Families Benefit After Utilization of a Clinic-Based Food Pantry Irrespective of Food Insecurity Experiences in a Pediatric Obesity Treatment Program.

PURPOSE: To evaluate the congruence between food insecurity screening outcome and clinic-based food pantry utilization and to examine caregiver reported comfort, motivation, and benefits of utilization. DESIGN: Mixed-methods study. SETTING: Academic pediatric obesity treatment clinic. SUBJECTS: Convenience sample of caregivers. INTERVENTION: Clinic-based food pantry offered irrespective of food insecurity screening outcome. MEASURES: Food insecurity screening (Hunger Vital Sign) and severity, self-rated caregiver health, willingness to disclose food insecurity and receive food, and food-related stress. ANALYSIS: Chi-square and t-tests were utilized to examine associations and descriptive analysis explored benefits. Rapid qualitative analysis was utilized to identify themes. RESULTS: Caregivers of 120 children were included (child mean age 11.8; 56.7% female, 67.6% Non-Hispanic Black), with 47 of 59 eligible completing follow-up surveys and 14 completing in-depth interviews. Approximately half (N = 30/59, 50.8%) of families utilizing the food pantry screened negative for food insecurity. Families utilizing the food pantry were more likely to report severe food insecurity (N = 23/59; 38.9%) compared to those declining (N = 3/61; 4.9%, P < .001). Caregivers accepting food were able to meet a child health goal (N = 30/47, 63.8%). Caregivers reported feeling comfortable receiving food (N = 13/14) and felt utilizing the food pantry led to consumption of healthier foods (N = 7/14). CONCLUSIONS: Families who screened both positive and negative for food insecurity utilized and benefited from a clinic-based food pantry. Clinics should consider strategies offering food resources to all families irrespective of screening outcome.

Associations Between Neighborhood Opportunity and Indicators of Physical Fitness for New York City Public School Youth.

Background: Fewer than 1/4th of US children and adolescents meet physical activity (PA) guidelines, leading to health disparities that track into adulthood. Neighborhood opportunity may serve as a critical modifiable factor to improve fitness attainment and reduce these disparities. We drew data from the Child Opportunity Index to examine associations between neighborhood indicators of opportunity for PA and multiple fitness indicators among New York City public school youth. Methods: Multilevel generalized linear mixed models were used to estimate the overall and sex-stratified associations between neighborhood indicators (green space, healthy food, walkability, commute time) and indicators for physical fitness [curl-ups, push-ups, Progressive Aerobic Cardiovascular Endurance Run (PACER), sit-and-reach] using the New York City FITNESSGRAM data set. Results: The analytic sample [n = 299,839; median (interquartile range) age = 16 (12-17)] was 50.1% female, 37.5% Hispanic, 26.2% non-Hispanic Black, and most (69.5%) qualified for free/reduced price school meals. Neighborhood indicators were positively associated with higher values of indicators for physical fitness. The strongest associations were observed between walkability and both BMI and PACER, and commute time with BMI, push-ups, and PACER. For example, walkability had the greatest magnitude of effects for BMI and muscular strength and endurance (BMI: ß: -0.75, 95% confidence interval, CI: -1.01 to -0.49; PACER: ß: 1.98, 95% CI: 1.59 to 2.37), and particularly for girls compared with boys (BMI, girls: ß: -0.91, 95% CI: -1.22 to -0.66); BMI, boys: ß: -0.56, 95% CI: -0.86 to -0.25); PACER, girls: ß: 2.11, 95% CI: 1.68 to 2.54; push-ups, boys: ß: 1.71, 95% CI: 1.31 to 2.12). Conclusion: Neighborhood indicators were associated with multiple measures of youth fitness. Continued research on neighborhood opportunity and youth fitness may better inform place-based public health interventions to reduce disparities.

A multidomain decision support tool to prevent falls in older people: the FinCH cluster RCT.

BACKGROUND: Falls in care home residents are common, unpleasant, costly and difficult to prevent. OBJECTIVES: The objectives were to evaluate the clinical effectiveness and cost-effectiveness of the Guide to Action for falls prevention in Care Homes (GtACH) programme. DESIGN: A multicentre, cluster, parallel, 1 : 1 randomised controlled trial with embedded process evaluation and economic evaluation. Care homes were randomised on a 1 : 1 basis to the GtACH programme or usual care using a secure web-based randomisation service. Research assistants, participating residents and staff informants were blind to allocation at recruitment; research assistants were blind to allocation at follow-up. NHS Digital data were extracted blindly. SETTING: Older people's care homes from 10 UK sites. PARTICIPANTS: Older care home residents. INTERVENTION: The GtACH programme, which includes care home staff training, systematic use of a multidomain decision support tool and implementation of falls prevention actions, compared to usual falls prevention care. OUTCOMES: The primary trial outcome was the rate of falls per participating resident occurring during the 90-day period between 91 and 180 days post randomisation. The primary outcome for the cost-effectiveness analysis was the cost per fall averted, and the primary outcome for the cost-utility analysis was the incremental cost per quality adjusted life-year. Secondary outcomes included the rate of falls over days 0-90 and 181-360 post randomisation, activity levels, dependency and fractures. The number of falls per resident was compared between arms using a negative binomial regression model (generalised estimating equation). RESULTS: A total of 84 care homes were randomised: 39 to the GtACH arm and 45 to the control arm. A total of 1657 residents consented and provided baseline measures (mean age 85 years, 32% men). GtACH programme training was delivered to 1051 staff (71% of eligible staff) over 146 group sessions. Primary outcome data were available for 630 GtACH participants and 712 control participants. The primary outcome result showed an unadjusted incidence rate ratio of 0.57 (95% CI 0.45 to 0.71; p < 0.01) in favour of the GtACH programme. Falls rates were lower in the GtACH arm in the period 0-90 days. There were no other differences between arms in the secondary outcomes. Care home staff valued the training, systematic strategies and specialist peer support, but the incorporation of the GtACH programme documentation into routine care home practice was limited. No adverse events were recorded. The incremental cost was £20,889.42 per Dementia Specific Quality of Life-based quality-adjusted life-year and £4543.69 per quality-adjusted life-year based on the EuroQol-5 dimensions, five-level version. The mean number of falls was 1.889 (standard deviation 3.662) in the GtACH arm and 2.747 (standard deviation 7.414) in the control arm. Therefore, 0.858 falls were averted. The base-case incremental cost per fall averted was £190.62. CONCLUSION: The GtACH programme significantly reduced the falls rate in the study care homes without restricting residents' activity levels or increasing their dependency, and was cost-effective at current thresholds in the NHS. FUTURE WORK: Future work should include a broad implementation programme, focusing on scale and sustainability of the GtACH programme. LIMITATIONS: A key limitation was the fact that care home staff were not blinded, although risk was small because of the UK statutory requirement to record falls in care homes. TRIAL REGISTRATION: This trial is registered as ISRCTN34353836. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 9. See the NIHR Journals Library website for further project information.

