Effect of Financial Incentives on Breastfeeding: A Cluster Randomized Clinical Trial.

Importance: Although breastfeeding has a positive effect on an infant's health and development, the prevalence is low in many communities. The effect of financial incentives to improve breastfeeding prevalence is unknown. Objective: To assess the effect of an area-level financial incentive for breastfeeding on breastfeeding prevalence at 6 to 8 weeks post partum. Design, Setting, and Participants: The Nourishing Start for Health (NOSH) trial, a cluster randomized trial with 6 to 8 weeks follow-up, was conducted between April 1, 2015, and March 31, 2016, in 92 electoral ward areas in England with baseline breastfeeding prevalence at 6 to 8 weeks post partum less than 40%. A total of 10 010 mother-infant dyads resident in the 92 study electoral ward areas where the infant's estimated or actual birth date fell between February 18, 2015, and February 17, 2016, were included. Areas were randomized to the incentive plus usual care (n = 46) (5398 mother-infant dyads) or to usual care alone (n = 46) (4612 mother-infant dyads). Interventions: Usual care was delivered by clinicians (mainly midwives, health visitors) in a variety of maternity, neonatal, and infant feeding services, all of which were implementing the UNICEF UK Baby Friendly Initiative standards. Shopping vouchers worth £40 (US$50) were offered to mothers 5 times based on infant age (2 days, 10 days, 6-8 weeks, 3 months, 6 months), conditional on the infant receiving any breast milk. Main Outcomes and Measures: The primary outcome was electoral ward area-level 6- to 8-week breastfeeding period prevalence, as assessed by clinicians at the routine 6- to 8-week postnatal check visit. Secondary outcomes were area-level period prevalence for breastfeeding initiation and for exclusive breastfeeding at 6 to 8 weeks. Results: In the intervention (5398 mother-infant dyads) and control (4612 mother-infant dyads) group, the median (interquartile range) percentage of women aged 16 to 44 years was 36.2% (3.0%) and 37.4% (3.6%) years, respectively. After adjusting for baseline breastfeeding prevalence and local government area and weighting to reflect unequal cluster-level breastfeeding prevalence variances, a difference in mean 6- to 8-week breastfeeding prevalence of 5.7 percentage points (37.9% vs 31.7%; 95% CI for adjusted difference, 2.7% to 8.6%; P < .001) in favor of the intervention vs usual care was observed. No significant differences were observed for the mean prevalence of breastfeeding initiation (61.9% vs 57.5%; adjusted mean difference, 2.9 percentage points; 95%, CI, -0.4 to 6.2; P = .08) or the mean prevalence of exclusive breastfeeding at 6 to 8 weeks (27.0% vs 24.1%; adjusted mean difference, 2.3 percentage points; 95% CI, -0.2 to 4.8; P = .07). Conclusions and Relevance: Financial incentives may improve breastfeeding rates in areas with low baseline prevalence. Offering a financial incentive to women in areas of England with breastfeeding rates below 40% compared with usual care resulted in a modest but statistically significant increase in breastfeeding prevalence at 6 to 8 weeks. This was measured using routinely collected data. Trial Registration: International Standard Randomized Controlled Trial Registry: ISRCTN44898617.

Maximising the impact of qualitative research in feasibility studies for randomised controlled trials: guidance for researchers.

Feasibility studies are increasingly undertaken in preparation for randomised controlled trials in order to explore uncertainties and enable trialists to optimise the intervention or the conduct of the trial. Qualitative research can be used to examine and address key uncertainties prior to a full trial. We present guidance that researchers, research funders and reviewers may wish to consider when assessing or undertaking qualitative research within feasibility studies for randomised controlled trials. The guidance consists of 16 items within five domains: research questions, data collection, analysis, teamwork and reporting. Appropriate and well conducted qualitative research can make an important contribution to feasibility studies for randomised controlled trials. This guidance may help researchers to consider the full range of contributions that qualitative research can make in relation to their particular trial. The guidance may also help researchers and others to reflect on the utility of such qualitative research in practice, so that trial teams can decide when and how best to use these approaches in future studies.

Healthcare providers' views on the acceptability of financial incentives for breastfeeding: a qualitative study.

