Systematic review and meta-analysis of measurement properties of the Hip disability and Osteoarthritis Outcome Score - Physical Function Shortform (HOOS-PS) and the Knee Injury and Osteoarthritis Outcome Score - Physical Function Shortform (KOOS-PS).

OBJECTIVE: The aim of this systematic review and meta-analysis was to evaluate all evidence on measurement properties of the Hip disability and Osteoarthritis Outcome Score - Physical function Shortform (HOOS-PS) and the Knee Injury and Osteoarthritis Outcome Score - Physical function Shortform (KOOS-PS). DESIGN: This study was conducted according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guideline for systematic reviews of PROMs. MEDLINE, EMBASE, The Cochrane Library, CINAHL and PsychINFO through February 2019 were searched. Eligible studies evaluated patients with hip or knee complaints and described a measurement property, interpretability, feasibility, or the development of either the HOOS-PS or KOOS-PS. RESULTS: Twenty-three studies were included. For both questionnaires, the content validity was found inconsistent and the quality evidence was moderate for a sufficient reliability and high for an insufficient construct validity. The HOOS-PS had a high quality evidence of sufficient structural validity and internal consistency (pooled Cronbach's alpha 0.80; n = 3761) and low quality evidence of sufficient measurement error and indeterminate responsiveness. Concerning the KOOS-PS, the quality evidence was high for an insufficient responsiveness, moderate for an inconsistent structural validity and internal consistency and low for an inconsistent measurement error. CONCLUSIONS: The inconsistent evidence for content validity implies that scores on the HOOS-PS and KOOS-PS may inadequately reflect physical functioning. Furthermore, there is evidence for insufficient construct validity and responsiveness in patients with knee osteoarthritis receiving conservative treatment. Using the HOOS-PS or KOOS-PS as outcome measurement instruments for comparing outcomes, measuring improvements or benchmarking in patients with hip or knee complaints or undergoing arthroplasty should only be done with great caution. REVIEW REGISTRATION: PROSPERO number CRD42017069539.

A systematic review of outcome reporting in laser treatments for dermatological diseases.

The standardization of outcome reporting is crucial for interpretation and comparison of studies related to laser treatment of skin disorders. In collaboration with the Cochrane Skin-Core Outcome Set Initiative (CS-COUSIN), a procedure has been proposed to find consensus on the most important generic outcome domains (what to measure) for implementation in the international Laser TrEAtment in Dermatology (LEAD) registry. As the first step in the development of a generic outcome set for the LEAD registry, we undertook a systematic review to identify outcomes, outcome measurement instruments, methods and definitions reported in recently published literature of laser treatments for skin disorders. A systematic search was conducted and generated a total of 707 papers. We assessed 150 studies including all types of studies involving laser treatments for the skin. Two researchers independently extracted the type, definition and frequency of all outcomes and used outcome measurement instruments. We identified 105 verbatim outcomes that were categorized into eight domains recommended by the COMET framework: appearance, long-term effects, physician and patient-reported physical signs, satisfaction, health-related quality of life, psychological functioning and adverse events. Heterogeneity in outcome reporting (e.g. categories and outcome measurement instruments) was high, and definitions were insufficiently reported. There was a clear under representation of life impact domains, including satisfaction (23%) quality of life (3%) and psychological functioning (1%). Outcome reporting concerning laser treatments for the skin is heterogeneous. Standardized outcomes are needed for improving evidence synthesis. Results of this review will be used in the next step to reach consensus between stakeholders on the outcome domains to be implemented in the LEAD registry.

Performance properties of health-related measurement instruments in whiplash: systematic review protocol.

