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Background: Administration of magnesium sulphate (MgSO4) to women with imminent preterm birth at <34 weeks is an evidence-based antenatal neuroprotective strategy to prevent cerebral palsy. Although a Society of Obstetricians and Gynaecologists of Canada (SOGC) national guideline with practice recommendations based on relevant clinical evidence exists, ongoing controversies about aspects of this treatment remain. Given this, we anticipated managed knowledge translation (KT) would be needed to facilitate uptake of the guidelines into practice. As part of the Canadian Institutes of Health Research (CIHR)-funded MAG-CP (MAGnesium sulphate to prevent Cerebral Palsy) project, we aimed to compare three KT methods designed to impact both individual health care providers and the organizational systems in which they work.Methods: The KT methods undertaken were an interactive online e-learning module available to all SOGC members, and at MAG-CP participating sites, on-site educational rounds and focus group discussions, and circulation of an anonymous 'Barriers and Facilitators' survey for the systematic identification of facilitators and barriers for uptake of practice change. We compared these strategies according to: (i) breadth of respondents reached; (ii) rates and richness of identified barriers, facilitators, and knowledge needed; and (iii) cost.Results: No individual KT method was superior to the others by all criteria, and in combination, they provided richer information than any individual method. The e-learning module reached the most diverse audience of health care providers, the site visits provided opportunity for iterative dialogue, and the survey was the least expensive. Although the site visits provided the most detailed information around individual and organizational barriers, the 'Barriers and Facilitators' survey provided more detail regarding social-level barriers. The facilitators identified varied by KT method. The type of knowledge needed was further defined by the e-learning module and surveys.Conclusions: Our findings suggest that a multifaceted approach to KT is optimal for translating national obstetric guidelines into clinical practice. As audit and feedback are essential parts of the process by which evidence to practice gaps are closed, MAG-CP is continuing the iterative KT process described in this paper concurrent with tracking of MgSO4 use for fetal neuroprotection and maternal and child outcomes until September 2015; results are anticipated in 2016. [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: Patient-reported outcomes (PRO) provide a more comprehensive picture of patients' quality of life than do mere physicians' ratings. Electronic data collection of PRO offers several advantages and allows assessments at patients' homes as well. This study reports on patients' personal internet use, their attitudes towards electronic and web-based PRO assessment (clinic-ePRO and home-ePRO) and the feasibility of these two assessment modes.Methods: At the Medical University of Innsbruck and Kufstein County Hospital, cancer patients who participated in clinic-ePRO/home-ePRO were asked to complete a comprehensive evaluation form on their personal internet usage, attitudes towards and the feasibility of routine clinic-ePRO/home-ePRO with the Computer-based Health Evaluation System (CHES) software.Results: In total, 113 patients completed the evaluation form for clinic-ePRO (Ø 45 years, SD 14) and 45 patients for home-ePRO (Ø 58 years, SD 10; 33.1 per cent inclusion rate for this sample). Most patients expressed willingness to complete routine clinic-ePRO assessments in the future (94.7 per cent of clinic-ePRO patients and 84.4 per cent of home-ePRO patients) and to discuss their data with attending physicians (82.2 per cent, home-ePRO patients only). Overall, patients preferred the software over paper-pencil questionnaires (67.2 per cent of clinic-ePRO patients and 60 per cent of home-ePRO patients) and experienced it as easy to use. Only a few minor suggestions for improvement were made (e.g. adjustable font sizes).Conclusions: The use of clinic-ePRO/home-ePRO was in general shown to be feasible and well accepted. However, to be more inclusive in the implementation of clinic-ePRO/home-ePRO, educational programs concerning their particular benefit in oncology practice potentially could enhance patients' attitudes towards, and consequently their acceptance of and compliance with electronic PRO assessments. [ABSTRACT FROM AUTHOR]

Background: Adjuvant radiotherapy (RT) of regional lymph nodes (LN) in early breast cancer is still a matter of debate. RT increases the Overall survival (OS) rate of breast cancer patients after breast conserving surgery and after mastectomy in patients with involved LN. The contribution of RT to regional LN to this improvement was poorly identified. Recently, the results of three large randomized trials addressing this question were published as full papers.Material and Methods: Published data of the MA.20 (n = 1832), the EORTC22922-10925 (EORTC) (n = 4004) trial and the French trial (n = 1334) were the foundation of this meta-analysis. Major eligibility criteria were positive i) axillary LN (all trials), ii) LN negative disease with high risk for recurrence (MA.20), and iii) medial/central tumor location (French, EORTC). The MA.20 and the EORTC trial analyzed the effect of additional regional RT to the internal mammary (IM) LN and medial supraclavicular (MS) LN, whereas in the French trial all patients received RT to the MS-LN and solely RT to the IM-LN was randomized. Primary endpoint was OS. Secondary endpoints were disease-free survival (DFS) and distant metastasis free survival (DMFS).Results: Regional RT of MS-LN and IM-LN (MA.20 and EORTC) resulted in a significant improvement of OS [Hazard Ratio (HR) 0.88 (95 % CL 0.78 - 0.99)]. Adding results of the French trial and using a random effects model to respect the different design of the French trial, the effect on OS of regional RT remained significant [HR 0.90 (95 % CL 0.82 - 0.99)]. The absolute benefits in OS were 1 % in the MA.20 trial at 10 years, 1.6 % in the EORTC trial at 10 years, and 3.3 % in the French trial at 10 years (not significant in single trials). Regional RT of MS-LN and IM-LN (MA.20 and EORTC) yielded to a significant improvement of DFS [HR 0.86 (95 % CL 0.78 - 0.95)] and DMFS [HR 0.84 (95 % CL 0.75 - 0.94)].Conclusion: Additional regional RT to the internal mammary and medial supraclavicular LN statistically significantly improved DFS, DMFS, and OS in stage I-III breast cancer. [ABSTRACT FROM AUTHOR]

Background: The following article describes the concept of optical measurement of blood volume in ventricular assist devices (VAD's) of the pulsatile type. The paper presents the current state of art in blood volume measurements of such devices and introduces a newly developed solution in the optic domain. The objective of the research is to overcome the disadvantages of the previously developed acoustic method-the requirement of additional sensor chamber.Methods: The idea of a compact measurement system has been introduced, followed by laboratory measurements. Static tests of the system have been presented, followed by dynamic measurements on a physical model of the human ventricular system. The results involving the measurements of blood chamber volume acquired by means of an optical system have been compared with the results acquired by means of the Transonic T410 ultrasound flow rate sensor (11PLX transducer, uncertainty ±5 %).Results: Preliminary dynamic measurements conducted on the physical model of the human cardiovascular system show that the proposed optical measurement system may be used to measure the transient blood chamber volumes of pulsatile VAD's with the uncertainties (standard mean deviation) lower than 10 %.Conclusions: The results show that the noninvasive measurements of the temporary blood chamber volume in the POLVAD prosthesis with the use of the developed optical system allows us to carry out accurate static and dynamic measurements. [ABSTRACT FROM AUTHOR]

Background: With ongoing concerns about the sexual health and wellbeing of young people, there is increasing need to innovate intervention approaches. Engaging parents as agents to support their children, alongside capitalising on increasingly sophisticated technological options could jointly enhance support. Converting existing programmes into interactive game based options has the potential to broaden learning access whilst preserving behaviour change technique fidelity. However the acceptability of this approach and viability of adapting resources in this way is yet to be established. This paper reports on the process of converting an existing group programme ("What Should We Tell the Children?") and tests the acceptability within a community setting.Methods: Translation of the original programme included selecting exercises and gathering user feedback on character and message framing preferences. For acceptability testing, parents were randomised to either the game (n = 106) or a control (non-interactive webpage) condition (n = 76). At time 1 all participants completed a survey on demographics, computer literacy and Theory of Planned Behaviour (TPB) items. Post intervention (time 2) users repeated the TPB questions in addition to acceptability items. Interviews (n = 17) were conducted 3 months post intervention to gather qualitative feedback on transfer of learning into real life.Results: The process of conversion identified clear preferences for first person role play, home setting and realistic characters alongside positively phrased feedback. Evaluation results show that the game was acceptable to parents on cognitive and emotional dimensions, particularly for parents of younger children. Acceptability was not influenced by baseline demographics, computer skills or baseline TPB variables. MANOVA analysis and qualitative feedback suggest potential for effective translation of learning into real life. However attrition was more likely in the game condition, potentially due to feedback text volume.Conclusions: A manualised group programme can be viably converted into a serious game format which is both cognitively and emotionally acceptable. The intervention may be more effectively targeted at parents with younger children, and further game developments must particularly address information dosing. Establishing the viability of digitally converting a group programme is a significant step forward for implementation focused research. [ABSTRACT FROM AUTHOR]

Background: Few studies have focused on investigating hypoalbuminemia in patients during earlier stages of chronic kidney disease (CKD). In particular, little is known about the role of gastrointestinal (GI) symptoms. Our goal in this paper is to study how GI symptoms relate to serum albumin levels in CKD, especially in the context of and compared with inflammation.Methods: We performed a cross-sectional study of 3599 patients with chronic kidney disease enrolled in the Chronic Renal Insufficiency Cohort (CRIC) study. All subjects were asked to complete the Modification of Diet in Renal Disease (MDRD) study patient symptom form. Our main predictor is GI symptom score. Serum level of C-reactive protein (CRP) was measured as well. Main outcome measures are serum albumin levels and prevalence of hypoalbuminemia.Results: Of the participants assessed, mean serum albumin was 3.95 ± 0.46 g/dL; 12.7 % had hypoalbuminemia. Patients with lower estimated glomerular filtration rate (eGFR) were likely to have more GI symptoms (apparent at an eGFR <45 ml/min/1.73 m(2)). Patients with worse GI symptoms had lower dietary protein intake. GI symptoms, like inflammation, were risk factors for lower serum albumin levels. However, adding GI symptom score or CRP into the multivariable regression analysis, did not attenuate the association between lower eGFR and lower albumin or hypoalbuminemia.Conclusions: Increased prevalence of GI symptoms become apparent among CKD patients at relatively high eGFR levels (45 ml/min/1.73 m(2)), long before ESRD. Patients with more severe GI symptoms scores are more likely to have hypoalbuminemia. But our data do not support GI symptoms/decreased protein intake or inflammation as being the main determinants of serum albumin level in CKD patients. [ABSTRACT FROM AUTHOR]

