bluuebunny/crossref_metadata_2025_split huggingface dataset:
The cost-effectiveness of specialized nursing interventions for people with Parkinson’s disease: the NICE-PD study protocol for a randomized controlled clinical trial
Authors: Radder Danique L. M. , Lennaerts Herma H. , Vermeulen Hester , van Asseldonk Thies , Delnooz Cathérine C. S. , Hagen Rob H. , Munneke Marten , Bloem Bastiaan R. , de Vries Nienke M. 
Published: January 2020

Abstract
Background
Current guidelines recommend that every person with Parkinson’s disease (PD) should have access to Parkinson’s disease nurse specialist (PDNS) care. However, there is little scientific evidence of the cost-effectiveness of PDNS care. This hampers wider implementation, creates unequal access to care, and possibly leads to avoidable disability and costs. Therefore, we aim to study the (cost-)effectiveness of specialized nursing care provided by a PDNS compared with usual care (without PDNS) for people with PD in all disease stages. To gain more insight into the deployed interventions and their effects, a preplanned subgroup analysis will be performed on the basis of disease duration (diagnosis < 5, 5–10, or > 10 years ago).

Methods
We will perform an 18-month, single-blind, randomized controlled clinical trial in eight community hospitals in the Netherlands. A total of 240 people with PD who have not been treated by a PDNS over the past 2 years will be included, independent of disease severity or duration. In each hospital, 30 patients will randomly be allocated in a 1:1 ratio to receive either care by a PDNS (who works according to a recent guideline on PDNS care) or usual care. We will use two co-primary outcomes: quality of life (measured with the Parkinson’s Disease Questionnaire-39) and motor symptoms (measured with the Movement Disorders Society-sponsored revision of the Unified Parkinson’s Disease Rating Scale part III). Secondary outcomes include nonmotor symptoms, health-related quality of life, experienced quality of care, self-management, medication adherence, caregiver burden, and coping skills. Data will be collected after 12 months and 18 months by a blinded researcher. A healthcare utilization and productivity loss questionnaire will be completed every 3 months.

Discussion
The results of this trial will have an immediate impact on the current care of people with PD. We hypothesize that by offering more patients access to PDNS care, quality of life will increase. We also expect healthcare costs to remain equal because increases in direct medical costs (funding additional nurses) will be offset by a reduced number of consultations with the general practitioner and neurologist. If these outcomes are reached, wide implementation of PDNS care will be warranted.

Trial registration
ClinicalTrials.gov, NCT03830190. Registered February 5, 2019 (retrospectively registered).
Evaluating a digital tool for supporting breast cancer patients: a randomized controlled trial protocol (ADAPT)
Authors: Lidington Emma , McGrath Sophie E , Noble Jillian , Stanway Susannah , Lucas Amanda , Mohammed Kabir , van der Graaf Winette , Husson Olga 
Published: January 2020

Abstract
Background
There are a growing number of mHealth tools for breast cancer patients but a lack of scientific evidence for their effects. Recent studies have shown a mix of positive and negative impacts on users. Here we will assess the impact of OWise Breast Cancer, a mobile application for self-monitoring symptoms and managing care, on the process of self-management.

Methods
This randomized controlled trial with early stage breast cancer patients will assess the effect of OWise use on patient activation at 3 months from diagnosis measured by the PAM-13 questionnaire. We will also assess differences in changes in health-related quality of life, psychological distress, health status, and National Health Service (NHS) health resource utilization over the first year from diagnosis. Participants will be randomly allocated (1:1) to standard care or standard care plus OWise. Participants will complete questionnaires before starting anti-cancer treatment and at 3, 6, and 12 months from diagnosis. Clinical and patient-reported outcome data will be linked to health resource utilization data from Discover, an integrated care record of primary, secondary, and social care in North West London. We will measure contamination in the control group and adjust the sample size to mitigate the dilution of effect estimates. A per-protocol analysis will be conducted as a sensitivity analysis to assess robustness of the primary results.

Discussion
This study aims to generate evidence for the effectiveness of OWise at improving patient activation for women with early-stage breast cancer. The results will show the impact of using the tool at the patient level and the NHS health system level. The outcomes of the study will have implications for the application of OWise across the NHS for breast cancer patients and expansion into other tumor types. Assessing publicly available mHealth tools poses a challenge to trialists due to the risk of contamination. Here we apply various methods to measure, mitigate, and assess the effects of contamination.

