Willingness of emergency department patients with musculoskeletal complaints to participate in complementary and alternative medicine research

EM Advances

CJEM 2002;4(6):401-407

Abstract

Résumé

Introduction | Methods | Results | Discussion | References

Introduction

Complementary and alternative medicine (CAM) can be informally defined as any treatments, remedies or procedures not routinely prescribed by a conventional medical doctor, but which have been -- or are currently being -- utilized for some sort of expected health benefit. Although culturally based, this definition is functional and consistent with those used in previous research.^1-4

Over the last decade CAM has gained significant popularity throughout the industrialized world.^1-3,5-8 A United States population-based survey found a 25% increase in CAM use, a 47% increase in visits to CAM practitioners and a 45% increase in out-of-pocket expenditures for CAM services between 1990 and 1997.² Canadian data show similar trends,^4,8 and a 1997 study by the Fraser Institute reported 73% of Canadians had used at least one alternative therapy sometime in their lives.⁹ Studies that have specifically evaluated emergency department (ED) patients have found a similarly high prevalence of CAM usage in this population.^10-12 This has led to increasing support in Canada for the inclusion of CAM in medical education.¹³

One of the greatest controversies arising from the growth of CAM has been the degree to which these therapies have been subjected to scientific evaluation. Most health professionals believe there is an urgent need for rigorous studies on the safety and efficacy of many CAM therapies. In this regard, Health Canada recently allocated $7 million to establish a new regulatory authority, the Directorate of Natural Health Products.¹⁴ Currently, only $1 million annually from this office is dedicated to funding natural health product research.¹⁵ However, Canada's premier health research funding agency, the Canadian Institutes of Health Research, now includes "complementary and alternative care strategies" as a fundable domaine (www.cihr-irsc.gc.ca/institutes/ihspr/about_ihspr/ihspr_about_institute_e.shtml; accessed 2002 Sept 10).

The ED is a unique, and perhaps ideal, location to recruit subjects for CAM research studies, particularly those involving musculoskeletal complaints. Since many such patients present to the ED acutely following an injury, clinical trials evaluating the efficacy and safety of early-initiated CAM therapy may be possible. The willingness, however, of ED patients to participate in such research, and the previous CAM exposure and characteristics of those interested in participating, has never been established.

A Medline search from 1966 to present combining the terms "complementary therapies" or "alternative medicine" and "emergency department" or "emergency room" or "emergency medicine" failed to identify any ED-based clinical trials evaluating a CAM therapy. We felt that prior to embarking on an ED-based CAM study, the feasibility and projected enrollment of such research, with a particular focus on chiropractic and traditional Chinese medicine (TCM), required evaluation. Our interest in chiropractic and TCM arose from the areas of expertise within our study group and the widespread utilization of these two therapies for both acute and chronic musculoskeletal conditions. This study was designed to address the following 2 questions: 1) What proportion of ED patients with musculoskeletal complaints state a willingness to participate in CAM research for their presenting problem?; and 2) What are the demographic and other characteristics of this population?

Methods

Design and location

This prospective descriptive study was conducted in the ED of Vancouver General Hospital, Vancouver, BC. This tertiary trauma centre has an annual ED census of 53 000 patients, 56% of whom are triaged to the treatment (non-urgent) area of the department.

Ethics and approval

The study was approved by the Behavioural Research Ethics Board of the University of British Columbia and by Vancouver Hospital and Health Sciences Centre. Written informed consent was obtained from all subjects prior to participation.

Study setting and population

From Oct. 16, 2002, to Nov. 21, 2000, sequential patients over age 16 who were triaged to the treatment area weekdays between 10 am and 6 pm were eligible if they presented with a musculoskeletal complaint involving any of the following locations: spine (cervical, thoracic, lumbosacral); upper extremity (shoulder/upper arm, elbow/forearm, wrist/hand); or lower extremity (hip/thigh, knee/lower leg, ankle/foot). Patients were excluded if they were unable to provide informed consent, had pain severe enough to impair their ability to answer questions, or if they had already been assessed by the emergency physician. A research nurse determined patient eligibility and documented any reasons for exclusion.

Sample

The times and days of study sampling were chosen to maximize patient enrollment during the period of high ED volume when research personnel are available. Based on projecting sufficiently narrow confidence intervals (CIs) for the proportion of subjects hypothetically willing to enroll in a CAM study (± 10% for an anticipated 50% enrollment), it was determined a priori that our minimum sample size requirement was 80 patients.

