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Biomedical subjects

G Waddell

Publications and source records attributed to G Waddell.

At least 19 recordsLinked to original sources
PubMed2006

The development of an evidence-based patient booklet for patients undergoing lumbar discectomy and un-instrumented decompression.

Post-operative management after lumbar surgery is inconsistent leading to uncertainty amongst surgeons and patients about post-operative restrictions, reactivation, and return to work. This study aimed to review the evidence on post-operative management, with a view to developing evidence-based messages for a patient booklet on post-operative management after lumbar discectomy or un-instrumented decompression. A systematic literature search produced a best-evidence synthesis of information and advice on post-operative restrictions, activation, rehabilitation, and expectations about outcomes. Evidence statements were extracted and developed into patient-centred messages for an educational booklet. The draft text was evaluated by peer and patient review. The literature review found little evidence for post-operative activity restrictions, and a strong case for an early active approach to post-operative management. The booklet was built around key messages derived from the literature review and aimed to reduce uncertainty, promote positive beliefs, encourage early reactivation, and provide practical advice on self-management. Feedback from the evaluations were favourable from both review groups, suggesting that this evidence-based approach to management is acceptable and it has clinical potential.

Decompression, Surgical↗
PubMed2005

Surgery for degenerative lumbar spondylosis.

BACKGROUND: Surgical investigations and interventions account for large health care utilisation and costs, but the scientific evidence for most procedures is still limited. OBJECTIVES: Degenerative conditions affecting the lumbar spine are variously described as lumbar spondylosis or degenerative disc disease (which we regarded as one entity) and may be associated with back pain and associated leg symptoms, instability, spinal stenosis and/or degenerative spondylolisthesis. The objective of this review was to assess current scientific evidence on the effectiveness of surgical interventions for degenerative lumbar spondylosis. SEARCH STRATEGY: We searched CENTRAL, MEDLINE, PubMed, Spine and ISSLS abstracts, with citation tracking from the retrieved articles. We also corresponded with experts. All data found up to 31 March 2005 are included. SELECTION CRITERIA: Randomised (RCTs) or quasi-randomised trials of surgical treatment of lumbar spondylosis. DATA COLLECTION AND ANALYSIS: Two authors assessed trial quality and extracted data from published papers. Additional information was sought from the authors if necessary. MAIN RESULTS: Thirty-one published RCTs of all forms of surgical treatment for degenerative lumbar spondylosis were identified. The trials varied in quality: only the more recent trials used appropriate methods of randomization, blinding and independent assessment of outcome. Most of the earlier published results were of technical surgical outcomes with some crude ratings of clinical outcome. More of the recent trials also reported patient-centered outcomes of pain or disability, but there is still very little information on occupational outcomes. There was a particular lack of long term outcomes beyond two to three years. Seven heterogeneous trials on spondylolisthesis, spinal stenosis and nerve compression permitted limited conclusions. Two new trials on the effectiveness of fusion showed conflicting results. One showed that fusion gave better clinical outcomes than conventional physiotherapy, while the other showed that fusion was no better than a modern exercise and rehabilitation programme. Eight trials showed that instrumented fusion produced a higher fusion rate (though that needs to be qualified by the difficulty of assessing fusion in the presence of metal-work), but any improvement in clinical outcomes is probably marginal, while there is other evidence that it may be associated with higher complication rates. Three trials with conflicting results did not permit any conclusions about the relative effectiveness of anterior, posterior or circumferential fusion. Preliminary results of two small trials of intra-discal electrotherapy showed conflicting results. Preliminary data from three trials of disc arthroplasty did not permit any firm conclusions. AUTHORS' CONCLUSIONS: Limited evidence is now available to support some aspects of surgical practice. Surgeons should be encouraged to perform further RCTs in this field.

Decompression, Surgical↗
PubMed2005

Surgery for degenerative lumbar spondylosis.

