What is the potential of compensation funds for addressing COVID-related personal injury?

The COVID-19 pandemic continues to present new challenges at the frontiers of social risk. Its significant societal impact has prompted the consideration of alternative frameworks like compensation funds to better allocate the risks and impacts of COVID-related injury. Although there has been discussion about the potential of alternative liability structures for vaccine-related injury, there has been less analysis of the right way to compensate other types of injury, such as long-term illness, disability and death, associated with the SARS-CoV-2 virus. In France, a universal compensation fund for COVID-19-related injuries, designed similarly to asbestos-related schemes, was considered by the parliament. With an eye on scientific knowledge of the best practice in the development and operation of compensation frameworks, this paper analyses the design of such funds in Europe as applied to COVID-19 injury and considers the position of compensation funds in relation to tort law, private insurance and social security models.

Reflecting on 'insider' and 'outsider' positionality when undertaking culturally sensitive research with young Pakistani men: insights from a female researcher.

BACKGROUND: Conducting culturally sensitive research into male experiences can be challenging for female researchers. Despite this, there are very few published reflective accounts of how they have overcome these difficulties. AIM: To illustrate a female researcher's challenges in conducting research into young men's experiences of puberty in Pakistan and highlight the strategies used to overcome these. DISCUSSION: An important challenge for the researcher was creating an environment in which participants felt able to share their experiences. This was overcome by the incorporation of the experiences of public involvement contributors in the development of the project, offering a choice of interview format to participants and other solutions driven by the 'insider' position of the researcher. The researcher's 'outsider' role as a mature and pregnant woman appeared to create a 'safe' environment, allowing the young men to openly share their personal experiences. CONCLUSION: Female researchers can successfully conduct culturally sensitive research with young men in patriarchal societies such as Pakistan. The key is to be aware of potential cultural issues and to use any insider/outsider positionality to the greatest effect. IMPLICATIONS FOR PRACTICE: In addition to adapting procedures, such as gaining trust, building rapport and assuring a non-judgemental and comfortable environment, the 'outsider' position of the female researcher should be given due consideration when undertaking culturally sensitive research with men.

The importance of face to face, group antenatal education classes for first time mothers: A qualitative study.

OBJECTIVES: To explore and understand perspectives of women expecting their first child and why they wanted to attend NHS antenatal education. This included what worries and concerns they wanted to be addressed and why this would be beneficial. It also included what they wanted their partners to be able to gain from attending classes. DESIGN: A longitudinal qualitative study using Template Analysis was undertaken with data collection during pregnancy and postpartum. A semi-structured topic guide was used to guide data collection, either via focus groups or one to one interviews which were audio recorded and transcribed. SETTING: National Health Service Trusts providing maternity services to women for labour and birth, purposively selected to allow the perspectives of specific groups of women to be included. PARTICIPANTS: Women expecting their first child from one of three groups: Women from the general population aged 20 years or more, women from ethnic minority groups and young women aged 16 to 19 years. FINDINGS: Eighty-two pregnant women participated. Three substantive themes are reported: the search for information, the functions of antenatal classes, and the specific information desired. Women wanted to attend NHS antenatal education to access trustworthy information that would reassure, increase confidence, and help them feel prepared. Women wanted to meet others in the same situation to help normalise concerns and offer the potential for ongoing relationships. Classes were seen as a way to help partners engage more fully with the transition to parenthood. Specific information required and shared by all groups was around understanding the stages of labour, managing labour, and common interventions. CONCLUSIONS: Access to a wide range of information increases women's anxieties about labour that women want addressed through antenatal education. However, antenatal classes serve broader functions beyond information- giving and women anticipate that attending antenatal classes will address both their own and their partners' needs. IMPLICATIONS: Service providers should ensure their antenatal education provision provides the information required and is structured in a way that enables women to develop relationships and supports partners' engagement in the transition to parenthood.

Hearing the unheard voice-puberty experiences of young Pakistani men: A qualitative study.

