bluuebunny/crossref_metadata_2025_split huggingface dataset:
Realist evaluation of a complex integrated care programme: protocol for a mixed methods study
Authors: Nurjono Milawaty , Shrestha Pami , Lee Alice , Lim Xin Ya , Shiraz Farah , Tan Shermin , Wong Shing Hei , Foo Kah Mun , Wee Thomas , Toh Sue-Anne , Yoong Joanne , Maria Vrijhoef Hubertus Johannes 
Published: March 2018

IntroductionThe lack of understanding of how complex integrated care programmes achieve their outcomes due to the lack of acceptable methods leads to difficulties in the development, implementation, adaptation and scaling up of similar interventions. In this study, we evaluate an integrated care network, the National University Health System (NUHS) Regional Health System (RHS), consisting of acute hospitals, step down care, primary care providers, social services and community partners using a theory-driven realist evaluation approach. This study aims to examine how and for whom the NUHS-RHS works to improve healthcare utilisations, outcomes, care experiences and reduce healthcare costs. By using a realist approach that balances the needs of context-specific evaluation with international comparability, this study carries the potential to address current research gaps.Methods and analysisThis evaluation will be conducted in three research phases: (1) development of initial programme theory (IPT) underlying the NUHS-RHS; (2) testing of programme theory using empirical data; and (3) refinement of IPT. IPT was elicited and developed through reviews of programme documents, informal discussions and in-depth interviews with relevant stakeholders. Then, a convergent parallel mixed method study will be conducted to assess context (C), mechanisms (M) and outcomes (O) to test the IPT. Findings will then be analysed according to the realist evaluation formula of CMO in which findings on the context, mechanisms will be used to explain the outcomes. Finally, based on findings gathered, IPT will be refined to highlight how to improve the NUHS-RHS by detailing what works (outcome), as well as how (mechanisms) and under what conditions (context).Ethics and disseminationThe National Healthcare Group, Singapore, Domain Specific Review Board reviewed and approved this study protocol. Study results will be published in international peer-reviewed journals and presented at conferences and internally to NUHS-RHS and Ministry of Health, Singapore.
Dental caries and preterm birth: a systematic review and meta-analysis
Authors: Wagle Madhu , D’Antonio Francesco , Reierth Eirik , Basnet Purusotam , Trovik Tordis A , Orsini Giovanna , Manzoli Lamberto , Acharya Ganesh 
Published: March 2018

ObjectivesThe primary objective of this systematic review was to evaluate the association between dental caries and preterm birth (PTB). The secondary objective was ascertaining the difference between women with dental caries who experienced PTB and those who did not with regard to decayed, missing and filled teeth (DMFT), and decayed, missing and filled surfaces (DMFS) indices.MethodsMEDLINE, Embase, CINAHL and Cochrane databases were searched initially in November 2015 and repeated in December 2016. We included observational cohort and case–control studies. Only studies reporting the risk of PTB in women affected compared with those not affected by dental caries in pregnancy were included. Random-effect meta-analyses were used to compute the summary OR of PTB among women with caries versus women without caries, and the mean difference in either DMFT or DMFS indices between women experiencing PTB and those without PTB.ResultsNine observational studies (4826 pregnancies) were included. Women affected by dental caries during pregnancy did not show a significantly higher risk of PTB (OR: 1.16, 95% CI 0.90 to 1.49, P=0.25, I2=35%). Also, the women with PTB did not show significantly higher DMFT or DMFS indices (summary mean differences: 1.56, P=0.10; I2=92% and −0.15, P=0.9, I2=89%, respectively).ConclusionDental caries does not appear to be a substantial risk factor for PTB.Trial registration numberNCT01675180; Pre-results.
Model-based recursive partitioning to identify risk clusters for metabolic syndrome and its components: findings from the International Mobility in Aging Study
Authors: Pirkle Catherine M , Wu Yan Yan , Zunzunegui Maria-Victoria , Gómez José Fernando 
Published: March 2018