BACKGROUND: Whiplash is a common traumatic cervical injury which is most often a consequence of rear-end motor vehicle accidents. It has been estimated that up to 50% of the whiplash patients suffer from chronic symptoms, resulting in extensive individual and societal burden. Several measurement instruments are used for initial assessment of whiplash and evaluation of response to treatment. However, a comprehensive assessment of the performance of these measures is lacking. Furthermore, there is no consensus on the most relevant outcome domains and their corresponding measurement instruments of choice. This systematic review aims to identify, describe, and critically appraise the performance properties of health-related measurement instruments in whiplash population. METHODS: The following literature databases will be searched from their date of establishment: PubMed, Embase®, MEDLINE, CINAHL Complete, PsycINFO, and HAPI. All original articles evaluating the reliability, validity, responsiveness, and feasibility of health-related measurement instruments in whiplash will be included, without additional restriction on their intended use, source of data, and structure. Risk of bias will be assessed using the COSMIN Risk of Bias checklist. Findings of the studies will be judged against the criteria for good measurement properties, and results from all studies will be qualitatively summarized to generate an overall quality of findings. Overall quality of evidence will be determined using a modified GRADE approach, which will be used in conjunction with the overall quality of results for generation of recommendations. Two reviewers will perform all steps of the review independently. Discrepancies will be discussed between the reviewers, and in case of remaining disagreement, the senior reviewer will make the final decision. DISCUSSION: This systematic review will summarize the body of literature on health-related measurement instruments in whiplash, aiming to facilitate the selection of high-quality measurement instrument for researchers and physicians. Findings of this study will guide the ongoing efforts for development of a core outcome set. SYSTEMATIC REVIEW REGISTRATION: PROSPERO reference number CRD42018070901.

Clinical visible signs of disease activity in vitiligo: a systematic review and meta-analysis.

Vitiligo is an unpredictable depigmenting disorder for which a static method to assess disease activity is lacking. Presence of certain skin manifestations may be indicative of disease activity. Here, we evaluated the current evidence for an association between clinical signs and reported disease activity in vitiligo. A systematic review and meta-analysis was performed based on a search in PubMed, Embase and Cochrane Library. Literature reporting skin manifestations and disease activity was analysed based on descriptive analyses and, if applicable, odd ratios. Forty-six observational studies were selected and analysed, including 28 case reports. Reported clinical signs in relation to active vitiligo were as follows: Koebner's phenomenon, confetti-like depigmentations, tri- and hypochromic lesions (including poorly defined borders), inflammatory borders/areas, itch and leukotrichia. Based on this search, strong evidence was found for Koebner's phenomenon. Poorly defined borders and confetti lesions are potential markers, although more data are needed to confirm this. Evidence for other skin manifestations was inconclusive, whereas case reports on inflammatory borders were indicative of active disease. Limitations included the lack of randomized controlled trials, large-scale prospective studies and heterogeneity due to inconsistent definitions. This systematic review urges the vitiligo community to come forward with consensus-based definitions as well as a reliable scoring system to assess these clinical signs and to design optimal trials to investigate their true predictive value.

The OARSI core set of performance-based measures for knee osteoarthritis is reliable but not valid and responsive.

PURPOSE: The Osteoarthritis Research Society International has identified a core set of performance-based tests of physical function for use in people with knee osteoarthritis (OA). The core set consists of the 30-second chair stand test (30-s CST), 4 × 10 m fast-paced walk test (40 m FPWT) and a stair climb test. The aim of this study was to evaluate the reliability, validity and responsiveness of these performance-based measures to assess the ability to measure physical function in knee OA patients. METHODS: A prospective cohort study of 85 knee OA patients indicated for total knee arthroplasty (TKA) was performed. Construct validity and responsiveness were assessed by testing of predefined hypotheses. A subgroup (n = 30) underwent test-retest measurements for reliability analysis. The Oxford Knee Score, Knee injury and Osteoarthritis Outcome Score-Physical Function Short Form, pain during activity score and knee extensor strength were used as comparator instruments. Measurements were obtained at baseline and 12 months after TKA. RESULTS: Appropriate test-retest reliability was found for all three tests. Intraclass correlation coefficient (ICC) for the 30-s CST was 0.90 (95% CI 0.68; 0.96), 40 m FPWT 0.93 (0.85; 0.96) and for the 10-step stair climb test (10-step SCT) 0.94 (0.89; 0.97). Adequate construct validity could not be confirmed for the three tests. For the 30-s CST, 42% of the predefined hypotheses were confirmed; for the 40 m FPWT, 27% and for the 10-step SCT 36% were confirmed. The 40 m FPWT was found to be responsive with 75% of predefined hypothesis confirmed, whereas the responsiveness for the other tests could not be confirmed. For the 30 s CST and 10-step SCT, only 50% of hypotheses were confirmed. CONCLUSIONS: The three performance-based tests had good reliability, but poor construct validity and responsiveness in the assessment of function for the domains sit-to-stand movement, walking short distances and stair negotiation. The findings of the present study do not justify their use for clinical practice. LEVEL OF EVIDENCE: Level 1. Diagnostic study.

