nils-herrmann/clean_scirepeval huggingface dataset:
A Prospective Cost-Consequence Analysis of Adding Lamivudine to Zidovudine-Containing Antiretroviral Treatment Regimens for HIV Infection in the US

Healthcare resource use data were collected for 1 year as part of the CAESAR (Canada, Australia, Europe, South Africa) clinical trial, which evaluated the effect of adding lamivudine to treatment regimens containing zidovudine in patients with HIV infection. This study showed that lamivudine-containing regimens reduced HIV disease progression to AIDS or death, in addition to significantly reducing the number of hospital stays, unscheduled outpatient visits, and medications for HIV-related illness. Estimates of US unit costs for each healthcare service were derived from nationally representative data sources, and were used to determine the costs of treatment during the trial period for the treatment and control groups.  A cost-consequence analysis showed that, in addition to the health benefits associated with the lamivudine regimen, costs for treating HIV-related illness and adverse events were lower with the lamivudine regimen. The average decrease in costs per patient for the 1-year period ranged from $US1922 to $US2645, depending on the data source used to estimate hospital length of stay. The incremental cost of lamivudine therapy for the 1-year period was $US2293. The estimated difference in total costs for the 2 treatment regimens thus ranged from an increase of $US371 to a cost saving of $US353.  Our findings indicate that treatments which slow the progression of HIV infection have the potential to reduce the monthly costs associated with HIV-related illness and adverse events during the time period that progression is slowed.
Cerebral neoplastic enhancing lesions: multicenter, randomized, crossover intraindividual comparison between gadobutrol (1.0M) and gadoterate meglumine (0.5M) at 0.1 mmol Gd/kg body weight in a clinical setting.

Two macrocyclic extracellular contrast agents, one-molar neutral gadobutrol and ionic gadoterate meglumine, were compared to determine the overall preference for one or the other in a clinical setting.



Multicenter, randomized, single-blind, intra-individually controlled, comparison study with a corresponding blinded read. Efficacy analysis was based on 136 patients who underwent identical MRI examinations: group A first received 1.0M gadobutrol followed by 0.5M gadoterate meglumine 48 h to 7 days later; group B had a reversed administration order. Three independent blinded readers assessed off-site their overall diagnostic preference (primary efficacy parameter) based on a matched pairs approach.



Superiority of gadobutrol over gadoterate meglumine was demonstrated for the qualitative assessment of overall preference across all readers by a statistically significant difference between both contrast agents for this primary endpoint. Preferences in lesion enhancement (secondary endpoint) were also found significantly in favor of gadobutrol. For preference in lesion delineation from surrounding tissue/edema and for internal structure only a trend towards a higher proportion for gadobutrol was found (except for internal structure reported by one reader, which showed a result of statistical significance). Lesion contrast and relative lesion enhancement (quantitative parameters) were statistically significantly higher for gadobutrol compared to gadoterate meglumine.



Contrast-enhanced MRI of neoplastic brain lesions at a dose of 0.1 mmol Gd/kg body weight, assessed in a standardized off-site blinded reading, results in a significantly higher qualitative and quantitative preference for gadobutrol compared to gadoterate meglumine.
Can a supported self-management program for COPD upon hospital discharge reduce readmissions? A randomized controlled trial

Patients with COPD experience exacerbations that may require hospitalization. Patients do not always feel supported upon discharge and frequently get readmitted. A Self-management Program of Activity, Coping, and Education for COPD (SPACE for COPD), a brief self-management program, may help address this issue.



To investigate if SPACE for COPD employed upon hospital discharge would reduce readmission rates at 3 months, compared with usual care.



This is a prospective, single-blinded, two-center trial (ISRCTN84599369) with participants admitted for an exacerbation, randomized to usual care or SPACE for COPD. Measures, including health-related quality of life and exercise capacity, were taken at baseline (hospital discharge) and at 3 months. The primary outcome measure was respiratory readmission at 3 months.



Seventy-eight patients were recruited (n=39 to both groups). No differences were found in readmission rates or mortality at 3 months between the groups. Ten control patients were readmitted within 30 days compared to five patients in the intervention group (P>0.05). Both groups significantly improved their exercise tolerance and Chronic Respiratory Questionnaire (CRQ-SR) results, with between-group differences approaching statistical significance for CRQ-dyspnea and CRQ-emotion, in favor of the intervention. The "Ready for Home" survey revealed that patients receiving the intervention reported feeling better able to arrange their life to cope with COPD, knew when to seek help about feeling unwell, and more often took their medications as prescribed, compared to usual care (P<0.05).



