nils-herrmann/clean_scirepeval huggingface dataset:
Cost-effectiveness of acupuncture treatment in patients with chronic neck pain

Acupuncture is increasingly used in patients with chronic pain, but there is a lack of evidence on the cost-benefit relationship of this treatment strategy. The objective of this study was to assess costs and cost-effectiveness of additional acupuncture treatment in patients with chronic neck pain compared to patients receiving routine care alone. A randomized controlled trial including patients (18 years of age) with chronic neck pain (>6 months) was carried out. We assessed the resource use and health related quality of life (SF-36) at baseline and after 3 months using complete social health insurance funds and standardized questionnaires, respectively. The main outcome parameters were direct and indirect cost differences during the 3 months study period and the incremental cost-effectiveness ratio (ICER) of acupuncture treatment. A total of 3,451 patients (1,753 acupuncture-group, 1,698 control-group) were randomized (31% men, age 53.5+/-12.9 years; 69% women, 49.2+/-12.7 years). Acupuncture treatment was associated with significantly higher costs over the 3 months study duration compared to routine care (925.53+/-1,551.06 euros vs. 648.06+/-1,459.13 euros; mean difference: 277.47 euros [95% CI: 175.71 euros-379.23 euros]). This cost increase was mainly due to costs of acupuncture (361.76+/-90.16 euros). The ICER was 12,469 euros per QALY gained and proved robust in additional sensitivity analyses. Since health insurance databases were used, private medical expenses such as over the counter medication were not included. Beyond the 3 months study duration, acupuncture might be associated with further health economic effects. According to international cost-effectiveness threshold values, acupuncture is a cost-effective treatment strategy in patients with chronic neck pain.
pERK, pAKT and p53 as tissue biomarkers in erlotinib-treated patients with advanced pancreatic cancer: a translational subgroup analysis from AIO-PK0104

The role of pERK, pAKT and p53 as biomarkers in patients with advanced pancreatic cancer has not yet been defined. Within the phase III study AIO-PK0104 281 patients with advanced pancreatic cancer received an erlotinib-based 1st-line regimen. Archival tissue from 153 patients was available for central immunohistochemistry staining for pERK, pAKT and p53. Within a subgroup analysis, biomarker data were correlated with efficacy endpoints and skin rash using a Cox regression model. Fifty-five out of 153 patients were classified as pERKlow and 98 patients as pERKhigh; median overall survival (OS) was 6.2 months and 5.7 months, respectively (HR 1.29, p = 0.16). When analysing pERK as continuous variable, the pERK score was significantly associated with OS (HR 1.06, 95% CI 1.0-1.12, p = 0.05). Twenty-one of 35 patients were pAKTlow and 14/35 pAKThigh with a corresponding median OS of 6.4 months and 6.8 months, respectively (HR 1.03, p = 0.93). Four out of 50 patients had a complete loss of p53 expression, 20 patients a regular expression and 26 patients had tumors with p53 overexpression. The p53 status had no impact on OS (p = 0.91); however, a significant improvement in progression-free survival (PFS) (6.0 vs 1.8 months, HR 0.24, p = 0.02) and a higher rate of skin rash (84% vs 25%, p = 0.02) was observed for patients with a regular p53 expression compared to patients with a complete loss of p53. pERK expression may have an impact on OS in erlotinib-treated patients with advanced pancreatic cancer; p53 should be further investigated for its potential role as a predictive marker for PFS and skin rash. NCT00440167 (registration date: February 22, 2007).
Fanconi anemia and solid malignancies in childhood: a national retrospective study.

Fanconi anemia (FA) predisposes to hematologic disorders and myeloid neoplasia in childhood and to solid cancers, mainly oral carcinomas, in early adulthood. Few cases of solid cancers have been reported in childhood.


PROCEDURES
We conducted a national retrospective study of solid tumors occurring in patients registered with or determined to have FA during childhood in France. Phenotypic features, tumor type, cancer treatment, and outcome were analyzed. Whenever available, fresh-frozen tumors were analyzed by microarray-based comparative genomics hybridization.



