Brian Kavanagh critiques the GRADE system of grading guidelines, arguing that even though it has evolved through the Evidence-Based Medicine movement, there is no evidence that GRADE itself is reliable. Professional medical groups commonly issue clinical practice guidelines. Such guidelines are traditionally the result of consensus conferences or expert panels and represent attempts to synthesize—from the best available evidence and expertise—practical guidance on the best possible care. Beyond issuing a guideline, many organizations have felt the need to provide a grading of each guideline's quality, thereby conveying to the reader a sense of the confidence that might be placed in it. This article addresses only the grading of guidelines, not their use or development.The idea that evidence in the medical literature should be graded was initially proposed in publications from McMaster University The pursuit of better approaches to grading guidelines has resulted in GRADE , introduced in 2004 Agency for Healthcare Research and Quality (USA)Agenzia Sanitaria Regionale American College of Chest Physicians (USA)American College of Physicians (USA)American Thoracic Society (USA)Ärztliches Zentrum für Qualität in der Medizin (Germany)British Medical Journal (United Kingdom)BMJ Clinical Evidence (United Kingdom)COMPUS at The Canadian Agency for Drugs and Technologies in Health (Canada)The Cochrane Collaboration EMB Guidelines The Endocrine Society (USA)European Respiratory Society (Europe)European Society of Thoracic Surgeons Evidence-based Nursing Südtirol German Center for Evidence-based Nursing “sapere aude” (Germany)Infectious Diseases Society of America (USA)Japanese Society for Temporomandibular Joint (Japan)Journal of Infection in Developing Countries Kidney Disease: Improving Global Outcome Ministry for Health and Long-Term Care, Ontario (Canada)National Board of Health and Welfare (Sweden)National Institute for Health and Clinical Excellence (United Kingdom)Norwegian Knowledge Centre for the Health Services (Norway)Polish Institute for EBM (Poland)Society for Critical Care Medicine (USA)Society for Vascular Surgery (USA)Spanish Society for Family and Community Medicine (Spain)Surviving Sepsis Campaign University of Pennsylvania Health System Center for Evidence-Based Practice (USA)UpToDate (USA)World Health Organization The developers of the GRADE system emphasized consistency in the rating of guidelines, as well as a wish to incorporate, and distinguish between, the “strength” of each guideline and the “quality” of the underlying studies  upon which it is based. Yet there is a central paradox: while GRADE has evolved through the evidence-based medicine movement, there is no evidence that GRADE itself is reliable.GRADE is one of several different systems for grading clinical evidence and creating clinical practice guidelines based on this underlying evidence. How do these systems compare with each other?Atkins and colleagues, from the GRADE Working Group, compared six different systems  [9]. TweAtkins and colleagues compared the following six systems http://www.chestnet.org/education/hsp/guidelinesProducts.php)The American College of Chest Physicians Evidence-Based Guidelines (http://www.nhmrc.gov.au/guidelines/index.htm)Australian National Health and Medical Research Council Guidelines (http://www.cebm.net/)Oxford Centre for Evidence-Based Medicine (http://www.sign.ac.uk/)Scottish Intercollegiate Guidelines Network (http://www.ahrq.gov/CLINIC/uspstfix.htm#Recommendations)US Preventive Services Task Force Recommendations (http://www.thecommunityguide.org/about/findings.html)US Task Force on Community Preventive Services Recommendations (But the example of the Surviving Sepsis Campaign (SSC), an important attempt to produce guidelines to improve the care of patients with sepsis or septic shock, suggests that GRADE has not overcome these problems see  and 4 [1In 2004 the SSC guidelines recommended that for serious sepsis, intravenous antibiotic therapy should be rapidly instituted In 2008, the SSC issued almost the identical recommendation but this time assigned to it a grade of 1B (if shock is present) and 1D (if shock is absent), where grade 1 corresponds to a “strong” In 2004 the SSC guidelines recommended that levels of positive end-expiratory pressure (PEEP) should be set to prevent lung collapse at expiration In 2005, the GRADE working group—all experts who themselves developed the GRADE system—published a pilot study of the system Comparing expert opinion on sepsis with the result of the GRADE process further suggests that GRADE lacks internal consistency.First, glucose control in the critically ill is a complex issue Second, the SSC strongly recommends  specific resuscitation targets  GRADE provides an expression of the strength of the recommendation and also provides a rating on the quality of the evidence upon which the recommendation is based. In terms of strength, GRADE considers evidence to be “strong” or “weak.” The GRADE group considers strength to reflect “the degree of confidence that the desirable effects of adherence to a recommendation outweigh the undesirable effects” Another problem is the “leveling” process proposed to determine the quality of the evidence. GRADE ranks the quality of evidence on the basis of the type of study, “quality” issues , consistency, directness , and effect size. The graders are instructed to raise or lower the level of quality and trade off, for example, the presence of sparse data against demonstration of a dose-response effect The basis for the GRADE system is articulated in several publications The GRADE documents suggested that strong recommendations should require little debate and would be implemented in most circumstances The GRADE system has been adopted as is, or with minor modifications, by a large number of professional, statutory, and medically related governance organizations . It is hThe SSC describes in detail how members of the GRADE group interacted with the sepsis experts and influenced the grading decisions The GRADE group writes that for clinicians, strong recommendations should be seen as a quality criterion or performance indicator, and for policy makers, be adopted as policy It is not clear that the opinion of a conscientious, judicious, well-educated, and experienced clinician would necessarily be inferior to a systemized opinion, such as GRADE, especially if GRADE is not valid. Conferring a “strong” rating upon a guideline will constitute a major deterrent to a clinician considering an alternative clinical route, particularly if GRADE recommendations were to be adopted as a policy by regulatory bodies A key question that arises when a system is questioned is: what is the alternative? There is a very good alternative to using the GRADE system to rate clinical guidelines: clinicians and organizations should use published guidelines while considering the clinical context, the credentials, and any conflicts of interest among the authors, as well as the expertise, experience, and education of the practitioner. If in the future a guideline grading system is shown to improve outcome and is without harm, it could usefully be incorporated into clinical practice.


