Dr. Dennis Leduc, a McGill University pediatrician recently stated that “There are no physical ailments in childhood, whether they be ear infections, asthma, or other physical problems, that have ever been shown to be amenable to chiropractic
manipulation or therapy.” The story released Friday by The StarPhoenix reports that the concern is over 5,297 chiropractic pediatric treatments at the cost of $80,921 paid in Saskatchewan this last year.
1 The Health Ministry is considering if it will continue to subsidize chiropractic pediatric care in Saskatchewan.
The key issue is the rampant misunderstanding or intentional misuse of the original concept of evidence based care. Governments and the insurance industry often view evidence based care as treatment supported only by rigorous scientific evidence. The original concept had three components; the current scientific literature, which included more than randomized controlled clinical trials, the clinical expertise of the health provider and the desires and needs of the patient. Recent attempts to deny chiropractic care in the U.S. and Canada have ignored these latter two elements and focused solely on limited components of the literature.
Dr. Leduc was the past president of the Canadian Pediatric Society. The official journal of the Society is Pediatrics and Child Health. Ironically, a 2005 a review of evidence supporting chiropractic care appeared in the 2005 issue of that very journal.2 This was the first chiropractic paper published in the journal of the Canadian Pediatric Society. An updated review was published in 2008.3 Both reviews attempt to harvest the available scientific literature supporting chiropractic care of children and, although the quantity and quality of research supporting chiropractic care for children is limited, there is a growing body of literature supporting such care. This literature surpasses some of the limited literature used to support reimbursement for some medical interventions.
A recent chiropractic consensus process by Hawk, et. al. used a number of experienced pediatric chiropractors.4 The level of consensus among that group relative to key concepts of child and infant care was high (80%). These consensus processes help fill some of the gaps in current evidence and help direct future research.
The difficulty of providing high quality pediatric research is very challenging for the chiropractic profession. There are added requirements in terms of bioethics and Institutional Review Board review constraints that create challenges. As one medical group put it “excessive regulatory oversight is seriously affecting translational research and quality improvement efforts.” They have identified 5 problem areas that restrict pediatric research.5 The same constraints apply to chiropractic research.
Two other major impediments to chiropractic research in general are 1) the limited number of the profession engaged in research, and 2) the very limited funding available. There are also only a hundred or so chiropractic researchers who have extremely limited funding to conduct their work. With this backdrop, it is more incumbent upon individual chiropractors and chiropractic organizations to support pediatric research.
2.
Assessing the evidence for the use of chiropractic manipulation in pediatric health conditions – a systematic review. Pediatr Child Health 2005, 10(3):157-161.
Gotlib A, Rupert R
OBJECTIVE: To review the biomedical literature up to and including 2003, and determine the extent of the evidence related to the therapeutic application of chiropractic manipulation for paediatric health conditions. No critical appraisal of the evidence is undertaken.
DATA SOURCES: The indexed manual therapy sector including medical, chiropractic, physiotherapy, naturopathic and osteopathic literature was searched. This included PubMed; the Manual, Alternative, and Natural Therapy Index System; the Cumulative Index to Nursing and Allied Health Literature; the Index to Chiropractic Literature; the Paediatric Economic Database Evaluation Project; the Cochrane Library; the Canadian Coordinating Office for Health Technology Assessment database; and the Agency for Healthcare Research and Quality database. Other resources included research conference and symposium proceedings, and the references of identified studies.
RESULT: The search identified 1731 articles, of which 166 met the eligibility criteria. Two reviewers determined by consensus each citation's appropriate level on the strength of evidence scale. There was one systematic review, nine randomized controlled trials, one observational study, 141 descriptive case studies and 14 conference abstracts.
SUMMARY: Health claims made by practitioners regarding the application of chiropractic manipulation as a health care intervention for paediatric health conditions are, for the most part, supported by low levels of scientific evidence. Chiropractors, in particular, employ manipulation for the treatment of a wide variety of paediatric health conditions. The evidence rests primarily with clinical experience, descriptive case studies and a few randomized controlled trials. There is a need for more rigorous scientific inquiry to examine the value of manipulative therapy in the treatment of paediatric conditions. To advance the health interests of paediatric patients, health care decisions made on the basis of expert opinion or clinical experience must integrate the best research evidence available from high-quality, scientific studies.