We identified eight patients with FA with solid tumor from 1986 to 2012. For two patients, the diagnosis of FA was unknown at the time of cancer diagnosis. Moreover, we identified one fetus with a brain tumor. All patients showed failure to thrive and had dysmorphic features and abnormal skin pigmentation. Seven patients had BRCA2/FANCD1 mutations; five of these featured more than one malignancy and the median age at the time of cancer diagnosis was 11 months (range 0.4-3 years). Solid tumor types included five nephroblastomas, two rhabdomyosarcomas, two neuroblastomas, and three brain tumors. Two children died from the toxic effects of chemotherapy, two patients from the cancer, and one patient from secondary leukemia. Only one BRCA2 patient was alive more than 3 years after diagnosis, after tailored chemotherapy.



Solid tumors are rare in FA during childhood, except in patients with BRCA2/FANCD1 mutations. The proper genetic diagnosis is mandatory to tailor the treatment.
[Validation of the Spanish version of the King's Health questionnaire for evaluating quality of life related to urinary incontinence in patients with spinal cord injury].

To determine the validity of the Spanish version of the King's Health Questionnaire (KHQ) in patients with spinal cord injury.



A cross-sectional study, including a total of 120 patients with spinal cord injury. The feasibility, cross-cultural validity, and internal consistency of the KHQ were evaluated.



The dimensions with the highest scores were: impact of urinary symptoms, personal relations, and physical limitations. The following groups presented a significantly poorer HRQoL: persons of advanced age in personal relations (P=0.042), women in limitations of daily life activities (P=0.009) and in the impact of urinary incontinence (P<0.01), paraplegic patients in personal relations, and patients with incomplete cord lesions in sleeping and energy (P<0.01). Patients with an external condom catheter presented a better HRQoL with significant differences in the dimension, limitations of daily life activities (P=0.04). The KHQ showed good internal consistency (Cronbach alpha 0.91).



KHQ is a valid instrument for evaluating HRQoL related with urinary incontinence in patients with spinal cord injury.
Prolonged lateral steep position impairs respiratory mechanics during continuous lateral rotation therapy in respiratory failure

To establish whether prolonged lateral steep position during continuous rotation therapy leads to improvement on pulmonary gas exchange, respiratory mechanics and hemodynamics. Prospective observational study. Intensive care unit of a university hospital. Twelve consecutive patients suffering from acute lung injury or adult respiratory distress syndrome undergoing continuous rotation therapy. Blood gas analysis, static lung compliance, blood pressure, cardiac index and pulmonary shunt fraction were measured in supine as well as in left and right lateral steep position at 62° during continuous rotation therapy (phase I). Rotation was then stopped for 30 min with the patients in supine position, left and right lateral steep position, and the same measurements were performed every 10 min (phase II). Phase I and II revealed no significant changes in PaO2/FiO2 ratio, mean arterial blood pressure, pulmonary shunt fraction, or cardiac index. Significantly lower static compliance was observed in lateral steep position than in supine position (p < 0.001). Concomitantly, PaCO2 was significantly lower in supine position than in left and right lateral steep position (p < 0.01). Lateral steep positioning impairs the compliance of the respiratory system. Prolonged lateral steep position does not lead to benefits with respect to oxygenation or hemodynamics. Individual response to the different positions is unpredictable. The pauses in “extreme” positions should be as short as possible.
Histology of symptomatic gastroesophageal reflux disease: is it predictive of response to proton pump inhibitors?

To examine the differences in esophageal histopathology between non-erosive reflux disease (NERD) and reflux esophagitis (RE), and to investigate whether baseline esophageal histopathology can predict the therapeutic response to proton pump inhibitors (PPIs).



The subjects comprised 94 patients with NERD (n = 71) or mild RE (n = 23). Tissue was biopsied from 5 cm above the squamo-columnar junction (SCJ), and the degree or presence of nine histopathological markers was assessed. The patients were treated with rabeprazole (RPZ) 10 mg once daily for 4 weeks. If complete heartburn relief was not achieved, RPZ was increased to 10 mg twice daily for another 2 weeks, and then to 20 mg twice daily for another 2 weeks if heartburn remained.



