Table 4.

Challenges identified in the literature by CONSORT Statement’s main headings [40–45]

Section/Topic	Challenge	Threat	Adapted CONSORT categories
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

Abbreviations: CONSORT Consolidated Standards of Reporting Trials, N/A not applicable