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Table 3 Feasibility outcomes

From: An anti-inflammatory diet intervention for knee osteoarthritis: a feasibility study

  Anti-inflammatory intervention Recommendations for full-scale clinical trial
Recruitment and retention
 Recruitment rate 14 participants per month Could be increased utilising physiotherapy and orthopaedic clinics.
 Eligibility rate 48 of 73 (66%) screened participants eligible  
 Enrolment rate 28 of 48 (58%) of eligible participants enrolled  
 Drop-out rate 6 (21%) Strategies required to improve drop-out rate may include better education of intervention and follow-up requirements prior to enrolment, having a patient ambassador or using an interactive mobile app to optimise engagement.
Adherence and attendance
 Dietary adherence 96% reported adherence on the Likert scale of ≥4/5 at final follow-up Increased meal plans/recipes.
Utilisation of interactive food recording tools.
 Telehealth attendance 99% consult attendance  
 Food Diary completion 100% completion of diaries  
Adverse events
 Injury or illness N = 2
(1 constipation, 1 increased knee pain following fall)
Could incorporate more overt preventive strategies for constipation.
Acceptability of outcomes
 Treatment satisfaction Participants reported appointments were appropriate regarding: availability, frequency and duration. Participants were satisfied with the diet intervention with most (86%) of interviewed participants stating they would continue the diet. Consider initial baseline face-to-face consultation with tele-health follow-up.
 Time to collect data Baseline appointments completed in <90 min. Follow-up appointments completed in 10–15 min.  
 Completeness of patient-reported outcomes Of the 22 participants attending the 9-week follow-up, with a total of 88 data collection events (4 each):
- Missing data n = 1 (1%)
- Incomplete data n = 6 (7%)
Data checking mechanisms to reduce incomplete data.
 Adherence monitoring 15 participants used Easy Diet Diary, 7 used paper food records. Participants reported food diary was useful for motivation and accountability.
Participants reported that the macronutrient tracker on the Easy Diet Diary was helpful in providing real-time analysis of foods consumed, which aided food choices.