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An independent assessment of chiropractic practice guidelines
Abstract
To evaluate the quality of Recommended Clinical Protocols and Guidelines for the Practice of Chiropractic (ICA guidelines) published by the International Chiropractors Association (ICA), August, 2000.
The Appraisal Instrument for Clinical Guidelines (Cluzeau instrument) was applied to the ICA guidelines by 10 independent experienced evaluators. An independent, global assessment was also made by each evaluator.
Mean scores (with 95% confidence limit) for each of the instrument's 3 dimensions were Rigor of Development, 27% (5.1); Context and Content, 18.3% (9.4); and Application, 2% (3.9). The unanimous global assessment was "not recommended as suitable for utilization in practice." Comparison of the ICA guideline scores with the Council on Chiropractic Practice's Clinical Practice Guideline No. 1, Vertebral Subluxation in Chiropractic Practice (CCP guidelines) scores and Guidelines for Chiropractic Quality Assurance and Practice Parameters (Mercy guidelines) Cluzeau instrument-based scores revealed that the ICA guidelines received slightly higher scores than the CCP guidelines but substantially lower scores than the Mercy guidelines for all dimensions.
The ICA guidelines were assessed as not suitable for utilization in chiropractic practice.
... Both internal consistency and interrater reliability are well in line with the original validation study by the AGREE Collaboration 8) . This is in agreement with other recent studies that have tested AGREE in medical or paramedical fields of health care where the original instrument was not developed [24][25][26] . ...
... In the field of occupational health, Cates et al. 25) recently evaluated the American ACOEM Guidelines with the use of AGREE and concluded that future ACOEM guidelines should incorporate better reporting and give closer attention to the guideline process. Figure 1 shows the comparison between the domain scores between the American and Dutch occupational health practice guidelines. ...
The purpose of this study was to evaluate the acceptance, validity, reliability and feasibility of the AGREE (Appraisal of Guidelines and REsearch and Evaluation) instrument to assess the quality of evidence-based practice guidelines for occupational physicians. In total, 6 practice guidelines of the Netherlands Society of Occupational Medicine (NVAB) were appraised by 20 occupational health professionals and experts in guideline development or implementation. Although appraisers often disagreed on individual item scores, the internal consistency and interrater reliability for most domains was sufficient. The AGREE criteria were in general considered relevant and no major suggestions for additional items for use in the context of occupational health were brought up. The domain scores for the individual guidelines show a wide variety: 'applicability' had on average the lowest mean score (53%) while 'scope and purpose' had the highest one (87%). Low scores indicate where improvements are possible and necessary, e.g. by providing more information about the development. Key experts in occupational health report that AGREE is a relevant and easy to use instrument to evaluate quality aspects and the included criteria provide a good framework to develop or update evidence-based practice guidelines in the field of occupational health.
... What may render a clinical guideline useful for individual patients is its reliance upon valid evidence in establishing decision points and risks of care [4]. An appraisal of risk is essential to clinical guideline development [5][6][7]. Estimations of the balance of benefits against risks or harms helps to ensure guideline credibility for stakeholders [8]. A significant limitation with current SMUA guidelines, and the collective scientific knowledge on this subject, is inadequate recognition of the risk profiles and outcomes indicators that contribute to patient selection. ...
Over a period of decades chiropractors have utilized spinal manipulation under anesthesia (SMUA) to treat chronic back and neck pain. As an advanced form of manual therapy, SMUA is reserved for the patient whose condition has proven refractory to office-based manipulation and other modes of conservative care. Historically, the protocols and guidelines put forth by chiropractic MUA proponents have served as the clinical compass for directing MUA practice. With many authors and MUA advocates having focused primarily on anticipated benefit, the published literature contains no resource dedicated to treatment precautions and contraindications. Also absent from current relevant literature is acknowledgement or guidance on the preliminary evidence that may predict poor clinical outcomes with SMUA. This review considers risk and unfavorable outcomes indicators in therapeutic decision making for spinal manipulation under anesthesia. A new risk classification system is proposed that identifies patient safety and quality of care interests for a procedure that remains without higher-level research evidence. A scale which categorizes risk and outcome potential for SMUA is offered for the chiropractic clinician, which aims to elevate the standard of care and improve patient selection through the incorporation of specific indices from existing medical literature.
... It is important to note that this chiropractic definition of subluxation should be distinguished from the orthopedic definition of subluxation of the spine, which often results from trauma, may be unstable, and in many cases contraindicates the use of closed manipulation procedures. Within the chiropractic profession, vertebral subluxation is a theoretical construct that, although widely debated,58 has yet to be validated by experimental evidence.59,60 Despite the fact that the term may be out of date, Medicare requires this because it is a part of the original 1972 provision. ...
