Health outcomes research in medicine最新文献

{"title":"WITHDRAWN: Utility and Work Productivity Data for Economic Evaluation of Breast Cancer Therapies in the Netherlands and Sweden","authors":"G. Frederix, N. Quadri, A. Hövels, F. V. D. Wetering, H. Tamminga, J. Schellens, A. Lloyd","doi":"10.1016/J.EHRM.2012.11.003","DOIUrl":"https://doi.org/10.1016/J.EHRM.2012.11.003","url":null,"abstract":"","PeriodicalId":88882,"journal":{"name":"Health outcomes research in medicine","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2012-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/J.EHRM.2012.11.003","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"54246286","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Health Care Utilization and Costs among Medicaid-enrolled Patients with Schizophrenia Experiencing Multiple Psychiatric Relapses","authors":"Sudeep J. Karve PhD ,&nbsp;Jessica M. Panish MHS ,&nbsp;Riad G. Dirani PhD ,&nbsp;Sean D. Candrilli PhD","doi":"10.1016/j.ehrm.2012.06.003","DOIUrl":"10.1016/j.ehrm.2012.06.003","url":null,"abstract":"<div><h3>Objective</h3><p><span>This study compared all-cause and schizophrenia-related health care utilization and costs among patients with schizophrenia using second-generation oral </span>antipsychotics (SGOAs) and experiencing ≥2 psychiatric-related relapses with those experiencing &lt;2 relapses.</p></div><div><h3>Study Design</h3><p>Patients with schizophrenia who initiated SGOA therapy were identified in the MarketScan^®<span> Medicaid Multi-State database between July 1, 2004 and December 31, 2007. Patients were stratified by &lt;2 psychiatric-related relapse events and ≥2 psychiatric-related relapse events during the 12-month period following SGOA initiation. All-cause and schizophrenia-related health care utilization and costs were estimated for each cohort in various care settings. Univariate and multivariate regression analyses were conducted to assess the differences in all-cause and schizophrenia-related health care utilization and costs between the 2 cohorts. No adjustments were made for multiple inferential statistical tests.</span></p></div><div><h3>Results</h3><p>The cohort consisted of 19,813 patients, of whom 3714 (18.75%) had ≥2 psychiatric-related relapse events during the follow-up period. On average, patients with ≥2 psychiatric-related relapse events were younger than patients with &lt;2 psychiatric-related relapse events (42.62 years vs. 44.21 years; <em>P</em> &lt; 0.001), and the all-cause and schizophrenia-related inpatient costs were approximately 12 and 23 times higher, respectively. The mean covariate-adjusted predicted schizophrenia-related total medical costs per patient were significantly higher among patients with ≥2 psychiatric-related relapse events than among patients with &lt;2 psychiatric-related relapse events ($17,910 vs. $10,346; <em>P</em> &lt; 0.001).</p></div><div><h3>Conclusion</h3><p>Patients who received an SGOA and experienced ≥2 psychiatric-related relapse events within the first year of treatment incurred significantly greater all-cause and schizophrenia-related total medical costs than those with &lt;2.</p></div>","PeriodicalId":88882,"journal":{"name":"Health outcomes research in medicine","volume":"3 4","pages":"Pages e183-e194"},"PeriodicalIF":0.0,"publicationDate":"2012-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.ehrm.2012.06.003","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"54246204","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Satisfaction with Treatment in Type 2 Diabetes Patients Requiring Insulin Treatment in Buenos Aires, Argentina","authors":"Andrés Pichon-Riviere MD, MSc, PhD ,&nbsp;Vilma Irazola MD, MSc ,&nbsp;Andrea Beratarrechea MD ,&nbsp;Andrea Alcaraz MD, MSc ,&nbsp;Carolina Carrara MD","doi":"10.1016/j.ehrm.2012.11.001","DOIUrl":"10.1016/j.ehrm.2012.11.001","url":null,"abstract":"<div><h3>Objective</h3><p><span>To assess different dimensions of treatment satisfaction </span>in patients<span> with type 2 diabetes mellitus (T2DM) receiving insulin therapy.</span></p></div><div><h3>Study Design</h3><p>Cross-sectional study. We included 183 patients with T2DM followed by diabetes specialists in an ambulatory setting: 93 treated with neutral protamine Hagedorn insulin<span> (NPH) and 90 with insulin glargine (IG). We used a Spanish version of the Diabetes Treatment Satisfaction Questionnaire (DTSQ) for Argentina.