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Percutaneous tibial nerve stimulation (PTNS) is a new ambulatory therapy for faecal incontinence. Data from case series suggest it has beneficial outcomes in 50–80% patients; however its effectiveness against sham electrical stimulation has not been investigated. We therefore aimed to assess the short-term efficacy of PTNS against sham electrical stimulation in adults with faecal incontinence. We did a double-blind, multicentre, pragmatic, parallel-group, randomised controlled trial (CONtrol of Faecal Incontinence using Distal NeuromodulaTion [CONFIDeNT]) in 17 specialist hospital units in the UK that had the skills to manage patients with faecal incontinence. Eligible participants aged 18 years or older with substantial faecal incontinence for whom conservative treatments (such as dietary changes and pelvic floor exercises) had not worked, were randomly assigned (1:1) to receive either PTNS (via the Urgent PC neuromodulation system) or sham stimulation (via a transcutaneous electrical nerve stimulation machine to the lateral forefoot) once per week for 12 weeks. Randomisation was done with permuted block sizes of two, four, and six, and was stratified by sex and then by centre for women. Patients and outcome assessors were both masked to treatment allocation for the 14-week duration of the trial (but investigators giving the treatment were not masked). The primary outcome was a clinical response to treatment, which we defined as a 50% or greater reduction in episodes of faecal incontinence per week. We assessed this outcome after 12 treatment sessions, using data from patients' bowel diaries. Analysis was by intention to treat, and missing data were multiply imputed. This trial is registered with the ISRCTN registry, number 88559475, and is closed to new participants. Between Jan 23, 2012, and Oct 31, 2013, we randomly assigned 227 eligible patients (of 373 screened) to receive either PTNS (n=115) or sham stimulation (n=112). 12 patients withdrew from the trial: seven from the PTNS group and five from the sham group (mainly because they could not commit to receiving treatment every week). Two patients (one in each group) withdrew because of an adverse event that was unrelated to treatment (exacerbation of fibromyalgia and rectal bleeding). 39 (38%) of 103 patients with full data from bowel diaries in the PTNS group had a 50% or greater reduction in the number of episodes of faecal incontinence per week compared with 32 (31%) of 102 patients in the sham group (adjusted odds ratio 1·28, 95% CI 0·72–2·28; p=0·396). No serious adverse events related to treatment were reported in the trial. Seven mild, related adverse events were reported in each treatment group, mainly pain at the needle site (four in PTNS, three in sham). PTNS given for 12 weeks did not confer significant clinical benefit over sham electrical stimulation in the treatment of adults with faecal incontinence. Further studies are warranted to determine its efficacy in the long term, and in patient subgroups (ie, those with urgency). National Institute for Health Research.

Background Most studies on integration of neglected tropical disease programmes have focused on mass drug administration or environmental measures rather than Disease Management, Disability and Inclusion (DMDI). The study reported here explored integration of a DMDI care package across three disabling, stigmatising neglected tropical diseases (podoconiosis, lymphatic filariasis and leprosy), across physical and mental health, and into the state health system. Methods We conducted this pre-post study, the third phase of an implementation research project, in two predominantly rural districts in north-west Ethiopia in 2021. We assessed physical and mental health outcomes on 192 affected persons and 817 community members at baseline and 6 months after initiation of the integrated care package, implemented by nurses and health officers. Key outcomes measured were disability (using WHODAS-2.0), depression (Patient Health Questionnaire-9), discrimination (Discrimination and Stigma Scale), internalised stigma (Internalized Stigma Related to Lymphoedema), quality of life (Dermatology Life Quality Index) and social support (Oslo-3 Social Support Scale). Mixed effects linear regression models were used to estimate change in outcomes between baseline and 6 months after initiation of the care package. We also evaluated implementation feasibility and conducted cost-effectiveness analysis. Results Among 221 patients, improvements were observed in foot (− 2.3 cm; 95% CI: − 2.2, − 1.8) and leg circumference (− 1.8 cm; − 2.0, − 1.7) and acute attacks (6.2; 0.0, 6.6); these were statistically significant at the 5% level. Reductions were seen in disability scores (− 6.5; − 7.6, − 5.5), depression (− 5.3; − 6.6, − 4.6), discrimination (− 3.3; − 4.2, − 2.3), internalised stigma (− 3.7; − 4.6, − 2.8), quality of life (− 4.0; − 4.8, − 3.2), and alcohol use (− 1.6; − 2.4, − 0.8). No notable changes were found in the presence of wounds or moss, or perceived social support. Across 817 community members, there was strong evidence that knowledge improved, and stigmatising attitudes and social distance reduced. The intervention was cost-effective in reducing depression and disability and improving health-related quality of life and feasible to implement. Conclusion The integrated intervention is feasible and cost-effective even in remote areas and appears ideal for scale-up to other endemic regions in Ethiopia and other countries.

