nils-herrmann/clean_scirepeval huggingface dataset:
Estimation of minimally important differences in the EQ-5D and SF-6D indices and their utility in stroke

The aim of the present study was to estimate minimally important differences (MIDs) in EQ-5D and SF-6D indices and to explore the responsiveness of EQ-5D and SF-6D indices in stroke.



We used observational longitudinal survey data of EQ-5D and SF-36 that were administered to stroke patients at baseline and at 10 months. A range of MIDs for both indexes was estimated using anchor-based approaches. The modified Rankin scale and the Barthel index were used as an anchor.



The MID estimates for EQ-5D ranged from 0.08 to 0.12 and those for SF-6D ranged from 0.04 to 0.14 in stroke patients. The MID values for these two utility measures differed in absolute magnitude, as the SF-6D index has wider range that that of the EQ-5D index.



The MID values for these two utility measures differed in absolute magnitude, as the SF-6D index has wider range that that of the EQ-5D index. These MID estimates may assist the interpretation of health related quality of life assessments related to health care intervention in stroke patients.
The Scottish perinatal neuropathology study: clinicopathological correlation in early neonatal deaths.

A proportion of neonatal deaths from asphyxia have been shown to be associated with pre-existing brain injury.



(a) To compare the epidemiology of infants displaying signs of birth asphyxia with those not showing signs; (b) to examine the neuropathology and determine if possible the timing of brain insult comparing asphyxiated with non-asphyxiated infants; (c) to compare the clinical features of those born with birth asphyxia with and without pre-labour damage.



Over a two year period, all 22 Scottish delivery units collected clinical details on early neonatal deaths. Requests for post mortem included separate requests for detailed neuropathological examination of the brain. Infants were classified into two groups: birth asphyxia and non-birth asphyxia. Clinicopathological correlation was used to attempt to define the time of brain insult.



Detailed clinical data were available on 137 of 174 early neonatal deaths that met the inclusion criteria. Seventy of 88 parents who had agreed to post mortem examination consented to a detailed examination of additional samples from the brain; in 53 of these cases the infant was born in an asphyxiated condition. All asphyxiated and encephalopathic infants, 38% of mature and 52% of preterm infants with features of birth asphyxia but without encephalopathy, and only one of 12 infants without any signs of birth asphyxia showed damage consistent with onset before the start of labour.



In a large proportion of neonatal deaths, brain injury predates the onset of labour. This is more common in infants born in an asphyxiated condition.
Circulating tumor cell biomarker panel as an individual-level surrogate for survival in metastatic castration-resistant prostate cancer.

Trials in castration-resistant prostate cancer (CRPC) need new clinical end points that are valid surrogates for survival. We evaluated circulating tumor cell (CTC) enumeration as a surrogate outcome measure.



Examining CTCs alone and in combination with other biomarkers as a surrogate for overall survival was a secondary objective of COU-AA-301, a multinational, randomized, double-blind phase III trial of abiraterone acetate plus prednisone versus prednisone alone in patients with metastatic CRPC previously treated with docetaxel. The biomarkers were measured at baseline and 4, 8, and 12 weeks, with 12 weeks being the primary measure of interest. The Prentice criteria were applied to test candidate biomarkers as surrogates for overall survival at the individual-patient level.



A biomarker panel using CTC count and lactate dehydrogenase (LDH) level was shown to satisfy the four Prentice criteria for individual-level surrogacy. Twelve-week surrogate biomarker data were available for 711 patients. The abiraterone acetate plus prednisone and prednisone-alone groups demonstrated a significant survival difference (P = .034); surrogate distribution at 12 weeks differed by treatment (P < .001); the discriminatory power of the surrogate to predict mortality was high (weighted c-index, 0.81); and adding the surrogate to the model eliminated the treatment effect on survival. Overall, 2-year survival of patients with CTCs < 5 (low risk) versus patients with CTCs ≥ 5 cells/7.5 mL of blood and LDH > 250 U/L (high risk) at 12 weeks was 46% and 2%, respectively.