</span></p></div><div><h3>Results</h3><p>Overall treatment satisfaction was 30.04 (SD 5.40) for a maximum score of 36. The lowest score observed was for the satisfaction item “Flexibility of treatment” (4.7 out of 6, SD 1.27), and the highest score for the item “Recommending treatment to others” (5.39 out of 6, SD 1.23). In patients treated with IG, the overall treatment satisfaction score was 30.56 (SD 4.43); and 29.64 (SD 6.13) for those receiving NPH, not reaching a statistically significant difference. Perception of hypoglycemia was infrequent, with a mean score of 1.82 out of 6 (SD 1.62). For hyperglycemia, the mean score was 2.62 out of 6 (SD 1.54). In both cases, we found no difference between patients treated with IG and those treated with NPH insulin.</p></div><div><h3>Conclusion</h3><p>This is the first study describing patient satisfaction with treatment in T2DM patients in Argentina. We have found levels of treatment satisfaction similar or greater to those described in developed countries. We expect that the results of this study may encourage physicians not to delay the initiation of insulin therapy in poorly controlled patients.</p></div>","PeriodicalId":88882,"journal":{"name":"Health outcomes research in medicine","volume":"3 4","pages":"Pages e231-e237"},"PeriodicalIF":0.0,"publicationDate":"2012-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.ehrm.2012.11.001","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"54246263","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Changing Regulations, Changing Care?","authors":"Donald E. Stull Jr. PhD (Editor-in-Chief)","doi":"10.1016/j.ehrm.2012.11.002","DOIUrl":"10.1016/j.ehrm.2012.11.002","url":null,"abstract":"","PeriodicalId":88882,"journal":{"name":"Health outcomes research in medicine","volume":"3 4","pages":"Pages e181-e182"},"PeriodicalIF":0.0,"publicationDate":"2012-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.ehrm.2012.11.002","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"54246275","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Long-term Adherence to Hormone Therapy in Medicaid-enrolled Women with Breast Cancer","authors":"Jun Wu PhD,&nbsp;Dana Stafkey-Mailey PharmD, PhD,&nbsp;Charles L. Bennett MD, PhD","doi":"10.1016/j.ehrm.2012.10.001","DOIUrl":"10.1016/j.ehrm.2012.10.001","url":null,"abstract":"<div><h3>Objective</h3><p>This study assessed long-term adherence to hormone therapy in women with breast cancer enrolled in Medicaid.</p></div><div><h3>Methods</h3><p><span>We identified women diagnosed with nonmetastatic breast cancer (2000–2008) and prescribed tamoxifen<span><span> or aromatase inhibitors (AIs) as hormone therapy within 1 year of diagnosis in the South Carolina Central </span>Cancer Registry and South Carolina Medicaid linked data set. All the patients were followed-up for 1, 2, 3, or 4 years after initiation of hormone therapy. Adherence rate was measured as proportion of days covered (PDC) by tamoxifen or AIs in a given interval (1, 2, 3, or 4 years). Predictors of adherence to hormone therapy (PDC ≥80%) were identified using </span></span>generalized linear models for repeated measures.</p></div><div><h3>Results</h3><p>The population consisted of 612 eligible women who filled at least one prescription for AIs (n = 339, 55%) or tamoxifen (n = 273, 45%) within 1 year of diagnosis. The mean PDCs were 71% in the first year and 49% after 4 years. Only 25% of women receiving hormone therapy maintained a PDC of at least 80% after 4 years.</p></div><div><h3>Conclusions</h3><p>Long-term use of hormone therapy remains low in the study population. Early interventions must be undertaken to improve adherence over the treatment period.</p></div>","PeriodicalId":88882,"journal":{"name":"Health outcomes research in medicine","volume":"3 4","pages":"Pages e195-e203"},"PeriodicalIF":0.0,"publicationDate":"2012-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.ehrm.2012.10.001","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"54246243","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Outcomes-based Risk-sharing Schemes: Is There a Potential Role in the Asia-Pacific Markets?","authors":"Lisbet Coulton BA ,&nbsp;Lieven Annemans PhD ,&nbsp;Rob Carter PhD ,&nbsp;Maya Baltazar Herrera FASP, PhD ,&nbsp;Hasbullah Thabrany MPH, DRPH ,&nbsp;Jeremy Lim MBBS, MPH, MRCS (Edin), MMed (Surg), FAMS ,&nbsp;Kenneth K.C. Lee BS (Pharm), MPhil, PhD ,&nbsp;Wen Chen PhD ,&nbsp;Nathorn Chaiyakunapruk PharmD, PhD ,&nbsp;Herng-Der Chern MD, PhD ,&nbsp;Tae-Jin Lee PhD ,&nbsp;Hiroshi Nakamura PhD ,&nbsp;Tony Yen-Huei Tarn MS, PhD ,&nbsp;Abdulkadir Keskinaslan MD, MBA, MPH","doi":"10.1016/j.ehrm.2012.07.002","DOIUrl":"10.1016/j.ehrm.2012.07.002","url":null,"abstract":"<div><h3>Objectives</h3><p>To provide a commentary on outcomes-based risk-sharing schemes in Europe and the US, and to assess characteristics of such schemes and whether they have a potential role in the Asia-Pacific markets. This commentary also examines current experience in the Asia-Pacific markets and considers criteria for such agreements as they might relate to the different health care environments.