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. |  |