Background: This paper reports on the feasibility and initial efficacy of a culturally sensitive, comprehensive women-centered substance use intervention for women who inject drugs in Georgia in terms of the primary and secondary sex risk outcomes. The hypothesis under examination was that, relative to case management participants, participants in a culturally sensitive, comprehensive women-specific and -centered intervention would, on average, show significant decreases in past-30-day frequency of unprotected sex, unprotected sex at the last sexual encounter, and increases in condom use and safer sex actions.Methods: The study was a two-arm randomized trial, in which 173 potentially eligible women were screened, and those 128 women determined to be eligible were assigned at random to either Reinforcement-based Treatment plus Women's Co-Op (RBT + WC) or case management (CM). RBT + WC participants received 12 sessions of a structured intervention with the goal of reducing risky sex and substance use and improving physical and mental health. CM participants received 12 sessions of case management and informational brochures that focused on the same issues on which RBT + WC focused. Participants were assessed at baseline, post-treatment, and 3 months following treatment enrollment.Results: Analyses revealed case management having significantly overall higher Safer Sex action scores than RBT + WC, and a significant decrease over time for past 30-day number of unprotected sex acts. Unprotected sex at the last encounter and Condom Use action scores were nonsignificant.Conclusions: Women who inject drugs in Georgia are engaging in risky sexual practices, and are in need of an intervention that addresses these risky behaviors. Reasons for the failure to find differences between a culturally sensitive, comprehensive women-centered intervention and case management tailored to the needs of women who inject drugs in Georgia may have been the result of inadequate power to detect an effect in a sample whose drug use was not as serious as warranted by the intervention. (ClinicalTrials.gov Identifier: NCT01331460 ). [ABSTRACT FROM AUTHOR]

Background: Interventions on adolescents' lifestyle are important, but the main mechanisms that explain the changes (mediating variables) on lifestyle are unclear. This paper presents the rationale and methods of an intervention program focused on promoting active and healthy lifestyles (especially physical activity [PA] practice and reducing screen time) among Brazilian students-the Fortaleça sua Saúde program (Portuguese for "strengthen your health").Methods/design: This is a school-based cluster-randomized controlled trial. Three intervention and three control (no intervention) full-time public schools were randomly selected in Fortaleza, northeastern Brazil. Students (n = 1,272) from classes in Grades 7-9 were eligible, and 1,085 (548 in the intervention and 537 in control schools) completed the baseline and follow-up measures. The program duration was approximately four months and took place in 2014. Intervention strategies focused on teacher training, activities on health in the curriculum, active opportunities in the school environment (the availability of equipment for PA), and health education (health materials for students and parents). Data collection was undertaken before and immediately after the intervention. The primary variables included the practice of PA (weekly PA volume, PA behavior change stage and preference for PA during leisure-time) and screen time (TV and computer/video games). Potential intrapersonal, interpersonal and environmental mediators of PA and screen time were evaluated by a standardized questionnaire. Other lifestyle components (e.g., eating habits, substance use), psychological (e.g., self-rated health, body satisfaction) and biological (general and abdominal obesity) aspects, as well as academic performance were also evaluated in the total sample. Depressive symptoms, eating disorders, sleep quality, objectively-measured PA, and sedentary time were evaluated in obese students.Discussion: If effective, this program will contribute to the development of public policies for the promotion of active and healthy lifestyles in youth, especially those from low- and middle-income countries. The main intrapersonal, interpersonal and/or environmental mediators of PA and screen time may also be indicated. Finally, we anticipate that the proposed strategies may be adaptable to public schools and may even be extended to the entire school system.Trial Registration: ClinicalTrials.Gov: NCT02439827 . Registration date: May 3, 2015. [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: With regard to the global childhood obesity epidemic, it is imperative that effective lifestyle interventions are devised to combat childhood obesity. This paper describes the development and implementation of a comprehensive (a combination of diet and physical activity (PA)), social cognitive behaviour modification intervention using accelerometry and a dietary diary to tackle child overweight and obesity. The comprehensive intervention effect was evaluated in a comparison with diet only, PA only and a no-treatment control group.Methods: A pilot study was conducted with a non-randomized cluster design. Four hundred thirty-eight overweight and obese children aged 7-12 years from ten primary schools in Beijing were recruited to receive a one-year intervention. Participants were allocated into one of four groups: the comprehensive intervention group; the PA only group (Happy 10 program); the diet only group (nutrition education program); and a control group. The effects of intervention on adiposity, blood pressure, and biochemical indicators were assessed by examining 2-way interactions (time × intervention) in linear mixed models. Means and 95 % confidence intervals (CI) for the adjusted changes between post-intervention and baseline relative to changes in the control group were calculated and reported as effect sizes.Results: The percentage of body fat in the comprehensive intervention group showed a significant relative decrease (adjusted change: -1.01 %, 95 % CI: (-1.81, -0.20) %) compared with the PA only, diet only or control groups (P < 0.001). Systolic blood pressure significantly decreased in the comprehensive intervention group (adjusted change: -4.37 mmHg, 95 % CI: (-8.42, -0.33) mmHg), as did diastolic blood pressure (adjusted change: -5.50 mmHg, 95 % CI (-8.81, -2.19) mmHg) (P < 0.05). Compared with the other two intervention groups and the control group, positive adjusted changes in fasting glucose in the comprehensive group were found, although not for the biochemical lipid metabolism indicators. Positive but non-significant adjusted changes in body mass index and waist circumference were observed.Conclusions: Compared with the diet or PA only intervention groups, the current comprehensive program had superior positive effects on body fat percentage and blood pressure but not on the biochemical lipid metabolism indicators in Chinese overweight and obese children. Future randomized controlled trials and long-term follow-up studies are required to elaborate the findings of the current intervention.Trial Registration: ClinicalTrials.gov identifier: NCT02228434. [ABSTRACT FROM AUTHOR]

Background: Surveys are commonly used in health research to assess patient satisfaction with hospital care. Achieving an adequate response rate, in the face of declining trends over time, threatens the quality and reliability of survey results. This paper evaluates a strategy to increase the response rate in a postal satisfaction survey with women who had recently given birth.Methods: A sample of 2048 Australian women who had recently given birth at seven maternity units in New South Wales were invited to participate in a postal survey about their recent experiences with maternity care. The study design included a randomised controlled trial that tested two types of pre-notification letter (with or without the option of opting out of the survey). The study also explored the acceptability of a request for consent to link survey data with existing routinely collected health data (omitting the latter data items from the survey reduced survey length and participant burden). This consent was requested of all women.Results: The survey had an overall response rate of 46% (913 completed surveys returned, total sample 1989). Women receiving the pre-notification letter with the option of opting out of the survey were more likely to actively decline to participate than women receiving the letter without this option, although the overall numbers of women declining were small (27 versus 12). Letter type was not significantly associated with the return of a completed survey. Among women who completed the survey, 97% gave consent to link their survey data with existing health data.Conclusions: The two types of pre-notification letters used in our study did not influence the survey response rate. However, seeking consent for record linkage was highly acceptable to women who completed the survey, and represents an important strategy to add to the arsenal for designing and implementing effective surveys. In addition to aspects of survey design, future research should explore how to more effectively influence personal constructs that contribute to the decision to participate in surveys. [ABSTRACT FROM AUTHOR]

Background: Research indicates that exercise can have a positive effect on both physical and mental health in nursing home patients with dementia, however the lasting effect is rarely studied. In a previously published article we investigated the immediate effect of a 12 weeks functional exercise program on physical function and mental health in nursing home residents with dementia. In this paper we studied the long-term effect of this exercise program. We explored the differences between the exercise and control group from baseline to 6 months follow-up and during the detraining period from month 3 to 6.Methods: A single blind, randomized controlled trial was conducted and a total of 170 nursing home residents with dementia were included. The participants were randomly allocated to an intervention (n = 87) or a control group (n = 83). The intervention consisted of intensive strengthening and balance exercises in small groups twice a week for 12 weeks. The control condition was leisure activities. Thirty participants were lost between baseline and six-month follow-up. Linear mixed model analyses for repeated measurements were used to investigate the effect of exercise after detraining period.Results: The exercise group improved their scores on Berg Balance Scale from baseline to 6 months follow-up by 2.7 points in average. The control group deteriorated in the same period and the difference between groups was statistically significant (p = 0.031). The exercise group also scored better on NPI agitation sub-score after 6 months (p = 0.045).Conclusion: The results demonstrate long-time positive effects of a high intensity functional exercise program on balance and indicate a positive effect on agitation, after an intervention period of 12 weeks followed by a detraining period of 12 weeks. Identifier at ClinicalTrials.gov: NCT02262104. [ABSTRACT FROM AUTHOR]

Background: The 'Sponsoring National Processes for Evidence-Informed Policy Making in the Health Sector of Developing Countries' program was launched by the Alliance for Health Policy and Systems Research, WHO, in July 2008. The program aimed to catalyse the use of evidence generated through health policy and systems research in policymaking processes through (1) promoting researchers and policy advocates to present their evidence in a manner that is easy for policymakers to understand and use, (2) creating mechanisms to spur the demand for and application of research evidence in policymaking, and (3) increased interaction between researchers, policy advocates, and policymakers. Grants ran for three years and five projects were supported in Argentina, Bangladesh, Cameroon, Nigeria and Zambia. This paper seeks to understand why projects in some settings were perceived by the key stakeholders involved to have made progress towards their goals, whereas others were perceived to have not done so well. Additionally, by comparing experiences across five countries, we seek to illustrate general learnings to inform future evidence-to-policy efforts in low- and middle-income countries.Methods: We adopted the theory of knowledge translation developed by Jacobson et al. (J Health Serv Res Policy 8(2):94-9, 2003) as a framing device to reflect on project experiences across the five cases. Using data from the projects' external evaluation reports, which included information from semi-structured interviews and quantitative evaluation surveys of those involved in projects, and supplemented by information from the projects' individual technical reports, we applied the theoretical framework with a partially grounded approach to analyse each of the cases and make comparisons.Results and Conclusion: There was wide variation across projects in the type of activities carried out as well as their intensity. Based on our findings, we can conclude that projects perceived as having made progress towards their goals were characterized by the coming together of a number of domains identified by the theory. The domains of Jacobson's theoretical framework, initially developed for high-income settings, are of relevance to the low- and middle-income country context, but may need modification to be fully applicable to these settings. Specifically, the relative fragility of institutions and the concomitantly more significant role of individual leaders point to the need to look at leadership as an additional domain influencing the evidence-to-policy process. [ABSTRACT FROM AUTHOR]