</p></div><div><h3>Summary</h3><p>Future opportunities for patient access schemes, and specifically, a role for outcomes-based risk-sharing schemes, exist in the Asia-Pacific markets. Four types of agreements across the Asia-Pacific markets were identified that are not purely outcomes-based or risk-sharing, but cover innovative high-cost medicines, areas of high unmet need, areas affecting small patient populations, and medicines where the evidence is uncertain. Key factors for consideration are the public environment and the general acceptance of such agreements; the level of available resources that impact the health care priorities in each market and the public demand for access to medicines and to innovation. The ability to undertake such agreements appears to depend significantly on the degree of centralized decision-making and the dominance of a “single payer” for negotiation; the ability to manage data – both to undertake health technology assessments and to have systems/infrastructure to collect data and demonstrate outcomes; the nature of local health care structures and the capabilities to implement schemes where the financing is linked to outcomes. Caution was shared across markets with a trend to “watch and wait” while evidence emerges elsewhere.</p></div>","PeriodicalId":88882,"journal":{"name":"Health outcomes research in medicine","volume":"3 4","pages":"Pages e205-e219"},"PeriodicalIF":0.0,"publicationDate":"2012-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.ehrm.2012.07.002","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"54246223","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparative Effectiveness of On-Pump versus Off-Pump Coronary Artery Bypass Grafting Among Elderly Patients: A Propensity Score-Matched Analysis","authors":"Manasi Datar MS ,&nbsp;Yi Yang MD, PhD ,&nbsp;Rohan Mahabaleshwarkar MS ,&nbsp;John P. Bentley PhD ,&nbsp;Benjamin F. Banahan III PhD","doi":"10.1016/j.ehrm.2012.09.002","DOIUrl":"10.1016/j.ehrm.2012.09.002","url":null,"abstract":"<div><h3>Objective</h3><p>Coronary artery bypass grafting<span> (CABG) is a procedure used to restore blood flow to the heart for patients with coronary artery disease. The purpose of this study was to compare the effectiveness of on-pump versus off-pump CABG in elderly patients using the 2006–2008 5% national sample of Medicare administrative claims.</span></p></div><div><h3>Study Design</h3><p><span>A retrospective matched cohort study design was used. Elderly patients (over 65 years of age) undergoing CABG between July 1, 2006 and June 30, 2008 were identified using International Classification of Diseases, 9</span>^th<span><span><span> Revision, Clinical Modification codes. Propensity scores were used to match patients undergoing on-pump versus off-pump CABG in a ratio of 1:1. Outcomes assessed in this study include a composite cardiovascular end point consisting of postoperative acute myocardial infarction, stroke, or </span>revascularization (percutaneous coronary intervention or CABG) and all-cause mortality. </span>Descriptive statistics<span> were reported along with Kaplan-Meier estimates. Postoperative risk of adverse cardiovascular outcomes and all-cause mortality in these groups was compared using Cox proportional hazards models.</span></span></p></div><div><h3>Results</h3><p>The matched sample consisted of 5356 patients (2678 patients in each group). The risk of composite outcome in the 2 groups was not significantly different (hazard ratio [HR] 0.915; <em>P</em> <!-->=<!--> <!-->0.316). The risk of all-cause mortality was significantly lower among on-pump CABG patients compared with off-pump CABG patients (HR 0.544; <em>P</em> <!-->&lt;<!--> <!-->0.0001).</p></div><div><h3>Conclusion</h3><p>This study shows that elderly patients undergoing on-pump CABG have a lower risk of mortality as compared with those receiving off-pump CABG. Caution should be exercised when recommending elderly patients for off-pump CABG.