Placebo comparator group selection and use in surgical trials: the ASPIRE project including expert workshop.

BACKGROUND: The use of placebo comparisons for randomised trials assessing the efficacy of surgical interventions is increasingly being considered. However, a placebo control is a complex type of comparison group in the surgical setting and, although powerful, presents many challenges. OBJECTIVES: To provide a summary of knowledge on placebo controls in surgical trials and to summarise any recommendations for designers, evaluators and funders of placebo-controlled surgical trials. DESIGN: To carry out a state-of-the-art workshop and produce a corresponding report involving key stakeholders throughout. SETTING: A workshop to discuss and summarise the existing knowledge and to develop the new guidelines. RESULTS: To assess what a placebo control entails and to assess the understanding of this tool in the context of surgery is considered, along with when placebo controls in surgery are acceptable (and when they are desirable). We have considered ethics arguments and regulatory requirements, how a placebo control should be designed, how to identify and mitigate risk for participants in these trials, and how such trials should be carried out and interpreted. The use of placebo controls is justified in randomised controlled trials of surgical interventions provided that there is a strong scientific and ethics rationale. Surgical placebos might be most appropriate when there is poor evidence for the efficacy of the procedure and a justified concern that results of a trial would be associated with a high risk of bias, particularly because of the placebo effect. CONCLUSIONS: The use of placebo controls is justified in randomised controlled trials of surgical interventions provided that there is a strong scientific and ethics rationale. Feasibility work is recommended to optimise the design and implementation of randomised controlled trials. An outline for best practice was produced in the form of the Applying Surgical Placebo in Randomised Evaluations (ASPIRE) guidelines for those considering the use of a placebo control in a surgical randomised controlled trial. LIMITATIONS: Although the workshop participants involved international members, the majority of participants were from the UK. Therefore, although every attempt was made to make the recommendations applicable to all health systems, the guidelines may, unconsciously, be particularly applicable to clinical practice in the UK NHS. FUTURE WORK: Future work should evaluate the use of the ASPIRE guidelines in making decisions about the use of a placebo-controlled surgical trial. In addition, further work is required on the appropriate nomenclature to adopt in this space. FUNDING: Funded by the Medical Research Council UK and the National Institute for Health Research as part of the Medical Research Council-National Institute for Health Research Methodology Research programme.

WHAT WAS THE RESEARCH ABOUT?: One of the best ways to prove that a new medicine really works is to use a scientific test called a 'placebo-controlled trial'. In this type of test, half of the participants are given a new pill and the other half are given a 'placebo', which is a dummy pill (usually a sugar pill) that is made to taste and look the same as the active pill, but has no active ingredients. The results are then compared. Just like medicines, new surgical procedures need to be tested to show that they are safe and benefit patients. Ideally, they would also be tested using the 'placebo-controlled trial' approach, but asking patients to have 'dummy' surgery is not the same as asking people to take a dummy pill. Placebo surgery raises lots of ethics questions and is controversial. As it is controversial, guidelines are needed to recommend when placebo surgery studies can be used (if at all) and what special considerations need to be taken into account. Our research team was commissioned to develop these guidelines. WHAT DID WE DO?: We summarised, to the best of our knowledge, all previous research that had used placebo surgery and reviewed all the ethics literature on this topic. We also looked at the latest scientific understanding of how placebos work. We then held a workshop to discuss and summarise the existing knowledge and to develop the new guidelines. This involved an international team of patients, surgeons, researchers, ethicists, psychologists, physiologists and funders. We published the guidelines [i.e. the ASPIRE (Applying Surgical Placebo in Randomised Evaluations) guidelines] in an influential medical journal and also wrote several other publications. This report provides a slightly more detailed version of our findings and recommendations. WHO WILL THIS HELP?: The guidelines will help researchers and doctors know when, and how, to best design placebo surgery studies in the future.

Lifestyle and Health Behavior Change in Traditional Acupuncture Practice: A Systematic Critical Interpretive Synthesis.

