Charlotte Paterson

Characteristic and incidental (placebo) effects in complex interventions such as acupuncture

The specific effects of non-pharmaceutical treatments are not always divisible from placebo effects and may be missed in randomised trials The randomised double blind controlled trial has proved an invaluable tool for testing the efficacy of new drugs. However, it is now used to evaluate complex non-pharmaceutical interventions, many of which are based on different therapeutic theories. For example, randomised controlled trials are used to test physiotherapy, a complex intervention with a basis in biomedical theory, and acupuncture, which is often based on Chinese medicine. In order to use a placebo or sham controlled design, an intervention has to be divided into characteristic (specific) and incidental (placebo, non-specific) elements. However, recent research suggests that it is not meaningful to split complex interventions into characteristic and incidental elements. Elements that are categorised as incidental in drug trials may be integral to non-pharmaceutical interventions. If this is true, the use of placebo or sham controlled trial designs in evaluating complex non-pharmaceutical interventions may generate false negative results. ![][1] The characteristic effects of acupuncture extend beyond needling Credit: WELLCOME PHOTOGRAPHIC LIBRARY A treatment, or healthcare delivery encounter,1 contains a spectrum of treatment factors and associated effects for which numerous terms and definitions are used. We will use the terms characteristic effects (specific effects) and incidental effects (placebo, non-specific, context effects) as defined by Grunbaum.2 3 Characteristic factors are therapeutic actions or strategies that are theoretically derived, unique to a specific treatment, and believed to be causally responsible for the outcome—for example, a drug. Incidental factors are the many other factors that have also been shown to affect outcome, such as the credibility of the intervention, patient expectations, the manner and consultation style of the practitioner, and the therapeutic setting.1 4 In randomised controlled designs, these incidental factors also include a dummy … [1]: /embed/graphic-1.gif

The experience of using complementary therapies after a diagnosis of cancer: A qualitative synthesis

This article describes a qualitative synthesis of published research on cancer patients’ experiences of complementary therapies. We conducted a systematic search for qualitative studies on this subject published between 1998 and 2007. Twenty-six refereed journal articles met the inclusion criteria. These 26 articles were repeatedly read by the research team and key concepts emerging from them were identified. Differences and variations were examined in association with treatment, therapy type and by stage of cancer (early stage, mid-treatment, advanced cancer, palliative care and long term ‘survivors’). Six overarching concepts were located, which describe the key aspects of patients’ experiences of the use of complementary and alternative medicine after a diagnosis of cancer: Connection; Control; Well-being; Transformation; Integration; and Polarization. These are described in a ‘line of argument’ synthesis, and differences associated with treatment type and stage of disease are noted. The findings are presented in a table showing the six concepts according to treatment type and stage; as a composite story; and in a diagrammatic model showing the individual, practitioner and organizational levels. The synthesis identified various specific ways in which complementary therapies supported cancer patients, as well as occasional negative effects. The most notable barrier was the perceived polarization of complementary therapies and biomedicine; patients reported better experiences in integrated settings.

Measuring changes in self-concept: a qualitative evaluation of outcome questionnaires in people having acupuncture for their chronic health problems

BackgroundChanges in self-concept are an important potential outcome for many interventions for people with long-term conditions. This study sought to identify and evaluate outcome questionnaires suitable for quantifying changes in self-concept in people with long-term conditions, in the context of treatment with acupuncture and Chinese medicine.MethodsA literature search was followed by an evaluation of three questionnaires: The Wellbeing Questionnaire W-BQ12, the Patient Enablement Instrument (PEI), and the Arizona Integrative Outcome Scale (AIOS). A convenience sample of 23 people completed the questionnaires on two occasions and were interviewed about their experience and their questionnaire responses. All acupuncturists were interviewed.ResultsChanges in self-concept were common and emerged over time. The three questionnaires had different strengths and weaknesses in relation to measuring changes in self-concept. The generic AIOS had face validity and was sensitive to changes in self-concept over time, but it lacked specificity. The PEI was sensitive and specific in measuring these changes but had lower acceptability. The sensitivity of the W-BQ12 was affected by initial high scores (ceiling effect) and a shorter timescale but was acceptable and is suitable for repeated administration. The PEI and W-BQ12 questionnaires worked well in combination.ConclusionChanges in self-concept are important outcomes of complex interventions for people with long-term illness and their measurement requires carefully evaluated tools and long-term follow-up. The literature review and the analysis of the strengths and weaknesses of the questionnaires is a resource for other researchers. The W-BQ12 and the PEI both proved useful for this population and a larger quantitative study is planned.

