nils-herrmann/clean_scirepeval huggingface dataset:
Effects and feasibility of a multi-disciplinary orientation program for newly registered cancer patients: design of a randomised controlled trial

Diagnosis and treatment of cancer can contribute to psychological distress and anxiety amongst patients. Evidence indicates that information giving can be beneficial in reducing patient anxiety, so oncology specific information may have a major impact on this patient group. This study investigates the effects of an orientation program on levels of anxiety and self-efficacy amongst newly registered cancer patients who are about to undergo chemotherapy and/or radiation therapy in the cancer care centre of a large tertiary Australian hospital.



The concept of interventions for orienting new cancer patients needs revisiting due to the dynamic health care system. Historically, most orientation programs at this cancer centre were conducted by one nurse. A randomised controlled trial has been designed to test the effectiveness of an orientation program with bundled interventions; a face-to-face program which includes introduction to the hospital facilities, introduction to the multi-disciplinary team and an overview of treatment side effects and self care strategies. The aim is to orientate patients to the cancer centre and to meet the health care team. We hypothesize that patients who receive this orientation will experience lower levels of anxiety and distress, and a higher level of self-efficacy.



An orientation program is a common health care service provided by cancer care centres for new cancer patients. Such programs aim to give information to patients at the beginning of their encounter at a cancer care centre. It is clear in the literature that interventions that aim to improve self-efficacy in patients may demonstrate potential improvement in health outcomes. Yet, evidence on the effects of orientation programs for cancer patients on self-efficacy remains scarce, particularly with respect to the use of multidisciplinary team members. This paper presents the design of a randomised controlled trial that will evaluate the effects and feasibility of a multidisciplinary orientation program for new cancer patients.
Behavioral changes in brain-injured critical care adults with different levels of consciousness during nociceptive stimulation: an observational study

The primary objective of this study was to describe the frequency of behaviors observed during rest, a non-nociceptive procedure, and a nociceptive procedure in brain-injured intensive care unit (ICU) patients with different levels of consciousness (LOC). Second, it examined the inter-rater reliability and discriminant and concurrent validity of the behavioral checklist used. The non-nociceptive procedure involved calling the patient and shaking his/her shoulder. The nociceptive procedure involved turning the patient. The frequency of behaviors was recorded using a behavioral checklist. Patients with absence of movement, or stereotyped flexion or extension responses to a nociceptive stimulus displayed more behaviors during turning (median 5.5, range 0–14) than patients with localized responses (median 4, range 0–10) or able to self-report their pain (median 4, range 0–10). Face flushing, clenched teeth, clenched fist, and tremor were more frequent in patients with absence of movement, or stereotyped responses to a nociceptive stimulus. The reliability of the checklist was supported by a high intra-class correlation coefficient (0.77–0.92), and the internal consistency was acceptable in all three groups (KR 20, 0.71–0.85). Discriminant validity was supported as significantly more behaviors were observed during nociceptive stimulation than at rest. Concurrent validity was confirmed as checklist scores were correlated to the patients’ self-reports of pain (r s = 0.53; 95 % CI 0.21–0.75). Brain-injured patients reacted significantly more during a nociceptive stimulus and the number of observed behaviors was higher in patients with a stereotyped response.
Safety and efficacy of two-step peginterferon α-2a treatment in patients of chronic hepatitis B with acute exacerbation

