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Study Design: Literature review, expert panel, and a workshop during the "VIII International Forum on Primary Care Research on Low Back Pain" (Amsterdam, June 2006)., Objective: To develop practical guidance regarding the minimal important change (MIC) on frequently used measures of pain and functional status for low back pain., Summary of Background Data: Empirical studies have tried to determine meaningful changes for back pain, using different methodologies. This has led to confusion about what change is clinically important for commonly used back pain outcome measures., Methods: This study covered the Visual Analogue Scale (0-100) and the Numerical Rating Scale (0-10) for pain and for function, the Roland Disability Questionnaire (0-24), the Oswestry Disability Index (0-100), and the Quebec Back Pain Disability Questionnaire (0-100). The literature was reviewed for empirical evidence. Additionally, experts and participants of the VIII International Forum on Primary Care Research on Low Back Pain were consulted to develop international consensus on clinical interpretation., Results: There was wide variation in study design and the methods used to estimate MICs, and in values found for MIC, where MIC is the improvement in clinical status of an individual patient. However, after discussion among experts and workshop participants a reasonable consensus was achieved. Proposed MIC values are: 15 for the Visual Analogue Scale, 2 for the Numerical Rating Scale, 5 for the Roland Disability Questionnaire, 10 for the Oswestry Disability Index, and 20 for the QBDQ. When the baseline score is taken into account, a 30% improvement was considered a useful threshold for identifying clinically meaningful improvement on each of these measures., Conclusion: For a range of commonly used back pain outcome measures, a 30% change from baseline may be considered clinically meaningful improvement when comparing before and after measures for individual patients. It is hoped that these proposals facilitate the use of these measures in clinical practice and the comparability of future studies. The proposed MIC values are not the final answer but offer a common starting point for future research.

Aim: To estimate the minimal important change (MIC) of the total PRAFAB questionnaire (PRAFAB-Q) score in women referred for physiotherapy intervention following primary or recurrent episodes of stress urinary incontinence. MIC values could be applied to individual patients and used as a threshold by which practitioners decide to continue, change or end a specific intervention., Methods: Data were derived from a prospective cohort study of 279 mainly Caucasian women. MIC values were determined by: (1) the 'mean change' method, (2) the ROC method, and (3) the 95% limit cut-off point, visualized by the 'anchor-based MIC distribution'. These MIC values were compared to the smallest detectable change (SDC) accounting for measurement error. The effect of initial baseline scores on the MIC was assessed., Results: The results of all methods used to define the MIC ranged from 1.9 to 2.7 points (SDC = 1.6) for the non-severe and 3.6-4.1 (SDC = 2.3) for the severe stratified patients. All MIC estimates were larger than the measurement error as determined by the SDC., Conclusions: The total PRAFAB-Q score is a brief and simple outcome measure that easily can be used to monitor progress and to interpret meaningful improvement in individual women with stress UI in everyday clinical practice.

Background: Carpal tunnel syndrome is a common disorder for which several surgical treatment options are available., Objectives: To compare the efficacy of the various surgical techniques in relieving symptoms and promoting return to work or activities of daily living and to compare the occurrence of side-effects and complications in patients suffering from carpal tunnel syndrome., Search Strategy: We updated the searches in 2006. We conducted computer-aided searches of the Cochrane Neuromuscular Disease Group Trials Register (searched in June 2006), Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2006, Issue 2), MEDLINE (January 1966 to June 2006), EMBASE (January 1980 to June 2006) and also tracked references in bibliographies., Selection Criteria: Randomised controlled trials comparing various surgical techniques for the treatment of carpal tunnel syndrome., Data Collection and Analysis: Two review authors performed study selection, assessment of methodological quality and data extraction independently of each other., Main Results: Thirty-three studies were included in the review of which 10 were newly identified in this update. The methodological quality of the trials ranged from fair to good; however, the use of allocation concealment was mentioned explicitly in only seven trials. Many studies failed to present the results in sufficient detail to enable statistical pooling. Pooling was also impeded by the vast variety of outcome measures that were applied in the various studies. None of the existing alternatives to standard open carpal tunnel release offered significantly better relief from symptoms in the short- or long-term. In three studies with a total of 294 participants, endoscopic carpal tunnel release resulted in earlier return to work or activities of daily living than open carpal tunnel release, with a weighted mean difference of -6 days (95% CI -9 to -3 days)., Authors' Conclusions: There is no strong evidence supporting the need for replacement of standard open carpal tunnel release by existing alternative surgical procedures for the treatment of carpal tunnel syndrome. The decision to apply endoscopic carpal tunnel release instead of open carpal tunnel release seems to be guided by the surgeon's and patient's preferences.

Background: Balneotherapy (or spa therapy, mineral baths) for patients with arthritis is one of the oldest forms of therapy. One of the aims of balneotherapy is to soothe the pain and as a consequence to relieve patients' suffering and make them feel well. In this update we included one extra study., Objectives: To assess the effectiveness of balneotherapy for patients with osteoarthritis (OA)., Search Strategy: We searched the following databases up to October 2006: EMBASE, PubMed, the Cochrane 'Rehabilitation and Related Therapies' Field database, PEDro, CENTRAL (Issue 3, 2006) and performed reference checking and communicated with authors to retrieve eligible studies., Selection Criteria: Randomised controlled trials (RCT) comparing balneotherapy with any intervention or no intervention. At least 90% of the patient population had to be diagnosed with OA., Data Collection and Analysis: Two authors independently assessed quality and extracted data. Disagreements were solved by consensus. In the event of clinical heterogeneity or lack of data we refrained from statistical pooling., Main Results: Seven trials (498 patients) were included in this review. Two studies compared spa-treatment with no treatment. One study evaluated baths as an add-on treatment to home exercises and another compared thermal water from Cserkeszölö with tap water (placebo). Three studies evaluated sulphur or Dead Sea baths with no treatment or mineral baths with tap water baths or no treatment. Only one of the trials performed an intention-to-treat analysis and two studies provided data to perform an intention-to-treat analysis ourselves. A 'quality of life' outcome was reported by one trial. We found: silver level evidence concerning the beneficial effects on pain, quality of life and analgesic intake of mineral baths compared to no treatment (SMD between 1.82 and 0.34). a statistically significant difference in pain and function of Dead Sea + sulphur versus no treatment, only at end of treatment (WMD 5.7, 95%CI 3.3 to 8.1), but not at 3 month follow-up (WMD 2.6, 95%CI -1.1 to 6.3). no statistically significant differences in pain or function at one or three months of Dead Sea baths versus no treatment (WMD 0.5, 95%CI -0.6 to 1.6) or at one or three months of sulphur baths versus no treatment (WMD 0.4, 95%CI -0.9 to 1.7). Adverse events were not measured in the included trials., Authors' Conclusions: We found silver level evidence (www.cochranemsk.org) concerning the beneficial effects of mineral baths compared to no treatment. Of all other balneological treatments no clear effects were found. However, the scientific evidence is weak because of the poor methodological quality and the absence of an adequate statistical analysis and data presentation. Therefore, the noted "positive findings" should be viewed with caution.

Background: Successful management of workers on sick leave due to low back pain by the general physician and physiotherapist depends on reliable prognostic information on the course of low back pain and work resumption., Methods: Retrospective cohort study in 194 patients who were compensated because of chronic low back pain and who were treated by a physiotherapy functional restoration program. Patient-reported and clinician based prognostic indicators were assessed at baseline before patients entered the functional restoration program. We investigated the predictive value of these indicators on work status at 6 months. Relationships were studied using logistic regression analysis in a 2-step bootstrap modelling approach and a nomogram was developed. Discrimination and calibration of the nomogram was evaluated internally and the explained variation of the nomogram calculated., Results: Seventy percent of workers were back to work at 6 months. We found that including duration of complaints, functional disability, disc herniation and fear avoidance beliefs resulted in the "best" prognostic model. All these factors delayed work resumption. This model was used to construct a nomogram. The explained variation of the nomogram was 23.7%. Discrimination was estimated by the area under the receiver operating characteristic curve and was 0.76 and for calibration we used the slope estimate that was 0.91. The positive predictive values of the nomogram at different cut-off levels of predicted probability were good., Conclusions: Knowledge of the predictive value of these indicators by physicians and physiotherapists will help to identify subgroups of patients and will thus enhance clinical decision-making.

