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Background: An estimated 11 million individuals are released from U.S. jails and prisons each year. Individuals with a history of incarceration have higher rates of cardiovascular disease (CVD) events and mortality compared to the general population, especially in the weeks following release from carceral facilities. Healthy sleep, associated with cardiovascular health, is an underexplored factor in the epidemiology of CVD in this population. Incarcerated people may have unique individual, environmental, and institutional policy-level reasons for being sleep deficient. The social and physical environment within carceral facilities and post-release housing may synergistically affect sleep, creating disparities in sleep and cardiovascular health. Since carceral facilities disproportionately house poor and minoritized groups, population-specific risk factors that impact sleep may also contribute to inequities in cardiovascular outcomes. Methods: This study is ancillary to an ongoing prospective cohort recruiting 500 individuals with known cardiovascular risk factors within three months of release from incarceration, the Justice-Involved Individuals Cardiovascular Disease Epidemiology (JUSTICE) study. The Sleep Justice study will measure sleep health among participants at baseline and six months using three validated surveys: the Pittsburgh Sleep Quality Index (PSQI), the STOP-Bang, and the Brief Index of Sleep Control. In a subsample of 100 individuals, we will assess sleep over the course of one week using wrist actigraphy, a validated objective measure of sleep that collects data on rest-activity patterns, sleep, and ambient light levels. Using this data, we will estimate and compare sleep health and its association with CVD risk factor control in individuals recently released from carceral facilities. Discussion: The incarceration of millions of poor and minoritized groups presents an urgent need to understand how incarceration affects CVD epidemiology. This study will improve our understanding of sleep health among people released from carceral facilities and its potential relationship to CVD risk factor control. Using subjective and objective measures of sleep will allow us to identify unique targets to improve sleep health and mitigate cardiovascular risk in an otherwise understudied population. [ABSTRACT FROM AUTHOR]

Background: Diagnosis of life threatening childhood illness or injury can lead to significant distress reactions in parents, with many experiencing clinically significant levels of post-traumatic stress symptoms. These symptoms can have long-term adverse impacts on parent mental health, family functioning, and the adjustment of the ill child. Independent studies have found such reactions in several different illness groups. However, very little research has systematically compared the prevalence, impact and trajectories over time of post-traumatic stress symptoms in parents across different childhood illness groups with an acute life threat. The current study seeks to map the course of post-traumatic stress reactions in parents of children with various life threatening illnesses over an 18 month period, and identify factors that predict successful adaptation in families. Method/Design: The current study described is of a prospective, longitudinal design. The sample included parents of children admitted to four major hospital departments at the Royal Children's Hospital, Melbourne, Australia, for a life threatening illness or injury. Eligible parents were those who were caregivers of children aged 0-to 18-years admitted to the Oncology, Cardiology, Neurology and Pediatric Intensive Care Unit. Parents were recruited acutely, and completed self-report questionnaires at four time-points: within the first 4 weeks (T1:); then at 4 months (T2); 7 months (T3); and 19 months (T4) after admission. Questionnaires assessed parent and child mental health and wellbeing, and a number of risk and reliance factors such child illness factors, parent demographic factors, and psychosocial factors. Discussion: This study is one of the first to document the trajectory of post-traumatic stress responses in parents of very ill children, across illness groups. Given that it will also identify risk and resilience factors, and map the course of parent outcomes over an 18 monthperiod, it has the potential to inform novel strategies for intervention. [ABSTRACT FROM AUTHOR]

Background: Patterns of survey response and the characteristics associated with response over time in longitudinal studies are important to discern for the development of tailored retention efforts aimed at minimizing response bias. The Millennium Cohort Study, the largest and longest running cohort study of military personnel and veterans, is designed to examine the long-term health effects of military service and experiences and thus relies on continued participant survey responses over time. Here, we describe the response rates for follow-up survey data collected over 15 years and identify characteristics associated with follow-up survey response and mode of response (paper vs. web). Method: Patterns of follow-up survey response and response mode (web, paper, none) were examined among eligible participants (n=198,833), who were initially recruited in four panels from 2001 to 2013 in the Millennium Cohort Study, for a follow-up period of 3–15 years (2004–2016). Military and sociodemographic factors (i.e., enrollment panel, sex, birth year, race and ethnicity, educational attainment, marital status, service component, service branch, pay grade, military occupation, length of service, and time deployed), life experiences and health-related factors (i.e., military deployment/combat experience, life stressors, mental health, physical health, and unhealthy behaviors) were used to examine follow-up response and survey mode over time in multivariable generalized estimating equation models. Results: Overall, an average response rate of 60% was observed across all follow-up waves. Factors associated with follow-up survey response over time included increased educational attainment, married status, female sex, older age, military deployment (regardless of combat experience), and higher number of life stressors, mental health issues, and physical health diagnoses. Conclusion: Despite the challenges associated with collecting multiple waves of follow-up survey data from members of the U.S. military during and after service, the Millennium Cohort Study has maintained a relatively robust response rate over time. The incorporation of tailored messages and outreach to those groups least likely to respond over time may improve retention and thereby increase the representativeness and generalizability of collected survey data. [ABSTRACT FROM AUTHOR]

Background: Recruiting large cohorts efficiently can speed the translation of findings into care across a range of scientific disciplines and medical specialties. Recruitment can be hampered by factors such as financial barriers, logistical concerns, and lack of resources for patients and clinicians. These and other challenges can lead to underrepresentation in groups such as rural residents and racial and ethnic minorities. Here we discuss the implementation of various recruitment strategies for enrolling participants into a large, prospective cohort study, assessing the need for adaptations and making them in real-time, while maintaining high adherence to the protocol and high participant satisfaction. Methods: While conducting a large, prospective trial of a multi-cancer early detection blood test at Geisinger, an integrated health system in central Pennsylvania, we monitored recruitment progress, adherence to the protocol, and participants' satisfaction. Tracking mechanisms such as paper records, electronic health records, research databases, dashboards, and electronic files were utilized to measure each outcome. We then reviewed study procedures and timelines to list the implementation strategies that were used to address barriers to recruitment, protocol adherence and participant satisfaction. Results: Adaptations to methods that contributed to achieving the enrollment goal included offering multiple recruitment options, adopting group consenting, improving visit convenience, increasing the use of electronic capture and the tracking of data and source documents, staffing optimization via leveraging resources external to the study team when appropriate, and integrating the disclosure of study results into routine clinical care without adding unfunded work for clinicians. We maintained high protocol adherence and positive participant experience as exhibited by a very low rate of protocol deviations and participant complaints. Conclusion: Recruiting rapidly for large studies – and thereby facilitating clinical translation – requires a nimble, creative approach that marshals available resources and changes course according to data. Planning a rigorous assessment of a study's implementation outcomes prior to study recruitment can further ground study adaptations and facilitate translation into practice. This can be accomplished by proactively and continuously assessing and revising implementation strategies. [ABSTRACT FROM AUTHOR]

Background: Osteogenesis Imperfecta (OI) is characterised by bone fragility. Among several features, easy bruising and multiple case reports on haemorrhagic events have been reported. This paper describes the diverse manifestations of bleeding and bruising in a large cohort of 328 OI patients. The aim of this study is to provide insight in the diverse aspects and therapeutic considerations of bleedings in OI. Methods: This descriptive cohort study was conducted at the National Expert Center for adults with OI in the Netherlands. Bleeding was assessed by the validated self-bleeding assessment tool (Self-BAT) The tool was distributed among 328 adults with different clinically confirmed types of OI. Results: 195 of 328 invited patients (completion rate 60%) with OI type 1 (n = 144), OI type 3 (n = 17) and OI type 4 (n = 34), aged between 18 and 82 years, completed the tool. Self-BAT scores were above the normal range in 42% of all patients. For males Self-BAT scores were increased in 37% with a mean score of 3.7, ranged between 0 and 18. For females the Self-BAT scores were increased in 44% with a mean of 5.4 and a range of 0–24. No statistical differences in OI subtypes were found. Conclusions: Bleeding tendency appears to be a relevant complication in OI patients as this study confirms the presumption of bleeding tendency. There are specific recommendations to clinicians who treat OI patients to consider an assessment of bleeding tendency and use potential interventions to reduce haemorrhagic complications and improve quality of life. [ABSTRACT FROM AUTHOR]

Background: Data-driven process analysis is an important area that relies on software support. Process variant analysis is a sort of analysis technique in which analysts compare executed process variants, a.k.a. process cohorts. This comparison can help to identify insights for improving processes. There are a few software supports to enable process cohort comparison based on the frequencies of process activities and performance metrics. These metrics are effective in cohort analysis, but they cannot support cohort comparison based on the probability of transitions among states, which is an important enabler for cohort analysis in healthcare.Results: This paper defines an approach to compare process cohorts using Markov models. The approach is formalized, and it is implemented as an open-source python library, named dfgcompare. This library can be used by other researchers to compare process cohorts. The implementation is also used to compare caregivers' behavior when prescribing drugs in the Stockholm Region. The result shows that the approach enables the comparison of process cohorts in practice.Conclusions: We conclude that dfgcompare supports identifying differences among process cohorts. [ABSTRACT FROM AUTHOR]

Background: Evaluating the effectiveness of early years parenting interventions provides evidence to improve the development and wellbeing of children. This protocol paper describes a study to explore the feasibility of evaluating the Incredible Years Toddler early life intervention programme, which is offered to parents of 1–3-year-olds via the Better Start Bradford programme. The study aims to use a Trial within a Cohort Study (TwiCS) design that randomly selects individuals participating in a cohort to be offered an intervention. The TwiCS information and consent process is person-centred and aims to replicate real-world practice whereby only those who are offered the intervention are given information about the intervention. The cohort is the Born in Bradford's Better Start (BiBBS) cohort, an interventional birth cohort recruiting expectant parents in three areas of Bradford, UK. The study will assess the feasibility of TwiCS procedures, staged consent, and intervention take-up. Methods: We will conduct a feasibility TwiCS to test study procedures. We aim to establish the following: (1) whether TwiCS methodology can be implemented to create control and intervention arms, whilst documenting any incidences of contamination within the cohort; (2) whether satisfactory rates of intervention uptake are achieved among participants allocated to the intervention; and (3) whether satisfactory rates of retention of participants in the intervention can be achieved. A Red Amber Green (RAG) rating system has been applied to support the feasibility assessment of each objective: to be rated red (not achieved), amber (partly achieved), and green (achieved). Eligible participants in the BiBBS cohort will be individually randomised 1:1 to the intervention or control arms, with stratification by child age (1 or 2 years old at the time of randomisation) and ethnicity (White British, South Asian, or other). BiBBS researchers will seek consent from participants randomised to the intervention to pass their contact details onto Incredible Years' delivery agents. Discussion: This feasibility study will inform the utility of the TwiCs approach within an experimental birth cohort to evaluate interventions for infants, toddlers, and their families. Trial registration: The study was prospectively registered on ISRCTN (ISRCTN16150114). [ABSTRACT FROM AUTHOR]