Objectives:
Private insurance plans typically reimburse doctors of chiropractic for a range of clinical services, but Medicare reimbursements are restricted to spinal manipulation procedures. Medicare pays for evaluations performed by medical and osteopathic physicians, nurse practitioners, physician assistants, podiatrists, physical therapists, and occupational therapists; however, it does not reimburse the same services provided by chiropractic physicians. Advocates for expanded coverage of chiropractic services under Medicare cite clinical effectiveness and patient satisfaction, whereas critics point to unnecessary services, inadequate clinical documentation, and projected cost increases. To further inform this debate, the purpose of this commentary is to address the following questions: (1) What are the barriers to expand coverage for chiropractic services? (2) What could potentially be done to address these issues? (3) Is there a rationale for Centers for Medicare and Medicaid Services to expand coverage for chiropractic services?
Methods:
A literature search was conducted of Google and PubMed for peer-reviewed articles and US government reports relevant to the provision of chiropractic care under Medicare. We reviewed relevant articles and reports to identify key issues concerning the expansion of coverage for chiropractic under Medicare, including identification of barriers and rationale for expanded coverage.
Results:
The literature search yielded 29 peer-reviewed articles and 7 federal government reports. Our review of these documents revealed 3 key barriers to full coverage of chiropractic services under Medicare: inadequate documentation of chiropractic claims, possible provision of unnecessary preventive care services, and the uncertain costs of expanded coverage. Our recommendations to address these barriers include the following: individual chiropractic physicians, as well as state and national chiropractic organizations, should continue to strengthen efforts to improve claims and documentation practices; and additional rigorous efficacy/effectiveness research and clinical studies for chiropractic services need to be performed. Research of chiropractic services should target the triple aim of high-quality care, affordability, and improved health.
Conclusions:
The barriers that were identified in this study can be addressed. To overcome these barriers, the chiropractic profession and individual physicians must assume responsibility for correcting deficiencies in compliance and documentation; further research needs to be done to evaluate chiropractic services; and effectiveness of extended episodes of preventive chiropractic care should be rigorously evaluated. Centers for Medicare and Medicaid Services policies related to chiropractic reimbursement should be reexamined using the same standards applicable to other health care providers. The integration of chiropractic physicians as fully engaged Medicare providers has the potential to enhance the capacity of the Medicare workforce to care for the growing population. We recommend that Medicare policy makers consider limited expansion of Medicare coverage to include, at a minimum, reimbursement for evaluation and management services by chiropractic physicians.
... A limited number of chiropractic guidelines have been published since the Mercy Guideline in 1993, 35 and divergent recommendations among available guidelines may only serve to confuse clinicians. 36 Finally, like most other professions, chiropractic has yet to develop coordinated efforts to address KT issues between researchers, practitioners, and stakeholders while ongoing debates, legislation, and internal evolution about the chiropractic profession's own identity 37 result in low coherence of beliefs and evidence-based practices. ...
... 169 Independent assessment of 3 of these chiropractic guidelines concluded that neither the CCP nor the ICA alternatives were suitable for utilization in chiropractic practice, whereas the Mercy guidelines were recommended for application in chiropractic practice, with the provision that new scientific data should be considered. 170,171 The different premises on which chiropractic guidelines are established may derive from a longstanding ideological debate among chiropractors regarding the identity of chiropractic. [172][173][174][175] Mootz 176 proposes that chiropractic institutions and organizations focus on an evidence-based and best practice-oriented research priority, constructive engagement of the greater health care system, and successful ethical business models. ...
Imaging technology can improve patient outcomes by allowing greater precision in diagnosing and treating patients. However, there is evidence that overuse, underuse, and misuse of imaging services occur. The purpose of this project was to develop evidence-based diagnostic imaging practice guidelines for musculoskeletal complaints for use by doctors of chiropractic and other primary health care professionals.
An electronic search of the English and French language literature (phase 1) was conducted on several databases. Cross references, and references provided by clinicians, were also used. Independent assessment of the quality of the citations used to support recommendations in the guidelines was performed using the QUADAS, the AGREE,and the SPREAD evaluation tools. A first draft of a diagnostic imaging practice guideline was produced, using the European Commission's Referral Guidelines for Imaging document as a template. Results were sent to 12 chiropractic specialists for a first external review. A modified Delphi process, including 149 international experts, was used to generate consensus on recommendations for diagnostic imaging studies. The reliability of proposed recommendations was further tested on field chiropractors and on a group of specialists both in chiropractic and in medicine in both Canada and the United States. All recommendations were graded according to the strength of the evidence.
The research procedure resulted in the recommendations for diagnostic imaging guidelines of adult extremity and spine disorders supported by more than 685 primary and secondary citations. High levels of agreement among Delphi panelists were reached for all proposed recommendations. Comments received by specialists were generally very favorable and reflected high levels of agreement with the proposed recommendations, perceived ease of use of guidelines, and implementation feasibility.
These evidence-based diagnostic imaging practice guidelines are intended to assist chiropractors and other primary care providers in decision making on the appropriate use of diagnostic imaging for specific clinical presentations. In all cases, the guidelines are intended to be used in conjunction with sound clinical judgment and experience. Application of these guidelines should help avoid unnecessary radiographs, increase examination precision,and decrease health care costs without compromising the quality of care. All guidelines are documents to be refined and modified regularly with new information and experience.