SPACE for COPD did not reduce readmission rates at 3 months above that of usual care. However, encouraging results were seen in secondary outcomes for those receiving the intervention. Importantly, SPACE for COPD appears to be safe and may help prevent readmission with 30 days.
Efficiency, satisfaction, and costs for remote video visits following radical prostatectomy: a randomized controlled trial.

Telemedicine in an ambulatory surgical population remains incompletely evaluated.



To investigate patient encounters in the outpatient setting using video visit (VV) technology compared to traditional office visits (OVs).



From June 2013 to March 2014, 55 prescreened men with a history of prostate cancer were prospectively randomized. VVs, with the patient at home or at work, were included in the outpatient clinic calendar of urologists.



Remote VV versus traditional OV.



An equivalence analysis was used to assess the primary outcome, visit efficiency as measured by time studies. Secondary outcomes were patient/provider satisfaction and costs.



There were 28 VVs and 27 OVs. VVs were equivalent in efficiency to relative to OVs, as measured by patient-provider face time (mean 14.5 vs 14.3min; p=0.96), patient wait time (18.4 vs 13.0min; p=0.20), and total time devoted to care (17.9 vs 17.8min; p=0.97). There were no significant differences in patient perception of visit confidentiality, efficiency, education quality, or overall satisfaction. VVs incurred lower costs, including distance traveled (median 0 vs 95 miles), travel time (0 vs 95min), missed work (0 vs 1 d), and money spent on travel ($0 vs $48; all p<0.0001). There was a high level of urologist satisfaction for both VVs (88%) and OVs (90%). The major limitation was sample size.



VV in the ambulatory postprostatectomy setting may have a future role in health care delivery models. We found equivalent efficiency, similar satisfaction, but significantly reduced patient costs for VV compared to OV. Further prospective analyses are warranted.



Among men with surgically treated prostate cancer, we evaluated the utility of remote video visits compared to office visits for outpatient consultation with a urologist. Video visits were associated with equivalent efficiency, similar satisfaction, and significantly lower patient costs when compared to office visits. We conclude that video visits may have a future role in health care delivery models.
Validity of a short diet-quality index to predict changes in anthropometric and cardiovascular risk factors: a simulation study

Coronary heart disease prevention in the primary care setting, where time is extremely limited, requires valid instruments that efficiently screen for unhealthy lifestyle habits. Identification of the individuals who would most benefit from dietary intervention is particularly important in this context. We used dietary intake data derived from a full-length food frequency questionnaire to simulate responses to our previously validated short dietary quality screener. We determined the prospective association of the resulting diet-quality index (DQI) with changes in anthropometric and cardiometabolic risk variables in 2181 men and women in a 10-year follow-up. Multiple linear regression analyses revealed that a higher DQI score at baseline related directly (P=0.002) to high-density lipoprotein cholesterol (HDL-C) and inversely (P<0.016) to waist circumference (WC), triacylglycerides (TG), the TG to HDL-C ratio and the total cholesterol to HDL-C ratio at follow-up. A low DQI score is predictive for an increase in WC and the development of an unfavourable cardiometabolic profile.
Final Overall Survival: Fulvestrant 500mg vs 250mg in the Randomized CONFIRM Trial

At the time of the initial analysis of overall survival (OS) for the Comparison of Faslodex in Recurrent or Metastatic Breast Cancer (CONFIRM) randomized, double-blind, phase III trial, approximately 50% of patients had died. A final analysis of OS was subsequently planned for when 75% of patients had died.



Patients were randomly assigned 1:1 to fulvestrant 500 mg administered as two 5-mL intramuscular injections on days 0, 14, and 28 and every 28 (±3) days thereafter or fulvestrant 250 mg administered as two 5-mL intramuscular injections (one fulvestrant and one placebo [identical in appearance to study drug]) on days 0, 14 (two placebo injections only), and 28 and every 28 (±3) days thereafter. OS was analyzed using an unadjusted log-rank test. No adjustments were made for multiplicity. Serious adverse events (SAEs) and best response to subsequent therapy were also reported. All statistical tests were two-sided.



