Assessing the solutions to tobacco control's funding gap problem.

Since its entry into force in February 2005, the WHO Framework Convention on Tobacco Control (FCTC) has had many significant achievements. It is one of the most widely ratified treaties within the United Nations; its Conference of the Parties has adopted many high-quality implementation guidelines, and implementation of the policy guidance in the treaty and its guidelines have decreased tobacco consumption and prevalence. Despite the effectiveness of these measures, however, FCTC implementation has been highly uneven across countries. A medium-term strategic plan was launched to clearly articulate a small number of priority areas for action in order to accelerate the pace of progress-the Global Strategy to Accelerate Tobacco Control (2019-2025)-but several barriers block its success, including the chronic lack of sustainable, long-term funding. Governments need adequate funds in order to implement FCTC policies and interventions, but many do not have the necessary resources. The global funding gap for tobacco control has been estimated at US$427.4 billion, with no signs of shrinking in the face of the ongoing pandemic. This paper is concerned with the analysis of solutions to the funding gap problem, assessing possibilities according to feasibility, opportunities, and past or potential effectiveness. Existing solutions include Official Development Assistance, FCTC extrabudgetarily funded projects like the FCTC 2030 project and domestic resource mobilisation via tobacco taxation. The paper will also consider new options including pooled funding mechanisms. Ultimately, a combination of solutions must be pursued in order to ensure Parties' national tobacco control budgets are funded in line with FCTC and Global Strategy priorities.

MENOS4 trial: a multicentre randomised controlled trial (RCT) of a breast care nurse delivered cognitive behavioural therapy (CBT) intervention to reduce the impact of hot flushes in women with breast cancer: Study Protocol.

BACKGROUND: Women who have been treated for breast cancer may identify vasomotor symptoms, such as hot flushes and night sweats (HFNS), as a serious problem. HFNS are unpleasant to experience and can have a significant impact on daily life, potentially leading to reduced adherence to life saving adjuvant hormonal therapy. It is known that Cognitive Behavioural Therapy (CBT) is effective for the alleviation of hot flushes in both well women and women who have had breast cancer. Most women with breast cancer will see a breast care nurse and there is evidence that nurses can be trained to deliver psychological treatments to a satisfactory level, whilst also maintaining treatment fidelity. The research team will assess whether breast care nurses can effectively deliver a CBT intervention to alleviate hot flushes in women with breast cancer. METHODS: This study is a multi-centre phase III individually randomised controlled trial of group CBT versus usual care to reduce the impact of hot flushes in women with breast cancer. 120-160 women with primary breast cancer experiencing seven or more problematic HFNS a week will be randomised to receive either treatment as usual (TAU) or participation in the group CBT intervention plus TAU (CBT Group). A process evaluation using May's Normalisation Process Theory will be conducted, as well as practical and organisational issues relating to the implementation of the intervention. Fidelity of implementation of the intervention will be conducted by expert assessment. The cost effectiveness of the intervention will also be assessed. DISCUSSION: There is a need for studies that enable effective interventions to be implemented in practice. There is good evidence that CBT is helpful for women with breast cancer who experience HFNS, yet it is not widely available. It is not yet known whether the intervention can be effectively delivered by breast care nurses or implemented in practice. This study will provide information on both whether the intervention can effectively help women with hot flushes and whether and how it can be translated into routine clinical practice. TRIAL REGISTRATION: ISRCTN 12824632 . Registered 25-01-2017.

Improving recruitment to clinical trials during pregnancy: A mixed methods investigation.

OBJECTIVE: To identify reasons underlying women's refusal to participate in a pregnancy trial and to identify ways of increasing recruitment. DESIGN: Mixed methods study using a questionnaire and qualitative interviews. SAMPLE: A questionnaire asking them to indicate reasons for their decision was completed by 296 pregnant women who declined to participate in one of two trials of nutritional supplementation in a large teaching hospital in southern England. Qualitative interview data were collected from two samples of pregnant women: 1) 30 women who declined to participate in a trial but completed the questionnaire; and 2) 44 women who participated in a trial. RESULTS: Questionnaire data from pregnant women who declined to participate suggested the major barriers to participation were study requirements, including taking study medication, having a bone scan or blood tests, or being too busy. Thematic analysis of interview data identified differences in self-efficacy and levels of trust in medical research between participants and decliners. Participants believed that the research would cause no harm, while decliners felt they or their unborn child would be at risk. When faced with potential obstacles, participants found ways around them while decliners felt they were insurmountable. CONCLUSIONS: Recruitment methods for pregnancy trials should focus on building women's trust in the trial, and on enhancing women's self-efficacy so they feel able to meet trial requirements. Suggestions for building trust include investing time in open, honest discussion of the risks and benefits of participation, improving visibility of the research team, testimonials from previous participants and advertising study safety and ethical conduct. Self-efficacy can be enhanced by training research staff in empowering styles of communication enabling women to feel heard and supported to problem-solve. These strategies could be implemented relatively easily into pregnancy trial protocols, and their effectiveness tested through their impact on recruitment rates.

A Systematic Review of Digital Interventions for Improving the Diet and Physical Activity Behaviors of Adolescents.