The focus of this study was to evaluate the safety and efficacy of sequential peginterferon α-2a (Pegasys) therapy for chronic hepatitis B with acute exacerbation [ALT > 10 × upper limit of normal (ULN), bilirubin <2.0 mg/dL]. Four groups of patients categorized by HBeAg status and treatment regimens were studied since May 2007. Nineteen HBeAg-positive patients (Group 1) had received entecavir  pretreatment  (when ALT > 10 × ULN) plus Pegasys (180 μg/kg/week, when ALT was 5-10 × ULN) for 24 weeks. Thirteen HBeAg-negative patients (Group 2) had the same protocol for 48 weeks. In both groups, entecavir was then discontinued 14 days after the initiation of Pegasys. The results were compared, respectively, to 35 HBeAg-positive patients (Group 3) and 24 HBeAg-negative patients (Group 4), all with ALT > 5 × ULN, under continual entecavir monotherapy. The ALT levels of patients in Group 1 and 2 who had received entecavir pretreatment for a duration of 19.63 ± 3.34 days were below four times of ULN following 4 weeks of Pegasys treatment. At week 96, the rates of sustained virological response were 69.2% (9/13) and 80% (8/10), and the relapse rates were 23.1% (3/13) and 11.2% (1/9) for HBeAg-positive and HBeAg-negative patients with two-step Pegasys treatment, respectively. The HBeAg seroconversion rates were 46.2% in Group 1, and 42.1% in Group 3; HBsAg loss rates were 15.4% (2/13) in Group 1, and 30% (3/10) in Group 2, whereas none achieved HBsAg loss with entecavir monotherapy (Group 3 and 4). The two-step Pegasys treatment offers an alternative, other than the nucleos(t)ides, for treating chronic hepatitis B with acute exacerbation and provides a safe, efficacious, short-term and finite strategy.
The influence of motivational messages on future planning behaviors among HIV concordant positive and discordant couples in Lusaka, Zambia.

In Zambia the HIV/AIDS epidemic has resulted in many single female-headed households. Strong patriarchal laws and customs prevent widows and children from maintaining economic assets. This study examines the impact of a video-based motivational intervention promoting future planning in 1,504 HIV-infected couples in Lusaka, Zambia. Following a group video session, couples randomized to the motivational arm could choose to write a will, identify a guardian for their children and make financial plans. Desirable behaviours modelled in the motivational video were measured at quarterly intervals for a year and compared in intervention and control arms. Demographic measures including age, income and educational status were not associated with planning behaviours. Participation in the intervention was associated with will writing (23% versus 5%) and naming a guardian (32% versus 17%) but not with other planning behaviours. The study demonstrates the ability of motivational messages integrated into HIV VCT to encourage future planning behaviour and points to the need to expand existing HIV and VCT services to meet other non-health needs of those living with HIV.
Effect of switching to risperidone after unsuccessful treatment with aripiprazole on plasma monoamine metabolites level in the treatment of acute schizophrenia.

In the treatment of acute schizophrenia, risperidone and aripiprazole are both placed the first line antipsychotics. These two antipsychotics have different pharmacological effects. We investigated the effects of risperidone on plasma levels of homovanillic acid (HVA) and 3-methoxy-4hydroxyphenylglycol after unsuccessful aripiprazole treatment in acute schizophrenia.



Ten Japanese patients with acute schizophrenia were enrolled to this study. Plasma levels of monoamine metabolites were analyzed with high-performance liquid chromatography with electrochemical detection.



Risperidone improved the symptoms and 4 of 10 patients were responders. Risperidone showed a tendency to decrease plasma HVA (pHVA) levels in responders (p = 0.068), but not in non-responders (p = 1.0). At baseline, pHVA levels of responders were significantly higher than that of non-responders (p = 0.033). A trend for negative correlation was found between pHVA at baseline and the changes in Positive and Negative Syndrome Scale-Total (p = 0.061, r = -0.61).



Our results suggest that high pHVA level before switching may predict good response to the second line antipsychotics after unsuccessful first antipsychotic treatment. If aripiprazole is not effective in acute schizophrenia, switching to risperidone may be effective and reasonable strategy for improving symptoms.
A controlled study of potential risk factors preceding exacerbation in multiple sclerosis.

A wide variety of potential risk factors for acute exacerbations in multiple sclerosis were evaluated in a one year case-control study. Eighty nine consecutive patients with clinically definite multiple sclerosis and relapsing remitting course presenting with a relapse between January and December 1992 were compared with patients matched for age, sex, and degree of disability, who did not experience clinical exacerbations during the same period. Only potential risk factors occurring in the three months preceding the interview were considered patients. Relapsing patients reported no significant increase in the frequency of any risk factor in the three month period before exacerbation compared with the control group. These results suggest that most relapses are not preceded by the conditions commonly considered as risk factors.
Outcomes of a single centre registry of patients with ischaemic heart disease, qualified for an RF ablation of ventricular arrhythmia after ICD intervention.