In total, 736 women (median age = 61.0 years) were randomly assigned to fulvestrant 500 mg (n = 362) or 250 mg (n = 374). At the final survival analysis, 554 of 736 (75.3%) patients had died. Median OS was 26.4 months for fulvestrant 500 mg and 22.3 months for 250 mg (hazard ratio = 0.81; 95% confidence interval = 0.69-0.96; nominal P = .02). There were no clinically important differences in SAE profiles between the treatment groups; no clustering of SAEs could be detected in either treatment group. Type of first subsequent therapy and objective responses to first subsequent therapy were well balanced between the two treatment groups.



In patients with locally advanced or metastatic estrogen receptor-positive breast cancer, fulvestrant 500 mg is associated with a 19% reduction in risk of death and a 4.1-month difference in median OS compared with fulvestrant 250 mg. Fulvestrant 500 mg was well tolerated, and no new safety concerns were identified.
Sotatercept in patients with osteolytic lesions of multiple myeloma

This phase IIa study evaluated the safety and tolerability of sotatercept, and its effects on bone metabolism and haematopoiesis in newly diagnosed and relapsed multiple myeloma (MM) patients. Patients were randomized (4:1) to receive four 28-d cycles of sotatercept (0·1, 0·3, or 0·5 mg/kg) or placebo. Patients also received six cycles of combination oral melphalan, prednisolone, and thalidomide (MPT). Thirty patients were enrolled; six received placebo and 24 received sotatercept. Overall, 25% of patients received all four sotatercept doses; 71% of sotatercept-treated patients had ≥1 dose interruption mainly due to increases in haemoglobin levels. Grade ≥3 adverse events (AEs) were reported in 17% of patients receiving placebo and 58% receiving sotatercept. Grade 4 AEs in sotatercept-treated patients were neutropenia, granulocytopenia, and atrial fibrillation (one patient each). In patients without bisphosphonate use, anabolic improvements in bone mineral density and in bone formation relative to placebo occurred, whereas bone resorption was minimally affected. Increases in haemoglobin levels, versus baseline, and the duration of the increases, were higher in the sotatercept-treated patients, with a trend suggesting a dose-related effect. Multiple doses of sotatercept plus MPT appear to be safe and generally well-tolerated in MM patients.
The prevalence of hyperhidrosis in patients with spinal cord injuries and an evaluation of the effect of dextropropoxyphene hydrochloride in therapy

The prevalence of annoying hyperhidrosis (HH) in patients with spinal cord traumatic lesions was investigated by a questionnaire. A total of 192 patients were sent the questionnaire, 154 patients answered, and 41 patients reported annoying sweating. Of these 41 patients, 13 had a somatic underlying cause and 28 indicated having annoying HH without a contributing somatic cause.Twenty-five patients with spinal cord injury (SCI) were included in a double-blind, randomized, placebo-controlled, crossover trial using dextropropoxyphene hydrochloride (DP) in a slow release form (Abalgin Retard® 150 mg Benzon Pharma A/S, Copenhagen) twice a day, for the treatment of annoying HH. Nineteen patients with lesions between C4 and L4 completed the study. Eight found the active drug to be so effective that they wanted to continue the treatment while 3 preferred placebo. Six patients dropped out, 5 due to adverse effects. There was a trend towards an effect on sweating in daytime (p = 0.08–0.14). Given that the patients had a preference, which 15 of 19 had, the true frequency of patients preferring active treatment ranged from 32 to 84% (95% exact confidence limits). For those with SCI above T6 level the limits ranged from 40 to 97%.We conclude that in spite of the lack of statistically significant effect, it seems worthwhile to try DP for annoying HH, especially in patients with lesions above T6 level.
Psychometric properties of the SCOPA-AUT Brazilian Portuguese version.

