nils-herrmann/clean_scirepeval huggingface dataset:
Development and Psychometric Testing of the Turkish-Version Oral Chemotherapy Adherence Scale.

To ensure the quality of patient care, the bioavailability of drugs, and the success of the treatment, it is imperative that nurses evaluate the adherence of patients to pharmaceutical treatments using standard measurement tools that are integrated into the treatment process. No scale that uses psychometric analyses to evaluate this adherence in patients who are on oral chemotherapy is currently available.



This study developed and tested the validity and reliability of a Turkish version of the standardized Oral Chemotherapy AdherenceScale (OCAS), a tool that may be used by healthcare personnel to better evaluate patient adherence to their therapies.



We developed and examined the validity and reliability of the OCAS using a sample of 306 patients with cancer who were receiving oral chemotherapy. A literature review was conducted to generate the items. An expert panel evaluated content validity; preimplementation was used to evaluate face validity, factor analysis was used to evaluate construct validity, and criterion validity was evaluated using the Medication Adherence Self-Efficacy Scale.



The Cronbach's alpha calculated for OCAS (19 items) was .738. A highly significant and positive correlation was observed between the test-retest scores of the participants. A positive significant correlation was observed between the total scores of the participants obtained from OCAS and Medication Adherence Self-Efficacy Scale. As a result of the factor analysis performed for the construct validity of the scale, three factors were defined that accounted for approximately 43% of the total variance.



The OCAS has acceptable psychometric properties and is appropriate for use in research and clinical practice settings to evaluate patient adherence to their therapies.
Impact of antihypertensive treatment on quality of life: comparison between bisoprolol and bendrofluazide

To compare quality of life with the selective β1-blocker bisoprolol and the thiazide diuretic bendrofluazide in patients with mild to moderate hypertension.  Multi centric, randomised, double-blind, two-way crossover study carried out at six general practice centres.  Eighty-one patients with newly diagnosed or previously treated hypertension, who had a mean diastolic blood pressure (BP) of 95–120 mm Hg after receiving placebo for 4–6 weeks.  In random order, patients received bisoprolol (5 mg once daily) or bendrofluazide (2.5 mg once daily) for 8 weeks.  Quality of life and antihypertensive effect.  Decrease in systolic/diastolic BP did not differ between bisoprolol (10 ± 2/13 ± 1 mm Hg) and bendrofluazide (9 ± 2/11 ± 1 mm Hg). Between bisoprolol and bendrofluazide neither in the intention-to-treat nor in the efficacy analysis any difference was found in quality of life variables, such as Health Status Index, somatic symptoms, anxiety, depression, total psychiatric morbidity, cognitive symptoms and hostility score. Compared to baseline the Health Status Index improved (P < 0.05) during bisoprolol. none of the other investigated quality of life variables changed compared to baseline. no patients dropped out during bisoprolol or bendrofluazide treatment. although, the total number of reported adverse events appeared lower during bendrofluazide than during bisoprolol treatment, it is unclear whether drug related adverse events also differ between the two drugs.  At equipotent antihypertensive dosages, the effect of an 8-week treatment on quality of life does not differ between the selective β1-blocker bisoprolol and the thiazide diuretic bendrofluazide.
Computed tomographic pulmonary angiography vs ventilation-perfusion lung scanning in patients with suspected pulmonary embolism: a randomized controlled trial.

Ventilation-perfusion (V(dot)Q(dot) lung scanning and computed tomographic pulmonary angiography (CTPA) are widely used imaging procedures for the evaluation of patients with suspected pulmonary embolism. Ventilation-perfusion scanning has been largely replaced by CTPA in many centers despite limited comparative formal evaluations and concerns about CTPA's low sensitivity (ie, chance of missing clinically important pulmonary embuli).



To determine whether CTPA may be relied upon as a safe alternative to V(dot)Q(dot scanning as the initial pulmonary imaging procedure for excluding the diagnosis of pulmonary embolism in acutely symptomatic patients.



Randomized, single-blinded noninferiority clinical trial performed at 4 Canadian and 1 US tertiary care centers between May 2001 and April 2005 and involving 1417 patients considered likely to have acute pulmonary embolism based on a Wells clinical model score of 4.5 or greater or a positive D-dimer assay result.



