nils-herrmann/clean_scirepeval huggingface dataset:
Reasons for therapeutic inertia when managing hypertension in clinical practice in non-Western countries

Insufficient awareness of hypertension guidelines by physicians may be an impediment to achieving adequate blood pressure (BP) control rates in clinical practice. We therefore conducted an open intervention survey among primary care physicians in 1596 centres from 16 countries in four different continents to prospectively assess what is the BP goal defined by physicians for individual patients and what are the reasons for not intensifying antihypertensive treatment when BP goals are not achieved. Enrolled patients (N=35 302) were either not treated to goal (N=22 887) or previously untreated (N=12 250). Baseline systolic and diastolic BP averaged 159/95±15/12 mm Hg. BP goals defined by physicians averaged 136±6 mm Hg for systolic and 86±5 mm Hg for diastolic BP. Patients' individual risk stratification determined BP goals. At last visit BP averaged 132/81±11/8 mm Hg and values of ⩽140/90 were reached in 92% of untreated and 80% of previously uncontrolled treated hypertensives. The main reasons for not intensifying antihypertensive treatment when BP remained above goal were the assumption that the time after starting the new drug was too short to attain its full effect, the satisfaction with a clear improvement of BP or with a BP nearing the goal, and the acceptance of good self-measurements. In this open intervention program in primary care, a large proportion of patients achieved recommended BP goals. The belief that a clear improvement in BP is acceptable and that the full drug effect may take up to several weeks to be reached are frequent reasons for treatment inertia when goals are not achieved.
A double-blind, placebo-controlled study of sertraline with naltrexone for alcohol dependence.

Significant preclinical evidence exists for a synergistic interaction between the opioid and the serotonin systems in determining alcohol consumption. Naltrexone, an opiate receptor antagonist, is approved for the treatment of alcohol dependence. This double-blind placebo-controlled study examined whether the efficacy of naltrexone would be augmented by concurrent treatment with sertraline, a selective serotonin receptor uptake inhibitor (SSRI).



One hundred and thirteen participants meeting DSM IV alcohol dependence criteria, who were abstinent from alcohol between 5 and 30 days, were randomly assigned to receive one of two treatments at two sites. One group received naltrexone 12.5 mg once daily for 3 days, 25 mg once daily for 4 days, and 50 mg once daily for the next 11 weeks, together with placebo sertraline. The other group received naltrexone as outlined and simultaneously received sertraline 50 mg once daily for 2 weeks, followed by 100 mg once daily for 10 weeks. Both groups received group relapse prevention psychotherapy on a weekly basis.



Compliance and attendance rates were comparable and high. The groups did not differ on the two primary outcomes, time to first drink and time to relapse to heavy drinking, or on secondary treatment outcomes. With the exception of sexual side effects which were more common in the combination group, most adverse events were similar for the two conditions.



As the doses are tested in combination with specialized behavioral therapy, this study does not provide sufficient evidence for the combined use of sertraline and naltrexone above naltrexone alone.
A randomized controlled trial of a discharge nursing intervention to promote self-regulation of care for early discharge interventional cardiology patients.

This randomized controlled trial examined a discharge nursing intervention aimed at promoting self-regulation of care for early discharge interventional cardiology patients. The purpose of this study was to compare medication adherence, patient satisfaction, use of urgent care, and illness perception in patients with cardiovascular disease undergoing interventional revascularization procedures who receive usual care and those who receive a discharge nursing intervention.
Guideline adaptation and implementation planning: a prospective observational study

Adaptation of high-quality practice guidelines for local use has been advanced as an efficient means to improve acceptability and applicability of evidence-informed care. In a pan-Canadian study, we examined how cancer care groups adapted pre-existing guidelines to their unique context and began implementation planning.



Using a mixed-methods, case-study design, five cases were purposefully sampled from self-identified groups and followed as they used a structured method and resources for guideline adaptation. Cases received the ADAPTE Collaboration toolkit, facilitation, methodological and logistical support, resources and assistance as required. Documentary and primary data collection methods captured individual case experience, including monthly summaries of meeting and field notes, email/telephone correspondence, and project records. Site visits, process audits, interviews, and a final evaluation forum with all cases contributed to a comprehensive account of participant experience.



