Search

This year marks the 20th anniversary of the Cochrane Collaboration. This means that for 2 decades, members of the Collaboration have searched, reviewed, and synthesized clinical trials, with the goal of facilitating a timely and efficient transfer of research evidence into practice. Members of the C

Study Design. Literature review. Objective. To assess the influence of various factors in statistical heterogeneity of meta-analyses of interventions for low back pain. One of these factors was study design: randomized controlled trial (RCT) versus nonrandomized study (NRS). Summary of Background Data. The presence of statistical heterogeneity poses a challenge to the conduct and interpretation of meta-analyses. Methods. We searched MEDLINE, EMBASE, and The Cochrane Library up to May 2005 for comparative studies of interventions for low back pain. The interventions with the highest number of NRSs were selected. All NRSs and RCTs of the same interventions were combined using meta-analysis. Subgroup analyses and meta-regression were performed according to study design and other factors that were selected by a panel of 20 experts. Results. NRSs frequently either agree with RCTs or underestimate the effects compared with RCTs. The interventions and the respective factors that explained statistical heterogeneity were a) surgery versus conservative treatments (17 NRSs and 8 RCTs): study design (odds ratio, OR: 1.56 and 4.69 for nonrandomized and randomized studies, respectively), pain duration (OR: 1.75 and 3.55 for chronic and acute, respectively), and involvement of workers’ compensation (OR: 1.85 and 5.07, with and without, respectively); b) surgery with fusion versus surgery without fusion (17 NRSs and 3 RCTs): spondylolisthesis (OR: 2.15 and 1.22, with and without, respectively); c) Instrumented fusion versus noninstrumented fusion (15 NRSs and 8 RCTs): previous surgery (OR: 2.89 and 1.36, with and without, respectively) and levels fused (OR: 1.50 and 2.98, single and multilevel, respectively). Conclusion. Comparisons between RCTs and NRSs may be influenced by various factors, including study design. However, other factors were more powerful explanatory variables than study design. These factors included pain duration, involvement of workers’ compensation, presence of spondylolisthesis, previous surgery, and levels fused.

Clinical cohort.To measure the adherence to 3 radiography guidelines for low back pain in chiropractic teaching clinics.Evidence-based guidelines for low back pain suggest that plain radiography should be restricted to patients with suspected serious disease. Among primary healthcare providers who can request radiographs, chiropractors are thought to have utilization rates that exceed what is recommended by practice guidelines. It is uncertain whether this gap between evidence and practice begins in undergraduate training.We screened 1241 consecutive patients with a new episode of low back pain who presented to any of the 6 out-patient teaching clinics of the Canadian Memorial Chiropractic College between January 2004 and September 2004. We collected information about red flags and radiography recommendations from patients and chiropractic trainees using self-administered questionnaires. Radiography recommendations were compared with criteria used in 3 radiography guidelines. Adherence was measured as the proportion of patients without red flags who were not recommended for radiography.Of the 503 eligible patients, 448 (89.1%) agreed to participate in the study. Radiography was recommended for 12.3% of patients. According to the selected radiography guidelines, the proportion of patients with red flags ranged from 45.3% to 70.5%. The proportion of patients without red flags who were not recommended for radiography ranged from 89.4% (95% confidence interval, 85.5%-93.2%) to 94.7% (95% confidence interval, 90.9%-98.5%) for the selected guidelines.The results suggest a strong adherence to radiography guidelines for patients with a new episode of low back pain who presented to chiropractic teaching clinics. Although a high proportion of patients had red flags, radiography utilization was lower than rates reported in previous studies suggesting that adherence to guidelines may help prevent unnecessary radiography.