INTRODUCTION: Puberty experiences of male adolescents can have significant impacts on physical and psychological health outcomes. This qualitative study explored the puberty experiences of young males in Pakistan, as there are limited accounts of what shapes these puberty experiences, especially for adolescent males living in a restrictive culture. METHODS: Twenty-two young Pakistani men (aged 18-21 years) from two urban sites in Karachi participated in individual face-to-face (n=19) and Skype (n=3) interviews. Qualitative thematic analysis was conducted using an inductive approach to identity and examine the patterns emerging from the data. RESULTS: Participants described puberty as a challenging phase for which they were unprepared with a combination of various socio-cultural factors exposing them to negative impacts. As a result, young men expressed feelings of anxiety, embarrassment and isolation. Societal and gender norms around masculinity, sexuality and the roles and responsibilities of young men had a significant impact on how participants experienced puberty. While negative reactions towards puberty were dominant, participants described adopting coping strategies (e.g. social support) to help them deal with negative experiences. CONCLUSIONS: Findings highlight the significance of culturally appropriate puberty education and various facilitating factors that may improve the puberty experiences for future young men. While extending current literature, this study also identifies key factors that could inform the development of health promotion programmes, which may aid adolescent males' puberty transition and positively influence their long-term health, well-being and identity.

Reflections on an educational intervention to encourage midwives to work in a continuity of care model - exploration and potential solutions.

OBJECTIVE: To explore barriers and facilitators for midwives working in a midwifery continuity of carer model, and to assess if an educational intervention could help address some of these barriers, designed to help achieve NHS England's target of majority of women receiving midwifery continuity of carer by March 2021. DESIGN: Two-day workshops were co-designed by experienced continuity midwives, service managers and midwifery educators using implementation theory delivered to maternity staff, with barriers assessed prior to training and re-assessed at the end. SETTING AND PARTICIPANTS: 1407 maternity healthcare professionals from 62 different National Health Service trusts across England attended 56 different workshops. FINDINGS: Perceived barriers to working in this model were reported more frequently than facilitators. Reported facilitators prior to training included perceived benefits to the midwife and to women. Reported barriers included personal and professional concerns, fear, issues with the national agenda and institutional and/or organisational issues. The educational intervention was able to address the majority of barriers raised. The training was well evaluated, with an average rating of 4.2 on a five-point Likert scale. KEY CONCLUSIONS: While this specific educational intervention appears to have been useful in addressing concerns with working in a continuity model, further work is needed to identify barriers to change. This will aid more local designed interventions. IMPLICATIONS FOR PRACTICE: If policy targets related to continuity of carer are to be achieved then working in this way needs to be sustainable and appeal to the current midwifery workforce.

'The rollercoaster': A qualitative study of midwifery students' experiences affecting their mental wellbeing.

OBJECTIVE: Midwifery student mental wellbeing is an important consideration for the sustainability of the profession, however it has seldom been the subject of empirical research. Previous studies of the lived experience of midwifery students have focused on the impact of transition experiences and student satisfaction, rather than specifically on mental health and students' views on support for their mental wellbeing. DESIGN: A qualitative descriptive study using semi-structured interviews. SETTING: A midwifery undergraduate programme in one university in the South of England. PARTICIPANTS: 20 BSc midwifery students. FINDINGS: Two inductive themes were developed from our analysis. The theme of 'the rollercoaster' encapsulated students' experience over the length of the course, characterised by multiple culture shocks of being in different worlds, from one clinical placement to the next, from university to clinical placement. This experience was emotionally taxing. The theme of 'being noticed, feeling connected' encapsulated midwifery students' views on what could help them enjoy their training. They wanted to be seen as individuals by at least one educator, they wanted opportunities to connect with their peers and they wanted the support available to them to be consistent. CONCLUSIONS: Listening to students' insights into the lived experience of being a midwifery student can enable midwifery educators to improve the way courses are designed and support structures are put in place. The importance of having consistent contact with peers and educators cannot be underestimated. IMPLICATIONS FOR PRACTICE: The emotional demands of midwifery training must be acknowledged. Educators should identify ways in which they can provide students with consistent individualised support and regular opportunities to meet with their peers.