Objectives: There is conflicting evidence around the role of sex hormones with cardiovascular outcomes. The aim of this study was to examine the association of sex hormones with the risk of myocardial infarction (MI) in pre- and post-menopausal women, and men in the UK Biobank. Methods: The UK Biobank is a prospective population-based cohort study, that recruited over 500,000 (aged 40–69 years) women and men between 2006 and 2010. Sex specific cox regression models, estimating hazard ratios (HRs) and women to men ratio of HRs (RHR) with respective 95% confidence intervals (CI), were used to model the association of sex hormones [oestrogen, testosterone, oestrogen: testosterone (O/T) ratio, sex hormone–binding globulin (SHBG) and the free androgen index (FAI)], measured at study baseline, with incident MI for women and men. Results: Data were from 479,797 participants [264,282 (55.1%) women] without a history of MI at study baseline. Over 12.5 years of follow-up, there were 4,908 MI events in women and 10,517 in men. Neither oestrogen nor testosterone were associated with MI in women and men after multiple adjustment. For men, but not women, a unit higher log-transformed O/T ratio was associated with a lower risk of MI 0.79 (0.65, 0.95) after adjustment for traditional CVD risk factors. The corresponding women to men RHR (95% CI) was 1.24 (0.99, 1.56). Higher SHBG (per unit) was also associated with a lower risk of MI in men 0.94 (0.89, 0.99), and not in women 1.02 (0.95, 1.09) after multiple adjustment, the corresponding women to men RHR (95% CI) was 1.09 (1.00, 1.18). Higher FAI was associated with a higher risk of MI in men 1.09 (1.02, 1.15), though not in women 0.97 (0.92, 1.02), the corresponding women to men RHR was 0.89 (0.82, 0.97). Finally, there were differential effects in the association of SHBG and FAI between pre- and post-menopausal women. Conclusions: A higher O/T ratio was associated with a lower risk of MI, and a higher FAI with a higher risk of MI after adjustment for CVD risk factors in men, but not in women. Thus, hormone ratios, rather than each alone, may play an important role in modulating the effect of MI. Plain Language Summary: There are conflicting findings surrounding the association of sex hormones and myocardial infarction (MI) (heart disease). In particular, high oestradiol levels in women are often thought to be protective and explain why the rates of heart disease are lower in women than men. For men, those with low levels of testosterone are often thought to be more prone to develop heart disease in their lifetimes. Our study presents a comprehensive analysis of the association of sex hormones (in isolation and also together via their ratios), in women and men using the large-scale UK Biobank. We found that neither oestrogen nor testosterone alone were associated with heart disease in women and men after accounting for cardiovascular risk factors, but the ratio of testosterone and oestrogen was associated with a lower risk of heart disease in men, though not in women. We also saw the association of sex hormone–binding globulin (SHBG), and free androgen index (FAI) (calculated by the ratio of total testosterone level to SHBG) with heart disease was different between women and men, and between pre- and post-menopausal women. This paper highlights the complex interplay between sex hormones with heart disease in the presence of age and cardiovascular risk factors. In particular the balance (ratio) of sex hormones maybe more important, rather than each in isolation, when exploring their association with heart disease. Highlights: Neither oestrogen nor testosterone were associated with MI in women and men after multiple adjustment. For men, but not women, higher oestrogen/testosterone ratio was associated with a lower risk of MI after adjustment for traditional CVD risk factors. Higher SHBG was associated with a lower risk of MI in men, but not women overall. Higher FAI was associated with a higher risk of MI in men but not women overall. There were differential effects in SHBG and FAI between pre- and post-menopausal women. [ABSTRACT FROM AUTHOR]

Background: During the COVID-19 pandemic, a great number of patients required Mechanical Ventilation (MV). Tracheostomy is the preferred procedure when difficult weaning is presented. Surgical techniques available for performing tracheostomy are open and percutaneous, with contradictory reports on the right choice. This paper aims to describe the clinical results after performing a tracheostomy in patients with COVID-19, regarding both surgical techniques. Methods: An observational, analytical study of a retrospective cohort was designed. All patients admitted to the Hospital Universitario Mayor Méderi, between March 2020 and April 2021 who presented COVID-19 requiring MV and who underwent tracheostomy were reviewed. Open versus percutaneous tracheostomy groups were compared and the primary outcome evaluated was in-hospital mortality. Results: A total of 113 patients were included in the final analysis. The median age was 66.0 (IQR: 57.2 – 72.0) years old and 77 (68.14%) were male. Open tracheostomy was performed in 64.6% (n = 73) of the patients and percutaneous tracheostomy in 35.4% (n = 40) with an in-hospital mortality of 65.7% (n = 48) and 25% (n = 10), respectively (p < 0.001). In a multivariate analysis, open tracheostomy technique [OR 9.45 (95% CI 3.20–27.92)], older age [OR 1.05 (95% CI 1.01–1.09)] and APACHE II score [OR 1.10 (95% CI 1.02–1.19)] were identified as independent risk factors for in-hospital mortality. Late tracheostomy (after 14 days) [OR 0.31 (95% CI 0.09–1.02)] and tracheostomy day PaO2/FiO2 [OR 1.10 (95% CI 1.02–1.19)] were not associated to in-hospital mortality. Conclusions: Percutaneous tracheostomy was independently associated with lower in-hospital mortality and should be considered the first option to perform this type of surgery in patients with COVID-19 in extended MV or difficulty weaning. [ABSTRACT FROM AUTHOR]

Background: Longitudinal cohort studies have made significant contributions to medical discoveries and provide the impetus for health interventions which reduce the risk of disease. Establishing and maintaining these cohorts is challenging and costly. While some attrition is unavoidable, maintaining a sufficient number of participants ensures that results remain representative and free from bias. Numerous studies have investigated ways to reduce attrition but few studies have sought to understand the experience of participants, and none have examined this through a social marketing framework. This first paper in a two part-series describes participants' experiences according to: benefits, barriers, motivators and influencers. The second paper uses this understanding to address issues relating to the 4Ps (product, price, place, promotion) of social marketing.Methods: Participants were recruited from the Raine Study, a pregnancy cohort study that has been running in Western Australia since 1989. Qualitative interviews were conducted with 29 active and inactive participants from the Generation 2 cohort, who were originally enrolled in the Raine Study at birth by their parents (Generation 1). 'Active' participants (n = 17) were defined as those who agreed to attend their 27 year follow-up, while 'inactive' (n = 12) participants were defined as those who had not attended either of the past two follow-ups (at 22 and 27 years).Results: There were considerable differences between active and inactive participants, with active participants perceiving far more personal and collective benefits from their participation. Inactive participants described being constrained by structural barriers around work and life, whereas active participants were able to overcome them to attend follow-ups. Inactive participants also described the value of extrinsic incentives which might motivate their attendance, and active participants described the role of their parents as significant influencers in their propensity to remain in the study.Conclusions: This paper provides rich descriptions of what participation in a long-running study means to participants. Use of a social marketing framework ensured that participants were constructed as 'human consumers' who are influenced by individual and broader social systems. Understanding participants in this way means that differentiated strategies can be tailored to enhance retention. [ABSTRACT FROM AUTHOR]

Background: In Canada, publicly-funded home care programs enable older adults to remain and be cared for in their home for as long as possible but they often differ in types of services offered, and the way services are delivered. This paper examines whether these differing approaches to care shape the pathway that home care clients will take. Older adult client pathways refer to trajectories within, and out of, the home care system (e.g., improvement, long term care (LTC) placement, death). Methods: A retrospective analysis of home care assessment data (RAI-HC was linked with health administrative data, long-term care admissions and vital statistics in Nova Scotia Health (NSH) and Winnipeg Regional Health Authority (WRHA). The study cohort consists of clients age 60 + years, admitted to home care between January 1, 2011 to December 31, 2013 and up to four years from baseline. Differences in home care service use, client characteristics and their pathways were tested across the two jurisdictions overall, and among the four discharge streams within jurisdictions using t-tests and chi-square tests of significance. Results: NS and WHRA clients were similar in age, sex, and marital status. NS clients had higher levels of need (ADL, cognitive impairment, CHESS) at base line and were more likely discharged to LTC (43% compared to 38% in WRHA). Caregiver distress was a factor correlated with being discharged to LTC. While a third remained as home care clients after 4 years; more than half were no longer in the community – either discharged to LTC placement or death. Such discharges occurred on average at around two years, a relatively short time period. Conclusions: By following older clients over 4 years, we provide enhanced evidence of client pathways, the characteristics that influence these paths, as well as the length of time to the outcomes. This evidence is central to identification of clients at risk in the community and aids in planning for future home care servicing needs that will allow more older adults to remain living in the community. [ABSTRACT FROM AUTHOR]

Background: Postoperative hypotension is common after major non-cardiac surgery, due predominantly to vasodilation. Administration of infused vasopressors postoperatively may often be considered a surrogate indicator of vasodilation. The incidence of postoperative vasopressors has never been described for non-cardiac surgery, nor have outcomes associated with their use. This paper presents a protocol for a prospective international cohort study to address these gaps in knowledge. The primary objectives are to estimate the proportion of patients who receive postoperative vasopressor infusions (PVI) and to document the variation in this proportion between hospitals and internationally. Furthermore, we will identify factors in variation of care (patient, condition, surgery, and intraoperative management) associated with receipt of PVI and investigate how PVI use is associated with patient outcomes, including organ dysfunction, length of hospital stay, and 30-day in-hospital mortality. Method: This will be a prospective, international, multicentre cohort study that includes all adult (≥ 18 years) non-cardiac surgical patients in participating centres. Patients undergoing cardiac, obstetric, or day-case surgery will be excluded. We will recruit two cohorts of patients: cohort A will include all eligible patients admitted to participating hospitals for seven consecutive days. Cohort B will include 30 sequential patients per hospital, with the single additional inclusion criterion of postoperative vasopressor usage. We expect to collect data on approximately 40,000 patients for cohort A and 12,800 patients for cohort B. Discussion: While in cardiac surgery, clinical trials have informed the choice of vasopressors used to treat postoperative vasoplegia; there remains equipoise over the best approach in non-cardiac surgery. Our study will represent the first large-scale assessment of the use of vasopressors after non-cardiac surgery. These data will inform future studies, including trials of different vasopressors and potential management options to improve outcomes and reduce resource use after surgery. Trial registration: ClinicalTrials.gov Identifier: NCT03805230, 15 January 2019. [ABSTRACT FROM AUTHOR]