ObjectiveConceptual models underpinning much epidemiological research on ageing acknowledge that environmental, social and biological systems interact to influence health outcomes. Recursive partitioning is a data-driven approach that allows for concurrent exploration of distinct mixtures, or clusters, of individuals that have a particular outcome. Our aim is to use recursive partitioning to examine risk clusters for metabolic syndrome (MetS) and its components, in order to identify vulnerable populations.Study designCross-sectional analysis of baseline data from a prospective longitudinal cohort called the International Mobility in Aging Study (IMIAS).SettingIMIAS includes sites from three middle-income countries—Tirana (Albania), Natal (Brazil) and Manizales (Colombia)—and two from Canada—Kingston (Ontario) and Saint-Hyacinthe (Quebec).ParticipantsCommunity-dwelling male and female adults, aged 64–75 years (n=2002).Primary and secondary outcome measuresWe apply recursive partitioning to investigate social and behavioural risk factors for MetS and its components. Model-based recursive partitioning (MOB) was used to cluster participants into age-adjusted risk groups based on variabilities in: study site, sex, education, living arrangements, childhood adversities, adult occupation, current employment status, income, perceived income sufficiency, smoking status and weekly minutes of physical activity.Results43% of participants had MetS. Using MOB, the primary partitioning variable was participant sex. Among women from middle-incomes sites, the predicted proportion with MetS ranged from 58% to 68%. Canadian women with limited physical activity had elevated predicted proportions of MetS (49%, 95% CI 39% to 58%). Among men, MetS ranged from 26% to 41% depending on childhood social adversity and education. Clustering for MetS components differed from the syndrome and across components. Study site was a primary partitioning variable for all components except HDL cholesterol. Sex was important for most components.ConclusionMOB is a promising technique for identifying disease risk clusters (eg, vulnerable populations) in modestly sized samples.
Development of an English-language version of a Japanese iPad application to facilitate collaborative goal setting in rehabilitation: a Delphi study and field test
Authors: Levack William , Tomori Kounosuke , Takahashi Kayoko , Sherrington Aidan J 
Published: March 2018

ObjectiveThis study aimed to investigate the content of an English-language version of a Japanese iPad application designed to facilitate shared decision-making around goal setting in rehabilitation: Aid for Decision-making in Occupational Choice—English (ADOC-E).DesignPhase 1: Delphi methods to reach consensus with an international group of expert occupational therapists on the text and images in ADOC-E. Phase 2: Testing correct recognition (unprompted and prompted) of images in ADOC-E by health service users in inpatient rehabilitation and residential care.SettingPhase 1: International, online. Phase 2: Three healthcare services in New Zealand—(1) a residential rehabilitation service for traumatic brain injury, (2) a nursing home for frail older adults and (3) an inpatient rehabilitation ward in a public hospital.ParticipantsPhase 1: Fourteen experienced occupational therapists from New Zealand (4), Australia (4), UK (2) and USA (4). Phase 2: Twenty-four rehabilitation and residential care service users (10 men, 14 women; 20–95 years; Mini-Mental State Exam scores 13–30).ResultsFour Delphi rounds were required to reach consensus with the experienced occupational therapists on the content of ADOC-E, ending with 100 items covering daily activities that people do and social roles they participate in. Ninety-five per cent (95/100) of ADOC-E items could each be correctly identified by over 80% of service user participants with either unprompted or prompted recognition.ConclusionWhile a few of the more abstract concepts in ADOC-E (related to complex social roles) were less likely to be correctly recognised by all participants, the text and images ADOC-E were deemed to be fit for purpose overall and ready for future clinical testing.
Interventions to encourage smoke-free homes in remote indigenous Australian communities: a study protocol to evaluate the effects of a community-inspired awareness-raising and motivational enhancement strategy
Authors: Clough Alan R , Grant Kristy , Robertson Jan , Wrigley Matthew , Nichols Nina , Fitzgibbon Tracey 
Published: March 2018

