Search

AimTo co-produce with young people an educational package about the human papillomavirus (HPV) vaccine that is tailored to increase vaccine uptake in schools and populations with lower uptake.IntroductionPersistent infection with HPV can result in cancers affecting men and especially women. From September 2019, the English-schools-based HPV vaccination programme was expanded to include young men (in addition to young women) aged 12–13 years. Some young people attending schools with lower uptake of the vaccine have unmet information needs. We hypothesise that mechanisms to address information needs and increase young people’s autonomy in consent procedures will result in higher uptake.Methods and analysisThe Medical Research Council’s framework for development and evaluation of complex interventions will inform intervention development. Recruitment of young people aged 12–15 years and key stakeholders (National Health Service commissioners, school staff, immunisation nurses and youth workers/practitioners) will be facilitated through existing links with healthcare organisations, schools and youth organisations in areas with lower uptake of the HPV vaccination programme. The proposed research will comprise three phases: (1) a rapid review of adolescent immunisation materials and preliminary qualitative interviews with young people and key stakeholders, (2) theory development and co-production of HPV vaccine communication materials through an iterative process with young people and (iii) testing delivery mechanisms and acceptability of the educational package in four schools with lower uptake.Ethics and disseminationThe University of Bristol’s Faculty of Health Sciences and London School of Hygiene and Tropical Medicine's Research Ethics Committees provided approvals for the study. A dissemination event for young people and key stakeholders and webinar with the National Immunisation Network will be organised. The study findings will be published in peer-reviewed journals and presented at conferences. Recommendations for a future larger scale study will be made.

Background: BATHE is a brief psychosocial intervention designed for physician use in patient consultations. The technique has gained some international recognition, but there is currently limited research evidence to demonstrate its acceptability and benefits to patient care. We conducted a pilot cluster randomised controlled trial and feasibility study to explore the use of BATHE as a key component of a person-focused intervention to improve the care of frequent attending patients in UK primary care. Methods: A nested qualitative interview study conducted within a pilot trial. The trial took place in six general practices in the South West of England. Eligible patients had been identified as being in the top 3% of attenders in the previous 12 months. General practitioners (GPs) were trained to use BATHE during a one-hour initial training session, and two top-up trainings which included feedback on implementation fidelity. GPs were asked to use BATHE with their study patients for a period of 12 months. 34 GPs were trained and documented using BATHE in a total of 577 consultations with eligible patients during the intervention period. At the end of the intervention period, GPs and study patients from the intervention practices were invited to take part in an interview. Interviews were semi-structured, audio-recorded and transcribed. Thematic analysis was used. Results: Eleven GPs and 16 patients took part in post-intervention interviews. Benefits of using BATHE included making consultations more person-centred, challenging assumptions that the GP knew what was going on for the patient and their main concerns, and supporting self-management. Difficulties reported included changing existing consultation habits, identifying appropriate consultations in which to use BATHE, and organisational constraints. Conclusions: The study suggests that using BATHE is both acceptable and beneficial but also highlighted some of the difficulties GPs had incorporating BATHE into routine practice. Strategies to reduce these difficulties are needed before the extent of the potential benefits of BATHE can be fully assessed.Trial Registration: ISRCTN62939408 Prospectively registered on 24/06/2015

Despite many countries having physical activity guidelines, there have been few concerted efforts to mobilize this information to the public. The aim of this study was to understand the preferences of under-served community groups about how the benefits of physical activity, and associated guidelines, can be better communicated to the public. Participatory workshops, co-developed between researchers, a local charity, and a community artist, were used to gather data from four groups in Bristol, UK: young people (n = 17), adults (n = 11), older adults (n = 5), and Somali women (n = 15). Workshop content was structured around the study aims. The community artist and/or the local charity delivered the workshops, with researchers gathering data via observation, photos, and audio-recordings, which were analysed using the framework method. All four groups noted that the benefits of physical activity should be included within any communications efforts, though not restricted to health-related benefits. Language used should be simple and jargon-free, terms such as &ldquo, sedentary&rdquo, &ldquo, vigorous&rdquo, and &ldquo, intensity&rdquo, were deemed inaccessible, however all groups liked the message &ldquo, some is good, more is better&rdquo, Views about preferred mechanisms, and messenger, for delivering physical activity messages varied both between, and within, groups. Recommendations for those working in physical activity communications, research, and policy are provided.

