Suzanne Cochrane

Development of an instrument to assess the quality of acupuncture: Results from a Delphi process

BACKGROUND Quality acupuncture influences the outcomes of clinical research, and issues associated with effective administration of acupuncture in randomized controlled trials need to be addressed when appraising studies. OBJECTIVE The study objective was to achieve consensus on domains and items for inclusion in a rating scale to assess quality acupuncture administered in clinical research. STUDY DESIGN AND SUBJECTS An active group of Australian acupuncture researchers initially identified a pool of items assessing quality. The Delphi consensus process was then used to select and reduce the number of items, and an additional expert panel of 42 researchers were invited to participate. Participants initially ranked items along a five-point scale for the first Delphi round, and indicated an agree or disagree response during the second round. For an item to be retained into the second round, an item had to attain greater than 80% agreement that the item described a dimension of quality acupuncture and related study design. RESULTS Thirty-two (32) experts agreed to participate in the study. After two rounds of the Delphi process, consensus was reached on 14 domains and 26 items relating to quality acupuncture. Domains, items, and minimum standards related to study design; rationale of the intervention; criteria relating to needling stimulation either manual or electrostimulation; duration and frequency of treatment; and practitioner training. CONCLUSIONS Items for inclusion in an instrument to assess quality acupuncture in clinical research were identified. Further development of the instrument including relative weighting of items and reliability testing is under way.

Using a Delphi consensus process to develop an acupuncture treatment protocol by consensus for women undergoing Assisted Reproductive Technology (ART) treatment

BackgroundAssisted reproductive technologies (ART) are increasingly utilised for resolving difficulties conceiving. These technologies are expensive to both the public purse and the individual consumers. Acupuncture is widely used as an adjunct to ART with indications that it may assist reducing the time to conception and increasing live birth rates. Heterogeneity is high between treatment protocols.The aim of this study was to examine what fertility acupuncturists consider key components of best practice acupuncture during an ART cycle, and to establish an acupuncture protocol by consensus.MethodsFifteen international acupuncturists with extensive experience treating women during ART interventions participated in 3 rounds of Delphi questionnaires. The first round focused on identifying the parameters of acupuncture treatment as adjunct to ART, the second round evaluated statements derived from the earlier round, and the third evaluated specific parameters for a proposed trial protocol. Consensus was defined as greater than 80% agreement.ResultsSignificant agreement was achieved on the parameters of best practice acupuncture, including an acupuncture protocol suitable for future research. Study participants confirmed the importance of needling aspects relating to the dose of acupuncture, the therapeutic relationship, tailoring treatment to the individual, and the role of co-interventions. From two rounds of the Delphi a consensus was achieved on seven treatment parameters for the design of the acupuncture treatment to be used in a clinical trial of acupuncture as an adjunct to ART. The treatment protocol includes the use of the traditional Chinese medicine acupuncture, use of manual acupuncture, a first treatment administered between day 6–8 of the stimulated ART cycle which is individualised to the participant, two treatments will be administered on the day of embryo transfer, and will include points SP8, SP10, LR3, ST29, CV4, and post transfer include: GV20, KD3, ST36, SP6, and PC6. Auricular points Shenmen and Zigong will be used. Practitioner intent or yi will be addressed in the treatment protocol.ConclusionsDespite a lack of homogeneity in the research and clinical literature on ART and acupuncture, a consensus amongst experts on key components of a best practice treatment protocol was possible. Such consensus offers guidance for further research.

Development of a fertility acupuncture protocol: defining an acupuncture treatment protocol to support and treat women experiencing conception delays.

BACKGROUND The influence of acupuncture on female fertility is of interest to people in clinical practice and acupuncture researchers. Despite developing research in the field, there is a marked absence of research defining an adequate treatment to support and treat women experiencing delays in conceiving. OBJECTIVES The aims of this study were to develop a consensus among acupuncture fertility specialists on what is adequate acupuncture treatment to promote female fertility in the periconception period; to examine what acupuncturists do in a consultation; to examine their actions and their exchanges with their patients; and to finalize an acupuncture intervention for a clinical trial of fertility problems. DESIGN AND SUBJECTS An online consensus-building technique was used among acupuncturists who are recognized experts in the field of womens reproductive health. The 10 subjects were selected on the basis of their published work with respect to treating female fertility problems or on the recommendation of researchers who had published articles in this discipline. All 10 subjects currently, or until recently, treated (some exclusively) women facing fertility problems using acupuncture as one of the modalities to address these problems. RESULTS Although the participants were relatively diverse, a consensus emerged regarding the best way to provide acupuncture to women with fertility problems. Along the way, a rich vein of qualitative data emerged about the way in which acupuncture is applied. These data included, for example, the high value placed on differential diagnosis and the importance of the practitioner-patient relationship for the therapeutic outcome. CONCLUSIONS Consensus building among experts provides a transparent method of protocol development suited to acupuncture research that will then hold relevance to clinical practice.

