Publications by authors named "Caroline B Terwee"

212 Publications

A Patient-Reported Outcomes Measurement Information System Short Form for Measuring Physical Function During Geriatric Rehabilitation: Test-Retest Reliability, Construct Validity, Responsiveness, and Interpretability.

J Am Med Dir Assoc 2021 Feb 25. Epub 2021 Feb 25.

Department of Epidemiology and Biostatistics, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.

Objectives: To study the test-retest reliability and measurement error, construct validity, responsiveness, interpretability, and floor/ceiling effects of a Patient-Reported Outcomes Measurement Information System (PROMIS) short form designed to measure physical function in geriatric rehabilitation patients (PROMIS-PF-GR).

Design: Prospective cohort.

Setting And Participants: Inpatient geriatric rehabilitation patients.

Methods: We evaluated the test-retest reliability by re-administering PROMIS-PF-GR 3 to 5 days after the admission measurement. The intraclass correlation coefficient (ICC) was calculated to determine test-retest reliability; an ICC of ≥0.70 was considered sufficient. Measurement error was established by calculating the standard error of measurement and smallest detectable change. Construct validity and responsiveness were determined by testing a priori formulated hypotheses (criterion: ≥75% hypothesis not rejected). Interpretability was evaluated by calculating the minimal important change using predictive modeling and a global rating as criterion for change. Floor/ceiling effects were established by calculating the percentage patients with the minimum/maximum raw score (criterion: ≤15%) at admission and discharge.

Results: A total of 207 patients participated in the study [mean ± standard deviation age (80 ± 8.3 years), 58% female]. More than one-half of patients (56%) reported to be improved during rehabilitation. The ICC was 0.79 (95% confidence interval 0.70-0.84), the standardized error of measurement was 3.8, and the smallest detectable change 10.6. None of the 4 hypotheses for construct validity were rejected; 2 out of 5 hypotheses for responsiveness were rejected. The minimal important change was 8.0 (95% confidence interval 4.1-12.5). No floor/ceiling effects were found.

Conclusions And Implications: The PROMIS-PG-GR showed sufficient test-retest reliability, measurement error, and construct validity. We did not find sufficient evidence for responsiveness, which may be due to the unexplained weak correlation between the PROMIS change score and the Global Rating Scale. We still recommend the use the PROMIS-PG-GR for measuring self-reported physical function in geriatric rehabilitation.
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http://dx.doi.org/10.1016/j.jamda.2021.01.079DOI Listing
February 2021

Psychometric properties of the Patient-Reported Outcomes Measurement Information System (PROMIS®) pediatric item bank peer relationships in the Dutch general population.

Qual Life Res 2021 Feb 19. Epub 2021 Feb 19.

Child and Adolescent Psychiatry & Psychosocial Care, Amsterdam Reproduction and Development, Amsterdam Public Health, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Postbus 22660, 1100 AD, Amsterdam, The Netherlands.

Purpose: This study aimed to validate the PROMIS Pediatric item bank v2.0 Peer Relationships and compare reliability of the full item bank to its short form, computerized adaptive test (CAT) and the social functioning (SF) subscale of the Pediatric Quality of Life Inventory (PedsQL™).

Methods: Children aged 8-18 (n = 1327), representative of the Dutch population completed the Peer Relationships item bank. A graded response model (GRM) was fit to the data. Structural validity was assessed by checking item-fit statistics (S-X, p < 0.001 = misfit). For construct validity, a moderately strong correlation (> 0.50) was expected between Peer Relationships and the PedsQL SF subscale. Cross-cultural DIF between U.S. and NL was assessed using logistic regression, where an item with McFadden's pseudo R > 0.02 was considered to have DIF. Percentage of participants reliably measured was assessed using the standard error of measurement (SEM) < 0.32 as a criterion (reliability of 0.90). Relative efficiency ((1-SEM)/n) was calculated to compare how well the instruments performed relative to the amount of items administered.

Results: In total, 527 (response rate: 39.7%) children completed the PROMIS v2.0 Peer Relationships item bank (n = 15) and the PedsQL™ (n = 23). Structural validity of the Peer Relationships item bank was sufficient, but one item displayed misfit in the GRM model (S-X < 0.001); 5152R1r ("I played alone and kept to myself"). The item 733R1r ("I was a good friend") was the only item that displayed cross-cultural DIF (R = 0.0253). The item bank correlated moderately high (r = 0.61) with the PedsQL SF subscale Reliable measurements were obtained at the population mean and > 2SD in the clinically relevant direction. CAT outperformed all other measures in efficiency. Mean T-score of the Dutch general population was 46.9(SD 9.5).

Conclusion: The pediatric PROMIS Peer Relationships item bank was successfully validated for use within the Dutch population and reference data are now available.
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http://dx.doi.org/10.1007/s11136-021-02781-wDOI Listing
February 2021

International application of PROMIS computerized adaptive tests: US versus country-specific item parameters can be consequential for individual patient scores.

J Clin Epidemiol 2021 Jan 30;134:1-13. Epub 2021 Jan 30.

Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.

Objective: PROMIS offers computerized adaptive tests (CAT) of patient-reported outcomes, using a single set of US-based IRT item parameters across populations and language-versions. The use of country-specific item parameters has local appeal, but also disadvantages. We illustrate the effects of choosing US or country-specific item parameters on PROMIS CAT T-scores.

Study Design And Setting: Simulations were performed on response data from Dutch chronic pain patients (n = 1110) who completed the PROMIS Pain Behavior item bank. We compared CAT T-scores obtained with (1) US parameters; (2) Dutch item parameters; (3) US item parameters for DIF-free items and Dutch item parameters (rescaled to the US metric) for DIF items; (4) Dutch item parameters for all items (rescaled to the US metric).

Results: Without anchoring to a common metric, CAT T-scores cannot be compared. When scores were rescaled to the US metric, mean differences in CAT T-scores based on US vs. Dutch item parameters were negligible. However, 0.9%-4.3% of the T-score differences were larger than 5 points (0.5 SD).

Conclusion: The choice of item parameters can be consequential for individual patient scores. We recommend more studies of translated CATs to examine if strategies that allow for country-specific item parameters should be further investigated.
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http://dx.doi.org/10.1016/j.jclinepi.2021.01.011DOI Listing
January 2021

EULAR recommendations for the reporting of ultrasound studies in rheumatic and musculoskeletal diseases (RMDs).

Ann Rheum Dis 2021 Jan 22. Epub 2021 Jan 22.