Reference method for digital surface measurement of target lesions in vitiligo: a comparative analysis.

BACKGROUND: Objective measurement of target lesions in vitiligo is important for clinical practice and trials, yet no preferred tool has been defined. Reported digital tools have shortcomings related to feasibility aspects and often lack information on validity, reliability and responsiveness. Moreover, studies are not yet based on ultraviolet (UV) photography. OBJECTIVES: To assess the reliability, validity and feasibility of two functions in ImageJ for measurement of target lesions, based on three different types of images including UV pictures. METHODS: Planimetric measurements were performed on photographs with and without UV, and lesion contours on transparent sheets of 52 vitiligo lesions from 10 patients with vitiligo. The ImageJ functions 'wand' and 'threshold' were used by three and four assessors, respectively. Inter- and intrarater reliability, hypothesis testing for construct validity, and feasibility were evaluated. RESULTS: The inter- and intrarater reliability for the 'wand' and 'threshold' functions were excellent [intraclass correlation coefficient (ICC) > 0·9] for measurement on pictures (with or without UV). The highest agreement (ICC > 0·95) and lowest variance were obtained for measurements on transparent sheets. All four hypotheses for construct validity were confirmed for all measurements. Overall, all measurement methods scored satisfactorily for user-friendliness. However, measurements on transparent sheets were preferred and the completion time was significantly faster. CONCLUSIONS: This study confirmed the reliability, validity and feasibility of two functions in ImageJ to measure target lesions in vitiligo. Based on the feasibility and included three-dimensional aspects, transparent sheets measured with the ImageJ 'wand' function can be proposed for future trials as a reference method to investigate the criterion validity of other digital instruments.

Recommendations on the most suitable quality-of-life measurement instruments for bariatric and body contouring surgery: a systematic review.

OBJECTIVE: The objective of this study is to systematically assess the quality of existing patient-reported outcome measures developed and/or validated for Quality of Life measurement in bariatric surgery (BS) and body contouring surgery (BCS). METHODS: We conducted a systematic literature search in PubMed, EMBASE, PsycINFO, CINAHL, Cochrane Database Systematic Reviews and CENTRAL identifying studies on measurement properties of BS and BCS Quality of Life instruments. For all eligible studies, we evaluated the methodological quality of the studies by using the COnsensus-based Standards for the selection of health Measurement INstruments checklist and the quality of the measurement instruments by applying quality criteria. Four degrees of recommendation were assigned to validated instruments (A-D). RESULTS: Out of 4,354 articles, a total of 26 articles describing 24 instruments were included. No instrument met all requirements (category A). Seven instruments have the potential to be recommended depending on further validation studies (category B). Of these seven, the BODY-Q has the strongest evidence for content validity in BS and BCS. Two instruments had poor quality in at least one required quality criterion (category C). Fifteen instruments were minimally validated (category D). CONCLUSION: The BODY-Q, developed for BS and BCS, possessed the strongest evidence for quality of measurement properties and has the potential to be recommended in future clinical trials.

Report from the fifth international consensus meeting to harmonize core outcome measures for atopic eczema/dermatitis clinical trials (HOME initiative).

