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Objectives: Minimal important difference (MID), the smallest change or difference that patients perceive as important, aids interpretation of change in patient-reported outcome measure (PROM) scores. A credibility instrument that assesses the methodological rigor of an anchor-based MID includes one core item addressing the correlation between the PROM and the anchor. However, the majority of MID studies in the literature fail to report the correlation. To address this issue, we extended the anchor-based MID credibility instrument by adding an item addressing construct proximity as an alternative to the correlation item. Study Design and Setting: Informed by an MID methodological survey, we added an alternative item—a subjective assessment of similarity of the constructs (i.e., construct proximity) between PROM and anchor—to the correlation item and generated principles for the assessment. We sampled 101 MIDs and analyzed the assessments performed by each pair of raters. By calculating weighted Cohen's kappa, we assessed the reliability of the assessments. Results: Construct proximity assessment is based on the anticipated association between the anchor and PROM constructs: the closer the anticipated association, the higher the rating. Our detailed principles address the most frequently used anchors: transition ratings, measures of satisfaction, other PROMs, and clinical measures. The assessments showed acceptable agreement (weighted kappa 0.74, 95% CI 0.55–0.94) between raters. Conclusion: In the absence of a reported correlation coefficient, construct proximity assessment provides a useful alternative in the credibility assessment of anchor-based MID estimates.

Objective: Patient-reported transition ratings are supposed to reflect the change between a previous baseline health state and a present follow-up state, but may reflect the present state to a greater extent. This so-called “present state bias” (PSB) potentially threatens the validity of transition ratings. Several criteria have been proposed to assess PSB. We examined how well these criteria perform and to which extent confirmatory factor analysis (CFA) for categorical data provides an accurate assessment of the degree of PSB. Study Design and Setting: We simulated multiple samples with baseline and follow-up item responses to a hypothetical questionnaire, and transition ratings. The samples varied with respect to various distributional characteristics and the degree of PSB. The performance of criteria proposed in the literature, and a new CFA-based criterion, were evaluated by the proportion of explained variance in PSB. In addition, four real datasets were analyzed. Results: The known criteria explained 36–74% of the variance in PSB. A new CFA-based criterion, namely the ratio of the factor loadings of the transition ratings plus one, explained 81–98% of the variance in PSB across the samples. Conclusion: Present state bias in transition ratings can be estimated accurately using CFA.

Objectives Responsiveness is one of nine measurement properties that reflect the quality of outcome measurement instruments. Methods In this article, we explain that responsiveness is considered longitudinal validity, which refers to the degree to which an instrument is able to measure change in the construct to be measured. Results Responsiveness should be assessed in a longitudinal design, where hypotheses are tested about (1) the expected direction and magnitude of correlations between change scores on the instrument of interest and change scores of other instruments; (2) expected differences in change scores between different subgroups (i.e. known groups); or (3) the magnitude of the change in score that is expected on the construct of interest after a treatment with known efficacy. Conclusion Responsiveness cannot be proven, though, it is an ongoing process of testing hypotheses.

To systematically describe the use and outcomes of Patient-Reported Outcomes Measurement Information System (PROMIS) measures in clinical studies in populations with stroke.A systematic search on the use of PROMIS measures in clinical stroke studies in 9 electronic databases.Studies had to be original, reporting on outcome data using PROMIS measures in populations with stroke (ischemic and/or hemorrhagic), from January 1st, 2007. Initially, 174 unique studies met the inclusion criteria. In 2 steps, titles, abstracts and full-text articles were screened for eligibility (2 authors independently).From the selected articles, study characteristics, type of PROMIS measures, and its outcomes were extracted by 2 authors independently. The authors discussed their views to achieve consensus. A third author was consulted if necessary.In total, 27 studies (24,366 patients) were included, predominantly from the United States (22); most study populations were hospital-based (20); the number of patients ranged from 30-3283. In general, patients had no or mild symptoms (median modified Rankin scale 1). Two different generic PROMIS measures were reported (PROMIS Global Health, PROMIS 29) and 9 PROMIS measures focusing on specific domains (sleep, pain, physical functioning, self-efficacy, satisfaction with social roles, depression, anxiety, cognition, fatigue). These match the International Classification of Functioning, Disability, and Health (ICF) domains mentioned in the Core Set for Stroke. The measures were administered 1-55 months after stroke. Outcome data are provided. Pooling of data was not achieved because of a large variety in study characteristics (inclusion criteria, follow-up moments, data processing).The PROMIS measures in this review could be relevant from a patient's perspective, covering ICF core set domains for patients with stroke. The large variety in study characteristics hampers comparisons across populations. Many different outcome measures are used to report results of stroke rehabilitation studies.

