nils-herrmann/clean_scirepeval huggingface dataset:
Cost analysis related to dose-response of spinal manipulative therapy for chronic low back pain: outcomes from a randomized controlled trial.

The purpose of this analysis is to report the incremental costs and benefits of different doses of spinal manipulative therapy (SMT) in patients with chronic low back pain (LBP).



We randomized 400 patients with chronic LBP to receive a dose of 0, 6, 12, or 18 sessions of SMT. Participants were scheduled for 18 visits for 6 weeks and received SMT or light massage control from a doctor of chiropractic. Societal costs in the year after study enrollment were estimated using patient reports of health care use and lost productivity. The main health outcomes were the number of pain-free days and disability-free days. Multiple regression was performed on outcomes and log-transformed cost data.



Lost productivity accounts for most societal costs of chronic LBP. Cost of treatment and lost productivity ranged from $3398 for 12 SMT sessions to $3815 for 0 SMT sessions with no statistically significant differences between groups. Baseline patient characteristics related to increase in costs were greater age (P = .03), greater disability (P = .01), lower quality-adjusted life year scores (P = .01), and higher costs in the period preceding enrollment (P < .01). Pain-free and disability-free days were greater for all SMT doses compared with control, but only SMT 12 yielded a statistically significant benefit of 22.9 pain-free days (P = .03) and 19.8 disability-free days (P = .04). No statistically significant group differences in quality-adjusted life years were noted.



A dose of 12 SMT sessions yielded a modest benefit in pain-free and disability-free days. Care of chronic LBP with SMT did not increase the costs of treatment plus lost productivity.
Efficacy of Cognitive Behavioral Therapy for Insomnia in Adolescents: A Randomized Controlled Trial with Internet Therapy, Group Therapy and A Waiting List Condition.

To investigate the efficacy of cognitive behavioral therapy for insomnia (CBTI) in adolescents.



A randomized controlled trial of CBTI in group therapy (GT), guided internet therapy (IT), and a waiting list (WL), with assessments at baseline, directly after treatment (post-test), and at 2 months follow-up.



Diagnostic interviews were held at the laboratory of the Research Institute of Child Development and Education at the University of Amsterdam. Treatment for GT occurred at the mental health care center UvAMinds in Amsterdam, the Netherlands.



One hundred sixteen adolescents (mean age = 15.6 y, SD = 1.6 y, 25% males) meeting DSM-IV criteria for insomnia, were randomized to IT, GT, or WL.



CBTI of 6 weekly sessions, consisted of psychoeducation, sleep hygiene, restriction of time in bed, stimulus control, cognitive therapy, and relaxation techniques. GT was conducted in groups of 6 to 8 adolescents, guided by 2 trained sleep therapists. IT was applied through an online guided self-help website with programmed instructions and written feedback from a trained sleep therapist.



Sleep was measured with actigraphy and sleep logs for 7 consecutive days. Symptoms of insomnia and chronic sleep reduction were measured with questionnaires. Results showed that adolescents in both IT and GT, compared to WL, improved significantly on sleep efficiency, sleep onset latency, wake after sleep onset, and total sleep time at post-test, and improvements were maintained at follow-up. Most of these improvements were found in both objective and subjective measures. Furthermore, insomnia complaints and symptoms of chronic sleep reduction also decreased significantly in both treatment conditions compared to WL. Effect sizes for improvements ranged from medium to large. A greater proportion of participants from the treatment conditions showed high end-state functioning and clinically significant improvement after treatment and at follow-up compared to WL.



