Browsing by Subject "Comparative Effectiveness Research"
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Item Open Access Assessing applicability when comparing medical interventions: AHRQ and the Effective Health Care Program.(Journal of clinical epidemiology, 2011-11) Atkins, David; Chang, Stephanie M; Gartlehner, Gerald; Buckley, David I; Whitlock, Evelyn P; Berliner, Elise; Matchar, DavidObjective
To describe a systematic approach for identifying, reporting, and synthesizing information to allow consistent and transparent consideration of the applicability of the evidence in a systematic review according to the Population, Intervention, Comparator, Outcome, Setting domains.Study design and setting
Comparative effectiveness reviews need to consider whether available evidence is applicable to specific clinical or policy questions to be useful to decision makers. Authors reviewed the literature and developed guidance for the Effective Health Care program.Results
Because applicability depends on the specific questions and needs of the users, it is difficult to devise a valid uniform scale for rating the overall applicability of individual studies or body of evidence. We recommend consulting stakeholders to identify the factors most relevant to applicability for their decisions. Applicability should be considered separately for benefits and harms. Observational studies can help determine whether trial populations and interventions are representative of "real world" practice. Reviewers should describe differences between available evidence and the ideally applicable evidence for the question being asked and offer a qualitative judgment about the importance and potential effect of those differences.Conclusion
Careful consideration of applicability may improve the usefulness of systematic reviews in informing practice and policy.Item Open Access Deriving Real-World Insights From Real-World Data: Biostatistics to the Rescue.(Annals of internal medicine, 2018-09) Pencina, Michael J; Rockhold, Frank W; D'Agostino, Ralph BItem Open Access Design of the North Carolina Prostate Cancer Comparative Effectiveness and Survivorship Study (NC ProCESS).(Journal of comparative effectiveness research, 2015-01) Chen, Ronald C; Carpenter, William R; Kim, Mimi; Hendrix, Laura H; Agans, Robert P; Meyer, Anne-Marie; Hoffmeyer, Anna; Reeve, Bryce B; Nielsen, Matthew E; Usinger, Deborah S; Strigo, Tara S; Jackman, Anne M; Anderson, Mary; Godley, Paul AThe North Carolina Prostate Cancer Comparative Effectiveness & Survivorship Study (NC ProCESS) was designed in collaboration with stakeholders to compare the effectiveness of different treatment options for localized prostate cancer. Using the Rapid Case Ascertainment system of the North Carolina Central Cancer Registry, 1,419 patients (57% of eligible) with newly-diagnosed localized prostate cancer were enrolled from January 2011 to June 2013, on average 5 weeks after diagnosis. All participants were enrolled prior to treatment and this population-based cohort is sociodemographically diverse. Prospective follow-up continues to collect data on treatments received, disease control, survival and patient-reported outcomes. This study highlights several important considerations regarding stakeholder involvement, study design and generalizability regarding comparative effectiveness research in prostate cancer.Item Open Access Diagnostic performance of short portable mental status questionnaire for screening dementia among patients attending cognitive assessment clinics in Singapore.(Annals of the Academy of Medicine, Singapore, 2013-07) Malhotra, Chetna; Chan, Angelique; Matchar, David; Seow, Dennis; Chuo, Adeline; Do, Young KyungIntroduction
The Short Portable Mental Status Questionnaire (SPMSQ) is a brief cognitive screening instrument, which is easy to use by a healthcare worker with little training. However, the validity of this instrument has not been established in Singapore. Thus, the primary aim of this study was to determine the diagnostic performance of SPMSQ for screening dementia among patients attending outpatient cognitive assessment clinics and to assess whether the appropriate cut-off score varies by patient's age and education. A secondary aim of the study was to map the SPMSQ scores with Mini-Mental State Examination (MMSE) scores.Materials and methods
SPMSQ and MMSE were administered by a trained interviewer to 127 patients visiting outpatient cognitive assessment clinics at the Singapore General Hospital, Changi General Hospital and Tan Tock Seng Hospital. The geriatricians at these clinics then diagnosed these patients with dementia or no dementia (reference standard). Sensitivity and specificity of SPMSQ with different cut-off points (number of errors) were calculated and compared to the reference standard using the Receiver Operator Characteristic (ROC) analysis. Correlation coefficient was also calculated between MMSE and SPMSQ scores.Results
Based on the ROC analysis and a balance of sensitivity and specificity, the appropriate cut-off for SPMSQ was found to be 5 or more errors (sensitivity 78%, specificity 75%). The cut-off varied by education, but not by patient's age. There was a high correlation between SPMSQ and MMSE scores (r = 0.814, P <0.0001).Conclusion
Despite the advantage of being a brief screening instrument for dementia, the use of SPMSQ is limited by its low sensitivity and specificity, especially among patients with less than 6 years of education.Item Open Access Incorporating Comparative Effectiveness Research Results into the U.S. Medicare Program(2010-12) Savitz, SamuelComparative Effectiveness Research (CER) is a method of evaluation that compares the effectiveness of two or more medical treatments by assessing comparative health outcomes. Historically, there has been a lack of implementation of the findings from CER. Typically, the approval process for a new treatment judges it on the criterion of whether it works efficaciously with little to no consideration of the relative effectiveness with existing treatments. This process for approving new treatments fails to measure how treatments of a similar type perform relative to one another and does not account for the costs of alternative treatments. My primary research question asks how the IPAB can successfully incorporate CER into clinical practice decisions within the Medicare system. I will evaluate this question by looking at the data for three specific medical conditions that will serve as case studies. Specifically, I will examine: 1) the use of stents in the treatment coronary artery disease; 2) knee-arthroplasty; and 