Cross-cultural adaptation and psychometric assessment of the Scales for Outcomes in Parkinson's Disease-Autonomic questionnaire (SCOPA-AUT) Brazilian Portuguese version. 150 consecutive Parkinson's disease (PD) patients were evaluated by means of the SCOPA-motor scale (SCOPA-M), SCOPA-cognition (SCOPA-COG), Hoehn and Yahr staging (H&Y), nonmotor symptoms scale (NMSS), PD questionnaire (PDQ-39), and SCOPA-AUT. The following psychometric attributes were explored: acceptability, scaling assumptions, reliability, precision, and construct validity. Patients' age (mean +/- standard deviation) was 63.1 +/- 11.1 years (56.7% men; duration of disease, 8.7 +/- 5.3 years; median H&Y, 2). Mean SCOPA-AUT was 23.0 +/- 11.2. SCOPA-AUT did not show floor or ceiling effect. As a whole, the SCOPA-AUT item-domain correlation was satisfactory, except for items 2 (Saliva), 7 (Faecal incontinence), 16 (Syncope), and 19 (Cold intolerance) (|r(S)| = 0.03-0.32). Internal consistency was adequate, except for thermoregulatory and cardiovascular domains (alpha coefficients, 0.56 and 0.63, respectively). Intraclass correlation coefficient for the total score was 0.71, whereas weighted kappa for individual items ranged from 0.15 to 0.71 (only items 4 and 7 were <0.40). Standard error of measurement was 6.04. The SCOPA-AUT total score correlated closely with the NMSS total score (r(S) = 0.65) and PDQ-39 Summary Index (r(S) = 0.61) and at a moderate level with H&Y staging (r(S) = 0.35) and SCOPA-MS total score (r(S) = 0.39) (all r(S) values, P < 0.0001). Correlation of SCOPA-AUT with SCOPA-COG was weak. SCOPA-AUT significantly increased as the H&Y stage increased (Kruskal-Wallis, P < 0.0001). The SCOPA-AUT Brazilian Portuguese version is an acceptable, reliable, and valid questionnaire to evaluate autonomic dysfunction in PD.
Real-Time MRI-Guided Focused Ultrasound for Focal Therapy of Locally Confined Low-Risk Prostate Cancer: Feasibility and Preliminary Outcomes.

Focal therapy is an emerging approach to the treatment of localized prostate cancer. The purpose of this study was to report the 6-month follow-up oncologic and functional data of the initial phase 1 trial of patients treated with focal transrectal MRI-guided focused ultrasound in North America.



Four patients with a prostate-specific antigen (PSA) level of 10 ng/mL or less, tumor classification cT2a or less, and a Gleason score of 6 (3 + 3) were prospectively enrolled in the study and underwent multiparametric MRI and transrectal ultrasound-guided prostate systematic biopsy. Under MRI guidance and real-time monitoring with MR thermography, focused high-frequency ultrasound energy was delivered to ablate the target tissue. The incidence and severity of treatment-related adverse events were recorded along with responses to serial quality-of-life questionnaires for 6 months after treatment. Oncologic outcomes were evaluated with multiparametric MRI and repeat transrectal ultrasound-guided biopsy 6 months after treatment.



Four patients with a total of six target lesions were treated and had complications graded Clavien-Dindo I or less. Quality-of-life parameters were similar between baseline and 6-months. All four patients had normal MRI findings in the treated regions (100%), biopsy showed that three patients (75%) were clear of disease in the treated regions, representing complete ablation of five target lesions (83%). All patients had at least one Gleason 6-positive core outside of the treated zone.



MRI-guided focused ultrasound is a feasible method of noninvasively ablating low-risk prostate cancers with low morbidity. Further investigation and follow-up are warranted in a larger patient series with appropriate statistical analysis of oncologic and functional outcome measures.
The effects of femoral derotation osteotomy in children with cerebral palsy: an evaluation using energy cost and functional mobility.

The effect of femoral derotation osteotomy (FDO) in children with cerebral palsy (CP) has hitherto been examined using various outcome measures including range of motion of lower extremity joints and gait parameters. However, functional ambulation following this procedure has been scarcely investigated.



To evaluate the effect of FDO on energy cost during stair climbing and functional mobility in children with CP.



A prospective case series study was conducted on 18 children with CP, 11 at Gross Motor Functional Classification System (GMFCS) II and 7 with GMFCS III, aged 8.5 +/- 1.24 years (range, 6.9-11 years) who underwent FDO to correct hip internal rotation. The energy cost was measured using the heart beat cost index (HBCI) during stair climbing test, whereas functional mobility was assessed using the Gillette Functional Assessment Questionnaire (FAQ). Tests were administered before surgery (P0), 6 months (P1), and at approximately a year postoperatively (P2).



