Developing digital interventions: a methodological guide.

Digital interventions are becoming an increasingly popular method of delivering healthcare as they enable and promote patient self-management. This paper provides a methodological guide to the processes involved in developing effective digital interventions, detailing how to plan and develop such interventions to avoid common pitfalls. It demonstrates the need for mixed qualitative and quantitative methods in order to develop digital interventions which are effective, feasible, and acceptable to users and stakeholders

Informed consent and placebo effects: a content analysis of information leaflets to identify what clinical trial participants are told about placebos

BackgroundPlacebo groups are used in randomised clinical trials (RCTs) to control for placebo effects, which can be large. Participants in trials can misunderstand written information particularly regarding technical aspects of trial design such as randomisation; the adequacy of written information about placebos has not been explored. We aimed to identify what participants in major RCTs in the UK are told about placebos and their effects.Methods and FindingsWe conducted a content analysis of 45 Participant Information Leaflets (PILs) using quantitative and qualitative methodologies. PILs were obtained from trials on a major registry of current UK clinical trials (the UKCRN database). Eligible leaflets were received from 44 non-commercial trials but only 1 commercial trial. The main limitation is the low response rate (13.5%), but characteristics of included trials were broadly representative of all non-commercial trials on the database. 84% of PILs were for trials with 50:50 randomisation ratios yet in almost every comparison the target treatments were prioritized over the placebos. Placebos were referred to significantly less frequently than target treatments (7 vs. 27 mentions, p<001) and were significantly less likely than target treatments to be described as triggering either beneficial effects (1 vs. 45, p<001) or adverse effects (4 vs. 39, p<001). 8 PILs (18%) explicitly stated that the placebo treatment was either undesirable or ineffective.ConclusionsPILs from recent high quality clinical trials emphasise the benefits and adverse effects of the target treatment, while largely ignoring the possible effects of the placebo. Thus they provide incomplete and at times inaccurate information about placebos. Trial participants should be more fully informed about the health changes that they might experience from a placebo. To do otherwise jeopardises informed consent and is inconsistent with not only the science of placebos but also the fundamental rationale underpinning placebo controlled trials

Depression and anxiety in prostate cancer: a systematic review and meta-analysis of prevalence rates

ObjectivesTo systematically review the literature pertaining to the prevalence of depression and anxiety in patients with prostate cancer as a function of treatment stage.DesignSystematic review and meta-analysis.Participants4494 patients with prostate cancer from primary research investigations.Primary outcome measureThe prevalence of clinical depression and anxiety in patients with prostate cancer as a function of treatment stage.ResultsWe identified 27 full journal articles that met the inclusion criteria for entry into the meta-analysis resulting in a pooled sample size of 4494 patients. The meta-analysis of prevalence rates identified pretreatment, on-treatment and post-treatment depression prevalences of 17.27% (95% CI 15.06% to 19.72%), 14.70% (95% CI 11.92% to 17.99%) and 18.44% (95% CI 15.18% to 22.22%), respectively. Pretreatment, on-treatment and post-treatment anxiety prevalences were 27.04% (95% CI 24.26% to 30.01%), 15.09% (95% CI 12.15% to 18.60%) and 18.49% (95% CI 13.81% to 24.31%), respectively.ConclusionsOur findings suggest that the prevalence of depression and anxiety in men with prostate cancer, across the treatment spectrum, is relatively high. In light of the growing emphasis placed on cancer survivorship, we consider that further research within this area is warranted to ensure that psychological distress in patients with prostate cancer is not underdiagnosed and undertreated

A Review of Psychosocial Predictors of Treatment Outcomes: What Factors Might Determine the Clinical Success of Acupuncture for Pain?

AbstractThis narrative review examines the psychosocial factors that might predict clinical outcomes in acupuncture for pain. Given existing evidence concerning the clinical effectiveness and safety of acupuncture in painful conditions, it is important to consider how clinicians might further improve their effectiveness. The relevant theoretical frameworks focus primarily on the patient, suggesting that their background characteristics and their beliefs about pain and acupuncture should be considered as potential predictors of outcome. The self-regulation model within health psychology helps us understand how people manage their health and integrate interventions like acupuncture into the management of their illness. This model also implies that the therapeutic relationship, in particular patients' perceptions of that relationship, is likely to be related to outcome. The empirical literature in this area is sparse. However, the findings to date do suggest that a number of psychosocial factors, in particular patients' beliefs about acupuncture, are significant predictors of treatment outcomes from acupuncture for pain. Factors related to the therapeutic relationship are also likely to be important in facilitating good clinical outcomes. We discuss the limitations of the existing studies and make recommendations for future research in this area. If we can better understand the psychosocial factors involved in acupuncture, then we should be able to enhance acupuncture treatments and improve outcomes for patients. These observations will, therefore, have potential to allow us to develop techniques that may improve clinical outcomes in the treatment of pain

Patient coping strategies in COPD across disease severity and quality of life: a qualitative study

Quality of life (QoL) has a weak relationship with lung function (LF) impairment in COPD; some cope well despite poor LF, while others suffer disproportionate QoL impairment despite well-preserved LF. Adjuvant non-pharmacological interventions such as rehabilitation and psychological/behavioural support may help if acceptable and targeted appropriately, but are under-used and sometimes declined by patients. This study aimed to explore and understand variations in experiences and coping strategies in patients with different severities of disease and disease-specific QoL. Thirty four participants were purposively sampled across a spectrum of LF and QoL impairment, to cover a grid of sub-groups (‘very severe LF, good QoL’, moderate LF, poor QoL’ etc.). Semi-structured interviews, digitally recorded, were analysed by thematic analysis. Data saturation was achieved. Four themes emerged: symptom impact, coping strategies, coping challenges, support needs. Most described employing multiple coping strategies yet over half reported significant challenges coping with COPD including: psychological impact, non-acceptance of diagnosis and/or disease progression, effects of comorbidities and inadequate self-management skills. Approximately half wanted further help, ideally nonpharmacological, across all LF impairment groups but mainly with lower QoL. Those with lower QoL additionally reported greater psychological distress and greater use of non-pharmacological support strategies where accessible. Patients who develop effective coping strategies, have better quality of life independent of objective LF, whereas others cope poorly, are aware of this, and report more use of non-pharmacological approaches. This study suggests that severely impaired QoL, irrelevant of lung function, is a powerful patient centred indication to explore the positive benefits of psychological and behavioural support for distressed

The Day After Tomorrows Doctors: UK Undergraduate Medical Student Resilience, Reports on the Symposium 2016

There is growing evidence that students and qualified doctors’ are experiencing high levels of workplace stress and burnout. Many medical students find student training and subsequently the transition to foundation year difficult. Medical schools have been tasked by the GMC to teach personal resilience as part of professional development. Despite this responsibility, it is far from clear whether medical schools have in fact integrated topics such as stress management, resilience training and self-care into their professional development curriculum. As far as we can establish this is the first meeting of UK medical educators to specifically address this topic

‘The Science of CAIM: What's Next for Complementary, Alternative and Integrative Medical Research?’

symposium on the future of complementary, alternative and integrative medical research featuring nationally recognized speakers. The symposium took place on the UCLA campus in late January and was targeted to the Geffen School of Medicine’s Institutional Review Board (IRB). Its purpose was to address the finding by th