STUDY DESIGN. A systematic review of randomized controlled trials. OBJECTIVES. To determine the effectiveness of herbal medicine compared with placebo, no intervention, or "standard/accepted/conventional treatments" for nonspecific low back pain. SUMMARY OF BACKGROUND DATA. Low back pain is a common condition and a substantial economic burden in industrialized societies. A large proportion of patients with chronic low back pain use complementary and alternative medicine (CAM) and/or visit CAM practitioners. Several herbal medicines have been purported for use in low back pain. METHODS. The following databases were searched: Medline (1966 to April 2003), Embase (1980 to April 2003), Cochrane Controlled Trials Register (Issue 1, 2003), and Cochrane Complementary Medicine (CM) field Trials Register. Additionally, reference lists in review articles, guidelines, and in the retrieved trials were checked. Randomized controlled trials (RCTs), using adults (>18 years of age) suffering from acute, subacute, or chronic nonspecific low back pain. Types of interventions included herbal medicines defined as a plant that is used for medicinal purposes in any form. Primary outcome measures were pain and function. Two reviewers (J.J.G. and M.W.T.) conducted electronic searches in all databases. One reviewer (J.J.G.) contacted content experts and acquired relevant citations. Authors, title, subject headings, publication type, and abstract of the isolated studies were downloaded or a hard copy was retrieved. Methodologic quality and clinical relevance were assessed separately by two individuals (J.J.G. and M.W.T.). Disagreements were resolved by consensus. RESULTS. Ten trials were included in this review. Two high-quality trials utilizing Harpagophytum procumbens (Devil's claw) found strong evidence for short-term improvements in pain and rescue medication for daily doses standardized to 50 mg or 100 mg harpagoside with another high-quality trial demonstrating relative equivalence to 12.5 mg per day of rofecoxib. Two moderate-quality trials utilizing Salix alba (White willow bark) found moderate evidence for short-term improvements in pain and rescue medication for daily doses standardized to 120 mg or 240 mg salicin with an additional trial demonstrating relative equivalence to 12.5 mg per day of rofecoxib. Three low-quality trials using Capsicum frutescens (Cayenne) using various topical preparations found moderate evidence for favorable results against placebo and one trial found equivalence to a homeopathic ointment. CONCLUSIONS. Harpagophytum procumbens, Salix alba, and Capsicum frutescens seem to reduce pain more than placebo. Additional trials testing these herbal medicines against standard treatments will clarify their equivalence in terms of efficacy. The quality of reporting in these trials was generally poor; thus, trialists should refer to the CONSORT statement in reporting clinical trials of herbal medicines. © 2007 Lippincott Williams & Wilkins, Inc.

Study design Descriptive method guidelines. Objectives To help reviewers design, conduct, and report reviews of trials in the field of back and neck pain. Summary of background data In 1997, the Cochrane Collaboration Back Review Group published method guidelines for systematic reviews. Since its publication, new methodologic evidence emerged and more experience was acquired in conducting reviews. Methods All reviews and protocols of the Back Review Group were assessed for compliance with the 1997 method guidelines. Also, the most recent version of the Cochrane Handbook (4.1) was checked for new recommendations. In addition, some important topics that were not addressed in the 1997 method guidelines were included (e.g., methods for qualitative analysis, reporting of conclusions, and discussion of clinical relevance of the results). In May 2002, preliminary results were presented and discussed in a workshop. In two rounds, a list of all possible recommendations and the final draft were circulated for comments among the editors of the Back Review Group. Results The recommendations are divided in five categories: literature search, inclusion criteria, methodologic quality assessment, data extraction, and data analysis. Each recommendation is classified in minimum criteria and further guidance. Additional recommendations are included regarding assessment of clinical relevance, and reporting of results and conclusions. Conclusions Systematic reviews need to be conducted as carefully as the trials they report and, to achieve full impact, systematic reviews need to meet high methodologic standards.

