bluuebunny/crossref_metadata_2025_split huggingface dataset:
Electroacupuncture for treating insomnia in patients with cancer: a study protocol for a randomised pilot clinical trial
Authors: Kim Mikyung , Kim Jung-Eun , Lee Hye-Yoon , Kim Ae-Ran , Park Hyo-Ju , Kwon O-Jin , Kim Bo-Kyung , Cho Jung Hyo , Kim Joo-Hee 
Published: August 2017

IntroductionAlthough insomnia is one of the most prevalent and disturbing symptoms among patients with cancer, it has not been properly managed. Electroacupuncture (EA) has received attention as a promising intervention for insomnia, and a few previous studies have reported that this intervention may be beneficial for treating insomnia in patients with cancer. The aim of this pilot study is to explore the feasibility and preliminary effectiveness of EA on the sleep disturbance of patients with cancer with insomnia using a subjective method, patient-reported questionnaires and an objective tool, actigraphy, to measure the quality of sleep.Methods and analysisThis is a study protocol for a randomised, three-arm, multicentre, pilot clinical trial. A total of 45 patients with cancer who have continuous insomnia related to cancer treatment or cancer itself will be randomly allocated to an EA group, sham EA group or usual care group in equal proportions. The EA group will receive 10 sessions of EA treatment over 4 weeks. The sham EA group will receive sham EA at non-acupoints using non-penetrating Streitberger acupuncture needles with mock EA. The usual care group will not receive EA treatment. All participants will be provided a brochure on the management of sleep disorders regardless of their group assignment. The primary outcome measure is the mean change in the insomnia severity index from the baseline to week 5. Information related to sleep quality will also be obtained through the Pittsburgh Sleep Quality Index, a sleep diary and actigraphy. Participants will complete the trial by visiting the research centre at week 9 for follow-up assessment.Ethics and disseminationThis study protocol was approved by the institutional review boards of each research centre. Written informed consent will be obtained from all participants. The result of this study will be published in peer-reviewed journals or presented at academic conferences.Trial registration numberKCT0002162; Pre-results.
‘It's trying to manage the work’: a qualitative evaluation of recruitment processes within a UK multicentre trial
Authors: Skea Zoë Christina , Treweek Shaun , Gillies Katie 
Published: August 2017

ObjectivesTo explore trial site staff's perceptions regarding barriers and facilitators to local recruitment.DesignQualitative semi-structured interviews with a range of trial site staff from four trial sites in the UK. Interviews were analysed thematically to identify common themes across sites, barriers that could be addressed and facilitators that could be shared with other sites.Participants11 members of staff from four trial sites: clinical grant Co-applicant (n=1); Principal Investigators (n=3); Consultant Urologist (n=1); Research Nurses (n=5); Research Assistant (n=1).SettingEmbedded within an ongoing randomised controlled trial (the TISU trial). TISU is a UK multicentre trial comparing therapeutic interventions for ureteric stones.ResultsOur study draws attention to the initial and ongoing burden of trial work that is involved throughout the duration of a clinical trial. In terms of building and sustaining a research culture, trial staff described the ongoing work of engagement that was required to ensure that clinical staff were both educated and motivated to help with the process of identifying and screening potential participants. Having adequate and sufficient organisational and staffing resources was highlighted as being a necessary prerequisite to successful recruitment both in terms of accessing potentially eligible patients and being able to maximise recruitment after patient identification. The nature of the research study design can also potentially generate challenging communicative work for recruiting staff which can prove particularly problematic.ConclusionsOur paper adds to existing research highlighting the importance of the hidden and complex work that is involved in clinical trial recruitment. Those designing and supporting the operationalisation of clinical trials must recognise and support the mitigation of this ‘work’. While much of the work is likely to be contextually sensitive at the level of local sites and for individual trials, some aspects are ubiquitous issues for delivery of trials more generally.Trial registration numberISRCTN No 92289221; Pre-results.
Non-pharmacological self-management for people living with migraine or tension-type headache: a systematic review including analysis of intervention components
Authors: Probyn Katrin , Bowers Hannah , Mistry Dipesh , Caldwell Fiona , Underwood Martin , Patel Shilpa , Sandhu Harbinder Kaur , Matharu Manjit , Pincus Tamar 
Published: August 2017