Background and Purpose. Osteoarthritis (OA) affects a large and growing proportion of the population. The purpose of this project was to create guidelines for the use of therapeutic exercises and manual therapy in the management of adult patients (> 18 years of age) with a diagnosis of CIA. All stages of the disease were included in the analysis, and studies of patients who had recent surgery or other rheumatologic, musculoskeletal, or spinal problems or of subjects without known pathology or impairments Were excluded. Methods: The Ottawa Methods Group used Cochrane Collaboration methods to find and synthesize evidence from comparative controlled trials and then asked stakeholder groups to nominate representatives to serve on a panel of experts. The Ottawa Panel agreed on criteria for grading the strength of the recommendations and their supporting evidence. Of the 609 potential articles on therapeutic exercises for CIA that were identified, 113 were considered potentially relevant, and 26 randomized controlled trials and controlled clinical trials were ultimately used. Results. Sixteen positive recommendations of clinical benefit were developed fortherapeutic exercises, especially strengthening exercises and general physical activity, particularly for the management of pain and improvement of functional status. Manual therapy combined with exercises also is recommended in the management of patients with OA. Discussion and Conclusion. The Ottawa Panel recommends the use of therapeutic exercises alone, or combined with manual therapy, for managing patients with CIA. There were a total of 16 positive recommendations: 13 grade A and 3 grade C+. The Ottawa Panel recommends the use of therapeutic exercises because of the strong evidence (grades A, B, and C+) in the literature.
An index of publications. Volume 1: 1989 to 2004
SUMMARY
This literature survey is based on publications with the keywords “thermograpy” or “thermology“ or “thermal imaging” or “thermometry” or “temperature measurements” listed in the databases Medline, Embase, HighWire and Science Direct between 1.1.2003 and 31.12.2003. This has resulted in 1087 references, which is the highest number of references since this annual literature survey was first published. Thermography was the main subject of 271 papers, but a number of other methods for temperature measurement are used in clinical medicine. Papers dealing with non medical applications of thermal imaging were separately analysed. Non destructive testing and quality control in the pharceutical industry were the most frequently found non medical applications.
It is not clear if good methodologic quality in current practice guidelines necessarily leads to more valid recommendations, i.e., those that are supported with consistent research evidence or, when evidence is conflicting or lacking, with sufficient consensus among the guideline development team. To help clarify this issue, we assessed whether there is a link between methodologic quality and recommendation validity in practice guidelines for the use of laboratory tests in the management of patients with non-small cell lung cancer (NSCLC).
We conducted a systematic review of data on laboratory tests in NSCLC published in English or in French within the last 10 years and retrieved 11 practice guidelines for the use of these tests. The guidelines were critically appraised and scored for methodologic quality and recommendation validity based on the Appraisal of Guidelines Research and Evaluation (AGREE) criteria and on the systematic review.
Overall, these 11 guidelines had considerable shortcomings in methodologic quality and, to a lesser extent, in recommendation validity. Practice guidelines with the best methodologic quality were not necessarily the most valid in their recommendations, and conversely.
Poor methodologic quality and lack of recommendation validity in laboratory medicine call for methodologic standards of guideline development and for international collaboration of guideline development agencies. We advise readers of guidelines to critically evaluate the methods used as well as the content of the recommendations before adopting them for use in practice.
A large number of practice guidelines are being produced by numerous organizations. Health-care professionals need to critically evaluate these practice guidelines to understand whether they are well constructed and representative of the preponderance of evidence. The guideline development process should be precise and rigorous to ensure that the results are reproducible and not vague.
To evaluate the quality of the second edition of the practice guidelines published by the American College of Occupational and Environmental Medicine (ACOEM Guidelines).
Four appraisers used the AGREE (Appraisal of Guidelines Research and Evaluation) guideline evaluation instrument to evaluate the ACOEM Guidelines.
The Guidelines were evaluated with the AGREE guideline evaluation instrument. The AGREE instrument has been widely adopted around the world, and the authors recommended that it be adopted as the standard of guideline construction process evaluation in the United States. The instrument standardizes the quantitative assessment of quality for a guideline's development process across six domains that include: scope and purpose, stakeholder involvement, rigor of development, clarity and presentation, application, and editorial independence. Scores from four assessors were collected and interpreted. Additionally, each evaluator selected one of four global assessment choices: "strongly recommended for use in practice," "recommended for use with some modification or proviso," "not recommended as suitable for use in practice," or "unsure".
The ACOEM Guidelines scored highest in the dimensions that evaluated reporting of the guideline's scope and purpose (79.63) as well as clarity and presentation (86.81). The guideline scored much lower in the remaining areas that included stakeholder involvement (46.06), rigor of development (26.59), application (31.48), and editorial independence (19.17). The global assessment was unanimous with all four evaluators assessing the guideline as recommend with proviso.