Background: Rates of perinatal depression (antenatal and postnatal depression) in South Asia are among the highest in the world. The delivery of effective psychological treatments for perinatal depression through existing health systems is a challenge due to a lack of human resources. This paper reports on a trial protocol that aims to evaluate the effectiveness and cost-effectiveness of the Thinking Healthy Programme delivered by peers (Thinking Healthy Programme Peer-delivered; THPP), for women with moderate to severe perinatal depression in rural and urban settings in Pakistan and India.Methods/design: THPP is evaluated with two randomised controlled trials: a cluster trial in Rawalpindi, Pakistan, and an individually randomised trial in Goa, India. Trial participants are pregnant women who are registered with the lady health workers in the study area in Pakistan and pregnant women attending outpatient antenatal clinics in India. They will be screened using the patient health questionnaire-9 (PHQ-9) for depression symptoms and will be eligible if their PHQ-9 is equal to or greater than 10 (PHQ-9 ≥ 10). The sample size will be 560 and 280 women in Pakistan and India, respectively. Women in the intervention arm (THPP) will be offered ten individual and four group sessions (Pakistan) or 6-14 individual sessions (India) delivered by a peer (defined as a mother from the same community who is trained and supervised in delivering the intervention). Women in the control arm (enhanced usual care) will receive health care as usual, enhanced by providing the gynaecologist or primary-health facilities with adapted WHO mhGAP guidelines for depression treatment, and providing the woman with her diagnosis and information on how to seek help for herself. The primary outcomes are remission and severity of depression symptoms at the 6-month postnatal follow-up. Secondary outcomes include remission and severity of depression symptoms at the 3-month postnatal follow-up, functional disability, perceived social support, breastfeeding rates, infant height and weight, and costs of health care at the 3- and 6-month postnatal follow-ups. The primary analysis will be intention-to-treat.Discussion: The trials have the potential to strengthen the evidence on the effectiveness and cost-effectiveness of an evidence-based psychological treatment recommended by the World Health Organisation and delivered by peers for perinatal depression. The trials have the unique opportunity to overcome the shortage of human resources in global mental health and may advance our understanding about the use of peers who work in partnership with the existing health systems in low-resource settings.Trial Registration: Pakistan Trial: ClinicalTrials.gov Identifier: NCT02111915 (9 April 2014) India Trial: ClinicalTrials.gov Identifier: NCT02104232 (1 April 2014). [ABSTRACT FROM AUTHOR]

Background: Using patient-reported outcome measures (PROMs) to assess Quality of Life (QoL) is well established, but commonly-used PROM item-sets do not necessarily capture what all respondents consider important. Measuring complex constructs is particularly difficult in randomised controlled trials (RCTs). The Mother-Generated Index (MGI) is a validated antenatal and postnatal QoL instrument in which the variables and scores are completely respondent-driven. This paper reports on the feasibility and acceptability of the MGI in an RCT, and compares the resulting variables and QoL scores with more commonly used instruments.Methods: The single-page MGI was included at the end of a ten page questionnaire pack and posted to the RCT participants at baseline (28-32 weeks' gestation) and follow-up (six weeks postnatal). Feasibility and acceptability were assessed by ease of administration, data entry and completion rates. Variables cited by women were analysed thematically. MGI QoL scores were compared with outcomes from the EQ-5D-3 L; Edinburgh Postnatal Depression Scale; Satisfaction With Life Scale; and State Trait Anxiety Inventory.Results: Six hundred and seventy eight pregnant women returned the pack at baseline; 668 completed the MGI (98.5%); 383/400 returns at follow up included a completed MGI (95.7%). Quantitative data were scanned into SPSS using a standard data scanning system, and were largely error-free; qualitative data were entered manually. The variables recorded by participants on the MGI forms incorporated many of those in the comparison instruments, and other outcomes commonly used in intrapartum trials, but they also revealed a wider range of issues affecting their quality of life. These included financial and work-related worries; moving house; and concerns over family illness and pets. The MGI scores demonstrated low-to-moderate correlation with other tools (all r values p < .01).Conclusions: Without face-to-face explanation and at the end of a long questionnaire, the MGI was feasible to use, and acceptable to RCT participants. It allowed individual participants to include issues that were important to them, but which are not well captured by existing tools. The MGI unites the explanatory power of qualitative research with the comparative power of quantitative designs, is inexpensive to administer, and requires minimal linguistic and conceptual translation.Trial Registration: ISRCTN27575146 (date assigned 23 March 2011). [ABSTRACT FROM AUTHOR]

Introduction: Due to a limited health workforce, many health care providers in Africa must take on health leadership roles with minimal formal training in leadership. Hence, the need to equip health care providers with practical skills required to lead high-impact health care programs. In Uganda, the Afya Bora Global Health Leadership Fellowship is implemented through the Makerere University College of Health Sciences (MakCHS) and her partner institutions. Lessons learned from the program, presented in this paper, may guide development of in-service training opportunities to enhance leadership skills of health workers in resource-limited settings.Methods: The Afya Bora Consortium, a consortium of four African and four U.S. academic institutions, offers 1-year global health leadership-training opportunities for nurses and doctors. Applications are received and vetted internationally by members of the consortium institutions in Botswana, Kenya, Tanzania, Uganda, and the USA. Fellows have 3 months of didactic modules and 9 months of mentored field attachment with 80% time dedicated to fellowship activities. Fellows' projects and experiences, documented during weekly mentor-fellow meetings and monthly mentoring team meetings, were compiled and analyzed manually using pre-determined themes to assess the effect of the program on fellows' daily leadership opportunities.Results: Between January 2011 and January 2015, 15 Ugandan fellows (nine doctors and six nurses) participated in the program. Each fellow received 8 weeks of didactic modules held at one of the African partner institutions and three online modules to enhance fellows' foundation in leadership, communication, monitoring and evaluation, health informatics, research methodology, grant writing, implementation science, and responsible conduct of research. In addition, fellows embarked on innovative projects that covered a wide spectrum of global health challenges including critical analysis of policy formulation and review processes, bottlenecks in implementation of national HIV early infant diagnosis and prevention of mother-to-child HIV-transmission programs, and use of routine laboratory data about antibiotic resistance to guide updates of essential drug lists.Conclusion: In-service leadership training was feasible, with ensured protected time for fellows to generate evidence-based solutions to challenges within their work environment. With structured mentorship, collaborative activities at academic institutions and local health care programs equipped health care providers with leadership skills. [ABSTRACT FROM AUTHOR]

Background: Colorectal cancer (CRC) has a high incidence, especially in New Zealand. The reasons for this are unknown. While most cancers develop sporadically, a positive family history, determined by the number and age at diagnosis of affected first and second degree relatives with CRC is one of the major factors, which may increase an individual's lifetime risk. Before a patient can be enrolled in a surveillance program a detailed assessment and documentation of the family history is important but time consuming and often inaccurate. The documentation is usually paper-based. Our aim was therefore to develop and validate the usability and efficacy of a web-based family history assessment tool for CRC suitable for the general population. The tool was also to calculate the risk and make a recommendation for surveillance.Methods: Two versions of an electronic assessment tool, diagram-based and questionnaire-based, were developed with the risk analysis and recommendations for surveillance based on the New Zealand Guidelines Group recommendations. Accuracy of our tool was tested prior to the study by comparing risk calculations based on family history by experienced gastroenterologists with the electronic assessment. The general public, visiting a local science fair were asked to use and comment on the usability of the two interfaces.Results: Ninety people assessed and commented on the two interfaces. Both interfaces were effective in assessing the risk to develop CRC through their familial history for CRC. However, the questionnaire-based interface performed with significantly better satisfaction (p = 0.001) than the diagram-based interface. There was no difference in efficacy though.Conclusion: We conclude that a web-based questionnaire tool can assist in the accurate documentation and analysis of the family history relevant to determine the individual risk of CRC based on local guidelines. The calculator is now implemented and assessable through the web-page of a local charity for colorectal cancer awareness and integral part of the local general practitioners' e-referral system for colonic imaging. [ABSTRACT FROM AUTHOR]

Background: Health care organizations need to be responsive to the needs of increasingly diverse patient populations. We compared the contents of six publicly available approaches to organizational responsiveness to diversity. The central questions addressed in this paper are: what are the most consistently recommended issues for health care organizations to address in order to be responsive to the needs of diverse groups that differ from the majority population? How much consensus is there between various approaches?Methods: We purposively sampled six approaches from the US, Australia and Europe and used qualitative textual analysis to categorize the content of each approach into domains (conceptually distinct topic areas) and, within each domain, into dimensions (operationalizations). The resulting classification framework was used for comparative analysis of the content of the six approaches.Results: We identified seven domains that were represented in most or all approaches: organizational commitment, empirical evidence on inequalities and needs, a competent and diverse workforce, ensuring access for all users, ensuring responsiveness in care provision, fostering patient and community participation, and actively promoting responsiveness. Variations in the operationalization of these domains related to different scopes, contexts and types of diversity. For example, approaches that focus on ethnic diversity mostly provide recommendations to handle cultural and language differences; approaches that take an intersectional approach and broaden their target population to vulnerable groups in a more general sense also pay attention to factors such as socio-economic status and gender.Conclusions: Despite differences in labeling, there is a broad consensus about what health care organizations need to do in order to be responsive to patient diversity. This opens the way to full scale implementation of organizational responsiveness in healthcare and structured evaluation of its effectiveness in improving patient outcomes. [ABSTRACT FROM AUTHOR]