ObjectivesTo assess the effect of non-pharmacological self-management interventions against usual care, and to explore diﬀerent components and delivery methods within those interventionsParticipantsPeople living with migraine and/or tension-type headacheInterventionsNon-pharmacological educational or psychological self-management interventions; excluding biofeedback and physical therapy.We assessed the overall effectiveness against usual care on headache frequency, pain intensity, mood, headache-related disability, quality of life and medication consumption in meta-analysis.We also provide preliminary evidence on the effectiveness of intervention components and delivery methods.ResultsWe found a small overall effect for the superiority of self-management interventions over usual care, with a standardised mean diﬀerence (SMD) of −0.36 (−0.45 to −0.26) for pain intensity; −0.32 (−0.42 to −0.22) for headache-related disability, 0.32 (0.20 to 0.45) for quality of life and a moderate effect on mood (SMD=0.53 (−0.66 to −0.40)). We did not find an effect on headache frequency (SMD=−0.07 (−0.22 to 0.08)).Assessment of components and characteristics suggests a larger effect on pain intensity in interventions that included explicit educational components (−0.51 (−0.68 to −0.34) vs −0.28 (−0.40 to −0.16)); mindfulness components (−0.50 (−0.82 to −0.18) vs 0.34 (−0.44 to −0.24)) and in interventions delivered in groups vs one-to-one delivery (0.56 (−0.72 to −0.40) vs −0.39 (−0.52 to −0.27)) and larger effects on mood in interventions including a cognitive–behavioural therapy (CBT) component with an SMD of −0.72 (−0.93 to −0.51) compared with those without CBT −0.41 (−0.58 to −0.24).ConclusionOverall we found that self-management interventions for migraine and tension-type headache are more effective than usual care in reducing pain intensity, mood and headache-related disability, but have no effect on headache frequency. Preliminary findings also suggest that including CBT, mindfulness and educational components in interventions, and delivery in groups may increase effectiveness.Trial registration numberPROSPERO 2016:CRD42016041291
Patient preferences for venous thromboembolism prophylaxis after injury: a discrete choice experiment
Authors: Haac Bryce E , O'Hara Nathan N , Mullins C Daniel , Stein Deborah M , Manson Theodore T , Johal Herman , Castillo Renan , O'Toole Robert V , Slobogean Gerald P 
Published: August 2017

ObjectiveLimited evidence for the optimal venous thromboembolism (VTE) prophylaxis regimen in orthopaedic trauma leads to variability in regimens. We sought to delineate patient preferences towards cost, complication profile, and administration route (oral tablet vs. subcutaneous injection).DesignDiscrete choice experiment (DCE).SettingLevel 1 trauma center in Baltimore, USA.Participants232 adult trauma patients (mean age 47.9 years) with pelvic or acetabular fractures or operative extremity fractures.Primary and secondary outcome measuresRelative preferences and trade-off estimates for a 1% reduction in complications were estimated using multinomial logit modelling. Interaction terms were added to the model to assess heterogeneity in preferences.ResultsPatients preferred oral tablets over subcutaneous injections (marginal utility, 0.16; 95% CI: 0.11 - 0.21,P<0.0001). Preferences changed in favor of subcutaneous injections with an absolute risk reduction of 6.98% in bleeding, 4.53% in wound complications requiring reoperation, 1.27% in VTE, and 0.07% in death from pulmonary embolism (PE). Patient characteristics (sex, race, type of injury, time since injury) affected patient preferences (P<0.01).ConclusionsPatients preferred oral prophylaxis and were most concerned about risk of death from PE. Furthermore, the findings estimated the trade-offs acceptable to patients and heterogeneity in preferences for VTE prophylaxis.
Association between pregravid physical activity and family history of stroke and risk of stillbirth: population-based cohort study
Authors: Egeland Grace M , Tell Grethe S , Næss Øyvind , Igland Jannicke , Klungsøyr Kari 
Published: August 2017

