nils-herrmann/clean_scirepeval huggingface dataset:
Cost-effectiveness of lumbar supports for home care workers with recurrent low back pain: an economic evaluation alongside a randomized-controlled trial.

Economic evaluation from a societal perspective alongside a 12-months randomized-controlled trial.



To determine the cost-effectiveness of wearing a lumbar support for home care workers with recurrent low back pain (LBP) (secondary prevention).



LBP is a large medical and economical burden. Evidence on the secondary preventive use of lumbar supports is sparse.



A total of 360 home care workers with a self-reported history of LBP were randomly assigned to usual care or usual care plus wearing a lumbar support on working days with LBP, during a 1-year period. Primary clinical outcome measures were the average number of self-reported days with LBP, number of calendar days sick leave in general, and quality of life. Direct and indirect costs were measured by means of cost diaries. Differences in mean costs between groups, cost-effectiveness, and cost-utility ratios were evaluated, and cost-effectiveness planes and acceptability curves presented by applying nonparametric bootstrapping techniques.



During the intervention period, the home care workers using a lumbar support in addition to usual care reported on average 54 fewer days with LBP (95% confidence interval [CI], -85 to -29). The estimated mean difference in sick leave was not statistically significant (-5.0 days per year in favor of the lumbar support group; 95% CI, -21.1 to 6.8). There was no statistically significant difference in quality of life. Direct costs were 235 euros (US$ 266) lower in the lumbar support group (95% CI, -386 to -79). Indirect costs were 255 euros (US$ 288) lower, but this was not statistically significant (95% CI, -879 to 299).



Lumbar support seems to be a cost-effective addition to usual care for home care workers with recurrent LBP. For estimating the LBP-related indirect costs, it would be more precise when an objective measure for LBP-related sick leave would have been available. There is a need for more evidence to confirm these findings, also in other working populations.
Effects of tai chi mind-body movement therapy on functional status and exercise capacity in patients with chronic heart failure: a randomized controlled trial.

To examine the effects of a 12-week tai chi program on quality of life and exercise capacity in patients with heart failure.



Thirty patients with chronic stable heart failure and left ventricular ejection fraction < or =40% (mean [+/- SD] age, 64 +/- 13 years; mean baseline ejection fraction, 23% +/- 7%; median New York Heart Association class, 2 [range, 1 to 4]) were randomly assigned to receive usual care (n = 15), which included pharmacologic therapy and dietary and exercise counseling, or 12 weeks of tai chi training (n = 15) in addition to usual care. Tai chi training consisted of a 1-hour class held twice weekly. Primary outcomes included quality of life and exercise capacity. Secondary outcomes included serum B-type natriuretic peptide and plasma catecholamine levels. For 3 control patients with missing data items at 12 weeks, previous values were carried forward.



At 12 weeks, patients in the tai chi group showed improved quality-of-life scores (mean between-group difference in change, -25 points, P = 0.001), increased distance walked in 6 minutes (135 meters, P = 0.001), and decreased serum B-type natriuretic peptide levels (-138 pg/mL, P = 0.03) compared with patients in the control group. A trend towards improvement was seen in peak oxygen uptake. No differences were detected in catecholamine levels.



Tai chi may be a beneficial adjunctive treatment that enhances quality of life and functional capacity in patients with chronic heart failure who are already receiving standard medical therapy.
Schizophrenia, Monoamine Oxidase Activity, and Cigarette Smoking

Reduced monoamine oxidase activity has been proposed as a marker for vulnerability to schizophrenia. Reduced monamine oxidase activity has also been shown to occur in cigarette smokers. This study compared monamine oxidase activity level in a matched group of patients with schizophrenia who smoked with a group who did not. Lower levels of monoamine oxidase activity were found in the smokers and this is the likely explanation for the low levels hypothesized as a marker for schizophrenia.
Simplifying ART cohort monitoring: Can pharmacy stocks provide accurate estimates of patients retained on antiretroviral therapy in Malawi?

