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Purpose This study is to develop a structured approach to distinguishing large-artery vasculitis from atherosclerosis using 18-fluorodeoxyglucose positron emission tomography combined with low-dose computed tomography (FDG PET/CT). Methods FDG PET/CT images of 60 patients were evaluated, 30 having biopsy-proven giant cell arteritis (GCA; the most common form of large-artery vasculitis), and 30 with severe atherosclerosis. Images were evaluated by 12 nuclear medicine physicians using 5 criteria: FDG uptake pattern (intensity, distribution, circularity), the degree of calcification, and co-localization of calcifications with FDG-uptake. Criteria that passed agreement, and reliability tests were subsequently analysed for accuracy using receiver operator curve (ROC) analyses. Criteria that showed discriminative ability were then combined in a multi-component scoring system. Both initial and final ‘gestalt’ conclusion were also reported by observers before and after detailed examination of the images. Results Agreement and reliability analyses disqualified 3 of the 5 criteria, leaving only FDG uptake intensity compared to liver uptake and arterial wall calcification for potential use in a scoring system. ROC analysis showed an area under the curve (AUC) of 0.90 (95%CI 0.87–0.92) for FDG uptake intensity. Degree of calcification showed poor discriminative ability on its own (AUC of 0.62; 95%CI 0.58–0.66). When combining presence of calcification with FDG uptake intensity into a 6-tiered scoring system, the AUC remained similar at 0.91 (95%CI 0.88–0.93). After exclusion of cases with arterial prostheses, the AUC increased to 0.93 (95%CI 0.91–0.95). The accuracy of the ‘gestalt’ conclusion was initially 89% (95%CI 86–91%) and increased to 93% (95%CI 91–95%) after detailed image examination. Conclusion Standardised assessment of arterial wall FDG uptake intensity, preferably combined with assessment of arterial calcifications into a scoring method, enables accurate, but not perfect, distinction between large artery vasculitis and atherosclerosis.

Interim 18F-fluorodeoxyglucose positron emission tomography (Interim- 18F-FDG-PET,hereafter I-PET) has the potential to guide treatment of patients with diffuse large B-celllymphoma (DLBCL) if the prognostic value is known. The aim of this study was to determinethe optimal timing and response criteria for evaluating prognosis with I-PET in DLBCL.Individual patient data from 1692 patients with de novo DLBCL were combined and scans were harmonized. I-PET was performed at various time points during treatment with rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) therapy. Scans were interpreted using the Deauville score (DS) and change in maximum standardized uptake value (DSUVmax ). Multilevel Cox proportional hazards models corrected for International Prognostic Index (IPI) score were used to study the effects oftiming and response criteria on 2-year progression-free survival (PFS). I-PET after 2 cycles (I-PET2) and I-PET4 significantly discriminated good responders from poor responders, with the highest hazard ratios (HRs) for I-PET4. Multivariable HRs for a PET-positive result at I-PET2 and I-PET4 were 1.71 and 2.95 using DS4-5, 4.91 and 6.20 using DS5, and 2.93 and 4.65 using DSUVmax , respectively. DSUVmax identified a larger proportion of poor respondersthan DS5 did. For all criteria, the negative predictive value was >80%, and positivepredictive values ranged from 30% to 70% at I-PET2 and I-PET4. Unlike I-PET1, I-PET3discriminated good responders from poor responders using DS4-5 and DS5 thresholds (HRs,2.94 and 4.67, respectively). I-PET2 and I-PET4 predict good response equally during R-CHOPtherapy in DLBCL. Optimal timing and response criteria depend on the clinical context. Goodresponse at I-PET2 is suggested for de-escalation trials, and poor response using DSUVmax atI-PET4 is suggested for randomized trials that are evaluating new therapies

Objective: To reassess reliability and validity of the Submental Nasal Appearance Scale (SNAS) compared to the preliminary pilot study, for assessment of patient photographs with repaired unilateral cleft lip and palate (UCLP). When utilizing the SNAS, 3 nasal features (1. nasal outline; 2. alar base position; 3. nostril axis) must be graded according to symmetry between the cleft and noncleft side using a 5-point scale with reference photographs for each feature. The mean score calculated from the graded features reflects the overall degree of nasal symmetry, which is considered an important goal when repairing UCLP. Design: Fifty patient photographs were selected and cropped, displaying the submental view. Six raters assessed these photographs using the SNAS and a separate 5-point scale to assess the overall submental appearance. Interrater reliability was determined for both methods and correlation was calculated between these as an indication of construct validity. Setting: Amsterdam UMC, location VUmc, Amsterdam, The Netherlands. Patients: Six- to 9-year-old patients with repaired UCLP. Results: Interrater reliability of 0.73 and 0.48 was found for the SNAS and overall appearance assessment, respectively, while in the pilot study values of 0.79 and 0.69 were found. Correlation of 0.59 and 0.74 was found in the current and pilot study, respectively, between the SNAS and overall appearance assessment. Conclusions: The SNAS is a reliable tool to assess nasal symmetry from the submental perspective. Reliability of the SNAS is higher compared to grading overall appearance, but validity of the SNAS was less well supported.

Purpose MYC gene rearrangements in diffuse large B-cell lymphoma (DLBCL) patients are associated with poor prognosis. Our aim was to compare patterns of 2[18F]fluoro-2-deoxy-D-glucose positron emission tomography computed tomography (PET/CT) response in MYC + and MYC- DLBCL patients. Methods Interim PET/CT (I-PET) and end of treatment PET/CT (EoT-PET) scans of 81 MYC + and 129 MYC- DLBCL patients from 2 HOVON trials were reviewed using the Deauville 5-point scale (DS). DS1-3 was regarded as negative and DS4-5 as positive. Standardized uptake values (SUV) and metabolic tumor volume (MTV) were quantified at baseline, I-PET, and EoT-PET. Negative (NPV) and positive predictive values (PPV) were calculated using 2-year overall survival. Results MYC + DLBCL patients had significantly more positive EoT-PET scans than MYC- patients (32.5 vs 15.7%, p = 0.004). I-PET positivity rates were comparable (28.8 vs 23.8%). In MYC + patients 23.2% of the I-PET negative patients converted to positive at EoT-PET, vs only 2% for the MYC- patients (p = 0.002). Nine (34.6%) MYC + DLBCL showed initially uninvolved localizations at EoT-PET, compared to one (5.3%) MYC- patient. A total of 80.8% of EoT-PET positive MYC + patients showed both increased lesional SUV and MTV compared to I-PET. In MYC- patients, 31.6% showed increased SUV and 42.1% showed increased MTV. NPV of I-PET and EoT-PET was high for both MYC subgroups (81.8–94.1%). PPV was highest at EoT-PET for MYC + patients (61.5%). Conclusion MYC + DLBCL patients demonstrate aberrant PET response patterns compared to MYC- patients with more frequent progression during treatment after I-PET negative assessment and new lesions at sites that were not initially involved. Trial registration number and date of registration HOVON-84: EudraCT: 2006–005,174-42, retrospectively registered 01–08-2008. HOVON-130: EudraCT: 2014–002,654-39, registered 26–01-2015

Ethics support services like Moral Case Deliberation (MCD) intend to support healthcare professionals in ethically difficult situations. To assess outcomes of MCD, the Euro-MCD Instrument has been developed. Field studies to test this instrument are needed and have been conducted, examining important outcomes before MCD participation and experienced outcomes. The current study aimed to (1) describe how participants’ perceive the importance of MCD outcomes after MCD; (2) compare these perceptions with those before MCD participation; and (3) test the factor structure of these outcomes. Swedish, Norwegian and Dutch healthcare professionals rated the importance of outcomes in the Euro-MCD Instrument after four and eight MCDs. Ratings were compared with those before MCD participation using paired and independent samples t-tests. The factor structure was tested using exploratory factor analyses. After 4 and 8 MCDs, 443 respectively 247 respondents completed the instrument. More than 69% rated all MCD outcomes as ‘quite’ or ‘very’ important, especially outcomes from Enhanced Collaboration, Improved Moral Reflexivity and Improved Moral Attitude. Significant differences for 16 outcomes regarding ratings before and after MCD participation were not considered meaningful. Factor analyses suggested three categories, which seemingly resemble the domains Improved Moral Reflexivity, Enhanced Collaboration and a combination of Improved Moral Attitude and Enhanced Emotional Support. After participation in MCDs, respondents confirmed the importance of outcomes in the Euro-MCD Instrument. The question on perceived importance and the categorization of outcomes need reconsideration. The revised instrument will be presented elsewhere, based on all field studies and theoretical reflections.

