Economic return of clinical trials performed under the pediatric exclusivity program.

CONTEXT: In 1997, Congress authorized the US Food and Drug Administration (FDA) to grant 6-month extensions of marketing rights through the Pediatric Exclusivity Program if industry sponsors complete FDA-requested pediatric trials. The program has been praised for creating incentives for studies in children and has been criticized as a "windfall" to the innovator drug industry. This critique has been a substantial part of congressional debate on the program, which is due to expire in 2007. OBJECTIVE: To quantify the economic return to industry for completing pediatric exclusivity trials. DESIGN AND SETTING: A cohort study of programs conducted for pediatric exclusivity. Nine drugs that were granted pediatric exclusivity were selected. From the final study reports submitted to the FDA (2002-2004), key elements of the clinical trial design and study operations were obtained, and the cost of performing each study was estimated and converted into estimates of after-tax cash outflows. Three-year market sales were obtained and converted into estimates of after-tax cash inflows based on 6 months of additional market protection. Net economic return (cash inflows minus outflows) and net return-to-costs ratio (net economic return divided by cash outflows) for each product were then calculated. MAIN OUTCOME MEASURES: Net economic return and net return-to-cost ratio. RESULTS: The indications studied reflect a broad representation of the program: asthma, tumors, attention-deficit/hyperactivity disorder, hypertension, depression/generalized anxiety disorder, diabetes mellitus, gastroesophageal reflux, bacterial infection, and bone mineralization. The distribution of net economic return for 6 months of exclusivity varied substantially among products (net economic return ranged from -$8.9 million to $507.9 million and net return-to-cost ratio ranged from -0.68 to 73.63). CONCLUSIONS: The economic return for pediatric exclusivity is variable. As an incentive to complete much-needed clinical trials in children, pediatric exclusivity can generate lucrative returns or produce more modest returns on investment.

Are State legislatures responding to public opinion when allocating funds for tobacco control programs?

This study explored the factors associated with state-level allocations to tobacco-control programs. The primary research question was whether public sentiment regarding tobacco control was a significant factor in the states' 2001 budget decisions. In addition to public opinion, several additional political and economic measures were considered. Significant associations were found between our outcome, state-level tobacco-control funding per capita, and key variables of interest including public opinion, amount of tobacco settlement received, the party affiliation of the governor, the state's smoking rate, excise tax revenue received, and whether the state was a major producer of tobacco. The findings from this study supported our hypothesis that states with citizens who favor more restrictive indoor air policies allocate more to tobacco control. Effective public education to change public opinion and the cultural norms surrounding smoking may affect political decisions and, in turn, increase funding for crucial public health programs.

Study protocol: home-based telehealth stroke care: a randomized trial for veterans.

BACKGROUND: Stroke is one of the most disabling and costly impairments of adulthood in the United States. Stroke patients clearly benefit from intensive inpatient care, but due to the high cost, there is considerable interest in implementing interventions to reduce hospital lengths of stay. Early discharge rehabilitation programs require coordinated, well-organized home-based rehabilitation, yet lack of sufficient information about the home setting impedes successful rehabilitation. This trial examines a multifaceted telerehabilitation (TR) intervention that uses telehealth technology to simultaneously evaluate the home environment, assess the patient's mobility skills, initiate rehabilitative treatment, prescribe exercises tailored for stroke patients and provide periodic goal oriented reassessment, feedback and encouragement. METHODS: We describe an ongoing Phase II, 2-arm, 3-site randomized controlled trial (RCT) that determines primarily the effect of TR on physical function and secondarily the effect on disability, falls-related self-efficacy, and patient satisfaction. Fifty participants with a diagnosis of ischemic or hemorrhagic stroke will be randomly assigned to one of two groups: (a) TR; or (b) Usual Care. The TR intervention uses a combination of three videotaped visits and five telephone calls, an in-home messaging device, and additional telephonic contact as needed over a 3-month study period, to provide a progressive rehabilitative intervention with a treatment goal of safe functional mobility of the individual within an accessible home environment. Dependent variables will be measured at baseline, 3-, and 6-months and analyzed with a linear mixed-effects model across all time points. DISCUSSION: For patients recovering from stroke, the use of TR to provide home assessments and follow-up training in prescribed equipment has the potential to effectively supplement existing home health services, assist transition to home and increase efficiency. This may be particularly relevant when patients live in remote locations, as is the case for many veterans. TRIAL REGISTRATION: Clinical Trials.gov Identifier: NCT00384748.