Reduction of ICD interventions improves the quality of life and possibly reduces mortality. Ablation reduces ICD interventions in patients with ablatable arrhythmia, but its effectiveness needs to be proven for patients with coronary artery disease (CAD) regardless of the type of arrhythmia. Our study was designed to address this issue, but it had to be terminated due to recruitment problems. The reasons for early termination are described in this paper.



Patients with CAD and implanted ICD, who within the past three months survived an episode of VT/VF, were selected for this study. Patients were to be randomised for ablation or pharmacotherapy. A group of 209 patients was screened between June and December of 2007.



Out of 209 patients, 39 (18.7%) had appropriate ICD therapy during the last three months and were potentially eligible for the trial. Out of 39 patients, 34 could not be randomised, due to the presence of exclusion criteria (n-25) or consent refusal (n-9). Previous ablation (n-10), left ventricular thrombus (n-3) or presence of mitral or aortic artificial valve (n-3) were the most frequent exclusion criteria. During follow-up of 12 months one patient required ablation due to frequent ICD discharges. From the five randomised patients, two were randomised to ablation and three to the pharmacotherapy arm.



1. Ablation might not be suitable as a routine treatment for all patients with ICD interventions, as a significant group prefers not to undergo RF ablation as a routine treatment or there are contraindications for the ablation. 2. There are obstacles in prospective and randomised evaluation of the role of ablation in patients with CAD and ICD interventions, which are related both to patients' medical conditions and to patients' will. These limitations should be taken into account when designing further studies.
Prognostic value of metabolic response in breast cancer patients receiving neoadjuvant chemotherapy

Today's clinical diagnostic tools are insufficient for giving accurate prognosis to breast cancer patients. The aim of our study was to examine the tumor metabolic changes in patients with locally advanced breast cancer caused by neoadjuvant chemotherapy (NAC), relating these changes to clinical treatment response and long-term survival. Patients (n = 89) participating in a randomized open-label multicenter study were allocated to receive either NAC as epirubicin or paclitaxel monotherapy. Biopsies were excised pre- and post-treatment, and analyzed by high resolution magic angle spinning magnetic resonance spectroscopy (HR MAS MRS). The metabolite profiles were examined by paired and unpaired multivariate methods and findings of important metabolites were confirmed by spectral integration of the metabolite peaks. All patients had a significant metabolic response to NAC, and pre- and post-treatment spectra could be discriminated with 87.9%/68.9% classification accuracy by paired/unpaired partial least squares discriminant analysis (PLS-DA) (p < 0.001). Similar metabolic responses were observed for the two chemotherapeutic agents. The metabolic responses were related to patient outcome. Non-survivors (< 5 years) had increased tumor levels of lactate (p = 0.004) after treatment, while survivors (≥ 5 years) experienced a decrease in the levels of glycine (p = 0.047) and choline-containing compounds (p ≤ 0.013) and an increase in glucose (p = 0.002) levels. The metabolic responses were not related to clinical treatment response. The differences in tumor metabolic response to NAC were associated with breast cancer survival, but not to clinical response. Monitoring metabolic responses to NAC by HR MAS MRS may provide information about tumor biology related to individual prognosis.
Effect of bisoprolol on respiratory function and exercise capacity in chronic obstructive pulmonary disease.

Cardioselective β blockers are considered to have little impact on lung function at rest in patients with chronic obstructive pulmonary disease (COPD). However, their effects on dynamic hyperinflation, an important mechanism contributing to symptoms and exercise tolerance in patients with COPD, have not been evaluated. Twenty-seven patients with moderate to severe COPD (forced expiratory volume in 1 second 52 ± 13% predicted) completed pulmonary function tests, echocardiography, maximal exercise tests, and cycle endurance tests at baseline. Inspiratory capacity was measured at 2-minute intervals during the cycle endurance test to quantify dynamic hyperinflation. Pulmonary function and cycle endurance testing were repeated after 14 days of bisoprolol 10 mg/day and 14 days of placebo in a randomized, double-blind, placebo-controlled, crossover trial. The extent of dynamic hyperinflation at peak isotime exercise with bisoprolol and placebo was compared. Peak isotime was defined as the latest time point that was reached during the 2 cycle endurance tests. Changes in inspiratory capacity from rest to peak isotime were different with bisoprolol compared to placebo (-0.50 ± 0.35 vs -0.41 ± 0.33 L, p = 0.01). Exercise duration tended to be lower with bisoprolol compared to placebo (305 ± 125 vs 353 ± 172 seconds, p = 0.11). The magnitude of change in exercise duration between the bisoprolol and placebo conditions was correlated with the magnitude of change in inspiratory capacity (r = 0.57, p <0.01). In conclusion, bisoprolol was associated with modest worsening dynamic hyperinflation, whereas exercise duration remained unchanged in patients with moderate to severe COPD. The magnitude of these effects was small and should not contraindicate the use of bisoprolol in patients with COPD.
In this Issue – 8.5

