nils-herrmann/clean_scirepeval huggingface dataset:
Reply to comparison of cervical cancer screening results among 256,648 women in multiple clinical practices

Blatt et al have presented data regarding the correlations of routine high-risk human papillomavirus (HPV) and Papanicolaou (Pap) “cotesting” results with biopsy diagnosis in approximately one-quarter of million women aged 30 to 65 years. These data complement those from Kaiser Permanente Northern California, in which >1 million women aged 30 to 65 years have been cotested since 2003. Unfortunately, the analysis by Blatt et al introduces a bias that favors disease detected by Pap testing and, by extension, cotesting. Guidelines recommend that women who have an HPV-positive atypical squamous cells of undetermined significance, low-grade squamous intraepithelial lesion, or more severe cytologic interpretation are referred for immediate colposcopy. Women who test positive for HPV but have a negative Pap test (HPV1/ Pap2) are recommended to undergo rescreening within a year and sent to colposcopy if they have a cytologic abnormality or evidence of persistent high-risk HPV. Thus, including only those women who underwent a biopsy within 1 year excludes a significant percentage of women with HPV1/Pap2 results who came back for rescreening, because many women do not come back exactly at 1 year (or less) but return over the course of several months past the one-year anniversary. Restricting to 1-year follow-up likely results in an underattribution of disease detected by HPV screening and missed by Pap testing. It therefore will be important to reanalyze these data with ample follow-up of the women with HPV1/ Pap2 results to better reflect the real-world performance of HPV testing and cotesting. More importantly, the critical question should be what cervical cancer screening strategy is more effective and cost-effective, and has a better benefits-to-harms ratio over a “screening lifetime.” Although a single cotest will always be more sensitive than either test alone, how does cotesting every 5 years compare with HPV testing alone every 3 or 4 years projected over 20 or 30 years? For example, over a 20-year period, are 4 rounds of cotesting every 5 years more effective than 5 rounds of HPV testing alone every 4 years? Recent data from Kaiser Permanente Northern California have demonstrated that the 5-year reassurance after a negative cotest is approximately the same as the 4-year reassurance after a negative HPV test. Cotesting every 5 years would have one fewer HPV test but 4 more Pap tests than HPV testing every 4 years to achieve approximately the same level of effectiveness in that period of time. Over a 30-year period, cotesting every 5 years would have 4 fewer HPV tests but 6 more Pap tests and possibly less reassurance than HPV testing every 3 years. Thus, screening modalities must be projected over the screening lifetime to estimate its relative programmatic benefits, harms, and costs to make an informed decision regarding which approach is best for women.
Effect of human placental extract on menopausal symptoms, fatigue, and risk factors for cardiovascular disease in middle-aged Korean women.

In Korea, human placental extract (HPE) has recently been used to treat various diseases (chronic liver diseases, menopause syndrome, chronic fatigue, skin pigment diseases, etc.), but evidence-based studies are not yet sufficient. The aim of this study was to examine the effects of HPE on menopausal symptoms, fatigue, and risk factors for cardiovascular disease in middle-aged Korean women in a randomized controlled trial.



Korean women, aged 40 to 64 years, with menopausal symptoms and fatigue were recruited as participants. The women were randomly assigned to a placebo group or an HPE group. The HPE group received subcutaneous injections of HPE in the abdomen for 8 weeks, whereas the placebo group received normal saline. Then, the Menopause Rating Scale, and Fatigue Severity Scale, and Visual Analog Scale were administered, and risk factors for cardiovascular disease were assessed.



The Menopause Rating Scale total baseline score was not different between the two groups; however, the score of the HPE group decreased significantly at 8 weeks compared with that of the placebo group (P = 0.033). Fatigue Severity Scale and Visual Analog Scale scores of the placebo group did not change, whereas the scores of the HPE group decreased significantly during the study period (Fatigue Severity Scale, P = 0.002; Visual Analog Scale, P = 0.001). The baseline 17beta-estradiol level was not significantly different between the two groups, but the 17beta-estradiol level of the HPE group was significantly increased at 8 weeks compared with that of the placebo group (P = 0.031). No changes in risk factors for cardiovascular disease were observed in either group.