BACKGROUND: Surgical investigations and interventions account for large health care utilisation and costs, but the scientific evidence for most procedures is still limited. OBJECTIVES: Degenerative conditions affecting the lumbar spine are variously described as lumbar spondylosis or degenerative disc disease (which we regarded as one entity) and may be associated with back pain and associated leg symptoms, instability, spinal stenosis and/or degenerative spondylolisthesis. The objective of this review was to assess current scientific evidence on the effectiveness of surgical interventions for degenerative lumbar spondylosis. SEARCH STRATEGY: We searched CENTRAL, MEDLINE, PubMed, Spine and ISSLS abstracts, with citation tracking from the retrieved articles. We also corresponded with experts. All data found up to 31 March 2004 are included. SELECTION CRITERIA: Randomised (RCTs) or quasi-randomised trials of surgical treatment of lumbar spondylosis. DATA COLLECTION AND ANALYSIS: Two authors assessed trial quality and extracted data from published papers. Additional information was sought from the authors if necessary. MAIN RESULTS: Thirty-one published RCTs of all forms of surgical treatment for degenerative lumbar spondylosis were identified. The trials varied in quality: only the more recent trials used appropriate methods of randomization, blinding and independent assessment of outcome. Most of the earlier published results were of technical surgical outcomes with some crude ratings of clinical outcome. More of the recent trials also reported patient-centered outcomes of pain or disability, but there is still very little information on occupational outcomes. There was a particular lack of long term outcomes beyond two to three years. Seven heterogeneous trials on spondylolisthesis, spinal stenosis and nerve compression permitted limited conclusions. Two new trials on the effectiveness of fusion showed conflicting results. One showed that fusion gave better clinical outcomes than conventional physiotherapy, while the other showed that fusion was no better than a modern exercise and rehabilitation programme. Eight trials showed that instrumented fusion produced a higher fusion rate (though that needs to be qualified by the difficulty of assessing fusion in the presence of metal-work), but did not improve clinical outcomes, while there is other evidence that it may be associated with higher complication rates. Three trials with conflicting results did not permit any conclusions about the relative effectiveness of anterior, posterior or circumferential fusion. Preliminary results of two small trials of intra-discal electrotherapy showed conflicting results. Preliminary data from three trials of disc arthroplasty did not permit any firm conclusions. AUTHORS' CONCLUSIONS: Limited evidence is now available to support some aspects of surgical practice. Surgeons should be encouraged to perform further RCTs in this field.

Decompression, Surgical↗
PubMed2003

Evaluation of an evidence based patient educational booklet for management of whiplash associated disorders.

OBJECTIVES: This study aimed to develop and evaluate an evidence based educational booklet on whiplash associated disorders. METHODS: A comprehensive review of the available scientific evidence produced a set of unambiguous patient centred messages that challenge unhelpful beliefs about whiplash and promote an active approach to recovery. These messages were incorporated into a novel booklet, which was then evaluated qualitatively for end user acceptability and its ability to impart the intended messages, and quantitatively for its ability to improve beliefs about whiplash and what to do about it. The subjects comprised people attending accident and emergency or manipulative practice with a whiplash associated disorder, along with a sample of workers without a whiplash associated disorder (n = 142). RESULTS: The qualitative results showed that the booklet was considered easy to read, understandable, believable, and conveyed its key messages. Quantitatively, it produced a substantial statistically significant improvement in beliefs about whiplash among accident and emergency patients (mean 6.5, 95% CI 3.9 to 9.1, p<0.001), and among workers (mean 9.4, 95% CI 7.9 to 10.9, p<0.001), but the shift in the more chronic manipulation patients was substantially smaller (mean 3.3, 95% CI 0.5 to 6.1, p<0.05). CONCLUSIONS: A rigorously developed educational booklet on whiplash (The Whiplash Book) was found acceptable to patients, and capable of improving beliefs about whiplash and its management; it seems suitable for use in the accident and emergency environment, and for wider distribution at the population level. A randomised controlled trial would be required to determine whether it exerts an effect on behaviour and clinical outcomes.

Adolescent↗
PubMed2003

Occupational health guidelines for the management of low back pain: an international comparison.

