Barriers and facilitators when implementing midwifery continuity of carer: a narrative analysis of the international literature.

BACKGROUND: Midwifery continuity of carer (MCoC) is a model of care in which the same midwife or small team of midwives supports women throughout pregnancy, birth and the postnatal period. The model has been prioritised by policy makers in a number of high-income countries, but widespread implementation and sustainability has proved challenging. METHODS: In this narrative review and synthesis of the global literature on the implementation and sustainability of midwifery continuity of carer, we identify barriers to, and facilitators of, this model of delivering maternity care. By mapping existing research evidence onto the Consolidated Framework for Implementation Research (CFIR), we identify factors for organisations to consider when planning and implementing midwifery continuity of carer as well as gaps in the current research evidence. RESULTS: Analysing international evidence using the CFIR shows that evidence around midwifery continuity of carer implementation is patchy and fragmented, and that the impetus for change is not critically examined. Existing literature pays insufficient attention to core aspects of the innovation such as the centrality of on call working arrangements and alignment with the professional values of midwifery. There is also limited attention to the political and structural contexts into which midwifery continuity of carer is introduced. CONCLUSIONS: By synthesizing international research evidence with the CFIR, we identify factors for organisations to consider when planning and implementing midwifery continuity of carer. We also call for more systematic and contextual evidence to aid understanding of the implementation or non-implementation of midwifery continuity of carer. Existing evidence should be critically evaluated and used more cautiously in support of claims about the model of care and its implementation, especially when implementation is occurring in different settings and contexts to the research being cited.

Maternal and neonatal outcomes among spontaneous vaginal births occurring in or out of water following intrapartum water immersion: The POOL cohort study.

OBJECTIVE: Warm water immersion during labour provides women with analgesia and comfort. This cohort study aimed to establish among women using intrapartum water immersion analgesia, without antenatal or intrapartum risk factors, whether waterbirth is as safe for them and their babies as leaving the water before birth. DESIGN: Cohort study with non-inferiority design. SETTING: Twenty-six UK NHS maternity services. SAMPLE: A total of 73 229 women without antenatal or intrapartum risk factors, using intrapartum water immersion, between 1 January 2015 and 30 June 2022. The analysis excluded 12 827 (17.5%) women who received obstetric or anaesthetic interventions before birth. METHODS: Non-inferiority analysis of retrospective and prospective data captured in NHS maternity and neonatal information systems. MAIN OUTCOME MEASURES: Maternal primary outcome: obstetric anal sphincter injury (OASI) by parity; neonatal composite primary outcome: fetal or neonatal death, neonatal unit admission with respiratory support or administration of antibiotics within 48 hours of birth. RESULTS: Rates of the primary outcomes were no higher among waterbirths compared with births out of water: rates of OASI among nulliparous women (waterbirth: 730/15 176 [4.8%] versus births out of water: 641/12 210 [5.3%]; adjusted odds ratio [aOR] 0.97, one-sided 95% CI, -∞ to 1.08); rates of OASI among parous women (waterbirth: 269/24 451 [1.1%] versus births out of water 144/8565 [1.7%]; aOR 0.64, one-sided 95% CI -∞ to 0.78) and rates of the composite adverse outcome among babies (waterbirth 263/9868 [2.7%] versus births out of water 224/5078 [4.4%]; aOR 0.65, one-sided 95% CI -∞ to 0.79). CONCLUSION: Among women using water immersion during labour, remaining in the pool and giving birth in water was not associated with an increase in the incidence of adverse primary maternal or neonatal outcomes.

Acceptability and feasibility of a planned preconception weight loss intervention in women with long-acting reversible contraception: the Plan-it mixed-methods study.

