Systematic Techniques to Enhance rEtention in Randomised controlled trials: the STEER study protocol

Background Non-retention of participants seriously affects the credibility of clinical trial results and significantly reduces the potential of a trial to influence clinical practice. Non-retention can be defined as instances where participants leave the study prematurely. Examples include withdrawal of consent and loss to follow-up and thus outcome data cannot be obtained. The majority of existing interventions targeting retention fail to describe any theoretical basis for the observed improvement, or lack of improvement. Moreover, most of these interventions lack involvement of participants in their conception and/or design, raising questions about their relevance and acceptability. Many of the causes of non-retention involve people performing a behaviour (e.g. not returning a questionnaire). Behaviour change is difficult, and the importance of a strong theoretical basis for interventions that aim to change behaviour is increasingly recognised. This research aims to develop and pilot theoretically informed, participant-centred, evidence-based behaviour change interventions to improve retention in trials. Methods This research will generate data through semi-structured interviews on stakeholders’ perspectives of the reasons for trial non-retention. It will identify perceived barriers and enablers to trial retention using the Theoretical Domains Framework. The intervention development work will involve identification of behaviour change techniques, using recognised methodology, and co-production of retention interventions through discussion groups with end-users. An evaluation of intervention acceptability and feasibility will be conducted in focus groups. Finally, a ready-to-use evaluation framework to deploy in Studies Within A Trial as well as an explanatory retention framework will be developed for identifying and tackling modifiable issues to improve trial retention. Discussion We believe this to be one of the first studies to apply a theoretical lens to the development of interventions to improve trial retention that have been informed by, and are embedded within, participants’ experiential accounts. By developing and identifying priority interventions this study will support efforts to reduce research waste

Is brief advice in primary care a cost-effective way to promote physical activity?

This article is made available through the Brunel Open Access Publishing Fund. This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 3.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial.Aim: This study models the cost-effectiveness of brief advice (BA) in primary care for physical activity (PA) addressing the limitations in the current limited economic literature through the use of a time-based modelling approach. Methods: A Markov model was used to compare the lifetime costs and outcomes of a cohort of 100 000 people exposed to BA versus usual care. Health outcomes were expressed in terms of quality-adjusted life years (QALYs). Costs were assessed from a health provider perspective (£2010/11 prices). Data to populate the model were derived from systematic literature reviews and the literature searches of economic evaluations that were conducted for national guidelines. Deterministic and probability sensitivity analyses explored the uncertainty in parameter estimates including short-term mental health gains associated with PA. Results: Compared with usual care, BA is more expensive, incurring additional costs of £806 809 but it is more effective leading to 466 QALYs gained in the total cohort, a QALY gain of 0.0047/person. The incremental cost per QALY of BA is £1730 (including mental health gains) and thus can be considered cost-effective at a threshold of £20 000/QALY. Most changes in assumptions resulted in the incremental cost-effectiveness ratio (ICER) falling at or below £12 000/QALY gained. However, when short-term mental health gains were excluded the ICER was £27 000/QALY gained. The probabilistic sensitivity analysis showed that, at a threshold of £20 000/QALY, there was a 99.9% chance that BA would be cost-effective. Conclusions: BA is a cost-effective way to improve PA among adults, provided short-term mental health gains are considered. Further research is required to provide more accurate evidence on factors contributing to the cost-effectiveness of BA.NICE Centre for Public Health Excellenc

Piloting staff education in Australia to reduce falls in older hospital patients experiencing delirium

This study piloted a hospital-based delirium and falls education program to investigate the impacts on staff knowledge and practice plus patient falls. On a medical ward, staff knowledge was compared before and after education sessions. Other data – collected a day before and after program implementation – addressed documentation of patients' delirium and evidence of compliance with falls risk minimization protocols. These data, and numbers of patient falls, were compared before and after program implementation. Almost all ward staff members participated in education sessions (7 doctors, 7 allied health practitioners, and 45 nurses) and knowledge was significantly improved in the 22 who completed surveys both before and after session attendance. Patients assessed as having delirium (5 before implementation, 4 afterwards) were all documented as either confused or delirious. Small changes eventuated in adherence with falls risk management protocols for confused patients and the number of falls decreased. The program merits a stronger emphasis on staff activities relating to the detection, documentation, and management of delirium to inter-professional roles and communication. Evidence of practice enhancement from program implementation should precede rigorous testing of impacts upon falls

