Seasonal vaccination with RTS,S/AS01E vaccine with or without seasonal malaria chemoprevention in children up to the age of 5 years in Burkina Faso and Mali: a double-blind, randomised, controlled, phase 3 trial.

BACKGROUND: Seasonal vaccination with the RTS,S/AS01E vaccine combined with seasonal malaria chemoprevention (SMC) prevented malaria in young children more effectively than either intervention given alone over a 3 year period. The objective of this study was to establish whether the added protection provided by the combination could be sustained for a further 2 years. METHODS: This was a double-blind, individually randomised, controlled, non-inferiority and superiority, phase 3 trial done at two sites: the Bougouni district and neighbouring areas in Mali and Houndé district, Burkina Faso. Children who had been enrolled in the initial 3-year trial when aged 5-17 months were initially randomly assigned individually to receive SMC with sulphadoxine-pyrimethamine and amodiaquine plus control vaccines, RTS,S/AS01E plus placebo SMC, or SMC plus RTS,S/AS01E. They continued to receive the same interventions until the age of 5 years. The primary trial endpoint was the incidence of clinical malaria over the 5-year trial period in both the modified intention-to-treat and per-protocol populations. Over the 5-year period, non-inferiority was defined as a 20% increase in clinical malaria in the RTS,S/AS01E-alone group compared with the SMC alone group. Superiority was defined as a 12% difference in the incidence of clinical malaria between the combined and single intervention groups. The study is registered with ClinicalTrials.gov, NCT04319380, and is complete. FINDINGS: In April, 2020, of 6861 children originally recruited, 5098 (94%) of the 5433 children who completed the initial 3-year follow-up were re-enrolled in the extension study. Over 5 years, the incidence of clinical malaria per 1000 person-years at risk was 313 in the SMC alone group, 320 in the RTS,S/AS01E-alone group, and 133 in the combined group. The combination of RTS,S/AS01E and SMC was superior to SMC (protective efficacy 57·7%, 95% CI 53·3 to 61·7) and to RTS,S/AS01E (protective efficacy 59·0%, 54·7 to 62·8) in preventing clinical malaria. RTS,S/AS01E was non-inferior to SMC (hazard ratio 1·03 [95% CI 0·95 to 1·12]). The protective efficacy of the combination versus SMC over the 5-year period of the study was very similar to that seen in the first 3 years with the protective efficacy of the combination versus SMC being 57·7% (53·3 to 61·7) and versus RTS/AS01E-alone being 59·0% (54·7 to 62·8). The comparable figures for the first 3 years of the study were 62·8% (58·4 to 66·8) and 59·6% (54·7 to 64·0%), respectively. Hospital admissions for WHO-defined severe malaria were reduced by 66·8% (95% CI 40·3 to 81·5), for malarial anaemia by 65·9% (34·1 to 82·4), for blood transfusion by 68·1% (32·6 to 84·9), for all-cause deaths by 44·5% (2·8 to 68·3), for deaths excluding external causes or surgery by 41·1% (-9·2 to 68·3), and for deaths from malaria by 66·8% (-2·7 to 89·3) in the combined group compared with the SMC alone group. No safety signals were detected. INTERPRETATION: Substantial protection against malaria was sustained over 5 years by combining seasonal malaria vaccination with seasonal chemoprevention, offering a potential new approach to malaria control in areas with seasonal malaria transmission. FUNDING: UK Joint Global Health Trials and PATH's Malaria Vaccine Initiative (through a grant from the Bill & Melinda Gates Foundation). TRANSLATION: For the French translation of the abstract see Supplementary Materials section.

Delivery strategies for malaria vaccination in areas with seasonal malaria transmission.

