Spillover adherence effects of fixed-dose combination HIV therapy

The impact of fixed-dose combination (FDC) products on adherence to other, non-fixed regimen components has not been examined. We compared adherence to a third antiretroviral (ART) component among patients receiving a nucleoside reverse transcriptase inhibitor (NRTI) backbone consisting of the FDC Epzicom®, GlaxoSmithKline Inc, Research Triangle Park, NC (abacavir sulfate 600 mg + lamivudine 300 mg; FDC group) versus NRTI combinations taken as two separate pills (NRTI Combo group) using data from a national sample of 30 health plans covering approximately 38 million lives from 1997 to 2005. Adherence was measured as the medication possession ratio (MPR). Multivariate logistic regression compared treatment groups based on the likelihood of achieving ≥95% adherence, with sensitivity analyses using alternative thresholds. MPR was assessed as a continuous variable using multivariate linear regression. Covariates included age, gender, insurance payer type, year of study drug initiation, presence of mental health and substance abuse disorders, and third agent class. The study sample consisted of 650 FDC and 1947 NRTI Combo patients. Unadjusted mean adherence to the third agent was higher in the FDC group than the NRTI Combo group (0.92 vs 0.85; P < 0.0001). In regression analyses, FDC patients were 48% and 39% more likely to achieve 95% and 90% third agent adherence, respectively (P ≤ 0.03). None of the other MPR specifications achieved comparable results. Among managed care patients, use of an FDC appears to substantially improve adherence to a third regimen component and thus the likelihood of achieving the accepted standard for adherence to HIV therapy of 95%

Use of Home Health Care by ESRD and Medicare Beneficiaries

The use of home health care (HHC) services among Medicare end stage renal disease (ESRD) enrollees remains an understudied area. In this article, the authors report sociodemographic characteristics and patterns of HHC utilization by Medicare-covered ESRD patients. The authors found that those who were female, age 85 or over, diabetic, and residing in the New England or West South Central census divisions were more likely to use HHC services and were also more intensive users. Analysis of use patterns in such high-risk populations is necessary to ensure that health policy changes do not have unintended consequences for vulnerable patients

An Open-Label, Pragmatic, Randomized Controlled Clinical Trial to Evaluate the Comparative Effectiveness of Daptomycin Versus Vancomycin for the Treatment of Complicated Skin and Skin Structure Infection

Treatment of complicated skin and skin structure infection (cSSSI) places a tremendous burden on the health care system. Understanding relative resource utilization associated with different antimicrobials is important for decision making by patients, health care providers, and payers. Methods: The authors conducted an open-label, pragmatic, randomized (1:1) clinical study (N = 250) to compare the effectiveness of daptomycin with that of vancomycin for treatment of patients hospitalized with cSSSI caused by suspected or documented methicillin-resistant Staphylococcus aureus infection. The primary study end point was infection-related length of stay (IRLOS). Secondary end points included health care resource utilization, cost, clinical response, and patient-reported outcomes. Patient assessments were performed daily until the end of antibiotic therapy or until hospital discharge, and at 14 days and 30 days after discharge. Results: No difference was found for IRLOS, total LOS, and total inpatient cost between cohorts. Hospital LOS contributed 85.9 % to the total hospitalization cost, compared with 6.4 % for drug costs. Daptomycin showed a nonsignificant trend toward a higher clinical success rate, compared with vancomycin, at treatment days 2 and 3. In the multivariate analyses, vancomycin was associated with a lower likelihood of day 2 clinical success (odds ratio [OR] = 0.498, 95 % confidence interval [CI], 0.249-0.997; P < 0.05). Conclusion: This study did not provide conclusive evidence of the superiority of one treatment over the other in terms of clinical, economic, or patient outcomes. The data suggest that physician and patient preference, rather than drug acquisition cost, should be the primary driver of initial antibiotic selection for hospitalized patients with cSSSI.Merck & Co., Inc., Kenilworth, NJ USAKinesiology and Health Educatio

Factors influencing the participation of gastroenterologists and hepatologists in clinical research

<p>Abstract</p> <p>Background</p> <p>Although clinical research is integral to the advancement of medical knowledge, physicians face a variety of obstacles to their participation as investigators in clinical trials. We examined factors that influence the participation of gastroenterologists and hepatologists in clinical research.</p> <p>Methods</p> <p>We surveyed 1050 members of the American Association for the Study of Liver Diseases regarding their participation in clinical research. We compared the survey responses by specialty and level of clinical trial experience.</p> <p>Results</p> <p>A majority of the respondents (71.6%) reported involvement in research activities. Factors most influential in clinical trial participation included funding and compensation (88.3%) and intellectual pursuit (87.8%). Barriers to participation were similar between gastroenterologists (n = 160) and hepatologists (n = 189) and between highly experienced (n = 62) and less experienced (n = 159) clinical researchers. These barriers included uncompensated research costs and lack of specialized support. Industry marketing was a greater influence among respondents with less trial experience, compared to those with extensive experience (15.7% vs 1.6%; <it>P </it>< .01). Hepatologists and respondents with extensive clinical trial experience tended to be more interested in phase 1 and 2 studies, whereas gastroenterologists and less experienced investigators were more interested in phase 4 studies.</p> <p>Conclusion</p> <p>This study suggests that the greatest barrier to participation in clinical research is lack of adequate resources. Respondents also favored industry-sponsored research with less complex trial protocols and studies of relatively short duration.</p

Inhibitor clinical burden of disease: a comparative analysis of the CHESS data.