ObjectivesTo evaluate whether family history of disease and pregravid lifestyle and cardiovascular risk factors are associated with subsequent stillbirth delivery.DesignPrepregnancy cohort study.SettingCohort Norway regional health surveys (1994–2003) linked to Medical Birth Registry of Norway for deliveries through 2012.Participants13 497 singleton births (>22 weeks gestation) in 8478 women.Main outcome measureRisk of stillbirth evaluated by Poisson regression.ResultsMean (SD) length of follow-up was 5.5 (3.5) years. In analyses adjusting for baseline age and length of follow-up, ≥3 hours of baseline past-year vigorous physical activity per week (resulting in shortness of breath/sweating) was associated with increased risk of stillbirth compared with <1 hour/week of vigorous activity (incidence rate ratio, IRR 2.46; 95% CI 1.23 to 4.90). In contrast, baseline past-year light physical activity of ≥3 hours per week associated with reduced risk of stillbirth compared with <3 hours of light physical activity per week (IRR 0.53; 95% CI 0.30 to 0.93). A family history of stroke associated with increased risk of stillbirth delivery (IRR 2.53; 95% CI 1.06 to 6.01). Because overweight/obese women may experience shortness of breath and sweating with less physical exertion than normal weight women, a sensitivity analysis was conducted limited to women with a normal BMI (>18.5 and <25 kg/m2). Vigorous activity of ≥3 hours per week (IRR of 4.50; 95% CI 1.72 to 11.79) and a family history of stroke (IRR of 3.81; 95% CI 1.31 to 11.07) were more strongly related to stillbirth risk among women with a normal BMI than that observed for all women combined. Established risk factors also associated with stillbirth risk.ConclusionsThe study identified physical activity and family history of stroke as potential new risk factors for stillbirth delivery.
Socioeconomic and geographical variation in general practitioner consultations for allergic rhinitis in England, 2003–2014: an observational study
Authors: Todkill Daniel , Loveridge Paul , Elliot Alex James , Morbey Roger , Lusignan Simon de , Edeghere Obaghe , Smith Gillian 
Published: August 2017

ObjectiveAllergic rhinitis (AR) is a global health problem, potentially impacting individuals’ sleep, work and social life. We aimed to use a surveillance network of general practitioners (GPs) to describe the epidemiology of AR consultations in England.SettingA large GP surveillance network covering approximately 53% of the English population.MethodsGP consultations for AR across England between 30 December 2002 and 31 December 2014 were analysed. Using more granular data available between 2 April 2012 and 31 December 2014 rates and rate ratios (RR) of AR were further analysed in different age groups, gender, rural-urban classification and index of multiple deprivation score quintile of location of GP.ResultsThe mean weekly rate for AR consultations was 19.8 consultations per 100 000 GP registered patients (range 1.13–207), with a regular peak occurring during June (weeks 24–26), and a smaller peak during April. Between 1 April 2012 and 31 December 2014, the highest mean daily rates of consultations per 1 00 000 were: in age group 5–14 years (rate=8.02, RR 6.65, 95% CI 6.38 to 6.93); females (rate=4.57, RR 1.12 95% CI 1.12 to 1.13); persons registered at a GP in the most socioeconomically deprived quintile local authority (rate=5.69, RR 1.48, 95% CI 1.47 to 1.49) or in an urban area with major conurbation (rate=5.91, RR 1.78, 95% CI 1.69 to 1.87).ConclusionsAR rates were higher in those aged 5–14 years, females and in urban and socioeconomically deprived areas. This needs to be viewed in the context of this study’s limitations but should be considered in health promotion and service planning.
Psychiatric disorders among people with cancer in low- and lower-middle-income countries: study protocol for a systematic review and meta-analysis
Authors: Walker Zoe J , Jones Michael P , Ravindran Arun V 
Published: August 2017

IntroductionCancer is a rapidly growing public health problem in low- and lower-middle-income countries (LLMICs). There is evidence from upper-income countries that comorbid mental illness is common and can adversely impact cancer outcomes. Little is known about this burden in LLMICs. This systematic review has two aims. The first is to review the prevalence and patterns of psychiatric comorbidity in adults with cancer in LLMICs. The second is to review psychiatric treatment outcomes in this population.Methods and analysisThe review will be reported according to the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) guidelines. A systematic search of electronic databases (MEDLINE, PsycInfo, Embase and CINAHL) will be conducted. Studies will be included if they report the prevalence of psychiatric comorbidity, or if they evaluate psychiatric treatment outcomes, in adults with cancer living in LLMICs. The search will be limited to studies published in peer-reviewed journals between March 2002 and March 2017. The reference lists of included studies will be hand searched. Critical appraisal will be performed using Quality Assessment Tools from the National Institute of Health. Pooled prevalence meta-analysis is planned.Ethics and disseminationEthics approval is not required as no primary data will be collected. The results will be presented at conferences and published in a peer-reviewed journal.Systematic review registrationPROSPERO CRD42017057103.
Developing core economic outcome sets for asthma studies: a protocol for a systematic review
Authors: Hounsome Natalia , Fitzsimmons Deborah , Phillips Ceri , Patel Anita 
Published: August 2017