This is the report from the fifth meeting of the Harmonising Outcome Measures for Eczema initiative (HOME V). The meeting was held on 12-14 June 2017 in Nantes, France, with 81 participants. The main aims of the meeting were (i) to achieve consensus over the definition of the core domain of long-term control and how to measure it and (ii) to prioritize future areas of research for the measurement of the core domain of quality of life (QoL) in children. Moderated whole-group and small-group consensus discussions were informed by presentations of qualitative studies, systematic reviews and validation studies. Small-group allocations were performed a priori to ensure that each group included different stakeholders from a variety of geographical regions. Anonymous whole-group voting was carried out using handheld electronic voting pads according to predefined consensus rules. It was agreed by consensus that the long-term control domain should include signs, symptoms, quality of life and a patient global instrument. The group agreed that itch intensity should be measured when assessing long-term control of eczema in addition to the frequency of itch captured by the symptoms domain. There was no recommendation of an instrument for the core outcome domain of quality of life in children, but existing instruments were assessed for face validity and feasibility, and future work that will facilitate the recommendation of an instrument was agreed upon.

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.

Variation in the diagnosis and clinical management of lentigo maligna across Europe: a survey study among European Association of Dermatologists and Venereologists members.

BACKGROUND: Lentigo maligna (LM), a form of melanoma in situ, is treated to prevent progression to lentigo maligna melanoma (LMM). Surgical treatment is the gold standard. However, treatment guidelines are based on expert opinion, and comparative studies are lacking. OBJECTIVE: The objective of this study was to assess the diagnostic methods and clinical management of LM patients among European dermatologists and residents. METHODS: A survey consisting of 29 questions about diagnostic methods and treatment options used for LM patients was sent to 3308 members of the European Association of Dermatologists and Venereologists (EADV). RESULTS: Most questions were multiple choice, and multiple answers could be ticked per question. A total of N = 415 (12.5%) completed surveys were included in the analyses. A combination of clinical diagnosis (65.7%), dermatoscopy (83.4%) and histopathology (88.2%) is used by most respondents to diagnose LM. Tissue for histopathological evaluation was collected most often using a single punch biopsy in 61.0%. The most common treatment for LM patients <60 years of age is surgery (97.6%). For LM patients >70 years of age, 66.8% of the respondents preferred surgical treatment. Non-surgical options such as radiotherapy (17.0%), topical imiquimod (30.6%), watchful waiting (19.6%) or cryotherapy (20.4%) were used in this elderly group. Subanalysis showed that respondents who take into account patient preference used topical imiquimod, radiotherapy and watchful waiting more often. CONCLUSION: In conclusion, the results of this survey show that there is a variance in the diagnostic methods and treatment modalities used for LM across Europe. Surgery remains the most utilized option. However, non-surgical options, such as topical imiquimod and radiotherapy, are most often used for elderly patients. We recommend that future studies focus on patient preference and compare surgical to non-surgical therapy.

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.

Interrater and intrarater agreement of confocal microscopy imaging in diagnosing and subtyping basal cell carcinoma.

BACKGROUND: Reflectance confocal microscopy (RCM) imaging can be used to diagnose and subtype basal cell carcinoma (BCC) but relies on individual morphologic pattern recognition that might vary among users. OBJECTIVES: We assessed the inter-rater and intrarater agreement of RCM in correctly diagnosing and subtyping BCC. METHODS: In this prospective study, we evaluated the inter-rater and intrarater agreement of RCM on BCC presence and subtype among three raters with varying experience who independently assessed static images of 48 RCM cases twice with four-week interval (T1 and T2). Histopathologic confirmation of presence and subtype of BCC from surgical excision specimen was defined as the reference standard. RESULTS: The inter-rater agreement of RCM for BCC presence showed an agreement of 82% at T1 and 84% at T2. The agreements for subtyping BCC were lower (52% for T1 and 47% for T2). The intrarater agreement of RCM for BCC presence showed an observed agreement that varied from 79% to 92%. The observed agreements for subtyping varied from 56% to 71%. CONCLUSIONS: In conclusion, our results show that RCM is reliable in correctly diagnosing BCC based on the assessment of static RCM images. RCM could potentially play an important role in BCC management if accurate subtyping will be achieved. Therefore, future clinical studies on reliability and specific RCM features for BCC subtypes are required.