Background: Clinical Ethics Support (CES) services are offered to support healthcare professionals in dealing with ethically difficult situations. Evaluation of CES is important to understand if it is indeed a supportive service in order to inform and improve future implementation of CES. Yet, methods to measure outcomes of CES are scarce. In 2014, the European Moral Case Deliberation Outcomes Instrument (Euro-MCD) was developed to measure outcomes of Moral Case Deliberation (MCD). To further validate the instrument, we tested it in field studies and revised it. This paper presents the Euro-MCD 2.0 and describes the revision process. Methods: The revision process comprised an iterative dialogue among the authors as Euro-MCD-project team, including empirical findings from six Euro-MCD field-studies and input from European experts in CES and theory. Empirical findings contained perceptions and experiences of MCD outcomes among healthcare professionals who participated in MCDs in various settings in Norway, Sweden and the Netherlands. Theoretical viewpoints on CES, literature on goals of CES and MCD and ethics theory guided the interpretation of the empirical findings and final selection of MCD outcomes. Results: The Euro-MCD 2.0 Instrument includes three domains: Moral Competence, Moral Teamwork and Moral Action. Moral Competence consists of items about moral sensitivity, analytical skills and virtuous attitude. Moral Teamwork includes open dialogue and supportive relationships and Moral Action refers to moral decision-making and responsible care. During the revision process, we made decisions about adding and reformulating items as well as decreasing the number from 26 to 15 items. We also altered the sentence structure of items to assess the current status of outcomes (e.g. 'now') instead of an assumed improvement over time (e.g. 'better') and we omitted the question about perceived importance. Conclusions: The Euro-MCD 2.0 is shorter, less complex and more strongly substantiated by an integration of empirical findings, theoretical reflections and dialogues with participants and experts. Use of the Euro-MCD 2.0 will facilitate evaluation of MCD and can thereby monitor and foster implementation and quality of MCD. The Euro-MCD 2.0 will strengthen future research on evaluation of outcomes of MCD.

This study aims to validate the HIC monitor as a model-fidelity scale to the High and Intensive Care (HIC) model, a recently developed model for acute psychiatric wards. To assess the psychometric properties of the HIC monitor, 37 audits were held on closed inpatient wards at 20 psychiatric hospitals in the Netherlands. Interrater reliability, construct validity and content validity were examined. Our results suggest that the HIC monitor has good psychometric properties. It can be used as a tool for assessing the implementation of the HIC model on acute psychiatric wards in the Netherlands, and for quality assessment and improvement.

Background: Due to differences in the definition of frailty, many different screening instruments have been developed. However, the predictive validity of these instruments among community-dwelling older people remains uncertain. Objective: To investigate whether combined (i.e. sequential or parallel) use of available frailty instruments improves the predictive power of dependency in (instrumental) activities of daily living ((I)ADL), mortality and hospitalization. Design, setting and participants: A prospective cohort study with two-year follow-up was conducted among pre-frail and frail community-dwelling older people in the Netherlands. Measurements: Four combinations of two highly specific frailty instruments (Frailty Phenotype, Frailty Index) and two highly sensitive instruments (Tilburg Frailty Indicator, Groningen Frailty Indicator) were investigated. We calculated sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) for all single instruments as well as for the four combinations, sequential and parallel. Results: 2,420 individuals participated (mean age 76.3 ± 6.6 years, 60.5% female) in our study. Sequential use increased the levels of specificity, as expected, whereas the PPV hardly increased. Parallel use increased the levels of sensitivity, although the NPV hardly increased. Conclusions: Applying two frailty instruments sequential or parallel might not be a solution for achieving better predictions of frailty in community-dwelling older people. Our results show that the combination of different screening instruments does not improve predictive validity. However, as this is one of the first studies to investigate the combined use of screening instruments, we recommend further exploration of other combinations of instruments among other study populations.

Background The most commonly performed surgical procedure for obstructive sleep apnea (OSA) is uvulopalatopharyngoplasty with or without tonsillectomy (UPPP ± TE). However, there is currently no review solely focusing on clinically relevant effects of standard UPPP technique with or without tonsillectomy as a monotherapy in patients with OSA. Methods A systematic review and meta-analysis were performed to assess the effects of isolated UPPP ± TE in patients with OSA. Studies of any design referring to adult patients with obstructive sleep apnea diagnosed via polysomnography or comparable objective measures were considered, in which isolated “standard” UPPP ± TE was performed. Results Forty-eight studies were included for the qualitative analysis. All but one study demonstrated a reduction in the frequency of respiratory events and success/response rates ranged from 35 to 95.2%. In the six studies that reported pre- and postoperative mean scores of the Epworth Sleepiness Scale (ESS), a reduction in sleepiness scores was demonstrated. Data addressing the effect of UPPP ± TE in comparison to no treatment or control were available from two randomized controlled trials (RCT). When pooling the data, UPPP ± TE was significantly more effective in reducing the apnea-hypopnea index (AHI) and Epworth Sleepiness Scale (ESS) (large effect): an AHI mean difference (MD) of −18.59 (95% CI −34.14, −3.04) and an ESS MD of −5.37 (95% CI −7,03, −3.72). Data addressing effect of UPPP ± TE in comparison to baseline was available from three RCT. When pooling the data, the AHI was reduced from a mean 35.4 to 17.9 (49.5% reduction); a MD of −20.41, 95% CI −32.78, −8.04 (−1.80, −1.15) (large effect). Various additional beneficial effects of UPPP ± TE were demonstrated including improvement in sexual function, ventricular function, sleep stages, serum lipid, depressive disorder and driving performance. Conclusion UPPP ± TE reduces respiratory events and daytime sleepiness in adult patients with OSA and UPPP ± TE is superior to non-treated controls in this regard. Further research is needed to establish the long-term benefit, the impact on cardiovascular morbidity and the role of UPPP ± TE in the variety of available treatment options for OSA.

Background Scores on an outcome measurement instrument depend on the type and settings of the instrument used, how instructions are given to patients, how professionals administer and score the instrument, etc. The impact of all these sources of variation on scores can be assessed in studies on reliability and measurement error, if properly designed and analyzed. The aim of this study was to develop standards to assess the quality of studies on reliability and measurement error of clinician-reported outcome measurement instruments, performance-based outcome measurement instrument, and laboratory values. Methods We conducted a 3-round Delphi study involving 52 panelists. Results Consensus was reached on how a comprehensive research question can be deduced from the design of a reliability study to determine how the results of a study inform us about the quality of the outcome measurement instrument at issue. Consensus was reached on components of outcome measurement instruments, i.e. the potential sources of variation. Next, we reached consensus on standards on design requirements (n = 5), standards on preferred statistical methods for reliability (n = 3) and measurement error (n = 2), and their ratings on a four-point scale. There was one term for a component and one rating of one standard on which no consensus was reached, and therefore required a decision by the steering committee. Conclusion We developed a tool that enables researchers with and without thorough knowledge on measurement properties to assess the quality of a study on reliability and measurement error of outcome measurement instruments.