Chinese primiparous women's experience of the traditional postnatal practice of "Doing the month": A descriptive method study.

AIM: "Doing the month" has been a traditionally postnatal practice that women follow for one full month after giving birth. The aim of this study was to explore Chinese primiparous women's experience of "Doing the month" and why Chinese women felt satisfied or dissatisfied with the experience. METHODS: This was a descriptive survey using open and closed questions. In total, 420 Chinese primiparous women were recruited in obstetric wards at three hospitals in Xiamen City, China. Baseline questionnaires were distributed to the participants face-to-face by the researcher on the postnatal ward at 3 days' postnatally. Follow-up questionnaires of "Doing the month" were sent via email by the researcher to the participants at 6 weeks' postnatally and were returned by the participants via email. The quantitative data were analyzed with SPSS and the qualitative data were analyzed by using a thematic text analysis. RESULTS: Most of the women thought that "Doing the month" after childbirth was necessary. Some women felt satisfied with "Doing the month" because their family helped them to have a good rest, they felt a sense of achievement when taking care of their baby, and that having an appreciative attitude helped them to get along with the older generations. In contrast, some women felt dissatisfied with "Doing the month" because of being tired of following taboos, having conflicts with their mother-in-law, the lack of family help and care, and undue expectations of "Doing the month." CONCLUSIONS: In order to improve postnatal care for Chinese primiparous women, health professionals could be more aware of how health care needs to be customized to fit the special tradition of "Doing the month."

Changes in maternal self-efficacy, postnatal depression symptoms and social support among Chinese primiparous women during the initial postpartum period: A longitudinal study.

BACKGROUND: There are many parenting problems during infancy for Chinese primiparous women. As an important determinant of good parenting, maternal self-efficacy (MSE) should be paid more attention by researchers. At present, the limitations of previous research examining MSE during infancy are that most studies were conducted with a homogeneous sample and there were few studies with Chinese women. Secondly, the trajectory of change in MSE, postnatal depression symptoms and social support for Chinese primiparous women was not clear during the initial postpartum period in earlier studies. OBJECTIVES: This study aimed to describe changes in MSE, postnatal depression symptoms and social support among Chinese primiparous women in the first three months postnatally. DESIGN: A quantitative longitudinal study using questionnaires was conducted. SETTING: Obstetric wards at three hospitals in Xiamen City, South-East China. PARTICIPANTS: In total, 420 Chinese primiparous women were recruited. METHODS: Initial baseline questionnaires to measure socio-demographic and clinical characteristics at three days postnatally were distributed to participants face-to-face by the researcher on the postnatal ward. Follow-up questionnaires at six and 12 weeks postnatally were sent via e-mail by the researcher to participants, including the Self-efficacy in Infant Care Scale (SICS), the Edinburgh Postnatal Depression Scale (EPDS) and the Postpartum Social Support Scale (PSSS) to measure MSE, postnatal depression symptoms and social support, respectively. These were returned by participants via e-mail. Quantitative data were analysed using SPSS. RESULTS: The mean MSE score at six weeks postnatally was 74.92 (SD = 11.05), and increased to 77.78 (SD = 11.13) at 12 weeks postnatally. The mean social support scores at six and 12 weeks postnatally were 40.99 (SD = 9.31) and 43.00 (SD = 9.55). The mean EPDS scores decreased from 9.09 (SD = 4.33) at six weeks postnatally to 8.63 (SD = 4.40) at 12 weeks postnatally; the proportion of women with an EPDS score of ten or more and 13 or more at the two time points declined from 47.4% to 38.3%, and from 21.4% to 18.2%, respectively. CONCLUSIONS: In this study, Chinese primiparous women had a moderate level of MSE and received a moderate level of social support at six and 12 weeks postnatally, and a higher proportion of Chinese women had postnatal depression symptoms than did women in Western countries. From six to 12 weeks postnatally, the mean MSE scores and social support scores had a statistically significant increase; the mean EPDS scores had a statistically significant decrease.