BACKGROUND: Seasonal vaccination with the RTS,S/AS01E malaria vaccine given alongside seasonal malaria chemoprevention (SMC) substantially reduces malaria in young children. The WHO has recommended the use of RTS,S/AS01E, including seasonal vaccination, in areas with seasonal malaria transmission. This study aimed to identify potential strategies to deliver RTS,S/AS01E, and assess the considerations and recommendations for delivery of seasonal malaria vaccination in Mali, a country with highly seasonal malaria. METHODS: Potential delivery strategies for RTS,S/AS01E in areas with seasonal malaria were identified through a series of high level discussions with the RTS,S/AS01E plus SMC trial investigators, international and national immunisation and malaria experts, and through the development of a theory of change. These were explored through qualitative in-depth interviews with 108 participants, including national-level, regional-level and district-level malaria and immunisation programme managers, health workers, caregivers of children under 5 years of age, and community stakeholders. A national-level workshop was held to confirm the qualitative findings and work towards consensus on an appropriate strategy. RESULTS: Four delivery strategies were identified: age-based vaccination delivered via the Essential Programme on Immunisation (EPI); seasonal vaccination via EPI mass vaccination campaigns (MVCs); a combination of age-based priming vaccination doses delivered via the EPI clinics and seasonal booster doses delivered via MVCs; and a combination of age-based priming vaccination doses and seasonal booster doses, all delivered via the EPI clinics, which was the preferred strategy for delivery of RTS,S/AS01E in Mali identified during the national workshop. Participants recommended that supportive interventions, including communications and mobilisation, would be needed for this strategy to achieve required coverage. CONCLUSIONS: Four delivery strategies were identified for administration of RTS,S/AS01E alongside SMC in countries with seasonal malaria transmission. Components of these delivery strategies were defined as the vaccination schedule, and the delivery system(s) plus the supportive interventions needed for the strategies to be effective. Further implementation research and evaluation is needed to explore how, where, when and what effective coverage is achievable via these new strategies and their supportive interventions.

Feasibility and acceptability of telehealth and contactless delivery of human papillomavirus (HPV) self-testing for cervical screening with Maori and Pacific women in a COVID-19 outbreak in Aotearoa New Zealand.

AIM: To determine the feasibility and acceptability of a telehealth offer and contactless delivery of human papillomavirus (HPV) cervical screening self-test during the 2021 COVID-19 Level 4 lockdown in Auckland, New Zealand. METHODS: A small proof-of-concept study was undertaken to test telehealth approaches in never-screened, due or overdue Maori and Pacific women enrolled in a local Primary Health Organisation (PHO). Study invitation, active follow-up, nurse-led discussions, result notification and a post-test questionnaire were all delivered through telehealth. RESULTS: A sample of 197 eligible Maori and Pacific women were invited to take part, of which 86 women were successfully contacted. Sixty-six agreed to take part. Overall uptake was 61 samples returned (31.8%) and uptake of all contactable women was 70.9%. Six of the 61 HPV self-tests (9.8%) were positive, all for non 16/18 types, and were referred for cytology. Three had negative cytology results, and three with positive cytology results were referred for colposcopy. CONCLUSION: The offer of HPV self-testing during COVID-19 lockdown was both feasible and highly acceptable for Maori and Pacific women. Importantly, HPV self-testing via telehealth and mail-out, alongside other options, offers a potential pro-equity approach for addressing the impact of deferred screens due to COVID-19 and other longstanding coverage issues.

The duration of protection against clinical malaria provided by the combination of seasonal RTS,S/AS01E vaccination and seasonal malaria chemoprevention versus either intervention given alone.

BACKGROUND: A recent trial of 5920 children in Burkina Faso and Mali showed that the combination of seasonal vaccination with the RTS,S/AS01E malaria vaccine (primary series and two seasonal boosters) and seasonal malaria chemoprevention (four monthly cycles per year) was markedly more effective than either intervention given alone in preventing clinical malaria, severe malaria, and deaths from malaria. METHODS: In order to help optimise the timing of these two interventions, trial data were reanalysed to estimate the duration of protection against clinical malaria provided by RTS,S/AS01E when deployed seasonally, by comparing the group who received the combination of SMC and RTS,S/AS01E with the group who received SMC alone. The duration of protection from SMC was also estimated comparing the combined intervention group with the group who received RTS,S/AS01E alone. Three methods were used: Piecewise Cox regression, Flexible parametric survival models and Smoothed Schoenfeld residuals from Cox models, stratifying on the study area and using robust standard errors to control for within-child clustering of multiple episodes. RESULTS: The overall protective efficacy from RTS,S/AS01E over 6 months was at least 60% following the primary series and the two seasonal booster doses and remained at a high level over the full malaria transmission season. Beyond 6 months, protective efficacy appeared to wane more rapidly, but the uncertainty around the estimates increases due to the lower number of cases during this period (coinciding with the onset of the dry season). Protection from SMC exceeded 90% in the first 2-3 weeks post-administration after several cycles, but was not 100%, even immediately post-administration. Efficacy begins to decline from approximately day 21 and then declines more sharply after day 28, indicating the importance of preserving the delivery interval for SMC cycles at a maximum of four weeks. CONCLUSIONS: The efficacy of both interventions was highest immediately post-administration. Understanding differences between these interventions in their peak efficacy and how rapidly efficacy declines over time will help to optimise the scheduling of SMC, malaria vaccination and the combination in areas of seasonal transmission with differing epidemiology, and using different vaccine delivery systems. TRIAL REGISTRATION: The RTS,S-SMC trial in which these data were collected was registered at clinicaltrials.gov: NCT03143218.