Trial registration
The study was registered at clincaltrials.gov (NCT03866655) on 7 March 2019.
Moderators of the effectiveness of an intervention to increase colorectal cancer screening through mailed fecal immunochemical test kits: results from a pragmatic randomized trial
Authors: O’Connor Elizabeth A. , Vollmer William M. , Petrik Amanda F. , Green Beverly B. , Coronado Gloria D. 
Published: January 2020

Abstract
Background
Colorectal cancer (CRC) screening rates remain suboptimal, particularly in low-income and underserved populations. Mailed fecal immunochemical testing (FIT) may overcome common barriers to screening; however, the effect of mailed FIT kits may differ across important subpopulations. The goal of the current study was to examine sociodemographic and health-related factors that moderate the effect of an intervention of automated direct mail of FIT kits at health clinics serving low-income populations.

Methods
This study is a secondary analysis of the Strategies and Opportunities to Stop Colon Cancer in Priority Populations (STOP CRC) study, a cluster-randomized pragmatic trial to increase uptake of CRC screening in patients seen at federally qualified health centers. The intervention involved tools embedded in the electronic medical records to enable participating clinics to mail FIT kits and related materials to eligible participants. We examined the rate of FIT completion by potential moderating characteristics using electronic health record data supplemented by the American Community Survey and the Centers for Medicare & Medicaid Services Geographic Variation datasets, linked via geocoding to patients’ addresses. All patients aged 50–75 seen in participating health clinics who were eligible for CRC screening were included.

Results
Although not always statistically significant, we saw a consistent pattern of increased FIT return rates among intervention participants compared to control participants across all subgroups studied, with incidence rate ratios (IRRs) generally ranging from 1.25 to 1.50. FIT completion in the intervention group ranged from 15 and 20% across subpopulations, typically three to six percentage points higher than the control group participants. The only moderator with a statistically significant interaction was race: persons of Asian descent showed a twofold response to the intervention (adjusted incidence rate ratio [aIRR] = 2.06, 95% confidence interval 1.41 to 3.00).

Conclusions
Response to a mailed FIT intervention was generally consistent across a wide range of individual and neighborhood-level patient characteristics, including typically underserved patients and those in low-resource communities.

Trial registration
ClinicalTrials.gov, NCT01742065. Registered on 5 December 2012.
A pilot randomized controlled trial of 7 versus 14 days of antibiotic treatment for bloodstream infection on non-intensive care versus intensive care wards
Authors:   on behalf of the Canadian Critical Care Trials Group, Daneman Nick , Rishu Asgar H. , Pinto Ruxandra , Arabi Yaseen , Belley-Cote Emilie P. , Cirone Robert , Downing Mark , Cook Deborah J. , Hall Richard , McGuinness Shay , McIntyre Lauralyn , Muscedere John , Parke Rachael , Reynolds Steven , Rogers Benjamin A. , Shehabi Yahya , Shin Phillip , Whitlock Richard , Fowler Robert A. 
Published: January 2020

Abstract
Background
The optimal treatment duration for patients with bloodstream infection is understudied. The Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness (BALANCE) pilot randomized clinical trial (RCT) determined that it was feasible to enroll and randomize intensive care unit (ICU) patients with bloodstream infection to 7 versus 14 days of treatment, and served as the vanguard for the ongoing BALANCE main RCT. We performed this BALANCE-Ward pilot RCT to examine the feasibility and impact of potentially extending the BALANCE main RCT to include patients hospitalized on non-ICU wards.

Methods
We conducted an open pilot RCT among a subset of six sites participating in the ongoing BALANCE RCT, randomizing patients with positive non-Staphylococcus aureus blood cultures on non-ICU wards to 7 versus 14 days of antibiotic treatment. The co-primary feasibility outcomes were recruitment rate and adherence to treatment duration protocol. We compared feasibility outcomes, patient/pathogen characteristics, and overall outcomes among those enrolled in this BALANCE-Ward and prior BALANCE-ICU pilot RCTs. We estimated the sample size and non-inferiority margin impacts of expanding the BALANCE main RCT to include non-ICU patients.

