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Biomedical subjects

Raymond W J G Ostelo

Publications and source records attributed to Raymond W J G Ostelo.

16 recordsLinked to original sources

Minimally important change determined by a visual method integrating an anchor-based and a distribution-based approach.

BACKGROUND: Minimally important changes (MIC) in scores help interpret results from health status instruments. Various distribution-based and anchor-based approaches have been proposed to assess MIC. OBJECTIVES: To describe and apply a visual method, called the anchor-based MIC distribution method, which integrates both approaches. METHOD: Using an anchor, patients are categorized as persons with an important improvement, an important deterioration, or without important change. For these three groups the distribution of the change scores on the health status instrument are depicted in a graph. We present two cut-off points for an MIC: the ROC cut-off point and the 95% limit cut-off point. RESULTS: We illustrate our anchor-based MIC distribution method determining the MIC for the Pain Intensity Numerical Rating Scale in patients with low back pain, using two conceivable definitions of minimal important change on the anchor. The graph shows the distribution of the scores of the health status instrument for the relevant categories on the anchor, and also the consequences of choosing the ROC cut-off point or the 95% limit cut-off point. DISCUSSION: The anchor-based MIC distribution method provides a general framework, applicable to all kind of anchors. This method forces researchers to choose and justify their choice of an appropriate anchor and to define minimal importance on that anchor. The MIC is not an invariable characteristic of a measurement instrument, but may depend, among other things, on the perspective from which minimal importance is considered and the baseline values on the measurement instrument under study. A balance needs to be struck between the practicality of a single MIC value and the validity of a range of MIC values.

Health Status Indicators↗

Reproducibility of the STARD checklist: an instrument to assess the quality of reporting of diagnostic accuracy studies.

BACKGROUND: In January 2003, STAndards for the Reporting of Diagnostic accuracy studies (STARD) were published in a number of journals, to improve the quality of reporting in diagnostic accuracy studies. We designed a study to investigate the inter-assessment reproducibility, and intra- and inter-observer reproducibility of the items in the STARD statement. METHODS: Thirty-two diagnostic accuracy studies published in 2000 in medical journals with an impact factor of at least 4 were included. Two reviewers independently evaluated the quality of reporting of these studies using the 25 items of the STARD statement. A consensus evaluation was obtained by discussing and resolving disagreements between reviewers. Almost two years later, the same studies were evaluated by the same reviewers. For each item, percentages agreement and Cohen's kappa between first and second consensus assessments (inter-assessment) were calculated. Intraclass Correlation coefficients (ICC) were calculated to evaluate its reliability. RESULTS: The overall inter-assessment agreement for all items of the STARD statement was 85% (Cohen's kappa 0.70) and varied from 63% to 100% for individual items. The largest differences between the two assessments were found for the reporting of the rationale of the reference standard (kappa 0.37), number of included participants that underwent tests (kappa 0.28), distribution of the severity of the disease (kappa 0.23), a cross tabulation of the results of the index test by the results of the reference standard (kappa 0.33) and how indeterminate results, missing data and outliers were handled (kappa 0.25). Within and between reviewers, also large differences were observed for these items. The inter-assessment reliability of the STARD checklist was satisfactory (ICC = 0.79 [95% CI: 0.62 to 0.89]). CONCLUSION: Although the overall reproducibility of the quality of reporting on diagnostic accuracy studies using the STARD statement was found to be good, substantial disagreements were found for specific items. These disagreements were not so much caused by differences in interpretation of the items by the reviewers but rather by difficulties in assessing the reporting of these items due to lack of clarity within the articles. Including a flow diagram in all reports on diagnostic accuracy studies would be very helpful in reducing confusion between readers and among reviewers.

Advisory Committees↗

Minimal clinically important change for pain intensity, functional status, and general health status in patients with nonspecific low back pain.

