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No. 028. Are screening trial recruitment logs an accurate reflection of the eligibility criteria of a clinical trial? Experience of the RAVES 0803 trial using a comprehensive surgical screening & referral log.

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No. 028

Are screening trial recruitment logs an accurate reflection of the eligibility criteria of a clinical trial? Experience of the RAVES 0803 trial using a comprehensive surgical screening & referral log

P Sundaresan1,2 A Kneebone1,3 M Pearse4 S Turner1,5 C Fraser-Browne4 H Woo 1

1. The University of Sydney , Sydney, Australia, 2. Royal Prince Alfred Hospital, Sydney, Australia, 3. Royal North Shore Hospital , Sydney, Australia, 4. Auckland Hospital, Auckland, New Zealand, 5.Westmead Hospital, Sydney Australia

Introduction

Screening & recruitment logs are useful in clinical trials to prompt clinicians about open trials and gauge how many patients eligible for trial participation actually enrol. Information on reasons for ineligibility and non-participation are crucial when reporting and interpreting trial findings, particularly in relation to generalisability1,2. The RAVES trial for men with high-risk features after radical prostatectomy compares adjuvant radiotherapy (RT) with early salvage RT2. Recruitment is dependent on timely surgical referral of potentially eligible men to a trial centre for radiation oncologist (RO) assessment. Screening logs at RT centres only reflect men referred to the centres. They may not reflect the actual number of potentially eligible participants.

Results

Patient flow from radical prostatectomy through to subsequent management

  • Aims
  • Examine a surgical screening & referral log maintained by a urologist (active RAVES participant) in order to determine the actual number of men potentially eligible for the RAVES trial
  • Identify reasons why some men were not, or were unwilling to be, referred for further assessment.

Methods

Men who underwent radical prostatectomy from September 2009 to September 2010 were prospectively entered on a comprehensive screening & referral database maintained by the participating urologist. Histopathological findings & information on whether men were referred to a RAVES trial radiotherapy (RT) centre for a radiation oncology (RO) assessment and if not, the reasons for this (unsuitable / patient preference) were also recorded.

Patients recruited at RT centre = 31% (5/16): This is the “recruitment rate” reflected in the formal RAVES trial screening log

Considering all those eligible on histopathology and PSA criteria, “true recruitment rate” = 16% (5/ 31)

Data on patients not referred for radiation oncology assessment

  • Conclusions
  • Screening logs at RT trial centres may not accurately reflect the true population of potentially eligible patients when trials are dependent on surgical referrals.
  • Surgical screening & referral logs can provide important information in these settings and offer insights into barriers to trial recruitment.

References

Seale J P, Gebski V, Keech A C, Generalising the results of trials to clinical practice. Medical Journal of Australia, 2004;181(10):558-560

Moher D, Schultz.K., Altman DG, The CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomised trials. Lancet, 2001; 357: 1197-1194

Trans Tasman Radiation Oncology Group, Radiotherapy-Adjuvant Versus Early Salvage (RAVES) trial (NCT00860652), ClinicalTrials.gov [Internet].: http://clinicaltrials.gov/ct2/show/NCT00860652 2009, Bethesda (MD): National Library of Medicine (US)

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