Results
A total of 134 patients were recruited over 47 site-months (mean 2.9 patients/site-month, median 1.0, range 0.1–4.4 patients/site-month). The overall recruitment rate exceeded the BALANCE-ICU pilot RCT (mean 1.10 patients/site-month, p < 0.0001). Overall protocol adherence also exceeded the adherence in the BALANCE-ICU pilot RCT (125/134, 93% vs 89/115, 77%, p = 0.0003). BALANCE-Ward patients were older, with lower Sequential Organ Failure Assessment scores, and higher proportions of infections caused by Escherichia coli and genito-urinary sources of bloodstream infection. The BALANCE-Ward pilot RCT patients had an overall 90-day mortality rate of 17/133 (12.8%), which was comparable to the 90-day mortality rate in the ICU pilot RCT (17/115, 14.8%) (p = 0.65). Simulation models indicated there would be minimal sample size and non-inferiority margin implications of expanding enrolment to increasing proportions of non-ICU versus ICU patients.

Conclusion
It is feasible to enroll non-ICU patients in a trial of 7 versus 14 days of antibiotics for bloodstream infection, and expanding the BALANCE RCT hospital-wide has the potential to improve the timeliness and generalizability of trial results.

Trial registration
Clinicaltrials.gov, NCT02917551. Registered on September 28, 2016.
The mosquito electrocuting trap as an exposure-free method for measuring human-biting rates by Aedes mosquito vectors
Authors: Ortega-López Leonardo D. , Pondeville Emilie , Kohl Alain , León Renato , Betancourth Mauro Pazmiño , Almire Floriane , Torres-Valencia Sergio , Saldarriaga Segundo , Mirzai Nosrat , Ferguson Heather M. 
Published: January 2020

AbstractBackgroundEntomological monitoring ofAedesvectors has largely relied on surveillance of larvae, pupae and non-host-seeking adults, which have been poorly correlated with human disease incidence. Exposure to mosquito-borne diseases can be more directly estimated using human landing catches (HLC), although this method is not recommended forAedes-borne arboviruses. We evaluated a new method previously tested with malaria vectors, the mosquito electrocuting trap (MET) as an exposure-free alternative for measuring landing rates ofAedesmosquitoes on people. Aims were to (i) compare the MET to the BG-sentinel (BGS) trap gold standard approach for sampling host-seekingAedesvectors; and (ii) characterize the diel activity ofAedesvectors and their association with microclimatic conditions.MethodsThe study was conducted over 12 days in Quinindé (Ecuador) in May 2017. Mosquito sampling stations were set up in the peridomestic area of four houses. On each day of sampling, each house was allocated either a MET or a BGS trap, which were rotated amongst the four houses daily in a Latin square design. Mosquito abundance and microclimatic conditions were recorded hourly at each sampling station between 7:00–19:00 h to assess variation between vector abundance, trapping methods, and environmental conditions. AllAedes aegyptifemales were tested for the presence of Zika (ZIKV), dengue (DENV) and chikungunya (CHIKV) viruses.ResultsA higher number ofAe. aegyptifemales were found in MET than in BGS collections, although no statistically significant differences in meanAe. aegyptiabundance between trapping methods were found. Both trapping methods indicated femaleAe. aegyptihad bimodal patterns of host-seeking, being highest during early morning and late afternoon hours. MeanAe. aegyptidaily abundance was negatively associated with daily temperature. No infection by ZIKV, DENV or CHIKV was detected in anyAedesmosquitoes caught by either trapping method.ConclusionWe conclude the MET performs at least as well as the BGS standard and offers the additional advantage of direct measurement ofper capitahuman-biting rates. If detection of arboviruses can be confirmed in MET-collectedAedesin future studies, this surveillance method could provide a valuable tool for surveillance and prediction on human arboviral exposure risk.
Validation of prediction models of severe disease course and non-achievement of remission in juvenile idiopathic arthritis part 2: results of the Nordic model in the Canadian cohort
Authors:   for the ReACCh-Out and NoSPeR Investigators, Henrey Andrew , Rypdal Veronika , Rypdal Martin , Loughin Thomas , Nordal Ellen , Guzman Jaime 
Published: January 2020

Abstract
Background
Validated clinical prediction models to identify children with poor prognosis at the time of juvenile idiopathic arthritis (JIA) diagnosis would be very helpful for tailoring treatments, and avoiding under- or over-treatment. Our objective was to externally validate Nordic clinical prediction models in Canadian patients with JIA.

