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OBJECTIVE: To assess the effectiveness of individualized physiotherapy in combination with rigid taping compared with individualized physiotherapy alone in patients with subacromial pain syndrome.DESIGN: A prospective randomized trial with concealed allocation.PATIENTS: A total of 140 patients between 18 and 65 years of age from primary physiotherapy settings.METHODS: The intervention group received individualized physiotherapy and shoulder taping. The control group received individualized physiotherapy only. Primary outcomes were: pain intensit (numerical rating scale) and functioning (Simple Shoulder Test). Secondary outcomes were: global perceived effect and patient-specific complaints. Data were collected at baseline, and at 4, 12 and 26 weeks' follow-up.RESULTS: During the 6-month follow-up period multilevel analysis showed a significant difference between groups favouring the control group on pain intensity (p = 0.02), but not on functioning. Regarding secondary outcomes, a significant difference between groups was found favouring the intervention group for global perceived effect (p = 0.02), but not for patient-specific complaints.CONCLUSION: Rigid shoulder taping, as used in this study, cannot be recommended for improving physiotherapy outcomes in people with subacromial pain syndrome.

Background Limited walking ability is an important problem for patients with multiple sclerosis. A better understanding of how gait impairments lead to limited walking ability may help to develop more targeted interventions. Although gait classifications are available in cerebral palsy and stroke, relevant knowledge in MS is scarce. Objective The aims of this study were: (1) to identify distinctive gait patterns in patients with MS based on a combined evaluation of kinematics, gait features, and muscle activity during walking and (2) to determine the clinical relevance of these gait patterns. Design This was a cross-sectional study of 81 patients with MS of mild-to-moderate severity (Expanded Disability Status Scale [EDSS] median score=3.0, range=1.0–7.0) and an age range of 28 to 69 years. Method The patients participated in 2-dimensional video gait analysis, with concurrent measurement of surface electromyography and ground reaction forces. A score chart of 73 gait items was used to rate each gait analysis. A single rater performed the scoring. Latent class analysis was used to identify gait classes. Results Analysis of the 73 gait variables revealed that 9 variables could distinguish 3 clinically meaningful gait classes. The 9 variables were: (1) heel-rise in terminal stance, (2) push-off, (3) clearance in initial swing, (4) plantar-flexion position in mid-swing, (5) pelvic rotation, (6) arm-trunk movement, (7) activity of the gastrocnemius muscle in pre-swing, (8) M-wave, and (9) propulsive force. The EDSS score and gait speed worsened in ascending classes. Limitations Most participants had mild-to-moderate limitations in walking ability based on their EDSS scores, and the number of walkers who were severely limited was small. Conclusions Based on a small set of 9 variables measured with 2-dimensional clinical gait analysis, patients with MS could be divided into 3 different gait classes. The gait variables are suggestive of insufficient ankle push-off.

Aim To determine if psychosocial factors are associated with outcome in patients with neck pain or low back pain. Methods In a prospective, multi-center chiropractic practice-based cohort study in Belgium and The Netherlands, 917 patients, of which 326 with neck pain and 591 with low back pain, completed self-administered questionnaires at baseline, following the second visit, and at 1, 3, 6 and 12 months. Psychosocial factors assessed at baseline were: distress, depression, anxiety and somatization via the Four Dimensional Symptom Questionnaire, patient's beliefs regarding the effect of physical activity and work on their complaint via the Fear Avoidance Beliefs Questionnaire, and social support via the Feij social support scale. Primary outcome measures were perceived recovery, pain intensity, and functional status which was measured with the Neck Disability Index and Oswestry Disability Index. A univariable regression analysis to estimate the relation between each psychological variable and outcome was followed by a multivariable multilevel regression analysis. Results There were no differences in baseline patient characteristics between the patient population from Belgium and the Netherlands. Somatization scores are consistently associated with perceived recovery, functional status and pain for both neck pain and low-back pain. Depression was associated with poorer functioning in patients with LBP. There was a small association between fear and function and pain for patients with neck pain or low-back pain. Conclusion Somatization was the only variable consistently found to be associated with diminished perceived recovery, higher degree of neck or low back disability, and increased neck or low back pain.

IMPORTANCE: Amyloid-β positron emission tomography (PET) imaging allows in vivo detection of fibrillar plaques, a core neuropathological feature of Alzheimer disease (AD). Its diagnostic utility is still unclear because amyloid plaques also occur in patients with non-AD dementia. OBJECTIVE: To use individual participant data meta-analysis to estimate the prevalence of amyloid positivity on PET in a wide variety of dementia syndromes. DATA SOURCES: The MEDLINE and Web of Science databases were searched from January 2004 to April 2015 for amyloid PET studies. STUDY SELECTION: Case reports and studies on neurological or psychiatric diseases other than dementia were excluded. Corresponding authors of eligible cohorts were invited to provide individual participant data. DATA EXTRACTION AND SYNTHESIS: Data were provided for 1359 participants with clinically diagnosed AD and 538 participants with non-AD dementia. The reference groups were 1849 healthy control participants (based on amyloid PET) and an independent sample of 1369 AD participants (based on autopsy). MAIN OUTCOMES AND MEASURES: Estimated prevalence of positive amyloid PET scans according to diagnosis, age, and apolipoprotein E (APOE) ε4 status, using the generalized estimating equations method. RESULTS: The likelihood of amyloid positivity was associated with age and APOE ε4 status. In AD dementia, the prevalence of amyloid positivity decreased from age 50 to 90 years in APOE ε4 noncarriers (86% [95% CI, 73%-94%] at 50 years to 68% [95% CI, 57%-77%] at 90 years; n = 377) and to a lesser degree in APOE ε4 carriers (97% [95% CI, 92%-99%] at 50 years to 90% [95% CI, 83%-94%] at 90 years; n = 593; P

BACKGROUND AND PURPOSE: DWI is typically performed with EPI sequences in single-center studies. The purpose of this study was to determine the reproducibility of ADC values in the head and neck region in healthy subjects. In addition, the reproducibility of ADC values in different tissues was assessed to identify the most suitable reference tissue. MATERIALS AND METHODS: We prospectively studied 7 healthy subjects, with EPI and TSE sequences, on 5 MR imaging systems at 3 time points in 2 institutions. ADC maps of EPI (with 2 b-values and 6 b-values) and TSE sequences were compared. Mean ADC values for different tissues (submandibular gland, sternocleidomastoid muscle, spinal cord, subdigastric lymph node, and tonsil) were used to evaluate intra- and intersubject, intersystem, and intersequence variability by using a linear mixed model. RESULTS: On 97% of images, a region of interest could be placed on the spinal cord, compared with 87% in the tonsil. ADC values derived from EPI-DWI with 2 b-values and calculated EPI-DWI with 2 b-values extracted from EPI-DWI with 6 b-values did not differ significantly. The standard error of ADC measurement was the smallest for the tonsil and spinal cord (standard error of measurement = 151.2 × 10(−6) mm/s(2) and 190.1 × 10(−6) mm/s(2), respectively). The intersystem difference for mean ADC values and the influence of the MR imaging system on ADC values among the subjects were statistically significant (P < .001). The mean difference among examinations was negligible (ie

Introduction This study aimed to investigate the sensitivity to change over time of a new informant-based instrument to assess instrumental activities of daily living (IADL) during the course of dementia: the Amsterdam IADL Questionnaire© (A-IADL-Q). Methods Participants (n = 102) were patients and their informants who visited the Alzheimer Center of the VU University Medical Center. Linear mixed models with random effects were used to relate longitudinal change on the A-IADL-Q to diagnosis and to longitudinal change in cognitive measures. Results We found longitudinal change on the A-IADL-Q to differ between diagnosis (P = .003), with dementia patients showing the fastest rate of decline (P < .001). In addition, we found longitudinal change on the A-IADL-Q to be related to longitudinal change in cognitive measures (global cognition: P < .001; memory: P = .024; executive functioning: P = .028). Discussion Findings indicate the A-IADL-Q is sensitive to change over time in IADL functioning and can be used in evaluating treatment effects and assessing individual disease progress.

