Minimizing sample bias due to stigmatized behaviours: the representativeness of participants in a cohort study of alcohol in pregnancy.

BACKGROUND: Stigmatized behaviours are often underreported, especially in pregnancy, making them challenging to address. The Alcohol and Child Development Study (ACDS) seeks to inform prevention of foetal alcohol harm, linking self-report as well as a maternal blood alcohol biomarker with child developmental outcomes. Samples were requested using passive, generic consent. The success of this approach at minimizing bias is presented comparing characteristics of women who provided samples to those who did not. METHODS: All pregnant women in the study city were sent a Patient Information Sheet (PIS) with their first NHS obstetric appointment letter. The PIS informed them that the NHS would like to take an extra blood sample for research purposes, unless they opted out. Neither the women nor the midwives were informed that the samples might be tested for an alcohol biomarker. This paper examines the extent to which women who provided the extra sample were representative of women where no sample was provided, in terms of routinely collected information: age; body mass index; area-based deprivation; previous pregnancies, abortions and caesarians; smoking status and carbon monoxide level; self-reported alcohol use, gestation and birth weight of their baby. Chi-square and Mann-Whitney U tests were used to compare groups. RESULTS: 3436 (85%) of the 4049 pregnant women who attended their appointment provided the extra sample. Women who did not were significantly younger (p < 0.001), more materially deprived (p < 0.001), and less likely to be considered for intervention based on self-reported alcohol use (p < 0.001). There were no significant differences between the two groups on other routine data. CONCLUSIONS: The use of passive consent without disclosure of the specific research focus resulted in a high level of sample provision. There was no evidence that study blinding was breached, and women who provided a sample were more likely to report alcohol consumption. Passive consent to draw additional blood for research purposes at routine antenatal venipuncture reduced sampling bias compared to asking women to give blood for an alcohol study. This methodology may be useful for other stigmatised behaviours.

State of science: the future of work - ergonomics and human factors contributions to the field.

This article is concerned with scholarly ergonomics and human factors (E/HF) contributions to date to the field of research inquiry known as the 'future of work'. The review considers E/HF perspectives on how the nature of work is changing and what this means for the practice of E/HF and for human performance and wellbeing at work. This field of research has attracted much attention from scholars from various disciplines as flexible working arrangements and casualised employment, in particular, have come under the microscope during the COVID-19 pandemic. The article begins by setting out the future of work field, focussing on the mega trends and future of work forces that are most relevant to the discipline. Next, E/HF contributions to this field are identified and discussed. Surprisingly, given the E/HF tradition as a system discipline fundamentally concerned with the study of human work, and as a contributor to transdisciplinary research related to the design of work systems, a search of the scholarly literature found few contributions outside of the automation systems field that addressed the future of work and E/HF directly. A research agenda is presented to address gaps in current knowledge in a number of key future of work domains. Practitioner's Summary: We reflect on E/HF contributions to the 'future of work' field and how the practice of E/HF needs to consider the changing nature of work. We outline future of work concerns and suggest research areas for further E/HF attention towards the design of decent and sustainable work for all. Abbreviations: E/HF: ergonomics and human factors; ILO: International Labour Organisation; COVID-19.

Development of a biochemical marker to detect current breast milk intake.

The WHO recommends exclusive breastfeeding for 6 months, but despite interventions, breastfeeding rates remain stubbornly low. Financial voucher incentives have shown promise but require a biomarker for validation of intake. This study aimed to develop a simple biochemical assay of infant urine that would tell if an infant was receiving any breast milk to validate maternal report. Urine samples were collected and snap frozen from 34 infants attending with minor illness or feeding problems, of whom 12 infants were exclusively breastfed, nine exclusively formula fed, and 11 mixed breast/formula fed. High-performance anion exchange chromatography was used to identify discriminating patterns of monosaccharide composition of unconjugated glycans in a sequence of three experiments. The absolute concentration of all human milk oligosaccharides measured blind could detect "any breastfeeding" only with a sensitivity of 48% and specificity of 78%. Unblinded examination of N-acetylglucosamine (GlcNAc) measured as GlcNH2 after hydrolysis of GlcNAc improved sensitivity to 75% at the expense of a specificity of 28%. Estimation of the relative abundance of GlcNH2 (GlcNH2[%]) or the ratio of GlcNH2 to endogenous mannose (Man) improved accuracy. In a further blind experiment, the GlcNH2/Man ratio with a cut-off of 1.5 correctly identified all those receiving "any breast milk," while excluding exclusively formula fed infants. The GlcNH2/Man ratio in infant urine is a promising test to provide biochemical confirmation of any breastfeeding for trials of breastfeeding promotion.