A quantitative longitudinal study to explore factors which influence maternal self-efficacy among Chinese primiparous women during the initial postpartum period.

BACKGROUND: parenting during infancy is highly problematic for Chinese primiparous women. As an important determinant of good parenting, maternal self-efficacy (MSE) should be paid more attention by researchers. At present, the limitations of previous research about MSE during infancy are that the factors which influence MSE remained poorly explored, there were few studies with Chinese women, and the studies did not consider the effect of different cultures. OBJECTIVES: to explore factors which influence MSE in primiparous women in China in the first three months postnatally. METHODS: a quantitative longitudinal study using questionnaires was conducted. In total, 420 Chinese primiparous women were recruited in obstetric wards at three hospitals in Xiamen City, Fujian Province of China. Initial baseline questionnaires to measure socio-demographic and clinical characteristics were distributed to participants face-to-face by the researcher on the postnatal ward at three days postnatally. Follow-up questionnaires at six and 12 weeks postnatally were sent via e-mail by the researcher to participants, including the Self-efficacy in Infant Care Scale (SICS), the Edinburgh Postnatal Depression Scale (EPDS) and the Postpartum Social Support Scale (PSSS) to measure MSE, postnatal depression symptoms and social support, respectively. These were returned by participants via e-mail. Quantitative data were analysed using SPSS. RESULTS: the variables: social support, women's satisfaction with 'Doing the month', postnatal depression, maternal education, baby health, and maternal occupation had an influence on MSE at six weeks postnatally (Adjusted R2 = 0.510, F = 46.084, P<0.01); and the variables: postnatal depression, social support, baby health, women's satisfaction with 'Doing the month', and baby fussiness were the factors influencing MSE at 12 weeks postnatally (Adjusted R2 = 0.485, F = 41.082, P<0.01). CONCLUSIONS: obstetric nurses and women's family members need to be aware of the significant contribution of social support, women's satisfaction with 'Doing the month' in positively influencing primiparous women's MSE, and the significant effect of postnatal depression symptoms in negatively impacting on first-time mothers' MSE; they should pay more attention to primiparous women with less education, unemployed mothers, women with unskilled occupations, women with an unhealthy baby, and women with a baby with a difficult temperament to improve their comparatively lower MSE levels during the initial postnatal period.

Experiences and impact of mistreatment and obstetric violence on women during childbearing: a systematic review protocol.

REVIEW QUESTION/OBJECTIVE: The aim of this review is to synthesize the best available evidence on the experiences of mistreatment and/or obstetric violence in women. Specifically, the objective is to explore, from a woman's point of view, the impacts and consequences of mistreatment and/or obstetric violence during childbearing. The review question is: "What are the experiences and impact of mistreatment and obstetric violence on women during the active period of childbearing?"

An integrative review of the impact of mobile technologies used by healthcare professionals to support education and practice.

AIM: The aim of this study was to provide evidence of the impact of mobile technologies among healthcare professionals in education and practice settings. DESIGN: Integrative literature review. METHODS: Electronic databases including MEDLINE, CINAHL, PsycINFO, EMBASE, ERIC and Web of Science were searched for papers published between 2002-2012. Quantitative studies were critically evaluated based on Thomas et al.'s framework, while the consolidated criteria for reporting qualitative research was used to appraise the rigour of the qualitative studies. RESULTS: Seventeen quantitative and three qualitative studies were included. The findings suggest a largely positive influence of mobile technologies on various clinical practice and educational outcomes. However, robust evidence was limited. Use of mobile technologies in health care are associated with improvements in access to information, accuracy and efficiency, evidence-based decision making at the point of care and enhancement in performance, confidence and engagement in different contexts.

