bluuebunny/crossref_metadata_2025_split huggingface dataset:
Interventions to increase immunisation coverage among children 12–23 months of age in India through participatory learning and community engagement: pilot study for a cluster randomised trial
Authors: Johri Mira , Chandra Dinesh , Koné Georges K , Dudeja Sakshi , Sylvestre Marie-Pierre , Sharma Jitendar K , Pahwa Smriti 
Published: September 2015

ObjectiveWith the aim of conducting a future cluster randomised trial to assess intervention impact on child vaccination coverage, we designed a pilot study to assess feasibility and aid in refining methods for the larger study.Trial designCluster-randomised design with a 1:1 allocation ratio.MethodsClusters were 12 villages in rural Uttar Pradesh. All women residing in a selected village who were mothers of a child 0–23 months of age were eligible; participants were chosen at random. Over 4 months, intervention group (IG) villages received: (1) home visits by volunteers; (2) community mobilisation events to promote immunisation. Control group (CG) villages received community mobilisation to promote nutrition. A toll-free number for immunisation was offered to all IG and CG village residents. Primary outcomes were ex-ante criteria for feasibility of the main study related to processes for recruitment and randomisation (50% of villages would agree to participate and accept randomisation; 30 women could be recruited in 70% of villages), and retention of participants (50% of women retained from baseline to endline). Clusters were assigned to IG or CG using a computer-generated randomisation schedule. Neither participants nor those delivering interventions were blinded, but those assessing outcomes were blinded to group assignment.ResultsAll villages contacted agreed to participate and accepted randomisation. 36 women were recruited per village; 432 participants were randomised (IG n=216; CG n=216). No clusters were lost to follow-up. The main analysis included 86% (373/432) of participants, 90% (195/216) from the IG and 82% (178/216) from the CG.ConclusionsCriteria related to feasibility were satisfied, giving us confidence that we can successfully conduct a larger cluster randomised trial. Methodological lessons will inform design of the main study.Trial registration numberISRCTN16703097
How parents and practitioners experience research without prior consent (deferred consent) for emergency research involving children with life threatening conditions: a mixed method study
Authors: Woolfall Kerry , Frith Lucy , Gamble Carrol , Gilbert Ruth , Mok Quen , Young Bridget ,   the CONNECT advisory group
Published: September 2015

ObjectiveAlternatives to prospective informed consent to enable children with life-threatening conditions to be entered into trials of emergency treatments are needed. Across Europe, a process called deferred consent has been developed as an alternative. Little is known about the views and experiences of those with first-hand experience of this controversial consent process. To inform how consent is sought for future paediatric critical care trials, we explored the views and experiences of parents and practitioners involved in the CATheter infections in CHildren (CATCH) trial, which allowed for deferred consent in certain circumstances.DesignMixed method survey, interview and focus group study.Participants275 parents completed a questionnaire; 20 families participated in an interview (18 mothers, 5 fathers). 17 CATCH practitioners participated in one of four focus groups (10 nurses, 3 doctors and 4 clinical trial unit staff).Setting12 UK children's hospitals.ResultsSome parents were momentarily shocked or angered to discover that their child had or could have been entered into CATCH without their prior consent. Although these feelings resolved after the reasons why consent needed to be deferred were explained and that the CATCH interventions were already used in clinical care. Prior to seeking deferred consent for the first few times, CATCH practitioners were apprehensive, although their feelings abated with experience of talking to parents about CATCH. Parents reported that their decisions about their child's participation in the trial had been voluntary. However, mistiming the deferred consent discussion had caused distress for some. Practitioners and parents supported the use of deferred consent in CATCH and in future trials of interventions already used in clinical care.ConclusionsOur study provides evidence to support the use of deferred consent in paediatric emergency medicine; it also indicates the crucial importance of practitioner communication and appropriate timing of deferred consent discussions.
Trends and interaction of polypharmacy and potentially inappropriate prescribing in primary care over 15 years in Ireland: a repeated cross-sectional study
Authors: Moriarty Frank , Hardy Colin , Bennett Kathleen , Smith Susan M , Fahey Tom 
Published: September 2015