Conceptualizing workplace cyberbullying: Toward a definition for research and practice in nursing.

AIMS: To explore nurses' understandings and perceptions of workplace cyberbullying, in order to develop a relevant and meaningful definition of the phenomenon for future research and practice. BACKGROUND: Although previous research places nurses at an elevated risk of exposure to traditional workplace bullying, there is a notable absence of research investigating workplace cyberbullying within this profession. Considering the detrimental outcomes experienced by the targets of workplace cyberbullying, this is an issue that warrants focus. METHODS: Utilizing relevant scenarios as prompts, semi-structured interviews were conducted with 16 nurses (practising and in training) to explore their understanding of the concept and dynamics of workplace cyberbullying. RESULTS: Three high-level themes were identified and discussed: (1) cyber-specific features that make cyberbullying more damaging than traditional bullying; (2) the importance of context; and (3) the work environment factors that facilitate the occurrence of workplace cyberbullying. CONCLUSIONS: Our refined definition facilitates the investigation of a broader and more inclusive range of behaviours that targets may experience as workplace cyberbullying, and our findings in general highlight potential antecedents in common with traditional workplace bullying. IMPLICATIONS FOR NURSING MANAGEMENT: Given the work environment and the challenges faced by the nursing profession, a system-wide approach to intervention and management is recommended, along with utilizing a nursing-specific definition.

Breastfeeding is associated with reduced childhood hospitalization: evidence from a Scottish Birth Cohort (1997-2009).

OBJECTIVE: To evaluate the risk of childhood hospitalization associated with infant feeding patterns at 6-8 weeks of age in Scotland. STUDY DESIGN: A retrospective population level study based on the linkage of birth, death, maternity, infant health, child health surveillance, and admission records for children born as single births in Scotland between 1997 and 2009 (n = 502 948) followed up to March 2012. Descriptive analyses, Kaplan Meier tests, and Cox regression were used to quantify the association between the mode of infant feeding and risk of childhood hospitalization for respiratory, gastrointestinal, and urinary tract infections, and other common childhood ailments during the study period. RESULTS: Within the first 6 months of life, there was a greater hazard ratio (HR) of hospitalization for common childhood illnesses among formula-fed infants (HR 1.40; 95% CI 1.35-1.45) and mixed-fed infants (HR 1.18; 95% CI 1.11-1.25) compared with infants exclusively breastfed after adjustment for parental, maternal, and infant health characteristics. Within the first year of life and beyond, a greater relative risk of hospitalization was observed among formula-fed infants for a range of individual illnesses reported in childhood including gastrointestinal, respiratory, and urinary tract infections, otitis media, fever, asthma, diabetes, and dental caries. CONCLUSIONS: Using linked administrative data, we found greater risks of hospitalization in early childhood for a range of common childhood illnesses among Scottish infants who were not exclusively breastfed at 6-8 weeks of age.

Levelling up health in the early years: A cost-analysis of infant feeding and healthcare.

BACKGROUND: Although breastfeeding is recommended as the optimal form of nutrition in the first six months, it is not sustained as the predominant mode of feeding infants in Scotland. This study estimated the impact of infant feeding choices on primary and secondary healthcare service costs in a 13-year birth cohort. METHOD: Using linked administrative datasets, in a retrospective cohort design of 502,948 singletons born in Scotland between 1997 and 2009, we estimated the cost of GP consultations and hospital admissions by area deprivation and mode of infant feeding up to 6-8 weeks for ten common childhood conditions from birth to 27 months. Additionally, we calculated the potential healthcare savings if all infants in the cohort had been exclusively breastfed at 6-8 weeks. Discounting of 1.5% was applied following current health economic conventions and 2009/10 used as the base year. RESULTS: Over the study period, the estimated cost of hospital admissions in the cohort was £111 million and £2 million for the 2% subset of the cohort with primary care records. Within each quintile of deprivation, exclusively breastfed infants used fewer healthcare services and incurred lower costs compared to infants fed (any) formula milk. At least £10 million of healthcare costs may have been avoided if formula-fed infants had been exclusively breastfed within the first 6-8 weeks of birth. CONCLUSIONS: This study using a representative birth cohort demonstrates how breastmilk can promote equitable child health by reducing childhood illness and healthcare utilisation in the early years.

