Public demand and the integration of complementary and alternative medicine in the US health care system.

Public use of complementary and alternative medicine (CAM) grew 25% between 1990 and 1997 and had a number of implications for chiropractic and the US health care system. Recent surveys describe the issues surrounding definitions of CAM; patterns of CAM use and its costs; attitudes of the public, health care providers and business entities; increasing scientific research; and changes in the health care system. Almost one third (192 million) of the 629 million visits to CAM providers in 1997 were to chiropractors. The new US National Center for Complementary and Alternative Medicine have funded chiropractic and other CAM research as a regular part of its scientific portfolio. Health maintenance organizations and other health care business entities have created new markets for CAM services, including chiropractic. profession, chiropractic appears to be positioned somewhere between mainstream practice and CAM, with conflicting opinions held by the public, the health care industry, and chiropractors themselves. The benefits and risks of chiropractic being identified with the CAM movement must be weighed carefully.

Research productivity of chiropractic college faculty.

BACKGROUND: There is a growing need for research to further the goals of the chiropractic profession. Because of available resources, chiropractic faculty may be in the best position to accomplish much of the profession's research needs. A widely used method of assessing faculty research productivity is to count the number of peer-reviewed research publications over a selected time frame. OBJECTIVE: To investigate the research productivity of chiropractic college faculty and identify parameters associated with increased peer-reviewed publication. STUDY DESIGN: A survey was administered to collect data in a cross-sectional design. METHOD: Data were collected through a survey administered to all full-time chiropractic college faculty working in the United States. Although the survey addressed many scholarly activities, the criterion variable selected for this study is the number of peer-reviewed journal articles published over the past 3 yr. RESULTS: Three groups of faculty had more publications: those primarily assigned to research, those with either a D.C. degree or a D.C. and Ph.D. degree, and finally those with a rank of full professor. Faculty age and gender were not associated with the reported number of publications. The majority of faculty members (72.2%) have not published a single peer-reviewed article in the last 3 yr. Less than 2% of the faculty members has published 10 or more peer-reviewed articles in the last 3 yr. CONCLUSION: Many faculty are not involved in research activities. Faculty development and incentive programs need to be implemented to stimulate these individuals. Increasing faculty research activities benefits the faculty, their institutions and their profession.

The National Workshop to Develop the Chiropractic Research Agenda.

OBJECTIVE: To convene a national meeting to develop a research agenda for the chiropractic profession that targets the need to increase chiropractic's research capacity. DESIGN: The project was funded by a contract between the U.S. Health Resources and Services Administration Bureau of Health Professions (HRSA BHPr) and Palmer College of Chiropractic. Groundwork was established through a literature review and creation of position papers by teams of recognized authorities on the current status and recommendations for the future on the topics of clinical, educational, outcomes, basic science, and health services research and research infrastructure in chiropractic. The workshop took place July 12-14, 1996, in Washington, DC, with participants representing relevant segments of the research community of the health care professions, health professions education, health care policy, and all portions of the chiropractic community, including researchers, practitioners, faculty, administrators, and members of professional organizations. Work groups in each of the five target areas developed recommendations based on the seed material presented in the position papers. The results were incorporated into the final position papers. RESULTS: The primary outcome of the workshop was the completion of five position papers, one for each of the topics addressed. Also, a consensus process was initiated at the workshop on infrastructure needs of the profession but, because of the diversity of experience and opinions and the broad scope of the topic, was not completed by the end of the project year. CONCLUSIONS: Consensus was not reached on the development of a research agenda for the chiropractic profession, and a continuation of the contract has been agreed upon by HRSA BHPr to continue the process for another project year.

Manipulation and mobilization of the cervical spine. A systematic review of the literature.