IntroductionCore outcome sets are standardised lists of outcomes, which should be measured and reported in all clinical studies of a specific condition. This study aims to develop core outcome sets for economic evaluations in asthma studies. Economic outcomes include items such as costs, resource use or quality-adjusted life years. The starting point in developing core outcome sets will be conducting a systematic literature review to establish a preliminary list of reporting items to be considered for inclusion in the core outcome set.Methods and analysisWe will conduct literature searches of peer-reviewed studies published from January 1990 to January 2017. These will include any comparative or observational studies (including economic models) and systematic reviews reporting economic outcomes. All identified economic outcomes will be tabulated together with the major study characteristics, such as population, study design, the nature and intensity of the intervention, mode of data collection and instrument(s) used to derive an outcome. We will undertake a ‘realist synthesis review’ to analyse the identified economic outcomes. The outcomes will be summarised in the context of evaluation perspectives, types of economic evaluation and methodological approaches. Parallel to undertaking a systematic review, we will conduct semistructured interviews with stakeholders (including people with personal experience of asthma, health professionals, researchers and decision makers) in order to explore additional outcomes which have not been considered, or used, in published studies. The list of outcomes generated from the systematic review and interviews with stakeholders will form the basis of a Delphi survey to refine the identified outcomes into a core outcome set.Ethics and disseminationThe review will not involve access to individual-level data. Findings from our systematic review will be communicated to a broad range of stakeholders including clinical guideline developers, research funders, trial registries, ethics committees and other regulators.
Differences in the pregnancy gestation period and mean birth weights in infants born to Indian, Pakistani, Bangladeshi and white British mothers in Luton, UK: a retrospective analysis of routinely collected data
Authors: Garcia Rebecca , Ali Nasreen , Guppy Andy , Griffiths Malcolm , Randhawa Gurch 
Published: August 2017

ObjectiveTo compare mean birth weights and gestational age at delivery of infants born to Indian, Pakistani, Bangladeshi and white British mothers in Luton, UK.DesignRetrospective analysis using routinely recorded secondary data in Ciconia Maternity information System, between 2008 and 2013.SettingLuton, UK.ParticipantsMothers whose ethnicity was recorded as white British, Bangladeshi, Pakistani or Indian and living in Luton, aged over 16, who had a live singleton birth over 24 weeks of gestation were included in the analysis (n=14 871).Outcome measuresPrimary outcome measures were mean birth weight and gestational age at delivery.ResultsAfter controlling for maternal age, smoking, diabetes, gestation age, parity and maternal height and body mass index at booking, a significant difference in infants’ mean birth weight was found between white British and Indian, Pakistani and Bangladeshi infants, F(3, 12 287)=300.32, p<0.0001. The partial Eta-squared for maternal ethnicity was η2=0.067. The adjusted mean birth weight for white British infants was found to be 3377.89 g (95% CI 3365.34 to 3390.44); Indian infants, 3033.09 g (95% CI 3038.63 to 3103.55); Pakistani infants, 3129.49 g (95% CI 3114.5 to 3144.48); and Bangladeshi infants, 3064.21 g (95% CI 3041.36 to 3087.06). There was a significant association in preterm delivery found in primipara Indian mothers, compared with Indian mothers (Wald=8.192, df 1, p<0.005).ConclusionsResults show important differences in adjusted mean birth weight between Indian, Pakistani, Bangladeshi and white British women. Moreover, an association was found between primipara Indian mothers and preterm delivery, when compared with Pakistani, Bangladeshi and white British women.
Associations between polypharmacy and treatment intensity for hypertension and diabetes: a cross-sectional study of nursing home patients in British Columbia, Canada
Authors: McCracken Rita , McCormack James , McGregor Margaret J , Wong Sabrina T , Garrison Scott 
Published: August 2017