ObjectivesTo assess disease-free survival (DFS) in head and neck squamous cell carcinoma (HNSCC) treated with (chemo)radiotherapy ([C]RT).MethodsPretreatment MR-images of 78 patients were retrospectively studied. Apparent diffusion coefficients (ADC) were calculated with two sets of two b-values: 0–750s/mm2 (ADC750) and 0–1000s/mm2 (ADC1000). One observer assessed tumor volume on T1-WI. Two independent observers assessed ADC-values of primary tumor and largest lymph node in two sessions (i.e. without and with including CE-T1WI in image analysis). Interobserver and intersession agreement were assessed with intraclass correlation coefficients (ICC) separately for ADC750 and ADC1000. Lesion volumes and ADC-values were related to DFS using Cox regression analysis.ResultsMedian follow-up was 18 months. Interobserver ICC was better without than with CE-T1WI (primary tumor: 0.92 and 0.75–0.83, respectively; lymph node: 0.81–0.83 and 0.61–0.64, respectively). Intersession ICC ranged from 0.84 to 0.89. With CE-T1WI, mean ADC-values of primary tumor and lymph node were higher at both b-values than without CE-T1WI (P

Background: Low serum 25-hydroxyvitamin D [25(OH)D] concentrations have been associated with insulin resistance, the metabolic syndrome, and type 2 diabetes. Because many non-Western immigrants in the Netherlands are vitamin D deficient, obese, and at high risk of diabetes, vitamin D supplementation may contribute to prevent diabetes and insulin resistance. Objective: We examined the effect of vitamin D supplementation on insulin sensitivity and b cell function in overweight, vitamin D‐ deficient, non-Western immigrants at high risk of diabetes. Design: The study was a 16-wk, randomized, placebo-controlled trial. A total of 130 non-Western immigrants with prediabetes (fasting glucose concentration .5.5 mmol/L or random glucose concentration from 7.8 to 11.1 mmol/L) and vitamin D deficiency (serum 25[OH]D concentration ,50 nmol/L) were randomly assigned after stratification by sex to receive either cholecalciferol (1200 IU/d) or a placebo for 16 wk. All participants received 500 mg Ca/d as calcium carbonate. The primary outcome was the difference in the area under the curve of insulin and glucose after a 75-g oral-glucose-tolerance test after 4 mo of treatment. Secondary outcomes were insulin-sensitivity variables, b cell‐function variables, and metabolic syndrome. Results: Mean serum 25(OH)D concentrations increased significantly in the vitamin D compared with placebo groups. After 4 mo of therapy, the mean between-group difference was 38 nmol/L (95% CI: 32.1, 43.9 nmol/L; P , 0.001). There was no significant effect on insulin sensitivity and b cell function. In a post hoc analysis, when patients with diabetes at baseline were excluded, a significant increase in the insulinogenic index was observed in participants who obtained a 25(OH)D concentration $60 nmol/L (P =0 .040). Conclusions: Vitamin D supplementation in non-Western vitamin D‐deficient immigrants with prediabetes did not improve insulin sensitivity or b cell function or change the incidence of metabolic syndrome. However, after the exclusion of diabetic subjects, an improvement in the insulinogenic index was observed in participants who obtained a 25(OH)D concentration $60 nmol/L. This trial was registered at trialregister.nl as NTR1827. Am J Clin Nutr 2014;100:152‐60.

Objective To examine the temporal evolution of spinal cord (SC) atrophy in multiple sclerosis (MS), and its association with clinical progression in a large MS cohort. Methods A total of 352 patients from two centres with MS (relapsing remitting MS (RRMS): 256, secondary progressive MS (SPMS): 73, primary progressive MS (PPMS): 23) were included. Clinical and MRI parameters were obtained at baseline, after 12 months and 24 months of follow-up. In addition to conventional brain and SC MRI parameters, the annualised percentage brain volume change and the annualised percentage upper cervical cord cross-sectional area change (aUCCA) were quantified. Main outcome measure was disease progression, defined by expanded disability status scale increase after 24 months. Results UCCA was lower in SPMS and PPMS compared with RRMS for all time points. aUCCA over 24 months was highest in patients with SPMS (-2.2% per year) and was significantly higher in patients with disease progression (-2.3% per year) than in stable patients (-1.2% per year; p=0.003), while annualised percentage brain volume change did not differ between subtypes (RRMS: -0.42% per year; SPMS -0.6% per year; PPMS: -0.46% per year) nor between progressive and stable patients (p=0.055). Baseline UCCA and aUCCA over 24 months were found to be relevant contributors of expanded disability status scale at month-24, while baseline UCCA as well as number of SC segments involved by lesions at baseline but not aUCCA were relevant contributors of disease progression. Conclusions SC MRI parameters including baseline UCCA and SC lesions were significant MRI predictors of disease progression. Progressive 24-month upper SC atrophy occurred in all MS subtypes, and was faster in patients exhibiting disease progression at month-24. © 2014 by the BMJ Publishing Group Ltd.

Purpose: To assess the intra- and inter-rater reliability of a standardized protocol for measuring proximal tibia and distal femur bone mineral density (BMD) using dual-energy X-ray absorptiometry (DXA).Methods: Ten able-bodied individuals (7 males) participated in this study. During one measurement session, the knee of each participant was scanned twice by rater 1 using DXA. Both scans were analyzed twice by rater 1 as well as once by a second rater. Intraclass correlation coefficients (ICCs), standard error of measurements (SEMs) and smallest detectable differences (SDDs) were calculated for the outcome measures proximal tibia and distal femur BMD. A decision study was performed to determine the effect of study protocol adjustments (i.e. increasing the number of scan repetitions, or scan analyses by the same rater) on SEM and SDD values.Results: High intra- and inter-rater ICCs (0.97-0.98) were found for both proximal tibia and distal femur BMD. Low SEMs (0.017-0.028 g/cm(2)) and SDDs (0.047-0.077 g/cm(2)) were found, with a slightly better result for proximal tibia BMD. Increasing the number of scan analyses by the same rater did not markedly reduce SEM and SDD values, while increasing the number of scan repetitions did.Conclusions: Proximal tibia and distal femur BMD can be reliably assessed with this method. (C) 2013 IPEM. Published by Elsevier Ltd. All rights reserved.

PURPOSE Consultations for forefoot pain are frequent in primary care, but scientific support of treatment options is scarce. The purpose of this study is to investigate the effect of podiatric treatment vs standardized advice on proper shoe characteristics and fit of shoes by means of an information leaflet for people aged 50 years and older with forefoot pain in primary care. METHODS In this randomized controlled trial, 205 participants aged 50 years and older with hindering nontraumatic forefoot pain have been recruited at their general practitioner’s office. Exclusion criteria were treatment of forefoot problem of less than 6 months’ duration before inclusion, rheumatoid arthritis, and diabetic neuropathy or having pain considered not to be musculoskeletal (eg, warts). Participants received shoe advice by means of an information leaflet or podiatric care. Foot pain, foot-related dysfunction, general health, and social participation were assessed by means of questionnaires every 3 months for 1 year. Using multilevel analysis, we analyzed results at the level of (1) outcome measures, (2) the individual, and (3) the general practitioner. RESULTS No differences were found between the 2 treatment groups. Both intervention groups showed an improvement over time in foot pain and foot-related dysfunction. CONCLUSION This study found that shoe advice provided to patients consulting their general practitioner for forefoot pain and symptom relief resulted in outcomes similar to treatment outcomes in patients consulting a podiatrist. Based on these results, primary care physicians should be cautious when referring a patient to a podiatrist; instead, they should start by providing advice on proper characteristics and fit of shoes.

Background: Measuring impairments in “instrumental activities of daily living” (IADL) is important in dementia, but challenging due to the lack of reliable and valid instruments. We recently developed the Amsterdam Instrumental Activities of Daily Living Questionnaire (A-IADL-Q; note 1). We aim to investigate the diagnostic accuracy of the A-IADL-Q for dementia in a memory clinic setting. Methods: Patients visiting the Alzheimer Center of the VU University Medical Center with their informants between 2009 and 2011 were included (N = 278). Diagnoses were established in a multidisciplinary consensus meeting, independent of the A-IADL-Q scores. An optimal A-IADL-Q cutoff point was determined, and sensitivity and specificity were calculated. Area under the curves (AUCs) were compared between A-IADL-Q and “disability assessment of dementia” (DAD). The additional diagnostic value of the A-IADL-Q to Mini-Mental State Examination (MMSE) was examined using logistic regression analyses. Results: Dementia prevalence was 50.5%. Overall diagnostic accuracy based on the AUC was 0.75 (95% confidence interval [CI]: 0.70-0.81) for the A-IADL-Q and 0.70 (95% CI: 0.63-0.77) for the DAD, which did not differ significantly. The optimal cutoff score for the A-IADL-Q was 51.4, resulting in sensitivity of 0.74 and specificity of 0.64. Combining the A-IADL-Q with the MMSE improved specificity (0.94), with a decline in sensitivity (0.55). Logistic regression models showed that adding A-IADL-Q improved the diagnostic accuracy (Z = 2.55, P = .011), whereas the DAD did not. Conclusions: In this study, we showed a fair diagnostic accuracy for A-IADL-Q and an additional value in the diagnosis of dementia. These results support the role of A-IADL-Q as a valuable diagnostic tool.