Routine monitoring of patients on antiretroviral therapy (ART) is crucial for measuring program success and accurate drug forecasting. However, compiling data from patient registers to measure retention in ART is labour-intensive. To address this challenge, we conducted a pilot study in Malawi to assess whether patient ART retention could be determined using pharmacy records as compared to estimates of retention based on standardized paper- or electronic based cohort reports.



Twelve ART facilities were included in the study: six used paper-based registers and six used electronic data systems. One ART facility implemented an electronic data system in quarter three and was included as a paper-based system facility in quarter two only. Routine patient retention cohort reports, paper or electronic, were collected from facilities for both quarter two [April-June] and quarter three [July-September], 2010. Pharmacy stock data were also collected from the 12 ART facilities over the same period. Numbers of ART continuation bottles recorded on pharmacy stock cards at the beginning and end of each quarter were documented. These pharmacy data were used to calculate the total bottles dispensed to patients in each quarter with intent to estimate the number of patients retained on ART. Information for time required to determine ART retention was gathered through interviews with clinicians tasked with compiling the data.



Among ART clinics with paper-based systems, three of six facilities in quarter two and four of five facilities in quarter three had similar numbers of patients retained on ART comparing cohort reports to pharmacy stock records. In ART clinics with electronic systems, five of six facilities in quarter two and five of seven facilities in quarter three had similar numbers of patients retained on ART when comparing retention numbers from electronically generated cohort reports to pharmacy stock records. Among paper-based facilities, an average of 13 4 hours was needed to calculate patient retention for cohort reporting using patient registers as compared to 2.25 hours using pharmacy stock cards.



The numbers of patients retained on ART as estimated using pharmacy stock records were largely similar to estimates based on either paper registers or electronic data system. Furthermore, less time and staff effort was needed to estimate ART patient retention using pharmacy stock records versus paper-based registers. Reinforcing ARV stock management may improve the precision of estimates.
Expectation and dopamine release: mechanism of the placebo effect in Parkinson's disease.

The power of placebos has long been recognized for improving numerous medical conditions such as Parkinson's disease (PD). Little is known, however, about the mechanism underlying the placebo effect. Using the ability of endogenous dopamine to compete for [11C]raclopride binding as measured by positron emission tomography, we provide in vivo evidence for substantial release of endogenous dopamine in the striatum of PD patients in response to placebo. Our findings indicate that the placebo effect in PD is powerful and is mediated through activation of the damaged nigrostriatal dopamine system.
A pilot randomized trial comparing long-term effects of red and white wines on biomarkers of atherosclerosis (in vino veritas: IVV trial).

Since early 90', growing body of evidence indicates that the Mediterranean diet with mild to moderate consumption of wine, mostly red wine, has a protective effect on cardiovascular diseases. Several mechanisms have been discussed to participate in the beneficial effect of red wine, such as antioxidant or vasodilating activity. However, later it has been shown that also other alcoholic beverages have a protective effect on atherosclerosis. Up to now, data from the prospective, long-term, head-to-head comparisons of the effects of different drinks on markers of atherosclerosis are insufficient.



The IVV (in vino veritas) study is a long-term, prospective, multicenter, randomized trial comparing the effect of red and white wines on the markers of atherosclerosis. One hundred and twenty healthy subjects with mild to moderate risk of atherosclerosis will be randomized to regular consumption of red wine (Pinot Noir) or white wine (Chardonnay-Pinot) for one year. The primary endpoint is the level of HDL-cholesterol at one year, while secondary endpoints are levels of other markers of atherosclerosis (LDL-cholesterol, C-reactive protein, myeloperoxidase, advanced oxidation protein product, interleukins 6 and 18, matrix metalloproteinases, glutathione s-transferase, monocyte chemoattractant protein 1, soluble CD40L).



