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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.

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