Objective: To determine the content, structural, and construct validity of the Dutch version of the Neck Disability Index (NDI). Study Design and Setting: To assess content validity, 11 neck pain experts and 10 patients commented on the construct, comprehensiveness, and relevance of the NDI. Structural validity was assessed by item factor analysis (FA) and item response theory modeling using the generalized partial credit model. Differential item functioning (DIF) analysis for gender was examined. Pearson correlation coefficient with the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire was calculated to assess construct validity. Results: In addition to a suboptimal translation, we found a lack of consensus on the construct the NDI intends to measure. Experts and patients suggested that the NDI measures more than physical functioning. Unidimensionality of the NDI could not be confirmed. DIF analysis for gender showed DIF for the headache item. The goodness-of-fit statistics for FA with one factor were satisfactory when the item ‘‘concentration’’ was omitted. A correlation of 0.75 with the DASH was found supporting construct validity. Conclusion: It is questionable whether in research the NDI should be the instrument of choice for use as a primary outcome measure. Definition of the construct to be measured is a prerequisite for the assessment of validity. 2013 Elsevier Inc. All rights reserved.

Purpose: Fatigue is a complex, multidimensional construct. Most questionnaires measuring fatigue do not meet the standards for good measurement properties. Therefore, the Neurological Fatigue Index for multiple sclerosis (NFIMS) is recently developed using thorough methods. The aim of this study was to develop and validate the Dutch version of the NFI-MS. Methods: The original English version of the NFI-MS was translated into Dutch using a forward-backward procedure. Reliability (intraclass correlation coefficient (ICC) and standard error of measurement (SEM)) were assessed for the summary score and the four subscale scores separately. Construct validity was assessed by testing hypotheses about expected correlations between the NFI-MS and other constructs (e.g. impact on functioning and depression) and expected differences on NFI scores between groups defined on the basis of disease type and work status. Results: The reliability analyses (n = 118) showed that the ICC was 0.78 (NFI-MS summary) and ranged from 0.75 to 0.83 for the four subscales and the SEM was 2.5 (NFI-MS summary) and ranged from 1.1 to 2.2 for the four subscales. For construct validity (n = 136), 50 out of the 57 expected hypotheses were confirmed (88 %). Conclusion: The present study shows that the Dutch version of the NFI-MS is a reliable and valid self-report questionnaire for measuring fatigue in Dutch patients with MS. © Springer Science+Business Media Dordrecht 2013.

Background: This study describes the validation of a new instrument measuring instrumental activities of daily living (IADL), the Amsterdam IADL Questionnaire© (a registered copyright of the Alzheimer Center of the VU University Medical Center). This informant-based tool aimed at detecting IADL problems in incipient dementia was previously found to have a high internal consistency and test-retest reliability. Methods: Patients and their informants who visited the Alzheimer Center of the VU University Medical Center were included in this study. Item response theory was used to estimate the individuals' trait levels as a measure of IADL disability. Construct validity was tested by correlating estimated trait levels with clinical and demographic measures using Pearson's or Kendall's τ correlation coefficients. Additionally, estimated trait levels between patients with and without dementia and between patients with early- and late-onset dementia were compared using independent t tests. Results: A total of 206 informants of patients completed the Amsterdam IADL Questionnaire. The correlations between estimated trait levels and other measures were in concordance with previously formed hypotheses. Patients diagnosed with dementia (n = 93) had higher estimated trait levels than patients without dementia (n = 96), Cohen's effect size, d = 1.04, t(187) = 7.1, p < 0.001. We found no differences between early- and late-onset dementia patients. Conclusions: Results suggest that the Amsterdam IADL Questionnaire is a reliable and valid instrument in the evaluation of dementia.

BACKGROUND: The surface area of scars is an important outcome parameter in scar assessment. It is often used to quantify the extent of scar features, such as pigmentation disturbances, hypertrophy, and contracture. Currently available techniques for measuring the surface area are known to be cumbersome or do not meet the basic clinimetric criteria (i.e., reliability and validity). Three-dimensional stereophotogrammetry is a technique that may improve the quality of surface area measurements. The aim of this study was to investigate the reliability and validity of three-dimensional stereophotogrammetry for measuring scar surface area. METHODS: In a cross-sectional study, two independent clinicians photographed and measured 50 scar areas of 32 patients using a handheld stereographic camera, to assess reliability. Subsequently, using planimetry, the scar surface was traced on a transparent sheet (considered the accepted standard) to assess validity. RESULTS: Three-dimensional stereophotogrammetry showed good reliability, with an intraclass correlation coefficient of 0.99 and a coefficient of variation of 6.8 percent. To visualize the differences between the two observers, data were plotted and the limits of agreement were calculated at 0 ± 0.19 × mean surface area. Also, excellent validity was found, with a concordance correlation coefficient of 0.99. CONCLUSION: This study showed that three-dimensional stereophotogrammetry is a reliable and valid tool for research purposes in the field of scar surface area measurements. Copyright © 2013 by the American Society of Plastic Surgeons.

Purpose: To assess the efficacy of client-centred occupational therapy (OT) according to a client-centred process framework, as compared to usual care OT, in patients with multiple sclerosis (MS). Method: A multicentre cluster randomised controlled trial with the institution (i.e. hospital or rehabilitation centre) as the unit of randomisation was performed. A total of 269 outpatients with MS, 13 hospitals and rehabilitation centres and 29 occupational therapists participated. Primary outcomes included measures of disability, participation and autonomy. Secondary outcomes included fatigue, generic health-related quality of life, quality and evaluation of therapy, therapy compliance and therapy frequency. Measurements were taken at baseline, four months and at eight months follow-up. Results: Primary outcome measures did not show significant differences between the two interventions. Secondary outcomes revealed significant differences in favour of the usual care OT on fatigue (physical scale and total scale) and health-related quality of life (bodily pain and vitality) at four months. After eight months only significant differences on mental health were found. Process outcomes (i.e. the information scale of therapy quality and the client-centredness of the organisation) were in favour of the client-centred intervention. Conclusion: Because the client-centred intervention resulted in no effects on the primary outcomes and small but negative effects on the secondary functional outcomes, we should seriously reconsider the application of client-centred practice.Implications for RehabilitationAn increasing number of interventions claim to incorporate client-centred practice. Client-centred practice is associated with improved satisfaction but the effects on functional health-related outcomes have not been fully evaluated.The findings of this study show that the process outcomes of therapy were in favour of the client-centred intervention, but no effects were found on the primary outcomes and negative effects on the secondary functional health outcomes.It is suggested that the implementation of client-centred practice should be adjusted in order to achieve optimal health outcomes. © 2013 Informa UK Ltd.

Study design Prospective cohort study. Background Although lumbar radiculopathy is regarded as a specific diagnosis, the most effective treatment strategy is unclear. Commonly used treatments include transforaminal epidural steroid injections (TESIs) and Mechanical Diagnosis & Therapy (MDT), but no studies have investigated the effectiveness of this combination. MDT differentiates pain centralization (C) from non-centralization (NC), which indicates good vs. poor prognostic validity respectively. Objective The main aims were 1) to determine changes in Mechanical Diagnosis and Therapy (MDT) pain response classifications after transforaminal epidural steroid injections (TESIs) in candidates for lumbar herniated disc surgery and 2) to evaluate differences in short and long term outcomes for patients with different pain response classifications. Methods Candidates for lumbar herniated disc surgery were assessed with a MDT protocol and their pain response classified as centralizing or peripheralizing. For this study,only patients were eligible who showed a peripheralizing pain response at intake. All patients then received TESIs and were reassessed and classified using the MDT protocol, into groups according to pain response (resolved, centralizing, peripheralizing with less pain and peripheralising with severe pain). After receiving targeted treatment based on pain response after TESIs, ranging from advice, MDT or surgery, follow-up assessments were completed at discharge and at 12 months. The primary outcomes were disability (Roland-Morris Disability Questionnaire [RMDQ] for Sciatica), pain severity in leg (visual analogue scale [VAS], 0-100) and global perceived effect (GPE). Linear mixed-models were used to determine between-groups differences in outcome. Results A total of 77 patients with lumbar disc herniation and peripheralizing symptoms were included. Patients received an average of 2 (SD 0.7) TESIs. After TESIs, 17 patients (22%) were classified as peripheralizing with continuing severe pain.These patients underwent surgery and were not further evaluated. Eleven (14%) patients were classified as resolved, 37 (48%) as centralizing with significant less pain, and 12 (16%) as peripheralizing with significant less pain. None of these patients underwent surgery. Resolved and centralizer subgroups had better outcomes in terms of VAS and RMDQ than the non-operated peripheralizers at discharge and at 12 months. The succes rates (GPE) for the resolved, centralizing, and peripheralizing with less pain patients were 100%, 100% and 33% respectively at short term, and 100%, 92% and 50% respectively at long term. Conclusion After TESIs, a peripheralizing pain pattern changed to resolved or centralizing in 62% of the patients. For the non-operated patients, those with a centralising pattern after TESIs reported better pain and disability outcomes than those with peripheralizing pattern at short and long term.