Background: The Northern Ireland Cohort for the Longitudinal Study of Ageing (NICOLA) is a prospective, longitudinal study of a representative cohort of older adults living in Northern Ireland, United Kingdom. Its aim is to explore the social, behavioural, economic and biological factors of ageing and how these factors change as people age. The study has been designed to maximize comparability with other international studies of ageing thereby facilitating cross-country comparisons. This paper provides an overview of the design and methodology of the health assessment which was carried out as part of Wave 1. Methods: Three thousand, six hundred and fifty five community dwelling adults, aged 50 years and over participated in the health assessment as part of Wave 1 of NICOLA. The health assessment included a battery of measurements across various domains that addressed key indicators of ageing namely: physical function, vision and hearing, cognitive function, and cardiovascular health. This manuscript describes the scientific rationale for the choice of assessments, provides an overview of the core objective measures carried out in the health assessment and describes the differences in characteristics of participants who took part in the health assessment compared to those who did not take part. Results: The manuscript highlights the importance of incorporating objective measures of health in population based studies as a means of complementing subjective measures and as a way to advance our understanding of the ageing process. The findings contextualize NICOLA as a data resource within Dementias Platform UK (DPUK), the Gateway to Global Ageing (G2G) and other existing networks of population based longitudinal studies of ageing. Conclusion: This manuscript can help inform design considerations for other population based studies of ageing and facilitate cross-country comparative analysis of key life-course factors affecting healthy ageing such as educational attainment, diet, the accumulation of chronic conditions (including Alzheimer's disease, dementia and cardiovascular disease) as well as welfare and retirement policies. [ABSTRACT FROM AUTHOR]

Background: Nowadays, both lateral mass screw (LMS) and pedicle screw were effective instrumentation for posterior stabilization of cervical spine. This study aims to evaluate the feasibility of a new free-hand technique of C7 pedicle screw insertion without fluoroscopic guidance for cervical spondylotic myelopathy (CSM) patients with C3 to C6 instrumented by lateral mass screws. Methods: A total of 53 CSM patients underwent lateral mass screws instrumentation at C3 to C6 levels and pedicle screw instrumentation at C7 level were included. The preoperative 3-dimenional computed tomography (CT) reconstruction images of cervical spine were used to determine 2 different C7 pedicle screw trajectories. Trajectory A passed through the axis of the C7 pedicle while trajectory B selected the midpoint of the base of C7 superior facet as the entry point. All these 53 patients had the C7 pedicle screw inserted through trajectory B by free-hand without fluoroscopic guidance and the postoperative CT images were obtained to evaluate the accuracy of C7 pedicle screw insertion. Results: Trajectory B had smaller transverse angle, smaller screw length, and smaller screw width but both similar sagittal angle and similar pedicle height when compared with trajectory A. A total of 106 pedicle screws were inserted at C7 through trajectory B and only 8 screws were displaced with the accuracy of screw placement as high as 92.5%. Conclusion: In CSM patients with C3 to C6 instrumented by LMS, using trajectory B for C7 pedicle screw insertion is easy to both identify the entry point and facilitate the rod insertion. [ABSTRACT FROM AUTHOR]

Background : In spite of the global reduction of 21% in malaria incidence between 2010 and 2015, the disease still threatens many lives of children and pregnant mothers in African countries. A correct assessment and evaluation of the impact of malaria control strategies still remains quintessential in order to eliminate the disease and its burden. Malaria follow-up studies typically involve routine visits at pre-scheduled time points and/or clinical visits whenever individuals experience malaria-like symptoms. In the latter case, infection triggers outcome assessment, thereby leading to outcome-dependent sampling (ODS). Commonly used methods to analyze such longitudinal data ignore ODS and potentially lead to biased estimates of malaria-specific transmission parameters, hence, inducing an incorrect assessment and evaluation of malaria control strategies. Methods : In this paper, a new method is proposed to handle ODS by use of a joint model for the longitudinal binary outcome measured at routine visits and the clinical event times. The methodology is applied to malaria parasitaemia data from a cohort of n = 988 Ugandan children aged 0.5–10 years from 3 regions (Walukuba—300 children, Kihihi—355 children and Nagongera—333 children) with varying transmission intensities (entomological inoculation rate equal to 2.8, 32 and 310 infectious bites per unit year, respectively) collected between 2011–2014. Results : The results indicate that malaria parasite prevalence and force of infection (FOI) increase with age in the region of high malaria intensity with highest FOI in age group 5–10 years. For the region of medium intensity, the prevalence slightly increases with age and the FOI for the routine process is highest in age group 5–10 years, yet for the clinical infections, the FOI gradually decreases with increasing age. For the region with low intensity, both the prevalence and FOI peak at the age of 1 year after which the former remains constant with age yet the latter suddenly decreases with age for the clinically observed infections. Conclusion : Malaria parasite prevalence and FOI increase with age in the region of high malaria intensity. In all study sites, both the prevalence and FOI are highest among previously asymptomatic children and lowest among their symptomatic counterparts. Using a simulation study inspired by the malaria data at hand, the proposed methodology shows to have the smallest bias, especially when consecutive positive malaria parasitaemia presence results within a time period of 35 days were considered to be due to the same infection. [ABSTRACT FROM AUTHOR]

Background: Bronchopulmonary dysplasia (BPD) is a chronic disease that affects the immature lungs of preterm infants. Infants born before 32 weeks of gestation are at a greater risk of developing BPD due to the need for respiratory support with higher oxygen requirement. Pulmonary vascular remodelling in early BPD can impose an additional burden on the right ventricle (RV) and RV dysfunction. This protocol outlines the study design and aims to formulate a prediction model to identify early BPD through the data generated from echo scans analysis. Methods: The mixed-methods observational cohort feasibility study, which comprises three work-packages (WPs), will be conducted at the regional neonatal unit, University Hospital Plymouth, Plymouth, UK. WP-I will recruit 40 preterm infants; each participant will have two heart scans performed in the first ten days after birth (DABs). WP-II will collect the documentation of the participating preterm infants' parents in the study neonatal unit diaries in the first 10 DABs. WP-III will involve semi-structured interviews of 10–15 parents of participating preterm infants and 10–15 health professionals who participated in WP-I. The study recruitment will be conducted over 18-months. The start date is 01 June 2022. WP-I and WP-II recruitment will occur during this period, while WP-III recruitment will occur during the second half. The results are expected to be submitted for publication by mid-2024. Discussion: This paper outlines the study design. If the study successfully identifies the most sensitive echo parameter in recognising the RV dysfunction associated with early BPD, it will be an important finding in constructing an early BPD prediction model. Trial registration: ClinicalTrials.gov Identifier is NCT05235399 [ABSTRACT FROM AUTHOR]

Background: Volunteering has been advocated by the United Nations, and American and European governments as a way to engage people in their local communities and improve social capital, with the potential for public health benefits such as improving wellbeing and decreasing health inequalities. Furthermore, the US Corporation for National and Community Service Strategic Plan for 2011-2015 focused on increasing the impact of national service on community needs, supporting volunteers' wellbeing, and prioritising recruitment and engagement of underrepresented populations. The aims of this review were to examine the effect of formal volunteering on volunteers' physical and mental health and survival, and to explore the influence of volunteering type and intensity on health outcomes. Methods: Experimental and cohort studies comparing the physical and mental health outcomes and mortality of a volunteering group to a non-volunteering group were identified from twelve electronic databases (Cochrane Library, Medline, Embase, PsychINFO, CINAHL, ERIC, HMIC, SSCI, ASSIA, Social Care Online, Social Policy and Practice) and citation tracking in January 2013. No language, country or date restrictions were applied. Data synthesis was based on vote counting and random effects meta-analysis of mortality risk ratios. Results: Forty papers were selected: five randomised controlled trials (RCTs, seven papers); four non-RCTs; and 17 cohort studies (29 papers). Cohort studies showed volunteering had favourable effects on depression, life satisfaction, wellbeing but not on physical health. These findings were not confirmed by experimental studies. Meta-analysis of five cohort studies found volunteers to be at lower risk of mortality (risk ratio: 0.78; 95% CI: 0.66, 0.90). There was insufficient evidence to demonstrate a consistent influence of volunteering type or intensity on outcomes. Conclusion: Observational evidence suggested that volunteering may benefit mental health and survival although the causal mechanisms remain unclear. Consequently, there was limited robustly designed research to guide the development of volunteering as a public health promotion intervention. Future studies should explicitly map intervention design to clear health outcomes as well as use pragmatic RCT methodology to test effects. [ABSTRACT FROM AUTHOR]

Background: Ankyloglossia is commonly reported as one of the major causes of breastfeeding difficulty. There is a lack of research on infant growth and latching performance with clinical measures.Cases Presentation: We describe a series of eight clinical cases (three female and five male infants) in a specialized breastfeeding center in a tertiary hospital in Northeast Brazil. The mothers were of mixed race and ranged from 13 to 41 years of age. Ankyloglossia was diagnosed within the first 48 hours after delivery. We measured the standards of growth, the mothers' perception of breastfeeding, and a pain indicator, and performed an assessment of breastfeeding. The regularity of breastfeeding was maintained despite the early diagnosis of ankyloglossia. Growth indicators were not affected in the sixth month in any of the babies, with only one measuring below expectations in the third month, with no impact on general health.Conclusions: In the cases reported in this paper, the infants overcame the initial difficulties in breastfeeding and maintained their normal growth course in the first 6 months of life. [ABSTRACT FROM AUTHOR]