L'évaluation des données probantes favorables à l'usage de la manipulation chiropratique en cas de troubles de santé pédiatriques : Une analyse systématiqueA Gotlib, R Rupert
OBJECTIF : Analyser la documentation biomédicale jusqu'en 2003, inclusivement, et déterminer la portée des données probantes reliées à l'application thérapeutique de la manipulation chiropratique en cas de troubles de santé pédiatriques. Aucune évaluation critique des données probantes n'est entreprise.
SOURCES DES DONNÉES : Le secteur indexé de la thérapie par manipulations a fait l'objet de recherches, y compris la documentation médicale, chiropratique, physiothérapeutique, naturopathique et ostéopathique. Il inclut PubMed, le Manual, Alternative, and Natural Therapy Index System, le Cumulative Index to Nursing and Allied Health Literature, l'Index to Chiropractic Literature, la Paediatric Economic Database Evaluation Project, la Cochrane Library, la base de données Canadian Coordinating Office for Health Technology Assessment et la base de données de l'Agency for Healthcare Research and Quality. Parmi les autres ressources, soulignons les débats de conférences et de symposiums de recherches et les références des études repérées.
RÉSULTAT : La recherche a permis de repérer 1 731 articles, dont 166 respectaient les critères d'admissibilité. Deux évaluateurs ont déterminé par consensus le taux pertinent de chaque citation sur la solidité de l'échelle des données probantes. On a recueilli une analyse systématique, neuf essais aléatoires et contrôlés, une étude par observation, 141 études descriptives de cas et 14 résumés de conférences.
SOMMAIRE : Les revendications en santé faites par les praticiens au sujet de l'application des manipulations chiropratiques à titre d'interventions en santé auprès de la population pédiatrique sont, pour la plupart, soutenue par des données probantes scientifiques faibles. Les chiropraticiens, surtout, utilisent la manipulation pour traiter toute une série de troubles de santé pédiatriques. Les données probantes reposent surtout sur l'expérience clinique, des études descriptives de cas et quelques études aléatoires et contrôlées. Une enquête scientifique plus rigoureuse s'impose pour examiner la valeur de la thérapie par manipulations dans le traitement des troubles pédiatriques. Pour faire progresser les intérêts en santé de patients pédiatriques, les décisions en matière de santé, prises selon l'avis d'experts ou l'expérience clinique, doivent intégrer les meilleures données de recherche disponibles à partir d'études scientifiques de qualité.
3.
Chiropractic manipulation in pediatric health conditions - an updated systematic review.Chiropr Osteopat. 2008 Sep 12;16:11.
Gotlib A, Rupert R.
Canadian Chiropractic Association, CMCC Homewood Professor, 30 St, Patrick St, Suite 600, Toronto, Ontario, M5T 3A3, Canada. algotlib@ccachiro.org.
ABSTRACT:
OBJECTIVE: Our purpose was to review the biomedical literature from January 2004 to June 2007 inclusive to determine the extent of new evidence related to the therapeutic application of manipulation for pediatric health conditions. This updates a previous systematic review published in 2005. No critical appraisal of the evidence is undertaken.
DATA SOURCES: We searched both the indexed and non-indexed biomedical manual therapy literature. This included PubMed, MANTIS, CINAHL, ICL, as well as reference tracking. Other resources included the Cochrane Library, CCOHTA, PEDro, WHO ICTRP, AMED, EMBASE and AHRQ databases, as well as research conferences and symposium proceedings.
RESULTS: The search identified 1275 citations of which 57 discrete citations met the eligibility criteria determined by three reviewers who then determined by consensus, each citation's appropriate level on the strength of evidence scale. The new evidence from the relevant time period was 1 systematic review, 1
RCT, 2 observational studies, 36 descriptive case studies and 17 conference abstracts. When this additional evidence is combined with the previous systematic review undertaken up to 2003, there are now in total, 2 systematic reviews, 10 RCT's, 3 observational studies, 177 descriptive studies, and 31 conference abstracts defining this body of knowledge.