Background: The Patient-Reported Outcomes Measurement Information System (PROMIS) item banks ‘Ability to Participate in Social Roles and Activities’ (35 items) and ‘Satisfaction with Social Roles and Activities’ (44 items) were developed to measure (satisfaction with) participation more efficiently and precisely than current instruments, by using Computerized Adaptive Testing (CAT). We validated these item banks in a Dutch general population. Methods: Participants in an internet panel completed both item banks. Unidimensionality, local dependence, monotonicity, Graded Response Model item fit, Differential Item Functioning (DIF) for age, gender, education, region, ethnicity, and language (Dutch compared to US Social Supplement), and reliability were assessed. Results: A representative Dutch sample of 1002 people participated. We found for the Ability to Participate and Satisfaction with Participation item banks, respectively, sufficient unidimensionality (CFI: 0.971, 0.960; TLI: 0.970, 0.958; RMSEA: 0.108, 0.108), no local dependence, sufficient monotonicity (H: 0.75, 0.73), good item fit (2 out of 35 items, 1 out of 44 items with S-X2p-value < 0.001). No DIF was found. We found a reliability of at least 0.90 with simulated CATs in 86% and 94% of the participants with on average 4.7 (range 2–12) and 4.3 (range 3–12) items, respectively. Discussion: The PROMIS participation item banks showed sufficient psychometric properties in a general Dutch population and can be used as CAT. PROMIS CATs allow reliable and valid measurement of participation in an efficient and user-friendly way with limited administration time.

Purpose: Systematic reviews of patient-reported outcome measures (PROMs) differ from reviews of interventions and diagnostic test accuracy studies and are complex. In fact, conducting a review of one or more PROMs comprises of multiple reviews (i.e., one review for each measurement property of each PROM). In the absence of guidance specifically designed for reviews on measurement properties, our aim was to develop a guideline for conducting systematic reviews of PROMs. Methods: Based on literature reviews and expert opinions, and in concordance with existing guidelines, the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) steering committee developed a guideline for systematic reviews of PROMs. Results: A consecutive ten-step procedure for conducting a systematic review of PROMs is proposed. Steps 1–4 concern preparing and performing the literature search, and selecting relevant studies. Steps 5–8 concern the evaluation of the quality of the eligible studies, the measurement properties, and the interpretability and feasibility aspects. Steps 9 and 10 concern formulating recommendations and reporting the systematic review. Conclusions: The COSMIN guideline for systematic reviews of PROMs includes methodology to combine the methodological quality of studies on measurement properties with the quality of the PROM itself (i.e., its measurement properties). This enables reviewers to draw transparent conclusions and making evidence-based recommendations on the quality of PROMs, and supports the evidence-based selection of PROMs for use in research and in clinical practice CP has received funding from the European Union’s Seventh Framework Programme [FP7/2007-2013] under Grant Agreement No. 305081.

Objective: To develop a reliable and easy-to-use method to assess the nasolabial appearance of 18-year-old patients with unilateral cleft lip and palate (CLP). Design: Retrospective analysis of nasolabial aesthetics using a 5-point ordinal scale and newly developed photographic reference scale: the Cleft Aesthetic Rating Scale (CARS). Three cleft surgeons and 20 medical students scored the nasolabial appearance on standardized frontal photographs. Setting: VU University Medical Center, Amsterdam. Patients: Inclusion criteria: 18-year-old patients, unilateral cleft lip and palate, available photograph of the frontal view. Exclusion criteria: history of facial trauma, congenital syndromes affecting facial appearance. Eighty photographs were available for scoring. Main Outcome Measures: The interobserver and intraobserver reliability of the CARS for 18-year-old patients when used by cleft surgeons and medical students. Results: The interobserver reliability for the nose and lip together was 0.64 for the cleft surgeons and 0.61 for the medical students. There was an intraobserver reliability of 0.75 and 0.78 from the surgeons and students, respectively, on the nose and lip together. No significant difference was found between the cleft surgeons and medical students in the way they scored the nose ( P = 0.22) and lip ( P = 0.72). Conclusions: The Cleft Aesthetic Rating Scale for 18-year-old patients has a substantial overall estimated reliability when the average score is taken from three or more cleft surgeons or medical students assessing the nasolabial aesthetics of CLP patients.

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.

Purpose The original COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist was developed to assess the methodological quality of single studies on measurement properties of Patient-Reported Outcome Measures (PROMs). Now it is our aim to adapt the COSMIN checklist and its four-point rating system into a version exclusively for use in systematic reviews of PROMs, aiming to assess risk of bias of studies on measurement properties. Methods For each standard (i.e., a design requirement or preferred statistical method), it was discussed within the COSMIN steering committee if and how it should be adapted. The adapted checklist was pilot-tested to strengthen content validity in a systematic review on the quality of PROMs for patients with hand osteoarthritis. Results Most important changes were the reordering of the measurement properties to be assessed in a systematic review of PROMs; the deletion of standards that concerned reporting issues and standards that not necessarily lead to biased results; the integration of standards on general requirements for studies on item response theory with standards for specific measurement properties; the recommendation to the review team to specify hypotheses for construct validity and responsiveness in advance, and subsequently the removal of the standards about formulating hypotheses; and the change in the labels of the four-point rating system. Conclusions The COSMIN Risk of Bias checklist was developed exclusively for use in systematic reviews of PROMs to distinguish this application from other purposes of assessing the methodological quality of studies on measurement properties, such as guidance for designing or reporting a study on the measurement properties. Electronic supplementary material The online version of this article (10.1007/s11136-017-1765-4) contains supplementary material, which is available to authorized users.

Background Content validity is the most important measurement property of a patient-reported outcome measure (PROM) and the most challenging to assess. Our aims were to: (1) develop standards for evaluating the quality of PROM development; (2) update the original COSMIN standards for assessing the quality of content validity studies of PROMs; (3) develop criteria for what constitutes good content validity of PROMs, and (4) develop a rating system for summarizing the evidence on a PROM’s content validity and grading the quality of the evidence in systematic reviews of PROMs. Methods An online 4-round Delphi study was performed among 159 experts from 21 countries. Panelists rated the degree to which they (dis)agreed to proposed standards, criteria, and rating issues on 5-point rating scales (‘strongly disagree’ to ‘strongly agree’), and provided arguments for their ratings. Results Discussion focused on sample size requirements, recording and field notes, transcribing cognitive interviews, and data coding. After four rounds, the required 67% consensus was reached on all standards, criteria, and rating issues. After pilot-testing, the steering committee made some final changes. Ten criteria for good content validity were defined regarding item relevance, appropriateness of response options and recall period, comprehensiveness, and comprehensibility of the PROM. Discussion The consensus-based COSMIN methodology for content validity is more detailed, standardized, and transparent than earlier published guidelines, including the previous COSMIN standards. This methodology can contribute to the selection and use of high-quality PROMs in research and clinical practice. Electronic supplementary material The online version of this article (10.1007/s11136-018-1829-0) contains supplementary material, which is available to authorized users.

OBJECTIVE: The aim of the study was to determine the internal consistency, test-retest reliability and measurement error of the Animated Activity Questionnaire (AAQ) for assessing activity limitations in hip and knee osteoarthritis (HKOA) patients.METHODS: A total of 1,177 patients, from six countries (the Netherlands, UK, France, Denmark, Italy and Spain), completed the AAQ, a questionnaire consisting of videos displaying 17 activities with 3-5 levels of performance, from which patients choose the video that best matches their own performance. Unidimensionality was assessed by means of confirmatory factor analysis (CFA), using the following fit indices: the Tucker-Lewis index (TFI) >0.95, comparative fit index (CFI) >0.95, and root mean square error of approximation (RMSEA) RESULTS: The fit indices for unidimensionality were CFI 0.957, TLI 0.950, and RMSEA 0.144. Cronbach's alpha was 0.95. ICC for test-retest reliability was 0.93 (95% confidence interval 0.91 to 0.95), ranging from 0.85 to 0.98 across countries. SEM and SDC were 4.9 and 13.6, respectively, on a scale from 0 to 100, and ranging from 2.7 to 6.7, and from 7.5 to 18.4, respectively, across countries. The AAQ appeared to measure slightly more precisely in patients with knee problems and patients without prosthesis.CONCLUSION: The AAQ seemed to be unidimensional, and showed good internal consistency and test-retest reliability. The SDC indicated that changes in scores of at least 14% indicate real improvement in activity limitations.