BACKGROUND: The enormous socioeconomic burden of low back pain emphasises the need for effective management of this problem, especially in an occupational context. To address this, occupational guidelines have been issued in various countries. AIMS: To compare available international guidelines dealing with the management of low back pain in an occupational health care setting. METHODS: The guidelines were compared regarding generally accepted quality criteria using the AGREE instrument, and also summarised regarding the guideline committee, the presentation, the target group, and assessment and management recommendations (that is, advice, return to work strategy, and treatment). RESULTS: and CONCLUSIONS: The results show that the quality criteria were variously met by the guidelines. Common flaws concerned the absence of proper external reviewing in the development process, lack of attention to organisational barriers and cost implications, and lack of information on the extent to which editors and developers were independent. There was general agreement on numerous issues fundamental to occupational health management of back pain. The assessment recommendations consisted of diagnostic triage, screening for "red flags" and neurological problems, and the identification of potential psychosocial and workplace barriers for recovery. The guidelines also agreed on advice that low back pain is a self limiting condition and, importantly, that remaining at work or an early (gradual) return to work, if necessary with modified duties, should be encouraged and supported.

Disability Evaluation↗
PubMed2002

Rehabilitation after lumbar disc surgery.

BACKGROUND: Although several rehabilitation programs, physical fitness programs or protocols regarding instruction for patients to return to work after lumbar disc surgery have been suggested, little is known about the efficacy and effectiveness of these treatments. There are still persistent fears of causing re-injury, re-herniation, or instability. OBJECTIVES: The objective of this systematic review was to evaluate the effectiveness of active treatments that are used in the rehabilitation after first-time lumbar disc surgery. SEARCH STRATEGY: We searched the MEDLINE, EMBASE and Psyclit databases up to April 2000 and the Cochrane Controlled Trials Register 2001, Issue 3. SELECTION CRITERIA: Both randomized and non-randomized controlled trials on any type of active rehabilitation program after first-time disc surgery were included. DATA COLLECTION AND ANALYSIS: Two independent reviewers performed the inclusion of studies and two other reviewers independently performed the methodological quality assessment. A rating system that consists of four levels of scientific evidence summarizes the results. MAIN RESULTS: Thirteen studies were included, six of which were of high quality. There is no strong evidence for the effectiveness for any treatment starting immediately post-surgery, mainly because of lack of (good quality) studies. For treatments that start four to six weeks post-surgery there is strong evidence (level 1) that intensive exercise programs are more effective on functional status and faster return to work (short-term follow-up) as compared to mild exercise programs and there is strong evidence (level 1) that on long term follow up there is no difference between intensive exercise programs and mild exercise programs with regard to overall improvement. For all other primary outcome measures for the comparison between intensive and mild exercise programs there is conflicting evidence (level 3) with regard to long-term follow-up. Furthermore, there is no strong evidence for the effectiveness of supervised training as compared to home exercises. There was also no strong evidence for the effectiveness of multidisciplinary rehabilitation as compared to usual care. There is limited evidence (level 3) that treatments in working populations that aim at return to work are more effective than usual care with regard to return to work. Also, there is limited evidence (level 3) that low-tech and high-tech exercises, started more than 12 months post-surgery are more effective in improving low back functional status as compared to physical agents, joint manipulations or no treatment. Finally, there is no strong evidence for the effectiveness of any specific intervention when added to an exercise program, regardless of whether exercise programs start immediately post-surgery or later. None of the investigated treatments seem harmful with regard to re-herniation or re-operation. REVIEWER'S CONCLUSIONS: There is no evidence that patients need to have their activities restricted after first time lumbar disc surgery. There is strong evidence for intensive exercise programs (at least if started about 4-6 weeks post-operative) on short term for functional status and faster return to work and there is no evidence they increase the re-operation rate. It is unclear what the exact content of post-surgery rehabilitation should be. Moreover, there are no studies that investigated whether active rehabilitation programs should start immediately post-surgery or possibly four to six weeks later.

Exercise Therapy↗
PubMed2002

Whiplash associated disorders: a review of the literature to guide patient information and advice.