STUDY DESIGN: Cohort study. OBJECTIVES: To estimate the Minimal Clinically Important Change (MCIC) of the pain intensity numerical rating scale (PI-NRS), the Quebec Back Pain Disability Scale (QBPDS), and the Euroqol (EQ) in patients with low back pain. SUMMARY OF BACKGROUND DATA: MCIC can provide valuable information for researchers, healthcare providers, and policymakers. METHODS: Data from a randomized controlled trial with 442 patients with low back pain were used. The MCIC was estimated over a 12-week period, and three different methods were used: 1) mean change scores, 2) minimal detectable change, and 3) optimal cutoff point in receiver operant curves. The global perceived effect scale (GPE) was used as an external criterion. The effect of initial scores on the MCIC was also assessed. RESULTS: The MCIC of the PI-NRS ranged from 3.5 to 4.7 points in (sub)acute patients and 2.5 to 4.5 points in chronic patients with low back pain. The MCIC of the QBPDS was estimated between 17.5 to 32.9 points and 8.5 to 24.6 points for (sub)acute and chronic patients with low back pain. The MCIC for the EQ ranged from 0.07 to 0.58 in (sub)acute patients and 0.09 to 0.28 in patients with chronic low back pain. CONCLUSION: Reporting the percentage of patients who have made a MCIC adds to the interpretability of study results. We present a range of MCIC values and advocate the choice of a single MCIC value according to the specific context.

Adult↗

Comparison of the effectiveness of a behavioural graded activity program and manual therapy in patients with sub-acute neck pain: design of a randomized clinical trial.

The objective is to present the design of a randomized clinical trial (RCT) on the effectiveness and cost effectiveness of a behavioural graded activity programme compared with manual therapy in patients with sub-acute neck pain. Sub-acute is defined as pain existing for 4-12 weeks. The behavioural graded activity programme is a time-contingent increase in activities from baseline towards pre-determined goals. Manual therapy consists mainly of specific spinal mobilization techniques and exercises. The primary outcomes are global perceived effect and functional status. Secondary outcomes are kinesiophobia, distress, coping, depression and somatization. The intensity and persistence of the pain and its interference with activities are also assessed. Direct and indirect costs are measured by means of cost diaries. Measurements take place at baseline and 6 and 12 weeks after randomization. To assess the long-term effect, measurements will also take place after 6 and 12 months. Finally some challenges are discussed concerning the use of a behavioural graded activity programme, manual therapy and outcomes.

Behavior↗

Quality of reporting of diagnostic accuracy studies.

PURPOSE: To evaluate quality of reporting in diagnostic accuracy articles published in 2000 in journals with impact factor of at least 4 by using items of Standards for Reporting of Diagnostic Accuracy (STARD) statement published later in 2003. MATERIALS AND METHODS: English-language articles on primary diagnostic accuracy studies in 2000 were identified with validated search strategy in MEDLINE. Articles published in journals with impact factor of 4 or higher that regularly publish articles on diagnostic accuracy were selected. Two independent reviewers evaluated quality of reporting by using STARD statement, which consists of 25 items and encourages use of a flow diagram. Total STARD score for each article was calculated by summing number of reported items. Subgroup analyses were performed for study design (case-control or cohort study) by using Student t tests for continuous outcomes and chi(2) tests for dichotomous outcomes. RESULTS: Included were 124 articles published in 2000 in 12 journals: 33 case-control and 91 cohort studies. Only 41% of articles (51 of 124) reported on more than 50% of STARD items, while no articles reported on more than 80%. A flow chart was presented in two articles. Assessment of reporting on individual items of STARD statement revealed wide variation, with some items described in 11% of articles and others in 92%. Mean STARD score (0-25 points available) was 11.9 (range, 3.5-19.5). Mean difference in STARD score between cohort studies and case-control studies was 1.53 (95% confidence interval: 0.24, 2.82). CONCLUSION: Quality of reporting in diagnostic accuracy articles published in 2000 is less than optimal, even in journals with high impact factor. Authors, editors, and reviewers should pay more attention to reporting by checking STARD statement items and including a flow diagram to represent study design and patient flow.

Case-Control Studies↗

Residual complaints following lumbar disc surgery: prognostic indicators of outcome.