UVSQ, Inserm U1173, Infection et inflammation, Laboratory of Excellence INFLAMEX, Université Paris-Saclay, Montigny-le-Bretonneux, France

Objective: To produce European League Against Rheumatism (EULAR) recommendations for the reporting of ultrasound studies in rheumatic and musculoskeletal diseases (RMDs).

Methods: Based on the literature reviews and expert opinion (through Delphi surveys), a taskforce of 23 members (12 experts in ultrasound in RMDs, 9 in methodology and biostatistics together with a patient research partner and a health professional in rheumatology) developed a checklist of items to be reported in every RMD study using ultrasound. This checklist was further refined by involving a panel of 79 external experts (musculoskeletal imaging experts, methodologists, journal editors), who evaluated its comprehensibility, feasibility and comprehensiveness. Agreement on each proposed item was assessed with an 11-point Likert scale, grading from 0 (total disagreement) to 10 (full agreement).

Results: Two face-to-face meetings, as well as two Delphi rounds of voting, resulted in a final checklist of 23 items, including a glossary of terminology. Twenty-one of these were considered 'mandatory' items to be reported in every study (such as blinding, development of scoring systems, definition of target pathologies) and 2 'optional' to be reported only if applicable, such as possible confounding factors (ie, ambient conditions) or experience of the sonographers.

Conclusion: An EULAR taskforce developed a checklist to ensure transparent and comprehensive reporting of aspects concerning research and procedures that need to be presented in studies using ultrasound in RMDs. This checklist, if widely adopted by authors and editors, will greatly improve the interpretability of study development and results, including the assessment of validity, generalisability and applicability.
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http://dx.doi.org/10.1136/annrheumdis-2020-219816DOI Listing
January 2021

Harms reported by patients in rheumatology drug trials: a systematic review of randomized trials in the cochrane library from an OMERACT working group.

Semin Arthritis Rheum 2021 Jan 9. Epub 2021 Jan 9.

Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark; Research Unit of Rheumatology, Department of Clinical Research, University of Southern Denmark, Odense University Hospital, Denmark. Electronic address:

Background: Underreporting of harms in randomized controlled trials (RCTs) may lead to incomplete or erroneous assessments of the perceived benefit-to-harm profile of an intervention. To compare benefit with harm in clinical practice and future clinical studies, adverse event (AE) profiles including severity need to be understood. Even though patients report harm symptoms earlier and more frequently than clinicians, rheumatology RCTs currently do not provide a reporting framework from the patient's perspective regarding harms. Our objective for this meta-research project was to identify AEs in order to determine harm clusters and whether these could be self-reported by patients. Our other objective was to examine reported severity grading of the reported harms.

Methods: We considered primary publications of RCTs eligible if they were published between 2008 and 2018 evaluating pharmacological interventions in patients with a rheumatic or musculoskeletal condition and if they were included in Cochrane reviews. We extracted data on harms such as reported AE terms together with severity (if described), and categorized AE- and severity-terms into overall groups. We deemed all AEs with felt components appropriate for patient self-reporting.

Results: The literature search identified 187 possible Cochrane reviews, of which 94 were eligible for evaluation, comprising 1,297 articles on individual RCTs. Of these RCTs, 93 pharmacological trials met our inclusion criteria (including 31,023 patients; representing 20,844 accumulated patient years), which reported a total of 21,498 AEs, corresponding to 693 unique reported terms for AEs. We further sub-categorized these terms into 280 harm clusters (i.e., themes). AEs appropriate for patient self-reporting accounted for 58% of the AEs reported. Among the reported AEs, we identified medical terms for all of the 117 harm clusters appropriate for patient reporting and lay language terms for 86%. We intended to include severity grades of the reported AEs, but there was no evidence for systematic reporting of clinician- or patient-reported severity in the primary articles of the 93 trials. However, we identified 33 terms suggesting severity, but severity grading was discernible in only 9%, precluding a breakdown by severity in this systematic review.

Conclusions: Our results support the need for a standardized framework for patients' reporting of harms in rheumatology trials. Reporting of AEs with severity should be included in future reporting of harms, both from the patients' and investigators' perspectives.

Registration: PROSPERO: CRD42018108393.
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http://dx.doi.org/10.1016/j.semarthrit.2020.09.023DOI Listing
January 2021

Translation and cross-cultural adaptation of Nepali versions of the patient-reported outcomes measurement information system (PROMIS®) pain intensity, pain interference, pain behavior, depression, and sleep disturbance short forms in chronic musculoskeletal pain.

Qual Life Res 2021 Jan 22. Epub 2021 Jan 22.

Department of Rehabilitation Medicine, University of Washington, Seattle, WA, USA.

Purpose: The Patient-Reported Outcomes Meaurement Information System (PROMIS®) measures have been translated into many languages and have been shown to have strong measurement properties across a wide range of clinical conditions. However, Nepali translations of the PROMIS short forms are not yet available. The aim of this study was to translate and cross-culturally adapt the PROMIS Pain Intensity, Pain Interference, Pain Behavior, Depression, and Sleep Disturbance short forms into Nepali.

Methods: We used the Functional Assessment of Chronic Illness Therapy (FACIT) translation methodology, which incorporated two forward translations, synthesis of the translations, a back-translation, and three independent reviews, harmonization, cognitive debriefing, revisions, and proof reading. The translation and review teams were fluent in Nepali and English and represented five different countries and four continents. We evaluated the short forms for comprehensibility and relevance (two key aspects of the content validity of an instrument), conducting cognitive debriefing with six adults with chronic musculoskeletal pain, in compliance with recommendations by the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN). The final version was proofread by two native Nepali speakers before and three new proofreaders after cognitive debriefing.

Results: All five short forms were successfully translated and cross-culturally adapted into Nepali while maintaining equivalence to the source.

Conclusions: The translation and review team, along with a sample from the target population with chronic musculoskeletal pain and the proofreaders considered all five PROMIS short forms relevant and comprehensible. An important next step is to evaluate the measurement properties of these instruments.
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http://dx.doi.org/10.1007/s11136-020-02745-6DOI Listing
January 2021

Patient-reported outcome measures (PROMs): making sense of individual PROM scores and changes in PROM scores over time.

Nephrology (Carlton) 2020 Dec 16. Epub 2020 Dec 16.

Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands.

Patient-reported outcome measures (PROMs) are increasingly being used in nephrology care. However, in contrast to well-known clinical measures such as blood pressure, health-care professionals are less familiar with PROMs and the interpretation of PROM scores is therefore perceived as challenging. In this paper, we provide insight into the interpretation of PROM scores by introducing the different types and characteristics of PROMs, and the most relevant concepts for the interpretation of PROM scores. Concepts such as minimal detectable change, minimal important change and response shift are explained and illustrated with examples from nephrology care.
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http://dx.doi.org/10.1111/nep.13843DOI Listing
December 2020

Operationalization of the Brief ICF Core Set for Hearing Loss: An ICF-Based e-Intake Tool in Clinical Otology and Audiology Practice.