Depression is common and is associated with poor outcomes among elderly care-home residents. Exercise is a promising low-risk intervention for depression in this population. We tested the hypothesis that a moderate intensity exercise programme would reduce the burden of depressive symptoms in residents of care homes. We did a cluster-randomised controlled trial in care homes in two regions in England; northeast London, and Coventry and Warwickshire. Residents aged 65 years or older were eligible for inclusion. A statistician independent of the study randomised each home (1 to 1·5 ratio, stratified by location, minimised by type of home provider [local authority, voluntary, private and care home, private and nursing home] and size of home [<32 or ≥32 residents]) into intervention and control groups. The intervention package included depression awareness training for care-home staff, 45 min physiotherapist-led group exercise sessions for residents (delivered twice weekly), and a whole home component designed to encourage more physical activity in daily life. The control consisted of only the depression awareness training. Researchers collecting follow-up data from individual participants and the participants themselves were inevitably aware of home randomisation because of the physiotherapists' activities within the home. A researcher masked to study allocation coded NHS routine data. The primary outcome was number of depressive symptoms on the geriatric depression scale-15 (GDS-15). Follow-up was for 12 months. This trial is registered with ISRCTN Register, number ISRCTN43769277. Care homes were randomised between Dec 15, 2008, and April 9, 2010. At randomisation, 891 individuals in 78 care homes (35 intervention, 43 control) had provided baseline data. We delivered 3191 group exercise sessions attended on average by five study participants and five non-study residents. Of residents with a GDS-15 score, 374 of 765 (49%) were depressed at baseline; 484 of 765 (63%) provided 12 month follow-up scores. Overall the GDS-15 score was 0·13 (95% CI −0·33 to 0·60) points higher (worse) at 12 months for the intervention group compared with the control group. Among residents depressed at baseline, GDS-15 score was 0·22 (95% CI −0·52 to 0·95) points higher at 6 months in the intervention group than in the control group. In an end of study cross-sectional analysis, including 132 additional residents joining after randomisation, the odds of being depressed were 0·76 (95% CI 0·53 to 1·09) for the intervention group compared with the control group. This moderately intense exercise programme did not reduce depressive symptoms in residents of care homes. In this frail population, alternative strategies to manage psychological symptoms are required. National Institute for Health Research Health Technology Assessment.

The adverse effects of traffic-related air pollution on children's respiratory health have been widely reported, but few studies have evaluated the impact of traffic-control policies designed to reduce urban air pollution. We assessed associations between traffic-related air pollutants and respiratory/allergic symptoms amongst 8-9 year-old schoolchildren living within the London Low Emission Zone (LEZ). Information on respiratory/allergic symptoms was obtained using a parent-completed questionnaire and linked to modelled annual air pollutant concentrations based on the residential address of each child, using a multivariable mixed effects logistic regression analysis. Exposure to traffic-related air pollutants was associated with current rhinitis: NOx (OR 1.01, 95% CI 1.00-1.02), NO2 (1.03, 1.00-1.06), PM10 (1.16, 1.04-1.28) and PM2.5 (1.38, 1.08-1.78), all per μg/m3 of pollutant, but not with other respiratory/allergic symptoms. The LEZ did not reduce ambient air pollution levels, or affect the prevalence of respiratory/allergic symptoms over the period studied. These data confirm the previous association between traffic-related air pollutant exposures and symptoms of current rhinitis. Importantly, the London LEZ has not significantly improved air quality within the city, or the respiratory health of the resident population in its first three years of operation. This highlights the need for more robust measures to reduce traffic emissions.