Study design A prospective, systematic review of web sites related to back pain. Objective To assess the nature and quality of back pain-related information on the World Wide Web during a 2-year period. Summary of background data The Internet has become a rich source of medical information. Limited knowledge is available, however, about the quality of online resources. Although previous systematic reviews on medical-related web sites found problems in varying degrees with the credibility of information, no such review was conducted to assess the back pain-related sites. Methods A search of web sites was conducted in November 1996 using five search engines (AltaVista, Infoseek, Lycos, Yahoo, and Magellan) and two key terms ("back pain" and "back problems"). A sample of sites was evaluated by two independent reviewers. Each site was described by the type and nature of the sponsor, target audience, and content. Overall quality was assessed in terms of evidence-based information available. Results Seventy-four web sites were reviewed in 1996, and nine of them (12.2%) were identified as high-quality sites. Advertising was the focus of 80.8% of the sites. Eleven sites (14.9%) were found to be discontinued 1 year later, and 20 (27.0%) were not accessible by the reviewers at the 2-year follow-up evaluation. Of the remaining 54 sites, 44.4% were produced by for-profit companies, and most sites targeted people with back pain (63.0%). Only seven out of the nine high-quality sites held their ratings at the 2-year follow-up evaluation. Conclusion Most back pain-related web sites can be classified as advertising. The quality varied considerably, resulting in difficulties for patients to find useful information in this field. The increasing number of people seeking medical information on the Web creates a need for more high quality sites. Further, systematic review of web sites should be encouraged to monitor the accuracy of Internet publication.

Clinicians and researchers increasingly recognize the importance of the patient's perspective in the evaluations of the effectiveness of treatment. The rapid growth in the number and types of patient-based outcome measures can be confusing. This supplement provides a state-of-the-art review of the available tools. In this paper, the key recommendations from the participating authors are summarized. A core set of measures should include the following five domains: back specific function, generic health status, pain, work disability, and patient satisfaction. Two commonly used measures of back-specific function are recommended: the Roland-Morris Disability Questionnaire and the Oswestry Disability Index. Among the generic measures, the SF-36 strikes the best balance between length, reliability, validity, responsiveness, and experience in large populations of patients with back pain. Moreover, the SF-36 Bodily Pain Scale provides a brief measure of pain intensity and pain interference with activities. Health-related work disability should include at a minimum a measure of work status and work-time loss. For those who are still at work, new measures are being developed to measure health-related work limitations. No single measure of patient satisfaction is clearly preferred but guiding principles are provided to choose among available measures. In addition to the five recommended domains, preference-based health outcome measures, including patients utilities, may be useful when there is a need to value alternative health outcomes.

With the increase in the number of multinational and multicultural research projects, the need to adapt health status measures for use in other than the source language has also grown rapidly. 1,4,27 Most questionnaires were developed in English-speaking countries, 11 but even within these countries, researchers must consider immigrant populations in studies of health, especially when their exclusion could lead to a systematic bias in studies of health care utilization or quality of life. 9,11 The cross-cultural adaptation of a health status selfadministered questionnaire for use in a new country, culture, and/or language necessitates use of a unique method, to reach equivalence between the original source and target versions of the questionnaire. It is now recognized that if measures are to be used across cultures, the items must not only be translated well linguistically, but also must be adapted culturally to maintain the content validity of the instrument at a conceptual level across different cultures. 6,11‐13,15,24 Attention to this level of detail allows increased confidence that the impact of a disease or its treatment is described in a similar manner in multinational trials or outcome evaluations. The term “cross-cultural adaptation” is used to encompass a process that looks at both language (translation) and cultural adaptation issues in the process of preparing a questionnaire for use in another setting. Cross-cultural adaptations should be considered for several different scenarios. In some cases, this is more obvious than in others. Guillemin et al 11 suggest five different examples of when attention should be paid to this adaptation by comparing the target (where it is going to be used) and source (where it was developed) language and culture. The first scenario is that it is to be used in the same language and culture in which it was developed. No adaptation is necessary. The last scenario is the opposite extreme, the application of a questionnaire in a different culture, language and country—moving the Short Form 36-item questionnaire from the United States (source) to Japan (target) 7 which would necessitate translation and cultural adaptation. The other scenarios are summarized in Table 1 and reflect situations when some translation and/or adaptation is needed. The guidelines described in this document are based on a review of cross-cultural adaptation in the medical, sociological, and psychological literature. This review led to the description of a thorough adaptation process designed to maximize the attainment of semantic, idiomatic, experiential, and conceptual equivalence between the source and target questionnaires. 13 . Further experience in cross-cultural adaptation of generic and diseasespecific instruments and alternative strategies driven by different research groups 18 have led to some refinements