Cost-effectiveness of left ventricular assist devices (LVADs) for patients with advanced heart failure : analysis of the British NHS Bridge to Transplant (BTT) program

Background: A previous cost-effectiveness analysis showed that bridge to transplant (BTT) with early design left ventricular assist devices (LVADs) for advanced heart failure was more expensive than medical management while appearing less beneficial. Older LVADs were pulsatile, but current second and third generation LVADs are continuous flow pumps. This study aimed to estimate comparative cost-effectiveness of BTT with durable implantable continuous flow LVADs compared to medical management in the British NHS. Methods and results: A semi-Markov multi-state economic model was built using NHS costs data and patient data in the British NHS Blood and Transplant Database (BTDB). Quality-adjusted life years (QALYs) and incremental costs per QALY were calculated for patients receiving LVADs compared to those receiving inotrope supported medical management. LVADs cost £80,569 ($127,887) at 2011 prices and delivered greater benefit than medical management. The estimated probabilistic incremental cost-effectiveness ratio (ICER) was £53,527 ($84,963)/QALY (95%CI: £31,802–£94,853; $50,479–$150,560) (over a lifetime horizon). Estimates were sensitive to choice of comparator population, relative likelihood of receiving a heart transplant, time to transplant, and LVAD costs. Reducing the device cost by 15% decreased the ICER to £50,106 ($79,533)/QALY. Conclusions: Durable implantable continuous flow LVADs deliver greater benefits at higher costs than medical management in Britain. At the current UK threshold of £20,000 to £30,000/QALY LVADs are not cost effective but the ICER now begins to approach that of an intervention for end of life care recently recommended by the British NHS. Cost-effectiveness estimates are hampered by the lack of randomized trials

Cost-effectiveness of left ventricular assist devices (LVADs) for patients with advanced heart failure : analysis of the British NHS Bridge to Transplant (BTT) program

Background: A previous cost-effectiveness analysis showed that bridge to transplant (BTT) with early design left ventricular assist devices (LVADs) for advanced heart failure was more expensive than medical management while appearing less beneficial. Older LVADs were pulsatile, but current second and third generation LVADs are continuous flow pumps. This study aimed to estimate comparative cost-effectiveness of BTT with durable implantable continuous flow LVADs compared to medical management in the British NHS. Methods and results: A semi-Markov multi-state economic model was built using NHS costs data and patient data in the British NHS Blood and Transplant Database (BTDB). Quality-adjusted life years (QALYs) and incremental costs per QALY were calculated for patients receiving LVADs compared to those receiving inotrope supported medical management. LVADs cost £80,569 ($127,887) at 2011 prices and delivered greater benefit than medical management. The estimated probabilistic incremental cost-effectiveness ratio (ICER) was £53,527 ($84,963)/QALY (95%CI: £31,802–£94,853; $50,479–$150,560) (over a lifetime horizon). Estimates were sensitive to choice of comparator population, relative likelihood of receiving a heart transplant, time to transplant, and LVAD costs. Reducing the device cost by 15% decreased the ICER to £50,106 ($79,533)/QALY. Conclusions: Durable implantable continuous flow LVADs deliver greater benefits at higher costs than medical management in Britain. At the current UK threshold of £20,000 to £30,000/QALY LVADs are not cost effective but the ICER now begins to approach that of an intervention for end of life care recently recommended by the British NHS. Cost-effectiveness estimates are hampered by the lack of randomized trials

