Table 6 Santé-AF recommendations for changes to the methods of a future trial

 Objective 1: Participants’ willingness to take part

No recommendations

n/a

Objective 2: Appropriateness of eligibility criteria

Either stratify randomisation on characteristics that may affect response to treatment or include as covariates in analyses

To prevent baseline imbalance between groups

Widen eligibility criteria by extending the upper age limit to 85 years, removing 60-month limit on diagnosis length, removing the paroxysmal AF criterion and discarding eligibility criteria relating to COVID-19

To enfranchise a cohort more representative of the general population with AF

Objective 3: Participant retention

No recommendations

n/a

Objective 4: Intervention acceptability

Recruit practitioners closer to participants’ homes

Reducing travelling times and the general burden of compliance

Objective 5: Acceptability of study assessments

Retain both symptom diary and CardioSTAT® ECG monitor as measurements of symptomaticity

Ability to compare between self-report and objective measures

Carry out study assessments in person at a study centre, with a suitably trained healthcare professional taking anthropometric measurements and blood pressure, and fitting CardioSTAT® ECG monitor

To reduce participant burden, increase acceptability of study assessments, and increase measurement validity

Objective 6: Utility of CardioSTAT® monitor

See Objective 5 above

–

Objective 7: Experience of study participation

No recommendations

–

General recommendations

Emphasise to participants the confidentiality of reporting; data collectors and outcomes assessors should be blinded to treatment allocation

To avoid reporting biases in a pragmatic trial assessed partly by self-report

Include longer follow-ups than in this feasibility study

To demonstrate any effects of acupuncture and nutritional therapy over a longer term

Design as a multi-centre trial

Enhance generalisability

Include supplementation and functional testing in the scope of Nutritional therapy

Enhance real-world applicability of trial findings