A biomarker panel containing CTC number and LDH level was shown to be a surrogate for survival at the individual-patient level in this trial of abiraterone acetate plus prednisone versus prednisone alone for patients with metastatic CRPC. Additional trials are ongoing to validate the findings.
Antitumour activity of three second-line treatment combinations in patients with metastatic colorectal cancer after optimal 5-FU regimen failure: a randomised, multicentre phase II study.

We have investigated the efficacy, safety and quality of life profiles of three therapeutic combinations [irinotecan + leucovorin (LV)/5-fluorouracil (5-FU), oxaliplatin + LV/5-FU and irinotecan +oxaliplatin] in patients with metastatic colorectal cancer after failure of a 5-FU-based regimen, or whose disease had progressed within 6 months of the end of treatment.



One hundred and one patients were randomised to receive either: (i) irinotecan 180 mg/m(2) on day 1 followed by an LV 200 mg/m(2) infusion, before a 5-FU 400 mg/m(2) bolus followed by a 5-FU 600 mg/m(2) infusion (LV5FU2 regimen), on days 1 and 2 every 2 weeks; (ii) oxaliplatin 85 mg/m(2) on day 1 followed by the LV5FU2 regimen on days 1 and 2 every 2 weeks; or (iii) oxaliplatin 85 mg/m(2) followed by irinotecan 200 mg/m(2), both on day 1 every 3 weeks. The primary end point was overall response rate (ORR).



The intention-to-treat ORRs were 11.4% [95% confidence interval (CI) 3.2-26.7), 21.2% (95% CI 9.0-38.9) and 15.2% (95% CI 5.1-31.9), respectively, in the three arms. Tumour growth control was >or=60% for all three combinations and overall survivals were 12.2 months (95% CI 9.2-16.0), 11.5 months (95% CI 9.0-14.1) and 11.0 months (95% CI 8.1-12.2), respectively. All patients were evaluable for safety. Main grade 3-4 toxicity was neutropenia (33 to 39% of patients).



Thus, second-line treatment with irinotecan/LV5FU2, oxaliplatin/LV5FU2 or irinotecan/oxaliplatin, provides good tumour growth control and survival coupled with an acceptable safety profile.
Clinic-integrated behavioral intervention for families of youth with type 1 diabetes: randomized clinical trial.

To test the effect on diabetes management outcomes of a low-intensity, clinic-integrated behavioral intervention for families of youth with type 1 diabetes.



Families (n = 390) obtaining care for type 1 diabetes participated in a 2-year randomized clinical trial of a clinic-integrated behavioral intervention designed to improve family diabetes management practices. Measurement of hemoglobin A1c, the primary outcome, was obtained at each clinic visit and analyzed centrally. Blood glucose meter data were downloaded at each visit. Adherence was assessed by using a semistructured interview at baseline, mid-study, and follow-up. Analyses included 2-sample t tests at predefined time intervals and mixed-effect linear-quadratic models to assess for difference in change in outcomes across the study duration.



A significant overall intervention effect on change in glycemic control from baseline was observed at the 24-month interval (P = .03). The mixed-effect model showed a significant intervention by age interaction (P < .001). Among participants aged 12 to 14, a significant effect on glycemic control was observed (P = .009 for change from baseline to 24-month interval; P = .035 for mixed-effect model across study duration), but there was no effect among those aged 9 to 11. There was no intervention effect on child or parent report of adherence; however, associations of change in adherence with change in glycemic control were weak.



This clinic-integrated behavioral intervention was effective in preventing the deterioration in glycemic control evident during adolescence, offering a potential model for integrating medical and behavioral sciences in clinical care.
Results of a Randomized Controlled Trial of a Peer Mentor HIV/STI Prevention Intervention for Women Over an 18 Month Follow-Up