BACKGROUND: Women with overweight (a body mass index of ≥ 25 kg/m2) or obesity (a body mass index of ≥ 30 kg/m2) are at greater risk of experiencing complications during pregnancy and labour than women with a healthy weight. Women who remove their long-acting reversible contraception (i.e. coils or implants) are one of the few groups of people who contact services as part of their preparation for conception, creating an opportunity to offer a weight loss intervention. OBJECTIVES: The objectives were to understand if routine NHS data captured the pathway from long-acting reversible contraception removal to pregnancy and included body mass index; to identify the suitable components of a preconception weight loss intervention; and to engage with key stakeholders to determine the acceptability and feasibility of asking women with overweight/obesity to delay the removal of their long-acting reversible contraception in order to take part in a preconception weight loss intervention. DESIGN: This was a preparatory mixed-methods study, assessing the acceptability and feasibility of a potential intervention, using routine NHS data and purposefully collected qualitative data. PARTICIPANTS: The NHS routine data included all women with a long-acting reversible contraception code. There were three groups of participants in the surveys and interviews: health-care practitioners who remove long-acting reversible contraception; weight management consultants; and women of reproductive age with experience of overweight/obesity and of using long-acting reversible contraception. SETTING: UK-based health-care practitioners recruited at professional meetings; and weight management consultants and contraceptive users recruited via social media. DATA SOURCES: Anonymised routine data from UK sexual health clinics and the Clinical Practice Research Datalink, including the Pregnancy Register; and online surveys and qualitative interviews with stakeholders. RESULTS: The records of 2,632,871 women aged 16-48 years showed that 318,040 had at least one long-acting reversible contraception event, with 62% of records including a body mass index. Given the identified limitations of the routine NHS data sets, it would not be feasible to reliably identify women with overweight/obesity who request a long-acting reversible contraception removal with an intention to become pregnant. Online surveys were completed by 100 health-care practitioners, four weight management consultants and 243 contraceptive users. Ten health-care practitioners and 20 long-acting reversible contraception users completed qualitative interviews. A realist-informed approach generated a hypothesised programme theory. The combination of weight discussions and the delay of long-acting reversible contraception removal was unacceptable as an intervention to contraceptive users for ethical and practical reasons. However, a preconception health intervention incorporating weight loss could be acceptable, and one potential programme is outlined. LIMITATIONS: There was very limited engagement with weight management consultants, and the sample of participating stakeholders may not be representative. CONCLUSIONS: An intervention that asks women to delay long-acting reversible contraception removal to participate in a preconception weight loss intervention would be neither feasible nor acceptable. A preconception health programme, including weight management, would be welcomed but requires risk communication training of health-care practitioners. FUTURE WORK: Work to improve routine data sets, increase awareness of the importance of preconception health and overcome health-care practitioner barriers to discussing weight as part of preconception care is a priority. TRIAL REGISTRATION: This trial is registered as ISRCTN14733020. FUNDING: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 27, No. 1.

If a woman has overweight or obesity when she is pregnant, then there is a greater risk of health problems for her and her baby. About half of women of childbearing age have overweight or obesity, so we need to find ways of supporting women to lose weight before they become pregnant (described here as 'preconception'). This can be difficult because women do not usually talk to a health-care practitioner (e.g. general practitioners, sexual health doctors, nurses) about becoming pregnant, but one group of women who do are those who need to have a long-acting reversible contraceptive (e.g. a coil or an implant) removed. This study was designed as preparatory work for a potential future study of a preconception weight loss intervention. We wanted to answer three questions: (1) would women with experience of overweight and of using a long-acting reversible contraceptive think that it would be acceptable to ask women to delay having their long-acting reversible contraceptive removed to take part in a weight loss intervention before pregnancy; (2) what did health-care practitioners think about that idea, and would they be happy to ask women to take part; and (3) can NHS information (routine data) tell us how many women might potentially take part in such an intervention? We looked at NHS routine data and the research on preconception weight loss interventions. A total of 100 health-care practitioners and 243 users of long-acting reversible contraceptives completed surveys, and 10 health-care practitioners and 20 users of long-acting reversible contraceptives took part in interviews. We found that routine data could not be used to identify people reliably. Designing a weight loss intervention that needed women to delay the removal of a long-acting reversible contraceptive was not acceptable to women. A population-based preconception weight loss intervention with a positive focus was acceptable, but, for such a programme to be delivered by the NHS, health-care practitioners need more knowledge, skills and confidence in talking about weight with patients.

The acceptability of asking women to delay removal of a long-acting reversible contraceptive to take part in a preconception weight loss programme: a mixed methods study using qualitative and routine data (Plan-it).

