Evaluating the use of reactivity levels to inform risk communication and improve service user experience in an HIV self-sampling service.

OBJECTIVES: This service improvement study scoped the value of using quantitative reactivity levels (RL) to introduce a two-tier counselling approach in HIV self-sampling services. The objectives were to (1) use self-reported confirmatory test results to estimate the positive predictive value (PPV) of the first-line assay and (2) to calculate the impact on the PPV and theoretical negative predictive value of a range of proposed RL thresholds, which could be used to differentiate between higher and lower reactive results. METHODS: We studied HIV testing data from a UK-based online sexual health service from 1 December 2018 to 15 July 2020. Routinely collected, anonymised data on RL and self-reported confirmatory testing outcomes were used to calculate PPV at a range of RL thresholds. RESULTS: 116 474 adequate HIV tests were reported during the study period, of which 889 were reactive (0.76%, 95% CI 0.71% to 0.82%). Confirmatory testing outcomes were self-reported by 572 (64.34%) reactive service users, of whom 43 (7.52%) had a new HIV diagnosis, 412 (72.03%) were negative and 117 (20.45%) already had a known HIV diagnosis. PPV was 9.45% at an RL threshold of >1. Quantitative RLs were reported for 30 281 results, of which 200 were reactive. PPV increased to 80% at an RL threshold of >30. No confirmed HIV diagnoses were reported among service users with RL <30. CONCLUSION: RLs could be used to support a more nuanced approach to counselling, potentially reducing anxiety prior to confirmatory testing.

Addressing childhood obesity in low-income, ethnically diverse families: outcomes and peer effects of MEND 7-13 when delivered at scale in US communities.

OBJECTIVES: Implementation of a large-scale, child weight management program in low-income, ethnically diverse communities provided an important opportunity to evaluate its effectiveness under service level conditions (i.e. provision as a primary care child weight management service). METHODS: MEND 7-13 is a community-based, multi-component, childhood obesity intervention designed to improve dietary, physical activity and sedentary behaviors. It comprises twice weekly sessions for 10 consecutive weeks (35 contact hours) and is delivered to groups of children and accompanying parents/caregivers. The evaluation used an uncontrolled, repeated measures design. Overall, 3782 children with overweight or obesity attended 415 MEND 7-13 programs in eight US states, of whom 2482 children (65.6%) had complete data for change in zBMI. The intervention targeted low-income, ethnically diverse families. Changes in anthropometric, cardiovascular fitness and psychological outcomes were evaluated. A longitudinal multivariate imputation model was used to impute missing data. Peer effects analysis was conducted using the instrumental variables approach and group fixed effects. RESULTS: Mean changes in BMI and zBMI at 10 weeks were -0.49 kg/m2 (95% CI: -0.67, -0.31) and -0.06 (95% CI: -0.08, -0.05), respectively. Benefits were observed for cardiovascular fitness and psychological outcomes. Mean peer reduction in zBMI was associated with a reduction in participant zBMI in the instrumental variables model (B = 0.78, P = 0.04, 95% CI: 0.03, 1.53). Mean program attendance and retention were 73.9% and 88.5%, respectively. CONCLUSION: Implementing MEND 7-13 under service level conditions was associated with short-term improvements in anthropometric, fitness and psychological indices in a large sample of low-income, ethnically diverse children with overweight and obesity. A peer effect was quantified showing that benefits for an individual child were enhanced, if peers in the same group also performed well. To our knowledge, this is the first US study to evaluate outcomes of an up-scaled community-based, child weight management program and to show positive peer effects associated with participation in the intervention.

What works in practice: user and provider perspectives on the acceptability, affordability, implementation, and impact of a family-based intervention for child overweight and obesity delivered at scale.

BACKGROUND: As part of a study considering the impact of a child weight management programme when rolled out at scale following an RCT, this qualitative study focused on acceptability and implementation for providers and for families taking part. METHODS: Participants were selected on the basis of a maximum variation sample providing a range of experiences and social contexts. Qualitative interviews were conducted with 29 professionals who commissioned or delivered the programme, and 64 individuals from 23 families in 3 English regions. Topic guides were used as a tool rather than a rule, enabling participants to construct a narrative about their experiences. Transcripts were analysed using framework analysis. RESULTS: Practical problems such as transport, work schedules and competing demands on family time were common barriers to participation. Delivery partners often put considerable efforts into recruiting, retaining and motivating families, which increased uptake but also increased cost. Parents and providers valued skilled delivery staff. Some providers made adaptations to meet local social and cultural needs. Both providers and parents expressed concerns about long term outcomes, and how this was compromised by an obesogenic environment. Concerns about funding together with barriers to uptake and engagement could translate into barriers to commissioning. Where these barriers were not experienced, commissioners were enthusiastic about continuing the programme. CONCLUSIONS: Most families felt that they had gained something from the programme, but few felt that it had 'worked' for them. The demands on families including time and emotional work were experienced as difficult. For commissioners, an RCT with positive results was an important driver, but family barriers, alongside concerns about recruitment and retention, a desire for local adaptability with qualified motivated staff, and funding changes discouraged some from planning to use the intervention in future.

Swab pooling enables rapid expansion of high-throughput capacity for SARS-CoV-2 community testing.