From Europe PMC via Jisc Publications Router.Publication status: PublishedBACKGROUND:Patients with hemophilia and inhibitors generally face greater disease burden compared to patients without inhibitors. While raising awareness of relative burden may improve the standard of care for patients with inhibitors, comparative data are sparse. Analyzing data drawn from the Cost of Haemophilia across Europe - a Socioeconomic Survey (CHESS) study, the aim of this study was to compare the clinical burden of disease in patients with severe hemophilia with and without inhibitors. Hemophilia specialists (N = 139) across five European countries completed an online survey between January-April 2015, providing demographic, clinical and 12-month ambulatory/secondary care activity data for 1285 patients. Patients with hemophilia who currently presented with inhibitors and those who never had inhibitors were matched on baseline characteristics via propensity score matching. Outcomes were compared between the two cohorts using a paired t-test or Wilcoxon signed-rank or McNemar's test. RESULTS:The proportion of patients who currently presented with inhibitors was 4.5% (58/1285). Compared to PS-matched patients without inhibitors, patients with inhibitors experienced more than twice the mean annual number of bleeds (mean ± standard deviation, 8.29 ± 9.18 vs 3.72 ± 3.95; p < .0001) and joint bleeds (2.17 ± 1.90 vs 0.98 ± 1.15; p < .0001), and required more hemophilia-related (mean ± standard deviation, 1.79 ± 1.83 vs 0.64 ± 1.13) and bleed-related hospitalizations (1.86 ± 1.88 vs 0.81 ± 1.26), hemophilia-related consultations (9.30 ± 4.99 vs 6.77 ± 4.47), and outpatient visits (22.09 ± 17.77 vs 11.48 ± 16.00) (all, p < .001). More than one-half (53.5%) experienced moderate/severe pain necessitating medication compared to one-third (32.8%) of patients without inhibitors (p = .01). CONCLUSIONS:Patients with hemophilia and inhibitors exhibited greater clinical burden and higher resource utilization compared to their peers without inhibitors. Strategies for improving the standard of care may alleviate burden in this population

A Model of Patient Choice with Mid-Therapy Information

For many treatments, a patient's prognosis may be refined by conducting a mid-therapy assessment (MTA). When therapy lasts some time, an MTA predicts a patient's ultimate outcome based on early signs of response. The availability and timing of such assessments also serve as a mechanism by which policy makers can influence patients' treatment-initiation decisions. In this article, we examine how patients evaluate treatment options using MTAs of treatment effectiveness and discuss the policy implications of patient decision making in such contexts. To this end, we use indifference-curve analysis to characterize trade-offs between potential treatment success versus potential adverse effects in therapeutic situations where patients are encouraged to consider their own motivations for initiating treatment. Treatment initiation for chronic hepatitis C virus (HCV) infection is used for illustration, but the analysis can be easily adapted to a variety of clinical scenarios. Analysis shows that the existence of MTAs influences patients' initial treatment decisions by affecting the expectations of treatment success and adverse effects. Earlier MTAs have lower sensitivity and higher specificity, and the prior expectation of adverse effects is accordingly lower for two reasons. First, the lower chance for a false signal of treatment response and the higher chance for a false signal of no response make it more likely that the patient receives a signal leading to discontinuation. Second, if a signal to discontinue is received, fewer weeks of adverse effects have been endured before discontinuation occurs. Both factors make the expected burden of adverse effects lower when the MTA occurs earlier. Later MTAs have higher sensitivity and lower specificity, both of which serve to increase the probability of treatment completion, causing a higher prior likelihood of treatment success. These findings indicate that treatment demand may be increased by changing the timing of MTAs, depending on the information content of the alternative mid-therapy signals and the nature of patient preferences. In HCV infection and other diseases, clinical practice guidelines for conducting MTAs might be modified to better achieve public health or other policy objectives by studying the economics of patient choice.

Reconciling Decision Models With the Real World: An Application to Anaemia of Renal Failure

Objective: The choice of evidence used in decision modelling of healthcare interventions divides analysts into 2 groups: 1. those who favour randomised clinical trial (RCT) data; and 2. those who prefer `real world' data. This preference may have serious consequences if the end result is to inform healthcare policy. This paper uses Medicare coverage of epoetin-alpha [erythropoietin (EPO)] as a case study to illustrate a technique which can be used to overcome some of the bias inherent in RCT data while avoiding some of the common pitfalls associated with the use of observational data. Design and setting: Cost analysis of 2 treatments for anaemia of renal failure primarily in an outpatient setting is modelled in a decision tree. This method can be used to analyse healthcare interventions or policies in any setting. Patients and participants: Patients with nontransplanted end-stage renal disease (ESRD) who received either EPO or blood transfusion for treatment of anaemia at any time during the 1-year study period (July 1989 to June 1990) were included in the sample. Methods: Outcome effects in the natural setting are decomposed into 2 parts: a treatment effect and a population effect. This is then extended to the special case of policy analysis. Logistic and multiple regression are used to estimate branch probabilities and payoffs, respectively, for 2 treatment options. Main outcome measures and results: Under standard methods of decision analysis, an increase of $US7032 per patient following EPO coverage is observed. With the decomposition technique, the policy effect is estimated to be less,$US6172, the difference coming from the population effect. Conclusions: Failure to remove population effects from observed outcome effects may lead to biased decision-making. Although not directly observable, the population effect can be imputed from secondary data. The decomposition and imputing technique allows for a more meaningful interpretation of the results for the purpose of policy analysis.Pharmacoeconomics, Anaemia, Epoetin-alfa, Blood-transfusion, Cost-analysis, Renal-failure, Haemodialysis, Decision-analysis, Antianaemics