OBJECTIVES: To review the literature and provide an evidence based framework for patient centred information and advice on whiplash associated disorders. METHODS: A systematic literature search was conducted, which included both clinical and non-clinical articles to encompass the wide range of patients' informational needs. From the studies and previous reviews retrieved, 163 were selected for detailed review. The review process considered the quantity, consistency, and relevance of all selected articles. These were categorised under a grading system to reflect the quality of the evidence, and then linked to derived evidence statements. RESULTS: The main messages that emerged were: physical serious injury is rare; reassurance about good prognosis is important; over-medicalisation is detrimental; recovery is improved by early return to normal pre-accident activities, self exercise, and manual therapy; positive attitudes and beliefs are helpful in regaining activity levels; collars, rest, and negative attitudes and beliefs delay recovery and contribute to chronicity. These findings were synthesised into patient centred messages with the potential to reduce the risk of chronicity. CONCLUSIONS: The scientific evidence on whiplash associated disorders is of variable quality, but sufficiently robust and consistent for the purpose of guiding patient information and advice. While the delivery of appropriate messages can be both oral and written, consistency is imperative, so an innovative patient educational booklet, The Whiplash Book, has been developed and published.

Humans↗
PubMed2001

Clinical guidelines for the management of low back pain in primary care: an international comparison.

STUDY DESIGN: Descriptive study. OBJECTIVES: To compare national clinical guidelines on low back pain. SUMMARY OF BACKGROUND DATA: To rationalize the management of low back pain, clinical guidelines have been issued in various countries around the world. Given that the available scientific evidence is the same, irrespective of the country, one would expect these guidelines to include more or less similar recommendations regarding diagnosis and treatment. METHODS: Guidelines were included that met the following criteria: the target group consisted of primary care health professionals, and the guideline was published in English, German, or Dutch. Only one guideline per country was included: the one most recently published. RESULTS: Clinical guidelines from 11 different countries published from 1994 until 2000 were included in this review. The content of the guidelines appeared to be quite similar regarding the diagnostic classification (diagnostic triage) and the use of diagnostic and therapeutic interventions. Consistent features were the early and gradual activation of patients, the discouragement of prescribed bed rest, and the recognition of psychosocial factors as risk factors for chronicity. However, there were discrepancies for recommendations regarding exercise therapy, spinal manipulation, muscle relaxants, and patient information. CONCLUSION: The comparison of clinical guidelines for the management of low back pain showed that diagnostic and therapeutic recommendations were generally similar. Updates of the guidelines are planned in most countries, although so far produced only in the United Kingdom. However, new evidence may lead to stronger conclusions and enable future guidelines to become even more concordant.

Australia↗
PubMed2001

Occupational health guidelines for the management of low back pain at work: evidence review.

There is increasing demand for evidence-based health care. Back pain is one of the most common and difficult occupational health problems, but there has been no readily available evidence base or guidance on management. There are well-established clinical guidelines for the management of low back pain, but these provide limited guidance on the occupational aspects. Occupational Health Guidelines for the Management of Low Back Pain at Work were launched by the Faculty of Occupational Medicine in March 2000. These are the first national occupational health guidelines in the UK and, as far as we are aware, the first truly evidence-linked occupational health guidelines for back pain in the world. They were based on an extensive, systematic review of the scientific literature predominantly from occupational settings or concerning occupational outcomes. The full evidence review is on the Faculty web site (www.facoccmed.ac.uk), but an abridged version is presented here to aid its dissemination.

Disability Evaluation↗
PubMed2000

Surgery for lumbar disc prolapse.

OBJECTIVES: The primary rationale for surgery for disc prolapse is to relieve nerve root irritation or compression due to herniated disc material. Claims of the merits of alternative surgical procedures are made without clear evidence about clinical outcomes. The objective of this review was to assess the effects of surgical interventions for the treatment of lumbar disc prolapse. SEARCH STRATEGY: We searched the Cochrane Controlled Trials Register, Medline, Embase, Biosis, Dissertation Abstracts, Index to UK Thesis, and reference lists of the retrieved articles up to March 1997 and we corresponded with experts. SELECTION CRITERIA: Randomised and quasi-randomised trials of the surgical management of lumbar disc prolapse. DATA COLLECTION AND ANALYSIS: Two reviewers assessed trial quality and extracted data from published papers. Additional information was sought from the authors if necessary. MAIN RESULTS: Twenty-seven trials were found. There were methodological weaknesses in many of the trials. Sixteen of the 27 trials were of some form of chemonucleolysis. Ten trials compared different surgical techniques, although only one of these compared surgical discectomy with conservative management. Surgical discectomy produced better clinical outcomes than chemonucleolysis with chymopapain, and chemonucleolysis produced better clinical outcomes than placebo. Three trials showed no difference in clinical outcomes between microdiscectomy and standard discectomy. Three trials failed to show a significant reduction in scar formation or improved clinical outcomes by inserting an inter-position membra ne to cover the spinal dura after discectomy. Three trials of percutaneous discectomy provided moderate evidence that it produces poorer clinical outcomes than standard discectomy or chymopapain. We found no published randomised trials of laser discectomy. REVIEWER'S CONCLUSIONS: Chemonucleolysis is more effective than placebo and it is less invasive but less effective than surgical disectomy. Surgical discectomy for carefully selected patients with sciatica due to lumbar disc prolapse provides faster relief from the acute attack than conservative management, although any positive or negative effects on the lifetime natural history of the underlying disc disease are unclear.