The study aim was to assess implementation fidelity (i.e., adherence) to a talk-based primary care intervention using Conversation Analytic (CA) methods. The context was a UK feasibility trial where General Practitioners (GPs) were trained to use “BATHE” (Background, Affect, Trouble, Handling, Empathy) – a technique to screen for psychosocial issues during consultations – with frequently attending patients. 35 GPs received BATHE training between July–October 2015. 15 GPs across six practices self-selected to record a sample of their consultations with study patients at three and six months. 31 consultations were recorded. 21/26 patients in four intervention practices gave permission for analysis. The recordings were transcribed and initially coded for the presence or absence of the five BATHE components. CA methods were applied to assess delivery, focusing on position and composition of each component, and patients’ responses. Initial coding showed most of the BATHE components to be present in most contacts. However the CA analysis revealed unplanned deviations in position and adaptations in composition. Frequently the intervention was initiated too early in the consultation, and the BATHE questions misunderstood by patients as pertaining to their presenting problems rather than the psychosocial context for their problems. Often these deviations resulted in reducing theoretical fidelity of the intervention as a whole. A CA approach enabled a dynamic assessment of the delivery and receipt of BATHE in situ revealing common pitfalls in delivery and provided valuable examples of more and less efficacious implementations. During the trial this evidence was used in top-up trainings to address problems in delivery and to improve GP engagement. Using CA methods enabled a more accurate assessment of implementation fidelity, a fuller description of the intervention itself, and enhanced resources for future training. When positioned appropriately, BATHE can be a useful tool for eliciting information about the wider context of the medical visit.

Objective To assess whether non-clinical staff can effectively manage people at high risk of cardiovascular disease using digital health technologies. Design Pragmatic, multicentre, randomised controlled trial. Setting 42 general practices in three areas of England. Participants Between 3 December 2012 and 23 July 2013 we recruited 641 adults aged 40 to 74 years with a 10 year cardiovascular disease risk of 20% or more, no previous cardiovascular event, at least one modifiable risk factor (systolic blood pressure ≥140 mm Hg, body mass index ≥30, current smoker), and access to a telephone, the internet, and email. Participants were individually allocated to intervention (n=325) or control (n=316) groups using automated randomisation stratified by site, minimised by practice and baseline risk score. Interventions Intervention was the Healthlines service (alongside usual care), comprising regular telephone calls from trained lay health advisors following scripts generated by interactive software. Advisors facilitated self management by supporting participants to use online resources to reduce risk factors, and sought to optimise drug use, improve treatment adherence, and encourage healthier lifestyles. The control group comprised usual care alone. Main outcome measures The primary outcome was the proportion of participants responding to treatment, defined as maintaining or reducing their cardiovascular risk after 12 months. Outcomes were collected six and 12 months after randomisation and analysed masked. Participants were not masked. Results 50% (148/295) of participants in the intervention group responded to treatment compared with 43% (124/291) in the control group (adjusted odds ratio 1.3, 95% confidence interval 1.0 to 1.9; number needed to treat=13); a difference possibly due to chance (P=0.08). The intervention was associated with reductions in blood pressure (difference in mean systolic −2.7 mm Hg (95% confidence interval −4.7 to −0.6 mm Hg), mean diastolic −2.8 (−4.0 to −1.6 mm Hg); weight −1.0 kg (−1.8 to −0.3 kg), and body mass index −0.4 ( −0.6 to −0.1) but not cholesterol −0.1 (−0.2 to 0.0), smoking status (adjusted odds ratio 0.4, 0.2 to 1.0), or overall cardiovascular risk as a continuous measure (−0.4, −1.2 to 0.3)). The intervention was associated with improvements in diet, physical activity, drug adherence, and satisfaction with access to care, treatment received, and care coordination. One serious related adverse event occurred, when a participant was admitted to hospital with low blood pressure. Conclusions This evidence based telehealth approach was associated with small clinical benefits for a minority of people with high cardiovascular risk, and there was no overall improvement in average risk. The Healthlines service was, however, associated with improvements in some risk behaviours, and in perceptions of support and access to care. Trial registration Current Controlled Trials ISRCTN 27508731.