Systematic review of randomised controlled clinical trials examining effectiveness of contingent financial rewards for smoking cessation during pregnancy: intention-to-treat and causal effects on birthweight.

BACKGROUND: Objective: To examine birth weight change caused by adding financial rewards for smoking cessation compared to no rewards for pregnant women. To estimate the average expected birth weight change for those who quit because of rewards. METHODS: This study updates a previous systematic review and refocuses the outcome from smoking cessation to birth weight.Eligibility Criteria: Trials with an experimental design allowing treatment effects to be attributed to rewards were included. Trials involving non-pregnant participants, or with no report of magnitude, treatment duration, timing or where most rewards were contingent on another behaviour (e.g., treatment attendance) were excluded.Information sources: Medline, PsycInfo, Embase, Cochrane (Central Register of Controlled Trials, Tobacco Addiction Group Specialised Register and Database of Systematic Reviews), and PubMed searched to 5th December 2023.Risk of bias: Risk of bias and certainty of evidence used Cochrane 'Risk of bias 2' and GRADE assessments.Synthesis of results: Primary analysis estimated Intention-To-Treat (ITT) mean birthweight difference when randomised to offer of rewards versus control. Within-trial estimates and standard errors were derived from mean, standard deviation, and sample size data provided, or from publications. Pooled ITT estimates used common (fixed) and random effects models. Secondary analyses used trial team supplied data to derive Complier Average Causal Effect (CACE) estimate of smoking cessation on birth weight, and a standard error. Estimates were pooled using common and random effects models. Similar analyses were applied to low birth weight (<2500g), birth weight for gestational age z-scores, and small for gestational age (<10 th percentile). RESULTS: Included studies: Primary analysis included 8 trials (2351 participants) from the UK (2 trials, 1475 participants); France (1 trial, 407 participants), and the US (6 trials, 469 participants). Secondary analysis included 7 trials as data retrieval from one US trial (51 participants) was not possible.Synthesis of results: Primary ITT analysis (2351 participants) estimated a mean 46.3g (95% CI: 0.0 to 92.6) birth weight increase when offered financial rewards for smoking cessation. Secondary CACE analysis (2239 participants) estimated a mean 206.0g (95% CI: -69.1 to 481.1) increase for smokers who quit because of rewards. There was no effect on low birth weight (<2500g), or birth weight adjusted for gestational age, though less babies were born small for gestational age, particularly if cessation was because of rewards (CACE risk difference -17.7%; 95% CI: -34.9% to -0.4%). DISCUSSION: Limitation of evidence: Sample size led to imprecision - maximum 2351 participants. A single trial of 3712 participants would give 80% power at 5% significance to show a 46g increase from 3.1kg to 3.146kg with 0.5kg standard deviation in both groups. Consistency - trials where smoking cessation increased (7 of 8) all showed a mean birth weight increase. In one trial smoking cessation fell as did birth weight. Bias is unlikely as 3 of 4 trials with no birth weight data showed increased cessation consistent with higher mean birth weight. Interpretation: Trials of contingent financial rewards for smoking cessation have previously been shown to more than double pregnancy quit rates. We have uncovered a significant (46g) population level increase in mean birth weight, driven by a clinically important mean increase (206g) for those who quit because of financial rewards associated with a reduction in Small for Gestational Age births. OTHER: Funding: Review update - The U.S. National Institute of Health, National Institute of General Medical Sciences Center of Biomedical Research Excellence Award P30GM149331. Data retrieval, synthesis and analysis - Scottish Cot Death Trust.Registration: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42024494262.

Give It Up For Baby: outcomes and factors influencing uptake of a pilot smoking cessation incentive scheme for pregnant women.