BACKGROUND: Having a body mass index (BMI) which is classified as overweight (BMI ≥ 25) or obese (BMI ≥ 30) increases the risk of complications during pregnancy and labour. Weight-management interventions which target excess gestational weight gain during pregnancy have had limited success. Women who use long-acting reversible contraception (LARC) are in contact with services as part of their preparation for conception, creating a potential opportunity to offer a preconception weight-loss intervention. The aims of this mixed methods study were to assess the acceptability and practicability of a weight-loss intervention which asked people to delay LARC removal in order to lose weight before conceiving. METHODS: Routine UK NHS data were analysed to identify pathways from LARC removal to pregnancy. Qualitative surveys and advisory group discussions with service providers and LARC users with experience of being overweight were conducted and analysed thematically. RESULTS: Three hundred fifteen thousand seven hundred fifty-five UK women aged 16-48 years between 2009-2018 had at least one LARC-related event (e.g. insertion, removal) and 1.7% of those events were recorded as related to planning a pregnancy. BMI was included in 62% of women's records, with 54% of those BMI being classified as overweight or obese. Online surveys were completed by 100 healthcare practitioners and 243 LARC users. Stakeholders identified facilitators and barriers associated with the proposed intervention including sensitivities of discussing weight, service-user past experiences, practitioner skills, the setting and ethical implications of the proposed intervention. CONCLUSIONS: Although women and service providers recognised potential benefits, a preconception weight-loss intervention asking people to delay LARC removal posed many barriers, due mainly to the acceptability of such an intervention to women and healthcare practitioners. Weight-loss interventions that target the general population, together with a focus on improving public knowledge of preconception health, may be more acceptable than interventions which solely focus on LARC users. Many of the barriers identified, including communication, understanding and beliefs about weight and risk, appointment systems and the limitations of routine datasets also have relevance for any preconception weight-loss intervention. Work to improve routine datasets and reducing communication barriers to discussing weight are priorities. TRIAL REGISTRATION: ISRCTN14733020 registered 10.05.2019.

The impact of a specialist home-visiting intervention on the language outcomes of young mothers and their children: a pragmatic randomised controlled trial.

BACKGROUND: Young mothers are more likely to provide a suboptimal early language environment for their children who in turn show impairments in their language development, yet few studies have used observational methods to assess the effectiveness of home-visiting programmes in improving the language outcomes of young mothers and their children. The Family Nurse Partnership (FNP) is a licensed home-visiting intervention developed in the USA and introduced into practice in England. The intervention involves up to 64 structured home visits from early pregnancy until the child's second birthday by specially recruited and trained Family Nurses. We assessed the effectiveness of FNP in improving the language outcomes of first-time teenage mothers and their infants. METHOD: We conducted a pragmatic, non-blinded, randomised controlled trial to test whether the FNP programme improved mothers' and children's language production at 24 months postpartum. Eligible participants were nulliparous, aged 19 years or younger, and were recruited at less than 25 weeks' gestation from community midwifery settings (Country). Pregnant young mothers were randomly assigned to FNP plus usual care (n = 243) or usual care alone (n = 233). At 24 months postpartum, mother-child dyads were observed during a standardised free-play task with their first-born child and features of their language production was coded. Data was analysed using multi-level modelling; linear or poisson/negative binomial regression models were used as appropriate. RESULTS: A small effect of FNP on mothers' productive language was detected, where mothers in the FNP group demonstrated higher mean length of utterances than mothers who received usual care alone, mean difference (adjusted by minimisation variables and by site, linear regression) = 0.10, p < .05, 95% CI (0.004-0.20), d = .18. No differences were detected between groups regarding other characteristics of maternal language or children's language outcomes. CONCLUSION: This observational study conducted within the context of a randomised-controlled trial suggests that the FNP home-visiting programme may have a small, but potentially important impact on young mothers' speech to their toddlers. Exploratory analyses identified family environment, maternal, and child related predictors of the language outcomes of young mothers and their offspring. Trial registration This trial is registered with ISRCTN, number ISRCTN23019866, 20/04/2009.

Factors influencing water immersion during labour: qualitative case studies of six maternity units in the United Kingdom.