Patients were randomized to undergo either V(dot)Q(dot scanning or CTPA. Patients in whom pulmonary embolism was considered excluded did not receive antithrombotic therapy and were followed up for a 3-month period.



The primary outcome was the subsequent development of symptomatic pulmonary embolism or proximal deep vein thrombosis in patients in whom pulmonary embolism had initially been excluded.



Seven hundred one patients were randomized to CTPA and 716 to V(dot)Q(dot scanning. Of these, 133 patients (19.2%) in the CTPA group vs 101 (14.2%) in the V(dot)Q(dot scan group were diagnosed as having pulmonary embolism in the initial evaluation period (difference, 5.0%; 95% confidence interval [CI], 1.1% to 8.9%) and were treated with anticoagulant therapy. Of those in whom pulmonary embolism was considered excluded, 2 of 561 patients (0.4%) randomized to CTPA vs 6 of 611 patients (1.0%) undergoing V(dot)Q(dot scanning developed venous thromboembolism in follow-up (difference, -0.6%; 95% CI, -1.6% to 0.3%) including one patient with fatal pulmonary embolism in the V(dot)Q(dot group.



In this study, CTPA was not inferior to V(dot)Q(dot scanning in ruling out pulmonary embolism. However, significantly more patients were diagnosed with pulmonary embolism using the CTPA approach. Further research is required to determine whether all pulmonary emboli detected by CTPA should be managed with anticoagulant therapy.
Influence of renal function on the steady-state pharmacokinetics of the antiarrhythmic propafenone and its Phase I and Phase II metabolites

The aim of this study was to investigate the disposition of propafenone and its Phase I and II metabolites in relation to kidney function under steady-state conditions. The mechanism of the renal handling of propafenone glucuronides (filtration, secretion) was also examined. Racemic (R/S) propafenone was administered to 7 young volunteers, to 5 older patients with a normal glomerular filtration rate and to 4 patients with chronic renal failure. No difference was found in the plasma concentrations of propafenone and 5-hydroxypropafenone between the three groups. The propafenone glucuronide (PPFG) concentration was elevated in the older compared to the younger subjects (S-PPFG: 544 vs. 222 nmol · ml−1 · mol−1; R-PPFG: 576 vs. 304 nmol · ml−1 · mol−1). Although Glomerular filtration rate did not differ, the renal clearance of propafenone glucuronides was reduced in the former group, which could be attributed to their impaired renal secretion. A dramatic increase in propafenone glucuronide concentration was observed in the patients with renal failure (S-PPFG: 2783 nmol · ml−1 · mol−1; R-PPFG: 7340 nmol · ml−1 · mol−1). In summary, the disposition of propafenone and of its active metabolite 5-hydroxypropafenone was not affected by kidney dysfunction, indicating that no dose adjustment is necessary in patients with renal failure. The accumulation of drug glucuronides in older patients with apparently normal kidney function should be taken into account as a possible factor modifying drug therapy.
Risk Factors Associated With Corneal Nerve Alteration in Type 1 Diabetes in the Absence of Neuropathy: A Longitudinal In Vivo Corneal Confocal Microscopy Study.

The aim of this study was to determine alterations to the corneal subbasal nerve plexus (SNP) over 4 years using in vivo corneal confocal microscopy in participants with type 1 diabetes and to identify significant risk factors associated with these alterations.



A cohort of 108 individuals with type 1 diabetes and no evidence of peripheral neuropathy at enrollment underwent laser-scanning in vivo corneal confocal microscopy, ocular screening, and health and metabolic assessment at baseline, and the examinations continued for 4 subsequent annual visits. At each annual visit, 8 central corneal images of the SNP were selected and analyzed to quantify corneal nerve fiber density, corneal nerve branch density and corneal nerve fiber length. Linear mixed model approaches were fitted to examine the relationship between risk factors and corneal nerve parameters.



A total of 96 participants completed the final visit and 91 participants completed all visits. No significant relationships were found between corneal nerve parameters and time, sex, duration of diabetes, smoking, alcohol consumption, blood pressure, or body mass index. However, corneal nerve fiber density was negatively associated with glycated hemoglobin (β = -0.76, P < 0.01) and age (β = -0.13, P < 0.01) and positively related to high-density lipids (β = 2.01, P = 0.03). Higher glycated hemoglobin (β = -1.58, P = 0.04) and age (β = -0.23, P < 0.01) also negatively impacted corneal nerve branch density. Corneal nerve fiber length was only affected by higher age (β = -0.06, P < 0.01).