Falls in care home residents are common, unpleasant, costly and hard to prevent. We tested whether or not the Guide to Action for falls prevention in Care Homes (GtACH) programme was effective in preventing falls. In this programme, care home staff were systematically trained and supported in the assessment of residents' risk of falling and the generation of a falls reduction care plan. We undertook a randomised controlled trial comparing the GtACH programme with usual care, which does not involve this systematic attention to falls prevention. We also undertook a process evaluation, observing organisational and care processes, and an economic study to evaluate value for money. A total of 39 care homes were randomly allocated to the GtACH programme and 45 care homes were randomly allocated to usual care, involving a total of 1657 residents. The main comparison between the two arms was the rate of falls during months 4­6 after randomisation, when we expected any effect to be at its peak. We also assessed the falls rates before and 6 months after this period. We measured activity and dependency levels, as it was important to be sure that any reduction in the rate of falls was not achieved through restrictive care practices. We saw a 43% reduction in the falls rates of the GtACH programme participants during months 4­6, without observing any reduction in residents' activity or dependency. Care home staff and relatives were positive about the GtACH programme. The GtACH programme was good value for money, as it was likely to be cost-effective. The effect of the programme waned over months 6­12, which may be because some staff did not embed the GtACH programme in their usual practice routines, and awareness levels may have dropped.

Multifactorial falls prevention programme compared with usual care in UK care homes for older people: multicentre cluster randomised controlled trial with economic evaluation.

OBJECTIVES: To determine the clinical and cost effectiveness of a multifactorial fall prevention programme compared with usual care in long term care homes. DESIGN: Multicentre, parallel, cluster randomised controlled trial. SETTING: Long term care homes in the UK, registered to care for older people or those with dementia. PARTICIPANTS: 1657 consenting residents and 84 care homes. 39 were randomised to the intervention group and 45 were randomised to usual care. INTERVENTIONS: Guide to Action for Care Homes (GtACH): a multifactorial fall prevention programme or usual care. MAIN OUTCOME MEASURES: Primary outcome measure was fall rate at 91-180 days after randomisation. The economic evaluation measured health related quality of life using quality adjusted life years (QALYs) derived from the five domain five level version of the EuroQoL index (EQ-5D-5L) or proxy version (EQ-5D-5L-P) and the Dementia Quality of Life utility measure (DEMQOL-U), which were self-completed by competent residents and by a care home staff member proxy (DEMQOL-P-U) for all residents (in case the ability to complete changed during the study) until 12 months after randomisation. Secondary outcome measures were falls at 1-90, 181-270, and 271-360 days after randomisation, Barthel index score, and the Physical Activity Measure-Residential Care Homes (PAM-RC) score at 91, 180, 270, and 360 days after randomisation. RESULTS: Mean age of residents was 85 years. 32% were men. GtACH training was delivered to 1051/1480 staff (71%). Primary outcome data were available for 630 participants in the GtACH group and 712 in the usual care group. The unadjusted incidence rate ratio for falls between 91 and 180 days was 0.57 (95% confidence interval 0.45 to 0.71, P<0.001) in favour of the GtACH programme (GtACH: six falls/1000 residents v usual care: 10 falls/1000). Barthel activities of daily living indices and PAM-RC scores were similar between groups at all time points. The incremental cost was £108 (95% confidence interval -£271.06 to 487.58), incremental QALYs gained for EQ-5D-5L-P was 0.024 (95% confidence interval 0.004 to 0.044) and for DEMQOL-P-U was 0.005 (-0.019 to 0.03). The incremental costs per EQ-5D-5L-P and DEMQOL-P-U based QALY were £4544 and £20 889, respectively. CONCLUSIONS: The GtACH programme was associated with a reduction in fall rate and cost effectiveness, without a decrease in activity or increase in dependency. TRIAL REGISTRATION: ISRCTN34353836.

The Association Between Neighborhood Public Transportation Usage and Youth Physical Activity.

INTRODUCTION: Routine adolescent physical activity is a well-established predictor of positive health across the lifespan, although wide disparities in youth physical activity engagement persist across sex and race/ethnicity. Transportation barriers may be related to adolescents' ability to access physical activity opportunities. This study examines the association between neighborhood public transportation usage and adolescent physical activity using a national sample. METHODS: Cross-sectional data were drawn from the Family Life, Activity, Sun, Health, and Eating study (2014), a national sample of adolescents aged 12-17 years. Linear regression examined the association between neighborhood public transportation usage on the basis of neighborhood-level public transportation use and individual-level youth moderate-to-vigorous physical activity minutes per week. Models were developed for weekday, weekend, and combined moderate-to-vigorous physical activity for all youth and across sex and race/ethnicity subgroups. Analyses were run in 2020. RESULTS: The final analytic data set included 1,247 adolescents aged 12-17 years (71% non-Hispanic White, 49% male, mean age=14.52 [SD=1.59] years). Adjusted models showed a stronger magnitude of association between high neighborhood public transportation usage and both weekday (ß=8.79, 95% CI=1.00, 16.59) and combined (ß=13.74, 95% CI=1.14, 26.35) moderate-to-vigorous physical activity than between low/moderate neighborhood public transportation usage and moderate-to-vigorous physical activity. The magnitude of the neighborhood public transportation usage-moderate-to-vigorous physical activity association was strongest among non-Hispanic Black and Hispanic adolescent girls. CONCLUSIONS: This study found an association between neighborhood public transportation usage and adolescent moderate-to-vigorous physical activity, particularly among non-Hispanic Black and Hispanic adolescent girls. Findings from this research have the potential to inform targeted interventions for promoting adolescent physical activity to ultimately reduce chronic health disparities across the lifespan.