Background: Characterization of the prognostic variables for persistent neuropathic pain (PNP) remains incomplete despite multiple articles addressing this topic. To provide more insight into the recovery and prognosis of neuropathic pain, high-quality data are required that provide information about the predictors that contribute to the development of PNP. Objective: To determine the methodological quality of studies about predictors for PNP and to summarize findings of predictors found in high-quality studies. Study Design: A systematic review. Setting: VU University Medical Center, Amsterdam, The Netherlands. Methods: Studies were identified by searching the electronic databases PubMed, Embase, and Cochrane Library. Methodological quality of each article was independently assessed by 2 reviewers. Results: Forty-six relevant studies were identified, classified into 4 different neuropathic pain (NP)- syndromes: postherpetic neuralgia (n = 35), radicular pain and sciatica (n = 3), postsurgical pain (n = 6), and other types of NP (n = 2). Seven studies were of high quality. The 3 high-quality studies found for PHN reported male gender, older age, smoking, trauma at the site of lesion, missed antiviral prescriptions, higher acute pain severity, higher rash severity, more neuropathic characteristics, shorter rash duration, and a lower health status as predictors for PNP. For persistence of radicular pain one high-quality study reported negative outcome expectancies, pain-related fear of movement, and passive pain coping as predictors for PNP. Psychological distress, acute pain, breast cancer surgery, higher body mass index, area of secondary hyperalgesia, neuropathic characteristics, hypoesthesia, and hyperesthesia were found to be predictive for postsurgical pain in 3 high-quality studies. Limitations: Some publications may have been missed during literature search. The low-quality of the studies could be the result of an incomplete description of their methods. Conclusions: High-quality studies mainly assessed factors related to disease functions and structures. Due to shortcomings in methodological quality and limited areas of predictor selection, there is a need for high-quality studies focusing on predictor measurement, statistical analysis and the use of a standardized set of predictors. Key words: Neuropathic pain, persistent pain, systematic review, literature search, predictors, quality assessment, ICF-model

Treating burn scar contracture remains a challenging problem for reconstructive surgeons. At present, no consensus exists on when to use what kind of technique. Therefore, a systematic review was performed on the effectiveness of the different surgical techniques after burn scar contracture release. Electronic databases were searched using a predefined search strategy. Studies evaluating the outcome of surgical techniques for the treatment of burn scar contractures were included. The methodological quality was tested and the data were summarized. One thousand six hundred fourty-nine papers were identified of which 17 met the inclusion criteria. Three papers reported on a controlled trial, 14 were cohort studies, including 10 of a pre-post operative design and 4 of a comparative design. The papers described outcomes of grafts, flaps with random or defined vascularization, and dermal substitutes. All studies had methodological shortcomings and most used inappropriate statistical methods. The current evidence on the effectiveness of reconstruction techniques for burn scar contractures was summarized. Due to the scarcity and low quality of the included studies, no definitive conclusions could be reached about the effectiveness of different techniques. Therefore, no direct implications for daily practice could be made. However, recommendations could be given for improvement of the quality of further primary research on the effectiveness of surgical treatment strategies for burn scar contracture release.

The aim of this study is to investigate a novel method for dealing with incomplete scale scores in longitudinal data that result from missing item responses. This method includes item information as auxiliary variables, which is advantageous because it incorporates the observed item-level data while maintaining the scale scores as the focus of the analysis. These auxiliary variables do not change the analysis model, but improve missing data handling. The investigated novel method uses the item scores or some summary of a parcel of item scores as auxiliary variables, while treating the scale scores missing in a latent growth model. The performance of these methods was examined in several simulated longitudinal data conditions and analyzed through bias, mean square error, and coverage. Results show that including the item information as auxiliary variables results in rather dramatic power gains compared with analyses without auxiliary variables under varying conditions.

Objective To develop an Animated Activity Questionnaire (AAQ) based on video animations for assessing activity limitations in patients with hip/knee osteoarthritis (OA) that combines the advantages of self-reported questionnaires and performance-based tests without many of their limitations and to preliminarily assess its reliability and validity. We hypothesized that the AAQ would correlate highly with performance-based tests and moderately with self-reported questionnaires. Methods Item selection was based on the pilot AAQ, prespecified conditions, the International Classification of Functioning, Disability, and Health core set for OA, existing measurement instruments, and focus groups of patients. Test–retest reliability was assessed in 30 of 110 patients. In 110 patients, correlations were calculated between the AAQ and the self-reported Hip Disability/Knee Injury and Osteoarthritis Outcome Score activities of daily living subscale (H/KOOS). In 45 of 110 patients, correlations with performance-based tests (stair climbing test, timed up and go test, and 30-second chair stand test) were calculated. Results In total, 17 basic daily activities were chosen for the AAQ. Video animations were made showing a person performing each activity with 3–5 different levels of difficulty. Patients were asked to select the level that best matched their own performance. Reliability was high (intraclass correlation coefficient 0.97 [95% confidence interval 0.93–0.98]); the AAQ correlated highly with performance-based tests (0.62), but higher with the H/KOOS (0.76) than expected. Conclusion A computerized AAQ for assessing activity limitations was developed. Content validity was considered good. Preliminary validation results showed high reliability, but construct validity needs further study with a larger sample size. Continuing research will focus on construct validity and crosscultural validity.

Background Despite increased attention for palliative care in patients with dementia dying in ursing homes, recent studies found burdensome symptoms and unmet family caregivers’ needs in the last phase of life. Audit- and feedback were expected to improve quality of palliative care. Aim To assess the effect of two audit- and feedback strategies on care quality in Dutch nursing homes using the EOLD-Satisfaction With Care scale (EOLD-SWC) and on outcome using the EOLD-Comfort Assessment in Dying scale (EOLD-CAD). Methods In a cluster randomized controlled trial, two auditand feedback strategies, either generic feedback based on mean EOLD-scores or feedback with patient-specific EOLDscores (six nursing homes each) were compared to a control group (six nursing homes) without feedback. The intervention groups discussed EOLD-ratings representing family views after death-in team meetings and formulated actions for care improvement. Multi-level analyses were performed to assess effects and a process evaluation catalogued barriers and facilitators of the intervention using semi-structured interviews. Results A total of 668 families rated the EOLD-instruments. Compared to no feedback, the generic strategy resulted in lower satisfaction in both adjusted and unadjusted analyses, while the patient-specific strategy increased comfort in unadjusted analyses only. The interviews showed that staff felt that regular team discussions about EOLD-scores were not always feasible. Improvement actions were not formulated sufficiently clear enough and were not followed-up, and favorable EOLD-scores did not seem to motivate teams to do better. Conclusion The disappointing effectiveness of audit and feedback may be explained by suboptimal conditions and insufficient skills to translate the feedback into care improvements. Feedback with favorable family ratings might even have triggered opposite effects in the context of Dutch long-term care. Trial number: NTR 3942.

Background In the assessment of patients with rheumatoid arthritis (RA) it is important to measure physical function, fatigue, pain behavior and pain interference. The Patient-Reported Outcomes Measurement Information System (PROMIS) initiative developed item banks for measuring these concepts. These item banks were translated into Dutch-Flemish language. Objectives To facilitate interpretation and implementation of PROMIS in the Netherlands, we aimed to calibrate and validate the Dutch-Flemish PROMIS Physical Function (DF-PROMIS-PF), Fatigue (DF-PROMIS-FA), Pain Behavior (DF-PROMISPB) and Pain Interference (DF-PROMIS-PI) Item Banks in the general Dutch population, to obtain Dutch norm scores for these item banks. Methods 3365 persons of the general Dutch population completed a web-based survey, of which 1309 persons completed the full DF-PROMIS-PF (121 items), 1007 persons completed the full DF-PROMIS-FA (95 items), and 1049 persons completed the full DF-PROMIS-PB (39 items) and the full DF-PROMIS-PI (40 items). The sample was stratified for gender, age, education, and ethnicity according to the distribution of the 2015 census of the general Dutch population. A one-factor confirmatory factor analysis (CFA) was performed per item bank to assess unidimensionality. A graded item response model (GRM) was fitted per item bank to evaluate the item characteristics of the item banks and to facilitate future development of computer adaptive tests (CATs). Ordinal regression models were used to evaluate Differential Item Functioning (DIF) for language (Dutch vs. English) as a measure of cross-cultural validity. Results All four item banks showed good fit to the GRM: they showed good fit indices for CFA and high percentages of explained variance by first factor. The item banks showed only little local dependency and the scalability coefficients suggested strong scalability for all four item banks. The item characteristics showed good coverage across the range of the four concepts. DIF analyses are in progress. Conclusions The item banks exhibited good psychometric properties in the general Dutch population. The four Dutch-Flemish PROMIS item banks can be used to develop CATs for measuring physical function, fatigue, pain behavior and pain interference in the Netherlands. Dutch norm scores are presented. Disclosure of Interest None declared