Objective To synthesize the measurement properties of six health-related quality of life instruments (Short Form 36 [SF-36], Short Form 12 [SF-12], EuroQol 5D-3L [EQ-5D-3L], EuroQol 5D-5L [EQ-5D-5L], Nottingham Health Profile (NHP), and Patient-Reported Outcome Measurement Information System Global Health [PROMIS-GH-10]) in patients with low back pain (LBP). Study Design and Setting Six electronic databases (MEDLINE, EMBASE, CINAHL, PsycINFO, SportDiscus, and Google Scholar) were searched (July 2017). Studies assessing any measurement property in nonspecific LBP patients were included. Two reviewers independently screened the articles and assessed the risk of bias (COSMIN checklist). Consensus-based criteria were used to rate measurement properties results as sufficient, insufficient, or inconsistent; a modified GRADE approach was adopted for evidence synthesis. Results High quality evidence was found for insufficient construct validity of SF-36 summary scores, and EQ-5D-3L utility and visual analogue scale scores. Moderate evidence was found for sufficient construct validity of SF-12 physical summary score and inconsistent responsiveness of EQ-5D-3L utility score. Very low quality evidence was found on each instrument's content validity; very low to low evidence underpinned the other assessed measurement properties. EQ-5D-5L, NHP and PROMIS Global Health-10 were not evaluated in LBP patients. Conclusion Documentation of the measurement properties of health-related quality of life instruments in LBP is incomplete. Future clinimetric studies should prioritize content validity.

BACKGROUND: An updated psoriatic arthritis (PsA) core outcome set (COS) for randomized controlled trials (RCTs) was endorsed at the Outcome Measures in Rheumatology (OMERACT) meeting in 2016.OBJECTIVES: To synthesize the evidence on measurement properties of patient reported outcome measures (PROMs) for PsA and thereby contribute to development of a PsA core outcome measurement set (COMS) as described by the OMERACT Filter 2.0.METHODS: A systematic literature search was performed in EMBASE, MEDLINE and PsycINFO on Jan 1, 2017 to identify full-text articles with an aim of assessing the measurement properties of PROMs in PsA. Two independent reviewers rated the quality of studies using the COnsensus based standards for the Selection of health Measurement INstruments (COSMIN) checklist, and performed a qualitative evidence synthesis.RESULTS: Fifty-five studies were included in the systematic review. Forty-four instruments and a total of 89 scales were analyzed. PROMs measuring COS domains with at least fair quality evidence for good validity and reliability (and no evidence for poor properties) included the Stockerau Activity Score for PsA (German), Psoriasis Symptom Inventory, visual analogue scale for Patient Global, 36 Item Short Form Health Survey Physical Function subscale, Health Assessment Questionnaire Disability Index, Bath Ankylosing Spondylitis Functional Index, PsA Impact of Disease questionnaire, PsA Quality of Life questionnaire, VITACORA-19, Functional Assessment of Chronic Illness Therapy Fatigue scale and Social Role Participation Questionnaire.CONCLUSIONS: At least one PROM with some evidence for aspects of validity and reliability was available for six of the eight mandatory domains of the PsA COS.

