Debra P. Ritzwoller

Practical clinical trials for translating research to practice: design and measurement recommendations.

Rationale:There is a pressing need for practical clinical trials (PCTs) that are more relevant to clinicians and decision-makers, but many are unaware of these trials. Furthermore, such trials can be challenging to conduct and to report. Objective:The objective of this study was to build on the seminal paper by Tunis et al (Practical clinical trials. Increasing the value of clinical research for decision making in clinical and health policy. JAMA. 2003;290:1624–1632.) and to provide recommendations and examples of how practical clinical trials can be conducted and the results reported to enhance external validity without sacrificing internal validity. Key Issues:We discuss evaluating practical intervention options, alternative research designs, representativeness of samples participating at both the patient and the setting/clinician level, and the need for multiple outcomes to address clinical and policy implications. Conclusions:We provide a set of specific recommendations for issues to be reported in PCTs to increase their relevance to clinicians and policymakers, and to help reduce the gap between research and practice.

Long-term effects of the Mediterranean lifestyle program: a randomized clinical trial for postmenopausal women with type 2 diabetes

BackgroundMultiple-risk-factor interventions offer a promising means for addressing the complex interactions between lifestyle behaviors, psychosocial factors, and the social environment. This report examines the long-term effects of a multiple-risk-factor intervention.MethodsPostmenopausal women (N = 279) with type 2 diabetes participated in the Mediterranean Lifestyle Program (MLP), a randomized, comprehensive lifestyle intervention study. The intervention targeted healthful eating, physical activity, stress management, smoking cessation, and social support. Outcomes included lifestyle behaviors (i.e., dietary intake, physical activity, stress management, smoking cessation), psychosocial variables (e.g., social support, problem solving, self-efficacy, depression, quality of life), and cost analyses at baseline, and 6, 12, and 24 months.ResultsMLP participants showed significant 12- and 24-month improvements in all targeted lifestyle behaviors with one exception (there were too few smokers to analyze tobacco use effects), and in psychosocial measures of use of supportive resources, problem solving, self-efficacy, and quality of life.ConclusionThe MLP was more effective than usual care over 24 months in producing improvements on behavioral and psychosocial outcomes. Directions for future research include replication with other populations.

Effectiveness of the 2003–2004 Influenza Vaccine Among Children 6 Months to 8 Years of Age, With 1 vs 2 Doses

Objective. To evaluate the effectiveness of 1 and 2 doses of the 2003–2004 influenza vaccine in preventing medically attended influenza-like illness (ILI) among children 6 to 23 months and 6 months to 8 years of age. Design and Methods. Outpatient and emergency department visits and immunization records were used to conduct a retrospective cohort study among children 6 months to 8 years of age. ILI and pneumonia and influenza (P&I) outcomes were defined on the basis of International Classification of Diseases, Ninth Revision, codes. Influenza vaccine effectiveness (VE) was calculated as (1 − hazard rate ratio) × 100. Results. A total of 29726 children were included in the analyses; 17.3% were 6 to 23 months of age. By November 19, 2003, the start of peak influenza activity, 7.5% and 9.9% of children 6 months to 8 years were fully or partially vaccinated against influenza, respectively. For fully vaccinated children 6 to 23 months of age, VE against ILI and P&I was 25% and 49%, respectively. No statistically significant reduction in ILI or P&I rates was observed for partially vaccinated children 6 to 23 months of age (−3% and 22%, respectively). For fully vaccinated children 6 months to 8 years of age, VE against ILI and P&I was 23% and 51%, respectively. For partial vaccination, VE was significant only for P&I (23%). Conclusions. Despite a suboptimal match between the influenza vaccine and predominant circulating strains, influenza vaccination provided substantial protection for fully vaccinated children and possibly some protection for partially vaccinated children <9 years of age. These findings support vaccinating targeted children even when the vaccine match is suboptimal, and they highlight the need to vaccinate previously unvaccinated children with 2 doses for optimal protection.

The association of comorbidities, utilization and costs for patients identified with low back pain

BackgroundExisting studies have examined the high prevalence of LBP along with the high treatment costs of patients with low back pain (LBP). Various factors have been shown to be correlated or predictive of chronic or episodic LBP including the characteristics of the initial episode, pain, comorbid conditions, psychosocial issues, and opiate use. This study replicates and extends earlier studies by examining the association of patient characteristics including baseline comorbidities with patterns of healthcare service use and cost.MethodsThis is a retrospective analysis of measures of comorbidities, healthcare use, and cost for patients identified with LBP, stratified by the number of LBP episodes. Administrative data associated with outpatient and hospital based care for the years 1996 through 2001, were used to identify adult patients with LBP. LBP patients continuously enrolled for 12 months prior and 24 months after their initial LBP event were included in the study. A LBP episode was identified as the number of 30-day periods where a patient had one or more healthcare events with a diagnosis consistent with LBP. Chi-square and multivariate regression analyses were employed to estimate the variation in utilization and costs.ResultsOf 16,567 patients enrolled, 67% were identified with only one LBP episode and 4.5% had ≥6. The prevalence of comorbidities, analgesic use, and healthcare service use, varied by the number of back pain episodes. Diabetes, rheumatoid arthritis, anxiety, psychotic illness, depression, use of opiates and NSAIDs were associated with significant incremental increases in costs (P < .003).ConclusionPhysical and mental health co-morbidities and measures of analgesic use were associated with chronicity, healthcare utilization and costs. Given the association of comorbidities and cost for patients with LBP, management approaches that are effective across chronic illnesses may prove to be beneficial for high cost patients identified with LBP.

