Acupuncture as a complex intervention for depression: A consensus method to develop a standardised treatment protocol for a randomised controlled trial

Objective: To standardise a complex intervention by defining the characteristic (specific) components of treatment for a randomised controlled trial of acupuncture as an intervention for individuals who have been diagnosed with depression using a consensus method. Methods: A nominal group technique was used. Potential components of the acupuncture intervention were generated from the literature, experts and participants. These were categorised as constant or variable, the latter including active management techniques (such as providing relevant explanations), auxiliary techniques (such as auricular acupuncture), and other aspects of patient care (such as offering life-style and dietary advice), all of which were underpinned by defined theoretical frameworks. Participants were selected on the basis of their experience and training, to encompass a diverse range of styles of traditional acupuncture practice in the UK, and all rated components in two rounds. Results: Fifteen practitioners rated 52 variable components in the first round and 55 in the second. There was group support for 16 active management components, three auxiliary techniques and five areas of life-style support, all driven by eight theoretical diagnostic and treatment frameworks. For the 39 components that were rated twice, group support increased between rounds from 75 to 79% (z=-2.2, p=0.03), while the absolute average deviation from the median dropped from 1.04 to 0.83 (z=-2.5, p=0.011). Conclusion: Standardising the characteristic components of a complex intervention for a randomised controlled trial of acupuncture for depression using a consensus approach is feasible. The method can be generalised to other clinical situations and other treatment modalities. Crown Copyright (c) 2006 Published by Elsevier Ltd. All rights reserved

Acupuncture Research: Strategies for Clinical Evaluation: Workshop Report, York, July 5–8, 2006

This report summarizes a ground-breaking workshop on the strategic direction of acupuncture research which was held in York in early July 2006. Three days were spent discussing the history, the philosophy and the practicalities of researching acupuncture. Attending the workshop were an international group of researchers with varied backgrounds, including acupuncturists, physicians, physiotherapists, sociologists and anthropologists. Supported by the Medical Research Council's Health Services Research Collaboration, Elsevier and others, this workshop was an opportunity to brainstorm the issues and to the concerns in the field and set out directions for research that would tackle some of the major challenges facing the acupuncture research community

Cardiovascular effects of serotonergic agents

Serotonin (5-hydroxytryptamine, 5-HT) is a neurotransmitter which exerts its cardiovascular effects predominantly by interaction with specific 5-HT1 and 5- HT2 receptors. The effects of serotonergic agents differ between in vivo and in vitro preparations and display wide inter-species variation. It is therefore impossible to extrapolate results from animal or in vitro studies to the clinical situation. The role of these two receptors has therefore been studied in patients with suspected coronary artery disease using 3 different 5-HT1 agonists and ketanserin, a 5-HT2 antagonist. Sumatriptan and naratriptan, 5-HT1B/D receptor agonists, vasoconstrict the systemic and pulmonary circulations. Sumatriptan-induced vasoconstriction appears more pronounced in the pulmonary circulation suggesting a greater density of 5-HT1 receptors in the pulmonary compared to the systemic circulation. Although left ventricular end diastolic pressure and pulmonary artery wedge pressure rose after sumatriptan, there was no change in peak rate of left ventricular pressure rise, indicating the absence of a negative inotropic action. Naratriptan, an analogue of sumatriptan, displayed no significant effect on coronary artery diameter, a finding previously noted with sumatriptan. Eletriptan, a selective 5-HT1D agonist with less 5-HT1B activity, had little vasoconstrictor effect on the systemic, pulmonary or coronary circulation perhaps suggesting that the 5-HT1B receptor subtype mediates vasoconstriction. The effect of sumatriptan on systolic time intervals and forearm blood flow was also assessed. The results suggest that STI's are of potential use in the non-invasive assessment of 5-HT1 agonists. No significant effect on forearm blood flow was observed but plasma noradrenaline levels fell after subcutaneous sumatriptan. Ketanserin, a 5-HT2 antagonist, acted as a vasodilator in the systemic and pulmonary circulation but failed to vasodilate the coronary arteries, presumably because the patients in this study had stable angina without platelet activation and therefore had low circulating levels of serotonin

GP Participation and Recruitment of Patients to RCTs: Lessons from Trials of Acupuncture and Exercise for Low Back Pain in Primary Care