This Issue of LJPC displays the breadth of matters that primary care practitioners routinely care about. Howells, McKay, Hussein and Majeed provide guidance on how to manage people who are at high risk of developing diabetes. ‘Intermediate’, or ‘non-diabetic hyperglycaemia’ are those whose HbA1c level is between 42 and 47 mmol/mol (6.0–6.4%) or have fasting blood glucose measurement of 5.5–6.9 mM. They need to be monitored. Thorne examines ways that the quality and outcomes framework could do more to tackle health inequalities. This is a hot topic, exposed by the BMJ in August 2016. Thorne suggests ways to address the challenge. Ma and Shah discuss the shortage of training places and long waiting list for clinicians who wish to train in sexual and reproductive healthcare. Their survey of medical educators identified considerable numbers of GP already trained and interested in having such roles. They signal a need for us all to be aware of the untapped potential sitting under our noses. In a comparison of two legal cases that arrived at exactly opposite conclusions, Gee elegantly describes how to think about doing the right thing by a patient who has lost mental capacity. It is important to weigh up the wishes, feelings, beliefs and values of a mentally incapacitated patient when deciding what treatment to give. This paper is worth reading simply to see the quality of thinking of our judges as well as how we make decisions about patient care. Through the Hippokrates Exchange Program, Siraj shadowed an experienced GP in Madrid. She found considerable similarities with what a GP does in the UK and some interestingly different things, including an intense working regime (7 min with a patient) and excellent continuity of care. Siraj makes the point that the paternalistic consultation style, less favoured these days, can be effective when applied appropriately and respectfully, but it does increase referral rates!
Thrice-weekly versus daily buprenorphine maintenance

Buprenorphine is a promising alternative to methadone or levo-acetyl alpha methadol for opioid agonist maintenance treatment, and thrice-weekly dosing would facilitate its use for this purpose.



After a 3-day induction, opioid-dependent patients (n = 92) were randomly assigned to daily clinic attendance and 12-weeks maintenance treatment with sublingual buprenorphine administered double blind either daily (n = 45; 16 mg/70 kg) or thrice weekly (n = 47; 34 mg/70 kg on Fridays and Sundays and 44 mg/70 kg on Tuesdays). Outcome measures include retention, results of 3x/week urine toxicology tests, and weekly self-reported illicit drug use.



There were no significant differences at baseline in important social, demographic, and drug-use features. Retention was 71% in the daily and 77% in the 3x/week conditions. The proportion of opioid-positive urine tests decreased significantly from baseline in both groups and averaged 57% (daily) and 58% in 3x/week. There were no significant differences between groups in self-reported number of bags of heroin used for any day of the week, including Thursdays (48-72 hours following the last buprenorphine dose for subjects in the 3x/week condition), or in medication compliance (92%, 91%) and counseling attendance (82%, 82%).



At an equivalent weekly dose of 112 mg/70 kg, thrice-weekly and daily sublingual buprenorphine appear comparable in efficacy with regard to retention and reductions in illicit opioid and other drug use. These findings support the potential for utilizing thrice-weekly buprenorphine dosing in novel settings.
Triage, decision-making and follow-up of patients referred to a UK forensic service: validation of the DUNDRUM toolkit

Forensic medium secure services in the UK are a scarce but essential resource providing care for those in the criminal justice system with severe mental disorder. Appropriate allocation of beds to those most in need is essential to ensure efficient use of this resource. To improve decision-making processes in a UK forensic service, an admissions panel utilized the DUNDRUM 1&2 (D1 & D2) triage instruments.