Background/Aims: Appropriate and timely screening instruments that sensitively capture the cognitive functioning of multiple sclerosis (MS) patients are the need of the hour. We evaluated newly derived regression-based norms for the Symbol Digit Modalities Test (SDMT) in a Dutch-speaking sample, as an indicator of the cognitive state of MS patients. Methods: Regression-based norms for the SDMT were created from a healthy control sample (n = 96) and used to convert MS patients' (n = 157) raw scores to demographically adjusted Z-scores, correcting for the effects of age, age2, gender, and education. Conventional and regression-based norms were compared on their impairment-classification rates and related to other neuropsychological measures. Results: The regression analyses revealed that age was the only significantly influencing demographic in our healthy sample. Regression-based norms for the SDMT more readily detected impairment in MS patients than conventional normalization methods (32 patients instead of 15). Patients changing from an SDMT-preserved to -impaired status (n = 17) were also impaired on other cognitive domains (p < 0.05), except for visuospatial memory (p = 0.34). Conclusions: Regression-based norms for the SDMT more readily detect abnormal performance in MS patients than conventional norms, identifying those patients at highest risk for cognitive impairment, which was supported by a worse performance on other neuropsychological measures.

The objective of this study was to evaluate whether self-reported knee instability is associated with activity limitations in patients with knee osteoarthritis (OA), in addition to knee pain and muscle strength. A cohort of 248 patients diagnosed with knee OA was examined. Self-reported knee instability was defined as the perception of any episode of buckling, shifting, or giving way of the knee in the past 3 months. Knee pain was assessed using a numeric rating scale, and knee extensor and flexor strength were measured using an isokinetic dynamometer. Activity limitations were measured by using the Western Ontario and McMasters Universities Osteoarthritis Index physical function questionnaire, the timed Get Up and Go, and the timed stair climbing and three questionnaires evaluating walking, climbing stairs, and rising from a chair. Other potential determinants of activity limitations were also collected, including joint proprioception, joint laxity, age, sex, body mass index (BMI), disease duration, and radiographic disease severity. Regression analyses evaluated the effect of adding self-reported knee instability to knee pain and muscle strength, when examining associations with the activity limitations measures. Self-reported knee instability was common (65 %) in this cohort of patients with knee OA. Analyses revealed that self-reported knee instability is significantly associated with activity limitations, even after controlling for knee pain and muscle strength. Joint proprioception, joint laxity, age, sex, BMI, duration of complaints, and radiographic severity did not confound the associations. In conclusion, self-reported knee instability is associated with activity limitations in patients with knee OA, in addition to knee pain and muscle strength. Clinically, self-reported knee instability should be assessed in addition to knee pain and muscle strength.

Background Pain-related avoidance of activities is hypothesized to lead to lower muscle strength and thereby activity limitations. Negative affect (e.g., low vitality, depression) is thought to strengthen the tendency to avoid activities. Purpose The aim of this study was to assess the validity of this "avoidance model" in patients with early symptomatic knee osteoarthritis (OA). Methods Cross-sectional data (n=151) were used. The associations between pain, negative affect, avoidance, muscle strength, and activity limitations were modeled using structural equation modeling. Results Pain and negative affect were associated with lower muscle strength via avoidance (mediation by avoidance). Avoidance was associated with activity limitations via lower muscle strength (mediation by muscle strength). There were also direct associations between pain, negative affect, avoidance, muscle strength, and activity limitations. Conclusions The results support the validity of the avoidance model, which explains the associations between pain, negative affect, avoidance, muscle strength, and activity limitations in patients with early symptomatic knee OA. © The Society of Behavioral Medicine 2012.

PURPOSE. In addition to performance-based measures, visionrelated quality of life (QOL) and other subjective measures of psychosocial functioning are considered important outcomes of training in the visually impaired. In a multicenter, masked, randomized controlled trial, subjective effects of training in the use of closed-circuit televisions (CCTV) were investigated. METHODS. Patients (n ¼ 122) were randomized either to a treatment group that received usual delivery instructions from the supplier combined with concise outpatient training, or to a control group that received delivery instructions only. Subjective outcomes were the Low Vision Quality-of-Life Questionnaire (LVQOL), EuroQOL 5 Dimensions, Adaptation to AgeRelated Vision Loss (AVL), and the Center of Epidemiologic Studies Depression scales. Linear mixed models were used to investigate treatment effects. Differential effects of patient characteristics were studied by implementing higher order interactions into the models. RESULTS. From baseline to follow-up, all patients perceived significantly less problems on the reading and fine work dimension (-28.8 points; P < 0.001) and the adaptation dimension (-4.67 points; P ¼ 0.04) of the LVQOL. However, no treatment effect was found based on the intention-to-treat analysis. CONCLUSIONS. This study demonstrated the effect of receiving and using a CCTV on two vision-related QOL dimensions; however, outpatient training in the use of CCTVs had no additional value. (trialregister.nl number, NTR1031.) (Invest Ophthalmol Vis Sci. 2012;53:3645‐3652) DOI:10.1167/ iovs.11-9226

Purpose. This qualitative study investigates possible differences in identified rehabilitation needs indicated by the usual intake procedures at a Multidisciplinary Rehabilitation Center (MRC) for visually impaired persons compared with those indicated by the use of a structured Dutch version [based on the International Classification of the Disability, Functioning and Health (ICF)] of the Activity Inventory (D-AI). Methods. Twenty patients who enrolled at the MRC received a D-AI assessment by telephone, in addition to the usual intake. All patients received usual care, based on rehabilitation needs identified by the usual intake procedure at the MRC. Rehabilitation needs identified at the MRC were obtained from patient files retrospectively and were compared with rehabilitation needs identified by the D-AI. Results. The mean number of rehabilitation needs reported in the patient files was 6.9 (±5.1) vs. 24.0 (±11.2) using the D-AI. Only 22.6% (±14.3) of the rehabilitation needs identified by the D-AI were present in the patient files; 79.3% (±28.2) of the rehabilitation needs reported in the patient files were identified by the D-AI. Overall agreement corrected for chance between both intake methods revealed a fair Cohen kappa of 0.27. Conclusions. At the MRC, more needs were revealed using the D-AI compared with the usual intake procedure. The systematic character of the D-AI prevents important topics being overlooked. In the usual intake, it was not clear whether needs were investigated from the patient's perspective. This may hamper (medical) communication and shared decision making about the rehabilitation program that needs to be followed. Moreover, using the unstructured information from the patient files makes it difficult to evaluate rehabilitation outcomes. With the D-AI, although an extensive overview of rehabilitation needs is produced, it remains difficult to focus on the most relevant needs. However, after assessment with the D-AI, all aspects of the ICF, Disability, and Health scheme can be discussed in a process of shared decision making, which leads to the final determination of rehabilitation goals. © 2012 American Academy of Optometry.

STUDY DESIGN: A randomized controlled trial.OBJECTIVE: To assess the effectiveness of Delitto's classification-based treatment approach compared with usual physical therapy care in patients with subacute or chronic low back pain.SUMMARY OF BACKGROUND DATA: No trial has evaluated this approach in patients with subacute and chronic low back pain.METHODS: Before randomization, all patients were classified by research physical therapists according to a modified version of Delitto's classification-based system. Randomization was computer-generated, with centralized allocation concealment. The statistician and the physical therapists were unblinded. Patients and assistants who collected follow-up questionnaires were blinded. Follow-up assessments were completed at 8, 26, and 52 weeks. The primary analysis was performed according to the intention-to-treat principle, using multilevel analysis. The main outcomes were global perceived effect, disability (Oswestry Disability Index, 0-100), and pain intensity (Numerical Rating Scale, 0-10). Secondary outcomes were quality of life, fear-avoidance beliefs, and psychosocial status. RESULTS.: A total of 156 patients were included (classification-based group, n = 74; usual physical therapy group, n = 82). There were no statistically significant differences between the treatment groups for any of the outcomes at any of the follow-up time points. After 8 weeks, patients in the classification-based group had greater global perceived effect scores; adjusted odds ratio of 1.01 (95% confidence interval [CI], 0.31 to 3.28), and higher adjusted Oswestry Disability Index and Numerical Rating Scale scores; mean adjusted differences of 0.48 points (95% CI, -4.59 to 3.63) and 0.49 points (95% CI, -1.34 to 0.37) respectively, but all differences were statistically nonsignificant.CONCLUSION: The classification-based system used in this study was not effective for improving physical therapy care outcomes in a population of patients with subacute and chronic low back pain.