The objective of this study was to identify factors associated with general practitioner (GP) participation and the recruitment of people to trials in primary care, based on data from two trials of interventions for treating chronic low back pain. The study was based on data from two randomized controlled trials (RCTs), one involving exercise, the other acupuncture, and subsequent reporting by GPs in a postal questionnaire. The exercise trial achieved 62% recruitment whereas the acupuncture trial achieved 100% recruitment. In both trials GPs most efficient at referring patients were those with a special interest in the subject area, and those known personally to the research team. A follow-up GP questionnaire found that both trials had maintained a high profile with over 80% of GPs, and successful recruitment strategies included project reminder letters, updates and personal contacts. Achieving target recruitment of patients in the acupuncture trial was aided by the deliberate application of lessons learned in the exercise trial, in particular the need to keep initial study entry criteria broad, with subsequent filtering undertaken by the study researcher. In addition the use of effective methods of maintaining the trial profile, the involvement of a GP advisor, the decision to maximize the recruitment of GPs early in the trial and the direct recruitment of interested individual GPs. The successful recruitment of patients to trials in primary care requires careful planning and continuous monitoring from the outset. Prior to starting recruitment, it is useful to identify previous trials in a similar environment in order to learn from their experience and optimize patient recruitment

Practitioner perspectives on strategies to promote longer-term benefits of acupuncture or counselling for depression: a qualitative study

Background: Non-pharmacological interventions for depression may help patients manage their condition. Evidence from a recent large-scale trial (ACUDep) suggests that acupuncture and counselling can provide longer-term benefits for many patients with depression. This paper describes the strategies practitioners reported using to promote longer-term benefits for their patients. Methods: A qualitative sub-study of practitioners (acupuncturists and counsellors) embedded in a randomised controlled trial. Using topic guides, data was collected from telephone interviews and a focus group, altogether involving 19 counsellors and 17 acupuncturists. Data were audio recorded, transcribed verbatim and analysed using thematic content analysis. Results: For longer-term impact, both acupuncturists and counsellors encouraged insight into root causes of depression on an individual basis and saw small incremental changes as precursors to sustained benefit. Acupuncturists stressed the importance of addressing concurrent physical symptoms, for example helping patients relax or sleep better in order to be more receptive to change, and highlighted the importance of Chinese medicine theory-based lifestyle change for lasting benefit. Counsellors more often highlighted the importance of the therapeutic relationship, emphasising the need for careful “pacing” such that the process and tools employed were tailored and timed for each individual, depending on the “readiness” to change. Our data is limited to acupuncture practitioners using the principles of traditional Chinese medicine, and counsellors using a humanistic, non-directive and person-centred approach. Conclusions: Long-term change appears to be an important focus within the practices of both acupuncturists and counsellors. To achieve this, practitioners stressed the need for an individualised approach with a focus on root causes

The acceptability of acupuncture for low back pain: a qualitative study of patient’s experiences nested within a randomised controlled trial. PLoS One

Article: Hopton, Ann Kathryn orcid.org/0000-0002-2505-1176, MacPherson, Hugh orcid.org/0000-0003-4255-4768 and Thomas, Kate (2013) The acceptability of acupuncture for low back pain : a qualitative study of patient's experiences nested within a randomised controlled trial. PLoS ONE. e56806. ISSN 1932-6203 https://doi.org/10.1371/journal.pone.0056806 [email protected] https://eprints.whiterose.ac.uk/ Reuse Items deposited in White Rose Research Online are protected by copyright, with all rights reserved unless indicated otherwise. They may be downloaded and/or printed for private study, or other acts as permitted by national copyright laws. The publisher or other rights holders may allow further reproduction and re-use of the full text version. This is indicated by the licence information on the White Rose Research Online record for the item. Takedown If you consider content in White Rose Research Online to be in breach of UK law, please notify us by emailing [email protected] including the URL of the record and the reason for the withdrawal request. This study used patient interviews following acupuncture treatment for back pain to identify, understand and describe the elements that contribute or detract from acceptability of treatment

Validity of single item responses to short message service texts to monitor depression:an mHealth sub-study of the UK ACUDep trial