Glycemic control, high-density lipid, and age have significant effects on SNP structure. These findings highlight the importance of diabetic management to prevent corneal nerve damage and the capability of in vivo corneal confocal microscopy for monitoring subclinical alterations in the corneal SNP in diabetes.
Randomised controlled trial of intrapleural streptokinase in community acquired pleural infection.

Standard treatment for pleural infection includes catheter drainage and antibiotics. Tube drainage often fails if the fluid is loculated by fibrinous adhesions when surgical drainage is needed. Streptokinase may aid the process of pleural drainage, but there have been no controlled trials to assess its efficacy.



Twenty four patients with infected community acquired parapneumonic effusions were studied. All had either frankly purulent/culture or Gram stain positive pleural fluid (13 cases; 54%) or fluid which fulfilled the biochemical criteria for pleural infection. Fluid was drained with a 14F catheter. The antibiotics used were cefuroxime and metronidazole or were guided by culture. Subjects were randomly assigned to receive intrapleural streptokinase, 250,000 i.u. daily, or control saline flushes for three days. The primary end points related to the efficacy of pleural drainage--namely, the volume of pleural fluid drained and the chest radiographic response to treatment. Other end points were the number of pleural procedures needed and blood indices of inflammation.



The streptokinase group drained more pleural fluid both during the days of streptokinase/control treatment (mean (SD) 391 (200) ml versus 124 (44) ml; difference 267 ml, 95% confidence interval (CI) 144 to 390; p < .001) and overall (2564 (1663) ml, 95% CI 465 to 2545; p < 0.01). They showed greater improvement on the chest radiograph at discharge, measured as the fall in the maximum dimension of the pleural collection (6.0 (2.7) cm versus 3.4 (2.7) cm; difference 2.9 cm, 95% CI 0.3 to 4.4; p < 0.05) and the overall reduction in pleural fluid collection size (p < 0.05, two-tailed Fisher's exact test). Systemic fibrinolysis and bleeding complications did not occur. Surgery was required by three control patients but none in the streptokinase group.



Intrapleural streptokinase probably aids the treatment of pleural infections by improving pleural drainage without causing systemic fibrinolysis or local haemorrhage.
Role of transesophageal echocardiography in percutaneous aortic valve replacement with the CoreValve Revalving system.

Percutaneous aortic valve replacement (PAVR) is an emerging therapy for nonsurgical patients with severe aortic stenosis (AS). We examined the role of transesophageal echocardiography (TEE) in PAVR. TEE was used initially to assess the native valve and aortic root, and served as a guide during PAVR. Following prosthetic valve deployment, TEE was used to assess valve function. Eleven patients aged 82 +/- 10 years with NYHA III-IV underwent PAVR. Periprocedural TEE gave immediate information on prosthetic position and function, LV function, mitral regurgitation, pericardium, and thoracic aorta anatomy. There was excellent visual agreement between fluoroscopic and TEE images of prosthetic positioning and deployment. TEE facilitated the detection and management of procedure-related complications. Compared with pre-PAVR, AV area (0.56 +/- 0.19 cm(2) vs. 1.3 +/- 0.4 cm(2); P < 0.001) and LVEF (49 +/- 17% vs. 56 +/- 11%; P < 0.001) increased. TEE provides key anatomical and functional information, and serves as a diagnostic guide for complications, which may arise during PAVR.
Evaluation of a Hepatitis B Lay Health Worker Intervention for Cambodian Americans

Cambodian Americans have high rates of chronic hepatitis B virus (HBV) infection. However, only about one-half of Cambodian Americans have been serologically tested for HBV. We conducted a randomized controlled trial to evaluate the impact of a lay health worker (LHW) intervention on HBV testing and knowledge levels among Cambodian Americans. The study group included 250 individuals who participated in a community based survey in metropolitan Seattle and had not been tested for HBV. Experimental group participants received a LHW intervention addressing HBV and control group participants received a LHW intervention addressing physical activity. Trial participants completed a follow-up survey 6 months after randomization. Over four-fifths (82 %) of randomized individuals participated in a LHW home visit and the follow-up survey response rate was 80 %. Among participants with follow-up data, 22 % of the experimental group and 3 % of the control group reported HBV testing (p < 0.001). The experimental and control group testing difference remained significant in an intent-to-treat analysis. The experimental group was significantly more likely than the control group to know that Cambodians have higher rates of HBV infection than whites, HBV cannot be spread by eating food prepared by an infected person, HBV cannot be spread by sharing chopsticks, and HBV cannot be spread by shaking hands. Our findings indicate LHW interventions are acceptable to Cambodian Americans and can positively impact both HBV testing and knowledge levels.
Combined therapy with tiotropium and formoterol in chronic obstructive pulmonary disease: effect on the 6-minute walk test.