Many of the Guidelines recommendations were consistent with current literature and guidelines; however, the AGREE assessment instrument evaluates the guideline development process and not the content. All the evaluators thought the content of the guidelines was substantially better than the documentation of the guideline construction process. The ACOEM Guidelines appear to have content consistent with their stated objectives, but the reporting of the guidelines construction process, particularly the rigor of recommendation development, is flawed, and the recommendations may not be valid owing to possible evidence selection deficiencies. The reader should consider these flaws and limitations when using the guideline. The reader should consider utilizing guidelines of higher quality when possible. Future guidelines should incorporate better reporting and give closer attention to guideline construction.
This project updates a previous effort to inventory health services research conducted on chiropractic and makes recommendations for a subsequent research agenda. A qualitative review of social sciences, medical, chiropractic, and health services research literature regarding chiropractic was done with emphasis on research published since the initial health services research agenda effort in 1995. This work informed development of updated health services research recommendations.
Literature was gathered through searches of electronic health care database retrieval systems and citation tracking. In addition to general collecting of new studies, the authors considered to what extent the 1995 research recommendations had been addressed in the new literature. A seed set of refined recommendations was formulated and initially distributed expert review and revision. The recommendations were made available for public comment and hearing at the 10th Annual Research Agenda Conference for Chiropractic in March 2005.
The past 10 years have seen numerous health service research studies related to chiropractic; however, nearly all of the research priorities identified in 1995 remain unaddressed and remain as important priorities. Thus, recommendations were reprioritized and revised to submit for open comment and hearing.
A smaller number of more concise recommendations with more specific action steps are proposed for clinical quality improvement, performing cost analyses, and assessing use barriers for chiropractic.
CLINICAL SCENARIO
You are relieved to find that the last patient in your busy primary care clinic is a previously well 48-year-old woman with acute dysuria. There has been no polydipsia, fever, or hematuria; the physical examination reveals suprapubic tenderness; and urinalysis shows pyuria but no casts. You arrange cultures and antibiotic treatment for a lower urinary tract infection. On her way out the door, your patient observes that her friend has just started taking "female hormones," and she wonders whether she should too. Her menstrual periods stopped 6 months ago and she has never had cervical, ovarian, uterine, breast, or cardiovascular problems, but her mother had a mastectomy at age 57 for postmenopausal breast cancer. You give the same general advice you have offered similar patients in the past, but suggest that the matter be discussed at greater length when she returns after completing the antibiotic treatment. Later, as
Guidelines published in major medical journals are very influential in determining clinical practice. It would be essential to evaluate whether conflicts of interests are disclosed in these publications. We evaluated the reporting of conflicts of interest and the factors that may affect such disclosure in a sample of 191 guidelines on therapeutic and/or preventive measures published in 6 major clinical journals (Annals of Internal Medicine, BMJ, JAMA, Lancet, New England Journal of Medicine, Pediatrics) in 1979, 1984, 1989, 1994 and 1999.
Only 7 guidelines (3.7%) mentioned conflicts of interest and all were published in 1999 (17.5% (7/40) of guidelines published in 1999 alone). Reporting of conflicts of interest differed significantly by journal (p=0.026), availability of disclosure policy by the journal (p=0.043), source of funding (p < 0.001) and number of authors (p=0.004). In the entire database of 191 guidelines, a mere 18 authors disclosed a total of 24 potential conflicts of interest and most pertained to minor issues.
Despite some recent improvement, reporting of conflicts of interest in clinical guidelines published in influential journals is largely neglected.
Animal Magnetism and Radionics were among several occult practices used during the 19th century for the treatment of disease. D.D. Palmer was exposed to these teachings and derived many of his ideas about health from the folk medicine practices of his time.
As post World War II science has flourished it was accompanied by an exponential growth in journals. In recent years, the credibility of scientific publications, particularly in the biomedical fields, has been challenged by the perception of financial conflicts of interest involving both scientists and their academic institutions. Woolf, a sociologist of science, has summarized the problem:
In modern science the disinterestedness of scientists has been linked to their objectivity and thus to the reliability of their research. Although most people recognize that scientists are unlikely to be completely neutral with respect to their studies, they are skeptical about scientists who appear as advocates for certain positions rather than as objective presenters of fact [citation]. In several allegations of research misconduct, there have been charges that apparent financial conflicts of interest have distorted the knowledge base on which other decisions depend (Woolf 1994, 90)
This is the second in a series of four articles on issues in the development and use of clinical guidelinesThe methods of guideline development should ensure that treating patients according to the guidelines will achieve the outcomes that are desired. This article presents a combination of the literature about guideline development and the results of our combined experience in guideline development in North America and Britain. It considers the five steps in the initial development of an evidence based guideline. The dissemination, implementation, and evaluation of practice guidelines will be discussed in the final article in this series.1
Summary points
Identifying and refining the subject area is the first step in developing a guidelineConvening and running guideline development groups is the next stepOn the basis of systematic reviews, the group assesses the evidence about the clinical question or conditionThis evidence is then translated into a recommendation within a clinical practice guidelineThe last step in guideline development is external review of the guideline
Identifying and refining the subject area of a guideline
Prioritising topics
Guidelines can be developed for a wide range of subjects. Clinical areas can be concerned with conditions (abnormal uterine bleeding, coronary artery disease) or procedures (hysterectomy, coronary artery bypass surgery). Given the large number of potential areas, some priority setting is needed to select an area for guideline development. Potential areas can emerge from an assessment of the major causes of morbidity and mortality for a given population, uncertainty about the appropriateness of healthcare processes or evidence that they are effective in improving patient outcomes, or the need to conserve resources in providing care.