Various guidelines have been proposed to assist psychiatrists all over the world in making appropriate health-care decisions. Though the fundamental premises of all guidelines are the same, yet they differ in certain important aspects; this hampers the universality of these guidelines. There are many internationally accepted guidelines which are based on robust research; still they do not necessarily address the geographical and cultural differences. This necessitates the formulation of regional guidelines, which usually lack the background of robust regional research. The Indian Psychiatric Society (IPS) guidelines were also formulated to cater to the needs of the Indian population. It is now almost three years old, and it is high time it should be compared to the international guidelines, so as to appraise ourselves of the success or shortcomings of the guidelines. This article critically analyzes the IPS guidelines in comparison with the available international guidelines and schematically brings out the positive points, as well as the shortcomings, with the aim of further improvement in our indigenous guidelines. Various clinical practice guidelines have been proposed, to assist practitioners in making appropriate health-care decisions by synthesizing the treatment literature into a usable form and facilitating the transfer of research into practice. Guidelines have also been used to control practice variation, to lower costs and to evaluate care processes.As many guidelines have been formulated, there have been problems of clinician's acceptance of the guidelines, as they lack universality. Despite the presence of international guidelines like American Psychiatric Association (APA) guidelines, Patient Though the IPS guidelines were drafted with utmost care, a comparison with the available international guidelines is necessary to impart a universal appeal to the guidelines. Such a comparison can bring to the fore many hidden issues, as well as serve to lift the standards of the guidelines to international levels. The IPS guidelines were compared with the international guidelines on the degree of scientific rigor, comprehensiveness and clinical parameters and clinical applicability, with the belief that it will assist the decision-making process for practitioners and health-care organizations that are considering the implementation of guidelines and will inform the development of future guidelines.Scientific background makes the most important pillar of any standard guidelines . GuideliThe guidelines produced by APA and by PORT are the most scientifically rigorous of those we examined. The developers of these guidelines conducted extensive structured literature reviews and considered study design and quality in making their recommendations. They also coded each recommendation to indicate the strength of the supporting evidence and included a list of references. However, neither of the sets of developers published formal evidence tables, and only PORT specified how expert review was incorporated into the final guideline.The developers of the Expert Consensus guidelines and of the TMAP algorithms conducted limited literature searches and did not code recommendations to indicate the level of supporting evidence. Indeed, the Expert Consensus guidelines were developed specifically to provide assistance to clinicians in areas in which scientific evidence was weak or lacking.The IPS guidelines consist of a detailed literature review, which adds to their effectiveness. It also mentions an elaborate list of the Indian studies, but the influence of these studies on the final drafting of the guidelines is not clear; and at most places, the guidelines seem to be a direct adaptation of the Western literature. Moreover, the studies occur separately as a table or in the bibliography, without any mention in the text.Comprehensive guidelines for the treatment of schizophrenia address more phases of the illness, discuss a wider variety of treatment modalities and make greater numbers of specific recommendations. They also have greater depth, with recommendations reflecting previous treatment trials and responses. Ideally, costs and resource allocation are also considered.The APA guideline has the most comprehensive literature review, with an extensive text summary of the treatment literature and an exhaustive list of references. But bulk comes as an unavoidable side effect of comprehensiveness. Though the IPS guidelines are less comprehensive than the APA guidelines, yet they address almost all the important areas of any illness. The literature review is also comprehensive, and attempt has been made to include almost all possible significant studies. The IPS guidelines have been carefully drafted to limit the bulk, even after including the maximum needed information. The PORT guideline references detailed review articles, whereas the Expert Consensus guidelines and the TMAP algorithms include only limited literature reviews and selected references.The APA and Expert Consensus guidelines make the most specific treatment recommendations, and PORT makes the fewest. Only a minority of the APA and PORT recommendations are contingent on a patient's treatment history. In contrast, the recommendations listed in the TMAP algorithms are based exclusively on the patient's treatment and response history. The IPS guidelines make recommendations on the basis of history, as well as mental status examination, and also address special issues elaborately. The recommendations made are clear and specific; the strength with which the recommendations are made is lacking.The IPS, APA, PORT and Expert Consensus guidelines include specific recommendations about treatment of the acute, continuation/stabilization, maintenance/stable phase of various mental illnesses. TMAP indicates that its algorithms are suitable for “any patient beginning medication treatment or taking a medication without a satisfactory response.”The IPS and APA guidelines include several recommendations about pharmacological management, group and individual therapy, vocational rehabilitation and specific psychosocial interventions. The PORT recommendations focus mainly on pharmacotherapy; but recommendations are also made for family interventions, psychological interventions, vocational rehabilitation and case management. The Expert Consensus guidelines address both pharmacological and psychosocial interventions and offer recommendations about the intensity or location of nonpharmacological services. In contrast, the TMAP algorithms address only the pharmacological management of schizophrenia.Cost-benefit ratio is one of the prime concerns of a clinician, especially while practicing in a developing country like ours. Developers of Indian guidelines failed to conceptualize this important aspect in the IPS guidelines. There is no mention of the cost of therapy of any of the illnesses; and thus at places, the recommendations have to be undermined while practicing. In fact, none of these guidelines include specific considerations about costs and resource allocation in their recommendations. Although the APA guidelines note that the advantages of the newer antipsychotic medications should be balanced against their costs, the PORT recommendations refer to the costs of assertive community treatment and clozapine; and the Expert Consensus guidelines include a policy section that recommends interventions to increase the cost-effectiveness of mental-health services.The algorithmic format employed by TMAP makes it the easiest to use. The IPS guidelines also have the distinct advantage of being easy to use and comprehend. The guidelines clearly convey the duration of treatment and other important issues. The algorithms given at the end of chapters further simplify the user's understanding. In the text also, rather than using a “paragraph” format, a point-wise listing of the guidelines makes them easier to comprehend and follow. The Expert Consensus guidelines, designed to be user-friendly, list recommendations in tabular form. The numbered PORT recommendations are quickly assimilated. The APA guidelines, written in the form of a literature review, are more difficult to assimilate and use. Almost all the guidelines barring the TMAP repeat the information given under various headings, making them unnecessarily cumbersome.A major difference between the IPS guidelines and other international guidelines is the area targeted by the guidelines. While the IPS guidelines are supposed to serve as guiding principles for the Indian psychiatrists, the other guidelines are more international in their approach. This fact has not been properly reflected in the drafting of the IPS guidelines. Mentions have been made of drugs or psychotherapeutic techniques which are not available in India or are available at very few centers. The guidelines do not give enough emphasis to the available resources while making the recommendations.The APA guidelines, published in 1997, were based on reviews of the scientific literature up to 1995. Revisions are scheduled at three- to five-year intervals. The PORT was based on literature reviews up to 1993 and no revisions are scheduled. The Expert Consensus guidelines were originally published in 1996 and were updated in 1999. TMAP revisions are made available at the TMAP website as new antipsychotic agents are introduced; the latest revision occurred in December 1999. The IPS guidelines are pretty young and a review can wait for another year or so, but timely review should be accepted as a policy.Guidelines that are specific and can be operationalized as rate-based monitors lend themselves to benchmarking and the establishment of best-practice parameters. Both the TMAP algorithms and the PORT recommendations are explicit, specific and easily operationalized. The Expert Consensus guidelines are more general; and the IPS and APA guidelines are almost didactic in format, making them more difficult to operationalize.In order to improve further, it is necessary to identify one's weaknesses. Therefore, just to aid in future improvements and not with any intention of criticism, we are mentioning a few areas needing improvement in the days to come.The development process of the guidelines should be more defined so as to allow a clinician to choose a recommendation based on its merit. The researchers across the country should be urged to contribute more for the development of the guidelines and in turn psychiatry as a whole, but efforts will be needed to minimize the contributor bias. The guidelines have been formulated with the intention of being universal and thus bringing accountability to the practice of Psychiatry in India. This universal appeal will need active participation not only of the prominent psychiatrists in India but also from small-town mental-health professionals. Though inputs are always welcome, they must be included only after carefully weighing the scientific emphasis they bring along. All the included studies must be assessed for their scientific legitimacy and quality, before making a recommendation based on the studies. Only enumeration of the studies might not be sufficient, but guidelines based on the regional researches will be more helpful.The APA guidelines give us an important example of rating the recommendations. By doing this they clearly show the strength with which they make a particular recommendation, which makes it much easier for the clinician to make decisions.The IPS guidelines lack a structured format which must be rigidly followed for describing all the illnesses, making the guidelines more uniform.Cost and resource considerations are one of the prime concerns of a clinician while prescribing treatment in a developing country like ours; unfortunately, this important issue has not been adequately addressed in the Indian guidelines. This aspect becomes more important as the insurance coverage is not extensive in India, unlike Western nations.Apart from cost, psychosocial and cultural considerations are also very important in our setup, especially while guiding the practitioner for nonpharmacological management. The strong family and social support systems in our country make the needs different, and also the unavailability of experts and infrastructure limits our armamentarium of psychotherapies.Dosages for medications have been found to be varying with race or ethnicity. Specific recommendations made for dosages of antipsychotics and other medications might be needed to suit the Indian population.Lastly, the guidelines can be made more user-friendly and easy to use by trying to be more precise and avoiding repetition of information.An ideal guideline for clinical practice would combine the best features of each of these efforts. The development process would be defined and specified in the guideline. It would be derived from a comprehensive literature review. It would explicitly assess the quality of supporting research studies and the methods used for synthesizing evidence. Evidence tables would be constructed and published in an ideal guideline. Questionnaires can be prepared to receive input from mental-health professionals all over the country. Both evidence-based and expert opinions need to be incorporated, but with a clear delineation between the two. Treatment recommendations would take into account important demographic, cultural and psychosocial issues. Cost considerations would be included. Dosage requirements for Indian population would be worked out and incorporated in the guidelines. Recommendations would be summarized in a concise, user-friendly format; and suggestions would be made about how the guidelines might be operationalized as quality monitors. Guidelines would be revised at three-year intervals.Guidelines that address the factors described in this review may be more effective in optimizing clinical practice. However, even excellent guidelines will require additional support, such as academic detailing and provider reminders, if best practices are to be disseminated widely. Though we strive to define a universal and ideal guideline, the importance of individual knowledge and belief can never be undermined.The standardized must gel with the personalized and the socialized to make for good psychiatric practice. It is a moot point whether a nomothetic-idiographic orientation is valid only for Psychiatry or for all of medicine.