BACKGROUND: The use of incentives to promote smoking cessation is a promising technique for increasing the effectiveness of interventions. This study evaluated the smoking cessation outcomes and factors associated with success for pregnant smokers who registered with a pilot incentivised smoking cessation scheme in a Scottish health board area (NHS Tayside). METHODS: All pregnant smokers who engaged with the scheme between March 2007 and December 2009 were included in the outcome evaluation which used routinely collected data. Data utilised included: the Scottish National Smoking Cessation Dataset; weekly and periodic carbon monoxide (CO) breath tests; status of smoking cessation quit attempts; and amount of incentive paid. Process evaluation incorporated in-depth interviews with a cross-sectional sample of service users, stratified according to level of engagement. RESULTS: Quit rates for those registering with Give It Up For Baby were 54% at 4 weeks, 32% at 12 weeks and 17% at 3 months post partum (all data validated by CO breath test). Among the population of women identified as smoking at first booking over a one year period, 20.1% engaged with Give It Up For Baby, with 7.8% of pregnant smokers quit at 4 weeks. Pregnant smokers from more affluent areas were more successful with their quit attempt. The process evaluation indicates financial incentives can encourage attendance at routine advisory sessions where they are seen to form part of a wider reward structure, but work less well with those on lowest incomes who demonstrate high reliance on the financial reward. CONCLUSIONS: Uptake of Give It Up For Baby by the target population was higher than for all other health board areas offering specialist or equivalent cessation services in Scotland. Quit successes also compared favorably with other specialist interventions, adding to evidence of the benefits of incentives in this setting. The process evaluation helped to explain variations in retention and quit rates achieved by the scheme.This study describes a series of positive outcomes achieved through the use of incentives to promote smoking cessation amongst pregnant smokers.

Development of an early nurse led intervention to treat children referred to secondary paediatric care with constipation with or without soiling.

BACKGROUND: Constipation is a common chronic childhood condition referred to secondary care. Effective treatment requires early intervention, prolonged medication to soften stools and behavioural support to achieve a regular habit of sitting on the toilet to pass a stool. The purpose of this audit and service development was to assess routine consultant paediatrician-led care against minimum standards and if appropriate to develop a nurse-led intervention. The new care package could then be tried out within general paediatric clinics in Glasgow as a service evaluation. NICE guideline (CG99) has a research recommendation to compare nurse-led care with routine consultant-led care. METHODS: Design was an audit then development of a nurse-led intervention followed by a service evaluation. Participants were children (age 0-13 years), referred by their General Practitioner (GP) to the Royal Hospital for Sick Children Glasgow, with constipation the main problem in the GP letter. The audit covered appointment waiting times, intervention provided, initial follow-up and parental satisfaction with routine consultant-led practice. The nurse-led intervention focused on self-help psychology practice with NICE guideline medical support. This was compared with routine consultant paediatrician care in a service evaluation. RESULTS: The audit found consultant-led care had long waiting times, delayed initial follow-up and variable intervention. The new nurse-led intervention is described in detail. The nurse-led intervention performed well compared with consultant-led care. Less 'nurse-led' children, 3/45 (7%), were still constipated passing less than 3 stools per week compared with 8/58 (14%) receiving consultant-led care. Less 'nurse-led' parents, 10/45 (22%), reported their child having pain passing stools in the previous week compared with consultant-led care, 26/58 (45%). The proportion of children, over 4 years, free from soiling accidents was similar, 15/23 (65%) in the nurse-led group and 18/29 (62%) with consultant-led care. Parental satisfaction was slightly better in the nurse-led group. CONCLUSION: It is difficult to achieve minimum standards using routine consultant-led care for children referred by their GP with constipation. Nurse-led early intervention is feasible and has produced promising results in a service evaluation. An exploratory trial is planned to develop a teaching module, robust outcomes including costs and benefits, and methodology for a definitive trial recommended by NICE.

Monitoring population levels of alcohol consumption in pregnant women: a case for using biomarkers.

A challenge to biochemically monitoring alcohol consumption in pregnancy is the prohibitive costs of collecting thousands of blood samples. This pilot study looks at the feasibility of using residual samples to monitor chronic and acute alcohol consumption in pregnancy. Residual anomalies screening samples (n = 150, 2006/7) were tested for carbohydrate-deficient transferrin (CDT, chronic marker) and ethyl glucuronide (EtG, acute marker). Valid readings were obtained for CDT but not EtG. These results pave the way for a larger representative study, to provide, for the first time, a national biochemical baseline estimate of chronic alcohol consumption in the pregnant population.

Assessing maternal alcohol consumption in pregnancy: does phosphatidylethanol measured from day 5 newborn blood spot cards have any value? An observational, population-based study.