Despite numerous behavioral interventions designed for women, rates of HIV and STIs are increasing. Interventions are needed that reach a large number of at-risk individuals. This study was a randomized clinical trial of a HIV/STI behavioral intervention conducted in Baltimore, MD, USA. Heterosexual women (n = 169) completed a baseline and three semiannual follow-up visits. Participants were randomized into a standard of care comparison condition or a Peer Mentor condition. At the 6-month follow-up, Peer Mentors were less likely to have multiple sex partners [AOR: 0.28 (95% CI: 0.13, 0.63)]. At the 18 month follow-up assessment, Peer Mentors increased their condom use during vaginal [AOR: 0.47 (95% CI: 0.25, 0.87)] and anal sex [AOR: 0.24 (95% CI: 0.09, 0.68)] as well as with main [AOR: 0.41 (95% CI: 0.21, 0.77)] and non-main partners [AOR: 0.33 (95% CI: 0.14, 0.79)]. Peer education is a sustainable approach to change risky sexual behaviors. A pesar de numerosas intervenciones de comportamientos diseñadas para las mujeres, están aumentando las tasas de VIH y enfermedades de transmisión sexual. Se necesitan intervenciones que llegar a un gran número de personas en situación de riesgo. Este estudio fue un ensayo clínico aleatorio de un VIH/ITS intervención conductual llevó a cabo en Baltimore, MD, USA. Las mujeres heterosexuales (n = 169) completó una línea de base y 3 visitas de seguimiento semestral. Los participantes fueron asignados al azar en un estándar de afección de comparación de atención o un Mentor del mismo nivel. En el seguimiento de 6 meses, mentores de Peer tenían menos probabilidades de tener múltiples compañeros sexuales [AOR: 0,28 (95% CI: 0,13, 0.63)]. En la evaluación de seguimiento de 18 meses, mentores de Peer aumentó su uso de condón durante vaginal [AOR: 0,47 (95% CI: 0,25, 0.87)] y sexo anal [AOR: 0,24 (95% CI: 0,09, 0,68)], así como con el principal [AOR: 0,41 (95% CI: 0,21, 0,77)] y no principales asociados [AOR: 0,33 (95% CI: 0,14; 0.79)]. La educación entre compañeros es un enfoque sostenible para cambiar los comportamientos sexuales riesgosos.
Socioeconomic predictors and consequences of depression among primary care attenders with non-communicable diseases in the Western Cape, South Africa: cohort study within a randomised trial

Socioeconomic predictors and consequences of depression and its treatment were investigated in 4393 adults with specified non-communicable diseases attending 38 public sector primary care clinics in the Eden and Overberg districts of the Western Cape, South Africa.



Participants were interviewed at baseline in 2011 and 14 months later, as part of a randomised controlled trial of a guideline-based intervention to improve diagnosis and management of chronic diseases. The 10-item Center for Epidemiologic Studies Depression Scale (CESD-10) was used to assess depression symptoms, with higher scores representing more depressed mood.



Higher CESD-10 scores at baseline were independently associated with being less educated (p = 0.004) and having lower income (p = 0.003). CESD-10 scores at follow-up were higher in participants with less education (p = 0.010) or receiving welfare grants (p = 0.007) independent of their baseline scores. Participants with CESD-10 scores of ten or more at baseline (56 % of all participants) had 25 % higher odds of being unemployed at follow-up (p = 0.016), independently of baseline CESD-10 score and treatment status. Among participants with baseline CESD-10 scores of ten or more, antidepressant medication at baseline was independently more likely in participants who had more education (p = 0.002), higher income (p < 0.001), or were unemployed (p = 0.001). Antidepressant medication at follow up was independently more likely in participants with higher income (p = 0.023), and in clinics with better access to pharmacists (p = 0.053) and off-site drug delivery (p = 0.013).



Socioeconomic disadvantage appears to be both a cause and consequence of depression, and may also be a barrier to treatment. There are opportunities for improving the prevention, diagnosis and treatment of depression in primary care in inequitable middle income countries like South Africa.
Evaluation of Factor Xa-Specific Chromogenic Substrate Assays and the Determination of Pharmacokinetics of Fondaparinux.

