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Lidwine B Mokkink,1,2 Iris Eekhout,1– 3 Maarten Boers,1,2 Cees PM van der Vleuten,4 Henrica CW de Vet1,2 1Amsterdam UMC, Vrije Universiteit Amsterdam, Epidemiology and Data Science, Amsterdam, the Netherlands; 2Amsterdam Public Health Research Institute, Amsterdam, the Netherlands; 3Child Health, Netherlands Organisation for Applied Scientific Research, Leiden, the Netherlands; 4Department of Educational Development and Research, School of Health Professions Education, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, the NetherlandsCorrespondence: Lidwine B Mokkink, Amsterdam UMC, AMC, J1B -225, Meibergdreef 9, Amsterdam, 1105 AZ, the Netherlands, Tel +31 20 44 44474, Email w.mokkink@amsterdamumc.nlAbstract: Reliability and measurement error are measurement properties that quantify the influence of specific sources of variation, such as raters, type of machine, or time, on the score of the individual measurement. Several designs can be chosen to assess reliability and measurement error of a measurement. Differences in design are due to specific choices about which sources of variation are varied over the repeated measurements in stable patients, which potential sources of variation are kept stable (ie, restricted), and about whether or not the entire measurement instrument (or measurement protocol) was repeated or only part of it. We explain how these choices determine how intraclass correlation coefficients and standard errors of measurement formulas are built for different designs by using Venn diagrams. Strategies for improving the measurement are explained, and recommendations for reporting the essentials of these studies are described. We hope that this paper will facilitate the understanding and improve the design, analysis, and reporting of future studies on reliability and measurement error of measurements.Keywords: reliability, measurement error, classical test theory, generalizability theory, intraclass correlation coefficient, standard error of measurement

Annelore H van Dalen-Kok,1 Wilco P Achterberg,1 Wieke E Rijkmans,1 Sara A Tukker-van Vuuren,1 Suzanne Delwel,2,3 Henrica CW de Vet,4 Frank Lobbezoo,2,5 Margot WM de Waal1 1Department of Public Health and Primary Care, Leiden University Medical Centre, Leiden, 2Department of Oral Kinesiology, Academic Centre for Dentistry Amsterdam (ACTA), University of Amsterdam and VU University Amsterdam, 3Department of Clinical Neuropsychology, Faculty of Behavioral and Movement Sciences, VU University, 4Department of Epidemiology and Biostatistics, The EMGO Institute for Health and Care Research, VU University Medical Center, 5MOVE Research Institute Amsterdam, VU University, Amsterdam, the Netherlands Objectives: Detection and measurement of pain in persons with dementia by using observational pain measurement tools is essential. However, the evidence for the psychometric properties of existing observational tools remains limited. Therefore, a new meta-tool has been developed: Pain Assessment in Impaired Cognition (PAIC), as a collaborative EU action. The aim is to describe the translation procedure and content validity of the Dutch version of the PAIC.Methods: Translation of the PAIC into Dutch followed the forward-backward approach of the Guidelines for Establishing Cultural Equivalence of Instruments. A questionnaire survey was administered to clinical nursing home experts (20 physicians and 20 nurses) to determine whether the PAIC items are indicative of pain and whether items are specific for pain or for other disorders (anxiety disorder, delirium, dementia, or depression). To quantify content validity, mean scores per item were calculated.Results: Eleven items were indicative of pain, for example, “frowning,” “freezing,” and “groaning.” Fifteen items were considered to be pain-specific, for example, “frowning,” “curling up,” and “complaining.” There were discrepancies between the notion of pain characteristics according to nurses and physicians, especially in the facial expressions domain.Discussion: Within the body movement domain, PAIC items correspond well with the clinical experience of the physicians and nurses. However, items in the facial expressions and vocalizations domains need further study with respect to item reduction. Also, differences were revealed in the notion of pain characteristics between physicians and nurses, suggesting the need for more interdisciplinary education on pain in dementia. Keywords: content validity, dementia, education, nursing home, observational pain measurement tool, pain

BACKGROUND: The long-term course of long-standing low back pain is largely unknown since long-term data are scarce. OBJECTIVE: We examined the course of self-reported low back pain in the prospective population-based Doetinchem cohort over a period of 10years. METHODS: Between 1993 and 2007, around 5700 randomly selected men and women in four age groups of originally 20-29, 30-39, 40-49, 50-59years were measured three times. Logistic regression analysis was used to study the association of sociodemographic (gender, age, education, work status) and lifestyle characteristics (BMI, smoking, physical activity) with persistent and new episodes of long-standing low back pain. RESULTS: The prevalence of long-standing low back pain is quite stable over a 10year period, approximately 20% on population level. On individual level, around 30% of the population was completely free of low back pain during the entire period, 6% can be characterized as persistent back pain sufferers. Individuals with persistent and a varying pattern have a more unhealthy lifestyle (BMI and smoking) than those without low back pain. Age, smoking, obesity and not having a paid job are associated with 10-year persistent back pain in the general population, whereas age and not having a paid job are associated in those with long-lasting back pain at baseline. New episodes of long-standing back pain are relatively frequent among women and smokers. CONCLUSIONS: Low back pain in the population is characterized as very dynamic which challenges epidemiological studies highly. Long-term information on the course of back pain is needed to define severe subgroups. [ABSTRACT FROM AUTHOR]