Refining the subject area
The topic for guideline development will usually need to be refined before the evidence can be assessed in order to answer exact questions. The usual way of refining the topic is by a dialogue among clinicians, patients, and the potential …
Despite clinical guidelines penetrating every aspect of clinical practice and health policy, doubts persist over their ability to improve patient care. We have designed and tested a generic critical appraisal instrument, that assesses whether developers have minimized the biases inherent in creating guidelines, and addressed the requirements for effective implementation.
Thirty-seven items describing suggested predictors of guideline quality were grouped into three dimensions covering the rigour of development, clarity of presentation (including the context and content) and implementation issues. The ease of use, reliability and validity of the instrument was tested on a national sample of guidelines for the management of asthma, breast cancer, depression and coronary heart disease, with 120 appraisers. A numerical score was derived to allow comparison of guidelines within and between diseases.
The instrument has acceptable reliability (Cronbach's alpha coefficient, 0.68-0.84; intra-class correlation coefficient, (0.82-0.90)). The results provided some evidence of validity (Pearson's correlation coefficient between appraisers' dimension scores and their global assessment was 0.49 for dimension one, 0.63 for dimension two and 0.40 for dimension three). The instrument could differentiate between national and local guidelines and was easy to apply. There was variation in the performance of guidelines with most not achieving a majority of criteria in each dimension.
Use of this instrument should encourage developers to create guidelines that reflect relevant research evidence more accurately. Potential users or groups adapting guidelines for local use could apply the instrument to help decide which one to follow. The National Health Service Executive is using the instrument to assist in deciding which guidelines to recommend to the UK National Health Service. This methodology forms the basis of a common approach to assessing guideline quality in Europe.
The parents of a healthy, asymptomatic 5-year-old boy are anxious about his health and ask about the appropriateness of undergoing a screening examination with urinalysis. You search for existing recommendations on this topic and find the book, Putting Prevention Into Practice.1 You find the 2 statements outlined below.American Academy of Family Physicians and US Preventive Services Task Force:Routine screening of males and most females for asymptomatic bacteriuria is not recommended. The Canadian Task Force on the Periodic Health Examination and the US Preventive Services Task Force recommend against screening for asymptomatic bacteriuria with urinalysis in infants, children, and adolescents.American Academy of Pediatrics:Urinalysis should be performed once at 5 years of age. Also, dipstick leukocyte esterase testing to screen for sexually transmitted diseases should be performed once in adolescence, preferably at 14 years of age. This clinical scenario raises a number of important questions:What sort of evidence has been used to come to these different conclusions?How have the 2 committees looked at and appraised the evidence?Have they used an explicit approach to classify the quality of existing studies?If they have, indeed, used an explicit approach, which elements—such as study design, study conduct, or relevance of the outcome measures—have they considered? Explicit recommendations for clinical practice, such as guidelines or diagnostic and therapeutic protocols, are published frequently, but many have conflicting recommendations. To decide which guidelines we should follow, we need common criteria to assess the quality of available evidence. Although it is generally agreed that practice guidelines should explicitly assess the quality of the evidence that supports different statements, this is still uncommon.2Historically, the Canadian Task Force was the first to attempt to classify levels of evidence supporting clinical recommendations. It did this by reviewing the indications for preventive interventions and producing recommendations with an explicit grading of the supporting evidence.3 These were subsequently adopted by the US Preventive Services Task Force.4 The original approach used by the Canadian Task Force classified randomized controlled trials (RCTs) as the highest level of evidence, followed by non-RCTs, cohort and case-control studies (representing fair evidence), comparisons among times and places with or without the intervention, and at the lowest level, “expert opinion.” This approach is simple to understand and easy to apply, but it implicitly assumes that RCTs, no matter how small or large or how properly conducted, always produce better evidence than nonexperimental studies such as cohort or case-control studies. This approach also ignores the issue of heterogeneity and, thus, what to do when results from several RCTs or other nonexperimental studies vary.Other scales proposed since that of the Canadian Task Force still rely on methodologic design of primary studies as the main criterion. These have incorporated systematic reviews and meta-analyses, which are placed above RCTs in the “hierarchy of evidence.” Whereas this allows for a possibly more refined grading of levels of evidence, it suffers from the same limitation—ie, that attention is given to the a priori validity of the methods used. More recently, scales assessing the quality of study conduct and the consistency of results across different studies have been proposed.The aims of this article are as follows:to review existing scales aimed at assessing the quality of evidence supporting treatment recommendationsto discuss the need to go beyond the assessment of methodologic quality—whether measured a priori by looking at study design or a posteriori by looking at study conduct—to include an explicit assessment of the epidemiologic and clinical relevance of the evidenceto suggest which direction research in this area should take. We will not address how strength of recommendations has been assessed. This is a complex concept that implies value judgments and an explicit methodologic assessment of available studies. As recently suggested (A Oxman, S Flottorp, J Cooper, et al, “Levels of Evidence and Strength of Recommendations,” unpublished data, 1999), “strength of recommendations” is a construct that should go beyond levels of evidence to incorporate more subjective considerations, such as patient- or setting-specific applicability; tradeoffs among risk, benefits, and costs; and the like.
