The patient-reported outcomes measurement information systems (PROMIS®) physical function and its derivative measures in adults: a systematic review of content validity.

PURPOSE: This study aims to systematically review and critically appraise the content validity of the adult versions of the Patient-Reported Outcomes Measurement Information System Physical Function (PROMIS-PF) item bank and its derivative measures in any adult population. METHODS: MEDLINE and EMBASE were searched in October 2021 for studies on measurement properties of PROMIS-PF measures in an adult population. Studies were included if the study described the development of a PROMIS-PF measure or investigated its relevance, comprehensiveness, or comprehensibility. Assessment of the methodological quality of eligible studies, rating of results, and summarizing evidence was performed following the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology for assessing content validity. A modified GRADE approach was used to determine the level of evidence. RESULTS: Three development studies and eight studies on the content validity of one or more of the PROMIS-PF measures were identified. The methodological quality of most studies was rated doubtful. There was low to high level evidence for sufficient relevance, comprehensiveness, and comprehensibility of most PROMIS-PF measures for healthy seniors and various disease populations. We found low to moderate level evidence for insufficient relevance of PROMIS-PF measures for patients with conditions that affected only one body part, and insufficient comprehensibility of the PROMIS-PF measures for minority elderly. CONCLUSION: Most PROMIS-PF measures demonstrate sufficient content validity in healthy seniors and various disease populations. However, the quality of this evidence is generally low to moderate, due to limitations in the methodological quality of the studies.

Dutch-Flemish translation and cross-cultural adaption of the Spinal Cord Injury-Quality of Life (SCI-QOL) short forms.

PURPOSE: A spinal cord injury (SCI) has a large impact on a person's physical, psychological, and social health. Previous studies focused on physical recovery in patients with SCI and assessed their health-related quality of life (HRQOL) with general questionnaires, which often contain irrelevant questions. The SCI-QOL questionnaire was developed to specifically assess the HRQOL of the SCI population. A comprehensive translation and cross-cultural adaptation are required to use this questionnaire in the Netherlands and Flanders, Belgium. METHODS: All 23 short forms of the SCI-QOL for adults were translated from English into Dutch-Flemish using the Functional Assessment of Chronic Illness Therapy translation methodology, with a cognitive debriefing being performed with 10 patients with SCI and 10 persons from the general population. RESULTS: The Dutch-Flemish PROMIS group previously translated 46 of the 207 items in the 23 short forms. Here, we achieved an acceptable translation of the other 161 items. A single Dutch-Flemish translation was obtained for 20 short forms, while separate Dutch and Flemish translations were necessary for the short forms Ambulation, Manual Wheelchair, and Stigma. CONCLUSION: The Dutch-Flemish translation of the SCI-QOL is now available for clinical and research purposes. Future studies should focus on the psychometric properties of this cross-culturally adapted version.

Patient-Reported Outcomes of Yearly Imaging Surveillance in Patients Following Endovascular Aortic Aneurysm Repair.

Little is known about the impact of standardized imaging surveillance on anxiety levels and well-being of patients after endovascular aortic aneurysm repair (EVAR). We hypothesize that patient anxiety levels increase just before receiving the imaging results compared with standard anxiety levels. METHODS: Prospective cohort study from November 2018 to May 2020 including post-EVAR patients visiting the outpatient clinics of 4 Dutch hospitals for imaging follow-up. The Patient-Reported Outcomes Measurement Information System (PROMIS) was used. Patients completed the PROMIS Anxiety v1.0 Short Form (SF) 4a, PROMIS-Global Health Scale v1.2, and PROMIS-Physical Function v1.2 SF8b at 2 time points: prior to the result of the imaging study (T1: pre-visit) and 6-8 months later (T2: reference measurement). Mean T-scores at T1 were compared to T2, and T2 to the general 65+ Dutch population. RESULTS: Altogether 342 invited patients were eligible, 214 completed the first questionnaire, 189 returned 2 completed questionnaires and 128 patients did not participate. Out of 214 respondents, 195 were male (91.1%) and the mean (standard deviation) age was 75.2 (7.0) years. There were no significant differences between T1 and T2 in anxiety levels (0.48; 95% confidence interval[CI] -0.42-1.38), global mental health (0.27; 95% CI -0.79-0.84), global physical health (0.10; 95% CI -0.38-1.18) and physical function (0.53; 95% CI -0.26-1.32). Compared with the 65+ Dutch population, at T2 patients experienced more anxiety (3.8; 95% CI 2.96-5.54), had worse global physical health (-3.2; 95% CI -4.38 - -2.02) and physical function (-2.4; 95% CI -4.00 - -0.80). Global mental health was similar (-1.0; 95% CI -2.21 - 0.21). CONCLUSIONS: Post-EVAR patients do not experience more anxiety just before receiving surveillance imaging results than outside this period, but do suffer from more anxiety and worse physical outcomes than the 65+ Dutch population.