OBJECTIVE: To identify subgroups or phenotypes of knee osteoarthritis (OA) patients based on similarities of clinically relevant patient characteristics, and to compare clinical outcomes of these phenotypes.METHODS: Data from 842 knee OA patients of the Osteoarthritis Initiative were used. A cluster analysis method was performed, in which clusters were formed based on similarities in 4 clinically relevant, easily available variables: severity of radiographic OA, lower extremity muscle strength, body mass index, and depression. Univariable and multivariable regression analyses were used to compare phenotypes on clinical outcomes (pain and activity limitations), taking into account possible confounders.RESULTS: Five phenotypes of knee OA patients were identified: "minimal joint disease phenotype," "strong muscle phenotype," "nonobese and weak muscle phenotype," "obese and weak muscle phenotype," and "depressive phenotype." The "depressive phenotype" and "obese and weak muscle phenotype" showed higher pain levels and more severe activity limitations than the other 3 phenotypes.CONCLUSION: Five phenotypes based on clinically relevant patient characteristics can be identified in the heterogeneous population of knee OA patients. These phenotypes showed different clinical outcomes. Interventions may need to be tailored to these clinical phenotypes.

Objective We developed the Determinants of Lifestyle Behavior Questionnaire (DLBQ) to measure determinants of lifestyle behavioral change according to the Theory of Planned Behavior (TPB) in adults at high risk of diabetes type 2 (T2DM) and cardiovascular diseases (CVD). The aim of the current study was to test the validity of the DLBQ. Methods From February to September 2008, a cross-sectional survey was conducted in the region West-Friesland (The Netherlands) among 622 adults, aged 30–50 years at high risk of T2DM or CVD participating in a lifestyle intervention trial. Structural equation modeling techniques were used for confirmatory factor analysis and to test correlations between the TPB constructs. Results The results demonstrate the factorial validity of the DLBQ in this population. The theoretical factor structure of the DLBQ is supported, and 41–56% of the variance in intentions to improve lifestyle behaviors is explained. Conclusions The DLBQ proves to be a valid instrument for measuring important determinants of the intention to change three lifestyle behaviors in adults at high risk of T2DM and CVD. Practice implications The identified ‘key-determinants’ of the TPB that seem to contribute to an increased intention to change behavior could be of value in designing future lifestyle interventions.

Background: Patient-reported outcome (PRO) scales are often used in multiple sclerosis (MS) research. Full understanding of items can be influenced by disease worsening, mood disturbances and cognitive problems of the MS patient. Earlier research with the Multiple Sclerosis Impact Scale (MSIS-29) showed that proxy respondents (i.e. partners of patients) can provide useful information. Objective: To determine agreement between patients and proxy respondents on different MS PRO scales. Methods: 139 Patients and partners completed the MSIS-29 (Physical and Psychological scale), Multiple Sclerosis Walking Scale (MSWS-12), Multiple Sclerosis Neuropsychological Screening Questionnaire (MSNQ) and Guy’s Neurological Disability Scale (GNDS). We calculated the mean difference and intra-class correlation coefficients (ICC) on scale level and weighted kappas (κw) on item level. Results: On all scales, except MSNQ, the partner score was higher. ICCs were good for MSWS, GNDS and MSIS Physical, and moderate for MSNQ and MSIS Psychological. κw was excellent for MSWS items, fair to good for GNDS, MSIS Physical and MSIS Psychological items, and poor for MSNQ items. Conclusion: Partners of patients with MS can be a useful source of information for several PRO scales, especially when the focus is on physical functioning. For psychological functioning this seems to be less reliable.

Introduction: Within the labour force workers without an employment contract represent a vulnerable group. In most cases, when sick-listed, these workers have no workplace/employer to return to. Therefore, the aim of this study was to evaluate the effectiveness on return-to-work of a participatory return-to-work program compared to usual care for unemployed workers and temporary agency workers, sick-listed due to musculoskeletal disorders. Methods: The workers, sick-listed for 2-8 weeks due to musculoskeletal disorders, were randomly allocated to the participatory return-to-work program (n = 79) or to usual care (n = 84). The new program is a stepwise procedure aimed at making a consensus-based return-to-work plan, with the possibility of a temporary (therapeutic) workplace. Outcomes were measured at baseline, 3, 6, 9 and 12 months. The primary outcome measure was time to sustainable first return-to-work. Secondary outcome measures were duration of sickness benefit, functional status, pain intensity, and perceived health. Results The median duration until sustainable first return-to-work was 161 days in the intervention group, compared to 299 days in the usual care group. The new return-to-work program resulted in a non-significant delay in RTW during the first 90 days, followed by a significant advantage in RTW rate after 90 days (hazard ratio of 2.24 [95% confidence interval 1.28-3.94] P = 0.005). No significant differences were found for the measured secondary outcomes. Conclusions The newly developed participatory return-to-work program seems to be a promising intervention to facilitate work resumption and reduce work disability among temporary agency workers and unemployed workers, sick-listed due to musculoskeletal disorders. © The Author(s) 2011.

Summary Background No consensus exists on the validity of the sentinel-lymph-node procedure for assessment of nodal status in patients with colorectal cancer. We aimed to assess the diagnostic performance of this procedure. Methods We searched Embase and PubMed databases for studies published before March 20, 2010. Eligible studies had a prospective design, a sample size of at least 20 patients, and reported the rate of sentinel-lymph-node positivity. Individual patient data were requested for localisation and T-stage stratification. A subset of reports with high methodological quality was selected and analysed. Findings We identified 52 eligible studies, which included 3767 sentinel-lymph-node procedures (2961 [78·6%] colon and 806 [21·4%] rectal carcinomas). Most tumours 2339 (62·1%) were stage T3 or T4. 1887 (50·1%) of patients were male, 1880 (49·9%) female. Mean overall weighted-detection rate was 0·94 (95% CI 0·92–0·95), at a pooled sensitivity of 0·76 (0·72–0·80) with limited heterogeneity (χ 2 =286·08, degrees of freedom=51; p=0·003). A mean weighted upstaging of 0·15 (95% CI 0·12–0·19) was noted. Individual patient data were available from 19 studies that included 1168 patients. Analysis of these data showed no significant difference in sensitivity between colon (0·86 [95% CI 0·83–0·90]) and rectal cancer (0·82 [0·77–0·88]; p=0·23). Also, there was no dependency of sensitivity on T stage for both colon (pT1: 0·79 [95% CI 0·73–0·84], pT2: 0·76 [0·62–0·90], pT3: 0·73 [0·59–0·87], pT4: 0·73 [0·53–0·93]) and rectal cancer (T1 or T2: 0·81 [0·52–0·94] vs T3 or T4: 0·80 [0·51–0·93]). The subgroup of eight studies with high methodological quality showed a mean detection rate of 0·96 (95% CI 0·90–0·99) for colonic tumours and 0·95 (0·75–0·99) for rectal tumours, and a mean sensitivity of 0·90 (95% CI 0·86–0·93) for colonic tumours and 0·82 (0·60–0·93) for rectal tumours. Interpretation The sentinel-lymph-node procedure shows a low sensitivity, regardless of T stage, localisation, or pathological technique. For every patient diagnosed with colon or rectal cancer without clinical evidence of lymph-node involvement or metastatic disease, this procedure in addition to conventional resection should be considered, since the prognostic information provided by this technique could be clinically significant. Funding Cancer Center Amsterdam Foundation, Amsterdam, Netherlands.

Background: Cortical lesions (CLs) occur frequently in multiple sclerosis (MS), but only few CLs are observed on conventional magnetic resonance imaging (MRI). Why some CLs are visible and others are not is currently unknown. Here, we investigated whether CLs that are visible on conventional MRI differ from MRI-invisible CLs in terms of underlying histopathology and quantitative MRI (qMRI) measures. Methods: A total of 16 brain slices from 10 patients with chronic MS were analysed histopathologically and with conventional and qMRI. A region-of-interest approach was used to compare MRI-visible CLs with MRI-invisible CLs. Results: Although under-powering cannot be completely excluded in this study, MRI-visible CLs did not seem to differ from MRI-invisible CLs in terms of histopathology or qMRI measures. They were, however, significantly larger than their invisible counterparts (mean 13.3 ± 1.7 mm2 versus 6.9 ± 1.3 mm2; p = 0.001). Furthermore, the number of MRI-visible lesions correlated with the overall number of CLs in the brain slice ( r = 0.96, p Conclusion: MRI visibility of CLs is determined by lesion size, and not by any distinctive underlying pathology. Visible CLs are associated with a higher total cortical lesion load, which suggests that when CLs in patients with MS become detectable on MRI, they merely represent ‘the tip of the pathological iceberg’.