Ear Hear 2020 Nov/Dec;41(6):1533-1544

Amsterdam UMC, Vrije Universiteit Amsterdam, Otolaryngology-Head and Neck Surgery, Ear & Hearing, Amsterdam Public Health, Amsterdam, Netherlands.

Objectives: According to the International Classification of Functioning, Disability and Health (ICF), functioning reflects the interplay between an individual's body structures and functions, activities, participation, environmental, and personal factors. To be useful in clinical practice, these concepts need to be operationalized into a practical and integral instrument. The Brief ICF Core Set for Hearing Loss (CSHL) provides a minimum standard for the assessment of functioning in adults with hearing loss. The objective of the present study was to operationalize the Brief CSHL into a digital intake tool that could be used in the otology-audiology practice for adults with ear and hearing problems as part of their intake assessment.

Design: A three-step approach was followed: (1) Selecting and formulating questionnaire items and response formats, using the 27 categories of the Brief CSHL as a basis. Additional categories were selected based on relevant literature and clinical expertise. Items were selected from existing, commonly used disease-specific questionnaires, generic questionnaires, or the WHO's official descriptions of ICF categories. The response format was based on the existing item's response categories or on the ICF qualifiers. (2) Carrying out an expert survey and a pilot study (using the three-step test interview. Relevant stakeholders and patients were asked to comment on the relevance, comprehensiveness, and comprehensibility of the items. Results were discussed in the project group, and items were modified based on consensus. (3) Integration of the intake tool into a computer-based system for use in clinical routine.

Results: The Brief CSHL was operationalized into 62 items, clustered into six domains: (1) general information, including reason for visit, sociodemographic, and medical background; (2) general body functions; (3) ear and hearing structures and functions; (4) activities and participation (A&P); (5) environmental factors (EF); and (6) personal factors (mastery and coping). Based on stakeholders' responses, the instructions of the items on A&P and EF were adapted. The three-step test interview showed that the tool had sufficient content validity but that some items on EF were redundant. Overall, the stakeholders and patients indicated that the intake tool was relevant and had a logical and clear structure. The tool was integrated in an online portal.

Conclusions: In the current study, an ICF-based e-intake tool was developed that aims to screen self-reported functioning problems in adults with an ear/hearing problem. The relevance, comprehensiveness, and comprehensibility of the originally proposed item list was supported, although the stakeholder and patient feedback resulted into some changes of the tool on item-level. Ultimately, the functioning information obtained with the tool could be used to promote patient-centered ear and hearing care taking a biopsychosocial perspective into account.
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http://dx.doi.org/10.1097/AUD.0000000000000867DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7722460PMC
November 2020

Validity of Clinical Measurement Instruments Assessing Scapular Function: Insufficient Evidence to Recommend Any Instrument for Assessing Scapular Posture, Movement, and Dysfunction-A Systematic Review.

J Orthop Sports Phys Ther 2020 11;50(11):632-641

Objective: To determine the construct validity, criterion validity, and responsiveness of measurement instruments evaluating scapular function.

Design: Systematic review of measurement properties.

Literature Search: The MEDLINE, Embase, CINAHL, and SPORTDiscus databases were systematically searched from inception until March 2019.

Study Selection Criteria: Studies published in Dutch, English, or German were included when they evaluated at least 1 of the measurement properties of interest. No restrictions were made regarding participants' health status.

Data Synthesis: Two reviewers independently evaluated study quality using the COSMIN checklist and extracted and analyzed data. Quality of evidence was graded by measurement property for each distinctive type of measurement.

Results: Thirty-one measurement instruments in 14 studies were categorized into instruments to measure scapular posture and movement, and to assess scapular dyskinesis. Quality of evidence was at most moderate for 4 instruments with respect to criterion validity. Of these, criterion validity for instruments measuring scapular protraction/retraction posture and rotation angles up to 120° of thoracohumeral elevation was sufficient. Criterion validity for instruments measuring asymmetrical scapular posture, range of motion, and the lateral scapular slide test was insufficient. Quality of evidence for measurement properties of all other instruments was graded lower.

Conclusion: There is currently insufficient evidence to recommend any instrument for the clinical examination of scapular function. Measurement instruments to assess scapular dyskinesis are prone to misinterpretation and should therefore not be used as such. .
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http://dx.doi.org/10.2519/jospt.2020.9265DOI Listing
November 2020

Changes in the ability to participate in and satisfaction with social roles and activities in patients in outpatient rehabilitation.

J Patient Rep Outcomes 2020 Sep 1;4(1):73. Epub 2020 Sep 1.

Basalt Rehabilitation, Leiden/The Hague, the Netherlands.

Background: One of the main aims of rehabilitation is to improve participation. Patient-Reported Outcomes Measurement Information System (PROMIS®) item banks 'Ability to Participate in Social roles and Activities, (PROMIS-APS) and 'Satisfaction with Social Roles and Activities' (PROMIS-SPS) are promising options to measure participation, but the literature on PROMIS measures of (satisfaction with) participation across diagnoses in rehabilitation is limited. Therefore, the objective of this study was to describe levels of and changes in participation, as assessed with the PROMIS-APS and the PROMIS-SPS short forms, of patients in outpatient rehabilitation.

Methods: This study had quantitative, observational design with assessments at admission and discharge. Consecutive patients treated between April and August 2018 receiving outpatient multidisciplinary rehabilitation were the population of this study. The following diagnosis categories were included: brain injury (e.g. stroke), spinal cord and nerve injury, neuromuscular disorder (e.g. lateral sclerosis), amputation, musculoskeletal condition (e.g. osteoarthritis) or heart or lung disease (e.g. myocardial infarction, chronic obstructive pulmonary disease). The main patient-reported outcomes (PRO) of this study were the short form of the PROMIS-APS (8 items, Dutch general population reference score 50.6 [SD 9.5]), and PROMIS-SPS (8 items, Dutch general population reference score 47.5 [SD 8.3].

Results: Of the 1279 patients invited, 777 (61%) completed the online forms at admission. Of those, 329 patients were invited at discharge, with 209 (64%) completing the forms. The mean (SD) T-scores of the PROMIS-APS and PROMIS-SPS were lower at admission (42.7 [SD 7.4]; (41.4 [SD 7.7]) and discharge (43.6 [SD 7.2]; (43.7 [SD 7.8]) than the Dutch general population. The change scores of the PROMIS-APS and PROMIS-SPS were 1.2 (95% CI 0.4-1.9; p = 0.004; effect size 0.16), and 2.4 (95% CI 1.6-3.2; p < 0.0001; effect size 0.31), respectively. In all diagnostic subgroups with > 30 paired measurements statistically significant improvements of PROMIS-APS, PROMIS-SPS or both were seen.