Psychometric properties of the Dutch-Flemish PROMIS® pediatric item banks Anxiety and Depressive Symptoms in a general population.

PURPOSE: This study aims to validate the Dutch-Flemish PROMIS pediatric item banks v2.0 Anxiety and Depressive Symptoms, the short forms 8a, and computerized adaptive tests (CATs) in a general Dutch population and to provide reference data. METHODS: Participants (N = 2,893, aged 8-18), recruited by two internet survey providers, completed both item banks. These item banks were assessed on unidimensionality, local independence, monotonicity, Graded Response Model (GRM) item fit, and differential item functioning (DIF) for gender, age group, region, ethnicity, and language. The short forms and CATs were assessed on reliability and construct validity compared to the Revised Child Anxiety and Depression Scale short version (RCADS-22) subscales. Reference scores were calculated. RESULTS: Both item banks showed sufficient unidimensionality, local independence, monotonicity, and GRM item fit, except for three Depressive Symptoms items that showed insufficient GRM item fit. No DIF was found when using ordinal regression analyses, except for two Depressive Symptoms items that showed DIF for language; all items showed DIF for language when using IRT PRO, except for one Anxiety item. Both short forms and CATs revealed sufficient reliability for moderate and severe levels of anxiety and depression, as well as high positive correlations with corresponding RCADS-22 subscales and slightly lower correlations with non-corresponding RCADS-22 subscales. CONCLUSION: The Dutch-Flemish PROMIS pediatric item banks v2.0 Anxiety and Depressive Symptoms, the short forms 8a and CATs are useful to assess and monitor anxiety and depression in a general population. Reference data are presented.

Translation and content validity of the Dutch Impact of Vision Impairment questionnaire assessed by Three-Step Test-Interviewing.

BACKGROUND: Patients suffering from exsudative retinal diseases may experience severe central vision loss and this might have impact on their daily activities and quality of life. To measure the disabilities these patients may have, the use of the Impact of Vision Impairment Profile questionnaire is recommended. The aim of this study was to translate the original English 28-item Impact of Vision Impairment Profile (IVI) into the Dutch language and evaluate its comprehensibility, comprehensiveness and relevance as evidence of content validity. The translation process was performed using standardized methods. Content validity was assessed by cognitive debriefing using a Three-Step Test-Interview (TSTI) method for participants diagnosed with exudative retinal diseases. Step 1 and 2 focused on assessment of comprehensibility of items, step 3 on comprehensiveness and relevance. Audio-recorded qualitative data was analyzed using Atlas.ti. Data regarding comprehensibility problems was further categorized into item-specific problems and general problems. RESULTS: Few minor discrepancies in wording were found after translation. After conducting 12 cognitive interviews, data saturation was reached. All participants reported comprehensibility problems resulting from specific items, these were; sentence structure, vocabulary and formulation, influence of conditions or composite items and influence of comorbid disorders. Several general comprehensibility problems resulting from instructions or response categories were detected. The main general comprehensibility problem resulted from the layout of the Dutch-IVI. Most participants considered the included items as relevant and indicated that they covered the problems that occur due to vision impairment. CONCLUSIONS: Minor problems in the Dutch translation were detected and adjusted. The layout and instructions of the Dutch-IVI resulted in some comprehensibility problems. The Dutch-IVI appeared to be at risk of being interpreted as a generic patient reported outcome measure, instead of a disease-specific instrument, mainly due to the influence of co-morbidities. Adaptations should improve validity and reliability of the Dutch-IVI, however, cross-cultural comparisons may be at stake.