Background: The etiology of hamstring strain injury (HSI) in American football is multi-factorial and understanding these risk factors is paramount to developing predictive models and guiding prevention and rehabilitation strategies. Many player-games are lost due to the lack of a clear understanding of risk factors and the absence of effective methods to minimize re-injury. This paper describes the protocol that will be followed to develop the HAMstring InjuRy (HAMIR) index risk prediction models for HSI and re-injury based on morphological, architectural, biomechanical and clinical factors in National Collegiate Athletic Association Division I collegiate football players. Methods: A 3-year, prospective study will be conducted involving collegiate football student-athletes at four institutions. Enrolled participants will complete preseason assessments of eccentric hamstring strength, on-field sprinting biomechanics and muscle–tendon volumes using magnetic-resonance imaging (MRI). Athletic trainers will monitor injuries and exposure for the duration of the study. Participants who sustain an HSI will undergo a clinical assessment at the time of injury along with MRI examinations. Following completion of structured rehabilitation and return to unrestricted sport participation, clinical assessments, MRI examinations and sprinting biomechanics will be repeated. Injury recurrence will be monitored through a 6-month follow-up period. HAMIR index prediction models for index HSI injury and re-injury will be constructed. Discussion: The most appropriate strategies for reducing risk of HSI are likely multi-factorial and depend on risk factors unique to each athlete. This study will be the largest-of-its-kind (1200 player-years) to gather detailed information on index and recurrent HSI, and will be the first study to simultaneously investigate the effect of morphological, biomechanical and clinical variables on risk of HSI in collegiate football athletes. The quantitative HAMIR index will be formulated to identify an athlete's propensity for HSI, and more importantly, identify targets for injury mitigation, thereby reducing the global burden of HSI in high-level American football players. Trial Registration The trial is prospectively registered on ClinicalTrials.gov (NCT05343052; April 22, 2022). [ABSTRACT FROM AUTHOR]

Background: Longitudinal data analysis can improve our understanding of the influences on health trajectories across the life-course. There are a variety of statistical models which can be used, and their fitting and interpretation can be complex, particularly where there is a nonlinear trajectory. Our aim was to provide an accessible guide along with applied examples to using four sophisticated modelling procedures for describing nonlinear growth trajectories.Methods: This expository paper provides an illustrative guide to summarising nonlinear growth trajectories for repeatedly measured continuous outcomes using (i) linear spline and (ii) natural cubic spline linear mixed-effects (LME) models, (iii) Super Imposition by Translation and Rotation (SITAR) nonlinear mixed effects models, and (iv) latent trajectory models. The underlying model for each approach, their similarities and differences, and their advantages and disadvantages are described. Their application and correct interpretation of their results is illustrated by analysing repeated bone mass measures to characterise bone growth patterns and their sex differences in three cohort studies from the UK, USA, and Canada comprising 8500 individuals and 37,000 measurements from ages 5-40 years. Recommendations for choosing a modelling approach are provided along with a discussion and signposting on further modelling extensions for analysing trajectory exposures and outcomes, and multiple cohorts.Results: Linear and natural cubic spline LME models and SITAR provided similar summary of the mean bone growth trajectory and growth velocity, and the sex differences in growth patterns. Growth velocity (in grams/year) peaked during adolescence, and peaked earlier in females than males e.g., mean age at peak bone mineral content accrual from multicohort SITAR models was 12.2 years in females and 13.9 years in males. Latent trajectory models (with trajectory shapes estimated using a natural cubic spline) identified up to four subgroups of individuals with distinct trajectories throughout adolescence.Conclusions: LME models with linear and natural cubic splines, SITAR, and latent trajectory models are useful for describing nonlinear growth trajectories, and these methods can be adapted for other complex traits. Choice of method depends on the research aims, complexity of the trajectory, and available data. Scripts and synthetic datasets are provided for readers to replicate trajectory modelling and visualisation using the R statistical computing software. [ABSTRACT FROM AUTHOR]

Background: Data privacy is one of the biggest challenges for any organisation which processes personal data, especially in the area of medical research where data include sensitive information about patients and study participants. Sharing of data is therefore problematic, which is at odds with the principle of open data that is so important to the advancement of society and science. Several statistical methods and computational tools have been developed to help data custodians and analysts overcome this challenge.Methods: In this paper, we propose a new deterministic approach for anonymising personal data. The method stratifies the underlying data by the categorical variables and re-distributes the continuous variables through a k nearest neighbours based algorithm.Results: We demonstrate the use of the deterministic anonymisation on real data, including data from a sample of Titanic passengers, and data from participants in the 1958 Birth Cohort.Conclusions: The proposed procedure makes data re-identification difficult while minimising the loss of utility (by preserving the spatial properties of the underlying data); the latter means that informative statistical analysis can still be conducted. [ABSTRACT FROM AUTHOR]

Background: Rapidly ageing populations means that many people now die in advanced age. This paper investigated public hospital and long-term care home costs in the 12 months before death in Māori and non-Māori of advanced age in New Zealand. Methods: Data from an existing longitudinal study (LiLACS NZ) was used, in which 937 older New Zealanders were enrolled in 2010. At the time of this study, 213 Māori and 241 non-Māori in the cohort had died. National Health Index numbers were linked to the hospitalisation National Minimum Dataset to ascertain public hospitalisation and care home costs in the last year of life. Results: The average total publicly funded hospital and long-term care home costs in the 12 months prior to death were $16,211 and $17,351 for Māori and non-Māori respectively. Non-Māori tended to have long lengths of stay in their last year of life, and non-Māori men had the highest proportion with high costs and long lengths of stay in care homes. Costs in the last year of life were 8.1 times higher in comparison to costs for individuals who did not die in the same time period. Conclusion: Despite New Zealand's commitment to providing an equitable level of healthcare, this study illustrated that ethnic and gender disparities are still apparent at the end of life. This raises questions as to whether money at the end of life is being spent appropriately, and how it could potentially be more equitably targeted to meet the diverse needs of older people and their families. [ABSTRACT FROM AUTHOR]

Background: In this evaluation, we aim to strengthen Routine Health Information Systems (RHIS) through the digitization of data quality assessment (DQA) processes. We leverage electronic data from the Kenya Health Information System (KHIS) which is based on the District Health Information System version 2 (DHIS2) to perform DQAs at scale. We provide a systematic guide to developing composite data quality scores and use these scores to assess data quality in Kenya. Methods: We evaluated 187 HIV care facilities with electronic medical records across Kenya. Using quarterly, longitudinal KHIS data from January 2011 to June 2018 (total N = 30 quarters), we extracted indicators encompassing general HIV services including services to prevent mother-to-child transmission (PMTCT). We assessed the accuracy (the extent to which data were correct and free of error) of these data using three data-driven composite scores: 1) completeness score; 2) consistency score; and 3) discrepancy score. Completeness refers to the presence of the appropriate amount of data. Consistency refers to uniformity of data across multiple indicators. Discrepancy (measured on a Z-scale) refers to the degree of alignment (or lack thereof) of data with rules that defined the possible valid values for the data. Results: A total of 5,610 unique facility-quarters were extracted from KHIS. The mean completeness score was 61.1% [standard deviation (SD) = 27%]. The mean consistency score was 80% (SD = 16.4%). The mean discrepancy score was 0.07 (SD = 0.22). A strong and positive correlation was identified between the consistency score and discrepancy score (correlation coefficient = 0.77), whereas the correlation of either score with the completeness score was low with a correlation coefficient of -0.12 (with consistency score) and -0.36 (with discrepancy score). General HIV indicators were more complete, but less consistent, and less plausible than PMTCT indicators. Conclusion: We observed a lack of correlation between the completeness score and the other two scores. As such, for a holistic DQA, completeness assessment should be paired with the measurement of either consistency or discrepancy to reflect distinct dimensions of data quality. Given the complexity of the discrepancy score, we recommend the simpler consistency score, since they were highly correlated. Routine use of composite scores on KHIS data could enhance efficiencies in DQA at scale as digitization of health information expands and could be applied to other health sectors beyondHIV clinics. [ABSTRACT FROM AUTHOR]

Background: Recently, time-driven activity-based costing (TDABC) is put forward as an alternative, more accurate costing method to calculate the cost of a medical treatment because it allows the assignment of costs directly to patients. The objective of this paper is the application of a time-driven activity-based method in order to estimate the cost of childbirth at a maternal department. Moreover, this study shows how this costing method can be used to outline how childbirth costs vary according to considered patient and disease characteristics. Through the use of process mapping, TDABC allows to exactly identify which activities and corresponding resources are impacted by these characteristics, leading to a more detailed understanding of childbirth cost.Methods: A prospective cohort study design is performed in a maternity department. Process maps were developed for two types of childbirth, vaginal delivery (VD) and caesarean section (CS). Costs were obtained from the financial department and capacity cost rates were calculated accordingly.Results: Overall, the cost of childbirth equals €1894,12 and is mainly driven by personnel costs (89,0%). Monitoring after birth is the most expensive activity on the pathway, costing €1149,70. Significant cost variations between type of delivery were found, with VD costing €1808,66 compared to €2463,98 for a CS. Prolonged clinical visit (+ 33,3 min) and monitoring (+ 775,2 min) in CS were the main contributors to this cost difference. Within each delivery type, age, parity, number of gestation weeks and education attainment were found to drive cost variations. In particular, for VD an age >  25 years, nulliparous, gestation weeks > 40 weeks and higher education attainment were associated with higher costs. Similar results were found within CS for age, parity and number of gestation weeks.Conclusions: TDABC is a valuable approach to measure and understand the variability in costs of childbirth and its associated drivers over the full care cycle. Accordingly, these findings can inform health care providers, managers and regulators on process improvements and cost containment initiatives. [ABSTRACT FROM AUTHOR]