The SNAP trial: a randomised placebo-controlled trial of nicotine replacement therapy in pregnancy--clinical effectiveness and safety until 2 years after delivery, with economic evaluation.

BACKGROUND: Smoking during pregnancy causes many adverse pregnancy and birth outcomes. Nicotine replacement therapy (NRT) is effective for cessation outside pregnancy but efficacy and safety in pregnancy are unknown. We hypothesised that NRT would increase smoking cessation in pregnancy without adversely affecting infants. OBJECTIVES: To compare (1) at delivery, the clinical effectiveness and cost-effectiveness for achieving biochemically validated smoking cessation of NRT patches with placebo patches in pregnancy and (2) in infants at 2 years of age, the effects of maternal NRT patch use with placebo patch use in pregnancy on behaviour, development and disability. DESIGN: Randomised, placebo-controlled, parallel-group trial and economic evaluation with follow-up at 4 weeks after randomisation, delivery and until infants were 2 years old. Randomisation was stratified by centre and a computer-generated sequence was used to allocate participants using a 1 : 1 ratio. Participants, site pharmacies and all study staff were blind to treatment allocation. SETTING: Seven antenatal hospitals in the Midlands and north-west England. PARTICIPANTS: Women between 12 and 24 weeks' gestation who smoked ≥ 10 cigarettes a day before and ≥ 5 during pregnancy, with an exhaled carbon monoxide (CO) reading of ≥ 8 parts per million (p.p.m.). INTERVENTIONS: NRT patches (15 mg per 16 hours) or matched placebo as an 8-week course issued in two equal batches. A second batch was dispensed at 4 weeks to those abstinent from smoking. PARTICIPANTS: self-reported, prolonged abstinence from smoking between a quit date and childbirth, validated at delivery by CO measurement and/or salivary cotinine (COT) (primary outcome). Infants, at 2 years: absence of impairment, defined as no disability or problems with behaviour and development. Economic: cost per 'quitter'. RESULTS: One thousand and fifty women enrolled (521 NRT, 529 placebo). There were 1010 live singleton births and 12 participants had live twins, while there were 14 fetal deaths and no birth data for 14 participants. Numbers of adverse pregnancy and birth outcomes were similar in trial groups, except for a greater number of caesarean deliveries in the NRT group. Smoking: all participants were included in the intention-to-treat (ITT) analyses; those lost to follow-up (7% for primary outcome) were assumed to be smoking. At 1 month after randomisation, the validated cessation rate was higher in the NRT group {21.3% vs. 11.7%, odds ratio [OR], [95% confidence interval (CI)] for cessation with NRT, 2.05 [1.46 to 2.88]}. At delivery, there was no difference between groups' smoking cessation rates: 9.4% in the NRT and 7.6% in the placebo group [OR (95% CI), 1.26 (0.82 to 1.96)]. Infants: at 2 years, analyses were based on data from 888 out of 1010 (87.9%) singleton infants (including four postnatal infant deaths) [445/503 (88.5%) NRT, 443/507 (87.4%) placebo] and used multiple imputation. In the NRT group, 72.6% (323/445) had no impairment compared with 65.5% (290/443) in placebo (OR 1.40, 95% CI 1.05 to 1.86). The incremental cost-effectiveness ratio for NRT use was £4156 per quitter (£4926 including twins), but there was substantial uncertainty around these estimates. CONCLUSIONS: Nicotine replacement therapy patches had no enduring, significant effect on smoking in pregnancy; however, 2-year-olds born to women who used NRT were more likely to have survived without any developmental impairment. Further studies should investigate the clinical effectiveness and safety of higher doses of NRT. TRIAL REGISTRATION: Current Controlled Trials ISRCTN07249128. 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. 54. See the NIHR Journals Library programme website for further project information.

Smartphone and medical related App use among medical students and junior doctors in the United Kingdom (UK): a regional survey.