IntroductionRates of secondhand smoke exposure are currently significantly higher among remote indigenous communities in the top end of Australia. By implementing a ‘smoke-free home’ rule, secondhand smoke exposure can be reduced. Smoke-free homes encourage quit attempts and improve the health of children. The prevalence of indigenous smoking rates in remote, discrete communities in Australia is elevated compared with their non-indigenous counterparts. The primary aim of this project is to examine the feasibility of conducting a health-driven intervention to encourage community members to make their homes a smoke-free zone.Methods and analysisThis study uses mixed-methods exploratory evaluation design to obtain data from key informants and community householders to assess their willingness to implement a ‘smoke-free’ rule in their homes. Initial focus groups will provide guidance on intervention content and deliver evaluation procedures and community requirements. A rapid survey will be conducted to ascertain interest from community members in having the project team visit to discuss study objectives further and to have a particle meter (with consent) placed in the house. Focus groups recordings will be transcribed and analysed thematically. Rapid surveys will be analysed using frequency distributions and tabulations of responses.Ethics and disseminationThe National Health and Medical Research Council guidelines on ethical research approaches to indigenous studies will be adhered to. The James Cook University Human Research Ethics Committee has provided ethics approval.
Does physiological distribution of blood parameters in children depend on socioeconomic status? Results of a German cross-sectional study
Authors: Rieger Kristin , Vogel Mandy , Engel Christoph , Ceglarek Uta , Harms Kristian , Wurst Ulrike , Lengfeld Holger , Richter Matthias , Kiess Wieland 
Published: March 2018

ObjectivesIn the present study, we examined the relation between socioeconomic status (SES) and the physiological distribution of iron-related blood parameters.DesignThis is a cross-sectional analysis of longitudinal population-based cohort study.SettingBased on a sample of healthy participants from a German research centre, various blood parameters and values of clinical examinations and questionnaires were collected.ParticipantsA total of 1206 healthy volunteers aged 2.5 to 19 years, one child per family randomly selected, were included.Primary and secondary outcome measuresAssociations between the SES of children by Winkler-Stolzenberg Index (WSI) and its dimensions (income, education, occupation) and iron-related blood parameters (haemoglobin, ferritin and transferrin) were analysed by linear regression analyses. Gender and pubertal stage were included as covariables. Additionally, associations between SES of children by WSI and physical activity (side-to-side jumps, push-ups) as well as body mass index (BMI) were analysed by linear regression analyses.ResultsChildren with high WSI or family income showed significantly increased z-scores for haemoglobin (P=0.046; P<0.001). Children with increased WSI or family income showed significantly lower z-scores for transferrin (P<0.001). There was a significant correlation between haemoglobin and gender (P<0.001) and between transferrin and pubertal stage (P=0.024). Furthermore, physical activity was positively correlated and BMI was negatively correlated with WSI (P<0.001).DiscussionOur data show an association between SES and the distribution of iron-dependent parameters. Lower SES is correlated with lower values for haemoglobin and higher values for transferrin. Furthermore, we demonstrate that physical activity and BMI are associated with SES. Whereas higher SES is correlated with higher values for physical activity and lower BMI. Our parameters are standardised as z-scores with the advantages that the results are comparable across different age groups and present physiological courses.Trial registration numberNCT02550236; Results.
Do non-inferiority trials of reduced intensity therapies show reduced effects? A descriptive analysis
Authors: Aberegg Scott K , Hersh Andrew M , Samore Matthew H 
Published: March 2018

ObjectivesTo identify non-inferiority trials within a cohort where the experimental therapy is the same as the active control comparator but at a reduced intensity and determine if these non-inferiority trials of reduced intensity therapies have less favourable results than other non-inferiority trials in the cohort. Such a finding would provide suggestive evidence of biocreep in these trials.DesignThis metaresearch study used a cohort of non-inferiority trials published in the five highest impact general medical journals during a 5-year period. Data relating to the characteristics and results of the trials were abstracted.Primary outcome measuresProportions of trials with a declaration of superiority, non-inferiority and point estimates favouring the experimental therapy and mean absolute risk differences for trials with outcomes expressed as a proportion.ResultsOur search yielded 163 trials reporting 182 non-inferiority comparisons; 36 comparisons from 31 trials were between the same therapy at reduced and full intensity. Compared with trials not evaluating reduced intensity therapies, fewer comparisons of reduced intensity therapies demonstrated a favourable result (non-inferiority or superiority) (58.3%vs82.2%; P=0.002) and fewer demonstrated superiority (2.8%vs18.5%; P=0.019). Likewise, point estimates for reduced intensity therapies more often favoured active control than those for other trials (77.8%vs39.7%; P<0.001) as did mean absolute risk differences (+2.5% vs −0.7%; P=0.018).ConclusionsNon-inferiority trials comparing a therapy at reduced intensity to the same therapy at full intensity showed reduced effects compared with other non-inferiority trials. This suggests these trials may have a high rate of type 1 errors and biocreep, with significant implications for the design and interpretation of future non-inferiority trials.
Cross-sectional and prospective associations of neighbourhood environmental attributes with screen time in Japanese middle-aged and older adults
Authors: Liao Yung , Shibata Ai , Ishii Kaori , Koohsari Mohammad Javad , Oka Koichiro 
Published: March 2018