Combined therapy with tiotropium and long-acting beta 2 agonists confers additional improvement in symptoms, lung function and aspects of health-related quality of life (QOL) compared with each drug alone in patients with COPD. However, the efficacy of combined therapy on walking distance, a surrogate measure of daily functional activity and morbidity remains unclear. The aim was, therefore, to quantify the benefit of this therapy on the six minute walk test. Secondary outcomes included change in lung function, symptoms, the BODE index and QOL. In a double-blind, crossover study, 38 participants with moderate to severe COPD on tiotropium were randomised to receive either formoterol or placebo for 6 weeks. Following a 2-week washout period, participants crossed over to the alternate arm of therapy for a further 6 weeks. Thirty-six participants, with an average age of 64.3 years and FEV1 predicted of 53%, completed the study. Combined therapy improved walking distance by a mean of 36 metres [95% CI: 2.4, 70.1; p = 0.04] compared with tiotropium. FEV1 increased in both groups (160 mL combination therapy versus 30 mL tiotropium) with a mean difference of 110 mL (95% CI: -100, 320; p = 0.07) between groups, These findings further support the emerging advantages of combined therapy in COPD. Australian New Zealand Clinical Trials.
Raltegravir Non-Inferior to Nucleoside Based Regimens in SECOND-LINE Therapy with Lopinavir/Ritonavir over 96 Weeks: A Randomised Open Label Study for the Treatment Of HIV-1 Infection

To determine the durability over 96 weeks of safety and efficacy of lopinavir/ritonavir (LPV/r) and raltegravir (RAL) which was demonstrated to have non-inferior efficacy relative to a regimen of LPV/r with nucleoside/nucleotide reverse transcriptase inhibitors (N(t)RTIs) (Control) in primary analysis at 48 weeks.



Open label, centrally randomised trial.



Recruitment was from 37 primary and secondary care sites from Africa, Asia, Australia, Europe and Latin America.



541 HIV-1 infected adults virologically failing first-line non-NRTI + 2N(t)RTI, with no previous exposure to protease inhibitors or integrase strand transfer inhibitors were analysed, 425 completed 96 weeks follow up on randomised therapy.



Randomisation was 1:1 to Control or RAL.



Differences between the proportion of participants with plasma HIV-1 RNA (VL) <200 copies/mL by intention to treat were compared with a non-inferiority margin of -12%. Differences in biochemical, haematological and metabolic changes were assessed using T-tests.



VL <200 copies/mL at 96 weeks was: RAL 80.4%, Control 76.0% (difference: 4.4 [95%CI -2.6, 11.3]) and met non-inferiority criteria. The RAL arm had a significantly higher mean change (difference Control-RAL; 95%CI) in haemoglobin (-2.9; -5.7, -1.1), total lymphocytes (-0.2; -0.3, -0.0), total cholesterol (-0.5; -0.8, -0.3), HDL cholesterol (-0.1; -0.1, -0.0) and LDL cholesterol (-0.3; -0.5, -0.2).



At 96 weeks, both RAL and Control maintained efficacy greater than 75% and continued to demonstrate similar safety profiles. These results support the use of a combination LPV/r and RAL regimen as an option following failure of 1st line NNRTI + 2N(t)RTIs.
Correlates of antiretroviral and antidepressant adherence among depressed HIV-infected patients.