Background: Type 2 diabetes (T2D) is common and increasing in prevalence. It is possible to prevent or delay T2D using lifestyle intervention programmes. Entry to these programmes is usually determined by a measure of glycaemia in the 'intermediate' range. This paper investigated the relationship between HbA1c and future diabetes risk and determined the impact of varying thresholds to identify those at high risk of developing T2D.Methods: We studied 4227 participants without diabetes aged ≥ 40 years recruited to the Exeter 10,000 population cohort in South West England. HbA1c was measured at study recruitment with repeat HbA1c available as part of usual care. Absolute risk of developing diabetes within 5 years, defined by HbA1c ≥ 48 mmol/mol (6.5%), according to baseline HbA1c, was assessed by a flexible parametric survival model.Results: The overall absolute 5-year risk (95% CI) of developing T2D in the cohort was 4.2% (3.6, 4.8%). This rose to 7.1% (6.1, 8.2%) in the 56% (n = 2358/4224) of participants classified 'high-risk' with HbA1c ≥ 39 mmol/mol (5.7%; ADA criteria). Under IEC criteria, HbA1c ≥ 42 mmol/mol (6.0%), 22% (n = 929/4277) of the cohort was classified high-risk with 5-year risk 14.9% (12.6, 17.2%). Those with the highest HbA1c values (44-47 mmol/mol [6.2-6.4%]) had much higher 5-year risk, 26.4% (22.0, 30.5%) compared with 2.1% (1.5, 2.6%) for 39-41 mmol/mol (5.7-5.9%) and 7.0% (5.4, 8.6%) for 42-43 mmol/mol (6.0-6.1%). Changing the entry criterion to prevention programmes from 39 to 42 mmol/mol (5.7-6.0%) reduced the proportion classified high-risk by 61%, and increased the positive predictive value (PPV) from 5.8 to 12.4% with negligible impact on the negative predictive value (NPV), 99.6% to 99.1%. Increasing the threshold further, to 44 mmol/mol (6.2%), reduced those classified high-risk by 59%, and markedly increased the PPV from 12.4 to 23.2% and had little impact on the NPV (99.1% to 98.5%).Conclusions: A large proportion of people are identified as high-risk using current thresholds. Increasing the risk threshold markedly reduces the number of people that would be classified as high-risk and entered into prevention programmes, although this must be balanced against cases missed. Raising the entry threshold would allow limited intervention opportunities to be focused on those most likely to develop T2D. [ABSTRACT FROM AUTHOR]

Background: Increasingly, strength-based approaches to health and wellbeing interventions with Aboriginal and Torres Strait Islander Australians are being explored. This is a welcome counter to deficit-based initiatives which can represent a non-Indigenous view of outcomes of interest. However, the evidence base is not well developed. This paper presents the protocol for evaluating a strengths-based initiative which provides life coaching services to Aboriginal and Torres Strait Islander community housing tenants. The study aims to evaluate the effect of life coaching on social and emotional wellbeing (SEWB) of tenants in three Victorian regions.Methods: The More Than a Landlord (MTAL) study is a prospective cohort study of Aboriginal Housing Victoria tenants aged 16 years and over that embeds the evaluation of a life coaching program. All tenant holders in one metropolitan and two regional areas of Victoria are invited to participate in a survey of SEWB, containing items consistent with key categories of SEWB as understood and defined by Aboriginal and Torres Strait Islander peoples, and key demographics, administered by Aboriginal and Torres Strait Islander peer researchers at baseline, 6 and 18 months. Survey participants are then invited to participate in strengths based life coaching, using the GROW model, for a duration of up to 18 months. Indigenous life coaches provide tenants with structured support in identifying and making progress towards their goals and aspirations, rather than needs. The study aims to recruit a minimum of 200 survey participants of which it is anticipated that approximately 73% will agree to life coaching.Discussion: The MTAL study is a response to Aboriginal and Torres Strait Islander community and organisational requests to build the evidence base for an initiative originally developed and piloted within an Aboriginal controlled organisation. The study design aligns with key principles for research in Indigenous communities in promoting control, decision making and capacity building. The MTAL study will provide essential evidence to evaluate the effectiveness of strengths-based initiatives in promoting SEWB in these communities and provide new evidence about the relationship between strengths, resilience, self-determination and wellbeing outcomes.Trial Registration: This trial was retrospectively registered with the ISRCTN Register on the 12/7/21 with the study ID: ISRCTN33665735 . [ABSTRACT FROM AUTHOR]

Background: Given the high rates of cannabis use among Canadian youth and that adolescence is a critical period for cannabis use trajectories, the purpose of this paper was to examine the effect of the early stages of the COVID-19 pandemic period on youth cannabis use in the context of a natural experiment. We used 3-year linked data from the COMPASS study, including 7653 Canadian (Quebec, Ontario) adolescents from which 1937 completed all 3 survey waves (pre-COVID-19 [2018, 2019] and online [2020] during the early pandemic period [May-July 2020]). Structural equation modeling (SEM) and double difference (DD) models were used to estimate pre-COVID-19 to initial COVID-19 pandemic period change (2019-2020) in cannabis use (monthly, weekly, daily) compared to 2018 to 2019 change to adjust for age-related effects. Models were adjusted for age of entry into the cohort and sociodemographic characteristics.Results: In the SEM and DD models, monthly, weekly, and daily cannabis use increased across all waves; however, the expected increases from the pre-COVID-19 wave (2019) to the initial COVID-19 period wave (2020) were lesser relative to the changes seen across the 2018 to 2019 waves. The cross-sectional data from May to July 2020 identified that the majority of youth who use cannabis did not report increased cannabis use due to COVID-19 or using cannabis to cope with COVID-19.Conclusion: During the early stages of the COVID-19 pandemic period, there does not appear to be a detrimental effect on youth cannabis use, when adjusted for age-related changes. Further prospective research is needed to explore the impact of the ongoing pandemic response on youth cannabis use onset and progression. [ABSTRACT FROM AUTHOR]

Background: There are limited data describing adverse infant outcomes in infants born to women with a low risk of complications during pregnancy, such as those who may be enrolled in maternal immunization trials. This retrospective study estimated incidence proportions of infant outcomes in different cohorts of liveborn infants in England between 2005 and 2017. Methods: The incidence proportions of 10 infant outcomes were calculated for liveborn infants from pregnancies represented in the Clinical Practice Research Datalink (CPRD) Mother-Baby Link (MBL) and linkage to Hospital Episode Statistics (HES). Three infant cohorts were designed: (1) the all pregnancies infants cohort (N = 185,119), (2) the all pregnancies with a gestational age (GA) ≥ 24 weeks infants cohort (N = 183,869), and (3) the low-risk pregnancies infants cohort (LR infants cohort, N = 121,871), which included pregnancies with a GA ≥ 24 weeks and no diagnosis of predefined high-risk medical conditions until 24 weeks GA. Results: The most common adverse infant outcome in the three infant cohorts was macrosomia (e.g., 1,085.9/10,000 live births in the LR infants cohort), followed by minor congenital anomalies (e.g., 800.6/10,000 in the LR infants cohort), very low/low birth weight (e.g., 400.6/10,000 in the LR infants cohort), and major congenital anomalies (e.g., 270.4/10,000 in the LR infants cohort). The incidence proportions for early-onset sepsis, very low/low birth weight, and minor and major congenital anomalies were lower in the LR infants than in the other cohorts (non-overlapping confidence intervals [CIs]). The incidence proportions of neonatal death, infant death, late-onset sepsis, macrosomia, small for GA, and large for GA were similar between cohorts (overlapping CIs). Conclusions: This study generated background rates of adverse infant outcomes from liveborn infants of all and low-risk pregnancies represented in the CPRD Pregnancy Register MBL and linkage to HES. The results indicate lower incidence proportions of several adverse infant outcomes in infants from low-risk pregnancies compared to all pregnancies, illustrating the importance of considering maternal risk factors. These background rates may facilitate the interpretation of safety data from maternal immunization trials and of pharmacovigilance data from maternal vaccines. They may also be of interest for other interventions studied in pregnant women. [ABSTRACT FROM AUTHOR]

Background: Telephone triage within out-of-hours (OOH) services aims to ascertain the urgency of a caller's medical condition in order to determine the correct type of health care needed, ensuring patient safety. To improve the triage process by increasing patient-centred communication, a triage tool has been developed, whereby callers are asked to rate their degree-of-worry (DOW) as a measure of self-evaluated urgency. Studies show that low socioeconomic status (SES), being single and non-Western ethnicity are associated to low self-rated health and high morbidity and these factors may also be associated with high DOW. The aim of this paper was to examine if low SES, being single and non-Western ethnicity were associated to high DOW of callers contacting OOH services.Methods: A prospective cohort study design, at the OOH services for the Capital Region of Denmark. Over 2 weeks, 6869 of 38,787 callers met the inclusion criteria: ≥18 years, patients themselves or close relative/friend, reported DOW, had a valid personal identification number and gave informed consent. Callers were asked to report their DOW (1 = minimal worry to 5 = maximal worry), which was dichotomized into low (1-3) and high (4, 5) DOW and linked to data from electronical medical records and Statistics Denmark. Socioeconomic factors (education and annual household income), marital status and ethnicity were assessed in relation to DOW by logistic regression.Results: High DOW was reported by 38.2% of the participants. Low SES (low educational level; OR 1.5, 95% CI 1.3-1.7 and low annual household income; 1.5, 1.3-1.6) was associated with high DOW and so too was being single; 1.2, 1.1-1.3 and of non-Western ethnicity; 2.9, 2.5-3.4.Conclusions: Knowledge of the association of low SES, marital status as single and non-Western ethnicity with high DOW among callers to OOH services may give call handlers a better understanding of callers' DOW. If this does not correspond to the call handler's perception of urgency, this knowledge may further encourage patient-centred communication, aid the triage process and increase patient safety. A better understanding of socioeconomic variables and their relation to callers' DOW gives direction for future research to improve telephone triage of OOH services. [ABSTRACT FROM AUTHOR]

Background: The majority of people with cancer have at least one other chronic health condition. With each additional chronic disease, the complexity of their care increases, as does the potential for negative outcomes including premature death. In this paper, we describe cancer patients' clinical complexity (i.e., multimorbidity; MMB) in order to inform strategic efforts to improve care and outcomes for people with cancer of all types and commonly occurring chronic diseases.Methods: We conducted a population-based, retrospective cohort study of adults diagnosed with cancer between 2003 and 2013 (N = 601,331) identified in Ontario, Canada healthcare administrative data. During a five to 15-year follow-up period (through March 2018), we identified up to 16 co-occurring conditions and patient outcomes for the cohort, including health service utilization and death.Results: MMB was extremely common, affecting more than 91% of people with cancer. Nearly one quarter (23%) of the population had five or more co-occurring conditions. While we saw no differences in MMB between sexes, MMB prevalence and level increased with age. MMB prevalence and type of co-occurring conditions also varied by cancer type. Overall, MMB was associated with higher rates of health service utilization and mortality, regardless of other patient characteristics, and specific conditions differentially impacted these rates.Conclusions: People with cancer are likely to have at least one other chronic medical condition and the presence of MMB negatively affects health service utilization and risk of premature death. These findings can help motivate and inform health system advances to improve care quality and outcomes for people with cancer and MMB. [ABSTRACT FROM AUTHOR]

