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

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

Health-care sector and complementary medicine: practitioners’ experiences of delivering acupuncture in the public and private sectors

AIM: The aim was to identify similarities and differences between private practice and the National Health Service (NHS) in practitioners' experiences of delivering acupuncture to treat pain. We wished to identify differences that could affect patients' experiences and inform our understanding of how trials conducted in private clinics relate to NHS clinical practice. BACKGROUND: Acupuncture is commonly used in primary care for lower back pain and is recommended in the National Institute for Health and Clinical Excellence's guidelines. Previous studies have identified differences in patients' accounts of receiving acupuncture in the NHS and in the private sector. The major recent UK trial of acupuncture for back pain was conducted in the private sector. METHODS: Semi-structured qualitative interviews were conducted with 16 acupuncturists who had experience of working in the private sector (n = 7), in the NHS (n =3), and in both the sectors (n = 6). The interviews lasted between 24 and 77 min (median=49 min) and explored acupuncturists' experiences of treating patients in pain. Inductive thematic analysis was used to identify similarities and differences across private practice and the NHS.FINDINGS: The perceived effectiveness of acupuncture was described consistently and participants felt they did (or would) deliver acupuncture similarly in NHS and in private practice. In both the sectors, patients sought acupuncture as a last resort and acupuncturist-patient relationships were deemed important. Acupuncture availability differed across sectors: in the NHS it was constrained by Trust policies and in the private sector by patients' financial resources. There were greater opportunities for autonomous practice in the private sector and regulation was important for different reasons in each sector. In general, NHS practitioners had Western-focussed training and also used conventional medical techniques, whereas private practitioners were more likely to have Traditional Chinese training and to practise other complementary therapies in addition to acupuncture. Future studies should examine the impact of these differences on patients' clinical outcomes

The impact of patient-reported outcome measures in clinical practice for pain: a systematic review

Purpose: Patient-reported outcome measures (PROMs) have increasingly been incorporated into clinical practice. Research suggests that PROMs could be viewed as active components of complex interventions and may affect the process and outcome of care. This systematic review examines PROMs in the context of treatment for non-malignant pain.Methods: An electronic search on: MEDLINE, EMBASE, PsycINFO, PsycARTICLES, Cochrane Library and Web of Science identified relevant papers (February 2015). The inclusion criteria were: focused on implementing PROMs into clinical practice, adults, and primary data studies. Critical interpretive synthesis was used to synthesise qualitative and quantitative findings into a theoretical argument.Results: Thirteen eligible studies were identified. Synthesis suggested that PROMs may be included in the initial consultation to assess patients and for shared decision-making regarding patient care. During the course of treatment, PROMs can be used to track progress, evaluate treatment, and change the course of care; using PROMs may also influence the therapeutic relationship. Post-treatment, using PROMs might directly influence other outcomes such as pain and patient satisfaction. However, although studies have investigated these areas, evidence is weak and inconclusive.Conclusion: Due to the poor quality, lack of generalisability and heterogeneity of these studies, it is not possible to provide a comprehensive understanding of how PROMs may impact clinical treatment of non-malignant pain. The literature suggests that PROMs enable pain assessment, decision-making, the therapeutic relationship, evaluation of treatment and may influence outcomes. Further research is needed to provide better evidence as to whether PROMs do indeed have any effects on these domains

What is the current NHS service provision for patients severely affected by chronic fatigue syndrome/myalgic encephalomyelitis? A national scoping exercise

Background: Chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME), in its most severe clinical presentation, can result in patients becoming housebound and bedbound so unable to access most available specialist services. This presents particular clinical risks and treatment needs for which the National Institute for Health and Care Excellence (NICE) advises specialist medical care and monitoring. The extent of National Health Service (NHS) specialist provision in England for severe CFS/ME is currently unknown. Objectives: To establish the current NHS provision for patients with severe CFS/ME in England. Setting and participants: All 49 English NHS specialist CFS/ME adult services in England, in 2013. Method: Cross-sectional survey by email questionnaire. Primary outcome measures: Adherence to NICE guidelines for severe CFS/ME. Results: All 49 services replied (100%). 33% (16/49) of specialist CFS/ME services provided no service for housebound patients. 55% (27/49) services did treat patients with severe CFS/ME and their interventions followed the NICE guidelines. The remaining services (12%, 6/49) offered occasional or minimal support where funding allowed. There was one NHS unit providing specialist inpatient CFS/ME provision in England. Conclusions: Study findings highlight substantial variation in access to specialist care for patients with severe presentation of CFS/ME. Where treatment was provided, this appeared to comply with NICE recommendations for this patient group

Feasibility study for a community based intervention for adults with severe chronic fatigue syndrome/ME

Background: Chronic Fatigue Syndrome/ME (CFS/ME) is characterised by debilitating fatigue with many bedbound patients. The study aims were: to determine whether a new intervention could be successfully delivered; to collect quantitative outcome data to guide the design of future studies; to explore qualitatively the experience of patients, carers and clinicians. Methods: Mixed-methods feasibility study with qualitative and quantitative evaluation. Participants: 12 UK patients who were housebound with severe CFS/ME. Intervention: Based on recovery skills identified through a 2.5 year Patient and Public Involvement development process involving individuals with first-hand experience of recovery from CFS/ME, as well as current patients and clinicians. The resulting one year intervention, delivered by a multi-disciplinary team, included domiciliary therapy visits and optional peer support group. Quantitative outcome measures: Patient-reported and therapist-reported outcome measures (including fatigue, physical function, anxiety, depression and other variables) and electronic activity measurement. Results: The study recruited and engaged twelve participants with no serious adverse events or dropouts. At end of intervention, 5/12 participants had improved in fatigue, physical function. Group mean scores improved overall for fatigue (Chalder fatigue scale), physical function (activity and physical function scale) and anxiety. Qualitative interviews suggested that the intervention was acceptable to patients, whilst also highlighting suggestions for improvement. Participants will be followed up for a further year to find out if improvements are sustained. Conclusion: This is the largest study ever conducted in severe CFS/ME and shows significant recovery suggesting further studies are indicated. Treatment is uniquely based on a patient inspired intervention

Influences on GP coping and resilience: a qualitative study in primary care.

