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Background: Previous research has found that a "web-push" approach to data collection, which involves contacting people by mail to request an Internet survey response while withholding a paper response option until later in the contact process, consistently achieves lower response rates than a "paper-only" approach, whereby all respondents are contacted and requested to respond by mail.Method: An experiment was designed, as part of the Millennium Cohort Family Study, to compare response rates, sample representativeness, and cost between a web-push and a paper-only approach; each approach comprised 3 stages of mail contacts. The invited sample (n = 4,935) consisted of spouses married to U.S. Service members, who had been serving in the military between 2 and 5 years as of October, 2011.Results: The web-push methodology produced a significantly higher response rate, 32.8% compared to 27.8%. Each of the 3 stages of postal contact significantly contributed to response for both treatments with 87.1% of the web-push responses received over the Internet. The per-respondent cost of the paper-only treatment was almost 40% higher than the web-push treatment group. Analyses revealed no meaningfully significant differences between treatment groups in representation.Conclusion: These results provide evidence that a web-push methodology is more effective and less expensive than a paper-only approach among young military spouses, perhaps due to their heavy reliance on the internet, and we suggest that this approach may be more effective with the general population as they become more uniformly internet savvy. [ABSTRACT FROM AUTHOR]

Background: Identifying critical life transitions in people's physical activity behaviors may illuminate the most opportune intervention apertures for chronic disease prevention. A substantive evidence base now indicates that parenthood is one of these critical transition points for physical activity decline. This study will examine whether a brief theory-based intervention can prevent a decline in physical activity among new parents over 6 months following intervention. This study protocol represents the first dyad-based physical activity initiative in the parenthood literature involving both mothers and fathers; prior research has focused on only mothers or only fathers (albeit limited), and has shown only short-term changes in physical activity. This study will be investigating whether a theory-based physical activity intervention can maintain or improve moderate to vigorous intensity physical activity measured via accelerometry of new parents over a 6 month period following intervention compared to a control group.Methods: This study is a 6-month longitudinal randomized controlled trial. Parents are measured at baseline (2 months postpartum) with two assessment points at 6 weeks (3.5 months postpartum) and 3 months (5 months postpartum) and a final follow-up assessment at 6 months (8 months postpartum). The content of the theory-based intervention was derived from the results of our prior longitudinal trial of new parents using an adapted theory of planned behavior framework to predict changes in physical activity.Results: A total of 152 couples have been recruited to date. Sixteen couples dropped out after baseline and a total of 88 couples have completed their 6-month measures.Discussion: If the intervention proves successful, couple-based physical activity promotion efforts among parents could be a promising avenue to pursue to help mitigate the declines of physical activity levels during parenthood. These findings could inform public health materials and practitioners.Trial Registration: This trial has been registered with the Clinical Trials Registry maintained by the National Library of Medicine at the National Institutes of Health on April 19, 2014. The registration ID is NCT02290808 . [ABSTRACT FROM AUTHOR]

Background: The role of housing as a social determinant of health is well-established, but the causal pathways are poorly understood beyond the direct effects of physical housing defects. For low-income, vulnerable households there are particular challenges in creating a sense of home in a new tenancy which may have substantial effects on health and wellbeing. This study examines the role of these less tangible aspects of the housing experience for tenants in the social and private rented sectors in west central Scotland.Methods: The paper analyses quantitative data from a mixed methods, longitudinal study of tenants from three housing organisations, collected across the first year of their tenancy. The paper postulates causal hypotheses on the basis of staff interviews and then uses a Realist Research approach to test and refine these into a theoretical framework for the connections between tenants' broader experience of housing and their health and wellbeing.Results: Housing service provision, tenants' experience of property quality and aspects of neighbourhood are all demonstrated to be significantly correlated with measures of of health and wellbeing. Analysis of contextual factors provides additional detail within the theoretical framework, offering a basis for further empirical work.Conclusions: The findings provide an empirically-informed realist theoretical framework for causal pathways connecting less tangible aspects of the housing experience to health and wellbeing. Applying this within housing policy and practice would facilitate a focus on housing as a public health intervention, with potential for significant impacts on the lives of low-income and vulnerable tenants. The framework also offers a basis for further research to refine our understanding of housing as a social determinant of health. [ABSTRACT FROM AUTHOR]

Background: In Europe, knowledge about the social determinants of health among undocumented migrants is scarce. The canton of Geneva, Switzerland, implemented in 2017-2018 a pilot public policy aiming at regularizing undocumented migrants. We sought to test for associations between self-rated health, proven eligibility for residence status regularization and social and economic integration.Methods: This paper reports data from the first wave of the Parchemins Study, a prospective study whose aim is to investigate the effect of residence status regularization on undocumented migrants' living conditions and health. The convenience sample included undocumented migrants living in Geneva for at least 3 years. We categorized them into those who were in the process of receiving or had just been granted a residence permit (eligible or newly regularized) and those who had not applied or were ineligible for regularization (undocumented). We conducted multivariate regression analyses to determine factors associated with better self-rated health, i.e., with excellent/very good vs. good/fair/poor self-rated health. Among these factors, measures of integration, social support and economic resources were included.Results: Of the 437 participants, 202 (46%) belonged to the eligible or newly regularized group. This group reported better health more frequently than the undocumented group (44.6% versus 28.9%, p-value < .001), but the association was no longer significant after adjustment for social support and economic factors (odds ratio (OR): 1.12; 95% confidence interval (CI): 0.67-1.87). Overall, better health was associated with larger social networks (OR: 1.66; 95% CI: 1.04-2.64). This association remained significant even after adjusting for health-related variables.Conclusion: At the onset of the regularization program, access to regularization was not associated with better self-rated health. Policies aiming at favouring undocumented migrants' inclusion and engagement in social networks may promote better health. Future research should investigate long-term effects of residence status regularization on self-rated health. [ABSTRACT FROM AUTHOR]

Objective: To predict the trend of AIDS in specific age groups and to determine the objective population for AIDS screening, this study explored the three transmission routes and characterized each patient group using the APC model based on the whole, local, and immigrant populations in Zhejiang, China.Methods: The data recruited in this paper was obtained from the national Comprehensive AIDS Prevention and Control Information System - Antiviral Therapy Management database and the Chinese Disease Prevention and Control Information System and the Statistical Yearbook of Zhejiang, China. An APC model was used to estimate the impact of age, period, and cohort on the incidence of AIDS, as well as to predict the AIDS incidence in specific age groups based on different sexes with different transmission routes.Results: The AIDS incidence peaked in males aged 20-35 years; the incidence of males was higher than that of females due to the impact of period; obvious cohort effect was observed among the immigrants. In the whole and local populations, the incidences of males in all age groups and females in both the 35-year-old group and the whole age group were predicted to increase sharply in 5 years. In the immigrant population, the AIDS incidences in both sexes in all age groups were expected to increase significantly in 5 years. Under the influence of period, the incidence of AIDS via homosexual transmission in the whole population and the local population increased and remained stable after 2015. At the same time, the incidence of AIDS transmitted by homosexual and heterosexual routes in the immigrants also showed an increasing trend.Conclusions: The results elucidate that there are sex differences in AIDS incidence, and the incidence of AIDS through various transmission routes in all groups is predicted to exhibit an upward trend in the 5 years to come. Effective intervention strategies should be developed and implemented by the public health departments in Zhejiang to control the epidemic of AIDS. [ABSTRACT FROM AUTHOR]

Background: The Australian Longitudinal Study on Male Health (Ten to Men) was established in 2011 to build the evidence base on male health to inform policy and program development.Methods: Ten to Men is a national longitudinal study with a stratified multi-stage cluster random sample design and oversampling in rural and regional areas. Household recruitment was conducted from October 2013 to July 2014. Males who were aged 10 to 55 years residing in private dwellings were eligible to participate. Data were collected via self-completion paper questionnaires (participants aged 15 to 55) and by computer-assisted personal interview (boys aged 10 to 14). Household and proxy health data for boys were collected from a parent via a self-completion paper-based questionnaire. Questions covered socio-demographics, health status, mental health and wellbeing, health behaviours, social determinants, and health knowledge and service use.Results: A cohort of 15,988 males aged between 10 and 55 years was recruited representing a response fraction of 35 %.Conclusion: Ten to Men is a unique resource for investigating male health and wellbeing. Wave 1 data are available for approved research projects. [ABSTRACT FROM AUTHOR]

Background: Many studies have demonstrated the benefits of the addition of growth hormone (GH) to the controlled ovarian stimulation protocol in vitro fertilization (IVF) cycles in poor-respond patients, but the effect of GH on patients with poor embryonic development remain unclear. This paper was designed to investigate the efficacy of GH co-treatment during IVF for the patients with poor embryonic development.Method: A randomized controlled trial including 158 patients with poor embryo development was conducted between July 2017 and February 2019. One hundred and seven patients were randomized for GH treatment (GH group) and 51 patients for untreated (control group). The primary end-points were the clinical pregnancy and live birth rates in the two groups. The oocyte competence were assessed through calculating the mitochondrial DNA (mtDNA) copy number in corresponding cumulus granulosa cells (CGCs). Quantitative PCR were used for calculation of mtDNA copy number.Results: Relative to the control group, GH co-treatment resulted in a significantly higher number of retrieved oocytes (10.29 ± 5.92 versus 8.16 ± 4.17, P = 0.023) and cleaved embryos (6.73 ± 4.25 versus 5.29 ± 3.23, P = 0.036). The implantation rate, clinical pregnancy rates per cycle, and live birth rate per cycle were higher in the GH group than in the control group (36.00% versus 17.86%, P = 0.005; 43.93% versus 19.61%, P = 0.005; 41.12% versus 17.65%, P = 0.006). CGCs of the GH group had significantly higher mtDNA copy numbers than CGCs of the control group (252 versus 204, P < 0.001).Conclusions: These data provided further evidence to indicate that GH supplementation may support more live births during IVF, in patients with poor embryonic development. It also appears that oocytes generated under GH co-treatment have a better developmental competence.Trial Registration: ChiCTR1900021992 posted March 19, 2019 (retrospectively registered). [ABSTRACT FROM AUTHOR]