Conclusions: Patients undergoing outpatient rehabilitation had, both at admission and discharge, considerably lower PROMIS-APS and PROMIS-SPS T-scores short forms than the general Dutch population, and showed small T-score improvements at discharge.
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http://dx.doi.org/10.1186/s41687-020-00236-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7462938PMC
September 2020

The value of core outcome sets in health psychology.

Br J Health Psychol 2020 09 1;25(3):377-389. Epub 2020 Jul 1.

School of Psychology, National University of Ireland, Galway, Ireland.

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http://dx.doi.org/10.1111/bjhp.12447DOI Listing
September 2020

Proposal to extend the PROMIS® item bank v2.0 'Ability to Participate in Social Roles and Activities': item generation and content validity.

Qual Life Res 2020 Oct 2;29(10):2851-2861. Epub 2020 Jun 2.

Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Public and Occupational Health, Amsterdam Public Health Research Institute, De Boelelaan, Amsterdam, Netherlands.

Purpose: Previous research indicated that the Patient-Reported Outcomes Measurement Information System (PROMIS®) item bank v2.0 'Ability to Participate in Social Roles and Activities' may miss subdomains of social participation. The purpose of this study was to generate items for these missing subdomains and to evaluate their content validity.

Methods: A three-step approach was followed: (1) Item generation for 16 International Classification of Functioning Disability and Health subdomains currently not covered by the item bank; (2) Evaluation of content validity of generated items through expert review (n = 20) and think-aloud interviews with a purposeful sample of people with and without (chronic) health conditions (n = 10), to assess item comprehensibility, relevance, and comprehensiveness; and 3) Item revision based on the results of step 2, in a consensus procedure.

Results: First, 48 items were generated. Second, overall, content experts indicated that the generated items were relevant. Furthermore, based on experts' responses, items were simplified and 'participation in social media' was identified as an important additional subdomain of social participation. Additionally, 'participating in various social roles simultaneously' was identified as a missing item. Based on the responses of the interviewed adults items were simplified. Third, in total 17 items, covering 17 subdomains, were proposed to be added to the original item bank.

Discussion: The relevance, comprehensibility and comprehensiveness of the 17 proposed items were supported. Whether the proposed extension of the item bank leads to better psychometric properties of the item bank should be tested in a large-scale field study.
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http://dx.doi.org/10.1007/s11136-020-02540-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7561593PMC
October 2020

Methods used in the selection of instruments for outcomes included in core outcome sets have improved since the publication of the COSMIN/COMET guideline.

J Clin Epidemiol 2020 09 26;125:64-75. Epub 2020 May 26.

Department of Epidemiology and Biostatistics, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Public Health Research Institute, Amsterdam, the Netherlands.

Objectives: Once a core outcome set (COS) has been defined, it is important to achieve consensus on how these outcomes should be measured. The aims of this systematic review were to gain insight into the methods used to select outcome measurement instruments and to determine whether methods have improved following the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN)/Core Outcome Measures in Effectiveness Trials (COMET) guideline publication.

Study Design And Setting: Eligible articles, which were identified from the annual COMET systematic review, concerned any COS development studies that provided a recommendation on how to measure the outcomes included in the COS. Data were extracted on the methods used to select outcome measurement instruments in accordance with the COSMIN/COMET guideline.

Results: Of the 118 studies included in the review, 48% used more than one source of information when finding outcome measurement instruments, and 74% performed some form of quality assessment of the measurement instruments. Twenty-three studies recommended one single instrument for each core outcome included in the COS. Clinical experts and public representatives were involved in selecting instruments in 62% and 28% of studies, respectively.

Conclusion: Methods used to select outcome measurement instruments have improved since the publication of the COSMIN/COMET guideline. Going forward, COS developers should ensure that recommended outcome measurement instruments have sufficient content validity. In addition, COS developers should recommend one instrument for each core outcome to contribute to the overarching goal of uniformity in outcome reporting.
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http://dx.doi.org/10.1016/j.jclinepi.2020.05.021DOI Listing
September 2020

Unlike ROC analysis, a new IRT method identified clinical thresholds unbiased by disease prevalence.

J Clin Epidemiol 2020 08 11;124:118-125. Epub 2020 May 11.

Department of Epidemiology and Biostatistics, Amsterdam Public Health research institute, Amsterdam UMC, Vrije Universiteit Amsterdam, de Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands.

Objective: This study introduces a new method to establish clinical thresholds for multi-item tests, based on item response theory (IRT), as an alternative to receiver operating characteristic (ROC) analysis. The performance of IRT method was examined and compared with the ROC method across multiple simulated data sets and in a real data set.

Study Design And Setting: Simulated data sets (sample size: 1,000) varied in means and variability of the test scores and the prevalence of disease. The true clinical threshold was defined as a predetermined location on the latent trait underlying the questionnaire, with its corresponding expected test score. The real data set (sample size: 295) comprised Hospital Anxiety Depression Scale (HADS) depression scores and Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition major depressive disorder (MDD) diagnoses.

Results: The IRT method recovered the clinical thresholds without bias, whereas the ROC method identified thresholds that were biased by the prevalence of disease. Mild MDD was clinically diagnosed in 23%, moderate MDD in 12%, and severe MDD in 14% of the participants. The IRT method identified the following HADS depression score thresholds for mild, moderate, and severe MDD: 10.7, 13.2, and 15.1, respectively.

Conclusion: The new IRT method identifies clinical thresholds that are unbiased by disease prevalence.
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http://dx.doi.org/10.1016/j.jclinepi.2020.05.008DOI Listing
August 2020

Controversy and Debate Series on Core Outcome Sets. Paper 4: Debate on Paper 1 from the perspective of COMET [Core Outcome Measures in Effectiveness Trials].

J Clin Epidemiol 2020 09 13;125:222-224. Epub 2020 May 13.

MRC-NIHR Trials Methodology Research Partnership, University of Liverpool, Liverpool L63 3GL, UK.

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http://dx.doi.org/10.1016/j.jclinepi.2020.05.014DOI Listing
September 2020

Psychometric properties of the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance and Sleep-Related Impairment item banks in adolescents.

J Sleep Res 2020 Mar 16:e13029. Epub 2020 Mar 16.