Prostate cancer and supportive care: a systematic review and qualitative synthesis of men's experiences and unmet needs.

Prostate cancer is the second most common cancer in men worldwide, accounting for an estimated 1.1 million new cases diagnosed in 2012 (www.globocan.iarc.fr). Currently, there is a lack of specific guidance on supportive care for men with prostate cancer. This article describes a qualitative systematic review and synthesis examining mens experience of and need for supportive care. Seven databases were searched; 20 journal articles were identified and critically appraised. A thematic synthesis was conducted in which descriptive themes were drawn out of the data. These were peer support, support from partner, online support, cancer specialist nurse support, self‐care, communication with health professionals, unmet needs (emotional support, information needs, support for treatment‐induced side effects of incontinence and erectile dysfunction) and mens suggestions for improved delivery of supportive care. This was followed by the development of overarching analytic themes which were: uncertainty, reframing, and the timing of receiving treatment, information and support. Our results show that the most valued form of support men experienced following diagnosis was one‐to‐one peer support and support from partners. This review highlights the need for improved access to cancer specialist nurses throughout the care pathway, individually tailored supportive care and psychosexual support for treatment side effects.

How to summarise and report written qualitative data from patients: a method for use in cancer support care.

Goals of workThe goal of this study is the determination of key themes to aid the analysis of qualitative data collected at three cancer support centres in England, using the Measure Yourself Concerns and Wellbeing (MYCaW) questionnaire.Patients and methodsPeople with cancer who use complementary therapies experience and value a wide range of treatment effects, yet tools are urgently required to quantitatively measure these outcomes. MYCaW is an individualised questionnaire used in cancer support centres providing complementary therapies, scoring ‘concerns or problems’ and ‘well-being’ and collecting qualitative data about other major events in a patient’s life and what has been most important to the patient. Content analysis on 782 MYCaW questionnaires from people at these cancer support centres was carried out. The ‘concerns,’ ‘other things going on in their life’ and ‘important aspects of centre’ were thematically categorised and externally validated by a focus group, and the inter-rater reliability was calculated.Main resultsClinical information from a cancer patient’s perspective was collected that is not measured on standard quality-of-life questionnaires; furthermore, some themes acknowledge the multi-faceted aspects of complementary and alternative medicine provision, rather than information only relating to the therapeutic intervention. Categories for qualitative MYCaW analysis have been established providing a tool for future research and/or service delivery improvement within cancer support centres such as these.ConclusionsThe established themes provide a framework to aid analysis of qualitative aspects of complementary therapy care for people with cancer, improving our understanding of how the patient’s cancer experience can be aided by complementary therapies in specialised cancer centres.

Building resilience: A preliminary exploration of women's perceptions of the use of acupuncture as an adjunct to In Vitro Fertilisation

BackgroundIn Vitro Fertilisation (IVF) is now an accepted and effective treatment for infertility, however IVF is acknowledged as contributing to, rather than lessening, the overall psychosocial effects of infertility. Psychological and counselling interventions have previously been widely recommended in parallel with infertility treatments but whilst in many jurisdictions counselling is recommended or mandatory, it may not be widely used. Acupuncture is increasingly used as an adjunct to IVF, in this preliminary study we sought to investigate the experience of infertile women who had used acupuncture to improve their fertility.MethodsA sample of 20 women was drawn from a cohort of women who had attended for a minimum of four acupuncture sessions in the practices of two acupuncturists in South Australia. Eight women were interviewed using a semi-structured questionnaire. Six had sought acupuncture during IVF treatment and two had begun acupuncture to enhance their fertility and had later progressed to IVF. Descriptive content analysis was employed to analyse the data.ResultsFour major categories of perceptions about acupuncture in relation to reproductive health were identified: (a) Awareness of, and perceived benefits of acupuncture; (b) perceptions of the body and the impact of acupuncture upon it; (c) perceptions of stress and the impact of acupuncture on resilience; and (d) perceptions of the intersection of medical treatment and acupuncture.ConclusionThis preliminary exploration, whilst confined to a small sample of women, confirms that acupuncture is indeed perceived by infertile women to have an impact to their health. All findings outlined here are reported cautiously because they are limited by the size of the sample. They suggest that further studies of acupuncture as an adjunct to IVF should systematically explore the issues of wellbeing, anxiety, personal and social resilience and womens identity in relation to sexuality and reproduction.

Outcomes of traditional Chinese medicine (traditional acupuncture) treatment for people with long-term conditions.