ObjectiveA comprehensive understanding of the factors contributing to perinatal blood pressure is vital to ensure optimal postnatal hemodynamic support. The objective of this study was to review existing literature on maternal and perinatal factors influencing blood pressure in neonates up to 3 months corrected age.MethodsA systematic search of published literature in OVID Medline, OVID Embase and the COCHRANE library identified publications relating to maternal factors affecting blood pressure of neonates up to corrected age of 3 months. Summary data were extracted and compared (PROSPERO CRD42018092886).ResultsOf the 3683 non-duplicate publications identified, 44 were eligible for inclusion in this review. Topics elicited were sociodemographic factors, maternal health status, medications, smoking during pregnancy, and cord management at birth. Limited data were available for each factor. Results regarding the impact of these factors on neonatal blood pressure were inconsistent across studies.ConclusionsThere is insufficient evidence to draw definitive conclusions regarding the impact of various maternal and perinatal factors on neonatal blood pressure. Future investigations of neonatal cardiovascular therapies should account for these factors in their study design. Similarly, studies on maternal diseases and perinatal interventions should include neonatal blood pressure as part of their primary or secondary analyses.

IntroductionNeglected tropical diseases (NTDs) causing lower limb lymphoedema such as podoconiosis, lymphatic filariasis (LF) and leprosy are common in Ethiopia. Routine health services for morbidity management and disability prevention (MMDP) of lymphoedema caused by these conditions are still lacking, even though it imposes a huge burden on affected individuals and their communities in terms of physical and mental health, and psychosocial and economic outcomes. This calls for an integrated, holistic approach to MMDP across these three diseases.Methods and analysisThe ‘Excellence in Disability Prevention Integrated across NTDs’ (EnDPoINT) implementation research study aims to assess the integration and scale-up of a holistic package of care—including physical health, mental health and psychosocial care—into routine health services for people with lymphoedema caused by podoconiosis, LF and leprosy in selected districts in Awi zone in the North–West of Ethiopia. The study is being carried out over three phases using a wide range of mixed methodologies. Phase 1 involves the development of a comprehensive holistic care package and strategies for its integration into the routine health services across the three diseases, and to examine the factors that influence integration and the roles of key health system actors. Phase 2 involves a pilot study conducted in one subdistrict in Awi zone, to establish the care package’s adoption, feasibility, acceptability, fidelity, potential effectiveness, its readiness for scale-up, costs of the interventions and the suitability of the training and training materials. Phase 3 involves scale-up of the care package in three whole districts, as well as its evaluation in regard to coverage, implementation, clinical (physical health, mental health and psychosocial) and economic outcomes.Ethics and disseminationEthics approval for the study has been obtained in the UK and Ethiopia. The results will be disseminated through publications in scientific journals, conference presentations, policy briefs and workshops.

ObjectiveHousehold damp exposure is an important public health issue. We aimed to assess the impact of the location of household damp on respiratory outcomes during early life.MethodsHousehold damp exposure was ascertained in children recruited to the GO-CHILD multicentre birth cohort study. The frequency of respiratory symptoms, infections, healthcare utilisation and medication prescription for wheezing were collected by postal questionnaires at 12 and 24 months. Log binomial and ordered logistic regression models were fitted to the data.ResultsFollow-up was obtained in 1344 children between August 2010 and January 2016. Visible damp was present in a quarter of households (25.3%) with 1 in 12 children’s bedrooms affected (8.3%). Damp in the bathroom, kitchen or living room was not associated with any respiratory or infection-related outcomes. Damp in the child’s bedroom was associated with an increased risk of dry cough (8.7% vs 5.7%) (adjusted relative risk 1.56, 95% CI 1.07 to 2.27; p=0.021) and odds of primary care attendance for cough and wheeze (7.6% vs 4.4%) (adjusted OR 1.37, 95% CI 1.07 to 1.76; p=0.009). There were also increased risk of inhaled corticosteroid (13.3% vs 5.9%) (adjusted RR 2.22, 95% CI 1.04 to 4.74; p=0.038) and reliever inhaler (8.3% vs 5.8%) (adjusted RR 2.01, 95% CI 1.21 to 2.79; p=0.018) prescription.ConclusionDamp in the child’s bedroom was associated with increased respiratory morbidity. In children presenting with recurrent respiratory symptoms, clinicians should enquire about both the existence and location of damp, the presence of which can help prioritise those families requiring urgent household damp assessment and remediation works.