Purpose. To determine the intrarater-reliability, interrater-reliability and normal reference scores of the Semmes Weinstein Monofilament test (SWM) of the feet of healthy subjects. In addition, the stability of the SWM for prospective use was assessed by determining systematic changes in sensory thresholds. Methods. Interrater-reliability was assessed on five locations of the plantar side of both feet using monofilaments 1.65, 2.36, 2.44, 2.83, 3.22, 3.61, 3.84, 4.08, 4.31, 5.56, 6.65 in 60 healthy subjects by two or three investigators (test day 1). Intrarater-reliability and systematic changes in sensory thresholds were assessed 3 weeks later (test day 22) by one investigator. Results. Median interrater-reliability for the five test locations for both feet was poor to moderate. Median intrarater-reliability was good for the left foot and poor to moderate for the right foot. Significantly lower median sensory thresholds were found for the first SWM measurement at test day 22 compared to the first and second measurement of test day 1. Given the observed reliability of the SWM, a normal sensory score for the feet was situated between monofilament 3.22 and 4.08. Conclusions. The SWM are reliable when measured by one researcher. Systematic changes in sensory thresholds were observed; therefore, the stability of the SWM for use in prospective studies could not be verified. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

STUDY DESIGN: Cross-sectional population-based study. OBJECTIVE: To study sex differences in consequences of musculoskeletal pain (MP): limited functioning, work leave or disability, and healthcare use. SUMMARY OF BACKGROUND DATA: MP is a major public health problem in developed countries due to high prevalence rates and considerable consequences. There are indications that consequences of MP differ for men and women. METHODS: Data of a Dutch population-based study were used, limited to persons 25 to 64 years of age (n = 2517). Data were collected by a postal questionnaire. RESULTS: Women with any MP report more healthcare use for MP, i.e., contact with a medical caregiver and use of medicines than men, while men report more work disability (ever in life) due to low back pain only, irrespective of work status. None of the sex differences can be explained by age, household composition, educational level, smoking status, overweight, physical activity, and pain catastrophizing. Older age was related to more limited functioning due to MP (women), work disability due to MP (men), and healthcare use due to MP (men and women). A one-person household was associated with work disability (women) and use of medicines (men). Low educational level was associated with limited functioning (men), work leave (men), contact with a medical caregiver (men), and work disability (men and women). Smoking was associated with limited functioning (men), work leave (women), and healthcare use (women). Physical inactivity was associated with limited functioning due to MP in women. Pain catastrophizing was associated with limited functioning, work leave, and healthcare use (men and women) and work disability (men). CONCLUSIONS: Consequences of MP show a slightly different pattern for men and women. Women with any MPreport more healthcare use for MP, while men report more work disability due to low back pain only. These sex differences can not be explained by general risk factors, but associations between these factors and consequences of MP show some sex differences. [ABSTRACT FROM AUTHOR]

STUDY DESIGN: Cross-sectional study of 11,428 women aged 20-59 years who were included in a postal questionnaire survey in the Dutch general population. OBJECTIVE: To examine how hormonal and reproductive factors are associated with chronic low back pain (LBP) and chronic upper extremity pain (UEP) in women. SUMMARY OF BACKGROUND DATA: Although LBP is suggested to be linked to hormonal and reproductive factors in women, results from previous studies are inconclusive. In addition, the association with chronic UEP is unknown. METHODS: Multivariate logistic regression models were used to examine associations between hormonal and reproductive factors (independent variables) and, respectively, chronic LBP, chronic UEP and combined chronic LBP/UEP. Associations were adjusted for age, level of education, working status, smoking, and overweight. RESULTS: Past pregnancy, young maternal age at first birth, duration of oral contraceptive use, and use of estrogens during menopause were associated with chronic LBP, while young age at menarche was associated with chronic UEP. Irregular or prolonged menstruation and hysterectomy were associated both with chronic LBP and chronic UEP. No positive associations were found for current pregnancy and number of children. CONCLUSIONS: In adult women, hormonal and reproductive factors are associated with chronic musculoskeletal pain in general. Factors related to increased estrogen levels may specifically increase the risk of chronic LBP. [ABSTRACT FROM AUTHOR]