ObjectivesDescribe nursing home polypharmacy prevalence in the context of prescribing for diabetes and hypertension and determine possible associations between lower surrogate markers for treated hypertension and diabetes (overtreatment) and polypharmacy.DesignCross-sectional study.Setting6 nursing homes in British Columbia, Canada.Participants214 patients residing in one of the selected facilities during data collection period.Primary and secondary outcome measuresPolypharmacy was defined as ≥9 regular medications. Overtreatment of diabetes was defined as being prescribed at least one hypoglycaemic medication and a glycosylated haemoglobin (HbA1c) ≤7.5%. Overtreatment of hypertension required being prescribed at least one hypertension medication and having a systolic blood pressure ≤128 mm Hg. Polypharmacy prescribing, independent of overtreatment, was calculated by subtracting condition-specific medications from total medications prescribed.ResultsData gathering was completed for 214 patients, 104 (48%) of whom were prescribed ≥9 medications. All patients were very frail. Patients with polypharmacy were more likely to have a diagnosis of hypertension (p=0.04) or congestive heart failure (p=0.003) and less likely to have a diagnosis of dementia (p=0.03). Patients with overtreated hypertension were more likely to also experience polypharmacy (Relative Risk (RR))1.77 (1.07 to 2.96), p=0.027). Patients with overtreated diabetes were prescribed more non-diabetic medications than those with a higher HbA1c (11.0±3.7vs 7.2±3.1, p=0.01).ConclusionOvertreated diabetes and hypertension appear to be prevalent in nursing home patients, and the presence of polypharmacy is associated with more aggressive treatment of these risk factors. The present study was limited by its small sample size and cross-sectional design. Further study of interventions designed to reduce overtreatment of hypertension and diabetes is needed to fully understand the potential links between polypharmacy and potential of harms of condition-specific overtreatment.
Validation of asthma recording in the Clinical Practice Research Datalink (CPRD)
Authors: Nissen Francis , Morales Daniel R , Mullerova Hana , Smeeth Liam , Douglas Ian J , Quint Jennifer K 
Published: August 2017

ObjectivesThe optimal method of identifying people with asthma from electronic health records in primary care is not known. The aim of this study is to determine the positive predictive value (PPV) of different algorithms using clinical codes and prescription data to identify people with asthma in the United Kingdom Clinical Practice Research Datalink (CPRD).Methods684 participants registered with a general practitioner (GP) practice contributing to CPRD between 1 December 2013 and 30 November 2015 were selected according to one of eight predefined potential asthma identification algorithms. A questionnaire was sent to the GPs to confirm asthma status and provide additional information to support an asthma diagnosis. Two study physicians independently reviewed and adjudicated the questionnaires and additional information to form a gold standard for asthma diagnosis. The PPV was calculated for each algorithm.Results684 questionnaires were sent, of which 494 (72%) were returned and 475 (69%) were complete and analysed. All five algorithms including a specific Read code indicating asthma or non-specific Read code accompanied by additional conditions performed well. The PPV for asthma diagnosis using only a specific asthma code was 86.4% (95% CI 77.4% to 95.4%). Extra information on asthma medication prescription (PPV 83.3%), evidence of reversibility testing (PPV 86.0%) or a combination of all three selection criteria (PPV 86.4%) did not result in a higher PPV. The algorithm using non-specific asthma codes, information on reversibility testing and respiratory medication use scored highest (PPV 90.7%, 95% CI (82.8% to 98.7%), but had a much lower identifiable population. Algorithms based on asthma symptom codes had low PPVs (43.1% to 57.8%)%).ConclusionsPeople with asthma can be accurately identified from UK primary care records using specific Read codes. The inclusion of spirometry or asthma medications in the algorithm did not clearly improve accuracy.Ethics and disseminationThe protocol for this research was approved by the Independent Scientific Advisory Committee (ISAC) for MHRA Database Research (protocol number15_257) and the approved protocol was made available to the journal and reviewers during peer review. Generic ethical approval for observational research using the CPRD with approval from ISAC has been granted by a Health Research Authority Research Ethics Committee (East Midlands—Derby, REC reference number 05/MRE04/87).The results will be submitted for publication and will be disseminated through research conferences and peer-reviewed journals.