Background: Patients infected with the Human Immunodeficiency Virus (HIV) are susceptible to many diseases. In these patients, the occurrence of one disease alters the chance of contracting another. Under such circumstances, methods for competing risks are required. Recently, competing risks analyses in the scope of flexible parametric models have risen to address this requirement. These lesser-known analyses have considerable advantages over conventional methods.Methods: Using data from Multi Centre AIDS Cohort Study (MACS), this paper reviews and applies methods of competing risks flexible parametric models to analyze the risk of the first disease (AIDS or non-AIDS) among HIV-infected patients. We compared two alternative subdistribution hazard flexible parametric models (SDHFPM1 and SDHFPM2) with the Fine & Gray model. To make a complete inference, we performed cause-specific hazard flexible parametric models for each event separately as well.Results: Both SDHFPM1 and SDHFPM2 provided consistent results regarding the magnitude of coefficients and risk estimations compared with estimations obtained from the Fine & Gray model, However, competing risks flexible parametric models provided more efficient and smoother estimations for the baseline risks of the first disease. We found that age at HIV diagnosis indirectly affected the risk of AIDS as the first event by increasing the number of patients who experience a non-AIDS disease prior to AIDS among > 40 years. Other significant covariates had direct effects on the risks of AIDS and non-AIDS.Discussion: The choice of an appropriate model depends on the research goals and computational challenges. The SDHFPM1 models each event separately and requires calculating censoring weights which is time-consuming. In contrast, SDHFPM2 models all events simultaneously and is more appropriate for large datasets, however, when the focus is on one particular event SDHFPM1 is more preferable. [ABSTRACT FROM AUTHOR]

Background: Continuity of care by a primary midwife during the antenatal, intrapartum and postpartum periods has been recommended in Australia and many hospitals have introduced a caseload midwifery model of care. The aim of this paper is to evaluate the effect of caseload midwifery on women's satisfaction with care across the maternity continuum.Methods: Pregnant women at low risk of complications, booking for care at a tertiary hospital in Melbourne, Australia, were recruited to a randomised controlled trial between September 2007 and June 2010. Women were randomised to caseload midwifery or standard care. The caseload model included antenatal, intrapartum and postpartum care from a primary midwife with back-up provided by another known midwife when necessary. Women allocated to standard care received midwife-led care with varying levels of continuity, junior obstetric care, or community-based general practitioner care. Data for this paper were collected by background questionnaire prior to randomisation and a follow-up questionnaire sent at two months postpartum. The primary analysis was by intention to treat. A secondary analysis explored the effect of intrapartum continuity of carer on overall satisfaction rating.Results: Two thousand, three hundred fourteen women were randomised: 1,156 to caseload care and 1,158 to standard care. The response rate to the two month survey was 88% in the caseload group and 74% in the standard care group. Compared with standard care, caseload care was associated with higher overall ratings of satisfaction with antenatal care (OR 3.35; 95% CI 2.79, 4.03), intrapartum care (OR 2.14; 95% CI 1.78, 2.57), hospital postpartum care (OR 1.56, 95% CI 1.32, 1.85) and home-based postpartum care (OR 3.19; 95% CI 2.64, 3.85).Conclusion: For women at low risk of medical complications, caseload midwifery increases women's satisfaction with antenatal, intrapartum and postpartum care.Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN012607000073404 (registration complete 23rd January 2007). [ABSTRACT FROM AUTHOR]

Background: Anxiety is a common concern of cancer survivors during the transition from active cancer treatment to cancer survivorship (the re-entry phase). This paper presents the study protocol for a novel group-based behavioral intervention to improve mental health, well-being, and medical use outcomes among anxious cancer survivors at re-entry.Methods/design: This two-armed, prospective randomized controlled trial will randomize a minimum of 100 re-entry-phase cancer survivors with moderate to high anxiety to the intervention or a usual care control condition. The intervention is delivered in a group format over 7 weeks; content is based on Acceptance and Commitment Therapy (ACT), an acceptance, mindfulness, and values-based intervention. Participants will be recruited from community cancer care centers and the intervention will be led by the onsite clinical social workers. Participants will be assessed at baseline, mid-intervention, post-intervention, and 3- and 6-month follow-up. ACT participants will complete process measures before the beginning of group sessions 2, 4, and 6; all participants will complete the process measures during the regular assessments. The primary outcome is anxiety symptoms; secondary outcomes include anxiety disorder severity, fear of recurrence, depressive symptoms, cancer-related trauma symptoms, sense of life meaning, vitality/fatigue, and medical utilization.Discussion: This clinical trial will provide valuable evidence regarding the efficacy of the group ACT intervention in community oncology settings.Trial Registration: Clinicaltrials.gov NCT02550925 . [ABSTRACT FROM AUTHOR]

Background: Aboriginal people in Australia experience significant health burden from chronic disease. There has been limited research to identify effective healthy lifestyle programs to address risk factors for chronic disease among Aboriginal people.Methods: The Knockout Health Challenge is a community-led healthy lifestyle program for Aboriginal communities across New South Wales, Australia. An evaluation of the 2013 Knockout Health Challenge was undertaken. Participants' self-reported physical activity and diet were measured at four time points - at the start and end of the Challenge (via paper form), and 5 and 9 months after the Challenge (via telephone survey). Participants' weight was measured objectively at the start and end of the Challenge, and self-reported (via telephone survey) 5 and 9 months after the Challenge. Changes in body composition, physical activity and diet between time points were analysed using linear mixed models. As part of the telephone survey participants were also asked to identify other impacts of the Challenge; these were analysed descriptively (quantitative items) and thematically (qualitative items).Results: A total of 586 people registered in 22 teams to participate in the Challenge. The mean weight at the start was 98.54kg (SD 22.4), and 94% of participants were overweight or obese. Among participants who provided data at all four time points (n=122), the mean weight loss from the start to the end of the Challenge was 2.3kg (95%CI -3.0 to -1.9, p<0.001), and from the start to 9 months after the Challenge was 2.3kg (95%CI -3.3 to -1.3, p<0.001). Body mass index decreased by an average of 0.9kg/m2 (95%CI -1.0 to -0.7, p<0.001) from the start to the end of the Challenge, and 0.8kg/m2 (95%CI -1.2 to -0.4, p<0.001) 9 months after. At the end of the Challenge, participants reported they were more physically active and had increased fruit and vegetable consumption compared with the start of the Challenge, and identified a range of other positive impacts.Conclusions: The Challenge was effective in reducing weight and promoting healthy lifestyles among Aboriginal people across New South Wales, and has potential to contribute to closing the health gap between Aboriginal and non-Aboriginal people. [ABSTRACT FROM AUTHOR]

Background: Translation encompasses the continuum from clinical efficacy to widespread adoption within the healthcare service and ultimately routine clinical practice. The Parenting, Eating and Activity for Child Health (PEACH™) program has previously demonstrated clinical effectiveness in the management of child obesity, and has been recently implemented as a large-scale community intervention in Queensland, Australia. This paper aims to describe the translation of the evaluation framework from a randomised controlled trial (RCT) to large-scale community intervention (PEACH™ QLD). Tensions between RCT paradigm and implementation research will be discussed along with lived evaluation challenges, responses to overcome these, and key learnings for future evaluation conducted at scale.Methods: The translation of evaluation from PEACH™ RCT to the large-scale community intervention PEACH™ QLD is described. While the CONSORT Statement was used to report findings from two previous RCTs, the REAIM framework was more suitable for the evaluation of upscaled delivery of the PEACH™ program. Evaluation of PEACH™ QLD was undertaken during the project delivery period from 2013 to 2016.Results: Experiential learnings from conducting the evaluation of PEACH™ QLD to the described evaluation framework are presented for the purposes of informing the future evaluation of upscaled programs. Evaluation changes in response to real-time changes in the delivery of the PEACH™ QLD Project were necessary at stages during the project term. Key evaluation challenges encountered included the collection of complete evaluation data from a diverse and geographically dispersed workforce and the systematic collection of process evaluation data in real time to support program changes during the project.Conclusions: Evaluation of large-scale community interventions in the real world is challenging and divergent from RCTs which are rigourously evaluated within a more tightly-controlled clinical research setting. Constructs explored in an RCT are inadequate in describing the enablers and barriers of upscaled community program implementation. Methods for data collection, analysis and reporting also require consideration. We present a number of experiential reflections and suggestions for the successful evaluation of future upscaled community programs which are scarcely reported in the literature.Trials Registration: PEACH™ QLD was retrospectively registered with the Australian New Zealand Clinical Trials Registry on 28 February 2017 (ACTRN12617000315314). [ABSTRACT FROM AUTHOR]

Background: Work life expectancy (WLE) expresses the expected time a person will remain in the labor market until he or she retires. This paper compares a life table approach to estimating WLE to an approach based on multi-state proportional hazards models. The two methods are used to estimate WLE in Danish members and non-members of an early retirement pensioning (ERP) scheme according to levels of health.Methods: In 2008, data on self-rated health (SRH) was collected from 5212 employees 55-65 years of age. Data on previous and subsequent long-term sickness absence, unemployment, returning to work, and disability pension was collected from national registers. WLE was estimated from multi-state life tables and through multi-state models.Results: Results from the multi-state model approach agreed with the life table approach but provided narrower confidence intervals for small groups. The shortest WLE was seen for employees with poor SRH and ERP membership while the longest WLE was seen for those with good SRH and no ERP membership. Employees aged 55-56 years with poor SRH but no ERP membership had shorter WLE than employees with good SRH and ERP membership. Relative WLE reversed for the two groups after age 57. At age 55, employees with poor SRH could be expected to spend approximately 12 months on long-term sick leave and 9-10 months unemployed before they retired - regardless of ERP membership. ERP members with poor SRH could be expected to spend 4.6 years working, while non-members could be expected to spend 7.1 years working.Conclusion: WLE estimated through multi-state models provided an effective way to summarize complex data on labor market affiliation. WLE differed noticeably between members and non-members of the ERP scheme. It has been hypothesized that while ERP membership would prompt some employees to retire earlier than they would have done otherwise, this effect would be partly offset by reduced time spent on long-term sick leave or unemployment. Our data showed no indication of such an effect, but this could be due to residual confounding and self-selection of people with poor health into the ERP scheme. [ABSTRACT FROM AUTHOR]

Background: Despite the resources and personnel mobilized in Latin America and the Caribbean to reduce the maternal mortality ratio (MMR, maternal deaths per 100 000 live births) in women aged 10–54 years by 75% between 2000 and 2015, the region failed to meet the Millenium Development Goals (MDGs) due to persistent barriers to access quality reproductive, maternal, and neonatal health services. Methods: Using 1990–2019 data from the Global Burden of Disease project, we carried out a two-stepwise analysis to (a) identify the differences in the MMR temporal patterns and (b) assess its relationship with selected indicators: government health expenditure (GHE), the GHE as percentage of gross domestic product (GDP), the availability of human resources for health (HRH), the coverage of effective interventions to reduce maternal mortality, and the level of economic development of each country. Findings: In the descriptive analysis, we observed a heterogeneous overall reduction of MMR in the region between 1990 and 2019 and heterogeneous overall increases in the GHE, GHE/GDP, and HRH availability. The correlation analysis showed a close, negative, and dependent association of the economic development level between the MMR and GHE per capita, the percentage of GHE to GDP, the availability of HRH, and the coverage of SBA. We observed the lowest MMRs when GHE as a percentage of GDP was close to 3% or about US$400 GHE per capita, HRH availability of 6 doctors, nurses, and midwives per 1,000 inhabitants, and skilled birth attendance levels above 90%. Conclusions: Within the framework of the Sustainable Development Goals (SDGs) agenda, health policies aimed at the effective reduction of maternal mortality should consider allocating more resources as a necessary but not sufficient condition to achieve the goals and should prioritize the implementation of new forms of care with a gender and rights approach, as well as strengthening actions focused on vulnerable groups. [ABSTRACT FROM AUTHOR]