COSMIN Risk of Bias tool to assess the quality of studies on reliability or measurement error of outcome measurement instruments: a Delphi study.

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

Development of a Patient-Reported Outcomes Measurement Information System (PROMIS®) short form for measuring physical function in geriatric rehabilitation patients.

PURPOSE: To develop and test the validity of a Patient-Reported Outcomes Measurement Information System (PROMIS®) short form for measuring physical function of geriatric rehabilitation patients. METHODS: Experts selected items from the Dutch-Flemish PROMIS v1.2 Physical Function (PROMIS-PF) item bank and proposed new items to develop the PROMIS-PF short form for geriatric rehabilitation (PROMIS-PF-GR). Patients evaluated its content validity. Structural validity was assessed by evaluating unidimensionality (confirmatory, exploratory, and bi-factor analyses [criterion: Omega H > 0.80 and ECV > 0.60]), local independence (criterion: residual correlation < 0.20) ,and monotonicity (criterion: Hi-coefficient ≥ 0.30). Measurement invariance was assessed by evaluating Differential Item Functioning (DIF) between geriatric rehabilitation patients and people from the general population using ordinal logistic regression. Internal consistency was assessed by calculating Cronbach's alpha (criterion: alpha ≥ 0.70). RESULTS: Experts selected 24 items from the PROMIS-PF item bank and proposed one new item which was not included in the short form. Patients considered the 24 items relevant and containing essential information. The PROMIS-PF-GR's psychometric properties were evaluated in 207 patients (mean age ± SD, 80.0 ± 8.3 year; 58% female). The 24 items were found to be sufficiently unidimensional (Omega H = 0.82, ECV = 0.70), locally independent (98.7% item pairs), and monotone (all ≥ 0.32). Five items were flagged for DIF, but their impact on the total score was negligible. Cronbach's alpha was 0.94. CONCLUSION: The PROMIS-PF-GR was developed from the PROMIS-PF and has good content validity, structural validity, measurement invariance, and internal consistency in Dutch geriatric rehabilitation patients. We recommend to confirm the content validity of the PROMIS-PF-GR in other countries.

Graded response model fit, measurement invariance and (comparative) precision of the Dutch-Flemish PROMIS® Upper Extremity V2.0 item bank in patients with upper extremity disorders.

BACKGROUND: The Dutch-Flemish PROMIS® Upper Extremity (DF-PROMIS-UE) V2.0 item bank was recently developed using Item Response Theory (IRT). Unknown for this bank are: (1) if it is legitimate to calculate IRT-based scores for short forms and Computerized Adaptive Tests (CATs), which requires that the items meet the assumptions of and fit the IRT-model (Graded Response Model [GRM]);(2) if it is legitimate to compare (sub) groups of patients using this measure, which requires measurement invariance; and (3) the precision of the estimated patients' scores for patients with different levels of functioning and compared to legacy measures. Aims were to evaluate (1) the assumptions of and fit to the GRM, (2) measurement invariance and (3) (comparative) precision of the DF-PROMIS-UE v2.0. METHODS: Cross-sectional data were collected in Dutch patients with upper extremity disorders. Assessed were IRT-assumptions (unidimensionality [bi-factor analysis], local independence [residual correlations], monotonicity [coefficient H]), GRM item fit, measurement invariance (absence of Differential Item Functioning [DIF] due to age, gender, center, duration, and location of complaints) and precision (standard error of IRT-based scores across levels of functioning). To study measurement invariance for language [Dutch vs. English], additional US data were used. Legacy instruments were the Disability of the Arm, Shoulder and Hand (DASH), the QuickDASH and the Michigan Hand Questionnaire (MHQ). RESULTS: In total 521 Dutch (mean age ± SD = 51 ± 17 years, 49% female) and 246 US patients (mean age ± SD = 48 ± 14 years, 69% female) participated. The DF-PROMIS-UE v2.0 item bank was sufficiently unidimensional (Omega-H = 0.80, Explained Common Variance = 0.68), had negligible local dependence (four out of 1035 correlations > 0.20), good monotonicity (H = 0.63), good GRM fit (no misfitting items) and demonstrated sufficient measurement invariance. Precise estimates (Standard Error < 3.2) were obtained for most patients (7-item short form, 88.5%; standard CAT, 91.3%; and, fixed 7-item CAT, 87.6%). The DASH displayed better reliability than the DF-PROMIS-UE short form and standard CAT, the QuickDASH displayed comparable reliability. The MHQ-ADL displayed better reliability than the DF-PROMIS-UE short form and standard CAT for T-scores between 28 and 50. For patients with low function, the DF-PROMIS-UE measures performed better. CONCLUSIONS: The DF-PROMIS-UE v2.0 item bank showed sufficient psychometric properties in Dutch patients with UE disorders.