Human papillomavirus self-testing among unscreened and under-screened Maori, Pasifika and Asian women in Aotearoa New Zealand: A preference survey among responders and interviews with clinical-trial nonresponders.

INTRODUCTION: Maori, Pasifika and Asian women are less likely to attend cervical screening and Maori and Pasifika women are more likely to be diagnosed with later-stage cervical cancer than other women in Aotearoa New Zealand. This study-with under-screened women taking part in a randomized-controlled trial comparing self-testing and standard screening-explored the acceptability of a human papillomavirus (HPV) self-test kit and the preferred method for receiving it. METHODS: Maori, Pasifika and Asian women (N= 376) completed a cross-sectional postal questionnaire. Twenty-six women who had not accepted the trial invitation were interviewed to understand their reasons for nonparticipation. RESULTS: Most women found the self-test kit easy and convenient to use and reported that they did not find it painful, uncomfortable or embarrassing. This was reflected in the preference for a self-test over a future smear test on the same grounds. Most women preferred to receive the kit by mail and take the test themselves, rather than having it done by a doctor or nurse. There was a range of preferences relating to how to return the kit. Phone calls with nonresponders revealed that, although most had received the test kit, the reasons for not choosing to be involved included not wanting to, being too busy or forgetting. CONCLUSION: HPV self-testing was acceptable for Maori, Pasifika and Asian women in Aotearoa New Zealand. HPV self-testing has considerable potential to reduce the inequities in the current screening programme and should be made available with appropriate delivery options as soon as possible. PATIENT OR PUBLIC CONTRIBUTION: This study explored the acceptability of HPV self-testing and their preferences for engaging with it among Maori, Pasifika and Asian women. Thus, women from these underserved communities were the participants and focus of this study.

Challenges and lessons learned during the planning and early implementation of the RTS,S/AS01E malaria vaccine in three regions of Ghana: a qualitative study.

BACKGROUND: In 2019, the RTS,S/AS01E malaria vaccine was introduced on a pilot basis in six regions of Ghana by the Ministry of Health/Ghana Health Service as part of the WHO-coordinated Malaria Vaccine Implementation Programme (MVIP). This is the first time a malaria vaccination programme has been implemented in any country. This paper describes the challenges faced, and lessons learned, during the planning and early implementation of the RTS,S/AS01E vaccine in three out of the six regions that implemented the programme in Ghana. METHODS: Twenty-one in-depth interviews were conducted with regional and district health service managers and frontline health workers three months after the start of MVIP in May 2019. Data were coded using NVivo software version 12 and a coding framework was developed to support thematic analysis to identify the challenges and lessons learned during the RTS,S/AS01E implementation pilot, which were also categorized into the Consolidated Framework for Implementation Research (CFIR). RESULTS: Participants reported challenges related to the characteristics of the intervention, such as issues with the vaccine schedule and eligibility criteria, and challenges related to how it was implemented as a pilot programme. Additionally, major challenges were faced due to the spread of rumours leading to vaccine refusals; thus, the outer setting of the CFIR was adapted to accommodate rumours within the community context. Health service managers and frontline health workers also experienced challenges with the process of implementing RTS,S/AS01E, including inadequate sensitization and training, as well as issues with the timeline. They also experienced challenges associated with the features of the systems within which the vaccine was being implemented, including inadequate resources for cold-chain at the health facility level and transportation at the district and health facility levels. This study identified the need for a longer, more intensive and sustained delivery of contextually-appropriate sensitization prior to implementation of a programme such as MVIP. CONCLUSIONS: This study identified 12 main challenges and lessons learned by health service managers and health workers during the planning and early implementation phases of the RTS,S/AS01E pilot introduction in Ghana. These findings are highly relevant to the likely scale-up of RTS,S/AS01E within Ghana and possible implementation in other African countries, as well as to other future introductions of novel vaccines.

