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Placebo 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. We 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. PILs 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.

Background The aim of this study was to compare patients' experiences of public and private sector healthcare, using acupuncture as an example. In the UK, acupuncture is popular with patients, is recommended in official guidelines for low back pain, and is available in both the private sector and the public sector (NHS). Consumerism was used as a theoretical framework to explore patients' experiences. Methods Semi-structured face-to-face interviews were conducted in 2007-8 with a purposive sample of 27 patients who had recently used acupuncture for painful conditions in the private sector and/or in the NHS. Inductive thematic analysis was used to develop themes that summarised the bulk of the data and provided insights into consumerism in NHS- and private practice-based acupuncture. Results Five main themes were identified: value for money and willingness to pay; free and fair access; individualised holistic care: feeling cared for; consequences of choice: empowerment and vulnerability; and \"just added extras\": physical environment. Patients who had received acupuncture in the private sector constructed detailed accounts of the benefits of private care. Patients who had not received acupuncture in the private sector expected minimal differences from NHS care, and those differences were seen as not integral to treatment. The private sector facilitated consumerist behaviour to a greater extent than did the NHS, but private consumers appeared to base their decisions on unreliable and incomplete information. Conclusions Patients used and experienced acupuncture differently in the NHS compared to the private sector. Eight different faces of consumerist behaviour were identified, but six were dominant: consumer as chooser, consumer as pragmatist, consumer as patient, consumer as earnest explorer, consumer as victim, and consumer as citizen. The decision to use acupuncture in either the private sector or the NHS was rarely well-informed: NHS and private patients both had misconceptions about acupuncture in the other sector. Future research should evaluate whether the differences we identified in patients' experiences across private and public healthcare are common, whether they translate into significant differences in clinical outcomes, and whether similar faces of consumerism characterise patients' experiences of other interventions in the private and public sectors.

Background Augmenting validated paper versions of existing outcome measures with an equivalent online version may offer substantial research advantages (cost, rapidity and reliability). However, equivalence of online and paper questionnaires cannot be assumed, nor can acceptability to respondents. The aim was to test whether online and written versions of the Roland Morris Disability Questionnaire (RMDQ), a standard measure of functional disability in back pain, are equivalent at both group and individual levels to establish whether they can be used interchangeably. Methods This is a within-participants equivalence study. 167 participants with back pain fully completed both the paper and online versions of the RMDQ in random order. Participants were recruited from a chiropractic clinic and patient support groups in Southern England. Limits of equivalence were pre-defined as 0.5 RMDQ points, the Bland-Altman range was calculated, and participants' comments were examined using content analysis. Results The mean score difference was 0.03 (SD = 1.43), with the 95% Confidence Interval falling entirely within our limits of equivalence (-0.19 to 0.25). The Bland-Altman range was -2.77 to 2.83 RMDQ points. Participants identified unique advantages and disadvantages associated with each version of the RMDQ. Conclusions The group and individual level data suggest that online and paper versions of the RMDQ are equivalent and can be used interchangeably. The Bland-Altman range appears to reflect the known measurement properties of the RMDQ. Furthermore, participants' comments confirmed the potential value to be had from offering them the choice of completing the RMDQ online or on paper.

Background Qualitative studies of participants' experiences in randomised clinical trials (RCTs) suggest that the psychosocial context of treatment in RCTs may be quite different to the psychosocial context of treatment in usual practice. This is important, as the psychosocial context of treatment is known to influence patient outcomes in chronic illness. Few studies have directly compared the psychosocial context of treatment across RCTs and usual practice. In this study, we explored differences in psychosocial context between RCT and usual practice settings, using acupuncture as our model. Methods We undertook a secondary analysis of existing qualitative interviews with 54 patients. 27 were drawn from a study of western and traditional acupuncture in usual practice (for a range of painful conditions). 27 were drawn from a qualitative study nested in an RCT of western acupuncture for osteoarthritis of the hip or knee. We used qualitative analysis software to facilitate an inductive thematic analysis in which we identified three main themes. Results In usual practice, starting acupuncture was more likely to be embedded in an active and ongoing search for pain relief, whereas in the RCT starting acupuncture was opportunistic. Usual practice patients reported few uncertainties and these had minimal consequences for them. In the RCT, patients experienced considerable uncertainties about their treatment and its effectiveness, and were particularly concerned about whether they were receiving real (or fake) acupuncture. Patients stopped acupuncture only at the end of the fixed course of treatment in the RCT, which was similar to those receiving acupuncture in the public sector National Health Service (NHS). In comparison, private sector patients re-evaluated and re-negotiated treatments particularly when starting to use acupuncture. Conclusions Differences in psychosocial context between RCTs and usual practice could reduce the impact of acupuncture in RCT settings and/or lead to under-reporting of benefit by patients in trials. New trial designs that ensure participants' experiences are similar to usual practice should minimise differences in psychosocial context and help attenuate these potentially confounding effects.

Quality of life (QoL) has a weak relationship with lung function (LF) impairment in COPD; some cope well despite poor LF, whereas 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 they 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’ and so on). Semi-structured interviews, digitally recorded, were analysed by thematic analysis. Data saturation was achieved. Four themes emerged: symptom impact, coping strategies, coping challenges and support needs. Most of them described using 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 co-morbidities and inadequate self-management skills. Approximately half of the participants wanted further help, ideally non-pharmacological, 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 a better QoL 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 COPD patients. Chronic obstructive pulmonary disease: How coping strategies affect patient experience Patients who adapt well to living with chronic obstructive pulmonary disorder (COPD) are more likely to have improved quality of life. Sarah Brien from Southampton General Hospital and colleagues interviewed 34 participants with COPD of varying severity and varying quality of life (QoL). Identifying four themes (disease impact, coping strategies, coping challenges and support needs), the team found that individuals successfully employing coping strategies (such as breathing rehabilitation) reported higher QoL than poorly adapted patients, irrespective of actual physical lung damage. Patients reporting poor QoL were more likely to seek out non-pharmacological coping strategies, including turning to complementary and alternative medicine. This study demonstrates a link between adaptation to COPD and QoL and indicates targeted intervention, based on QoL not disease severity, are needed, to improve patient self-management.