A decline in everyday cognitive functioning is important for diagnosing dementia. Informant questionnaires, such as the informant questionnaire on cognitive decline in the elderly (IQCODE), are used to measure this. Previously, conflicting results on the IQCODEs ability to discriminate between Alzheimer's disease (AD), mild cognitive impairment (MCI), and cognitively healthy elderly were found. We aim to investigate whether specific groups of items are more useful than others in discriminating between these patient groups. Informants of 180 AD, 59 MCI, and 89 patients with subjective memory complaints (SMC) completed the IQCODE. To investigate the grouping of questionnaire items, we used a two-dimensional graded response model (GRM).The association between IQCODE, age, gender, education, and diagnosis was modeled using structural equation modeling. The GRM with two groups of items fitted better than the unidimensional model. However, the high correlation between the dimensions (r=.90) suggested unidimensionality. The structural model showed that the IQCODE was able to differentiate between all patient groups. The IQCODE can be considered as unidimensional and as a useful addition to diagnostic screening in a memory clinic setting, as it was able to distinguish between AD, MCI, and SMC and was not influenced by gender or education. (JINS, 2011, 17, 674–681)

Summary Vitamin D deficiency is very common in non-western immigrants. In this randomized clinical trial, vitamin D 800 IU/day or 100,000 IU/3 months were compared with advised sunlight exposure. Vitamin D supplementation was more effective than advised sunlight exposure in improving vitamin D status and lowering parathyroid hormone levels. Introduction Vitamin D deficiency (25-hydroxyvitamin D [25(OH)D]

Objective: To investigate the impact of a higher magnetic field strength of 3 Tesla (T) on the detection rate of cortical lesions in multiple sclerosis (MS) patients, in particular using a dedicated double inversion recovery (DIR) pulse sequence. Methods: Thirty-four patients with clinically isolated syndromes or definite MS were included. All patients underwent magnetic resonance imaging (MRI) at 1.5 T and 3 T, including T2-weighted turbo spin echo (TSE), fluid-attenuated inversion recovery (FLAIR) and DIR sequences. All images were analysed for focal lesions categorised according to their anatomical location. Results: The total number of detected lesions was higher at 3 T across all pulse sequences. We observed significantly higher numbers of lesions involving the cortex at 3 T using a DIR sequence. DIR at 3 T showed 192% more pure intracortical (p

STUDY DESIGN: A randomized clinical trial. OBJECTIVE: To compare the effectiveness of a behavioral graded activity program with manual therapy in patients with subacute (4-12 weeks) nonspecific neck pain. SUMMARY OF BACKGROUND DATA: Neck pain is a common complaint, for which many conservative therapies are available in primary care. There is strong evidence for manual therapy in combination with exercises. Psychosocial factors are also believed to play a role in chronic pain. The evidence of the effectiveness of a program focused on these factors is still unknown. METHODS: A randomized clinical trial was conducted, involving 146 patients with subacute nonspecific neck pain. The BGA program can be described as a time-contingent increase in activities from baseline toward predetermined goals. Manual therapy consists of specific spinal mobilization techniques and exercises. Primary outcomes were global perceived effect, the Numerical Rating Scale for pain and the Neck Disability Index. Secondary outcomes were the Tampa Scale for Kinesiophobia, the 4 Dimensional Symptom Questionnaire, and the Pain Coping and Cognition List. Measurements were carried out at baseline and 6, 13, 26, and 52 weeks after randomization. Data are analyzed according to the intention-to-treat principle, using multilevel analysis. RESULTS: The success rates at 52 weeks, based on the GPE were 89.4% for the BGA program and 86.5% for MT. This difference was not statistically significant. For pain and disability, a difference was found in favor of the BGA program; mean difference for pain = 0.99 (95% CI 0.15-1.83) and mean difference for NDI = 2.42 (95% CI 0.52-4.32). All other differences between the interventions in the primary and secondary outcomes were not statistically significant. CONCLUSION: Based on this trial it can be concluded that there are only marginal, but not clinically relevant, differences between a BGA program and MT. Spine (Phila Pa 1976) ispartof: Spine vol:35 issue:10 pages:1017-1024 ispartof: location:United States status: published

The aim was to determine if psychological factors favourably influence the short and long-term outcome of patients with sub-acute neck pain in terms of global perceived recovery, pain, using a Numerical Rating Scale (NRS) and functional disability, using the Neck Disability Index (NDI). This study was conducted within the framework of a randomised clinical trial comparing two types of conservative therapy in 146 patients with sub-acute neck pain. Multilevel techniques were used for data-analysis. The short and long term results for the three outcomes were very diverse. The sub-scales of the used questionnaires, i.e. the Pain Coping and Cognition List (PCCL), and the 4 Dimensional Symptom Questionnaire (4DSQ), did not contribute significantly to all of the multilevel models. Only the factor 'fear of movement' was consistently and significantly present in the univariable analysis for all outcomes at both follow-up measurements. The explained variance in the short term ranged from 16% to 30%, and from 6% to 34% in the long term. This can be considered to be low. We conclude that all psychological factors showed a considerable variation on the specific measurement and time point used. Only 'fear of movement' consistently impedes short term and long term recovery. Further prognostic research is needed to achieve more consistent results. © 2009 Elsevier Ltd. All rights reserved.

Purpose: To examine the benefi ts of using near-isotropic single-slab three-dimensional (3D) magnetic resonance (MR) imaging for the creation of subtraction images and to evaluate their performance in the detection of active multiple sclerosis (MS) brain lesions in comparison with two-dimensional (2D) subtraction images. Materials and Methods: The study protocol was approved by the local ethics review board and all subjects gave written informed consent before investigation. Three-dimensional MR sequences, including double inversion-recovery, fl uid-attenuated inversion recovery, T2-weighted, and T1-weighted magnetization-prepared rapid acquisition gradient-echo (MP-RAGE), and corresponding 2D sequences were performed twice in 14 patients (eight women, six men; mean age, 37.6 years) with MS and nine age-matched healthy control subjects (three women, six men; mean age, 31.7 years). Active lesions were scored by two independent raters, followed by a consensus reading. Lesion counts were evaluated by using negative binomial regression; interrater agreement was evaluated by using intraclass correlation coefficient. Results: Three-dimensional subtraction images had less residual misregistration and fl ow artifacts and depicted higher numbers of active lesions with greater interobserver agreement compared with 2D subtraction images. Among the 3D sequences, MP-RAGE subtraction imaging enabled detection of a signifi cantly higher mean number of positive active MS lesions compared with 2D subtraction imaging (2.8 versus 1.7, P = .012), particularly infratentorial lesions (0.6 vs 0.1, P< .05), and a substantially higher (nonsignificant) mean number of small (< 3 mm) lesions (0.6 vs 0.1, P > .05). Conclusion: Three-dimensional subtraction imaging, after image registration, produced better image quality, leading to increased detection of active MS lesions with greater inter-observer agreement in comparison with 2D subtraction imaging; 3D MP-RAGE subtraction imaging represents a promising technique to increase sensitivity in ascertaining lesion dissemination in time and increase the power of MR imaging metrics for the evaluation of treatment effects in clinical trials. © RSNA, 2010.

Purpose The aim of this study was to improve the quality and applicability of the 6 Dutch scales of the Communication Profile for the Hearing Impaired (CPHI; Demorest & Erdman, 1986, 1987, 1988) using item response theory (IRT). IRT modeling can produce precise, valid, and relatively brief instruments, resulting in minimal response burden (Edelen & Reeve, 2006). Method We investigated (a) whether items fit to the graded response model (GRM; Samejima, 1969) using Stone and Zhang’s (2003) procedure to test goodness of fit and (b) whether items showed differential item functioning (DIF) with the IRT log-likelihood ratio approach for 5 group variables: gender, age, living arrangement, use of hearing aids, and degree of hearing impairment. We investigated the magnitude of DIF by calculating the maximum difference between expected item scores for subgroups of the group variables of items showing DIF. Results In a cross-sectional study, 408 consecutive individuals with hearing impairment completed the Dutch CPHI scales. Twelve items were deleted because of misfit to GRMs, 14 items showed uniform DIF, and 2 showed nonuniform DIF. Five items showing DIF were deleted due to large magnitude of DIF. The short form of the Dutch CPHI scales contains 35 items. Conclusions DIF analyses showed that the short form was relatively free of DIF with respect to the 5 group variables. Hence, there is no need to make adjustments for the calculation of subgroup scores.