Background: The treatment of anorexia nervosa (AN) is often challenging due to medical complications as well as high relapse and mortality rates. Studies about effective treatment options for people with AN are particularly scarce in the adolescent population. This paper is a study protocol for a multi-center cohort study assessing the feasibility, acceptability and efficacy of a new, manualized treatment program, the "Maudsley Model of Anorexia Nervosa Treatment for Adolescents and Young Adults" (MANTRa) compared to psychotherapeutic treatment as usual (TAU). Methods/design: One hundred patients between 13 and 21 years who meet the inclusion criteria will receive 24 to 34 individual weekly MANTRa therapy sessions or weekly TAU sessions. Primary outcome variables will be BMI and eating disorder psychopathology 12 months after baseline. Further changes in central coherence, cognitive flexibility, emotion recognition, comorbid psychopathology (e.g. depression, obsessive-compulsive and anxiety disorders, non-suicidal self-injury), personality factors and therapeutic alliance will be assessed. Discussion: This multi-center study will examine the utility of the treatment program MANTRa for adolescents with AN and, therefore enhances the current knowledge about potential treatments for this patient group. Trial registration: ClinicalTrials.gov Identifier: NCT03535714. Registered: 24/05/2018 (retrospectively registered, still recruiting). [ABSTRACT FROM AUTHOR]

Background: Treatment decisions concerning older patients can be very challenging and individualised treatment plans are often required in this very heterogeneous group. In 2015 we have implemented a routine clinical care pathway for older patients in need of intensive treatment, including a comprehensive geriatric assessment (CGA) that was used to support clinical decision making. An ongoing prospective cohort study, the Triaging Elderly Needing Treatment (TENT) study, has also been initiated in 2016 for participants in this clinical care pathway, to study associations between geriatric characteristics and outcomes of treatment that are relevant to older patients. The aim of this paper is to describe the implementation and rationale of the routine clinical care pathway and design of the TENT study.Methods: A routine clinical care pathway has been designed and implemented in multiple hospitals in the Netherlands. Patients aged ≥70 years who are candidates for intensive treatments, such as chemotherapy, (chemo-)radiation therapy or major surgery, undergo frailty screening based on the Geriatric 8 (G-8) questionnaire and the Six-Item Cognitive Impairment Test (6CIT). If screening reveals potential frailty, a CGA is performed. All patients are invited to participate in the TENT study. Clinical data and blood samples for biomarker studies are collected at baseline. During follow-up, information about treatment complications, hospitalisations, functional decline, quality of life and mortality is collected. The primary outcome is the composite endpoint of functional decline or mortality at 1 year.Discussion: Implementation of a routine clinical care pathway for older patients in need of intensive treatment provides the opportunity to study associations between determinants of frailty and outcomes of treatment. Results of the TENT study will support individualised treatment for future patients.Trial Registration: The study is retrospectively registered at the Netherlands Trial Register (NTR), trial number NL8107 . Date of registration: 22-10-2019. [ABSTRACT FROM AUTHOR]

Background: The development of ambulatory emergency care services, now called 'Same Day Emergency Care' (SDEC) has been advocated to provide sustainable high quality healthcare in an ageing population. However, there are few data on SDEC and the factors associated with successful ambulatory care in frail older people. We therefore undertook a prospective observational study to determine i) the clinical characteristics and frailty burden of a cohort in an SDEC designed around the needs of older patients and ii) the factors associated with hospital admission within 30-days after initial assessment.Methods: The study setting was the multidisciplinary Abingdon Emergency Medical Unit (EMU) located in a community hospital and led by a senior interface physician (geriatrician or general practitioner). Consecutive patients from August-December 2015 were assessed using a structured paper proforma including cognitive/delirium screen, comorbidities, functional, social, and nutritional status. Physiologic parameters were recorded. Illness severity was quantified using the Systemic Inflammatory Response Syndrome (SIRS> 1). Factors associated with hospitalization within 30-days were determined using multivariable logistic regression.Results: Among 533 patients (median (IQR) age = 81 (68-87), 315 (59%) female), 453 (86%) were living at home but 283 (54%) required some form of care and 299 (56%) had Barthel< 20. Falls, urinary incontinence and dementia affected 81/189 (43%), 50 (26%) and 40 (21%) of those aged > 85 years." Severe illness was present in 148 (28%) with broadly similar rates across age groups. Overall, 210 (39%) patients had a hospital admission within 30-days with higher rates in older patients: 96 (87%) of < 65 years remained on an ambulatory pathway versus only 91 (48%) of ≥ 85 years (p < 0.0001). Factors independently associated with hospital admission were severe illness (SIRS/point, OR = 1.46,95% CI = 1.15-1.87, p = 0.002) and markers of frailty: delirium (OR = 11.28,3.07-41.44, p < 0.0001), increased care needs (OR = 3.08,1.55-6.12, p = 0.001), transport requirement (OR = 1.92,1.13-3.27), and poor nutrition (OR = 1.13-3.79, p = 0.02).Conclusions: Even in an SDEC with a multidisciplinary approach, rates of hospital admission in those with severe illness and frailty were high. Further studies are required to understand the key components of hospital bed-based care that need to be replicated by models delivering acute frailty care closer to home, and the feasibility, cost-effectiveness and patient/carer acceptability of such models. [ABSTRACT FROM AUTHOR]

Background: Multiple sclerosis is a chronic, incurable, demyelinating disease that requires long-term treatment. Rates of non-adherence to prescribed therapy of up to 50% have been reported for chronic diseases. Strategies to improve treatment adherence are therefore of the utmost importance. This study will evaluate the effect of using electronic and paper diaries on treatment adherence to interferon beta-1b in patients with a first clinical isolated syndrome (CIS) or relapsing-remitting multiple sclerosis (RRMS). Here we report on the study design and results of baseline assessments. Methods: Patients were recruited into a prospective national multicenter cohort study for an observational period of 2 years. At the start of the study, patients opted to use a digital (DiD) or paper diary (PD) to document self-administered injections of interferon beta-1b. Adherence to treatment will be assessed on the dropout rate at the end of the observation period and on the regularity of injections every other day at 6-month intervals. Patient-related health outcomes will also be evaluated. Results: 700 patients with a mean age of 38.3 (SD 10.3) years and a mean duration of disease since diagnosis of 3.6 (SD 5.9) years were enrolled. 383 patients opted for the digital diary, 192 of which included an injection reminder. Significantly more male than female patients opted for the DiD. Only gender was identified as a factor influencing the decision for DiD or PD. Based on rating scales, a significantly higher proportion of women had depressive comorbidities at baseline. Conclusions: Demographic characteristics of the two cohorts were similar at baseline. More women chose a paper diary, and more had depression at baseline. These imbalances will be addressed in the analysis of the study as possible confounders influencing long-term treatment adherence in the digital and paper diary cohorts. [ABSTRACT FROM AUTHOR]

Background: Observational studies, if conducted appropriately, play an important role in the decision-making process providing invaluable information on effectiveness, patient-reported outcomes and costs in a real-world environment. We conducted a systematic review of large-scale, prospective, cohort studies with the aim of (a) summarising design characteristics, the interventions or aspects of the disease studied and the outcomes measured and (b) investigating methodological quality. Methods: We included prospective, cohort studies which included at least 100 adults with psoriasis or psoriatic arthritis. Studies were identified through searches in electronic databases (Pubmed, Medline, Cochrane library, Centre for Reviews and Dissemination). Information on study characteristics were extracted and tabulated and quality assessment, using a checklist of 18 questions, was conducted. Results: Thirty five papers covering 16 cohorts met the inclusion criteria. There were ten treatment-related studies, only two of which provided a comparison between treatments, and six non-treatment studies which examined a number of characteristics of the disease including mortality, morbidity, cost of illness and health-related quality of life. All studies included a clinical outcome measure and 11 included patient-reported outcomes, however only two studies reported information on patient utilities and two on costs. The quality of the assessed studies varied widely. Studies did well on a number of quality assessment questions including having clear objectives, documenting selection criteria, providing a representative sample, defining interventions/characteristics under study, defining and using appropriate outcomes, describing results clearly and using appropriate statistical tests. The quality assessment criteria least adhered to involved questions regarding sample size calculations, describing potential selection bias, defining and adjusting for confounders and losses to follow-up, and defining and describing a comparison group. Conclusion: The review highlights the need for well designed prospective observational studies on the effectiveness, patient-reported outcomes and economic impact of treatment regimes for patients with psoriasis and psoriatic arthritis in a real-world environment. [ABSTRACT FROM AUTHOR]

The aim of this review was to assess the evidence from recent prospective studies that long-term traffic pollution could contribute to the development of asthma-like symptoms and allergic sensitization in children. We have reviewed cohort studies published since 2002 and found in PubMed in Oct 2008. In all, 13 papers based on data from 9 cohorts have evaluated the relationship between traffic exposure and respiratory health. All surveys reported associations with at least some of the studied respiratory symptoms. The outcome varied, however, according to the age of the child. Nevertheless, the consistency in the results indicates that traffic exhaust contributes to the development of respiratory symptoms in healthy children. Potential effects of traffic exhaust on the development of allergic sensitization were only assessed in the four European birth cohorts. Long-term exposure to outdoor air pollutants had no association with sensitization in ten-year-old schoolchildren in Norway. In contrast, German, Dutch and Swedish preschool children had an increased risk of sensitization related to traffic exhaust despite fairly similar levels of outdoor air pollution as in Norway. Traffic-related effects on sensitization could be restricted to individuals with a specific genetic polymorphism. Assessment of gene-environment interactions on sensitization has so far only been carried out in a subgroup of the Swedish birth cohort. Further genetic association studies are required and may identify individuals vulnerable to adverse effects from traffic-related pollutants. Future studies should also evaluate effects of traffic exhaust on the development and long term outcome of different phenotypes of asthma and wheezing symptoms. [ABSTRACT FROM AUTHOR]