Introduction: Behavioral factors are the leading cause of ill-health worldwide. Diet, physical activity, smoking, and alcohol consumption are the focus of public health targets on promotion of healthy behavior. The science of behavior change is rapidly growing and has largely evolved within mainstream health care treatments. Traditional Chinese Medicine includes self-care practices that encourage healthy behavior alongside treatments such as acupuncture. Exploring behavior change within traditional acupuncture could potentially highlight new techniques and approaches, and contribute to developing models of behavior change. Aims: In this review, the authors aimed to critically appraise research exploring health behavior change within traditional acupuncture, to highlight gaps in the field, identify questions, and enable theory development. Design/Method: The authors were guided by a critical interpretive synthesis (CIS) method to explore a diverse mixture of research including qualitative and quantitative articles. Eight databases were searched up to October 2017 for articles published in English. Eleven thousand four hundred eighty-eight articles were identified (7,149 after deduplication). Titles and abstracts were screened by one reviewer (10% by a second reviewer). Eligible articles were selected using a Population, Intervention, Comparison, Outcome framework. CIS methods, including purposive sampling of eligible articles and a reflexive, dialectic process of critiquing evidence and theory, were used to synthesize the evidence. Results: Several articles examined the prevalence and patterns of behavior change and support for change, although methods varied and reliability of results was limited. There was more evidence concerning diet/exercise than alcohol/smoking. Aspects of acupuncturists' work identified as potential key elements for promoting behavior change included: individualized advice based on symptoms; holistic/biopsychosocial explanations; therapeutic relationship; simultaneous treatment of behavior-limiting symptoms; and patients' physical involvement with intervention. A logic model of the process of behavior change was developed, proposing that perceived support, mutual understanding, and active participation may facilitate change. Possible moderators included: single/multicomponent acupuncture; setting; patient/practitioner characteristics; treatment experience; timing; and treatment duration. Conclusion: These findings suggest behavior change work is a significant part of traditional acupuncture practice, although more reliable evidence is needed to understand the effectiveness, prevalence, and patterns of this work (in particular the patterns suggesting acupuncturists are more likely to work on changes to diet and physical activity than alcohol and smoking behaviors, and more likely to support changes in long-term compared with acute conditions). The proposed model of behavior change should be developed and tested with a view to refining the model and elaborating the suggested links with a wider theory of behavior and behavior change. This review was preregistered with PROSPERO as "Health behaviour change in traditional acupuncture treatment: a protocol for a critical interpretive synthesis": CRD42018099766.

Considerations and methods for placebo controls in surgical trials (ASPIRE guidelines).

Placebo comparisons are increasingly being considered for randomised trials assessing the efficacy of surgical interventions. The aim of this Review is to provide a summary of knowledge on placebo controls in surgical trials. A placebo control is a complex type of comparison group in the surgical setting and, although powerful, presents many challenges. This Review outlines what a placebo control entails and present understanding of this tool in the context of surgery. We consider when placebo controls in surgery are acceptable (and when they are desirable) in terms of ethical arguments and regulatory requirements, how a placebo control should be designed, how to identify and mitigate risk for participants in these trials, and how such trials should be done and interpreted. Use of placebo controls is justified in randomised controlled trials of surgical interventions provided there is a strong scientific and ethical rationale. Surgical placebos might be most appropriate when there is poor evidence for the efficacy of the procedure and a justified concern that results of a trial would be associated with high risk of bias, particularly because of the placebo effect. Feasibility work is recommended to optimise the design and implementation of randomised controlled trials. This Review forms an outline for best practice and provides guidance, in the form of the Applying Surgical Placebo in Randomised Evaluations (known as ASPIRE) checklist, for those considering the use of a placebo control in a surgical randomised controlled trial.

Subjunctive medicine: Enacting efficacy in general practice.