Background: Advance care planning (ACP) is particularly appropriate for persons with early dementia (PWED) since it promotes conversations about dementia-specific illness scenarios, addresses inconsistencies between advance directives and patients' observed behavior, emphasizes prospective and relational autonomy, and may be generally consistent with older persons' decision-making needs. However, despite evidence of its benefits, ACP is yet to become widely used among PWED. In this paper, we present a dementia-specific tool developed in Western Switzerland, discuss results of a pilot trial designed to promote ACP among PWED and their relatives, and discuss the feasibility and acceptability of the intervention and the study protocol in prevision of a large scale trial.Methods: This one-arm pre-post pilot trial consisted of four visits, with visits 2 and 3 being the ACP intervention. Quantitative outcome measures during visit 1 and 4 assessed the aptitude of the intervention to support PWED autonomy and relatives' knowledge of PWED's preferences. Feasibility was explored according to how the recruitment procedure unfurled and based on the necessary revisions to the study protocol and healthcare providers' reason for excluding a PWED from the study. Acceptability was assessed according to pre-post evaluations, difficulties regarding the intervention or trial participation, and pre-post qualitative interviews regarding participants' reasons to participate to the study, satisfaction with the tool and difficulties perceived.Results: The ACP intervention itself was well received by PWED and their relatives that expressed satisfaction with the procedure, especially regarding the opportunity to discuss a sensitive topic with the help of a facilitator. Five main challenges in terms of feasibility were 1) to locate eligible patients, 2) to tailor recruitment procedures to recruitment locations, 3) to adapt inclusion criteria to clinical routines, 4) to engage PWED and their relatives in ACP, and 5) to design a trial that does not burden PWED. Despite these challenges, the intervention increased the number of advance directives, the concordance between PWED's preferences and relatives' decision on their behalf, and relatives' perceived control over healthcare decisions.Conclusion: Misconceptions about dementia and ACP, in the patient, relatives, and healthcare providers, combined with structural and institutional challenges, have the power to impede research and implementation of ACP in dementia care. For this reason, we conclude that a large scale trial to test a dementia-specific tool of ACP is currently not feasible in Western Switzerland and should be endorsed in a systemic approach of ACP.Trial Registration: This trial was registered in the database clinicaltrial.gov with the number NCT03615027 . [ABSTRACT FROM AUTHOR]

Background: The purpose of this paper is to analyse the utilization of formal and informal home care among older patients with cancer (OCP) and to compare this with middle-aged patients with cancer (MCP) and older patients without cancer (ONC). Additionally, we examined predictors of transitions towards formal care one year after a cancer diagnosis.Methods: OCP and MCP had to be recruited within three months after a cancer diagnosis and have an estimated life expectancy over six months. ONC consisted of patients without known cancer, seen by the general practitioner. Formal and informal care were compared between the patient groups at baseline, i.e. shortly after a cancer diagnosis and changes in care were studied after one year.Results: A total of 844 patients were evaluable for formal care at baseline and 469 patients (56%) at follow-up. At baseline, about half of older adults and 18% of MCP used formal care, while about 85% of cancer patients and 57% ONC used informal care. Formal care increased for all groups after one year though not significantly in OCP. The amount of informal care only changed in MCP which decreased after one year. Cancer-related factors and changes in need factors predict a transition towards formal care after a cancer diagnosis.Conclusions: A cancer diagnosis has a different impact on the use of formal and informal care than ageing as such. The first year after a cancer diagnosis is an important time to follow-up on the patients' needs for home care. [ABSTRACT FROM AUTHOR]

Background: Although previous studies have reported the efficacy of communication skills training (CST) programs, specific training addressing communication about uncertainty and hope in oncology has not yet been studied. This paper describes the study protocol of a randomized controlled trial assessing the efficacy of a CST program aimed at improving physician ability to communicate about uncertainty and hope in encounters with cancer patients.Methods/design: Physician participants will be randomly assigned in groups (n = 3/group) to a 30-h CST program (experimental group) or to a waiting list (control group). The training program will include learner-centered, skills-focused, practice-oriented techniques. Training efficacy is assessed in the context of an encounter with a simulated advanced stage cancer patient at baseline and after the CST for the experimental group, and after four months for the waiting-list group. Efficacy assessments will include communicational, psychological and physiological measures. Group-by-time effects will be analyzed using a generalized estimating equation (GEE). A power analysis indicated that a sample size of 60 (30 experimental and 30 control) participants will be sufficient to detect effects.Discussion: The current study will aid in the development of effective CST programs to improve physician ability to communicate about uncertainty and hope in encounters with cancer patients.Trial Registration: US Clinical Trials Register NCT02836197 . [ABSTRACT FROM AUTHOR]

Background: Regular physical activity (PA) promotes and excessive sedentary behavior (SB) deteriorates health. Yet the Finnish working-aged population spends most of the day sitting. A 1-year Moving To Business (MTB) -intervention supported small and medium-size workplaces to combat sedentariness. This paper reports the changes in employees' PA and SB from before MTB (baseline) to 1 year after baseline (follow-up).Methods: Twelve workplaces with a total of 396 employees participated. Each workplace nominated a team to promote PA and reduce SB at organizational, working unit and employee level. The teams were mentored regionally through meetings, workshop and tools. Changes in PA and SB were assessed with a questionnaire and an accelerometer. Wald Confidence Interval (Cl) for a difference of proportions with matched pairs was used in the questionnaire data (%-points with 95% CI) and linear mixed model in the accelerometer data (minutes and % of wear-time with 95% CI).Results: The mean age of the respondents to the questionnaire (N = 296; 75%) was 42.6 (SD 10.9), 64% were women, 95% had some education after high school, 74% worked in the day shift, 71% did sedentary work and 51% were overweight. The mean number of actions implemented in the workplaces was 6.8 and the multilevel approach was fully applied in 6 workplaces. Based on the questionnaire the time spent in SB decreased from baseline to follow-up 16% (95% CI -29 to -3) in total and 22% (-41 to -3) at work. The accelerometer showed daily increases of 33.7 min (15.3 to 52.1) and 6.8% (3.1 to 10.4) in total PA, 30.9 min (15.3 to 46.5) and 6.1% (2.9 to 9.2) in light PA and 673 (209 to 1139) more steps at work. Daily SB at work decreased 44.9 min (-68.0 to -21.8) and 7.6% (-11.9 to -3.2). Daily leisure PA declined 11.0 min (-24.9 to 2.9) and 3.2% (-6.2 to -0.2). Number of levels or actions had no effect on changes.Conclusions: Employees' PA increased and SB reduced at work during the intervention. At the same time leisure PA decreased slightly. Workplaces can achieve meaningful changes in employees' PA and SB if assisted systematically. Controlled studies are needed to confirm the present findings.Trial Registration: NCT01999205 , registration date 11/01/2013. [ABSTRACT FROM AUTHOR]

Background: The Fit for School (FIT) programme integrates school health and Water, Sanitation and Hygiene interventions, which are implemented by the Ministries of Education in four Southeast Asian countries. This paper describes the findings of a Health Outcome Study, which aimed to assess the two-year effect of the FIT programme on the parasitological, weight, and oral health status of children attending schools implementing the programme in Cambodia, Indonesia and Lao PDR.Methods: The study was a non-randomized clustered controlled trial with a follow-up period of two years. The intervention group consisted of children attending public elementary schools implementing the FIT programme, including daily group handwashing with soap and toothbrushing with fluoride toothpaste, biannual school-based deworming; as well as construction of group handwashing facilities. Control schools implemented the regular government health education curriculum and biannual deworming. Per school, a random selection of six to seven-year-old grade-one students was drawn. Data on parasitological infections, anthropometric measurements, dental caries, odontogenic infections and sociodemographic characteristics were collected at baseline and at follow-up (24 months later). Data were analysed using the χ2-test, Mann Whitney U-test and multilevel logistic and linear regression.Results: A total of 1847 children (mean age = 6.7 years, range 6.0-8.0 years) participated in the baseline survey. Of these, 1499 children were available for follow-up examination - 478, 486 and 535 children in Cambodia, Indonesia and Lao PDR, respectively. In all three countries, children in intervention schools had a lower increment in the number of decayed, missing and filled permanent teeth between baseline and follow-up, in comparison to children in controls schools. The preventive fraction was 24% at average. The prevalence of soil-transmitted helminth infection (which was unexpectedly low at baseline), the prevalence of thinness and the prevalence of odontogenic infections did not significantly differ between baseline and follow-up, nor between intervention and control schools.Conclusions: The study found that the FIT programme significantly contributed to the prevention of dental caries in children. This study describes the challenges, learnings and, moreover, the importance of conducting real-life implementation research to evaluate health programmes to transform school settings into healthy learning environments for children. The study is retrospectively registered with the German Clinical Trials Register, University of Freiburg (Trial registration number: DRKS00004485, date of registration: 26th of February, 2013). [ABSTRACT FROM AUTHOR]

Background: Before establishing a prospective cohort, an initial pilot study is recommended. However, there are no precise guidelines on this subject. This paper reports the findings of a French regional pilot study carried out in three nephrology departments, before realizing a major prospective Non Dialysis Chronic Renal Insufficiency study (ND-CRIS).Methods: We carried out an internal pilot study. The objectives of this pilot study were to validate the feasibility (regulatory approval, providing patients with information, availability of variables, refusal rate of eligible patients) and quality criteria (missing data, rate of patients lost to follow-up, characteristics of the patients included and non-included eligible patients, quality control of the data gathered) and estimate the human resources necessary (number of clinical research associates required).Results: The authorizations obtained (CCTIRS - CNIL) and the contracts signed with hospitals have fulfilled the regulatory requirements. After validating the information on the study provided to patients, 1849 of them were included in three centres (university hospital, intercommunal hospital, town hospital) between April 2012 and September 2015. The low refusal rate (51 patients) and the characteristics of non-included patients have confirmed the benefit for patients of participating in the study and provide evidence of the feasibility and representativeness of the population studied. The lack of missing data on the variables studied, the quality of the data analyzed and the low number of patients lost to follow-up are evidence of the quality of the study. By taking into account the time spent by CRAs to enter data and to travel, as well as the annual patient numbers in each hospital, we estimate that five CRAs will be required in total.Conclusion: With no specific guidelines on how to realize a pilot study before implementing a major prospective cohort, we considered it pertinent to report our experience of P-ND-CRIS. This experience confirms that i) feasibility, ii) quality of data and iii) evaluating the resources required must be validated before carrying out a large prospective cohort study such as ND-CRIS. [ABSTRACT FROM AUTHOR]