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.

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.

A systematic review on the role of imiquimod in lentigo maligna and lentigo maligna melanoma: need for standardization of treatment schedule and outcome measures.

Lentigo maligna (LM) is an in situ variant of melanoma. Our objective was to systematically review clinical and histological clearance and recurrence rates of imiquimod treatment of LM with emphasis on progression to lentigo maligna melanoma (LMM). PubMed, EMBASE and the Cochrane library were searched from inception to May 2015. Articles were included if they described histologically proven LM treated with imiquimod 5% monotherapy or combined with another topical therapy. Analysed outcomes were clinical and histological clearance, recurrence rates and number of LMM. The quality was assessed using the GRADE-like checklist, and results were reported according to the PRISMA Statement. Twenty-six case reports, 11 retrospective studies, three prospective studies and one randomized controlled trial were included. One case report of poor quality was excluded. Complete clinical clearance was seen in 369 of 471 patients (78.3%). Histological clearance was present in 285 of 370 (77%) patients. LMM was diagnosed in nine (1.8%) patients 3.9 months (range 0-11 months) post-treatment. Univariate multinominal logistic regression showed that 6-7 applications/week had a 6.47 greater odds (P = 0.017) of resulting in complete clinical clearance compared to 1-4 applications/week. An intensity of 6-7 applications/week showed a 8.85 greater odds (P = 0.003) of resulting in histological clearance compared to 1-4 applications. Applying imiquimod >60 times during a treatment period of 12 weeks (range 4-36) showed a 7.75 greater odds (P = 0.001) of resulting in histological clearance compared to <60 total applications. In conclusion, a treatment schedule using imiquimod 6-7 applications per week, with at least 60 applications, shows the greatest odds of complete clinical and histological clearance of LM. Imiquimod is an option for patients unfit for or not willing to undergo surgery or radiotherapy. Nine cases of LM progressed to LMM shortly after treatment. Our hypothesis is that these LMM may have been present before starting imiquimod.

Patients with lichen sclerosus experience moderate satisfaction with treatment and impairment of quality of life: results of a cross-sectional study.

BACKGROUND: Although they are considered relevant, little is known about satisfaction with treatment and health-related quality of life (HRQoL) among patients with lichen sclerosus (LS). OBJECTIVES: In a cross-sectional study, we aimed to examine (i) satisfaction with treatment, (ii) patient characteristics associated with satisfaction and (iii) HRQoL in Dutch patients with LS. METHODS: Members of the Dutch LS Patient Association (n = 750) were invited to complete a web-based survey. We measured satisfaction with treatment with a study-specific questionnaire, and HRQoL with the Skindex-29. We calculated domain scores for symptoms, emotions and functioning, and categorized scores into little, mildly, moderately or severely impaired HRQoL. We used a multiple linear regression analysis to examine whether patient characteristics were associated with treatment satisfaction. RESULTS: In total 303 patients (40·4%) were included. Patients under current treatment (n = 265, 87·5%) were moderately satisfied with their treatment. Patients rated 'treatment effectiveness' as most important, although 58 (22%) were dissatisfied with the effectiveness of their current treatment. More impairment on the HRQoL emotions domain and a higher degree of disease severity were both associated with lower satisfaction with treatment and explained in total 13·5% of the variance in treatment satisfaction. On all HRQoL domains, one-third of the patients (range 34·7-38·9%) reported severe impairment. CONCLUSIONS: Patients with LS are moderately satisfied with their treatment, and one-third of patients experience severe impairment of HRQoL. To improve dermatological care, we recommend enhancement of doctor-patient communication, information provision and organization, which may be more amenable to change than treatment effectiveness or safety.