Features of esophageal histopathology 5 cm above the SCJ differed between NERD and RE patients. The esophageal histopathology in patients unresponsive to RPZ was characterized by Protein Gene Product (PGP) 9.5 negativity in those with NERD, and intraepithelial bleeding in those with RE. In addition, the combination of dilated intercellular spaces (DIS) (+)/PGP 9.5 (-) was indicative of strong resistance to PPI therapy in NERD patients.



The therapeutic efficacy of PPI can be predicted from the features of biopsied esophageal tissue. Factors predictive of resistance to treatment with PPI are negativity for PGP 9.5 in NERD patients and intraepithelial bleeding in RE patients.
Genetic determination of islet cell autoimmunity in monozygotic twin, dizygotic twin, and non-twin siblings of patients with type 1 diabetes: prospective twin study.

To test the hypothesis that non-diabetic dizygotic and monozygotic twin siblings of patients with type 1 diabetes have a similar high prevalence of islet cell autoantibodies, thus suggesting that islet cell autoimmunity is mainly environmentally determined.



Prospective twin study.



Two specialist centres for diabetes in the United States.



Non-diabetic monozygotic twin (n=53), dizygotic twin (n=30), and non-twin (n=149) siblings of patients with type 1 diabetes; 101 controls.



Analysis of progression to diabetes and expression of anti-islet autoantibodies.



Monozygotic twin siblings had a higher risk of progression to diabetes (12/53) than dizygotic twin siblings (0/30; P<0.005). At the last follow up 22 (41.5%) monozygotic twin siblings expressed autoantibodies compared with 6 (20%) dizygotic twin siblings (P<0.05), 16 (10.7%) non-twin siblings (P<0.0001), and 6 (5.9%) controls (P<0.0001). Monozygotic twin siblings expressed multiple (>/=2) antibodies more often than dizygotic twin siblings (10/38 v 1/23; P<0.05). By life table analysis the probability of developing positive autoantibodies was higher among the monozygotic twin siblings bearing the diabetes associated HLA DQ8/DQ2 genotype than in those without this genotype (64.2% (95% confidence interval 32.5% to 96%) v 23.5% (7% to 40%) at 10 years of discordance; P<0.05).



Monozygotic and dizygotic twins differ in progression to diabetes and expression of islet cell autoantibodies. Dizygotic twin siblings are similar to non-twin siblings. These two observations suggest that genetic factors play an important part in determination of islet cell autoimmunity, thus rejecting the hypothesis. In addition, there is a high penetrance of islet cell autoimmunity in DQ8/DQ2 monozygotic twin siblings.
Age But Not Sex Is Associated With Efficacy and Adverse Events Following Administration of Intravenous Migraine Medication: An Analysis of a Clinical Trial Database.

Migraine prevalence is associated with both sex and age. Differences in efficacy of parenteral migraine medication administration based on the sex and age of the patient have not been explored in the published literature.



The objective was to determine whether sex and age are associated with short-term headache relief, sustained headache freedom, or adverse medication effects in data collected during 3 emergency department (ED)-based acute migraine comparative efficacy trials.



Data were combined from 3 studies in which patients who presented to an ED with acute migraine were randomized to one of the following intravenous medication regimens: (1) metoclopramide combined with diphenhydramine; (2) metoclopramide combined with diphenhydramine and dexamethasone; (3) metoclopramide alone; (4) ketorolac; or (5) valproate. In each of these studies, (1) short-term efficacy (patient description of the headache as "mild" or "none" 1 hour after medication administration); (2) sustained efficacy (patient description of the headache as "none" within 2 hours of medication administration and no headache recurrence for 24 hours post ED discharge); and (3) the frequency of any adverse medication effects within 24 hours of medication administration was determined. For each of the medication regimens studied, efficacy and adverse event rates were compared between men vs women and the older vs the younger half of patients. Multivariate logistic regression models were constructed in which sex and age were maintained in the model as well as variables representing each of the medication regimens patients received.