Comparison of a video versus paper questionnaire on functional limitation in lower limb osteoarthritis.

INTRODUCTION: The video Animated Activity Questionnaire (AAQ) was developed to assess the impact of lower limb osteoarthritis (OA) on daily functional activities. The objective of the study was to compare the video and the HOOS/KOOS paper questionnaires and to assess the effect of order of administration. MATERIAL AND METHODS: Patients recruited in the KHOALA cohort were randomized in two groups: AAQ questionnaire first (AAQ-first group) and HOOS (hip)/KOOS (knee) questionnaire first (H/KOOS-first group). Within group differences between AAQ and HOOS/KOOS scores were compared using a Student t-test. The Spearman correlation coefficient between AAQ score and HOOS/KOOS score was calculated in each group then compared, using Fisher z-transformation. RESULTS: Among 200 randomized patients, 188 (65.8 years, 66.0% women) completed the questionnaires: 99 in the AAQ-first group and 89 in the H/KOOS-first group. The AAQ score was 85.9 (SD: 13.7) in the AAQ-first versus 87.8 (SD: 13.1) in the H/KOOS-first group (p = 0.34). The H/KOOS score was 72.5 (SD: 21.2) in the AAQ-first versus 73.5 (SD: 18.4) in the H/KOOS-first group (p = 0.71). The Spearman correlation coefficient between AAQ and H/KOOS in the AAQ-first was 0.84[0.77-0.89] and 0.73[0.61-0.81] in H/KOOS-first group. These correlations differed between groups significantly (p = 0.02). CONCLUSION: This study found video AAQ and paper HOOS/KOOS questionnaire highly correlated, with a moderate but significant effect of order administration of video and paper questionnaires evidencing a stronger correlation when the videos were viewed first.

Psychometric properties and norm scores of the sleep self report in Dutch children.

BACKGROUND: Psychometrically robust questionnaires to assess self-reported sleep problems in children are important since sleep problems can have a major impact on child development. The Sleep Self Report (SSR) is a 26-item self-report tool measuring different sleep domains in children aged 7-12 years. This study aims to evaluate the psychometric properties of the SSR and to provide Dutch norm scores. METHODS: Children aged 7-12 years from the general population were recruited through a professional market research agency. In this population, structural validity was assessed with confirmatory and exploratory factor analyses, internal consistency was assessed with the Cronbach's alpha coefficient and norm scores were provided. Additionally, children attending outpatient sleep clinics (clinical population) were invited to participate. SSR scores of the general population and the clinical population were compared to establish discriminative validity. RESULTS: In total, 619 children (mean age: 9.94 ± 1.72 years) from the general population and 34 children (mean age: 9.21 ± 1.63 years) from sleep clinics participated. The 1-factor structure of the SSR was not confirmed with factor analysis. Exploratory analyses did also not yield an appropriate multidimensional structure. Internal consistency of the total score was adequate (Cronbach's alpha: 0.76). The total score distinguished the clinical population from the general population (39.07 ± 5.31 versus 31.61 ± 5.31; P < 0.01). CONCLUSIONS: An appropriate structure of the SSR was not found with factor analyses in this Dutch population. The adequate internal consistency indicates that the total score can be interpreted as a measure of overall sleep problems. The SSR also shows good discriminative validity. We recommend the total score to assess overall sleep problems and item scores to evaluate specific sleep issues and to follow up children's sleep longitudinally, as opposite changes in different item scores may not reflect in the total score. Further research on the development of multidimensional psychometrically sound pediatric sleep self-reports is of major importance.