Background: Cancer-related fatigue is a distressing symptom experienced by many after cancer treatment. An exploratory randomised controlled trial was conducted to test proof of concept of RESTORE: a web-based tool to enhance self-efficacy to manage cancer-related fatigue. This paper reports findings from a qualitative process evaluation to determine feasibility and acceptability of the intervention and trial processes.Method: Qualitative process evaluation carried out at the end of the trial to explore participants' experiences using semi-structured telephone interviews with a purposive sample of participants from both trial arms. Normalisation Process Theory informed data collection and analysis. Analysis involved directed content analysis within a Framework Approach.Results: Nineteen participants took part. They understood the purpose and requirements of the trial and identified beneficial outcomes from taking part. For the majority, the work of the trial was easily accommodated into daily routines and did not require new skills. There were mixed views about the value of the information provided by RESTORE, depending on time since diagnosis and treatment. Personal factors, constraints of the intervention, and environmental context inhibited the integration and embedding of RESTORE into everyday life. Access to the intervention at an early stage in the treatment trajectory was important to effective utilisation, as were individual preferences for delivery of information.Conclusion: The theoretical foundations of the intervention were sound. Participants derived benefits from the intervention but barriers to implementation and integration suggest that RESTORE and the trial processes require some modification before testing in a full trial.Trial Registration: ISRCTN67521059 (10(th) October 2012). [ABSTRACT FROM AUTHOR]

Background: The objective of this paper is to explore whether IPV 12 months before and/or during pregnancy is associated with poor psychosocial health.Methods: From June 2010 to October 2012, a cross-sectional study was conducted in 11 antenatal care clinics in Belgium. Consenting pregnant women were asked to complete a questionnaire on socio-demographics, psychosocial health and violence in a separate room. Overall, 2586 women were invited to participate and we were able to use data from 1894 women (73.2%) for analysis. Ethical clearance was obtained in all participating hospitals.Results: We found a significant correlation between IPV and poor psychosocial health: within the group of women who reported IPV, 53.2% (n = 118) had poor psychosocial health, as compared to 21% (n = 286) in the group of women who did not report IPV (P < 0.001). Lower psychosocial health scores were associated with increased odds of reporting IPV (aOR 1.55; 95% CI 1.39-1.72), with adjustments made for the language in which the questionnaire was filled out, civil/marital status, education and age. In other words, a decrease of 10 points on the psychosocial health scale (total of 140) increased the odds of reporting IPV by 55 %. When accounting for the 6 psychosocial health subscales, the analysis revealed that all subscales (depression, anxiety, self-esteem, mastery, worry and stress) are strongly correlated to reporting IPV. However, when accounting for all subscales simultaneously in a logistic regression model, only depression (aOR 0.87; 95 % CI 0.84-0.91) and stress (aOR 0.85; 95 % CI 0.77-095) remained significantly associated with IPV. The association between overall psychosocial health and IPV remained significant after adjusting for socio-demographic status.Conclusion: Our research corroborated that IPV and psychosocial health are strongly associated. Due to the limitations of our study design, we believe that future research is needed to deepen understanding of the multitude of factors involved in the complex interactions between IPV and psychosocial health. [ABSTRACT FROM AUTHOR]

Background: Active for Life Year 5 (AFLY5) is an educational programme for Year 5 children (aged 9-10) designed to increase children's physical activity, decrease sedentary behaviour and increase fruit and vegetable intake. This paper reports findings from a process evaluation embedded within a randomised controlled trial evaluating the programme's effectiveness. It considers the fidelity of implementation of AFLY5 with a focus on three research questions: 1. To what extent was the intervention delivered as planned? 2. In what ways, if any, did the teachers amend the programme? and 3. What were the reasons for any amendments? Methods: Mixed methods were used including data collection via observation of the intervention delivery, questionnaire, teacher's intervention delivery log and semi-structured interviews with teachers and parents. Qualitative data were analysed thematically and quantitative data were summarised using descriptive statistics. Results: Following training, 42 of the 43 intervention school teachers/teaching staff (98 %) were confident they could deliver the nutrition and physical activity lessons according to plan. The mean number of lessons taught was 12.3 (s.d. 3.7), equating to 77 % of the intervention. Reach was high with 95 % of children in intervention schools receiving lessons. A mean of 6.2 (s.d. 2.6) out of 10 homeworks were delivered. Median lesson preparation time was 10 min (IQR 10-20) and 28 % of lessons were reported as having been amended. Qualitative findings revealed that those who amended the lessons did so to differentiate for student ability, update them for use with new technologies and to enhance teacher and student engagement. Teachers endorsed the aims of the intervention, but some were frustrated with having to adapt the lesson materials. Teachers also a reported tendency to delegate the physical activity lessons to other staff not trained in the intervention. Conclusions: Fidelity of intervention implementation was good but teachers' enthusiasm for the AFLY5 programme was mixed despite them believing that the messages behind the lessons were important. This may have meant that the intervention messages were not delivered as anticipated and explain why the intervention was found not to be effective. Trial registration: ISRCTN50133740. [ABSTRACT FROM AUTHOR]

Background: The LiGHT trial (Laser-1st versus Drops-1st for Glaucoma and Ocular Hypertension Trial) is a multicentre randomised controlled trial of two treatment pathways for patients who are newly diagnosed with open-angle glaucoma (OAG) and ocular hypertension (OHT). The main hypothesis for the trial is that lowering intraocular pressure (IOP) with selective laser trabeculoplasty (SLT) as the primary treatment ('Laser-1st') leads to a better health-related quality of life than for those started on IOP-lowering drops as their primary treatment ('Medicine-1st') and that this is associated with reduced costs and improved tolerability of treatment. This paper describes the statistical analysis plan for the study.Methods/design: The LiGHT trial is an unmasked, multi-centre randomised controlled trial. A total of 718 patients (359 per arm) are being randomised to two groups: medicine-first or laser-first treatment. Outcomes are recorded at baseline and at 6-month intervals up to 36 months. The primary outcome measure is health-related quality of life (HRQL) at 36 months measured using the EQ-5D-5L. The main secondary outcome is the Glaucoma Utility Index. We plan to analyse the patient outcome data according to the group to which the patient was originally assigned. Methods of statistical analysis are described, including the handling of missing data, the covariates used in the adjusted analyses and the planned sensitivity analyses.Trial Registration: The trial was registered with the ISRCTN register on 23/07/2012, number ISRCTN32038223 . [ABSTRACT FROM AUTHOR]

Background: International epidemiological research into violence against children is increasing in scope and frequency, but little has been written about practical management of the ethical aspects of conducting such research in low and middle-income countries. In this paper, we describe our study procedures and reflect on our experiences conducting a survey of more than 3,700 primary school children in Uganda as part of the Good Schools Study, a cluster randomised controlled trial of a school-based violence prevention intervention. Children were questioned extensively about their experiences of physical, sexual, and emotional violence from a range of different perpetrators. We describe our sensitisation and consent procedures, developed based on our previous research experience and requirements for our study setting. To respond to disclosures of abuse that occurred during our survey, we describe a referral algorithm developed in conjunction with local services. We then describe our experience of actually implementing these procedures in our 2012 survey, based on reflections of the research team. Drawing on 40 qualitative interviews, we describe children's experiences of participating in the survey and of being referred to local child protection services.Results: Although we were able to implement much of our protocol in a straightforward manner, we also encountered major challenges in relation to the response of local services to children's disclosures of violence. The research team had to intervene to ensure that children were provided with appropriate support and that our ethical obligations were met.Conclusions: In resource poor settings, finding local services that can provide appropriate support for children may be challenging, and researchers need to have concrete plans and back-up plans in place to ensure that obligations can be met. The merits of mandatory reporting of children's disclosures to local services need to be considered on a case by case basis-in some places this has the potential to do harm. Research teams also must agree on what level of ancillary care will be provided, and budget accordingly. Further practical examples of how to address the challenges encountered in this work are needed, in order to build a consensus on best practices.Trial Registration: NCT01678846 (clinicaltrials.gov), August 24, 2012. [ABSTRACT FROM AUTHOR]

Background: The assessment of treatment success in clinical trials when multiple (repeated) doses (courses) are involved is quite common, for example, in the case of infertility treatment with assisted reproductive technology (ART), and medical abortion using misoprostol alone or in combination with mifepristone. Under these or similar circumstances, most researchers assess success using binomial proportions after a certain number of consecutive doses, and some have used survival analysis. In this paper we discuss the main problems in using binomial proportions to summarize (the overall) efficacy after two or more consecutive doses of the relevant treatment, particularly for the case of misoprostol in medical abortion studies. We later discuss why the survival analysis is best suited under these circumstances, and illustrate this by using simulated data.Methods: The formulas required for the binomial proportion and survival analysis (without and with competing risks) approaches are summarized and analytically compared. Additionally, numerical results are computed and compared between the two approaches, for several theoretical scenarios.Results: The main conceptual limitations of the binomial proportion approach are identified and discussed, caused mainly by the presence of censoring and competing risks, and it is demonstrated how survival analysis can solve these problems. In general, the binomial proportion approach tends to underestimate the "real" success rate, and tends to overestimate the corresponding standard error.Conclusions: Depending on the rates of censored observations or competing events between repeated doses of the treatment, the bias of the binomial proportion approach as compared to the survival analysis approaches varies; however, the use of the binomial approach is unjustified as the survival analysis options are well known and available in multiple statistical packages. Our conclusions also apply to other situations where success is estimated after multiple (repeated) doses (courses) of the treatment. [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: A hybrid performance measurement system that combines patient-reported outcome data with administrative data has been developed for South African substance abuse treatment services. This paper describes the development and psychometric validation of one component of this system, the South African Addiction Treatment Services Assessment (SAATSA).Methods: First, a national steering committee identified five domains and corresponding indicators on which treatment quality should be assessed. A decision was made to develop a patient survey to assess several of these indicators. A stakeholder work group sourced survey items and generated additional items where appropriate. The feasibility and face validity of these items were examined during cognitive response testing with 16 patients. This led to the elimination of several items. Next, we conducted an initial psychometric validation of the SAATSA with 364 patients from residential and outpatient services. Exploratory (EFA) and confirmatory factor analyses (CFA) were conducted to assess the latent structure of the SAATSA. Findings highlighted areas where the SAATSA required revision. Following revision, we conducted another psychometric validation with an additional sample of 285 patients. We used EFA and CFA to assess construct validity and we assessed reliability using Cronbach's measure of internal consistency.Results: The final version of the SAATSA comprised 31 items (rated on a four-point response scale) that correspond to six scales. Four of these scales are patient-reported outcome measures (substance use, quality of life, social connectedness and HIV risk outcomes) that together assess the perceived effectiveness of treatment. The remaining two scales assess patients' perceptions of access to and quality of care. The models for the final revised scales had good fit and the internal reliability of these scales was good to excellent, with Cronbach's α ranging from 0.72 to 0.89.Conclusion: A lack of adequate measurement tools hampers efforts to improve the quality of substance abuse treatment. Our preliminary evidence suggests that the SAATSA, a novel patient survey that assesses patients' perceptions of the outcomes and quality of substance abuse treatment, is a psychometrically robust tool that can help fill this void. [ABSTRACT FROM AUTHOR]