Objective: The Children's Sleep Habits Questionnaire (CSHQ) was developed in the USA for children aged 4-10 years. The Dutch CSHQ has been validated for this age group, but not yet for toddlers. Furthermore, Dutch norm values for toddlers are unavailable. This study aimed to investigate the psychometric properties and collect norm values of the Dutch CSHQ in toddlers. Methods: Data collection was conducted by Taylor Nelson Sofres Netherlands Institute for Public Opinion (TNS-NIPO), a Dutch market research agency. The TNS-NIPO provided access to the TNS-NIPO base, which comprises a panel of respondents who have indicated that they are willing to regularly participate in research. Parents of children aged 2-3 years were invited to complete the CSHQ. The CSHQ is a multidimensional questionnaire to detect sleep problems in children. It is a 33-item, one-week retrospective (parent-)proxy survey. A higher score indicates more sleep problems. Results: The response rate was 61% (n = 201). The original eight-factor structure did not fit well in this population and a more appropriate structure could not be achieved with explorative factor analyses. The mean total score was 41.9 (SD 5.6), and was higher (indicating more sleep problems) compared to Dutch school-aged children. Conclusions: The one-dimensionality of the subscales of the CSHQ could not be confirmed in Dutch toddlers. Clinicians and researcher should be aware of the difficulty of reliably measuring sleep in this age group when using the CSHQ. For research purposes, it is therefore recommended to only use the total score. (C) 2017 Elsevier B.V. All rights reserved

Background: This study aims to identify elements perceived by Dutch fertility specialists as barriers and facilitators for the introduction of genetic testing, and their attitudes towards the use of genetic information. The genetic test would be implemented in routine screening for tubal pathology and identifies SNPs relevant for the immune response causing tubal pathology.Methods: Experienced reproductive specialists working in Dutch Academic Hospitals were interviewed. Based on the results of four interviews a questionnaire was developed and used to survey medical doctors in six out of eight Dutch Academic hospitals.Results: 60.4% (n = 91) stated that the addition of genetic markers to the Chlamydia trachomatis antibody test (CAT) in screening for tubal pathology would increase screening accuracy. 68.2% (n = 90) agreed they would require additional training on clinical genetics. Clinical utility (91.2%, n = 91) and costeffectiveness (95.6%, n = 91) were recognized by the respondents as important factors in gaining support for the new screening strategy.Conclusion: In summary, respondents showed a positive attitude towards the implementation of a genetic test combined with CAT for tubal factor infertility (TFI) screening. To gain their support the majority of respondents agreed that clinical utility, specifically cost-effectiveness, is an important factor. Comprehensive research about economic implications and utility regarding the introduction of genomic markers should be the next step in the implementation strategy. Furthermore, education and training would, need to be developed and offered to fertility care professionals about genetic markers, their interpretation, and implications for clinical decision-making. (C) 2017 Elsevier B.V. All rights reserved.

Objective Conduct a systematic review of pediatric randomized controlled trials (RCTs) published in high-impact journals to assess the reporting of primary outcomes and the psychometric properties of their measures. Study Design and Setting Systematic review with screening and simultaneous data extraction conducted by two independent reviewers. Electronic searches of six general medicine and four pediatric journals were conducted in MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials (CENTRAL) databases. RCTs of a single phase/step in a single publication, published in English between 2000 and 2010 with participants less than 21 years of age were included. Results A random sample of 20% ( n = 445) of 2,229 initial references was screened and 206 (46%) met inclusion criteria. Half (48.5%) of included studies reported a singular primary outcome, 27% did not identify any primary outcome, and 24% identified multiple primary outcomes (range 2–20). Twenty-one trials used an instrument to measure their primary outcome, but only 7 (33%) reported its psychometric properties. Conclusion Pediatric trials published in top medical journals have inadequate reporting of their primary outcomes and the psychometric properties of their outcome measures. Whether the issue is one of poor reporting and/or poor validation will be further investigated.

Objectives The Douleur Neuropathique 4 (DN4), ID Pain, Leeds Assessment of Neuropathic Symptoms and Signs (LANSS), PainDETECT, and Neuropathic Pain Questionnaire have been recommended as screening questionnaires for neuropathic pain. This systematic review aimed to evaluate the measurement properties (eg, criterion validity and reliability) of these questionnaires. Study Design and Setting Online database searches were conducted and two independent reviewers screened studies and extracted data. Methodological quality of included studies and the measurement properties were assessed against established criteria. A modified Grading of Recommendations Assessment, Development and Evaluation approach was used to summarize the level of evidence. Results Thirty-seven studies were included. Most studies recruited participants from pain clinics. The original version of the DN4 (French) and Neuropathic Pain Questionnaire (English) had the most number of satisfactory measurement properties. The ID Pain (English) demonstrated satisfactory hypothesis testing and reliability, but all other properties tested were unsatisfactory. The LANSS (English) was unsatisfactory for all properties, except specificity. The PainDETECT (English) demonstrated satisfactory hypothesis testing and criterion validity. In general, the cross-cultural adaptations had less evidence than the original versions. Conclusion Overall, the DN4 and Neuropathic Pain Questionnaire were most suitable for clinical use. These screening questionnaires should not replace a thorough clinical assessment.