Pediatric Oncology, Emma Children's Hospital, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.

Sleep problems have a high prevalence and negative daytime consequences in adolescents. Current sleep measures for this age group have limitations. The Patient-Reported Outcomes Measurement Information System (PROMIS ) developed sleep item banks for adults. In a previous validation study, these item banks were adapted to a shortened version for adolescents. The current study aimed to further explore the psychometric properties of the 11-item Sleep-Related Impairment and 23-item Sleep Disturbance item banks in Dutch adolescents. We investigated structural validity by testing item response theory assumptions and model fit; measurement invariance by performing differential item functioning analyses; performance as a computerized adaptive test; reliability by marginal reliability estimates and test-retest reliability (intraclass correlation coefficients and limits of agreement); and construct validity by hypothesis testing. Additionally, we provide mean values for the item banks. The study sample consisted of 1,046 adolescents (mean age 14.3 ± 1.6), including 1,013 high-school students and 33 sleep-clinic patients. The Sleep Disturbance-23 showed lack of unidimensionality, but had sufficient test-retest reliability, and could distinguish between adolescents with and without sleep or health issues. The Sleep-Related Impairment-11 showed sufficient unidimensionality and model fit and was thus tested as a computerized adaptive test, demonstrating an equal amount of reliable measures to the full item bank. Furthermore, the Sleep-Related Impairment-11 could distinguish between adolescents with and without sleep or health issues and test-retest reliability was moderate. The use of both item banks in the full form and the use of the Sleep-related Impairment-11 as a computer adaptive test is recommended.
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http://dx.doi.org/10.1111/jsr.13029DOI Listing
March 2020

A study of alternative approaches to non-normal latent trait distributions in item response theory models used for health outcome measurement.

Stat Methods Med Res 2020 04 11;29(4):1030-1048. Epub 2020 Mar 11.

Quantitative Methods, Faculty of Psychology, York University, Toronto, Canada.

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http://dx.doi.org/10.1177/0962280220907625DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7221458PMC
April 2020

The Value of Item Banks, CAT, and PROMIS for Dermatology.

J Invest Dermatol 2020 05 13;140(5):1089-1091. Epub 2020 Jan 13.

Department of Epidemiology and Biostatistics, Amsterdam Public Health Research Institute, Amsterdam UMC, Vrije Universiteit Amsterdam, Boelelaan 1117, Amsterdam, Netherlands. Electronic address:

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http://dx.doi.org/10.1016/j.jid.2019.12.017DOI Listing
May 2020

Translation, cross-cultural and construct validity of the Dutch-Flemish PROMIS® upper extremity item bank v2.0.

Qual Life Res 2020 Apr 1;29(4):1123-1135. Epub 2020 Jan 1.

Amsterdam Rehabilitation Research Center | Reade, Amsterdam, The Netherlands.

Purpose: To develop a Dutch-Flemish translation of the PROMIS® upper extremity (PROMIS-UE) item bank v2.0, and to investigate its cross-cultural and construct validity as well as its floor and ceiling effects in patients with musculoskeletal UE disorders.

Methods: State of the art translation methodology was used to develop the Dutch-Flemish PROMIS-UE item bank v2.0. The item bank and four legacy instruments were administered to 205 Dutch patients with musculoskeletal UE disorders visiting an orthopedic outpatient clinic. The validity of cross-cultural comparisons between English and Dutch patients was evaluated by studying differential item functioning (DIF) for language (Dutch vs. English) with ordinal logistic regression models and McFadden's pseudo R-change of ≥ 2% as critical value. Construct validity was assessed by formulating a priori hypotheses and calculating correlations with legacy instruments. Floor/ceiling effects were evaluated by determining the proportion of patients who achieved the lowest/highest possible raw score.

Results: Eight items showed DIF for language, but their impact on the test score was negligible. The item bank correlated, as hypothesized, moderately with the Dutch-Flemish PROMIS pain intensity item (Pearson's r = - 0.43) and strongly with the Disabilities of the Arm, Shoulder and Hand questionnaire, Subscale Disability/Symptoms (Spearman's ρ = - 0.87), the Functional Index for Hand Osteoarthritis (ρ = - 0.86), and the Michigan Hand Outcomes Questionnaire, Subscale Activities of Daily Living (ρ = 0.87). No patients achieved the lowest or highest possible raw score.

Conclusions: A Dutch-Flemish PROMIS-UE item bank v2.0 has been developed that showed sufficient cross-cultural and construct validity as well as absence of floor and ceiling effects.
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http://dx.doi.org/10.1007/s11136-019-02388-2DOI Listing
April 2020

Development of a framework with tools to support the selection and implementation of patient-reported outcome measures.

J Patient Rep Outcomes 2019 Dec 30;3(1):75. Epub 2019 Dec 30.

Radboud University Medical Center, Radboud Institute for Health Sciences, IQ Healthcare, Nijmegen, the Netherlands.

Background: Patient reported outcomes (PROs) provide information on a patient's health status coming directly from the patient. Measuring PROs with patient reported outcome measures (PROMs) has gained wide interest in clinical practice for individual patient care, as well as in quality improvement, and for providing transparency of outcomes to stakeholders through public reporting. However, current knowledge of selecting and implementing PROMs for these purposes is scattered, and not readily available for clinicians and quality managers in healthcare organizations. The objective of this study is to develop a framework with tools to support the systematic selection, implementation and evaluation of PROs and PROMs in individual patient care, for quality improvement and public reporting.

Methods: We developed the framework in a national project in the Netherlands following a user-centered design. The development process of the framework contained five iterative components: (a) identification of existing tools, (b) identification of user requirements and designing steps for selection and implementation of PROs and PROMs, (c) discussing a prototype of the framework during a national workshop, (d) developing a web version, (e) pre-testing of the framework. A total of 40 users with different perspectives (clinicians, patient representatives, quality managers, purchasers, researchers) have been consulted.

Results: The final framework is presented as the PROM-cycle that consists of eight steps in four phases: (1) goal setting, (2) selecting PROs and PROMs, (3) developing and testing of quality indicator(s), (4) implementing and evaluating the PROM(s) and indicator(s). Users emphasized that the first step is the key element in which the why, for whom and setting of the PROM has to be defined. This information is decisive for the following steps. For each step the PROM-cycle provides guidance and tools, with instruments, checklists, methods, handbooks, and standards supporting the process.

Conclusion: We developed a framework to support the selection and implementation of PROs and PROMs. Each step provides guidance and tools to support the process. The PROM-cycle and its tools are publicly available and can be used by clinicians, quality managers, patient representatives and other experts involved in using PROMS. Through periodic evaluation and updates, tools will be added for national and international use of the PROM-cycle.
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http://dx.doi.org/10.1186/s41687-019-0171-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6937349PMC
December 2019

Estimating Minimal Clinically Important Differences and Minimal Detectable Change.