Menopausal symptoms and fatigue in middle-aged Korean women improved after 8 weeks of HPE treatment, whereas risk factors for cardiovascular disease did not change during the study period.
Reproducibility and responsiveness of health status measures. Statistics and strategies for evaluation.

Before being introduced to wide use, health status instruments should be evaluated for reliability and validity. Increasingly, they are also tested for responsiveness to important clinical changes. Although standards exist for assessing these properties, confusion and inconsistency arise because multiple statistics are used for the same property; controversy exists over how to measure responsiveness; many statistics are unavailable on common software programs; strategies for measuring these properties vary; and it is often unclear how to define a clinically important change in patient status. Using data from a clinical trial of therapy for back pain, we demonstrate the calculation of several statistics for measuring reproducibility and responsiveness, and demonstrate relationships among them. Simple computational guides for several statistics are provided. We conclude that reproducibility should generally be quantified with the intraclass correlation coefficient rather than the more common Pearson r. Assessing reproducibility by retest at one-to-two week intervals (rather than a shorter interval) may result in more realistic estimates of the variability to be observed among control subjects in a longitudinal study. Instrument responsiveness should be quantified using indicators of effect size, a modified effect size statistic proposed by Guyatt, or the use of receiver operating characteristic (ROC) curves to describe how well various score changes can distinguish improved from unimproved patients.
Clinical comparison of 99mTc-HMDP and 99mTc-MDP

99mTc-Hydroxymethylene diphosphonate (HMDP) was compared to 99mTc-methylene diphosphonate (MDP) with respect to image quality, lesion detectability, and the uptake ratios of normal bone to soft tissue (B/S), metastatic bone to soft tissue (M/S) and bone metastases to normal bone (M/B) at 2 and 3 h after injection in the same subjects. Thirty-three patients with bone metastases were examined in six nuclear-medicine departments, with each center using its usual bone-scanning protocol which was identical for both compounds in the same patient. The uptake of 99mTc-HMDP in normal bone (B/S) was significantly higher than that of MDP at 2 and 3 h, but there were no significant differences between the two compounds with regard to the M/S or M/B or M/B ratios. The M/B of HMDP at 2 h was not significantly different from that of MDP at 3 h, the latter showing a significantly higher B/S and M/S ratio. All lesions were detected with both compounds, even at 2 h. The image quality was rated as follows (in decreasing order): HMDP (3 h), MDP (3 h), HMDP (2 h), and MDP (2 h). HMDP was shown to be a useful bone-imaging agent, especially when shorter intervals between injection and recording are required.
Randomized study of early hospital discharge following autologous blood SCT: medical outcomes and hospital costs

We report the first randomized study comparing early hospital discharge with standard hospital-based follow-up after high-dose chemotherapy (HDCT) and PBSCT. Patients aged 18–65 years, with an indication of PBSCT for non-leukemic malignant diseases were randomly assigned between two arms. Arm A consisted of early hospital discharge (HDCT during hospitalization, discharge at day 0, home stay with a caregiver, outpatient clinic follow-up). In arm B patients were followed up as inpatients. In total 131 patients were analyzed (66 in arm A and 65 in arm B). Patient characteristics and hematological reconstitution were comparable between the two groups. In arm A, 26 patients were actually discharged early. Patients in group A spent fewer days in hospital (11 vs 12 days, P=0.006). This strategy resulted in a 6% mean cost reduction per patient when compared with the conventional hospital-based group. The early discharge approach within the French health system, while safe and feasible, is highly dependent on social criteria (caregiver availability and home to hospital distance). It is almost always associated with conventional hospital readmission during the aplasia phase, and limits cost savings when considering the whole population of patients benefiting from HDCT in routine clinical practice.
Continuous multilead ST-monitoring identifies patients with unstable coronary artery disease who benefit from extended antithrombotic treatment.

Prolongation of anticoagulant treatment might reduce subsequent cardiac events in patients with unstable coronary artery disease. Multilead ST-segment monitoring identifies patients with a high risk of adverse outcome. The aim was to assess the value of multilead ST-monitoring in prospectively identifying patients who respond to extended anticoagulant treatment with low-molecular weight heparin when treated by a primarily non-invasive strategy.