Physical as well as psychological features might be important prognostic factors for residual complaints following lumbar disc surgery in primary care. No studies have yet investigated both factors simultaneously. The aim of this prospective cohort study was to identify indicators of the short and long-term outcome of residual complaints following lumbar disc surgery. Patients (n=105), aged between 18 and 65 years, were included if they still suffered residual complaints 6 weeks after first-time lumbar disc surgery and had therefore been referred to physiotherapy. All potential indicators were measured at baseline except treatment expectancy, which was measured after two treatment sessions enabling patients to rate treatment expectancy based on their actual perception of the treatment. Dimensions of recovery included perceived recovery, functional status, and pain intensity (back and leg) at the 3-month and 12-month follow-up. It was found that high treatment expectancy was associated with a favorable outcome on perceived recovery and functional status, both at the 3 and the 12-month follow-up. Taking pain medication and a poor functional status at baseline were associated with poor perceived recovery and functional status at both follow-up measurements. Leg pain and back pain at baseline were associated with residual leg and back pain at the 3 and the 12-month follow-up, respectively. The results for perceived recovery and functional status were rather robust. However, for leg pain and back pain, the results were less stable. Apparently, the clinical course to recovery of residual leg pain and residual back pain is not strongly influenced by these indicators.

Adolescent↗

Clinically important outcomes in low back pain.

Four important domains directly related to low back pain are: pain intensity, low-back-pain-specific disability, patient satisfaction with treatment outcome, and work disability. Within each of the domains, different questionnaires have been proposed. This chapter focuses on validated and widely used questionnaires. Details of the background and the measurement properties, and of the minimally clinically important change (MCIC) using these questionnaires, are described. The MCIC can be estimated using various methods and there is no consensus in the literature on what the most appropriate technique is. This chapter focuses primarily on two adequate and frequently used methods for estimating the MCIC. We argue that the MCIC should not be considered as a fixed value and that the MCIC values presented in this chapter are used as indications. For patients with subacute or chronic low back pain, the MCIC for pain on a visual analogue scale (VAS) should at least be 20mm and for acute low back pain it seems reasonable to suggest that the MCIC should at least be at the level of approximately 35mm. If a numerical rating scale (NRS) is used it seems reasonable to suggest that the MCIC should at least be 3.5 and 2.5 for patients with acute and chronic low back pain, respectively. For functional disability as measured with the Roland Disability Questionnaire it seems reasonable that the MCIC should at least be 3.5 points, whereas an MCIC of at least 10 points when the Oswestry Disability Index is used. For global perceived effect, we argue that the MCIC is most appropriately defined in terms of at least 'much improved' or 'very satisfied', instead of including 'slightly improved'. Finally, we argue that, from the point of view of cost effectiveness, every day of earlier return to work is important. The exact value for the MCIC can be determined, taking into account the aim of the measurement, the initial scores, the target population and the method used to assess MCIC.

Disability Evaluation↗

Health care providers' orientations towards common low back pain predict perceived harmfulness of physical activities and recommendations regarding return to normal activity.

The Pain Attitudes and Beliefs Scale for Physiotherapists (PABS-PT) differentiates between a biomedical versus a biopsychosocial treatment orientation with regard to common low back pain. This study re-examined the factor structure and psychometric properties of the PABS-PT, along with the relationship between PABS-PT scores and the perceived harmfulness of physical activities and treatment recommendations for common low back pain. Two hundred and ninety-seven paramedical therapists completed the PABS-PT and questionnaires measuring related concepts, rated the perceived harmfulness of 41 daily physical activities depicted in photographs and gave recommendations for return to normal activity for three patients with low back pain. Analysis revealed two factors labelled 'biomedical' and 'biopsychosocial treatment orientation'. Furthermore, scores on both factors of the PABS-PT were related to measures of related concepts (statistically significant Pearson correlation coefficients between 0.30 and 0.65) such as the HC-PAIRS and a therapist version of the TSK. Regression analyses revealed that both factors were consistent predictors of judgements of the harmfulness of physical activities (PHODA) and of recommendations for return to work and normal activity.