BACKGROUND: Smartphone usage has spread to many settings including that of healthcare with numerous potential and realised benefits. The ability to download custom-built software applications (apps) has created a new wealth of clinical resources available to healthcare staff, providing evidence-based decisional tools to reduce medical errors.Previous literature has examined how smartphones can be utilised by both medical student and doctor populations, to enhance educational and workplace activities, with the potential to improve overall patient care. However, this literature has not examined smartphone acceptance and patterns of medical app usage within the student and junior doctor populations. METHODS: An online survey of medical student and foundation level junior doctor cohorts was undertaken within one United Kingdom healthcare region. Participants were asked whether they owned a Smartphone and if they used apps on their Smartphones to support their education and practice activities. Frequency of use and type of app used was also investigated. Open response questions explored participants' views on apps that were desired or recommended and the characteristics of apps that were useful. RESULTS: 257 medical students and 131 junior doctors responded, equating to a response rate of 15.0% and 21.8% respectively. 79.0% (n=203/257) of medical students and 74.8% (n=98/131) of junior doctors owned a smartphone, with 56.6% (n=115/203) of students and 68.4% (n=67/98) of doctors owning an iPhone.The majority of students and doctors owned 1-5 medical related applications, with very few owning more than 10, and iPhone owners significantly more likely to own apps (Chi sq, p<0.001). Both populations showed similar trends of app usage of several times a day. Over 24 hours apps were used for between 1-30 minutes for students and 1-20 minutes for doctors, students used disease diagnosis/management and drug reference apps, with doctors favouring clinical score/calculator apps. CONCLUSIONS: This study found a high level of smartphone ownership and usage among medical students and junior doctors. Both groups endorse the development of more apps to support their education and clinical practice.

A randomized trial of nicotine-replacement therapy patches in pregnancy.

BACKGROUND: Nicotine-replacement therapy is effective for smoking cessation outside pregnancy and its use is widely recommended during pregnancy. We investigated the efficacy and safety of nicotine patches during pregnancy. METHODS: We recruited participants from seven hospitals in England who were 16 to 50 years of age with pregnancies of 12 to 24 weeks' gestation and who smoked five or more cigarettes per day. Participants received behavioral cessation support and were randomly assigned to 8 weeks of treatment with active nicotine patches (15 mg per 16 hours) or matched placebo patches. The primary outcome was abstinence from the date of smoking cessation until delivery, as validated by measurement of exhaled carbon monoxide or salivary cotinine. Safety was assessed by monitoring for adverse pregnancy and birth outcomes. RESULTS: Of 1050 participants, 521 were randomly assigned to nicotine-replacement therapy and 529 to placebo. There was no significant difference in the rate of abstinence from the quit date until delivery between the nicotine-replacement and placebo groups (9.4% and 7.6%, respectively; unadjusted odds ratio with nicotine-replacement therapy, 1.26; 95% confidence interval, 0.82 to 1.96), although the rate was higher at 1 month in the nicotine-replacement group than in the placebo group (21.3% vs. 11.7%). Compliance was low; only 7.2% of women assigned to nicotine-replacement therapy and 2.8% assigned to placebo used patches for more than 1 month. Rates of adverse pregnancy and birth outcomes were similar in the two groups. CONCLUSIONS: Adding a nicotine patch (15 mg per 16 hours) to behavioral cessation support for women who smoked during pregnancy did not significantly increase the rate of abstinence from smoking until delivery or the risk of adverse pregnancy or birth outcomes. However, low compliance rates substantially limited the assessment of safety. (Funded by the National Institute for Health Research Health Technology Assessment Programme; Current Controlled Trials number, ISRCTN07249128.).

Exploring the views of women on using nicotine replacement therapy in pregnancy.