Background: Risk factor control after a coronary event in a recent European multi-centre study was inadequate. Patient selection from academic centres and low participation rate, however, may underscore failing risk factor control in routine clinical practice. Improved understanding of the patient factors that influence risk factor control is needed to improve secondary preventive strategies. The objective of the present paper was to determine control of the major risk factors in a coronary population from routine clinical practice, and how risk factor control was influenced by the study factors age, gender, number of coronary events, and time since the index event.Methods: A cross-sectional study determined risk factor control and its association with study factors in 1127 patients (83% participated) aged 18-80 years with acute myocardial infarction and/or revascularization identified from medical records. Study data were collected from a self-report questionnaire, clinical examination, and blood samples after 2-36 months (median 16) follow-up.Results: Twenty-one percent were current smokers at follow-up. Of those smoking at the index event 56% continued smoking. Obesity was found in 34%, and 60% were physically inactive. Although 93% were taking blood-pressure lowering agents and statins, 46% were still hypertensive and 57% had LDL cholesterol >1.8 mmol/L at follow-up. Suboptimal control of diabetes was found in 59%. The patients failed on average to control three of the six major risk factors, and patients with >1 coronary events (p < 0.001) showed the poorest overall control. A linear increase in smoking (p < 0.01) and obesity (p < 0.05) with increasing time since the event was observed.Conclusions: The majority of coronary patients in a representative Norwegian population did not achieve risk factor control, and the poorest overall control was found in patients with several coronary events. New strategies for secondary prevention are clearly needed to improve risk factor control. Even modest advances will provide major health benefits.Trial Registration: Registered at ClinicalTrials.gov (ID NCT02309255 ). [ABSTRACT FROM AUTHOR]

Background: Men use health services less often than women and frequently delay seeking help even if experiencing serious health problems. This may put men at higher risk for developing serious health problems which, in part, may explain men's higher rates of some serious illnesses and shorter life span relative to women. This paper identifies factors that contribute to health care utilisation in a cohort of Australian men by exploring associations between socio-economic, health and lifestyle factors and the use of general practitioner (GP) services.Methods: We used data from Ten to Men, the Australian Longitudinal Study on Male Health. Health care utilisation was defined in two ways: at least one GP visit in the past 12 months and having at least yearly health check-ups with a doctor. Associations between these two measures and a range of contextual socio demographic factors (education, location, marital status, country of birth, employment, financial problems etc.) as well as individual health and lifestyle factors (self-rated health, smoking, drinking, healthy weight, pain medication) were examined using logistic regression analysis. The sample included 13,763 adult men aged 18 to 55 years. Analysis was stratified by age (18 to 34 year versus 35 to 55 years).Results: Overall, 81 % (95 % CI: 80.3-81.6) of men saw a GP for consultation in the 12 months prior to the study. The odds of visiting a GP increased with increasing age (p < 0.01), but decreased with increasing remoteness of residence (p < 0.01). Older men, smokers and those who rate their health as excellent were less likely to visit a GP in the last 12 months, but those on daily pain medication or with co-morbidities were more likely to have visited a GP. However, these factors were not associated with consulting a GP in the last 12 months among young men. Overall, 39 % (95 % CI: 38.3-39.9) reported having an annual health check. The odds of having an annual health check increased with increasing age (p < 0.01), but showed no association with area of residence (p = 0.60). Across both age groups, the odds of a regular health check increased with obesity and daily pain medication, but decreased with harmful levels of alcohol consumption.Conclusion: The majority of men (61 %) did not engage in regular health check-up visits, representing a missed opportunity for preventative health care discussions. Lower consultation rates may translate into lost opportunities to detect and intervene with problems early and this is where men may be missing out compared to women. [ABSTRACT FROM AUTHOR]

Background: Obstructive sleep apnoea is a common disorder with under-rated clinical impact, which is increasingly being recognised as having a major bearing on global disease burden. Men are especially vulnerable and become a priority group for preventative interventions. However, there is limited information on prevalence of the condition in Australia, its co-morbidities, and potential risk factors.Methods: We used data from 13,423 adult men included in the baseline wave of Ten to Men, an Australian national study of the health of males, assembled using stratified cluster sampling with oversampling from rural and regional areas. Those aged 18-55 years self-completed a paper-based questionnaire that included a question regarding health professional-diagnosed sleep apnoea, physical and mental health status, and health-related behaviours. Sampling weights were used to account for the sampling design when reporting the prevalence estimates. Odds ratios were used to describe the association between health professional-diagnosed sleep apnoea and potential correlates while adjusting for age, country of birth, and body-mass index (BMI).Results: Prevalence of self-reported health professional-diagnosed sleep apnoea increased from 2.2 % in age 18-25 years to 7.8 % in the age 45-55 years. Compared with those without sleep apnoea, those with sleep apnoea had significantly poorer physical, mental, and self-rated health as well as lower subjective wellbeing and poorer concentration/remembering (p < 0.001 for all). Sleep apnoea was significantly associated with older age (p < 0.001), unemployment (p < 0.001), asthma (p = 0.011), chronic obstructive pulmonary disease/chronic bronchitis (p = 0.002), diabetes (p < 0.001), hypercholesterolemia (p < 0.001), hypertension (p < 0.001), heart attack (p < 0.001), heart failure (p < 0.001), angina (p < 0.001), depression (p < 0.001), post-traumatic stress disorder (p < 0.001), other anxiety disorders (p < 0.001), schizophrenia (p = 0.002), overweight/obesity (p < 0.001), insufficient physical activity (p = 0.006), smoking (p = 0.005), and high alcohol consumption (p < 0.001).Conclusion: Health professional-diagnosed sleep apnoea is relatively common, particularly in older males. Associations between sleep apnoea and cardiovascular, metabolic, respiratory, and psychiatric disorders have important clinical and public health implications. As men are especially vulnerable to sleep apnoea as well as some of its chronic co-morbidities, they are potentially a priority group for health interventions. Modifiable lifestyle related factors such as smoking, alcohol consumption, level of physical activity and BMI are possible key foci for interventions. [ABSTRACT FROM AUTHOR]

Background: Employment status and working conditions are strong determinants of male health, and are therefore an important focus in the Australian Longitudinal Study on Male Health (Ten to Men). In this paper, we describe key work variables included in Ten to Men, and present analyses relating psychosocial job quality to mental health and subjective wellbeing at baseline.Methods: A national sample of males aged 10 to 55 years residing in private dwellings was drawn using a stratified multi-stage cluster random sample design. Data were collected between October 2013 and July 2014 for a cohort of 15,988 males, representing a response fraction of 35 %. This analysis was restricted to 18-55 year old working age participants (n = 13,456). Work-related measures included employment status, and, for those who were employed, a number of working conditions including an ordinal scale of psychosocial job quality (presence of low job control, high demand and complexity, high job insecurity, and low fairness of pay), and working time-related stressors such as long working hours and night shift work. Associations between psychosocial job quality and two outcome measures, mental ill-health and subjective wellbeing, were assessed using multiple linear regression.Results: The majority of participants aged 18-55 years were employed at baseline (85.6 %), with 8.4 % unemployed and looking for work, and 6.1 % not in the labour force. Among employed participants, there was a high prevalence of long working hours (49.9 % reported working more than 40 h/week) and night shift work (23.4 %). Psychosocial job quality (exposure to 0/1/2/3+ job stressors) prevalence was 36 %/ 37 %/ 20 %/ and 7 % of the working respondents. There was a dose-response relationship between psychosocial job quality and each of the two outcome measures of mental health and subjective wellbeing after adjusting for potential confounders, with higher magnitude associations between psychosocial job quality and subjective wellbeing.Conclusions: These results extend the study of psychosocial job quality to demonstrate associations with a global measure of subjective wellbeing. Ten to Men represents a valuable new resource for the longitudinal and life course study of work and health in the Australian male population. [ABSTRACT FROM AUTHOR]

Background: There are well-documented treatment gaps in secondary prevention of coronary heart disease and no clear guidelines to assist early physical activity after acute coronary syndromes (ACS). Smartphone technology may provide an innovative platform to close these gaps. This paper describes the study design of a randomized controlled trial assessing whether a smartphone-based secondary prevention program can facilitate early physical activity and improve cardiovascular health in patients with ACS.Methods: We have developed a multi-faceted, patient-centred smartphone-based secondary prevention program emphasizing early physical activity with a graduated walking program initiated on discharge from ACS admission. The program incorporates; physical activity tracking through the smartphone's accelerometer with interactive feedback and goal setting; a dynamic dashboard to review and optimize cardiovascular risk factors; educational messages delivered twice weekly; a photographic food diary; pharmacotherapy review; and support through a short message service. The primary endpoint of the trial is change in exercise capacity, as measured by the change in six-minute walk test distance at 8-weeks when compared to baseline. Secondary endpoints include improvements in cardiovascular risk factor status, psychological well-being and quality of life, medication adherence, uptake of cardiac rehabilitation and re-hospitalizations.Discussion: This randomized controlled trial will use a smartphone-phone based secondary prevention program to emphasize early physical activity post-ACS. It will provide evidence regarding the feasibility and utility of this innovative platform in closing the treatment gaps in secondary prevention.Trial Registration: The trial was retrospectively registered in the Australian New Zealand Clinical Trials Registry (ANZCTR) on April 4, 2016. The registration number is ACTRN12616000426482 . [ABSTRACT FROM AUTHOR]

Background: The aim of the proposed study is to perform a comparative analysis of functional training effects for the paretic upper limb with and without transcranial direct current stimulation over the primary motor cortex in children with spastic hemiparetic cerebral palsy.Methods: The sample will comprise 34 individuals with spastic hemiparetic cerebral palsy, 6 to 16 years old, classified at level I, II, or III of the Manual Ability Classification System. Participants will be randomly allocated to two groups: (1) functional training of the paretic upper limb combined with anodic transcranial stimulation; (2) functional training of the paretic upper limb combined with sham transcranial stimulation. Evaluation will involve three-dimensional movement analysis and electromyography using the SMART-D 140® system (BTS Engineering) and the FREEEMG® system (BTS Engineering), the Quality of Upper Extremity Skills Test, to assess functional mobility, the Portable Device and Ashworth Scale, to measure movement resistance and spasticity, and the Pediatric Evaluation of Disability Inventory, to evaluate performance. Functional reach training of the paretic upper limb will include a range of manual activities using educational toys associated with an induced constraint of the non-paretic limb during the training. Training will be performed in five weekly 20-minute sessions for two weeks. Transcranial stimulation over the primary motor cortex will be performed during the training sessions at an intensity of 1 mA. Findings will be analyzed statistically considering a 5 % significance level (P ≤ 0.05).Discussion: This paper presents a detailed description of a prospective, randomized, controlled, double-blind, clinical trial designed to demonstrate the effects of combining transcranial direct current stimulation over the primary motor cortex and functional training of the paretic limb in children with cerebral palsy classified at level I, II, or III of the Manual Ability Classification System. The results will be published and evidence found may contribute to the use of transcranial stimulation for this population.Trial Registration: ReBEC RBR-6V4Y3K . Registered on 11 February 2015. [ABSTRACT FROM AUTHOR]