Background: Conservative interventions such as physiotherapy and ergonomic adjustments (such as keyboard adjustments or ergonomic advice) play a major role in the treatment of most work-related complaints of the arm, neck or shoulder (CANS). Objectives. This systematic review aims to determine whether conservative interventions have a significant impact on outcomes for work-related CANS in adults. Search strategy. We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (March 2005) and Cochrane Rehabilitation and Related Therapies Field Specialised Register (March 2005), the Cochrane Controlled Trials Register (The Cochrane Library, Issue 1, 2005), PubMed, EMBASE, CINAHL, AMED and reference lists of articles. The date of the last search was March 2005. No language restrictions were applied. Selection criteria. We included randomised controlled trials and concurrent controlled trials studying conservative interventions (e.g. exercises, relaxation, physical applications, biofeedback, myofeedback and work-place adjustments) for adults suffering CANS. Data collection and analysis. Two authors independently selected trials from the search yield, assessed the methodological quality using the Delphi list, and extracted relevant data. We pooled data or, in the event of clinical heterogeneity or lack of data, we used a rating system to assess levels of evidence., Main Results: For this update we included six additional studies; twenty-one trials in total. Seventeen trials included people with chronic nonspecific neck or shoulder complaints, or nonspecific upper extremity disorders. Over twenty-five interventions were evaluated; six main subgroups of interventions could be determined: exercises, manual therapy, massage, ergonomics, energised splint and individual treatment versus group therapy. Overall, the quality of the studies was poor. In 14 studies a form of exercise was evaluated, and contrary to the previous review we now found limited evidence about the effectiveness of exercises when compared to massage and conflicting evidence when exercises are compared to no treatment. In this update there is limited evidence for adding breaks during computer work; massage as add-on treatment on manual therapy, manual therapy as add-on treatment on exercises; and some keyboard designs when compared to other keyboards or placebo in participants with carpal tunnel syndrome., Conclusions: There is limited evidence for the effectiveness of keyboards with an alternative force-displacement of the keys or an alternative geometry, and limited evidence for the effectiveness of exercises compared to massage, breaks during computer work compared to no breaks; massage as an add-on treatment to manual therapy, and manual therapy as an add-on treatment to exercises.

Background: To date, mental health problems and mental workload have been increasingly related to long-term sick leave and disability. However, there is, as yet, no structured protocol available for the identification and application of an intervention for stress-related mental health problems at the workplace. This paper describes the structured development, implementation and planning for the evaluation of a return-to-work intervention for sick-listed employees with stress-related mental disorders (SMDs). The intervention is based on an existing successful return-to-work intervention for sick-listed employees with low back pain., Methods: The principles of Intervention Mapping were applied to combine theory and evidence in the development, implementation and planning for the evaluation of a participatory workplace intervention, aimed at an early return-to-work for sick-listed employees with SMDs. All stakeholders were involved in focus group interviews: i.e. employees recently sick-listed with SMDs, supervisors and occupational health professionals., Results: The development of the participatory workplace intervention according to the Intervention Mapping principles resulted in a structured return-to-work intervention, specifically tailored to the needs of sick-listed employees with SMDs. Return-to-work was proposed as a behavioural change, and the Attitude - Social influence - self-Efficacy model was identified as a theoretical framework. Stakeholder involvement in focus group interviews served to enhance the implementation. The cost-effectiveness of the intervention will be evaluated in a randomised controlled trial., Conclusion: Intervention Mapping was found to be a promising method to develop interventions tailored to a specific target group in the field of occupational health.

Measuring quality of life is a necessity for adequate interventions. This paper concerns the usefulness of six self-report measures for overall quality of life for nursing home residents with various levels of cognitive impairment. It was investigated which proportion of residents from four cognition groups could complete a scale, and internal consistency and construct validity of the scales were studied. Data collection took place in ten Dutch nursing homes (N = 227). The proportion of residents that could complete each scale varied. The Depression List could be administered most often to the cognitively most impaired group (43%; Mini Mental State Examination-scores 0-4). In the three cognition groups with MMSE-score >5, internal consistency of the Depression List, Geriatric Depression Scale and Negative Affect Scale was adequate in all three groups (alpha > or =.68). Intercorrelation was highest for the Philadelphia Geriatric Center Morale Scale, the Depression List, and the Geriatric Depression Scale (rho > or =.65). Nonetheless, self-report scales were not strongly correlated with two observational scales for depression, especially in cognitively severely impaired residents (rho < or =.30). In conclusion, it may not be possible to measure overall quality of life through self-report, and possibly also through observation, in many nursing home residents.

Background: The Sense of Competence Questionnaire (SCQ) was originally developed for informal caregivers of patients with diagnosed dementia. In order to study the validity and usefulness of the SCQ when applied to informal caregivers of older adults with dementia symptoms (i.e. cognitive impairment, pre-diagnostic dementia or dementia in its early stages), we investigated the construct validity, feasibility, subscales, homogeneity, and floor and ceiling effects in this new target population., Methods: A psychometric evaluation was performed among 99 informal caregivers. To investigate construct validity, hypotheses were tested, concerning the association between sense of competence and burden, mental quality of life, depressive symptoms, and mastery. To investigate feasibility, response rate and the proportion of missing data were explored for each item. An exploratory principal component analysis was used to investigate whether the SCQ comprises the three subscales established in previous studies. Homogeneity was assessed for each subscale with Cronbach's alpha and item-total correlations. Floor and ceiling effects were explored., Results: Most hypotheses on construct validity were rejected. Only the subscale 'consequences of involvement in care' was found to be partly valid. Feasibility: 93 out of 99 persons completed the SCQ. The proportion of unanswered items per item ranged from 0-3%. Subscales: the SCQ comprises the three expected subscales. Homogeneity: Cronbach's alpha and item-total correlations of the three subscales were satisfactory. A ceiling effect occurred on the subscale 'satisfaction with the care recipient'., Conclusion: The three subscales of the SCQ showed good homogeneity and feasibility, but their validity is insufficient: only the subscale 'consequences of involvement' was found to be partly valid. The two other subscales might not be relevant yet for the new target population, since many of the items on these scales refer to problem behaviour and problematic interactions. Our message to clinicians is not to use these subscales.