Impact of seasonal RTS,S/AS01E vaccination plus seasonal malaria chemoprevention on the nutritional status of children in Burkina Faso and Mali.

BACKGROUND: A recent trial in Burkina Faso and Mali showed that combining seasonal RTS,S/AS01E malaria vaccination with seasonal malaria chemoprevention (SMC) substantially reduced the incidence of uncomplicated and severe malaria in young children compared to either intervention alone. Given the possible negative effect of malaria on nutrition, the study investigated whether these children also experienced lower prevalence of acute and chronic malnutrition. METHODS: In Burkina Faso and Mali 5920 children were randomized to receive either SMC alone, RTS,S/AS01E alone, or SMC combined with RTS,S/AS01E for three malaria transmission seasons (2017-2019). After each transmission season, anthropometric measurements were collected from all study children at a cross-sectional survey and used to derive nutritional status indicators, including the binary variables wasted and stunted (weight-for-height and height-for-age z-scores below - 2, respectively). Binary and continuous outcomes between treatment groups were compared by Poisson and linear regression. RESULTS: In 2017, compared to SMC alone, the combined intervention reduced the prevalence of wasting by approximately 12% [prevalence ratio (PR) = 0.88 (95% CI 0.75, 1.03)], and approximately 21% in 2018 [PR = 0.79 (95% CI 0.62, 1.01)]. Point estimates were similar for comparisons with RTS,S/AS01E, but there was stronger evidence of a difference. There was at least a 30% reduction in the point estimates for the prevalence of severe wasting in the combined group compared to the other two groups in 2017 and 2018. There was no difference in the prevalence of moderate or severe wasting between the groups in 2019. The prevalence of stunting, low-MUAC-for-age or being underweight did not differ between groups for any of the three years. The prevalence of severe stunting was higher in the combined group compared to both other groups in 2018, and compared to RTS,S/AS01E alone in 2017; this observation does not have an obvious explanation and may be a chance finding. Overall, malnutrition was very common in this cohort, but declined over the study as the children became older. CONCLUSIONS: Despite a high burden of malnutrition and malaria in the study populations, and a major reduction in the incidence of malaria in children receiving both interventions, this had only a modest impact on nutritional status. Therefore, other interventions are needed to reduce the high burden of malnutrition in these areas. TRIAL REGISTRATION: https://www.clinicaltrials.gov/ct2/show/NCT03143218 , registered 8th May 2017.

Human Papillomavirus (HPV) Self-Sampling among Never-and Under-Screened Indigenous Maori, Pacific and Asian Women in Aotearoa New Zealand: A Feasibility Study.

In Aotearoa, New Zealand, the majority of cervical cancer cases occur in women who have never been screened or are under-screened. Wahine Maori, Pacific and Asian women have the lowest rate of cervical screening. Self-sampling for human papillomavirus (HPV-SS) has been shown to increase participation in cervical cancer screening. A whole-of-system approach, driven by evidence in the most effective delivery of HPV-SS, is required to mitigate further widening of the avoidable gap in cervical screening access and outcomes between groups of women in Aotearoa. This single-arm feasibility and acceptability study of HPV self-sampling invited never- and under-screened (≥5 years overdue) 30-69-year-old women from general practices in Auckland, Aotearoa. Eligible women were identified by data matching between the National Cervical Programme (NCSP) Register and practice data. Focus groups were additionally held with eligible wahine Maori, Asian and Pacific women to co-design new patient information materials. Questionnaires on HPV knowledge and post-test experience were offered to women. Our follow-up protocols included shared decision-making principles, and we committed to follow-up ≥90% of women who tested positive for HPV. Data matching identified 366 eligible never- and under-screened wahine Maori, Pacific and Asian women in participating practices. We were only able to contact 114 women, and 17, during the discussion, were found to be ineligible. Identifying and contacting women overdue for a cervical screen was resource-intensive, with a high rate of un-contactability despite multiple attempts. We found the best uptake of self-sampling was at focus groups. Of the total 84 HPV-SS tests, there were five positive results (6%), including one participant with HPV18 who was found to have a cervical Adenocarcinoma at colposcopy. In our feasibility study, self-sampling was acceptable and effective at detecting HPV and preventing cervical cancer in under-screened urban wahine Maori, Pacific and Asian women in Aotearoa. This is the first report of cervical Adenocarcinoma (Grade 1B) as a result of an HPV-18 positive self-sample in Aotearoa. We co-designed new patient information materials taking a health literacy and ethnicity-specific approach. This work provides policy-relevant information to the NCSP on the resources required to implement an effective HPV self-sampling programme to improve equity in national cervical cancer screening.