Background: This paper describes about a study protocol of phase I/II multicenter prospective clinical trial evaluating the feasibility and efficacy of the hybrid of intracavitary and interstitial brachytherapy (HBT) for locally advanced uterine cervical cancer patients.Methods and Design: Patients with histologically confirmed FIGO stage IB2, IIA2, IIB, and IIIB uterine cervical carcinoma width of which is larger than 5 cm assessed by MRI will be entered to this clinical trial. Protocol therapy is 30-30.6 Gy in 15-17 fractions of whole pelvic radiotherapy concurrent with weekly CDDP (40 mg/m(2)), followed by 24 Gy in 4 fractions of HBT and central shield EBRT up to 50-50.4 Gy in 25-28 fractions. Tumor width is assessed again within one week before the first HBT and if the tumor width is larger than 4 cm, patients proceed to the secondary registration. In phase I section, feasibility of this will be investigated. If less than 10 % out of 20 patients experienced greater than grade 3 acute non-hematologic adverse effects, the study proceeds to phase II part. In phase II part a total of 55 patients will be accrued and the efficacy of the HBT will be investigated comparing with historical control data. If the lower margin of 90 % confidence interval of the 2-year pelvic progression-free survival of the HBT trial is higher than 64 %, the HBT is considered to be more effective than conventional ICBT.Discussion: The aim of this study is to demonstrate the feasibility and efficacy of the HBT for locally advanced cervical cancer. This trial will clarify the indication, feasibility, and efficacy of this new technique.Trial Registration: UMIN000019081 ; Registration date: 2015/9/30. [ABSTRACT FROM AUTHOR]

Background: Waiting lists for treatment are common in outpatient and community services, Existing methods for managing access and triage to these services can lead to inequities in service delivery, inefficiencies and divert resources from frontline care. Evidence from two controlled studies indicates that an alternative to the traditional "waitlist and triage" model known as STAT (Specific Timely Appointments for Triage) may be successful in reducing waiting times without adversely affecting other aspects of patient care. This trial aims to test whether the model is cost effective in reducing waiting time across multiple services, and to measure the impact on service provision, health-related quality of life and patient satisfaction.Methods/design: A stepped wedge cluster randomised controlled trial has been designed to evaluate the impact of the STAT model in 8 community health and outpatient services. The primary outcome will be waiting time from referral to first appointment. Secondary outcomes will be nature and quantity of service received (collected from all patients attending the service during the study period and health-related quality of life (AQOL-8D), patient satisfaction, health care utilisation and cost data (collected from a subgroup of patients at initial assessment and after 12 weeks). Data will be analysed with a multiple multi-level random-effects regression model that allows for cluster effects. An economic evaluation will be undertaken alongside the clinical trial.Discussion: This paper outlines the study protocol for a fully powered prospective stepped wedge cluster randomised controlled trial (SWCRCT) to establish whether the STAT model of access and triage can reduce waiting times applied across multiple settings, without increasing health service costs or adversely impacting on other aspects of patient care. If successful, it will provide evidence for the effectiveness of a practical model of access that can substantially reduce waiting time for outpatient and community services with subsequent benefits for both efficiency of health systems and patient care.Trial Registration: Australian and New Zealand Clinical Trials Registry ACTRN12615001016527 . Approved 15/9/2015. [ABSTRACT FROM AUTHOR]

Background: Total laryngectomy with or without adjuvant (chemo)radiation often induces speech, swallowing and neck and shoulder problems. Speech, swallowing and shoulder exercises may prevent or diminish these problems. The aim of the present paper is to describe the study, which is designed to investigate the effectiveness and cost-utility of a guided self-help exercise program built into the application "In Tune without Cords" among patients treated with total laryngectomy.Methods/design: Patients, up to 5 years earlier treated with total laryngectomy with or without (chemo)radiation will be recruited for participation in this study. Patients willing to participate will be randomized to the intervention or control group (1:1). Patients in the intervention group will be provided access to a guided self-help exercise program and a self-care education program built into the application "In Tune without Cords". Patients in the control group will only be provided access to the self-care education program. The primary outcome is the difference in swallowing quality (SWAL-QOL) between the intervention and control group. Secondary outcome measures address speech problems (SHI), shoulder disability (SDQ), quality of life (EORTC QLQ-C30, QLQ-H&N35 and EQ-5D), direct and indirect costs (adjusted iMCQ and iPCQ measures) and self-management (PAM). Patients will be asked to complete these outcome measures at baseline, immediately after the intervention or control period (i.e. at 3 months follow-up) and at 6 months follow-up.Discussion: This randomized controlled trial will provide knowledge on the effectiveness of a guided self-help exercise program for patients treated with total laryngectomy. In addition, information on the value for money of such an exercise program will be provided. If this guided self-help program is (cost)effective for patients treated with total laryngectomy, the next step will be to implement this exercise program in current clinical practice.Trial Registration: NTR5255 Protocol version 4 date September 2015. [ABSTRACT FROM AUTHOR]

Background: A systematic review on the use of incentives to promote questionnaire return in clinical trials suggest they are effective, but not all studies have sufficient funds to use them. Promising an incentive once data are returned can reduce the cost-burden of this approach, with possible further cost-savings if the offer were restricted to reminder letters only. This study aimed to evaluate the effect of promising a monetary incentive at first mailout versus a promise on reminder letters only.Methods: This was a randomised Study Within A Trial (SWAT) nested within BUMPES, a multicentre randomised controlled trial of maternal position in the late stage of labour in women with an epidural. The follow-up questionnaire asked for information on the women's health, wellbeing and health service use one year following the birth of their baby. Women who consented to be contacted were randomised to a promise of a monetary incentive at first mailout or a promise on reminder letters only. Women were given an option of completing the questionnaire on paper or on online. The incentive was posted out on receipt of a completed questionnaire. The primary outcome was the overall return rate, and secondary outcomes were the return rate without any chasing from the study office, and the total cost of the vouchers.Results: A total of 1,029 women were randomised, 508 to the first mailout group and 518 to the reminder group. There was no evidence to suggest a difference between groups in the overall return rate (adjusted RR 1.03 (95 % CI 0.96 to 1.11), however the proportion returned without chasing was higher in the first mailout group (adjusted RR 1.22, 95 % CI 1.07 to 1.39). The total cost of the vouchers per participant was higher in the first mailout group (mean difference £4.56, 95 % CI £4.02 to £5.11).Conclusions: Offering a monetary incentive when a reminder is required could be cost-effective depending on the sample size of the study and the resources available to administer the reminder letters.Trial Registration: The BUMPES Trial is registered with Current Controlled Trials: ISRCTN35706297 , 26(th) August 2009. [ABSTRACT FROM AUTHOR]

Background: Cervicogenic headache is a prevalent and costly pain condition commonly treated by chiropractors. There is evidence to support the effectiveness for spinal manipulation, but the dose of treatment required to achieve maximal relief remains unknown. The purpose of this paper is to describe the methodology for a randomized controlled trial evaluating the dose--response of spinal manipulation for chronic cervicogenic headache in an adult population. Methods/Design: This is a mixed-methods, two-site, prospective, parallel groups, observer-blind, randomized controlled trial conducted at university-affiliated research clinics in the Portland, OR and Minneapolis, MN areas. The primary outcome is patient reported headache frequency. Other outcomes include self-reported headache intensity, disability, quality of life, improvement, neck pain intensity and frequency, satisfaction, medication use, outside care, cervical motion, pain pressure thresholds, health care utilization, health care costs, and lost productivity. Qualitative interviews are also conducted to evaluate patients' expectations of treatment. Discussion: With growing concerns regarding the costs and side effects of commonly used conventional treatments, greater numbers of headache sufferers are seeking other approaches to care. This is the first full-scale randomized controlled trial assessing the dose--response of spinal manipulation therapy on outcomes for cervicogenic headache. The results of this study will provide important evidence for the management of cervicogenic headache in adults. Trial registration: ClinicalTrials.gov (Identifier: NCT01530321) [ABSTRACT FROM AUTHOR]

Background: The quality of the home learning environment has a significant influence on children's language and communication skills during the early years with children from disadvantaged families disproportionately affected. This paper describes the protocol and participant baseline characteristics of a community-based effectiveness study. It evaluates the effects of 'smalltalk', a brief group parenting intervention (with or without home coaching) on the quality of the early childhood home learning environment.Methods/design: The study comprises two cluster randomised controlled superiority trials (one for infants and one for toddlers) designed and conducted in parallel. In 20 local government areas (LGAs) in Victoria, Australia, six locations (clusters) were randomised to one of three conditions: standard care (control); smalltalk group-only program; or smalltalk plus (group program plus home coaching). Programs were delivered to parents experiencing socioeconomic disadvantage through two existing age-based services, the maternal and child health service (infant program, ages 6-12 months), and facilitated playgroups (toddler program, ages 12-36 months). Outcomes were assessed by parent report and direct observation at baseline (0 weeks), post-intervention (12 weeks) and follow-up (32 weeks). Primary outcomes were parent verbal responsivity and home activities with child at 32 weeks. Secondary outcomes included parenting confidence, parent wellbeing and children's communication, socio-emotional and general development skills. Analyses will use intention-to-treat random effects ("multilevel") models to account for clustering.Recruitment and Baseline Data: Across the 20 LGAs, 986 parents of infants and 1200 parents of toddlers enrolled and completed baseline measures. Eighty four percent of families demonstrated one or more of the targeted risk factors for poor child development (low income; receives government benefits; single, socially isolated or young parent; culturally or linguistically diverse background).Discussion: This study will provide unique data on the effectiveness of a brief group parenting intervention for enhancing the early home learning environment of young children from disadvantaged families. It will also provide evidence of the extent to which additional one-on-one support is required to achieve change and whether there are greater benefits when delivered in the 1st year of life or later. The program has been designed for scale-up across existing early childhood services if proven effective.Trial Registration: 8 September 2011; ACTRN12611000965909 . [ABSTRACT FROM AUTHOR]

