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Table 1 Methods and timing for assessing, recording and analysing outcome parameters

From: Feasibility and acceptability of group music therapy vs wait-list control for treatment of patients with long-term depression (the SYNCHRONY trial): study protocol for a randomised controlled trial

Outcome Method Success criteria Timing
Stop Continue, modify protocol Continue without modification but monitor closely Continue without modifications
Acceptability of methodology Recruitment and retention rates as below      End of recruitment (week 8)
Compliance Mean attendance <10 sessions Mean attendance <14 sessions Mean attendance 14 sessions Mean attendance 14+ sessions End of intervention (week 22)
End interviews Unfavourable views, serious concerns Unfavourable views, suggestions for modification Favourable views, suggestions for modification Favourable views, no concerns 1 month post-intervention (week 26)
Feasibility of recruitment processes Screening rates Identify <50 potentially eligible subjects Identify <100 potentially eligible subjects Identify 100–128 potentially eligible subjects Identify >128 potentially eligible subjects End of recruitment
Recruitment rates Recruit <50% of sample size N <25 in 8wks, <5% per week N = 25–30 in 8wks, <13% per week N = 30 in 8wks, 13% per week or greater End of recruitment
Participation rates Participation rate <5% Participation rate 5–15% Participation rate 15–25% Participation rate 25% or greater 6 months post-intervention
Retention rates Attrition >75% Attrition 50–75% Attrition 30 − 50% Attrition <30% 6 months post-intervention
End interviews N/A Major suggestions to improve recruitment processes Minor suggestions to improve recruitment processes No suggestions to improve expressed 1 month post-intervention (week 26)
Identify number of eligible participants, participant rates and retention rates Number identified by HCPs <50 identified 50–100 identified 100–128 identified >128 potentially eligible identified End of recruitment
Number expressing interest <30 express interest 30–40 express interest 40–60 express interest >60 express interest End of recruitment
Number providing consent <15 provide consent 15–25 provide consent 25–30 provide consent 30 provide consent End of recruitment post-intervention, 3 and 6 months post-intervention
Number lost to follow up Attrition >75% Attrition 50–75% Attrition 30–50% Attrition <30%
Researcher time and costs per participant Researcher diary N/A Researcher time exceeds allocated time requiring additional study support Researcher time and cost only just covers time required Researcher time and cost fully covers time required 6 months post-intervention
Appropriate outcome measures Variability of outcome Estimate of control mean and SD of change No difference or clinically important difference favouring control detected based on confidence limits Difference cannot be detected based on confidence limits but data suggest improvement favouring intervention Difference can be detected based on confidence limits Clinically important difference can be detected based on confidence limits End of intervention
Intervention components Therapist adherence Adherence <50% Adherence <50% Adherence 50–75% Adherence >75% End of intervention
End interviews Serious concerns expressed regarding intervention Major suggestions to adapt intervention Minor suggestions to adapt intervention No concerns or suggestions to adapt intervention
Intervention adherence Therapist self-rated adherence Video-rated adherence Adherence <25% Adherence 25–50% Adherence 50–75% Adherence >75% End of intervention
Estimate of cost of intervention and services received Therapist time CSRI Cost significantly greater than usual care, no potential to modify intervention, no indication of benefits Cost is greater than usual care - intervention may be modified, but outcomes suggest some benefits Cost is greater than usual care but outcomes strongly suggest benefits Cost is equivalent to or slightly greater than usual care, outcomes strongly suggest benefits 6 months post-intervention
  1. HCPs healthcare professionals, N/A not applicable, CSRI Client Services Receipt Inventory