BACKGROUND: Despite a gradual increase in breastfeeding rates, overall in the UK there are wide variations, with a trend towards breastfeeding rates at 6-8 weeks remaining below 40% in less affluent areas. While financial incentives have been used with varying success to encourage positive health related behaviour change, there is little research on their use in encouraging breastfeeding. In this paper, we report on healthcare providers' views around whether using financial incentives in areas with low breastfeeding rates would be acceptable in principle. This research was part of a larger project looking at the development and feasibility testing of a financial incentive scheme for breastfeeding in preparation for a cluster randomised controlled trial. METHODS: Fifty-three healthcare providers were interviewed about their views on financial incentives for breastfeeding. Participants were purposively sampled to include a wide range of experience and roles associated with supporting mothers with infant feeding. Semi-structured individual and group interviews were conducted. Data were analysed thematically drawing on the principles of Framework Analysis. RESULTS: The key theme emerging from healthcare providers' views on the acceptability of financial incentives for breastfeeding was their possible impact on 'facilitating or impeding relationships'. Within this theme several additional aspects were discussed: the mother's relationship with her healthcare provider and services, with her baby and her family, and with the wider community. In addition, a key priority for healthcare providers was that an incentive scheme should not impact negatively on their professional integrity and responsibility towards women. CONCLUSION: Healthcare providers believe that financial incentives could have both positive and negative impacts on a mother's relationship with her family, baby and healthcare provider. When designing a financial incentive scheme we must take care to minimise the potential negative impacts that have been highlighted, while at the same time recognising the potential positive impacts for women in areas where breastfeeding rates are low.

Getting added value from using qualitative research with randomized controlled trials: a qualitative interview study.

BACKGROUND: Qualitative research is undertaken with randomized controlled trials of health interventions. Our aim was to explore the perceptions of researchers with experience of this endeavour to understand the added value of qualitative research to the trial in practice. METHODS: A telephone semi-structured interview study with 18 researchers with experience of undertaking the trial and/or the qualitative research. RESULTS: Interviewees described the added value of qualitative research for the trial, explaining how it solved problems at the pretrial stage, explained findings, and helped to increase the utility of the evidence generated by the trial. From the interviews, we identified three models of relationship of the qualitative research to the trial. In 'the peripheral' model, the trial was an opportunity to undertake qualitative research, with no intention that it would add value to the trial. In 'the add-on' model, the qualitative researcher understood the potential value of the qualitative research but it was viewed as a separate and complementary endeavour by the trial lead investigator and wider team. Interviewees described how this could limit the value of the qualitative research to the trial. Finally 'the integral' model played out in two ways. In 'integral-in-theory' studies, the lead investigator viewed the qualitative research as essential to the trial. However, in practice the qualitative research was under-resourced relative to the trial, potentially limiting its ability to add value to the trial. In 'integral-in-practice' studies, interviewees described how the qualitative research was planned from the beginning of the study, senior qualitative expertise was on the team from beginning to end, and staff and time were dedicated to the qualitative research. In these studies interviewees described the qualitative research adding value to the trial although this value was not necessarily visible beyond the original research team due to the challenges of publishing this research. CONCLUSIONS: Health researchers combining qualitative research and trials viewed this practice as strengthening evaluative research. Teams viewing the qualitative research as essential to the trial, and resourcing it in practice, may have a better chance of delivering its added value to the trial.

Maximising the value of combining qualitative research and randomised controlled trials in health research: the QUAlitative Research in Trials (QUART) study--a mixed methods study.