In this substudy of the FRISC II trial, ST-monitoring with a continuous 12-lead ECG or vectorcardiography was performed for 24 h in 629 patients with unstable coronary artery disease randomized to receive either the low-molecular weight heparin dalteparin, or placebo for 3 months after at least 5 days' dalteparin treatment in all patients. Ischaemic episodes were detected in 34% during ST-monitoring. In the group with ischaemic episodes, the extended dalteparin treatment was associated with a lower rate of death, myocardial infarction, or revascularization (35.2% vs 53.4%, relative risk reduction: 34%, P=0.01). In patients without ischaemic episodes, long-term dalteparin treatment had no effect.



In patients with unstable coronary artery disease treated primarily with a non-invasive strategy, ischaemic episodes revealed while on multilead ST-monitoring identifies patients who benefit most from extended treatment with anticoagulants.
Three-dimensional fusion of coronary arteries with myocardial perfusion distributions: clinical validation.

Clinical decisions regarding diagnosis and effective treatment of coronary artery disease frequently require integration of information from various imaging modalities, which are acquired, processed, and read at different physical locations and times. We have developed methods to integrate the information in 2 cardiac imaging studies, perfusion SPECT and coronary angiography. Three-dimensional (3D) models of the coronary artery tree created from biplane angiograms were automatically aligned with 3D models of the left ventricular epicardial surface created from perfusion SPECT. Myocardial mass at risk was used as a unique measure to validate the accuracy of the unification.



Thirty patients were injected with the perfusion agent (99m)Tc-tetrosfosmin during balloon occlusion while undergoing percutaneous transluminal coronary angioplasty for single-vessel coronary artery disease. Thus, a single, severe perfusion defect was induced by a single coronary artery occlusion of known severity and placement. The accuracy of the unification was measured by computing the overlap between physiologic area at risk, determined using SPECT perfusion quantification techniques only, and anatomic area at risk, determined using coronary artery anatomy aligned with the epicardial surface of the left ventricle.



The unification resulted in an 80% overlap of areas at risk, and an overlap of 84% of normal areas, for all coronary artery distributions. The mass at risk measured based on the unified anatomic information correlated with the physiologically based mass at risk as y = 0.92x + 10.3 g; r = 0.76, SEE = 10.4 g.



A unification algorithm for automatically registering 3D models of the epicardial surface from perfusion SPECT and 3D coronary artery trees from coronary angiography has been presented and validated in 30 patient studies.
Quantitative Fluorescence Determination of Long-Fragment DNA in Stool as a Marker for the Early Detection of Colorectal Cancer

A variety of molecular markers have been evaluated for the development of a non-invasive approach to the diagnosis of colorectal cancer. We aimed to validate the diagnostic accuracy, using the same threshold as in the previous pilot study, of fluorescent long DNA test as a relatively simple and inexpensive tool for colorectal cancer detection.



A case-control study was conducted on 100 healthy subjects and 100 patients at first diagnosis of colorectal cancer. Human long-fragment DNA in stool was quantified by fluorescence primers and a standard curve and expressed in DNA nanograms.



We validated the 25-ng value, which emerged as the most accurate cut-off in the pilot study, obtaining 79% (95% CI, 71-87%) sensitivity and 89% (95% CI, 83-95%) specificity. Specificity was very high for all cut-off values (15-40 ng) analyzed, ranging from 78 to 96%. Sensitivity was only slightly lower, reaching 84% at the lowest cut-off and maintaining a good level at the higher values. Diagnostic potential was independent of gender, age and tumor site.



Fecal DNA analysis is a non-invasive and fairly simple test showing high diagnostic potential. These characteristics, together with the small amount of stool required, make it potentially suitable to be used alongside or as an alternative to current non-invasive screening approaches. Our next step will be to validate these results in a large-scale cohort study of a screening population, which is needed prior to implementation into clinical practice.
Pulsatile dry cupping in patients with osteoarthritis of the knee – a randomized controlled exploratory trial

Cupping is used in various traditional medicine forms to relieve pain in musculoskeletal diseases. The aim of this study was to investigate the effectiveness of cupping in relieving the symptoms of knee osteoarthritis (OA).