This study is the first randomized controlled trial that provides evidence that cognitive behavioral therapy for insomnia is effective for the treatment of adolescents with insomnia, with medium to large effect sizes. There were small differences between internet and group therapy, but both treatments reached comparable endpoints.
Mindfulness-based cognitive therapy (MBCT) versus the health-enhancement program (HEP) for adults with treatment-resistant depression: a randomized control trial study protocol

Major depressive disorder (MDD) is the leading cause of disability in the developed world, yet broadly effective treatments remain elusive. Up to 40% of patients with depression are unresponsive to at least two trials of antidepressant medication and thus have "treatment-resistant depression" (TRD). There is an urgent need for cost-effective, non-pharmacologic, evidence-based treatments for TRD. Mindfulness-Based Cognitive Therapy (MBCT) is an effective treatment for relapse prevention and residual depression in major depression, but has not been previously studied in patients with TRD in a large randomized trial.



The purpose of this study was to evaluate whether MBCT is an effective augmentation of antidepressants for adults with MDD who failed to respond to standard pharmacotherapy. MBCT was compared to an active control condition, the Health-Enhancement Program (HEP), which incorporates physical activity, functional movement, music therapy and nutritional advice. HEP was designed as a comparator condition for mindfulness-based interventions to control for non-specific effects. Originally investigated in a non-clinical sample to promote stress reduction, HEP was adapted for a depressed population for this study. Individuals age 18 and older with moderate to severe TRD, who failed to respond to at least two trials of antidepressants in the current episode, were recruited to participate. All participants were taking antidepressants (Treatment as usual; TAU) at the time of enrollment. After signing an informed consent, participants were randomly assigned to either MBCT or HEP condition. Participants were followed for 1 year and assessed at weeks 1-7, 8, 24, 36, and 52. Change in depression severity, rate of treatment response and remission after 8 weeks were the primary outcomes measured by the clinician-rated Hamilton Depression Severity Rating (HAM-D) 17-item scale. The participant-rated Quick Inventory of Depression Symptomology (QIDS-SR) 16-item scale was the secondary outcome measure of depression severity, response, and remission.



Treatment-resistant depression entails significant morbidity and has few effective treatments. We studied the effect of augmenting antidepressant medication with MBCT, compared with a HEP control, for patients with TRD. Analyses will focus on clinician and patient assessment of depression, participants' clinical global impression change, employment and social functioning scores and quality of life and satisfaction ratings.
A trial of recombinant human granulocyte colony stimulating factor for the treatment of very low birthweight infants with presumed sepsis and neutropenia.

The primary objective was to investigate the safety of recombinant human granulocyte colony stimulating factor (rhG-CSF) for the treatment of very low birthweight infants (VLBW) with sepsis and relative neutropenia, specifically with regard to worsening of respiratory distress and thrombocytopenia and all cause mortality. Secondary objectives were to evaluate duration of ventilation, intensive care, and antibiotic use as markers of efficacy.



Neonates (< or = 28 days) in intensive care, with birth weights of 500-1500 g, absolute neutrophil count (ANC) of < or = 5 x 10(9)/l, and clinical evidence of sepsis, were randomly assigned to receive either rhG-CSF (10 microg/kg/day) administered intravenously (n = 13), or placebo (n = 15) for a maximum of 14 days, in addition to standard treatment and antibiotics. All adverse events, oxygenation index, incidence of thrombocytopenia, all cause mortality, duration of ventilation, intensive care and antibiotic treatment, and ANC recovery were compared between the two groups.



Adverse events and oxygenation index were not increased by, and thrombocytopenia was not attributable to, treatment with rhG-CSF. At 6 and 12 months postmenstrual age, there were significantly fewer deaths in the group receiving rhG-CSF (1/13 v 7/15; p < or = 0.038). There was a non-significant trend towards a reduction in duration of ventilation, intensive care, and antibiotic use in the rhG-CSF group. There was a significantly more rapid increase in ANC in the rhG-CSF treated babies (p < 0.001).



In a small randomised placebo controlled trial in a highly selected group of neonates, adjuvant treatment with rhG-CSF increased ANC rapidly, and no treatment related adverse events were identified. Mortality at 6 and 12 months postmenstrual age was significantly lower in the treatment group. A large trial investigating efficacy in a similar group of neonates is warranted.
Development and validation of a score to predict postoperative respiratory failure in a multicentre European cohort: A prospective, observational study.

