The purpose of this report is to provide a succinct but comprehensive summary of the scientific evidence regarding the effectiveness of manual treatment for the management of a variety of musculoskeletal and non-musculoskeletal conditions.The conclusions are based on the results of systematic reviews of randomized clinical trials (RCTs), widely accepted and primarily UK and United States evidence-based clinical guidelines, plus the results of all RCTs not yet included in the first three categories. The strength/quality of the evidence regarding effectiveness was based on an adapted version of the grading system developed by the US Preventive Services Task Force and a study risk of bias assessment tool for the recent RCTs.By September 2009, 26 categories of conditions were located containing RCT evidence for the use of manual therapy: 13 musculoskeletal conditions, four types of chronic headache and nine non-musculoskeletal conditions. We identified 49 recent relevant systematic reviews and 16 evidence-based clinical guidelines plus an additional 46 RCTs not yet included in systematic reviews and guidelines.Additionally, brief references are made to other effective non-pharmacological, non-invasive physical treatments.Spinal manipulation/mobilization is effective in adults for: acute, subacute, and chronic low back pain; migraine and cervicogenic headache; cervicogenic dizziness; manipulation/mobilization is effective for several extremity joint conditions; and thoracic manipulation/mobilization is effective for acute/subacute neck pain. The evidence is inconclusive for cervical manipulation/mobilization alone for neck pain of any duration, and for manipulation/mobilization for mid back pain, sciatica, tension-type headache, coccydynia, temporomandibular joint disorders, fibromyalgia, premenstrual syndrome, and pneumonia in older adults. Spinal manipulation is not effective for asthma and dysmenorrhea when compared to sham manipulation, or for Stage 1 hypertension when added to an antihypertensive diet. In children, the evidence is inconclusive regarding the effectiveness for otitis media and enuresis, and it is not effective for infantile colic and asthma when compared to sham manipulation.Massage is effective in adults for chronic low back pain and chronic neck pain. The evidence is inconclusive for knee osteoarthritis, fibromyalgia, myofascial pain syndrome, migraine headache, and premenstrual syndrome. In children, the evidence is inconclusive for asthma and infantile colic. The impetus for this report stems from the media debate in the United Kingdom (UK) surrounding the scope of chiropractic care and claims regarding its effectiveness particularly for non-musculoskeletal conditions.The domain of evidence synthesis is always embedded within the structure of societal values . What coEBH is about doing the right things for the right people at the right time . It doesWhile some may argue that EBH is more science than art , the skiIt has become generally accepted that providing evidence-based healthcare will result in better patient outcomes than non-evidence-based healthcare . The debThe question is no longer "should" we embrace EBH but "how"? With EBH comes the need for new skills including: efficient literature search strategies and the application of formal rules of evidence in evaluating the clinical literature . It is ireally be in the best interests of the patient. In some cases this will require the abandonment of treatment and diagnostic approaches once believed to be helpful. In other cases it will require the acceptance and training in new methods. The ever-evolving scientific knowledge base demands that clinicians be accepting of the possibility that what is "right" today might not be "right" tomorrow. EBH requires that clinicians' actions are influenced by the evidence [Perhaps most critical is the clinician's willingness to change the way they practice when high quality scientific evidence becomes available. It requires flexibility born of intellectual honesty that recognizes one's current clinical practices may not evidence . ImportaThe purpose of this report is to provide a brief and succinct summary of the scientific evidence regarding the effectiveness of manual treatment as a therapeutic option for the management of a variety of musculoskeletal and non-musculoskeletal conditions based on the volume and quality of the evidence. Guidance in translating this evidence to application within clinical practice settings is presented.http://www.ahrq.gov/clinic/uspstf/grades.htm). The evidence grading system used for this report is a slight modification of the system used in the 2007 Joint Clinical Practice Guideline on low back pain from the American College of Physicians and the American Pain Society [For the purpose of this report, manual treatment includes spinal and extremity joint manipulation or mobilization, massage and various soft tissue techniques. Manipulation/mobilization under anaesthesia was not included in the report due to the procedure's invasive nature. The conclusions of the report are based on the results of the most recent and most updated (spans the last five to ten years) systematic reviews of RCTs, widely accepted evidence-based clinical guidelines and/or technology assessment reports (primarily from the UK and US if available), and all RCTs not yet included in the first three categories. While critical appraisal of the included reviews and guidelines would be ideal, it is beyond the scope of the present report. The presence of discordance between the conclusions of systematic reviews is explored and described. The conclusions regarding effectiveness are based on comparisons with placebo controls (efficacy) or commonly used treatments which may or may not have been shown to be effective (relative effectiveness), as well as comparison to no treatment. The strength/quality of the evidence relating to the efficacy/effectiveness of manual treatment is graded according to an adapted version of the latest grading system developed by the US Preventive Services Task Force (see  Society .Through a search strategy using the databases MEDLINE (PubMed), Ovid, Mantis, Index to Chiropractic Literature, CINAHL, the specialized databases Cochrane Airways Group trial registry, Cochrane Complementary Medicine Field, and Cochrane Rehabilitation Field, systematic reviews and RCTs as well as evidence-based clinical guidelines were identified. Search restrictions were human subjects, English language, peer-reviewed and indexed journals, and publications before October 2009. In addition, we screened and hand searched reference citations located in the reviewed publications. The description of the search strategy is provided in Additional file Although findings from studies using a nonrandomized design  can yield important preliminary evidence, the primary purpose of this report is to summarize the results of studies designed to address efficacy, relative efficacy or relative effectiveness and therefore the evidence base was restricted to RCTs. Pilot RCTs not designed or powered to assess effectiveness, and RCTs designed to test the immediate effect of individual treatment sessions were not part of the evidence base in this report.http://www.cochrane.org/resources/handbook/ discourages that scoring be applied to the risk of bias tool, it does provide suggestion for how trials can be summarized. We have been guided by that suggestion and the adapted evidence grading system used in this report requires that we assess the validity and impact of the latest trial evidence. These additional trials are categorized as higher, moderate, or lower-quality as determined by their attributed risk of bias. For details, see Additional file The quality of RCTs, which have not been formally quality-assessed within the context of systematic reviews or evidence based guidelines, was assessed by two reviewers with a scale assessing the risk of bias recommended for use in Cochrane systematic reviews of RCTs. Although the Cochrane Collaboration handbook high quality evidence, moderate quality evidence, and inconclusive  evidence. The operational definitions of these three categories follow below:The overall evidence grading system allows the strength of the evidence to be categorized into one of three categories: The available evidence usually includes consistent results from well-designed, well conducted studies in representative populations which assess the effects on health outcomes.low risk of bias) randomized trials. This conclusion is therefore unlikely to be strongly affected by the results of future studies.The evidence is based on at least two consistent higher-quality  with sufficient statistical power, two or more higher-quality (low risk of bias) randomized trials with some inconsistency; at least two consistent, lower-quality randomized trials (moderate risk of bias). As more information becomes available, the magnitude or direction of the observed effect could change, and this change may be large enough to alter the conclusion.The evidence is based on at least one higher-quality randomized trial .• Important flaws in study design or methods .Additionally, brief evidence statements are made regarding other non-pharmacological, non-invasive physical treatments (for example exercise) and patient educational interventions, shown to be effective and which can be incorporated into evidence-based therapeutic management or co-management strategies in chiropractic practices. These statements are based on conclusions of the most recent and most updated (within last five to ten years) systematic reviews of randomized clinical trials and widely accepted evidence-based clinical guidelines (primarily from the UK and US if available) identified through our search strategy.Translating evidence requires the communication of salient take-home messages in context of the user's applications . There aIn summary, the information derived within this report are directed to two applications 1) the determination of supportable public claims of treatment effectiveness for chiropractic care within the context of social values; and 2) the use of evidence information as a basis for individualized health care recommendations using the hierarchy of evidence  compared to sham OMT following hip arthroplasty. No other significant differences were found between the two groups . This st◦ Moderate quality evidence that hip manipulation is superior to exercise for the treatment of the symptoms of hip osteoarthritis .◦ Inconclusive evidence in a non-favorable direction regarding osteopathic manipulative therapy for rehabilitation following total hip arthroplasty .Exercise therapy, advice about weight loss, and appropriate footwear ,112,114Knee pain is defined as soreness, tension, and/or stiffness in the anatomical region of the knee and can be secondary to multiple conditions including knee osteoarthritis or patellofemoral pain syndrome.Diagnosis of knee pain is derived from the patient's history and physical exam with an unremarkable neurological exam and no indicators of potentially serious pathology. Imaging studies are confirmatory for diagnoses of moderate or severe osteoarthritis ,112.As of September 2009, one systematic review evaluating the benefit of manual therapy for knee pain has been identified . Ten RCTThe NICE national clinical guidelines for care and management of adults with osteoarthritis  recommenPollard et al  assessedPerlman et al  found maLicciardone et al  assessed◦ Moderate quality evidence that manual therapy of the knee and/or full kinetic chain (SI to foot) combined with multimodal or exercise therapy is effective for the symptoms of knee osteoarthritis .