Study cases took 12 to >24 months to complete guideline adaptation. Although participants appreciated the structure, most found the ADAPTE method complex and lacking practical aspects. They needed assistance establishing individual guideline mandate and infrastructure, articulating health questions, executing search strategies, appraising evidence, and achieving consensus. Facilitation was described as a multi-faceted process, a team effort, and an essential ingredient for guideline adaptation. While front-line care providers implicitly identified implementation issues during adaptation, they identified a need to add an explicit implementation planning component.



Guideline adaptation is a positive initial step toward evidence-informed care, but adaptation (vs. 'de novo' development) did not meet expectations for reducing time or resource commitments. Undertaking adaptation is as much about the process (engagement and capacity building) as it is about the product (adapted guideline). To adequately address local concerns, cases found it necessary to also search and appraise primary studies, resulting in hybrid (adaptation plus de novo) guideline development strategies that required advanced methodological skills.Adaptation was found to be an action element in the knowledge translation continuum that required integration of an implementation perspective. Accordingly, the adaptation methodology and resources were reformulated and substantially augmented to provide practical assistance to groups not supported by a dedicated guideline panel and to provide more implementation planning support. The resulting framework is called CAN-IMPLEMENT.
A pilot study of salt and water restriction in patients with chronic heart failure.

International guidelines recommend low sodium intake and fluid restriction for patients with chronic heart failure (CHF) despite little support from scientific research. We conducted a pilot study to evaluate if dietary restriction instructions and recommendations are effective in reducing sodium and fluid intake in patients with CHF and if such reductions affect quality of life, thirst and appetite.  A 12-week, prospective, randomized study with an intervention and control group. The intervention group (n=17) followed a sodium-restricted diet (2-3 g/day) and fluid restriction (1.5 L/day) while the control group (n=13) received general diet information on heart failure. Urine sodium excretion was measured on three consecutive days and para-aminobenzoic acid was used to secure urine collection. Individual dietary recommendations were provided.



Fluid intake was reduced in the intervention group compared with the control group from baseline to follow-up: 1.6(0.4)L to 1.2(0.5)L vs. 1.7(0.8)L to 1.6(0.9)L (p=0.04). Sodium excretion was reduced by > or =25% in 57% of the patients in the intervention group and in 25% in the control group (p=0.049).



Patients with CHF were able to reduce sodium and fluid intake. The effects in terms of patient perceptions and clinical outcomes need to be assessed in a larger study.
Local applications of GM-CSF induce the recruitment of immune cells in cervical low-grade squamous intraepithelial lesions.

Quantitative alterations of antigen-presenting cells (APC) in (pre)neoplastic lesions of the uterine cervix associated with human papillomavirus (HPV) infection suggest a diminished capacity to capture viral antigens and to induce a protective immune response.



To test whether a cervical application of GM-CSF could restore an immune response against HPV in women with cervical low-grade squamous intraepithelial lesions (LSIL), we performed two clinical trials with 11 healthy women and 15 patients with LSIL.



GM-CSF applications were well tolerated in all enrolled women, and no difference in toxicity between the treated and placebo groups was observed during the follow-up (until 30 months). Interestingly, in the GM-CSF treated group, a significant increase of APC and cytotoxic T-lymphocyte infiltration was observed in the cervical biopsies with no change in regulatory T cell numbers. All the HPV16(+) patients exhibited an immune response against HPV16 after GM-CSF applications, as shown by NK and/or T cells producing IFN-gamma whereas no cellular immune response was observed before the treatment. Moreover, the anti-virus-like particles antibody titers also increased after the treatment.