Scaling-Up Stage 4 Pediatric Obesity Clinics: Identifying Barriers and Future Directions Using Implementation Science.

Nearly one-fifth of the pediatric population in the United States has obesity. Comprehensive behavioral interventions, with at least 26 contact hours, are the recommended treatment for pediatric obesity; however, there are various barriers to implementing treatment. This Perspective applies the Exploration, Preparation, Implementation, and Sustainment (EPIS) framework to address barriers to implementing multidisciplinary pediatric weight management clinics and identify potential solutions and areas for additional research. Lack of insurance coverage and reimbursement, high operating costs, and limited access to stage 4 care clinics with sufficient capacity were among the main barriers identified. Clinicians, researchers, and patient advocates are encouraged to facilitate conversations with insurance companies and hospital and clinic administrators, increase telehealth adoption, request training to improve competency and self-efficacy discussing and implementing obesity care, and advocate for more stage 4 clinics.

Medicaid and CHIP Child Health Beneficiary Incentives: Program Landscape and Stakeholder Insights.

OBJECTIVES: To describe the landscape of Medicaid and the Children's Health Insurance Program beneficiary incentive programs for child health and garner key stakeholder insights on incentive program rationale, child and family engagement, and program evaluation. METHODS: We identified beneficiary health incentive programs from 2005 to 2018 through a search of peer-reviewed and publicly available documents and through semistructured interviews with 80 key stakeholders (Medicaid and managed-care leadership, program evaluators, patient advocates, etc). This study highlights insights from 23 of these stakeholders with expertise on programs targeting child health (<18 years old) to understand program rationale, beneficiary engagement, and program evaluation. RESULTS: We identified 82 child health-targeted beneficiary incentive programs in Medicaid and the Children's Health Insurance Program. Programs most commonly incentivized well-child checks (n = 77), preventive screenings (n = 30), and chronic disease management (n = 30). All programs included financial incentives (eg, gift cards, premium incentives); some also offered incentive material prizes (n = 12; eg, car seats). Loss-framed incentives were uncommon (n = 1; eg, lost benefits) and strongly discouraged by stakeholders. Stakeholders suggested family engagement strategies including multigenerational incentives or incentives addressing social determinants of health. Regarding evaluation, stakeholders suggested incentivizing evidence-based preventive services (eg, vaccinations) rather than well-child check attendance, and considering proximal measures of child well-being (eg, school functioning). CONCLUSIONS: As the landscape of beneficiary incentive programs for child health evolves, policy makers have unique opportunities to leverage intergenerational and social approaches for family engagement and to more effectively increase and evaluate programs' impact.

Time-lapse systems for embryo incubation and assessment in assisted reproduction.