Previous trials to assess the efficacy of lumbar traction for back pain have been methodologically flawed. To avoid these shortcomings, we conducted a randomised controlled trial in which high-dose traction was compared with sham traction. The sham traction was given with a specially developed brace that tightens in the back during traction. To the patient, the experience is that of traction. The patients and outcome assessor were blinded for the assigned treatment. 151 patients with at least six weeks of non-specific low back pain were randomised. Intention to treat analysis showed no differences between the groups on all outcome measures (patients' global perceived effect, severity of main complaints, functional status and pain); all 95% confidence intervals included the value zero. The number of withdrawals from treatment, loss to follow-up, and protocol deviations was low. Consequently, the per-protocol analysis showed results similar to the intention to treat analysis. Subgroup analyses did not show any group for which traction might seem promising. Our data do not support the claim that traction is effective for patients with low back pain. [ABSTRACT FROM AUTHOR]

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

A critique of Hankins, M: 'How discriminating are discriminative instruments?' Health and Quality of Life Outcomes 2008, 6:36. [ABSTRACT FROM AUTHOR]

Background: To investigate the factor structure, dimensionality and construct validity of the (5-item) PRAFAB questionnaire score in women with stress urinary incontinence (stress UI).Methods: A cross validation study design was used in a cohort of 279 patients who were randomly divided into Sample A or B. Sample A was used for preliminary exploratory factor analyses with promax rotation. Sample B provided an independent sample for confirming the premeditated and proposed factor structure and item retention. Internal consistency, item-total and subscale correlations were determined to assess the dimensionality. Construct validity was assessed by comparing factor-based scale means by clinical characteristics based on known relationships.Results: Factor analyses resulted in a two-factor structure or subscales: items related to 'leakage severity' (protection, amount and frequency) and items related to its 'perceived symptom impact' or consequences of stress UI on the patient's life (adjustment and body (or self) image). The patterns of the factor loadings were fairly identical for both study samples. The two constructed subscales demonstrated adequate internal consistency with Cronbach's alphas in a range of 0.78 and 0.84 respectively. Scale scores differed by clinical characteristics according to the expectations and supported the construct validity of the scales.Conclusion: The findings suggest a two-factorial structure of the PRAFAB questionnaire. Furthermore the results confirmed the internal consistency and construct validity as demonstrated in our previous study. The best description of the factorial structure of the PRAFAB questionnaire was given by a two-factor solution, measuring the stress UI leakage severity items and the perceived symptom impact items. Future research will be necessary to replicate these findings in different settings, type of UI and non-white women and men. [ABSTRACT FROM AUTHOR]

OBJECTIVE: A focus on the communicator competency is considered to be an important requirement to help physicians to acquire consultation skills. A feedback questionnaire, in which patients assess consultation skills might be a useful learning tool. An existing questionnaire on patient perception of patient-centeredness (PPPC) was adapted to cover the 'communicator' items in the competency profile. We assessed the face and content validity, the construct validity and the internal consistency of this new patient feedback on consultation skills (PFC) questionnaire. METHODS: We assessed the face validity of the PFC by interviewing patients and general practice trainees (GPTs) during the developmental process. The content validity was determined by experts (n=10). First-year GPTs (23) collected 222 PFCs, from which the data were used to assess the construct validity (factor analysis), internal consistency, response rates and ceiling effects. RESULTS: The PFC adequately covers the corresponding 'communicator' competency (face and content validity). Factor analysis showed a one-dimensional construct. The internal consistency was high (Cronbach's alpha 0.89). For the single items, the response rate varied from 89.2% to 100%; the maximum score (ceiling effect) varied from 45.5% to 89.2%. CONCLUSION: The PFC appears to be a valid, internally consistent instrument. PRACTICAL IMPLICATIONS: The PFC may be a valuable learning tool with which GPTs, other physicians and medical students can acquire feedback from patients regarding their consultation skills. [ABSTRACT FROM AUTHOR]

Background: Dementia palliative care is increasingly subject of research and practice improvement initiatives., Aim: To assess any changes over time in the evaluation of quality of care and quality of dying with dementia by family caregivers., Design: Combined analysis of eight studies with bereaved family caregivers' evaluations 2005-2019., Setting/participants: Family caregivers of nursing home residents with dementia in the Netherlands ( n = 1189) completed the End-of-Life in Dementia Satisfaction With Care (EOLD-SWC; quality of care) and Comfort Assessment in Dying (EOLD-CAD, four subscales; quality of dying) instruments. Changes in scores over time were analysed using mixed models with random effects for season and facility and adjustment for demographics, prospective design and urbanised region., Results: The mean total EOLD-SWC score was 33.40 (SD 5.08) and increased by 0.148 points per year (95% CI, 0.052-0.244; adjusted 0.170 points 95% CI, 0.055-0.258). The mean total EOLD-CAD score was 30.80 (SD 5.76) and, unadjusted, there was a trend of decreasing quality of dying over time of -0.175 points (95% CI, -0.291 to -0.058) per year increment. With adjustment, the trend was not significant (-0.070 EOLD-CAD total score points, 95% CI, -0.205 to 0.065) and only the EOLD-CAD subscale 'Well being' decreased., Conclusion: We identified divergent trends over 14 years of increased quality of care, while quality of dying did not increase and well-being in dying decreased. Further research is needed on what well-being in dying means to family. Quality improvement requires continued efforts to treat symptoms in dying with dementia.