Objective: To provide a practical example showing how to relate measurement error to minimal important change (MIC) to estimate sample sizes required for detecting important changes in research, and to determine the usefulness of patient-reported outcomes (PROs) in daily clinical practice. Study Design and Setting: The standard error of measurement (SEM) can be calculated as a parameter of measurement error. MIC can be determined by taking the mean change in score on the questionnaire in the subgroup of patients that reported to be ‘‘a little better’’ or ‘‘better’’ on a global rating scale minus the mean change in score in the subgroup of patients that reported to be ‘‘not changed.’’ Based on SEM and MIC, formulas are presented that can be used to estimate sample sizes and to determine whether the questionnaire can be used to monitor changes in individual patients in daily clinical practice. Results: A fully worked-out example is presented, using Western Ontario and McMaster University Osteoarthritis Index data from a cohort of patients undergoing hip or knee replacement. Conclusion: We strongly recommend investigators to present the SEM and MIC of PROs and use these to estimate sample sizes for research and to determine the usefulness of these outcomes in daily clinical practice. 2008 Elsevier Inc. All rights reserved.

Purpose To evaluate the psychometrics of the SF-36 Health Survey among Turkish and Moroccan ethnic minority populations in the Netherlands and to compare the results to those based on the indigenous Dutch population. Methods Data were derived from the Second Dutch National Survey of General Practice. In total, SF-36 data were available for 409 Turkish, 377 Moroccan, and 9,628 Dutch respondents. Language subgroup analyses were performed for the Turkish (n = 162) and Moroccan-Arabic (n = 52) versions of the SF-36. Psychometric properties were evaluated by descriptive statistics, factor analysis, internal consistency estimates, known-group comparisons, and differential item function (DIF) analysis. Results Low levels of missing SF-36 data were observed across all groups. Confirmatory factor analysis supported the hypothesized SF-36 scale structure for the Dutch and Turkish group, but high correlations between the MH and VT factors were observed in the Moroccan group. All Cronbach’s alpha coefficients were above 0.70, except for the Vitality scale in the Moroccan group and the Vitality and Social Functioning scales in the Moroccan-Arabic language subgroup. Known-groups validity was found across samples using age, sex, education, and comorbidity as grouping variables, but not marital status. Some evidence for DIF was found in both ethnic group samples. Conclusions The results generally support the use of the SF-36 for general population research among Turkish and Moroccan ethnic minorities in the Netherlands. Additional studies are needed to confirm the psychometrics of the questionnaire when used among these populations in other Western European countries.

STUDY DESIGN. Exploratory subgroup analysis in a randomized controlled trial (RCT). OBJECTIVE. To detect possible moderators in the effectiveness of a workplace intervention in a population of workers with sick leave due to sub acute nonspecific low back pain. SUMMARY OF BACKGROUND DATA. In a recently published RCT, a workplace intervention was effective on return to work, compared to usual care. Examining the heterogeneity of effect sizes within the population in this RCT (n = 196) can lead to information on the effectiveness of the intervention in subgroups of patients. METHODS. A subgroup analysis was performed by adding interaction terms to the statistical model. Before analysis the following possible moderators for treatment were identified: age, gender, pain, functional status, heavy work, and sick leave in the previous 12 months. Cox regression analyses were performed and survival curves were plotted. RESULTS. The interaction (P = 0.02) between age (dichotomized at the median value) and the workplace intervention indicates a modifying effect. The workplaceintervention is more effective for workers

Background A statistical distribution describing the number of new enhancing lesions seen on MRI in patients with MS is of great importance for improving the statistical methodology of clinical trials using new enhancing lesions as outcome measure. We examined whether there are superior alternatives for the currently proposed negative binomial (NB) distribution. Objective To determine the optimal statistical distribution describing new enhancing lesion counts from a selection of six conceivable models, and to assess the effect on the distribution of a treatment effect, varying follow-up duration and selection for activity at baseline. Methods The statistical NB, Poisson-Inverse Gaussian (P-IG), Poisson- Lognormal (P-LN), Neyman type A (NtA), Pólya-Aeppli (PA) and Zero Inflated Poisson (ZIP) distribution were fitted on new enhancing lesion data derived from one treated and two untreated cohorts of RRMS and relapsing SPMS patients and on subgroups of varying follow-up duration and selection for baseline activity. Measure of comparison was Akaike's information criterion (AIC). Results Both the subgroup analyses as well as a treatment had a noticeable effect on the distributional characteristics of new enhancing lesion counts. The NB distribution generally provided the most optimal fit, closely followed by the P-IG distribution and the P-LN distribution. Fits of the PA and NtA distribution were suboptimal, while the ZIP distribution was the least adequate for modelling new enhancing lesion counts. Conclusion The NB distribution is the optimal distribution for modelling new enhancing lesion counts, irrespective of the effect of treatment, follow-up duration or a baseline activity selection criterion.

A systematic review of measurement properties of health-status instruments is a tool for evaluating the quality of instruments. Our aim was to appraise the quality of the review process, to describe how authors assess the methodological quality of primary studies of measurement properties, and to describe how authors evaluate results of the studies. Literature searches were performed in three databases. One hundred and forty-eight reviews were included. The purpose of included reviews was to identify health status instruments used in an evaluative application and to report on the measurement properties of these instruments. Two independent reviewers selected the articles and extracted the data. Reviews were often of low quality: 22% of the reviews used one database, the search strategy was often poorly described, and in many cases it was not reported whether article selection (75%) and data extraction (71%) was done by two independent reviewers. In 11 reviews the methodological quality of the primary studies was evaluated for all measurement properties, and of these 11 reviews only 7 evaluated the results. Methods to evaluate the quality of the primary studies and the results differed widely. The poor quality of reviews hampers evidence-based selection of instruments. Guidelines for conducting and reporting systematic reviews of measurement properties should be developed. © 2009 The Author(s).

Objective: To determine the validity of varus-valgus motion as a measure of knee joint stability by establishing the relationship of varus-valgus motion with muscle strength, joint proprioception, joint laxity and skeletal alignment in patients with knee osteoarthritis (OA). Methods: Sixty-three patients with OA of the knee were tested. Varus-valgus motion was determined with a video-based optoelectronic gait analysis system. Muscle strength was measured using a computer-driven isokinetic dynamometer. Proprioceptive acuity was assessed by establishing the joint motion detection threshold in the anterior-posterior direction. Laxity was assessed using a device which measures the passive angular deviation of the knee in the frontal plane. Alignment was assessed using a goniometer. Regression analyses were performed to assess the relationship between varus-valgus motion, muscle strength, joint proprioception, joint laxity and skeletal alignment. Result: Varus-valgus motion was not related to muscle strength, joint proprioception, joint laxity and skeletal alignment. Conclusions: Knee joint stability cannot be measured as varus-valgus motion. Rather, a number of independent factors seem to contribute to the process of stabilization of the knee joint. © 2007 Osteoarthritis Research Society International.

In recent clinical gait studies, the use of net energy cost (EC) outcomes has been recommended. This study assessed the comparative reproducibility of gross and net EC of walking in adults and children with locomotion disorders, using a portable system for gas-exchange. Furthermore, methodological considerations were proposed for improving the reproducibility of these outcomes. Assessment of reproducibility was made in adults with polio residuals (n = 14) versus healthy adults (n = 14), and in children with cerebral palsy (n = 13) versus healthy children (n = 10). There were four repeated measurement sessions on different days, with inter-session periods of 1 week. All the measurements had been conducted at the outpatient clinic between 2002 and 2004. Based on the Generalizability Theory for data-analysis, it was shown that there was less intra-subject variability in gross EC of walking compared to net EC of walking among adults and children with locomotion disorders, which was apparent from the lower standard error of measurement values. Data-analysis optimisation and study design adjustments were considered and presented in a decision scheme, to demonstrate that the reproducibility of net EC can substantially be increased. The use of gross EC, rather than net EC, in patients with locomotion disorders seems a more reproducible measure of walking efficiency. However, reproducibility of net EC can substantially be improved by careful standardization and using a multiple repetition design, as a result of which this outcome measure becomes suitable for detecting clinically relevant changes at the individual level. © 2007 Elsevier B.V. All rights reserved.