OBJECTIVE: Prenatal alcohol exposure (PAE) places children at risk of fetal alcohol spectrum disorder (FASD) but ascertainment of PAE is problematic. Early intervention for children at risk of FASD may help mitigate long-term difficulties. Phosphatidylethanol (PEth), a metabolite of alcohol, is incorporated into red cell membranes and can be measured in dried blood spot (DBS) cards. In the UK, DBS samples are collected on day 5 for routine newborn screening. We sought to examine if PEth measured from DBS correlates with postnatal maternal self-report of alcohol consumption in pregnancy. DESIGN: Observational population-based study. Comparison of infant PEth concentration and self-report of maternal alcohol use during pregnancy. SETTING: Large maternity unit in Glasgow, Scotland. PARTICIPANTS: All singleton mother-infant dyads delivered during each fourth consecutive 24-hour period. INTERVENTIONS: Mother: direct, confidential, immediate postnatal interview by a single researcher examining alcohol use during pregnancy. Infant: one extra DBS collected coincident with routine newborn screening if bleeding continued. RESULTS: 92.5% of eligible mothers agreed to participate. 510 DBS were obtained of which 502 were successfully analysed. 216 (43%) samples contained PEth at a concentration of ≥8 ng/mL and 148 (29.5%) at ≥20 ng/mL. The sensitivity of PEth ≥8 ng/mL and ≥20 ng/mL in identifying women who self-reported modest alcohol use after 36 weeks' gestation was 50% and 36.4%, respectively. CONCLUSION: PEth measured from DBS obtained on day 5 of life does not reliably identify modest PAE after 36 weeks' gestation from maternal self-report.

Assessing maternal alcohol consumption in pregnancy: comparison of confidential postnatal maternal interview and measurement of alcohol biomarkers in meconium.

OBJECTIVE: Knowledge of alcohol consumption in pregnancy is important for early identification of children with fetal alcohol spectrum disorder. We investigated whether alcohol biomarkers fatty acid ethyl esters (FAEEs) and ethyl glucuronide (EtG) in meconium are predicted by maternal or newborn demographics and/or correlate with confidential early postnatal self-report of alcohol consumption in pregnancy. DESIGN: Anonymised, observational population-based study. SETTING: Inner-city maternity unit, Glasgow, UK. PATIENTS: Singleton mother/infant dyads delivering every fourth day. INTERVENTIONS: Mother: confidential postnatal interview. Baby: meconium sample for FAEEs and EtG. RESULTS: 840/908 mothers consented. 370 (46.4%) reported alcohol consumption in pregnancy, generally of modest amount; for 114 (13.6%) this was after 20 weeks' gestation. Alcohol consumption in later pregnancy was more commonly reported by older (31.3 vs 29.5 years) women of white British ethnicity (p<0.05); their babies were on average 118 g heavier (p=0.032). FAEEs were identified in all meconium samples; concentration was ≥600 ng/g in 39.6%. EtG concentration was ≥30 ng/g in 14.5%. Neither biomarker was associated with maternal age, body mass index or socioeconomic status but when EtG was ≥30 ng/g, the mother was less likely to identify as white British (71.3% vs 81.8%, p=0.028). Sensitivities of FAEEs ≥600 ng/g and EtG ≥30 ng/g were 43.1% and 11.6%, respectively for postnatal self-report of alcohol use in later pregnancy (specificities 60.6% and 84.8%). CONCLUSIONS: FAEEs and EtG measured in meconium have low sensitivity and specificity for self-reported alcohol consumption after 20 weeks' gestation in an unselected Scottish population.

Financial incentives for quitting smoking in pregnancy: Are they cost-effective?

AIMS: To evaluate whether adding financial incentives to usual care is cost-effective in encouraging pregnant women to quit tobacco smoking, compared with usual care alone. DESIGN: Cost-effectiveness analysis (CEA) and cost-utility analysis (CUA) from a health-care provider's perspective, embedded in the Smoking Cessation in Pregnancy Incentives Trial (CPIT III). Long-term analyses were conducted from the same perspective, using an existing Markov model over a life-time horizon. SETTING: Seven maternity smoking cessation sites in Scotland, England and Northern Ireland in the United Kingdom. PARTICIPANTS: In the short-term analysis, CPIT III participants were assessed: women 16 years or older, self-reporting as smokers, fewer than 24 weeks pregnant and English-speaking (n = 944). The same population was used for the life-time analysis, plus their infants. MEASUREMENTS: Costs included financial incentive vouchers and postage, cessation support and nicotine replacement therapy and neonatal stays. The outcome measure was a biochemically verified quit rate for the CEA and quality-adjusted life-years (QALYs) for CUA. Costs are presented in 2020 GBP sterling (£). Data for the life-time analysis came from the trial and were combined with data from published literature embedded in the model, reporting incremental cost per quitter and QALY. A 3.5% discount rate was applied. FINDINGS: The short-term incremental cost per quitter was £4400 and cost per QALY was £150 000. Results of sensitivity analyses confirmed these results. The long-term analysis combined costs and outcomes for mother and infants; results showed a cost saving of £37 [95% confidence interval (CI]) = £35-106] and increase in QALYs of 0.171 (95% CI = 0.124-0.229). These findings indicate that, over a life-time, financial incentives are cost-saving and improve health outcomes. CONCLUSIONS: In the United Kingdom, offering up to £400 financial incentives, in addition to usual care, to support pregnant women to stop smoking appears to be highly cost-effective over a life-time for mother and infants.