J Hand Surg Am 2019 12;44(12):e1

Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Epidemiology and Biostatistics, Amsterdam Public Health Research Institute, Amsterdam, the Netherlands.

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http://dx.doi.org/10.1016/j.jhsa.2019.10.001DOI Listing
December 2019

PROMIS Physical Function Short Forms Display Item- and Scale-Level Characteristics at Least as Good as the Roland Morris Disability Questionnaire in Patients With Chronic Low Back Pain.

Arch Phys Med Rehabil 2020 02 2;101(2):297-308. Epub 2019 Nov 2.

Department of Health Sciences, Faculty of Science, Amsterdam Movement Sciences Research Institute, VU University, Amsterdam, The Netherlands.

Objective: To compare dimensionality, item-level characteristics, scale-level reliability, and construct validity of PROMIS Physical Function short forms (PROMIS-PF) and 24-item Roland Morris Disability Questionnaire (RMDQ-24) in patients with chronic low back pain (LBP).

Design: Cross-sectional study.

Setting: Secondary care center for rehabilitation and rheumatology.

Participants: Patients with nonspecific LBP ≥3 months (N=768). Mean age was 49±13 years, 77% were female, and 54% displayed pain for more than 5 years.

Interventions: Not applicable.

Main Outcome Measures: Dutch versions of the 4-, 6-, 8-, 10-, and 20-item PROMIS-PF and of the RMDQ-24.

Results: PROMIS-PF-6, PROMIS-PF-8, and RMDQ-24 exhibited sufficient unidimensionality (confirmatory factor analysis: comparative fit index>0.950, Tucker-Lewis index>0.950, root means square error of approximation<0.060), whereas the other instruments did not. All instruments were free of local dependence except PROMIS-PF-20 with 4 item pairs with clear residual correlations. Mokken scale analysis found 1 nonmonotone item for PROMIS-PF-20 and 8 for RMDQ-24 (ie, the probability of endorsing these items was not increasing with increasing level on the underlying construct). PROMIS-PF-20 displayed 2 misfitting items (S-χP value>.001). Two-parameter item response theory models found 2 items with low discrimination for RMDQ-24. All other instruments had adequate fit statistics and item parameters. PROMIS-PF-20 displayed the best scale-level reliability. Construct validity was sufficient for all instruments as all hypotheses on expected correlations with other instruments and differences between relevant subgroups were met.

Conclusions: PROMIS-PF-6, PROMIS-PF-8, and RMDQ-24 exhibited better unidimensionality, whereas PROMIS-PF-4, PROMIS-PF-6, PROMIS-PF-8, and PROMIS-PF-10 showed superior item-level characteristics. PROMIS-PF-20 was the instrument with the best scale-level reliability. This study warrants assessment of other measurement properties of PROMIS-PF short forms in comparison with disease-specific physical functioning instruments in LBP.
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http://dx.doi.org/10.1016/j.apmr.2019.09.018DOI Listing
February 2020

Psychometric Properties of the Pediatric Patient-Reported Outcomes Measurement Information System Item Banks in a Dutch Clinical Sample of Children With Juvenile Idiopathic Arthritis.

Arthritis Care Res (Hoboken) 2020 12;72(12):1780-1789

Emma Children's Hospital, Amsterdam University Medical Center, University of Amsterdam, Amsterdam, The Netherlands.

Objective: To assess the psychometric properties of 8 pediatric Patient-Reported Outcomes Measurement Information System (PROMIS) item banks in a clinical sample of children with juvenile idiopathic arthritis (JIA).

Methods: A total of 154 Dutch children (mean ± SD age 14.4 ± 3.0 years; range 8-18 years) with JIA completed 8 pediatric version 1.0 PROMIS item banks (anger, anxiety, depressive symptoms, fatigue, pain interference, peer relationships, physical function mobility, physical function upper extremity) twice and the Pediatric Quality of Life Inventory (PedsQL) and the Childhood Health Assessment Questionnaire (C-HAQ) once. Structural validity of the item banks was assessed by fitting a graded response model (GRM) and inspecting GRM fit (comparative fit index [CFI], Tucker-Lewis index [TLI], and root mean square error of approximation [RMSEA]) and item fit (S-X statistic). Convergent validity (with PedsQL/C-HAQ subdomains) and discriminative validity (active/inactive disease) were assessed. Reliability of the item banks, short forms, and computerized adaptive testing (CAT) was expressed as the SE of theta (SE[θ]). Test-retest reliability was assessed using intraclass correlation coefficients (ICCs) and smallest detectable change.

Results: All item banks had sufficient overall GRM fit (CFI >0.95, TLI >0.95, RMSEA <0.08) and no item misfit (all S-X P > 0.001). High correlations (>0.70) were found between most PROMIS T scores and hypothesized PedsQL/C-HAQ (sub)domains. Mobility, pain interference, and upper extremity item banks were able to discriminate between patients with active and inactive disease. Regarding reliability, PROMIS item banks outperformed legacy instruments. Post hoc CAT simulations outperformed short forms. Test-retest reliability was strong (ICC >0.70) for all full-length item banks and short forms, except for the peer relationships item bank.

Conclusion: The pediatric PROMIS item banks displayed sufficient psychometric properties for Dutch children with JIA. PROMIS item banks are ready for use in clinical research and practice for children with JIA.
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http://dx.doi.org/10.1002/acr.24094DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7756261PMC
December 2020

Practical Significance of Longitudinal Measurement Invariance Violations in the Dutch-Flemish PROMIS Item Banks for Depression and Anxiety: An Illustration With Ordered-Categorical Data.

Assessment 2021 01 18;28(1):277-294. Epub 2019 Oct 18.

Leiden University, Leiden, Netherlands.

We investigated longitudinal measurement invariance in the Dutch-Flemish PROMIS adult v1.0 item banks for Depression and Anxiety using two clinical samples with mood and anxiety disorders ( = 640 and = 528, respectively). Factor analysis was used to evaluate whether the item banks were sufficiently unidimensional at two test-occasions and whether the measured constructs remained the same over time. The results indicated that the item banks were sufficiently unidimensional, but the thresholds and residual variances of the constructs changed over time. However, using tentative rules of thumb, these invariance violations did not substantially affect the endorsement of a specific response category of a specific item at a specific test-occasion. Furthermore, the impact on the mean latent change scores of the item banks remained below the proposed cutoff value for substantial bias. These findings suggest that the invariance violations lacked practical significance for test-users, meaning that the item banks provide sufficiently invariant latent factor scores for use in clinical practice.
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http://dx.doi.org/10.1177/1073191119880967DOI Listing
January 2021

First Validation of the Full PROMIS Pain Interference and Pain Behavior Item Banks in Patients With Rheumatoid Arthritis.