Modern general practice is complex. Issues such as multimorbidity, polypharmacy and chronic illness management can make applying myriad single condition evidence-based guidelines increasingly difficult. This is compounded because the problems presented in general practice often require both clinical and social solutions. In response to these issues, generalist clinicians are now expected to practise 'person-centred care': enabling and empowering patients by combining the technical rationality of medical science with individual values, needs and preferences. To explore this difficult undertaking we conducted an ethnography of a general practice surgery in England, including participant observation, interviews, and focus groups with patients, clinicians, and support staff, from February 2018 to March 2019. Our findings suggest that clinicians in our study faced considerable constraints, broadly conceived as the limits of biomedicine and the structural constraints of general practice. However, they mitigated these by getting into good habits, which we conceive in two categories: using expert judgement and taking patients seriously. We further propose that clinicians did not merely will themselves towards these good habits but developed and adapted them by intuitively adopting a second-order 'meta' habit of enaction - treating each consultation as collaboratively co-created anew. This suggests an important feature of the general practice consultation: it is conducted as much in the subjunctive as the indicative mood. Developing this proposition, we propose a more general form of medical practice - subjunctive medicine - extolling the value of the co-created social order of the general practice consultation itself. We suggest that practising subjunctive medicine may help clinicians sustainably and resiliently achieve the aims of person-centred care in modern general practice.

Health Behavior Change and Complementary Medicine Use: National Health Interview Survey 2012.

Background and objectives: Complementary and alternative medicine (CAM) use has been associated with preventive health behaviors. However, the role of CAM use in patients' health behaviors remains unclear. This study aimed to determine the extent to which patients report that CAM use motivates them to make changes to their health behaviors. Materials and Methods: This secondary analysis of 2012 National Health Interview Survey data involved 10,201 CAM users living in the United States who identified up to three CAM therapies most important to their health. Analyses assessed the extent to which participants reported that their CAM use motivated positive health behavior changes, specifically: eating healthier, eating more organic foods, cutting back/stopping drinking alcohol, cutting back/quitting smoking cigarettes, and/or exercising more regularly. Results: Overall, 45.4% of CAM users reported being motivated by CAM to make positive health behavior changes, including exercising more regularly (34.9%), eating healthier (31.4%), eating more organic foods (17.2%), reducing/stopping smoking (16.6% of smokers), or reducing/stopping drinking alcohol (8.7% of drinkers). Individual CAM therapies motivated positive health behavior changes in 22% (massage) to 81% (special diets) of users. People were more likely to report being motivated to change health behaviors if they were: aged 18-64 compared to those aged over 65 years; of female gender; not in a relationship; of Hispanic or Black ethnicity, compared to White; reporting at least college education, compared to people with less than high school education; without health insurance. Conclusions: A sizeable proportion of respondents were motivated by their CAM use to undertake health behavior changes. CAM practices and practitioners could help improve patients' health behavior and have potentially significant implications for public health and preventive medicine initiatives; this warrants further research attention.

Supporting informed choice in acupuncture: effects of a new person-, evidence- and theory-based website for patients with back pain.

OBJECTIVES: To test whether a newly developed person-, theory- and evidence-based website about acupuncture helps patients make informed decisions about whether or not to use acupuncture for back pain. METHODS: A randomised online study compared a newly developed 'enhanced website' to a 'standard website'. The enhanced website provided evidence-based information in a person-based manner and targeted psychological constructs. The standard website was based on a widely used patient information leaflet. In total, 350 adults with recent self-reported back pain were recruited from general practices in South West England. The two primary outcomes were knowledge change and making an informed choice about using acupuncture. Secondary outcomes were beliefs about and willingness to have acupuncture. RESULTS: Participants who viewed the enhanced acupuncture website had a significantly greater increase in knowledge about acupuncture (M = 1.1, standard deviation (SD) = 1.7) than participants who viewed the standard website (M = 0.2, SD = 1.1; F(1, 315) = 37.93, p < 0.001, η2 = .107). Participants who viewed the enhanced acupuncture website were also 3.3 times more likely to make an informed choice about using acupuncture than those who viewed the standard website (χ2(1) = 23.46, p < 0.001). There were no significant effects on treatment beliefs or willingness to have acupuncture. CONCLUSION: The enhanced website improved patients' knowledge and ability to make an informed choice about acupuncture, but did not optimise treatment beliefs or change willingness to have acupuncture. The enhanced website could be used to support informed decision-making among primary care patients and members of the general public considering using acupuncture for back pain.

"I just googled and read everything": Exploring breast cancer survivors' use of the internet to find information on complementary medicine.