Demographic, diagnostic and clinical information on a prospective sample of referrals to a UK adult forensic service was gathered (n = 195). D1 and D2 measures were scored by a panel of clinical managers considering referral information and clinician opinion in reaching their ratings; those not admitted were also followed up.



Within the sample, D1 ratings were predictive of decisions to admit (AUC = .79) and also differentiated between levels of security (F(4) = 16.54, p < .001). Non-admission was not significantly associated with increased risk of offending at follow-up. Items relating to self-harm and institutional behaviour did not show a predictive relationship with the panel decision to admit.



Use of a structured professional judgement tool showing good predictive validity has improved transparency of decisions and appears to be associated with more efficient use of resources, without increased risk to the public.
Tamoxifen and carboplatin combinational treatment of high-grade gliomas Results of a clinical trial on newly diagnosed patients

Between April, 1992 and December, 1995, forty consecutive patients with a cerebral malignant glioma (WHO Grade III and IV) were enrolled in a trial consisting in surgery and post-operative administration of radiotherapy (4500–6000 cGy), carboplatin (CBDCA; dose of 450–600 mg/m2), and oral tamoxifen (TAM; at doses of 40, 80 or 120 mg/day). Two patients of the TAM group died in the postoperative period from a pulmonary embolism and myocardial infarction, respectively. The patients (all dosages combined) had a median survival time of 13 months from the time of diagnosis. The 12-month and 24-month survival rates were 52% and 32%, respectively. The median relapse-free survival time was 7 months. Patients treated with higher doses of TAM (80–120 mg/day) demonstrated a longer median survival rate (13 months both) and a longer 12-month survival result (58% and 76%, respectively). Patients who assumed TAM for a period longer than 3 months (group+3) have a higher median survival rate (16 months) and better 12-month and 24-month results (62% and 40%, respectively). Moreover, the median relapse-free survival time was 10 months (versus 6 months in group−3; p=0.0038). However, it is not possible to exclude that patients of group+3 had a slower growing or a stable tumor and were well enough to assume TAM for a longer period. The results observed in the TAM-group have been compared with those of 40 matched controls treated with surgery, radiotherapy and CBDCA. These patients had a median survival time of 9 months (p = 0.04) and the 12-month and 24-month survival rates were 30% and 0%, respectively. The median relapse-free survival time was 4 months (p = 0.0014). These data suggest a potential role for combinational TAM-CBDCA therapy in the post-operative treatment of cerebral malignant gliomas; further clinical phase III trials, especially those with higher dosages of TAM are warranted.
Evaluation of advanced fibrosis measured by transient elastography after hepatitis C virus protease inhibitor-based triple therapy.

Few studies have investigated the course of liver stiffness after treatment with protease inhibitors. We evaluated the impact of this therapy on liver fibrosis measured by transient elastography.



This multicenter observational, cohort, prospective study included 90 patients with hepatitis C genotype 1 treated with telaprevir or boceprevir who had advanced fibrosis evidenced by liver stiffness (≥9.5 kPa). Liver stiffness was measured at baseline and 24 weeks after treatment ended, and was compared with virological responses at week 12.



Liver stiffness decreased in 89% of patients who achieved sustained virological response. The median intrapatient liver stiffness value at the end of follow-up decreased by 5.1 kPa (35%) from baseline compared with 0.1 kPa (0.5%) in those who did not achieve a sustained virological response (P<0.001). The liver stiffness level fell below 9.5 kPa in 58% of patients with sustained virological response, and 71% of those with sustained virological response and cirrhosis evidenced by liver stiffness at baseline achieved regression below 12.5 kPa by the end of follow-up. Sustained virological response was the only variable associated with improved liver stiffness in multivariate analysis (odds ratio: 17.3; 95% confidence interval: 4.4-67.6; P<0.001).



In patients with advanced fibrosis measured by transient elastography at the beginning of protease inhibitor-based therapy with sustained virological response, liver stiffness was significantly reduced 24 weeks after treatment. This suggests the possibility of liver cirrhosis evidenced by liver stiffness regression after sustained virological response in a significant proportion of patients.