BACKGROUND: Embryo incubation and assessment is a vital step in assisted reproductive technology (ART). Traditionally, embryo assessment has been achieved by removing embryos from a conventional incubator daily for quality assessment by an embryologist, under a microscope. In recent years time-lapse systems (TLS) have been developed which can take digital images of embryos at frequent time intervals. This allows embryologists, with or without the assistance of embryo selection software, to assess the quality of the embryos without physically removing them from the incubator.The potential advantages of a TLS include the ability to maintain a stable culture environment, therefore limiting the exposure of embryos to changes in gas composition, temperature, and movement. A TLS has the potential advantage of improving embryo selection for ART treatment by utilising additional information gained through continuously monitoring embryo development. Use of a TLS often adds significant extra cost to ART treatment. OBJECTIVES: To determine the effect of a TLS compared to conventional embryo incubation and assessment on clinical outcomes in couples undergoing ART. SEARCH METHODS: We used standard methodology recommended by Cochrane. We searched the Cochrane Gynaecology and Fertility (CGF) Group Trials Register, CENTRAL, MEDLINE, Embase, CINAHL, and two trials registers on 7 January 2019 and checked references of appropriate papers. SELECTION CRITERIA: We included randomised controlled trials (RCTs) comparing TLS, with or without embryo selection software, versus conventional incubation with morphological assessment; and TLS with embryo selection software versus TLS without embryo selection software among couples undergoing ART. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures recommended by Cochrane. The primary review outcomes were live birth or ongoing pregnancy, miscarriage and stillbirth, and cumulative live birth or ongoing pregnancy rate. The secondary outcomes were clinical pregnancy and cumulative clinical pregnancy. We assessed the quality of the evidence using GRADE methodology. We made the following comparisons.TLS with conventional morphological assessment of still TLS images versus conventional incubation and assessmentTLS utilising embryo selection software versus TLS with conventional morphological assessment of still TLS images TLS utilising embryo selection software versus conventional incubation and assessment MAIN RESULTS: We included nine RCTs (N = 2955 infertile couples). The quality of the evidence ranged from very low to low. The main limitations were high risk of bias in the included studies, imprecision, indirectness, and inconsistency. There were no data on cumulative live birth or ongoing pregnancy rate or cumulative clinical pregnancy rate.TLS with conventional morphological assessment of still TLS images versus conventional incubation and assessmentIt is unclear whether there is any difference between interventions in rates of live birth or ongoing pregnancy (odds ratio (OR) 0.91, 95% confidence interval (CI) 0.67 to 1.23, 3 RCTs, N = 826, I2 = 33%, low-quality evidence) or in miscarriage rates (OR 1.90, 95% CI 0.99 to 3.61, 3 RCTs, N = 826, I2 = 0%, low-quality evidence). The evidence suggests that if the rate of live birth or ongoing pregnancy associated with conventional incubation and assessment is 35%, the rate with the use of TLS with conventional morphological assessment of still TLS images would be between 27% and 40%, and if the miscarriage rate with conventional incubation is 4%, the rate associated with conventional morphological assessment of still TLS images would be between 4% and 14%. It is unclear whether there is a difference between the interventions in rates of stillbirth (OR 1.00, 95% CI 0.13 to 7.49, 1 RCT, N = 76, low-quality evidence) or clinical pregnancy (OR 1.06, 95% CI 0.79 to 1.41, 4 RCTs, N = 875, I2 = 0%, low-quality evidence).TLS utilising embryo selection software versus TLS with conventional morphological assessment of still TLS imagesAll findings for this comparison were very uncertain due to the very low-quality of the evidence. No data were available on live birth, but one RCT reported ongoing pregnancy. It is unclear whether there is any difference between the interventions in rates of ongoing pregnancy (OR 0.61, 95% CI 0.32 to 1.20, 1 RCT, N = 163); miscarriage (OR 1.39, 95% CI 0.64 to 3.01, 2 RCTs, N = 463, I2 = 0%); or clinical pregnancy (OR 0.97, 95% CI 0.67 to 1.42, 2 RCTs, N = 463, I2 = 0%). The evidence suggests that if the rate of ongoing pregnancy associated with TLS with conventional morphological assessment of still TLS images is 47%, the rate associated with TLS utilising embryo selection software would be between 22% and 52%, and if the miscarriage rate associated with conventional morphological assessment of still TLS images is 5%, the rate associated with TLS utilising embryo selection software would be between 4% and 15%. No studies reported stillbirth.TLS utilising embryo selection software versus conventional incubation and assessmentThe findings for this comparison were also very uncertain due to the very low quality of the evidence. It is unclear whether there is any difference between the interventions in rates of live birth (OR 1.12, 95% CI 0.92 to 1.36, 3 RCTs, N = 1617, I2 = 84%). There was very low-quality evidence that TLS might reduce miscarriage rates (OR 0.63, 95% CI 0.45 to 0.89, 3 RCTs, N = 1617, I2 = 0%). It is unclear whether there is any difference between the interventions in rates of clinical pregnancy (OR 0.95, 95% CI 0.78 to 1.16, 3 RCTs, N = 1617, I2 = 89%). The evidence suggests that if the rate of live birth associated with conventional incubation and assessment is 48%, the rate with TLS utilising embryo selection software would be between 46% and 55%, and if the miscarriage rate with conventional incubation and assessment is 11%, the rate associated with TLS would be between 5% and 10%. No stillbirths occurred in the only study reporting this outcome. AUTHORS' CONCLUSIONS: There is insufficient good-quality evidence of differences in live birth or ongoing pregnancy, miscarriage and stillbirth, or clinical pregnancy to choose between TLS, with or without embryo selection software, and conventional incubation. As the evidence is of low or very low-quality, our findings should be interpreted with caution.

Time-lapse systems for embryo incubation and assessment in assisted reproduction.

BACKGROUND: Embryo incubation and assessment is a vital step in assisted reproductive technology (ART). Traditionally, embryo assessment has been achieved by removing embryos from a conventional incubator daily for quality assessment by an embryologist, under a light microscope. Over recent years time-lapse systems have been developed which can take digital images of embryos at frequent time intervals. This allows embryologists, with or without the assistance of embryo selection software, to assess the quality of the embryos without physically removing them from the incubator.The potential advantages of a time-lapse system (TLS) include the ability to maintain a stable culture environment, therefore limiting the exposure of embryos to changes in gas composition, temperature and movement. A TLS has the potential advantage of improving embryo selection for ART treatment by utilising additional information gained through continuously monitoring embryo development. Use of a TLS often adds significant extra cost onto an in vitro fertilisation (IVF) cycle. OBJECTIVES: To determine the effect of a TLS compared to conventional embryo incubation and assessment on clinical outcomes in couples undergoing ART. SEARCH METHODS: We used standard methodology recommended by Cochrane. We searched the Cochrane Gynaecology and Fertility (CGF) Group trials register, CENTRAL, MEDLINE, Embase, CINAHL and two trials registers on 2 August 2017. SELECTION CRITERIA: We included randomised controlled trials (RCTs) in the following comparisons: comparing a TLS, with or without embryo selection software, versus conventional incubation with morphological assessment; and TLS with embryo selection software versus TLS without embryo selection software among couples undergoing ART. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures recommended by Cochrane. The primary review outcomes were live birth, miscarriage and stillbirth. Secondary outcomes were clinical pregnancy and cumulative clinical pregnancy. We reported quality of the evidence for important outcomes using GRADE methodology. We made the following comparisons.TLS with conventional morphological assessment of still TLS images versus conventional incubation and assessmentTLS utilising embryo selection software versus TLS with conventional morphological assessment of still TLS images TLS utilising embryo selection software versus conventional incubation and assessment MAIN RESULTS: We included eight RCTs (N = 2303 women). The quality of the evidence ranged from very low to moderate. The main limitations were imprecision and risk of bias associated with lack of blinding of participants and researchers, and indirectness secondary to significant heterogeneity between interventions in some studies. There were no data on cumulative clinical pregnancy.TLS with conventional morphological assessment of still TLS images versus conventional incubation and assessmentThere is no evidence of a difference between the interventions in terms of live birth rates (odds ratio (OR) 0.73, 95% CI 0.47 to 1.13, 2 RCTs, N = 440, I2 = 11% , moderate-quality evidence) and may also be no evidence of difference in miscarriage rates (OR 2.25, 95% CI 0.84 to 6.02, 2 RCTs, N = 440, I2 = 44%, low-quality evidence). The evidence suggests that if the live birth rate associated with conventional incubation and assessment is 33%, the rate with use of TLS with conventional morphological assessment of still TLS images is between 19% and 36%; and that if the miscarriage rate with conventional incubation is 3%, the rate associated with conventional morphological assessment of still TLS images would be between 3% and 18%. There is no evidence of a difference between the interventions in the stillbirth rate (OR 1.00, 95% CI 0.13 to 7.49, 1 RCT, N = 76, low-quality evidence). There is no evidence of a difference between the interventions in clinical pregnancy rates (OR 0.88, 95% CI 0.58 to 1.33, 3 RCTs, N = 489, I2 = 0%, moderate-quality evidence).TLS utilising embryo selection software versus TLS with conventional morphological assessment of still TLS imagesNo data were available on live birth or stillbirth. We are uncertain whether TLS utilising embryo selection software influences miscarriage rates (OR 1.39, 95% CI 0.64 to 3.01, 2 RCTs, N = 463, I2 = 0%, very low-quality evidence) and there may be no difference in clinical pregnancy rates (OR 0.97, 95% CI 0.67 to 1.42, 2 RCTs, N = 463, I2 = 0%, low-quality evidence). The evidence suggests that if the miscarriage rate associated with assessment of still TLS images is 5%, the rate with embryo selection software would be between 3% and 14%.TLS utilising embryo selection software versus conventional incubation and assessmentThere is no evidence of a difference between TLS utilising embryo selection software and conventional incubation improving live birth rates (OR 1.21, 95% CI 0.96 to 1.54, 2 RCTs, N = 1017, I2 = 0%, very low-quality evidence). We are uncertain whether TLS influences miscarriage rates (OR 0.73, 95% CI 0.49 to 1.08, 3 RCTs, N = 1351, I2 = 0%, very low-quality evidence). The evidence suggests that if the live birth rate associated with no TLS is 38%, the rate with use of conventional incubation would be between 36% and 58%, and that if miscarriage rate with conventional incubation is 9%, the rate associated with TLS would be between 4% and 10%. No data on stillbirths were available. It was uncertain whether the intervention influenced clinical pregnancy rates (OR 1.17, 95% CI 0.94 to 1.45, 3 RCTs, N = 1351, I2 = 42%, very low-quality evidence). AUTHORS' CONCLUSIONS: There is insufficient evidence of differences in live birth, miscarriage, stillbirth or clinical pregnancy to choose between TLS, with or without embryo selection software, and conventional incubation. The studies were at high risk of bias for randomisation and allocation concealment, the result should be interpreted with extreme caution.