Validation of two PROMIS item banks for measuring social participation in the Dutch general population.

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

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

OBJECTIVE: The aim of the study was to determine the internal consistency, test-retest reliability and measurement error of the Animated Activity Questionnaire (AAQ) for assessing activity limitations in hip and knee osteoarthritis (HKOA) patients. METHODS: A total of 1,177 patients, from six countries (the Netherlands, UK, France, Denmark, Italy and Spain), completed the AAQ, a questionnaire consisting of videos displaying 17 activities with 3-5 levels of performance, from which patients choose the video that best matches their own performance. Unidimensionality was assessed by means of confirmatory factor analysis (CFA), using the following fit indices: the Tucker-Lewis index (TFI) >0.95, comparative fit index (CFI) >0.95, and root mean square error of approximation (RMSEA) <0.06. Cronbach's alpha was computed. In 238 patients who completed the AAQ twice, the intra-class correlation coefficient (ICC) was calculated for test-retest reliability. The standard error of measurement (SEM) and the smallest detectable change (SDC) were calculated as parameters of measurement error. RESULTS: The fit indices for unidimensionality were CFI 0.957, TLI 0.950, and RMSEA 0.144. Cronbach's alpha was 0.95. ICC for test-retest reliability was 0.93 (95% confidence interval 0.91 to 0.95), ranging from 0.85 to 0.98 across countries. SEM and SDC were 4.9 and 13.6, respectively, on a scale from 0 to 100, and ranging from 2.7 to 6.7, and from 7.5 to 18.4, respectively, across countries. The AAQ appeared to measure slightly more precisely in patients with knee problems and patients without prosthesis. CONCLUSION: The AAQ seemed to be unidimensional, and showed good internal consistency and test-retest reliability. The SDC indicated that changes in scores of at least 14% indicate real improvement in activity limitations.

COSMIN methodology for evaluating the content validity of patient-reported outcome measures: a Delphi study.

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

COSMIN guideline for systematic reviews of patient-reported outcome measures.

PURPOSE: Systematic reviews of patient-reported outcome measures (PROMs) differ from reviews of interventions and diagnostic test accuracy studies and are complex. In fact, conducting a review of one or more PROMs comprises of multiple reviews (i.e., one review for each measurement property of each PROM). In the absence of guidance specifically designed for reviews on measurement properties, our aim was to develop a guideline for conducting systematic reviews of PROMs. METHODS: Based on literature reviews and expert opinions, and in concordance with existing guidelines, the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) steering committee developed a guideline for systematic reviews of PROMs. RESULTS: A consecutive ten-step procedure for conducting a systematic review of PROMs is proposed. Steps 1-4 concern preparing and performing the literature search, and selecting relevant studies. Steps 5-8 concern the evaluation of the quality of the eligible studies, the measurement properties, and the interpretability and feasibility aspects. Steps 9 and 10 concern formulating recommendations and reporting the systematic review. CONCLUSIONS: The COSMIN guideline for systematic reviews of PROMs includes methodology to combine the methodological quality of studies on measurement properties with the quality of the PROM itself (i.e., its measurement properties). This enables reviewers to draw transparent conclusions and making evidence-based recommendations on the quality of PROMs, and supports the evidence-based selection of PROMs for use in research and in clinical practice.

COSMIN Risk of Bias checklist for systematic reviews of Patient-Reported Outcome Measures.

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

Measurement properties of the most commonly used Foot- and Ankle-Specific Questionnaires: the FFI, FAOS and FAAM. A systematic review.

