Effects of financial incentives on volunteering for clinical trials: A randomized vignette experiment.

BACKGROUND: Financial incentives may aid recruitment to clinical trials, but evidence regarding risk/burden-driven variability in participant preferences for incentives is limited. We developed and tested a framework to support real-world decisions on recruitment budget. METHODS: We included two phases: an Anchoring Survey, to ensure we could capture perceived unpleasantness on a range of life events, and a Vignette Experiment, to explore relationships between financial incentives and participants' perceived risk/burden and willingness to participate in high- and low-risk/burden versions of five vignettes drawn from common research activities. We compared vignette ratings to identify similarly rated life events from the Anchoring Survey to contextualize ratings of study risk. RESULTS: In our Anchoring Survey (n = 643), mean ratings (scale 1 = lowest risk/burden to 5 = highest risk/burden) indicated that the questions made sense to participants, with highest risk assigned to losing house in a fire (4.72), and lowest risk assigned to having blood pressure taken (1.13). In the Vignette Experiment (n = 534), logistic regression indicated that amount of offered financial incentive and perceived risk/burden level were the top two drivers of willingness to participate in four of the five vignettes. Comparison of event ratings in the Anchoring Survey with the Vignette Experiment ratings suggested reasonable concordance on severity of risk/burden. CONCLUSIONS: We demonstrated feasibility of a framework for assessing participant perceptions of risk for study activities and discerned directionality of relationship between financial incentives and willingness to participate. Future work will explore use of this framework as an evidence-gathering approach for gauging appropriate incentives in real-world study contexts.

A four-year retrospective study of Assertive Community Treatment: change to more frequent, briefer client contact.

The authors explored the feasibility of providing frequent, brief client contact as a strategy for reallocating Assertive Community Treatment (ACT) staff time to new clients, while preserving relationships with current clients and ACT program fidelity standards. A retrospective analysis of 4 years of service records for a high-fidelity ACT team revealed gradual increases in staff-client contact frequency, and corresponding decreases in contact duration. During these years, fidelity to ACT standards remained moderately high, and clients' employment and hospitalization outcomes improved.

Person mobility in the design and analysis of cluster-randomized cohort prevention trials.

Person mobility is an inescapable fact of life for most cluster-randomized (e.g., schools, hospitals, clinic, cities, state) cohort prevention trials. Mobility rates are an important substantive consideration in estimating the effects of an intervention. In cluster-randomized trials, mobility rates are often correlated with ethnicity, poverty and other variables associated with disparity. This raises the possibility that estimated intervention effects may generalize to only the least mobile segments of a population and, thus, create a threat to external validity. Such mobility can also create threats to the internal validity of conclusions from randomized trials. Researchers must decide how to deal with persons who leave study clusters during a trial (dropouts), persons and clusters that do not comply with an assigned intervention, and persons who enter clusters during a trial (late entrants), in addition to the persons who remain for the duration of a trial (stayers). Statistical techniques alone cannot solve the key issues of internal and external validity raised by the phenomenon of person mobility. This commentary presents a systematic, Campbellian-type analysis of person mobility in cluster-randomized cohort prevention trials. It describes four approaches for dealing with dropouts, late entrants and stayers with respect to data collection, analysis and generalizability. The questions at issue are: 1) From whom should data be collected at each wave of data collection? 2) Which cases should be included in the analyses of an intervention effect? and 3) To what populations can trial results be generalized? The conclusions lead to recommendations for the design and analysis of future cluster-randomized cohort prevention trials.

Advancing the science of patient safety.

Despite a decade's worth of effort, patient safety has improved slowly, in part because of the limited evidence base for the development and widespread dissemination of successful patient safety practices. The Agency for Healthcare Research and Quality sponsored an international group of experts in patient safety and evaluation methods to develop criteria to improve the design, evaluation, and reporting of practice research in patient safety. This article reports the findings and recommendations of this group, which include greater use of theory and logic models, more detailed descriptions of interventions and their implementation, enhanced explanation of desired and unintended outcomes, and better description and measurement of context and of how context influences interventions. Using these criteria and measuring and reporting contexts will improve the science of patient safety.

Change what? Identifying quality improvement targets by investigating usual mental health care.

Efforts to improve community-based children's mental health care should be based on valid information about effective practices and current routine practices. Emerging research on routine care practices and outcomes has identified discrepancies between evidence-based practices and "usual care." These discrepancies highlight potentially potent quality improvement interventions. This article reviews existing research on routine or "usual care" practice, identifies strengths and weaknesses in routine psychotherapeutic care, as well as gaps in knowledge, and proposes quality improvement recommendations based on existing data to improve the effectiveness of children's mental health care. The two broad recommendations for bridging the research-practice gap are to implement valid, feasible measurement feedback systems and clinician training in common elements of evidence-based practice.

Intervening to improve communication between parents, teachers, and primary care providers of children with ADHD or at high risk for ADHD.

This study examines interventions designed to improve communication between individuals who take care of children with ADHD. A teacher rating of 6,171 elementary school children identifies 1,573 children with ADHD or with high risk for ADHD. Parent interviews and information from teachers are collected on 243 children who are randomized into treatment and control conditions and followed for 39 months. The interventions consisted of group workshops and single one-on-one tutorials with parents, teachers, and providers about the evaluation and treatment of ADHD that stressed the need for communication between the three parties. There are few significant effects on communication that are short lived. Results suggest that the interventions are insufficient to cause significant increase in communication. Future attempts to improve parent-teacher-provider coordination should be continuing rather than single-session interventions.

Dose response in child and adolescent mental health services.

This study examines the dose-response relationship, the correlation between the amount of mental health treatment a child receives (dose) and the outcome (response) in a community setting. Participants were 125 children treated in the Stark County Child and Adolescent Mental Health System. Study methods include multiple outcomes, multiple-dose definitions, longitudinal hierarchical analysis of repeated measures, and instrumental variable estimation to control for possible confounding between outcome and treatment dose. Results show no statistically significant dose response. The results do not support the existence of a dose response for children and adolescents consistent enough to guide clinicians, administrators, or policymakers.