OBJECTIVE: to explore women's views surrounding the use of nicotine replacement therapy (NRT) to aid smoking cessation. DESIGN AND SETTING: a qualitative approach using semi-structured interviews undertaken on 10 pregnant women in a semi-rural area of England. FINDINGS: the two main themes that emerged from the study were that NRT was an important component in stopping smoking, but this was in conjunction with support given by the midwife advisor. Both themes appeared to be equally important to the women in aiding their attempts at smoking cessation. Also, the importance of tailored interventions should not be dismissed when aiding women in smoking cessation. CONCLUSIONS: exploring the views of women enabled the researchers to gain a greater understanding of the problems and achievements that women encountered when using NRT as an aid to stop smoking during pregnancy. The study also demonstrated that smoking cessation strategies can be successful if they are tailored to the individual needs of each woman, taking into account her dependency, domestic circumstances and willingness to change. IMPLICATIONS FOR PRACTICE: the findings of this study add to the available research surrounding the efficacy of NRT in pregnancy. There is little evidence that the views of pregnant women have been taken into account prior to this study; as such, this report offers a different dimension to the available evidence. Although these findings could be adopted and utilized by practitioners, there is still the need for further research in this area on a larger scale.

Women's use of nicotine replacement therapy in pregnancy-a structured review of the literature.

OBJECTIVE: to review the literature of women's use of nicotine replacement therapy (NRT) during pregnancy. The review will examine NRT and nicotine, interventions and barriers to smoking cessation and the literature exploring women's views on using NRT in pregnancy. METHOD: a structured review of the literature was undertaken by accessing internet and library sources, restricted to English written articles between 1989 and 2003. Keywords were used to refine the search: pregnancy, smoking, NRT and smoking cessation. FINDINGS: several papers had examined interventions employed to aid pregnant women in smoking cessation and the efficacy of NRT. However, papers exploring the views of women on the use of NRT during pregnancy were limited. CONCLUSIONS: smoking cessation is unique to individual women; as such, appropriate support and advice should be tailored accordingly. Further research is needed to explore the views of women using NRT during pregnancy to aid smoking cessation. IMPLICATIONS FOR PRACTICE: the findings from this structured review raise awareness of the importance of smoking cessation during pregnancy, and the inclusion of women's views when discussing the use of NRT. Understanding women's views may enhance the care and advice given by midwives, thus improving smoking cessation rates in pregnancy.

Protocol for the smoking, nicotine and pregnancy (SNAP) trial: double-blind, placebo-randomised, controlled trial of nicotine replacement therapy in pregnancy.

BACKGROUND: Smoking in pregnancy remains a public health challenge. Nicotine replacement therapy (NRT) is effective for smoking cessation in non-pregnant people, but because women metabolise nicotine and cotinine much faster in pregnancy, it is unclear whether this will be effective for smoking cessation in pregnancy. The NHS Health Technology Assessment Programme (HTA)-funded smoking, nicotine and pregnancy (SNAP) trial will investigate whether or not nicotine replacement therapy (NRT) is effective, cost-effective and safe when used for smoking cessation by pregnant women. METHODS/DESIGN: Over two years, in 5 trial centres, 1050 pregnant women who are between 12 and 24 weeks pregnant will be randomised as they attend hospital for ante-natal ultrasound scans. Women will receive either nicotine or placebo transdermal patches with behavioural support. The primary outcome measure is biochemically-validated, self-reported, prolonged and total abstinence from smoking between a quit date (defined before randomisation and set within two weeks of this) and delivery. At six months after childbirth self-reported maternal smoking status will be ascertained and two years after childbirth, self-reported maternal smoking status and the behaviour, cognitive development and respiratory symptoms of children born in the trial will be compared in both groups. DISCUSSION: This trial is designed to ascertain whether or not standard doses of NRT (as transdermal patches) are effective and safe when used for smoking cessation during pregnancy.

Promoting child safety in primary care: a cluster randomised controlled trial to reduce baby walker use.