Background: Upper limb orthoses are frequently prescribed for children with cerebral palsy (CP) who have muscle overactivity predominantly due to spasticity, with little evidence of long-term effectiveness. Clinical consensus is that orthoses help to preserve range of movement: nevertheless, they can be complex to construct, expensive, uncomfortable and require commitment from parents and children to wear. This protocol paper describes a randomised controlled trial to evaluate whether long-term use of rigid wrist/hand orthoses (WHO) in children with CP, combined with usual multidisciplinary care, can prevent or reduce musculoskeletal impairments, including muscle stiffness/tone and loss of movement range, compared to usual multidisciplinary care alone.Methods/design: This pragmatic, multicentre, assessor-blinded randomised controlled trial with economic analysis will recruit 194 children with CP, aged 5-15 years, who present with flexor muscle stiffness of the wrist and/or fingers/thumb (Modified Ashworth Scale score ≥1). Children, recruited from treatment centres in Victoria, New South Wales and Western Australia, will be randomised to groups (1:1 allocation) using concealed procedures. All children will receive care typically provided by their treating organisation. The treatment group will receive a custom-made serially adjustable rigid WHO, prescribed for 6 h nightly (or daily) to wear for 3 years. An application developed for mobile devices will monitor WHO wearing time and adverse events. The control group will not receive a WHO, and will cease wearing one if previously prescribed. Outcomes will be measured 6 monthly over a period of 3 years. The primary outcome is passive range of wrist extension, measured with fingers extended using a goniometer at 3 years. Secondary outcomes include muscle stiffness, spasticity, pain, grip strength and hand deformity. Activity, participation, quality of life, cost and cost-effectiveness will also be assessed.Discussion: This study will provide evidence to inform clinicians, services, funding agencies and parents/carers of children with CP whether the provision of a rigid WHO to reduce upper limb impairment, in combination with usual multidisciplinary care, is worth the effort and costs.Trial Registration: ANZ Clinical Trials Registry: U1111-1164-0572 . [ABSTRACT FROM AUTHOR]

Background: Approximately 20 % of children and adolescents who have sustained mild traumatic brain injuries may experience long-term consequences, including cognitive problems, post-traumatic stress symptoms and reduced load-bearing capacity. The underestimation and belated recognition of these long-term consequences may lead to chronic and disruptive problems, such as participation problems in school and in social relationships. The aim of this study is to examine the level of activities and participation of children and adolescents up to 6 months after a mild traumatic brain injury and to identify possible outcome predictors. Another aim is to investigate the effectiveness of an early psychoeducational intervention and compare the results with those obtained with usual care.Methods/design: This paper presents the Brains Ahead! study design, a randomised controlled trial nested within a multicentre, longitudinal, prospective cohort study. The eligible participants include children and adolescents between 6 and 18 years of age who have experienced a mild traumatic brain injury within the last 2 weeks. The cohort study will include 500 children and adolescents with a mild traumatic brain injury and their caregivers. A subset of 140 participants and their caregivers will be included in the randomised controlled trial. Participants in the randomised controlled trial will be randomly assigned to either the psychoeducational intervention group or the usual care control group. The psychoeducational intervention involves one face-to-face contact and one phone contact with the interventionist, during which the consequences of mild traumatic brain injury and advice for coping with these consequences to prevent long-term problems will be discussed. Information will be provided both verbally and in a booklet. The primary outcome domain is activities and participation, which will be evaluated using the Child and Adolescent Scale of Participation. Participants are evaluated 2 weeks, 3 months and 6 months after the mild traumatic brain injury.Discussion: The results of this study will provide insight into which children with mild traumatic brain injury are at risk for long-term participation problems and may benefit from a psychoeducational intervention.Trial Registration: Netherlands Trial Register identifier NTR5153 . Registered on 17 Apr 2015. [ABSTRACT FROM AUTHOR]

Background: Healthy Alberta Communities (HAC) was a 3-year community-based intervention to reduce lifestyle-related risk factors for chronic disease and obesity at a population-level. The current paper examines changes in blood pressure (BP) and anthropometric indicators within HAC communities compared to secular trends.Methods: Between 2006 and 2009, this community-academic partnership sought to create environments supportive of healthier dietary and physical activity behaviours within four diverse communities in Alberta, Canada. Height, weight, waist and hip circumference and BP were measured among 1554 and 1808 community residents at baseline (2006) and follow-up (2009), respectively. A comparison sample was drawn from a representative national survey. Samples were stratified by age and change between pre- and post-intervention was assessed using t-tests. Changes in parameters over time between groups were compared using meta-analysis. The net difference in change in outcomes (change in intervention communities minus change in comparison group) represented the effect of the intervention.Results: Adjusted systolic (SBP) and diastolic (DBP) BP declined within most age groups in HAC communities from pre- to post-intervention. The net decline in SBP was 1 mmHg in 20-39 year olds (p = 0.006) and 2 mmHg in 40-59 year olds (p = 0.001), while the net decline in DBP was 3 mmHg in 20-39 year olds (p < 0.001), 2 mmHg in 40-59 year olds (p < 0.001) and 3 mmHg in 60-79 year olds (p < 0.001). The net increase in the proportion of individuals with normal BP was 5.9 % (p < 0.001), while the net decline in the proportion of individuals with stage 1 hypertension was 4.5 % (p < 0.001). BMI and body weight were unchanged. There was a significant net increase in waist and hip circumference among 20-39 year olds within intervention communities.Conclusions: Findings suggest HAC succeeded in shifting the population distribution of BP in a leftward direction. By contrast, anthropometric parameters remained unchanged or worsened within intervention communities. Therefore, while improvements in some clinical risk factors can be achieved through relatively diffuse and shorter-term community-level environmental changes, improvements in others may require interventions of greater intensity and duration. Evaluating the success of community-based interventions based on their efficacy in changing individual-level clinical indicators may, however, underestimate their potential. [ABSTRACT FROM AUTHOR]

Background: Risky sexual behaviors of adolescents in Mexico are a public health problem; 33.4 % of adolescent girls and 14.7 % of boys report not having used any protection at their first intercourse. The fertility rate is 77 births/1000 girls aged 15-19 years. The infrequent contact of adolescents with health services and the limited extent of school sex and reproductive health education require the support of innovative strategies. The objective of this paper is to present the design of an internet-based educational strategy to prevent risky sexual behaviors in Mexican adolescents.Methods: A field trial with intervention and comparison group and with ex-ante and ex-post measurements will be conducted in two public secondary schools. Adolescents between 14 and 15 years of age will participate. The intervention will be conducted in one school and the second school will serve as a comparison group where the investigators will observe the usual sex education provided by the school. The intervention will be delivered using an internet web page that includes four educational sessions provided during a 4 week period. Follow-up will last 3 months. Information on the study variables will be obtained through an Internet-based self-applied questionnaire and collected on three occasions: 1) when the adolescents enter the study (baseline), 2) once the intervention is completed (at 1 month) and 3) after 3 months of follow-up (at the fourth month). There will be three outcome variables: 1) knowledge in regard to sexually transmitted infections, 2) attitudes regarding condom use, and 3) self-efficacy toward consistent condom use. The generalized linear model will be used to assess changes in each outcome variable controlling for baseline measures and for study covariates.Discussion: The design and evaluation of an Internet-based educational strategy to prevent risky sexual behaviors in Mexican adolescents is important in order to provide a new, large-scale, easily implemented preventive tool.Trial Registration: The study was registered at the ClinicalTrials.gov ID: NCT02686736 . [ABSTRACT FROM AUTHOR]

Background: With increasing experience using anti-VEGF therapy for the treatment of neovascular age-related macular degeneration (nAMD), ophthalmologists have shifted away from a "one size fits all" to an "individualised" approach based on disease activity with the aim of achieving a fluid-free retina. The FLUID study investigates the non-inferiority of a Treat and Extend (T&E) protocol of 0.5 mg ranibizumab, which allows treatment extension in the presence of incomplete resolution of sub-retinal fluid (SRF) ≤200 μm at the foveal centre relative to a T&E protocol that requires complete resolution of all retinal fluid (i.e., both SRF and intra-retinal fluid [IRF]) in patients with nAMD.Methods/design: This 24 month, randomised, phase IV trial has completed recruitment of treatment-naïve patients randomised 1:1 to ranibizumab "intensive" treatment (complete resolution of IRF and SRF) or ranibizumab "relaxed" treatment (resolution of IRF or >200 μm SRF only at foveal centre). Patients in both arms follow a T&E regimen where extension decisions are based upon assessment of lesion activity: loss of ≥5 letters of visual acuity, new haemorrhage, presence of IRF and SRF on an optical coherence tomography (OCT) scan. The determination of SRF is conducted at a reading centre while the assessment of IRF is physician-determined. The primary endpoint is the mean change in best-corrected visual acuity (BCVA) from baseline to 24 months. Secondary endpoints include the mean change in central retinal thickness (CRT) from baseline to 12 and 24 months, the number of ranibizumab injections administered at 12 and 24 months, and the pharmacogenomic assessment of AMD Gene Consortium-identified single-nucleotide polymorphisms (SNPs) and their association with treatment response. Three hundred and forty seven (347) patients have been recruited by 16 Australian sites within approximately 16 months. A protocol to adjudicate on SRF has been established by the central reading centre and is demonstrating good concordance with investigator assessment.Discussion: This study will provide important insights into retreatment criteria for managing nAMD using a T&E regimen. The current paper describes the clinical rationale for using a less intensive treatment approach using ranibizumab and details of the treatment protocol.Trial Registration: Trial Registration Number: NCT01972789. Date of registration: 24th October 2013. [ABSTRACT FROM AUTHOR]

Background: Electronic administrative data exist in several domains which, if linked, are potentially useful for research. However, benefits from data linkage should be considered alongside risks such as the threat to privacy. Avon Longitudinal Study of Parents and Children (ALSPAC) is a birth cohort study. The Project to Enhance ALSPAC through Record Linkage (PEARL) was established to enrich the ALSPAC resource through linkage between ALSPAC participants and routine sources of health and social data. Qualitative research was incorporated in the PEARL study to examine participants' views about data linkage and inform approaches to information sharing. This paper focusses on issues of consent.Methods: Digitally recorded interviews were conducted with 55 participants aged 17-19 years. Terms and processes relating to consent, anonymization and data linkage were explained to interviewees. Scenarios were used to prompt consideration of linking different sources of data, and whether consent should be requested. Interview recordings were fully transcribed. Thematic analysis was undertaken using the Framework approach.Results: Participant views on data linkage appeared to be most influenced by: considerations around the social sensitivity of the research question, and; the possibility of tangible health benefits in the public interest. Some participants appeared unsure about the effectiveness of anonymization, or did not always view effective anonymization as making consent unnecessary. This was related to notions of ownership of personal information and etiquette around asking permission for secondary use. Despite different consent procedures being explained, participants tended to equate consent with 'opt-in' consent through which participants are 'asked' if their data can be used for a specific study. Participants raising similar concerns came to differing conclusions about whether consent was needed. Views changed when presented with different scenarios, and were sometimes inconsistent.Conclusions: Findings from this study question the validity of 'informed consent' as a cornerstone of good governance, and the extent to which potential research participants understand different types of consent and what they are consenting, or not consenting, to. Pragmatic, imaginative and flexible approaches are needed if research using data linkage is to successfully realise its potential for public good without undermining public trust in the research process. [ABSTRACT FROM AUTHOR]

