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"Jefferson, Ashlie"
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Patient-centered recruitment and retention for a randomized controlled study
2018
Background
Recruitment and retention strategies for patient-centered outcomes research are evolving and research on the subject is limited. In this work, we present a conceptual model of patient-centered recruitment and retention, and describe the recruitment and retention activities and related challenges in a patient-centered comparative effectiveness trial.
Methods
This is a multicenter, longitudinal randomized controlled trial in localized prostate cancer patients.
Results
We recruited 743 participants from three sites over 15 months period (January 2014 to March 2015), and followed them for 24 months. At site 1, of the 773 eligible participants, 551 (72%) were enrolled. At site 2, 34 participants were eligible and 23 (68%) enrolled. Of the 434 eligible participants at site 3, 169 (39%) enrolled. We observed that strategies related to the concepts of trust (e.g., physician involvement, ensuring protection of information), communication (e.g., brochures and pamphlets in physicians’ offices, continued contact during regular clinic visits and calling/emailing assessment), attitude (e.g., emphasizing the altruistic value of research, positive attitude of providers and research staff), and expectations (e.g., full disclosure of study requirements and time commitment, update letters) facilitated successful patient recruitment and retention. A stakeholders’ advisory board provided important input for the recruitment and retention activities. Active engagement, reminders at the offices, and personalized update letters helped retention during follow-up. Usefulness of telephone recruitment was site specific and, at one site, the time requirement for telephone recruitment was a challenge.
Conclusions
We have presented multilevel strategies for successful recruitment and retention in a clinical trial using a patient-centered approach. Our strategies were flexible to accommodate site-level requirements. These strategies as well as the challenges can aid recruitment and retention efforts of future large-scale, patient-centered research studies.
Trial registration
Clinicaltrials.gov
, ID:
NCT02032550
. Registered on 22 November 2013.
Journal Article
Knowledge and attitude for overactive bladder care among women: development and measurement
by
Newman, Diane K.
,
Chhatre, Sumedha
,
Jefferson, Ashlie E.
in
Analysis
,
Attitude surveys
,
Bladder
2018
Background
Overactive bladder (OAB) affects millions of women. It is important to assess knowledge and attitude in affected patients. The study objective was to develop surveys to assess OAB knowledge and OAB related attitude, and its association with OAB treatment status.
Methods
Systematic literature review and qualitative analysis of patient and provider focus groups helped identify OAB knowledge and attitude survey items. We determined psychometric properties of the two surveys in a cross-sectional sample of 104 women, 27% of whom had received OAB treatment.
Results
The OAB-knowledge survey consisted of 16 items and 3 condition-related concepts: perception of OAB; cause and information; and signs of OAB. The OAB-attitude survey consisted of 16 items and its concepts were treatment seeking; decision-making and effects. Both surveys demonstrated good construct validity and test-retest reliability ((≥ 0.60). In the cross-sectional validation sample, OAB-knowledge and attitude discriminated between those with different levels of ICIQ-UI scores. We observed some difference in the OAB knowledge, OAB attitude, and severity of symptoms between those treated for OAB vs. treatment naive.
Conclusions
OAB knowledge and attitude surveys provide a novel tool to assess OAB domains in women. Though we did not find statistical significance in OAB knowledge and attitude scores across treatment status, they may be potentially modifiable factors that affect OAB treatment uptake and treatment compliance. Refinement of these surveys in diverse sub-populations is necessary. Our study provides effect sizes for OAB knowledge and attitude. These effect sizes can help development of fully powered trials to study the association between OAB knowledge and attitude, type and length of treatment, treatment compliance, and quality of life, leading to interventions for enhancing OAB care.
Journal Article