These encouraging results obtained from a limited number of subjects justify further study on the therapeutic effect of APC in cervical (pre)neoplastic lesions.
Predictors of stunting, wasting, and underweight among Tanzanian children born to HIV-infected women

Children born to human immunodeficiency virus (HIV)-infected women are susceptible to undernutrition, but modifiable risk factors and the time course of the development of undernutrition have not been well characterized. The objective of this study was to identify maternal, socioeconomic and child characteristics that are associated with stunting, wasting and underweight among Tanzanian children born to HIV-infected mothers, followed from 6 weeks of age for 24 months.Maternal and socioeconomic characteristics were recorded during pregnancy, data pertaining to the infant’s birth were collected immediately after delivery, morbidity histories and anthropometric measurements were performed monthly. Multivariate Cox proportional hazards methods were used to assess the association between potential predictors and the time to first episode of stunting, wasting and underweight.A total of 2387 infants (54.0% male) were enrolled and followed for a median duration of 21.2 months. The respective prevalence of prematurity (<37 weeks) and low birth weight (<2500 g) was 15.2% and 7.0%; 11.3% of infants were HIV-positive at 6 weeks. Median time to first episode of stunting, wasting and underweight was 8.7, 7.2 and 7.0 months, respectively. Low maternal education, few household possessions, low infant birth weight, child HIV infection and male sex were all independent predictors of stunting, wasting and underweight. In addition, preterm infants were more likely to become wasted and underweight, whereas those with a low Apgar score at birth were more likely to become stunted.Interventions to improve maternal education and nutritional status, reduce mother-to-child transmission of HIV, and increase birth weight may lower the risk of undernutrition among children born to HIV-infected women.
Rationale and Design of the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE)

The epidemic of type 2 diabetes (T2DM) threatens to become the major public health problem of this century. However, a comprehensive comparison of the long-term effects of medications to treat T2DM has not been conducted. GRADE, a pragmatic, unmasked clinical trial, aims to compare commonly used diabetes medications, when combined with metformin, on glycemia-lowering effectiveness and patient-centered outcomes.



GRADE was designed with support from a U34 planning grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The consensus protocol was approved by NIDDK and the GRADE Research Group.  30 years of age at time of diagnosis, and baseline hemoglobin A1c (A1C) of 6.8-8.5% (51-69 mmol/mol). Medications representing four classes (sulfonylureas, dipeptidyl peptidase 4 inhibitors, glucagon-like peptide 1 receptor agonists, and insulin) will be randomly assigned and added to metformin (minimum-maximum 1,000-2,000 mg/day). The primary metabolic outcome is the time to primary failure defined as an A1C ≥ 7% (53 mmol/mol), subsequently confirmed, over an anticipated mean observation period of 4.8 years (range 4-7 years). Other long-term metabolic outcomes include the need for the addition of basal insulin after a confirmed A1C >7.5% (58 mmol/mol) and, ultimately, the need to implement an intensive basal/bolus insulin regimen. The four drugs will also be compared with respect to selected microvascular complications, cardiovascular disease risk factors, adverse effects, tolerability, quality of life, and cost-effectiveness.



GRADE will compare the long-term effectiveness of major glycemia-lowering medications and provide guidance to clinicians about the most appropriate medications to treat T2DM. GRADE begins recruitment at 37 centers in the U.S. in 2013.
Evaluation of pharmacological treatment of impulsivity in children with attention deficit hyperactivity disorder.

We used an assessment that involved competing reinforcer dimensions in a concurrent-schedules arrangement to examine the effects of stimulant medication on impulsivity (i.e., sensitivity of choices to reinforcer immediacy relative to rate, quality, and effort) with 4 students with attention deficit hyperactivity disorder. The assessments were administered in the context of a double-blind, placebo-controlled, counterbalanced reversal design. Reinforcer immediacy was the most influential dimension for 3 of the students and the second most influential dimension for 1 of the students across placebo and medication conditions; medication did not affect these sensitivities.
Effect of selenium supplementation on CD4 T-cell recovery, viral suppression, morbidity and quality of life of HIV-infected patients in Rwanda: study protocol for a randomized controlled trial

Low levels of serum selenium are associated with increased risk of mortality among HIV+ patients in East Africa. We aim to assess the effect of selenium supplementation on CD4 cell count, HIV viral load, opportunistic infections, and quality of life in HIV-infected patients in Rwanda.