◦ Moderate quality evidence that manual therapy of the knee and/or full kinetic chain (SI to foot) combined with multimodal or exercise therapy is effective for patellofemoral pain syndrome .◦ Inconclusive evidence in a favorable direction that massage therapy is effective for the symptoms of knee osteoarthritis .◦ Inconclusive evidence in a non-favorable direction for the effectiveness of osteopathic manipulative therapy for rehabilitation following total hip or knee arthroplasty .Exercise therapy, advice about weight loss, appropriate footwear, pulsed electromagnetic field therapy, acupuncture, and TENS ,127-131A variety of conditions are included under ankle and foot conditions including ankle sprains, plantar fasciitis, morton's neuroma, hallux limitus/rigidus, and hallux abducto valgus.The diagnosis of ankle/foot conditions relies mainly on the patient's history and physical examination. Imaging studies are indicated for morton's neuroma or in the presence of potential pathology .As of September 2009, two systematic reviews evaluating the benefit of manual therapy for ankle and foot conditions have been published ,132. TheThe review by Brantingham et al concluded there is fair evidence for manipulative therapy of the ankle and/or foot combined with multimodal or exercise therapy for ankle inversion sprain . The samThe review by van der Wees et al concluded it is likely that manual mobilization has an initial effect on dorsiflexion range of motion after ankle sprains .None making recommendations based on RCTs were locatedWynne et al found an osteopathic manipulative therapy group had greater improvement in plantar fasciitis symptoms versus placebo control. This study had a high risk of bias .Cleland et al compared manual therapy with exercise to electrotherapy with exercise for patients with plantar heel pain . They foLin et al found the addition of manual therapy (mobilization) to a standard physiotherapy program provided no additional benefit compared to the standard physiotherapy program alone for rehabilitation following ankle fracture . This st◦ Moderate quality evidence that mobilization is of no additional benefit to exercise in the rehabilitation following ankle fractures .◦ Moderate quality evidence that manual therapy of the foot and/or full kinetic chain (SI to foot) combined with exercise therapy is effective for plantar fasciitis .◦ Inconclusive evidence in a favorable direction for the effectiveness of manual therapy with multimodal or exercise therapy for ankle sprains .◦ Inconclusive evidence in a favorable direction regarding the effectiveness of manual therapy for morton's neuroma, hallux limitus, and hallux abducto valgus .Stretching and foot orthoses for plantar fasciitis , ankle sTemporomandibular disorders consist of a group of pathologies affecting the masticatory muscles, temporomandibular joint, and related structures .Diagnosis of temporomandibular disorders is derived from the patient's history and physical exam with no indicators of potentially serious pathology ,152.As of September 2009, two systematic reviews evaluating the benefit of manual therapy for temporomandibular dysfunction have been published ,154. ThrNone locatedMonaco et al  examinedIsmail et al  found ph◦ Inconclusive evidence in a favorable direction regarding mobilization and massage for temporomandibular dysfunction .NoneFibromyalgia syndrome (FMS) is a common rheumatological condition characterized by chronic widespread pain and reduced pain threshold, with hyperalgesia and allodynia .Diagnosis of fibromyalgia is made primarily from the patient's history and physical exam. The American College of Rheumatology have produced classification criteria for fibromyalgia including widespread pain involving both sides of the body, above and below the waist for at least three months and the presence of 11 out of 18 possible pre-specified tender points .Since 2004, three systematic reviews evaluating the benefit of manual therapy for fibromyalgia have been published -164. SixSchneider et al  concludeErnst  states tGoldenberg et al  concludeThe 2007 a multidisciplinary task force with members from 11 European countries published evidence based recommendation for FMS . The tasEkici et al  found im◦ Inconclusive evidence in a favorable direction regarding the effectiveness of massage and manual lymph drainage for the treatment of fibromyalgia ,172.◦ Inconclusive evidence in an unclear direction regarding the effectiveness of spinal manipulation for the treatment of fibromyalgia .Heated pool treatment with or without exercise, supervised aerobic exercise ,173Myofascial pain syndrome is a poorly defined condition that requires the presence of myofascial trigger points.Diagnosis of myofascial pain syndrome is made exclusively from the patient's history and physical exam.As of September 2009, one systematic review evaluating the benefit of manual therapy for myofascial pain syndrome was identified, which concludes there is limited evidence to support the use of some manual therapies for providing long-term relief of pain at myofascial trigger points . FifteenNoneNone◦ Inconclusive evidence in a favorable direction regarding the effectiveness of massage for the treatment of myofascial pain syndrome .Laser, acupuncture Migraine headache is defined as recurrent/episodic moderate or severe headaches which are usually unilateral, pulsating, aggravated by routine physical activity, and are associated with either nausea, vomiting, photophobia, or phonophobia ,190.Diagnosis of migraine headaches is made primarily from the patient's history and a negative neurological exam. Neuroimaging is only indicated in patients with a positive neurological exam or presence of a "red flag" .Since 2004, two systematic reviews evaluated the benefit of manual therapy for migraine headache ,192. TheThe SIGN guidelines  for the Lawler and Cameron  found th◦ Moderate quality evidence that spinal manipulation has an effectiveness similar to a first-line prophylactic prescription medication (amitriptyline) for the prophylactic treatment of migraine .◦ Inconclusive evidence in a favorable direction comparing spinal manipulation to sham interferential .◦ Inconclusive evidence in a favorable direction regarding the use of massage therapy alone .Trigger avoidance, stress management, acupuncture, biofeedback ,197,198Tension-type headache is defined as a headache that is pressing/tightening in quality, mild/moderate in intensity, bilateral in location, and does not worsen with routine physical activity ,190.Diagnosis of tension-type headaches is made primarily from the patient's history and a negative neurological exam . NeuroimSince 2002, five systematic reviews evaluated the benefit of manual therapy for tension-type headache ,199-201.The SIGN guideline  for the Anderson and Seniscal  found th◦ Moderate quality evidence that spinal manipulation in addition to massage is no more effective than massage alone for the treatment of episodic tension-type headache ,203.◦ Inconclusive evidence in an unclear direction regarding the use of spinal manipulation alone or in combination with therapies other than massage for most forms of tension-type headache ,199-202.Acupuncture, biofeedback ,214Cervicogenic headache is defined as unilateral or bilateral pain localized to the neck and occipital region which may project to regions on the head and/or face. Head pain is precipitated by neck movement, sustained awkward head positioning, or external pressure over the upper cervical or occipital region on the symptomatic side ,190,215.Diagnosis of cervicogenic headaches is made primarily from the patient's history and a negative neurological exam. Neuroimaging is only indicated in patients with a positive neurological exam or presence of a "red flag" .Since 2002, four systematic reviews have been published on manual therapy for cervicogenic headache ,192,216.The SIGN guidelines  for the Hall et al  evaluate◦ Moderate quality evidence that spinal manipulation is more effective than placebo manipulation, friction massage, and no treatment .◦ Moderate quality evidence that spinal manipulation is similar in effectiveness to exercise .◦ Moderate quality evidence that self-mobilizing natural apophyseal glides are more effective than placebo .◦ Inclusive evidence that deep friction massage with trigger point therapy is inferior to spinal manipulation .◦ Inconclusive evidence in an unclear direction for the use of mobilization .Neck exercises Headaches not classified as tension-type, migraine, or cervicogenic in nature according to the International Headache Society's 2004 diagnostic criteria .One systematic review (2004) evaluated the benefit of manual therapy for other types of chronic headache . One RCTNoneNone◦ Inconclusive evidence in a favorable direction regarding mobilization for post-traumatic headache .NoneAsthma is a common, complex chronic disorder of the airways that is characterized by variable and recurring symptoms, airflow obstruction, bronchial hyperresponsiveness, and an underlying inflammation .The diagnosis is made through the combination of the patient's history, upper respiratory physical exam, and pulmonary function testing (spirometry). Patient administered peak flow measurement is often used to monitor effects of treatment ,226.Since 2002, four systematic reviews, one a Cochrane review, on manual therapy for asthma have been published -230. Of The asthma guidelines by The US National Heart, Lung, and Blood Institutes  and by TNone◦ There is moderate quality evidence that spinal manipulation is not effective (similar to sham manipulation) for the treatment of asthma in children and adults on lung function and symptom severity ,228.◦ There is inconclusive evidence in a non-favorable direction regarding the effectiveness of foot manual reflexology for change in asthma symptoms and lung function in adults .◦ There is inconclusive evidence in a favorable direction regarding the effectiveness of osteopathic manipulative treatment for change in asthma symptoms and lung function in children .