Evidence-based medicine requires use of the best available evidence for optimal patient care. Increasingly scarce resources and escalating demands on time have led to emphasis on effective treatment. Opinion is slowly yielding to high-quality existent evidence. It is important that urologists adapt to these changes for them to deliver optimum care to the patients. This article discusses the levels of evidence, the nature of desirable evidence, means of assessing quality of clinical trials and meta-analysis and finally the practice of evidence-based urology with special reference to bedside evidence-based urology. Koch stated his postulates and the progress of evidence-based medicine thereafter has been explosive. The randomized controlled trial (RCT) was initially introduced into clinical medicine for the evaluation of the efficacy of streptomycin for tuberculosis in 1948.[Medical progress through the centuries has been based on the teaching of eminent physicians. It was usually based on carefully observed phenomena and backed by the authority of the presenter. Its level of acceptance was based largely on the eminence of the physician and the scientific basis was not vetted to any great extent. So entrenched was eminence-based medicine that it took more than a millennia for Vesalius 1514-1564) to contradict successfully the teachings of Galen.[514-1564  in 1948. Further  in 1948. but it w in 1948. The reasPubMed and IndMed were searched to identify articles (1985-2006) related to EBM and urology. Key words used included, EBM, evidence-based urology, strength of evidence and quality of care. Recent textbooks on the subject were referred. These were reviewed with focus on application of bedside EBM in urology.EBM is the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients. The practice of EBM means integrating individual clinical expertise with the best available external clinical evidence from systematic research. It is deResearch studies may be primary, involving clinical research i.e., RCT, cohort, case control studies, case series or case reports. It may be secondary, based on primary data, in the form of a meta-analysis or a clinical practice guideline. A meta-analysis of homogenous RCTs is by general agreement rated as the highest level of evidence. The otheA meta-analysis evaluates data and results systematically, from different trials on a single subject to arrive at a conclusion about a body of research. It is most frequently applied to RCTs and more recently to observational studies. When methodically sound, it provides a very accurate measurement of the clinical effectiveness of healthcare interventions and precise estimate of treatment effect. The basic requirements of a meta-analysis are well-designed representative trials. Randomized controlled trials based on heterogeneous data offer weaker evidence and if the original studies were poorly designed its conclusion may potentially mislead. In addition, the intervention applied and the settings differ between trials and there may be both loss of information on important outcomes and inappropriate subgroup analysis during a meta-analysis. Moreover, newer experimental data from mega trials on occasion are not always in concordance.The quality and consistency of reporting of research is varied. Efforts have been made to improve the reporting of RCTs and meta-analysis. These have resulted in the Consolidated Standards for Reporting Trials (CONSORT) guidelines for randomized trials and the Systematic reviews/meta-analysis or other primary studies do not provide recommendations or consider all potential consequences of a therapy, i.e., the cost, patient preferences, practicalities. Evidence-based practice systematically acquires, analyses and transfers research findings into clinical, management and policy areas. It involves an amalgamation of evidence, expertise and patient values; blending the science and art of medicine.The practice of evidence-based urology involves five steps:The question has to be framed in a way that can be answered in a systematic review. It must be specific and should include the type of patient, clinical intervention and the outcome of interest.The exact inclusion and exclusion criteria must be predecided before searching the literature in order to avoid bias due to arbitrary inclusion and exclusion of certain studies.A proper literature search to identify articles relevant to the topic of interest is then made to see the best available evidence. Access to the internet and medical database systems greatly facilitate the search. Using different search strategies and keywords can improve results.Many published articles contain methodical flaws or lack clinical applicability. It is important to determine the quality of the study i.e., the extent to which all aspects of a study design can be shown to protect against systematic bias and inferential error .All evidence, however strong is not universally applicable. Clinical judgment is essential when extrapolating evidence to clinical practice.16The sheer volume of scientific literature makes it rather difficult for even experts to be aware of all relevant literature. A selective skimming of leading journals may result in missed valuable information. A meta-aCPG are not new. While the recommendations of yesteryears were predominantly expert opinion-based, contemporary guidelines are primarily evidence-based and graded according to their strength of evidence. They are an attempt to distill a large body of evidence to a usable format.Quality of healthcare refers to the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge. Quality While guidelines are very useful in evidence-based urological practice they have several limitations. Several assumptions are made during the preparation of a clinical practice guideline. Firstly, a sufficient quantity of valid evidence must exist. Secondly, the majority of healthcare providers will study and implement these guidelines. Third, they will be organized and funded by independent agencies without conflicts of interests. And finally, they should result in an improvement in the quality of care and if possible lead to proper utilization of scarce resources. The process should be methodically sound to produce valid, reliable, clear and applicable recommendations.Even if these criteria are met, evidence-based recommendations and CPGs need to be sensitive to patient and societal preferences. Guidelines formulated in a particular social and economic context may not find total acceptance in another. For example, the AUA 2003 guidelines for benign hyperplasia of the prostate do not recommend routine ultrasound evaluation (USG) of the upper tract for back pressure changes in patients with benign prostatic hyperplasia. An ultraet al recommend rephrasing the question. “Is my patient so different from those in the trial that the results cannot help me?”[Most medical recommendations refer to groups of patients. They may or may not apply to or be acceptable to the patient in question. Sackett help me?” The resuhelp me?” patientshelp me?”.It is not for the research institutions and expert groups alone to evaluate evidence and to make recommendations for other urologists to follow. It is not sufficient for the urologist to say he/she practices EBM by merely following such recommendations. At the individual clinician level EBM is a way of practicing medicine by scientifically evaluating for evidence that the action they take is beneficial to the patient-a method sometimes referred to as “Bedside EBM”. The applicability and relevance of evidence-based medicine in routine patient care shall determine to a great extent its acceptability by urologists. Clinicians can generate around five knowledge “needs” for every inpatient and three “needs” for every outpatient.24 BedsidFor example in a patient with symptomatic overactive bladder (OAB) is Solifenacin better than Tolterodine? The outcome measures in this case can be-Its comparable effectiveness in urgency and urge incontinence? Does it have less incidence of dry mouth?et al, Randomized, double-blind placebo and Tolterodine-controlled trial of the once-daily antimuscarinic agent Solifenacin in patients with symptomatic overactive bladder,[A literature search was made using Pubmed. It took less than 10 minutes to identify an appropriate article for our question. The study by Chapple  bladder, deals wi bladder,.The number needed to treat (NNT) to get one desired outcome in this example was:Urgency: NNT = 7; possibly the benefits outweigh the risksUrge incontinence: NNT = 14; the benefits are questionableDry mouth: NNT = 20; Difficult to recommend a change for the symptom of dry mouth alone.A similar analysis of the MTOPS study is publiThe NNT remains one of the best measures of evidence. It is generally calculated from systematic reviews of RCTs, but it can be quantified from odds ratio and relative risk reduction. The ideal NNT is 1; a favorable outcome occurs in every patient treated and in no patient in the comparison group. The NNTs of very effective treatments are usually in the range of 2-4. The NNTs for prophylaxis will be larger as fewer patients are affected in a large population. For example, the use of aspirin for the prevention of one death after five weeks of myocardial infarction is 40 and yet is regarded as favorable. The NNTs may be negative in the sense that there are more good events with controls than with treatment . They are then expressed as the number needed to harm (NNH). Five