ObjectivesTo examine: (1) changes in polypharmacy in 1997, 2002, 2007 and 2012 and; (2) changes in potentially inappropriate prescribing (PIP) prevalence and the relationship between PIP and polypharmacy in individuals aged ≥65 years over this period in Ireland.MethodsThis repeated cross-sectional study using pharmacy claims data included all individuals eligible for the General Medical Services scheme in the former Eastern Health Board region of Ireland in 1997, 2002, 2007 and 2012 (range 338 025–539 752 individuals). Outcomes evaluated were prevalence of polypharmacy (being prescribed ≥5 regular medicines) and excessive polypharmacy (≥10 regular medicines) in all individuals and PIP prevalence in those aged ≥65 years determined by 30 criteria from the Screening Tool for Older Persons’ Prescriptions.ResultsThe prevalence of polypharmacy increased from 1997 to 2012, particularly among older individuals (from 17.8% to 60.4% in those aged ≥65 years). The adjusted incident rate ratio for polypharmacy in 2012 compared to 1997 was 4.16 (95% CI 3.23 to 5.36), and for excessive polypharmacy it was 10.53 (8.58 to 12.91). Prevalence of PIP rose from 32.6% in 1997 to 37.3% in 2012. High-dose aspirin and digoxin prescribing decreased over time, but long-term proton pump inhibitors at maximal dose increased substantially (from 0.8% to 23.8%). The odds of having any PIP in 2012 were lower compared to 1997 after controlling for gender and level of polypharmacy, OR 0.39 (95% CI 0.39 to 0.4).ConclusionsAccounting for the marked increase in polypharmacy, prescribing quality appears to have improved with a reduction in the odds of having PIP from 1997 to 2012. With growing numbers of people taking multiple regular medicines, strategies to address the related challenges of polypharmacy and PIP are needed.
Establishing nurse-led active surveillance for men with localised prostate cancer: development and formative evaluation of a model of care in the ProtecT trial
Authors: Wade Julia , Holding Peter N , Bonnington Susan , Rooshenas Leila , Lane J Athene , Salter C Elizabeth , Tilling Kate , Speakman Mark J , Brewster Simon F , Evans Simon , Neal David E , Hamdy Freddie C , Donovan Jenny L 
Published: September 2015

ObjectivesTo develop a nurse-led, urologist-supported model of care for men managed by active surveillance or active monitoring (AS/AM) for localised prostate cancer and provide a formative evaluation of its acceptability to patients, clinicians and nurses. Nurse-led care, comprising an explicit nurse-led protocol with support from urologists, was developed as part of the AM arm of the Prostate testing for cancer and Treatment (ProtecT) trial.DesignInterviews and questionnaire surveys of clinicians, nurses and patients assessed acceptability.SettingNurse-led clinics were established in 9 centres in the ProtecT trial and compared with 3 non-ProtecT urology centres elsewhere in UK.ParticipantsWithin ProtecT, 22 men receiving AM nurse-led care were interviewed about experiences of care; 11 urologists and 23 research nurses delivering ProtecT trial care completed a questionnaire about its acceptability; 20 men managed in urology clinics elsewhere in the UK were interviewed about models of AS/AM care; 12 urologists and three specialist nurses working in these clinics were also interviewed about management of AS/AM.ResultsNurse-led care was commended by ProtecT trial participants, who valued the flexibility, accessibility and continuity of the service and felt confident about the quality of care. ProtecT consultant urologists and nurses also rated it highly, identifying continuity of care and resource savings as key attributes. Clinicians and patients outside the ProtecT trial believed that nurse-led care could relieve pressure on urology clinics without compromising patient care.ConclusionsThe ProtecT AM nurse-led model of care was acceptable to men with localised prostate cancer and clinical specialists in urology. The protocol is available for implementation; we aim to evaluate its impact on routine clinical practice.Trial registration numbersNCT02044172;ISRCTN20141297.
Improving access to high-quality primary care for socioeconomically disadvantaged older people in rural areas: a mixed method study protocol
Authors: Ford John A , Jones Andrew P , Wong Geoff , Clark Allan B , Porter Tom , Shakespeare Tom , Swart Ann Marie , Steel Nicholas 
Published: September 2015