BACKGROUND: Baby walkers are commonly used items of nursery equipment, but cause more than 3000 injuries each year in the UK. There is currently little evidence regarding the effectiveness of interventions in primary care to reduce walker use. AIM: To evaluate the effectiveness of an educational package provided by midwives and health visitors to reduce baby walker possession and use. DESIGN OF STUDY: Cluster randomised controlled trial. SETTING: Sixty-four general practices in Nottingham and North Nottinghamshire, UK. METHOD: An educational package aimed at discouraging mothers-to-be from obtaining and using a walker was delivered by midwives and health visitors to 1174 mothers-to-be of at least 28 weeks gestation. The control arm received usual care. Primary outcome measures were the possession and use of a walker. Secondary outcome measures included the frequency and duration of walker use, knowledge and attitudes towards walkers, plans to use a walker with future children, recommending a walker to a friend, and use of stair gates and fire guards. RESULTS: Intervention arm participants were significantly less likely to own (odds ratio [OR] = 0.63, 95% confidence interval [CI] = 0.43 to 0.93) or to use a walker (OR = 0.26, 95% CI = 0.08 to 0.84). They were significantly less likely to plan to use a walker with their next child (OR = 0.52, 95% CI = 0.31 to 0.86) or to agree that walkers keep children safe (OR = 0.35, 95% CI = 0.16 to 0.78). There was some evidence that they were less likely to recommend a walker to a friend (OR = 0.51, 95% CI = 0.28 to 0.91) or to agree that they help children to walk more quickly (OR = 0.53, 95% CI = 0.29 to 0.95). CONCLUSION: An educational package delivered by midwives and health visitors was effective in reducing baby walker possession and use. Providers of primary healthcare services should include baby walker education in their injury prevention strategy and child health promotion programme.

Recruiting pregnant smokers for a placebo-randomised controlled trial of nicotine replacement therapy.

BACKGROUND: Smoking in pregnancy is a public health problem and effective methods for reducing this are required. Although nicotine replacement therapy (NRT) is effective for smoking cessation in non-pregnant people, there is no direct evidence concerning its effectiveness in pregnancy. Despite this, clinical guidelines recommend the cautious use of NRT during pregnancy. Randomised controlled trials are needed to determine the safety and efficacy of NRT when used by pregnant women for smoking cessation, but the feasibility of recruiting women to such trials is unknown. Consequently, in this study we aimed to determine i) the feasibility of recruiting women to a RCT of NRT in pregnancy as they attend hospital antenatal ultrasound examinations, ii) the proportion of such women who are eligible for and interested in trial enrollment and iii) research staff perceptions of how one method of trial recruitment could be improved. METHODS: During a one month period, all women attending for antenatal ultrasound examination in an English teaching hospital were asked to complete a questionnaire which determined their eligibility to enroll in a proposed placebo controlled randomised trial investigating the effectiveness of NRT in pregnancy. Women who were eligible to participate were asked whether they would do so and those who accepted enrollment were offered an appointment with a smoking cessation advisor. RESULTS: Over 99% (851/858) of women agreed to complete a questionnaire about smoking habits whilst waiting for ultrasound examinations. 10.3% (88/851) of women attending for antenatal ultrasound fitted eligibility criteria for a proposed RCT of NRT in pregnancy, but only 3.6% [(31/851), 95% CI, 2.4 to 4.9%] indicated on the questionnaire that they would like to take part in a study involving randomisation to placebo or active patches. Researchers offered trial enrollment to 26 of these 31 women and 96% (25) accepted. Staff recruiting women believed that trial recruitment would be maximised if women attending the ultrasound department knew about trial recruitment before attending and greater staff resources were made available for this. It was also perceived that women generally under-reported the amount they smoked on questionnaires completed whilst waiting in ultrasound department areas. CONCLUSIONS: It is feasible to recruit women for a trial of NRT in pregnancy as they wait for antenatal ultrasound examinations. Using similar recruitment methods, researchers can expect to recruit between 24 and 49 women per 1000 approached.