Postoperative respiratory failure (PRF) is the most frequent respiratory complication following surgery.



The objective of this study was to build a clinically useful predictive model for the development of PRF.



A prospective observational study of a multicentre cohort.



Sixty-three hospitals across Europe.



Patients undergoing any surgical procedure under general or regional anaesthesia during 7-day recruitment periods.



Development of PRF within 5 days of surgery. PRF was defined by a partial pressure of oxygen in arterial blood (PaO2) less than 8 kPa or new onset oxyhaemoglobin saturation measured by pulse oximetry (SpO2) less than 90% whilst breathing room air that required conventional oxygen therapy, noninvasive or invasive mechanical ventilation.



PRF developed in 224 patients (4.2% of the 5384 patients studied). In-hospital mortality [95% confidence interval (95% CI)] was higher in patients who developed PRF [10.3% (6.3 to 14.3) vs. 0.4% (0.2 to 0.6)]. Regression modelling identified a predictive PRF score that includes seven independent risk factors: low preoperative SpO2; at least one preoperative respiratory symptom; preoperative chronic liver disease; history of congestive heart failure; open intrathoracic or upper abdominal surgery; surgical procedure lasting at least 2 h; and emergency surgery. The area under the receiver operating characteristic curve (c-statistic) was 0.82 (95% CI 0.79 to 0.85) and the Hosmer-Lemeshow goodness-of-fit statistic was 7.08 (P = 0.253).



A risk score based on seven objective, easily assessed factors was able to predict which patients would develop PRF. The score could potentially facilitate preoperative risk assessment and management and provide a basis for testing interventions to improve outcomes.The study was registered at ClinicalTrials.gov (identifier NCT01346709).
Similar anti-inflammatory effects of intracoronary and intravenous abciximab during primary percutaneous coronary intervention: a randomized study.

Intracoronary Abciximab administration during primary percutaneous coronary intervention (pPCI) could offer theoretical advantages over the intravenous route. Besides antiplatelet effects, Abciximab can modulate inflammation via cross-reactivity with GPIIb/IIIa, avb3, and aMb2 receptors. The aim of our study was to assess whether the Abciximab administration route could influence its anti-inflammatory effects.



Eighty-nine consecutive ST elevation myocardial infarction patient candidates for pPCI were randomized to intracoronary (Group A-47 patients) or intravenous (Group B-42 patients) Abciximab bolus administration. The primary endpoint was the extent of inflammation, measured by C-reactive protein (CRP), vascular cell adhesion molecule 1 (VCAM-1) and inter-cellular adhesion molecule 1 (ICAM-1) levels. 
Data are expressed in medians (interquartiles). In both groups, troponin levels were similar [baseline: 0.12 (0.03-0.94) vs. 0.27 (0.07-1.24) ng/ml, P = 0.73; postprocedural: 22.00 (14.75-69.43) vs. 31.96 (8.23-7.20) ng/ml, P = 0.83]. Both groups also showed similar baseline [0.31 (0.14-0.69) vs. 0.22 (0.09-0.59) mg/ml, P = 0.80] and postprocedural CRP levels [2.28 (1.37-4.23) vs. 2.16 (1.15-3.22) mg/dl, P = 0.69], similar baseline [272.5 (224.7-340.8) vs. 262.2 (221.2-306.4) ng/ml, P = 0.33] and postprocedural soluble ICAM-1 levels [281.5 (244.6-337.4) vs. 287.2 (226.9-359.2) ng/ml P = 0.71], and similar baseline [771.6 (620.9-971.0) vs. 748.6 (592.2-838.8) ng/ml, P = 0.30] and postprocedural soluble VCAM-1 levels [785.2 (671.6-947.1) vs. 745.9 (641.1-841.9) ng/ml, P = 0.17]. In-hospital and 6-month event rates were similar in the two groups.



