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Table 3 Feasibility and acceptability success criteria

From: A cluster randomised feasibility trial evaluating nutritional interventions in the treatment of malnutrition in care home adult residents

Objectives:

Success criteria

Recruitment of care homes

• Recruitment target of six met in the time available (3 months)

Resident eligibility criteria and recruitment

• Favourable difference shown in number at risk of malnutrition and number that were deemed eligible (≤20 % difference)

• Estimated resident recruitment target of n ≥50 met

Retention of care homes and residents

• Retention of 100 % for care home sites

• Retention of ≥65 % for residents at 6 months follow-up, accounting for expected high mortality and attrition rates

Intervention acceptability to residents and staff

• Intervention crossover of ≤10 % for each trial arm

• Given that the clinical benefits of ONS (unknown for FB) are seen with one to three servings (300 to 900 kcal) daily:

- ≥80 % of residents to be compliant with ≥50 % dietetic-led intervention dose (≥300 to 450 kcal),

- ≥60 % of residents to be compliant with ≥75 % of the dietetic-led intervention dose (≥450 to 600 kcal)

• ≥85 % staff adherence to intervention schedule

Feasibility and acceptability of the outcomes piloted

• Data completeness of ≥ 80 %

• Reported and recorded values were considered complete. Unknown and blank values (due to lack of recording, resident refusal, and inability to measure) were considered missing values.

Objectives:

Success criteria

Recruitment of care homes

• Recruitment target of six met in the time available (3 months)

Resident eligibility criteria and recruitment

• Favourable difference shown in number at risk of malnutrition and number that were deemed eligible (≤20 % difference)

• Estimated resident recruitment target of n ≥50 met

Retention of care homes and residents

• Retention of 100 % for care home sites

• Retention of ≥65 % for residents at 6 months follow-up, accounting for expected high mortality and attrition rates

Intervention acceptability to residents and staff

• Intervention crossover of ≤10 % for each trial arm

• Given that the clinical benefits of ONS (unknown for FB) are seen with one to three servings (300 to 900 kcal) daily:

- ≥80 % of residents to be compliant with ≥50 % dietetic-led intervention dose (≥300 to 450 kcal),

- ≥60 % of residents to be compliant with ≥75 % of the dietetic-led intervention dose (≥450 to 600 kcal)

• ≥85 % staff adherence to intervention schedule

Feasibility and acceptability of the outcomes piloted

• Data completeness of ≥ 80 %

• Reported and recorded values were considered complete. Unknown and blank values (due to lack of recording, resident refusal, inability to measure) were considered missing values.