Table 4 Challenges identified in the literature by CONSORT Statement’s main headings [40,41,42,43,44,45]

Introduction

 Background and objectives

Ensure relevance of the problem to the context

Can reduce engagement

Background and setting

Methods

 Participants

Guarantee representativeness of the sample

Selection bias: can reduce internal and external validity

Recruitment and enrolment

 Intervention

Ensure cultural acceptability and practical feasibility

Adherence and withdrawal bias: can reduce internal validity

Intervention design and compliance

Improve fidelity to the intervention

Adherence bias: can reduce internal validity

 Outcome

Enhance reliability and quality of data

Information (instrument, recall and social desirability) bias: can reduce internal validity

Data collection

Maintain objectivity during the data collection process

 Sample size

Develop efficient recruitment methods

Selection bias: can reduce internal and external validity

Recruitment and enrolment

 Randomisation

Guarantee comparability between groups

Selection and confounding bias: can reduce internal and external validity

Randomisation and allocation

 Allocation

Reduce manipulation during the allocation

Selection and confounding bias: can reduce internal and external validity

 Implementation

Improve fidelity to the intervention

Adherence bias: can reduce internal validity

Intervention design and compliance

 Blinding

N/A

N/A

–

 Statistical methods

N/A

N/A

–

Result

 Participant flow

Minimise the number of participants leaving the study

Attrition and confounding bias: can reduce internal validity

Participant follow-up

 Recruitment

Develop efficient recruitment methods

Selection bias: can reduce internal and external validity

Recruitment and enrolment

 Baseline data and number analysed

N/A

N/A

–

 Outcomes and ancillary analyses

Identify the mechanisms underpinning the effect of the intervention

N/A

Analysis and results

 Harms

Enhance reliability and quality of data

Information (instrument, recall and social desirability) bias: can reduce internal validity

Data collection

Discussion

 Limitations

N/A

N/A

–

 Generalisability and applicability

Obtain buy-in from stakeholders

Can reduce implementation, sustainability and translation of results into practices

Background and setting

 Interpretation

Identify the mechanisms underpinning the effect of the intervention

N/A

Analysis and results