top English language journals were examined in 1989, 1992, 1995 and in 1998 for how RCTs report their results. Of the 359 articles, eight (2.2%) reported NNTs and 18 (5.0%) the absolute reduction rate.A CAT is easily made and stored for future reference. It is most valuable as a learning resource if made by the clinician, than obtained secondhand, though these may be available. It may be also generated as a group activity involving multiple residents in an institution or city level urology club and might be more useful than traditional journal clubs.Individual CATs can be wrong. A CAT is as good as the evidence that went into creating it. Garbage in, garbage out. They also contain a single element of the relevant literature. The article can potentially reflect the bias of the clinician. They also have a short shelf life and need to be periodically updated as newer best evidence is forthcoming. The NNTs too have their drawbacks; they are treatment and period-specific and describe the difference between treatment and control at a particular time. They are best used in trials with comparable outcomes in comparable patients. Where a positive outcome is partly due to a placebo effect, NNT is an overestimate. Also there exists no exact cutoff level for effectiveness.Self-directed evidence-based learning, critical appraisal and the information generated thereof can improve patient care, confidence in care and potentially affect decision-making in 78% of cases. The CentUrology is not static. New evidence may push previous ideas into obsolescence. Any practice based on previous evidence would have to necessarily give way to new evidence. Unless constantly updated previously appraised topics rapidly lose relevance. Reliable evidence does not exist for many clinical problems, especially the rarer ones. Moreover, randomization of surgical therapy is difficult and may be inappropriate. Any evidence is only as good as the input. Poor quality of the constituent trials will lead to poor quality evidence.There also is the problem of ‘negative evidence’ that rarely gets published. ‘Publication bias’ and censoring by the authors or their sponsors both contribute. Its lack remains an important impediment in compiling the complete picture. It has been suggested that registering trials with independent agencies and insistence of such registration by journals could reduce the proportion of unpublished evidence.33Can urology be evidence-based? Previous fears that EBM may lead to attrition of clinical skills and the art of medicine have been largely unfounded. Most agree on the need, some may quibble on the appropriateness of existing evidence. Practice of evidence-based urology may be a way of keeping abreast of the most relevant developments in the era of exponential growth of urological literature. By helping to hone critical appraisal skills it may possibly improve clinical expertise.


This is an accompanying commentary on the article by Gert Bronfort and colleagues about the effectiveness of manual therapy. The two commentaries were provided independently and combined into this single article by the journal editors. This paper is two commentaries on the article by Gert Bronfort and colleagues about the effectiveness of manual therapy . The firBronfort et al  are to bAlthough I have been very active as a panellist or chairman of evidence based guidelines for a number of associations  Government Agency for Health Care Policy and Research (AHCPR), the Bone and Joint Decade 20000-2010 Task Force on Neck Pain and Its Associated Disorders (NPTF), Guidelines for Chiropractic Quality Assurance and Practice Parameters, the American Academy of Occupational and Environmental Medicine, the California Department of Industrial Relations) my primary means of making a living for the past 40 years has been the care of patients in a private clinical practice. The question that I and other clinicians raise when reviewing this type of study is: "how can I use the conclusions and information to improve the care I provide to my patients?"I have a specific interest in guidelines of this type in that my primary practice is in the medical specialty of neurology with a special interest in spinal disorders. Most of my patients are referred for consultation and expect me to provide information on the treatment options available to them including medications, surgery, injections, rehabilitation, the different manual and chiropractic treatments and other complementary approaches to their health.One common response to the publication of evidence based guidelines that clinicians do not fully understand, is anger that their clinical experience and observations are discounted and their common practice procedures are being questioned. When the AHCPR Guidelines were published in the US on Acute Low Back Pain and did not endorse surgery for uncomplicated low back pain due a lack of evidence there was a national outcry followed by political attacks by surgeons that led the US Congress to prohibit further government agencies from producing guidelines. The recent fury by the United Kingdom (UK) pain specialists that led to the forced resignation of the president of their society after publication of the UK NICE Guidelines that was critical of the research supporting injections for back pain is another example of the difficulty clinicians have in accepting the assessment of the efficacy of their treatment approach. I would be surprised if practicing chiropractors whose clinical observations, like those of their medical counterparts in the above situations, suggest that they are helping patients with a number of conditions where the evidence for efficacy is either non-existent or contradicts their own experience will simply accept the conclusions in this document without further discussion.It is, however, a serious mistake to try to attack or disagree with the evidence when treating patients. It does not serve patients to provide treatment that has been shown to be ineffective or where there is insufficient evidence to reach a conclusion when there are other options available that have been demonstrated to be beneficial. It is not acceptable today to claim that a treatment is effective in helping patients when there is no evidence to support these claims. It does not help the reputation of a profession that is striving to be considered the authority in a field, if practitioners are unwilling to understand and practice according to the latest clinical evidence.Chiropractors are extremely fortunate in these times of evidence based health care. There was a time, not long ago, when there was little or no evidence to support the practice of manipulation that is the mainstay of chiropractic practice. There were also widely advertised claims that manipulation could have very serious complications and therefore should not be offered patients in the absence of evidence. There has, however, been a rapid growth in the number of clinical trials that have studied the effectiveness of manipulation, mobilization and massage over the past 20 years and, as this document demonstrates, there is now little dispute amongst knowledgeable scientists that manipulation is of value in the management of back pain, neck pain and headaches that make up 90% or more of all patients who seek chiropractic care. At the same time, a close review of the evidence, including the recent large population studies in Ontario [It is not unexpected, however, that numerous claims made by chiropractors over the years, based on their clinical observations, have not stood up to critical analysis and the results of studies often suggest that these observations are due to placebo or the natural course of the disorder rather than the actual treatment. This has been true of a vast number of medical treatments. A recent Special Issue of The Spine Journal on Evidence Informed Management of Chronic Low Back Pain listed over 200 treatments currently being offered patients with low back pain, most of which are offered by medical physicians . Of thesMy goal as a clinician is to ensure that I offer the highest quality of care to patients based on the best available knowledge. I find that this is easy to do and patients greatly appreciate, and in fact expect, care that has research support. In my personal practice I incorporate evidence such as that noted in this report in the following manner when caring for my patients:1. Ensure that I attend the scientific meetings where the latest clinical studies are presented and discussed.2. Ensure that I keep up to date with the latest research in order to be confident that I am as knowledgeable about my field of practice as any other clinician.3. Ensure that when I advertise my practice or talk to prospective patients that I only make claims that I can support by quoting the scientific evidence.4. Discuss with patients the scientific rationale of any treatment I am considering to address their problems and why I am suggesting a certain course of care.5. Avoid suggesting a treatment approach to a patient without discussing the expected benefits, the possible adverse reactions and the options that are available either through my office or by referral to another clinician.6. Determine the preferences of my patient for the different treatment options when the likely outcomes are similar and empower him or her with the knowledge to make an educated decision on his or her care.7. When a treatment option is decided on, I attempt to closely monitor the patient's positive and negative