The IVV trial is the first study focusing on the long-term prospective comparison of the effects of red and white wines consumption on HDL-cholesterol and other markers of atherosclerosis. Results of the IVV trial may extend our understanding of the widely discussed "French paradox"
A phase 3 trial assessing the efficacy and safety of grass allergy immunotherapy tablet in subjects with grass pollen-induced allergic rhinitis with or without conjunctivitis, with or without asthma

Design and execution of immunotherapy trials for seasonal allergies may be complicated by numerous factors including variable allergy testing methods, pollen levels, and timing and intensity of other seasonal allergens. We evaluated grass allergy immunotherapy tablet (AIT) treatment in North American adults with grass pollen-induced allergic rhinitis with or without conjunctivitis (AR/C), with/without asthma. Subjects age 18–65 with clinical history of grass pollen–induced AR/C, with/without asthma were randomized 1:1 to once-daily 2800 BAU Timothy grass AIT (oral lyophilisate, Phleum pratense, 75,000 SQ-T, containing approximately 15 μg of Phl p 5) or placebo. The AR/C symptom and medication scores were recorded daily. The primary end point was the average AR/C daily symptom score (DSS) during the entire grass pollen season (GPS). Ranked key secondary end points were Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score, daily medication score (DMS), and percentage of well days, all over entire GPS. Safety was monitored through adverse event reporting. Efficacy analysis included 289 subjects. Over the entire GPS, mean DSS was 6% lower with AIT versus placebo (5.69 vs. 6.06), but this difference was not statistically significant (p = 0.3475) despite significantly higher immunological response in the grass AIT group. No significant between-group differences were seen for key secondary end points. In general, DSS was high before GPS began and no clear relationship between DSS and grass pollen counts was seen during GPS. In post hoc analysis of subjects with pre-seasonal DSS ≤3, mean DSS and DMS were both significantly lower with grass AIT versus placebo (27%; p = 0.0327 and 68%; p = 0.0060, respectively). In this subgroup a relationship between DSS and grass pollen counts was observed. Grass AIT was generally well tolerated, with no events of anaphylactic shock or respiratory compromise. In this trial, 2800 BAU grass AIT did not demonstrate significant symptom improvement versus placebo. Lack of relationship between pollen count and symptom score in the study population, and post hoc findings among subjects with low pre-seasonal symptoms, suggest that the symptoms reported in this study were not primarily reflective of the effects of grass pollen exposure.
The VCDQ--a Questionnaire for symptom monitoring in vocal cord dysfunction.

Vocal cord dysfunction (VCD) typically involves abnormal adduction of the vocal cords during inspiration, mimics the symptoms of asthma and leads to the prescription of ineffective medications.



We aimed to develop a clinical tool to monitor symptoms and response to treatment in confirmed VCD.



We collated symptoms of VCD from focus groups comprising patients and healthcare professionals; phrases describing these symptoms were assessed for face validity and internal correlation and rated for importance. The resultant 12-item questionnaire (VCDQ) rated the impact of each on a 5-point Likert scale (total score range 12-60) and was tested for reliability, concurrent validity and performance in 31 patients with endoscopically confirmed VCD (± asthma), 29 asthmatics with no history of VCD and 14 healthy controls. We assessed response to speech and language therapy and the minimal important difference by measuring the VCDQ pre- and post- therapy in a 20 new patients.



The VCDQ had excellent test-retest reliability and differentiated VCD vs. healthy (Mann-Whitney U-test: z = -5.390, P < 0.001) and asthma (z = -5.730, P < 0.001). All patients improved post-therapy, assessed both by a global rating of change score (GRCS) and by the VCDQ [median (IQR) score pre-therapy 50.5 (48.0 - 54.8), post-therapy 35.0 (29.3 - 41.8), P < 0.001]. The minimal important difference in the VCDQ associated with a rating of 'minimally better' on the GRCS was 4 points.



The VCDQ is a valid and responsive tool suitable for measuring changes in symptoms in patients with VCD. It also gives insight into which symptoms are important to patients and could guide future therapy refinements. Future assessments of novel therapies for this condition should use an appropriately validated tool such as the VCDQ to measure response.
Effect of fluvastatin on cardiac outcomes in renal transplant recipients: a multicentre, randomised, placebo-controlled trial

Renal transplant recipients are at increased risk of premature cardiovascular disease. Although statins reduce cardiovascular risk in the general population, their efficacy and safety in renal transplant recipients have not been established. We investigated the effects of fluvastatin on cardiac and renal endpoints in this population.