Background: The Medical Research Council (MRC) Framework for complex interventions highlights the need to explore interactions between components of complex interventions, but this has not yet been fully explored within complex, non-pharmacological interventions. This paper draws on the process evaluation data of a suicide prevention programme implemented in four European countries to illustrate the synergistic interactions between intervention levels in a complex programme, and to present our method for exploring these.Methods: A realist evaluation approach informed the process evaluation, which drew on mixed methods, longitudinal case studies. Data collection consisted of 47 semi-structured interviews, 12 focus groups, one workshop, fieldnoted observations of six programme meetings and 20 questionnaires (delivered at six month intervals to each of the four intervention sites). Analysis drew on the framework approach, facilitated by the use of QSR NVivo (v10). Our qualitative approach to exploring synergistic interactions (QuaSIC) also developed a matrix of hypothesised synergies that were explored within one workshop and two waves of data collection.Results: All four implementation countries provided examples of synergistic interactions that added value beyond the sum of individual intervention levels or components in isolation. For instance, the launch ceremony of the public health campaign (a level 3 intervention) in Ireland had an impact on the community-based professional training, increasing uptake and visibility of training for journalists in particular. In turn, this led to increased media reporting of OSPI activities (monitored as part of the public health campaign) and also led to wider dissemination of editorial guidelines for responsible reporting of suicidal acts. Analysis of the total process evaluation dataset also revealed the new phenomenon of the OSPI programme acting as a catalyst for externally generated (and funded) activity that shared the goals of suicide prevention.Conclusions: The QuaSIC approach enabled us to develop and refine our definition of synergistic interactions and add the innovative concept of catalytic effects. This represents a novel approach to the evaluation of complex interventions. By exploring synergies and catalytic interactions related to a complex intervention or programme, we reveal the added value to planned activities and how they might be maximised. [ABSTRACT FROM AUTHOR]

Background: Over 30 % of older patients experience hospitalization-associated disability (HAD) (i.e., loss of independence in Activities of Daily Living (ADLs)) after an acute hospitalization. Despite its high prevalence, the mechanisms that underlie HAD remain elusive. This paper describes the protocol for the Hospital-Associated Disability and impact on daily Life (Hospital-ADL) study, which aims to unravel the potential mechanisms behind HAD from admission to three months post-discharge.Methods/design: The Hospital-ADL study is a multicenter, observational, prospective cohort study aiming to recruit 400 patients aged ≥70 years that are acutely hospitalized at departments of Internal Medicine, Cardiology or Geriatrics, involving six hospitals in the Netherlands. Eligible are patients hospitalized for at least 48 h, without major cognitive impairment (Mini Mental State Examination score ≥15), who have a life expectancy of more than three months, and without disablement in all six ADLs. The study will assess possible cognitive, behavioral, psychosocial, physical, and biological factors of HAD. Data will be collected through: 1] medical and demographical data; 2] personal interviews, which includes assessment of cognitive impairment, behavioral and psychosocial functioning, physical functioning, and health care utilization; 3] physical performance tests, which includes gait speed, hand grip strength, balance, bioelectrical impedance analysis (BIA), and an activity tracker (Fitbit Flex), and; 4] analyses of blood samples to assess inflammatory and metabolic markers. The primary endpoint is additional disabilities in ADLs three months post-hospital discharge compared to ADL function two weeks prior to hospital admission. Secondary outcomes are health care utilization, health-related quality of life (HRQoL), physical performance tests, and mortality. There will be at least five data collection points; within 48 h after admission (H1), at discharge (H3), and at one (P1; home visit), two (P2; by telephone) and three months (P3; home visit) post-discharge. If the patient is admitted for more than five days, additional measurements will be planned during hospitalization on Monday, Wednesday, and Friday (H2).Discussion: The Hospital-ADL study will provide information on cognitive, behavioral, psychosocial, physical, and biological factors associated with HAD and will be collected during and following hospitalization. These data may inform new interventions to prevent or restore hospitalization-associated disability. [ABSTRACT FROM AUTHOR]

Background: Quality of life (QoL) is an important measure and outcome within chronic disease management and treatment, including substance use disorders (SUD). The aim of this paper was to investigate correlates of poorer QoL of individuals entering SUD treatment in Norway, in order to identify subgroups that may most benefit from different interventions.Methods: Twenty-one treatment facilities invited all incoming patients to participate. Five hundred forty-nine patients who enrolled between December 2012 and April 2015 are analyzed. QoL, substance use, mental and physical comorbidities, and exercise behaviors were measured. Multinomial regression analysis was used to determine variables significantly associated with poorer QoL.Results: The majority of both genders (75 %) reported "poor" or "very poor" QoL at intake. Depression showed a strong association with poor QoL (relative risk ratio [RRR] 3.3, 95 % confidence interval [CI] 1.0-10.3) and very poor QoL (RRR 3.8, 1.2-11.8) among women. Physical inactivity among men was associated with very poor QoL (RRR 2.0, 1.1-3.7), as was reporting eating most meals alone (RRR 2.6, 1.4-4.8). Evaluating one's weight as too low was also associated with poor QoL (RRR 2.0, 1.0-3.9) and very poor QoL (RRR 2.0, 1.1-3.7) among men. Consuming methadone/buprenorphine was a protective factor for men reporting poor QoL (RRR 0.5, 0.3-0.9) and very poor QoL (RRR 0.4, 0.2-0.9), as well as for women reporting very poor QoL (RRR 0.2, 0.0-0.6).Conclusions: Factors associated with poorer QoL among other healthy and clinical populations, such as impaired social and physical well-being and psychological distress, were also seen associated in this sample. Treatment should be targeted towards patients with these particular vulnerabilities in addition to focusing on substance-related factors, and interventions proven to improve the QoL of other populations with these vulnerabilities should be explored in a SUD context. [ABSTRACT FROM AUTHOR]

Background: Implementation delays are common in health information technology (HIT) projects. In this paper, we sought to explore the reasons for delays in implementing major hospital-based HIT, through studying computerized physician order entry (CPOE) and clinical decision support (CDS) systems for prescribing and to develop a provisional taxonomy of causes of implementation delays.Methods: We undertook a series of longitudinal, qualitative case studies to investigate the implementation and adoption of CPOE and CDS systems for prescribing in hospitals in the U.K. We used a combination of semi-structured interviews from six case study sites and two whole day expert roundtable discussions to collect data. Interviews were carried out with users, implementers and suppliers of CPOE/CDS systems. We used thematic analysis to examine the results, drawing on perspectives surrounding the biography of artefacts.Results: We identified 15 major factors contributing to delays in implementation of CPOE and CDS systems. These were then categorized in a two-by-two delay classification matrix: one axis distinguishing tactical versus unintended causes of delay, and the second axis illustrating internal i.e., (the adopting hospital) versus external (i.e., suppliers, other hospitals, policymakers) related causes.Conclusions: Our taxonomy of delays in HIT implementation should enable system developers, implementers and policymakers to better plan and manage future implementations. More detailed planning at the outset, considering long-term strategies, sustained user engagement, and phased implementation approaches appeared to reduce the risks of delays. It should however be noted that whilst some delays are likely to be preventable, other delays cannot be easily avoided and taking steps to minimize these may negatively affect the longer-term use of the system. [ABSTRACT FROM AUTHOR]

Background: In 2009, we began recruiting dental practitioners across Germany to participate in a clinical trial to evaluate the clinical performance of EQUIA, a new glass ionomer restoration material. The aim of this paper is to discuss the outcomes of the dental practitioner recruitment and outline the process of establishing a practice-based research network.Methods: Study proposals were sent to randomly selected dental offices in 29 cities in Germany. The proposals were sent until a minimum of 10 clinics in each city declared participation. Later on, briefing lectures informed the participating practitioners about the design, methods, and material application procedure. Participants were familiarized with the guidelines of Good Manufacturing Practice (GMP) and Good Epidemiological Practice (GEP). A questionnaire describing the characteristics of each dental office was filled out by the participating practitioner. Additionally, participation levels were characterized according to the socioeconomic status and geographic districts of residence in Germany (Regions 0 to 9). The associations between the characteristics were tested by the Kruskal-Wallis Test and Chi-squared test (P < 0.05).Results: A total of 3194 private dental clinics were invited, 1712 clinics refused to participate, 1195 did not respond to the invitation, and 323 agreed to participate. Only 144 clinics participated in the lectures held in their cities and signed the participation agreement. Based on their geographic location, the highest participation was in Region 2 with a participation rate of 14.3%, and the lowest participation was in Region 6 with a participation rate of 1.7%. Regions with the lowest rate of unemployment and relatively higher rates of income (Regions 7 and 8) had the highest rate of refusals (86%).Conclusion: The initial results of the dental practitioner recruitment in this study suggest that the recruitment and pre-randomization design were successful, and by reaching out to a considerable number of private dental clinics to participate, we were able to recruit a smaller number of highly motivated dentists in this clinical study. Regional differences in socioeconomic status, practitioner specialization, and differences in patient health care insurance have to be considered when recruiting dental practitioners for clinical trials.Trial Registration: The trial has been registered at Deutsches Register Klinischer Studien (German register of clinical trials) on 6 September 2012 under DRKS-ID: DRKS00004220. [ABSTRACT FROM AUTHOR]

Background: In 2012 and 2013, we conducted a social network survey of a new translational research network (TRN) designed to deliver better care to cancer patients. Results of these two surveys showed that silos of researchers and clinicians existed before the TRN was established but that the network had mediated collaborative relationships. This paper reports on a third social network survey of the TRN and focusses on the structure of the collaborative arrangements among members.Methods: Members of the TRN were invited to complete an on-line, whole network survey in May 2015. The survey asked respondents to identify personal impacts, outputs and wider outcomes attributable to their TRN membership. The final question asked respondents to select the name of TRN members with whom they had collaborated either formally or informally. For each member nominated, they were asked to say whether they had known this person before joining the TRN.Results: Response rate was 70 %. Over 4 years, the TRN has grown in size from 68 to 244 members. Relationships within and across the TRN have become more collaborative and interactive, with 1658 collaborative ties between members and over 40 % of ties with people unknown to participants before they joined the TRN. This points to a well-functioning network which has retained its focus on the original goals of the TRN and has fostered collaboration between researchers, clinicians, managers, consumers and TRN operational staff. This survey shows that the TRN's impact goes beyond outcomes from formal TRN-funded projects. About one third of respondents could list projects not directly funded by the TRN but which are attributed to TRN membership. Examples of practice change brought about through the TRN were given by 77 % of respondents. A substantial risk factor for the future is the high levels of dependency on key or central TRN participants.Conclusions: The structure of the TRN with its active central actors and brokers has been able to foster collaboration on implementation initiatives that result in practice change. The role of a social professional network in driving this collaboration is shown. [ABSTRACT FROM AUTHOR]