response to the treatment and make adjustments to the type of care offered depending on the response.This does not preclude my right to offer a treatment approach that is off-label and for which there is limited evidence of effectiveness. I could not practice as a neurologist without this ability. It has been estimated that between 50-80 per cent of all treatments prescribed by medical physicians and specialists are off-label or have limited scientific support. There are many times when patients have tried all available evidence-based treatments without success and are requesting and are willing to try treatments based solely on my experience and recommendation. In this situation, however, I am very careful to tell the patient that there is no scientific support for the treatment we are considering, that no guarantees can be made for its success and that there are potential complications that may not be known. I am then willing to consider this approach for a limited period of time and discontinue the treatment if there is no positive response or a negative response becomes evident. I also avoid offering a treatment approach for which there is evidence that it is unlikely to be helpful, if the expense is too high to warrant the trial of what is essentially an experimental procedure or where the complication rate is known to be significant.The chiropractic profession is to be congratulated on formulating this Evidence Report. It should be of considerable help to practicing chiropractors who are trying to practice according to the best scientific evidence, to patients who are seeking care and trying to decide whether chiropractic is a reasonable option, to other physicians who wish to refer patients to or work closely with chiropractors and to policy makers who have to decide what treatments should be paid for. The primary weakness of studies such as this is that they reflect the evidence at the time of publication. Evidence on manipulation and other treatment approaches offered by chiropractors is advancing every year and I hope that we will see routine updates of this document so that we, as physicians and the chiropractors we work with, can provide better care to our patients.The effectiveness, or otherwise, of manual therapies is the subject of considerable debate. It sometimes appears that this, occasionally heated, debate is fuelled more by the prior beliefs of the protagonists than by a rational examination of the evidence. This evidence report brings together a summary of all the randomised controlled trial evidence and guideline recommendations for manual therapies. Importantly, this has focussed on the treatments offered, rather than the professional background of the therapist. Many, but not all, of these treatments may be delivered by therapists with conventional biomedical training, such as physiotherapists or by complementary practitioners such as osteopaths or chiropractors. Understanding the evidence for, or against, the use of manual therapy for different disorders is far too important to allow it to be used in a debate of the integrity of particular professional groups. Manual therapies are characterised by the use of the therapist's hands; thus they include massage, joint mobilization within the normal range of movement, or manipulation taking a joint beyond its normal range of movement. Any consideration of the effectiveness of manual therapies also needs to recognise that non-specific factors such as the interaction between the therapist and the patient may have a therapeutic effect, in addition to any specific effect resulting from the manual treatment itself. From an academic perspective, it is of considerable interest to be able to quantify the specific and non-specific effects of any particular treatment. From a patient perspective, however, knowing whether an overall package of care, which includes manual therapy, has shown to be effective, is probably of greater relevance.Any new drug treatments need to provide evidence of effectiveness prior to being marketed. In contrast new manual therapy approaches, some with a very poor theoretical underpinning, can be introduced and achieve popularity without any evidence of effectiveness being available. Few, if any, trials of manual therapy have been designed to show that an established treatment is ineffective. Many negative trials are too small to have been certain that an important therapeutic effect has not been overlooked. Thus, it is important when reading this report to remember that absence of evidence of effectiveness is not the same as evidence of absence of effectiveness.Minor, self limiting, adverse effects such as muscle soreness following manual therapy are common. Serious adverse events are rare. Good data on their frequency are not available - these need to come from observational studies rather than randomised controlled trials. Manual therapists do need to counsel their patients about the risk of both minor and serious adverse events. For manipulation of the lumbar spine in an otherwise fit young adult with non-specific low back pain the risk of a serious adverse event is probably not of great concern. On the other hand, manipulation of the cervical spine of someone who has recently sustained a significant whiplash injury should probably be avoided. Additionally, there is the hazard that consulting a manual therapist, for a treatment that has not been shown to be effective, may stop the patient seeking appropriate medical treatment. This may not be so important for a child previously diagnosed with infantile colic, a minor self-limiting disorder, for which medical treatment is largely ineffective. On the other hand choosing manual therapy for a potentially fatal condition, such as asthma, in preference to established drug treatments would be unwise.Notwithstanding these provisos, the key messages from this report are that:• there is evidence to support the use of manual therapies for a range of, primarily musculoskeletal, disorders for which it is biologically plausible that they might have a specific effect• there is not evidence for their use for a range of other disorders for which a biologically plausible mechanism for a specific effect is unclearThus, for example, the evidence supports use of manual therapy for non-specific low back pain and it does not support its use for enuresis or otitis media. Wherever possible we should use treatments of proven effectiveness. This dictum applies equally to the medical profession and to manual therapists. If a manual therapist is asked to treat a patient with a disorder for which they do not have a proven treatment approach they should first consider if a non-manual treatment would be more appropriate. If they do proceed to treat the patient, they need to explain to the patient the strength of the available evidence for effectiveness and what is known about potential adverse events. The vast majority of osteopaths and chiropractors in the UK are in private practice. This could lead to a concern that unproven treatments are being inappropriately offered for short-term commercial gain. Similar concerns might be raised for my medical colleagues who work in private practice. Such unprofessional behaviour should be avoided by all professions.For some non-musculoskeletal disorders for which manual treatment has achieved popularity, without evidence of effectiveness being available there is a need for new trials to produce definitive evidence of effectiveness/ineffectiveness of manual therapy. In the meantime, this excellent report gives clear guidance on the disorders for which the use of manual therapy is supported by objective evidence of effectiveness. I recommend this report as essential reading for all manual therapists before considering which treatments they should offer, and the information they give, to their patients.SH has served or continues to serve on a number of Guideline panels that have dealt with some of the topics included in this study. These committees have been established by the North American Spine Society, the United States (US) Government Agency for Health Care Policy and Research (AHCPR), the Bone and Joint Decade 20000-2010 Task Force on Neck Pain and Its Associated Disorders (NPTF), Guidelines for Chiropractic Quality Assurance and Practice Parameters, the American Academy of Occupational and Environmental Medicine and the California Department of Industrial Relations. He is not currently the recipient of any research grant or support funding. He does serve as a consultant to Palladian Health. He is currently president of World Spine Care, a charitable non-profit organization established with the goal of helping people in underserved regions of the world who suffer from spinal disorders.MU was one of the principal investigators on the UK BEAM trial of manipulation and exercise for low back pain which found a package of manual therapy to be effective for low back pain; he was chair of the National Institute of Health and Clinical Evidence (NICE) guideline development group that developed guidelines on the early management of persistent low back pain that recommended that manual therapy as a treatment option; he is a co-applicant on two current research projects into the incidence of adverse events following manual therapy funded by the National Council for Osteopathic ResearchBoth authors contributed equally to this manuscript and provided their commentaries independently. The journal editors combined their commentaries into this single paper.