ObjectivesTime series studies have shown adverse effects of outdoor air pollution on mortality and hospital admissions in patients with chronic obstructive pulmonary disease (COPD) but panel studies have been inconsistent. This study investigates short-term effects of outdoor nitrogen dioxide, ozone, sulfur dioxide, particulate matter (PM10) and black smoke on exacerbations, respiratory symptoms and lung function in 94 patients with COPD in east London.MethodsPatients were recruited from an outpatient clinic and were asked to complete daily diary cards (median follow-up 518 days) recording exacerbations, symptoms and lung function, and the amount of time spent outdoors. Outdoor air pollution exposure (lag 1 day) was obtained from local background monitoring stations.ResultsSymptoms but not lung function showed associations with raised pollution levels. Dyspnoea was significantly associated with PM10 (increase in odds for an IQR change in pollutant: 13% (95% CI 4% to 23%)) and this association remained after adjustment for other the pollutants measured. An IQR increase in nitrogen dioxide was associated with a 6% (0–13%) increase in the odds of a symptomatic fall in peak flow rate. The corresponding effect sizes for PM10 and black smoke were 12% (2–25%) and 7% (1–13%), respectively.ConclusionIt is concluded that outdoor air pollution is associated with important adverse effects on symptoms in patients with COPD living in London.

Background Older adult carers of people who experience psychosis are at increased risk of developing physical and mental health problems due to the compounding factors of supporting their care-recipient and the health changes associated with ageing. Effective interventions exist but can be difficult to access and maintain prolonged engagement. Self-directed writing therapies, frequently referred to as Written Emotional Disclosure (WED), might be a suitable alternative intervention to improve the wellbeing of carers. Methods This study aimed to determine the feasibility (recruitment, retention and primary outcome completion) and acceptability of a specific WED intervention known as Positive Written Disclosure (PWD). Informal carers of people with psychosis were randomised to PWD, neutral writing or no writing. Quantitative outcomes including positive and negative affect, carer wellbeing, quality of life, depression, anxiety, stress, self-efficacy, leisure time satisfaction as well as health care utilisation were collected at baseline, 1-, 3-, and 6-month assessments. Qualitative feedback was also collected via questionnaire and semi-structured interviews from those randomised to either writing group. Results We successfully met our progression criteria, recruiting to target and within timeframes whilst attaining 97% retention and 84% primary outcome data completed at 6 months. Carers randomised to the positive writing group described the intervention as enabling them to have a more positive attitude and focus on activities for themselves. Both writing groups described their tasks as providing distraction from caring responsibilities. However, some carers found the narrow positive emotion focus challenging. Conclusions PWD is a feasible and acceptable intervention for older adult carers of people with psychosis within a community setting. Further refinement of the writing protocol to include choice in type of emotion disclosed in addition to screening for some level of need may be required in future trials to reduce floor/ceiling effects of outcomes which may explain the lack of change observed.

Older adult carers of people who experience psychosis are at increased risk of developing physical and mental health problems due to the compounding factors of supporting their care-recipient and the health changes associated with ageing. Effective interventions exist but can be difficult to access and maintain prolonged engagement. Self-directed writing therapies, frequently referred to as Written Emotional Disclosure (WED), might be a suitable alternative intervention to improve the wellbeing of carers. This study aimed to determine the feasibility (recruitment, retention and primary outcome completion) and acceptability of a specific WED intervention known as Positive Written Disclosure (PWD). Informal carers of people with psychosis were randomised to PWD, neutral writing or no writing. Quantitative outcomes including positive and negative affect, carer wellbeing, quality of life, depression, anxiety, stress, self-efficacy, leisure time satisfaction as well as health care utilisation were collected at baseline, 1-, 3-, and 6-month assessments. Qualitative feedback was also collected via questionnaire and semi-structured interviews from those randomised to either writing group. We successfully met our progression criteria, recruiting to target and within timeframes whilst attaining 97% retention and 84% primary outcome data completed at 6 months. Carers randomised to the positive writing group described the intervention as enabling them to have a more positive attitude and focus on activities for themselves. Both writing groups described their tasks as providing distraction from caring responsibilities. However, some carers found the narrow positive emotion focus challenging. PWD is a feasible and acceptable intervention for older adult carers of people with psychosis within a community setting. Further refinement of the writing protocol to include choice in type of emotion disclosed in addition to screening for some level of need may be required in future trials to reduce floor/ceiling effects of outcomes which may explain the lack of change observed.