Background: Epidemiological evidence suggests that healthy diet is associated with a slowdown of cognitive decline leading to dementia, but the underlying mechanisms are still partially unexplored. Diet is the main determinant of gut microbiota composition, which in turn impacts on brain structures and functions, however to date no studies on this topic are available. The goal of the present paper is to describe the design and methodology of the NutBrain Study aimed at investigating the association of dietary habits with cognitive function and their role in modulating the gut microbiota composition, and brain measures as well.Methods/design: This is a population-based cohort study of community-dwelling adults aged 65 years or more living in Northern Milan, Italy. At the point of presentation people are screened for cognitive functions. Socio-demographic characteristics along with lifestyles and dietary habits, medical history, drugs, functional status, and anthropometric measurements are also recorded. Individuals suspected to have cognitive impairment at the screening phase undergo a clinical evaluation including a neurological examination and a Magnetic Resonance Imaging (MRI) scanning (both structural and functional). Stool and blood samples for the gut microbiota analysis and for the evaluation of putative biological markers are also collected. For each subject with a confirmed diagnosis of Mild Cognitive Impairment (MCI), two cognitively intact controls of the same sex and age are visited. We intend to enrol at least 683 individuals for the screening phase and 240 persons for the clinical assessment.Discussion: The NutBrain is an innovative study that incorporates modern and advanced technologies (i.e. microbiome and neuroimaging) into traditional epidemiologic design. The study represents a unique opportunity to address key questions about the role of modifiable risk factors on cognitive impairment, with a particular focus on dietary habits and their association with gut microbiota and markers of the brain-aging process. These findings will help to encourage and plan lifestyle interventions, for both prevention and treatment, aiming at promoting healthy cognitive ageing.Trial Registration: Trial registration number NCT04461951 , date of registration July 7, 2020 (retrospectively registered, ClinicalTrials.gov ). [ABSTRACT FROM AUTHOR]

Background: Posterior tibial nerve stimulation (PTNS) is a promising treatment for lower urinary tract symptoms (LUTS) in patients with MS. However, long term data focusing on PTNS impact on health-related quality of life (HRQOL), bowel and bladder symptoms are lacking. This paper describes a study protocol that examines the extended efficacy of PTNS on MS related bladder and bowel symptoms and resulting HRQOL.Methods/design: This is a single-centered, prospective, longitudinal, observational cohort study of patients with MS who suffer from LUTS and are refractory to two prior treatment modalities. Participants who have elected to pursue PTNS therapy for LUTS will be eligible. The primary outcome is the median number of urinary frequency and incontinence episodes on a 3-day voiding diary at 3, 12 and 24 months compared to baseline. Secondary outcome measures will include change in total AUA-SS, M-ISI, NBSS, SF-12, SSS and BCS scores from baseline The Expanded Disability Status Scale and magnetic resonance imaging will be evaluated at baseline and annually throughout the study.Discussion: This research protocol aims to expand on the existing literature regarding outcomes of PTNS in MS. Specifically, it will provide long term follow-up data on bladder, bowel, sexual and HRQOL outcomes. The completion of this study will provide longitudinal efficacy data of the impact of PTNS in MS patients.Trial Registration: NCT04063852. [ABSTRACT FROM AUTHOR]

Background: Early Intervention (EI) is a federally mandated, state-administered system of care for children with developmental delays and disabilities under the age of three. Gaps exist in the process of accessing EI through pediatric primary care, and low rates of EI access are well documented and disproportionately affect poor and minority children. The aims of this paper are to examine child characteristics associated with gaps in EI (1) referral, (2) access and (3) service use. To our knowledge, this is the first study to leverage linked safety net health system pediatric primary care and EI records data to follow EI-referred children longitudinally to understand EI service use gaps from EI referral to EI service utilization.Methods: In a retrospective cohort design (14,710 children with developmental disability or delay), we linked pediatric primary care records between a large, integrated safety net health system in metro Denver and its corresponding EI program (2014-2016). Using adjusted marginal effects [ME, (95% CI)], we estimated gaps in EI referral, access, and service type (i.e., physical [PT], occupational [OT], speech therapy [ST] and developmental intervention [DI]). Analyses accounted for child characteristics including socio-demographics, diagnosis, condition severity, and baseline function.Results: Only 18.7% of EI-eligible children (N = 2726) received a referral; 26% of those (N = 722) received services for a net enrollment rate of 5% among EI-eligible children. Having the most severe developmental condition was positively associated with EI referral [ME = 0.334 [0.249, 0.420]) and Individualized Family Services Plan (IFSP) receipt [ME = 0.156 [0.088, 0.223]). Children less likely to be EI-referred were Black, non-Hispanic (BNH) [ME = -0.029 (- 0.054, - 0.004)] and had a diagnosed condition ([ME = - 0.046 (- 0.087, - 0.005)]. Children with a diagnosis and those with higher income were more likely to receive PT or OT. Higher baseline cognitive and adaptive skills were associated with lower likelihood of PT [ME = -0.029 (- 0.054, - 0.004)], OT [ME = -0.029 (- 0.054, - 0.004)], and ST [ME = -0.029 (- 0.054, - 0.004)].Conclusions: We identified and characterized gaps in EI referral, access, and service use in an urban safety-net population of children with high rates of developmental delay. Interventions are needed to improve integrated systems of care affecting primary care and EI processes and coordination. [ABSTRACT FROM AUTHOR]

While exposure to hexavalent chromium (Cr(VI)) has been associated with increased lung cancer risk for more than 50 years, the chemical is not currently regulated by the U.S. Occupational Safety and Health Administration (OSHA) on the basis of its carcinogenicity. The agency was petitioned in 1993 and sued in 1997 and 2002 to lower the workplace Cr(VI) exposure limit, resulting in a court order to issue a final standard by February 2006. Faced with the threat of stronger regulation, the chromium industry initiated an effort to challenge the scientific evidence supporting a more protective standard. This effort included the use of "product defense" consultants to conduct post hoc analyses of a publicly-funded study to challenge results viewed unfavorably by the industry. The industry also ommissioned a study of the mortality experience of workers at four lowexposure chromium plants, but did not make the results available to OSHA in a timely manner, despite multiple agency requests for precisely these sorts of data. The commissioned study found a statistically significant elevation in lung cancer risk among Cr(VI)-exposed workers at levels far below the current standard. This finding changed when the multi-plant cohort was divided into two statistically underpowered components and then published separately. The findings of the first paper published have been used by the chromium industry to attempt to slow OSHA's standard setting process. The second paper was withheld from OSHA until it was accepted for publication in a scientific journal, after the rulemaking record had closed. Studies funded by private sponsors that seek to influence public regulatory proceedings should be subject to the same access and reporting provisions as those applied to publicly funded science. Parties in regulatory proceedings should be required to disclose whether the studies were performed by researchers who had the right to present their findings without the sponsor's consent or influence, and to certify that all relevant data have been submitted to the public record, whether published or not. [ABSTRACT FROM AUTHOR]

Background: The impact of dynamic changes in the degree of atherosclerosis on the development of prediabetes remains unclear. This study aims to investigate the association between cumulative atherogenic index of plasma (CumAIP) exposure during follow-up and the development of prediabetes in middle-aged and elderly individuals. Methods: A total of 2,939 prediabetic participants from the first wave of the China Health and Retirement Longitudinal Study (CHARLS) were included. The outcomes for these patients, including progression to diabetes and regression to normal fasting glucose (NFG), were determined using data from the third wave. CumAIP was calculated as the ratio of the average AIP values measured during the first and third waves to the total exposure duration. The association between CumAIP and the development of prediabetes was analyzed using multivariable Cox regression and restricted cubic spline (RCS) regression. Results: During a median follow-up period of 3 years, 15.21% of prediabetic patients progressed to diabetes, and 22.12% regressed to NFG. Among the groups categorized by CumAIP quartiles, the proportion of prediabetes progressing to diabetes gradually increased (Q1: 10.61%, Q2: 13.62%, Q3: 15.65%, Q4: 20.95%), while the proportion regressing to NFG gradually decreased (Q1: 23.54%, Q2: 23.71%, Q3: 22.18%, Q4: 19.05%). Multivariable-adjusted Cox regression showed a significant positive linear correlation between high CumAIP exposure and prediabetes progression, and a significant negative linear correlation with prediabetes regression. Furthermore, in a stratified analysis, it was found that compared to married individuals, those who were unmarried (including separated, divorced, widowed, or never married) had a relatively higher risk of CumAIP-related diabetes. Conclusion: CumAIP is closely associated with the development of prediabetes. High CumAIP exposure not only increases the risk of prediabetes progression but also hinders its regression within a certain range. These findings suggest that monitoring and maintaining appropriate AIP levels may help prevent the deterioration of blood glucose levels. [ABSTRACT FROM AUTHOR]

Background: Eating disorders (EDs) are serious, often chronic, conditions associated with pronounced morbidity, mortality, and dysfunction increasingly affecting young people worldwide. Illness progression, stages and recovery trajectories of EDs are still poorly characterised. The STORY study dynamically and longitudinally assesses young people with different EDs (restricting; bingeing/bulimic presentations) and illness durations (earlier; later stages) compared to healthy controls. Remote measurement technology (RMT) with active and passive sensing is used to advance understanding of the heterogeneity of earlier and more progressed clinical presentations and predictors of recovery or relapse. Methods: STORY follows 720 young people aged 16–25 with EDs and 120 healthy controls for 12 months. Online self-report questionnaires regularly assess ED symptoms, psychiatric comorbidities, quality of life, and socioeconomic environment. Additional ongoing monitoring using multi-parametric RMT via smartphones and wearable smart rings ('Ōura ring') unobtrusively measures individuals' daily behaviour and physiology (e.g., Bluetooth connections, sleep, autonomic arousal). A subgroup of participants completes additional in-person cognitive and neuroimaging assessments at study-baseline and after 12 months. Discussion: By leveraging these large-scale longitudinal data from participants across ED diagnoses and illness durations, the STORY study seeks to elucidate potential biopsychosocial predictors of outcome, their interplay with developmental and socioemotional changes, and barriers and facilitators of recovery. STORY holds the promise of providing actionable findings that can be translated into clinical practice by informing the development of both early intervention and personalised treatment that is tailored to illness stage and individual circumstances, ultimately disrupting the long-term burden of EDs on individuals and their families. [ABSTRACT FROM AUTHOR]