A set of outcome questionnaires has been developed to measure the range of treatment effects of traditional acupuncture. In this descriptive outcome study we validated these questionnaires in a busy National Health Service funded acupuncture clinic serving communities of diverse socio-economic circumstances. Some of the questionnaires performed better than others in this setting but EQ-5D and MYMOP-qual both showed statistically and clinically significant improvement in physical and psychological health after six weeks and six months, in all categories of disease and degrees of chronicity. Both the written qualitative data and the Patient Enablement Instrument (PEI) demonstrated considerable patient enablement and, for some patients, the acquisition of new coping and self-care strategies.The questionnaires were feasible to administer, acceptable to patients and clinic staff, and provided robust and detailed quantitative and qualitative outcome data of use for service provision, future planning, and as a basis for further cost-effectiveness studies.

A pilot study to evaluate the effects of floatation spa treatment on patients with osteoarthritis.

OBJECTIVE To conduct a preliminary investigation of the effects on floatation spa therapy on quality of life in patients with osteoarthritis to see if controlled trials are warranted. DESIGN Uncontrolled clinical trial. SETTING Private floatation spa therapy centre. PATIENTS Fourteen patients with chronic osteoarthritis of the weight-bearing joints, of whom four dropped out. INTERVENTION Six weekly sessions of floatation spa therapy. OUTCOME MEASURES SF36, AIMS2 and MYMOP quality-of-life questionnaires. MAIN RESULTS All patients improved. Differences between baseline and discharge scores showed statistically significant improvement for MYMOP, but not AIMS2 or SF-36. CONCLUSIONS Controlled trials of floatation spa therapy for patients with osteoarthritis are warranted.

Self-care in people with long term health problems: a community based survey.

BackgroundSelf-care is a key component of current policies to manage long term conditions. Although most people with long-term health problems care for themselves within lay networks, consultation rates for long-term undifferentiated illness remain high. Promotion of self-care in these individuals requires an understanding of their own self-care practices and needs to be understood in the context of health care pluralism. The aim was to investigate the extent and nature of self-care practices in patients experiencing long term health problems, sources of information used for self-care, and use of other forms of health care (conventional health care and complementary and alternative medicine).MethodsThe study involved a cross-sectional community-based survey set in three general practices in South West England: two in urban areas, one in a rural area. Data were collected using a postal questionnaire sent to a random sample of 3,060 registered adult patients. Respondents were asked to indicate which of six long term health problems they were experiencing, and to complete the questionnaire in reference to a single (most bothersome) problem only.ResultsOf the 1,347 (45% unadjusted response rate) who responded, 583 reported having one or more of the six long term health problems and 572 completed the survey questionnaire. Use of self-care was notably more prevalent than other forms of health care. Nearly all respondents reported using self-care (mean of four self-care practices each). Predictors of high self-care reported in regression analysis included the reported number of health problems, bothersomeness of the health problem and having received a diagnosis. Although GPs were the most frequently used and trusted source of information, their advice was not associated with greater use of self-care.ConclusionsThis study reveals both the high level and wide range of self-care practices undertaken by this population. It also highlights the importance of GPs as a source of trusted information and advice. Our findings suggest that in order to increase self-care without increasing consultation rates, GPs and other health care providers may need more resources to help them to endorse appropriate self-care practices and signpost patients to trusted sources of self-care support.

Communication about self-care in traditional acupuncture consultations: the co-construction of individualised support and advice.

OBJECTIVE To analyse the co-construction of self-care advice in traditional acupuncture consultations. METHOD Analysis of 27 audio-recorded and transcribed consultations, involving 7 practitioners, augmented by integrating the data from 15 patient interviews and regular practitioner discussions. RESULTS Self-care talk was initiated equally by practitioner and patient, and was threaded through and between acupuncture consultations. It involved interactive discussions that were interwoven with other types of talk, especially life-world and acupuncture talk. Practitioner engagement in self-care talk appeared to increase with experience. The self-care talk was co-constructed within the context of a relationship that was characterised by continuity, mutuality and trust. CONCLUSION Self-care support and advice was integral to the practice of traditional acupuncture and individualised in terms of the patients life-world and/or the Chinese medicine diagnosis. The co-construction of self-care talk did not replicate the asymmetry of conventional medical consultations. PRACTICE IMPLICATIONS The active participation of both patients and acupuncture practitioners in self-care talk may be related to professional practice that is underpinned by a holistic theory base such as Chinese medicine and is delivered in the context of therapeutic relationships based on continuity, mutuality and trust. These findings may inform professional education and the design of multi-disciplinary care pathways.