bluuebunny/crossref_metadata_2025_split huggingface dataset:
A qualitative study of diverse providers' behaviour in response to commissioners, patients and innovators in England: research protocol
Authors: Sheaff Rod , Halliday Joyce , Exworthy Mark , Allen Pauline , Mannion Russell , Asthana Sheena , Gibson Alex , Clark Jonathan 
Published: May 2016

IntroductionThe variety of organisations providing National Health Service (NHS)-funded services in England is growing. Besides NHS hospitals and general practitioners (GPs), they include corporations, social enterprises, voluntary organisations and others. The degree to which these organisational types vary, however, in the ways they manage and provide services and in the outcomes for service quality, patient experience and innovation, remains unclear. This research will help those who commission NHS services select among the different types of organisation for different tasks.Research questionsThe main research questions are how organisationally diverse NHS-funded service providers vary in their responsiveness to patient choice, NHS commissioning and policy changes; and their patterns of innovation. We aim to assess the implications for NHS commissioning and managerial practice which follow from these differences.Methods and analysisSystematic qualitative comparison across a purposive sample (c.12) of providers selected for maximum variety of organisational type, with qualitative studies of patient experience and choice (in the same sites). We focus is on NHS services heavily used by older people at high risk of hospital admission: community health services; out-of-hours primary care; and secondary care (planned orthopaedics or ophthalmology). The expected outputs will be evidence-based schemas showing how patterns of service development and delivery typically vary between different organisational types of provider.Ethics, benefits and disseminationWe will ensure informants' organisational and individual anonymity when dealing with high profile case studies and a competitive health economy. The frail elderly is a key demographic sector with significant policy and financial implications. For NHS commissioners, patients, doctors and other stakeholders, the main outcome will be better knowledge about the relative merits of different kinds of healthcare provider. Dissemination will make use of strategies suggested by patient and public involvement, as well as DH and service-specific outlets.
Can patients be ‘attached’ to healthcare providers? An observational study to measure attachment phenomena in patient–provider relationships
Authors: Maunder Robert G , Hunter Jonathan J 
Published: May 2016

ObjectivesTo develop and assess the validity of measures of patients' attachment-related perceptions of experiences with healthcare providers (HCPs).SettingOnline survey.Participants181 people provided consent and 119 completed the survey (66%). Most participants were women (80%).Primary and secondary outcome measuresQuestions were developed to assess possible attachment functions served by an HCP and patients' attachment-related attitudes towards an HCP. Scales were constructed based on exploratory factor analysis. Measures of adult attachment, therapeutic alliance, perceived HCP characteristics and health utilisation were used to validate scales.ResultsPossible safe haven and secure base functions served by HCPs were strongly endorsed. A model with good fit (root mean square error of approximation=0.056) yielded 3 factors: ‘HCP experienced as supportive and safe’ (SUPPORT, α=0.94), ‘HCP experienced as aversive’ (AVERSE, α=0.86) and ‘more and closer contact wanted with HCP’ (WANT, α=0.85). SUPPORT was correlated with positive HCP characteristics and not with attachment insecurity. AVERSE was inversely correlated with positive HCP attributes and correlated with attachment insecurity. WANT was unrelated to positive HCP attributes, but correlated with attachment insecurity. Frequency of HCP contact was related to WANT (Kruskal-Wallis=21.9, p<0.001) and SUPPORT (Kruskal-Wallis=13.2, p=0.02), but not to AVERSE (Kruskal-Wallis=1.7, p=0.89).ConclusionsPatients attribute attachment functions of secure base and safe haven to HCPs. SUPPORT is related to positive appraisal of HCP characteristics; AVERSE is associated with discomfort in the HCP relationship that is related with perceived HCP characteristics and patients' insecure attachment; WANT is associated with unmet needs for connection with an HCP related to insecure attachment, but not to perceived HCP characteristics. These scales may be useful in studying the application of attachment theory to the HCP–patient relationship.
Training primary care physicians to offer their patients faecal occult blood testing and colonoscopy for colorectal cancer screening on an equal basis: a pilot intervention with before–after and parallel group surveys
Authors: Selby Kevin , Cornuz Jacques , Gachoud David , Bulliard Jean-Luc , Nichita Cristina , Dorta Gian , Ducros Cyril , Auer Reto 
Published: May 2016