Objectives. We analyzed how patients use complementary and alternative medicine (CAM) and examined how patients’ perspectives relate to existing, expert-led taxonomies. Methods. We conducted semistructured interviews with 46 people who used CAM in southern England, then performed a qualitative thematic analysis of the interviews. Results. CAM appeared to be used in 4 different ways: as treats, and as alternative, complementary, or conventional treatments. Treats were portrayed as personal luxuries, not directed at an identified health need. Systematic differences in the context, anticipated benefits, and implications for financial justification were revealed when nonmedical therapies were viewed and used as alternative, complementary, or conventional treatments. Specific CAM practices were viewed and used in different ways by different participants. Conclusions. Some participants used CAM practices as a personal luxury, not as a health care technology. This is incongruent with existing expert-led taxonomies. Physicians and researchers need to be aware that patients’ views of what constitutes CAM can differ radically from their own. They should choose their terminology carefully to initiate meaningful dialogue with their patients and research participants.

•We identified three ways in which patients conceptualised acupuncturists.•The “technician” manipulates needles to treat patients’ symptoms.•The “caring professional” manipulates needles and creates a healing relationship.•The “wise healer” possesses extraordinary, special, wisdom and healing abilities. To explore how patients conceptualise acupuncturists, the meanings ascribed to the therapeutic relationship and valued therapeutic behaviours. Qualitative study. Semi-structured face-to-face interviews explored patients’ experiences of acupuncture. A diverse sample of 35 participants took part; they had used acupuncture for a variety of predominantly chronic conditions. Inductive thematic analysis was used to identify themes. Southern England. Participants conceptualised acupuncturists in three ways: technician, caring professional, and wise and gifted healer. Each conceptualisation had different implications for patient health. For example, lifestyle advice from a wise healer was seen as inspirational wisdom, while lifestyle advice from a caring professional was seen as evidence of caring. Participants inferred empathy when acupuncturists took a detailed history, took notes during treatment, and provided therapeutic commentaries. Participants inferred knowledge and/or wisdom when acupuncturists made changes to treatments over time, provided explanatory frameworks for their symptoms, and made effective recommendations concerning lifestyle and health behaviours. The findings provide novel insights into how patients view acupuncturists, suggesting acupuncture-specific models that do not directly map onto conventional models of doctor-patient relationships. Understanding how patients think about their acupuncturist and make sense of clinical interactions could help acupuncturists to hone their therapeutic skills.

Colquhoun presents an interesting point of view. 1 In the United Kingdom, 0.0085% of the medical research budget is spent on complementary and alternative medicine (CAM).

Research into the homeopathic consultation has largely focused on patients’ experiences, although the practitioner is a crucial component of the therapeutic context and may have an important part in optimizing health outcomes. Therefore the aim of this qualitative research was to gain an in-depth understanding of homeopathic practitioners’ perceptions and experiences of the consultation. Medical and non-medical homeopaths were sampled from the registers of the Faculty and Society of Homeopaths. Two phases of data collection were employed. Phase 1 used in depth face-to-face interviews enabling the development of an initial model of the homeopathic consultation. Phase 2 involved observations of homeopathic consultations and practitioner reflective diaries in order to confirm, refute, or enlarge the model. Using the constant comparative method of grounded theory five main categories emerged, exploring the journey, finding the level, responding therapeutically, understanding self, and connecting, forming a model entitled “a theoretical model of a UK classical homeopathic consultation” which describes how homeopaths view and enact the consultation process. This study suggests that the process of identifying and prescribing the remedy is embedded in the consultation, highlighting the interconnectedness of the whole homeopathic consultation and aspects of the consultation that are unique and specific to homeopathy.

The management of disabling breathlessness is poor, and a standardized form of acupuncture has been reported as offering benefit. This study was designed to evaluate the efficacy of standardized acupuncture treatment. A single-blind, randomized, crossover study. This study was carried out on a domiciliary basis in Southampton (UK). This study evaluated a standardized acupuncture technique vs an appropriately validated placebo/control (mock transcutaneous electrical nerve stimulation [TENS]) for disabling, nonmalignant breathlessness (largely COPD). The acupuncture was provided by an appropriately trained nurse acupuncturist. Each patient received six treatments in each phase of the study, with an intervening 2-week washout period. The primary outcome was worst breathlessness (visual analog scale, 0 to 100 mm), with the sample size based on an 80% power to detect a 10-mm difference between treatment means. Secondary outcomes included the St George's respiratory questionnaire score and treatment credibility. Thirty-six patients were entered into the study (33 with COPD), and 24 patients completed both treatment phases. The primary outcome improved significantly during the course of the study, but there were no significant treatment differences between acupuncture and the placebo/control of mock TENS for either primary or secondary outcomes. The placebo was shown to be a credible control. There was no evidence of a carryover effect from the first to second phase of the study. This standardized acupuncture technique does not show specific efficacy in disabling nonmalignant breathlessness, but those entered into the study did experience clinically significant benefit from both treatments.