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

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

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

Impure placebo as an unsound concept and other problems in the paper by Howick et al. : [eLetter]

Kommentti artikkeliin Placebo Use in the United Kingdom: Results from a National Survey of Primary Care Practitioners, Plos One 8(3):e58247. doi: 10.1371/journal.pone.0058247Howick et al. have reported the findings of a survey that addressed the use of placebos among primary care practitioners in the United Kingdom. They adopted methodology similar to that used in previous studies performed in other countries; however, the use of this approach also means that they repeated the conceptual confusion of the previous surveys. Therefore the findings are not useful. ... The paper’s main finding “placebos are commonly used in UK primary care” is not correct. Only 0.9% of the responding general practitioners reported using pure placebos frequently. The frequency with which impure placebos are used is irrelevant because the concept is useless, as described above. Misleading a patient by administering inert substances without the explicit consent of the patient is unethical. The authors' proposal to “develop ethical and cost-effective placebos” is not possible because saving money by misleading patients is unethical. There is substantial conceptual confusion in the area of placebo and placebo-effect research, and the paper by Howick et al. does not help to reduce this confusion.Non peer reviewe

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

The development and validation of an outcome measure for spiritual healing: A mixed methods study

Background: Spiritual healing, probably the oldest documented paramedical intervention, is a neglected area of research. In order to conduct further research into the effects of healing, a valid and reliable outcome measure is needed that captures the experience of individuals receiving healing (healees) and is not burdensome to complete. We aimed to develop such a measure. Methods: A mixed methods design was used. Focus groups and cognitive interviews were used to generate and refine questionnaire items grounded in the experiences and language of healees (Study 1). The resulting questionnaire was tested and its formal psychometric properties were evaluated (Study 2). Participants were recruited from a spiritual healing sanctuary and via individual healers (including registered spiritual healers, Reiki practitioners, healers affiliated with churches). Results: In Study 1, 24 participants took part in 7 focus groups and 6 cognitive interviews. 29 common effects were identified and grouped into 7 discrete dimensions that appeared to characterize potentially sustainable effects reported by participants following their experiences of spiritual healing. In Study 2, 393 participants returned completed baseline questionnaires, 243 of whom completed the questionnaire again 1–6 weeks later. Exploratory factor analysis generated 5 subscales, based on 20 of the items: outlook, energy, health, relationships and emotional balance. These subscales demonstrated acceptable internal consistency, convergent validity and test-retest reliability. Three of the subscales and the whole questionnaire demonstrated good sensitivity to change. Conclusions: We have produced a psychometrically sound healing impact questionnaire that is acceptable to healees, healers and researchers for use in future evaluations of spiritual healing.<br/