BACKGROUND: An increasing number of research designs are using text messaging (SMS) as a means of self-reported symptom and outcome monitoring in a variety of long-term health conditions, including severity ratings of depressed mood. The validity of such a single item SMS score to measure latent depression is not currently known and is vital if SMS data are to inform clinical evaluation in the future. METHODS: A sub-set of depressed participants in the UK ACUDep trial submitted a single SMS text score (R-SMS-DS) between 1 and 9 on how depressed they felt around the same time as completing the PHQ-9 depression questionnaire on paper at 3 months follow-up of the trial. Exploratory categorical data factor analysis (EFA) was used to ascertain the alignment of R-SMS-DS scores with the factor structure of the PHQ-9. Any response bias with regard to age or gender was assessed by differential item functioning (DIF) analysis. RESULTS: Depression scores based on the PHQ-9 and R-SMS-DS at 3 months were available for 337 participants (74 % female; mean age: 42 years, SD = 11.1), 213 of which completed the two outcomes within 6 days of each other. R-SMS-DS scores aligned with the underlying latent depression of the PHQ-9 (factor loading of 0.656) and in particular its affective rather than somatic dimension. The R-SMS-DS score was most strongly correlated with depressed mood (r = 0.607), feeling bad about oneself (r = 0.588) and anhedonia (r = 0.573). R-SMS-DS responses were invariant with respect to gender (p = 0.302). However, there was some evidence for age related response bias (p = 0.031), with older participants being more likely to endorse lower R-SMS-DS scores than younger ones. CONCLUSIONS: The R-SMS-DS used in the ACUDep trial was found to be a valid measure of latent affective depression with no gender related response bias. This text message item may therefore represent a useful assessment and monitoring tool meriting evaluation in further research. For future study designs we recommend the collection of outcome data by new health technologies in combination with gold standard instruments to ensure concurrent validity

Revised standards for reporting interventions in clinical trials of acupuncture (STRICTA) : Extending the CONSORT statement

The Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) were published in five journals in 2001 and 2002. These guidelines, in the form of a checklist and explanations for use by authors and journal editors, were designed to improve reporting of acupuncture trials, particularly the interventions, thereby facilitating their interpretation and replication. Subsequent reviews of the application and impact of STRICTA have highlighted the value of STRICTA as well as scope for improvements and revision

Evaluating Complex Healthcare Systems: A Critique of Four Approaches

The purpose of this paper is to bring clarity to the emerging conceptual and methodological literature that focuses on understanding and evaluating complex or ‘whole’ systems of healthcare. An international working group reviewed literature from interdisciplinary or interprofessional groups describing approaches to the evaluation of complex systems of healthcare. The following four key approaches were identified: a framework from the MRC (UK), whole systems research, whole medical systems research described by NCCAM (USA) and a model from NAFKAM (Norway). Main areas of congruence include acknowledgment of the inherent complexity of many healthcare interventions and the need to find new ways to evaluate these; the need to describe and understand the components of complex interventions in context (as they are actually practiced); the necessity of using mixed methods including randomized clinical trials (RCTs) (explanatory and pragmatic) and qualitative approaches; the perceived benefits of a multidisciplinary team approach to research; and the understanding that methodological developments in this field can be applied to both complementary and alternative medicine (CAM) as well as conventional therapies. In contrast, the approaches differ in the following ways: terminology used, the extent to which the approach attempts to be applicable to both CAM and conventional medical interventions; the prioritization of research questions (in order of what should be done first) especially with respect to how the ‘definitive’ RCT fits into the process of assessing complex healthcare systems; and the need for a staged approach. There appears to be a growing international understanding of the need for a new perspective on assessing complex healthcare systems

Acupuncture for chronic neck pain: a pilot for a randomised controlled trial

Background: Acupuncture is increasingly being used for many conditions including chronic neck pain. However the evidence remains inconclusive, indicating the need for further well-designed research. The aim of this study was to conduct a pilot randomised controlled parallel arm trial, to establish key features required for the design and implementation of a large-scale trial on acupuncture for chronic neck pain. Methods: Patients whose GPs had diagnosed neck pain were recruited from one general practice, and randomised to receive usual GP care only, or acupuncture ( up to 10 treatments over 3 months) as an adjunctive treatment to usual GP care. The primary outcome measure was the Northwick Park Neck Pain Questionnaire (NPQ) at 3 months. The primary analysis was to determine the sample size for the full scale study. Results: Of the 227 patients with neck pain identified from the GP database, 28 (12.3%) consenting patients were eligible to participate in the pilot and 24 (10.5%) were recruited to the trial. Ten patients were randomised to acupuncture, receiving an average of eight treatments from one of four acupuncturists, and 14 were randomised to usual GP care alone. The sample size for the full scale trial was calculated from a clinically meaningful difference of 5% on the NPQ and, from this pilot, an adjusted standard deviation of 15.3%. Assuming 90% power at the 5% significance level, a sample size of 229 would be required in each arm in a large-scale trial when allowing for a loss to follow-up rate of 14%. In order to achieve this sample, one would need to identify patients from databases of GP practices with a total population of 230,000 patients, or approximately 15 GP practices roughly equal in size to the one involved in this study (i.e. 15,694 patients). Conclusion: This pilot study has allowed a number of recommendations to be made to facilitate the design of a large-scale trial, which in turn will help to clarify the existing evidence base on acupuncture for neck pain