Twelve-month outcomes of an Internet-based diabetes self-management support program.

OBJECTIVE Internet-based programs offer potential for practical, cost-effective chronic illness self-management programs. METHODS We report 12-month results of an Internet-based diabetes self-management program, with and without additional support, compared to enhanced usual care in a 3-arm practical randomized trial. Patients (n=463) were randomized: 77.3% completed 12-month follow-up. Primary outcomes were changes in health behaviors of healthy eating, physical activity, and medication taking. Secondary outcomes were hemoglobin A1c, body mass index, lipids, blood pressure, and psychosocial factors. RESULTS Internet conditions improved health behaviors significantly vs. usual care over the 12-month period (d for effect size=.09-.16). All conditions improved moderately on biological and psychosocial outcomes. Latinos, lower literacy, and higher cardiovascular disease risk patients improved as much as other participants. CONCLUSIONS The Internet intervention meets the reach and feasibility criteria for a potentially broad public health impact. However, 12-month magnitude of effects was small, suggesting that different or more intensive approaches are necessary to support long-term outcomes. Research is needed to understand the linkages between intervention and maintenance processes and downstream outcomes. PRACTICE IMPLICATIONS Automated self-management interventions should be tailored and integrated into primary care; maintenance of patient self-management can be enhanced through links to community resources.

Impact of direct-to-consumer advertising for hereditary breast cancer testing on genetic services at a managed care organization: a naturally-occurring experiment.

Purpose: To describe the impact of Myriad Genetics, Inc.s direct-to-consumer advertising (DTC-ad) campaign on cancer genetic services within two Managed Care Organizations, Kaiser Permanente Colorado (KPCO), Denver, Colorado, where the ad campaign occurred, and Henry Ford Health System (HFHS), Detroit, Michigan, where there were no advertisements.Methods: The main outcome measures were the changes in number and pretest mutation probability of referrals approved for cancer genetic services at KPCO and HFHS during the campaign versus the year prior, and mutation probability of those undergoing testing.Results: At KPCO, referrals increased 244% during the DTC-ad compared to the same time period a year earlier (P value < 0.001). The proportion of referrals at high pretest probability of a mutation (10% or greater) dropped from 69% the previous year to 48% during the campaign (P value < 0.001). There was no significant change in pretest mutation probability among women who underwent testing between the two time periods. HFHS reported no significant change between the two time periods for numbers or mutation probability of referrals, or for mutation probability of women tested.Conclusion: The DTC-ad caused significant increase in demand for cancer genetic services. In the face of potential future DTC-ad for inherited cancer risk, providers and payers need to consider the delivery of genetic services and genetic education for persons of all risk levels.

Outcomes of Minimal and Moderate Support Versions of an Internet-Based Diabetes Self-Management Support Program

OBJECTIVEInternet and other interactive technology-based programs offer great potential for practical, effective, and cost-efficient diabetes self-management (DSM) programs capable of reaching large numbers of patients. This study evaluated minimal and moderate support versions of an Internet-based diabetes self-management program, compared to an enhanced usual care condition.RESEARCH DESIGN AND METHODSA three-arm practical randomized trial was conducted to evaluate minimal contact and moderate contact versions of an Internet-based diabetes self-management program, offered in English and Spanish, compared to enhanced usual care. A heterogeneous sample of 463 type 2 patients was randomized and 82.5% completed a 4-month follow-up. Primary outcomes were behavior changes in healthy eating, physical activity, and medication taking. Secondary outcomes included hemoglobin A1c, body mass index, lipids, and blood pressure.RESULTSThe Internet-based intervention produced significantly greater improvements than the enhanced usual care condition on three of four behavioral outcomes (effect sizes [d] for healthy eating = 0.32; fat intake = 0.28; physical activity= 0.19) in both intent-to-treat and complete-cases analyses. These changes did not translate into differential improvements in biological outcomes during the 4-month study period. Added contact did not further enhance outcomes beyond the minimal contact intervention.CONCLUSIONSThe Internet intervention meets several of the RE-AIM criteria for potential public health impact, including reaching a large number of persons, and being practical, feasible, and engaging for participants, but with mixed effectiveness in improving outcomes, and consistent results across different subgroups. Additional research is needed to evaluate longer-term outcomes, enhance effectiveness and cost-effectiveness, and understand the linkages between intervention processes and outcomes.

Costing Behavioral Interventions: A Practical Guide to Enhance Translation

Background/PurposeCost and cost effectiveness of behavioral interventions are critical parts of dissemination and implementation into non-academic settings. Due to the lack of indicative data and policy makers’ increasing demands for both program effectiveness and efficiency, cost analyses can serve as valuable tools in the evaluation process.MethodsTo stimulate and promote broader use of practical techniques that can be used to efficiently estimate the implementation costs of behavioral interventions, we propose a set of analytic steps that can be employed across a broad range of interventions.Results/ConclusionsIntervention costs must be distinguished from research, development, and recruitment costs. The inclusion of sensitivity analyses is recommended to understand the implications of implementation of the intervention into different settings using different intervention resources. To illustrate these procedures, we use data from a smoking reduction practical clinical trial to describe the techniques and methods used to estimate and evaluate the costs associated with the intervention. Estimated intervention costs per participant were

Recruitment to a Randomized Web-Based Nutritional Intervention Trial: Characteristics of Participants Compared to Non-Participants

419, with a range of

Designing a valid randomized pragmatic primary care implementation trial: The my own health report (MOHR) project

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