BACKGROUND: Theoretically, individual work performance (IWP) can be divided into four dimensions: task performance, contextual performance, adaptive performance, and counterproductive work behavior. However, there is no consensus on the indicators used to measure these dimensions. OBJECTIVE: This study was designed to (1) identify indicators for each dimension, (2) select the most relevant indicators, and (3) determine the relative weight of each dimension in ratings of work performance.METHODS: IWP indicators were identified from multiple research disciplines, via literature, existing questionnaires, and expert interviews. Subsequently, experts selected the most relevant indicators per dimension and scored the relative weight of each dimension in ratings of IWP.RESULTS: In total, 128 unique indicators were identified. Twenty-three of these indicators were selected by experts as most relevant for measuring IWP. Task performance determined 36% of the work performance rating, while the other three dimensions respectively determined 22%, 20% and 21% of the rating.CONCLUSIONS: Notable consensus was found on relevant indicators of IWP, reducing the number from 128 to 23 relevant indicators. This provides an important step towards the development of a standardized, generic and short measurement instrument for assessing IWP.

The inverted nipple is a frequently encountered problem which can cause difficulties with breastfeeding, sexuality, and aesthetic dissatisfaction. Up to now, no consensus exists on a preferred treatment method. We performed a systematic review to identify the best treatment method for correction of benign inverted nipples. Treatment techniques were subdivided in the categories lactiferous duct preserving and lactiferous duct damaging. A systematic review was performed using the PRISMA statement. Inclusion criteria were: female patients with congenital or acquired inverted nipples, a minimum sample size of 10 nipples, and studies reporting recurrence of inversion with a minimum follow-up of six months. Exclusion criteria were nipple inversion caused by malignancy. Thirteen studies met the inclusion criteria which all had a level of evidence IV. No non-invasive treatment techniques were identified. In the duct preserving category eight studies were included with a recurrence rate of 0.6% (2/350) versus 9.9% (16/161) in the duct damaging category (n = 5). Other outcome parameters were not systematically reported in all studies. Because of a small number of low quality studies with heterogeneous interventions and outcomes a meta-analysis could not be performed and no preferred treatment method was identified. Based on the available data there is no statistical evidence that duct damaging treatment is superior to duct preserving treatment. We recommend that the first method of choice should be a duct preserving treatment method. In the future, more studies of better methodological quality are required and recommendations were made on how these could be conducted.

Purpose: The purpose of this study was to gain insight into how low back pain (LBP) patients conceptualize the construct of expectations regarding treatment. Methods: This study was nested within a mixed-method randomized clinical trial comparing three primary care interventions for LBP. A total of 77 participants with LBP lasting longer than 6 weeks were included; semi-structured interviews were conducted querying patients about their expectations for treatment. Also factors influencing their expectations were explored. Interviews were administered following enrollment into the study, but prior to study treatment. Two researchers independently conducted a content analysis using NVIVO 9 software. Results: LBP patients' expectations could be categorized in two main domains: outcome and process expectations, each with subdomains. Patients expressed expectations in all subdomains both as values (what they hoped) and probabilities (what they thought was likely). In multiple subdomains, there were differences in the nature (positive vs. negative) and frequency of value and probability expectations. Participants reported that multiple factors influenced their expectations of which past experience with treatment appeared to be of major influence on probability expectations. Conclusion and recommendations: This study showed that LBP patients' expectations for treatment are multifaceted. Current measurement instruments do not cover all domains and subdomains of expectations. Therefore, we recommend the development of new or improved measures that make a distinction between value and probability expectations and assess process and/or outcome expectations covering multiple subdomains. Some of the influencing factors found in this study may be useful targets for altering patients' treatment expectations and improving health outcomes. © 2013 Springer-Verlag Berlin Heidelberg.

Attention-deficit/hyperactivity disorder (ADHD) has been shown to continue into old age. Studies in children and younger adults show a reduction in hyperactive-impulsive symptoms, whereas the number of inattentive symptoms stays stable. The current study examined the lifetime stability of ADHD symptoms up to old age. Data on ADHD diagnosis and symptoms were collected in a two-phase side-study (N = 231) of the Longitudinal Aging Study Amsterdam. Paired t tests and ANCOVAs were used to analyze the data. Paired t test suggests continuity of the number of reported ADHD symptoms currently present and present in childhood. The change in the balance of inattentive/hyperactive-impulsive symptoms at present and in childhood is also the same in persons with ADHD. Finally, the difference in the change in the balance of inattentive/hyperactive-impulsive symptoms in those with and without ADHD suggests continuity throughout the life span. Our results suggest that diagnostic criteria developed for younger adults may be used among older adults. However, we collected our data retrospectively, which may have biased our results. Future research should follow larger cohorts of patients with ADHD prospectively over the life span.

PURPOSE: Anorexia is a frequently observed symptom in patients with cancer and is associated with limited food intake and decreased quality of life. Diagnostic instruments such as the Anorexia/Cachexia Subscale (A/CS) of the Functional Assessment of Anorexia/Cachexia Therapy (FAACT) questionnaire and the visual analog scale (VAS) for appetite have been recommended in the assessment of anorexia, but validated cut-off values are lacking. This study aimed to obtain cut-off values of these instruments for the assessment of anorexia in patients with cancer.METHODS: The FAACT-A/CS and the VAS for appetite were administered to patients with cancer before start of chemotherapy. As reference standard for anorexia, two external criteria were used: (1) a cut-off value of ≥2 on the anorexia symptom scale of the EORTC QLQ C-30 and (2) the question "Do you experience a decreased appetite?" (yes/no). ROC curves were used to examine the optimal cut-off values for the FAACT-A/CS and VAS.RESULTS: A total of 273 patients (58 % male; 64.0 ± 10.6 years) were included. The median score on the FAACT-A/CS was 38 (IQR 32-42) points and 77 (IQR 47-93) points on the VAS. Considering both external criteria, the optimal cut-off value for the FAACT-A/CS was ≤37 (sensitivity (se) 80 %, specificity (sp) 81 %, positive predictive value (PV(+)) 79 %, negative predictive value (PV(-)) 82 %) and for the VAS was ≤70 (se 76 %, sp 83 %, PV(+) 80 %, PV(-) 79 %).CONCLUSIONS: For the assessment of anorexia in patients with cancer, our study suggests cut-off values of ≤37 for the FAACT-A/CS and ≤70 for the VAS. Future studies should confirm our findings in other patient samples.

Purpose. To develop an instrument that measures empowerment among people with a long-term work disability. Methods. aEuro integral A six-dimension empowerment model was chosen as a theoretical framework. These dimensions are as follows: competence, self-determination, meaning, impact, positive identity and group orientation. A literature search was conducted to find instruments that currently are being used to measure one or more of these constructs. Validated and applicable instruments from this search were used in a preliminary questionnaire. A pilot test was conducted consulting the target population and experts. On basis of changes from this pilot, a concept questionnaire was conducted. In a field test, this questionnaire was sent to 976 subjects who followed a vocational rehabilitation course in the years 2001--2003. Item-total correlations and factor analyses were performed on the collected data to reduce the number of items. Factor analysis was performed, and internal consistency was determined to get insight into the psychometric properties of the final questionnaire. Results. aEuro integral From all subjects who were approached, 385 (39%%) returned usable questionnaires that could be analysed. Item reduction by item-total correlations and factor analysis resulted in a final questionnaire consisting of 62 items divided over the six subscales. Internal consistency of the subscales was good: all subscales had Cronbach's alphas between 0.80 and 0.91. Some inter-correlation existed between the subscales competence, self-determination and impact. Conclusions. aEuro integral The ''VrijBaan'' questionnaire was developed to measure empowerment among people with a long-term work disability. Although the results support the internal consistency of the subscales, further psychometric work is needed to improve the quality of this questionnaire.