Protocol and data collection

One of 2 research nurses, dedicated to the study, was available each day during the study period and regularly reviewed the ED charts and computer tracking system for potentially eligible patients. In addition, triage and ED staff were trained to notify the research nurse of potentially eligible patients. All patients were approached by a research nurse and invited to participate in a standardized manner, after being triaged and prior to emergency physician assessment. All eligible patients were invited to participate. After being presented background information, consenting patients were asked a series of standardized questions by the research nurse during a 15-minute interview in a private setting. The questions were closed-ended and addressed the following: demographics; details of presenting complaint; previous exposure to CAM; and hypothetical willingness to participate in modality-specific research (both within and outside of the ED) for the presenting complaint, assuming such studies had been available. To maintain consistency, written definitions of the following terms were read to subjects during the interview: complementary and alternative medicine; traditional Chinese medicine; and chiropractic (see Appendix 1). These definitions are not necessarily comprehensive, but were intended to summarize the experiences patients could expect to undergo in the context of future studies being considered within our department. Subjects were informed that TCM research would involve ED-initiated treatment followed by 5 weeks of outpatient therapy, and chiropractic research would involve either a single chiropractic treatment in the ED or a series of treatments administered over 4 weeks. Subjects were informed that research involving CAM therapies would occur simultaneously with standard medical care and at no additional patient cost. Responses were verbal and were recorded by the research nurse on a study form at the time of the interview and subsequently transferred to a computer database for analysis.

Statistical analysis

SPSS (version 6.1, Macintosh) was used to generate descriptive statistics and perform logistic regression modeling. Bionomial 95% CIs for proportions, and tests of differences between proportions for exploratory purposes were calculated using Stata (Version 5.0, Macintosh). All statistical tests were 2-tailed and p ¾ 0.05 was considered statistically significant.

Results

Study population

During the study period 1404 patients were seen in the ED. Of 749 (53%) patients triaged to the treatment area, 150 (20%) presented with a musculoskeletal complaint and 107 (71%) of those patients met eligibility criteria (Fig. 1). Due to limitations in the computer registry system at the study site, the number of eligible patients presenting outside of the 10 am to 6 pm window is not known. Eighty-seven percent of eligible patients consented to participate and these 93 patients comprise the study population.

Fig. 1. Study population; no. (and %) of patients in each category. ED = emergency department.

The age of those studied ranged from 17 to 82, with a mean of 38 years. Fifty-six percent of subjects were male. The highest level of subjects' completed schooling was secondary school (51%); a diploma program/community college (23%); and a university degree (18%). English was the primary language spoken at home for 77% of patients, and 66% spoke no second language. The mean length of stay in the ED was 167 minutes, and no subjects were admitted to hospital. Table 1 indicates the details of subjects' presenting complaint including onset, location, severity and cause. Table 2 indicates subjects' previous exposure to CAM. Seventy-six percent of patients had utilized CAM previously during their lives, and 13% were currently using CAM for their presenting problem.

Willingness to participate in CAM research

The majority of subjects stated an informed hypothetical willingness to enroll in a CAM study of the following therapies for their presenting complaint: TCM 74% (69/93: 95%CI 64.1%-82.7%); chiropractic 70% (65/93: 95%CI 59.5%-79.0%); and other CAM therapies 92% (86/93: 95% CI 85.1%-96.9%). The other CAM therapies that subjects were hypothetically willing to receive within a study setting included: massage (98%); non-TCM acupuncture (65%); homeopathy (48%); and herbal remedies (54%).

Of the subjects willing to enroll in a TCM or chiropractic study, 99% stated they were willing to comply with 4 to 6 weeks of outpatient follow-up. Of the 89 patients who indicated a willingness to participate in some form of research, 62 (70%) stated they would participate in a placebo-controlled study. Logistic regression modeling was performed for secondary purposes and indicated that willingness to participate in TCM or chiropractic research was independent of age, sex, educational status, severity of pain or prior exposure to modality of interest.

Discussion

This study indicates that ED patients with musculoskeletal complaints have a high stated willingness to participate in CAM research, even if this involves outpatient follow-up or a placebo-controlled design. Seventy percent of subjects were willing to undergo a single chiropractic treatment for their presenting condition, 99% of whom would return for 8 treatment sessions over a 4-week period. Similarly, 74% were willing to undergo TCM treatments up to twice weekly for a 5-week period, 99% of whom would return for weekly research nurse follow up over 6 weeks.

These findings are consistent with the increasing North American interest in CAM; however, it is noteworthy that our analysis indicated that stated willingness to participate in CAM research was not dependent on previous exposure to CAM therapy. This suggests that ED-based studies on a "naïve" patient population (those with no prior experience with the modality of interest) would be feasible. It is well documented that in the general population CAM utilization is most prevalent among women, persons aged 25 to 49, those with higher education and income, and those with chronic conditions.^1,2,4 In contrast, the characteristics of CAM users and hypothetical research participants in our ED study, drawn from a sample of predominantly acutely injured males of intermediate education, differ from these population-based correlates. Our regression analysis indicated that willingness to enroll in CAM studies was independent of age, sex, educational status, and severity of pain; thus, it would appear that enrollment of a representative sample of ED patients with musculoskeletal complaints into a CAM study could be done. Moreover, as symptoms began within 1 week of presentation to the ED for 85% of our sample population, the ED may be an ideal location for early intervention studies.