BACKGROUND: Researchers sometimes undertake qualitative research with randomised controlled trials (RCTs) of health interventions. OBJECTIVES: To systematically explore how qualitative research is being used with trials and identify ways of maximising its value to the trial aim of providing evidence of effectiveness of health interventions. DESIGN: A sequential mixed methods study with four components. METHODS: (1) Database search of peer-reviewed journals between January 2008 and September 2010 for articles reporting the qualitative research undertaken with specific trials, (2) systematic search of database of registered trials to identify studies combining qualitative research and trials, (3) survey of 200 lead investigators of trials with no apparent qualitative research and (4) semistructured telephone interviews with 18 researchers purposively sampled from the first three methods. RESULTS: Qualitative research was undertaken with at least 12% of trials. A large number of articles reporting qualitative research undertaken with trials (n=296) were published between 2008 and 2010. A total of 28% (82/296) of articles reported qualitative research undertaken at the pre-trial stage and around one-quarter concerned drugs or devices. The articles focused on 22 aspects of the trial within five broad categories. Some focused on more than one aspect of the trial, totalling 356 examples. The qualitative research focused on the intervention being trialled (71%, 254/356), the design and conduct of the trial (15%, 54/356), the outcomes of the trial (1%, 5/356), the measures used in the trial (3%, 10/356), and the health condition in the trial (9%, 33/356). The potential value of the qualitative research to the trial endeavour included improving the external validity of trials and facilitating interpretation of trial findings. This value could be maximised by using qualitative research more at the pre-trial stage and reporting findings with explicit attention to the implications for the trial endeavour. During interviews, three models of study were identified: qualitative research as peripheral to the trial, qualitative research as an 'add-on' to the trial and a study with qualitative research and trial as essential components, with the third model offering more opportunity to maximise the value of the qualitative research. Interviewees valued the use of qualitative research with trials and identified team structures and wider structural issues which gave more value to the trial than the qualitative research as barriers to maximising the value of the qualitative research. CONCLUSION: A large number of articles were published between 2008 and 2010, addressing a wide range of aspects of trials. There were examples of this research affecting the trial by facilitating interpretation of trial findings, developing and refining interventions for testing in the trial and changing the measures used in the trial. However, researchers were not necessarily maximising the value of qualitative research undertaken with trials to the endeavour of generating evidence of effectiveness of health interventions. Researchers can maximise value by promoting its use at the pre-trial stage to ensure that the intervention and trial conduct is optimised at the main trial stage, being explicit about the conclusions for the trial endeavour in peer-reviewed journal articles reporting the qualitative research and valuing the contribution of the qualitative research as much as the trial. Future recommendations for researchers include: plan the qualitative research, design and implement studies not trials, use qualitative research at the feasibility and pilot stage of trials, be explicit in publications about the impact of the qualitative research on the trial and implications for the trial endeavour, undertake in-depth qualitative research, allow qualitative research to take a challenging role and develop a learning environment around the use of qualitative research and trials. FUNDING: This project was funded by the Medical Research Council (MRC) as part of the MRC-National Institute for Health Research Methodology Research programme.

Describing qualitative research undertaken with randomised controlled trials in grant proposals: a documentary analysis.

BACKGROUND: There is growing recognition of the value of conducting qualitative research with trials in health research. It is timely to reflect on how this qualitative research is presented in grant proposals to identify lessons for researchers and research commissioners. As part of a larger study focusing on how to maximise the value of undertaking qualitative research with trials, we undertook a documentary analysis of proposals of funded studies. METHODS: Using the metaRegister of Controlled Trials (mRCT) database we identified trials funded in the United Kingdom, ongoing between 2001 and 2010, and reporting the use of qualitative research. We requested copies of proposals from lead researchers. We extracted data from the proposals using closed and open questions, analysed using descriptive statistics and content analysis respectively. RESULTS: 2% (89/3812) of trials in the mRCT database described the use of qualitative research undertaken with the trial. From these 89 trials, we received copies of 36 full proposals, of which 32 met our inclusion criteria. 25% used less than a single paragraph to describe the qualitative research. The aims of the qualitative research described in these proposals focused mainly on the intervention or trial conduct. Just over half (56%) of the proposals included an explicit rationale for conducting the qualitative research with the trial, the most frequent being to optimise implementation into clinical practice or to interpret trial findings. Key information about methods, expertise and resources was missing in a large minority of proposals, in particular sample size, type of analysis, and non-personnel resources. 28% specifically stated that qualitative researchers would conduct the qualitative research. CONCLUSIONS: Our review of proposals of successfully funded studies identified good practice but also identified limited space given to describing the qualitative research, with an associated lack of attention to the rationale for doing the qualitative research and important methodological details. Acknowledging the space restrictions faced by researchers writing grant proposals, we suggest a starting point for providing practical guidance to help researchers write proposals and research commissioners assess proposals of qualitative research with trials.

Prevalence of visits to massage therapists by the general population: a systematic review.

OBJECTIVE: To systematically review 12-month prevalence of visits to massage therapists by representative samples of the general population across countries. METHODS: Surveys reporting estimates of overall CAM use were included. Studies were identified via database searches. Study quality was assessed using a six-item tool. RESULTS: Twenty-two surveys across six countries were included. Estimates for 12-month prevalence of visits to massage therapists by adults ranged from 0.4% to 20% and the median was 5.5%. Estimates for children were 0.3%-3.8% (median 0.7%), while estimates for older adults were 1.5%-16.2% (median 5.2%). 16 surveys (73%) met at least four of six quality criteria. CONCLUSIONS: This review summarises 12-month prevalence of visits to massage therapists in six countries (USA, UK, Canada, Australia, Singapore and South Korea). A small but significant percentage of these general populations visit massage therapists each year.