We did a multicentre, randomised, double-blind, placebo-controlled trial in 2102 renal transplant recipients with total cholesterol 4.0-9.0 mmol/L. We randomly assigned patients fluvastatin (n=1050) or placebo (n=1052) and follow up was for 5-6 years. The primary endpoint was the occurrence of a major adverse cardiac event, defined as cardiac death, non-fatal myocardial infarction (MI), or coronary intervention procedure. Secondary endpoints were individual cardiac events, combined cardiac death or non-fatal MI, cerebrovascular events, non-cardiovascular death, all-cause mortality, and graft loss or doubling of serum creatinine. Analysis was by intention to treat.



After a mean follow-up of 5.1 years, fluvastatin lowered LDL cholesterol concentrations by 32%. Risk reduction with fluvastatin for the primary endpoint (risk ratio 0.83 [95% CI 0.64-1.06], p=0.139) was not significant, although there were fewer cardiac deaths or non-fatal MI (70 vs 104, 0.65 [0.48-0.88] p=0.005) in the fluvastatin group than in the placebo group. Coronary intervention procedures and other secondary endpoints did not differ significantly between groups.



Although cardiac deaths and non-fatal MI seemed to be reduced, fluvastatin did not generally reduce rates of coronary intervention procedures or mortality. Overall effects of fluvastatin were similar to those of statins in other populations.
Assessing and conceptualizing orgasm after a spinal cord injury.

To provide a questionnaire for assessing the sensations characterizing orgasm. To test the hypothesis that orgasm is related to autonomic hyperreflexia (AHR) in individuals with a spinal cord injury (SCI).



A total of 97 men with SCI, of whom 50 showed AHR at ejaculation and 39 showed no AHR, were compared. Ejaculation was obtained through natural stimulation, vibrostimulation or vibrostimulation combined with midodrine (5-25 mg). Cardiovascular measures were recorded before, at, and after each test. Responses to the questionnaire were divided into four categories: cardiovascular, muscular, autonomic and dysreflexic sensations.



Significantly more sensations were described at ejaculation than with sexual stimulation alone. Men with SCI who experienced AHR at ejaculation reported significantly more cardiovascular, muscular, autonomic and dysreflexic responses than those who did not. There was no difference between men with complete and those with incomplete lesions.



The findings show that the questionnaire is a useful tool to assess orgasm and to guide patients in identifying the bodily sensations that accompany or build up to orgasm. The findings also support the hypothesis that orgasm may be related to the presence of AHR in individuals with SCI. Data from able-bodied men also suggest that AHR could be related to orgasm, as increases in blood pressure are observed at ejaculation along with cardiovascular, autonomic and muscular sensations.
Comparison of (18)F-FET and (18)F-FDG PET in brain tumors.

The purpose of this study was to compare the diagnostic value of positron emission tomography (PET) using [(18)F]-fluorodeoxyglucose ((18)F-FDG) and O-(2-[(18)F]fluoroethyl)-l-tyrosine ((18)F-FET) in patients with brain lesions suspicious of cerebral gliomas.



Fifty-two patients with suspicion of cerebral glioma were included in this study. From 30 to 50 min after injection of 180 MBq (18)F-FET, a first PET scan ((18)F-FET scan) was performed. Thereafter, 240 MBq (18)F-FDG was injected and a second PET scan was acquired from 30 to 60 min after the second injection ((18)F-FET/(18)F-FDG scan). The cerebral accumulation of (18)F-FDG was calculated by decay corrected subtraction of the (18)F-FET scan from the (18)F-FET/(18)F-FDG scan. Tracer uptake was evaluated by visual scoring and by lesion-to-background (L/B) ratios. The imaging results were compared with the histological results and prognosis.



