Perspectives on Future Research
Ruth Lindquist
Yeoungsuk Song
Mariah Snyder
Nursing’s commitment to the generation of high-quality, cost-effective patient outcomes requires that a sound scientific basis for practice be established. Previous chapters have identified existing research related to the therapies reviewed; however, most chapters end with statements that more research is needed. The need for more evidence related to the safety, efficacy, timing, “dose,” and specific indications for most therapies is clearly evident. As previously noted, there is a considerable and growing interest in and use of complementary therapies by the public. In a large and comprehensive examination of the use of complementary and alternative therapies, the number of annual visits to providers of complementary and alternative therapies was found to outnumber visits to primary care physicians (Institute of Medicine [IOM], 2002). Subsequently, the 2007 annual National Health Survey, a comprehensive in-person survey of Americans regarding their health, found that 38.8% of adults and 11.8% of children surveyed in the United States reported use of a form of complementary and alternative medicine in the preceding 12 months (Barnes, Bloom, & Nahin, 2008; NCCAM, 2008). More recently, a 2010 phone survey of more than 1,000 persons 50 years of age and older reported that more than one half of the respondents used some form of complementary and alternative medicine; however, only a little more than one half of those who reported use said that they had ever discussed their use with their health care providers (NCCAM, 2012a).
Interest in complementary therapies is encountered in a broad range of health care practice settings. Along with public and patient interest, there is a concomitant interest on the part of providers who not only want to deliver these therapies to patients but also have an interest in the same therapies for their own personal use (Lindquist, Tracy, & Savik, 2003). However, despite provider interest, it has been noted that the complementary and alternative therapies most often used by patients are not those that providers are familiar with or which are most understood (Zhang, Peck, Spalding, Jones, & Cook, 2012). In addition to the significant demand, common use, and lack of understanding of even commonly used complementary and alternative therapies, there is an urgency to increase knowledge among providers, and to expand the evidence base that supports their safety and efficacy, and which guides their use.
The world is shrinking. New therapies and new uses for old therapies are shared across continents. Health providers and researchers are challenged to create and employ a solid evidence base to undergird the broad range of complementary therapies used by substantial segments of the U.S. population and persons throughout the world. There is an acute need to know and understand benefits of therapies and whether they work according to the purpose for which they are used; there is also a need to ensure the safety and efficacy of complementary therapies and to understand their effects and interactions when used in combination with other complementary and allopathic therapies. In this chapter, the need for more evidence to support the expanding use of complementary therapies in practice is presented, research designs appropriate for the study of complementary therapies are explored, the overall state of research on complementary therapies is described, and implications that the state of evidence and expanded use of complementary therapies have for future nursing research are identified.
NEED TO EXPAND THE EVIDENCE BASE
The documented growing interest in and use of alternative and complementary therapies and alternative systems of care have caused health care providers to consider the appeal of these therapies to consumers as well as the consideration of their safety and efficacy. Concomitantly, questions regarding costs and cost-effectiveness for third-party payment and for individuals paying out-of-pocket need to be answered. Questions need to be answered through research related to which therapies and how many treatment sessions should be covered, and what results from the treatment can be expected and for what conditions. The optimal mix and relative cost of the complementary or alternative therapies versus traditional Western treatments must be determined.
With the widespread use of complementary and alternative therapies, there is reason for concern regarding the safety of their use and about their potential interactions with Western medicine (Bent, 2008). An example is the interaction of herbal remedies such as St. John’s wort with prescribed pharmacotherapy, including psychotropic agents, in the family of selective serotonin reuptake inhibitors. Contributing to the difficulty is the lack of regulation of complementary and alternative therapies such as herbal products (Bent, 2008), although increasing attention is being paid to this in an effort to provide guidance for use. The creation of the World Health Organization’s policy on herbal medicine recognizes the value of herbal medicine, but calls for systematic inventory and assessment, and regulatory measures to ensure quality control, and calls for international cooperation and coordination to conserve medicinal plants for future generations (World Health Organization, 1998). Indeed, scientific data in this area are needed by providers to inform their practice. Accurate and reliable knowledge is also needed by consumers who wish to make informed decisions regarding their own health practices.
There is a rising interest in and indeed a mandate for evidence-based practice. Evidence-based practice (EBP) has been defined simply as, “applying the best available research results (evidence) when making decisions about health care” (AHRQ, 2013). Further, “health care professionals who perform evidence-based practice use research evidence along with clinical expertise and patient preferences” (AHRQ, 2013). Indeed, nurses and other providers practicing in the context of conventional allopathic care rely on an evidence base. So, too, nurses and other health professionals are relying on or requiring similar evidence in their use of complementary therapies. However, in a national survey, critical care nurses generally reported that they required more evidence for conventional allopathic remedies than they did for complementary and alternative therapies (Tracy et al., 2005).