In a two-group, randomized controlled exploratory pilot study patients with a clinically and radiological confirmed knee OA (Kellgren-Lawrence Grading Scale: 2-4) and a pain intensity > 40 mm on a 100 mm visual analogue scale (VAS) were included. 40 Patients were randomized to either 8 sessions of pulsatile dry cupping within 4 weeks or no intervention (control). Paracetamol was allowed on demand for both groups. Outcomes were the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) score, the pain intensity on a VAS (0 mm = no pain to 100 mm = maximum intensity) and Quality of Life (SF-36) 4 and 12 weeks after randomization. Use of Paracetamol was documented within the 4-week treatment period. Analyses were performed by analysis of covariance adjusting for the baseline value for each outcome.



21 patients were allocated to the cupping group (5 male; mean age 68 ± SD 7.2) and 19 to the control group (8 male; 69 ± 6.8). After 4 weeks the WOMAC global score improved significantly more in the cupping group with a mean of 27.7 (95% confidence interval 22.1; 33.3) compared to 42.2 (36.3; 48.1) in the control group (p = 0.001). After 12 weeks the WOMAC global score were still significantly different in favor for cupping (31.0 (24.9; 37.2) vs. 40.8 (34.4; 47.3) p = 0.032), however the WOMAC subscores for pain and stiffness were not significant anymore. Significantly better outcomes in the cupping group were also observed for pain intensity on VAS and for the SF-36 Physical Component Scale compared to the control group after 4 and 12 weeks. No significant difference was observed for the SF-36 Mental Component Scale and the total number of consumed Paracetamol tablets between both groups (mean 9.1, SD ± 20.0 vs. 11.5 ± 15.9).



In this exploratory study dry cupping with a pulsatile cupping device relieved symptoms of knee OA compared to no intervention. Further studies comparing cupping with active treatments are needed.
Investigating factors influencing 4th-year physiotherapy students' opinions of cardiorespiratory physiotherapy as a career path.

Recruitment and retention issues in cardiorespiratory physiotherapy (CRP) have led to concerns for the future of this specialist area of physiotherapy. This study evaluated the career choices of student physiotherapists and elicited factors that influenced their perceptions of CRP. A postal questionnaire to two schools of physiotherapy in New Zealand and two in Australia was administered. Final year students were randomly selected and invited to complete the questionnaire. Details of respondents' clinical experience, future career intentions, and perceptions of CRP as a specialism were ascertained. A response rate of 61% (n=149) was obtained. Although the majority of respondents had undertaken cardiorespiratory placements, only 3% of respondents reported being "extremely interested" in specializing in CRP. The variety and timing of clinical placements and educational and clinical supervision were key factors that had the potential to both positively and negatively influence students' opinions of CRP. An understanding of the role of CRP beyond that of inpatient care appeared limited. To promote uptake of CRP as a career option, clinicians, educators, and managers should strive to provide positive clinical placements and educational opportunities. The extensive scope of clinical practice of cardiorespiratory physiotherapists could be a greater focus within physiotherapy curricula.
Mapping health assessment questionnaire disability index (HAQ-DI) score, pain visual analog scale (VAS), and disease activity score in 28 joints (DAS28) onto the EuroQol-5D (EQ-5D) utility score with the KORean Observational study Network for Arthritis (KORONA) registry data

The aim of this study was to estimate the mapping model for EuroQol-5D (EQ-5D) utility values using the health assessment questionnaire disability index (HAQ-DI), pain visual analog scale (VAS), and disease activity score in 28 joints (DAS28) in a large, nationwide cohort of rheumatoid arthritis (RA) patients in Korea. The KORean Observational study Network for Arthritis  registry data on 3557 patients with RA were used. Data were randomly divided into a modeling set (80 % of the data) and a validation set (20 % of the data). The ordinary least squares (OLS), Tobit, and two-part model methods were employed to construct a model to map to the EQ-5D index. Using a combination of HAQ-DI, pain VAS, and DAS28, four model versions were examined. To evaluate the predictive accuracy of the models, the root-mean-square error (RMSE) and mean absolute error (MAE) were calculated using the validation dataset. A model that included HAQ-DI, pain VAS, and DAS28 produced the highest adjusted R 2 as well as the lowest Akaike information criterion, RMSE, and MAE, regardless of the statistical methods used in modeling set. The mapping equation of the OLS method is given as EQ-5D = 0.95−0.21 × HAQ-DI−0.24 × pain VAS/100–0.01 × DAS28 (adjusted R 2 = 57.6 %, RMSE = 0.1654 and MAE = 0.1222). Also in the validation set, the RMSE and MAE were shown to be the smallest. The model with HAQ-DI, pain VAS, and DAS28 showed the best performance, and this mapping model enabled the estimation of an EQ-5D value for RA patients in whom utility values have not been measured.
Voltage and activation mapping: how the recording technique affects the outcome of catheter ablation procedures in patients with congenital heart disease.