The evaluation of the clinical utility of the clinical diagnostic tests and procedures, what works in spinal disorders, and for whom and how treatment affects a patient's symptoms and function are key questions of outcomes research. This paper describes the advantages and limitations of the main study approaches used. Examples from the spine literature on spinal stenosis are used for illustration.

There is growing recognition in the treatment of back pain that patient perspectives are essential in judging the results of treatment. Improving the patient's "quality of life" is often the main goal of therapy. Thus, although clinical research in the past has focused on physiologic outcomes, such as range of motion, muscle strength, or neurologic deficits, increasing attention is being given to the rigorous measurement of symptoms, functional status, role function, satisfaction with treatment, and health care costs. In many cases, these so-called "soft" outcomes can be measured with a level of reproducibility similar to more conventional clinical data such as imaging test results. Because symptoms and functional outcomes are sometimes only loosely associated with physiologic phenomena, the former outcomes should be measured directly. Modern questionnaires for measuring patient quality of life combine the expertise of social scientists and clinicians and have demonstrated validity. Furthermore, they have some important advantages over simple ratings of "excellent, good, fair, and poor" outcomes, or work status alone. Several modern instruments for measuring health-related quality of life in patients with low back pain are reviewed briefly, describing their content and length. Wider use of these instruments would help to increase clinician familiarity with their meaning and avoid duplication of effort in questionnaire development.

STUDY DESIGN This study systematically reviewed the literature on group education for people with low back pain. Findings are considered in relation to parameters such as the characteristics of the study participants, the intervention, and the setting. OBJECTIVE To make a recommendation regarding the effectiveness of group education as an intervention for people with low back pain. RESULTS Based on a systematic search of the literature, 13 primary studies are cited; 6 of these were sufficiently well designed and executed for their findings to be considered. Of the four quality studies with chronic back pain subjects, only one found a positive short-term effect on one of the outcome measures considered (pain intensity). In the two studies with acute cases, group education was found by one of the studies to reduce pain duration and initial sick leave duration in the short term, but the intervention also included work-site visits. At 1 year of follow-up, there was no evidence in the six studies of clinically important benefits on any of the outcome measures. CONCLUSIONS There is insufficient evidence to recommend group education for people with low back pain.

Systematic literature review.To critically appraise the methodology of systematic reviews of conservative therapies for chronic nonspecific low back pain and to study the relation between the methodologic quality and other characteristics of these reviews.Systematic reviews offer a concise summary of the evidence on treatment effectiveness, but flaws in their methodology can lead to invalid conclusions with serious implications for quality of patient care.Searches of MEDLINE, EMBASE, Psychinfo, and the Cochrane Library were conducted. Titles, abstracts, and articles were reviewed by two blinded authors using three inclusion criteria: 1) chronic nonspecific low back pain, 2) systematic review, and 3) conservative treatment intervention. Data were extracted from each review by three authors.The search strategy retrieved 1102 titles and abstracts; 109 met inclusion criteria. A review of the full text of these articles excluded an additional 73 articles. Data abstraction and methodologic assessment were conducted on 36 articles reviewing 19 discrete interventions. The average quality score was 4.1, ranging from 1 (low) to 7 (high). There was a trend for recent reviews to be of higher quality. Fifty-six percent of the reviews had positive conclusions, but they had lower quality scores compared with those that had negative or uncertain conclusions. There were 27 (73%) qualitative and 10 (27%) quantitative summaries of results.Although the overall quality of systematic reviews was satisfactory, the quality of the individual papers included in the reviews varied considerably. The reviews often provided contradictory evidence on the effectiveness of a wide range of commonly used conservative interventions for chronic nonspecific low back pain. These findings illustrate the pitfalls of systematic reviews where there are a number of low-quality trials and underscore the need for high-quality primary trials that will allow for more conclusive reviews.