A total of 884 patients were included in this analysis (140 men and 744 women). The median age was 35 years. After controlling for age and medication received, female sex was not associated with short-term efficacy (OR 0.98 [95% confidence interval (CI): 0.66, 1.46]), sustained efficacy (OR 0.72 [95%CI: 0.45, 1.15]), or adverse events (OR 1.14 [95%CI: 0.77, 1.71]). Age >36 years, however, was associated with short-term efficacy (OR 0.66 [95%CI: 0.49, 0.88]), sustained efficacy (OR 0.50 [95%CI: 0.34, 0.73]), and adverse events (OR 1.36 [95%CI: 1.02, 1.82]).



Sex was not associated with response to parenteral acute migraine medication. Age was associated with both efficacy and adverse events.
Multicentre phase II study of bifractionated CPT-11 with bimonthly leucovorin and 5-fluorouracil in patients with metastatic colorectal cancer pretreated with FOLFOX

This multicentre phase II study was designed to evaluate the antitumour activity and toxicity of bifractionated camptothecin (CPT-11) and 5-fluorouracil/ leucovorin (5-FU/LV) in the treatment of patients with metastatic colorectal cancer (MCC) who had been pretreated with 5-FU/LV-oxaliplatin (FOLFOX regimen). In all, 35 patients were enrolled in a two-stage trial. Treatment consisted of two daily doses of CPT-11, 90 mg m2 administered over 90 min, followed by LV, 200 mg m2 administered over 2 h plus 5-FU 400 mg m2 as a bolus and 600 mg m2 as a 22-h continuous infusion administered with disposable pumps as outpatient therapy. Toxicity was closely monitored. Response was evaluated by computed tomography scans every 8 weeks. All 35 patients were assessable for toxicity and response to treatment. Seven patients had a partial response, giving an overall response rate of 20%; 11 patients had stable disease (31.4%) and 17 progressed (48.5%). The median progression-free survival was 7.1 months and median survival was 14 months. A total of 10 patients (30%) experienced grade 3–4 toxicity, including nausea (15%), diarrhoea (12%) and neutropenia (15%), while seven patients (21%) had grade 2 alopecia. The bifractionated bimonthly schedule of CPT-11 plus 5-FU/LV showed substantial antitumour activity and was well tolerated in this group of patients with a poor prognosis, pretreated with the FOLFOX regimen.
Hormonal replacement therapy does not affect self-estimated pain or experimental pain responses in post-menopausal women suffering from fibromyalgia: a double-blind, randomized, placebo-controlled trial.

FM is a condition that preferentially affects women. Sex hormones, and in particular oestrogens, have been shown to affect pain processing and pain sensitivity, and oestrogen deficit has been considered a potentially promoting factor for FM. However, the effects of oestrogen treatment in patients suffering from FM have not been studied. Here, we examined the effect of transdermal oestrogen substitution treatment on experimental as well as self-estimated pain in women suffering from FM.



Twenty-nine post-menopausal women were randomized to either 8 weeks of treatment with transdermal 17β-oestradiol (50 µg/day) or placebo according to a double-blind protocol. A self-estimation of pain, a set of quantitative sensory tests measuring thresholds to temperature, thermal pain, cold pain and pressure pain, and a cold pressor test were performed on three occasions: before treatment, after 8 weeks of treatment and 20 weeks after cessation of treatment.



Hormonal replacement treatment significantly increased serum oestradiol levels as expected (P < 0.01). However, no differences in self-estimated pain were seen between treatment and placebo groups, nor were there any differences between the two groups regarding the results of the quantitative sensory tests or the cold pressor test at any of the examined time points.



Eight weeks of transdermal oestradiol treatment does not influence perceived pain, pain thresholds or pain tolerance as compared with placebo treatment in post-menopausal women suffering from FM.
Zero end-digit preference in recorded blood pressure and its impact on classification of patients for pharmacologic management in primary care - PREDICT-CVD-6.

Most blood pressure recordings end with a zero end-digit despite guidelines recommending measurement to the nearest 2 mmHg. The impact of rounding on management of cardiovascular disease (CVD) risk is unknown.



To document the use of rounding to zero end-digit and assess its potential impact on eligibility for pharmacologic management of CVD risk.



Cross-sectional study.



A total of 23,676 patients having opportunistic CVD risk assessment in primary care practices in New Zealand.