ObjectivesPrimary care physicians (PCPs) should prescribe faecal immunochemical testing (FIT) or colonoscopy for colorectal cancer screening based on their patient's values and preferences. However, there are wide variations between PCPs in the screening method prescribed. The objective was to assess the impact of an educational intervention on PCPs’ intent to offer FIT or colonoscopy on an equal basis.DesignSurvey before and after training seminars, with a parallel comparison through a mailed survey to PCPs not attending the training seminars.SettingAll PCPs in the canton of Vaud, Switzerland.ParticipantsOf 592 eligible PCPs, 133 (22%) attended a seminar and 106 (80%) filled both surveys. 109 (24%) PCPs who did not attend the seminars returned the mailed survey.InterventionA 2 h-long interactive seminar targeting PCP knowledge, skills and attitudes regarding offering a choice of colorectal cancer (CRC) screening options.Outcome measuresThe primary outcome was PCP intention of having their patients screened with FIT and colonoscopy in equal proportions (between 40% and 60% each). Secondary outcomes were the perceived role of PCPs in screening decisions (from paternalistic to informed decision-making) and correct answer to a clinical vignette.ResultsBefore the seminars, 8% of PCPs reported that they had equal proportions of their patients screened for CRC by FIT and colonoscopy; after the seminar, 33% foresaw having their patients screened in equal proportions (p<0.001). Among those not attending, there was no change (13% vs 14%, p=0.8). Of those attending, there was no change in their perceived role in screening decisions, while the proportion responding correctly to a clinical vignette increased (88–99%, p<0.001).ConclusionsAn interactive training seminar increased the proportion of physicians with the intention to prescribe FIT and colonoscopy in equal proportions.
Personalised long-term follow-up of cochlear implant patients using remote care, compared with those on the standard care pathway: study protocol for a feasibility randomised controlled trial
Authors: Cullington Helen , Kitterick Padraig , DeBold Lisa , Weal Mark , Clarke Nicholas , Newberry Eva , Aubert Lisa 
Published: May 2016

IntroductionMany resources are required to provide postoperative care to patients who receive a cochlear implant. The implant service commits to lifetime follow-up. The patient commits to regular adjustment and rehabilitation appointments in the first year and annual follow-up appointments thereafter. Offering remote follow-up may result in more stable hearing, reduced patient travel expense, time and disruption, more empowered patients, greater equality in service delivery and more freedom to optimise the allocation of clinic resources.Methods and analysisThis will be a two-arm feasibility randomised controlled trial (RCT) involving 60 adults using cochlear implants with at least 6 months device experience in a 6-month clinical trial of remote care. This project will design, implement and evaluate a person-centred long-term follow-up pathway for people using cochlear implants offering a triple approach of remote and self-monitoring, self-adjustment of device and a personalised online support tool for home speech recognition testing, information, self-rehabilitation, advice, equipment training and troubleshooting. The main outcome measure is patient activation. Secondary outcomes are stability and quality of hearing, stability of quality of life, clinic resources, patient and clinician experience, and any adverse events associated with remote care. We will examine the acceptability of remote care to service users and clinicians, the willingness of participants to be randomised, and attrition rates. We will estimate numbers required to plan a fully powered RCT.Ethics and disseminationEthical approval was received from North West—Greater Manchester South Research Ethics Committee (15/NW/0860) and the University of Southampton Research Governance Office (ERGO 15329).ResultsResults will be disseminated in the clinical and scientific communities and also to the patient population via peer-reviewed research publications both online and in print, conference and meeting presentations, posters, newsletter articles, website reports and social media.Trial registration numberISRCTN14644286; Pre-results.
Modified Balance Error Scoring System (M-BESS) test scores in athletes wearing protective equipment and cleats
Authors: Azad Aftab Mohammad , Al Juma Saad , Bhatti Junaid Ahmad , Delaney J Scott 
Published: May 2016