OBJECTIVE: Breast cancer survivors often turn to the internet as an information resource when deciding whether to use complementary and alternative medicine (CAM) but their use of online CAM-related resources is poorly understood. The objective was to explore breast cancer survivors' use of the internet when making decisions about CAM use. DESIGN: A purposive sample of 11 breast cancer survivors (mean age=56) completed a quantitative questionnaire and a qualitative telephone interview. The theory of planned behaviour (TPB) was used to guide interview questions. Framework analysis and descriptive statistics were used. SETTING: United Kingdom. RESULTS: All participants found information on CAM using the internet and used some form of CAM after their diagnosis. Themes from the interviews went beyond the standard definitions of the TPB areas. Despite the lack of approval from their social network and healthcare team, participants used the internet to find information on CAM. Further, participants' cancer diagnosis changed their needs, transforming how they perceived and experienced the internet CONCLUSIONS: Participants' use of the internet was more complex than can easily be explained by the TPB and was inherently connected to the experience of self-management for the consequences of cancer and its treatment. As breast cancer survivors may not disclose their use of the internet to their healthcare team, healthcare professionals need to be aware that the information available on the internet plays a factor in the decision-making process to use CAM.

What trial participants need to be told about placebo effects to give informed consent: a survey to establish existing knowledge among patients with back pain.

INTRODUCTION: Patients require an accurate knowledge about placebos and their possible effects to ensure consent for placebo-controlled clinical trials is adequately informed. However, few previous studies have explored patients' baseline (ie, pretrial recruitment) levels of understanding and knowledge about placebos. The present online survey aimed to assess knowledge about placebos among patients with a history of back pain. DESIGN: A 15-item questionnaire was constructed to measure knowledge about placebos. Additional questions assessed sociodemographic characteristics, duration and severity of back pain, and previous experience of receiving placebos. SETTING: Participants recruited from community settings completed the study online. RESULTS: 210 participants completed the questionnaire. 86.7% had back pain in the past 6 months, 44.3% currently had back pain. 4.3% had received a placebo intervention as part of a clinical trial and 68.1% had previously read or heard information about placebos. Overall knowledge of placebos was high, with participants on average answering 12.07 of 15 questions about placebos correctly (SD=2.35). However, few participants correctly answered questions about the nocebo effect (31.9% correct) and the impact of the colour of a placebo pill (55.2% correct). CONCLUSIONS: The findings identified key gaps in knowledge about placebos. The lack of understanding of the nocebo effect in particular has implications for the informed consent of trial participants. Research ethics committees and investigators should prioritise amending informed consent procedures to incorporate the fact that participants in the placebo arm might experience adverse side effects.

What techniques might be used to harness placebo effects in non-malignant pain? A literature review and survey to develop a taxonomy.

OBJECTIVES: Placebo effects can be clinically meaningful but are seldom fully exploited in clinical practice. This review aimed to facilitate translational research by producing a taxonomy of techniques that could augment placebo analgesia in clinical practice. DESIGN: Literature review and survey. METHODS: We systematically analysed methods which could plausibly be used to elicit placebo effects in 169 clinical and laboratory-based studies involving non-malignant pain, drawn from seven systematic reviews. In a validation exercise, we surveyed 33 leading placebo researchers (mean 12 years’ research experience, SD 9.8), who were asked to comment on and add to the draft taxonomy derived from the literature. RESULTS: The final taxonomy defines 30 procedures that may contribute to placebo effects in clinical and experimental research, proposes 60 possible clinical applications and classifies procedures into five domains: the patient’s characteristics and belief (5 procedures and 11 clinical applications), the practitioner’s characteristics and beliefs (2 procedures and 4 clinical applications), the healthcare setting (8 procedures and 13 clinical applications), treatment characteristics (8 procedures and 14 clinical applications) and the patientâ€"practitioner interaction (7 procedures and 18 clinical applications). CONCLUSION: The taxonomy provides a preliminary and novel tool with potential to guide translational research aiming to harness placebo effects for patient benefit in practice.

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.

Assessing knowledge about acupuncture: A survey of people with back pain in the UK.