Within nursing education, simulation has been recognised as an effective learning strategy. Embedding simulation within clinical units has the potential to enhance patient safety and improve clinical outcomes. However it is important to evaluate the effectiveness of this educational technique to support the actual value and effectiveness.This study aimed to implement and evaluate an innovative simulation experience for registered nurses.A high-fidelity simulation focusing on nursing assessment was conducted with 50 Registered Nurses in an Emergency Department (ED) at a large tertiary referral hospital. Two questionnaires were completed pre and post simulation to assess anxiety related to participating in the simulation, and self-efficacy in patient assessment. Participant satisfaction and self-confidence in learning was assessed post simulation. Additionally a documentation audit from the patient's electronic chart was completed to review documentation entries before and after participation in the simulation.Anxiety scores decreased significantly from pre (M = 38.56, SD = 9.87) to post (M = 33.54, SD = 8.99), t(49) = 4.273, p 0.001. There was a statistically significant increase in self-efficacy scores from pre (M = 195.16, SD = 28.09) to post (M = 214.12, SD =25.77), t(49) = 5.072, p 0.001. ED nurses were highly satisfied with their simulation training and they were in agreement with the statements about self-confidence in learning. There was a statistically significant increase in two components of the documentation scores; initial clinical handover increased from pre (M = 7.88, SD = 1.76) to post (M = 8.79, SD =1.22), t(41) = 3.41, p 0.001 and indicators of urgent illness increased from pre (M = 7.33, SD = 1.95) to post (M = 8.10, SD = 1.45), t(41) =2.27, p = 0.028.This study has demonstrated that a high fidelity simulation decreased participants' anxiety, increased self-efficiency in patient assessment, and improved documentation in patient records. Additionally ED nurses were highly satisfied with the simulation training.

Background\ud Despite effective assessment methods and medications targeting osteoporosis and related fractures, screening for fracture risk is not currently advocated in the UK. We tested whether a community-based screening intervention could reduce fractures in older women.\ud \ud Methods\ud We did a two-arm randomised controlled trial in women aged 70–85 years to compare a screening programme using the Fracture Risk Assessment Tool (FRAX) with usual management. Women were recruited from 100 general practitioner (GP) practices in seven regions of the UK: Birmingham, Bristol, Manchester, Norwich, Sheffield, Southampton, and York. We excluded women who were currently on prescription anti-osteoporotic drugs and any individuals deemed to be unsuitable to enter a research study (eg, known dementia, terminally ill, or recently bereaved). The primary outcome was the proportion of individuals who had one or more osteoporosis-related fractures over a 5-year period. In the screening group, treatment was recommended in women identified to be at high risk of hip fracture, according to the FRAX 10-year hip fracture probability. Prespecified secondary outcomes were the proportions of participants who had at least one hip fracture, any clinical fracture, or mortality; and the effect of screening on anxiety and health-related quality of life. This trial is registered with the International Standard Randomised Controlled Trial registry, number ISRCTN 55814835.\ud \ud Findings\ud 12 483 eligible women were identified and participated in the trial, and 6233 women randomly assigned to the screening group between April 15, 2008, and July 2, 2009. Treatment was recommended in 898 (14%) of 6233 women. Use of osteoporosis medication was higher at the end of year 1 in the screening group compared with controls (15% vs 4%), with uptake particularly high (78% at 6 months) in the screening high-risk subgroup. Screening did not reduce the primary outcome of incidence of all osteoporosis-related fractures (hazard ratio [HR] 0·94, 95% CI 0·85–1·03, p=0·178), nor the overall incidence of all clinical fractures (0·94, 0·86–1·03, p=0·183), but screening reduced the incidence of hip fractures (0·72, 0·59–0·89, p=0·002). There was no evidence of differences in mortality, anxiety levels, or quality of life.\ud \ud Interpretation\ud Systematic, community-based screening programme of fracture risk in older women in the UK is feasible, and could be effective in reducing hip fractures.\ud \ud Funding\ud Arthritis Research UK and Medical Research Council.\ud \ud

Omalizumab therapy of non-atopic asthmatics reduces bronchial mucosal IgE and inflammation and preserves/improves lung function when disease is destabilised by staged withdrawal of therapy.18 symptomatic, non-atopic asthmatics were randomised (1:1) to receive omalizumab or identical placebo treatment in addition to existing therapy for 20 weeks. Bronchial biopsies were collected before and after 12–14 weeks of treatment, then the patients destabilised by substantial, supervised reduction of their regular therapy. Primary outcome measures were changes in bronchial mucosal IgE+ cells at 12–14 weeks, prior to regular therapy reduction, and changes in lung function (forced expiratory volume in 1 s) after destabilisation at 20 weeks. Quality of life was also monitored.Omalizumab but not placebo therapy significantly reduced median total bronchial mucosal IgE+ cells (pOmalizumab therapy of non-atopic asthmatics reduces bronchial mucosal IgE+ mast cells and improves lung function despite withdrawal of conventional therapy.