BackgroundBalance testing is an important part of the initial concussion assessment. There is no research on the differences in Modified Balance Error Scoring System (M-BESS) scores when tested in real world as compared to control conditions.ObjectiveTo assess the difference in M-BESS scores in athletes wearing their protective equipment and cleats on different surfaces as compared to control conditions.MethodsThis cross-sectional study examined university North American football and soccer athletes. Three observers independently rated athletes performing the M-BESS test in three different conditions: (1) wearing shorts and T-shirt in bare feet on firm surface (control); (2) wearing athletic equipment with cleats on FieldTurf; and (3) wearing athletic equipment with cleats on firm surface. Mean M-BESS scores were compared between conditions.Results60 participants were recruited: 39 from football (all males) and 21 from soccer (11 males and 10 females). Average age was 21.1 years (SD=1.8). Mean M-BESS scores were significantly lower (p<0.001) for cleats on FieldTurf (mean=26.3; SD=2.0) and for cleats on firm surface (mean=26.6; SD=2.1) as compared to the control condition (mean=28.4; SD=1.5). Females had lower scores than males for cleats on FieldTurf condition (24.9 (SD=1.9) vs 27.3 (SD=1.6), p=0.005). Players who had taping or bracing on their ankles/feet had lower scores when tested with cleats on firm surface condition (24.6 (SD=1.7) vs 26.9 (SD=2.0), p=0.002).ConclusionsTotal M-BESS scores for athletes wearing protective equipment and cleats standing on FieldTurf or a firm surface are around two points lower than M-BESS scores performed on the same athletes under control conditions.
Factors associated with influenza vaccine uptake during a universal vaccination programme of preschool children in England and Wales: a cohort study
Authors: Hardelid Pia , Rait Greta , Gilbert Ruth , Petersen Irene 
Published: May 2016

IntroductionInfluenza vaccination through primary care has been recommended for all preschool children in the UK since 2013 as part of a universal immunisation programme. Vaccination is required annually and effectiveness varies by season. Factors associated with influenza vaccine receipt and those for other childhood vaccines may therefore differ.MethodsWe used The Health Improvement Network, a large primary care database, to create a cohort of children in England and Wales aged 2–4 years eligible for vaccination in the 2014/2015 season. Mixed-effects Poisson regression models were used to determine sociodemographic and clinical factors associated with influenza vaccine receipt, allowing for practice-level variation.ResultsOverall, 38.7% (95% CI 38.3% to 39.1%) of 57 545 children were vaccinated against influenza. Children in the poorest deprivation quintile were 19% less likely to receive influenza vaccine than those in the wealthiest quintile (adjusted risk ratio (ARR) 0.81, 95% CI 0.77 to 0.86). Children who received a timely first dose of measles-mumps-rubella vaccine were twice as likely to receive influenza vaccine (ARR 2.00 95% CI 1.87 to 2.13). Being 4 years old, not in a clinical risk group, or living with 2 or more other children were also significantly associated with a lower probability of vaccination.DiscussionChildren living in areas of higher deprivation and in larger families are less likely to receive influenza vaccine. Further research is required into whether interventions, such as offering vaccinations in other settings, could increase uptake in children, particularly in deprived areas.
Effect of water temperature on the hydrolysis of two absorbable sutures used in fish surgery
Authors: Cannizzo Sarah A. , Roe Simon C. , Harms Craig A. , Stoskopf Michael K. 
Published: May 2016

Persistence of absorbable sutures in fishes in waters below 10 °C affects surgical decisions including approach, closure strategy, and suture selection. We hypothesized that the rate of suture hydrolysis would vary directly with water temperature. Two absorbable monofilament 3-0 suture materials used in fish surgery, poliglecaprone (Monocryl™) and polyglyconate (Maxon™), were evaluated. The maximum tensile load (strength) was measured for suture loops ( n = 6) maintained in filtered city water for 2, 4, 6, or 8 weeks at 4, 25, or 37 °C. For Maxon™ at 4 or 25 °C, tensile strength did not decrease over time. However, for Monocryl™ at 4 °C, 2-, 4-, and 8-week loops were stronger than baseline loops. At 25 °C, tensile strength of the suture material declined after 2 weeks. Also, at 37 °C, the optimal design temperature for both suture materials, the strength of Maxon™ decreased at 6 and 8 weeks. Two 4-week loops of Monocryl™ disintegrated when handled, and after 6 and 8 weeks, all were untestable. This study confirms that absorbable sutures lose strength more slowly at ambient temperatures lower than the optimal design temperature (e.g., human body temperature) and will likely be retained longer in fishes living in waters below 25 °C.
Monte Carlo Comparison of Rival Experimental Designs For Two‐Agent Combined Action Studies
Authors: Greco William R , Sutor David C , Parsons John C , Khinkis Leonid A , Hsieh Lily , Rao Sowmya R , Tung Ying , Currie Christopher C , Susice Robin 
Published: May 2016

