Patient Reported Outcome (PRO) Compliance Measure

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A Patient Reported Outcome (PRO) Compliance Measure is a COA compliance measure for a PRO instrument.

References

2016

  • (Atherton et al., 2016) ⇒ Pamela J. Atherton, Kelli N. Burger, Levi D. Pederson, Suneetha Kaggal, and Jeff A. Sloan. (2016). “Patient-reported Outcomes Questionnaire Compliance in Cancer Cooperative Group Trials (Alliance N0992). ” In: Clinical Trials, 13(6).
    • Background/Aims: The use of Patient Reported Outcomes (PROs) in clinical trials is a focal point for research and policy. Non-compliance with planned questionnaires and missing data can threaten both internal validity and generalizability. This retrospective analysis was conducted to determine the extent of, and characteristics associated with, missing PROs.
    • Methods: Study characteristics, patient characteristics and adverse events, and reasons for non-compliance were compiled from 14 closed Alliance for Clinical Trials in Oncology, Mayo Clinic Cancer Center, or Mayo Clinic Cancer Research Consortium clinical trials. Compliance rates were calculated for each patient using the number of booklets completed while the patient was on trial divided by the number of booklets the patient was expected to complete. Frequency counts and summary statistics were compiled. Logistic regression techniques were employed.
    • Results: The 1640 included patients had a median age of 58 years, were mostly white (90.8%) and female (73.8%). Compliance rates per study ranged from 84.7% to 97.2%. The primary endpoint of overall compliance rate was 93.1%. A total of 1267 patients were compliant. Those non-compliant were slightly older (mean 58.6 vs 57.5, p=0.03) and had different types of cancer (p<0.01). There were no differences in compliance according to tumor status (p=0.66), clinical stage (p=0.81), baseline quality of life (p=0.42 for ≥8 vs <8 and p=0.12 for ≥6 vs <6) or maximum adverse event grade incidence (p=0.33 for grade 2+ incidence and p=0.36 for grade 3+ incidence). Reasons for non-compliance included patient refusal (N=136), booklet not administered to patient (N=199), no clinic visit at the scheduled time for booklet completion (N=40), and at-home completed booklet not returned (N=224). Logistic regression indicates gender (p<0.01), race (p<0.01), performance score (p=0.02), dose delay status (p=0.01) and incidence of grade 3 or higher adverse event (p=0.03) were correlates of compliance.
    • Conclusions: PROs have successfully been implemented into Alliance and Mayo Clinic trials with high rates of patient compliance. Further improvement in compliance can be made with staff commitment and education. Patients are typically noncompliant only when the task at hand is burdensome, unclear or logistically challenging. Existing tracking systems used for the other trial outcomes should be utilized to ensure successful capture of PRO outcomes.

2007

  • (Land et al., 2007) ⇒ Stephanie R. Land, Marcie W. Ritter, Joseph P. Costantino, Thomas B. Julian, Walter M. Cronin, Sarah R. Haile, Norman Wolmark, and Patricia A. Ganz. (2007). “Compliance with Patient-reported Outcomes in Multicenter Clinical Trials: Methodologic and Practical Approaches.” In: Journal of Clinical Oncology, 25(32).
    • Purpose: This report describes interventions undertaken by the National Surgical Adjuvant Breast and Bowel Project (NSABP) to improve compliance with patient-reported outcome (PRO) assessments in the setting of multicenter cancer clinical trials. We describe the effectiveness of several interventions and of observational factors.
    • Methods: PRO submission rates were analyzed for the following three NSABP protocols: the Study of Raloxifene and Tamoxifen (STAR), B-32, and B-35. Institutions participating in protocol B-35 were randomly assigned to receive automated reminders of upcoming assessments or not. Compliance was analyzed with a logistic repeated measures mixed modeling.
    • Results: Compliance was high in the three protocols, with rates greater than 80% for nearly all time points. Institutions were a significant source of variability (P < .01). The largest institutions had the highest compliance in STAR (odds ratio [OR] = 0.68 for < 50 participants enrolled and OR = 0.82 for 50 to 99 participants enrolled v larger institutions; P < .001). Midsized institutions had highest compliance in B-32 (OR = 4.63 for 31 to 50 patients enrolled and OR = 3.12 for > 50 patients enrolled v small institutions; P = .007). Compliance increased with participant age in STAR (OR = 0.57, 0.89, and 1.01 for ages < 50, 50 to 60, and 60 to 70 years, respectively, v > 70 years; P < .001). Race was significant in B-32 (OR = 2.63 for white v nonwhite; P < .001) and in STAR (OR = 1.41 for white v nonwhite; P < .001). Treatment group was significant in B-32 (OR = 0.74; P = .006). The B-35 prospective reminder did not improve compliance significantly (P = .30), but in B-32, delinquency sanctions were significant (OR = 1.56; P = .007).
    • Conclusion: Compliance in NSABP PRO studies is higher now than a decade ago. Results for compliance initiatives were mixed. Age and race are important factors, but institutional variation remains significant and largely unexplained.
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