Aged↗

Effectiveness of exercise therapy: a best-evidence summary of systematic reviews.

The purpose of this project was to summarise the available evidence on the effectiveness of exercise therapy for patients with disorders of the musculoskeletal, nervous, respiratory, and cardiovascular systems. Systematic reviews were identified by means of a comprehensive search strategy in 11 bibliographic databases (08/2002), in combination with reference tracking. Reviews that included (i) at least one randomised controlled trial investigating the effectiveness of exercise therapy, (ii) clinically relevant outcome measures, and (iii) full text written in English, German or Dutch, were selected by two reviewers. Thirteen independent and blinded reviewers participated in the selection, quality assessment and data-extraction of the systematic reviews. Conclusions about the effectiveness of exercise therapy were based on the results presented in reasonable or good quality systematic reviews (quality score > or = 60 out of 100 points). A total of 104 systematic reviews were selected, 45 of which were of reasonable or good quality. Exercise therapy is effective for patients with knee osteoarthritis, sub-acute (6 to 12 weeks) and chronic (> or = 12 weeks) low back pain, cystic fibrosis, chronic obstructive pulmonary disease, and intermittent claudication. Furthermore, there are indications that exercise therapy is effective for patients with ankylosing spondylitis, hip osteoarthritis, Parkinson's disease, and for patients who have suffered a stroke. There is insufficient evidence to support or refute the effectiveness of exercise therapy for patients with neck pain, shoulder pain, repetitive strain injury, rheumatoid arthritis, asthma, and bronchiectasis. Exercise therapy is not effective for patients with acute low back pain. It is concluded that exercise therapy is effective for a wide range of chronic disorders.

Chronic Disease↗

Conservative treatment in patients with an acute lumbosacral radicular syndrome: design of a randomised clinical trial [ISRCTN68857256].

BACKGROUND: The objective is to present the design of randomised clinical trial (RCT) on the effectiveness of physical therapy added to general practitioners management compared to general practitioners management only in patients with an acute lumbosacral radicular syndrome (also called sciatica). METHODS/DESIGN: Patients in general practice diagnosed with an acute (less than 6 weeks) lumbosacral radicular syndrome and an age above 18 years are eligible for participation. The general practitioners treatment follows their clinical guideline. The physical therapy treatment will consist of patient education and exercise therapy. The primary outcome measure is patients reported global perceived effect. Secondary outcome measures are severity of complaints, functional status, health status, fear of movement, medical consumption, sickness absence, costs and treatment preference. The follow-up is 52 weeks. DISCUSSION: Treatment by general practitioners and physical therapists in this study will be transparent and not a complete "black box". The results of this trial will contribute to the decision of the general practitioner regarding referral to physical therapy in patients with an acute lumbosacral radicular syndrome.

Acute Disease↗

Economic evaluation of a behavioral-graded activity program compared to physical therapy for patients following lumbar disc surgery.

STUDY DESIGN: An economic evaluation was conducted alongside a randomized controlled trial. SUMMARY OF BACKGROUND DATA: Little is known about the effectiveness of cognitive-behavioral treatment options for patients following lumbar disc surgery. If the knowledge available was supported by an economic evaluation, the information could then be used to make recommendations for the implementation of cognitive-behavioral treatment in the routine of rehabilitation following lumbar disc surgery. OBJECTIVE: To examine the cost-effectiveness of a behavioral-graded activity program, which is an operant treatment, compared to usual care as delivered by a physical therapist for patients following first-time lumbar disc surgery. METHODS: For the economic evaluation, a societal viewpoint was applied. The primary outcome measures (measured at the 12-month follow-up) were global perceived effect and functional status. To evaluate the economic consequences of the treatments, direct health care and non-health care costs were considered, as well as indirect costs. RESULTS: The clinical outcomes showed no relevant differences between behavioral-graded activity (n = 52) and UC (n = 53). Treatment costs were almost identical in the two intervention groups. The difference in direct health care costs was, although not statistically significant, 264 EURO [95% CI: -3-525] higher in behavioral-graded activity than in usual care per patient-year. It was mainly the excess cost of visiting the physiotherapist in the behavioral-graded activity group that accounted for this difference. The difference in direct non-health care costs, although not statistically significant, was 388 EURO [95% CI: -217; 992] lower in the usual care group due to unpaid help by friends or family. Consequently, although again not statistically significant, the total direct costs in behavioral-graded activity are 639 EURO [95% CI: -91; 1368] higher than in usual care. For the indirect costs, there was a statistically significant difference, behavioral-graded activity being more expensive. The sensitivity analysis showed that these results are fairly robust. CONCLUSIONS: This study concludes that there are no differences between the two treatment conditions on any of the clinical outcome measures but that behavioral-graded activity is associated with higher costs. Consequently, there is no reason for the implementation of behavioral-graded activity as the standard treatment for patients following lumbar disc surgery.