STUDY DESIGN: Cervical spine manipulation and mobilization were reviewed in an analysis of the literature from 1966 to the present. OBJECTIVES: To assess the evidence for the efficacy and complications of cervical spine manipulation and mobilization for the treatment of neck pain and headache. SUMMARY OF BACKGROUND DATA: Although recent research has demonstrated the efficacy of spinal manipulation for some patients with low back pain, little is known about its efficacy for neck pain and headache. METHODS: A structured search of four computerized bibliographic data bases was performed to identify articles on the efficacy and complications of cervical spine manual therapy. Data were summarized, and randomized controlled trials were critically appraised for study quality. The confidence profile method of meta-analysis was used to estimate the effect of spinal manipulation on patients' pain status. RESULTS: Two of three randomized controlled trials showed a short-term benefit for cervical mobilization for acute neck pain. The combination of three of the randomized controlled trials comparing spinal manipulation with other therapies for patients with subacute or chronic neck pain showed an improvement on a 100-mm visual analogue scale of pain at 3 weeks of 12.6 mm (95% confidence interval, -0.15, 25.5) for manipulation compared with muscle relaxants or usual medical care. The highest quality randomized controlled trial demonstrated that spinal manipulation provided short-term relief for patients with tension-type headache. The complication rate for cervical spine manipulation is estimated to be between 5 and 10 per 10 million manipulations. CONCLUSIONS: Cervical spine manipulation and mobilization probably provide at least short-term benefits for some patients with neck pain and headaches. Although the complication rate of manipulation is small, the potential for adverse outcomes must be considered because of the possibility of permanent impairment or death.

The future impact of clinical practice guidelines.

Clinical guidelines are a very hot topic. Many guidelines are being published, but many concerns about guidelines still exist. Guidelines may be able to increase the quality of health care while eliminating unnecessary or inappropriate care. Critics wonder if the process will instead lead to poorer care and a waste of time and effort. Although guidelines are targeted on providers of care, those with other roles will use guidelines for optimizing patient care and outcomes, assuring quality, cutting costs and tracking liability and risk management. Examination of guidelines and their impact suggest that the process and product are imperfect and that the impact is difficult to measure. The chiropractic profession will continue in its guideline efforts. The direct effects of guidelines will be on certain aspects of doctor knowledge, attitude, belief and behavior. The indirect effects will be largely attitudinal in nature at first but will eventually lead to action. The profession will embrace the need to (a) develop a more comprehensive and useful research database and (b) to develop sophisticated means for obtaining profession-wide consensus on fundamental clinical issues.

Transfection of ovarian cancer cells with tumor necrosis factor-alpha (TNF-alpha) antisense mRNA abolishes the proliferative response to interleukin-1 (IL-1) but not TNF-alpha.

Recombinant interleukin-1 (IL-1) and tumor necrosis factor-alpha (TNF-alpha) can induce endogenous TNF-alpha mRNA expression and stimulate proliferation of epithelial ovarian cancer cells. In a previous report, proliferation induced by either cytokine could be partially blocked by soluble TNF-alpha receptor or by neutralizing antibodies against TNF-alpha. In the present study, we have transfected the ovarian cancer cell line OVCA 432 with vectors that contain the TNF-alpha gene in the antisense or sense orientation. Antisense-transfected cells showed a 4.5- to 26-fold reduction in IL-1-induced TNF-alpha secretion. Similarly, the stimulation of [3H]thymidine incorporation by IL-1 but not by TNF-alpha was blocked by TNF-alpha antisense transfection. These results are consistent with a model in which the macrophage-derived cytokines IL-1 and TNF-alpha might stimulate endogenous production of TNF-alpha that in turn could stimulate proliferation of ovarian cancer cells by autocrine growth regulation.

Optimizing primary treatment for advanced laryngeal and pyriform sinus carcinoma.

Advocates of chemotherapy plus radiation as the definitive treatment for patients with advanced laryngeal cancer often cite older studies that attribute cure rates of less than 50% to laryngectomy plus radiation. The outcomes of patients with stage III and IV laryngeal and pyriform sinus carcinoma from 1980 to 1989 (96 patients) were compared with those of patients treated from 1962 to 1977 (84 patients). Demographics, the extent of disease, and nodal involvement were similar between the groups. There were more operative complications (45% versus 22%; p < 0.01) and deaths (10% versus 2%; p < 0.01) in the patients who underwent irradiation preoperatively. Overall survival was improved in the recent group compared with the early group (73% versus 54% at 5 years; p < 0.03), as was disease-free survival (64% versus 38% at 5 years; p < 0.02). Results of treatment for advanced laryngeal and pyriform sinus carcinoma have improved significantly. These modern results should be used to evaluate newer treatment modalities.

Proposal for establishing structure and process in the development of implicit chiropractic standards of care and practice guidelines.