SUMMARY: There has been no substantive shift in this body of knowledge during the past 3 1/2 years. The health claims made by chiropractors with respect to the application of manipulation as a health care intervention for pediatric health conditions continue to be supported by only low levels of scientific evidence. Chiropractors continue to treat a wide variety of pediatric health conditions. The evidence rests primarily with clinical experience, descriptive case studies and very few observational and experimental studies. The health interests of pediatric patients would be advanced if more rigorous scientific inquiry was undertaken to examine the value of manipulative therapy in the treatment of pediatric conditions.
4.
Best practices recommendations for chiropractic care for infants, children, and adolescents: results of a consensus process.J Manipulative Physiol Ther. 2009 Oct;32(8):639-47.
Hawk C, Schneider M, Ferrance RJ, Hewitt E, Van Loon M, Tanis L.
Cleveland Chiropractic College, Overland Park, KS 66210, USA. cheryl.hawk@cleveland.edu
OBJECTIVE: There has been much discussion about the role of chiropractic care in the evaluation, management, and treatment of pediatric patients. To date, no specific guidelines have been adopted that address this issue from an evidence based perspective. Previous systematic reviews of the chiropractic literature concluded that there is not yet a substantial body of high quality evidence from which to develop standard clinical guidelines. The purpose of this project was to develop recommendations on "best practices" related primarily to the evaluation and spinal manipulation aspects of pediatric chiropractic care; nonmanipulative therapies were not addressed in detail.
METHODS: Based on both clinical experience and the results of an extensive literature search, a set of seed documents was compiled to inform development of the seed statements. These were circulated electronically to the Delphi panel until consensus was reached, which was considered to be present when there was agreement by at least 80% of the panelists.
RESULTS: A multidisciplinary panel of 37 was made up primarily of doctors of chiropractic with a mean of 18 years in practice, many with
post-graduate training in pediatrics. The panel represented 5 countries and 17 states; there were members of the
American Chiropractic Association, the International Chiropractors Association, and the International Chiropractic Pediatric Association. The panel reached a minimum of 80% consensus on the 51 seed statements after 4 rounds.
CONCLUSIONS: A broad-based panel of experienced chiropractors was able to reach a high level (80%) of consensus regarding specific aspects of the chiropractic approach to clinical evaluation, management, and manual treatment for pediatric patients, based on both scientific evidence and clinical experience.
5. Grinding to a halt: the effects of the increasing regulatory burden on research and quality improvement efforts.
Clin Infect Dis. 2009 Aug 1;49(3):328-35.
Infectious Diseases Society of America.
Collaborators (18)
Janoff E, Bohjanen P, Boucher H, Burman W, D'Aquila R, Eisenstein B, Kauffman C, Lane C, Margolis D, Marshall G, Poutsiaka D, Ratner A, Reller B, Rice L, Ryan E, Spearman P, Thio C, Natarajan P.
Infectious Diseases Society of America, Alexandria, Virginia, USA.
The Infectious Diseases Society of America is concerned that excessive regulatory oversight is seriously affecting translational research and quality improvement efforts. Careful studies on the subject of research oversight have documented the adverse effects of regulatory burden on clinical, epidemiological, and health systems research. We identified 5 problem areas. First, the application of the Health Insurance Portability and Accountability Act to research has overburdened institutional review boards (IRBs), confused prospective research participants, and slowed research and increased its cost. Second, local review of multicenter studies delays research and does not improve protocols or consent forms. Third, reporting of off-site adverse events to local IRBs is wasteful of the resources of sponsors, investigators, and local IRBs and does not add to participant safety. Fourth, uncertainties about key terms in the regulations governing pediatric research lead to marked differences in the ways that local IRBs review research involving children. Fifth, the lack of consensus on when IRB review is required for quality improvement efforts is slowing progress in this critical area. Relatively simple steps, which do not require legislation or a change in the Common Rule, could improve regulatory oversight in these problem areas.