Despite the many published randomized clinical trials (RCTs), a substantial number of reviews and several national clinical guidelines, much controversy still remains regarding the evidence for or against efficacy of spinal manipulation for low back pain and neck pain.
To reassess the efficacy of spinal manipulative therapy (SMT) and mobilization (MOB) for the management of low back pain (LBP) and neck pain (NP), with special attention to applying more stringent criteria for study admissibility into evidence and for isolating the effect of SMT and/or MOB.
RCTs including 10 or more subjects per group receiving SMT or MOB and using patient-oriented primary outcome measures (eg, patient-rated pain, disability, global improvement and recovery time).
Articles in English, Danish, Swedish, Norwegian and Dutch reporting on randomized trials were identified by a comprehensive search of computerized and bibliographic literature databases up to the end of 2002. Two reviewers independently abstracted data and assessed study quality according to eight explicit criteria. A best evidence synthesis incorporating explicit, detailed information about outcome measures and interventions was used to evaluate treatment efficacy. The strength of evidence was assessed by a classification system that incorporated study validity and statistical significance of study results. Sixty-nine RCTs met the study selection criteria and were reviewed and assigned validity scores varying from 6 to 81 on a scale of 0 to 100. Forty-three RCTs met the admissibility criteria for evidence.
Acute LBP: There is moderate evidence that SMT provides more short-term pain relief than MOB and detuned diathermy, and limited evidence of faster recovery than a commonly used physical therapy treatment strategy. Chronic LBP: There is moderate evidence that SMT has an effect similar to an efficacious prescription nonsteroidal anti-inflammatory drug, SMT/MOB is effective in the short term when compared with placebo and general practitioner care, and in the long term compared to physical therapy. There is limited to moderate evidence that SMT is better than physical therapy and home back exercise in both the short and long term. There is limited evidence that SMT is superior to sham SMT in the short term and superior to chemonucleolysis for disc herniation in the short term. However, there is also limited evidence that MOB is inferior to back exercise after disc herniation surgery. Mix of acute and chronic LBP: SMT/MOB provides either similar or better pain outcomes in the short and long term when compared with placebo and with other treatments, such as McKenzie therapy, medical care, management by physical therapists, soft tissue treatment and back school. Acute NP: There are few studies, and the evidence is currently inconclusive. Chronic NP: There is moderate evidence that SMT/MOB is superior to general practitioner management for short-term pain reduction but that SMT offers at most similar pain relief to high-technology rehabilitative exercise in the short and long term. Mix of acute and chronic NP: The overall evidence is not clear. There is moderate evidence that MOB is superior to physical therapy and family physician care, and similar to SMT in both the short and long term. There is limited evidence that SMT, in both the short and long term, is inferior to physical therapy.
Our data synthesis suggests that recommendations can be made with some confidence regarding the use of SMT and/or MOB as a viable option for the treatment of both low back pain and NP. There have been few high-quality trials distinguishing between acute and chronic patients, and most are limited to shorter-term follow-up. Future trials should examine well-defined subgroups of patients, further address the value of SMT and MOB for acute patients, establish optimal number of treatment visits and consider the cost-effectiveness of care.
Many chiropractors treat patients with spinal adjustments based on the theory that correction of vertebral subluxations will restore and maintain health. This paper explores the controversy surrounding the practice of chiropractic and discusses some of the dangers associated with inappropriate use of spinal manipulation. Treatment of infants and children by subluxation-based chiropractors who do not endorse such medically accepted procedures as immunization or use of antibiotics is especially a cause for alarm. Explaining the scientifically rejected chiropractic subluxation therapy and describing some of the questionable treatment methods based on this theory, a veteran chiropractic reformer concludes that if the chiropractic profession fails to abandon the false premise upon which it is based, it will remain controversial and some aspects of chiropractic treatment will continue to be a threat to public health.
Competing interests: None declared
See this article on our web site for links to other articles in the series.
Authors Alessandro Liberati is affiliated with the Istituto di Statistica Medica, Universita degli Studi di Modena e Reggio Emilia. Alessandro Liberati, Roberto Buzzetti, and Nicola Magrini are affiliated with the Centro Valutazione Efficacia Assistenza Sanitaria, Modena; and Alessandro Liberati and Roberto Grilli are associated with the Centro Cochrane Italiano Istituto “Mario Negri,” Milan, Italy. Dr Grilli is also with the Agenzia Servizi Sanitari Regionali in Rome.