Fast and destructive density currents created by ocean-entering volcanic eruptions.

Volcanic eruptions on land create hot and fast pyroclastic density currents, triggering tsunamis or surges that travel over water where they reach the ocean. However, no field study has documented what happens when large volumes of erupted volcanic material are instead delivered directly into the ocean. We show how the rapid emplacement of large volumes of erupted material onto steep submerged slopes triggered extremely fast (122 kilometers per hour) and long-runout (>100 kilometers) seafloor currents. These density currents were faster than those triggered by earthquakes, floods, or storms, and they broke seafloor cables, cutting off a nation from the rest of the world. The deep scours excavated by these currents are similar to those around many submerged volcanoes, providing evidence of large eruptions at other sites worldwide.

Usual care in a multicentre randomised controlled trial of financial incentives for smoking cessation in pregnancy: qualitative findings from a mixed-methods process evaluation.

OBJECTIVES: Financial incentives are recommended by the UK's National Institute for Health and Care Excellence to aid smoking cessation in pregnancy. However, little is known about how implementation contexts might impact on their effectiveness. Variations in smoking cessation support (usual care) for pregnant women who smoke were examined qualitatively as part of a prospective process evaluation of the Cessation in Pregnancy Incentives Trial (CPIT III). DESIGN: Longitudinal case studies of five CPIT III trial sites informed by realist evaluation. SETTING: A stop smoking service (SSS) serving a maternity hospital constituted each case study, located in three UK countries. PARTICIPANTS: Data collection included semistructured interviews with trial participants (n=22), maternity (n=12) and SSS staff (n=17); and site observations and perspectives recorded in fieldnotes (n=85). RESULTS: Cessation support (usual care) for pregnant women varied in amount, location, staff capacity, flexibility and content across sites. SSS staff capacity was important to avoid gaps in support. Colocation and good working relationships between maternity and SSS professionals enabled prioritisation and reinforced the importance of smoking cessation. Sites with limited use of carbon monoxide (CO) monitoring reduced opportunities to identify smokers while inconsistency around automatic referral processes prevented the offer of cessation support. SSS professionals colocated within antenatal clinics were available to women they could not otherwise reach. Flexibility around location, timing and tailoring of approaches for support, facilitated initial and sustained engagement and reduced the burden on women. CONCLUSIONS: Trial sites faced varied barriers and facilitators to delivering cessation support, reflecting heterogeneity in usual care. If financial incentives are more effective with concurrent smoking cessation support, sites with fewer barriers and more facilitators regarding this support would be expected to have more promising trial outcomes. Future reporting of trial outcomes will assist in understanding incentives' generalisability across a wide range of usual care settings. TRIAL REGISTRATION NUMBER: ISRCTN15236311.

Effect of financial voucher incentives provided with UK stop smoking services on the cessation of smoking in pregnant women (CPIT III): pragmatic, multicentre, single blinded, phase 3, randomised controlled trial.