Diskectomy↗
PubMed2000

Surgery for degenerative lumbar spondylosis.

BACKGROUND: This section is under preparation and will be included in the next issue OBJECTIVES: Degenerative conditions affecting the lumbar spine are variously described as lumbar spondylosis or degenerative disc disease (which we regarded as one entity) and are associated with back pain, instability, spinal stenosis and degenerative spondylolisthesis. The objective of this review was to assess the effects of surgical interventions for the treatment of degenerative lumbar spondylosis. SEARCH STRATEGY: We searched the Cochrane Controlled Trials Register, Medline, Embase, Biosis, Dissertation Abstracts, Index to UK Thesis, and reference lists of the retrieved articles and we corresponded with experts. SELECTION CRITERIA: Randomised or quasi-randomised trials of surgical treatment of lumbar spondylosis DATA COLLECTION AND ANALYSIS: Two reviewers assessed trial quality and extracted data from published papers. Additional information was sought from the authors if necessary. MAIN RESULTS: Fourteen published trials of all forms of surgical treatment for degenerative lumbar spondylosis were identified. There were many serious weaknesses of trial design, including poor methods of randomisation, lack of blinding and lack of independent assessment of outcome which at times gave considerable potential for bias. Most of the published results were reporting on technical surgical outcomes with some crude ratings of clinical outcome, but few patient-centred outcomes of pain, disability or capacity for work. There was a particular lack of long-term outcomes. This review found no published trials comparing any form of surgery for degenerative lumbar spondylosis compared with natural history, placebo, or any form of conservative treatment. Nine trials randomly compared instrumented and non-instrumented fusion. Instrumented fusion produced a higher fusion rate (though that needs to be qualified by the difficulty of assessing fusion in the presence of metal-work) but did not improve clinical outcomes and there is evidence that it may be associated with higher complication rates. The few and heterogeneous trials on spondylolisthesis, spinal stenosis and nerve compression permitted very limited conclusions. REVIEWER'S CONCLUSIONS: There is no scientific evidence about the effectiveness of any form of surgical decompression or fusion for degenerative lumbar spondylosis compared with natural history, placebo, or conservative treatment.

Decompression, Surgical↗
PubMed1999

Information and advice to patients with back pain can have a positive effect. A randomized controlled trial of a novel educational booklet in primary care.

STUDY DESIGN: A double-blind, randomized controlled trial of a novel educational booklet compared with a traditional booklet for patients seeking treatment in primary care for acute or recurrent low back pain. OBJECTIVE: To test the impact of a novel educational booklet on patients' beliefs about back pain and functional outcome. SUMMARY OF BACKGROUND DATA: The information and advice that health professionals give to patients may be important in health care intervention, but there is little scientific evidence of their effectiveness. A novel patient educational booklet, The Back Book, has been developed to provide evidence-based information and advice consistent with current clinical guidelines. METHODS: One hundred sixty-two patients were given either the experimental booklet or a traditional booklet. The main outcomes studied were fear-avoidance beliefs about physical activity, beliefs about the inevitable consequences of back trouble, the Roland Disability Questionnaire, and visual analogue pain scales. Postal follow-up response at 1 year after initial treatment was 78%. RESULTS: Patients receiving the experimental booklet showed a statistically significant greater early improvement in beliefs which was maintained at 1 year. A greater proportion of patients with an initially high fear-avoidance beliefs score who received the experimental booklet had clinically important improvement in fear-avoidance beliefs about physical activity at 2 weeks, followed by a clinically important improvement in the Roland Disability Questionnaire score at 3 months. There was no effect on pain. CONCLUSION: This trial shows that carefully selected and presented information and advice about back pain can have a positive effect on patients' beliefs and clinical outcomes, and suggests that a study of clinically important effects in individual patients may provide further insights into the management of low back pain.