OBJECTIVE: The combined action of two or more chemotherapeutic agents and/or biological agents can be quantitatively described wilh empirical multidimensional concenlration‐effect response surface models. This intuitive statistical approach provides a framework for suggesting experimental designs for in vitro. in vivo and possibly clinical experiments of agent combinations. Five rival 32‐point experimental designs for in vitro continuous response two‐agent combined action studies were compared using Monte Carlo simulation.DESIGN: The designs were: factorial; central composite: one‐ray in duplicate; four‐ray; and D‐optimal.SETTING: Datasets were simulated by generating ideal data with the authors’ flagship two‐agent combined action model. which includes six parameters: the control sunrival Econ=100 (where Econ is the full range of response that can be affected by the drug); median effective concentrations. IC50.1=10. IC50.2= 1 for drug 1 and drug 2, Respectively; slope parameters. m1 =‐ 1. m2=‐2 for drug 1 and drug 2. respectively; and the interaction parameter, α=1 or α=5. For each design, for each of four types of error (absolute. relative with 1% coefficient of variation [cv]. relative with 10% cv. and relative with 10% cv plus a noise constant of 1% of Econ) . for each of two values of the true α (1, 5). 500 Monte Carlo datasets were generated. and then flt via weighted nonlinear regression wilh lhe flagship model.MAIN Results: For the α parameter. for relative error‐containing datasets. the D‐optimal designs had the smallest variances.CONCLUSION: The counterintuitive D‐optimal designs may be useful for studies in which the experimental units are relatively precious. and frugal designs are essential. In addition. it may be fruitful to add the D‐optimal design points lo standard experimental designs.
Diagnosis and Treatment of Gastroesophageal Reflux Disease in Infants and Children
Authors: Vandenplas Yvan 
Published: May 2016

Gastroesophageal reflux is a frequent,
nonspecific phenomenon in infants and children. The
recommended approach for infants with uncomplicated regurgitation
is the reassurance of the parents about the physiological nature
of excessive regurgitation, and if necessary, completed with
dietary recommendations for formula‐fed infants. If, despite these
efforts, the symptoms persist, the administration of prokinetics
such as cisapride is recommended before investigations such as
esophageal pH monitoring are begun. Cisapride is the drug of
choice because it has the best efficacy and safety profile. In infants
and children presenting with symptoms that suggest esophagitis,
endoscopy of the upper gastrointestinal tract is recommended. If
there is severe esophagitis, acid suppression with H2 receptor antagonists
or proton pomp inhibitors is recommended, eventually
in combination with prokinetics. In life‐threatening situations, or
in patients who are resistant to or dependent on acid suppressive
medication, a surgical procedure such as laparoscopic Nissen
should be considered.
Esophageal pH monitoring is recommended to document gastroesophageal
reflux disease in children presenting with unusual presentations
such as chronic respiratory disease. Treatment consists
of prokinetics and/or acid suppressive drugs, and surgery should be
considered in many of these patients.
Thrombocytopenia in Liver Disease
Authors: Peck-Radosavljevic Markus 
Published: May 2016

Moderate thrombocytopenia
is a frequent finding in cirrhosis of the liver and well
tolerated in most instances. The pathophysiology of thrombocytopenia
in liver disease has long been associated with the concept
of hypersplenism, where portal hypertension was thought to cause
pooling and sequestration of all corpuscular elements of the blood,
predominantly thrombocytes in the enlarged spleen. The concept of
hypersplenism was never proven beyond any doubt but was widely
accepted for the lack of alternative explanations.With the discovery of the lineage‐specific cytokine thrombopoietin
(TPO) the missing link between hepatocellular function
and thrombopoiesis was found. TPO is predominantly produced
by the liver and constitutively expressed by hepatocytes.TPOproduction
in humans is dependent on functional liver cell mass and
is reduced when liver cell mass is severely damaged. This leads to
reduced thrombopoiesis in the bone marrow and consequently to
thrombocytopenia in the peripheral blood of patients with
advanced‐stage liver disease.With recombinant TPOs in development, patients with liver disease
and TPO seem to be the ideal target population for this drug.
Once the efficacy of thrombopoietin in patients with liver disease
is proven, a potent yet safe drug may be available to treat cirrhotic
patients undergoing invasive or surgical procedures, during bleeding
episodes or when undergoing therapy with myelosuppressive
drugs such as interferon‐alpha.
Exercise-Induced Dose-Response Alterations in Adiponectin and Leptin Levels Are Dependent on Body Fat Changes in Women at Risk for Breast Cancer
Authors: Sturgeon Kathleen , Digiovanni Laura , Good Jerene , Salvatore Domenick , Fenderson Desiré , Domchek Susan , Stopfer Jill , Galantino Mary Lou , Bryan Cathy , Hwang Wei-Ting , Schmitz Kathryn 
Published: May 2016