There are limitations that should be considered in the interpretation of our results. First, and most importantly, it merits mention that this was a study of stated willingness to enroll in a hypothetical study. While we could find no literature on this subject, it is conceivable that a patients' stated willingness to participate in CAM research may not translate into actual enrollment when a study is ongoing. It is likely that our findings represent a liberal estimate and that true enrollment would be lower than suggested from this study. This being said, the proportion of our study population that indicated an interest in CAM research was striking and suggests that ED-based clinical trials are feasible. We do not feel this stated interest arose from a poor understanding of what was involved in study participation because we were careful to provide subjects with detailed information to facilitate an informed decision. As subjects were interviewed prior to being assessed by the emergency physician, it is unknown whether interest in enrollment would be different after interaction with an emergency physician. It is possible that other factors influenced some subjects' stated willingness to participate in CAM research, such as the attractiveness of receiving CAM therapy at no cost or acquiescing to the presumed desires of the interviewer. We attempted to minimize these possibilities through the use of standardized closed-ended interview questions and objective data collection techniques.

Our findings suggest that ED-based studies of selected CAM modalities in patients with musculoskeletal complaints, particularly those with acute injuries, would be feasible from an enrollment perspective. As our ED is similar to most tertiary Canadian centres, we believe our results are generalizable to such locations. It is noteworthy that different CAM modalities would require different degrees of patient commitment and motivation. Compliance and logistical ease would likely be maximized by a study of a single ED-based intervention. Our intention is to develop and implement a CAM study in our ED, as we feel such research appears feasible and should be pursued.

References

1. Eisenberg D, Kessler R, Foster C, Norlock F, Calkins D, Delbanco T. Unconventional medicine in the United States: prevalence, costs, and patterns of use. N Engl J Med 1993;328:246-52.
2. Eisenberg D, Davis R, Ettner S, Appel S, Wilkey S, Van Rompay M, et al. Trends in alternative medicine use in the United States, 1990-1997. JAMA 1998;280:1569-75.
3. Kessler RC, Davis RB, Foster DF, Van Rompay MI, Walters EE, Wilkey SA, et al. Long-term trends in the use of complementary and alternative medical therapies in the United States. Ann Intern Med 2001;135:262-8.
4. Millar W. Use of alternative health care practitioners by Canadians. Can J Pub Health 1997;88:154-8.
5. Goldbeck-Wood S, Dorozynski A, Lie L, Yamauchi M, Zinn C, Josefson D, et al. Complementary medicine is booming worldwide. BMJ 1996;313:131-3.
6. Harris P, Rees R. The prevalence of complementary and alternative medicine use among the general population: a systematic review of the literature. Compl Ther Med 2000;88-96.
7. MacLennan A, Wilson D, Taylor A. Prevalence and cost of alternative medicine in Australia. Lancet 1996;347:569-73.
8. Verhoef M, Russell M, Love E. Alternative medicine use in rural Alberta. Can J Pub Health 1994;85:308-9.
9. The Fraser Institute. Alternative medicine in Canada: use and public attitudes. Fraser Institute Public Policy Source 21, 1999.
10. Gulla J, Singer A. Use of alternative therapies among emergency department patients. Ann Emerg Med 2000;35:226-8.
11. Allen R, Cushman LF, Morris S, Feldman J, Wade C, McMahon D, et al. Use of complementary and alternative medicine among Dominican emergency department patients. Am J Emerg Med 2000;18:51-4.
12. Weiss S, Takakuwa K, Ernst A. Use, understanding, and beliefs about complementary and alternative medicines among emergency department patients. Acad Emerg Med 2001;8:41-7.
13. Verhoef MJ, Best A, Boon H. Role of complementary medicine in medical education: opinions of medical educators. Ann Roy Coll Phys Surg Can 2002;35:166-70.
14. Minister Rock accepts all 53 recommendations made in the Standing Committee report on natural health products, establishes new Office of Natural Health Products and announces funding for research [news release]. Health Canada; 1999 Mar 26. Available: www.hc-sc.gc.ca/hpb/onhp/rock_e.html (accessed 2002 Sept 10).
15. Smith M. Research in Complementary/Alternative Health Care (CAHC) and Natural Health Products (NHP) Canadian Institutes of Health Research (CIHR) Strategic Research Priorities Consensus Workshop. Toronto (ON): 2002 June 10.