Background: Injection with anaesthetics and/or steroids is one of the treatment modalities used in patients with chronic low back pain which needs evaluation with respect to the effectiveness on short and long term pain relief., Objectives: To evaluate the effectiveness of injection therapy in patients with low back pain lasting longer than one month. We distinguished between three injection sites: facet joint, epidural or local injections., Search Strategy: We searched the Medline and Embase databases up to 1996 and other search methods as advocated by the Back Review Group search strategy. Abstracts and unpublished studies were not included., Selection Criteria: Randomized controlled trials of injection therapy for pain relief (although additional treatments were allowed) in patients with benign low back pain lasting longer than one month and not originating from cancer., Data Collection and Analysis: Two authors independently assessed the trials for methodological quality. Subgroup analyses were made between trials with different control groups (placebo and active injections), with different injection site (facet joint, epidural and local injection), and timing of outcome measurement (short and long term). Within the resulting 12 subcategories of studies (2*3*2), the overall relative risks and corresponding 95% confidence intervals were estimated, using a random effects model (DerSimonian and Laird). In the case of trials in which control groups were active injections, we refrained from pooling the results., Main Results: Twenty-one randomized trials were included in this review. All studies involved patients with low back pain lasting longer than one month. Only 11 studies compared injection therapy with placebo injections (explanatory trials). The methodologic quality of many studies was low: only 8 studies had a methodologic score of 50 or more points. There were only three well designed explanatory clinical trials: one on injections into the facet joints with a short-term RR of 0.89 (95% CI: 0.65-1.21) and a long-term RR of 0.90 (95% CI: 0.69-1.17); one on epidural injections with a short-term RR of 0.94 (95% CI: 0.76-1.15) and a long-term RR of 1.00 (95% CI: 0.71-1.41); and one on local injections with a long-term RR of 0.79 (95% CI: 0.65-0.96). Within the 6 subcategories of explanatory studies the pooled RRs with 95% confidence intervals were: facet joint, short-term: RR=0.89 (0.65-1.21); facet joint, long-term: RR=0.90 (0.69-1.17); epidural, short-term: RR=0.93 (0.79-1.09); epidural, long-term: RR=0.92 (0.76-1.11); local, short-term: RR=0.80 (0.40-1.59); local, long-term: RR=0.79 (0.65-0.96)., Authors' Conclusions: Convincing evidence is lacking on the effects of injection therapies for low back pain. There is a need for more, well designed explanatory trials in this field.

Background: Missing data is a challenging problem in many prognostic studies. Multiple imputation (MI) accounts for imputation uncertainty that allows for adequate statistical testing. We developed and tested a methodology combining MI with bootstrapping techniques for studying prognostic variable selection., Method: In our prospective cohort study we merged data from three different randomized controlled trials (RCTs) to assess prognostic variables for chronicity of low back pain. Among the outcome and prognostic variables data were missing in the range of 0 and 48.1%. We used four methods to investigate the influence of respectively sampling and imputation variation: MI only, bootstrap only, and two methods that combine MI and bootstrapping. Variables were selected based on the inclusion frequency of each prognostic variable, i.e. the proportion of times that the variable appeared in the model. The discriminative and calibrative abilities of prognostic models developed by the four methods were assessed at different inclusion levels., Results: We found that the effect of imputation variation on the inclusion frequency was larger than the effect of sampling variation. When MI and bootstrapping were combined at the range of 0% (full model) to 90% of variable selection, bootstrap corrected c-index values of 0.70 to 0.71 and slope values of 0.64 to 0.86 were found., Conclusion: We recommend to account for both imputation and sampling variation in sets of missing data. The new procedure of combining MI with bootstrapping for variable selection, results in multivariable prognostic models with good performance and is therefore attractive to apply on data sets with missing values.

Objective: To examine whether a new screening method that identified patients with cognitive impairment who needed further examination on the presence of dementia yielded patients who were not detected by their general practitioner (GP), and to identify factors associated with GPs' awareness of patients identified by the screening., Methods: Cross-sectional comparison between two methods used to identify dementia symptoms: (1) usual identification of dementia by GPs; (2) a two-stage screening to identify cognitive impairment. The two methods were implemented on the same older general practice population. The study was set in primary care practices in the Netherlands. The participants were 44 GPs and 2,101 general practice patients aged 75+ who lived at home. The following measurements were used: (1) yield of the screening; (2) determinants of GPs' awareness of patients identified by the screening., Results: The two-stage screening yielded 117 patients with cognitive impairment who needed further examination; in most cases (n = 82, 70.1%) their GP was unaware of the symptoms. Among patients identified by the screening, GPs' awareness was associated with co-morbidity of chronic diseases [odds ratio (OR) = 3.19; 95% Confidence Interval (CI) = 1.25 to 8.15], depressive symptoms (OR = 0.41; 95% CI = 0.17 to 0.99), and cognitive functioning (per point on the MMSE, OR = 0.88; 95% CI = 0.79 to 0.98)., Conclusion: A two-stage screening method and increased alertness for cognitive impairment and dementia among patients with depressive symptoms may improve detection rate of dementia in general practice., (Copyright 2006 John Wiley & Sons, Ltd.)

Background: Traction is used to treat low-back pain (LBP), often with other treatments., Objectives: To determine traction's effectiveness, compared to reference treatments, placebo, sham traction or no treatment for LBP., Search Strategy: We searched CENTRAL (The Cochrane Library 2006, issue 4), MEDLINE, EMBASE, and CINAHL to October 2006, references in relevant reviews and personal files., Selection Criteria: Randomized controlled trials (RCTs) involving traction to treat acute (less than four weeks duration), sub-acute (four to 12 weeks) or chronic (more than 12 weeks) non-specific LBP with or without sciatica., Data Collection and Analysis: Study selection, methodological quality assessment and data extraction were done independently by two authors. As there were insufficient data for statistical pooling, we performed a qualitative analysis., Main Results: We included 25 RCTs (2206 patients; 1045 receiving traction). Five trials were considered high quality. For patients with mixed symptom patterns (acute, sub-acute and chronic LBP with and without sciatica) there is: strong evidence of no statistically significant difference in outcomes between traction as a single treatment and placebo, sham or no treatment; moderate evidence that traction as a single treatment is no more effective than other treatments; limited evidence of no significant difference in outcomes between a standard physical therapy program with or without continuous traction. For LBP patients with sciatica (with acute, sub-acute or chronic pain), there is conflicting evidence in several comparisons: autotraction compared to placebo, sham or no treatment; other forms of traction compared to other treatments; different forms of traction. In other comparisons, there were no statistically significant differences; the evidence is moderate for continuous or intermittent traction compared to placebo, sham or no treatment, and limited for light versus normal force traction., Implications for Practice: The results of the available studies involving mixed groups of acute, sub-acute and chronic patients with LBP with and without sciatica were quite consistent, indicating that continuous or intermittent traction as a single treatment for LBP is not likely effective for this group. Traction for patients with sciatica cannot be judged effective at present either, due to inconsistent results and methodological problems in most studies. We conclude that traction as a single treatment for LBP is probably not effective., Implications for Research: Any future research on traction for patients with LBP should distinguish between symptom pattern and duration, and should be carried out according to the highest methodological standards.

Clinical provocative tests of the neck, which position the neck and arm inorder to aggravate or relieve arm symptoms, are commonly used in clinical practice in patients with a suspected cervical radiculopathy. Their diagnostic accuracy, however, has never been examined in a systematic review. A comprehensive search was conducted in order to identify all possible studies fulfilling the inclusion criteria. A study was included if: (1) any provocative test of the neck for diagnosing cervical radiculopathy was identified; (2) any reference standard was used; (3) sensitivity and specificity were reported or could be (re-)calculated; and, (4) the publication was a full report. Two reviewers independently selected studies, and assessed methodological quality. Only six studies met the inclusion criteria, which evaluated five provocative tests. In general, Spurling's test demonstrated low to moderate sensitivity and high specificity, as did traction/neck distraction, and Valsalva's maneuver. The upper limb tension test (ULTT) demonstrated high sensitivity and low specificity, while the shoulder abduction test demonstrated low to moderate sensitivity and moderate to high specificity. Common methodological flaws included lack of an optimal reference standard, disease progression bias, spectrum bias, and review bias. Limitations include few primary studies, substantial heterogeneity, and numerous methodological flaws among the studies; therefore, a meta-analysis was not conducted. This review suggests that, when consistent with the history and other physical findings, a positive Spurling's, traction/neck distraction, and Valsalva's might be indicative of a cervical radiculopathy, while a negative ULTT might be used to rule it out. However, the lack of evidence precludes any firm conclusions regarding their diagnostic value, especially when used in primary care. More high quality studies are necessary in order to resolve this issue.