A 24-month, multi-centre, patient and provider-blinded, randomized, placebo-controlled clinical trial involving 300 pre-antiretroviral therapy (ART) HIV-infected patients will be carried out at two sites in Rwanda. Patients ≥ 21 years of age with documented HIV infection, CD4 cell count of 400-650 cells/mm3, and not yet on ART will be recruited. Patients will be randomized at each study site using a randomized block design to receive either the selenium micronutrient supplement or an identically appearing placebo taken once daily. The primary outcome is a composite of time from baseline to reduction of CD4 T lymphocyte count below 350 cells/mm3 (confirmed by two measures at least one week apart), or start of ART, or the emergence of a documented CDC-defined AIDS-defining illness. An intention-to-treat analysis will be conducted using stepwise regression and structural equation modeling.



Micronutrient interventions that aim to improve CD4 cell count, decrease opportunistic infections, decrease HIV viral load, and ultimately delay initiation of more costly ART may be beneficial, particularly in resource-constrained settings, such as sub-Saharan Africa. Additional trials are needed to determine if micro-supplementation can delay the need for more costly ART among HIV-infected patients. If shown to be effective, selenium supplementation may be of public health importance to HIV-infected populations, particularly in sub-Saharan Africa and other resource-constrained settings.
Vulnerable Elderly Survey 13 as a screening method for frailty in Polish elderly surgical patient--prospective study.

The Vulnerable Elders Survey (VES-13) is a simple function based frailty screening tool that can be also administered by the nonclinical personnel within 5 minutes and has been validated in the out- and in patient clinic and acute medical care settings. The aim of the study was to validate the accuracy of the VES-13 screening method for predicting the frailty syndrome based on a CGA in polish surgical patients.



We included prospectively 106 consecutive patients ≥65, that qualify for abdominal surgery (both due to oncological and benign reasons), at the tertiary referral hospital.We evaluated the diagnostic performance of VES-13 score comparing to the results from the CGA, accepted as the gold standard for identifying at risk frail elderly patients.



The prevalence of frailty as diagnosed by CGA was 59.4%. There was significantly higher number of frail patients in the oncological group (78% vs. 31%; p<0.01). According to the frailty screening methods, the frailty prevalence was 45.3%. The VES-13 score had a 60% sensitivity and 78% specificity in detecting frailty syndrome. The positive and negative predictive value was 81% and 57%, respectively. The overall predictive capacity was intermediate (AUC=0.69)  At present, the VES-13 screening tool for older patients cannot replace the comprehensive geriatric assessment; this is due to the insufficient discriminative power to select patients for further assessment. It might be helpful in a busy clinical practice and in facilities that do not have trained personal for geriatric assessment.
Effect of a 72 Hour Stroke Care Bundle on Early Outcomes after Acute Stroke: A Non Randomised Controlled Study

Integrated care pathways (ICP) in stroke management are increasingly being implemented to improve outcomes of acute stroke patients. We evaluated the effect of implementing a 72 hour stroke care bundle on early outcomes among patients admitted within seven days post stroke to the national referral hospital in Uganda.



In a one year non-randomised controlled study, 127 stroke patients who had 'usual care' (control group) were compared to 127 stroke patients who received selected elements from an ICP (intervention group). Patients were consecutively enrolled (controls first, intervention group second) into each group over 5 month periods and followed to 30-days post stroke. Incidence outcomes (mortality and functional ability) were compared using chi square test and adjusted for potential confounders. Kaplan Meier survival estimates and log rank test for comparison were used for time to death analysis for all strokes and by stroke severity categories. Secondary outcomes were in-hospital mortality, median survival time and median length of hospital stay.



Mortality within 7 days was higher in the intervention group compared to controls (RR 13.1, 95% CI 3.3-52.9). There was no difference in 30-day mortality between the two groups (RR 1.2, 95% CI 0.5-2.6). There was better 30-day survival in patients with severe stroke in the intervention group compared to controls (P = 0.018). The median survival time was 30 days (IQR 29-30 days) in the control group and 30 days (IQR 7-30 days) in the intervention group. In the intervention group, 41patients (32.3%) died in hospital compared to 23 (18.1%) in controls (P < 0.001). The median length of hospital stay was 8 days (IQR 5-12 days) in the controls and 4 days (IQR 2-7 days) in the intervention group. There was no difference in functional outcomes between the groups (RR 0.9, 95% CI 0.4-2.2).