ObjectivesThis study examined cross-sectional and 2-year prospective associations of perceived and objectively measured environmental attributes with screen time among middle-aged Japanese adults.DesignProspective cohort study.SettingNerima and Kanuma cities of Japan.ParticipantsData were collected from adults aged 40–69 years living in two cities of Japan in 2011 (baseline: n=1011; 55.3±8.4 years) and again in 2013 (follow-up: n=533; 52.7% of baseline sample).MeasuresThe exposure variables were five geographic information system-based and perceived attributes of neighbourhood environments (residential density, access to shops and public transport, footpaths, street connectivity), respectively. The outcome variables were baseline screen time (television viewing time and leisure-time internet use) and its change over 2 years. Multilevel generalised linear modelling was used.ResultsOn average, participants’ screen time was not statistically different over 2 years (2.3 hours/day at baseline and 2.2 hours/day at follow-up; P=0.24). There were cross-sectional associations of objective (exp(β): 1.11; 95% CI 1.01 to 1.22) and perceived (1.12; 1.02 to 1.23) good access to public transport, perceived good access to shop (1.18; 1.04 to 1.36) and perceived good street connectivity (1.11; 1.01 to 1.23) with higher time spent in screen time at baseline. No objective and perceived environmental attributes were significantly associated with change in screen time.ConclusionsActivity-supportive neighbourhood environmental attributes appear to be related to higher levels of screen time cross-sectionally. Pattern of screen time might be maintained rather than changed over time under the same neighbourhood environments. Environmental interventions that promote physical activity may need to consider the potential negative health impact of screen time in Japan.
Temporal trends in severe maternal and neonatal trauma during childbirth: a population-based observational study
Authors: Wen Qi , Muraca Giulia M , Ting Joseph , Coad Sarah , Lim Kenneth I , Lisonkova Sarka 
Published: March 2018

ObjectiveInstrumental vaginal delivery is associated with birth trauma to infant and obstetric trauma to mother. As caesarean delivery rates increased during the past decades, the rate of instrumental vaginal delivery declined. We examined concomitant temporal changes in the rates of severe birth trauma and maternal obstetric trauma.DesignA retrospective observational study.Settings and participantsAll hospital singleton live births in Washington State, USA, 2004–2013, excluding breech delivery. Severe birth trauma (brain, nerve injury, fractures and other severe birth trauma) and obstetric trauma (third/fourth degree perineal lacerations, cervical/high vaginal lacerations) were identified from hospitalisation data. Pregnancy and delivery characteristics were obtained from birth certificates. Temporal trends were assessed by the Cochran-Armitage test. Logistic regression was used to obtain adjusted ORs (AORs) and 95% CI.ResultsOverall, 732 818 live births were included. The rate of severe birth trauma declined from 5.3 in 2004 to 4.5 per 1000 live births in 2013 (P<0.001). The decline was observed only in spontaneous vaginal delivery, the rates of fractures and other severe birth trauma declined by 5% and 4% per year, respectively (AOR: 0.95, 95% CI 0.94 to 0.97 and AOR: 0.96, 95% CI 0.93 to 0.99; respectively). The rate of third/fourth degree lacerations declined in spontaneous vaginal delivery from 3.5% to 2.3% (AOR: 0.95; 95% CI 0.94 to 0.95) and in vacuum delivery from 17.3% to 14.5% (AOR: 0.97, 95% CI 0.96 to 0.98). Among women with forceps delivery, these rates declined from 29.8% to 23.4% (AOR: 0.98, 95% CI 0.96 to 1.00).ConclusionWhile the rates of fractures and other birth trauma declined among infants delivered by spontaneous vaginal delivery, the rate of birth trauma remained unchanged in instrumental vaginal delivery and caesarean delivery. Among mothers, the rates of severe perineal lacerations declined, except for women with forceps delivery.
Negotiating acceptable termination of pregnancy for non-lethal fetal anomaly: a qualitative study of professional perspectives
Authors: Crowe Lisa , Graham Ruth H , Robson Stephen C , Rankin Judith 
Published: March 2018