Introduction: Based on the data from the China Health and Retirement longitudinal study (CHARLS), we aimed to investigate the bidirectional relationship between depressive symptoms and functional disability. Methods: Data were collected across 3 waves from 2013 to 2018. The activities of daily living (ADLs) and the instrumental activities of daily living (IADLs) scales were used to measure functional disability and the CESD-10 was used to measure depressive symptoms. Cross-lagged models were performed to examine cross effect between depressive symptoms and functional disability across three waves. Results: Data on 10,092(mean [SD] age, 61.98[8.44] years; 3764 females [37.30%]) and 10,180 participants (mean [SD] age, 62.01[8.46] years; 3788 females [37.21%]) in IADL sample and ADL sample were included in the analyses. For IADL disability, the cross-lagged model shows a bidirectional association across three waves; the multivariable GEE model revealed that changes in CESD-10 score across waves were associated with worse IADL disability (β ranges: 0.08–0.10) and vice versa, worsen of IADL disability ascending developing of CESD-10 score (β ranges: 0.09–0.10). For ADL disability, the cross-lagged model shows a bidirectional association across three waves; the multivariable GEE model revealed that changes of CESD-10 score across waves were associated with worse IADL disability (β ranges: 0.08–0.10) and vice versa, worsen of IADL disability ascending developing of CESD-10 score (β ranges: 0.09–0.10). Discussion: Study findings underscore a significant bidirectional between depressive symptoms and functional disability in older adults. Thus, simultaneous intervention should be taken to manage the mutual development of functional disability and depression. [ABSTRACT FROM AUTHOR]

Background: Although aggregate data (AD) from randomised clinical trials (RCTs) are used in the majority of network meta-analyses (NMAs), other study designs (e.g., cohort studies and other non-randomised studies, NRS) can be informative about relative treatment effects. The individual participant data (IPD) of the study, when available, are preferred to AD for adjusting for important participant characteristics and to better handle heterogeneity and inconsistency in the network. Results: We developed the R package crossnma to perform cross-format (IPD and AD) and cross-design (RCT and NRS) NMA and network meta-regression (NMR). The models are implemented as Bayesian three-level hierarchical models using Just Another Gibbs Sampler (JAGS) software within the R environment. The R package crossnma includes functions to automatically create the JAGS model, reformat the data (based on user input), assess convergence and summarize the results. We demonstrate the workflow within crossnma by using a network of six trials comparing four treatments. Conclusions: The R package crossnma enables the user to perform NMA and NMR with different data types in a Bayesian framework and facilitates the inclusion of all types of evidence recognising differences in risk of bias. [ABSTRACT FROM AUTHOR]

Background: Measures of abdominal adiposity are strongly associated with all-cause mortality and cardiovascular disease (CVD). However, data are limited and conflicting regarding the consequences of changes in body fat distribution. The main aims of this paper are to investigate the association between changes in waist circumference (WC) and all-cause and CVD mortality and to examine these changes in relation to concurrent changes in weight.Methods: The European Prospective Investigation into Cancer and Nutrition (EPIC-Norfolk) study recruited 25,639 participants between 1993 and 1997, aged 39-79, a number of whom also attended a second examination (1998-2000), and were followed up to 2016 for mortality. Participants were eligible for inclusion if they had WC, weight and height measurements at both time-points; those with a self-reported history of CVD or cancer, body mass index < 18.5 kg/m2 or missing data on covariates were excluded, leaving 12,337 participants for analyses. The median (IQR) follow-up time was 16.4 (15.7, 17.2) years. Hazard Ratios (HRs) for all-cause (2866 deaths) and CVD mortality (822 deaths), by categories of WC change, were determined using Cox proportional hazards analyses.Results: After multivariable adjustment, the HRs (95% CIs) for all-cause mortality for men and women with a WC gain (WCG) >  5 cm were 1.51 (1.29-1.75) and 1.25 (1.06-1.46) respectively. For CVD mortality in men and women with a WCG >  5 cm, the HRs were 1.84 (1.39-2.43) and 1.15 (0.85-1.55) respectively. In analyses of concurrent changes in WC and weight, the greatest risk (HRs) (95% CIs) in men occurred with weight loss and WCG: 1.80 (1.13-2.86) for all-cause and 2.22 (1.03-4.82) for CVD mortality. In women, the greatest risk for both all-cause (HR 1.50 (1.16-1.95)) and CVD mortality (HR 1.81 (1.15-2.85)) was observed in those with weight loss and maintenance of WC (WCM).Conclusions: Objectively measured WCG > 5 cm, was associated with subsequent higher total mortality risk and higher CVD mortality risk in men. Interventions focusing on preventing increase in central adiposity rather than lowering weight per se in later life may potentially have greater health benefits. [ABSTRACT FROM AUTHOR]

Background: We investigate factors affecting Australian general practitioners' decisions to adopt novel oral anticoagulants (NOACs) for the prevention of stroke/systemic embolism among patients with atrial fibrillation. Australia has a national homogeneous review and coverage system, which enables us to distinguish physician level factors while maintaining system level factors and patient coverage information constant.Methods: We conduct a cohort analyses by using longitudinal physician survey data from the Medicine in Australia: Balancing Employment and Life panel survey of Australian physicians (MABEL). MABEL data contain rich physician-level information such as age, gender, education, risk preferences, personality, physicians' communications with other medical professionals, and other practice characteristics. Importantly, the survey data were linked, with physician's consent, to actual utilization data from the Australian Pharmaceutical Benefits Scheme and the Medicare Benefits Schedule between January 1, 2012 and December 31, 2015. We measure speed (days until first time prescribing) of adopting NOACs. We estimate a Cox proportional hazard model to estimate factors affecting the adoption speed.Results: Several factors predict earlier adoption of NOACs: being male, more likely to take clinical risk, higher prescribing volume, being a principal or partner in the practice instead of an employee, spending less time in a typical consultation, and practicing in more affluent areas or areas with a higher proportion of older patients. GPs in Queensland are more likely to adopt NOACs and more likely to be extensive early adopters compared to other GPs. Other characteristics including physician personality, family circumstances, their involvement with public hospitals and teaching activities, and the distance between physician practice location to other clinics in the area are not statistically associated with earlier adoption.Conclusions: Our paper is one of the first to study the relationship between GPs' risk preferences, personality and their decisions to adopt new prescription drugs. Because NOACs are commonly prescribed and considered more cost-effective than their older counterpart, understanding factors affecting physicians' decisions to adopt NOACs has direct policy implications. Our results also highlight that even with universal coverage for prescription drugs, access to new drugs is different among patients, partially because who their doctors are and where they practice. [ABSTRACT FROM AUTHOR]

Background: Multi-state models, as an extension of traditional models in survival analysis, have proved to be a flexible framework for analysing the transitions between various states of sickness absence and work over time. In this paper we study a cohort of work rehabilitation participants and analyse their subsequent sickness absence using Norwegian registry data on sickness benefits. Our aim is to study how detailed individual covariate information from questionnaires explain differences in sickness absence and work, and to use methods from causal inference to assess the effect of interventions to reduce sickness absence. Examples of the latter are to evaluate the use of partial versus full time sick leave and to estimate the effect of a cooperation agreement on a more inclusive working life.Methods: Covariate adjusted transition intensities are estimated using Cox proportional hazards and Aalen additive hazards models, while the effect of interventions are assessed using methods of inverse probability weighting and G-computation.Results: Results from covariate adjusted analyses show great differences in sickness absence and work for patients with assumed high risk and low risk covariate characteristics, for example based on age, type of work, income, health score and type of diagnosis. Causal analyses show small effects of partial versus full time sick leave and a positive effect of having a cooperation agreement, with about 5 percent points higher probability of returning to work.Conclusions: Detailed covariate information is important for explaining transitions between different states of sickness absence and work, also for patient specific cohorts. Methods for causal inference can provide the needed tools for going from covariate specific estimates to population average effects in multi-state models, and identify causal parameters with a straightforward interpretation based on interventions. [ABSTRACT FROM AUTHOR]

Objectives: Acute gastroenteritis (AG) is a usually self-limiting, but common disease worldwide. In Europe, incidence estimates range from 0.3–1.5 AG episodes/person-year. For Switzerland, available information on AG is restricted to notifiable foodborne diseases and findings from research studies starting at primary care level. The aims of this 1-year, population-based prospective cohort study are to assess the incidence, burden of disease, aetiology and socio-economic impact of AG in the Swiss general population. Additionally, the prevalence of bacterial gastrointestinal pathogens and bacteria harbouring antimicrobial resistances in the asymptomatic population shall be assessed. Results: Weekly follow-up of the cohort consisting of 3000 participants will provide incidence estimates of AG. Furthermore, information collected will be used to assess risk factors for experiencing an episode of AG, to explore determinants for help seeking, and to characterise the socio-economic impact of AG including absence from work and inability to perform daily activities. Aetiology of AG is determined by investigating stool samples from symptomatic participants. Finally, stool samples from participants collected during an asymptomatic period will be used to assess the prevalence of enterohaemorrhagic E. coli, Campylobacter spp., Salmonella spp. and Shigella spp. as well as of resistance to different antibiotics (extended-spectrum beta-lactamase-, fluoroquinolone- and carbapenemase-resistance). [ABSTRACT FROM AUTHOR]

A recent paper published in BMC Cardiovascular Disorders reported on a study into whether tobacco smoking may serve as a risk factor for depression in patients with heart disease. In the current paper, we discuss several limitations of that study, of which many apply not just to the study itself but to the nomothetic research design that was used. Particularly when bidirectionality between variables is expected, fluctuation in variables over time takes place, and/or inter-individual differences are considerable, a nomothetic research approach does not seem appropriate, and may lead to false conclusions. As an alternative, we describe an idiographic approach in which individuals are followed up over time using many repeated measurements, and from which individual models are estimated. Such intensive time-series studies are not common in medicine, but are well described in the fields of econometrics and meteorology. Combining idiographic research designs with more traditional nomothetic designs may lead to research findings that are not only useful for society but also valid in individuals. [ABSTRACT FROM AUTHOR]