Acceptability of human papillomavirus (HPV) self-sampling among never- and under-screened Indigenous and other minority women: a randomised three-arm community trial in Aotearoa New Zealand.

BACKGROUND: Internationally, self-sampling for human papillomavirus (HPV) has been shown to increase participation in cervical-cancer screening. In Aotearoa New Zealand, there are long-standing ethnic inequalities in cervical-cancer screening, incidence, and mortality, particularly for indigenous Maori women, as well as Pacific and Asian women. METHODS: We invited never- and markedly under-screened (≥5 years overdue) 30-69-year-old Maori, Pacific, and Asian women to participate in an open-label, three-arm, community-based, randomised controlled trial, with a nested sub-study. We aimed to assess whether two specific invitation methods for self-sampling improved screening participation over usual care among the least medically served populations. Women were individually randomised 3:3:1 to: clinic-based self-sampling (CLINIC - invited to take a self-sample at their usual general practice); home-based self-sampling (HOME - mailed a kit and invited to take a self-sample at home); and usual care (USUAL - invited to attend a clinic for collection of a standard cytology sample). Neither participants nor research staff could be blinded to the intervention. In a subset of general practices, women who did not participate within three months of invitation were opportunistically invited to take a self-sample, either next time they attended a clinic or by mail. FINDINGS: We randomised 3,553 women: 1,574 to CLINIC, 1,467 to HOME, and 512 to USUAL. Participation was highest in HOME (14.6% among Maori, 8.8% among Pacific, and 18.5% among Asian) with CLINIC (7.0%, 5.3% and 6.9%, respectively) and USUAL (2.0%, 1.7% and 4.5%, respectively) being lower. In fully adjusted models, participation was statistically significantly more likely in HOME than USUAL: Maori OR=9.7, (95%CI 3.0-31.5); Pacific OR=6.0 (1.8-19.5); and Asian OR=5.1 (2.4-10.9). There were no adverse outcomes reported. After three months, 2,780 non-responding women were invited to participate in a non-randomised, opportunistic, follow-on substudy. After 6 months,192 (6.9%) additional women had taken a self-sample. INTERPRETATION: Using recruitment methods that mimic usual practice, we provide critical evidence that self-sampling increases screening among the groups of women (never and under-screened) who experience the most barriers in Aotearoa New Zealand, although the absolute level of participation through this population approach was modest. Follow-up for most women was routine but a small proportion required intensive support. TRIAL REGISTRATION: ANZCTR Identifier: ACTRN12618000367246 (date registered 12/3/2018) https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371741&isReview=true; UTN: U1111-1189-0531. FUNDING: Health Research Council of New Zealand (HRC 16/405). PROTOCOL: http://publichealth.massey.ac.nz/assets/Uploads/Study-protocol-V2.1Self-sampling-for-HPV-screening-a-community-trial.pdf.

Correction to: Comparison of two invitation-based methods for human papillomavirus (HPV) self-sampling with usual care among un- and under-screened Maori, Pacific and Asian women: study protocol for a randomised controlled community trial to examine the effect of self-sampling on participation in cervical-cancer screening.

Following publication of the original article [1], the authors reported an error in the authorship list associated with the paper. Georgina McPherson has therefore been added.

Comparison of two invitation-based methods for human papillomavirus (HPV) self-sampling with usual care among un- and under-screened Maori, Pacific and Asian women: study protocol for a randomised controlled community trial to examine the effect of self-sampling on participation in cervical-cancer screening.