Objectives: To investigate the cost-effectiveness of a telehealth intervention for primary care patients with raised cardiovascular disease (CVD) risk.Design: A prospective within-trial patient-level economic evaluation conducted alongside a randomised controlled trial.Setting: Patients recruited through primary care, and intervention delivered via telehealth service. Participants: Adults with a 10-year CVD risk ≥20%, as measured by the QRISK2 algorithm, with at least one modifiable risk factor. Intervention: A series of up to 13 scripted, theory-led telehealth encounters with healthcare advisors, who supported participants to make behaviour change, use online resources, optimise medication, and improve adherence. Participants in the control arm received usual care. Primary and secondary outcome measures: Cost-effectiveness measured by net monetary benefit at the end of 12 months of follow-up, calculated from incremental cost and incremental quality-adjusted life years (QALYs). Productivity impacts, participant out-of-pocket expenditure, and the clinical outcome were presented in a cost-consequences framework.Results: 641 participants were randomised – 325 to receive the telehealth intervention in addition to usual care and 316 to receive only usual care. 18% of participants had missing data on either costs, utilities, or both. Multiple imputation was used for the base case results. The intervention was associated with incremental mean per-patient NHS costs of £138 (95% CI: £66 to £211) and an incremental QALY gain of 0.012 (95% CI:-0.001 to 0.026). The incremental cost-effectiveness ratio was £10,859. Net monetary benefit at a cost-effectiveness threshold of £20,000 per QALY was £116 (95% CI: -£58 to £291), and the probability that the intervention was cost-effective at this threshold value was 0.77. Similar results were obtained from a complete-case analysis.Conclusions: There is evidence to suggest that the Healthlines telehealth intervention was likely to be cost-effective at a threshold of £20,000 per QALY.Trial registration: ISRCTN27508731, prospectively registered 05/07/2012

Background: Many countries are exploring the potential of telehealth interventions to manage the rising number of people with chronic disorders. However, evidence of the effectiveness of telehealth is ambiguous. Based on an evidence-based conceptual framework, we developed an integrated telehealth service (the Healthlines Service) for chronic disorders and assessed its effectiveness in patients with depression. We aimed to compare the Healthlines Depression Service plus usual care with usual care alone.Methods: This study was a pragmatic, multicentre, randomised controlled trial with participants recruited from 43 general practices in three areas of England. To be eligible, participants needed to have access to the internet and email, a Patient Health Questionnaire 9 (PHQ-9) score of at least 10, and a confirmed diagnosis of depression. Participants were individually assigned (1:1) to either the Healthlines Depression Service plus usual care or usual care alone. Random assignment was done by use of a web-based automated randomisation system, stratified by site and minimised by practice and PHQ-9 score. Participants were aware of their allocation, but outcomes were analysed masked. The Healthlines Service consisted of regular telephone calls from non-clinical, trained health advisers who followed standardised scripts generated by interactive software. After an initial assessment and goal-setting telephone call, the advisers called each participant on six occasions over 4 months, and then made up to three more calls at intervals of roughly 2 months to provide reinforcement and to detect relapse. Advisers supported participants in the use of online resources (including computerised cognitive behavioural therapy) and sought to encourage healthier lifestyles, optimise medication, and improve treatment adherence. The primary outcome was the proportion of participants responding to the intervention (defined as PHQ-9 Findings: Between July 24, 2012, and July 31, 2013, we recruited 609 participants, randomly assigning 307 to the Healthlines Service plus usual care and 302 to usual care. Primary outcome data were available for 525 (86%) participants. At 4 months, 68 (27%) of 255 individuals in the intervention group had a treatment response compared with 50 (19%) of 270 individuals in the usual care group (adjusted odds ratio 1·7, 95% CI 1·1–2·5, p=0·019). Compared with usual care alone, intervention participants reported improvements in anxiety, better access to support and advice, greater satisfaction with the support they received, and improvements in self-management and health literacy. During the trial, 70 adverse events were reported by participants, one of which was related to the intervention (increased anxiety from discussing depression) and was not serious.Interpretation: This telehealth service based on non-clinically trained health advisers supporting patients in use of internet resources was both acceptable and effective compared with usual care. Our results provide support for the development and assessment of similar interventions in other chronic disorders to expand care provision.Funding: National Institute for Health Research (NIHR).

We have previously shown that differentiation of hypertrophic chondrocytes is delayed in mice expressing a mutated PTH/PTHrP receptor (PTHR) (called DSEL here) that stimulates adenylyl cyclase normally but fails to activate phospholipase C (PLC). To better understand the role of PLC signaling via the PTHR in skeletal and mineral homeostasis, we examined these mice fed a normal or calcium-deficient diet. On a standard diet, DSEL mice displayed a modest decrease in bone mass. Remarkably, when fed a low-calcium diet or infused with PTH, DSEL mice exhibited strikingly curtailed peritrabecular stromal cell responses and attenuated new bone formation when compared with Wt mice. Attenuated in vitro colony formation was also observed in bone marrow cells derived from DSEL mice fed a low-calcium diet. Furthermore, PTH stimulated proliferation and increased mRNAs encoding cyclin D1 in primary osteoblasts derived from Wt but not from DSEL mice. Our data indicate that PLC signaling through the PTHR is required for skeletal homeostasis.