Adult↗
PubMed1999

The Cochrane review of surgery for lumbar disc prolapse and degenerative lumbar spondylosis.

STUDY DESIGN: A Cochrane review of randomized controlled trials. OBJECTIVES: To collate the scientific evidence on surgical management for lumbar-disc prolapse and degenerative lumbar spondylosis. SUMMARY OF BACKGROUND DATA: Surgical investigations and interventions account for as much as one third of the health care costs for spinal disorders, but the scientific evidence for most procedures still is unclear. METHODS: A highly sensitive search strategy identified all published randomized controlled trials. Cochrane methodology was used for meta-analysis of the results. RESULTS: Twenty-six randomized controlled trials of surgery for lumbar disc prolapse and 14 trials of surgery for degenerative lumbar spondylosis were identified. Methodologic weaknesses were found in many of the trials. Only one trial directly compared discectomy and conservative management. Meta-analyses showed that surgical discectomy produces better clinical outcomes than chemonucleolysis, which is better than placebo. Three trials showed no difference in clinical outcomes between microdiscectomy and standard discectomy, but in three other studies, both produced better results than percutaneous discectomy. Three trials showed that inserting an interposition membrane after discectomy does not significantly reduce scar formation or alter clinical outcomes. Five heterogeneous trials on spinal stenosis and degenerative spondylolisthesis permit very limited conclusions. There were nine trials of instrumented versus noninstrumented fusion: Meta-analysis showed that instrumentation may facilitate fusion but does not improve clinical outcomes. CONCLUSIONS: There is now strong evidence on the relative effectiveness of surgical discectomy versus chemonucleolysis versus placebo. There is considerable evidence on the clinical effectiveness of discectomy for carefully selected patients with sciatica caused by lumbar disc prolapse that fails to resolve with conservative management. There is no scientific evidence on the effectiveness of any form of surgical decompression or fusion for degenerative lumbar spondylosis compared with natural history, placebo, or conservative management. The Cochrane reviews will be updated continuously as other trials become available.

Databases, Factual↗
PubMed1999

[Teaching resources of a hospital Gynecology-Obstetrics service. Review of the literature and practical applications].

OBJECTIVES: To summarize the methods encountered in a gynecological department for teaching medical students. STUDY: Review of the Medline literature underlying the benefits and disadvantages of each method using the issues of the modern theories of teaching. RESULTS: All the methods are helpful for learning, with different and complementary objectives. Students can constitute a set of skills using a teaching program containing clear objectives and evaluation on which the future medical practice will be based. CONCLUSION: Students have immediate benefits from an active clinical learning involving them and are prepared to the Continued Medical Education.

Case Management↗
PubMed1998

Behavioral responses to examination. A reappraisal of the interpretation of "nonorganic signs".

Waddell et al in 1980 developed a standardized assessment of behavioral responses to examination. The signs were associated with other clinical measures of illness behavior and distress, and are not simply a feature of medicolegal presentations. Despite clear caveats about the interpretation of the signs, they have been misinterpreted and misused both clinically and medicolegally. Behavioral responses to examination provide useful clinical information, but need to be interpreted with care and understanding. Isolated signs should not be overinterpreted. Multiple signs suggest that the patient does not have a straightforward physical problem, but that psychological factors also need to be considered. Some patients may require both physical management of their physical pathology and more careful management of the psychosocial and behavioral aspects of their illness. Behavioral signs should be understood as response affected by fear in the context of recovery from injury and the development of chronic incapacity. They offer only a psychological "yellow-flag" and not a complete psychological assessment. Behavioral signs are not on their own a test of credibility or faking.

Disability Evaluation↗
PubMed1998

Outcome measures for low back pain research. A proposal for standardized use.

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 meta-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 support such recommendations, more data on responsiveness and the minimally important change in scores are needed for most of the instruments.

Clinical Trials as Topic↗