OBJECTIVES: Despite the prevalence of acupuncture treatment in the UK, and the increasing evidence of safety and effectiveness, the information presented to patients by practitioners frequently contains inaccuracies. As knowledge of treatment affects both patient decision-making and treatment outcomes, this study aimed to establish what is known about acupuncture in a sample of people who had, and had not, previously experienced acupuncture. DESIGN: A 15-item questionnaire was constructed to assess knowledge of acupuncture. SETTING: Online survey of people with a history of back pain. RESULTS: 202 participants completed the questionnaire. 66.8% of the sample was female and 33.2% male, with a mean age of 35 years (range 18-74 years). 87.6% had back pain in the past six months, 44.1% currently. 21.8% had previously received acupuncture, and 69.8% had previously read or heard information about acupuncture. On average participants answered 11.03 of 15 questions about acupuncture correctly (SD=2.64). Items relating to common concerns about acupuncture, acupuncture efficacy, and types of acupuncture were correctly answered by ≥80% of participants. Participants possessed less knowledge of accessibility, Government legislation, and methods of administration. CONCLUSIONS: The study identified key gaps in knowledge about acupuncture among patients. In particular, many participants were unaware that acupuncture is available from the UK National Health Service and that acupuncturists are not subject to statutory regulation in the UK. These knowledge gaps should be addressed in order to increase people's understanding of and access to acupuncture.

Practice, practitioner, or placebo? A multifactorial, mixed-methods randomized controlled trial of acupuncture.

The nonspecific effects of acupuncture are well documented; we wished to quantify these factors in osteoarthritic (OA) pain, examining needling, the consultation, and the practitioner. In a prospective randomised, single-blind, placebo-controlled, multifactorial, mixed-methods trial, 221 patients with OA awaiting joint replacement surgery were recruited. Interventions were acupuncture, Streitberger placebo acupuncture, and mock electrical stimulation, each with empathic or nonempathic consultations. Interventions involved eight 30-minute treatments over 4 weeks. The primary outcome was pain (VAS) at 1 week posttreatment. Face-to-face qualitative interviews were conducted (purposive sample, 27 participants). Improvements occurred from baseline for all interventions with no significant differences between real and placebo acupuncture (mean difference -2.7 mm, 95% confidence intervals -9.0 to 3.6; P=.40) or mock stimulation (-3.9, -10.4 to 2.7; P=.25). Empathic consultations did not affect pain (3.0mm, -2.2 to 8.2; P=.26) but practitioner 3 achieved greater analgesia than practitioner 2 (10.9, 3.9 to 18.0; P=.002). Qualitative analysis indicated that patients' beliefs about treatment veracity and confidence in outcomes were reciprocally linked. The supportive nature of the trial attenuated differences between the different consultation styles. Improvements occurred from baseline, but acupuncture has no specific efficacy over either placebo. The individual practitioner and the patient's belief had a significant effect on outcome. The 2 placebos were equally as effective and credible as acupuncture. Needle and nonneedle placebos are equivalent. An unknown characteristic of the treating practitioner predicts outcome, as does the patient's belief (independently). Beliefs about treatment veracity shape how patients self-report outcome, complicating and confounding study interpretation.

How patients choose acupuncturists: a mixed-methods project.

OBJECTIVES: Patients can have difficulties choosing acupuncturists in the United Kingdom because acupuncturists are not all subject to statutory regulation. Research has identified factors that influence patients' choice of general practitioner. However, how patients choose acupuncturists has not been studied. The aim was to investigate how patients choose acupuncturists and to identify which factors might influence this choice. DESIGN: A mixed-methods design used an exploratory qualitative study followed by a quantitative study. The qualitative study explored patients' experiences of acupuncture. The quantitative vignette study investigated the impact of patient gender and practitioner factors (gender, training location, and qualifications) on choice of acupuncturist. METHODS: In the qualitative study, 35 acupuncture patients (recruited through maximum variation sampling from seven clinics and the community) participated in semistructured interviews about their acupuncture experiences. In the quantitative study, 73 participants imagined wanting to consult an acupuncturist for back pain. They rated 8 fictional acupuncturists; ratings were analyzed using analysis of covariance. RESULTS: Patients wanted qualified, personable acupuncturists and valued recommendations from trusted others. Without such recommendations, potential patients preferred female acupuncturists (F(1,69)=4.504, p<0.05) and those with medical qualifications (F(1,69)=44.832, p<0.01). CONCLUSIONS: The decision to consult a particular acupuncturist is not straightforward. Acupuncturists' trustworthiness and technical competence are important to (potential) patients; practitioner gender also influenced preferences. Patients need to be informed about proposals concerning statutory regulation in CAM and its implications; conventional practitioners might be able to better support their patients wanting to consult acupuncturists.