IntroductionThe UK has an ageing population, especially in rural areas, where deprivation is high among older people. Previous research has identified this group as at high risk of poor access to healthcare. The aim of this study is to generate a theory of how socioeconomically disadvantaged older people from rural areas access primary care, to develop an intervention based on this theory and test it in a feasibility trial.Methods and analysisOn the basis of the MRC Framework for Developing and Evaluating Complex Interventions, three methods will be used to generate the theory. First, a realist review will elucidate the patient pathway based on existing literature. Second, an analysis of the English Longitudinal Study of Ageing will be completed using structural equation modelling. Third, 15 semistructured interviews will be undertaken with patients and four focus groups with health professionals. A triangulation protocol will be used to allow each of these methods to inform and be informed by each other, and to integrate data into one overall realist theory. Based on this theory, an intervention will be developed in discussion with stakeholders to ensure that the intervention is feasible and practical. The intervention will be tested within a feasibility trial, the design of which will depend on the intervention. Lessons from the feasibility trial will be used to refine the intervention and gather the information needed for a definitive trial.Ethics and disseminationEthics approval from the regional ethics committee has been granted for the focus groups with health professionals and interviews with patients. Ethics approval will be sought for the feasibility trial after the intervention has been designed. Findings will be disseminated to the key stakeholders involved in intervention development, to researchers, clinicians and health planners through peer-reviewed journal articles and conference publications, and locally through a dissemination event.
UK Fixation of Distal Tibia Fractures (UK FixDT): protocol for a randomised controlled trial of ‘locking’ plate fixation versus intramedullary nail fixation in the treatment of adult patients with a displaced fracture of the distal tibia
Authors: Achten Juul , Parsons Nicholas R , McGuinness Katie R , Petrou Stavros , Lamb Sarah E , Costa Matthew L 
Published: September 2015

IntroductionThe treatment of displaced, extra-articular fractures of the distal tibia remains controversial. These injuries are difficult to manage due to limited soft tissue cover, poor vascularity of the area and proximity to the ankle joint. Surgical treatment options are expanding and include locked intramedullary nails, plate and screw fixation and external fixator systems. The nail and plate options are most commonly used in the UK, but controversy exists over which treatment is most clinically and cost-effective. In this multicentre randomised controlled trial we aim to assess ratings of disability 6 months postinjury in patients who have sustained a distal tibia fracture treated with either an intramedullary nail or plate and locking screw fixation.Methods and analysisAdult patients presenting at trial centres with an acute fracture of the distal tibia will be considered for inclusion. A total of 320 patients will provide 90% power to detect a difference of 8 points in Disability Rating Index (DRI) score at 6 months at the 5% level. The randomisation sequence is stratified by trial centre and age, and administered via web-based service with 1:1 treatment allocation. Baseline demographic and pre-injury functional data and radiographs will be collected using the DRI, Olerud and Molander, and EuroQol EQ-5D questionnaire. Clinical assessment, early complications and radiographs will be recorded at 6–8 weeks. Functional outcome, health-related quality of life and resource use will be collected at 3, 6 and 12 months postoperatively. The main analysis will investigate differences in DRI 6 months postsurgery, between the two treatment groups, on an intention-to-treat basis. Tests will be two-sided and considered to provide evidence for a significant difference if p values are <0.05.Ethics and disseminationNRES Committee West-Midlands, 6/11/2012 (ref:12/WM/0340). The results of the trial will be disseminated via peer-reviewed publications and presentations at relevant conferences.Trial registration numberISRCTN99771224.
Distinct Profiles for Mitochondrial t-RNAs and Small Nucleolar RNAs in Locally Invasive and Metastatic Colorectal Cancer
Authors: Xu Lai , Ziegelbauer Joseph , Wang Rong , Wu Wells W. , Shen Rong-Fong , Juhl Hartmut , Zhang Yaqin , Rosenberg Amy 
Published: September 2015