BACKGROUND: The challenges of rapid upscaling of testing capacity were a major lesson from the COVID-19 pandemic response. The need for process adjustments in high-throughput testing laboratories made sample pooling a challenging option to implement. OBJECTIVE: This study aimed to evaluate whether pooling samples at source (swab pooling) was as effective as qRT-PCR testing of individuals in identifying cases of SARS-CoV-2 in real-world community testing conditions using the same high-throughput pipeline. METHODS: Two cohorts of 10 (Pool10: 1,030 participants and 103 pools) and 6 (Pool6: 1,284 participants and 214 pools) samples per pool were tested for concordance, sensitivity, specificity, and Ct value differences with individual testing as reference. RESULTS: Swab pooling allowed unmodified application of an existing high-throughput SARS-Cov-2 testing pipeline with only marginal loss of accuracy. For Pool10, concordance was 98.1% (95% Confidence interval: 93.3-99.8%), sensitivity was 95.7% (85.5-99.5%), and specificity was 100.0% (93.6-100.0%). For Pool6, concordance was 97.2% (94.0-99.0%), sensitivity was 97.5% (93.7-99.3%), and specificity was 96.4% (87.7-99.6%). Differences of outcomes measure between pool size were not significant. Most positive individual samples, which were not detected in pools, had very low viral concentration. If only individual samples with a viral concentration > 400 copies/ml (i.e. Ct value < 30) were considered positive, the overall sensitivity of pooling increased to 99.5%. CONCLUSION: The study demonstrated high sensitivity and specificity by swab pooling and the immediate capability of high-throughput laboratories to implement this method making it an option in planning of rapid upscaling of laboratory capacity for future pandemics.

Associations between pre-pregnancy psychosocial risk factors and infant outcomes: a population-based cohort study in England.

BACKGROUND: Existing studies evaluating the association between maternal risk factors and specific infant outcomes such as birthweight, injury admissions, and mortality have mostly focused on single risk factors. We aimed to identify routinely recorded psychosocial characteristics of pregnant women most at risk of adverse infant outcomes to inform targeting of early intervention. METHODS: We created a cohort using administrative hospital data (Hospital Episode Statistics) for all births to mothers aged 15-44 years in England, UK, who gave birth on or after April 1, 2010, and who were discharged before or on March 31, 2015. We used generalised linear models to evaluate associations between psychosocial risk factors recorded in hospital records in the 2 years before the 20th week of pregnancy (ie, teenage motherhood, deprivation, pre-pregnancy hospital admissions for mental health or behavioural conditions, and pre-pregnancy hospital admissions for adversity, including drug or alcohol abuse, violence, and self-harm) and infant outcomes (ie, birthweight, unplanned admission for injury, or death from any cause, within 12 months from postnatal discharge). FINDINGS: Of 2 520 501 births initially assessed, 2 137 103 were eligible and were included in the birth outcome analysis. Among the eligible births, 93 279 (4·4%) were births to teenage mothers (age <20 years), 168 186 (7·9%) were births to previous teenage mothers, 51 312 (2·4%) were births to mothers who had a history of hospital admissions for mental health or behavioural conditions, 58 107 (2·7%) were births to mothers who had a history of hospital admissions for adversity, and 580 631 (27·2%) were births to mothers living in areas of high deprivation. 1 377 706 (64·5%) of births were to mothers with none of the above risk factors. Infants born to mothers with any of these risk factors had poorer outcomes than those born to mothers without these risk factors. Those born to mothers with a history of mental health or behavioural conditions were 124 g lighter (95% CI 114-134 g) than those born to mothers without these conditions. For teenage mothers compared with older mothers, 3·6% (95% CI 3·3-3·9%) more infants had an unplanned admission for injury, and there were 10·2 (95% CI 7·5-12·9) more deaths per 10 000 infants. INTERPRETATION: Health-care services should respond proactively to pre-pregnancy psychosocial risk factors. Our study demonstrates a need for effective interventions before, during, and after pregnancy to reduce the downstream burden on health services and prevent long-term adverse effects for children. FUNDING: Wellcome Trust.

Early Outcomes From the English National Health Service Diabetes Prevention Programme.

OBJECTIVE: To assess weight and HbA1c changes in the Healthier You: National Health Service Diabetes Prevention Programme (NHS DPP), the largest DPP globally to achieve universal population coverage. RESEARCH DESIGN AND METHODS: A service evaluation assessed intervention effectiveness for adults with nondiabetic hyperglycemia (HbA1c 42-47 mmol/mol [6.0-6.4%] or fasting plasma glucose 5.5-6.9 mmol/L) between program launch in June 2016 and December 2018, using prospectively collected, national service-level data in England. RESULTS: By December 2018, 324,699 people had been referred, 152,294 had attended the initial assessment, and 96,442 had attended at least 1 of 13 group-based intervention sessions. Allowing sufficient time to elapse, 53% attended an initial assessment, 36% attended at least one group-based session, and 19% completed the intervention (attended >60% of sessions). Of the 32,665 who attended at least one intervention session and had sufficient time to finish, 17,252 (53%) completed: intention-to-treat analyses demonstrated a mean weight loss of 2.3 kg (95% CI 2.2, 2.3) and an HbA1c reduction of 1.26 mmol/mol (1.20, 1.31) (0.12% [0.11, 0.12]); completer analysis demonstrated a mean weight loss of 3.3 kg (3.2, 3.4) and an HbA1c reduction of 2.04 mmol/mol (1.96, 2.12) (0.19% [0.18, 0.19]). Younger age, female sex, Asian and black ethnicity, lower socioeconomic status, and normal baseline BMI were associated with less weight loss. Older age, female sex, black ethnicity, lower socioeconomic status, and baseline overweight and obesity were associated with a smaller HbA1c reduction. CONCLUSIONS: Reductions in weight and HbA1c compare favorably with those reported in recent meta-analyses of pragmatic studies and suggest likely future reductions in participant type 2 diabetes incidence.