Methods
We used data from 513 subjects at the 3-year follow-up from the Research in Arthritis in Canadian Children emphasizing Outcomes (ReACCh-Out) cohort. The predicted outcomes were non-achievement of remission, severe disease course, and functional disability. The Nordic models were evaluated exactly as published and after fine-tuning the logistic regression coefficients using multiple data splits of the Canadian cohort. Missing data was handled with multiple imputation, and prediction ability was assessed with C-indices. C-index values > 0.7 were deemed to reflect helpful prediction.

Results
Overall, 81% of evaluable patients did not achieve remission off medications, 15% experienced a severe disease course, and 38% reported disability (CHAQ score > 0). The Nordic model for predicting non-achievement of remission had a C-index of 0.68 (95% CI 0.62–0.74), and 0.74 (0.67–0.80) after fine-tuning. For prediction of severe disease course, it had a C-index of 0.69 (0.61–0.78), and 0.79 (0.68–0.91) after fine-tuning. The fine-tuned Nordic model identified 85% of the cohort as low risk for a severe disease course (< 20% chance) and 7% as high risk (> 60% chance). The Nordic model to predict functional disability had a C-index of 0.57 (0.50–0.63), and 0.51 (0.39–0.63) after fine-tuning.

Conclusions
Fine-tuned Nordic models, combining active joint count, physician global assessment of disease activity, morning stiffness, and ankle involvement, predicted well non-achievement of remission and severe disease course in Canadian patients with JIA. The Nordic model for predicting disability could not predict functional disability in Canadian patients.
Psychometric properties of the Adelaide Diagnostic Learning Inventory-Brief (ADLIB)
Authors: Minas Harry 
Published: January 2020

Abstract
Objective
There has been increased attention in recent years to mental health, quality of life, stress and academic performance among university students, and the possible influence of learning styles. Brief reliable questionnaires are useful in large-scale multivariate research designs, such as the largely survey-based research on well-being and academic performance of university students. The objective of this study was to examine the psychometric properties of a briefer version of the 39-item Adelaide Diagnostic Learning Inventory.

Results
In two survey samples—medical and physiotherapy students—a 21-item version Adelaide Diagnostic Learning Inventory-Brief (ADLIB) was shown to have the same component structure as the parent instrument, and the component structure of the brief instrument was found to generalise across students of medicine and physiotherapy. Subscale reliability estimations were in the order of magnitude of the parent instrument. Subscale inter-correlations, inter-component congruence coefficients, and correlations between ADLIB subscale scores and several external measures provide support support for the construct and criterion validity of the instrument.
Tobacco and electronic cigarette cues for smoking and vaping: an online experimental study
Authors: Blackwell Anna K. M. , De-loyde Katie , Brocklebank Laura A. , Maynard Olivia M. , Marteau Theresa M. , Hollands Gareth J. , Fletcher Paul C. , Attwood Angela S. , Morris Richard W. , Munafò Marcus R. 
Published: January 2020

Abstract
Objective
This study examined whether exposure to smoking and vaping cues the urge to smoke or vape. It extends previous studies on first-generation cigalikes (visually similar to cigarettes) and second-generation devices (visually similar to pens) by including third-generation tank system devices (larger bulky units). In an online experiment, participants were randomly assigned to view one of four videos, which included smoking, vaping (cigalike or tank system), or neutral cues. The primary outcome was urge to smoke. Secondary outcomes were urge to vape, desire to smoke and vape, and intention to quit or remain abstinent from smoking.

Results
UK adults varying in smoking (current or former) and vaping (user or non-user) status (n = 1120) completed the study: 184 (16%) failed study attention checks meaning 936 were included in the final analysis. Urges to smoke were similar across cue groups. Urges to vape were higher following exposure to vaping compared to neutral cues. There was no clear evidence of an interaction between cue group and smoking or vaping status. The lack of cueing effects on smoking urges is inconsistent with previous research, raising questions about the ability to assess craving in online settings.
Behavioral effects of multiple-dose oxytocin treatment in autism: a randomized, placebo-controlled trial with long-term follow-up
Authors: Bernaerts Sylvie , Boets Bart , Bosmans Guy , Steyaert Jean , Alaerts Kaat 
Published: January 2020

Abstract
Background
Intranasal administration of the “prosocial” neuropeptide oxytocin is increasingly explored as a potential treatment for targeting the core characteristics of autism spectrum disorder (ASD). However, long-term follow-up studies, evaluating the possibility of long-lasting retention effects, are currently lacking.