This paper reports on the revision and extension of this evidence hierarchy to enable broader use within existing evidence assessment systems.In 1999 a four-level hierarchy of evidence was promoted by the National Health and Medical Research Council in Australia. The primary purpose of this hierarchy was to assist with clinical practice guideline development, although it was co-opted for use in systematic literature reviews and health technology assessments. In this hierarchy A working party identified and assessed empirical evidence, and used a commissioned review of existing evidence assessment schema, to support decision-making regarding revision of the hierarchy. The aim was to retain the existing evidence levels I-IV but increase their relevance for assessing the quality of individual diagnostic accuracy, prognostic, aetiologic and screening studies. Comprehensive public consultation was undertaken and the revised hierarchy was piloted by individual health technology assessment agencies and clinical practice guideline developers. After two and a half years, the hierarchy was again revised and commenced a further 18 month pilot period.A suitable framework was identified upon which to model the revision. Consistency was maintained in the hierarchy of "levels of evidence" across all types of clinical questions; empirical evidence was used to support the relationship between study design and ranking in the hierarchy wherever possible; and systematic reviews of lower level studies were themselves ascribed a ranking. The impact of ethics on the hierarchy of study designs was acknowledged in the framework, along with a consideration of how harms should be assessed.The revised evidence hierarchy is now widely used and provides a common standard against which to initially judge the likelihood of bias in individual studies evaluating interventional, diagnostic accuracy, prognostic, aetiologic or screening topics. Detailed quality appraisal of these individual studies, as well as grading of the body of evidence to answer each clinical, research or policy question, can then be undertaken as required. The corner-stone of evidence-based healthcare and health technology assessment is critical appraisal of the evidence underpinning a finding. Different methods are available for assessing the quality of the evidence, including ranking the body of evidence according to a hierarchy which indicates the level of bias associated with the different study designs that have contributed to the evidence-base. In Australia, the standard evidence hierarchy in use since 1999 has been the National Health and Medical Research Council (NHMRC) Designation of Levels of Evidence ; and iiiindividual study designs to address different types of questions. The second stage of developing or adapting a simple, intuitive system to grade the entire body of evidence is discussed elsewhere [This paper describes the first stage of developing a hierarchy to rank the quality of lsewhere ,4, and wThe existing NHMRC hierarchy of evidence was developed as part of a comprehensive series of handbooks which outlined the methods for evaluating evidence and developing and disseminating clinical practice guidelines ,2,5-9.evidence level, designated according to the hierarchy  to develop a revised hierarchy of evidence for individual studies (first stage) which addressed these issues, as well as a method for appraising the body of evidence (second stage) that could be used by guideline developers and others.The objective of the first stage was to create a framework that aligned as closely as possible with the original evidence hierarchy – to minimise confusion for current users and maintain consistency with previous use of the hierarchy – but which could also rank individual studies addressing questions other than therapeutic effectiveness. Due consideration was to be given to methods used by other organisations to develop "levels of evidence", in order to minimise duplication of effort.Recognising the need for an updated hierarchy of evidence, a review was conducted of existing frameworks for assessing non-randomised and non-interventional evidence that are used by Health Technology Assessment (HTA) agencies and guideline developers world-wide . This inThe report searched for comprehensive evidence frameworks that incorporated non-intervention evidence via HTA and Guideline group websites that were identified through the membership of the International Network of Agencies for Health Technology Assessment (INAHTA) and the Guidelines International Network (GIN) (see Appendix). Bibliographies of identified publications were examined and targeted Medline/EMBASE searches were conducted. Frameworks were included if they were published in English, were developed by a reputable HTA or guideline agency, and contained guidance on at least one of the methodological processes involved in undertaking an evidence-based assessment .The identified frameworks were then used to inform the revision of the NHMRC evidence hierarchy. Six key factors were considered integral to this revision process, specifically that:1. the hierarchy addressed all types of questions and was not limited to treatment effectiveness alone;2. the levels I-IV were maintained and aligned as closely as possible with the current NHMRC (treatment effectiveness) hierarchy;3. the hierarchy related to individual studies rather than a body of evidence ;4. the hierarchy remained broadly consistent across types of question;5. empirical evidence supported the placement of a particular study design in the evidence hierarchy wherever possible – that is, the relationship between study design and bias for each clinical or research question had been assessed empirically; or if not, there were good theoretical grounds for such placement in the hierarchy; and6. subjective terms regarding the "quality" of studies eg "well designed", "properly designed" would be removed. The level of evidence would be assessed on the basis of study design characteristics alone. Determination of the overall "quality" of the study would be independently determined using appropriate – and validated, where possible – checklists suitable for each study design and question.The "Levels" subgroup of the Working Party addressed each of these criteria while drafting a revision of the evidence hierarchy. This first iteration of the hierarchy was slightly modified after consultation with other methodological experts within the wider Working Party. A second iteration of the hierarchy was presented to Australian and New Zealand evaluators undertaking health technology assessments for the Australian Medical Services Advisory Committee (MSAC). Other international experts on evidence appraisal were contacted and provided feedback on the hierarchy. These suggestions were discussed and some substantial revisions – particularly concerning the diagnostic accuracy evidence hierarchy – were incorporated into a version of the hierarchy that was suitable for piloting.The hierarchy was piloted by NHMRC clinical practice guideline developers and health technology assessment evaluation groups in Australia and New Zealand from November 2004 until June 2007. Public consultation throughout this period was invited through the medium of international conferences and workshops – specifically the Cochrane Colloquium and the Health Technology Assessment international (HTAi) conference -13 – andThe 2004 report commissioned by the NHMRC identified 18 evidence frameworks that were relevant for clinical evaluation of non-interventional evidence at that time . Three oIn terms of addressing different types of questions, the CEBM framework was found to be the most comprehensive and a suitable evidence hierarchy upon which to model the revised NHMRC hierarchy of evidence, although all three provided useful information.Each of the six key factors considered integral to a revised NHMRC evidence hierarchy were adopted. Five separate research areas were addressed – interventions, diagnostic accuracy, prognosis, aetiology and screening.A greatly expanded table was created, largely based on the design of the CEBM framework, which included five separate columns for each of the different research areas . The 'Working Party' believes that any assessment of evidence underpinning a question involves three steps:1. determine the level of evidence of individual studies addressing that question and rank the evidence accordingly;2. appraise the quality of the evidence within each ranking using basic clinical epidemiology and biostatistical principles outlined in widely available critical appraisal checklists and tools; and3. synthesise the findings from steps 1 and 2 and give greatest weight to the highest quality/highest ranked evidence. After including consideration of contextual factors, make a clear and transparent decision or recommendation regarding the strength and applicability of the findings from the body of evidence, and grade that recommendation.Steps 1 and 2 are addressed in this paper. Step 3 was undertaken by the NHMRC Working Party through creating a process and system for classifying and grading the body of evidence that takes into account dimensions other than the internal validity of the studies – an issue which has received similar attention in other countries ,23. ProgWhile the revised hierarchy described in this paper has greatly expanded the types of studies that can be assigned a level of evidence, it does not cover qualitative research or economic analysis. There are existing hierarchies of evidence for economic analysis, although it is unclear if the methodological basis for the ranking within these hierarchies is supported by evidence and theory ,16. ShouMethods for synthesising qualitative research evidence are still being developed by groups such as the Cochrane Collaboration  and otheIn general, the Working Party took the view that systematic reviews should