Study Objective: Older adults presenting to the emergency department (ED) are at high risk of adverse health outcomes. This study aimed to evaluate the accuracy of 4 frequently used screening instruments for the prediction of adverse health outcomes among older adults in the ED., Methods: This was a prospective cohort study in patients ≥70 years of age presenting to the ED in 2 hospitals in the Netherlands. Screening instruments included the acutely presenting older patient screening program (APOP) (providing 2 risk scores-functional decline [APOP1] and mortality [APOP2]), the International Resident Assessment Instrument Emergendy Department screener (InterRAI ED), the Identification of Seniors At Risk-Hospitalized Patients (ISAR-HP), and the safety management system (VMS). The primary outcome measure was a composite outcome encompassing functional decline, institutionalization, and mortality at 3 months after ED presentation. Other follow-up time points were 1 and 6 months. Analyses were performed to assess prognostic accuracy., Results: In total, 889 patients were included. After 3 months, 267 (31%) patients experienced at least 1 adverse outcome. The positive likelihood ratio ranged from 1.67 (VMS) to 3.33 (APOP1), and the negative likelihood ratio ranged from 0.41 (ISAR-HP) to 0.88 (APOP2). Sensitivity ranged from 17% (APOP2) to 74% (ISAR-HP), and specificity ranged from 63% (ISAR-HP) to 94% (APOP2). The area under the curve ranged from 0.62 (APOP2) to 0.72 (APOP1 and ISAR-HP). Calibration was reasonable for APOP1 and VMS. The prognostic accuracy was comparable across all outcomes and at all follow-up time points., Conclusion: The frailty screening instruments assessed in this study showed poor to moderate prognostic accuracy, which brings into question their usability in the prediction of adverse health outcomes among older adults who present to the ED., (Copyright © 2021 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.)

Background: Moral case deliberation is a form of clinical ethics support to help healthcare professionals in dealing with ethically difficult situations. There is a lack of evidence about what outcomes healthcare professionals experience in daily practice after moral case deliberations. The Euro-MCD Instrument was developed to measure outcomes, based on the literature, a Delphi panel, and content validity testing. To examine relevance of items and adequateness of domains, a field study is needed., Aim: To describe experienced outcomes after participating in a series of moral case deliberations, both during sessions and in daily practice , and to explore correlations between items to further validate the Euro-MCD Instrument., Methods: In Sweden, the Netherlands, and Norway, healthcare institutions that planned a series of moral case deliberations were invited. Closed responses were quantitatively analyzed. The factor structure of the instrument was tested using exploratory factor analyses., Ethical Considerations: The study was approved in Sweden by a review board. In Norway and the Netherlands, data services and review boards were informed about the study., Results: The Euro-MCD Instrument was completed by 443 and 247 healthcare professionals after four and eight moral case deliberations, respectively. They experienced especially outcomes related to a better collaboration with co-workers and outcomes about individual moral reflexivity and attitude, both during sessions and in daily practice. Outcomes were experienced to a higher extent during sessions than in daily practice . The factor structure revealed four domains of outcomes, which did not confirm the six Euro-MCD domains., Conclusion: Field-testing the Euro-MCD Instrument showed the most frequently experienced outcomes and which outcomes correlated with each other. When revising the instrument, domains should be reconsidered, combined with theory about underlying concepts. In the future, a feasible and valid instrument will be presented to get insight into how moral case deliberation supports and improves healthcare.

Aim: To study the application of the meta-tool Pain Assessment in Impaired Cognition (PAIC) in a clinical setting in patients with moderate to severe dementia. Materials & methods: Observational study in five Dutch nursing homes, where residents were observed by nurses or nurse-assistants during rest and movement. Prevalence and observer agreement of individual items were examined. Results: An observer agreement of ≥70% was found for most items of the body movement domain and vocalization domain, although prevalence of these behaviors was low (especially during rest). Items of the facial expression domain had a percentage agreement <70%, especially during movement, but with high prevalence of behaviors. Conclusion: The pain assessment in impaired cognition items show promising interobserver and intraobserver agreement in a clinical setting.