BACKGROUND: Maori, Pacific and Asian women in New Zealand have lower cervical-cancer screening rates than European women, and there are persistent inequities in cervical cancer outcomes for Maori and Pacific women. Innovative ways to address access barriers are required. New Zealand is transitioning to screening with human papillomavirus (HPV) DNA testing, which could allow women themselves, rather than a clinician, to take the sample. Internationally, self-sampling has been found to increase screening participation rates. The aim of this open-label community-based randomised controlled trial is to investigate whether self-sampling increases screening participation among un- and under-screened Maori, Pacific and Asian women in New Zealand. METHODS/DESIGN: We aim to invite at least 3550 un- or under-screened (≥5 years overdue) Maori, Pacific and Asian women (1050, 1250, 1250 respectively), aged 30-69 years, for screening. The three study arms are: usual care in which women are invited to attend a clinic for a standard clinician-collected cytology test; clinic-based self-sampling in which women are invited to take a self-sample at their usual general practice; and mail-out self-sampling in which women are mailed a kit and invited to take a self-sample at home. Women will be randomised 3:3:1 to the clinic and mail-out self-sampling groups, and usual care. There is also a nested sub-study in which non-responding women in all allocation groups, when they subsequently present to the clinic for other reasons, are offered clinic or home-kit self-sampling. The primary outcome will be the proportion of women who participate (by taking a self-sample or cytology test). DISCUSSION: This trial is the first to evaluate the effectiveness of mailed self-sampling in New Zealand and will be one of the first internationally to evaluate the effectiveness of opportunistic in-clinic invitations for self-sampling. The trial will provide robust evidence on the impact on participation proportions from different invitation approaches for HPV self-sampling in New Zealand un- and under-screened Maori, Pacific and Asian women. TRIAL REGISTRATION: ANZCTR Identifier: ACTRN12618000367246 (date registered 12/3/2018) https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371741&isReview=true; UTN: U1111-1189-0531.

Elective caesarean delivery: a mixed method qualitative investigation.

BACKGROUND: the rates of primary, repeat, and elective caesarean deliveries have risen dramatically over the past several decades. The reasons for the rise are complex and likely reflect a cultural shift to a greater acceptance of surgical birth as a reasonable option, which may favour infant over maternal outcomes. The purpose of this interpretive qualitative study was to explore the complexities of women's and clinicians' choices around elective caesarean delivery. METHOD: this analysis was part of an institutional ethnography to understand the complex issues of childbearing care. Two English National Health Service Maternity Service Providers in an inner city setting were chosen for their reputation for commitment to normalising birth and decreasing caesarean birth rate. A sample of 27 women and 34 clinicians (midwifery, obstetric, anaesthesia) were interviewed and/or observed in practice settings. We also conducted a documentary analysis of local policy guidelines on elective caesarean delivery. Narrative analysis was conducted on interview, field observation, and document review data. Coding was conducted by three independent analysts and checked for consistency using Atlas.ti qualitative software. RESULTS: variations on elective caesarean choice and outcomes seemed to reflect how the team worked together and their underlying philosophies and commitments about caesarean birth. Four themes reflected the issues around elective caesarean birth: (1) the culture of caesarean, (2) caesarean counseling, (3) perceptions of choice and (4) negotiating the rules. CONCLUSIONS: counselling about elective caesarean and vaginal birth after a prior caesarean is complex and reflects an intersection of culture and science. Women and clinicians enter the discussion with different backgrounds and concerns, but ultimately want the best outcome possible. Future exploration should address shared decision-making, evidence-based clinical guidelines, and the social context of care.

An evaluation of the self-management support capacity of providers of chronic condition primary care.

Self-management support (SMS) is an important skill for health professionals providing chronic condition management in the primary health care sector. Training in SMS alone does not always lead to its utilisation. This study aimed to ascertain whether SMS is being used, and to identify barriers and enablers for SMS in practice. Health professionals who underwent SMS training were invited to participate in a semi-structured interview. A response rate of 55% (14 of 24) was achieved. All interviewees rated their understanding of the principles of SMS as moderate or better. In relation to how much they use these principles in their practice, several (5 of 14) said minimally or not at all. The tools they were most likely to use were SMART goals (8 of 14) and decision balance (5 of 14). Core skills that were being used included problem solving (11 of 14), reflective listening (13 of 14), open-ended questions (12 of 14), identifying readiness to change (12 of 14) and goal setting (10 of 14). The most important barriers to implementing SMS were current funding models for health care, lack of space and staff not interested in change. The most highly rated enabling strategies were more training for general practitioners and more training for practice nurses; the lowest rated was more training for receptionists. The increasing prevalence of chronic conditions due to ageing and lifestyle factors must be addressed through new ways of delivering primary health care services. Self-management support is a necessary component of such programs, so identified barriers to SMS must be overcome.