In old age, sufficient protein intake is important to preserve muscle mass and function. Around 50% of older adults (65+ y) consumes 1.0 g/kg adjusted body weight (BW)/day (d). There is no rapid method available to screen for low protein intake in old age. Therefore, we aimed to develop and validate a short food questionnaire to screen for low protein intake in community-dwelling older adults. We used data of 1348 older men and women (56–101 y) of the LASA study (the Netherlands) to develop the questionnaire and data of 563 older men and women (55–71 y) of the HELIUS study (the Netherlands) for external validation. In both samples, protein intake was measured by the 238-item semi-quantitative HELIUS food frequency questionnaire (FFQ). Multivariable logistic regression analysis was used to predict protein intake 1.0 g/kg adjusted BW/d (based on the HELIUS FFQ). Candidate predictor variables were FFQ questions on frequency and amount of intake of specific foods. In both samples, 30% had a protein intake 1.0 g/kg adjusted BW/d. Our final model included adjusted body weight and 10 questions on the consumption (amount on average day or frequency in 4 weeks) of: slices of bread (number); glasses of milk (number); meat with warm meal (portion size); cheese (amount and frequency); dairy products (like yoghurt) (frequency); egg(s) (frequency); pasta/noodles (frequency); fish (frequency); and nuts/peanuts (frequency). The area under the receiver operating characteristic curve (AUC) was 0.889 (95% CI 0.870–0.907). The calibration slope was 1.03 (optimal slope 1.00). At a cut-off of 0.8 g/kg adjusted BW/d, the AUC was 0.916 (96% CI 0.897–0.936). Applying the regression equation to the HELIUS sample, the AUC was 0.856 (95% CI 0.824–0.888) and the calibration slope 0.92. Regression coefficients were therefore subsequently shrunken by a linear factor 0.92. To conclude, the short food questionnaire (Pro55+) can be used to validly screen for protein intake 1.0 g/kg adjusted BW/d in community-dwelling older adults. An online version can be found at www.proteinscreener.nl. External validation in other countries is recommended.

Contains fulltext : 88987.pdf (Publisher’s version ) (Closed access) OBJECTIVE: Development and validation of a quick and easy screening tool for the early detection of undernourished residents in nursing homes and residential homes. DESIGN: Multi-center, cross sectional observational study. SETTING: Nursing homes and residential homes. PARTICIPANTS: The screening tool was developed in a total of 308 residents (development sample; sample A) and cross validated in a new sample of 720 residents (validation sample) consisting of 476 nursing home residents (Sample B1) and 244 residential home residents (sample B2). MEASUREMENTS: Patients were defined severely undernourished when they met at least one of the following criteria: BMI or= 5% unintentional weight loss in the past month and/or >or= 10% unintentional weight loss in the past 6 months. Patients were defined as moderately undernourished if they met the following criteria: BMI 20.1-22 kg/m2 and/or 5-10% unintentional weight loss in the past six months. The most predictive questions (originally derived from previously developed screening instruments) of undernourishment were selected in sample A and cross validated in sample B. In a second stage BMI was added to the SNAQRC in sample B. The diagnostic accuracy of the screening tool in the development and validation samples was expressed in sensitivity, specificity, and the negative and positive predictive value. RESULTS: The four most predictive questions for undernutrition related to: unintentional weight loss more than 6 kg during the past 6 months and more than 3 kg in the past month, capability of eating and drinking with help, and decreased appetite during the past month. The diagnostic accuracy of these questions alone was insufficient (Se=45%, Sp=87%, PPV=50% and NPV=84%). However, combining the questions with measured BMI sufficiently improved the diagnostic accuracy (Se=87%, Sp=82%, PPV=59% and NPV=95%). CONCLUSION: Early detection of undernourished nursing- and residential home residents is possible using four screening questions and measured BMI. 01 februari 2010

Objectives Treatment outcome studies ought to assess the fidelity of their treatments, including treatment delivery, but practical guidelines and examples for this are lacking. Based on general recommendations in available literature, this study proposes and illustrates the design and application of a Method of Assessing Treatment Delivery (MATD) in a behavioral medicine trial comparing two treatments for chronic low back pain. Study Design and Setting In designing MATD, two experts identified several feasible treatment elements. Agreement between the experts in classifying these elements into five categories (essential and unique, essential but not unique, unique but not essential, compatible, prohibited) was assessed. In applying MATD, treatment recordings were evaluated by two independent raters, who coded the (non)-occurrence of MATD elements and who categorized each session as belonging to one of the two treatments. Results MATDs content validity was supported by adequate agreement between the experts' classifications of the treatment elements. MATDs interrater reliability was good. Conclusion Comprehensive illustrations of designing and applying MATD may encourage the verification of treatment delivery as a partial reflection of treatment fidelity in forthcoming treatment outcome studies.

BACKGROUND & AIMS: It is known from earlier studies that only 15% of the malnourished hospital outpatient population is recognized and receives nutritional treatment. To increase this number, a quick and easy malnutrition screening tool would be helpful. Because such a tool is lacking, we developed one by using the SNAQ (Short Nutritional Assessment Questionnaire) as a basis. The aim of this study was to develop a quick and easy malnutrition screening tool and to measure its diagnostic accuracy in malnourished hospital outpatients.METHODS: First, an optimal set of questions was selected for the preoperative outpatient population. Secondly, the diagnostic accuracy for the preoperative outpatients was determined (979 patients) and finally, the diagnostic accuracy for general hospital outpatients was established (705 patients).RESULTS: The three original SNAQ questions proved to be the best set of questions for the outpatient population as well. In the preoperative and general outpatient population the diagnostic accuracy resulted respectively in a sensitivity of 53% and 67%, a specificity of 97% and 98%, a positive predictive value of 69% and 72% and a negative predictive value of 94% and 97%.CONCLUSIONS: With an acceptable diagnostic accuracy it may be concluded that the original SNAQ malnutrition screening tool is valid for the hospital outpatient population.

Dit artikel beschrijft de ontwikkeling van een interventie gericht op werkhervatting van werknemers met veelvoorkomende psychische klachten. Intervention Mapping is toegepast voor het combineren van theorie en wetenschappelijk bewijs. Daarnaast zijn de doelgroepen betrokken bij de ontwikkeling van de interventie. Werknemers, leidinggevenden en arboprofessionals hebben deelgenomen aan focusgroepen over de inhoud en de randvoorwaarden van de interventie. De resultaten bestaan uit een beschrijving van de stapsgewijze ontwikkeling van de werkaanpassingsinterventie, met een uitgebreide samenvatting van de focusgroepen en een beschrijving van de ontwikkelde interventie. Toepassing van Intervention Mapping heeft geleid tot een gestructureerde werkaanpassingsinterventie, gebaseerd op wat bij werknemers met verzuim door psychische klachten nodig wordt geacht. Door rekening te houden met visies uit de praktijk wordt een betere implementatie van de werkaanpassingsinterventie verwacht. Op basis van het ontwikkelingsproces wordt verondersteld dat Intervention Mapping een veelbelovende benadering is bij het ontwikkelen van een passende interventie voor doelgroepen in de bedrijfsgezondheidszorg.

Jansen APD, Van Hout HPJ, Nijpels G, Van Marwijk HWJ, De Vet HCW, Stalman WAB. Betere detectie van dementie. Huisarts Wet 2008;51(3):115-9.