Our study suggests that Abciximab has similar anti-inflammatory effects irrespective of the administration route. It is unlikely that the potential clinical benefits of intracoronary Abciximab can be related to modulation of integrin receptors.
Impact of a nurse telephone intervention among high-cardiovascular-risk, health fair participants.

Cardiovascular disease (CVD) is the leading cause of death in the United States, yet most individuals remain unaware of their risk. Current health fair models assess individual risk factors but miss the opportunity to assess, counsel, and follow-up with participants regarding global CVD risk. Objectives of this nurse telephone intervention were to (1) describe high-CVD-risk participants' healthcare-seeking behavior after the health fair and following a nurse telephone intervention and (2) describe CVD risk-reducing therapies provided to high-risk participants after the health fair and following a nurse telephone intervention.



Five hundred twenty-nine of 4,489 health fair participants who completed an interactive Framingham risk assessment in 2006 were identified with high CVD risk. These participants received a nurse telephone intervention approximately 1 month after the health fair, during which the risk message was reinforced, principles of motivational interviewing were applied, and follow-up care was assessed. We evaluated the proportion of high-CVD-risk participants who obtained healthcare before and after intervention, and we compared the care received before and after intervention.



Among 447 contacted high-CVD-risk participants, 59% (n = 262) saw a healthcare provider, and 86% of those discussed CVD risk at their healthcare visit. A greater proportion of participants were started on a cardioprotective drug (41% vs 20%; P < .01), and more participants discussed "heart health" (96% vs 75%; P < .001) after receiving the nurse telephone intervention. Our findings suggest that a nurse intervention may improve individuals' CVD risk awareness as well as activate providers to implement CVD risk reduction strategies.
Validation of diagnostic criteria for apathy in Parkinson's disease.

Apathy is a common neuropsychiatric syndrome in Parkinson's Disease (PD) that affects quality of life. Research into apathy has been hampered by a lack of broadly accepted diagnostic criteria. Recently, diagnostic criteria for apathy in neuropsychiatric disorders have been proposed, which to date have not been validated in PD.



To validate the proposed diagnostic criteria for apathy in PD.



In a cross-sectional study, outpatients with PD visiting a movement disorders clinic underwent a protocolized assessment of motor function, activities of daily living (ADL), cognition and mood. In addition, the diagnostic criteria for apathy were administered as well as two apathy rating instruments: the Lille Apathy Rating Scale (LARS) and the apathy section of the Neuropsychiatric Inventory (NPI).



Of the included patients 17.2% were diagnosed with apathy according to the criteria. Acceptability and internal consistency of the criteria was good, as was the concurrent validity with the LARS and apathy section of the NPI. Discriminant validity of the criteria with depression was moderate to good. All domains of criterion B (behavior, cognition, emotion) contributed to the diagnosis of apathy, of which reduced goal-directed behavior was the most frequently observed symptom.



The recently proposed diagnostic criteria for apathy are useful in clinical practice and in research with PD patients with and without cognitive impairment.
Beliefs and emotions have different roles in generating attitudes toward providing personal help and state-sponsored help for people with a mental illness.

The aim of this study was to examine the role of emotions like pity and anger in mediating the relationship between beliefs about the controllability of a mental illness, and the willingness to help someone with a mental illness. In particular, we tested the hypothesis that the effects of beliefs about controllability on the willingness to provide personal help are mediated by the emotions of pity and anger, but that the effects of beliefs about controllability on the willingness to condone state-organised help were more direct, and not mediated by emotions. A between-groups design was employed to investigate the effects of manipulating controllability attributions via 3 hypothetical vignettes. ANOVA analysis of responses to a revised version of the AQ-27 from 371 participants demonstrated that beliefs about controllability lead to significantly higher personal responsibility beliefs, negative affective reactions and decreased helping intentions in comparison to when the cause of mental illness was believed to be uncontrollable. A mediation analysis demonstrated that pity and anger fully mediate the relationship between beliefs about controllability and the willingness to offer personal help, and also demonstrated that pity and anger partially mediate the relationship between beliefs about controllability and the willingness to condone help provided by the state. The partial mediation may indicate that the effects of beliefs about controllability on state-sponsored may be mediated by pity in some people, but that in other people, beliefs have a more proximal effect on behavior.
Particle size matters: diagnostics and treatment of small airways involvement in asthma.