With the advent of health care's "era of accountability", the chiropractic profession is now faced with generating implicit standards and guidelines for care or having it done for us by outside agencies. Already we see chiropractic groups in individual states and provinces being pressured into naive efforts of guideline development. Current knowledge and experience are available through recent health care literature that clearly defines the structure and process of guideline development and offers suggestions on how to measure outcomes of those processes. In addition, the United States Congress has directed a new federal agency to oversee this activity and monitor outcomes of quality improvement programs. The time has come for the chiropractic profession to define its exact role in health care delivery and develop implicit standards of care and practice guidelines. This sentinel effort should be managed by a commissioned body of empaneled experts that generally represent the academic and clinical chiropractic profession. A protocol for selection of these panelists and the panel chairperson needs to be developed and memorialized. Appropriate methodology (with definitions) needs to be developed for the process of standards/guideline development. Adherence to the accepted structure and process of guideline development will ensure the continuity of this dynamic process in the coming generations. This proposal offers a preliminary definition of the structure and process, including a "seed" policy statement and decision flow chart, specific to guideline development. Once the structure and process of guideline development for chiropractic are defined, the profession can then present this product to federal and state agencies, private sector health care purchasers, patient advocacy groups and other stakeholders of chiropractic care.(ABSTRACT TRUNCATED AT 250 WORDS)

Assessing influence in regression analysis with censored data.

In this paper we show how to evaluate the effect that perturbations to the model, data, or case weights have on maximum likelihood estimates from censored survival data. The ideas and methods also apply to other nonlinear estimation problems. We review the ideas behind using log-likelihood displacement and local influence methods. We describe new interpretations for some local influence statistics and show how these statistics extend and complement traditional case deletion influence statistics for linear least squares. These statistics identify individual and combinations of cases that have important influence on estimates of parameters and functions of these parameters. We illustrate the methods by reanalyzing the Stanford Heart Transplant data with a parametric regression model.

A meta-analysis of clinical trials of spinal manipulation.

OBJECTIVE: To assess the efficacy of spinal manipulative therapy (SMT) in the treatment of back pain using meta-analytical techniques. DATA SOURCES: The literature was systematically searched for all studies of SMT through June 1989. The Index Medicus from 1980 was expanded by citation tracking. The Chiropractic Research Archives Collection was utilized as a regularly updated bibliographic source for the location of research publications. A hand search of professional chiropractic journals was also undertaken. STUDY SELECTION: Studies in English with concurrent controls treated by methods other than SMT, including sham, produced 23 randomized controlled clinical trials of the effectiveness of spinal manipulation. Because a single trial might include more than one comparison of treatments, these trials produced a total of 34 mutually exclusive, discrete samples. DATA EXTRACTION: Data were extracted via a standardized coding document by one author and verified by two of the others. Data were independently extracted from a subset of the studies by a blinded research assistant to ensure that coding methods produced acceptable consistency. DATA SYNTHESIS: Effect sizes (Cohen's D index) were calculated for nine outcome variables at eight time points following the initiation of treatment. Thirty-eight of 44 effect sizes indicated that SMT was better than the comparison treatment. It was also found that meta-analysis was an imperfect instrument for the kind of trials that were pooled in this study because the research protocols were highly diverse. Furthermore, because the nature of SMT does not permit an easy use of placebos, true no-treatment control groups were rare. Most studies compared SMT to an alternative treatment. This probably obscured the effectiveness of SMT since the comparison treatments were presumably also effective. CONCLUSIONS: SMT proved to be consistently more effective in the treatment of low back pain than were any of the array of comparison treatments. The analysis provided some suggestion that manipulation, as such, is more effective than mobilization, as such. For the future, it is suggested that researchers strive for more consistent measures in terms of explicit descriptions of the nature of SMT, the times of post-treatment assessments and the nature of outcome measures. Only then can meta-analysis fulfill its potential in this clinical area.

A statistical test to assess changes in spontaneous behavior of rats observed with a computer pattern recognition system.

A computer pattern recognition system, RAPID, has been used to study the spontaneous motor activity of Sprague-Dawley rats. This system produces a large number of measures of the activity of control and experimental groups in any given study. The large number of measures involved presents a problem when one attempts to decide whether the behavioral activity of the exposed group differs from that of the control group. Extensive Monte Carlo studies have been performed in an attempt to develop and validate a simple statistic to be used in such decisions.

A comparison of patients and patient complaints at six chiropractic college teaching clinics.

A cooperative study was undertaken by six chiropractic colleges for the purpose of studying similarities and/or differences among the patients and patient complaints at the college outpatient (teaching) clinics. There were some notable differences among the clinics with respect to the standard demographic variables of age, education, employment and income. The sociodemographic characteristics of patients appeared to be different to the extent that the characteristics of the neighborhoods in which the clinics were located were different. Patients referred to the clinics by chiropractic student/interns were more likely to attend for routine physical exam than patients referred by other sources. Although marked differences were observed in patient attendance for routine physical examination, the health problems for which patients sought treatment were very similar among all the clinics. Low back complaints were the most frequently reported health complaint. The characteristics of the low back complaints were very similar at all six sites.