To simulate rounding in practice, for patients with systolic blood pressures recorded without a zero end-digit, a second blood pressure measure was generated by arithmetically rounding to the nearest zero end-digit. A 10-year Framingham CVD risk score was estimated using actual and rounded blood pressures. Eligibility for pharmacologic treatment was then determined using the Joint British Societies' JBS2 and the British Hypertension Society BHS-IV guidelines based on actual and rounded blood pressure values.



Zero end-digits were recorded in 64% of systolic and 62% of diastolic blood pressures. When eligibility for drug treatment was based only on a Framingham 10year CVD risk threshold of 20% or more, rounding misclassified one in 41 of all those patients subject to this error. Under the two guidelines which use different combinations of CVD risk and blood pressure thresholds, one in 19 would be misclassified under JBS2 and one in 12 under the BHS-IV guidelines mostly towards increased treatment.



Zero end-digit preference significantly increases a patient's likelihood of being classified as eligible for drug treatment. Guidelines that base treatment decisions primarily on absolute CVD risk are less susceptible to these errors.
Surgery with versus without preoperative concurrent chemoradiotherapy for mid/low rectal cancer: an interim analysis of a prospective, randomized trial.

Multimodality therapy, including preoperative chemoradiotherapy (CRT) and total mesorectal excision (TME), has effectively reduced local recurrence rates of rectal cancer over the past decade. However, the benefits and risks of the addition of neoadjuvant CRT to surgery need to be evaluated. This study was to compare the efficacy of TME with versus without preoperative concurrent chemoradiotherapy (CCRT) involving XELOX regimen (oxaliplatin plus capecitabine) in Chinese patients with stages II and III mid/low rectal adenocarcinoma.



We randomly assigned patients to the TME group (TME without preoperative CCRT) or CCRT + TME group (TME with preoperative CCRT). The primary endpoint was disease-free survival (DFS); the secondary endpoints were overall survival (OS), local and distant recurrence, tumor response to CRT, toxicity, sphincter preservation, and surgical complications. An interim analysis of the potential inferiority of DFS in the CCRT + TME group was planned when the first 180 patients had been followed up for at least 6 months.



A total of 94 patients in the TME group and 90 patients in the CCRT + TME group were able to be evaluated. The 3-year DFS and OS rates were 86.3 % and 91.5 % in the whole cohort, respectively. The 3-year DFS rates of the TME and CCRT + TME groups were 85.7% and 87.9 % (P = 0.766), respectively, and the 3-year OS rates were 90.7 % and 92.3 % (P = 0.855), respectively. The functional sphincter preservation rates of the TME and CCRT + TME groups were 71.3 % and 70.0 % (P = 0.849), respectively. In the TME group, 16 (17.0 %) patients were proven to have pTNM stage I disease after surgery. In the CCRT + TME group, 32 (35.6 %) patients achieved a pathologic complete response (pCR).



Preliminary results indicated no significant differences in the DFS, OS, or functional sphincter preservation rates between the TME and CCRT + TME groups. However, preoperative CCRT with XELOX yielded a high pCR rate. Newer techniques are needed to improve the staging accuracy, and further investigation is warranted.
Total knee arthroplasty in Asian subjects: preoperative range of motion determines postoperative range of motion?

To evaluate whether preoperative range of motion is a key determinant of postoperative range of motion in Asian patients undergoing conventional total knee arthroplasty.



A retrospective review of 302 patients who underwent primary total knee arthroplasty performed by a single surgeon was conducted. Patients who had a fixed flexion deformity of ≥15° were excluded. Postoperative range of motion (ROM) was measured prospectively. Patients were stratified into two groups: preoperative ROM < 110° and preoperative ROM ≥ 110°. Postoperative ROM and mean change in ROM at 6 months and 2 years of follow-up were then compared using Student's t-test.



Group of ROM < 110° had a poorer postoperative range of motion at both 6-months and 2-years of follow-up than Group of ROM ≥ 110° (P < 0.001). Postoperatively, Group of ROM < 110° had gained range of motion whereas Group of ROM ≥ 110° had lost range of motion (P < 0.001).



Similar to the Western population, preoperative range of motion is a key determinant of postoperative range of motion in Asian patients. This should be taken into consideration by surgeons during preoperative planning and in managing patients' expectations.