3) prostate cancer treatment. I chose these three conditions because they each have extensive CER literature and there are reasonable alternative treatments. Further, the conditions are different in meaningful ways that will make my findings more generalizable. One such way is that intervention is far less discretionary for a patient in need of treatment for a coronary artery blockage, which is life-threatening in an immediate sense. Also, the preliminary literature review suggested that the evidence of clinical benefit for treatments differs significantly between prostate cancer and the other conditions with prostate cancer having much less clarity and many more options. Finally, mortality is not a concern with failing to provide knee-arthroscopy whereas it may occur with failure to treat the other conditions; knee function is purely a quality of life matter.Item Open Access Linked Sensitivity Analysis, Calibration, and Uncertainty Analysis Using a System Dynamics Model for Stroke Comparative Effectiveness Research.(Medical decision making : an international journal of the Society for Medical Decision Making, 2016-11) Tian, Yuan; Hassmiller Lich, Kristen; Osgood, Nathaniel D; Eom, Kirsten; Matchar, David BBackground
As health services researchers and decision makers tackle more difficult problems using simulation models, the number of parameters and the corresponding degree of uncertainty have increased. This often results in reduced confidence in such complex models to guide decision making.Objective
To demonstrate a systematic approach of linked sensitivity analysis, calibration, and uncertainty analysis to improve confidence in complex models.Methods
Four techniques were integrated and applied to a System Dynamics stroke model of US veterans, which was developed to inform systemwide intervention and research planning: Morris method (sensitivity analysis), multistart Powell hill-climbing algorithm and generalized likelihood uncertainty estimation (calibration), and Monte Carlo simulation (uncertainty analysis).Results
Of 60 uncertain parameters, sensitivity analysis identified 29 needing calibration, 7 that did not need calibration but significantly influenced key stroke outcomes, and 24 not influential to calibration or stroke outcomes that were fixed at their best guess values. One thousand alternative well-calibrated baselines were obtained to reflect calibration uncertainty and brought into uncertainty analysis. The initial stroke incidence rate among veterans was identified as the most influential uncertain parameter, for which further data should be collected. That said, accounting for current uncertainty, the analysis of 15 distinct prevention and treatment interventions provided a robust conclusion that hypertension control for all veterans would yield the largest gain in quality-adjusted life years.Conclusions
For complex health care models, a mixed approach was applied to examine the uncertainty surrounding key stroke outcomes and the robustness of conclusions. We demonstrate that this rigorous approach can be practical and advocate for such analysis to promote understanding of the limits of certainty in applying models to current decisions and to guide future data collection.Item Open Access Setting an agenda for comparative effectiveness systematic reviews in CKD care.(BMC Nephrol, 2012-08-01) Crews, Deidra C; Greer, Raquel C; Fadrowski, Jeffrey J; Choi, Michael J; Doggett, David; Segal, Jodi B; Fawole, Kemi A; Crawford, Pammie R; Boulware, L EbonySystematic reviews comparing the effectiveness of strategies to prevent, detect, and treat chronic kidney disease are needed to inform patient care. We engaged stakeholders in the chronic kidney disease community to prioritize topics for future comparative effectiveness research systematic reviews. We developed a preliminary list of suggested topics and stakeholders refined and ranked topics based on their importance. Among 46 topics identified, stakeholders nominated 18 as 'high' priority. Most pertained to strategies to slow disease progression, including: (a) treat proteinuria, (b) improve access to care, (c) treat hypertension, (d) use health information technology, and (e) implement dietary strategies. Most (15 of 18) topics had been previously studied with two or more randomized controlled trials, indicating feasibility of rigorous systematic reviews. Chronic kidney disease topics rated by stakeholders as 'high priority' are varied in scope and may lead to quality systematic reviews impacting practice and policy.Item Open Access Substance use disorders and comorbid Axis I and II psychiatric disorders among young psychiatric patients: findings from a large electronic health records database.(Journal of psychiatric research, 2011-11) Wu, Li-Tzy; Gersing, Ken; Burchett, Bruce; Woody, George E; Blazer, Dan GThis study examined the prevalence of substance use disorders (SUDs) among psychiatric patients aged 2-17 years in an electronic health records database (N=11,457) and determined patterns of comorbid diagnoses among patients with a SUD to inform emerging comparative effectiveness research (CER) efforts. DSM-IV diagnoses of all inpatients and outpatients at a large university-based hospital and its associated psychiatric clinics were systematically captured between 2000 and 2010: SUD, anxiety (AD), mood (MD), conduct (CD), attention deficit/hyperactivity (ADHD), personality (PD), adjustment, eating, impulse-control, psychotic, learning, mental retardation, and relational disorders. The prevalence of SUD in the 2-12-year age group (n=6210) was 1.6% and increased to 25% in the 13-17-year age group (n=5247). Cannabis diagnosis was the most prevalent SUD, accounting for more than 80% of all SUD cases. Among patients with a SUD (n=1423), children aged 2-12 years (95%) and females (75-100%) showed high rates of comorbidities; blacks were more likely than whites to be diagnosed with CD, impulse-control, and psychotic diagnoses, while whites had elevated odds of having AD, ADHD, MD, PD, relational, and eating diagnoses. Patients with a SUD used more inpatient treatment than patients without a SUD (43% vs. 21%); children, females, and blacks had elevated odds of inpatient psychiatric treatment. Collectively, results add clinical evidence on treatment needs and diagnostic patterns for understudied diagnoses.Item Open Access The Research RVU (rRVU): In Search of a Methodology to Incentivize and Compensate Clinicians for Participation in Clinical Research Activities.(Academic medicine : journal of the Association of American Medical Colleges, 2016-01) Severance, Harry W