Background: There is a lack of empirical research regarding the outcomes of such clinical ethics support methods as moral case deliberation (MCD). Empirical research in how healthcare professionals perceive potential outcomes is needed in order to evaluate the value and effectiveness of ethics support; and help to design future outcomes research. The aim was to use the European Moral Case Deliberation Outcome Instrument (Euro-MCD) instrument to examine the importance of various MCD outcomes, according to healthcare professionals, prior to participation., Methods: A North European field survey among healthcare professionals drawn from 73 workplaces in a variety of healthcare settings in the Netherlands, Norway and Sweden. The Euro-MCD instrument was used., Results: All outcomes regarding the domains of moral reflexivity, moral attitude, emotional support, collaboration, impact at organisational level and concrete results, were perceived as very or quite important by 76%-97% of the 703 respondents. Outcomes regarding collaboration and concrete results were perceived as most important. Outcomes assessed as least important were mostly about moral attitude. 'Better interactions with patient/family' emerged as a new domain from the qualitative analysis. Dutch respondents perceived most of the outcomes as significantly less important than the Scandinavians, especially regarding emotional support. Furthermore, men, those who were younger, and physician-respondents scored most of the outcomes as statistically significantly less important compared with the other respondents., Conclusions: The findings indicate a need for a broad instrument such as the Euro-MCD. Outcomes related to better interactions between professionals and patients must also be included in the future. The empirical findings raise the normative question of whether outcomes that were perceived as less important, such as moral reflexivity and moral attitude outcomes, should still be included. In the future, a combination of empirical findings (practice) and normative reflection (theories) will contribute to the revision of the instrument., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Previous studies showed that missing data in multi-item scales can best be handled by multiple imputation of item scores. However, when many scales are used, the number of items will become too large for the imputation model to reliably estimate imputations. A solution is to use passive imputation or a parcel summary score that combine and consequently reduce the number of variables in the imputation model. The performance of these methods was evaluated in a simulation study and illustrated in an example. Passive imputation, which updated scale scores from imputed items, and parcel summary scores that use the average over available item scores were compared to using all items simultaneously, imputing total scores of scales and complete-case analysis. Scale scores and coefficient estimates from linear regression were compared to "true" parameters on bias and precision. Passive imputation and using parcel summaries showed smaller bias and more precision than imputing total scores and complete-case analyses. Passive imputation or using parcel summary scores are valid missing data solutions in studies that include many multi-item scales.

Study Design Clinical measurement study, prospective cohort design. Background Shoulder pain is a common disorder, and treatment is most often focused on a reduction of pain and functional disabilities. Several reviews have encouraged the use of the Shoulder Pain and Disability Index (SPADI) to objectify functional disability. It is important to assess the responsiveness and interpretability of the SPADI in patients seeking physical therapy treatment for their shoulder pain in a primary care setting. Objective To assess the responsiveness and interpretability of the SPADI in patients with shoulder pain visiting a physical therapist in primary care. Methods The target population consisted of patients who consulted a physical therapist for their shoulder pain. The patients received physical therapy treatment and completed the Dutch-language version of the SPADI at baseline and at 26-week follow-up. The interpretability floor and ceiling effects and the minimal important change (MIC) were assessed using the receiver operating characteristic method, and a visual anchor-based MIC distribution method was used to assess several Global Perceived Effect scale (GPE)-based anchors. The measurement error was calculated using the smallest detectable change. For the responsiveness, the area under the receiver operating characteristic curve was used, and correlations with the GPE and the change score of the Shoulder Disability Questionnaire (as this questionnaire measures the same construct) were assessed. Results A total of 356 patients participated at baseline and 237 (67%) returned the SPADI after 26 weeks. The mean score on the SPADI at baseline was 46.7 points (on a 0-100 scale). The SPADI showed no signs of floor and ceiling effects. The smallest detectable change was 19.7 points. The MIC was 20 (43% of baseline value), and therefore a change of 43% or more in an individual patient was considered to be clinically relevant. The area under the receiver operating characteristic curve (AUC) was 0.81, the Spearman correlation between the SPADI change score and the GPE was 0.53, and the Pearson correlation between the Shoulder Disability Questionnaire and the SPADI change score was 0.71. Conclusion The results of this study confirm the responsiveness of the SPADI, making it a useful instrument to assess functional disability in longitudinal studies; however, the measurement error should be taken into account when making decisions in individual patients. J Orthop Sports Phys Ther 2017;47(4):278-286. Epub 3 Feb 2017. doi:10.2519/jospt.2017.7079.