Compared with P0, significant changes in hip rotation were observed at P1 and P2. There was a significant improvement in HBCI from P0 to P2, whereas FAQ improved significantly from P1 to P2. A moderate correlation was found between HBCI and GMFCS at all times (r = 0.61-0.78). Negative correlations were found between the HBCI and FAQ and between GMFCS and FAQ at all times (r = -0.5).



This study indicates that children with CP may benefit functionally from FDO as judged by HBCI and functional mobility rating.
Modelling the cost-effectiveness and capacity impact of changes to colposcopy referral guidelines for women with mild dyskaryosis in the UK Cervical Screening Programme.

To evaluate the capacity implications and health economic impact of new guidelines recommending referral to colposcopy after one mild result during cervical screening rather than after two consecutive mild results.



A mathematical model of the country's colposcopy services and the clinical pathways from smear result through to treatment is constructed. The model incorporates national questionnaire data on referral numbers and management practices, routine data and published research results.



All English NHS colposcopy services.



Women aged 25 to 64 years.



The national average workload impact of the change in referral guidelines is predicted, and the impact in differing local circumstances is evaluated within the model. A long-term health economic model examines the resulting costs and predicted change in quality-adjusted life years (QALYs).



Colposcopy workload implications for single mild dyskaryosis referral and cost per QALY analysis.



We found that single mild dyskaryosis referral implies, on average, a 21% increase in colposcopy workload for services not currently operating this policy. The health economic model predicted a cost per QALY gained as a result of the implementation of the new referral guidelines of around pound7,500.



Referral after one mild result will increase workload at colposcopy; however, it may be possible to counterbalance the additional workload by altering other clinical practice. The change to referral guidelines would be considered cost-effective in comparison with many interventions routinely available on the NHS.
Exposure-Response Relationship for Ombitasvir and Paritaprevir/Ritonavir in Hepatitis C Virus Subgenotype 1b-Infected Japanese Patients in the Phase 3 Randomized GIFT-I Study.

The all-oral 2 direct-acting antiviral (DAA) regimen of ombitasvir/paritaprevir/ritonavir 25/150/100 mg once a day has been evaluated in hepatitis C virus subgenotype 1b-infected Japanese adults in the GIFT-I study. The aim of this analysis was to evaluate potential relationships between DAA exposures and laboratory abnormalities/adverse events of peripheral edema in patients in GIFT-I.



The GIFT-I study consisted of a randomized, double-blind, placebo-controlled substudy in patients without cirrhosis and an open-label substudy in patients with compensated cirrhosis. Patients received ombitasvir/paritaprevir/ritonavir for 12 weeks. Exposure-response relationships between individual components of the ombitasvir/paritaprevir/ritonavir regimen and clinical parameters of interest were explored using pharmacokinetic and clinical data from patients in the study. Graphical analyses were performed. For events that occurred in at least 10 patients (total bilirubin elevation ≥grade 2 and peripheral edema ≥grade 1), multivariate logistic regression analyses were used to identify significant relationships between predictor variables (drug exposures) and response variables (probability of adverse events or laboratory abnormalities), with consideration for the effect of potential covariates and baseline status of response variables.



Data from 321 noncirrhotic and 42 compensated cirrhotic patients were analyzed. There were 14 events of peripheral edema (10 at grade 1 and 4 at grade 2) in patients who received concomitant administration of calcium channel blockers and ombitasvir/paritaprevir/ritonavir. There was no apparent relationship between the incidences of peripheral edema and exposures of paritaprevir, ombitasvir, or ritonavir. There was a shallow relationship between total bilirubin elevation and exposures of paritaprevir which is an inhibitor of bilirubin transporter organic anion-transporting polypeptide 1B. Based on graphical analyses, exposures of paritaprevir, ombitasvir, or ritonavir were weakly associated with hemoglobin decrease, but not associated with post baseline alanine aminotransferase or aspartate aminotransferase elevations.



In Japanese patients, there were no associations or only shallow relationships between DAA exposures and peripheral edema or laboratory abnormalities. Consequently, therapeutic drug monitoring is not expected to be beneficial in managing patients on the 2-DAA regimen.