Study Objective: Minimally invasive surgery aims to achieve at least a similar clinical effectiveness with a quicker recovery than traditional open techniques. Although there have been numerous randomized clinical trials comparing laparoscopic hysterectomy with hysterectomy by laparotomy, only a few studies have compared quality of life after different types of hysterectomy. None of these studies evaluated total laparoscopic hysterectomy. In this paper, we report on a randomized comparison of quality of life after total laparoscopic versus total abdominal hysterectomy., Design: Randomized, controlled trial (Canadian Task Force classification I)., Setting: Single-center teaching hospital in The Netherlands., Patients: Patients scheduled for hysterectomy for a benign condition, in whom a vaginal hysterectomy was not possible and laparoscopic hysterectomy was feasible (mobile uterus not exceeding the size of 18 weeks' gestation)., Interventions: Abdominal versus laparoscopic hysterectomy., Measurements and Main Results: Patients completed the Dutch version RAND-36 health survey preoperatively as well as at 5 time points in the first 12 weeks after surgery. The primary outcome of the study was quality of life as measured by the RAND-36. A linear mixed model was used for statistical analysis while accounting for baseline values. Secondary outcomes were hospital stay and complications. There were 88 patients eligible, of whom 59 gave consent for randomization. Twenty-seven women were allocated to the laparoscopic arm and 32 to the abdominal arm. We found a significant treatment effect favoring laparoscopic hysterectomy in the RAND-36 scale for vitality. Laparoscopic hysterectomy performed better on all other scales of the RAND-36, but these differences were not statistically significant., Conclusions: Laparoscopic hysterectomy results in more postoperative vitality when compared with abdominal hysterectomy. For this reason, all women with a benign condition requiring abdominal hysterectomy, in whom the laparoscopic approach is feasible, should have the chance to choose laparoscopic hysterectomy.

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.

Study Design: Population-based randomized controlled trial., Objective: To assess the effectiveness of workplace intervention and graded activity, separately and combined, for multidisciplinary rehabilitation of low back pain (LBP)., Summary of Background Data: Effective components for multidisciplinary rehabilitation of LBP are not yet established., Methods: Participants sick-listed 2 to 6 weeks due to nonspecific LBP were randomized to workplace intervention (n = 96) or usual care (n = 100). Workplace intervention consisted of workplace assessment, work modifications, and case management involving all stakeholders. Participants still sick-listed at 8 weeks were randomized for graded activity (n = 55) or usual care (n = 57). Graded activity comprised biweekly 1-hour exercise sessions based on operant-conditioning principles. Outcomes were lasting return to work, pain intensity and functional status, assessed at baseline, and at 12, 26, and 52 weeks after the start of sick leave., Results: Time until return to work for workers with workplace intervention was 77 versus 104 days (median) for workers without this intervention (P = 0.02). Workplace intervention was effective on return to work (hazard ratio = 1.7; 95% CI, 1.2-2.3; P = 0.002). Graded activity had a negative effect on return to work (hazard ratio = 0.4; 95% CI, 0.3-0.6; P < 0.001) and functional status. Combined intervention had no effect., Conclusion: Workplace intervention is advised for multidisciplinary rehabilitation of subacute LBP. Graded activity or combined intervention is not advised.

Objectives: Recently, an increasing number of systematic reviews have been published in which the measurement properties of health status questionnaires are compared. For a meaningful comparison, quality criteria for measurement properties are needed. Our aim was to develop quality criteria for design, methods, and outcomes of studies on the development and evaluation of health status questionnaires., Study Design and Setting: Quality criteria for content validity, internal consistency, criterion validity, construct validity, reproducibility, longitudinal validity, responsiveness, floor and ceiling effects, and interpretability were derived from existing guidelines and consensus within our research group., Results: For each measurement property a criterion was defined for a positive, negative, or indeterminate rating, depending on the design, methods, and outcomes of the validation study., Conclusion: Our criteria make a substantial contribution toward defining explicit quality criteria for measurement properties of health status questionnaires. Our criteria can be used in systematic reviews of health status questionnaires, to detect shortcomings and gaps in knowledge of measurement properties, and to design validation studies. The future challenge will be to refine and complete the criteria and to reach broad consensus, especially on quality criteria for good measurement properties.

Background: Successful management of workers on sick leave due to low back pain depends on the identification by the occupational physician of modifiable prognostic factors in the early phase of sick-leave. The prognostic value of factors which influence the course of low back pain and return to work in occupational health care is unclear., Methods: Secondary data analysis in a cohort of 299 workers on sick leave between 3 and 6 weeks due to low back pain was applied. We investigated the association of a broad set of prognostic indicators related to characteristics of worker, job, low back pain and psychosocial issues on return to work lasting at least 4 weeks (lasting-RTW) and minimally 1 day of first return to work (first-RTW). Relationships were studied using Cox regression analysis and covered a follow-up period of 12 months. The explained variation of the models was also calculated., Results: The median time to return to work using lasting-RTW and first-RTW was 76 and 71 days respectively. In addition to individual analysis of potential predictive factors a backward selection procedure resulted in the following multivariable model: self-predicted timing of return to work, pain intensity, job satisfaction, social support, pain radiation, expectations of treatment succes of the occupational physician. Similar results were found for first-RTW. The explained variance of the multivariate model of lasting-RTW was 18%., Conclusions: Factors concerning the expectations and beliefs of the worker affected the RTW process. Knowledge of these factors by the occupational physician in the early phase of low back pain and sick-leave may contribute to solutions to promote return to work.

Objective: To evaluate the cost-effectiveness and cost-utility of a return to work (RTW) program for workers on sick-leave due to low back pain (LBP), comparing a workplace intervention implemented between 2 to 8 weeks of sick-leave with usual care, and a clinical intervention after 8 weeks of sick-leave with usual care., Design: Economic evaluation alongside a randomised controlled trial (RCT)., Study Population: Workers sick-listed for a period of 2 to 6 weeks due to LBP., Interventions: 1. workplace assessment, work modifications and case management). 2. physiotherapy based on operant behavioural principles. 3. usual care: provided by an occupational physician., Outcomes: The primary outcome was return to work (RTW). Other outcomes were pain intensity, functional status, quality of life and general health. The economic evaluation was conducted from a societal perspective. Outcomes were assessed at baseline (after 2-6 weeks on sick-leave), and 12 weeks, 26 weeks, and 52 weeks after the first day of sick-leave., Results: The workplace intervention group returned to work 30.0 days (95% CI=[3.1, 51.3]) earlier on average than the usual care group at slightly higher direct costs (ratio of 1 day: 19 euro). Workers in the clinical intervention group that had received usual care in the first 8 weeks returned to work 21.3 days (95% CI= [-74.1, 29.2]) later on average. The group that had received the workplace intervention in the first 8 weeks and the clinical intervention after 8 weeks returned to work 50.9 days (95% CI=[-89.4, -2.7]) later on average. A workplace intervention was more effective than usual care in RTW at slightly higher costs and was equally effective as usual care at equal costs on other outcomes. A clinical intervention was less effective than usual care and associated with higher costs., Conclusion: The workplace intervention results in a safe and faster RTW than usual care at reasonable costs for workers on sick-leave for two to six weeks due to LBP.

Background: Carpal tunnel syndrome (CTS) is a common disorder, often treated with surgery or wrist splinting. The objective of this economic evaluation alongside a randomized trial was to evaluate the cost-effectiveness of splinting and surgery for patients with CTS., Methods: Patients at 13 neurological outpatient clinics with clinically and electrophysiologically confirmed idiopathic CTS were randomly allocated to splinting (n = 89) or surgery (n = 87). Clinical outcome measures included number of nights waking up due to symptoms, general improvement, severity of the main complaint, paraesthesia at night and during the day, and utility. The economic evaluation was performed from a societal perspective and involved all relevant costs., Results: There were no differences in costs. The mean total costs per patient were in the surgery group EURO 2,126 compared to EURO 2,111 in the splint group. After 12 months, the success rate in the surgery group (92%) was significantly higher than in the splint group (72%). The acceptability curve showed that at a relatively low ceiling ratio of EURO 2,500 per patient there is a 90% probability that surgery is cost-effective., Conclusion: In the Netherlands, surgery is more cost-effective compared with splinting, and recommended as the preferred method of treatment for patients with CTS.