PURPOSE: In the foot and ankle literature, a wide range of patient-reported outcome measures (PROMs) is used, however, consensus as to which PROMs are preferred is lacking. Selection of a PROM is among other reasons, often based on measurement properties without considering the methodological quality of the studies that evaluate these measurement properties. The aim of current study was first to identify the most frequently used foot and ankle-specific PROMs in recent orthopaedic foot and ankle literature, and second to conduct a systematic review to synthesize and critically appraise the measurement properties of these PROMS. METHODS: Six PubMed indexed journals focussing on foot and ankle research were screened to identify most commonly used foot and ankle-specific PROMs over a 2 year period (2015-2016). Subsequently, a systematic literature search was performed in PubMed, EMBASE, SPORTDiscus and Scopus to identify relevant studies on their measurement properties. Methodological quality assessment was performed using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist, criteria for good measurement properties were applied, and a level of evidence was determined for the measurement properties of each domain of the questionnaires. RESULTS: The three most frequently reported PROMs were the Foot Function Index (FFI), the Foot and Ankle Outcome Score (FAOS) and the Foot and Ankle Activity Measure (FAAM). Among 2046 unique citations, 50 studies were included evaluating these PROMs. Evidence to support the measurement properties of the FFI was mainly lacking due to poor methodological quality. More evidence was available for the measurement properties of the FAOS and the FAAM, but overall evidence supporting all measurement properties is not yet sufficient. CONCLUSION: The best available evidence retrieved in this review showed that the FAOS and the FAAM are promising outcome measures for evaluation of patients with foot and ankle conditions, but their shortcomings should be taken into account when interpreting results in clinical setting or trials. LEVEL OF EVIDENCE: I.

Health-related quality of life questionnaires in individuals with haemophilia: a systematic review of their measurement properties.

BACKGROUND: The evaluation of health related quality of life (HRQOL) is essential for a full assessment of the influence of an illness on patients' lives. The aim of this paper is to critically appraise and compare the measurement properties of HRQOL questionnaires studied in haemophilia. METHODS: Bibliographic databases (Embase, Medline, Cinahl and PsycInfo) were searched for articles evaluating measurement properties of HRQOL questionnaires in haemophilia. Articles were excluded that did not report HRQOL measurement properties, or when <50% of the study population had haemophilia. The methodological quality of the selected studies was evaluated using the COSMIN checklist. The measurement properties of the HRQL questionnaires were rated as 'positive', 'indeterminate' or 'negative', accompanied by levels of evidence. RESULTS: The search resulted in 1597 unique hits, of which 22 studies were included. These articles evaluated three questionnaires for children (CHO-KLAT, Haemo-QoL and one unnamed measure) and five for adults (Hemofilia-QoL, Haemophilia Well-Being Index, HAEMO-QoL-A, Haem-A-QoL, and SF-36). The CHO-KLAT was the paediatric measure that showed the strongest measurement properties in high-quality studies. The Haemophilia Well-Being Index and HAEMO-QoL-A performed best among the adult measures. None of the studies reported measurement error and responsiveness. CONCLUSION: Our findings suggest that there is no need for new disease-specific HRQOL questionnaires for haemophilia, but rather that additional research is necessary to document the measurement properties of the currently available questionnaires, specifically focusing on the structural validity, measurement error and responsiveness of these questionnaires.

Evaluation of the measurement properties of symptom measurement instruments for atopic eczema: a systematic review.

BACKGROUND: Symptoms have been identified as a core outcome domain for atopic eczema (AE) trials. Various instruments exist to measure symptoms in AE, but they vary in quality and there is a lack of standardization between clinical trials. Our objective was to systematically evaluate the quality of the evidence on the measurement properties of AE symptom instruments, thereby informing consensus discussions within the Harmonising Outcome Measures for Eczema (HOME) initiative regarding the most appropriate instruments for the core outcome domain symptoms. METHODS: Using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist and predefined criteria for good measurement properties on identified development and validation studies of AE symptom instruments, a best evidence synthesis was performed to draw an overall conclusion on quality of the instruments and to provide recommendations. RESULTS: Eighteen instruments were identified and evaluated. When the quality and results of the studies were considered, only five of these instruments had sufficient validation data to consider them for the core outcome set for the core outcome domain symptoms. These were the paediatric Itch Severity Scale (ISS), Patient-Oriented Eczema Measure (POEM), Patient-Oriented SCOring Atopic Dermatitis (PO-SCORAD), Self-Administered Eczema Area and Severity Index (SA-EASI) and adapted SA-EASI. CONCLUSIONS: ISS (paediatric version), POEM, PO-SCORAD, SA-EASI and adapted SA-EASI are currently the most appropriate instruments and therefore have the potential to be recommended as core symptom instrument in future clinical trials. These findings will be utilized for the development of a core outcome set for AE.