Background: Communities are a pivotal setting in which to promote increases in child and adolescent physical activity behaviours. Interventions implemented in these settings require effective evaluation to facilitate translation of findings to wider settings. The aims of this paper are to i) present findings from a RE-AIM evaluation of a community-based physical activity program, and ii) review the methodological challenges faced when applying RE-AIM in practice.Methods: A single mixed-methods case study was conducted based on a concurrent triangulation design. Five sources of data were collected via interviews, questionnaires, archival records, documentation and field notes. Evidence was triangulated within RE-AIM to assess individual and organisational-level program outcomes.Results: Inconsistent availability of data and a lack of robust reporting challenged assessment of all five dimensions. Reach, Implementation and setting-level Adoption were less successful, Effectiveness and Maintenance at an individual and organisational level were moderately successful. Only community-level Adoption was highly successful, reflecting the key program goal to provide community-wide participation in sport and physical activity.Conclusions: This research highlighted important methodological constraints associated with the use of RE-AIM in practice settings. Future evaluators wishing to use RE-AIM may benefit from a mixed-method triangulation approach to offset challenges with data availability and reliability. [ABSTRACT FROM AUTHOR]

Background: Clinically effective and cost-effective methods for managing problematic sexual behaviour in adolescents are urgently needed. Adolescents who show problematic sexual behaviour have a range of negative psychosocial outcomes, and they and their parents can experience stigma, hostility and rejection from their community. Multisystemic therapy (MST) shows some evidence for helping to reduce adolescent sexual reoffending and is one of the few promising interventions available to young people who show problematic sexual behaviour. This paper describes the protocol for Services for Teens Engaging in Problem Sexual Behaviour (STEPS-B), a feasibility trial of MST for problem sexual behaviour (MST-PSB) in antisocial adolescents at high risk of out-of-home placement due to problematic sexual behaviour.Methods/design: Eighty participants and their families recruited from five London boroughs will be randomized to MST-PSB or management as usual with follow-up to 20 months post-randomization. The primary outcome is out-of-home placement at 20 months. Secondary outcomes include sexual and non-sexual offending rates and antisocial behaviours, participant well-being, educational outcomes and total service and criminal justice sector costs. Feasibility outcomes include mapping the clinical service pathways needed to recruit adolescents displaying problematic sexual behaviour, acceptability of a randomized controlled trial to the key systems involved in managing these adolescents, and acceptability of the research protocol to young people and their families. Data will be gathered from police computer records, the National Pupil Database and interviews and self-report measures administered to adolescents and parents and will be analysed on an intention-to-treat basis.Discussion: The STEPS-B feasibility trial aims to inform policymakers, commissioners of services and professionals about the potential for implementing MST-PSB as an intervention for adolescents showing problem sexual behaviour. Should MST-PSB show potential, STEPS-B will determine what would be necessary to implement the programme more fully and at a scale that would warrant a full trial.Trial Registration: ISRCTN28441235 (registered 25 January 2012). [ABSTRACT FROM AUTHOR]

Background: In Lao PDR, health warnings were first introduced with printed warning messages on the side of the cigarette package in 1993 and again in 2004. Lao PDR same year ratified the Framework Convention on Tobacco Control (WHO FCTC) but has not yet implemented pictorial health warnings. This paper aims to examine the perception and opinion of policymakers on "text-only" and "pictorial" health warnings and to understand lay people's perceptions on current health warnings and their opinions on the recommended types of health warnings.Methods: A combination of quantitative and qualitative methods were used in this cross-sectional study conducted in 2008. A purposive sample of 15 policymakers, and a representative sample of 1360 smokers and non-smokers were recruited. A range of different areas were covered including consumer attitudes towards current and proposed cigarette package design, views on health warning messages on the flip/slide and inserts, and views on the relative importance of the size, content and pictures of health warning messages. Descriptive statistics and content analysis were used.Results: Policy makers and survey respondents said that the current health warning messages were inappropriate, ineffective, and too small in size. All respondents perceived pictorial health warnings as a potentially powerful element that could be added to the messages that can communicate quickly, and dramatically. The majority of policymakers and survey respondents strongly supported the implementation of pictorial health warnings. The non-smokers agreed that the graphic pictorial health warnings were generally more likely than written health warnings to stimulate thinking about the health risks of smoking, by conveying potential health effects, increasing and reinforcing awareness of the negative health effect of smoking, aiding memorability of the health effects and arousing fear of smoking among smokers.Conclusions: The study suggested that current warnings are too small and that content is inadequate and designed to be hidden on the side pack. These findings are in line with FCTC's requirements and provide strong support for introducing pictorial warning labels also in Lao PDR. Furthermore, the awareness of Members of Parliament about tobacco control measures holds promise at the highest political level. [ABSTRACT FROM AUTHOR]

Background: Although some 300 million Indian children travel to school every day, little is known about how they get there. This information is important for transport planners and public health authorities. This paper presents the development of a self-administered questionnaire and examines its reliability and validity in estimating distance and mode of travel to school in a low resource urban setting.Methods: We developed a questionnaire on children's travel to school. We assessed test re-test reliability by repeating the questionnaire one week later (n = 61). The questionnaire was improved and re-tested (n = 68). We examined the convergent validity of distance estimates by comparing estimates based on the nearest landmark to children's homes with a 'gold standard' based on one-to-one interviews with children using detailed maps (n = 50).Results: Most questions showed fair to almost perfect agreement. Questions on usual mode of travel (κ 0.73- 0.84) and road injury (κ 0.61- 0.72) were found to be more reliable than those on parental permissions (κ 0.18- 0.30), perception of safety (κ 0.00- 0.54), and physical activity (κ -0.01- 0.07). The distance estimated by the nearest landmark method was not significantly different than the in-depth method for walking , 52 m [95 % CI -32 m to 135 m], 10 % of the mean difference, and for walking and cycling combined, 65 m [95 % CI -30 m to 159 m], 11 % of the mean difference. For children who used motorized transport (excluding private school bus), the nearest landmark method under-estimated distance by an average of 325 metres [95 % CI -664 m to 1314 m], 15 % of the mean difference.Conclusions: A self-administered questionnaire was found to provide reliable information on the usual mode of travel to school, and road injury, in a small sample of children in Hyderabad, India. The 'nearest landmark' method can be applied in similar low-resource settings, for a reasonably accurate estimate of the distance from a child's home to school. [ABSTRACT FROM AUTHOR]

Background: There are 600 million girls in low and middle income countries (LMICs), many of whom are at great risk for poor health and education. There is thus great need for programs that can effectively improve wellbeing for these girls. Although many interventions have been developed to address these issues, most focus on health and education without integrating attention to social and emotional factors. This omission is unfortunate, as nascent evidence indicates that these factors are closely related to health and education. This paper describes the methods of a 4-arm randomized controlled trial among 3,560 adolescent girls in rural Bihar, India that tested whether adding an intervention targeting social-emotional issues (based on a "resilience framework") to an adolescent health intervention would improve emotional, social, physical, and educational wellbeing to a greater extent than its components and a control group. Study arms were: (1) Girls First, a combination of the Girls First Resilience Curriculum (RC) and the Girls First Health Curriculum (HC); (2) Girls First Resilience Curriculum (RC) alone; (3) Girls First Health Curriculum (HC) alone; and (4) a school-as-usual control group (SC).Methods: Seventy-six schools were randomized (19 per condition) and 74 local women with a tenth grade education were trained and monitored to facilitate the program. Quantitative data were collected from 3,560 girls over 4 assessment points with very low rates of participant attrition. Qualitative assessments were conducted with a subset of 99 girls and 27 facilitators.Results and Conclusions: In this article, we discuss guiding principles that facilitated trial implementation, including integrating diverse local and non-local sources of knowledge, focusing on flexibility of planning and implementation, prioritizing systematic measurement selection, and striking a balance between scientific rigor and real-world feasibility.Trial Registration: Clinicaltrials.gov NCT02429661 . Registered 24 April 2015. [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]