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.

Consecutive patients (n = 215) who were referred to optometric (55%) or multidisciplinary (45%) low-vision services and above 50 years of age were recruited from four hospitals in the Netherlands. They completed two vision-related quality of life questionnaires, the Vision Quality of Life Core Measure (VCM1) and the Low Vision Quality of Life Questionnaire (LVQOL), before their first visit with low-vision services and 1 year later. At follow-up, patients referred to multidisciplinary low-vision services had lower scores on the mobility subscale of the LVQOL than patients referred to optometric low-vision services [5.3 points; 95% confidence interval (CI): 0.2-10.5]. Paired sample t-tests for the two groups of patients taken together show improvement for the VCM1 (3.1 points; 95% CI: 0.6-5.6) and deterioration for the basic aspects of vision (3.5 points; 95% CI: 1.1-5.9) and the mobility (6.6 points; 95% CI: 3.7-9.5) subscales of the LVQOL. In conclusion, people referred to optometric services showed less deterioration in mobility than those referred to multidisciplinary services. No differences were observed for any of the other subscales of the LVQOL and the VCM1. Future research in this field should include randomized controlled designs comparing low-vision services with no treatment or placebo.

Background: Low back pain is a common medical and social problem associated with disability and absence from work. Knowledge on effective return to work (RTW) interventions is scarce., Objective: To determine the effectiveness of graded activity as part of a multistage RTW programme., Design: Randomised controlled trial., Setting: Occupational healthcare., Subjects: 112 workers absent from work for more than eight weeks due to low back pain were randomised to either graded activity (n = 55) or usual care (n = 57)., Intervention: Graded activity, a physical exercise programme aimed at RTW based on operant-conditioning behavioural principles., Main Outcome Measures: The number of days off work until first RTW for more then 28 days, total number of days on sick leave during follow up, functional status, and severity of pain. Follow up was 26 weeks., Results: Graded activity prolonged RTW. Median time until RTW was equal to the total number of days on sick leave and was 139 (IQR = 69) days in the graded activity group and 111 (IQR = 76) days in the usual care group (hazard ratio = 0.52, 95% CI 0.32 to 0.86). An interaction between a prior workplace intervention and graded activity, together with a delay in the start of the graded activity intervention, explained most of the delay in RTW (hazard ratio = 0.86, 95% CI 0.40 to 1.84 without prior intervention and 0.39, 95% CI 0.19 to 0.81 with prior intervention). Graded activity did not improve pain or functional status clinically significantly., Conclusions: Graded activity was not effective for any of the outcome measures. Different interventions combined can lead to a delay in RTW. Delay in referral to graded activity delays RTW. In implementing graded activity special attention should be paid to the structure and process of care.

Objectives: Many studies report a higher prevalence of musculoskeletal pain in women than in men. This paper presents an overview of sex differences in musculoskeletal pain with specific attention for: different parameters for duration of musculoskeletal pain (ie, 1-y period prevalence, point prevalence, prevalence of chronic pain, and prevalence of persistent chronic pain); and (2) different anatomic pain sites., Methods: For the analyses, data from 2 general population-based prospective surveys (Dutch population-based Musculoskeletal Complaints and Consequences Cohort study and Monitoring Project on Risk Factors for Chronic Diseases-study) were used. The study population consisted of persons aged 25 to 64 years living in the Netherlands. Data on self-reported pain complaints were assessed by written questionnaires., Results: The results of this study showed that prevalence rates of musculoskeletal pain were higher for women than for men in the Dutch general population aged 25 to 64 years on the basis of 2 population-based surveys. For musculoskeletal pain in any location, 39% of men and 45% of women reported chronic complaints. Highest female predominance was found for the hip and wrist/hand, whereas lowest and not statistically significant sex differences were found for the lower back and knee. All duration parameters of musculoskeletal pain showed a female predominance of musculoskeletal pain (1-y period prevalence, point prevalence, prevalence of chronic pain, and prevalence of persistent chronic pain). In those with persistent chronic pain, women tended to report higher severity scores., Discussion: The present study shows that women have higher prevalence rates of musculoskeletal pain in most anatomic pain sites, no matter the duration of musculoskeletal pain. Future research should focus on explaining these sex differences with the ultimate goal to develop better prevention and management strategies for musculoskeletal pain in both men and women.

Background: Reproducibility concerns the degree to which repeated measurements provide similar results. Agreement parameters assess how close the results of the repeated measurements are, by estimating the measurement error in repeated measurements. Reliability parameters assess whether study objects, often persons, can be distinguished from each other, despite measurement errors. In that case, the measurement error is related to the variability between persons. Consequently, reliability parameters are highly dependent on the heterogeneity of the study sample, while the agreement parameters, based on measurement error, are more a pure characteristic of the measurement instrument., Methods and Results: Using an example of an interrater study, in which different physical therapists measure the range of motion of the arm in patients with shoulder complaints, the differences and relationships between reliability and agreement parameters for continuous variables are illustrated., Conclusion: If the research question concerns the distinction of persons, reliability parameters are the most appropriate. But if the aim is to measure change in health status, which is often the case in clinical practice, parameters of agreement are preferred.

To select the most useful evaluative outcome measures for early multiple sclerosis, we included 156 recently diagnosed patients in a 3-year follow-up study, and assessed them on 23 outcome measures in the domains of disease-specific outcomes, physical functioning, mental health, social functioning and general health. A global rating scale (GRS) and the Expanded Disability Status Scale (EDSS) were used as external criteria to determine the minimally important change (MIC) for each outcome measure. Subsequently, we determined whether the outcome measures could detect their MIC reliably. From these, per domain the outcome measure that was found to be most sensitive to changes (responsive) was identified. At group level, 11 outcomes of the domains of physical functioning, mental health, social functioning and general health could reliably detect the MIC. Of these 11, the most responsive measures per domain were the Medical Outcome Study 36 Short Form sub-scale physical functioning (SF36pf), the Disability and Impact Profile (DIP) sub-scale psychological, the Rehabilitation Activities Profile sub-scale occupation (RAPocc) and the SF36 sub-scale health, respectively. Overall, the most responsive measures were the SF36pf and the RAPocc. In individual patients, none of the measures could reliably detect the MIC. In sum, in the early stages of multiple sclerosis the most useful evaluative outcome measures for research are the SF36pf (physical functioning) and the RAPocc (social functioning).

Many studies report a female predominance in the prevalence of chronic musculoskeletal pain (CMP) but the mechanisms explaining these sex differences are poorly understood. Data from a random postal questionnaire survey in the Dutch general population were used to examine whether sex differences in the prevalences of CMP are due to sex differences in the distribution of known potential risk factors for CMP (exposure model) and/or to the different importance of risk factors for CMP (i.e. show different strength of association) in men and women (vulnerability model). In the present analyses, 909 men and 1178 women aged 25-65 were included. CMP was defined as pain lasting longer than 3 months and was assessed for 10 anatomical locations (neck, shoulder, higher back, elbow, wrist/hand, lower back, hip, knee, ankle, foot). Sex differences in CMP could not be explained by a different distribution of age, educational level, smoking status, overweight, physical activity, and pain catastrophizing. Having no paid job was associated with CMP, explaining part of the sex differences, but its role seems complex. Risk factors with a sex-specific association were: overweight (all pain locations) and older age (lower extremities)--both having only an effect among women--and pain catastrophizing (upper extremities), which was stronger associated with CMP among men than among women. In conclusion, sex differences in prevalence of CMP may partly be explained by sex differences in vulnerability to risk factors for CMP. Future research towards sex-specific identification of risk factors for CMP is warranted. Eventually this may lead to sex-specific prevention and management of CMP.