Abstract
Background: Dysregulation of adipokines, such as adiponectin and leptin, is associated with a variety of chronic diseases, including cancer. Physical activity protects against breast cancer and one of the mechanisms which may underlie this association is exercise-induced changes in adipokine levels. The WISER Sister Trial was a three-armed randomized controlled trial in premenopausal women (n = 137) with an elevated risk for breast cancer.
Methods: A 5-menstrual-cycle-long dosed aerobic exercise intervention compared low-dose exercise (150 min/wk; n = 44) or high-dose exercise (300 min/wk; n = 48) with a control group asked to maintain usual activity levels (n = 45). Exercise intensity progressed to and was maintained at 70% to 80% of age predicted heart rate max. Body composition and adipokine levels were measured at baseline and follow-up.
Results: We observed significant linear trends for increased fitness capacity (Δ%: −2.0% control, 10.1% low dose, 13.1% high dose), decreased fat tissue-to-total tissue mass (Δ%: 0.7% control, −2.9% low dose, −3.7% high dose), increased body fat adjusted adiponectin (Δ%: −0.6% control, 0.6% low dose, 0.9% high dose), and decreased body fat adjusted leptin (Δ%: 0.7% control, −8.2% low dose, −10.2% high dose).
Conclusions: In this randomized clinical trial of premenopausal women at risk for breast cancer, we demonstrate a dose–response effect of exercise on adiponectin and leptin and that dose response is dependent on changes in body fat.
Impact: Improved adipokine levels, achieved by aerobic exercise training-induced decreases in body fat, may decrease breast cancer risk for high-risk premenopausal women. Cancer Epidemiol Biomarkers Prev; 25(8); 1195–200. ©2016 AACR.
Phase I Study of the Investigational Anti-Guanylyl Cyclase Antibody–Drug Conjugate TAK-264 (MLN0264) in Adult Patients with Advanced Gastrointestinal Malignancies
Authors: Almhanna Khaldoun , Kalebic Thea , Cruz Cristina , Faris Jason E. , Ryan David P. , Jung JungAh , Wyant Tim , Fasanmade Adedigbo A. , Messersmith Wells , Rodon Jordi 
Published: May 2016

Abstract
Purpose: To assess the safety, tolerability, and preliminary antitumor activity of the investigational anti–guanylyl cyclase C (GCC) antibody–drug conjugate TAK-264 (formerly MLN0264) in adult patients with advanced gastrointestinal malignancies.
Experimental Design: Adult patients with GCC-expressing gastrointestinal malignancies (H-score ≥ 10) were eligible for inclusion. TAK-264 was administered as a 30-minute intravenous infusion once every 3 weeks for up to 17 cycles. Dose escalation proceeded using a Bayesian continual reassessment method. At the maximum tolerated dose (MTD), 25 patients with metastatic colorectal cancer were enrolled in a prespecified dose expansion cohort.
Results: Forty-one patients were enrolled, including 35 (85%) with metastatic colorectal cancer. During dose escalation (0.3–2.4 mg/kg), four of 19 patients experienced dose-limiting toxicities of grade 4 neutropenia; the MTD was determined as 1.8 mg/kg. Patients received a median of two cycles of TAK-264 (range, 1–12); nine received ≥four cycles. Common drug-related adverse events (AEs) included nausea and decreased appetite (each 41%), fatigue (32%), diarrhea, anemia, alopecia, and neutropenia (each 27%); grade ≥3 AEs included neutropenia (22%), hypokalemia, and febrile neutropenia (each 7%). Peripheral neuropathy was reported in four (10%) patients. Pharmacokinetic data showed approximately dose proportional systemic exposure and a mean plasma half-life of around 4 days, supporting the dosing schedule. Overall, 39 patients were response-evaluable; three experienced durable stable disease; and one with gastric adenocarcinoma had a partial response. GCC expression did not appear to correlate with treatment duration.
Conclusions: These findings suggest that TAK-264 has a manageable safety profile, with preliminary evidence of potential antitumor activity in specific gastrointestinal malignancies. Further investigation is underway. Clin Cancer Res; 22(20); 5049–57. ©2016 AACR.