Background: The present study protocol describes the evaluation of a comprehensive integrated care model implemented at two hospital sites at the University Hospital of North Norway (UNN). The PAtient Centred Team (PACT) model includes proactive, patient-centred interdisciplinary teams that aim to improve the continuum and quality of care of frail elderly patients and reduce health care costs. The main objectives of the evaluation are to analyse the effectiveness and cost effectiveness of using patient-centred teams as part of routine service provision for this patient group. The evaluation will analyse the effect on patient health and functional status, patient experiences and hospital utilisation, and it will conduct an economic evaluation. This paper describes the PACT model and the rationale for and design of the planned effectiveness and cost-effectiveness study.Methods/design: This is a prospective, non-randomised matched control before-and-after intervention study. Patients in the intervention group will be recruited from the hospital sites that have implemented the PACT model. The controls will be recruited from two hospitals without the model. The control patients and the index patients will be matched according to sex, age and number of long-term conditions. The study aims to include 600 patients in each group, which will provide sufficient power to detect a clinical change in the primary outcome. The primary outcome is the physical dimension of the Short Form Health Survey (SF-36). Secondary outcomes are the Patient Generated Index (PGI), the Patient Activation Measure (PAM), the Patient Assessment of Chronic Illness Care (PACIC), hospitalisation and length of stay. The cost-effectiveness study takes a health provider perspective and calculates the cost per quality-adjusted life-years (QALYs) gained. The data will be collected at baseline, 6 and 12 months. The data will be analysed using techniques and models that recognise the lack of randomisation and the correlation of cost and effect data.Discussion: The study results will provide knowledge about whether the integrated care model implemented at UNN improves the quality of care for the frail elderly with multiple conditions. The study will establish whether the PAC. T model improves health and functional status and is cost effective compared to the usual care for this patient group.Trial Registration: ClinicalTrials.gov: NCT02541474. [ABSTRACT FROM AUTHOR]

Background: Recommendations for care in the first week of a newborn's life include thermal care practices such as drying and wrapping, skin to skin contact, immediate breastfeeding and delayed bathing. This paper examines beliefs and practices related to neonatal thermal care in three African countries.Methods: Data were collected in the same way in each site and included 16-20 narrative interviews with recent mothers, eight observations of neonatal bathing, and in-depth interviews with 12-16 mothers, 9-12 grandmothers, eight health workers and 0-12 birth attendants in each site.Results: We found similarities across sites in relation to understanding the importance of warmth, a lack of opportunities for skin to skin care, beliefs about the importance of several baths per day and beliefs that the Vernix caseosa was related to poor maternal behaviours. There was variation between sites in beliefs and practices around wrapping and drying after delivery, and the timing of the first bath with recent behavior change in some sites. There was near universal early bathing of babies in both Nigerian sites. This was linked to a deep-rooted belief about body odour. When asked about keeping the baby warm, respondents across the sites rarely mentioned recommended thermal care practices, suggesting that these are not perceived as salient.Conclusion: More effort is needed to promote appropriate thermal care practices both in facilities and at home. Programmers should be aware that changing deep rooted practices, such as early bathing in Nigeria, may take time and should utilize the current beliefs in the importance of neonatal warmth to facilitate behaviour change. [ABSTRACT FROM AUTHOR]

Background: A strong health system requires a competent and caring workforce. A more satisfied and motivated health workforce should be more willing to serve in difficult areas, have lower turnover, and theoretically provide better care to patients. This paper examines the motivation, satisfaction, and correlation with clinical knowledge, of community health nurses (CHNs), a cadre of provider focused on maternal, newborn and child health in rural Ghana.Methods: This study employed three methods of evaluation. Two quantitative measurements were used: (1) a survey of health worker satisfaction and motivation and (2) a clinical knowledge assessment focusing on maternal, newborn and child health. Both were administered to all rostered CHNs working in the five sampled districts in the Greater Accra and Volta regions in Eastern Ghana (N = 205). Qualitative interviews (N = 29) and focus group discussions (N = 4) were held with selected CHNs in the same districts. These data were analysed using NVivo (Version 10) and Stata (Version 13.0) based on domains of extrinsic and intrinsic motivation including general satisfaction, work environment and access to resources, respect and recognition received and opportunities for advancement.Results: CHNs desired more training, especially those who were posted at the community level (a Community-based Health Planning and Services post or "CHPS") versus at a health facility. CHNs working at CHPS believed their work to be more difficult than those posted at health facilities, due to challenges associated with foot travel to visit patients at home, and they were more likely to report having insufficient resources to do their jobs (48% vs 36%). However, CHNs posted at health facilities were more likely to report insufficient opportunities for career advancement than the CHPS nurses (49% vs 33%). CHNs generally reported good relationships with colleagues and being respected by patients but desired more respect from supervisors. The median score on the knowledge assessment was 78%. On average, subgroups of CHNs with different reported levels of satisfaction did not perform differently on the knowledge assessment.Conclusions: CHNs in Ghana were satisfied overall but desired more training, more guidance and supervision, fair pay and opportunities to advance in their career. Improving health worker satisfaction and morale may be important for health worker retention and certain aspects of care but may not have a significant influence on clinical knowledge or performance. [ABSTRACT FROM AUTHOR]

Introduction: Unsafe abortion is a major contributor to the continued high global maternal mortality and morbidity rates. Legal abortion frameworks and access to sexuality education and contraception have been pointed out as vital to reduce unsafe abortion rates. This paper explores the relationship between abortion law, policy and women's access to safe abortion services within the different legal and political contexts of Ethiopia, Tanzania and Zambia. The research is inspired by recent calls for contextualized policy research. Methods: The research was based in Addis Ababa (Ethiopa), Dar es Salaam (Tanzania) and Lusaka (Zambia) and had a qualitative exploratory research design. The project involved studying the three countries' abortion laws and policies. It moreover targeted formal organizations as implementers of policy as well as stakeholders in support of, or in opposition to the existing abortion laws. Semi-structured interviews were carried out with study participants (79) differently situated vis-à-vis abortion, exploring their views on abortion-related legal- and policy frames and their perceived implications for access. Results: The abortion laws have been classified as 'liberal' in Zambia, 'semi-liberal' in Ethiopia and 'restrictive' in Tanzania, but what we encountered in the three study contexts was a seeming paradoxical relationship between national abortion laws, abortion policy and women's actual access to safe abortion services. The study findings moreover reveal that the texts that make up the three national abortion laws are highly ambiguous. The on-paper liberal Zambian and semi-liberal Ethiopian laws in no way ensure access, while the strict Tanzanian law is hardly sufficient to prevent young women from seeking and obtaining abortion. In line with Walt and Gilson's call to move beyond a narrow focus on the content of policy, our study demonstrates that the connection between law, health policy and access to health services is complex and critically dependent on the socio-economic and political context of implementation. Conclusions: Legal frameworks are vital instruments for securing the right to health, but broad contextualized studies rather than classifications of law along a liberal-restrictive continuum are demanded in order to enhance existing knowledge on access to safe abortion services in a given context. [ABSTRACT FROM AUTHOR]

Background: In low-income settings, community health workers (CHWs) are frequently the first point of contact for newborns. Mobile technology may aid health workers in classifying illness and providing referral and management guidance for newborn care. This study evaluates the potential for mobile health technology to improve diagnosis and case management of newborns in Bangladesh.Methods: A mobile application based on Bangladesh's Comprehensive Newborn Care Package national guidelines (mCNCP) was developed to aid CHWs in identifying and managing small and sick infants. After a 2-day training, CHWs assessed newborns at Sylhet Osmani Medical College Hospital and in the Projahnmo research site (Sylhet, Bangladesh) using either mCNCP or a comparable paper form (pCNCP), similar to standard IMCI-formatted paper forms. CHWs were randomized to conduct a block of ~ 6 newborn assessments starting with either mCNCP or pCNCP, then switched to the alternate method. Physicians using mCNCP served as gold standard assessors. CHW performance with mCNCP and pCNCP were compared using chi-squared tests of independence for equality of proportions, and logistic regressions clustered by CHW.Results: Two hundred seven total CHW assessments were completed on 101 enrolled infants. mCNCP assessments were more often fully completed and completed faster than pCNCP assessments (100% vs 23.8%, p < 0.001; 17.5 vs 23.6 min; p < 0.001). mCNCP facilitated calculations of respiratory rate, temperature, and gestational age. CHWs using mCNCP were more likely to identify small newborns (Odds Ratio (OR): 20.8, Confidence Interval (CI): (7.1, 60.8), p < 0.001), and to correctly classify 7 out of 16 newborn conditions evaluated, including severe weight loss (OR: 13.1, CI: (4.6, 37.5), p < 0.001), poor movement (OR: 6.6, CI: (2.3, 19.3), p = 0.001), hypothermia (OR: 14.9, CI: (2.7, 82.2), p = 0.002), and feeding intolerance (OR: 2.1, CI: (1.3, 3.3), p = 0.003). CHWs with mCNCP were more likely to provide counseling as needed on 4 out of 7 case management recommendations evaluated, including kangaroo mother care.Conclusions: CHWs in rural Bangladesh with limited experience using tablets successfully used a mobile application for neonatal assessment after a two-day training. mCNCP may aid frontline health workers in Bangladesh to improve completion of neonatal assessment, classification of illnesses, and adherence to neonatal management guidelines. [ABSTRACT FROM AUTHOR]

Background: After the first six months of exclusive breastfeeding, children are introduced to liquids and semi-solid food, known as the complementary feeding phase. This phase is critical because it is often accompanied by improper feeding in children, which may lead to wasting and other nutrition problems. Fortified biscuits have been provided for wasting children as a nationwide programme. However, the ability of children to accept food supplementation remains questionable. This paper describes the protocol of a study investigating the efficacy of food supplementation (PMT biscuit) and nutrition education to improve the nutritional status of wasting children in Indonesia.Method: The efficacy of a government food supplementation programme will be examined using a randomized control trial design. Parents with wasting children aged 6-17 months will be recruited to participate in the study. After obtaining informed consent and pre-intervention measures, participants will be assigned into three arms of intervention with PMT biscuits and/or nutrition education only. The two primary outcomes for this study are the nutritional status of wasting children and PMT biscuit compliance. Characteristics of all subjects in each arm will be analysed and compared with each other to assess their comparability at the beginning. The data will be collected at pre-intervention, at 3 months of intervention, post-intervention, and at the 6- to 9-month follow up.Discussion: This paper aims to describe the study protocol of a randomized controlled trial investigating the effects of different PMT biscuit portion and nutrition education in two arms and nutrition education only in another arm. This study is important because it will provide evidence for the Indonesian government regarding the efficacy of food supplementation and/or food-based recommendations to improve the nutritional status of wasting children aged 6-23 months in Indonesia.Trial Registration: The study has been registered at clinicaltrials.gov, maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH), on April 26, 2018, and was last updated on April 30, 2018 (registration number: NCT03509155 ). [ABSTRACT FROM AUTHOR]