◦ There is inconclusive evidence in an unclear direction regarding the effectiveness of massage for change in asthma symptoms and lung function in children .Education and advice on self-management, maintaining normal activity levels, control of environmental factors and smoking cessation ,226Pneumonia is defined as an acute inflammation of the lungs caused by infection ,237.Diagnosis of pneumonia relies primarily on chest radiography in conjunction with the patient's history, examination, and laboratory findings ,237.Since 2007, one systematic review evaluating the benefit of manual therapy for pneumonia has been published . One RCTNone addressing the use of manual therapyNone◦ There is inconclusive evidence in a favorable direction regarding the effectiveness of osteopathic manual treatment for the treatment of acute pneumonia in elderly hospitalized patients .Cases of pneumonia that are of public health concern should be reported immediately to the local health department. Respiratory hygiene measures, including the use of hand hygiene and masks or tissues for patients with cough, should be used in outpatient settings as a means to reduce the spread of respiratory infections ,237.Vertigo is defined as a false sensation of movement of the self or the environment. Vertigo is a sensation and not necessarily a diagnosis as there are multiple underlying pathologies responsible for vertigo ,240.Diagnosis of vertigo relies primarily on the patient's history and clinical examination. Potential causes of vertigo include both pathological disorders such as vertebrobasilar insufficiency or central nervous system lesions as well as more benign causes such as cervicogenic vertigo or benign paroxysmal positional vertigo .Since 2004, two systematic reviews evaluating the benefit of manual therapy for vertigo have been published ,240. OneNone addressing the use of manual therapyReid et al  compared◦ Moderate quality evidence that manual treatment  is an effective treatment for cervicogenic dizziness, at least in the short term .Particle repositioning maneuvers for benign paroxysmal positional vertigo, vestibular rehabilitation ,243Colic is a poorly defined condition characterized by excessive, uncontrollable crying in infants.The diagnosis of colic is based solely on the patient's history and the absence of other explanations for the excessive crying. The "rule of threes" is the most common criteria used in making a diagnosis of colic. The rule of three's is defined as an otherwise healthy and well fed infant with paroxysms of crying and fussing lasting for a total of three hours a day and occurring more than three days a week for at least three weeks ,245.Since 2003, six systematic reviews evaluating the benefit of manual therapy for infantile colic have been published ,245-249.No clinical guidelines locatedHayden et al  found crHuhtala et al  found noArikan et al  found al◦ Moderate quality evidence that spinal manipulation is no more effective than sham spinal manipulation for the treatment of infantile colic .◦ Inconclusive evidence in a favorable direction regarding the effectiveness of cranial osteopathic manual treatment and massage for the treatment of infantile colic ,257.Reduce stimulation, herbal tea, and trial of hypoallergenic formula milk ,259Nocturnal enuresis is defined as the involuntary loss of urine at night, in the absence of organic disease, at an age when a child could reasonably be expected to be dry  .The diagnosis of nocturnal enuresis is derived mainly from the patient's history given the absence of other organic causes including congenital or acquired defects of the central nervous system. Psychological factors can be contributory in some children requiring proper assessment and treatment .Since 2005, two systematic reviews, one a Cochrane review, evaluating the benefit of manual therapy for nocturnal enuresis were published ,262. TheNone addressing manual therapy as a treatment optionNone◦ Inconclusive evidence in a favorable direction regarding the effectiveness of chiropractic care for the treatment of enuresis ,262.Education, simple behavioral interventions, and alarm treatment Otitis media is characterized by middle ear inflammation which can exist in an acute or chronic state and can occur with or without symptoms .Diagnosis of otitis media relies on otoscopic signs and symptoms consistent with a purulent middle ear effusion in association with systemic signs of illness .Hawk et al  found prThe American Academy of Pediatrics 2004 guidelines on the diagnosis and management of acute otitis media  concludeWahl et al investigated the efficacy of osteopathic manipulative treatment with and without Echinacea compared to sham and placebo for the treatment of otitis media . The stu◦ Inconclusive evidence in an unclear direction regarding the effectiveness of osteopathic manipulative therapy for otitis media ,269.Patient education and "watch and wait" approach for 72 hours for acute otitis media ,268Hypertension is defined as the sustained elevation of systolic blood pressure over 140 mmHg, diastolic blood pressure over 90 mm Hg, or both ,271.Diagnosis of hypertension is made by the physical exam, specifically sphygmomanometry. The patient's history, clinical exam and laboratory tests help identify potential etiologies ,271.Since 2007, one systematic review evaluating the benefit of manual therapy for hypertension has been published  . Two RCTNone addressing the use of manual therapyA study by Bakris et al  found NU◦ Moderate quality evidence that diversified spinal manipulation is not effective when added to a diet in the treatment of stage I hypertension .◦ Inconclusive evidence in a favorable direction regarding upper cervical NUCCA manipulation for stage I hypertension .◦ Inconclusive evidence in an unclear direction regarding instrument assisted spinal manipulation for hypertension .Advice on lifestyle interventions including diet, exercise, moderate alcohol consumption and smoking cessation ,271Relaxation therapies including biofeedback, meditation, or muscle relaxation Dysmenorrhea is defined as painful menstrual cramps of uterine origin. Dysmenorrhea is grouped into two categories, primary and secondary dysmenorrhea. Secondary dysmenorrhea is painful menstruation associated with a pelvic pathology like endometriosis, while primary dysmenorrhea is painful menstruation in the absence of pelvic disease .Diagnosis of primary dysmenorrhea is made from the patient's history. Diagnosis of secondary dysmenorrhea requires further investigation including a pelvic exam and potential ultrasound or laparoscopy .We identified two systematic reviews evaluating the benefit of manual therapy for dysmenorrhea ,276. FivWe identified consensus guidelines from the Society of Obstetricians and Gynecologists of Canada (SOGC) published in 2005 which included an assessment of manual treatment for primary dysmenorrhea. The authors concluded there is no evidence to support spinal manipulation as an effective treatment for primary dysmenorrhea .None◦ Moderate quality evidence that spinal manipulation is no more effective than sham manipulation in the treatment of primary dysmenorrhea ,281.High frequency TENS Premenstrual syndrome is defined as distressing physical, behavioral, and psychological symptoms, in the absence of organic or underlying psychiatric disease, which regularly recurs during the luteal phase of the menstrual cycle and disappears or significantly regresses by the end of menstruation and is associated with impairment in daily functioning and/or relationships ,283.Diagnosis of premenstrual syndrome is made through patient history and the use of a patient diary over two menstrual cycles ,283.Since 2007, three systematic reviews evaluating the benefit of manual therapy for premenstrual syndrome have been published ,284,285.None discussing manual therapyNone◦ Inconclusive evidence in a favorable direction regarding the effectiveness of reflexology and massage therapy for the treatment of premenstrual syndrome .◦ Inconclusive evidence in an unclear direction regarding the effectiveness of spinal manipulation for the treatment of premenstrual syndrome .Cognitive behavioral therapy There are two important questions underlying the medical and media debate surrounding the scope of chiropractic care and claims regarding its effectiveness particularly for non-musculoskeletal conditions: 1) should health professionals be permitted to use generally safe but as yet unproven methods? 2) What claims, if any, can and should be made with respect to the potential value of unproven treatments?really be in the best interests of the patient and as better evidence emerges, clinicians are obligated to change. Further, where evidence is absent, they are open to promoting the development of new knowledge that expands understanding of appropriate health care delivery.In response to the first question, a reasonable answer is "yes" given that professionals operate within the context of EBH, where it is acknowledged what is known today, might change tomorrow. It requires flexibility born of intellectual honesty that recognizes one's current clinical practices may not In response to the second question, no claims of efficacy/effectiveness should be made for which there isn't sufficient evidence. Unsubstantiated claims can be dangerous to patient health . We mainWhy is it that the results of RCTs often do not confirm the results observed in clinical practice? There are several reasons. One of the problems is that both the provider and the patient are likely to interpret any improvement as being solely a result of the intervention being provided. However this is seldom the case. First, the natural history of the disorder (for example. acute LBP) is expected to partially or completely resolve by itself regardless of treatment. Second, the phenomenon of regression to the mean often accounts for some of the observed improvement in the condition. Regression to the mean is a statistical phenomenon associated with the fact that patients often present to the clinic or in clinical trials at a time where they have relatively high scores on severity outcome measures. If measured repeatedly before the commencement of treatment the severity scores usually regress towards lower more normal average values .Additionally, there is substantial evidence to show that the ritual of the patient practitioner interaction has a therapeutic effect in itself separate from any specific effects of the treatment applied. This phenomenon is termed contextual effects ,291. TheIn a placebo-controlled RCT the question is: does the treatment provided have a specific effect over and above the contextual or non-specific effects. The result of such a trial may show that there is no important difference between the active intervention and the sham intervention. However, the patients may exhibit clinically important changes from baseline in both groups and thus the outcome would be consistent with what clinicians observe in their practice. An example of this is the results of the pragmatic placebo controlled RCT on chiropractic co-management of chronic asthma in adults , which showed that patients improved equally during both the active and the sham intervention phases of the trial .It is essential to recognize what each piece of the EBH puzzle offers. Patient values and preferences do not provide sound evidence of a treatment's effectiveness and may be misleading. A patient can be satisfied with a treatment, but it still may not be effective. The clinician's observations, if well documented, can attest to patient improvement while under care and encourage perception of a treatment's clinical plausibility. However, the narrow focus of attention under non-systematic observations common to practice experience tends to obscure other factors influencing case outcome. Similarly, EBH can be flawed, not because it fails to be scientific, but because-like all sciences-it imports the biases of researchers and clinicians . Well-peclinically plausible. That is, clinical observations demonstrate that it is possible that an intervention is effective. However, a gain in plausibility, biological or clinical, does NOT constitute proof of a treatment's efficacy in human populations. Conversely lack of proof  does not exclude plausibility [Other authors' work has been used to argue that a range of study types should be included when evaluating a treatment's efficacy/effectiveness  ,300. We sibility ,302.th Century, there was an underlying presumption that the long-term practice of these methods provided a sound clinical wisdom on which to ground RCTs, bypassing mechanistic studies. The early emphasis on clinical trials has illuminated the gaps in understanding