Purpose To evaluate which questionnaire, the Knee Injury and Osteoarthritis Outcome Score (KOOS) or the International Knee Documentation Committee Subjective Knee Form (IKDC subjective), is most useful to evaluate patients with recent anterior cruciate ligament (ACL) ruptures or those within 1 year of an ACL reconstruction. Methods Patients with recent (0-6 months) ACL ruptures or those with indications for ACL reconstruction were included. All patients completed the questionnaires shortly after trauma or preoperatively and again 1 year later. The KOOS has 5 subscales, each scored separately. The IKDC subjective consists of one total score. The following measurement properties of the KOOS and IKDC subjective were assessed: content validity (n = 45), construct validity (n = 100), test-retest reliability (n = 50), and responsiveness (n = 50). Results Regarding content validity, 2 KOOS subscales (Pain and Activities of Daily Living) were scored as nonrelevant. Two of the 18 questions on the IKDC subjective were assessed as nonrelevant. Only the KOOS subscale Sport and Recreation Function had acceptable construct validity (79% confirmation of the predefined hypotheses). None of the KOOS subscales had a sufficient score for responsiveness ( Conclusions The IKDC subjective is more useful than the KOOS questionnaire to evaluate both patients with recent ACL ruptures and those in the first year after ACL reconstruction. Level of Evidence Level III, prognostic validation study.

Purpose: The computerized Animated Activity Questionnaire (AAQ) for assessing activity limitations in hip and knee osteoarthritis (HKOA) consists of video animations from which patients can choose the animation that best matches their own performance. The AAQ has demonstrated good validity and reliability. Application of the AAQ in international studies, requires good cross-cultural validity, i.e., minimal Differential Item Functioning (DIF) across countries. The aim of this study was to evaluate cross-cultural validity. Methods: Patients in 7 European countries patients completed the AAQ on a computer. Ordinal logistic regression analysis was used to evaluate DIF across languages (Dutch versus 6 other languages). DIF is defined as follows: If a patient in a country has the same level of activity limitation as a patient in the Netherlands (the reference country in which the AAQ is developed), they should score the same on each item of the AAQ. If there is a statistical significant difference between countries, there is DIF. We used frequently described criteria in literature to assess DIF between countries. Criteria for non-uniform DIF were set as a statistical significance (p

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

Terwee CB, de Winter AF, Scholten RJ, Jans MP, Deville W, van Schaardenburg D, Bouter LM. Interobserver reproducibility of the visual estimation of range of motion of the shoulder. Objectives To assess interobserver reproducibility (agreement and reliability) of visually estimated shoulder range of motion (ROM) and to study the influence of clinical characteristics on the reproducibility. Design Test-retest analyses. Setting Various health care settings in the Netherlands. Participants Consecutive patients with shoulder complaints (N=201) referred by 20 general practitioners, 2 orthopedic physicians, and 20 rheumatologists. Interventions Not applicable. Main Outcome Measures Independent visual estimation by 2 physiotherapists of the ROM. Agreement was calculated as the mean difference in visual estimation between examiners ±1.96 × standard deviations of this mean difference. The intraclass correlation coefficient (ICC) was calculated as a measure of reliability, based on a 2-way random effects analysis of variance. Results The lowest level of agreement was for visual estimation of active and passive elevation (limits of agreement, −43.4 to 39.8 and −46.7 to 41.5, respectively, for the difference between the affected and contralateral sides), for which the level of agreement was most clearly associated with pain severity and disability. The ability to differentiate between subjects was acceptable for all movements for the difference between the affected and contralateral sides (ICCs, >.70) except for horizontal adduction (ICC=.49). Conclusions Interobserver agreement was low for the assessment of active and passive elevation, especially for patients with a high pain severity and disability. Except for horizontal adduction, visual estimation seems suitable for distinguishing differences between affected and contralateral ROM between subjects.