only be assigned a level of evidence as high as the studies contained therein. Even the best quality systematic reviews will still only be able to answer a research question on the basis of the evidence it has collated and synthesised. Thus any overall conclusions will be affected by the internal validity of the primary research evidence included. However, consistent with the original NHMRC hierarchy of evidence, Level I of the revised hierarchy was retained as a systematic review of all relevant level II studies, recognising that meta-analysis of Level II studies can increase the precision of the findings of individual Level II studies .The effectiveness of a diagnostic test or a screening test requires either direct evidence ie the impact of the test on patient health outcomes   or, if cThe development of levels of evidence for studies of diagnostic accuracy proved to be more difficult than for the other types of research question. In studies of diagnostic accuracy the basic study design is cross-sectional, in which all participants receive both the index test and the reference standard. In order to rank the validity of each individual study's results it was found that a more specific discussion of study design was required. To aid with the interpretation and ranking of studies comprehensive explanatory notes were developed. To some extent the degree of bias introduced by a particular study design feature is dependent upon both the disease and the diagnostic test context under investigation. Well-developed critical appraisal skills of the reviewers of diagnostic test interventions are therefore essential. Methods for assessing diagnostic test accuracy by systematic review and meta-analysis have been progressing over a relatively short period of time  -37. As tall the population has the condition/disease and the aim is to determine what factors will predict an outcome for that population  [One other difficulty has been noted with use of the evidence hierarchy. The difficulty is not with the study designs or the ranking of the study designs, but rather with distinguishing between an aetiological and prognostic research question – and thus correct use of the relevant hierarchy. Both aetiology and prognosis relate to an identification of risk factors for an outcome and so the relevant study designs are quite similar. The key when determining if a research question is aetiological or prognostic is to identify the population of interest. For prognostic questions, urvival) . For exaurvival) . For exaThe revised hierarchy of evidence is intended to be used as just one component in determining the strength of the evidence; that is, determining the likelihood of bias from the study design alone. This component is seen as a broad indicator of likely bias and can be used to roughly rank individual studies within a body of evidence. However, study quality within each of the levels of evidence needs to be assessed more rigorously. The Working Party believes that there are so many factors affecting the internal validity of study results , with different factors affecting different study designs, that a proper assessment of study quality can only occur with the use of an appropriate and/or validated checklist suitable for each study design or research question ,25,37,38The impact of ethics on the hierarchy of study designs was acknowledged in the revised evidence hierarchy. Separate columns for aetiology and intervention research questions were produced in order to address trial feasibility and ethical issues. Explanatory notes appended to the hierarchy indicate that if it is possible and/or ethical to determine a causal relationship using experimental evidence, then the 'Intervention' hierarchy of evidence should be used. However, if it is only possible and/or ethical to determine a causal relationship using observational evidence , then the 'Aetiology' hierarchy of evidence should be used ,40. In tThere is guidance in the explanatory notes about how to deal with the evaluation of comparative harms and safety in the research area of interest. Assessment of comparative harms/safety should occur according to the hierarchy presented for each of the research questions, with the proviso that this assessment occurs within the context of the topic being assessed. Some harms (as well as some effectiveness outcomes) are rare and cannot feasibly be captured within randomised controlled trials ,42, in wNo single evidence-framework can address all of the safety and effectiveness issues associated with different research areas. The aim of the explanatory note was to explicitly recognise that these differences will occur and to adapt the hierarchy where necessary.Given the extensive pilot process – four years – this new evidence hierarchy is now the standard for judging "levels of evidence" for the purposes of health technology assessment and clinical practice guideline development in Australia.Although this broad ranking tool for assessing study quality is intended for use as an intermediary step within the new NHMRC system to grade the body of evidence addressing a clinical, research or policy question , it can within each evidence level with the use of appropriate and validated quality appraisal checklists. A grading of the body of evidence can then be applied, if relevant.This tool is particularly advantageous for structuring a narrative meta-synthesis of results in an evidence report or health technology assessment. Studies and study results can initially be ranked by study design (evidence level) using the revised evidence hierarchy, and then be further ranked Meeting attendance fees for this methodological work were paid to the authors by the National Health and Medical Research Council (NHMRC), a not-for-profit research organisation funded by the Australian Government Department of Health and Ageing. One of the functions of the NHMRC is to develop and disseminate health publications to health professionals and consumers in Australia. They produce health advisories, evidence-based clinical practice guidelines and methodology publications.TM instigated the revision of the original NHMRC evidence hierarchy, co-developed the revised evidence hierarchy, wrote the explanatory notes and glossary, drafted the manuscript, and incorporated the feedback received on both the hierarchy and the manuscript. AW conducted the review of international frameworks assessing non-randomised or non-interventional evidence (in conjunction with Dr Kristina Coleman and Dr Sarah Norris), co-developed the revised evidence hierarchy, and contributed to the development of the manuscript. RT co-developed the revised evidence hierarchy and contributed to the development of the manuscript. All authors read and approved the final manuscript.Searches were conducted in June 2004. Enquiries regarding the search strategies should be directed to the Evidence Translation Section, National Health and Medical Research Council, Canberra, ACT, Australia.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2288/9/34/prepubAdditional File 1NHMRC Evidence Hierarchy: designations of 'levels of evidence' according to type of research question (including explanatory notes). Revised NHMRC evidence hierarchy and explanatory notes.Click here for fileAdditional File 2Study design glossary . Description of study designs included in the revised NHMRC evidence hierarchy.Click here for file


Integrative oncology uses both conventional and complementary medicine to meet the needs of individual patients and to focus on the whole person. The core principles of integrative oncology include individualization, holism, dynamism, synergism, and collaboration, but the nature of the evidence to guide the development of integrative oncology has been given little attention.To discuss the need for evidence to support the integration of complementary therapies for integrative oncology care.To emphasize that the evidence base must be valid and respect the underlying principles of individual complementary therapies and integrative oncology practice.To suggest ways to begin developing the evidence base.Although the evidence for safety and efficacy seems paramount for supporting the integration of an individual complementary therapy into mainstream cancer care, the need for evidence to support the overall practice of integrative oncology has to be considered as well.We argue that developing an evidence base for integrative oncology requires a contextual and comprehensive research approach that assesses a range of outcomes over a suitable period of time that the patient and the patient’s family, in addition to the health care providers, deem important.A whole-systems framework to the development of the evidence base for integrative oncology can guide the development of evidence that respects the complex nature of many complementary and integrative practices and their underlying principles of care delivery. Cancer patients desire care that not only focuses on treating their disease, but also manages the course of their illness experience, optimizing health and enhancing well-being. Most cancer patients use complementary medicine alongside conventional medicine to meet these needs qi gong, among others) The field of integrative oncology has emerged as a response both to cancer patients’ advocacy for holistic care and to an increasing evidence base for the safety and effectiveness of many complementary approaches, commonly called complementary and alternative medicine  understanding of evidence needs to be revisited and expanded.Integrative oncology makes a deliberate, yet fluid, distinction between complementary therapies, which are supported by evidence and used in combination with conventional cancer care, and alternative therapies, which are unproven and used as a replacement for conventional cancer care The practice of integrative oncology therefore depends mainly on complementary therapies