This article was edited by Virginia A Moyer of the department of pediatrics, University of Texas Medical Center at Houston. Articles in this series are based on chapters from Moyer VA, Elliott EJ, Davis RL, et al, eds. Evidence-Based Pediatrics and Child Health. London: BMJ Books; 2000.
Clinical practice guidelines developed by the Canadian Chiropractic Association (CCA) and the Council on Chiropractic Practice (CCP) were evaluated by three independent appraisers using the most current version of the Appraisal of Guidelines for Research and Evaluation in Europe (AGREE) Instrument. Eighteen eligible chapters within the two documents (nine from each organization) were evaluated. In general, the CCA document was rated more favourably than the CCP document. The strengths of both documents include clarity of objectives and target users and complete descriptions of methods used to formulate recommendations. Areas of improvement for both documents include the need for more detail regarding the bodies of evidence under consideration for each section of the guideline. This paper presents the complete results of the evaluation, discusses the strengths of each guideline document, and makes suggestions for areas of improvement.
A review of the literature reveals strong evidence for both the mechanical model of disease production (structural) and the neurobiological model (functional). Outdated models which attempt to describe a scientific basis for chiropractic theory are inadequate and indeed harmful to the progress and acceptance of chiropractic. Pragmatic or empirical arguments that "Chiropractic works and that's what counts" have served a useful purpose, but now must be augmented by extant research findings. The "paradigm shift" is on. Research investigators around the world are focusing on the multiple components of the chiropractic subluxation complex (CSC), a definitive, provable clinical entity. No longer can "informed" critics support the accusation that "chiropractic practice is based upon irrational, untenable premises." Only a few more pieces of the puzzle need to be fitted into place to produce the "big picture," i.e., the vertebral column is one of the most neglected vital organs in the human body--the sine qua non of the neurobiomechanical system--which influences every structure and function. Historically, its role in maintaining health has been almost totally ignored and for nearly a century chiropractors have battled against the consequences of this neglect. The scientific community is about to see that chiropractic is leading the way in discovering the "new world" in health care. Past, present and future research is discussed.
Several theories have been put forth in attempts to explain the possible mechanisms by which patients presumed to be suffering from any of a variety of internal organ diseases are occasionally found to respond quickly and dramatically to therapies delivered to purely somatic structures (e.g., spinal manipulation). The purpose of this review is to examine the scientific bases upon which these sorts of clinical phenomenaight be interpreted.
A review was conducted of over 350 articles that have appeared in the scientific literature over the last 75 years. Initially, a MEDLINE search was performed; however, because of the variability of indexing terms employed by investigators within a wide variety of biomedical disciplines, most of this literature had to be located article by article.
At present, there have been no appropriately controlled studies that establish that spinal manipulation or any other form of somatic therapy represents a valid curative strategy for the treatment of any internal organ disease. Furthermore, current scientific knowledge also fails to support the existence of a plausible biological mechanism that could account for a causal segmentally or regionally related "somato-visceral disease" relationship. On the other hand, it has now been firmly established that somatic dysfunction is notorious in its ability to create overt signs and symptoms that can mimic, or simulate (rather than cause), internal organ disease.
The proper differential diagnosis of somatic vs. visceral dysfunction represents a challenge for both the medical and chiropractic physician. The afferent convergence mechanisms, which can create signs and symptoms that are virtually indistinguishable with respect to their somatic vs. visceral etiologies, need to be appreciated by all portal-of-entry health care providers, to insure timely referral of patients to the health specialist appropriate to their condition. Furthermore, it is not unreasonable that this somatic visceral-disease mimicry could very well account for the "cures" of presumed organ disease that have been observed over the years in response to various somatic therapies (e.g., spinal manipulation, acupuncture, Rolfing, Qi Gong, etc.) and may represent a common phenomenon that has led to "holistic" health care claims on the part of such clinical disciplines.
There is increasing concern about the quality, reliability, and independence of practice guidelines. Because no information is available on the methodological quality of the guidelines developed by specialty societies, we undertook a survey on those published in peer-reviewed journals.
Practice guidelines produced by specialty societies and published in English between January, 1988, and July, 1998, where identified through MEDLINE. Their quality was assessed in terms of whether they reported: the type of professionals and stakeholders involved in the development process; the strategy to identify primary evidence; and an explicit grading of recommendations according to the quality of supporting evidence.
Overall, 431 guidelines were eligible for the study. Most did not meet the criteria: 67% did not report any description of the type of stakeholders, 88% gave no information on searches for published studies, and 82% did not give any explicit grading of the strength of recommendations. There was improvement over time for searches (from 2% to 18%, p<0.001) and explicit grading of evidence (from 6% to 27%, p<0.001). All three criteria for quality were met in only 22 (5%) guidelines.