Adult↗

24-item Roland-Morris Disability Questionnaire was preferred out of six functional status questionnaires for post-lumbar disc surgery.

OBJECTIVE: Measurement properties of questionnaires should be based on samples of populations on whom these measurements will be used. The purpose of this study is to establish an evidence based recommendation regarding the use of functional status questionnaires in patients following a lumbar disc surgery by a direct comparison of the reproducibility and responsiveness. STUDY DESIGN AND SETTING: The measurement properties of six functional status questionnaires were assessed: 1) Roland-Morris Disability Questionnaire (RDQ-24), 2) Modified Roland-Morris Disability Questionnaire (MRDQ), 3) short Roland-Morris Disability Questionnaire (RM-18), 4) Physical Functioning scale, 5) Role Limitations-Physical scale of the SF-36, and 6) The Main Complaint (MC). Subjects (n=97) that still suffered residual complaints 6 weeks following a lumbar disc surgery completed the questionnaires before and 3 months after treatment. In a direct comparison the A) The test-retest reproducibility (Intraclass Correlation Coefficients [ICC] and the Standard Error of Measurement [SEM]) and B) 3 parameters of responsiveness (Minimal Detectable Change [MDC], Standardised Response Mean [SRM], and the Area Under the receiver operator characteristic Curve [AUC]) were assessed. RESULTS: This study suggests the superiority of the 3 versions of the RDQ compared to the 3 other questionnaires. Comparing the 3 versions of the RDQ reveals no substantial differences thereby indicating that the 2 modified version of the RDQ hold no better measurement properties in this specific population. CONCLUSION: The use of the RDQ-24 for this specific post-surgery population is suggested. The optimal cut-off point of the RDQ-24 that minimizes the overall classification error was found to be 3.5 with a sensitivity of 94.6% and a specificity of 88.2%.

Activities of Daily Living↗

Behavioral graded activity following first-time lumbar disc surgery: 1-year results of a randomized clinical trial.

STUDY DESIGN AND OBJECTIVES: In a randomized clinical trial, the effectiveness of behavioral graded activity was assessed as compared to usual care provided by physiotherapists for patients after first-time lumbar disc surgery (n = 105). SUMMARY OF BACKGROUND DATA: Little is known about the effectiveness of rehabilitation programs following lumbar disc surgery. Most programs focus on biomechanical aspects, whereas psychosocial factors are hardly addressed. The aim of the behavioral graded activity program, which is an operant treatment, is to alter psycho-social factors such as fear of movement and pain catastrophizing, which might subsequently lead to improved functional status and higher rates of recovery. Behavioral treatments for patients following lumbar disc surgery have not yet been assessed in a randomized clinical trial. METHODS INCLUSION CRITERIA: age between 18 and 65 years; first-time lumbar disc surgery; restrictions in normal activities of daily living. EXCLUSION CRITERIA: surgical complications and confirmed and relevant underlying diseases. Outcome assessment took place at 6 and 12 months after randomization. RESULTS: Six months after randomization, 62% of the patients had recovered following usual care versus 65% of the patients following behavioral graded activity. After 12 months, 73% and 75%, respectively, had recovered. Differences between intervention groups, 3% and 2% respectively, after 6 and 12 months are not statistically significant. Furthermore, there were no differences between the two groups regarding functional status, pain, pain catastrophizing, fear of movement, range of motion, general health, social functioning or return to work. After 1 year, 4 of the behavioral graded activity cases had undergone another operation versus 2 of usual care cases. CONCLUSION: Both fear of movement and pain catastrophizing seem to be unaffected by either treatment in these patients. It is concluded that treatment principles derived from theories within the field of chronic low back pain might not apply to these patients. After 1 year of follow-up, there were no statistically significant or clinically relevant differences between the behavioral graded activity program and usual care as provided by physiotherapists for patients following first-time lumbar disc surgery.