Background: The Pelvic Floor Distress Inventory-20 is used to evaluate symptoms and treatment effects in women with pelvic floor disorders. To interpret changes in the scores of this inventory, information is needed about what patients and clinicians perceive as the minimal important (meaningful) change. Although this change in the inventory score has been investigated previously in women who have undergone pelvic floor surgery, the results could not be generalized to women with milder symptoms (ie, lower scores) who often require only conservative treatment., Objective: We aimed to estimate the minimal important change in the Pelvic Floor Distress Inventory-20 that was needed to demonstrate clinical improvement in women who qualify for conservative pelvic floor treatment., Study Design: The data of 214 women aged ≥55 years were used. All participants were from 2 randomized controlled trials that compared conservative prolapse treatments in primary care in The Netherlands. The degree of prolapse was assessed with the use of the Pelvic Organ Prolapse Quantification system; participants completed the Pelvic Floor Distress Inventory-20 at baseline and at 12 months, with a global perception of improvement question at 12 months. To assess both the patient perspective and the clinical perspective, 2 anchors were assessed: (1) the global perception of improvement was considered the anchor for the patients' perspective, and (2) the difference in the degree of prolapse was considered the anchor for the clinical perspective. Provided that the anchors were correlated by at least 0.3 to the Pelvic Floor Distress Inventory-20 change scores, we estimated the following minimal important changes: (1) the optimal cutoff-point of the receiver operating characteristics curve that discriminates between women with and without improvement in the global perception of improvement scale and (2) the mean Pelvic Floor Distress Inventory-20 change score of participants who improved 1 assessment stage. We then calculated the smallest detectable change to check whether the minimal important change was larger than the measurement error of the questionnaire., Results: Using the global perception of improvement as the anchor, we found a minimal important change for improvement of 13.5 points (95% confidence interval, 6.2-20.9). The Pelvic Organ Prolapse Quantification change scores correlated poorly to the Pelvic Floor Distress Inventory-20 change scores and therefore could not be used as an anchor. The smallest detectable change at the group level was 5.5 points. Thus, the minimal important change was larger than the smallest detectable change at the group level., Conclusion: In women with relatively mild pelvic floor symptoms, an improvement of 13.5 points (or a 23% reduction) in the Pelvic Floor Distress Inventory-20 score can be considered clinically relevant. This minimal important change can be used for clinical trial planning and evaluation of treatment effects in women whose condition is considered suitable for conservative treatment., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Objectives: Record review is the most used method to quantify patient safety. We systematically reviewed the reliability and validity of adverse event detection with record review., Design: A systematic review of the literature., Methods: We searched PubMed, EMBASE, CINAHL, PsycINFO and the Cochrane Library and from their inception through February 2015. We included all studies that aimed to describe the reliability and/or validity of record review. Two reviewers conducted data extraction. We pooled κ values (κ) and analysed the differences in subgroups according to number of reviewers, reviewer experience and training level, adjusted for the prevalence of adverse events., Results: In 25 studies, the psychometric data of the Global Trigger Tool (GTT) and the Harvard Medical Practice Study (HMPS) were reported and 24 studies were included for statistical pooling. The inter-raterreliability of the GTT and HMPS showed a pooled κ of 0.65 and 0.55, respectively. The inter-rater agreement was statistically significantly higher when the group of reviewers within a study consisted of a maximum five reviewers. We found no studies reporting on the validity of the GTT and HMPS., Conclusions: The reliability of record review is moderate to substantial and improved when a small group of reviewers carried out record review. The validity of the record review method has never been evaluated, while clinical data registries, autopsy or direct observations of patient care are methods that can be used to test concurrent validity.

Background: The network approach to psychopathology conceives mental disorders as sets of symptoms causally impacting on each other. The strengths of the connections between symptoms are key elements in the description of those symptom networks. Typically, the connections are analysed as linear associations (i.e., correlations or regression coefficients). However, there is insufficient awareness of the fact that differences in variance may account for differences in connection strength. Differences in variance frequently occur when subgroups are based on skewed data. An illustrative example is a study published in PLoS One (2013;8(3):e59559) that aimed to test the hypothesis that the development of psychopathology through "staging" was characterized by increasing connection strength between mental states. Three mental states (negative affect, positive affect, and paranoia) were studied in severity subgroups of a general population sample. The connection strength was found to increase with increasing severity in six of nine models. However, the method used (linear mixed modelling) is not suitable for skewed data., Methods: We reanalysed the data using inverse Gaussian generalized linear mixed modelling, a method suited for positively skewed data (such as symptoms in the general population)., Results: The distribution of positive affect was normal, but the distributions of negative affect and paranoia were heavily skewed. The variance of the skewed variables increased with increasing severity. Reanalysis of the data did not confirm increasing connection strength, except for one of nine models., Conclusions: Reanalysis of the data did not provide convincing evidence in support of staging as characterized by increasing connection strength between mental states. Network researchers should be aware that differences in connection strength between symptoms may be caused by differences in variances, in which case they should not be interpreted as differences in impact of one symptom on another symptom., Competing Interests: The authors have declared that no competing interests exist.