Prevalence of visits to five types of complementary and alternative medicine practitioners by the general population: a systematic review.

OBJECTIVE: To systematically review surveys of 12-month prevalence of visits to complementary and alternative medicine (CAM) practitioners for five therapies: acupuncture, homeopathy, osteopathy, chiropractic, and medical herbalism. METHODS: Studies were identified via database searches to 2011. Study quality was assessed using a six-item tool. RESULTS: Forty-one surveys across 12 countries were included. Twenty-five (61%) met four of six quality criteria. Prevalence of visits by adults were (median, range): acupuncturists 1.4% (0.2-7.5%, N = 27 surveys), homeopaths 1.5% (0.2-2.9%, N = 20 surveys), osteopaths 1.9% (0.2-4.4%, N = 9 surveys), chiropractors 7.5% (0.3-16.7, N = 33 surveys), medical herbalists 0.9% (0.3-4.7%, N = 14 surveys). Estimates were slightly lower for children and higher for older adults. There was little change over the past 15-20 years. CONCLUSIONS: This review summarises 12-month prevalence of visits to CAM practitioners in Europe, North America, Australia, East Asia, Saudi Arabia and Israel. A small but significant percentage of these general populations visit CAM practitioners each year.

Getting inside acupuncture trials--exploring intervention theory and rationale.

BACKGROUND: Acupuncture can be described as a complex intervention. In reports of clinical trials the mechanism of acupuncture (that is, the process by which change is effected) is often left unstated or not known. This is problematic in assisting understanding of how acupuncture might work and in drawing together evidence on the potential benefits of acupuncture. Our aim was to aid the identification of the assumed mechanisms underlying the acupuncture interventions in clinical trials by developing an analytical framework to differentiate two contrasting approaches to acupuncture (traditional acupuncture and Western medical acupuncture). METHODS: Based on the principles of realist review, an analytical framework to differentiate these two contrasting approaches was developed. In order to see how useful the framework was in uncovering the theoretical rationale, it was applied to a set of trials of acupuncture for fatigue and vasomotor symptoms, identified from a wider literature review of acupuncture and early stage breast cancer. RESULTS: When examined for the degree to which a study demonstrated adherence to a theoretical model, two of the fourteen selected studies could be considered TA, five MA, with the remaining seven not fitting into any recognisable model. When examined by symptom, five of the nine vasomotor studies, all from one group of researchers, are arguably in the MA category, and two a TA model; in contrast, none of the five fatigue studies could be classed as either MA or TA and all studies had a weak rationale for the chosen treatment for fatigue. CONCLUSION: Our application of the framework to the selected studies suggests that it is a useful tool to help uncover the therapeutic rationale of acupuncture interventions in clinical trials, for distinguishing between TA and MA approaches and for exploring issues of model validity. English language acupuncture trials frequently fail to report enough detail relating to the intervention. We advocate using this framework to aid reporting, along with further testing and refinement of the framework.

'Homeopathy': untangling the debate.

There are active public campaigns both for and against homeopathy, and its continuing availability in the NHS is debated in the medical, scientific and popular press. However, there is a lack of clarity in key terms used in the debate, and in how the evidence base of homeopathy is described and interpreted. The term 'homeopathy' is used with several different meanings including: the therapeutic system, homeopathic medicine, treatment by a homeopath, and the principles of 'homeopathy'. Conclusions drawn from one of these aspects are often inappropriately applied to another aspect. In interpreting the homeopathy evidence it is important to understand that the existing clinical experimental (randomised controlled trial) evidence base provides evidence as to the efficacy of homeopathic medicines, but not the effectiveness of treatment by a homeopath. The observational evidence base provides evidence as to the effectiveness of treatment by a homeopath. We make four recommendations to promote clarity in the reporting, design and interpretation of homeopathy research.

"Any other comments?" Open questions on questionnaires - a bane or a bonus to research?