A content analysis of oral health messages in Australian mass media

Accepted manuscript online: 27 JAN 2015Background: Social analysis regarding oral health and oral health promotion are almost non-existent in the Australian context. The usefulness of such exploration lies in framing and informing research methodologies and health promotion initiatives and can improve our understanding of oral health behaviours and their social contexts. Methods: We conducted a systematic content analysis of a random sample of popular Australian magazines, newspapers and television shows from May to September 2012. Our sample included the top three best-selling magazines, six weekly newspapers, one from each available Australian state; and the four highest-ranked Australian prime-time television shows and their associated commercials. Results: Data comprised of 72 hours of prime-time television and 14,628 pages of hardcopy media. 71 oral health related media ‘incidents’ were counted during a five month period. Only 1.5% of incidents referenced fluoride and only two made dietary references. Women were represented almost six times more than men and the majority of oral health related incidents conveyed no social context (63%). Conclusions: Oral health messages conveyed in Australian media fail to provide a social context for preventative or health-promoting behaviours. In light of increased levels of oral disease and retention of natural teeth, more community-based oral health promotion and support for oral health literacy would be prudent in the Australian context.Kelly Jones, Jessica Merrick and Christine Beasle

Supporting adherence for people starting a new medication for a long-term condition through community pharmacies: a pragmatic randomised controlled trial of the New Medicine Service

Objective: To examine the effectiveness of the New Medicine Service (NMS), a national community pharmacy service to support medicines-taking in people starting a new medicine for a long-term condition, compared with normal practice. Methods: Pragmatic patient-level parallel randomised controlled trial, in 46 community pharmacies in England. Patients 1:1 block randomisation stratified by drug/disease group within each pharmacy. 504 participants (NMS: 251) aged 14 years and over, identified in the pharmacy on presentation of a prescription for asthma/chronic obstructive pulmonary disease, hypertension, type 2 diabetes or an anticoagulant/antiplatelet agent. NMS intervention: One consultation 7–14 days after presentation of prescription followed by another 14–21 days thereafter to identify problems with treatment and provide support if needed. Controls received normal practice. Adherence, defined as missing no doses without the advice of a medical professional in the previous 7 days, was assessed through patient self-report at 10 weeks. Intention-to-treat analysis was employed, with outcome adjusted for recruiting pharmacy, NMS disease category, age, sex and medication count. Cost to the National Health Service (NHS) was collected. Results: At 10 weeks, 53 patients had withdrawn and 443 (85%) patients were contacted successfully by telephone. In the unadjusted analysis of 378 patients still taking the initial medicine, 61% (95% CI 54% to 67%) and 71% (95% CI 64% to 77%) patients were adherent in the normal practice and NMS arms, respectively (p=0.04 for difference). In the adjusted intention-to-treat analysis, the OR for increased adherence was 1.67 (95% CI 1.06 to 2.62; p=0.027) in favour of the NMS arm. There was a general trend to reduced NHS costs, albeit, statistically non-significant, for the NMS intervention: saving £21 (95% CI −£59 to £100, p=0.128) per patient. Conclusions: The NMS significantly increased the proportion of patients adhering to their new medicine by about 10%, compared with normal practice

Early childhood nutrition concerns, resources, and services for Aboriginal families in Victoria

Abstract Objective: To investigate the child nutrition concerns of Aboriginal families with young children attending Aboriginal health and early childhood services in Victoria; training needs of early childhood practitioners; and sources of nutrition and child health information and advice for Aboriginal families with young children. Method: Qualitative needs assessment involving consultation with Aboriginal parents of young children aged 0–8 years attending Aboriginal health and early childhood services, and early childhood practitioners from Aboriginal health and early childhood services in urban and regional Victoria. Focus groups were conducted with 35 Aboriginal parents and interviews conducted with 45 health and early childhood practitioners. Thematic analysis was used to generate and then refine distinct, internally consistent common themes from the data. Results: The most frequent issues identified were low levels of breastfeeding, inappropriate introduction of solids, reliance on bottles, sweet drinks, and energy‐dense foods, poor oral health and overweight. Concerns about staff training and capacity, and access to maternal and child health services were also common. Conclusion and implication: This study identifies major gaps in service delivery for Aboriginal families with young children and points to the need for a coordinated, culturally responsive systems approach to providing support for breastfeeding and child nutrition advice and support for Aboriginal families, including capacity building for staff, and supportive systems and policy