ObjectiveThis study aims to explore the perspectives of professionals around the issue of termination of pregnancy for non-lethal fetal anomaly (TOPFA).MethodsSemi-structured interviews were undertaken with medical professionals (14 consultants in fetal medicine, obstetrics, neonatology and paediatrics) and social care professionals (nine individuals with roles supporting people living with impairment) from the Northeast of England. Analysis adopted an inductive thematic approach facilitated by NVivo.ResultsThe overarching theme to emerge from the interview data was of professionals, medical and social care, wanting to present an acceptable self-image of their views on TOPFA. Professionals’ values on ‘fixing’, pain and ‘normality’ influenced what aspects of moral acceptability they gave priority to in terms of their standpoint and, in turn, their conceptualisations of acceptable TOPFA. Thus, if a termination could be defended morally, including negotiation of several key issues (including ‘fixing’, perceptions of pain and normality), then participants conceptualised TOPFA as an acceptable pregnancy outcome.ConclusionDespite different professional experiences, these professional groups were able to negotiate their way through difficult terrain to conceptualise TOPFA as a morally acceptable principle. While professionals have different moral thresholds, no one argued for a restriction of the current legislation. The data suggest that social care professionals also look at the wider social context of a person with an impairment when discussing their views regarding TOPFA. Medical professionals focus more on the individual impairment when discussing their views on TOPFA.
IPMNs with co-occurring invasive cancers: neighbours but not always relatives
Authors: Felsenstein Matthäus , Noë Michaël , Masica David L , Hosoda Waki , Chianchiano Peter , Fischer Catherine G , Lionheart Gemma , Brosens Lodewijk A A , Pea Antonio , Yu Jun , Gemenetzis Georgios , Groot Vincent P , Makary Martin A , He Jin , Weiss Matthew J , Cameron John L , Wolfgang Christopher L , Hruban Ralph H , Roberts Nicholas J , Karchin Rachel , Goggins Michael G , Wood Laura D 
Published: March 2018

ObjectiveIntraductal papillary mucinous neoplasms (IPMNs) are precursor lesions that can give rise to invasive pancreatic carcinoma. Although approximately 8% of patients with resected pancreatic ductal adenocarcinoma have a co-occurring IPMN, the precise genetic relationship between these two lesions has not been systematically investigated.DesignWe analysed all available patients with co-occurring IPMN and invasive intrapancreatic carcinoma over a 10-year period at a single institution. For each patient, we separately isolated DNA from the carcinoma, adjacent IPMN and distant IPMN and performed targeted next generation sequencing of a panel of pancreatic cancer driver genes. We then used the identified mutations to infer the relatedness of the IPMN and co-occurring invasive carcinoma in each patient.ResultsWe analysed co-occurring IPMN and invasive carcinoma from 61 patients with IPMN/ductal adenocarcinoma as well as 13 patients with IPMN/colloid carcinoma and 7 patients with IPMN/carcinoma of the ampullary region. Of the patients with co-occurring IPMN and ductal adenocarcinoma, 51% were likely related. Surprisingly, 18% of co-occurring IPMN and ductal adenocarcinomas were likely independent, suggesting that the carcinoma arose from an independent precursor. By contrast, all colloid carcinomas were likely related to their associated IPMNs. In addition, these analyses showed striking genetic heterogeneity in IPMNs, even with respect to well-characterised driver genes.ConclusionThis study demonstrates a higher prevalence of likely independent co-occurring IPMN and ductal adenocarcinoma than previously appreciated. These findings have important implications for molecular risk stratification of patients with IPMN.