BACKGROUND: The habitual "any other comments" general open question at the end of structured questionnaires has the potential to increase response rates, elaborate responses to closed questions, and allow respondents to identify new issues not captured in the closed questions. However, we believe that many researchers have collected such data and failed to analyse or present it. DISCUSSION: General open questions at the end of structured questionnaires can present a problem because of their uncomfortable status of being strictly neither qualitative nor quantitative data, the consequent lack of clarity around how to analyse and report them, and the time and expertise needed to do so. We suggest that the value of these questions can be optimised if researchers start with a clear understanding of the type of data they wish to generate from such a question, and employ an appropriate strategy when designing the study. The intention can be to generate depth data or 'stories' from purposively defined groups of respondents for qualitative analysis, or to produce quantifiable data, representative of the population sampled, as a 'safety net' to identify issues which might complement the closed questions. SUMMARY: We encourage researchers to consider developing a more strategic use of general open questions at the end of structured questionnaires. This may optimise the quality of the data and the analysis, reduce dilemmas regarding whether and how to analyse such data, and result in a more ethical approach to making best use of the data which respondents kindly provide.

Evaluating decision aids--where next?

Decision aids have been developed to help patients become involved in decision-making about their individual health care. During the evaluation of a particular decision aid in maternity care--a set of 10 'Informed Choice' leaflets--we considered the lessons learnt for evaluation of decision aids in the future. Decision aids have been tested mainly in explanatory trials and have been found to be effective. We argue that existing decision aids should be subjected to more pragmatic trials to test their effectiveness in the real world. The small amount of evidence on their use in the real world shows that they face challenges, resulting in poor implementation. Therefore, we propose that implementation strategies are developed which take heed of the findings of research on getting evidence into practice, and in particular address structural barriers such as the lack of time available to health professionals. We recommend that these 'decision aid implementation packages' are developed in conjunction with both health professionals and patients, and identify and address potential barriers to both the delivery of patient involvement in decision-making, and the use of decision aids, in the real world. These 'packages' can then be submitted to pragmatic evaluation.

A randomised, controlled, triple-blind trial of the efficacy of homeopathic treatment for chronic fatigue syndrome.

OBJECTIVE: There is no management regime for chronic fatigue syndrome (CFS) that has been found to be universally beneficial and no treatment can be considered a "cure". Patients with CFS may use complementary and alternative medicine (CAM). Our aim was to evaluate homeopathic treatment in reducing subjective symptoms of CFS. METHOD: Using a triple-blind design (patient and homeopath blind to group assignment and data analyst blind to group until after initial analyses to reduce the possibility of bias due to data analyst), we randomly assigned patients to homeopathic medicine or identical placebo. One hundred and three patients meeting the Oxford criteria for CFS were recruited from two specialist hospital out patient departments. Patients had monthly consultations with a professional homeopath for 6 months. Main outcome measures were scores on the subscales of the Multidimensional Fatigue Inventory (MFI) and proportions of each group attaining clinically significant improvements on each subscale. Secondary outcome measures were the Fatigue Impact Scale (FIS) and the Functional Limitations Profile (FLP). Ninety-two patients completed treatment in the trial (47 homeopathic treatment, 45 placebo). Eighty-six patients returned fully or partially completed posttreatment outcome measures (41 homeopathic treatment group who completed treatment, 2 homeopathic treatment group who did not complete treatment, 38 placebo group who completed treatment, and 5 placebo group who did not complete treatment). RESULTS: Seventeen of 103 patients withdrew from treatment or were lost to follow-up. Patients in the homeopathic medicine group showed significantly more improvement on the MFI general fatigue subscale (one of the primary outcome measures) and the FLP physical subscale but not on other subscales. Although group differences were not statistically significant on four out of the five MFI subscales (the primary outcome measures), more people in the homeopathic medicine group showed clinically significant improvement. More people in the homeopathic medicine group showed clinical improvement on all primary outcomes (relative risk=2.75, P=.09). CONCLUSIONS: There is weak but equivocal evidence that the effects of homeopathic medicine are superior to placebo. Results also suggest that there may be nonspecific benefits from the homeopathic consultation. Further studies are needed to determine whether these differences hold in larger samples.

Nurses' views of using computerized decision support software in NHS Direct.