Arthritis Care Res (Hoboken) 2020 11;72(11):1550-1559

Amsterdam Rehabilitation Research Center, Reade, Amsterdam, The Netherlands.

Objective: Pain interference and pain behavior are highly relevant outcomes in patients with rheumatoid arthritis (RA). The Patient-Reported Outcomes Measurement Information System (PROMIS) is a universally applicable set of item banks measuring patient-reported health, and if applied as computerized adaptive tests (CATs), more efficiently and precisely than current instruments. The objective was to study the psychometric properties of the Dutch-Flemish PROMIS pain interference (PROMIS-PI) and the PROMIS pain behavior (PROMIS-PB) item banks in patients with RA.

Methods: A total of 2,029 patients with RA completed the full PROMIS-PI (version 1.1, 40 items), and 1,554 patients completed the full PROMIS-PB (version 1.1, 39 items). The following psychometric properties were studied: unidimensionality, local dependence, monotonicity and graded response model (GRM) fit, cross-cultural validity (differential item functioning [DIF] for language [Dutch versus Flemish]), other forms of measurement invariance, construct validity, reliability, and floor and ceiling effects.

Results: The PROMIS-PI and PROMIS-PB banks were sufficiently unidimensional (Omega-hierarchical [Omega-H] 0.99, 0.95, and explained common variance 0.95, 0.78, respectively), had negligible local dependence (0.3-1.4% of item pairs), good monotonicity (H 0.75, 0.46), and a good GRM model fit (no misfitting items). Furthermore, both item banks showed good cross-cultural validity (no DIF for language), measurement invariance (no DIF for age, sex, administration mode, and disease activity), good construct validity (all hypotheses met), high reliability (>0.90 in the range of patients with RA), and an absence of floor and ceiling effects (0% minimum or maximum score, respectively).

Conclusion: Both PROMIS-PI and PROMIS-PB banks showed good psychometric properties in patients with RA and can be used as CATs in research and clinical practice.
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http://dx.doi.org/10.1002/acr.24077DOI Listing
November 2020

Proposal for Improvement of the Hospital Anxiety and Depression Scale for the Assessment of Emotional Distress in Patients With Chronic Musculoskeletal Pain: A Bifactor and Item Response Theory Analysis.

J Pain 2020 Mar - Apr;21(3-4):375-389. Epub 2019 Aug 14.

Department of Health Sciences, Amsterdam Movement Sciences research institute, VU University, Amsterdam, the Netherlands; Department of General Practice, Erasmus MC, University Medical Center, Rotterdam, the Netherlands.

The Hospital Anxiety and Depression Scale (HADS) is a scale originally developed for the assessment of anxiety and depression in hospitalized patients. Despite its wide diffusion, research on its factorial structure has displayed inconsistent results, leaving doubts about its use in chronic musculoskeletal pain. The purpose of this study was to thoroughly assess the factorial structure of the HADS in patients with chronic pain and to give guidance for a potential refinement. Data from 2,522 patients with chronic pain from the Amsterdam Pain (AMS-PAIN) cohort were analyzed through: 1) exploratory bifactor analysis based on a Schmid-Leiman orthogonalization, 2) confirmatory factor analysis comparing a unidimensional model, the original correlated factors model and a bifactor model, 3) item response theory (IRT) analysis based on the graded response model. The results of the confirmatory factor analysis and of the IRT analysis were then cross-validated in an independent sample of patients with chronic pain (n = 8,604). Both exploratory and confirmatory analyses revealed the presence of a strong general emotional distress factor, suggesting that the HADS can be used as a unidimensional scale. The IRT analysis led to the exclusion of three items and to the recoding of one item. The refined 11-item HADS scale was successfully cross-validated and confirmed as a unidimensional, locally independent, monotonic, and reliable scale. PERSPECTIVE: An 11-item shorter version of the HADS could be used to measure emotional distress in patients with chronic musculoskeletal pain. Given its unidimensionality, the use of its total score seems appropriate.
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http://dx.doi.org/10.1016/j.jpain.2019.08.003DOI Listing
August 2019

Structural validity and construct validity of the Dutch-Flemish PROMIS physical function-upper extremity version 2.0 item bank in Dutch patients with upper extremity injuries.

Disabil Rehabil 2019 Aug 14:1-9. Epub 2019 Aug 14.

Department of Epidemiology and Biostatistics, Amsterdam Public Health Research Institute, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.

Aim of this study was to validate the Dutch-Flemish Patient-Reported Outcomes Measurement Information System Physical Function - Upper Extremity version 2.0 item bank in patients with upper extremity injuries. Cross-sectional study. Structural validity was assessed using Confirmatory Factor Analysis examining unidimensionality. In addition, a bi-factor model was fitted. Internal consistency was assessed by Cronbach's alpha. Construct validity was examined by assessing correlations with legacy instruments Disability of Arm Shoulder and Hand, Patient Reported Wrist Evaluation and Michigan Hand Questionnaire subscale Activities in Daily Life. A total of 303 patients (144 female) with mean age of 50 years (standard deviation 18) were included. Confirmatory Factor Analysis showed Comparative Fit Index of 0.94, a Tucker Lewis Index of 0.93, a Root Mean Square Error of Approximation of 0.12 and a Standardized Root Mean Residual of 0.09. Factor loadings were all above 0.70. Bifactor analysis showed an omega-H of 0.79 and Explained Common Variance of 0.67. The correlations with the legacy instruments were as expected or higher than expected. The Dutch-Flemish Patient-Reported Outcomes Measurement Information System Physical Function - Upper Extremity version 2.0 item bank measures a unidimensional trait and sufficient construct validity was found.IMPLICATIONS FOR REHABILITATIONCompleting Patient Reported Outcomes is time-consuming for patients and interpretability of outcomes is sometimes unclear due to some variation in psychometric properties.Computerized Adaptive Testing reduces the burden for patients by using an algorithm which decreases the amount of questions that need to be answered to 4 to 7 items.The Dutch-Flemish Patient-Reported Outcomes Measurement Information System Physical Function - Upper Extremity version 2.0 item bank measures a unidimensional trait and has sufficient structural validity, internal consistency and construct validity.After calibration of the Patient-Reported Outcomes Measurement Information System Physical Function - Upper Extremity version 2.0, the item bank is operable to use with Computerized Adaptive Testing.
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http://dx.doi.org/10.1080/09638288.2019.1651908DOI Listing
August 2019

Responsiveness and interpretability of the Animated Activity Questionnaire for assessing activity limitations of patients with hip or knee osteoarthritis.