Diagnostic accuracy studies are, like other clinical studies, at risk of bias due to shortcomings in design and conduct, and the results of a diagnostic accuracy study may not apply to other patient groups and settings. Readers of study reports need to be informed about study design and conduct, in sufficient detail to judge the trustworthiness and applicability of the study findings. The STARD statement (Standards for Reporting of Diagnostic Accuracy Studies) was developed to improve the completeness and transparency of reports of diagnostic accuracy studies. STARD contains a list of essential items that can be used as a checklist, by authors, reviewers and other readers, to ensure that a report of a diagnostic accuracy study contains the necessary information. STARD was recently updated. All updated STARD materials, including the checklist, are available at http://www.equator-network.org/reporting-guidelines/stard Here, we present the STARD 2015 explanation and elaboration document. Through commented examples of appropriate reporting, we clarify the rationale for each of the 30 items on the STARD 2015 checklist, and describe what is expected from authors in developing sufficiently informative study reports., Competing Interests: Conflicts of Interest: None declared., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.)

Transepidermal water loss (TEWL) is a physiological characteristic to measure the efficiency of the skin barrier. The aim was to investigate the reliability of the Tewameter TM300 for the assessment of TEWL (g/m 2 /h) in burn scars. Also the relation between TEWL scar values and scar quality parameters was investigated. Three different study areas (scar, healthy adjacent and contralateral skin) were assessed in 55 adult patients. The intra- and inter-observer reliability were tested using the intra-class correlation coefficient (ICC) and the standard error of measurement (SEM). The inter-observer reliability for the three areas was excellent with ICC values between 0.85 and 0.94. SEM values were between 1.76 and 3.97g/m 2 /h. Bland-Altman plots showed relatively wide LoA values for scar and healthy skin. Mean TEWL scar values were significantly higher than healthy skin (p<0.001). Significant correlations were found between TEWL hypertrophic scar values and erythema (r=0.60, p=0.001) and a negative correlation for weeks after burn (r=-0.61, p=0.001). TEWL values were significantly different between 3 and 6 months and 3 and 12 months old scars (respectively p=0.021 and p=0.002). To evaluate the skin barrier function over time as a measure for scar maturation, Tewameter TM300 measurements have to be performed according to strict and standardized protocols., (Copyright © 2016 Elsevier Ltd and ISBI. All rights reserved.)

Objectives: Little is known about the validity and reliability of expert assessments of the quality of antimicrobial prescribing, despite their importance in antimicrobial stewardship. We investigated how infectious disease doctors' assessments compared with a reference standard (modal expert opinion) and with the assessments of their colleagues., Methods: Twenty-four doctors specialized in infectious diseases or clinical microbiology (16 specialists and 8 residents) from five hospitals were asked to assess the appropriateness of antimicrobial agents prescribed for a broad spectrum of indications in 56 paper cases. They were instructed how to handle guideline applicability and deviations. We created a reference standard of antimicrobial appropriateness using the modal assessment of 16 specialists. We calculated criterion validity and interrater and intrarater overall and specific agreement with an index expert (senior infectious disease physician) and analysed the influence of doctor characteristics on validity., Results: Specialists agreed with the reference standard in 80% of cases (range 75%-86%), with a sensitivity and specificity of 75% and 84%, respectively. This did not differ by clinical specialty, hospital or years of experience, and residents had similar results. Specialists agreed with the index expert in 76% of cases and the index expert agreed with his previous assessments in 71% of cases., Conclusions: Doctors specialized in infectious diseases and clinical microbiology assess the appropriateness of antimicrobials prescribed for a broad spectrum of indications with acceptable agreement and validity, regardless of their experience or hospital of employment. However, there is room for improvement, which merits attention in multidisciplinary discussions and education., (© The Author 2016. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.)

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., (Copyright © 2016 Elsevier Ltd. All rights reserved.)