meeting standards of safety and, to a lesser extent, effectiveness . As a result, an understanding of what constitutes appropriate evidence is crucial to the foundation and future development of the field.cam treatments. We argue that this line of thinking misses an important point. To begin the discussion, a distinction must first be made between evidence for complementary therapies and evidence for integrative oncology practice. The first issue concerns evidence that supports the safety and effectiveness of individual complementary therapies, thus determining their suitability for integration into mainstream care. The second—and often forgotten—aspect concerns evidence that supports the synergistic integration of complementary and conventional practices in a collaborative and supportive manner within cancer care.Despite agreement on the need for evidence to support the integration of complementary therapies into conventional cancer care rcts (level 1)] to preclinical in vitro and in vivo studies and traditional medicines (level 4). Level 1 evidence is required for the use of complementary therapies with anti-neoplastic goals, but lower levels of evidence, such as nonrandomized trials or observational studies, are acceptable for less-invasive procedures and preventive or supportive goals. However, this hierarchy does not capture the multidisciplinary, synergistic approach that characterizes complementary therapies and integrative oncology alike in comparison with conventional care According to Stark, Hess, and Shaw A need arises to revisit traditional notions of evidence as they apply to complementary therapies. Traditional research methods are challenged in the attempt to evaluate complementary therapies, because these methods cannot account for the fundamental issues of individualization, synergism, and holism Further to answering whether a complementary therapy works and is safe, questions regarding the appropriateness of integration must be examined. To this end, it is critical to document the ways in which complementary therapies and conventional care are being integrated and the outcomes that are important and relevant.cam may be driven by an attempt to minimize potential side effects and to feel empowered Integration can occur at many levels: individual, clinical, institutional, regulatory, or policy “Integrating” must also be distinguished from “combining.” “Combining” is more akin to adding various therapies to a treatment plan without considering the overall picture. “Integrating” involves synergistically applying a range of treatments to address holistic treatment goals as they change over time and in accordance with patient needs and values. Currently, although the goals and philosophy underlying integrative oncology are well developed, practical knowledge is not available concerning the extent to which and the manner in which diverse therapies are being integrated or combined.Finally, integrative care seems to represent untapped opportunities (which so far remain understudied) for meeting the needs of cancer patients across the cancer trajectory.As development of an evidence base begins both for individual complementary therapies and for integrative oncology, assurance is needed that the evidence base is valid—“validity” referring to the extent that appropriate research methods were used to support a conclusion regarding the efficacy or effectiveness of a therapy.“Validity” commonly includes internal validity and external validity. Model validity is separate from both of those, but is just as important. Model validity is often overlooked because of the biomedical focus of most health care research. It refers to the extent to which the research methods used have addressed the unique theory and therapeutic context of the intervention being assessed qi  in an approach using Traditional Chinese Medicine.Traditional clinical research methods have been developed to assess biomedical interventions, and thus model validity can typically be assumed. For research results to be valid in the case of integrative oncology, the research methods used must address the underlying principles of integrative oncology, such as its individualized, synergistic, holistic, and collaborative nature. The same is true for research regarding individual complementary therapies that are often based on assumptions contrary to biomedicine, such as the network of channels and blood vessels connected by rct is often upheld as the “gold standard” in clinical research, because of its strong internal validity arising from the ability to control for expected and unexpected bias, confounding factors, and error. However, it is impossible to achieve model validity while applying the blinded rct design to the practice of integrative oncology and many complementary therapies The double-blind rct design to the study of select complementary therapies. Examples include difficulties in determining appropriate placebos or sham treatments, the impossibility of double-blinding when the practitioner is part of the intervention, and problems respecting the individualized approach of many complementary practices. Acupuncture provides a good example, because the choice of an appropriate sham treatment for acupuncture has been an ongoing challenge rct is problematic if model validity is to be upheld.Sagar rct is not designed to measure the effect that each patient’s unique physical, social, and cultural context and corresponding reasons for integration may have on treatment outcomes. Further, the rct cannot assess the synergism that results from the integration of various therapies, coupled with the healing context and the clinical skills and expertise of the integrative team.The same argument can easily be extended to integrative oncology practice, in which therapies from diverse philosophical backgrounds are combined, thus making model validity even more difficult to attain. In addition to the problems of defining a placebo, blinding, and standardization, the Developing an evidence base for integrative oncology requires a contextual and comprehensive research approach that assesses a range of outcomes over a suitable period of time that the patient, the patient’s family, and health care providers deem important. We next highlight some approaches that begin to meet the requirements of internal, external, and model validity. Readers should consult the papers referenced in this section for detailed descriptions of these approaches.rct in its classical form cannot meet the requirements for model validity when applied to complementary therapies or integrative oncology, some variations have been suggested that address many of the shortcomings. For example, pragmatic rcts do not require standardization of the intervention and thus allow for the individualized nature of the treatments to be assessed. Preference rcts account for the effect that beliefs and preferences of patients for certain treatment types will have on treatment outcomes. In a preference rct, patients with treatment preferences receive their preferred treatment; patients who do not have a preference are randomized as usual.Although the Although quantitative research approaches have been well established in evaluating treatment interventions, the importance of qualitative research cannot be overlooked or dismissed as development begins of the evidence base for complementary therapies and integrative oncology. Qualitative research has amazing potential to explore, in depth, from a variety of perspectives , how integrative cancer treatment and care are experienced. Including qualitative inquiry in the evaluation of interventions should be an integral part of evidence-based medicine Qualitative research aims to understand the nature of phenomena; it will prove crucial as exploration of the potential of integrative oncology for cancer care moves forward. For example, qualitative research is ideally suited to answer the question of what integrative oncology is, how it is being practiced, how it can best be practiced, and the benefits that are possible. Such exploratory work can help to elucidate the key components in integrative care and their synergistic relationships from the viewpoint of patients and of practitioners.rct method that addresses the requirements of internal, external, and model validity. This approach can help to elicit whether, why, and how patients benefit from a complex intervention and can explore relevant outcomes from a variety of perspectives.Because qualitative research can fill an important niche in this field, it should, when possible, be nested within clinical trials or other quantitative designs Whichever research methods are ultimately adopted to study complementary therapies and integrative oncology, investigators must systematically capture the complexity inherent in these approaches to healing. A “whole-systems” research framework is helpful to conceptualize the important issues that need attention and to design step-wise programs of research that will answer the multifaceted questions.The notion of whole-systems research has recently been given attention in the literature, both with regard to complementary therapies rcts, variations of rcts, observational trials, and qualitative research, ideally mixing methods as appropriate, depending on the specific focus. A program of whole-systems research would thus produce research that collectively has strong validity.The relevance of a whole-systems framework to the development of the evidence base for integrative oncology should be apparent. It can guide the development of evidence that respects the complex nature of many complementary and integrative practices and their underlying principles of care delivery cam as a way to complement their cancer care, it is crucial that health care professionals become informed about the evidence base behind this group of practices As cancer patients increasingly turn to