Background: Increasingly, it is being suggested that translational gaps might be eradicated or narrowed by bringing research users and producers closer together, a theory that is largely untested. This paper reports a national study to fill a gap in the evidence about the conditions, processes and outcomes related to collaboration and implementation.Methods: A longitudinal realist evaluation using multiple qualitative methods case studies was conducted with three Collaborations for Leadership in Applied Health Research in Care (England). Data were collected over four rounds of theory development, refinement and testing. Over 200 participants were involved in semi-structured interviews, non-participant observations of events and meetings, and stakeholder engagement. A combined inductive and deductive data analysis process was focused on proposition refinement and testing iteratively over data collection rounds.Results: The quality of existing relationships between higher education and local health service, and views about whether implementation was a collaborative act, created a path dependency. Where implementation was perceived to be removed from service and there was a lack of organisational connections, this resulted in a focus on knowledge production and transfer, rather than co-production. The collaborations' architectures were counterproductive because they did not facilitate connectivity and had emphasised professional and epistemic boundaries. More distributed leadership was associated with greater potential for engagement. The creation of boundary spanning roles was the most visible investment in implementation, and credible individuals in these roles resulted in cross-boundary work, in facilitation and in direct impacts. The academic-practice divide played out strongly as a context for motivation to engage, in that 'what's in it for me' resulted in variable levels of engagement along a co-operation-collaboration continuum. Learning within and across collaborations was patchy depending on attention to evaluation.Conclusions: These collaborations did not emerge from a vacuum, and they needed time to learn and develop. Their life cycle started with their position on collaboration, knowledge and implementation. More impactful attempts at collective action in implementation might be determined by the deliberate alignment of a number of features, including foundational relationships, vision, values, structures and processes and views about the nature of the collaboration and implementation. [ABSTRACT FROM AUTHOR]

Background: There are inherent methodological challenges in the measurement of mental health problems in longitudinal research. There is constant development in definitions, taxonomies and demands concerning the properties of mental health measurements. The aim of this paper was to construct composite measures of mental health problems (according to today's standard) from single questionnaire items devised in the early 1980s, and to evaluate their internal consistency and factorial invariance across the life course using the Northern Swedish Cohort.Methods: All pupils in the last year of compulsory school in Luleå in 1981 (n = 1083) form a prospective cohort study where the participants have been followed with questionnaires from the age of 16 (in 1981) until the age of 43 (in 2008). We created and tested the following composite measures from self-reports at each follow-up: depressive symptoms, anxiety symptoms, functional somatic symptoms, modified GHQ and positive health. Validity and internal consistency were tested by confirmatory factor analysis, including tests of factorial invariance over time.Results: As an overall assessment, the results showed that the composite measures (based on more than 30-year-old single item questions) are likely to have acceptable factorial invariance as well as internal consistency over time.Conclusions: Testing the properties of the mental health measures used in older studies according to the standards of today is of great importance in longitudinal research. Our study demonstrates that composite measures of mental health problems can be constructed from single items which are more than 30 years old and that these measures seem to have the same factorial structure and internal consistency across a significant part of the life course. Thus, it can be possible to overcome some specific inherent methodological challenges in using historical data in longitudinal research. [ABSTRACT FROM AUTHOR]

Background: The current study investigated the association between breastfeeding and adult weight distribution using an emerging indicator of weight distribution, the waist-to-height ratio (WHtR).Methods: The study sample consisted of two subsamples of individuals that were part of the National Longitudinal Study of Adolescent Health. One sample (n = 1,179) consisted of individuals from the sibling pair data. A second sample (n = 4,648) consisted of individuals that were not part of the paired data. Regression models were constructed to establish if there was a relationship between breastfeeding and two measures of weight distribution: WHtR and body mass index (BMI). Controls for parental socioeconomic status, maternal smoking, race, sex, age, birth weight, maternal BMI, genetic ancestry, and a genetic risk score (GRS) for obesity were included. In addition, a behavioral risk score (BRS) was constructed to control for other residual confounding factors.Results: A significant, inverse relationship between breastfeeding and adult WHtR persisted in models constructed from the sibling pair sample (P = 0.002) and unrelated sample (P < 0.0001). This association remained significant with the inclusion of ancestry principal components, GRS, and a measure of maternal obesity.Conclusions: The moderate association between breastfeeding and weight distribution persists into adulthood while controlling for potential confounders. This paper also provides evidence that the WHtR may be a superior outcome measure to BMI in studies investigating breastfeeding and obesity. [ABSTRACT FROM AUTHOR]

Background: A major unresolved safety concern for malaria case management is the use of artemisinin combination therapies (ACTs) in the first trimester of pregnancy. There is a need for human data to inform policy makers and treatment guidelines on the safety of artemisinin combination therapies (ACT) when used during early pregnancy. Methods: The overall goal of this paper is to describe the methods and implementation of a study aimed at developing surveillance systems for identifying exposures to antimalarials during early pregnancy and for monitoring pregnancy outcomes using health and demographic surveillance platforms. This was a multi-center prospective observational cohort study involving women at health and demographic surveillance sites in three countries in Africa: Burkina Faso, Kenya and Mozambique [(ClinicalTrials.gov Identifier: NCT01232530)]. The study was designed to identify pregnant women with artemisinin exposure in the first trimester and compare them to: 1) pregnant women without malaria, 2) pregnant women treated for malaria, but exposed to other antimalarials, and 3) pregnant women with malaria and treated with artemisinins in the 2nd or 3rd trimesters from the same settings. Pregnant women were recruited through community-based surveys and attendance at health facilities, including antenatal care clinics and followed until delivery. Data from the three sites will be pooled for analysis at the end of the study. Results are forthcoming. Discussion: Despite few limitations, the methods described here are relevant to the development of sustainable pharmacovigilance systems for drugs used by pregnant women in the tropics using health and demographic surveillance sites to prospectively ascertain drug safety in early pregnancy. Trial registration: NCT01232530 [ABSTRACT FROM AUTHOR]

Background: A common complication after stroke is development of cognitive impairment and dementia. However, effective strategies for reducing the risk of developing these problems remain undefined. Potential strategies include intensive lowering of blood pressure (BP) and/or lipids. This paper summarises the baseline characteristics, statistical analysis plan and feasibility of a randomised control trial of blood pressure and lipid lowering in patients post-stroke with the primary objective of reducing cognitive impairment and dementia.Methods: The Prevention Of Decline in Cognition After Stroke Trial (PODCAST) was a multi-centre prospective randomised open-label blinded-endpoint controlled partial-factorial internal pilot trial running in secondary and primary care. Participants without dementia were enrolled 3-7 months post ischaemic stroke or spontaneous intracerebral haemorrhage, and randomised to intensive versus guideline BP lowering (target systolic BP <125 mmHg versus <140 mmHg); patients with ischaemic stroke were also randomised to intensive or guideline lipid lowering (target LDL cholesterol <1.4 mmol/L versus <3 mmol/L). The primary outcome was the Addenbrooke's Cognitive Examination-Revised; a key secondary outcome was to assess feasibility of performing a large trial of one or both interventions. Data are number (%) or mean (standard deviation). The trial was planned to last for 8 years with follow-up between 1 and 8 years. The plan for reporting the main results is included as Additional file 2.Results: 83 patients (of a planned 600) were recruited from 19 UK sites between 7 October 2010 and 31 January 2014. Delays, due to difficulties in the provision of excess treatment costs and to complexity of follow-up, led to few centres taking part and a much lower recruitment rate than planned. Patient characteristics at baseline were: age 74 (SD 7) years, male 64 (77 %), index stroke ischaemic 77 (93 %), stroke onset to randomisation 4.5 [SD 1.3] months, Addenbrooke's Cognitive Examination-Revised 86 (of 100, SD 8), Montreal Cognitive Assessment 24 (of 30, SD 3), BP 147/82 (SD 19/11) mmHg, total cholesterol 4.0 (SD 0.8) mmol/L and LDL cholesterol 2.0 (SD 0.7) mmol/L, modified Rankin Scale 1.1 (SD 0.8).Conclusion: Limited recruitment suggests that a large trial is not feasible using the current protocol. The effects of the interventions on BP, lipids, and cognition will be reported in the main publication.Trial Registration: ISRCTN85562386 registered on 23 September 2009. [ABSTRACT FROM AUTHOR]

Background: Nosocomial infections are the most common complication during inpatient hospital care. An increasing proportion of these infections are caused by multidrug-resistant organisms (MDROs). This report describes an intervention study which was designed to address the practical problems encountered in trying to avoid and treat infections caused by MDROs. The aim of the HARMONIC (Harmonized Approach to avert Multidrug-resistant Organisms and Nosocomial Infections) study is to provide comprehensive support to hospitals in a defined study area in north-east Germany, to meet statutory requirements. To this end, a multimodal system of hygiene management was implemented in the participating hospitals.Methods/design: HARMONIC is a controlled intervention study conducted in eight acute care hospitals in the 'Health Region Baltic Sea Coast' in Germany. The intervention measures include the provision of written recommendations on methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococci (VRE) and multi-resistant Gram-negative bacteria (MRGN), supplemented by regional recommendations for antibiotic prescriptions. In addition, there is theoretical and practical training of health care workers (HCWs) in the prevention and handling of MDROs, as well as targeted and critically gauged applications of antibiotics. The main outcomes of the implementation and analysis of the HARMONIC study are: (i) screening rates for MRSA, VRE and MRGN in high-risk patients, (ii) the frequency of MRSA decolonization, (iii) the level of knowledge of HCWs concerning MDROs, and (iv) specific types and amounts of antibiotics used. The data are predominantly obtained by paper-based questionnaires and documentation sheets. A computer-assisted workflow-based documentation system was developed in order to provide support to the participating facilities. The investigation includes three nested studies on risk profiles of MDROs, health-related quality of life, and cost analysis. A six-month follow-up study investigates the quality of life after discharge, the long-term costs of the treatment of infections caused by MDROs, and the sustainability of MRSA eradication.Discussion: The aim of this study is to implement and evaluate an area-wide harmonized hygiene program to control the nosocomial spreading of MDROs. Comparability between the intervention and control group is ensured by matching the hospitals according to size (number of discharges per year/number of beds) and level of care (standard or maximum). The results of the study may provide important indications for the implementation of regional MDRO management programs. [ABSTRACT FROM AUTHOR]