</p></div>","PeriodicalId":88882,"journal":{"name":"Health outcomes research in medicine","volume":"3 4","pages":"Pages e221-e230"},"PeriodicalIF":0.0,"publicationDate":"2012-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.ehrm.2012.09.002","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"54246233","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Associations between Joblessness and Oral Anti-diabetic Medication Adherence in US Diabetic Working-age Adults","authors":"Mary L. Davis-Ajami PhD ,&nbsp;Milap C. Nahata PharmD ,&nbsp;Gregory Reardon RPh, PhD ,&nbsp;Eric E. Seiber PhD ,&nbsp;Rajesh Balkrishnan PhD","doi":"10.1016/j.ehrm.2012.06.001","DOIUrl":"10.1016/j.ehrm.2012.06.001","url":null,"abstract":"<div><h3>Objective</h3><p>To assess potential associations between joblessness and oral anti-diabetic (OAD) medication adherence in US diabetic working-age adults.</p></div><div><h3>Study Design</h3><p><span>A retrospective longitudinal panel design used pooled 2001-2007 Medical Expenditure Panel Survey (MEPS) data forming a nationally representative sample of diabetic individuals, ages 24-59 years. Pregnancy, seasonal job status, retired persons, a student designation, and those prescribed insulin were excluded. Adherence was measured using the proportion of days covered (PDC). A PDC ≥0.80 was classified as adherent. Descriptive statistics and multivariate </span>regression analysis accounting for the MEPS' complex survey design were conducted.</p></div><div><h3>Results</h3><p><span><span>There were 2256 individuals (means: age 48.3 years [SD 8.15], body mass index<span> 31.1 [SD 0.30], Charlson Comorbidity Index 0.37 [SD 0.79]) who met study criteria. Thirty-four percent were jobless at the first interview round and 29% remained jobless all 5 interview rounds during the 2-year panel period. Reasons cited for joblessness included: waiting to start a new job (73%) and unable to work due to illness or disability (20%). Negligible proportions cited staying home to care for family members or </span></span>maternity leave as reasons for joblessness. Proportionately, more individuals were nonadherent (55%, SE 0.006). Joblessness was associated with a 16% significant reduction in the PDC (β −15.9, </span><em>P</em> &lt; 0.001), and a 25% less likelihood of OAD medication adherence compared with those employed (odds ratio 0.75; 95% confidence interval, 0.64-0.90, <em>P</em> = 0.002), while holding all other variables constant.</p></div><div><h3>Conclusions</h3><p>The results indicate that jobless working-age individuals with diabetes were significantly less likely to adhere to OAD medication than employed individuals.</p></div>","PeriodicalId":88882,"journal":{"name":"Health outcomes research in medicine","volume":"3 3","pages":"Pages e139-e151"},"PeriodicalIF":0.0,"publicationDate":"2012-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.ehrm.2012.06.001","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"54246186","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinician Education Improves Lipid Monitoring in Patients Taking Second-Generation Antipsychotic Agents, Nationally and Locally","authors":"Sandra Haas Binford MAEd,&nbsp;Monique D. Johnson MD, CCMEP,&nbsp;Robert S. Kennedy MA,&nbsp;Joy Bartnett Leffler BS, MLA, NASW, CSE,&nbsp;CME Outfitters, LLC","doi":"10.1016/j.ehrm.2012.05.002","DOIUrl":"10.1016/j.ehrm.2012.05.002","url":null,"abstract":"<div><h3>Background</h3><p><span>Continuing medical education (CME) seeks to improve patient health by promoting clinician practice change. Many patients with a diagnosis of either </span>bipolar disorder<span> or schizophrenia are predisposed to cardiovascular risk, and the use of second-generation antipsychotic (SGA) medications that can cause significant weight gain and altering of lipid profiles may compound this risk. An educational analysis identified a performance gap related to psychiatrists' gathering of baseline lipid data in their patients.</span></p></div><div><h3>Objective</h3><p>This study analyzes the degree to which participation in 2 CME activities improves clinicians' rates of lipid monitoring in patients with mental illness who take SGAs.</p></div><div><h3>Study Design</h3><p>After participation in 1 or 2 CME activities on improved cardiometabolic monitoring in patients with major mental illness—in which one activity focused on schizophrenia and the other on bipolar disorder—a nationwide group (NG) of clinician learners was surveyed about lipid monitoring practices among patients during these patients' first 16 weeks of SGA therapy over a 12-month period. Responses from the NG were compared with those from 1) a nationwide control group (CG) and 2) a local group of activity participants at the Lindner Center of HOPE—Cincinnati, Ohio (LG), whose measured rates were documented via medical records data extraction; the LG also received institutional encouragement and support for practice change for lipid monitoring in these patients.