Telehealth interventions use information and communication technology to provide clinical support. Some randomised controlled trials of telehealth report high patient decline rates. A large study was undertaken to determine which patients decline to participate in telehealth trials and their reasons for doing so. Two linked randomised controlled trials were undertaken, one for patients with depression and one for patients with raised cardiovascular disease risk (the Healthlines Study). The trials compared usual care with additional support delivered by the telephone and internet. Patients were recruited via their general practice and could return a form about why they were not participating. Of the patients invited, 82.9 % (20,021/24,152) did not accept the study invite, either by returning a decline form (n = 7134) or by not responding (n = 12,887). In both trials patients registered at deprived general practices were less likely to accept the study invite. Decline forms were received from 29.5 % (7134/24,152) of patients invited. There were four frequently reported types of reasons for declining. The most common was telehealth-related: 54.7 % (3889/,7115) of decliners said they did not have access or the skills to use the internet and/or computers. This was more prevalent amongst older patients and patients registered at deprived general practices. The second was health need-related: 40.1 % (n = 2852) of decliners reported that they did not need additional support for their health condition. The third was related to life circumstances: 27.2 % (n = 1932) of decliners reported being too busy. The fourth was research-related: 15.3 % (n = 1092) of decliners were not interested in the research. A large proportion of patients declining participation in these telehealth trials did so because they were unable to engage with telehealth or did not perceive a need for it. This has implications for engagement with telehealth in routine practice, as well as for trials, with a need to offer technological support to increase patients’ engagement with telehealth. More generally, triallists should assess why people decline to participate in their studies. The Healthlines Study has the following trial registrations: depression trial: ISRCTN14172341 (registered 26 June 2012) and CVD risk trial: ISRCTN27508731 (registered 05 July 2012).

BackgroundThere is growing interest in telehealth—the use of technology to support the remote delivery of health care and promote self-management—as a potential alternative to face-to-face care for patients with chronic diseases. However, little is known about what precipitates interest in the use of telehealth among these patients. ObjectiveThis survey forms part of a research program to develop and evaluate a telehealth intervention for patients with two exemplar chronic diseases: depression and raised cardiovascular disease (CVD) risk. The survey was designed to explore the key factors that influence interest in using telehealth in these patient groups. MethodsThirty-four general practices were recruited from two different regions within England. Practice records were searched for patients with (1) depression (aged 18+ years) or (2) 10-year risk of CVD ≥20% and at least one modifiable risk factor (aged 40-74 years). Within each general practice, 54 patients in each chronic disease group were randomly selected to receive a postal questionnaire. Questions assessed five key constructs: sociodemographics, health needs, difficulties accessing health care, technology-related factors (availability, confidence using technology, perceived benefits and drawbacks of telehealth), and satisfaction with prior use of telehealth. Respondents also rated their interest in using different technologies for telehealth (phone, email and Internet, or social media). Relationships between the key constructs and interest in using the three mediums of telehealth were examined using multivariable regression models. ResultsOf the 3329 patients who were sent a study questionnaire, 44.40% completed it (872/1740, 50.11% CVD risk; 606/1589, 38.14% depression). Overall, there was moderate interest in using phone-based (854/1423, 60.01%) and email/Internet-based (816/1425, 57.26%) telehealth, but very little interest in social media (243/1430, 16.99%). After adjusting for health needs, access difficulties, technology-related factors, and prior use of telehealth, interest in telehealth had largely no association with sociodemographic variables. For both patient groups and for each of the three technology mediums, the most important constructs related to interest in telehealth were having the confidence to use the associated technology, as well as perceiving greater advantages and fewer disadvantages from using telehealth. To illustrate, greater confidence using phone technologies (b=.16, 95% CI 0.002-0.33), while also perceiving more benefits (b=.31, 95% CI 0.21-0.40) and fewer drawbacks (b=-.23, 95% CI -0.28 to -0.17) to using telehealth were associated with more interest in using phone-based telehealth technologies for patients with depression. ConclusionsThere is widespread interest in using phone-based and email/Internet-based telehealth among patients with chronic diseases, regardless of their health status, access difficulties, age, or many other sociodemographic factors. This interest could be increased by helping patients gain confidence using technologies and through highlighting benefits and addressing concerns about telehealth. While the same pattern exists for social media telehealth, interest in using these technologies is minimal.