Although crucial for efficacy of pharmacotherapy, adherence to prescribed medication regimens for both antiretrovirals and antidepressants is often suboptimal. As many depressed HIV-infected individuals are prescribed both antiretrovirals and antidepressants, it is important to know whether correlates of nonadherence are similar or different across type of regimen. The HIV Translating Initiatives for Depression into Effective Solutions (HI-TIDES) study was a single-blinded, longitudinal, randomized controlled effectiveness trial comparing collaborative care to usual depression care at three Veterans Affairs HIV clinics. The current investigation utilized self-report baseline interview and chart-abstracted data. Participants were 225 depressed HIV-infected patients who were prescribed an antidepressant (n=146), an antiretroviral (n=192), or both (n=113). Treatment adherence over the last 4 days was dichotomized as "less than 90% adherence" or "90% or greater adherence." After identifying potential correlates of nonadherence, we used a seemingly unrelated regression (SUR) bivariate probit model, in which the probability of adherence to HIV medications and the probability of adherence to antidepressant medications are modeled jointly. Results indicated that 75.5% (n=146) of those prescribed antiretrovirals reported 90%-plus adherence to their antiretroviral prescription and 76.7% (n=112) of those prescribed antidepressants reported 90%-plus adherence to their antidepressant prescription, while 67% of those prescribed both (n=113) reported more than 90% adherence to both regimens. SUR results indicated that education, age, and HIV symptom severity were significant correlates of antiretroviral medication adherence while gender and generalized anxiety disorder diagnosis were significant correlates of adherence to antidepressant medications. In addition, antiretroviral adherence did not predict antidepressant adherence (β=1.62, p=0.17), however, antidepressant adherence did predict antiretroviral adherence (β=2.30, p<0.05).
Impact of diuretic dosing on mortality in acute heart failure using a propensity-matched analysis.

Loop diuretics are recommended to treat congestion in heart failure (HF), despite limited quality evidence. High-dose (HD) loop diuretics seem to worsen outcomes in chronic HF, though; data for acute HF are scarce, with equivocal results.



The ALARM-HF study recorded in-hospital HF therapy in 4953 patients from nine countries. A post-hoc analysis was performed to determine if there was an interaction between intravenous (iv) bolus diuretic dosing and outcomes. Patients were classified as receiving high- or low-dose iv furosemide if their total initial 24 h dose was above (HD) or below [low dose (LD)] 1 mg/kg. Propensity scoring, matching an extensive list of variables, was performed. High-dose and LD patients were matched by propensity scores and outcomes determined. We identified 2460 LD and 848 HD patients, with overall in-hospital mortality of 9 and 13% (P= 0.002), respectively. After propensity matching, there were 506 patients in each subgroup, with the matched LD and HD cohorts having similar mortality (13 vs. 15%; P= 0.4). We further investigated in which subgroups of patients HD diuretics influenced mortality. Before matching, HD diuretics were associated with a greater risk of in-hospital death in some subgroups, including patients aged >80 years, those with an acute coronary syndrome, or with a left ventricular ejection fraction <40%. However, after propensity score matching, no association was found between diuretic dosing and death in any of the studied subgroups.



In the initial management of acute HF, HD iv diuretics, per se, do not influence short-term mortality.
Randomised clinical trial: sustained response to PPI treatment of symptoms resembling functional dyspepsia and irritable bowel syndrome in patients suffering from an overlap with erosive gastro-oesophageal reflux disease.

Gastro-oesophageal reflux disease (GERD), functional dyspepsia (FD) and irritable bowel syndrome (IBS) are highly prevalent gastrointestinal conditions with accumulating evidence of overlap in patients. Despite availability of a vast body of research related to individual disorders, major pharmacological breakthrough in treatment of the overlap condition is still lacking.



To assess sustainability of GERD healing and whether known beneficial effects of proton pump inhibitor treatment on GERD also extend to symptoms suggestive of FD and IBS.



A total of 626 patients with reflux oesophagitis were treated with pantoprazole for up to 16 weeks depending on healing of GERD, followed by an observational phase of up to 6 months without treatment. Rates of patients suffering from GERD, FD or IBS were assessed at baseline, and at last visits of treatment and observational phase.



Rates of patients with reflux oesophagitis and concomitantly with reflux symptoms, FD or IBS were each significantly lower after pantoprazole treatment (P < 0.0001). While rates of patients with reflux signs or symptoms increased again during observational phase, rates of FD and IBS were maintained at the low level after cessation of medication (P < 0.0001).



Pantoprazole is efficacious in the treatment of patients suffering from signs and symptoms suggesting an overlap of GERD, FD and/or IBS, providing a sustained response post-treatment in FD and IBS symptom categories. Mechanisms underlying the beneficial effects of improvement in reflux oesophagitis on symptoms suggestive of FD or IBS still need to be determined.