A review of the validity and efficacy of the Health Risk Appraisal instrument.

The Health Risk Appraisal instrument links life-style factors with the probability of death by comparing an individual's profile to national averages. The result, usually generated by computer, is used to counsel the individual to modify risk factors that could lead to disease. This paper reviews the validity of the Health Risk Appraisal, its reliability, and its effect on health behavior. While the results of observational studies support the efficacy of the Health Risk Appraisal, more controlled studies have not been able to demonstrate a strong effect. Methodological problems are briefly discussed. Although there are valid criticisms leveled at the procedure, the Health Risk Appraisal has become quite popular as a health education tool and may represent the future in preventive care.

Neuromusculoskeletal thermography: a valuable diagnostic tool?

The use of neuromusculoskeletal thermography is rapidly increasing. Recent studies have begun to document the types of diagnostic and other clinically useful information which may be derived from the procedure. This paper provides a review and summary of current research and a comparison with myelography, computerized tomography, electromyography and clinical and surgical findings in cases of presumed musculoskeletal pain syndromes. The importance of diagnostic sensitivity, specificity, positive and negative predictive value, and accuracy (validity) are discussed. In general, the literature reports high sensitivity and negative predictive value, but lower specificity and positive predictive value. The implications of these findings are examined in regard to clinical case management, with emphasis on potential usefulness to chiropractors. Although thermography appears to be a promising diagnostic tool, there remain a number of threats to the scientific validity of current research which must be accounted for in future work.

A multivariate time-series descriptive case study of chiropractic care in the treatment of cervical pain.

This paper presents a multivariate quantitative description of the temporal course of 13 clinical variables measured before, during and after a multimodal chiropractic treatment package. Clinical measures included total and peak daily cervical pain, unleveling of the pelvis, shoulders and cranium; bilateral grip strength; and cervical ranges of motion. Intervention techniques included heel wedges; cervical, abdominal, and foot exercises; and spinal adjustments (cervical spine and ilium). Data are presented in tabular and graphic formats, and limitations in validity and reliability are reviewed. Interpretive limitations included confounding by multiple and sequential interventions and by lack of experimental control comparisons. However, the study suggests the plausible influence of biomechanical and adjustive care upon mediators and clinical outcomes. Strengths inherent in multivariate time-series research are noted.

Combined chemotherapy, radiation, and surgery for epithelial cancer of the anal canal.

Combined chemotherapy and radiation therapy have been reported to produce a high incidence of complete regression of epithelial cancer of the anal canal, resulting in prolonged disease-free survival. This modality has been advocated as an alternative to abdominoperineal resection as a primary treatment for this disease. Our group treated 19 patients between 1979 and 1985. Treatment included two infusions of 5-fluorouracil (1000 mg/m2/24 hours), one dose of mitomycin C (15 mg/m2), and simultaneous whole-pelvis radiation (3000 rad). The complete response rate was 88%. Three patients had anal cancer incompletely controlled by that therapy. They underwent abdominoperineal resections and are alive without disease at 10, 39, and 43 months, respectively. Actuarial disease-free survival at 40 months was 87.5 +/- 8.8 (% +/- standard error of the mean [SEM]). Complications included gastrointestinal, hematologic, and cutaneous toxicity. These results confirmed a high complete response rate to this therapy. Local treatment failures may occur, but these may be salvaged with abdominoperineal resection.

Toward an experimental chiropractic: time-series designs.

If chiropractic is to develop as a clinical science, it must develop an experimental data-base. Despite numerous continuing obstacles, a growing segment of the profession is advocating chiropractic clinical trials. However, the large-scale control-group clinical-experimental designs which have most frequently been recommended are usually beyond the economic means of chiropractic institutions. Moreover, such designs are impractical in many ways for the chiropractic field-doctor who wishes to integrate the roles of scientist and practitioner. Time-series experimental (and case study) designs offer practical and economical alternatives for the DC, whether inter, solo-practitioner, or academic researcher. Several types of time-series designs are described, published examples from related health-care literature are noted, and the role of time-series research in furthering the goals of chiropractic research are reviewed. Ethical considerations in clinical research are briefly noted.