Baseline anatomical assessment of the uterus and ovaries in infertile women: a systematic review of the evidence on which assessment methods are the safest and most effective in terms of improving fertility outcomes.

BACKGROUND: This review focuses on the initial presentation of women who suspect that they are infertile, and how best to assess the anatomy of their uterus and ovaries in order to investigate the cause of their infertility, and potentially improve desired fertility outcomes. This review was undertaken as part of a World Health Organization initiative to assess the evidence available to address guidance for the diagnosis and treatment of infertility within a global context. Providing access to care for infertile women will help to ease the psycho-social burdens, such as ostracization, intimate partner violence and other negative consequences of being involuntarily childless or unable to become pregnant despite desiring a biological child or children. OBJECTIVE AND RATIONALE: The aim of this paper was to present an evidence base for the diagnostic and prognostic value of various investigations used for detecting uterine and/or ovarian pathology in women presenting at fertility clinics for their initial assessment. SEARCH METHODS: We performed a comprehensive search of relevant studies on 28 August and 10 September 2014. A further search was performed on 6 June 2016 to ensure all possible studies were captured. These strategies were not limited by date or language. The search returned 3968 publications in total; 63 full text articles were retrieved and 10 additional studies were found through hand-searching. After excluding 54, a total of 19 studies were analysed. We extracted and tabulated data on the characteristics, quality and results of each eligible study and combined the findings in a narrative synthesis. Risk of bias was assessed according to article type using tools such as assessment of the methodological quality of systematic reviews, Newcastle Ottawa Scale, Cochrane risk of bias tool, quality assessment tool for diagnostic accuracy studies and quality in prognostic studies. Nineteen studies were selected as being the best evidence available. A narrative synthesis of the data was undertaken. Discussion of the data, and resultant consensus for best practice were accomplished in a consensus expert consultation in Geneva, October 2015. An independent expert review process concerning this work and outcomes was conducted during 2016. OUTCOMES: The draft recommendations presented here apply to infertile women whether or not they are undergoing fertility treatment. Transvaginal ultrasound (TVUS) should be offered to all infertile women with symptoms or signs of anatomic pelvic pathology. TVUS should not be offered routinely to women without symptoms of pelvic pathology. Hysteroscopy should be offered if intrauterine pathology is suspected by TVUS. Hysteroscopy should not be routinely offered to infertile women who have normal TVUS findings. In women who have normal TVUS findings and are undergoing IVF, hysteroscopy does not improve the outcome. Good practice points recommend that providers of fertility care should confirm that all infertile women have a recent pelvic examination, recent cervical screening and well-woman screening in line with local guidelines. Additionally, hystero-contrast salpingography in infertile women does not improve clinical pregnancy rates with expectant management in heterosexual couples and should not be offered as a therapeutic procedure. Most of the findings of this review on diagnosis are based on a low, or very low, quality of evidence, according to GRADE Working Group (grading of recommendations, assessment, development and evaluation) criteria. A low quality grading indicates that further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate, while a very low grade indicates that any estimate of effect is very uncertain. WIDER IMPLICATIONS: This review provides the most reliable evidence available to guide clinicians worldwide in the initial, evidence-based investigation of women with fertility problems in order to undertake the most useful investigation and avoid the burden of unnecessary tests.

Establishment of the Pediatric Obesity Weight Evaluation Registry: A National Research Collaborative for Identifying the Optimal Assessment and Treatment of Pediatric Obesity.