Musculoskeletal Care 2019 12 12;17(4):327-334. Epub 2019 Aug 12.

Department of Epidemiology and Biostatistics, Amsterdam Public Health Research Institute, Amsterdam, the Netherlands.

Purpose: The aim of the study was to determine the responsiveness and interpretability of the Animated Activity Questionnaire (AAQ), an online questionnaire in which osteoarthritis patients select animations that best match their performance of daily activities.

Methods: A longitudinal study was carried out, in which 94 patients with hip or knee osteoarthritis were assessed at baseline, and 3 and 6 months after treatment (conservative and surgical). Responsiveness was assessed by means of testing hypotheses about expected correlations between change in AAQ, a Global Rating Scale of change (GRS) and change in the Activities of Daily Living subscale of the Hip disability or Knee injury and Osteoarthritis Outcome Score (H/KOOS), and a combination of performance-based tests (the 30 s chair-stand test, the timed up-and-go test and the nine-step stair climbing test). The minimal important change (MIC) was estimated by means of the receiving operating characteristics (ROC) method.

Results: The correlations of the AAQ with the H/KOOS were as expected, but other correlations were lower than anticipated. The area under the ROC curve was 0.74 at 6 months. At 3 months' follow-up, the correlations were too low to calculate a MIC. A total of 20% of the results at 3 months and 80% of the results at 6 months were in accordance with the hypotheses. The MIC was 9 points at 6 months.

Conclusions: The AAQ was sufficiently responsive at the six-months follow-up, but not at the three-month follow-up. The MIC at the 6-month follow-up (9 points) was slightly lower than the smallest detectable change of 14 points found in a previous study.
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http://dx.doi.org/10.1002/msc.1418DOI Listing
December 2019

The International Index of Erectile Function (IIEF)-A Systematic Review of Measurement Properties.

J Sex Med 2019 07 27;16(7):1078-1091. Epub 2019 May 27.

Vrije Universiteit Amsterdam, Department of Clinical, Neuro- and Developmental Psychology, Amsterdam Public Health Research Institute, Cancer Center Amsterdam, Amsterdam, The Netherlands; Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Otolaryngology Head and Neck Surgery, Cancer Center Amsterdam, Amsterdam, The Netherlands. Electronic address:

Introduction: The International Index of Erectile Function (IIEF) is a patient-reported outcome measure to evaluate erectile dysfunction and other sexual problems in men.

Aim: To perform a systematic review of the measurement properties of the 15-item patient-reported outcome measure (IIEF-15) and the shortened 5-item version (IIEF-5).

Methods: A systematic search of scientific literature up to April 2018 was performed. Data were extracted and analyzed according to COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines for structural validity, internal consistency, reliability, measurement error, hypothesis testing for construct validity, and responsiveness. Evidence of measurement properties was categorized into sufficient, insufficient, inconsistent, or indeterminate, and quality of evidence as very high, high, moderate, or low.

Results: 40 studies were included. The evidence for criterion validity (of the Erectile Function subscale), and responsiveness of the IIEF-15 was sufficient (high quality), but inconsistent (moderate quality) for structural validity, internal consistency, construct validity, and test-retest reliability. Evidence for structural validity, test-retest reliability, construct validity, and criterion validity of the IIEF-5 was sufficient (moderate quality) but indeterminate for internal consistency, measurement error, and responsiveness.

Clinical Implications: Lack of evidence for and evidence not supporting some of the measurement properties of the IIEF-15 and IIEF-5 shows the importance of further research on the validity of these questionnaires in clinical research and clinical practice.

Strengths & Limitations: A strength of the current review is the use of predefined guidelines (COSMIN). A limitation of this review is the use of a precise rather than a sensitive search filter regarding measurement properties to identify studies to be included.

Conclusion: The IIEF requires more research on structural validity (IIEF-15), internal consistency (IIEF-15 and IIEF-5), construct validity (IIEF-15), measurement error (IIEF-15 and IIEF-5), and responsiveness (IIEF-5). The most pressing matter for future research is determining the unidimensionality of the IIEF-5 and the exact factor structure of the IIEF-15. Neijenhuijs KI, Holtmaat K, Aaronson NK, et al. The International Index of Erectile Function (IIEF)-A Systematic Review of Measurement Properties. J Sex Med 2019;16:1078-1091.
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http://dx.doi.org/10.1016/j.jsxm.2019.04.010DOI Listing
July 2019

Psychometric properties of the Dutch-Flemish Patient-Reported Outcomes Measurement Information System Pain Behavior item bank in patients with musculoskeletal complaints.

J Pain 2019 11 9;20(11):1328-1337. Epub 2019 May 9.

Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Epidemiology and Biostatistics, Amsterdam Public Health Research Institute, Amsterdam, the Netherlands.

We studied the psychometric properties of the 39-item v1.1 Dutch-Flemish Patient-Reported Outcomes Measurement Information System Pain Behavior item bank in a sample of 1,602 patients with musculoskeletal complaints. We evaluated the assumptions of the underlying item response theory (IRT) model (unidimensionality and local dependency with confirmatory factor analyses), and monotonicity with scalability coefficients). We studied the IRT model fit of all items and estimated the item parameters of the IRT model. Differential item functioning (DIF) was studied for age and gender, and DIF for language was studied as a measure of cross-cultural validity. Confirmatory factor analyses showed suboptimal fit of a unidimensional model, but a bifactor model showed low risk of bias when a unidimensional model was assumed (Omega H = .92, explained common variance of .70). Fifteen item pairs (2%) were locally dependent. Five items showed poor scalability. All items fitted the IRT model; slope parameters ranged from .60 to 2.00, and threshold parameters from -2.05 to 6.80. One item showed DIF for age, 1 item DIF for gender, and 5 items showed DIF for language, but the impact on total scores was low. Our study shows limitations of the Dutch-Flemish Patient-Reported Outcomes Measurement Information System Pain Behavior item bank when used in a primary care population with musculoskeletal complaints. PERSPECTIVE: We studied the psychometric properties of the Dutch-Flemish Patient-Reported Outcomes Measurement Information System Pain Behavior item bank in a large primary care population of patients with musculoskeletal complaints. It showed that the Pain Behavior item bank has limitations when used in this population.
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http://dx.doi.org/10.1016/j.jpain.2019.05.003DOI Listing
November 2019