Acupuncture and women's health : an overview of the role of acupuncture and its clinical management in women's reproductive health

Background Acupuncture and other modalities of Chinese/East Asian medicine have been used to treat women’s health for many centuries. Gynecology specialties focus particularly on menstrual and reproductive disorders. Both the adoption of the use of acupuncture outside Asia, and the incorporation of scientific analysis in Asia have challenged biomedical conceptions of what can be achieved with this treatment method. The scale of research activity in relation to acupuncture and women’s health has increased over the last 20 years. Objective This review aims to explore the research evidence in relation to acupuncture use for women’s reproductive disorders, focusing on both clinical findings and experimental research on acupuncture’s mechanisms of action in relation to women’s health. Methods A narrative literature search was undertaken using searches of electronic databases and manual searches of journals and textbooks. The search included all literature published prior to June 2013. The literature was assessed as to the nature of the study it was reporting and findings synthesized into a commentary. Results For acupuncture’s mechanism of action the search resulted in 114 relevant documents; in relation to clinical reports on the use of acupuncture for women’s health 204 documents were found and assessed. Conclusion There is preliminary data indicating acupuncture may improve menstrual health and coping for women experiencing delays falling pregnant. There is experimental data showing that acupuncture can influence female reproductive functioning, although the actual mechanisms involved are not yet clarified. Further well-conducted clinical research would benefit our understanding of the usefulness of acupuncture to women’s health.

Reliability of the NICMAN scale: An instrument to assess the quality of acupuncture administered in clinical trials

Background The aim of this study was to examine the reliability of a scale to assess the methodological quality of acupuncture administered in clinical research. Methods We invited 36 acupuncture researchers and postgraduate students to participate in the study. Firstly, participants rated two articles using the scale. Following this initial stage, modifications were made to scale items and the exercise was repeated. Interrater reliability was assessed for individual items using the Fleiss kappa statistic, whilst the overall scale used the intraclass correlation coefficient statistic. A threshold agreement of ≥0.61 was acceptable. Results We received 26 responses and a 72% response rate. The first phase of testing found moderate reliability with intraclass correlation coefficients of 0.46 and 0.55 for the articles. The interrater reliability of the scales varied between and within the researchers (0.35, 0.60) and was more consistent with the postgraduate students (0.54, 0.54). Five items on the scale scored below the threshold and were revised for further testing. In this phase the intraclass correlation coefficient demonstrated variability between articles but improved to achieve reliability above the agreed threshold. Conclusion This study provides evidence of the reliability of the NICMAN scale although improvements to a small number of items remain.

Looking outside the square: The use of qualitative methods within complementary and alternative medicine—-The movement towards rigour

This paper explores why qualitative research in the field of complementary and alternative medicine (CAM) is underused and, when used, done so defensively. It argues that qualitative research methods can encompass the complexity of CAM and identify richer veins for research exploration. The rigorous application of holistic research methods, used non-defensively, can only benefit CAM and the knowledge base of science.

Current Usage of Traditional Chinese Medicine for Breast Cancer—A Narrative Approach to the Experiences of Women with Breast Cancer in Australia—A Pilot Study

