Summary
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.
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).
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.
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.
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.
PROSPERO number CRD42017069539
The clinical assessment of vitiligo involves an estimation of the affected body surface area. The most commonly used method is the “palm of hand 1% rule” as integrated in the Vitiligo Area Scoring ...Index. However, this method can be challenging and time consuming. In this study, we introduce a global Vitiligo Extent Score (VES). In the first part of the study, this measurement instrument was developed and subsequently optimized during a pilot scoring session. In a subsequent stage, the inter- and intrarater reliability of the instrument were tested. Live scoring showed an excellent interrater reliability for the VES (intraclass correlation VES: 0.924 vs. Vitiligo Area Scoring Index: 0.846). Subsequent scoring on pictures was comparable with the live evaluation and demonstrated an excellent intrarater reliability. A high intraclass correlation for the VES (intraclass correlation VES: 0.923 vs. Vitiligo Area Scoring Index: 0.757) was also found in an additional subgroup of patients with extensive vitiligo. Moreover, user-friendliness and timing were scored very favorably. In conclusion, this measurement instrument allows us to monitor accurately and easily the affected body surface area in a standardized way. Moreover, our results provide evidence that the VES can be proposed as a promising tool to measure the vitiligo extent in clinical trials and in daily practice.
The aim of this study was to describe the many ways in which quality of life (QoL) measurement may potentially be advantageous in routine clinical dermatology practice. Thirteen members of the EADV ...Task Force on Quality of Life, eight dermatologists, three health psychologists, one epidemiologist and one pharmacoepidemiologist, independently listed all of the ways they thought this may be advantageous. A total of 108 different ways of using QoL information in clinical practice were suggested (median per participant = 8, range = 4-15), and were classified into 20 descriptive groups. These were sorted into the following five categories: inform clinical decisions, clinician-patient communication, awareness of skin disease burden, informing the consultation and clinical service administration. The wide range of potential benefits identified may not only encourage clinicians to use these measures but also highlights many areas requiring evidence to establish the true value of routine use of QoL measures.
Summary
A major obstacle of evidence‐based clinical decision making is the use of nonstandardized, partly untested outcome measurement instruments. Core Outcome Sets (COSs) are currently developed in ...different medical fields to standardize and improve the selection of outcomes and outcome measurement instruments in clinical trials, in order to pool results of trials or to allow indirect comparison between interventions. A COS is an agreed minimum set of outcomes that should be measured and reported in all clinical trials of a specific disease or trial population. The international, multidisciplinary Cochrane Skin Group Core Outcome Set Initiative (CSG‐COUSIN) aims to develop and implement COSs in dermatology, thus making trial evidence comparable and, herewith, more useful for clinical decision making. The inaugural meeting of CSG‐COUSIN was held on 17–18 March 2015 in Dresden, Germany, as the exclusive theme of the Annual Cochrane Skin Group Meeting. In total, 29 individuals representing a broad mix of different stakeholder groups, professions, skills and perspectives attended. This report provides a description of existing COS initiatives in dermatology, highlights current methodological challenges in COS development, and presents the concept, aims and structure of CSG‐COUSIN.
What's already known about this topic?
Many different outcomes and outcome measurement instruments are used in clinical trials to assess the benefits and harms of treatments.
The use of noncomparable outcome measurement instruments, often with unknown measurement properties, makes the combining of results in systematic reviews difficult.
The inability to compare outcomes across trials hampers evidence‐based recommendations and clinical decision making.
Core Outcome Sets (COSs) have been suggested to standardize the measurement and reporting of study endpoints.
What does this study add?
The theme of the 2015 Annual Cochrane Skin Group Meeting was the initiation of the international, multidisciplinary Cochrane Skin Group Core Outcome Set Initiative (CSG‐COUSIN).
The mission of CSG‐COUSIN is to develop and implement high‐quality COSs in dermatology to make trial evidence comparable and more useful.
The CSG‐COUSIN management team and methods group will develop methodological approaches and standards to optimize the COS development procedure and to guarantee high‐quality recommendations for outcomes and outcome measurement instruments.
Patient-Reported Outcome Measures (PROMs) are important tools to assess outcomes relevant to patients, with Health-Related Quality Of Life (HRQOL) as an important construct to be measured. Many ...different HRQOL PROMs are used in the type 2 diabetes field, however a complete overview of these PROMs is currently lacking. We therefore aimed to systematically describe and classify the content of all PROMs that have specifically been developed or validated to measure (aspects of) HRQOL in people with type 2 diabetes. A literature search was performed in PubMed and EMBASE until 31 December 2021. Studies on the development or validation of a PROM measuring HRQOL, or aspects of HRQOL, in people with type 2 diabetes were included. Title and abstract and full-text screening were conducted by two independent researchers and data extraction was performed independently by one of the researchers. Data were extracted on language in which the PROM was developed, target population, construct(s) being measured, names of (sub)scales and number of items per (sub)scale. In addition, all PROMs and subscales were classified according to specific aspects of HRQOL based on the Wilson & Cleary model (symptom status, functional status, general health perceptions) to aid researchers in PROM selection. In total 220 studies were identified that developed or validated PROMs that measure (aspects of) HRQOL in people with type 2 diabetes. Of the 116 unique HRQOL PROMs, 91 (of the subscales) measured symptom status, 60 measured functional status and 26 measured general health perceptions. In addition, 16 of the PROMs (subscales) measured global quality of life. 61 of the 116 PROMs (subscales) also include characteristics of the individual (e.g. aspects of personality, coping) or environment (e.g. social or financial support) and patient-reported experience measures (PREMs, e.g. measure of a patient's perception of their personal experience of the healthcare they have received, e.g. treatment satisfaction), which are not part of the HRQOL construct. Only 9 of the 116 PROMs measure all aspects of HRQOL based on the Wilson & Cleary model. Finally, 8 of the 116 PROMs stating to measure HRQOL, measured no HRQOL construct. In conclusion, a large number of PROMs are available for people with type 2 diabetes, which intend to measure (aspects of) HRQOL. These PROMs measure a large variety of (sub)constructs, which are not all HRQOL constructs, with a small amount of PROMs not measuring HRQOL at all. There is a need for consensus on which aspects of HRQOL should be measured in people with type 2 diabetes and which PROMs to use in research and daily practice. PROSPERO: CRD42017071012. COMET database:
http://www.comet-initiative.org/studies/details/956
.
Summary
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.
What's already known about this topic?
Patients' satisfaction with treatment is an important indicator of quality of care.
Little is known about patients' satisfaction with treatment of lichen sclerosus (LS).
LS appears to have a negative impact on health‐related quality of life (HRQoL).
What does this study add?
Patients with LS are moderately satisfied with their current treatment.
Patients with LS are least satisfied with the effectiveness of their treatment, but do rate it as most important.
One‐third of patients with LS experience severe impairment of HRQoL (symptoms, emotions and functioning domains of Skindex‐29).
More impairment on the emotions domain and a higher degree of disease severity are both associated with lower satisfaction with treatment.
What are the clinical implications of this work?
To improve dermatological care, we recommend enhancement of doctor–patient communication, information provision and organization.
In daily clinical practice, we recommend recurrently to assess satisfaction and HRQoL in patients with LS, in addition to clinical measures.
Routine measurement of patient‐reported outcomes in daily practice may be facilitated by a web‐based application, but implementation of such an intervention is not self‐evident.
Respond to this article
Linked Comment: Dizon and Chren. Br J Dermatol 2017; 176:1431–1432
Plain language summary available online
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.
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