OBJECTIVE: To examine effectiveness, cost effectiveness, generalisability, and acceptability of financial incentives for smoking cessation during pregnancy in addition to variously organised UK stop smoking services. DESIGN: Pragmatic, multicentre, single blinded, phase 3, randomised controlled trial (Cessation in Pregnancy Incentives Trial phase 3 (CPIT III)). SETTING: Seven UK stop smoking services provided in primary and secondary care facilities in Scotland, Northern Ireland, and England. PARTICIPANTS: 944 pregnant women (age ≥16 years) who self-reported as being smokers (at least one cigarette in the past week) when asked at first maternity visit, less than 24 weeks' gestation, and notified to the trial team by routine stop smoking services. INTERVENTIONS: Participants in the control group were offered the standard stop smoking services, which includes the offer of counselling by specially trained workers using withdrawal orientated therapy and the offer of free nicotine replacement therapy. The intervention was the offer of usual support from the stop smoking services and the addition of up to £400 ($440; €455) of LoveToShop financial voucher incentives for engaging with current stop smoking services or to stop smoking, or both, during pregnancy. MAIN OUTCOME MEASURES: Self-reported smoking cessation in late pregnancy (between 34 and 38 weeks' gestation) corroborated by saliva cotinine (and anabasine if using nicotine replacement products). Results were adjusted for age, smoking years, index of multiple deprivation, Fagerström score, before or after covid, and recruitment site. Secondary outcomes included point and continuous abstinence six months after expected date of delivery, engagement with stop smoking services, biochemically validated abstinence from smoking at four weeks after stop smoking date, birth weight of baby, cost effectiveness, generalisability documenting formats of stop smoking services, and acceptability to pregnant women and their carers. RESULTS: From 9 January 2018 to 4 April 2020, of 4032 women screened by stop smoking services, 944 people were randomly assigned to the intervention group (n=471) or the control group (n=470). Three people asked for their data to be removed. 126 (27%) of 471 participants stopped smoking from the intervention group and 58 (12%) of 470 from the control group (adjusted odds ratio 2.78 (1.94 to 3.97) P<0.001). Serious adverse events were miscarriages and other expected pregnancy events requiring hospital admission; all serious adverse events were unrelated to the intervention. Most people who stopped smoking from both groups relapsed after their baby was born. CONCLUSIONS: The offer of up to £400 of financial voucher incentives to stop smoking during pregnancy as an addition to current UK stop smoking services is highly effective. This bolt-on intervention supports new guidance from the UK National Institute for Health and Care Excellence, which includes the addition of financial incentives to support pregnant women to stop smoking. Continuing incentives to 12 months after birth is being examined to prevent relapse. TRIAL REGISTRATION: ISRCTN Registry ISRCTN15236311.

Behavioural and cognitive interventions with or without other treatments for the management of faecal incontinence in children.

BACKGROUND: Faecal incontinence is a common and potentially distressing disorder of childhood. OBJECTIVES: To assess the effects of behavioural and/or cognitive interventions for the management of faecal incontinence in children. SEARCH METHODS: We searched the Cochrane Incontinence Group Specialised Trials Register (searched 28 October 2011), which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and CINAHL, and handsearching of journals and conference proceedings, and the reference lists of relevant articles. We contacted authors in the field to identify any additional or unpublished studies. SELECTION CRITERIA: Randomised and quasi-randomised trials of behavioural and/or cognitive interventions with or without other treatments for the management of faecal incontinence in children. DATA COLLECTION AND ANALYSIS: Reviewers selected studies from the literature, assessed study quality, and extracted data. Data were combined in a meta-analysis when appropriate. MAIN RESULTS: Twenty one randomised trials with a total of 1371 children met the inclusion criteria. Sample sizes were generally small. All studies but one investigated children with functional faecal incontinence. Interventions varied amongst trials and few outcomes were shared by trials addressing the same comparisons.Combined results of nine trials showed higher rather than lower rates of persisting symptoms of faecal incontinence up to 12 months when biofeedback was added to conventional treatment (OR 1.11 CI 95% 0.78 to 1.58). This result was consistent with that of two trials with longer follow-up (OR 1.31 CI 95% 0.80 to 2.15). In one trial the adjunct of anorectal manometry to conventional treatment did not result in higher success rates in chronically constipated children (OR 1.40 95% CI 0.72 to 2.73 at 24 months).In one small trial the adjunct of behaviour modification to laxative therapy was associated with a significant reduction in children's soiling episodes at both the three month (OR 0.14 CI 95% 0.04 to 0.51) and the 12 month assessment (OR 0.20 CI 95% 0.06 to 0.65). AUTHORS' CONCLUSIONS: There is no evidence that biofeedback training adds any benefit to conventional treatment in the management of functional faecal incontinence in children. There was not enough evidence on which to assess the effects of biofeedback for the management of organic faecal incontinence. There is some evidence that behavioural interventions plus laxative therapy, rather than laxative therapy alone, improves continence in children with functional faecal incontinence associated with constipation.

Incorporating organisational safety culture within ergonomics practice.