BACKGROUND: Prospective patient registries have been successfully utilized in several disease states with a goal of improving treatment approaches through multi-institutional collaboration. The prevalence of youth with severe obesity is at a historic high in the United States, yet evidence to guide effective weight management is limited. The Pediatric Obesity Weight Evaluation Registry (POWER) was established in 2013 to identify and promote effective intervention strategies for pediatric obesity. METHODS: Sites in POWER provide multicomponent pediatric weight management (PWM) care for youth with obesity and collect a defined set of demographic and clinical parameters, which they regularly submit to the POWER Data Coordinating Center. A program profile survey was completed by sites to describe characteristics of the respective PWM programs. RESULTS: From January 2014 through December 2015, 26 US sites were enrolled in POWER and had submitted data on 3643 youth with obesity. Ninety-five percent were 6-18 years of age, 54% female, 32% nonwhite, 32% Hispanic, and 59% publicly insured. Over two-thirds had severe obesity. All sites included a medical provider and used weight status in their referral criteria. Other program characteristics varied widely between sites. CONCLUSION: POWER is an established national registry representing a diverse sample of youth with obesity participating in multicomponent PWM programs across the United States. Using high-quality data collection and a collaborative research infrastructure, POWER aims to contribute to the development of evidence-based guidelines for multicomponent PWM programs.

Assessment of Potential Live Kidney Donors and Computed Tomographic Renal Angiograms at Christchurch Hospital.

Aims. To examine the outcome of potential live kidney donors (PLKD) assessment program at Christchurch Hospital and, also, to review findings of Computed Tomographic (CT) renal angiograms that led to exclusion in the surgical assessment. Methods. Clinical data was obtained from the database of kidney transplants, Proton. Radiological investigations were reviewed using the hospital database, Éclair. The transplant coordinator was interviewed to clarify information about PLKD who did not proceed to surgery, and a consultant radiologist was interviewed to explain unfavorable findings on CT renal angiograms. Results. 162 PLKD were identified during the period January 04-June 08. Of those, 65 (40%) proceeded to have nephrectomy, 15 were accepted and planned to proceed to surgery, 13 were awaiting further assessment, and 69 (42.5%) did not proceed to nephrectomy. Of the 162 PLKD, 142 (88%) were directed donors. The proportion of altruistic PLKD who opted out was significantly higher than that of directed PLKD (45% versus 7%, P = 0.00004). Conclusions. This audit demonstrated a positive experience of live kidney donation at Christchurch Hospital. CT renal angiogram can potentially detect incidental or controversial pathologies in the kidney and the surrounding structures. Altruistic donation remains controversial with higher rates of opting out.

The Falls In Care Home study: a feasibility randomized controlled trial of the use of a risk assessment and decision support tool to prevent falls in care homes.

OBJECTIVE: To explore the feasibility of implementing and evaluating the Guide to Action Care Home fall prevention intervention. DESIGN: Two-centre, cluster feasibility randomized controlled trial and process evaluation. SETTING: Purposive sample of six diverse old age/learning disability, long stay care homes in Nottinghamshire, UK. SUBJECTS: Residents aged over 50 years, who had fallen at least once in the past year, not bed-bound, hoist-dependent or terminally ill. INTERVENTIONS: Intervention homes (n = 3) received Guide to Action Care Home fall prevention intervention training and support. Control homes (n = 3) received usual care. OUTCOMES: Recruitment, attrition, baseline and six-month outcome completion, contamination and intervention fidelity, compliance, tolerability, acceptance and impact. RESULTS: A total of 81 of 145 (56%) care homes expressed participatory interest. Six of 22 letter respondent homes (27%) participated. The expected resident recruitment target was achieved by 76% (52/68). Ten (19%) residents did not complete follow-up (seven died, three moved). In intervention homes 36/114 (32%) staff attended training. Two of three (75%) care homes received protocol compliant training. Staff valued the training, but advised greater management involvement to improve intervention implementation. Fall risks were assessed, actioned and recorded in care records. Of 115 recorded falls, 533/570 (93%) of details were complete. Six-month resident fall rates were 1.9 and 4.0 per year for intervention and control homes, respectively. CONCLUSIONS: The Guide to Action Care Home is implementable under trial conditions. Recruitment and follow-up rates indicate that a definitive trial can be completed. Falls (primary outcome) can be ascertained reliably from care records.

Time-lapse systems for embryo incubation and assessment in assisted reproduction.