Background: The Four-Dimensional Symptom Questionnaire (4DSQ) is a self-report questionnaire that has been developed in primary care to distinguish non-specific general distress from depression, anxiety and somatization. The purpose of this paper is to evaluate its criterion and construct validity., Methods: Data from 10 different primary care studies have been used. Criterion validity was assessed by comparing the 4DSQ scores with clinical diagnoses, the GPs' diagnosis of any psychosocial problem for Distress, standardised psychiatric diagnoses for Depression and Anxiety, and GPs' suspicion of somatization for Somatization. ROC analyses and logistic regression analyses were used to examine the associations. Construct validity was evaluated by investigating the inter-correlations between the scales, the factorial structure, the associations with other symptom questionnaires, and the associations with stress, personality and social functioning. The factorial structure of the 4DSQ was assessed through confirmatory factor analysis (CFA). The associations with other questionnaires were assessed with Pearson correlations and regression analyses., Results: Regarding criterion validity, the Distress scale was associated with any psychosocial diagnosis (area under the ROC curve [AUC] 0.79), the Depression scale was associated with major depression (AUC = 0.83), the Anxiety scale was associated with anxiety disorder (AUC = 0.66), and the Somatization scale was associated with the GPs' suspicion of somatization (AUC = 0.65). Regarding the construct validity, the 4DSQ scales appeared to have considerable inter-correlations (r = 0.35-0.71). However, 30-40% of the variance of each scale was unique for that scale. CFA confirmed the 4-factor structure with a comparative fit index (CFI) of 0.92. The 4DSQ scales correlated with most other questionnaires measuring corresponding constructs. However, the 4DSQ Distress scale appeared to correlate with some other depression scales more than the 4DSQ Depression scale. Measures of stress (i.e. life events, psychosocial problems, and work stress) were mainly associated with Distress, while Distress, in turn, was mainly associated with psychosocial dysfunctioning, including sick leave., Conclusion: The 4DSQ seems to be a valid self-report questionnaire to measure distress, depression, anxiety and somatization in primary care patients. The 4DSQ Distress scale appears to measure the most general, most common, expression of psychological problems.

Changes in scores on health status questionnaires are difficult to interpret. Several methods to determine minimally important changes (MICs) have been proposed which can broadly be divided in distribution-based and anchor-based methods. Comparisons of these methods have led to insight into essential differences between these approaches. Some authors have tried to come to a uniform measure for the MIC, such as 0.5 standard deviation and the value of one standard error of measurement (SEM). Others have emphasized the diversity of MIC values, depending on the type of anchor, the definition of minimal importance on the anchor, and characteristics of the disease under study. A closer look makes clear that some distribution-based methods have been merely focused on minimally detectable changes. For assessing minimally important changes, anchor-based methods are preferred, as they include a definition of what is minimally important. Acknowledging the distinction between minimally detectable and minimally important changes is useful, not only to avoid confusion among MIC methods, but also to gain information on two important benchmarks on the scale of a health status measurement instrument. Appreciating the distinction, it becomes possible to judge whether the minimally detectable change of a measurement instrument is sufficiently small to detect minimally important changes.

Background: Conservative interventions such as physiotherapy and ergonomic adjustments (such as keyboard adjustments or ergonomic advice) play a major role in the treatment of most work-related complaints of the arm, neck or shoulder (CANS)., Objectives: This systematic review aims to determine whether conservative interventions have a significant impact on outcomes for work-related CANS in adults., Search Strategy: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (March 2005) and Cochrane Rehabilitation and Related Therapies Field Specialised Register (March 2005), the Cochrane Controlled Trials Register (The Cochrane Library, Issue 1, 2005), PubMed, EMBASE, CINAHL, AMED and reference lists of articles. The date of the last search was March 2005. No language restrictions were applied., Selection Criteria: We included randomised and non-randomised controlled trials studying conservative interventions (e.g. exercises, relaxation, physical applications, biofeedback, myofeedback and work-place adjustments) for adults suffering CANS., Data Collection and Analysis: Two authors independently selected trials from the search yield, assessed the methodological quality using the Delphi list, and extracted relevant data. We pooled data or, in the event of clinical heterogeneity or lack of data, we used a rating system to assess levels of evidence., Main Results: For this update we included six additional studies; 21 trials in total. Seventeen trials included people with chronic non-specific neck or shoulder complaints, or non-specific upper extremity disorders. Over 25 interventions were evaluated; five main subgroups of interventions could be determined: exercises, manual therapy, massage, ergonomics, and energised splint. Overall, the quality of the studies was poor. In 14 studies a form of exercise was evaluated, and contrary to the previous review we now found limited evidence about the effectiveness of exercises when compared to massage and conflicting evidence when exercises are compared to no treatment. In this update there is limited evidence for adding breaks during computer work; massage as add-on treatment on manual therapy, manual therapy as add-on treatment on exercises; and some keyboard designs when compared to other keyboards or placebo in participants with carpal tunnel syndrome., Authors' Conclusions: There is limited evidence for the effectiveness of keyboards with an alternative force-displacement of the keys or an alternative geometry, and limited evidence for the effectiveness of exercises compared to massage; breaks during computer work compared to no breaks; massage as an add-on treatment to manual therapy; and manual therapy as an add-on treatment to exercises.

Background and Objectives: To test the hypothesis that self-reported physical functioning is more influenced by pain than performance-based physical functioning., Methods: 163 knee-osteoarthritis patients completed the performance-based DynaPort KneeTest (DPKT), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and SF-36 (self-report measures of pain and physical functioning) before, 3, 6, and 12 months after knee replacement., Results: Correlations between (two) self-reported measures of functioning and (two) pain measures were higher (0.57-0.74) than correlations between the performance-based measure of functioning and the two pain measures (0.20 and 0.26). In factor analysis, WOMAC and SF-36 pain and physical functioning subscores loaded on the first factor (eigenvalue 3.2), while DPKT KneeScore2 loaded on the second factor (eigenvalue 0.92). Before surgery, correlations between performance-based and self-reported physical functioning were higher in patients with less pain (0.43) compared to patients with more pain (0.17), for the WOMAC (as expected), but not for the SF-36. After surgery, when the pain had diminished, the correlations between performance-based and self-reported physical functioning were higher, especially for the WOMAC., Conclusions: Our hypothesis was convincingly supported by the results of the WOMAC, and somewhat less by the results of the SF-36. We consider this as evidence for a lack of content validity of the WOMAC.

Objectives: The authors' goals were to compare the effectiveness of manual therapy (MT; mainly spinal mobilization), physical therapy (PT; mainly exercise therapy), and continued care by the general practitioner (GP; analgesics, counseling and education) over a period of 1 year., Methods: One hundred eighty-three patients suffering for at least 2 weeks from nonspecific neck pain were randomized to receive a 6-week treatment strategy of MT once a week, PT twice a week, or GP care once every 2 weeks. The primary outcome measures were perceived recovery, severity of physical dysfunctioning, pain intensity, and functional disability., Results: The differences between groups considered over 1 year were statistically significant (repeated measurements analyses P<0.001 to P=0.02) for all outcomes but borderline for the Neck Disability Index (P=0.06). Higher improvement scores were observed for MT for all outcomes, followed by PT and GP care. The success rate, based on perceived recovery after 13 weeks, was 72% for MT, which was significantly higher than the success rate for continued GP care (42%, P=0.001) but not significantly higher compared with PT treatment (59%, P=0.16). The difference between PT and GP approached statistical significance (P=0.06). After 1 year the success rates were 75%, 63%, and 56%, respectively, and no longer significantly different., Conclusions: Short-term results (at 7 weeks) have shown that MT speeded recovery compared with GP care and, to a lesser extent, also compared with PT. In the long-term, GP treatment and PT caught up with MT, and differences between the three treatment groups decreased and lost statistical significance at the 13-week and 52-week follow-up.