Getting to the heart of care.

Taking up my role as a support nurse at the Cardiomyopathy Association has been a fascinating career move, building on my background in intensive and cardiac care, and vascular surgery.

Awareness of obesity and diabetes: a survey of a subset of British male drivers.

UNLABELLED: Behavior modification necessary to tackle obesity and type 2 diabetes mellitus (T2DM) requires individual awareness of the existing problem. OBJECTIVES: This study aimed to assess body weight perception, awareness of the relation between adiposity and T2DM, and the relation between adiposity and weight loss attempts. METHODS: Male drivers were recruited randomly from motorway service stations between May and July 2007, completed a questionnaire and had body mass index (BMI), waist circumference (WC), and body composition. RESULTS: Participants included 266 men, median age 52 years, and BMI 28.25 kg/m2. Obesity prevalence was 46% based on BMI and 73% based on WC. Participants underestimated their WC (94.3 ± 10.2 vs. 102.9 ± 11.41 cm, estimated vs. actual, p < .001). Of participants with normal BMI, 18% thought they were overweight, whereas 26% of overweight thought they were "just right" and 19% of obese recognized their obesity. Based on WC, 30% of participants with normal WC thought they were obese and 9% of obese realized they were obese. Only 25% and 42% of participants recognized that T2DM is associated with large waist and obesity, respectively. A total of 81% of overweight and 62% of obese participants (based on BMI) believed that they were not at increased risk of T2DM. Self-perception of adiposity weakly predicted weight loss attempts (λ = 0.28, p = .008). CONCLUSION: Male drivers significantly underestimate their adiposity and risk of T2DM. Further public education regarding obesity, its associated health risks, and the benefits of weight loss is needed.

Normalizing birth in England: a qualitative study.

INTRODUCTION: This study examined factors that foster or hinder the support of normal birth in two English National Health Service Trusts identified for public recognition of their work to normalize birth. METHODS: This interpretative qualitative study was guided by institutional ethnographic and narrative methods. Purposive sampling was conducted to achieve maximal variation across social, demographic, cultural and ethnic groups. In-depth interviews explored clinician's and women's views and experiences of normal birth. Ethnographic observations of practice, clinical and administrative meetings, educational sessions, and informal discussions were conducted over 6 months at one of the maternity settings. Antenatal and intrapartum clinical guidelines were reviewed and analyzed. RESULTS: Three key strategies supported the normalization of birth: 1) an "ethos" of normality; 2) "working" the evidence; and 3) "trusting" women to make informed choices best for them. Inappropriate use of technology, disregarding risk status when assigning women to units, lack of physician preparation in normal birth, and poor staffing levels were cited as barriers. DISCUSSION: These strategies should be carefully examined for translation to the United States and future research.

How to put all your eggs in one basket: empirical patterns of offspring provisioning throughout a mother's lifetime.

Maternal effects arise when a mother's phenotype or the environment she experiences influences the phenotype of her progeny. Most studies of adaptive maternal effects are a "snapshot" of a mother's lifetime offspring provisioning and do not generally consider the effects of earlier siblings on those produced later. Here we show that in soil mites, offspring provisioning strategies are dynamic, changing from an emphasis on egg number in young females to egg size in older females. This pattern may be adaptive if it increases the survival of younger offspring that must compete with older, larger siblings. The dynamic shift in egg provisioning was greater in high-food environments in which females lived longer, creating increasing asymmetry in offspring competitive abilities. Females reared in isolation and in the presence of a high-density colony had identical provisioning strategies, suggesting that, unlike males in this species, females do not use pheromones to assess colony size. Our findings suggest that the adaptive significance of maternal effects may be misinterpreted when studies consider only a snapshot of a female's offspring provisioning strategy or when components of the offspring provisioning strategy are studied in isolation.