Adult↗

Rehabilitation following first-time lumbar disc surgery: a systematic review within the framework of the cochrane collaboration.

STUDY DESIGN: A systematic review of randomized controlled trials. 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 of these treatments, and there are still persistent fears of causing reinjury, reherniation, 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. METHODS: The authors searched the MEDLINE, Embase, and Psyclit databases up to April 2000 and the Cochrane Controlled Trials Register 2001, issue 3. Both randomized and nonrandomized controlled trials on any type of active rehabilitation program after first-time disc surgery were included. Two independent reviewers performed the inclusion of studies, and two other reviewers independently performed the methodologic quality assessment. A rating system that consists of four levels of scientific evidence summarizes the results. 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 postsurgery, mainly because of the lack of good quality studies. For treatments that start 4 to 6 weeks postsurgery, 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 is 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 postsurgery, 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 postsurgery or later. None of the investigated treatments seem harmful with regard to reherniation or reoperation. 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 postoperative) and no evidence they increase the reoperation rate. It is unclear what the exact content of postsurgery rehabilitation should be. Moreover, there are no studies that investigated whether active rehabilitation programs should start immediately postsurgery or possibly 4 to 6 weeks later.

Controlled Clinical Trials as Topic↗

Health care providers' attitudes and beliefs towards common low back pain: factor structure and psychometric properties of the HC-PAIRS.

OBJECTIVE: The factor structure, reliability and validity of the Health Care Providers' Pain and Impairment Relationship Scale (HC-PAIRS) were determined in the current study. Furthermore, the ability of the HC-PAIRS to serve as a predictor for work and activity recommendations of paramedical health care providers was examined. DESIGN: For the current study, 156 therapists from several paramedical disciplines (mostly physiotherapy, manual therapy, chiropractic, and McKenzie) completed the HC-PAIRS and questionnaires measuring the perceived harmfulness of physical activities. Furthermore, the therapists gave recommendations for work and physical activity for patients described in vignettes. Since a factor structure was already known for the HC-PAIRS a confirmatory factor analysis was carried out. Reliability of the HC-PAIRS was determined by computing Cronbach's alpha. Validity was examined by reviewing associations between scores on the HC-PAIRS and scores on measures of the harmfulness of physical activities and recommendations for work and physical activity. Regression analyses were carried out to determine whether scores on the HC-PAIRS were a predictor of recommendations for work and physical activity while controlling for other variables. RESULTS: In contrast to previous research, factor analysis revealed only 1 factor and suggested that 2 items should be removed from the HC-PAIRS. This factor had a Cronbach's alpha of 0.84. The HC-PAIRS showed adequate validity. All associations between scores on the HC-PAIRS and scores on measures of the harmfulness of physical activities and recommendations for work and physical activity were in the expected directions and ranged between 0.25 and 0.62 (P < 0.01). Scores on the HC-PAIRS were the only significant predictor of recommendations for work and physical activity when controlling for possible confounders including gender, years of experience in the treatment of back pain, judgments of severity of symptoms, and judgments of severity of pathology. CONCLUSION: The HC-PAIRS appears to be a reliable and valid measure of health care providers' attitudes and beliefs about the relationship between pain and impairment. The role of health care providers' attitudes in the treatment of low back pain is discussed.

Activities of Daily Living↗