Despite improvement over time, the quality of practice guidelines developed by specialty societies is unsatisfactory. Explicit methodological criteria for the production of guidelines shared among public agencies, scientific societies, and patients' associations need to be set up. Common standards of reporting, following the same principles that led to the CONSORT statement for randomised clinical trials, should be promoted.
To identify and compare clinical practice guideline appraisal instruments.
Appraisal instruments, defined as instruments intended to be used for guideline evaluation, were identified by searching MEDLINE (1966-99) using the Medical Subject Heading (MeSH) practice guidelines, reviewing bibliographies of the retrieved articles, and contacting authors of guideline appraisal instruments. Two reviewers independently examined the questions/statements from all the instruments and thematically grouped them. The 44 groupings were collapsed into 10 guideline attributes. Using the items, two reviewers independently undertook a content analysis of the instruments.
Fifteen instruments were identified, and two were excluded because they were not focused on evaluation. All instruments were developed after 1992 and contained 8 to 142 questions/statements. Of the 44 items used for the content analysis, the number of items covered by each instrument ranged from 6 to 34. Only the instrument by Cluzeau and colleagues included at least one item for each of the 10 attributes, and it addressed 28 of the 44 items. This instrument and that of Shaneyfelt et al. are the only instruments that have so far been validated.
A comprehensive, concise, and valid instrument could help users systematically judge the quality and utility of clinical practice guidelines. The current instruments vary widely in length and comprehensiveness. There is insufficient evidence to support the exclusive use of any one instrument, although the Cluzeau instrument has received the greatest evaluation. More research is required on the reliability and validity of existing guideline appraisal instruments before any one instrument can become widely adopted.
To review and identify established methods for evaluating the quality of practice guidelines and to use a selected assessment tool to assess 2 chiropractic practice guideline documents.
A search of the medical literature was performed to identify current methods and procedures for practice guideline evaluation. Two chiropractic practice guideline documents, Vertebral Subluxation in Chiropractic Practice (CCP) and Guidelines for Chiropractic Quality Assurance and Practice Parameters (Mercy) were then independently evaluated for validity by 10 appraisers using the identified appraisal tool. The appraisal scores were tabulated, and consensus appraisals were generated for the CCP and Mercy guideline documents.
The "Appraisal Instrument for Clinical Guidelines" (Cluzeau instrument) was identified as a reliable and valid method of guideline evaluation. The result of the application of this appraisal tool in the assessment of the CCP and Mercy guideline documents was that the former scored notably lower than the latter. On the basis of the results of the guideline appraisals, the CCP document is not recommended, and its guidelines are not considered suitable for application in chiropractic practice. The Mercy guidelines are recommended for application in chiropractic practice, with the proviso that new scientific data should be considered.
The literature reviewed suggests that professional organizations or groups should undertake a critical review of guidelines using available critical guideline appraisal tools. Guideline validity appraisal should be done before acceptance by the chiropractic profession. To avoid unwarranted utilization of poorly constructed guidelines, it is strongly recommended that all future guidelines be reviewed for validity and scientific accuracy with the findings published in a medically indexed journal before they are adopted by the chiropractic community.
Vertebral subluxation-centered straight chiropractic research
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The chiropractic profession: its educa-tion, practice, research and future directions
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Appraisal instrument for clinical guidelines. London: St George's Hos-pital Medical School
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Vertebral subluxation in chiropractic practice. Chandler (AZ): The Council; 1998. Clinical Practice Guideline No
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Council on Chiropractic Practice. Vertebral subluxation in chiropractic practice. Chandler (AZ): The Council; 1998. Clinical Practice Guideline No. 1.
Guidelines for chiropractic quality assurance and practice parameters. Pro-ceedings of the Mercy Center Consensus Conference
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Health, subluxation, adjustment: semantic and scientific challenges still exist
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Poll results for the following question: Do you believe that the subluxation is a major source of disease? Dynamic Chiropractic
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Clinical guidelines for chiropractic practice in Canada: Proceedings of a Consensus Conference Commissioned by the Canadian Chiropractic Association
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Concepts germane to an evidence-based application of chiropractic theory
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The chiropractic profession: its educa-tion, practice, research and future directions. West Des Moines (IA): NCMIC Group Inc
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Chapman-Smith DA. The chiropractic profession: its educa-tion, practice, research and future directions. West Des Moines (IA): NCMIC Group Inc; 2000. p. 96.
Which guidelines can we trust? Assessing strength of evidence behind recommendations for clinical practice.
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Guidelines for chiropractic quality assurance and practice parameters
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Haldeman S, Chapman-Smith D, Petersen DM. Guidelines for
chiropractic quality assurance and practice parameters. Proceedings of the Mercy Center Consensus Conference; 1992
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Appraisal instrument for clinical guidelines.
- Cluzeau F.
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Development and application of a generic methodology to assess the quality of clinical guidelines.
- Cluzeau F.
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- Feder G.
- Morgan S.
The chiropractic profession: its education, practice, research and future directions.
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Innate intelligence.
- Morgan L.
Somatic dysfunction and the phenomenon of visceral disease simulation
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