BACKGROUND: Embryo incubation and assessment is a vital step in assisted reproductive technology (ART). Traditionally, embryo assessment has been achieved by removing embryos from a conventional incubator daily for assessment of quality by an embryologist, under a light microscope. Over recent years time-lapse systems (TLSs) have been developed which can take digital images of embryos at frequent time intervals. This allows embryologists, with or without the assistance of computer algorithms, to assess the quality of the embryos without physically removing them from the incubator.The potential advantages of a TLS include the ability to maintain a stable culture environment, therefore limiting the exposure of embryos to changes in gas composition, temperature and movement. Additionally a TLS has the potential advantage of improving embryo selection for ART treatment by utilising additional information gained through monitoring embryo development. OBJECTIVES: To determine the effect of a TLS compared to conventional embryo incubation and assessment on clinical outcomes in couples undergoing ART. SEARCH METHODS: A comprehensive search of all the major electronic databases, including grey literature, was undertaken in co-ordination with the Trials Search Co-ordinator of the Cochrane Menstrual Disorders and Subfertility Group in July 2014 and repeated in November 2014 to confirm that the review is up to date. SELECTION CRITERIA: Two authors (SA and NA) independently scanned the titles and abstracts of the articles retrieved by the search. Full texts of potentially eligible randomised controlled trials (RCTs) were obtained and examined independently by the authors for their suitability according to the review inclusion criteria. In the case of doubt between the two authors, a third author (LC) was consulted to gain consensus. The selection process is documented with a Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flow chart. DATA COLLECTION AND ANALYSIS: Data were obtained and extracted by two authors. Disagreement was resolved by consensus. Trial authors were contacted by e-mail to obtain further study information and data. All extracted data were dichotomous outcomes and odds ratios (OR) were calculated on an intention-to-treat basis. Where enough data were available, meta-analysis was undertaken. MAIN RESULTS: Three studies involving 994 women were found for inclusion. Data from all three studies were used to address comparison one, TLS with or without cell-tracking algorithms versus conventional incubation. No studies were found to address comparison two, TLS utilising cell-tracking algorithms versus TLS not utilising cell-tracking algorithms.There was only one study which reported live birth (n = 76). The results demonstrated no conclusive evidence of a difference in live birth rate per couple randomly assigned to the TLS and conventional incubation arms of the study (OR 1.1, 95% CI 0.45 to 2.73, 1 RCT, n = 76, moderate quality evidence).All three studies reported miscarriage (n = 994). There was no conclusive evidence of a difference in miscarriage rates per couple randomly assigned to the TLS and conventional incubation arms (OR 0.70, 95% CI 0.47 to 1.04, 3 RCTs, n = 994, I(2) = 0%, low quality evidence).Only one study reported stillbirth rates (n = 76). There were equal numbers of stillbirths in both the TLS and conventional incubation arms of the study. Therefore, there was no evidence of a difference in the stillbirth rate per couple randomly assigned to TLS and conventional incubation (OR 1.0, 95% CI 0.13 to 7.49, 1 RCT, moderate quality evidence).All three studies reported clinical pregnancy rates (n = 994). There was no conclusive evidence of a difference in clinical pregnancy rate per couple randomly assigned to the TLS and conventional incubation arms (OR 1.23, 95% CI 0.96 to 1.59, 3 RCTs, n = 994, I(2) = 0%, low quality evidence). None of the included studies reported cumulative clinical pregnancy rates. AUTHORS' CONCLUSIONS: There is insufficient evidence of differences in live birth, miscarriage, stillbirth or clinical pregnancy to choose between TLS and conventional incubation. Further data explicitly comparing the incubation environment, the algorithm for embryo selection, or both, are required before recommendations for a change of routine practice can be justified.

Rehabilitation aimed at improving outdoor mobility for people after stroke: a multicentre randomised controlled study (the Getting out of the House Study).

BACKGROUND: One-third of stroke patients are dependent on others to get outside their homes. This can cause people to become housebound, leading to increased immobility, poor health, isolation and misery. There is some evidence that outdoor mobility rehabilitation can reduce these limitations. OBJECTIVE: To test the clinical effectiveness and cost-effectiveness of an outdoor mobility rehabilitation intervention for stroke patients. DESIGN: Multicentre, parallel-group randomised controlled trial, with two groups allocated at a 1 : 1 ratio plus qualitative participant interviews. SETTING: Fifteen UK NHS stroke services throughout England, Scotland and Wales. PARTICIPANTS: A total of 568 stroke patients who wished to get out of the house more often, mean age of 71 years: 508 reached the 6-month follow-up and 10 were interviewed. INTERVENTION: Control was delivered prior to randomisation to all participants, and consisted of verbal advice and transport and outdoor mobility leaflets. Intervention was a targeted outdoor mobility rehabilitation programme delivered by 29 NHS therapists to 287 randomly chosen participants for up to 12 sessions over 4 months. MAIN OUTCOME MEASURES: Primary outcome was participant health-related quality of life, measured by the Short Form questionnaire-36 items, version 2 (Social Function domain), 6 months after baseline. Secondary outcomes were functional ability, mobility, number of journeys (from monthly travel diaries), satisfaction with outdoor mobility (SWOM), psychological well-being and resource use [health care and Personal Social Services (PSS)] 6 months after baseline. Carer well-being was recorded. All outcome measures were collected by post and repeated 12 months after baseline. Outcomes for the groups were compared using statistical significance testing and adjusted for multiple membership to account for the effect of multiple therapists at different sites. Interviews were analysed using interpretive phenomenology to explore confidence. RESULTS: A median of seven intervention sessions [interquartile range (IQR) 3-7 sessions], median duration of 369 minutes (IQR 170-691.5 minutes) per participant was delivered. There was no significant difference between the groups on health-related quality of life (social function). There were no significant differences between groups in functional ability, psychological well-being or SWOM at 6- or 12-month follow-ups. There was a significant difference observed for travel journeys with the intervention group being 42% more likely to make a journey compared with the control group [rate ratio 1.42, 95% confidence interval (95% CI) 1.14 to 1.67] at 6 months and 76% more likely (rate ratio 1.76, 95% CI 1.36 to 1.95) at 12 months. The number of journeys was affected by the therapist effect. The mean incremental cost (total NHS and PSS cost) of the intervention was £3413.75 (95% CI -£448.43 to £7121.00), with an incremental quality-adjusted life-year gain of -0.027 (95% CI -0.060 to 0.007) according to the European Quality of Life-5 Dimensions and -0.003 (95% CI -0.016 to 0.006) according to the Short Form questionnaire-6 Dimensions. At baseline, 259 out of 281 (92.2%) participants in the control group were dissatisfied with outdoor mobility but at the 6-month assessment this had reduced to 77.7% (181/233), a 15% reduction. The corresponding reduction in the intervention group was slightly greater (21%) than 268 out of 287 (93.4%) participants dissatisfied with outdoor mobility at baseline to 189 out of 261 (72.4%) at 6 months. Participants described losing confidence after stroke as being detrimental to outdoor mobility. Recruitment and retention rates were high. The intervention was deliverable by the NHS but had a neutral effect in all areas apart from potentially increasing the number of journeys. This was dependent on the therapist effect, meaning that some therapists were more successful than others. The control appeared to affect change. CONCLUSIONS: The outdoor mobility intervention provided in this study to these stroke patients was not clinically effective or cost-effective. However, the provision of personalised information and monthly diaries should be considered for all people who wish to get out more. TRIAL REGISTRATION: Current Controlled Trials ISRCTN58683841. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 18, No. 29. See the NIHR Journals Library website for further project information.