It is important that resources to access knowledge about complementary and alternative therapies be identified, made available, and used by providers. Research findings regarding the safety and efficacy of therapies must be disseminated broadly to practitioners, who need to be informed so that the safety of patients can be protected and the potential benefits of therapies realized. A number of personal data assistants (PDA)-based resources provide access to authoritative information as a resource to professional practice. Databases of research findings (e.g., the Cochrane Database of Systematic Reviews) are good resources for synthesized research findings (www.cochrane.org/re-views). As of 2013, a simple search of “complementary and alternative therapies” on this online source produced 204 hits, including, but not limited to, reviews related to healing therapies such as healing touch, dietary products, acupuncture, reflexology, meditation, relaxation techniques, herbal medicine, manual therapies, mind-body therapies, hypnosis, aromatherapy,
and homeopathy. These reviews are an excellent source of well-integrated research-based knowledge about what is known regarding the use of therapies for specific conditions. Additionally, websites of government agencies, such as the National Institutes of Health’s (NIH) National Center for Complementary and Alternative Medicine (NCCAM) (nccam.nih.gov/health/bytreatment.htm) or the Office of Cancer Complementary and Alternative Medicine (OCCAM), provide other sources of information on a wide range of complementary and alternative therapies. The Natural Standard Database provides high-quality information, graded to reflect the level of scientific evidence available on a scale ranging from A to F, regarding herbs, dietary supplements, natural products, and other complementary therapies used for specific health conditions (Natural Standard, 2013) (www.naturalstandard.com).
and homeopathy. These reviews are an excellent source of well-integrated research-based knowledge about what is known regarding the use of therapies for specific conditions. Additionally, websites of government agencies, such as the National Institutes of Health’s (NIH) National Center for Complementary and Alternative Medicine (NCCAM) (nccam.nih.gov/health/bytreatment.htm) or the Office of Cancer Complementary and Alternative Medicine (OCCAM), provide other sources of information on a wide range of complementary and alternative therapies. The Natural Standard Database provides high-quality information, graded to reflect the level of scientific evidence available on a scale ranging from A to F, regarding herbs, dietary supplements, natural products, and other complementary therapies used for specific health conditions (Natural Standard, 2013) (www.naturalstandard.com).
NCCAM supports investigator-initiated research and interdisciplinary research training initiatives (NCCAM, 2013). With a special encouragement of research that focuses on complementary and alternative therapies that are commonly used by the American public, NCCAM has begun building a solid foundation from which therapies can be selected and delivered with growing confidence as to their safety and efficacy. However, there is much work to be done. The ideal evidence base for complementary therapies would support decision making in a broad range of complex patient situations. It would differentiate effects on and appropriateness for persons with diverse characteristics (e.g., age, gender, body mass), from various cultures (accounting for dietary practices, social acceptability, and cultural traditions, and so forth), and genetic make-up, and would outline the potential differing effects and indications for persons suffering the full range of pathologies and comorbidities.
There are legitimate safety concerns related to therapy selection, quality of the product (the purity or technique of delivery), dose, timing, duration, and other considerations related to specific therapies such as herbal therapies, nutraceuticals, and supplements. For example, more research is needed to identify potentially adverse drug-herb interactions, to answer questions related to whether particular drugs and herbs can be ingested simultaneously; if not, the half-life of herbs in the body, or their “washout” times, need to be determined. Research is also needed to provide data to document the relative risks and benefits of therapies such as the use of diet therapy for hypertension (as opposed to standard allopathic pharmacological therapies), or to consider the potential reduction of the side effects of an allopathic agent if used at a reduced dose in combination with a complementary therapy.
The growing evidence base provides much needed information for the consumer and provider. However, additional research is needed to determine the potential beneficial outcomes of complementary therapies. Likewise, studies are necessary to generate findings that protect the public from harm or from needless, costly therapies that have no evidence to
support them, or when evidence clearly shows no benefit. For example, therapies such as the use of laetrile to combat cancer caused concern among allopathic providers who feared that the false hope of cure would dissuade patients from seeking legitimate forms of cancer therapy while bleeding fortunes from desperate families, despite the fact that there was no basis for its claims of beneficial effects (National Cancer Institute, 2012; Pinn, 2001). Extramural funding opportunities and the peer review system of NIH ensure the continued accumulation of high-quality evidence and encourage investigators who have the ideas, curiosity, and scientific expertise to explore potential therapies for human use.
support them, or when evidence clearly shows no benefit. For example, therapies such as the use of laetrile to combat cancer caused concern among allopathic providers who feared that the false hope of cure would dissuade patients from seeking legitimate forms of cancer therapy while bleeding fortunes from desperate families, despite the fact that there was no basis for its claims of beneficial effects (National Cancer Institute, 2012; Pinn, 2001). Extramural funding opportunities and the peer review system of NIH ensure the continued accumulation of high-quality evidence and encourage investigators who have the ideas, curiosity, and scientific expertise to explore potential therapies for human use.
RESEARCH DESIGNS FOR COMPLEMENTARY THERAPIES
Most scientists would agree that the most rigorous design to test complementary and alternative therapies is the randomized, placebo-controlled, double-blind design that has long been the standard for testing therapies and advancing fields of inquiry (Duley & Farrell, 2002; Misra, 2012). However, this design is not the only one that provides useful information, and data that are generated from quantitative studies are not the only available evidence base for practice. Other designs and sources of evidence are also important and contribute to our knowledge and understanding of patients’ responses to therapies, both allopathic and nonallopathic.
Consumers may be increasingly reluctant to enroll in clinical trials; hence, alternative study designs and strategies for the conduct of clinical research to advance the field have been called for (Gross & Fogg, 2001). The Committee on the Use of Complementary and Alternative Medicine by the American Public was commissioned by the Institute of Medicine, the AHCRQ, NCCAM, and 15 other agencies and institutes of NIH to study and provide specific recommendations regarding complementary and alternative therapies. As part of their report (IOM, 2002), innovative alternative designs to provide information about the effectiveness of therapies were identified, including:
Preference randomized controlled trials (RCTs)—trials that include randomized and nonrandomized arms, which then permit comparisons between patients who chose a particular treatment and those who were randomly assigned to it
Observational and cohort studies—studies that involve the identification of patients who are eligible for study and who may receive a specified treatment as part of the studyStay updated, free articles. Join our Telegram channel
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