Background Systematic reviews of outcome measurement instruments are important tools for the selection of instruments for research and clinical practice. Our aim was to assess the quality of systematic reviews of health-related outcome measurement instruments and to determine whether the quality has improved since our previous study in 2007. Methods A systematic literature search was performed in MEDLINE and EMBASE between July 1, 2013, and June 19, 2014. The quality of the reviews was rated using a study-specific checklist. Results A total of 102 reviews were included. In many reviews the search strategy was considered not comprehensive; in only 59 % of the reviews a search was performed in EMBASE and in about half of the reviews there was doubt about the comprehensiveness of the search terms used for type of measurement instruments and measurement properties. In 41 % of the reviews, compared to 30 % in our previous study, the methodological quality of the included studies was assessed. In 58 %, compared to 55 %, the quality of the included instruments was assessed. In 42 %, compared to 7 %, a data synthesis was performed in which the results from multiple studies on the same instrument were somehow combined. Conclusion Despite a clear improvement in the quality of systematic reviews of outcome measurement instruments in comparison with our previous study in 2007, there is still room for improvement with regard to the search strategy, and especially the quality assessment of the included studies and the included instruments, and the data synthesis.

BackgroundThe aims of the current study were to calibrate the item parameters of the Dutch-Flemish PROMIS Pain Behavior item bank using a sample of Dutch patients with chronic pain and to evaluate cross-cultural validity between the Dutch-Flemish and the US PROMIS Pain Behavior item banks. Furthermore, reliability and construct validity of the Dutch-Flemish PROMIS Pain Behavior item bank were evaluated.MethodsThe 39 items in the bank were completed by 1042 Dutch patients with chronic pain. To evaluate unidimensionality, a one-factor confirmatory factor analysis (CFA) was performed. A graded response model (GRM) was used to calibrate the items. To evaluate cross-cultural validity, Differential item functioning (DIF) for language (Dutch vs. English) was evaluated. Reliability of the item bank was also examined and construct validity was studied using several legacy instruments, e.g. the Roland Morris Disability Questionnaire.ResultsCFA supported the unidimensionality of the Dutch-Flemish PROMIS Pain Behavior item bank (CFI = 0.960, TLI = 0.958), the data also fit the GRM, and demonstrated good coverage across the pain behavior construct (threshold parameters range: −3.42 to 3.54). Analysis showed good cross-cultural validity (only six DIF items), reliability (Cronbach's α = 0.95) and construct validity (all correlations ≥0.53).ConclusionsThe Dutch-Flemish PROMIS Pain Behavior item bank was found to have good cross-cultural validity, reliability and construct validity. The development of the Dutch-Flemish PROMIS Pain Behavior item bank will serve as the basis for Dutch-Flemish PROMIS short forms and computer adaptive testing (CAT).

It is believed that patients' expectancies about the effectiveness of treatment influence their treatment outcomes, but the working mechanism is rarely studied in patients with low back pain. Theoretical models suggest that adherence to treatment may be an important pathway. The aim of this study was to assess the mediating role of adherence to treatment in the relationship between expectancies and the outcomes of recovery and pain intensity in patients with acute low back pain. This study used data from a randomized placebo-controlled trial of paracetamol for acute low back pain. Expectancies were measured with the Credibility Expectancy Questionnaire. Adherence was measured with a medication diary. Pain intensity was recorded daily in a diary on a 0 to 10 pain scale, and recovery was defined as the first of 7 consecutive days scoring 0 or 1 on a 6-point pain scale. Cox regression (dependent variable: recovery) and linear mixed-model analyses (dependent variable: daily pain intensity scores) were performed. The "difference in coefficients" approach was used to establish mediation. A total of 1573 participants were included in current analyses. There was a small but highly significant relationship between expectancies and outcomes; 3.3% of the relationship between expectancies and recovery and 14.2% of the relationship between expectancies and pain intensity were mediated by adherence to treatment. This study does not convincingly support the theory that adherence is a key pathway in the relationship between treatment outcome expectancies and recovery and pain intensity in this acute low back pain population.

Item does not contain fulltext BACKGROUND: Infections frequently occur in patients with dementia and antibiotics are often prescribed, but may also be withheld. OBJECTIVES: The aim of this systematic review is to provide a systematic overview of the prevalence of antibiotic use, and factors associated with prescribing antibiotics in patients with dementia. DATA SOURCES: A systematic search of MEDLINE, EMBASE, PSYCINFO, CINAHL, and the Cochrane library databases until February 13, 2014 was performed, using both controlled terms and free-text terms. RESULTS: Thirty-seven articles were included. The point prevalence of antibiotic use in patients with dementia ranged from 3.3 to 16.6%. The period prevalence ranged from 4.4 to 88% overall, and from 23.5 to 94% in variable time frames before death; the median use was 52% (median period 14 days) and 48% (median period 22 days), respectively. Most patients with lower respiratory tract infections or urinary tract infections (77-91%) received antibiotic treatment. Factors associated with antibiotic use related to patients, families, physicians, and the healthcare context. More severe dementia and a poor prognosis were associated with less antibiotic use in various countries. Associations with aspiration and illness severity differed by country. CONCLUSIONS AND IMPLICATIONS: Antibiotic use in patients with dementia is substantial, and probably highly associated with the particular healthcare context. Future studies may report antibiotic use by infection type and stage of dementia, and compare cross-nationally.

Objective: To evaluate the cost effectiveness of physiotherapy, manual therapy, and care by a general practitioner for patients with neck pain. Design: Economic evaluation alongside a randomized controlled trial. Setting: Primary care. Participants: A total of 183 patients with neck pain for at least two weeks recruited by 42 general practitioners and randomly allocated to manual therapy (n=60, spinal mobilization), physiotherapy (n=59, mainly exercise), or general practitioner care (n=64, counseling, education, and drugs). Main outcome measures: Clinical outcomes were perceived: recovery, intensity of pain, functional disability, and quality of life. Direct and indirect costs were measured by means of cost diaries that were kept by patients for one year. Differences in mean costs between groups, cost effectiveness, and cost utility ratios were evaluated by applying non-parametric bootstrapping techniques. Results: The manual therapy group showed a faster improvement than the physiotherapy group and the general practitioner care group up to 26 weeks, but differences were negligible by follow-up at 52 weeks. The total costs of manual therapy (447 EUR) were around one third of the costs of physiotherapy (1297 EUR) and general practitioner care (1379 EUR). These differences were significant:p

OBJECTIVE: For the early detection and treatment of malnourished hospital patients no valid screening instrument for the Dutch language exists. Calculation of percentage weight loss and body mass index (BMI) by the nurse at admission to the hospital appeared to be not feasible. Therefore, the short, nutritional assessment questionnaire (SNAQ), was developed.RESEARCH, DESIGN AND METHODS: Two hundred and ninety one patients on the mixed internal and surgery/oncology wards of the VU University medical center were screened on nutritional status and classified as well nourished (18.5), moderately malnourished (5-10% weight loss in the last 6 months and BMI>18.5) or severely malnourished (>10% weight loss in the last 6 months or >5% in the last month or BMIRESULTS: The questions 'Did you lose weight unintentionally?'. 'Did you experience a decreased appetite over the last month?' and 'Did you use supplemental drinks or tube feeding over the last month?' were most predictive of malnutrition. The instrument proved to be valid and reproducible.CONCLUSION: SNAQ is an easy, short, valid and reproducible questionnaire for early detection of hospital malnutrition.