of appropriate indications for treatment, dosage and duration of care, consistency of treatment application, and the appropriate outcome measures to monitor results [Research on systematic reviews have taught us that individual studies can often lead to a conclusion very different from that of a systematic analysis of all available studies . Moreove results . In resp results . Data frChoosing an intervention should always be tempered by the risk of adverse events or harm. Adverse events associated with manual treatment can be classified into two categories: 1) benign, minor or non-serious and 2) serious. Generally those that are benign are transient, mild to moderate in intensity, have little effect on activities, and are short lasting. Most commonly, these involve pain or discomfort to the musculoskeletal system. Less commonly, nausea, dizziness or tiredness are reported. Serious adverse events are disabling, require hospitalization and may be life-threatening. The most documented and discussed serious adverse event associated with spinal manipulation  is vertebrobasilar artery (VBA) stroke ,305. LesEstimates of serious adverse events as a result of spinal manipulation have been uncertain and varied. Much of the available evidence has been relatively poor due to challenges in establishing accurate risk estimates for rare events. Such estimates are best derived from sound population based studies, preferably those that are prospective in nature ,306.Estimates of VBA stroke subsequent to cervical spine manipulation range from one event in 200,000 treatments to one in several million ,308. In Appropriately, the risk-benefit of cervical spine manipulation has been debated ,305. As Estimates of cervical or lumbar disc herniation are also uncertain, and are based on case studies and case series. It has been estimated that the risk of a serious adverse event, including lumbar disc herniation is approximately 1 per million patient visits . Cauda eThe true incidence of serious adverse events in children as a result of spinal manipulation remains unknown. A systematic review published in 2007 identified 14 cases of direct adverse events involving neurologic or musculoskeletal events, nine of which were considered serious  . AnotherImportantly, the authors postulate that a possible reason for incorrect diagnosis  is due to lack of sufficient pediatric training. They cite their own survey  which foThe conclusions in this report regarding the strength of evidence of presence or absence of effectiveness are predicated on the rules chosen for which there are no absolute standards. Different evidence grading systems and rules regarding impact of study quality may lead to different conclusions. However, we have applied a synthesis methodology consistent with the latest recommendations from authoritative organizations involved in setting standards for evidence synthesis. Although we used a comprehensive literature search strategy we may not have identified all relevant RCTs, guidelines, and technology reports. Conditions for which this report concludes the evidence currently shows manual treatment to be effective or even ineffective, sometimes rests on a single RCT with adequate statistical power and low risk of bias. Additional high quality RCTs on the same topics have a substantial likelihood of changing the conclusions. Including only English language reviews and trials may be considered another limitation of this report leading to language bias; however, the impact of excluding non-English trials from meta-analyses and systematic reviews is conflicting ,320, andSpinal manipulation/mobilization is effective in adults for acute, subacute, and chronic low back pain; for migraine and cervicogenic headache; cervicogenic dizziness; and a number of upper and lower extremity joint conditions. Thoracic spinal manipulation/mobilization is effective for acute/subacute neck pain, and, when combined with exercise, cervical spinal/manipulation is effective for acute whiplash-associated disorders and for chronic neck pain. The evidence is inconclusive for cervical manipulation/mobilization alone for neck pain of any duration, and for any type of manipulation/mobilization for mid back pain, sciatica, tension-type headache, coccydynia, temporomandibular joint disorders, fibromyalgia, premenstrual syndrome, and pneumonia in older adults. Spinal manipulation is not effective for asthma and dysmenorrhea when compared to sham manipulation, or for Stage 1 hypertension when added to an antihypertensive diet. For children, the evidence is inconclusive regarding the effectiveness of spinal manipulation/mobilization for otitis media and enuresis, but shows it is not effective for infantile colic and for improving lung function in asthma when compared to sham manipulation.The evidence regarding massage shows that for adults it is an effective treatment option for chronic LBP and chronic neck pain. The evidence is inconclusive for knee osteoarthritis, fibromyalgia, myofascial pain syndrome, migraine headache, and premenstrual syndrome. For children, the evidence is inconclusive for asthma and infantile colic.All authors are trained as doctors of chiropractic but are now full time professional researchers.GB was responsible for the methodology used to select and summarize the evidence, for organizing and participating in the analysis of the evidence and formulating conclusions and drafting and finalizing the report.MH participated in analyzing the evidence and formulating conclusions for the majority of the musculoskeletal conditions and the different types of headache.RE participated in analyzing the evidence and formulating conclusion for part of the musculoskeletal and non-musculoskeletal conditions and providing substantial input to the background and discussion sections.BL was responsible for retrieving the research articles and providing draft summary statements for all conditions as well as participating in drafting and proof reading the manuscript.JT was responsible for conceiving and drafting the section on translation of research into action and providing substantial input to the background and discussion sections.All authors have read and approved the final manuscript.The literature search strategy.Click here for fileIncludes the criteria used for evaluating risk of bias from randomized controlled trials not included within systematic reviews, evidence based guidelines, or health technology assessments.Click here for file


Clinical practice guidelines (CPGs) are commonly used to support practitioners to improve practice. However many studies have raised concerns about guideline quality. The reasons why guidelines are not developed following the established development methods are not clear.The SEA-ORCHID project aims to increase the generation and use of locally relevant research and improve clinical practice in maternal and perinatal care in four countries in South East Asia. Baseline data highlighted that development of evidence-based CPGs according to recommended processes was very rare in the SEA-ORCHID hospitals. The project investigators suggested that there were aspects of the recommended development process that made it very difficult in the participating hospitals.We therefore aimed to explore the experience of guideline development and particularly the enablers of and barriers to developing evidence-based guidelines in the nine hospitals in South East Asia participating in the SEA-ORCHID project, so as to better understand how evidence-based guideline development could be facilitated in these settings.Semi-structured, face-to-face interviews were undertaken with senior and junior healthcare providers  from the maternal and neonatal services at each of the nine participating hospitals. Interviews were audio-recorded, transcribed and a thematic analysis undertaken.Seventy-five individual, 25 pair and eleven group interviews were conducted. Participants clearly valued evidence-based guidelines. However they also identified several major barriers to guideline development including time, lack of awareness of process, difficulties searching for evidence and arranging guideline development group meetings, issues with achieving multi-disciplinarity and consumer involvement. They also highlighted the central importance of keeping guidelines up-to-date.Healthcare providers in the SEA-ORCHID hospitals face a series of barriers to developing evidence-based guidelines. At present, in many hospitals, several of these barriers are insurmountable, and as a result, rigorous, evidence-based guidelines are not being developed. Given the acknowledged benefits of evidence-based guidelines, perhaps a new approach to supporting their development in these contexts is needed. Clinical practice guidelines (CPGs) are commonly used to support practitioners to improve practice. Guidelines are "systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances". EvidencDespite the fact that development of evidence-based guidelines is increasing ,3 and thThe reasons why guidelines are not developed following the established evidence-based guideline development methods are not clear, though the recommended process is extremely time and resource-intensive ,16-18 an) project is a five-year collaborative project between Thailand, Malaysia, the Philippines, Indonesia, and Australia. By establishing a network of researchers and teachers of evidence-based health care in nine hospitals, across four South East Asian countries, supported from Australia, SEA-ORCHID aims to increase the generation and use of locally relevant research and improve clinical practice in management of pregnancy and childbirth. SEA-ORCHID is jointly funded by the Wellcome Trust and the Australian National Health and Medical Research Council.The South East Asia Optimising Reproductive and Child Health in Developing Countries , semi-structured, face-to-face interviews were undertaken with healthcare providers  from the maternal and neonatal services at each of the nine participating hospitals.The interviews were conducted by two Australian SEA-ORCHID team members, a psychologist (JS) and a health services researcher (TT). The interviewers did not have clinical experience in the research area, but both had a background in evidence-based practice and research methods. JS had experience in supporting behavioural change from a psychological perspective and TT had experience implementing evidence-based change in a clinical setting and substantial experience in developing evidence-based guidelines. Where possible the interviews were conducted with both interviewers present, however, where made necessary by time limitations, interviews were conducted by one or other of the interviewers.Participants were healthcare providers working in the maternal and neonatal areas of the SEA-ORCHID hospitals. At each hospital we aimed to interview two junior and two senior doctors, and two junior and two senior nurses or midwives, as relevant to the hospital structure. Interviewees included all levels of clinicians, including those responsible for patient care and organisational policy setting. We had hoped to interview consumers however this was not covered by our ethics approval.We also interviewed healthcare providers who had undertaken evidence-based practice training fellowships offered at the Australian SEA-ORCHID hospitals during the course of the project and the members of the SEA-ORCHID team at each of the hospitals.Interviews were most often