Study Design: Randomized controlled trial., Objectives: To compare high- and low-intensity back schools with usual care in occupational health care., Summary of Background Data: The content and intensity of back schools vary widely and the methodologic quality of randomized controlled trials is generally weak. Until now, no back school has proven to be superior for workers sick-listed because of subacute nonspecific low back pain., Methods: Workers (n = 299) sick-listed for a period of 3 to 6 weeks because of nonspecific low back pain were recruited by the occupational physician and randomly assigned to a high-intensity back school, a low-intensity back school, or care as usual. Outcome measures were days until return to work, total days of sick-leave, pain, functional status, kinesiophobia, and perceived recovery and were assessed at baseline and at 3 and 6 months of follow-up. Principal analyses were performed according to the intention-to-treat principle., Results: We randomly allocated 299 workers. Workers in the low-intensity back school returned to work faster compared with usual care and the high-intensity back school, with hazard ratios of 1.4 (P = 0.06) and 1.3 (P = 0.09), respectively. The comparison between high-intensity back school and usual care resulted in a hazard ratio of 1.0 (P = 0.83). The median number of sick-leave days was 68, 75, and 85 in the low-intensity back school, usual care, and high-intensity back school, respectively. Beneficial effects on functional status and kinesiophobia were found at 3 months in favor of the low-intensity back school. No substantial differences on pain and perceived recovery were found between groups., Conclusions: The low-intensity back school was most effective in reducing work absence, functional disability, and kinesiophobia, and more workers in this group scored a higher perceived recovery during the 6-month follow-up.

Recently it has been shown that complementary or alternative medicine (CAM) is used in about 30% of paediatric patients. Is this a problem? It has also been shown that most parents would like their paediatrician to advise them on the subject. But what can be the basis of such advice? Little is known and less has been published regarding the effectiveness of CAM. Society and the medical profession are notoriously ambiguous on the subject. Sound scientific evidence is advocated to make bold decisions on whether to allow and reimburse the use of CAM.

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.

The Low Vision Quality of Life (LVQOL) questionnaire and the Vision-related Quality of Life Core Measure (VCM1) are two of the many vision-related quality of life (QOL) questionnaires that have been developed in recent years. Although psychometric properties of the LVQOL and VCM1 compare well with other vision-related QOL questionnaires, construct and longitudinal validity have not been assessed (adequately). The purpose of this study was to examine the cross-sectional and longitudinal construct validity of these questionnaires by testing specific pre-specified hypotheses about the relations of these questionnaires with other measures. The percentage of hypotheses regarding the cross-sectional construct validity that were refuted for the LVQOL was 22% for the basic aspects of vision subscale, 50% for the mobility subscale, 39% for the adjustment subscale and 17% for the reading and fine work subscale. For the VCM1 this percentage was 57%. For the longitudinal construct validity the percentage of hypotheses that were refuted ranged from 33 to 75% for the LVQOL subscales and was 50% for the VCM1. In conclusion, cross-sectional construct validity was satisfactory for the LVQOL subscales, but seemed poor for the VCM1. In addition, the longitudinal validity of these scales was poor to moderate.

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.

Objective: To examine among adolescents (1) the prevalence of neck/shoulder, low back, and arm pain within different sociodemographic groups and (2) the association of neck/shoulder, low back, and arm pain with computer use, physical activity, depression, and stress., Methods: A school-based questionnaire survey in 2002 and 2003 of neck/shoulder, low back, and arm pain, computer use, physical activity, depression, and stress. The survey was given to 3485 adolescents aged 12 to 16 years who attended secondary schools in Amsterdam, Netherlands., Results: The overall prevalence of neck/shoulder, low back, and arm pain was 11.5%, 7.5%, and 3.9%, respectively. The prevalence of neck/shoulder pain was higher among girls and adolescents not living with both parents. The prevalence of low back pain also was higher among girls. Depressive symptoms were associated with neck/shoulder pain, low back pain, and arm pain. The stress experienced was associated with neck/shoulder pain and with low back pain., Conclusions: This study strengthens the findings that musculoskeletal pain is common among adolescents and is associated with depression and stress but not with computer use and physical activity.

Background: Choosing an adequate measurement instrument depends on the proposed use of the instrument, the concept to be measured, the measurement properties (e.g. internal consistency, reproducibility, content and construct validity, responsiveness, and interpretability), the requirements, the burden for subjects, and costs of the available instruments. As far as measurement properties are concerned, there are no sufficiently specific standards for the evaluation of measurement properties of instruments to measure health status, and also no explicit criteria for what constitutes good measurement properties. In this paper we describe the protocol for the COSMIN study, the objective of which is to develop a checklist that contains COnsensus-based Standards for the selection of health Measurement INstruments, including explicit criteria for satisfying these standards. We will focus on evaluative health related patient-reported outcomes (HR-PROs), i.e. patient-reported health measurement instruments used in a longitudinal design as an outcome measure, excluding health care related PROs, such as satisfaction with care or adherence. The COSMIN standards will be made available in the form of an easily applicable checklist., Method: An international Delphi study will be performed to reach consensus on which and how measurement properties should be assessed, and on criteria for good measurement properties. Two sources of input will be used for the Delphi study: (1) a systematic review of properties, standards and criteria of measurement properties found in systematic reviews of measurement instruments, and (2) an additional literature search of methodological articles presenting a comprehensive checklist of standards and criteria. The Delphi study will consist of four (written) Delphi rounds, with approximately 30 expert panel members with different backgrounds in clinical medicine, biostatistics, psychology, and epidemiology. The final checklist will subsequently be field-tested by assessing the inter-rater reproducibility of the checklist., Discussion: Since the study will mainly be anonymous, problems that are commonly encountered in face-to-face group meetings, such as the dominance of certain persons in the communication process, will be avoided. By performing a Delphi study and involving many experts, the likelihood that the checklist will have sufficient credibility to be accepted and implemented will increase.

Purpose: This paper focuses on the construct validity of instruments measuring impairments in body structures and function in rheumatic disorders. The objective is: 1) to make an inventory of constructs, based on the domains of the International Classification of Functioning, Disabilities and Health problems (ICF), against which instruments measuring impairments in body structures and function were validated; 2) to analyse whether validation against a similar construct resulted in higher correlation coefficients than validation against a dissimilar construct., Methods: In a systematic review papers were identified in which instruments measuring impairments in body structures and function for patients with rheumatic disorders were validated. The instruments identified were assessed on their methodological properties and the constructs against which they were validated. Subsequently, pooled (interclass) correlations of similar constructs and dissimilar constructs against which was validated were compared. An instrument was decided to have good construct validity, if the correlation coefficient was 0.50 or higher, and the measurement instrument in question is validated against similar constructs., Results: In total 216 papers were identified analysing the validity of 42 different instruments. Only 16% of these instruments were validated against instruments that represent the most similar construct. In general, estimates of construct validity were lower when validated against dissimilar constructs, except for instruments measuring impairments in mental functions., Conclusion: There is a trend that validation against a similar construct yields higher correlation coefficients than validation against a dissimilar construct. If an instrument measuring impairments is validated against the most similar construct, and a criterion of r > 0.50 is applied, only 10 out of the 42 identified instruments turned out to be valid.