Background: The use of Traditional Chinese Medicine (TCM) by breast cancer patients is growing. Few studies have examined the complexity of breast cancer survivors’ attitudes, lived experiences, barriers, and perceptions in using TCM as part of their treatment journey. This article examines breast cancer survivors’ experiences, perceptions of, and benefits (or not) in using TCM. Methods: Qualitative research, using semi-structured interviews, was the chosen methodology. Results: Participants used TCM as a form of self-help and as a complement, not an alternative, to standard care. Overall, 100% of the participants used acupuncture, 62% used Chinese herbal medicine, 23% used Qigong, and 23% used Chinese dietary therapy. Participants reported perceived outcomes and health benefits from TCM usage ranging from increased coping mechanisms, relieving stress and side-effects of standard treatment, the desire to be pro-active in the treatment journey, and to have a locus of control. Some cited the need to have “time-out” and the therapeutic relationship with the practitioner as being important. Conclusion: There is a clear need to understand breast cancer survivors’ needs for physical and psychological support as they aim to regain control over their life through their experience of illness. More studies are needed to measure and evaluate these outcomes and to help identify breast cancer survivors’ healthcare seeking behaviours, during and after the acute treatment stage that addresses their physical, emotional, and spiritual needs. These results aim to inform future research design and evaluate and develop support services that are patient-centred and focus on whole health outcomes, shared decision-making, and quality of life.

Current Usage of Traditional Chinese Medicine in the Management of Breast Cancer: A Practitioner's Perspective.

Introduction. This qualitative study seeks to explore the role within the context of Australian breast cancer oncology treatments that traditional Chinese medicine (TCM) practitioners play in the treatment of breast cancer. Methods. Semistructured interviews were used on 2 groups: the first group was TCM practitioners who were recognized experts in breast cancer, and the second group consisted of TCM practitioners who treated breast cancer as part of their practice but were not recognized experts. Data analysis was achieved through grounded theory with open coding. Results. The main themes reported on here are the following: the role of TCM in the biomedical management of breast cancer, TCM strategies for the management of breast cancer, and the perceived holistic approach of the TCM practitioner and the importance of a TCM diagnosis in the role of breast cancer care. Discussion. The role of TCM in biomedical breast cancer management is a supportive one; however, this role is difficult as there is a lack of understanding of TCM by biomedical practitioners. The viewpoints of practitioners differed on key strategies of TCM: diagnosis, and treatment protocols. Patients sought the holistic approach of TCM practitioners as they felt it addressed all aspects of their health and not just the symptoms relating to breast cancer. Conclusion. The lack of an integrated medicine approach in relation to TCM makes it difficult to demonstrate the value of the contribution TCM can make to biomedicine in the field of breast care oncology. Effectiveness studies are needed that can accurately represent TCM in this field.

The consequences of integrating complementary and alternative medicine : an analysis of impacts on practice

Abstract The call for increased integration of complementary and alternative medicine (CAM) with biomedicine implies an acceptance and compatibility of the theories, practices and research of these medicines, as well as recognition of consumer demand. CAMs slow integration into hospital systems, medical practices and research institutes can be argued to provide greater choice and autonomy to the medical consumer. As this mainstreaming of CAM continues it not only produces these potential ‘goods’ but also negative unintended consequences for the various practices that CAM encompasses, which in turn impacts on the consumer. CAM is often reflected poorly using the standard tools of evidence-based medicine (EBM) assessment which is demanded by not only medical institutions but also funding bodies. This paper examines the complex interactions generated by this process giving attention to the consequences for CAM practitioners and the subsequent impact on practice and accordingly on the consumer.

Prior to Conception: The Role of an Acupuncture Protocol in Improving Women's Reproductive Functioning Assessed by a Pilot Pragmatic Randomised Controlled Trial.

The global average of couples with fertility problems is 9%. Assisted reproductive technologies are often inaccessible. Evidence points to acupuncture offering an opportunity to promote natural fertility. This study asked whether providing a multiphasic fertility acupuncture protocol to women with sub/infertility would increase their awareness of fertility and achieve normalisation of their menstrual cycle compared with a lifestyle control. In a pragmatic randomised controlled trial sub/infertile women were offered an intervention of acupuncture and lifestyle modification or lifestyle modification only. There was a statistically significant increase in fertility awareness in the acupuncture group (86.4%, 19) compared to 40% (n = 8) of the lifestyle only participants (Relative Risk (RR) 2.38, 95% confidence interval (CI) of 1.25, 4.50), with an adjusted p value of 0.011. Changes in menstrual regularity were not statistically significant. There was no statistical difference in the pregnancy rate with seven women (adjusted p = 0.992) achieving pregnancy during the course of the study intervention. Those receiving the acupuncture conceived within an average of 5.5 weeks compared to 10.67 weeks for the lifestyle only group (p = 0.422). The acupuncture protocol tested influenced women who received it compared to women who used lifestyle modification alone: their fertility awareness and wellbeing increased, and those who conceived did so in half the time.