BACKGROUND: Water immersion during labour can provide benefits including reduced need for regional analgesia and a shorter labour. However, in the United Kingdom a minority of women use a pool for labour or birth, with pool use particularly uncommon in obstetric-led settings. Maternity unit culture has been identified as an important influence on pool use, but this and other possible factors have not been explored in-depth. Therefore, the aim of this study was to identify factors influencing pool use through qualitative case studies of three obstetric units and three midwifery units in the UK. METHODS: Case study units with a range of waterbirth rates and representing geographically diverse locations were selected. Data collection methods comprised semi-structured interviews, collation of service documentation and public-facing information, and observations of the unit environment. There were 111 interview participants, purposively sampled to include midwives, postnatal women, obstetricians, neonatologists, midwifery support workers and doulas. A framework approach was used to analyse all case study data. RESULTS: Obstetric unit culture was a key factor restricting pool use. We found substantial differences between obstetric and midwifery units in terms of equipment and resources, staff attitudes and confidence, senior staff support and women's awareness of water immersion. Generic factors influencing use of pools across all units included limited access to waterbirth training, sociodemographic differences in desire for pool use and issues using waterproof fetal monitoring equipment. CONCLUSIONS: Case study findings provide new insights into the influence of maternity unit culture on waterbirth rates. Access to pool use could be improved through midwives based in obstetric units having more experience of waterbirth, providing obstetricians and neonatologists with information on the practicalities of pool use and improving accessibility of antenatal information. In terms of resources, recommendations include increasing pool provision, ensuring birth room allocation maximises the use of unit resources, and providing pool room environments that are acceptable to midwives.

Qualitative process evaluation of the Fostering Changes program for foster carers as part of the Confidence in Care randomized controlled trial.

BACKGROUND: Fostering Changes is an in-service training program for foster carers designed to enhance carer skills, coping strategies and carer-child relationships. The training program has been evaluated in a randomised controlled trial comparing Fostering Changes to usual care. OBJECTIVE: To conduct a qualitative process evaluation drawing on stakeholder perspectives to describe the logic model of Fostering Changes, identify potential mechanisms of impact of the program and enhance understanding of the trial results. PARTICIPANTS AND SETTING: Participants were stakeholders in the Fostering Changes program delivered in Wales, UK including foster carers invited to attend the program (18 attendees, eight non-attendees), two program developers, five trainers, 12 social workers who attended or recruited to the program. METHODS: Total population sampling with qualitative data collection methods. Qualitative data were subject to thematic analysis. RESULTS: A logic model summarising the program resources, activities and anticipated outcomes was generated. Implementation themes were quality of training, setting and group composition. Mechanisms of impact were identified with themes falling into two categories, group process and skills development. Potential barriers to effectiveness included a poor fit between the carer needs and the program in relation to levels of challenge being faced, age-appropriate content and responsiveness. Contextual factors were also relevant, including the existing relationship between foster carers and the agency and the perceived value of training. CONCLUSIONS: Although the group aspects of the program were well received, the program itself did not help foster carers deal with more complex challenges and needed to be more targeted in terms of carers needs and circumstances.

A pragmatic randomised controlled trial of the fostering changes programme.

BACKGROUND: Many looked after young people in Wales are cared for by foster or kinship carers, usually as a consequence of maltreatment or developmentally traumatising experiences within a family context. Confidence in Care is a pragmatic unblinded individually randomised controlled parallel group trial evaluating a training programme to improve foster carer self-efficacy, when compared to usual care. OBJECTIVE: To determine whether group-based training improves foster carer self-efficacy. PARTICIPANTS AND SETTING: Participants are foster carers, currently looking after children aged 2+ years for at least 12 weeks. Carers from households where one or more carer had previously attended the training were not eligible. Sixteen local authorities and three independent fostering providers in Wales took part. METHODS: The primary outcome measure was the Carer Efficacy Questionnaire assessed at 12 months. Secondary outcomes included the Strengths and Difficulties Questionnaire, Quality of Attachment Questionnaire, Carer Defined Problems Scale, Carer Coping Strategies, placement moves. RESULTS: 312 consented foster carers were allocated to FC (n = 204) or usual care (n = 108) group. 65.3 % of FC group participants attended sufficient training sessions (8/12, including sessions three and four). There were no differences in carer-reported self-efficacy at 12 months (adjusted difference in means (95 % CI): -0.19 (-1.38 to 1.00)). Small differences in carer-reported child behaviour difficulties and carer coping strategies over time favoured the intervention but these effects diminished from three to 12 months. No other intervention effects were observed. CONCLUSIONS: Although well-received by participants, training was associated with small and mostly short-term benefit for trial secondary outcomes.