</p></div><div><h3>Results</h3><p>Percentages of patients monitored by clinicians in the NG increased by 18.0 percentage points over 1 year from baseline (<em>P</em> <!-->=<!--> <!-->0.00001) and represented a rate change that was higher than that seen in the CG (<em>P</em> &lt; 0.00001). Gross, median monitoring rates in the NG increased from 27.5% to 80.0%, and all clinicians at or above the 75th percentile of monitoring rates monitored 100% of their patients after participating. Monitoring rate increases for clinicians in the NG were greater among clinicians with higher patient counts. The LG saw a 28 percentage-point increase (from 27.5% to 55.5%), representing a 102% increase over the baseline LG rate and a 56% increase over the rate change seen in the NG.</p></div><div><h3>Conclusions</h3><p>CME interventions can improve lipid-monitoring practices among clinicians who treat patients with major mental illness who take SGAs. Local, institutional support for guideline-recommended monitoring may increase nationwide CME-induced change yet further.</p></div>","PeriodicalId":88882,"journal":{"name":"Health outcomes research in medicine","volume":"3 3","pages":"Pages e121-e137"},"PeriodicalIF":0.0,"publicationDate":"2012-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.ehrm.2012.05.002","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"54245920","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Changes in Patient-reported Neuropsychiatric Outcomes during the SENSE Trial: First-line Treatment with Two Nucleoside Analogues plus Etravirine or Efavirenz","authors":"Chloe Orkin MD ,&nbsp;Mark Nelson MD ,&nbsp;Christine Katlama MD ,&nbsp;Philippe Morlat MD, PhD ,&nbsp;Hansjakob Furrer MD ,&nbsp;Yvon van Delft MSc ,&nbsp;Marjolein Janssen MSc ,&nbsp;Andrew Hill PhD ,&nbsp;Stephan Marks MD","doi":"10.1016/j.ehrm.2012.06.002","DOIUrl":"10.1016/j.ehrm.2012.06.002","url":null,"abstract":"<div><h3>Background</h3><p><span>Efavirenz </span>treatment has been associated with an increased risk of neuropsychiatric adverse events, some of which may last for only the first few weeks of treatment.</p></div><div><h3>Methods</h3><p><span>In this double-blind placebo-controlled trial, 157 treatment-naïve patients with human immunodeficiency virus (HIV) RNA &gt;5000 copies/mL, were randomized 1:1 to either etravirine 400 mg once daily (n</span> <!-->=<!--> <!-->79), or efavirenz 600 mg once daily (n<!--> <!-->=<!--> <span>78), plus 2 nucleoside analogues. At screening, baseline, and during the trial, subjects completed the HIV-Patient Symptoms Profile (HPSP) questionnaire on the impact of adverse events associated with their treatment. There were 14 symptom domains, with 5 classified as neuropsychiatric and 9 other domains. The mean scores of each domain were compared between the arms at the Week 2 and Week 48 visits.</span></p></div><div><h3>Results</h3><p><span>The treatment arms were comparable at baseline (overall median CD4 count 302 cells/uL, median HIV RNA 4.8 log10 copies/mL). In the analysis of the HPSP questionnaire, the mean score for the domains of dizziness<span> and sleep of the etravirine arm was significantly better than the efavirenz arm at Week 2. There were no significant differences between the arms at Week 48, for any of the domains. At the baseline visit, patients with a medical history of neuropsychiatric adverse events had significantly worse scores in the neuropsychiatric domains (</span></span><em>P</em> &lt; 0.01). During the trial, patients with at least one neuropsychiatric adverse event had significantly worse scores in the neuropsychiatric domains of the HPSP questionnaire (<em>P</em> &lt; 0.01).</p></div><div><h3>Conclusions</h3><p>In the SENSE trial, dizziness and sleep disorders showed significantly worse HPSP scores in the efavirenz arm, compared with the etravirine arm at the Week 2 visit. However, at Week 48 there were no significant differences between the treatment arms in any domain of the patient HPSP. This suggests that the impact of efavirenz on quality of life may be short term for the majority of patients.</p></div>","PeriodicalId":88882,"journal":{"name":"Health outcomes research in medicine","volume":"3 3","pages":"Pages e113-e119"},"PeriodicalIF":0.0,"publicationDate":"2012-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.ehrm.2012.06.002","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"54246195","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}