While implementing elements of a stroke-focused ICP in a Ugandan national referral hospital appeared to have little overall benefit in mortality and functioning, patients with severe stroke may benefit on selected outcomes. More research is needed to better understand how and when stroke protocols should be implemented in sub-Saharan African settings.
Goserelin for ovarian protection during breast-cancer adjuvant chemotherapy.

Ovarian failure is a common toxic effect of chemotherapy. Studies of the use of gonadotropin-releasing hormone (GnRH) agonists to protect ovarian function have shown mixed results and lack data on pregnancy outcomes.



We randomly assigned 257 premenopausal women with operable hormone-receptor-negative breast cancer to receive standard chemotherapy with the GnRH agonist goserelin (goserelin group) or standard chemotherapy without goserelin (chemotherapy-alone group). The primary study end point was the rate of ovarian failure at 2 years, with ovarian failure defined as the absence of menses in the preceding 6 months and levels of follicle-stimulating hormone (FSH) in the postmenopausal range. Rates were compared with the use of conditional logistic regression. Secondary end points included pregnancy outcomes and disease-free and overall survival.



At baseline, 218 patients were eligible and could be evaluated. Among 135 with complete primary end-point data, the ovarian failure rate was 8% in the goserelin group and 22% in the chemotherapy-alone group (odds ratio, 0.30; 95% confidence interval [CI], 0.09 to 0.97; two-sided P=0.04). Owing to missing primary end-point data, sensitivity analyses were performed, and the results were consistent with the main findings. Missing data did not differ according to treatment group or according to the stratification factors of age and planned chemotherapy regimen. Among the 218 patients who could be evaluated, pregnancy occurred in more women in the goserelin group than in the chemotherapy-alone group (21% vs. 11%, P=0.03); women in the goserelin group also had improved disease-free survival (P=0.04) and overall survival (P=0.05).



Although missing data weaken interpretation of the findings, administration of goserelin with chemotherapy appeared to protect against ovarian failure, reducing the risk of early menopause and improving prospects for fertility. (Funded by the National Cancer Institute and others; POEMS/S0230 ClinicalTrials.gov number, NCT00068601.).
Erythropoietin therapy, hemoglobin targets, and quality of life in healthy hemodialysis patients: a randomized trial.

The effects of different hemoglobin targets when using erythropoiesis-stimulating agents on quality of life are somewhat controversial, and predictors of change in quality of life in endstage renal disease have not been well characterized.



Five hundred ninety-six incident hemodialysis patients without symptomatic cardiac disease were randomly assigned to hemoglobin targets of 9.5 to 11.5 g/dl or 13.5 to 14.5 g/dl for 96 weeks, using epoetin_alfa as primary therapy. Patients and attending physicians were masked to treatment assignment. Quality of life, a secondary outcome, was prospectively recorded using the Kidney Disease Quality of Life (KDQoL) questionnaire at weeks 0, 24, 36, 48, 60, 72, 84, and 96, with prespecified outcomes being fatigue and quality of social interaction.



The mean age and prior duration of dialysis therapy of the study population were 50.8 and 0.8 yr. Mortality was low, reflecting the relatively healthy group enrolled. Of 20 domains within the KDQoL only the prespecified domain of fatigue showed significant change over time between the two groups. Improvement in fatigue scores in the high-target group ranged from 3.2 to 7.9 over time (P = 0.007) compared with change in the low-target group. Higher body mass index and lower erythropoietin dose at baseline were independent predictors of improvement in multiple KDQoL domains.



In relatively healthy hemodialysis patients, normal hemoglobin targets may have beneficial effects on fatigue. Improvement in multiple domains of quality of life is associated with higher body mass index and lower erythropoietin requirements.