Study design.: Prospective, multicenter, cohort study. Objective.: To examine which clinical and sociodemographic baseline variables can predict a favorable outcome in subjects with neck pain treated by chiropractors. Summary of background data.: Relatively little is known on predictors of neck pain, particularly for those subjects undergoing chiropractic care. No previous study has examined predictors of outcome for subjects with neck pain by modeling the trajectories of subjects in a longitudinal design. Methods.: All new, consecutive patients, between 18 and 65 years of age with neck pain of any duration, who had not undergone chiropractic or manual therapy in the prior 3 months, were recruited. Questionnaires were administered at the first 3 visits, and at 3 and 12 months. In all, 29 putative prognostic baseline variables were evaluated. Multivariate multilevel longitudinal regression analyses were conducted using neck pain, neck disability, and perceived recovery as outcomes. Results.: In total, 529 patients fulfilled the inclusion criteria. The response rate at 12-months was 92%. In the multivariate analyses, 14 (48%) of the prognostic variables examined were retained in at least one of the models. Shorter duration of neck pain at the first visit was the only variable retained in all 3 final regression models. The following were predictive of a favorable outcome for any 2 of the 3 outcome measures examined: intermittent neck pain, those not on sick-leave or receiving workers compensation at baseline, a higher level of education, less tiredness, higher expectations that the treatment would be beneficial, lack of morning pain, and worse perceived general health. Conclusion.: On the basis of the patient's history, the clinician can identify a number of determinants, which are predictive of a favorable outcome. Shorter duration of neck pain at the first visit was the only variable consistently found to be predictive of a favorable outcome for all 3 outcome measures examined. © 2008, Lippincott Williams & Wilkins.

Objective: The aim was to evaluate the effect of the implementation of an information handover form regarding patients receiving palliative care. Outcome was the information available for the out-of-hours GP co-operative. Design: We conducted a controlled trial. Setting: All GPs in Amsterdam, The Netherlands. Intervention: The experimental group (N = 240) received an information handover form and an invitation for a one-hour training, the control group (N = 186) did not receive a handover form or training. We studied contacts with the GP co-operative concerning patients in palliative care for the presence and quality of information transferred by the patient's own GP. Main outcome measures: Proportion of contacts in which information was available and proportion of adequate information transfer. Results. Overall information was transferred by the GPs in 179 of the 772 first palliative contacts (23.2%). The number of contacts in the experimental group in which information was available increased significantly after intervention from 21% to 30%, compared to a decrease from 23% to 19% in the control group. The training had no additional effect. The content of the transferred information was adequate in 61.5%. There was no significant difference in the quality of the content between the groups. Conclusion: The introduction of a handover form resulted in a moderate increase of information transfers to the GP co-operative. However, the total percentage of contacts in which this information was present remained rather low. GP co-operatives should develop additional policies to improve information transfer. Key Points The out-of-hours period is potentially problematic for the delivery of optimal palliative care, often due to inadequate information transfer. Introduction of a handover form resulted in a moderate increase of transferred information. The percentage of palliative contacts remained low in cases where information was available. Adequate information was transferred in more than half of the cases.

Background: The Tampa Scale for Kinesiophobia (TSK) and the Fear-Avoidance Beliefs Questionnaire (FABQ) are frequently used questionnaires for pain-related fear, and the visual analogue scale (VAS) is for pain. Purpose: This study aims to determine the smallest detectable change (SDC) of these questionnaires in patients with acute low back pain (LBP), as well as ceiling and/or floor effects. Results: The SDC for the TSK (scoring range: 17-68) was 9.2 (95% CI: 8.4; 10.3). The estimated SDC was 9.4 (95% CI: 8.5; 10.6) and 12.7 (95% CI: 11.5; 14.1) for the FABQ physical activity subscale (scoring range: 0-24) and/or work subscale (scoring range: 0-42), respectively. For the VAS for pain (0-100 mm), the SDC turned out to be 36.2 mm (95% CI: 32.4; 41.0). The FABQ physical activity subscale and pain (VAS) seem to have considerable problems in detecting improvement and deterioration. The TSK appears to be able to detect improvement as well as deterioration. Conclusion: The SDCs of the (subscales of) questionnaires range from 18% to 40%. Floor and/or ceiling effects were detected for most scales, except the TSK total and the TSK activity avoidance subscale. These results should be considered when using these questionnaires as measures of therapeutic change in acute LBP.

The prioritisation of patients on waiting lists is ascribed high potential for diminishing the consequences of waiting times for elective surgery. However, consistent evidence is lacking about which factors determine patient priority and it is unclear whether different stakeholders have different opinions on this issue. This study, conducted in the Netherlands, investigates the judgements of patients, laypersons (i.e. patients on other waiting lists), and physicians on the priority of patients on waiting lists. Participants were former patients with varicose veins (N=82), inguinal hernia (N=86), and gallstones (N=89), 101 surgeons, 95 occupational physicians, and 65 general practitioners. Each participant judged the priority of paper vignettes of patients with varicose veins, inguinal hernia, and gallstones. The vignettes were designed according to conjoint analysis methodology and described the physical symptoms, the psychological distress, the social limitations, and impairments in work of patients. Multilevel regression analysis of the responses showed that all groups made significant distinctions in patient priority depending on the severity of each characteristic in the vignettes. The physical symptoms and impairments in work had on average the highest impact on priority, but the summed impact of non-physical factors exceeded that of the physical symptoms. The different groups of participants appraised only the importance of the physical symptoms differently, but opinions on priority varied widely within each group. Whereas the high level of agreement between the different groups would facilitate the acceptance and the implementation of explicit prioritisation of patients on the waiting list, the high inter-individual variation signifies that consensus criteria for prioritisation are needed to warrant equity and transparency in care provision.

Objective: This study describes both positive clinical outcomes and adverse events in patients treated for neck pain by a chiropractor. Methods: This study was a prospective, multicenter, observational cohort study. Patients with neck pain of any duration who fulfilled the inclusion criteria were recruited in a practice-based study. Data were collected on the patients and from the chiropractors at baseline, the first 3 visits, and at 3 and 12 months. Clinical outcome measures included (1) neck pain in the 24 hours preceding the visit, (2) neck disability, (3) treatment satisfaction, (4) global assessment, and (5) adverse events. Recovery was defined as "completely improved" or "much better" using the global assessment scale. An adverse event was defined as either a new related complaint or a worsening of the presenting or existing complaint by >30% based upon an 11-point numerical rating scale. Results: In all, 79 chiropractors participated, recruiting 529 subjects, representing 4891 treatment consultations. Follow-up was possible for 90% and 92%, respectively, at 3 and 12 months. Most patients had chronic, recurrent complaints; mild to moderate disability of the neck; and a mild amount of pain at baseline; and two thirds had sought previous care for the presenting complaint in the preceding 6 months. Adverse events after any of the first 3 treatments were reported by 56%, and 13% of the study population reported these events to be severe in intensity. The most common adverse events affected the musculoskeletal system or were pain related, whereas symptoms such as tiredness, dizziness, nausea, or ringing in the ears were uncommon (

Objectives Multi-item questionnaires are frequently used to measure outcomes in randomized controlled trials (RCTs) in patients with sciatica. Knowing the minimaly important change (MIC) values for these instruments will facilitate interpretation of change scores. MIC values have been shown to be dependent on baseline values. The question is whether they also depend on the type of intervention. To estimate the MIC of the Roland Morris Disability Questionnaire (modified 23 item version) (RMDQ) and of intensity of leg pain measured by a Visual Analogue Scale (VAS) in patients with sciatica and to assess to what extent MIC values depend on type of intervention and on baseline values. Study Design and Setting This is a secondary analysis of RCT data of the effects of early surgery vs. prolonged conservative treatment in patients with sciatica. Baseline and 8-week data were used to assess MIC of the RMDQ-23 and VAS leg pain. We used the receiver operator characteristic (ROC) method to assess the MIC. Global Perceived Recovery (rated 8 weeks after baseline) was used as anchor. Subgroups were created based on type of treatment and baseline severity. Results The MIC value of the RMDQ-23 for the total group of sciatica patients was 7.5. The values were 8.1 and 6.9 for surgery and conservative treatment, respectively. For high and low baseline values, the MICs were 9.0 and 4.9, respectively, irrespective of treatment received. The MIC values of the VAS leg pain were 34.4 for the total group. For surgery and conservative treatment, the MIC values were 38.5 and 30.4, respectively, whereas for groups with high and low baseline values, MIC values of 53.5 and 17.2 were found. Conclusion The MIC values of the RMDQ-23 and VAS leg pain were found to be highly dependent on their baseline values, although the type of intervention appeared to influence the MIC value only slightly.