Endocardial mapping is mandatory before radiofrequency catheter ablation (RFCA). Mapping can be performed with either unipolar or bipolar recordings. Impact of the recording technique used was studied in patients with and without structural heart disease using the 3D electroanatomic CARTO mapping system.



Patients (n=44; 16 males; age 43+/-16 years) referred for RFCA of atrial flutter (AFL, n=18), focal atrial tachycardia (FAT, n=4), AV nodal reentrant tachycardia (AVNRT, n=5), or scar-related atrial reentrant tachycardia (IART, n=17) were studied. Voltage and activation maps were constructed. Unipolar and bipolar voltage distribution in the different groups was studied to establish a cutoff voltage value to facilitate delineation of scar tissue. Electrograms were recorded during tachycardia (FAT: n=246, cycle length [CL]=449+/-35 ms; AVNRT: n=182, CL=359+/-47 ms; AFL: n=1164, CL=255+/-56 ms; IART: n=2431, CL=280+/-74 ms). Unipolar voltages were greater than bipolar voltages (P<0.001). Unipolar voltages < or =1.0 mV were equally distributed in both AFL and IART patients. Bipolar voltages < or =0.1 mV were only found in patients with IART, and subsequently 0.1 mV was used as the cutoff value to delineate scar tissue. No unipolar cutoff value could be established. Timing of unipolar and bipolar local activation was correlated in all patient groups.



The recording technique used has considerable impact on reconstruction of reentrant pathways and on the outcome of RFCA. In general, unipolar and bipolar recordings provide complementary information; however, only bipolar recordings allow voltage-based scar tissue delineation in patients with congenital heart disease.
Randomized phase II study of docetaxel and prednisone with or without OGX-011 in patients with metastatic castration-resistant prostate cancer.

To determine the clinical activity of OGX-011, an antisense inhibitor of clusterin, in combination with docetaxel/prednisone in patients with metastatic castration-resistant prostate cancer.



Patients were randomly assigned 1:1 to receive docetaxel/prednisone either with (arm A) or without (arm B) OGX-011 640 mg intravenously weekly. The primary end point was the proportion of patients with a prostate-specific antigen (PSA) decline of ≥ 50% from baseline, with the experimental therapy being considered of interest if the proportion of patients with a PSA decline was more than 60%. Secondary end points were objective response rate, progression-free survival (PFS), overall survival (OS), and changes in serum clusterin.



Eighty-two patients were accrued, 41 to each arm. OGX-011 adverse effects included rigors and fevers. After cycle 1, median serum clusterin decreased by 26% in arm A and increased by 0.9% in arm B (P < .001). PSA declined by ≥ 50% in 58% of patients in arm A and 54% in arm B. Partial response occurred in 19% and 25% of patients in arms A and B, respectively. Median PFS and OS times were 7.3 months (95% CI, 5.3 to 8.8 months) and 23.8 months (95% CI, 16.2 months to not reached), respectively, in arm A and 6.1 months (95% CI, 3.7 to 8.6 months) and 16.9 months (95% CI, 12.8 to 25.8 months), respectively, in arm B. Baseline factors associated with improved OS on exploratory multivariate analysis were an Eastern Cooperative Oncology Group performance status of 0 (hazard ratio [HR], 0.27; 95% CI, 0.14 to 0.51), presence of bone or lymph node metastases only (HR, 0.45; 95% CI, 0.25 to 0.79), and treatment assignment to OGX-011 (HR, 0.50; 95% CI, 0.29 to 0.87).



Treatment with OGX-011 and docetaxel was well tolerated with evidence of biologic effect and was associated with improved survival. Further evaluation is warranted.