Methods
Using a double-blind, randomized, placebo-controlled, parallel design, this pilot clinical trial explored the possibility of long-lasting behavioral effects of 4 weeks of intranasal oxytocin treatment (24 International Units once daily in the morning) in 40 adult men with ASD. To do so, self-report and informant-based questionnaires assessing core autism symptoms and characterizations of attachment were administered at baseline, immediately after 4 weeks of treatment (approximately 24 h after the last nasal spray administration), and at two follow-up sessions, 4 weeks and 1 year post-treatment.

Results
No treatment-specific effects were identified in the primary outcome assessing social symptoms (Social Responsiveness Scale, self- and informant-rated). In particular, with respect to self-reported social responsiveness, improvements were evident both in the oxytocin and in the placebo group, yielding no significant between-group difference (p = .37). Also informant-rated improvements in social responsiveness were not significantly larger in the oxytocin, compared to the placebo group (between-group difference: p = .19). Among the secondary outcome measures, treatment-specific improvements were identified in the Repetitive Behavior Scale and State Adult Attachment Measure, indicating reductions in self-reported repetitive behaviors (p = .04) and reduced feelings of avoidance toward others (p = .03) in the oxytocin group compared to the placebo group, up to 1 month and even 1 year post-treatment. Treatment-specific effects were also revealed in screenings of mood states (Profile of Mood States), indicating higher reports of “vigor” (feeling energetic, active, lively) in the oxytocin, compared to the placebo group (p = .03).

Conclusions
While no treatment-specific improvements were evident in terms of core social symptoms, the current observations of long-term beneficial effects on repetitive behaviors and feelings of avoidance are promising and suggestive of a therapeutic potential of oxytocin treatment for ASD. However, given the exploratory nature of this pilot study, future studies are warranted to evaluate the long-term effects of OT administration further.

Trial registration
The trial was registered with the European Clinical Trial Registry (Eudract 2014-000586-45) on January 22, 2014 (https://www.clinicaltrialsregister.eu/ctr-search/trial/2014-000586-45/BE).
A rare association between true thymic hyperplasia and thyroid follicular tumor: a case report
Authors: Kiwaki Takumi , Tanaka Hiroyuki , Akiyama Yutaka , Akaki Mayumi , Tomita Masaki , Kataoka Hiroaki 
Published: January 2020

Abstract
Background
True thymic hyperplasia is a rare condition characterized by enlargement of the thymus while its normal structure is retained. True thymic hyperplasia is known to accompany Graves’ disease, but no association between true thymic hyperplasia and thyroid follicular tumor has been reported so far. We report a case of true thymic hyperplasia in a patient with a thyroid follicular tumor.

Case presentation
A 52-year-old Japanese man was referred to our hospital for evaluation of a thyroid mass and a mediastinal mass. His serum thyroglobulin level was high, and hemithyroidectomy was performed to remove the thyroid mass. The resected mass was diagnosed as a follicular tumor of uncertain malignant potential. After resection of the thyroid lesion, the patient’s serum thyroglobulin levels were markedly decreased. Seven months later, the patient underwent resection of the mediastinal mass. On pathological examination, the mass was found to consist of lobules, which formed a corticomedullary structure with Hassall’s bodies, indicating a normal thymic mass with hyperplastic thymic tissue, less organized cellular cords, and intermingled adipose tissue. Immunostaining for cytokeratin 19 and cytokeratin 7 indicated that the lesion was consistent with thymic tissue. The lesion was diagnosed as true thymic hyperplasia, and the histological findings suggested that secondary atrophy had occurred. No evidence of recurrence was observed at 24 months after surgery.

Conclusions
We present a case of a combination of true thymic hyperplasia and thyroidal follicular tumors that, to our knowledge, has not been reported previously. High serum thyroglobulin levels might play a role in hyperplasia of the thymus. Although true thymic hyperplasia is a rare disorder, it should be included in the differential diagnosis of a mediastinal mass in patients with thyroid disease.