conducted with individuals or pairs of healthcare providers, however a small number of group interviews were conducted.SEA-ORCHID personnel were asked to identify potential participants at each of the sites. Selection was largely pragmatic, based on availability for interview. Potential participants received an explanatory statement and signed a consent form to indicate informed consent. In Malaysia and the Philippines, explanatory statement and consent forms were provided in English, and interviews were conducted in English. In Indonesia and Thailand, the explanatory statement and consent forms were translated into the local languages and interpreters were used for the interviews.Ethics approval was granted by the University of Sydney, Monash University and the relevant ethics committees in each of the South East Asian countries.Interviews were loosely based on a pre-specified interview protocol, but the detailed questions asked varied according to the level of experience and interest, and previous responses of the interviewees. The questions were designed to explore the interviewees' awareness and experience of undertaking evidence-base practice, doing research and developing guidelines or protocols. In this paper we report the results relating to development of guidelines or protocols.Interviews were audio recorded, transcribed and de-identified, and the data analysed thematically using NVivo software. Data relevant to guideline development were analysed in emerging themes based around the value, product and process of guideline development.Seventy-five individual, 25 pair and eleven group interviews were conducted in the nine SEA-ORCHID hospitals. In a small number of hospitals we were unable to interview the planned number of staff as there were insufficient staff employed and/or available. In other hospitals more interviews were conducted because of wider interest.Participants had a wide range of levels of experience with evidence-based guideline development. Very few nurses or midwives had personal experience of developing evidence-based practice guidelines. Familiarity with the process was more common among doctors, and particularly senior doctors. Several senior doctors had attempted, or were currently attempting, to write guidelines and a small number were very experienced, having produced evidence-based guidelines at a local, regional and national level. Many of those who were currently involved in evidence-based guideline development had been taught or supported to do this through the SEA-ORCHID Project. Most interviewees had some experience of developing guidelines in their units, following non-evidence-based methods.Responses were grouped into emerging themes as described below.While there was wide variation between hospitals in levels of resourcing, organisational structure, number of deliveries etc, the results of the interviews were remarkably consistent across hospitals and countries. Particular thematic differences between hospitals are noted in the text.Themes emerging from analysis:THE VALUE:The usefulness of guidelinesTHE PRODUCT:Use of evidence in guidelinesFormat of guidelinesTHE PROCESS:Time consuming and difficultLack of awareness of processScope of guidelinesAdapting existing guidelinesSearching for evidenceArranging guideline development group meetingsMulti-disciplinarityConsumer involvementAchieving consensusImportance of keeping guidelines up-to-dateMost interviewees believed that guidelines could be useful in staff training, outlining the process of care, keeping practice up-to-date with research and standardising practice.If you have guidelines everybody does the same thing and do the standard thing. Junior NurseSome clinicians, however, expressed doubts about whether guidelines were being used.Q: Do you think guidelines are useful?A: It is useful if you, if most of us read them.Q: Do you think they are used?A: I don't think so. Senior DoctorQ: So how often would you... look at a policy or a guideline?A: Honestly?Q: Yeah, honestly.A: Not at all. Senior NurseAlmost all interviewees believed that it was important to base guidelines on evidence.First a good guideline for me is one that is based on research and good research that has been verified and the bad ones would be those that are not based on valid research. Junior NurseIt is important because basically if it is based on the evidence previously tested in studies then we know, ... we can have proof to the patient that we have done our best. Junior DoctorMany noted, however, that the guidelines they developed, or those developed by others, were not based on research evidence.The guidelines are still, in most hospitals, especially in the local hospitals outside the centre of education, I think from the experience are based on textbooks, according to what they've got when they are residents. Senior DoctorInterviewees thought that the format of guidelines was very important. However, two very different thoughts were expressed by interviewees about the ideal format of guidelines: that they must be simple and quick to read and that they should be detailed and thorough.It should be short and easy for read. Junior DoctorI think a good guideline should be very specific, in detail, so that everybody can read it and everybody can understand it more. Senior DoctorInterviewees also suggested that a diagram or flowchart was a very useful format for a guideline.Definitely the flowchart because it is easier to understand and faster. Junior DoctorOne of the recurring barriers to development identified in the interviews was how difficult and time consuming the process of guideline development was when undertaken rigorously. Many interviewees mentioned guideline development methods that were designed to meet the AGREE  Instrument  criteriaMaking a guideline from scratch is a whole lot of work, ...according to the book it takes it's a process of years. Senior DoctorBecause the full guideline with AGREE tool, I think if I want to develop the guideline for breech presentation I have to, ... make the question for the patient and then I have to search for the literature for each question and then I have to approve into the recommendations and level of evidence or grading of recommendation and then I have to send this draft to the committee who develop the guideline and then make it a full version. So it's just really, really long way. Senior DoctorSome interviewees identified that there was a lack of awareness or acceptance of the process of developing evidence-based guidelines among their colleagues, and that this was a barrier to developing high-quality guidelines.There is a society for all the neonatologists in [our country], and they had a weekend meeting, and they wanted us to do a guideline right then and there. ... And so they have no idea what is really involved. So I think that's the barrier, that's one of the barriers here, that people don't really know what the guidelines means. Senior DoctorSome interviewees noted that the scope or breadth of the guidelines had a substantial impact on the amount of work involved in developing the guideline.So I think that why it takes a long time is because of the scope. Senior DoctorSeveral of the interviewees noted that they adapted guidelines for use in their hospitals based on those produced in other settings.So I think our guidelines are more adaptations from, more than guidelines, it's not like we start from scratch to develop them. Senior DoctorSeveral different concerns were expressed about the difficulty of adapting externally generated guidelines for use in SEA-ORCHID hospitals. These included relevance of the existing guideline to the new setting, methodological concerns about the process of adapting guidelines, and availability of guidelines to adapt.Relevance of guidelines was a central concern. Differences in patient population, in culture, economic status and availability of equipment and infrastructure were all reported to reduce the relevance of guidelines developed in other settings.Many of our protocols are quite heavily based on RPA  protocols as well, and we have some national guidelines, and all of them need some scrutiny because [the local area] is quite different from the rest of the country actually. ... Our culture is quite different and our economic status is quite different. Senior DoctorAmong those clinicians who accepted the concept of adapting existing guidelines, and had found relevant guidelines, some had concerns about the validity of methods for adapting guidelines.The process [of adapting a guideline] also I think maybe easier but we have to have a good methodology to do this. ... [Can] you put the reference to this just only one this guideline or you have to look the reference from the good guideline already and then put it into your guideline? ... – He has done already but you copy on your own, is not good, I think. Senior DoctorInterviewees also noted that following established methods for appraising the quality of guidelines before adapting them was also very time consuming.No, we have not used the AGREE tool to appraise them because I think even that takes a long time. Senior DoctorTwo barriers were identified as limiting the availability of guidelines to adapt. The first was an access issue; in some SEA-ORCHID hospitals clinicians reported that they were very limited in being able to access recent guidelines. The second issue was the lack of existing evidence-based guidelines in areas of interest.I believe that we can apply these guidelines to the situation here, but one of the problems that I encounter is it's very difficult for us to actually get the guidelines because of access problems and sometimes we get guidelines that's not updated. Junior DoctorA: What we are using now are the American guidelines. But many of the points there aren't really applicable here. So adapting a new one.Q: Are the guidelines here that you're adapting, are they evidence-based guidelines?A: That's it, they're not. Senior DoctorInterviewees noted that searching for evidence to underpin their guidelines was of fundamental importance to the development process, but also that it was very time consuming.The search for literature is very important because we have to get the most updated, the highest level of evidence. That takes time. Senior DoctorSome interviewees explained that they did not undertake a systematic review of the literature as recommended by accepted methods of guideline development, but took a more pragmatic approach.A few papers, probably RCTs or guidelines from books, from journals ... five to six references for each chapter – that's all what we do. Not an extensive literature review on that topic. Senior DoctorOther interviewees noted that they were limited in their ability to carry out searches for research evidence because of limitations on availability of computers, internet access and full text journal articles.We have internet access here, but our computer is non-functional right now. ... It's, we have only one computer for that area, ... we're using only one for about 50 people actually. Junior DoctorThe electronic resources is not very reliable. There is but sometimes it's running very slow ... and people don't want to sit there very long in front of the computer on the internet so that is also one of the challenges we have to face so not only the skills but also the resources itself is not very adequate. Senior DoctorThough not often linked directly to guideline development, participants, and particularly