Fondaparinux (FPX), a synthesized factor Xa inhibitor, is one of the most popular anticoagulants for the prevention of postoperative venous thromboembolism (VTE). Although routine monitoring is not required, the bleeding adverse events cannot be neglected, and the measurement of anti-Xa activity is expected to be monitored. The primary purpose of this study is to evaluate the performances of 2 chromogenic assays for the detection of anti-Xa activity. Furthermore, the pharmacokinetics of FPX was examined using chromogenic assays. Anti-Xa activity was measured using 2 FPX-based chromogenic substrates (S2222 and STA-Liquid Anti-Xa). The reproducibility, detection limits, linearity, and correlations between the substrates were examined using normal plasma doped with low and high concentrations of FPX formulation. In addition, anti-Xa activity in 235 clinical samples from 164 cases treated was measured, and the pharmacokinetics of FPX was evaluated. Both of the tested substrates were capable of accurately measuring the anti-Xa activity of FPX, with a lower limit of 0.05 μg/mL and a coefficient of variation of less than 10%. The repeated administration of FPX induced a gradual but significant increase in the anti-Xa activity, which was negatively correlated with body weight and estimated glomerular filtration rate. No significant correlation between the anti-Xa activity and the occurrence of postoperative VTE or bleeding event was observed. Anti-Xa activity can be successfully determined using 2 chromogenic assays and automated biochemical analyzers. The clinical significance of anti-Xa activity monitoring should be examined in the future study.
Use of a routine mental health measure in an adolescent secure unit.

We examined the use of a staff-completed measure, the Health of the Nation Outcome Scales for Children and Adolescents (HoNOSCA), to record mental health problems in adolescents in local authority secure accommodation. It proved possible to train staff and implement completion of the HoNOSCA on 64 consecutive admissions. Interrater reliability was high. The HoNOSCA identified high levels of psychological problems on admission (mean 18.5, s.d.=5.5). Follow-up HoNOSCA ratings proved sensitive to change; however, correlation between HoNOSCA and adolescent-completed questionnaires was poor. We concluded that HoNOSCA can be helpful in documenting mental health problems among young people admitted to secure local authority units.
Validation of Brunei’s Malay EQ-5D Questionnaire in Patients with Type 2 Diabetes

The Malay spoken in Brunei a South East Asian country where Malay is the national language is distinctive and different from Malay spoken in Malaysia, Singapore and Indonesia. This study aimed to develop a Brunei Malay version of the 5-level EQ-5D questionnaire (EQ-5D-5L) and to assess its psychometric properties among patients with type 2 diabetes mellitus (T2DM).



The Brunei Malay EQ-5D-5L was developed by culturally adapting two existing Malay versions. A total of 154 Bruneians with T2DM completed the questionnaire in two different points of time with one week apart. Known-groups validity of the utility-based EQ-5D-5L index and visual analogue scale (EQ-VAS) was evaluated by comparing subgroups of patients known to differ in health status. Test-retest reliability was assessed using the intraclass correlation coefficient (ICC) or Cohen's kappa.



As hypothesized, patients known to have 'better' health had higher EQ-5D-5L index scores than those having 'worse' health in all 7 known-groups comparisons. The hypothesized difference in the EQ-VAS scores was observed in only 4 of the 7 known-groups comparisons. Kappa values ranged from 0.206 to 0.446 for the EQ-5D-5L items; the ICC value for the EQ-5D-5L index and EQ-VAS was 0.626 and 0.521, respectively.



The utility-based EQ-5D-5L index appears to be valid and reliable for measuring the health of Brunei patients with T2DM. The validity of the EQ-VAS in Brunei requires further investigation.
Efficacy and safety of vildagliptin in new-onset diabetes after kidney transplantation--a randomized, double-blind, placebo-controlled trial.

New-onset diabetes after transplantation (NODAT) is a serious complication after kidney transplantation, but therapeutic strategies remain underexplored. Dipeptidyl peptidase-4 (DPP-4) inhibitors selectively foster insulin secretion without inducing hypoglycemia, which might be advantageous in kidney transplant recipients (KTRs) with NODAT. We conducted a randomized, double-blind, placebo-controlled, phase II trial to assess safety and efficacy of the DPP-4 inhibitor vildagliptin. Intraindividual differences in oral glucose tolerance test (OGTT)-derived 2-h plasma glucose (2HPG) from baseline to 3 months after treatment served as primary endpoint. Among secondary outcomes, we evaluated HbA1c, metabolic and safety parameters, as well as OGTTs at 1 month after drug discontinuation. Of 509 stable KTRs who were screened in our outpatient clinic, 63 (12.4%) had 2HPG ≥ 200 mg/dL, 33 of them were randomized and 32 completed the study. In the vildagliptin group 2HPG and HbA1c were profoundly reduced in comparison to placebo (vildagliptin: 2HPG = 182.7 mg/dL, HbA1c = 6.1%; placebo: 2HPG = 231.2 mg/dL, HbA1c = 6.5%; both p ≤ 0.05), and statistical significance was achieved for the primary endpoint (vildagliptin: 2HPG-difference -73.7 ± 51.3 mg/dL; placebo: -5.7 ± 41.4 mg/dL; p < 0.01). Adverse events were generally mild and occurred at similar rates in both groups. In conclusion, DPP-4 inhibition in KTRs with overt NODAT was safe and efficient, providing a novel treatment alternative for this specific form of diabetes.
A pilot randomised controlled trial of resistance exercise bands in the management of sedentary subjects with type 2 diabetes.