Abstract
Purpose: To gain insight into factors involved in tumor progression and metastasis, we examined the role of noncoding RNAs in the biologic characteristics of colorectal carcinoma, in paired samples of tumor together with normal mucosa from the same colorectal carcinoma patient. The tumor and healthy tissue samples were collected and stored under stringent conditions, thereby minimizing warm ischemic time.
Experimental Design: We focused particularly on distinctions among high-stage tumors and tumors with known metastases, performing RNA-Seq analysis that quantifies transcript abundance and identifies novel transcripts.
Results: In comparing 35 colorectal carcinomas, including 9 metastatic tumors (metastases to lymph nodes and lymphatic vessels), with their matched healthy control mucosa, we found a distinct signature of mitochondrial transfer RNAs (MT-tRNA) and small nucleolar RNAs (snoRNA) for metastatic and high-stage colorectal carcinoma. We also found the following: (i) MT-TF (phenylalanine) and snord12B expression correlated with a substantial number of miRNAs and mRNAs in 14 colorectal carcinomas examined; (ii) an miRNA signature of oxidative stress, hypoxia, and a shift to glycolytic metabolism in 14 colorectal carcinomas, regardless of grade and stage; and (iii) heterogeneous MT-tRNA/snoRNA fingerprints for 35 pairs.
Conclusions: These findings could potentially assist in more accurate and predictive staging of colorectal carcinoma, including identification of those colorectal carcinomas likely to metastasize. Clin Cancer Res; 22(3); 773–84. ©2015 AACR.
Severe Hypoglycemia and the Role of the Significant Other
Authors: King Jennie , Overland Jane , Fisher Murray , White Kate 
Published: September 2015

Purpose The purpose of the study was to gain a better understanding of what severe hypoglycemia means to significant others. Methods Narrative inquiry methodology was utilized. In-depth interviews were conducted with 7 significant others of adults with type 1 diabetes about their experience with severe hypoglycemia. Interviews were recorded, transcribed verbatim, and then developed into narrated core stories through a process of selecting and organizing events and by describing the relationship among these events. This was followed by thematic analysis to reveal the shared narrative of significant others. Results Episodes of severe hypoglycemia were found to turn the participants’ lives upside down. The inability of the individual with diabetes to manage severe hypoglycemia required the significant other to detect and treat these episodes. The theme “managing disruption” captured how the significant others’ role shifted from one of background support to an active, primary role in severe hypoglycemia management. They became (1) the expert by arming themselves with knowledge and skills to assist with the severe hypoglycemia episodes, (2) the sentry by becoming more vigilant and prepared for these episodes, and (3) the protector of the person with diabetes by shielding him or her from the vulnerable position that the severe hypoglycemia episodes placed one in. Conclusions This study highlights the important role that significant others play in the management of severe hypoglycemia. It also emphasizes the need for health care professionals to provide appropriate education and support.
Psychiatric disorders and adherence to antiretroviral therapy among a population of HIV-infected adults in Nigeria
Authors: Adejumo Olurotimi , Oladeji Bibilola , Akpa Onoja , Malee Kay , Baiyewu Olusegun , Ogunniyi Adesola , Evans Scott , Berzins Baiba , Taiwo Babafemi 
Published: September 2015

Summary Psychiatric disorders are common among people living with HIV in Nigeria. Adherence is necessary to optimise the outcome of antiretroviral therapy. In this study, we aimed to identify associations between antiretroviral adherence, measured by one-week and one-month self-reported missed doses, and psychiatric illness in a cohort previously assessed for psychiatric disorders using the Composite International Diagnostic Interview. The study participants comprised 151 adults with major depression, anxiety or suicidal symptoms, and 302 matched-control participants. Two controls were randomly selected for each case within the same gender and education level. We compared participants with psychiatric disorders (WPDs) and no psychiatric disorders (NPDs) on selected demographic and clinical variables, in addition to adherence. Participants with one or more missed doses in the preceding month had twice the odds of having a major depressive episode as those with no missed doses during this period (OR 2.22, 95% CI 1.03, 4.79). This association remained significant after adjusting for selected risk factors. There was no statistically significant difference between WPD and NPD groups on either one-week or one-month adherence, or on age, marital status, occupational class, HIV viral load at enrolment or current CD4 cell count. Among Nigerian adults with HIV, suboptimal antiretroviral adherence is associated with, and could be a sign of, depression. Routine self-report adherence assessments may potentially be utilised in identifying individuals at risk among this population.
Circulating CD4+CD28null and extra-thymic CD4+CD8+ double positive T cells are independently associated with disease damage in systemic lupus erythematosus patients
Authors: Ugarte-Gil M F , Sánchez-Zúñiga C , Gamboa-Cárdenas R V , Aliaga-Zamudio M , Zevallos F , Tineo-Pozo G , Cucho-Venegas J M , Mosqueira-Riveros A , Medina M , Perich-Campos R A , Alfaro-Lozano J L , Rodriguez-Bellido Z , Alarcón G S , Pastor-Asurza C A 
Published: September 2015