nurses, frequently noted that lack of skill in English and lack of skill in using computers and the internet limited their ability to search for evidenceI do this to search from website Cochrane Library but I have the problem with English, it's a little bit difficult for me to read. Junior NurseWell, the SEA-ORCHID project has already given us great facilities, like the computer for internet, for browsing. But unfortunately we have such lack of capacity in actually using the internet. Senior NurseInterviewees highlighted that there were basic hurdles with the guideline development process that could not easily be overcome. One of the most frequently mentioned was the need to arrange meetings of those involved in guideline development.So if you want to meet with the four of us, it's almost impossible to have everybody free at one time. We can make a minimum of three, but ... it's so difficult actually, sometimes they have something on, and then we have something on, and it gets postponed. And it dies off. Senior DoctorWe're at a standstill now, we're still in review of literature, we haven't been able to move on, it's so hard to get everyone together. Senior DoctorHaving a multidisciplinary group responsible for guideline development, as is recommended by evidence-based guideline development methods, was not usual practice at most SEA-ORCHID hospitals. Most often the guidelines were largely developed by the senior medical staff.Q: Are nurses involved in writing the protocols?A: No. Consultants. Consultants and the specialists they are the ones who go in a closed room I think. ... Then they come up with the protocol. Senior NurseEven the nurses, they are not easily involved. I mean, it's usually the doctors who develop it. It's because it's the doctors who make the orders. So it's usually those who develop it. Senior DoctorIn some hospitals this was beginning to change.I won't say that all guidelines, but most guidelines will actually involve the nurses because in the past there was only the doctors would decide. But recently the nurses contribution and this is slightly more. Senior DoctorAnd in some hospitals it was usual practice to involve nurses and midwives in some aspects of the guideline development process.Before we started the development of CPG we invite all the midwives and also nurses to have a meeting with us and then we have a brainstorming about any question about pre-term delivery in your mind. Senior DoctorNone of the interviewees had experience in involving patients or their families or carers in the development of guidelines, as is recommended by evidence-based guideline development methods.We don't usually involve the consumers.... During our stay in Australia, we had a visit with a group of consumers, and when I realise that we have to involve the consumers in developing guidelines, that unfortunately we don't easily involve them. Senior DoctorSome interviewees were very uncomfortable with the idea of involving consumers in guidelines development. These interviewees were all less experienced with the guideline development process.I don't think it's very practical, and it's not very safe. Because what patients know and what patients want do not always correspond to what is the best practice at that point in time. Junior DoctorOther interviewees thought that there might be a role for consumers, but felt that there were substantial limitations on that role.Q: What do you think about consumer involvement in a hospital setting?A: Ideally that would be great.Q: But?A: But I don't think it might be applicable for all aspects of the CPGs. For example, I think it will be applicable if the topic was enema or shaving or episiotomy even, but I don't know how much influence they can have on what type of suture I have to use for caesarean section or what's the best antibiotic that I have to use or whether I have to use CPAP or mechanical ventilation. So it's more applicable for some issues and topics, but not all. Senior DoctorThe process of achieving consensus on the recommendations of the guideline was felt to be very important, especially in terms of enabling the later implementability of the guideline, but also a potential barrier to development if agreement could not be reached.A: In our case, we are stopping the guidelines because there have been some problems ...Q: So you've had to stop for a while, is it for clinical reasons? Because you were too busy or?A: No, not the clinical reason [laughs]...I think it's more on conflicting ideas. Junior DoctorOne of the clearest messages from interviewees was that guidelines should be regularly updated.One thing that can improve about babies' management, I think we should routinely upgrade the protocol. Junior DoctorRegularly updated guidelines were seen to support evidence-based practice, and to enable change in line with new evidence.I think in [our department], changing the practice is not very hard because we are always updating our protocol, if we think that it is not up-to-date any more. Senior DoctorOutdated guidelines were seen to be potentially detrimental, particularly if clinicians were diligent in following guidelines.Well it's very difficult because you know everybody here abides by the guidelines. But then some of these guidelines are not up to date. You know, we have a lot of new information, we have a lot of new practice, the correct practice, but it's not updating the guidelines. Whereas people follow the guidelines, so... Junior DoctorOne interviewee noted that what was need was a regular updating process, with dedicated clinicians to maintain the guidelines.With these guidelines is that some of them are outdated already, so they have to be updated. So there has to be a committed set of people who will – like in Cochrane, that they have updates periodically. Senior DoctorAlmost all the healthcare providers interviewed in these hospitals were positive about the potential for guidelines to improve and standardise practice – at least in theory. Interviewees were less confident that the guidelines were achieving their potential, largely as the result of two factors, barriers to the development of guidelines and barriers to the use of guidelines. These results echo those of other studies in similar settings. For example, a study of facilitators and barriers to the adoption of evidence-based perinatal care in Latin America found that guidelines were both valued and felt to be necessary but were not enough to change practice on their own (Belizan 2007).Healthcare providers in our study were also clear that guidelines should be developed on the basis of the best available research evidence, but expressed strong concerns about the feasibility of the current methods to achieve that in their setting. The substantial time investment required to find evidence and lack of access to the internet and evidence sources, were repeatedly mentioned as barriers to this process. Limitations in skill in finding and appraising evidence for use in guidelines were mentioned only in passing, however this may reflect the fact that most interviewees had not undertaken the systematic reviews of research required by the established guideline development methods, and were unaware of the skills required. Lack of awareness of the development process or lack of acceptance of an evidence-based framework to clinical practice were also noted barriers.Arranging times for the guideline development group to meet was a major barrier to guideline development. This is particularly interesting given that at most sites, these meetings were only of the senior medical staff. Involving nurses or midwives, junior staff and consumers would be likely to make arranging meetings only more difficult. Wider representation may also complicate the process of achieving consensus, which several clinicians reported was already very difficult.One of the strongest messages from the interviews was the central importance of keeping guidelines up-to-date with advances in research. While acknowledging the work involved, interviewees felt very strongly that this should be a priority.There are clearly substantial barriers to developing evidence-based guidelines in the SEA-ORCHID hospitals. The extensive time commitment required for systematic reviews, need for reliable access to research evidence and difficulties in arranging guideline development group meetings were fundamental problems that stopped interviewees from developing evidence-based guidelines. While adapting existing guidelines can be a useful approach, clinicians report that it is not always possible or appropriate. Issues like multidisciplinary representation and involvement of consumers were also reported as being difficult to address. If evidence-based guidelines are going to be developed or adapted and implemented in these resource-poor environments, perhaps a more pragmatic approach is needed. Such an approach might limit the process of searching for evidence to a small number of reliable sources of high quality evidence, require a less intensive multidisciplinary consultation process, or focus on a smaller number of priority clinical questions with the potential to more significantly impact to on clinical practice, rather than aiming to address an entire clinical area. It would be interesting to develop and test a simpler, more practical approach to guideline development and compare the results of this new approach against the established rigorous processes. Alternative strategies such as financial incentives or regulatory requirements for hospitals to have guidelines might also be beneficial in increasing the development of guidelines. Similar research in developed country settings would also provide useful information on to what extent the experience of guideline development is common across settings.This study has a number of limitations. Interviewees were selected on a largely pragmatic basis and their views may not be representative of all of their colleagues. However the healthcare providers interviewed provided a wide range of views on the issues discussed. Only a minority of the healthcare providers interviewed had in-depth experience with the evidence-based guideline development process, and those who were familiar with the process were more likely to be experienced and from a medical background, so these results may overemphasise the views of these groups of clinicians. However the fact that junior clinicians and nurses or midwives were less likely to have been involved in guideline development highlights one of the aspects of the recommended guideline development process which is not being followed at many of the SEA-ORCHID sites, a guideline development group that includes representation from all relevant professional disciplines, levels of seniority and consumers.Healthcare providers in the SEA-ORCHID hospitals face a series of barriers to developing evidence-based guidelines. At present, in many hospitals, several of these barriers seem insurmountable, and as a result, rigorous, evidence-based guidelines are not being developed. Given the acknowledged benefits of evidence-based guidelines, perhaps a new approach to supporting their development in these contexts is needed.The authors declare that they have no competing interests.TJT conceived of the project, undertook the analysis and prepared the first draft of the article. TJT and JS developed the methods, undertook the interviews and revised subsequent drafts. Both authors read and approved the final manuscript.