Information relaxations and duality in stochastic dynamic programs

We describe a general technique for determining upper bounds on maximal values (or lower bounds on minimal costs) in stochastic dynamic programs. In this approach, we relax the nonanticipativity constraints that require decisions to depend only on the information available at the time a decision is made and impose a "penalty" that punishes violations of nonanticipativity. In applications, the hope is that this relaxed version of the problem will be simpler to solve than the original dynamic program. The upper bounds provided by this dual approach complement lower bounds on values that may be found by simulating with heuristic policies. We describe the theory underlying this dual approach and establish weak duality, strong duality, and complementary slackness results that are analogous to the duality results of linear programming. We also study properties of good penalties. Finally, we demonstrate the use of this dual approach in an adaptive inventory control problem with an unknown and changing demand distribution and in valuing options with stochastic volatilities and interest rates. These are complex problems of significant practical interest that are quite difficult to solve to optimality. In these examples, our dual approach requires relatively little additional computation and leads to tight bounds on the optimal values. © 2010 INFORMS.

The effect of a urinary incontinence self-management program for older women in South Korea: A pilot study

© 2015 Chinese Nursing Association.Background Although self-management approaches have shown strong evidence of positive outcomes for urinary incontinence prevention and management, few programs have been developed for Korean rural communities. Objectives This pilot study aimed to develop, implement, and evaluate a urinary incontinence self-management program for community-dwelling women aged 55 and older with urinary incontinence in rural South Korea. Methods This study used a one-group pre- post-test design to measure the effects of the intervention using standardized urinary incontinence symptom, knowledge, and attitude measures. Seventeen community-dwelling older women completed weekly 90-min group sessions for 5 weeks. Descriptive statistics and paired t-tests and were used to analyze data. Results The mean of the overall interference on daily life from urine leakage (pre-test: M = 5.76 ± 2.68, post-test: M = 2.29 ± 1.93, t = -4.609, p < 0.001) and the sum of International Consultation on Incontinence Questionnaire scores (pre-test: M = 11.59 ± 3.00, post-test: M = 5.29 ± 3.02, t = -5.881, p < 0.001) indicated significant improvement after the intervention. Improvement was also noted on the mean knowledge (pre-test: M = 19.07 ± 3.34, post-test: M = 23.15 ± 2.60, t = 7.550, p < 0.001) and attitude scores (pre-test: M = 2.64 ± 0.19, post-test: M = 3.08 ± 0.41, t = 5.150, p < 0.001). Weekly assignments were completed 82.4% of the time. Participants showed a high satisfaction level (M = 26.82 ± 1.74, range 22-28) with the group program. Conclusions Implementation of a urinary incontinence self-management program was accompanied by improved outcomes for Korean older women living in rural communities who have scarce resources for urinary incontinence management and treatment. Urinary incontinence self-management education approaches have potential for widespread implementation in nursing practice.

Scholarly research productivity is not related to higher three-year licensure pass rates for physical therapy academic programs.

BACKGROUND: In the domain of academia, the scholarship of research may include, but not limited to, peer-reviewed publications, presentations, or grant submissions. Programmatic research productivity is one of many measures of academic program reputation and ranking. Another measure or tool for quantifying learning success among physical therapists education programs in the USA is 100 % three year pass rates of graduates on the standardized National Physical Therapy Examination (NPTE). In this study, we endeavored to determine if there was an association between research productivity through artifacts and 100 % three year pass rates on the NPTE. METHODS: This observational study involved using pre-approved database exploration representing all accredited programs in the USA who graduated physical therapists during 2009, 2010 and 2011. Descriptive variables captured included raw research productivity artifacts such as peer reviewed publications and books, number of professional presentations, number of scholarly submissions, total grant dollars, and numbers of grants submitted. Descriptive statistics and comparisons (using chi square and t-tests) among program characteristics and research artifacts were calculated. Univariate logistic regression analyses, with appropriate control variables were used to determine associations between research artifacts and 100 % pass rates. RESULTS: Number of scholarly artifacts submitted, faculty with grants, and grant proposals submitted were significantly higher in programs with 100 % three year pass rates. However, after controlling for program characteristics such as grade point average, diversity percentage of cohort, public/private institution, and number of faculty, there were no significant associations between scholarly artifacts and 100 % three year pass rates. CONCLUSIONS: Factors outside of research artifacts are likely better predictors for passing the NPTE.

Protocol for the "Implementation, adoption, and utility of family history in diverse care settings" study.