Small airways are an important site of inflammation and obstruction in asthma, which contributes to the severity of airway hyperresponsiveness (AHR) that is usually measured by nebulisation of large-particle stimuli. We investigated whether small and large particle sizes of aerosolised adenosine monophospate (AMP) provoke similar severity of AHR. Additionally, effects of the small-particle inhaled corticosteroid (ICS) ciclesonide and large-particle ICS fluticasone on AHR to large- and small-particle size AMP were assessed. After a 4-week run-in period using open-label fluticasone (100 μg b.i.d.), 37 mild-to-moderate asthmatics underwent provocations with standard-size (3.7 μm), large-particle (9.9 μm) and small-particle (1.06 μm) AMP. Subjects received 4-week ciclesonide (160 μg s.i.d.) or fluticasone (100 μg b.i.d.) treatment (double-blind and double-dummy) followed by large- and small-particle AMP provocation. Small-particle AMP induced a 20% decrease in forced expiratory volume in 1 s (FEV(1)) at a significantly higher dose than large-particle AMP. Ciclesonide and fluticasone had comparable effects on AMP provocations. Not all subjects reached the provocative concentration causing a 20% fall in FEV(1) (PC(20)) at the highest AMP dose. In those who did, ciclesonide improved small-particle AMP PC(20) by 1.74 doubling doses (DD) (p = 0.03), whereas fluticasone did not. Conversely, fluticasone improved large-particle AMP PC(20) significantly (1.32 DD; p = 0.03), whereas ciclesonide did not. Small-particle AMP provocation appears to be a promising tool to assess changes in small airway inflammation. Future adjustments are necessary taking into account the very small particle size used, with large exhaled fractions. In asthmatics reaching a PC(20) with small- and large-particle AMP provocations, ciclesonide improves hyperresponsiveness to small particle size AMP, and fluticasone to large particle size. This warrants further research to target provocations and treatment to specific airway sizes.
“Young people, adult worries”: RCT of an internet-based self-support method “Feel the ViBe” for children, adolescents and young adults exposed to family violence, a study protocol

Violence in families affects children. Exposure to violence is seen as child abuse. Figures show that about one third of children exposed to violence become victim or perpetrator in their adult life: known as intergenerational transmission. Violence also affects sexual and reproductive health. To prevent problems in adult life, children need help and support. However, while trying to protect their parents, children often do not seek help, or perceive the threshold as too high. Since almost all children of the current generation have access to the internet, an online intervention will make help better available for this target group. In 2011, an internet-based self-support method for children, adolescents and young adults exposed to family violence was developed in the Netherlands: "Feel the ViBe". The intervention was developed in close collaboration with the target group. This article describes the protocol of the RCT to study the effectiveness of this intervention.



This study is a randomized controlled trial using the method of minimization to randomize the participants in two parallel groups with a 1:1 allocation ratio, being an intervention group, having access to "Feel the ViBe" and usual care (UC), and a control group, having access to minimally enhanced usual care (mEUC) followed by access to the intervention after twelve weeks. Outcomes are measured with questionnaires on PTSD symptoms, mental health and sexual and reproductive health. Routine Outcome Measurement (ROM) will be used to measure a direct effect of participating in the intervention. Data from a web evaluation questionnaire (WEQ), user statistics and qualitative analysis of online data will be used to support the findings. To compare results Cohen's d effect sizes will be used.



A RCT and process evaluation will test effectiveness and provide information of how the effects can be explained, how the intervention meets the expectation of participants and which possible barriers and facilitators for implementation exist. A qualitative analysis of the data will add information to interpret the quantitative data. This makes "Feel the ViBe" unique in its field.