The concept of evidence-based medicine has strongly influenced the appraisal and application of empirical information in health care decision-making. One principal characteristic of this concept is the distinction between "evidence" in the sense of high-quality empirical information on the one hand and rather low-quality empirical information on the other hand. In the last 5 to 10 years an increasing number of articles published in international journals have made use of the term "evidence-based ethics", making a systematic analysis and explication of the term and its applicability in ethics important.In this article four descriptive and two normative characteristics of the general concept "evidence-based" are presented and explained systematically. These characteristics are to then serve as a framework for assessing the methodological and practical challenges of evidence-based ethics as a developing methodology. The superiority of evidence in contrast to other empirical information has several normative implications such as the legitimization of decisions in medicine and ethics. This implicit normativity poses ethical concerns if there is no formal consent on which sort of empirical information deserves the label "evidence" and which does not. In empirical ethics, which relies primarily on interview research and other methods from the social sciences, we still lack gold standards for assessing the quality of study designs and appraising their findings.The use of the term "evidence-based ethics" should be discouraged, unless there is enough consensus on how to differentiate between high- and low-quality information produced by empirical ethics. In the meantime, whenever empirical information plays a role, the process of ethical decision-making should make use of systematic reviews of empirical studies that involve a critical appraisal and comparative discussion of data. The concept of "evidence-based ethics", modeled after the concept of evidence-based medicine,  has incrThe concept of EB was first used in 1992 in the context of  medicine . In the To provide a more accurate picture of the challenges and peculiarities of evidence-based ethics, this article is divided into three sections. The first is a systematic presentation of central descriptive and normative dimensions inherent in a non-trivial reading of the EB concept. The second section will then discuss the ethical problem areas associated with these normative dimensions using examples from EBM. In a final step these practical problems will be mapped onto the particularities of applied ethics  in order to clarify the challenges and limits of evidence-based ethics.The critical analysis of the particularities of evidence-based ethics is important to ward off the potential misuse of the EB concept in medical ethics in a timely manner. But beyond this the results of this analysis are also significant for two further debates within modern bioethics. On the one hand, the results help to clarify more precisely how ethics conceives itself in its relation to empirical data per se . And on In Sackett's definition, EBM is described in a more general version as follows:"Evidence-based medicine is the conscientious, explicit and judicious use of current best evidence in making decisions about the medical care of individual patients. The practice of EBM means integrating individual clinical expertise with the best available external clinical evidence from systematic research."  p. 71In the context of evidence-based ethics it is not the specification of EB for medicine that interests us so much but the characterization of what evidence or EB means in general. Textbooks and other writings on EBM provide us with further specifications of the content and the scope of the EB concept . The folIn medicine and medical ethics we encounter empirical information in various forms, such as quantitative and qualitative indications of the benefit and harm of medical measures, reports of the number of organ donations, or on the level of satisfaction with clinical ethics consultation. This empirical information can be divided into the information that one has garnered in the course of one's life and professional experience  and information that others have garnered  in studies. As emphasized in the quotation from Sackett, the concept of evidence in EB stands for externally generated empirical information.External evidence alone cannot influence any decisions – it always exists in a complementary relation to context-specific framing conditions, ethical principles and other decision-theoretical elements. Furthermore, typically various pieces of empirical information play a role in decisions. In the medical context, besides the internal and external information on the benefit of a measure, the individual or group-specific preferences of the patients in particular should also be taken into consideration. Complementary elements in ethical decisions also include context-sensitive ethical principles or norms (see below).On a reasonable, non-trivial reading evidence  cannot be simply equated with empirical information per se. Not all available empirical information on a certain question counts directly as evidence according to the EB concept. Empirical information has to hold up under critical appraisal, a sort of qualifying exam, in order to be accepted into the higher class of evidence. Sackett writes:"Because the randomised trial, and especially the systematic review of several randomised trials, is so much more likely to inform us and so much less likely to mislead us, it has become the 'gold standard' for judging whether a treatment does more good than harm. [...]And if no randomised trial has been carried out for our patient's predicament, we must follow the trail to the next best external evidence and work from there."  p. 72According to this conception of EB only the available information that is sufficiently reliable (as determined by context) and demonstrates internal and external validity can be called evidence. This point is of central importance – in principle each question prompts a new decision about which information is to be considered evidence. The reliability determines how exactly a study measures a certain characteristic. There are various measures for quantifying the reliability of a test that cannot be individually discussed here . The criHence there is a gradual relationship between empirical information per se and the empirical information that the EB concept considers evidence. In the field of medicine, for example, this often leads to a situation where, despite the availability of results from studies on the benefit of a certain medical procedure, its efficacy or effectiveness is not considered evidence-based, since the quality of the studies  or the generalizability of their results  have not been judged satisfactory. Here we have to keep in mind that medical and statistical experts often arrive at different answers to the central question: is the effectiveness of this specific medical intervention evidence-based or not? Examples of this include the controversy surrounding the early detection of breast cancer with mammography screening  or medicThe EB concept includes the normative dimension of the legitimation of action. Whenever empirical information plays a role in decision-making , according to the EB concept the information should be given preference that fits or best fits the criteria of evidence (see above). Empirical information that reaches the highest EB status should be trusted more in action-oriented decisions than empirical information that does not satisfy the criteria of evidence. The legitimation of action that this involves does not arise on its own, nor are we dealing with a naturalistic fallacy. Rather the typical case is that previous specification of principles  and otheThe decision as to what should be considered evidence is based on the quality of the underlying studies, i.e. their reliability and validity. Only the empirical information supported by a context-sensitive study of appropriate quality is to be considered evidence. But who can or should decide, using which criteria, whether the quality standards have been met or not? In actual medical practice and in empirical ethics we will have to continually lower the bar, since the perfect study without any susceptibility for systematic bias does not exist. This holds for experimental studies that generate the greater share of evidence in medicine and even more for qualitative studies and survey research that, according to the overview taken by Borry et al., represent the most common form of empirical research in ethics . In manyIn the following the descriptive and normative dimensions of the EB concept will serve as a framework for a critical analysis of the associated challenges in general and for an evidence-based ethics in particular. It is important to keep in mind that the basic idea underlying the EB concept deserves our strong endorsement from an ethical perspective. When empirical information plays a role in decision-making, it should be weighted differently depending on its quality. However, from an ethical perspective the application of the EB concept becomes problematic when it is used uncritically or misused in order to legitimate actions. When a group of experts determines that the benefit of a certain medical procedure is evidence-based, this has a strong legitimating effect on certain actions at present. Doctors could come into conflict with their liability in civil law if they do not take evidence-based action, and insurance companies find it much harder to justify themselves if they wish to not fund evidence-based procedures. Yet before we can determine which empirical information deserves the "evidence-based" seal of quality, we first need context-specific standards for the optimal or at least sufficient internal and external validity. The search for consensus on such standards runs into significant problems in the case of internal validity, and the question of external validity only exacerbates them. Within EBM, for example, it is a matter of contentious debate whether the demands for internal validity are met by the use of a certain experimental study design  or whether further aspects have to be considered (e.g. the dropout rate of the study participants) . With thlegitimation of action even though there is no sufficient consensus regarding the relevant normative values posited in the quality assessment dimension. In other words: decisions can then be legitimated under the "evidence-based" seal of approval even though there is no consensus concerning what should count as evidence and what not in the particular context. Of course, this also works the other way round: The EB concept can also be exploited to argue against certain actions, e.g. the clinical use or coverage of medical interventions.Depending on how strict we make the criteria for the needed empirical information to count as evidence-based, we will come to different conclusions about the underlying question  the question is to determine majority views or to analyze opinions and attitudes). The selection and concretization of these criteria always involves normative judgments (see above). This would not in