Study Design. An international group of back pain researchers considered recommendations for standardized measures in clinical outcomes research in patients with back pain. Objectives. To promote more standardization of outcome measurement in clinical trials and other types of outcomes research, including recta-analyses, cost-effectiveness analyses, and multicenter studies. Summary of Background Data. Better standardization of outcome measurement would facilitate comparison of results among studies, and more complete reporting of relevant outcomes. Because back pain is rarely fatal or completely cured, outcome assessment is complex and involves multiple dimensions. These include symptoms, function, general well-being, work disability, and satisfaction, with care. Methods. The panel considered several factors in recommending a standard battery of outcome measures. These included reliability, validity, responsiveness, and practicality of the measures. In addition, compatibility with widely used and promoted batteries such as the American Academy of Orthopaedic Surgeons Lumbar Cluster were considered to minimize the need for changes when these instruments are used. Results. First, a six-item set was proposed, which is sufficiently brief that it could be used in routine care settings for quality improvement and for research purposes. An expanded outcome set, which would provide more precise measurement for research purposes, includes measures of severity and frequency of symptoms, either the Roland or the Oswestry Disability Scale, either the SF-12 or the EuroQol measure of general health status, a question about satisfaction with symptoms, three types of 'disability days,' and an optional single item on overall satisfaction with medical care. Conclusion. Standardized measurement of outcomes would facilitate scientific advances in clinical care. A short, 6-item questionnaire and a somewhat expanded, more precise battery of questionnaires can be recommended. Although many considerations sup port such recommendations, more data on responsiveness and the minimally important change n scores are needed for most of the instruments.

Clinicians are bombarded by reports of new diagnostic tests or treatments for patients with spine problems. To provide the best possible patient care, clinicians need to be able to critically appraise the results of such studies for validity and relevance to patient care. Important questions to be asked of any description of diagnostic or treatment studies are the following questions: 1) Are the patients described in detail so that you can decide whether they are comparable to those that you see in your practice? 2) Are the treatments or assessments described well enough so that you could provide the same for your patients? 3) Was a clinically relevant endpoint measured? 4) Is there an appropriate comparison group? 5) Are potential sources of bias appropriately attended to? 6) Are the results clinically significant?

Understanding disease etiology is key for effective preventive or therapeutic interventions. Knowledge about risk factors is useful to the clinician to answer patients' questions about the possible cause(s) of their presenting disorders. This article describes the three most common types of etiologic studies using examples from the published literature on the risk factors for back pain. Cohort studies typically follow a group of "healthy" people forward in time to assess disease outcome after risk factors have already been measured. Case-control studies use people selected on the basis of outcome status; risk factors are assessed after the fact. Although more prone to bias than cohort studies, case control studies are more common in back pain research because of the ease of examining several risk factors simultaneously and the expense of cohort studies. Prevalence studies use a random sample of people collected at a single point in time; consequently there is no predetermined number of "cases" and "controls," their numbers depending on the prevalence of disease and exposures in the samples. To assist in the interpretation of research findings this paper presents a general framework for assessing the strengths and weaknesses of an individual study. Case-control studies are discussed in more detail because they are so commonly encountered in the etiologic literature. Finally, because the evidence from a single study, no matter how well designed and executed, is never enough on its own to decide if a risk factor is causal or not, the paper concludes by briefly summarizing the criteria for inferring causation using the full body of available biologic and epidemiologic literature.

Study Design.Prospective inception cohort study.Objective.To develop a prognostic model that predicts time receiving workers’ compensation benefits for low back pain claimants.Summary of Background Data.As the cost and difficulty of managing low back pain escalate, any predictor of outcome is advant