In an era in which cost-effective care is high on the political agenda, considerable attention has been paid to the scientific principles of physiotherapy. Every care-provider is expected to be informed about the most effective treatment in his profession. Evidence for effectiveness should preferably be provided by randomised clinical trials. There has been a rapid increase in the number of randomised trials and it is therefore very difficult for care providers to keep up-to-date. Literature reviews, in the form of systematic reviews, or meta-analyses, make it easier for care providers to keep abreast of the knowledge in a specific field. Reviews form the basis of ‘evidence-based’ medicine. This research note elaborates on the importance of literature research and describes the design and execution of systematic reviews. There is increasing pressure from politicians and insurance companies to provide scientific evidence of the effectiveness of health care. The professions have therefore been given the task of demonstrating the effectiveness of their treatments. This development is reflected in the emergence of evidencebased medicine. In the past decade the number of published effect studies has risen dramatically. The Medline database illustrates the rapid increase: in 1964 only 16 new randomised trials were published in the field of medicine and allied health care, in 1982 this had risen to 2038, and in 2000 a further 35 000 new randomised trials were published worldwide. In the database of the Cochrane domain ‘Rehabilitation and Related Therapies’ there are currently over 2000 randomised trials, many of them focusing on physiotherapy. It is all too clear that practising physiotherapists can never keep up with such a wealth of literature, even if they could obtain all the journals (more than 200) in which these studies are published. In practice, it appears that professionals are aware of only a very small portion of the published research, and this is what forms the basis of their conclusions regarding treatment. Their conclusions would, perhaps, be different if they had access to (almost) all of the available information, because the outcomes of the various studies on the same subject can vary considerably. This is why literature research plays an increasingly important role in summarising the available knowledge. Types of literature research

Attitudes and beliefs, or the treatment orientation, of health care providers appear to be important in the management of non-specific chronic low back pain (CLBP). The aims of the current study were two-fold: First of all, the physiotherapists' opinion towards various aspects of the management of CLBP was surveyed. Secondly, in a principal factor analysis, it was investigated whether underlying dimensions could be identified in order to develop the Pain Attitudes and Beliefs Scale for Physiotherapists (PABS_PT). In total, 421 physiotherapists (response rate 62.3%) participated in this study. The results suggested that the majority of physiotherapists hold the opinion that CLBP is not a dangerous condition, that sport should not be discouraged and that patients should not refrain from all physical activity. Moreover physiotherapists seem to hold the opinion that the way patients view their pain influences the progress of symptoms. Finally, physiotherapists seem to hold the opinion that therapy can completely alleviate the functional symptoms and that therapy may have been successful even if pain remains. The principal factor analysis (PAF) yielded an interpretable 2-factor model. Based on highest loading items, factor 1 was labelled 'biomedical orientation', whereas factor 2 was labelled 'behavioural orientation'. The internal consistency (Cronbach's Alpha) of factor 1 was 0.84 and for factor 2, 0.54 explaining 25.2% and 8.2%, respectively, of the total variance. Assessment of the effect of the physiotherapists' characteristics on scores on the different scales was encouraging as results pointed in the directions one would expect. Physiotherapists who attended biopsychosocial education courses had statistically significantly higher scores on the 'behavioural orientation' factor and vice versa. Biomedical specialists scored statistically significantly higher on the 'biomedical orientation' factor. Furthermore, the findings suggested that the PABS_PT discriminates between physiotherapists with a 'behavioural orientation' vs those with a 'biomedical orientation'. To examine the influence of these different treatment orientations with regard to CLBP on patient outcome is a challenge for the near future.

Behavioral approaches to treating patients following lumbar disc surgery are becoming increasingly popular. The treatment method is based on the assumption that pain and pain disability are not only influenced by somatic pathology, if found, but also by psychological and social factors. A recent study high-lighted the effectiveness of cognitive-behavioral interventions, as compared to no treatment, for chronic low back patients. However, to the authors' knowledge, there is no randomized controlled trial that evaluates a behavioral program for patients following lumbar disc surgery. The purpose of this study was to assess the effectiveness of a behavioral graded activity (BGA) program compared to usual care (UC) in physiotherapy following first-time lumbar disc surgery. The BGA program was a patient-tailored intervention based upon operant therapy. The essence of the BGA is to teach patients that it is safe to increase activity levels. The study was designed as a randomized controlled trial. Assessments were carried out before and after treatment by an observer blinded to treatment allocation. Patients suffering residual symptoms restricting their activities of daily living and/or work at the 6 weeks post-surgery consultation by the neurosurgeon were included. The exclusion criteria were: complications during surgery, any relevant underlying pathology, and any contraindication to physiotherapy or the BGA program. Primary outcome measures were the patient's Global Perceived Effect and the functional status. Secondary measures were: fear of movement, viewing pain as extremely threatening, pain, severity of the main complaint, range of motion, and relapses. Physiotherapists in the BGA group received proper training. Between November 1997 and December 1999, 105 patients were randomized; 53 into the UC group and 52 into the BGA group. The unadjusted analysis shows a 19.3% (95% CI: 0.1 to 38.5) statistically significant difference to the advantage of the UC group on Global Perceived Effect. This result, however, is not robust, as the adjusted analyses reveal a difference of 15.7% (95% CI: -3.9 to 35.2), which is not statistically significant. For all other outcome measures there were no statistically significant or clinically relevant differences between the two intervention groups. In general, the physiotherapists' compliance with the BGA program was satisfactory, although not all treatments, either in the BGA or the UC group, were delivered exactly as planned, resulting in less contrast between the two interventions than had been planned for. There was one re-operation in each group. The BGA program was not more effective than UC in patients following first-time lumbar disc surgery. For Global Perceived Effect there was a borderline statistically significant difference to the advantage of the UC group. On functional status and all other outcome measures there were no relevant differences between interventions. The number of re-operations was negligible, indicating that it is safe to exercise after first-time disc surgery.

The objective of this study was to compare sick leave data obtained from questionnaires with data from company records. During a period of 12 months, questionnaires were completed monthly for 6 months and then at 9 and 12 months. The sensitivity and specificity of questionnaires for detecting an episode of sick leave were determined, using the company records as a reference standard. In addition, the duration of sick leave episodes reported in the two data sets was compared. In this analysis, company records were not assumed to be superior, and agreement was assessed with intraclass correlation coefficients (ICCs). The sensitivity of questionnaires for detecting an episode of sick leave was 55% (95% CI = 0.50-0.60) and the specificity 83% (95% CI = 0.72-0.94). The ICC for all episodes was 0.58 (95% CI = 0.47-0.67). The only satisfactory ICC (0.87; 95% CI = 0.74-0.93) was found for the questionnaires at 9 and 12 months. No large systematic differences were found between the duration of episodes reported in the two data sets. In conclusion, in our study, the sensitivity of questionnaires for detecting an episode of sick leave was very low. Furthermore, when episodes were recalled, there was little agreement on the duration of the episode between questionnaire data and data in the company records. Based on these results and considering the risk of missing questionnaires, data on sick leave gathered from company records are clearly preferable as an outcome measure in research.

AIMS: To compare the results of a traditional approach using standard regression for the analysis of data from a prospective cohort study with the results of generalised estimating equations (GEE) analysis.METHODS: The research was part of a three year prospective cohort study on work related risk factors for low back pain. The study population consisted of a cohort of 1192 workers with no low back pain at baseline. Information on work related physical and psychosocial factors and the occurrence of low back pain was obtained by means of questionnaires at baseline and at the three annual follow up measurements. In a traditional standard logistic regression model, physical and psychosocial risk factors at baseline were related to the cumulative incidence of low back pain during the three year follow up period. In a GEE logistic model, repeated measurements of the physical and psychosocial risk factors were related to low back pain reported at one measurement point later.RESULTS: The traditional standard regression model showed a significant effect of flexion and/or rotation of the upper part of the body (OR = 1.8; 95% CI: 1.2 to 3.0), but not of moving heavy loads (OR = 1.4; 95% CI: 0.7 to 3.1). The GEE model showed a significant effect of both flexion and/or rotation of the upper part of the body (OR = 2.2; 95% CI: 1.5 to 3.3) and moving heavy loads (OR = 1.5; 95% CI: 1.0 to 2.4). No significant associations with low back pain were found for the psychosocial work characteristics with either method, but the GEE model showed weaker odds ratios for these variables than the traditional standard regression model.CONCLUSIONS: Results show that there are differences between the two analytical approaches in both the magnitude and the precision of the observed odds ratios.

Fried’s phenotype frailty criteria include three self-report questions (weight loss, exhaustion and low physical activity) and two performance-based measures (slowness (walk time) and weakness (handgrip strength)). The present study investigates whether the two performance-based criteria could be replaced by self-report questions. A cross-sectional validation study was conducted among 135 community-dwelling older people (65+) with different stages of frailty. Eleven questions related to walk time and ten questions about handgrip strength were selected. Both the self-report questions and performance-based measurements of walk time (time needed to walk 15 feet at own pace) and handgrip strength (maximum handgrip strength using a hand dynamometer) were assessed. Backward logistic regression analyses showed that four questions for walk time and two questions for handgrip strength were optimal. This indicates that it seems possible to replace the two performance-based measures by a small set of self-report questions, which can particularly be helpful in Iarge-scale research.