Health assessment of gasoline and fuel oxygenate vapors: immunotoxicity evaluation.

Female Sprague Dawley rats were exposed via inhalation to vapor condensates of either gasoline or gasoline combined with various fuel oxygenates to assess potential immunotoxicity of evaporative emissions. Test articles included vapor condensates prepared from "baseline gasoline" (BGVC), or gasoline combined with methyl tertiary butyl ether (G/MTBE), ethyl t-butyl ether (G/ETBE), t-amyl methyl ether (G/TAME), diisopropyl ether (G/DIPE), ethanol (G/EtOH), or t-butyl alcohol (G/TBA). Target concentrations were 0, 2000, 10,000 or 20,000mg/mg(3) administered for 6h/day, 5days/week for 4weeks. The antibody-forming cell (AFC) response to the T-dependent antigen, sheep erythrocyte (sRBC), was used to determine the effects of the gasoline vapor condensates on the humoral components of the immune system. Exposure to BGVC, G/MTBE, G/TAME, and G/TBA did not result in significant changes in the IgM AFC response to sRBC, when evaluated as either specific activity (AFC/10(6) spleen cells) or as total spleen activity (AFC/spleen). Exposure to G/EtOH and G/DIPE resulted in a dose-dependent decrease in the AFC response, reaching the level of statistical significance only at the high 20,000mg/m(3) level. Exposure to G/ETBE resulted in a statistically significant decrease in the AFC response at the middle (10,000mg/m(3)) and high (20,000mg/m(3)) exposure concentrations.

The effect of the electronic transmission of prescriptions on dispensing errors and prescription enhancements made in English community pharmacies: a naturalistic stepped wedge study.

OBJECTIVES: To compare prevalence and types of dispensing errors and pharmacists' labelling enhancements, for prescriptions transmitted electronically versus paper prescriptions. DESIGN: Naturalistic stepped wedge study. SETTING: 15 English community pharmacies. INTERVENTION: Electronic transmission of prescriptions between prescriber and pharmacy. MAIN OUTCOME MEASURES: Prevalence of labelling errors, content errors and labelling enhancements (beneficial additions to the instructions), as identified by researchers visiting each pharmacy. RESULTS: Overall, we identified labelling errors in 5.4% of 16,357 dispensed items, and content errors in 1.4%; enhancements were made for 13.6%. Pharmacists also edited the label for a further 21.9% of electronically transmitted items. Electronically transmitted prescriptions had a higher prevalence of labelling errors (7.4% of 3733 items) than other prescriptions (4.8% of 12,624); OR 1.46 (95% CI 1.21 to 1.76). There was no difference for content errors or enhancements. The increase in labelling errors was mainly accounted for by errors (mainly at one pharmacy) involving omission of the indication, where specified by the prescriber, from the label. A sensitivity analysis in which these cases (n=158) were not considered errors revealed no remaining difference between prescription types. CONCLUSIONS: We identified a higher prevalence of labelling errors for items transmitted electronically, but this was predominantly accounted for by local practice in a single pharmacy, independent of prescription type. Community pharmacists made labelling enhancements to about one in seven dispensed items, whether electronically transmitted or not. Community pharmacists, prescribers, professional bodies and software providers should work together to agree how items should be dispensed and labelled to best reap the benefits of electronically transmitted prescriptions. Community pharmacists need to ensure their computer systems are promptly updated to help reduce errors.

How policy makers can smooth the way for communication-and- resolution programs.

Communication-and-resolution programs (CRPs) in health care organizations seek to identify medical injuries promptly; ensure that they are disclosed to patients compassionately; pursue timely resolution through patient engagement, explanation, and, where appropriate, apology and compensation; and use lessons learned to improve patient safety. CRPs have existed for years, but they are being tested in new settings and primed for broad implementation through grants from the Agency for Healthcare Research and Quality. These projects do not require changing laws. However, grantees' experiences suggest that the path to successful dissemination of CRPs would be smoother if the legal environment supported them. State and federal policy makers should try to allay potential defendants' fears of litigation (for example, by protecting apologies from use in court), facilitate patient participation (for example, by ensuring access to legal representation), and address the reputational and economic concerns of health care providers (for example, by clarifying practices governing National Practitioner Data Bank reporting and payers' financial recourse following medical error).

The prevalence and nature of prescribing and monitoring errors in English general practice: a retrospective case note review.

BACKGROUND: Relatively little is known about prescribing errors in general practice, or the factors associated with error. AIM: To determine the prevalence and nature of prescribing and monitoring errors in general practices in England. DESIGN AND SETTING: Retrospective case-note review of unique medication items prescribed over a 12-month period to a 2% random sample of patients. Fifteen general practices across three primary care trusts in England. METHOD: A total of 6048 unique prescription items prescribed over the previous 12 months for 1777 patients were examined. The data were analysed by mixed effects logistic regression. The main outcome measures were prevalence of prescribing and monitoring errors, and severity of errors, using validated definitions. RESULTS: Prescribing and/or monitoring errors were detected in 4.9% (296/6048) of all prescription items (95% confidence interval [CI] = 4.4% to 5.5%). The vast majority of errors were of mild to moderate severity, with 0.2% (11/6048) of items having a severe error. After adjusting for covariates, patient-related factors associated with an increased risk of prescribing and/or monitoring errors were: age <15 years (odds ratio [OR] = 1.87, 95% CI = 1.19 to 2.94, P = 0.006) or >64 years (OR = 1.68, 95% CI = 1.04 to 2.73, P = 0.035), and higher numbers of unique medication items prescribed (OR = 1.16, 95% CI = 1.12 to 1.19, P<0.001). CONCLUSION: Prescribing and monitoring errors are common in English general practice, although severe errors are unusual. Many factors increase the risk of error. Having identified the most common and important errors, and the factors associated with these, strategies to prevent future errors should be developed, based on the study findings.