Many adolescents have poor diet and physical activity behaviors, which can lead to the development of noncommunicable diseases in later life. Digital platforms offer inexpensive means of delivering health interventions, but little is known about their effectiveness. This systematic review was conducted to synthesize evidence on the effectiveness of digital interventions to improve diet quality and increase physical activity in adolescents, to effective intervention components and to assess the cost-effectiveness of these interventions. Following a systematic search, abstracts were assessed against inclusion criteria, and data extraction and quality assessment were performed for included studies. Data were analyzed to identify key features that are associated with significant improvement in behavior. A total of 27 studies met inclusion criteria. Most (n = 15) were Web site interventions. Other delivery methods were text messages, games, multicomponent interventions, emails, and social media. Significant behavior change was often seen when interventions included education, goal setting, self-monitoring, and parental involvement. None of the publications reported cost-effectiveness. Due to heterogeneity of studies, meta-analysis was not feasible.It is possible to effect significant health behavior change in adolescents through digital interventions that incorporate education, goal setting, self-monitoring, and parental involvement. Most of the evidence relates to Web sites and further research into alternate media is needed, and longer term outcomes should be evaluated. There is a paucity of data on the cost-effectiveness of digital health interventions, and future trials should report these data.

Translating Developmental Origins: Improving the Health of Women and Their Children Using a Sustainable Approach to Behaviour Change.

Theories of the developmental origins of health and disease imply that optimising the growth and development of babies is an essential route to improving the health of populations. A key factor in the growth of babies is the nutritional status of their mothers. Since women from more disadvantaged backgrounds have poorer quality diets and the worst pregnancy outcomes, they need to be a particular focus. The behavioural sciences have made a substantial contribution to the development of interventions to support dietary changes in disadvantaged women. Translation of such interventions into routine practice is an ideal that is rarely achieved, however. This paper illustrates how re-orientating health and social care services towards an empowerment approach to behaviour change might underpin a new developmental focus to improving long-term health, using learning from a community-based intervention to improve the diets and lifestyles of disadvantaged women. The Southampton Initiative for Health aimed to improve the diets and lifestyles of women of child-bearing age through training health and social care practitioners in skills to support behaviour change. Analysis illustrates the necessary steps in mounting such an intervention: building trust; matching agendas and changing culture. The Southampton Initiative for Health demonstrates that developing sustainable; workable interventions and effective community partnerships; requires commitment beginning long before intervention delivery but is key to the translation of developmental origins research into improvements in human health.

Southampton PRegnancy Intervention for the Next Generation (SPRING): protocol for a randomised controlled trial.

BACKGROUND: The nutritional status and health of mothers influence the growth and development of infants during pregnancy and postnatal life. Interventions that focus on improving the nutritional status and lifestyle of mothers have the potential to optimise the development of the fetus as well as improve the health of mothers themselves. Improving the diets of women of childbearing age is likely to require complex interventions that are delivered in a socially and culturally appropriate context. In this study we aim to test the efficacy of two interventions: behaviour change (Healthy Conversation Skills) and vitamin D supplementation, and to explore the efficacy of an intervention that combines both, in improving the diet quality and nutritional status of pregnant women. METHODS/DESIGN: Women attending the maternity hospital in Southampton are recruited at between 8 and 12 weeks gestation. They are randomised to one of four groups following a factorial design: Healthy Conversation Skills support plus vitamin D supplementation (1000 IU cholecalciferol) (n = 150); Healthy Conversation Skills support plus placebo (n = 150); usual care plus vitamin D supplementation (n = 150); usual care plus placebo (n = 150). Questionnaire data include parity, sunlight exposure, diet assessment allowing assessment of diet quality, cigarette and alcohol consumption, well-being, self-efficacy and food involvement. At 19 and 34 weeks maternal anthropometry is assessed and blood samples taken to measure 25(OH) vitamin D. Maternal diet quality and 25(OH) vitamin D are the primary outcomes. Secondary outcomes are women's level of self-efficacy at 34 weeks, pregnancy weight gain, women's self-efficacy and breastfeeding status at one month after birth and neonatal bone mineral content, assessed by DXA within the first 14 days after birth. DISCUSSION: This trial is evaluating two approaches to improving maternal diet: a behaviour change intervention and vitamin D supplementation. The factorial design of this trial has the advantage of enabling each intervention to be tested separately as well as allowing exploration of the synergistic effect of both interventions on women's diets and vitamin D levels. TRIAL REGISTRATION: ISRCTN07227232 . Registered on 13 September 2013.

Compound eye formation in the termite Incisitermes minor (Isoptera: Kalotermitidae).

The postembryonic development and caste differentiation patterns of lower termites have been described multiple times in a variety of different species. However, most of these studies focused on gross ontogeny, without carefully describing the maturation of any particular organ or organ system. The few studies that have attempted to correlate caste development and organ differentiation have produced somewhat inconsistent results, especially in the area of eye formation. Therefore, in order to help further elucidate the relationship between eye formation and postembryonic differentiation in lower termites, we studied eye development in the termite, Incisitermes minor (Hagen). Eye formation in I. minor began in the earliest larvae, with only an eye primordium. However, in all later larval stages, characteristic eye structures were observed and were shown to progressively differentiate through larval and nymphal stages. Curiously, pigmentation began with three to eight groups of cells in early larvae and the number of these pigmented groups increased along the developmental time course. Ultimately, a uniformly pigmented eye area was formed by the early nymphal stage. The overall eye area also gradually increased along with normal caste development, but the characteristic lenses seen in a prototypical insect compound eye did not completely form until after the final nymphal stage. Electrophysiological measurements provided clear evidence that eyes were indeed functional at all stages of development where pigment was present. Based upon this data, the eye development pattern in I. minor appeared to follow a divergent pathway from holometabolous insects and an intermediate pathway between typical hemimetabolous eye development and the heterochronic shift observed in other termite species.