randomised intervention

c. Adherence over treatment period ^c

i) Method

Description of method used to measure adherence over treatment period (and of an additional method to check reliability if trial involves participant-administered intervention)

If participant compliance data are collected, the reliability of the method used to record compliance should ideally be checked by use of another method (for example, treatment diaries backed up by counts of remaining tablets at the end of each course of treatment) [26]

ii) Justification for definition

Justification for any reported definition of adherence (for example, if a threshold is used to define adequate adherence)^d

‘If patients are to be divided into “compliant” and “noncompliant” groups, the division should ideally be made on the grounds of the relationship of the compliance level to the therapeutic response or outcome’ [29]

iii) Results

Measure of participant and/or treatment provider adherence with randomised intervention (as appropriate)^d

Any participant or treatment provider nonadherence^d

3. Analysis

a. Analysed

Analysed^a

Any exclusion of participants from analysis

‘Attrition as a result of loss to follow up, which is often unavoidable, needs to be distinguished from investigator-determined exclusion for such reasons as ineligibility, withdrawal from treatment, and poor adherence to the trial protocol…Participants who were excluded after allocation are unlikely to be representative of all participants in the study.’

b. Analysis set composition

How analysis sets differ from randomised groups

Any difference between analysis sets and randomisation groups

‘Erroneous conclusions can be reached if participants are excluded from analysis, and imbalances in such omissions between groups may be especially indicative of bias.’