BACKGROUND: Risk assessment with a thorough family health history is recommended by numerous organizations and is now a required component of the annual physical for Medicare beneficiaries under the Affordable Care Act. However, there are several barriers to incorporating robust risk assessments into routine care. MeTree, a web-based patient-facing health risk assessment tool, was developed with the aim of overcoming these barriers. In order to better understand what factors will be instrumental for broader adoption of risk assessment programs like MeTree in clinical settings, we obtained funding to perform a type III hybrid implementation-effectiveness study in primary care clinics at five diverse healthcare systems. Here, we describe the study's protocol. METHODS/DESIGN: MeTree collects personal medical information and a three-generation family health history from patients on 98 conditions. Using algorithms built entirely from current clinical guidelines, it provides clinical decision support to providers and patients on 30 conditions. All adult patients with an upcoming well-visit appointment at one of the 20 intervention clinics are eligible to participate. Patient-oriented risk reports are provided in real time. Provider-oriented risk reports are uploaded to the electronic medical record for review at the time of the appointment. Implementation outcomes are enrollment rate of clinics, providers, and patients (enrolled vs approached) and their representativeness compared to the underlying population. Primary effectiveness outcomes are the percent of participants newly identified as being at increased risk for one of the clinical decision support conditions and the percent with appropriate risk-based screening. Secondary outcomes include percent change in those meeting goals for a healthy lifestyle (diet, exercise, and smoking). Outcomes are measured through electronic medical record data abstraction, patient surveys, and surveys/qualitative interviews of clinical staff. DISCUSSION: This study evaluates factors that are critical to successful implementation of a web-based risk assessment tool into routine clinical care in a variety of healthcare settings. The result will identify resource needs and potential barriers and solutions to implementation in each setting as well as an understanding potential effectiveness. TRIAL REGISTRATION: NCT01956773.

Selectivity of physiotherapist programs in the United States does not differ by institutional funding source or research activity level.

PURPOSE: This study aimed to compare selectivity characteristics among institution characteristics to determine differences by institutional funding source (public vs. private) or research activity level (research vs. non-research). METHODS: This study included information provided by the Commission on Accreditation in Physical Therapy Education (CAPTE) and the Federation of State Boards of Physical Therapy. Data were extracted from all students who graduated in 2011 from accredited physical therapy programs in the United States. The public and private designations of the institutions were extracted directly from the classifications from the 'CAPTE annual accreditation report,' and high and low research activity was determined based on Carnegie classifications. The institutions were classified into four groups: public/research intensive, public/non-research intensive, private/research intensive, and private/non-research intensive. Descriptive and comparison analyses with post hoc testing were performed to determine whether there were statistically significant differences among the four groups. RESULTS: Although there were statistically significant baseline grade point average differences among the four categorized groups, there were no significant differences in licensure pass rates or for any of the selectivity variables of interest. CONCLUSION: Selectivity characteristics did not differ by institutional funding source (public vs. private) or research activity level (research vs. non-research). This suggests that the concerns about reduced selectivity among physiotherapy programs, specifically the types that are experiencing the largest proliferation, appear less warranted.

A pilot study of orthopaedic resident self-assessment using a milestones' survey just prior to milestones implementation.

OBJECTIVE: To pilot test if Orthopaedic Surgery residents could self-assess their performance using newly created milestones, as defined by the Accreditation Council on Graduate Medical Education. METHODS: In June 2012, an email was sent to Program Directors and administrative coordinators of the 154 accredited Orthopaedic Surgery Programs, asking them to send their residents a link to an online survey. The survey was adapted from the Orthopaedic Surgery Milestone Project. Completed surveys were aggregated in an anonymous, confidential database. SAS 9.3 was used to perform the analyses. RESULTS: Responses from 71 residents were analyzed. First and second year residents indicated through self-assessment that they had substantially achieved Level 1 and Level 2 milestones. Third year residents reported they had substantially achieved 30/41, and fourth year residents, all Level 3 milestones. Fifth year, graduating residents, reported they had substantially achieved 17 Level 4 milestones, and were extremely close on another 15. No milestone was rated at Level 5, the maximum possible. Earlier in training, Patient Care and Medical Knowledge milestones were rated lower than the milestones reflecting the other four competencies of Practice Based Learning and Improvement, Systems Based Practice, Professionalism, and Interpersonal Communication. The gap was closed by the fourth year. CONCLUSIONS: Residents were able to successfully self-assess using the 41 Orthopaedic Surgery milestones. Respondents' rate improved proficiency over time. Graduating residents report they have substantially, or close to substantially, achieved all Level 4 milestones. Milestone self-assessment may be a useful tool as one component of a program's overall performance assessment strategy.