Background: Pragmatic randomised controlled trials (PRCTs) aim to assess intervention effectiveness by accounting for 'real life' implementation challenges in routine practice. The methodological challenges of PRCT implementation, particularly in primary care, are not well understood. The Kanyini Guidelines Adherence to Polypill study (Kanyini GAP) was a recent primary care PRCT involving multiple private general practices, Indigenous community controlled health services and private community pharmacies. Through the experiences of Kanyini GAP participants, and using data from study materials, this paper identifies the critical enablers and barriers to implementing a PRCT across diverse practice settings and makes recommendations for future PRCT implementation.Methods: Qualitative data from 94 semi-structured interviews (47 healthcare providers (pharmacists, general practitioners, Aboriginal health workers; 47 patients) conducted for the process evaluation of Kanyini GAP was used. Data coded to 'trial impact', 'research motivation' and 'real world' were explored and triangulated with data extracted from study materials (e.g. Emails, memoranda of understanding and financial statements).Results: PRCT implementation was facilitated by an extensive process of relationship building at the trial outset including building on existing relationships between core investigators and service providers. Health providers' and participants' altruism, increased professional satisfaction, collaboration, research capacity and opportunities for improved patient care enabled implementation. Inadequate research infrastructure, excessive administrative demands, insufficient numbers of adequately trained staff and the potential financial impact on private practice were considered implementation barriers. These were largely related to this being the first experience of trial involvement for many sites. The significant costs of addressing these barriers drew study resources from the task of achieving recruitment targets.Conclusions: Conducting PRCTs is crucial to generating credible evidence of intervention effectiveness in routine practice. PRCT implementation needs to account for the particular challenges of implementing collaborative research across diverse stakeholder organisations. Reliance on goodwill to participate is crucial at the outset. However, participation costs, particularly for organisations with little or no research experience, can be substantial and should be factored into PRCT funding models. Investment in a pool to fund infrastructure in the form of primary health research networks will offset some of these costs, enabling future studies to be implemented more cost-effectively.Trial Registration: ACTRN126080005833347. [ABSTRACT FROM AUTHOR]

Background: The Connor-Davidson Resilience Scale (CD-RISC) is inarguably one of the best-known instruments in the field of resilience assessment. However, the criteria for the psychometric quality of the instrument were based only on classical test theory.Method: The aim of this paper has focused on the calibration of the CD-RISC with a nonclinical sample of 444 adults using the Rasch-Andrich Rating Scale Model, in order to clarify its structure and analyze its psychometric properties at the level of item.Results: Two items showed misfit to the model and were eliminated. The remaining 22 items form basically a unidimensional scale. The CD-RISC has good psychometric properties. The fit of both the items and the persons to the Rasch model was good, and the response categories were functioning properly. Two of the items showed differential item functioning.Conclusions: The CD-RISC has an obvious ceiling effect, which suggests to include more difficult items in future versions of the scale. [ABSTRACT FROM AUTHOR]

Background: Persons suffering from progressive muscular weakness, like those with Duchenne muscular dystrophy (DMD), gradually lose the ability to stand, walk and to use their arms. This hinders them from performing daily activities, social participation and being independent. Wheelchairs are used to overcome the loss of walking. However, there are currently few efficient functional substitutes to support the arms. Arm supports or robotic arms can be mounted to wheelchairs to aid in arm motion, but they are quite visible (stigmatizing), and limited in their possibilities due to their fixation to the wheelchair. The users prefer inconspicuous arm supports that are comfortable to wear and easy to control.Methods: In this paper the design, characterization, and pilot validation of a passive arm support prototype, which is worn on the body, is presented. The A-gear runs along the body from the contact surface between seat and upper legs via torso and upper arm to the forearm. Freedom of motion is accomplished by mechanical joints, which are nearly aligned with the human joints. The system compensates for the arm weight, using elastic bands for static balance, in every position of the arm. As opposed to existing devices, the proposed kinematic structure allows trunk motion and requires fewer links and less joint space without compromising balancing precision. The functional prototype has been validated in three DMD patients, using 3D motion analysis.Results: Measurements have shown increased arm performance when the subjects were wearing the prototype. Upward and forward movements were easier to perform. The arm support is easy to put on and remove. Moreover, the device felt comfortable for the subjects. However, downward movements were more difficult, and the patients would prefer the device to be even more inconspicuous.Conclusion: The A-gear prototype is a step towards inconspicuousness and therefore well-received dynamic arm supports for people with muscular weakness. [ABSTRACT FROM AUTHOR]

Background: Major depression is one of the most debilitating diseases in terms of quality of life. Less than half of patients suffering from depression can achieve remission after adequate antidepressant treatment. Another promising treatment option is cognitive-behavior therapy (CBT). However, the need for experienced therapists and substantive dedicated time prevent CBT from being widely disseminated. In the present study, we aim to examine the effectiveness of switching antidepressants and starting a smartphone-based CBT program at the same time, in comparison to switching antidepressants only, among patients still suffering from depression after adequate antidepressant treatment.Methods/design: A multi-center randomized trial is currently being conducted since September 2014. The smartphone-based CBT program, named the "Kokoro-App," for major depression has been developed and its feasibility has been confirmed in a previous open study. The program consists of an introduction, 6 sessions and an epilogue, and is expected to be completed within 9 weeks by patients. In the present trial, 164 patients with DSM-5 major depressive disorder and still suffering from depressive symptoms after adequate antidepressant treatment for more than 4 weeks will be allocated to the Kokoro-App plus switching antidepressant group or the switching antidepressant alone group. The participants allocated to the latter group will receive full components of the Kokoro-App after 9 weeks. The primary outcome is the change in the total score on the Patient Health Questionnaire through the 9 weeks of the program, as assessed at week 0, 1, 5 and 9 via telephone by blinded raters. The secondary outcomes include the change in the total score of the Beck Depression Inventory-II, change in side effects as assessed by the Frequency, Intensity and Burden of Side Effects Rating, and treatment satisfaction.Discussion: An effective and reachable intervention may not only lead to healthier mental status among depressed patients, but also to reduced social burden from this illness. This paper outlines the background and methods of a trial that evaluates the possible additive value of a smartphone-based CBT program for treatment-resistant depression.Trial Registration: UMIN-CTR: UMIN000013693 (registered on 1 June 2014). [ABSTRACT FROM AUTHOR]

Background: Pakistan observes a very high i.e. 37 percent modern contraceptive method related discontinuation rates within 12 months of their initiation. And almost 10 percent of these episodes of discontinuation happened due to the side effects or health concerns experienced by the women. Most importantly, it was noted that more than 12,000 first-level care facilities are located in the rural areas, including rural health centers, basic health units, and family welfare centers, but more than 30% of these facilities are nonfunctional. This paper presents a study protocol and participants' profiling of a prospective cohort follow-up to compare the effectiveness of household based and telephonic approaches in sustaining the use of Long Acting Reversible Contraceptives (LARC) whilst to facilitate lowering method related discontinuation and increasing switching amongst the contraceptive users. Methods: A 12-month multi-centre, non-inferiority prospective user follow-up is employed using three different study categories: a) household based follow-up; b) telephonic follow-up; and c) passive or need-based follow-up along with the hypothetical assumption that the telephonic client follow-up is not inferior to the household based follow-up by continuation rate of LARC and the telephonic follow-up is less-costly than the household based client follow-up. This follow-up will be conducted in 22 health facilities - (16 rural and 6 urban based facilities) in district Chakwal. The first two study categories will receive scheduled but different follow-up from the field workers at 1, 3, 6, 9, and 12 month while the third one i.e. the ‘passive or need-based follow-up' will serve as a control group. Using sampling software PASS 11, it was estimated to have 414 clients in each study category and around 1366 clients will be recruited to account for 10% attrition rate. Discussion: The study will help us to examine a more convenient method of effective follow-up for managing side effects, decreasing method discontinuation and increasing switching amongst users. The study information will also facilitate to develop a robust, effective and efficient mechanism for client follow-up to promote the continuation rates of LARC methods. The follow-up results and lessons learnt will be widely shared with stakeholders for their implementation and streamlining in health system. [ABSTRACT FROM AUTHOR]

The two main societies clinically dealing with idiopathic scoliosis are the Scoliosis Research Society (SRS), founded in 1966, and the international Society on Scoliosis Orthopedic and Rehabilitation Treatment (SOSORT), started in 2004. Inside the SRS, the Non-Operative Management Committee (SRS-NOC) has the same clinical interest of SOSORT, that is the Orthopaedic and Rehabilitation (or Non-Operative, or conservative) Management of idiopathic scoliosis patients. The aim of this paper is to present the results of a Consensus among the best experts of non-operative treatment of Idiopathic Scoliosis, as represented by SOSORT and SRS, on the recommendation for research studies on treatment of Idiopathic Scoliosis. The goal of the consensus statement is to establish a framework for research with clearly delineated inclusion criteria, methodologies, and outcome measures so that future meta- analysis or comparative studies could occur. A Delphi method was used to generate a consensus to develop a set of recommendations for clinical studies on treatment of Idiopathic Scoliosis. It included the development of a reference scheme, which was judged during two Delphi Rounds; after this first phase, it was decided to develop the recommendations and 4 other Delphi Rounds followed. The process finished with a Consensus Meeting, that was held during the SOSORT Meeting in Wiesbaden, 8-10 May 2014, moderated by the Presidents of SOSORT (JP O’Brien) and SRS (SD Glassman) and by the Chairs of the involved Committees (SOSORT Consensus Committee: S Negrini; SRS Non-Operative Committee: MT Hresko). The Boards of the SRS and SOSORT formally accepted the final recommendations. The 18 Recommendations focused: Research needs (3), Clinically significant outcomes (4), Radiographic outcomes (3), Other key outcomes (Quality of Life, adherence to treatment) (2), Standardization of methods of non-operative research (6). [ABSTRACT FROM AUTHOR]