BACKGROUND: 'Neoliberal' work policies, austerity, NHS restructuring, and increased GP consultation rates provide the backdrop against increasing reports of GP burnout and an impending shortage of GPs. AIM: To explore GPs' experiences of workplace challenges and stresses, and their coping strategies, particularly focusing on understanding the impact of recent NHS workplace change. DESIGN AND SETTING: Study design was qualitative, with data collected from two focus groups and seven one-to-one telephone interviews. METHOD: Focus groups and one-to-one telephone interviews explored the experiences of GPs currently practising in England, recruited through convenience sampling. Data were collected using a semi-structured interview approach and analysed using thematic analysis. RESULTS: There were 22 GP participants recruited: focus groups (n = 15) and interviews (n = 7). Interviewees understood GPs to be under intense and historically unprecedented pressures, which were tied to the contexts in which they work, with important moral implications for 'good' doctoring. Many reported that being a full-time GP was too stressful: work-related stress led to mood changes, sleep disruption, increases in anxiety, and tensions with loved ones. Some had subsequently sought ways to downsize their clinical workload. Workplace change resulted in little time for the things that helped GP resilience: a good work-life balance and better contact with colleagues. Although some GPs were coping better than others, GPs acknowledged that there was only so much an individual GP could do to manage their stress, given the external work issues they faced. CONCLUSION: GPs experience their emotional lives and stresses as being meaningfully shaped by NHS factors. To support GPs to provide effective care, resilience building should move beyond the individual to include systemic work issues

Controlled interventions to reduce burnout in physicians a systematic review and meta-analysis

IMPORTANCE Burnout is prevalent in physicians and can have a negative influence on performance, career continuation, and patient care. Existing evidence does not allow clear recommendations for the management of burnout in physicians. OBJECTIVE To evaluate the effectiveness of interventions to reduce burnout in physicians and whether different types of interventions (physician-directed or organization-directed interventions), physician characteristics (length of experience), and health care setting characteristics (primary or secondary care) were associated with improved effects. DATA SOURCES MEDLINE, Embase, PsycINFO, CINAHL, and Cochrane Register of Controlled Trials were searched from inception to May 31, 2016. The reference lists of eligible studies and other relevant systematic reviews were hand searched. STUDY SELECTION Randomized clinical trials and controlled before-after studies of interventions targeting burnout in physicians. DATA EXTRACTION AND SYNTHESIS Two independent reviewers extracted data and assessed the risk of bias. The main meta-analysis was followed by a number of prespecified subgroup and sensitivity analyses. All analyses were performed using random-effects models and heterogeneity was quantified. MAIN OUTCOMES AND MEASURES The core outcomewas burnout scores focused on emotional exhaustion, reported as standardized mean differences and their 95confidence intervals. RESULTS Twenty independent comparisons from 19 studieswere included in the meta-analysis (n = 1550 physicians; mean SD age, 40.3 9.5 years; 49%male). Interventionswere associated with small significant reductions in burnout (standardized mean difference SMD = ?0.29; 95%CI, ?0.42 to ?0.16; equal to a drop of 3 points on the emotional exhaustion domain of the Maslach Burnout Inventory above change in the controls). Subgroup analyses suggested significantly improved effects for organization-directed interventions (SMD = ?0.45; 95%CI, ?0.62 to ?0.28) compared with physician-directed interventions (SMD = ?0.18; 95%CI, ?0.32 to ?0.03). Interventions delivered in experienced physicians and in primary care were associated with higher effects compared with interventions delivered in inexperienced physicians and in secondary care, but these differences were not significant. The results were not influenced by the risk of bias ratings. CONCLUSIONS AND RELEVANCE Evidence from this meta-analysis suggests that recent intervention programs for burnout in physicians were associated with small benefits that may be boosted by adoption of organization-directed approaches. This finding provides support for the view that burnout is a problem of the whole health care organization, rather than individuals

GPs' perceptions of resilience training: a qualitative study.

BACKGROUND: GPs are reporting increasing levels of burnout, stress, and job dissatisfaction, and there is a looming GP shortage. Promoting resilience is a key strategy for enhancing the sustainability of the healthcare workforce and improving patient care. AIM: To explore GPs' perspectives on the content, context, and acceptability of resilience training programmes in general practice, in order to build more effective GP resilience programmes. DESIGN AND SETTING: This was a qualitative study of the perspectives of GPs currently practising in England. METHOD: GPs were recruited through convenience sampling, and data were collected from two focus groups (n = 15) and one-to-one telephone interviews (n = 7). A semi-structured interview approach was used and data were analysed using thematic analysis. RESULTS: Participants perceived resilience training to be potentially of value in ameliorating workplace stresses. Nevertheless, uncertainty was expressed regarding how best to provide training for stressed GPs who have limited time. Participants suspected that GPs most likely to benefit from resilience training were the least likely to engage, as stress and being busy worked against engagement. Conflicting views were expressed about the most suitable training delivery method for promoting better engagement. Participants also emphasised that training should not only place the focus on the individual, but also focus on organisation issues. CONCLUSION: A multimodal, flexible approach based on individual needs and learning aims, including resilience workshops within undergraduate training and in individual practices, is likely to be the optimal way to promote resilience