Assessing the impact of a family nurse-led intervention on young mothers' references to internal states.

A mother's propensity to refer to internal states during mother-child interactions is important for her child's developing social understanding. However, adolescent mothers are less likely to reference internal states when interacting with their children. We investigated whether young mothers' references to internal states are promoted by the Family Nurse Partnership (FNP) intervention, an intensive home-visiting programme designed to support adolescent mothers in England. We also investigated family, maternal, and child factors associated with young mothers' references to inner states during interactions with their children. Adolescent mothers (n = 483, aged ≤ 19 years when recruited in pregnancy) and their children participated in an observational substudy of a randomized controlled trial investigating the impact of FNP compared to usual care. Mother-child dyads were video-recorded during free play, and mothers' speech was coded for use of internal state language (references to cognitions, desires, emotions, intentions, preferences, physiology, and perception). We found no differences in mothers' use of internal state language between the FNP and usual care groups. A sample-wide investigation identified that other features of mothers' language and relationship status with the child's father were associated with internal state language use. Findings are discussed with reference to targeted interventions and implications for future research.

La tendencia de la madre a referirse a los estados internos durante las interacciones madre-niño es importante para el desarrollo social cognitivo de su niño. Sin embargo, las madres adolescentes están menos propensas a referirse a los estados internos cuando interactúan con sus niños. Investigamos si la tendencia de las madres jóvenes a referirse a estados internos es promovida por la intervención de Asociación entre Familia y Enfermera (FNP), un programa intensivo de visitas a casa diseñado para apoyar a madres adolescentes en el Reino Unido. También investigamos factores de familia, maternos y del niño asociados con las interacciones de las jóvenes madres con sus niños. Las madres adolescentes (n = 483, edad ≤ 19 años) y sus niños participaron en un sub-estudio de observación, un ensayo controlado al azar que investigaba el impacto de FNP comparado con el cuidado usual. Las díadas madre-niño fueron grabadas en video durante el juego libre, y se codificó el habla de las madres en cuanto al uso del lenguaje de estados internos (referencias a cogniciones, deseos, emociones, intenciones, preferencias, fisiología y percepción). No encontramos diferencias en cuanto al uso del lenguaje de estados internos en las madres entre la FNP y los grupos de cuidado usual. Una muestra de investigación amplia identificó que otras características del lenguaje de las madres y condiciones de la relación con el padre del niño estaban asociadas con el uso del lenguaje de estados internos. Los resultados se discuten con referencia a intervenciones elegidas como objetivo e implicaciones para la futura investigación.

La propension d'une mère à faire référence à ses états internes durant les interactions mère-enfant est importante pour le développement social et cognitif de son enfant. Cependant, les mères adolescentes sont moins à même de faire référence à leurs états internes dans leur interaction avec leurs enfants. Notre étude a porté sur si la propension des jeunes mères à faire référence à leurs états internes est promue par l'intervention Partenariat Famille Infirmières (en anglais Family Nurse Partnership, soit FNP), un programme intensif de visite à domicile conçu afin de soutenir les mères adolescentes au Royaume Uni. Nous avons également étudié les facteurs familiaux, maternels, et liés aux enfants, liés aux interactions des jeunes mères avec leurs enfants. Les mères adolescentes (n = 483, âgés ≤ 19 ans) et leurs enfants ont participé à une sous-étude observationnelle d'un essai contrôlé randomisé portant sur l'impact de la FNP comparé aux soins normaux. Les dyades mères-enfant ont été filmées durant un jeu libre et les paroles des mères ont été codées pour son utilisation de langage d'état interne (références aux cognitions, désirs, émotions, intentions, préférences, physiologie et perception). Nous n'avons trouvé aucune différence dans l'utilisation des mères du langage d'état interne entre le groupe FNP et les groupes de contrôle. Une étude de l'échantillon a révélé que d'autres traits du langage des mères et du statut de la relation avec le père de l'enfant étaient liés à l'utilisation de langage de l'état interne. Les résultats sont discutés par rapport aux interventions ciblées et aux implications pour les recherches futures.

The impact of maternal prenatal and postnatal anxiety on children's emotional problems: a systematic review.