Objective To determine whether circulating CD4+CD28null and extra-thymic CD4+CD8+ double positive (DP) T cells are independently associated with damage accrual in systemic lupus erythematosus (SLE) patients. Methods This cross-sectional study was conducted between September 2013 and April 2014 in consecutive SLE patients from our Rheumatology Department. CD4+CD28null and CD4+CD8+ DP T-cell frequencies were analyzed by flow-cytometry. The association of damage (SLICC/ACR Damage Index, SDI) and CD4+CD28null and CD4+CD8+ DP T cells was examined by univariable and multivariable Poisson regression models, adjusting for possible confounders. All analyses were performed using SPSS 21.0. Results Patients’ ( n = 133) mean (SD) age at diagnosis was 35.5 (16.8) years, 124 (93.2%) were female; all were mestizo (mixed Caucasian and Amerindian ancestry). Disease duration was 7.4 (6.8) years. The SLE Disease Activity Index was 5.5 (4.2), and the SDI 0.9 (1.2). The percentages of CD4+CD28null and CD4+CD8+ DP T cells were 17.1 (14.4) and 0.4 (1.4), respectively. The percentage of CD4+CD28null and CD4+CD8+ DP T cells were positively associated with a higher SDI in both univariable (rate ratio (RR) 1.02, 95% confidence interval (CI): 1.01–1.03 and 1.17, 95% CI: 1.07–1.27, respectively; p < 0.001 for both) and multivariable analyses RR 1.02, 95% CI: 1.01–1.03, p = 0.001 for CD4+CD28null T cells and 1.28, 95% CI: 1.13–1.44, p < 0.001 for CD4+CD8+ DP T cells). Only the renal domain remained associated with CD4+CD28null in multivariable analyses (RR 1.023 (1.002–1.045); p = 0.034). Conclusions In SLE patients, CD4+CD28null and CD4+CD8+ DP T cells are independently associated with disease damage. Longitudinal studies are warranted to determine the predictive value of these associations.
Comparison of two different formulas for body surface area in adults at extremes of height and weight
Authors: Fancher Karen M , Sacco Alicia J , Gwin Robert C , Gormley Luke K , Mitchell Caitlin B 
Published: September 2015

Background Different equations for predicting body surface area have been derived. The DuBois and Mosteller body surface area equations are considered equivalent, but the accuracy in adult patients at extremes of height and weight is unknown. Purpose To compare body surface area in patients at extremes of height and weight using both formulas to determine whether a difference affected chemotherapy dose. Methods Anthropometric data were extracted from the 2012 Centers for Disease Control and Prevention Vital and Health Statistics. Data for both males and females were examined. The 50th percentiles of weight and height were used to calculate the body surface area with both formulas. Calculations were repeated using the 5th through 95th percentiles for weight, then the 5th through 95th percentiles for height, and so forth until all extremes of height and weight were examined. Each body surface area was used to calculate a chemotherapy dose. A difference of ≥4.5% in dose was considered clinically significant. Results Differences were apparent in both males and females. Dosing differences were most apparent in patients in the 50th, 75th or 95th percentile for both height and weight. Differences are also noted in other percentiles, suggesting that patients of smaller stature may also be affected. Conclusion Guidelines recommend full doses of chemotherapy for patients with curative intent but do not specify which body surface area formula is preferred. Our results imply that the Mosteller equation provides a greater chemotherapy dose, and this difference may be clinically significant in patients who are in the 50th to 95th percentiles for height, weight or both. Further study is necessary to validate these results and determine the impact on patient outcomes.