Background: The aims of this study were to assess patients' preoperative expectations of the outcome of total hip or knee arthroplasty (THA/TKA) regarding specific aspects of functioning and to determine to what extent each expectation was fulfilled after 1 year., Methods: This was a prospective cohort study. Preoperative expectations and their fulfillment after 1 year were measured with the Hospital for Special Surgery Hip/Knee arthroplasty Expectations Surveys. Preoperative and postoperative scores were subtracted to calculate whether expectations were unfulfilled, fulfilled, or exceeded., Results: A total of 343 THA and 322 TKA patients with complete follow-up were included. Preoperatively, >60% of patients (both THA/TKA) expected to get back to normal or have much improvement in 19 of 20 (THA) and 12 of 19 (TKA) items. Expectations were fulfilled or exceeded in >60% of patients in all 20 items for THA and 17 of 19 items for TKA. In THA, items with the largest proportions patients with unfulfilled expectations (>30%) were "improvement in walking ability: long distances" (31%), "walking stairs" (33%), and "improve ability to cut toenails" (38%). In TKA, expectations for 12 of 19 items were unfulfilled in >30% of patients, with the largest proportions seen for "being able to kneel down" (44%) and "being able to squat" (47%)., Conclusion: Although for most items, >60% of THA and TKA patients indicated that their expectations were met or exceeded, there was a substantial number of patients, particularly TKA patients, having unfulfilled expectations. These need more attention in preoperative patient information and education., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Background: The Four-Dimensional Symptom Questionnaire (4DSQ) is a self-report questionnaire measuring distress, depression, anxiety and somatization with separate scales. The 4DSQ has extensively been validated in clinical samples, especially from primary care settings. Information about measurement properties and normative data in the general population was lacking. In a Dutch general population sample we examined the 4DSQ scales' structure, the scales' reliability and measurement invariance with respect to gender, age and education, the scales' score distributions across demographic categories, and normative data., Methods: 4DSQ data were collected in a representative Dutch Internet panel. Confirmatory factor analysis was used to examine the scales' structure. Reliability was examined by Cronbach's alpha, and coefficients omega-total and omega-hierarchical. Differential item functioning (DIF) analysis was used to evaluate measurement invariance across gender, age and education., Results: The total response rate was 82.4 % (n = 5273/6399). The depression scale proved to be unidimensional. The other scales were best represented as bifactor models consisting of a large general factor and one or more smaller specific factors. The general factors accounted for more than 95 % of the reliable variance of the scales. Reliability was high (≥0.85) by all estimates. The distress-, depression- and anxiety scales were invariant across gender, age and education. The somatization scale demonstrated some lack of measurement invariance as a result of decreased thresholds for some of the items in young people (16-24 years) and increased thresholds in elderly people (65+ years). The somatization scale was invariant regarding gender and education. The 4DSQ scores varied significantly across demographic categories, but the explained variance was small (<6 %). Normative data were generated for gender and age categories. Approximately 17 % of the participants scored above average on de distress scale, whereas 12 % scored above average on de somatization scale. Percentages of people scoring high enough on depression or anxiety as to suspect the presence of depressive or anxiety disorder were 4.1 and 2.5 respectively., Conclusions: Evidence supports reliability and measurement invariance of the 4DSQ in the general Dutch population. The normative data provided in this study can be used to compare a subject's 4DSQ scores with a general population reference group.

Aim of this study was to explore which characteristics of nursing home residents relate to factors influencing their dignity. Questionnaires containing the Measurement Instrument for Dignity AMsterdam - for Long-Term Care facilities (MIDAM-LTC) were administered to 95 nursing home residents, residing on the general medical wards of six nursing homes in the Netherlands. Associations between residents' characteristics and each MIDAM-LTC item as well as the total number of items considerably influencing dignity were calculated. Results showed that not being optimistic, being male and/or being heavily dependent predispose nursing home residents to have their dignity undermined. Residents with these characteristics should therefore be given special attention in the provision of dignity-conserving care. Age, cultural background, religion, length of stay and socioeconomic status were very rarely related to individual MIDAM-LTC items. Knowledge of associations between characteristics and factors undermining dignity can be used to raise nursing home staff's sensitivity toward these factors., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Adequate assessment of burn wounds is crucial in the management of burn patients. Thermography, as a noninvasive measurement tool, can be utilized to detect the remaining perfusion over large burn wound areas by measuring temperature, thereby reflecting the healing potential (HP) (i.e., number of days that burns require to heal). The objective of this study was to evaluate the clinimetric properties (i.e., reliability and validity) of thermography for measuring burn wound HP. To evaluate reliability, two independent observers performed a thermography measurement of 50 burns. The intraclass correlation coefficient (ICC), the standard error of measurement (SEM), and the limits of agreement (LoA) were calculated. To assess validity, temperature differences between burned and nonburned skin (?T) were compared to the HP found by laser Doppler imaging (serving as the reference standard). By applying a visual method, one ?T cutoff point was identified to differentiate between burns requiring conservative versus surgical treatment. The ICC was 0.99, expressing an excellent correlation between two measurements. The SEM was calculated at 0.22°C, the LoA at ?0.58°C and 0.64°C. The ?T cutoff point was ?0.07°C (sensitivity 80%; specificity 80%). These results show that thermography is a reliable and valid technique in the assessment of burn wound HP.