Maternal mental health problems during pregnancy and the postnatal period are a major public health issue. Despite evidence that symptoms of both depression and anxiety are common during pregnancy and the postpartum, the impact of maternal anxiety on the child has received relatively less attention than the impact of maternal depression. Furthermore, the evidence base for the direct impact of maternal anxiety during pregnancy and the postpartum on children's emotional outcomes lacks cohesion. The aim of this systematic review is to summarise the empirical evidence regarding the impact of maternal prenatal and postnatal anxiety on children's emotional outcomes. Overall, both maternal prenatal and postnatal anxiety have a small adverse effect on child emotional outcomes. However, the evidence appears stronger for the negative impact of prenatal anxiety. Several methodological weaknesses make conclusions problematic and replication of findings is required to improve the identification of at-risk parents and children with appropriate opportunities for intervention and prevention.

"Keeping it on your radar"-assessing the barriers and facilitators to a timely diagnosis of type 1 diabetes in childhood: A qualitative study from the early detection of type 1 diabetes in youth study.

AIMS: The aim of this study was to explore from the perspectives of key stakeholders involved in the pathway to diagnosis, the barriers and facilitators to a timely diagnosis of type 1 diabetes in childhood. METHODS: Qualitative interviews and free-text analyses were undertaken in 21 parents with a child diagnosed with type 1 diabetes, 60 parents without a child diagnosed with type 1 diabetes, 9 primary healthcare professionals, 9 teachers and 3 community diabetes liaison nurses. Data were analysed thematically and 30% double coded. RESULTS: Two key themes were identified, namely the importance of widespread awareness and knowledge and seeking healthcare professional help. Parents with a child diagnosed with type 1 diabetes described seeking opinions from a number of individuals prior to seeking health professional help. Healthcare professionals recognized the rarity of the condition and the need for it to be kept on their "radar", to ensure they considered it when examining an unwell child. The process of obtaining a primary healthcare appointment was identified as potentially playing a crucial role in the diagnostic process. However, most parents with a child diagnosed with type 1 diabetes described receiving an appointment on the day they sought it. CONCLUSIONS: Knowledge and awareness of type 1 diabetes in childhood remain limited in the general population and misconceptions persist relating to how children present with this serious condition. An effective community-based intervention to raise awareness amongst key stakeholders is required to ensure children receive a timely diagnosis once symptomatic.

Development and Evaluation of a Psychosocial Intervention for Children and Teenagers Experiencing Diabetes (DEPICTED): a protocol for a cluster randomised controlled trial of the effectiveness of a communication skills training programme for healthcare professionals working with young people with type 1 diabetes.

BACKGROUND: Diabetes is the third most common chronic condition in childhood and poor glycaemic control leads to serious short-term and life-limiting long-term complications. In addition to optimal medical management, it is widely recognised that psychosocial and educational factors play a key role in improving outcomes for young people with diabetes. Recent systematic reviews of psycho-educational interventions recognise the need for new methods to be developed in consultation with key stakeholders including patients, their families and the multidisciplinary diabetes healthcare team. METHODS/DESIGN: Following a development phase involving key stakeholders, a psychosocial intervention for use by paediatric diabetes staff and not requiring input from trained psychologists has been developed, incorporating a communication skills training programme for health professionals and a shared agenda-setting tool. The effectiveness of the intervention will be evaluated in a cluster-randomised controlled trial (RCT). The primary outcome, to be measured in children aged 4-15 years diagnosed with type 1 diabetes for at least one year, is the effect on glycaemic control (HbA1c) during the year after training of the healthcare team is completed. Secondary outcomes include quality of life for patients and carers and cost-effectiveness. Patient and carer preferences for service delivery will also be assessed. Twenty-six paediatric diabetes teams are participating in the trial, recruiting a total of 700 patients for evaluation of outcome measures. Half the participating teams will be randomised to receive the intervention at the beginning of the trial and remaining centres offered the training package at the end of the one year trial period. DISCUSSION: The primary aim of the trial is to determine whether a communication skills training intervention for specialist paediatric diabetes teams will improve clinical and psychological outcomes for young people with type 1 diabetes. Previous research indicates the effectiveness of specialist psychological interventions in achieving sustained improvements in glycaemic control. This trial will evaluate an intervention which does not require the involvement of trained psychologists, maximising the potential feasibility of delivery in a wider NHS context. TRIAL REGISTRATION: Current Controlled Trials ISRCTN61568050.