BACKGROUND: Nurses working in NHS Direct, the 24-hour telephone advice line in England, use computerized decision support software to recommend to callers the most appropriate service to contact, or to advise on self-care. AIMS: To explore nurses' views of their roles and the computerized decision support software in NHS Direct. METHODS: Qualitative analysis of semi-structured interviews with 24 NHS Direct nurses in 12 sites. FINDINGS: Nurses described both the software and themselves as essential to the clinical decision-making process. The software acted as safety net, provider of consistency, and provider of script, and was relied upon more when nurses did not have clinical knowledge relevant to the call. The nurse handled problems not covered by the software, probed patients for the appropriate information to enter into the software, and interpreted software recommendations in the light of contextual information which the software was unable to use. Nurses described a dual process of decision-making, with the nurse as active decision maker looking for consensus with the software recommendation and ready to override recommendations made by the software if necessary. However, nurses' accounts of the software as a guide, prompt or support did not fully acknowledge the power of the software, which they are required to use, and the recommendation of which they are required to follow under some management policies. Over time, the influence of nurse and software merges as nurses internalize the software script as their own knowledge, and navigate the software to produce recommendations that they feel are most appropriate. CONCLUSIONS: The nurse and the software have distinct roles in NHS Direct, although the effect of each on the clinical decision-making process may be difficult to determine in practice.

Complementary and alternative medicine use by patients with cancer in Wales: a cross sectional survey.

OBJECTIVES: To determine the prevalence and cost of complementary and alternative medicine (CAM) use, and examine perceived satisfaction and reasons for using CAM. DESIGN AND SETTING: Cross sectional survey of 1697 patients with breast, prostate, lung or neurological cancer registered with a single NHS authority in Wales. PARTICIPANTS: One thousand and seventy-seven (64%) of patients, aged 18 years or over with cancer diagnosis of at least 3 months, returned analysable questionnaires. Thirty patients were interviewed by telephone. MAIN OUTCOME MEASURES: Number and proportion that had used CAM in the past 12 months, the types of CAM used, expenditure, satisfaction, demographic characteristics, and reasons for using CAM. RESULTS: Five hundred and thirty-four, 49.6% (95% CI 46.6-52.6) of participants, reported using at least one type of CAM during the past 12 months: 221, 16.4% (95% CI 14.3-18.8), had consulted a CAM practitioner (average cost per person, 28 lbs. per month); 166, 15.4% (95% CI 13.4-17.7), indicated using CAM techniques (average cost per person, 16 lbs. per month); 456, 42.3% (95% CI 39.4-45.3), reported using over-the-counter diets, remedies or supplements (average cost per person, 10 lbs. per month). Dissatisfaction with CAM use was low, and most users indicated that they represented value for money. CAM users were more likely to be female, younger, better qualified, and to have used CAM before their current illness than non-users. Patients used CAM primarily for symptom relief and relaxation. CONCLUSIONS: Nearly half the cancer patients in this study had used CAM. A co-ordinated approach to quality assurance, information and advice, and the assessment of risk/benefit and cost effectiveness of CAM use is needed.

Empathy, enablement, and outcome: an exploratory study on acupuncture patients' perceptions.

OBJECTIVES: To conduct an exploratory, retrospective study of acupuncture patients' perceptions of practitioner empathy, patient enablement, and health outcome, and to investigate the associations between them. METHODS: In a retrospective, observational study, questionnaires were distributed to 192 patients randomly selected from a population of 6348 who, several months previously, had participated in a survey of acupuncture safety, and had agreed to be contacted again. The main measures included patients' perceptions of their practitioners' empathy using the Consultation and Relational Empathy Measure, the Patient Enablement Instrument, and the Glasgow Homeopathic Hospital Outcome Scale (measuring change in main complaint and well-being). RESULTS: A total of 143 (74%) patients responded (27% men and 73% women) with an average age of 51 years. Comparisons between the population, the sample selected, and the responding sample showed reasonable equivalence. The majority of patients (71%) were in the middle of an ongoing course of treatment at the time of completing the questionnaires for this study. 36% of patients were attending for reasons of "general well-being," 34% for musculoskeletal problems, 11% for emotional or psychological problems, and 19% for other reasons. Empathy and enablement scores were not influenced by age or reason for attendance, but men showed significantly lower scores than women (p < 0.05). Patient enablement was significantly positively correlated with perception of their practitioners' empathy (Spearman's rho = 0.256, p < 0.01). Enablement in turn was strongly positively correlated with the outcome of both the main complaint (rho = 0.457, p < 0.0001) and improved well-being (rho = 0.521, p < 0.0001). CONCLUSION: Patients' perceptions of consultations with their acupuncturists suggest that their experience of empathy is significantly associated with patient enablement, which in turn is highly correlated with improved self-reported health outcomes.