We conducted a 4-month randomised controlled trial of home-based resistance training using exercise bands, amongst people with type 2 diabetes and co-morbidities limiting aerobic exercise capacity. The intervention did not improve HbA1c, anthropometric variables or functional capacity. We conclude that short-term use of exercise bands does not improve glycaemic control.
The influence of platelet-derived products on angiogenesis and tissue repair: a concise update

Platelet degranulation allows the release of a large amount of soluble mediators, is an essential step for wound healing initiation, and stimulates clotting, and angiogenesis. The latter process is one of the most critical biological events observed during tissue repair, increasing the growth of blood vessels in the maturing wound. Angiogenesis requires the action of a variety of growth factors that act in an appropriate physiological ratio to assure functional blood vessel restoration. Platelets release main regulators of angiogenesis: Vascular Endothelial Growth Factors (VEGFs), basic fibroblast growth factor (FGF-2), and Platelet derived growth factors (PDGFs), among others. In order to stimulate tissue repair, platelet derived fractions have been used as an autologous source of growth factors and biomolecules, namely Platelet Rich Plasma (PRP), Platelet Poor Plasma (PPP), and Platelet Rich Fibrin (PRF). The continuous release of these growth factors has been proposed to promote angiogenesis both in vitro and in vivo. Considering the existence of clinical trials currently evaluating the efficacy of autologous PRP, the present review analyses fundamental questions regarding the putative role of platelet derived fractions as regulators of angiogenesis and evaluates the possible clinical implications of these formulations.
Trusting the design process

the journey? I see it as a composition of core elements that define a " trust fabric " woven into the work of practicing interaction design with our cross-functional peers. Let me explain further... Mindset as the foundation of a good process. There are some excellent habits of mind for a successful journey through a design process. All are grounded in a " bias to action " —as design is a practical art—yet motivated by a desire to reflect and learn and adapt, while moving forward. For instance, all project participants should adopt a Zen " beginner's mind " —a sense of curiosity, of truly wanting to know about a customer's unmet needs and latent pains. They should always be asking, " How can we make things better? " They should ask how they can apply HCI-informed techniques toward understanding or resolving the complexity of a situation, beyond agile project spreadsheets or arbitrarily selected metrics. Everyone must be totally willing to try, risk, and fail forward! It's all about learning to improve oneself, the entire team, the philosophy of success, and the overall strategic approach of progressively creating and capturing value via supporting customers' goals. Design skills and methods as the tradecraft to deliver something real. Knowing the mechanics underlying the technical execution of HCI methods is crucial, since that serves the actual, tangible basis of showing the evidence of a process transpiring and helps others to witness its applicability and value. Therein lies a vital aspect of the trusting—seeing expertise unfold in execution! From contextual inquiry to heuristic evaluation to generative models of ideation, HCI I t's often stated—usually in a casual way, to offset any anxiety by non-design stakeholders in the midst of a lengthy project engagement— " Let's trust the design process. " But what does that mean? And is there even a bona fide design process to trust? As HCI-informed experts in the technology sector, we're loath to see the practice of designing good interactions as some messy, funky artistry of random inspiration à la Don Draper in Mad Men—fueled by whiskey, cigarettes, and couture. That misguided notion is certainly not helpful to our quest to be viewed as critical to business and technology value, with a seat at the table in enabling strategically impactful decisions. Thus, UX firms and corporate UX departments dutifully cite a rigorous process that connotes systematic action and thoughtful predictability, with …