This paper conceptualises organisational safety culture and considers its relevance to ergonomics practice. Issues discussed in the paper include the modest contribution that ergonomists and ergonomics as a discipline have made to this burgeoning field of study and the significance of safety culture to a systems approach. The relevance of safety culture to ergonomics work with regard to the analysis, design, implementation and evaluation process, and implications for participatory ergonomics approaches, are also discussed. A potential user-friendly, qualitative approach to assessing safety culture as part of ergonomics work is presented, based on a recently published conceptual framework that recognises the dynamic and multi-dimensional nature of safety culture. The paper concludes by considering the use of such an approach, where an understanding of different aspects of safety culture within an organisation is seen as important to the success of ergonomics projects. STATEMENT OF RELEVANCE: The relevance of safety culture to ergonomics practice is a key focus of this paper, including its relationship with the systems approach, participatory ergonomics and the ergonomics analysis, design, implementation and evaluation process. An approach to assessing safety culture as part of ergonomics work is presented.

Challenging the view that lack of fibre causes childhood constipation.

OBJECTIVES: To assess evidence supporting the view that 'low fibre causes childhood constipation'. DESIGN: Triangulation integrated three approaches: a systematic review NICE guideline CG99 examining effectiveness of increasing fibre; a cohort study, Avon Longitudinal Study of Parents and Children (ALSPAC), to assess if constipation (or hard stools) can precede fibre intake at weaning; and a literature search for twin studies to calculate heredity. SETTING: CG99 examined the literature regarding the effectiveness of increasing fibre. ALSPAC asked parents about: hard stools at 4 weeks, 6 months and 2.5 years and constipation at age 4-10 years, as well as fibre intake at 2 years. Twin studies and data from ALSPAC were pooled to calculate concordance of constipation comparing monozygotic and dizygous twin pairs. PARTICIPANTS: CG99 reported six randomised controlled trials (RCTs). ALSPAC hard stool data from 6796 children at 4 weeks, 9828 at 6 months and 9452 at 2.5 years plus constipation data on 8401 at 4-10 years were compared with fibre intake at 2 years. Twin studies had 338 and 93 twin pairs and ALSPAC added a further 45. RESULTS: Increasing fibre did not effectively treat constipation. Hard stools at 4 weeks predated fibre and at 6 months predicted lower fibre intake at 2 years (p=0.003). Heredity explained 59% of constipation. CONCLUSIONS: RCTs indicate that increasing fibre is not an effective treatment for constipation in children. Hard stools can precede and predict later fibre intake. Genetic inheritance explains most childhood constipation. Extended treatment with stool softeners may improve fibre intake and limit long-term damaging sequelae of constipation.

A protocol for the economic evaluation of the smoking Cessation in Pregnancy Incentives Trial III (CPIT III).

INTRODUCTION: Smoking results in an average 10-year loss of life, but smokers who permanently quit before age 40 can expect a near normal lifespan. Pregnancy poses a good opportunity to help women to stop; around 80% of women in the UK have a baby, most of whom are less than 40 years of age. Smoking prevalence during pregnancy is high: 17%-23% in the UK. Smoking during pregnancy causes low birth weight and increases the risk of premature birth. After birth, passive smoking is linked to sudden infant death syndrome, respiratory diseases and increased likelihood of taking up smoking. These risks impact the long-term health of the child with associated increase in health costs. Emerging evidence suggests that offering financial incentives to pregnant women to quit is highly cost effective.This protocol describes the economic evaluation of a multi-centre randomised controlled trial (Cessation in Pregnancy Incentives Trial III, CPIT III) designed to establish whether offering financial incentives, in addition to usual care, is effective and cost effective in helping pregnant women to quit. METHODS AND ANALYSIS: The economic evaluation will identify, measure and value resource use and outcomes from CPIT III, comparing participants randomised to either usual care or usual care plus up to £400 financial incentives. Within-trial and long-term analyses will be conducted from a National Health Service and Personal Social Services perspective; the outcome for both analyses will be quality adjusted life-years measured using EQ-5D-5L. Patient level data collected during the trial will be used for the within-trial analysis, with an additional outcome of cotinine validated quit rates at 34-38 weeks gestation and 6 months postpartum. The long-term model will be informed by data from the trial and published literature. ETHICS AND DISSEMINATION: TRIAL REGISTRATION NUMBER: ISRCTN15236311; Pre-results (https://doi.org/10.1186/ISRCTN15236311).