itself be so problematic, were it not for the fact that in practice we see various decision-makers frequently working with different criteria of assessment – hence the need to make these normative judgments transparent . If theyThese considerations should have made it clear that the often criticized dimension of legitimation of action is not, in itself, the real ethical problem with the EB concept. Quite the contrary, it represents the reasonable and yet crucial ethical demand that medical and ethical decisions should be based on reliable and valid information, not on whatever information might have been gathered together arbitrarily or that might otherwise be susceptible to bias. Rather, for EBM and evidence-based ethics the particular ethical and methodological challenges are to analyze the normative judgments for distinguishing evidence from empirical information per se and account for them in practice with sufficient transparency. Before we can critically analyze this normativity implicit in the dimension of quality assessment of empirical information we need to have sufficient transparency about these value judgments in the first place.In order to analyze the particularities of an evidence-based ethics, the following will begin by outlining a conception of the relation between normative and empirically descriptive statements. The relation between norms and facts has become an occasion of controversial debate in the past years, with the notable key terms including the "empirical turn in bioethics"  and the The classical principles of medical ethics  need to external evidence. Only after a sufficiently critical assessment of the internal and external validity of the available empirical information are we justified in speaking of external evidence as the foundation for the specification of ethical principles. In principle we could conceive a similar process for one's own  experiences. In an ethical dilemma one could classify one's previous experiences as potentially distorted  or as not relevant for the case at hand (relevance assessment). Those experiences considered adequate and relevant could be termed internal evidence, in analogy to external evidence. However, since this assessment process cannot be examined intersubjectively and remains of necessity purely subjective, this internal evidence cannot be counted as evidence in the sense of evidence-based ethics .Besides this interactional scheme, the figure also shows the characteristic normative dimensions of an evidence-based ethics. In the processes of quality assessment (A) and relevance assessment (B) typically there is some available external empirical information that does not reach the status of evidence. We could picture these processes as a sieve that sorts out some empirical information and leaves behind only reflective equilibrium [external evidence.According to the interactional scheme in figure ilibrium ,26. In rHaving presented a rational and non-trivial reading of evidence-based ethics as a theoretical conception, this paper is now particularly concerned to identify the limits of evidence-based ethics in practice and the risks that go along with it. Whether the idealized conception of an evidence-based ethics presented in the previous section can be realized in the conditions of actual practice depends on several factors.Before we can speak of evidence-based ethical decisions in practice, we have to demonstrate the extent to which we can assume a consensus on the specific use of the concept of evidence. To avoid misuse of the dimension of action legitimation (see above) or at least constrain it within certain limits we need a transparent justification for the use of the EB concept. This justification is not found in the articles cited at the beginning of this paper that use the concept of evidence-based ethics -5.Another practical problem facing us is how to provide the EB concept with specific content depending on the methods used in studies. For example, the results of psychometric studies to determine the decision-making competence of patients with dementia could be relevant to research ethics. In the ethical discussion of advance health care directives, in turn, the results of quantitative and/or qualitative interview studies to determine patient preferences can be relevant. Various studies are available for both of these problem areas that can be expected to vary greatly in their validity and reliability ,28. WhicWhat problems does all this imply for an evidence-based ethics? As long as the relevant evidence of evidence-based ethics relates to the beneficial and harmful results of medical interventions, we can assume similar problems to those described in medicine. However, a more in-depth look at the practice of evidence-based ethics will have to consider the fact that most studies grouped under the heading "empirical ethics" use non-experimental methods taken from the social sciences. Quantitative and qualitative interview and questionnaire studies are conducted quite frequently in the course of projects on applied ethics ,28. ThesThese problems do not speak against carrying out these sorts of studies or using the results in making ethical decisions. They do, however, clearly point to the practical problems that arise in using the concept of evidence-based ethics. Without the appropriate tools to distinguish better and worse empirical studies, the EB concept cannot find any application in ethics.A rational, non-trivial reading of the EB concept has to be distinguished from empirical information per se. Because of its normative dimension of action legitimation, we need a transparent and rational justification of the context-specific use of the EB concept in medicine as well as in ethics. This is to be ensured through an explicit discussion within each field as to the validity and relevance of the empirical information to be considered evidence.The relation between norms and facts was described as complementary in applied ethics. Empirical information per se is necessary to give concrete and context-specific reality to ethical principles. Yet neither empirical information nor ethical principles are sufficient for an ethical decision-making process in the context of medical ethics. The necessary interdependence of norms and facts is not sufficient to fully characterize the concept of evidence-based ethics. A rational, non-trivial reading of evidence-based ethics is characterized by a well-justified, context-specific differentiation between empirical information per se and the more qualitatively valuable evidence that has greater weight in the legitimation of action.Yet so long as no criteria or standards with sufficient general acceptance are available to justify a transparent characterization of empirical information as evidence, we should refrain from using the EB concept in the context of applied ethics. An unexamined use of the EB concept in applied ethics without context-specific justification should be seen very critically due to its legitimating effect on actions. Hence collaborative, interdisciplinary work is needed, for example between professional societies in medical ethics and the social sciences, to work out agreed-upon criteria and standards. These standards for quality assessment in empirical ethics could then be used to assess research proposals or manuscripts submitted to journals. They could also be helpful in critically interpreting the results of studies in empirical ethics.critical appraisal of empirical information in the context of totality of data. Here, in a first step, systematic reviews aim to identify all studies that focused on research questions relevant for a certain ethical dilemma [Until these quality assessment measures can be found for empirical ethics, it is likewise problematic to speak of "empirically supported ethical decisions" if there is no differentiation between various levels of quality of empirical information and hence no transparent discussion of the internal and external quality of the empirical information. A middle course between the evidence-based ethics that is not currently possible and a merely superficial treatment of empirical information is an ethics that calls for the  dilemma . In a seA critical appraisal of empirical ethics can only be implemented in practice if the question of what comprises better or worse empirical information in ethics can be intersubjectively discussed and negotiated. This article has presented various difficulties that require further pragmatic discussion for their solution. Furthering this process of clarification, which has been neglected so far, is at least as important as the current intensive discussion about the relation between ethics and empirical information.The author declares that he has no competing interests.The pre-publication history for this paper can be accessed here:


The following symposium marks the commitment of the Indian Journal of Orthopaedics to foster education in the practice of good research practice and the principles collectively known as evidence-based orthopedics.The term evidence-based medicine (EBM) first appeared in autumn 1990 in a document for applicants to the Internal Medicine residency program at McMaster University that described EBM as an attitude of enlightened skepticism towards the application of diagnostic, therapeutic and prognostic technologies. The most sophisticated practice of EBM requires, in turn, a clear delineation of relevant clinical questions, a thorough search of the literature relating to the questions, a critical appraisal of available evidence and its applicability to the clinical situation and a balanced application of the conclusions to the clinical problem.1Over the last several years the concepts and ideas attributed to and labeled collectively as EBM have become a part of daily clinical lives and clinicians increasingly hear about evidence-based guidelines, evidence-based care paths and evidence-based questions and solutions. The controversy has shifted from whether to implement the new concepts to how to do so sensibly and efficiently, while avoiding potential problems associated with a number of misconceptions about what EBM is and what it is not (see below). The EBM-related concepts of hierarchy of evidence, meta-analyses, confidence intervals, study design and critical appraisal are so widespread, that surgeons willing to use today's orthopedic literature with understanding have no choice but to become familiar with EBM principles and methodologies.With the ever-increasing amount of available information, surgeons must consider a shift in paradigm from traditional practice to one which involves question formulation, validity assessment of available studies and appropriate application of research evidence to individual patients.This symposium highlights articles with a focus on clinical research methodology, common statistical fallacies in research and evidence-based orthopedics. We have several excellent contributions from authors internationally. Along with Dr. Jain, Editor, The Indian Journal of Orthopaedics, we have aimed to develop a practical guide for readers to improve understanding of research methodology and evidence-based approaches in the design and conduct of research studies.