Background: Reproducibility measurements of the range of motion are an important prerequisite for the interpretation of study results. The aim of the study is to assess the intra-rater and inter-rater reproducibility of the measurement of active Range of Motion (ROM) in patients with neck pain using the Cybex Electronic Digital Inclinometer-320 (EDI-320)., Methods: In an outpatient clinic in a primary care setting 32 patients with at least 2 weeks of pain and/or stiffness in the neck were randomly assessed, in a test- retest design with blinded raters using a standardized measurement protocol. Cervical flexion-extension, lateral flexion and rotation were assessed., Results: Reliability expressed by the Intraclass Correlation Coefficient (ICC) was 0.93 (lateral flexion) or higher for intra-rater reliability and 0.89 (lateral flexion) or higher for inter-rater reliability. The 95% limits of agreement for intra-rater agreement, expressing the range of the differences between two ratings were -2.5 +/- 11.1 degrees for flexion-extension, -0.1 +/- 10.4 degrees for lateral flexion and -5.9 +/- 13.5 degrees for rotation. For inter-rater agreement the limits of agreement were 3.3 +/- 17.0 degrees for flexion-extension, 0.5 +/- 17.0 degrees for lateral flexion and -1.3 +/- 24.6 degrees for rotation., Conclusion: In general, the intra-rater reproducibility and the inter-rater reproducibility were good. We recommend to compare the reproducibility and clinical applicability of the EDI-320 inclinometer with other cervical ROM measures in symptomatic patients.

Background: Information on prognostic factors for duration of sick leave due to low-back pain (LBP) is growing. In this prospective cohort study prognostic factors for duration of sick leave and course of disability were identified in a very early stage of sick leave due to LBP in an occupational health care setting., Methods: A total of 615 workers calling in sick from work due to LBP at an occupational health service (OHS) of one institution completed a questionnaire. Duration of follow-up was 26 weeks. Prognostic factors were identified by means of Cox regression analysis and multiple linear regression analysis, and explained variance was calculated., Results: Median time to first return to work (RTW) was 5 days (Inter Quartile Range (IQR) = 2-12). Median time to lasting return to work (LRTW) was 6 days (IQR = 3-13). The final model for delayed RTW included self-reported expected duration of sick-leave, treatment by GP or specialist, care-seeking, diminished mobility, and the interaction between care-seeking and diminished mobility. The final model for LRTW included: self-reported expected duration of sick-leave, treatment by GP or specialist, care-seeking, the interaction between the self-reported expected duration of sick-leave and seeking care at OHS, complaints due to job stress, diminished mobility, and the interactions between expected duration of more then 10 days and seeking OP care and diminished mobility. Median total days on sick leave (TDSL) was 6 days (IQR = 3-13 days). The final model for TDSL included: age, expected duration of sick leave, treatment by GP or medical specialist, seeking OP care, complaints due to physical load, and diminished mobility. Explained variance (R2) of these models ranged from 30 to 35%., Conclusions: Poor prognosis for duration of sick leave can be identified by means of a simple questionnaire administered on the first day of sick leave. Workers at high risk for longer duration of sick leave (all outcomes) expected to stay off work longer, were already being treated by a MD, sought OP care, and had diminished mobility. In case of delayed LRTW workers reported job stress as a possible cause of sick leave. Interactions were found in both RTW and LRTW between care-seeking and diminished mobility and in LRTW between expected duration of sick leave and seeking OP care. Older age increased TDSL with borderline significance.

Background and Objective: Psychometrically sound questionnaires for the assessment of vision-related quality of life (QOL) are scarce. Therefore, the objective was to further validate two vision-related QOL questionnaires in a Dutch population of visually impaired elderly., Methods: A total of 329 visually impaired older persons referred to low vision services completed the low vision QOL (LVQOL) and Vision-Related Quality of Life Core Measure (VCM1) questionnaires at baseline, after 1-4 weeks (retest), and after 5 months. Confirmatory factor analyses were performed on baseline data. The smallest detectable change (SDC) was assessed, based on the standard error of measurement (SEM). Change scores between the baseline and 5 months follow-up data were related to a general transition question to assess the minimal important change (MIC). Furthermore, the MIC was related to the SDC, to examine whether the MICs were detectable beyond measurement error., Results: The original factor structures could not be confirmed. After omitting items and remodeling, adequate fits were obtained. SDCs comprised at least one quarter of the scale for all scales and subscales on the individual level and exceeded the MICs on every occasion., Conclusion: We propose MICs of 5-10 points for the scales and subscales of the LVQOL and VCM1. The questionnaires are not useful in the follow-up of individual patients.

Background: Various types of traction are used in the treatment of low-back pain (LBP), often in conjunction with other treatments., Objectives: To determine the effectiveness of traction in the management of LBP., Search Strategy: We searched The Cochrane Library 2004, Issue 4, MEDLINE, EMBASE, and CINAHL to November 2004, references in relevant reviews, and our personal files., Selection Criteria: Randomized controlled trials (RCTs) examining any type of traction for the treatment of acute (less than four weeks duration), sub-acute (four to 12 weeks) or chronic (more than 12 weeks) non-specific LBP with or without sciatica., Data Collection and Analysis: Study selection, methodological quality assessment and data extraction were done independently by sets of two reviewers. As available studies did not provide sufficient data for statistical pooling, a qualitative analysis was performed., Main Results: Twenty-four RCTs, involving 2177 patients (1016 receiving traction) were included in the review. Five trials were considered high quality. There is strong evidence that there is no significant difference in short or long-term outcomes between either continuous or intermittent traction and placebo, sham, or other treatments for patients with a mixed duration of LBP, with or without sciatica. There is moderate evidence that: autotraction is more effective other forms of traction are no more effective than placebo, sham or no treatment for patients with a mixed duration of LBP with sciatica. There is limited evidence that: there is no significant difference in outcomes between a standard physical therapy program with continuous traction and the same program without traction, for patients with a mixed duration of LBP, with or without sciatica autotraction on its own is more effective than a physical therapy program that includes Tru-Trac traction for patients with a mixed duration of LBP with sciatica. There is conflicting evidence regarding the short-term effectiveness of either continuous or intermittent traction compared to placebo, sham or other treatments, in the management of patients who have either chronic LBP or a mixed duration of LBP with sciatica., Authors' Conclusions: The evidence suggests that traction is probably not effective. Neither continuous nor intermittent traction by itself was more effective in improving pain, disability or work absence than placebo, sham or other treatments for patients with a mixed duration of LBP, with or without sciatica. Although trials studying patients with sciatica had methodological limitations and inconsistent results, there was moderate evidence that autotraction was more effective than mechanical traction for global improvement in this population.

Objective: To assess the construct validity of the DynaPort KneeTest (KneeTest), which is a performance-based test to assess functioning of patients with knee osteoarthritis (OA). Scores on the KneeTest (KneeScore) were compared with observations of physical therapists of the patients' functional disability. The reliability of these observations was also assessed., Method: Twelve physical therapists received identical video tapes showing the performance of 33 patients on the KneeTest. Each physical therapist rated the functional disability of each patient, performing the 23 activities of the KneeTest, on 23 Visual Analogue Scales (VAS(activity)). The 23 VAS(activity) scores were averaged into a VAS(average) score. At the end of the test, an overall rating for the general performance of the patient was given on a VAS(overall). Inter-observer Reliability was assessed for the VAS(activity) scores, VAS(average), and the VAS(overall)., Results: Inter-observer reliability of the VAS(average) was higher (ICC 0.85, 95% CI 0.74-0.92) than the VAS(overall) (ICC 0.65, 95% CI 0.51-0.77). The correlation between the KneeScore and the VAS(average), averaged over the 12 physiotherapists, was 0.86., Conclusion: The construct validity of the KneeTest was supported by the strong correlation with the ratings of the patients' disability by physical therapists. Given these findings and the high test-retest reliability of the KneeTest that was found in our previous study, we conclude that the KneeTest is a valid measure for assessing functioning in orthopedic and physical therapy research in patients with knee-OA before and after total knee replacement. Longitudinal validity has to be evaluated yet.