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.

Prevalence of complementary medicine use in pediatric cancer: a systematic review.

CONTEXT: Complementary and alternative medicine (CAM) is used by pediatric patients with cancer, but the actual frequency of CAM use is undetermined. OBJECTIVE: In this systematic review we summarize the current evidence on the prevalence of CAM use in pediatric patients with cancer and assess the reported quality of included studies. METHODS: We systematically searched 6 major electronic databases, reference lists of existing reviews, and personal files. We included full articles about primary research studies (without language restriction) that reported the prevalence of CAM use if all or a defined subsample of participants were pediatric patients with cancer. Detailed information regarding methods and results was extracted from the original articles. A quality-assessment tool was rigorously developed on the basis of the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement and used to assess reported study quality. Formal tests of interrater agreement were conducted. RESULTS: We included 28 studies with survey data (collected from 1975 to 2005) from 3526 children. In 20 studies with 2871 participants, the prevalence of any CAM use (since cancer diagnosis) ranged from 6% to 91%; considerable heterogeneity across studies precluded meta-analysis. Study quality was mixed and not correlated with CAM prevalence. Herbal remedies were the most popular CAM modality, followed by diets/nutrition and faith-healing. Commonly reported reasons for CAM use included to help cure or fight the child's cancer, symptomatic relief, and support of ongoing use of conventional therapy. There was little evidence of an association between CAM use and patients' sociodemographic characteristics. CONCLUSIONS: Many pediatric patients with cancer use CAM. It is important that pediatricians be aware of this fact and encourage open communication with patients and their parents. Using standardized survey methods and CAM definitions in future studies could improve their quality and help generate comparable data. Our quality-assessment tool could prove valuable for other reviews of prevalence studies.

Who Uses CAM? A Narrative Review of Demographic Characteristics and Health Factors Associated with CAM Use.

Complementary and Alternative Medicines (CAM) are used by an extensive number of patients in the UK and elsewhere. In order to understand this pattern of behavior, it is helpful to examine the characteristics of people who use CAM. This narrative review collates and evaluates the evidence concerning the demographic characteristics and health status factors associated with CAM use in community-based non-clinical populations. A systematic literature search of computerized databases was conducted, and published research papers which present evidence concerning associations between CAM use and demographic and health characteristics are discussed and evaluated. The evidence suggests that people who use CAM tend to be female, of middle age and have more education. In terms of their health, CAM users tend to have more than one medical condition, but might not be more likely than non-users to have specific conditions such as cancer or to rate their own general health as poor. The multivariate studies that have been conducted suggest that both demographic and health characteristics contribute independently to CAM use. In conclusion, demographic characteristics and factors related to an individual's health status are associated with CAM use. Future research is needed to address methodological limitations in existing studies.

Constructing agency in treatment decisions: negotiating responsibility in cancer.

People belonging to cancer patient support groups participated in focus groups concerning their experiences of orthodox and complementary medicine. Their accounts of treatment decisions for cancer were analysed through discourse analysis. Accounts of both complementary and orthodox medicine addressed an ideological dilemma concerning the positioning of individuals as active or passive. Active positions were congruent with the everyday value of autonomy and responsible individuality, but conflicted with the established expertise of the medical profession in cancer and entailed being accountable for one's health. Passive positions reversed this situation. Complementary medicine provided an opportunity for people with cancer to negotiate active positions in a limited domain of health care. The responsibility for health associated with taking active treatment decisions was problematic in accounts of both orthodox and complementary medicine.