Histology revealed 24 low-grade gliomas (LGG) of World Health Organization (WHO) Grade II and 19 high-grade gliomas (HGG) of WHO Grade III or IV, as well as nine others, mainly benign histologies. The gliomas showed increased (18)F-FET uptake (>normal brain) in 86% and increased (18)F-FDG uptake (>white matter) in 35%. (18)F-FET PET provided diagnostically useful delineation of tumor extent while this was impractical with (18)F-FDG due to high tracer uptake in the gray matter. A local maximum in the tumor area for biopsy guidance could be identified with (18)F-FET in 76% and with (18)F-FDG in 28%. The L/B ratios showed significant differences between LGG and HGG for both tracers but considerable overlap so that reliable preoperative grading was not possible. A significant correlation of tracer uptake with overall survival was found with (18)F-FDG only. In some benign lesions like abscesses, increased uptake was observed for both tracers indicating a limited specificity of both techniques.



(18)F-FET PET is superior to (18)F-FDG for biopsy guidance and treatment planning of cerebral gliomas. The uptake of (18)F-FDG is associated with prognosis, but the predictive value is limited and a histological evaluation of tumor tissue remains necessary. Therefore, amino acids like (18)F-FET are the preferred PET tracers for the clinical management of cerebral gliomas.
Group cognitive behavior therapy for chronic posttraumatic stress disorder: an initial randomized pilot study.

Individuals with posttraumatic stress disorder (PTSD) related to a serious motor vehicle accident were randomly assigned to either group cognitive behavioral treatment(GCBT) or a minimum contact comparison group (MCC).Compared to the MCC participants (n=16), individuals who completed GCBT (n=17) showed significant reductions in PTSD symptoms, whether assessed using clinical interview or a self-report measure. Among treatment completers, 88.3% of GCBT participants did not satisfy criteria for PTSD at posttreatment assessment, relative to31.3% of the MCC participants. Examination of anxiety,depression, and pain measures did not show a unique advantage of GCBT. Treatment-related gains were maintained over a 3-month follow-up interval. Patients reported satisfaction with GCBT, and attrition from this treatment was comparable with individually administered CBTs.Results are discussed in light of modifications necessitated by the group treatment format, with suggestions for future study of this group intervention.
Key concepts of migraine postdrome: a qualitative study to develop a post-migraine questionnaire.

To understand migraine postdrome by directly interviewing migraine patients with postdrome symptoms. To document these symptoms, as well as impacts, as a prelude to developing a postdrome migraine questionnaire.



Migraine attacks are traditionally divided into 4 phases. Of these, the postdrome is the least studied, and no patient-reported outcomes to assess symptoms and impacts of this migraine phase have been published.



Qualitative concept elicitation focus groups were conducted with 34 patients in 3 geographically diverse US cities to elicit the symptoms and burden of migraine postdrome. Data elicited from focus groups were coded using Atlas.ti software to facilitate identification of concepts and terminologies of migraine postdrome. A draft questionnaire was developed based on the symptoms and impacts of migraine postdrome described by patients. Cognitive debriefing interviews were conducted with 15 patients in Connecticut and Chicago to confirm content validity, relevance, and comprehension.



Patients defined the onset of postdrome as when they no longer experienced the migraine pain. Postdrome was often described as "[being] or [feeling] wiped out" and "headache hangover." The symptoms most frequently reported by the patients who participated in the focus groups and included in the draft post-migraine questionnaire were: tiredness, difficulty concentrating, weakness, dizziness, lightheadedness, and decreased energy. Patients also reported decreased activity level as a result of experiencing postdrome symptoms. Postdrome symptoms were reported to impact the ability to work, to affect family interactions and social life, and to cause cognitive impairment. A preliminary questionnaire measuring severity and duration of symptoms and severity of impacts of the post-migraine experience, with an 11-point (0 to 10) response scale, was developed. This preliminary questionnaire was tested for content validity, relevance, and comprehension using cognitive debriefing interviews. All patients reported that the questionnaire was relevant to their condition. Irrelevant and redundant items such as body tension and annoyance were eliminated.



Migraine postdrome is debilitating for those who experience it. Concept elicitation and cognitive debriefing research support the relevance of the items in the post-migraine questionnaire. Future research will provide evidence of the post-migraine questionnaire's psychometric properties and interpretation guidelines.