Background: Aetiology of childhood leukaemia and childhood neoplasm is poorly understood. Information on the prevalence of risk factors in the childhood population is limited. SETIL is a population based case?control study on childhood leukaemia, conducted with two companion studies on non-Hodgkin Lymphoma (NHL) and neuroblastoma. The study relies on questionnaire interviews and 50 Hz magnetic field (ELF-MF) indoor measurements. This paper discusses the SETIL study design and includes descriptive information. Methods: The study was carried out in 14 Italian regions (78.3% of Italian population aged 0?10). It included leukaemia, NHL and neuroblastoma cases incident in 0?10 year olds in 1998?2001, registered by the Italian Association of Paediatric Haematology and Oncology (AIEOP) (accrual over 95% of estimated incidence). Two controls for each leukaemia case were randomly sampled from the Local Health Authorities rolls, matched by gender, birthdate and residence. The same controls were used in NHL and neuroblastoma studies. Parents were interviewed at home on: physical agents (ELF-MF and ionizing radiation), chemicals (smoking, solvents, traffic, insecticides), occupation, medical and personal history of children and parents, infectious diseases, immunizations and associated factors. Occupational exposure was collected using job specific modules. ELF-MF was measured in the main rooms (spot measurement) and close to child?s bed (48 hours measurement). Results: The study included: 683 leukaemia cases (87% ALL, 13% AnLL), 97 NHL, 155 neuroblastomas, and 1044 controls. ELF-MF long term measurements were obtained for 61.1% of controls and 81.6% of leukaemia cases; 8.8% of controls were exposed at over 0.1 microTesla (p,T), 3.5% and 2.1% at respectively over 0.2 and 0.3 p,T. 25% of controls? fathers had smoked over 10 cigarettes/day during the year of conception, varying according to education and region. Maternal smoking was less common (71.4% did not smoke in pregnancy). Maternal passive smoking during pregnancy was reported by 31.2% of controls; the child?s passive smoking for 28.6%. Occupational exposure to solvents was estimated in 18.3% of controls? fathers and 7.7% of mothers. Contact with public was more frequent among mothers (36.1%) than fathers (23.4%). Conclusions: SETIL represents a data source on exposure of Italian children to a broad array of potential carcinogenic factors. [ABSTRACT FROM AUTHOR]

Background: Systematic reviews suggest that multi-component interventions are effective in reducing bullying victimisation and perpetration. We are undertaking a phase III randomised trial of the INCLUSIVE multi-component intervention. This trial aims to assess the effectiveness and cost-effectiveness of the INCLUSIVE intervention in reducing aggression and bullying victimisation in English secondary schools. This paper updates the original trial protocol published in 2014 (Trials 15:381, 2014) and presents the changes in the process evaluation protocol and the secondary outcome data collection.Methods: The methods are summarised as follows.Design: cluster randomised trial.Participants: 40 state secondary schools. Outcomes assessed among the cohort of students at the end of year 7 (n = 6667) at baseline.Intervention: INCLUSIVE is a multi-component school intervention including a social and emotional learning curriculum, changes to school environment (an action group comprising staff and students reviews local data on needs to review rules and policies and determine other local actions) and staff training in restorative practice. The intervention will be delivered by schools supported in the first two years by educational facilitators independent of the research team, with a third intervention year involving no external facilitation but all other elements. Comparator: normal practice.Outcomes: Primary: Two primary outcomes at student level assessed at baseline and at 36 months: 1. Aggressive behaviours in school: Edinburgh Study of Youth Transitions and Crime school misbehaviour subscale (ESYTC) 2. Bullying and victimisation: Gatehouse Bullying Scale (GBS) Secondary outcomes assessed at baseline, 24 and 36 months will include measures relating to the economic evaluation, psychosocial outcomes in students and staff and school-level truancy and exclusion rates.Sample Size: 20 schools per arm will provide 90% power to identify an effect size of 0.25 SD with a 5% significance level. Randomisation: eligible consenting schools were randomised stratified for single-sex versus mixed-sex schools, school-level deprivation and measures of school attainment.Discussion: The trial involves independent research and intervention teams and is supervised by a Trial Steering Committee and a Data Monitoring Committee.Trial Registration: Current Controlled Trials, ISRCTN10751359 . Registered on 11 March 2014. [ABSTRACT FROM AUTHOR]

Background: Patients with acute leukemia experience a substantial symptom burden and are at risk of developing infections throughout the course of repeated cycles of intensive chemotherapy. Physical activity in recent years has been a strategy for rehabilitation in cancer patients to remedy disease and treatment related symptoms and side effects. To date, there are no clinical practice exercise guidelines for patients with acute leukemia undergoing induction and consolidation chemotherapy. A randomized controlled trial is needed to determine if patients with acute leukemia can benefit by a structured and supervised counseling and exercise program.Methods/design: This paper presents the study protocol: Patient Activation through Counseling and Exercise--Acute Leukemia (PACE-AL) trial, a two center, randomized controlled trial of 70 patients with acute leukemia (35 patients/study arm) following induction chemotherapy in the outpatient setting. Eligible patients will be randomized to usual care or to the 12 week exercise and counseling program. The intervention includes 3 hours + 30 minutes per week of supervised and structured aerobic training (moderate to high intensity 70-80%) on an ergometer cycle, strength exercises using hand weights and relaxation exercise. Individual health counseling sessions include a self directed home walk program with a step counter. The primary endpoint is functional performance/exercise capacity (6 minute walk distance). The secondary endpoints are submaximal VO₂ max test, sit to stand and bicep curl test, physical activity levels, patient reported outcomes (quality of life, anxiety and depression, symptom prevalence, intensity and interference). Evaluation of clinical outcomes will be explored including incidence of infection, hospitalization days, body mass index, time to recurrence and survival. Qualitative exploration of patients' health behavior and experiences.Discussion: PACE-AL will provide evidence of the effect of exercise and health promotion counseling on functional and physical capacity, the symptom burden and quality of life in patients with acute leukemia during out patient management. The results will inform clinical practice exercise guidelines and rehabilitation programs for patients undergoing treatment for acute leukemia. Optimizing the treatment and care pathway may ease the transition for patients from illness to the resumption of everyday activities.Trial Registration: ClinicalTrials.gov Identifier: NCT01404520. [ABSTRACT FROM AUTHOR]

Background: Globally the state of palliative care research remains uncertain. Questions remain regarding impact, funding, and research priorities. Building upon previous research, this review examines palliative care research in Ireland and contributes to a wider international debate on the state of palliative care research. Methods: A systematic mapping review was undertaken. Eight bibliographic databases and thesis repositories were searched from May 2012 to April 2017. Palliative care related search terms were combined with "Ireland" or "Irish" to increase search sensitivity. Inclusion criteria were applied by two independent reviewers. Descriptive analysis was completed using IBM SPSS v23. Thematic analysis was undertaken using a data-driven approach to develop new themes. Results: In total, 808 studies were screened and 151 papers from 117 studies were included for review. The top two areas of research focus included: (1) specific groups, services, and settings (n = 70); and (2) identification, communication and education (n = 37). A diverse variety of research methods were used including mixed methods (25%), surveys (22%), interviews (20%), and reviews (17%). One randomised control trial was conducted. The predominance of research papers focused solely on health care professionals (n = 35%), and the community setting was the most frequent location for data collection (41%). The majority of data was collected across the two jurisdictions of the Republic of Ireland (ROI) and Northern Ireland (NI) (37%), and 23% of studies included data outside of Ireland and the UK. The most frequent sources of funding were: consortiums (n = 40); government (n = 24); and philanthropic bodies (n = 20). Forty percent (n = 60) of papers were either unfunded or did not acknowledge a funder. Conclusions: There is a continued increase in palliative care research in Ireland with increased collaborative working nationally and internationally. The quantity and impact of research has increased from the previous review, which can be attributed to significant investment in research funding and collaborative networks. However, research gaps continue to exist including out of hours' care, physical and psychological symptom control, intervention studies, and the patient and family perspective. Areas for attention include the need to ensure knowledge exchange and demonstrate impact of the research on patient and family carer outcomes. [ABSTRACT FROM AUTHOR]

Background: The arthroscopic and open Latarjet procedures are both known to successfully treat shoulder instability with high success rates. The objective of this study was to compare the clinical outcomes and positioning of the coracoid graft and screws between the arthroscopic and open Latarjet procedures.Methods: The electronic databases MEDLINE, EMBASE, and PubMed were searched for relevant studies between database creation and 2018. Only studies directly comparing open and arthroscopic Latarjet procedures were included.Results: There were 8 included studies, with a total of 580 patients treated arthroscopically and 362 patients treated with an open Latarjet procedure. Several papers found significantly better standardized outcome scores for either the open or arthroscopic procedure but these findings were not consistent across papers. Patients treated with arthroscopic Latarjet procedures had significantly lower initial post-operative pain, however pain scores became equivalent by one month post-operatively. Three of the five included studies found no significant difference in the coracoid graft positioning and two of three included studies found no significant difference in screw divergence angles between the two techniques. Arthroscopic procedures (112.2 min) appear to take, on average, longer than open procedures (93.3 min). However, operative times and complication rates decrease with surgeon experience with the arthroscopic procedure. Overall 3.8% of the patients treated arthroscopically and 6.4% of the patients treated with the open procedure went on to have post-operative complications.Conclusions: Both open and arthroscopic Latarjet procedures can be used to effectively treat shoulder instability with similarly low rates of complications, recurrent instability and need for revision surgery. Arthroscopic Latarjet procedures are associated with less early post-operative pain but require increased operative time. The evidence does not support there being any significant difference in graft or screw positioning between the two techniques. At this time neither procedure shows clear superiority over the other. [ABSTRACT FROM AUTHOR]