COnsensus-based Standards For The Selection Of Health Measurement INstruments Research Articles

How Much Does Presenteeism Change in Response to Interventions or Alterations in Health Status? A Systematic Review and Meta-Analysis Using the COSMIN Methodology.

Purpose The purpose of this study was to estimate the extent to which measures of presenteeism among workers change in response to alterations in health status induced by treatment or natural history. Methods We searched eight databases in August 2020 for studies published since 2012 measuring presenteeism longitudinally. Two independent reviewers screened the titles, abstracts, and full-text articles and performed data extraction. Studies were stratified into longitudinal studies using presenteeism as an outcome and measurement studies designed to test the responsiveness of presenteeism measures. We appraised the methodological quality of the measurement studies using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) risk of bias checklist. Standardized response means (SRMs) for interventional studies where participants reported improvement on anchor measures were quantitatively pooled.Results Our searches returned 2882 results. Eleven measurement studies and 126 longitudinal studies were included. Of the measurement studies (n = 2625 participants), 7 had adequate study quality and 4 studies were deemed doubtful. Anchors and responsiveness methods varied considerably. Our estimate of responsiveness from 5 measurement studies and 4 presenteeism measures is an SRM of 0.85 (95% CI 0.77, 0.92) and Cohen's d of 0.54 (95% CI 0.49, 0.58), translating to an average important change of 17/100. For deterioration, the value is -17/100. Conclusions We found considerable variation regarding how responsiveness data was reported in measurement studies. There is evidence that responsiveness is strong for four presenteeism measures: the Work Productivity Survey, the Work Functioning Impairment Scale, the Work Role Functioning Questionnaire, and the Nurses Work Functioning Questionnaire.

A systematic review of mood and depression measures in people with severe cognitive and communication impairments following acquired brain injury

Aim A systematic review to identify which mood and depression measures are valid for use with people with severe cognitive and communication impairments following severe acquired brain injury. Method A systematic search of Cochrane, Web of Science, Ovid, and EBSCOhost was performed in March 2020, July 2021, and September 2022. The search focused on self-report and observer-rated assessment tools used to assess mood, depression, and/or distress in those described as having a severe acquired brain injury. Psychometric properties were extracted using the Consensus-based standards for the selection of health measurement instruments (COSMIN) risk of bias checklist. Qualitative synthesis was performed on extracted patient data. Results Nineteen papers detailing the psychometric properties of 25 measures were included, involving 2,914 participants. Nine papers provided details confirming the severity of participants’ cognitive and communication impairments. The remaining papers described including severely injured participants but provided limited details so that precise level of severity could not be confirmed. Only one paper showed evidence of adequate psychometric properties and included those with severe cognitive impairments in a study of two observer-rated measures, the Stroke Aphasia Depression Questionnaire (10 items) and the Aphasia Depression Rating Scale. Conclusions Due to the exclusion of individuals with severe cognitive and communication consequences following brain injury, no studies using self-report measures showed adequate validity evidence to recommend their use in this population. A small study using two observer-rated scales included those with severe cognitive impairments and showed satisfactory evidence that these measures can be validly used with this population.

Quality of the adaptation procedures and psychometric properties of the scale of oral health outcomes for 5-year-old children (SOHO-5): a systematic review.

The aim of this study was to assess the quality of the cross-cultural adaptations and psychometric properties of the Scale of Oral Health Outcomes for 5-year-old children (SOHO-5). A systematic search was performed in three databases, PubMed, SCOPUS, and Dentistry and Oral Science Source (EBSCO). Studies relating to the cross-cultural adaptation and psychometric properties of SOHO-5 were included. The quality of cross-cultural adaptation was assessed in five aspects including translation, synthesis, back-translation, expert committee review, and pretesting. The Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) checklist was used to assess the psychometric properties in seven domains including responsiveness, internal consistency, reliability, measurement error, and structural, construct, and cross-cultural validity. The search identified 162 papers for screening; from these, 107 articles and 9 systematic reviews were excluded. 21 full papers were retrieved and 6 studies that met the inclusion criteria were included. Out of six, two reported all five aspects of cross-cultural adaptation procedures. Regarding the psychometric properties, none of the studies evaluated all aspects of psychometric properties. Almost all of the studies reported internal consistency (Cronbach's alpha ranging from 0.71 to 0.90), test-retest reliability (Intraclass Correlation Coefficient 0.46-0.98), and construct validity. None reported the cross-cultural validity and responsiveness of the measures. While these studies provided satisfactory results regarding the validity and reliability of SOHO-5, the majority of the included studies did not report all domains of the cross-cultural adaptations and psychometric properties. Overall, the quality of the cross-cultural adaptations and psychometric properties of the included studies is doubtful. Future research should follow the guidelines to assess all aspects of psychometric properties and adaptation procedures in cross-cultural settings.

Rating Scales for Medication Adherence in Parkinson's Disease: A Systematic Review for Critique and Recommendations.

Behaviors interfering with medication adherence (MA) are common and often complex in Parkinson's disease (PD), negatively affecting quality of life and undermining the value of clinical trials. The Clinical Outcome Assessments (COA) Scientific Evaluation Committee of the International Parkinson and Movement Disorder Society (MDS) commissioned the assessment of MA rating scales to recommend the use in PD. Critically review the measurement properties of rating scales used to assess MA in PD and to issue recommendations. We conducted systematic review across seven databases to identify structured scales to assess MA in PD. Eligible studies were critically appraised for methodological quality using the Consensus-based Standards for the Selection of Health Measurement Instruments (COSMIN) Risk of Bias checklist. Standards for good measurement properties of the selected scales were summarized narratively using the COSMIN, the MDS-COA Committee methodology, the World Health Organization concepts, and the Ascertaining Barriers to Compliance taxonomy. The certainty of the evidence was determined using the modified Grades of Recommendation, Assessment, Development and Evaluation approach with final assessments (highest to lowest) of "Recommended," "Suggested" and "Listed". Of the nine reviewed scales, none met the designation "Recommended". The Morisky Medication Adherence Scale (MMAS-8); Beliefs Related to Medications Adherence questionnaire, Beliefs about Medication Questionnaire, Medication Adherence Rating Scale, and Satisfaction with Information on Medicines Scale were rated "Suggested". We suggest further work focusing on resolving the problems of the suggested scales or developing a new scale meeting all required criteria.

Psychometric properties of the sit-to-stand test for patients with pulmonary hypertension: A systematic review protocol.

BackgroundPulmonary hypertension (PH) is a complex syndrome characterized by increased pulmonary arterial pressure and classified into five groups, according to dyspnea on exertion and systemic muscle dysfunction. These symptoms can be identified using the sit-to-stand test (STS), which indirectly evaluates exercise tolerance and lower limb muscle strength. Previous studies used the STS in PH; however, psychometric properties to understand and validate this test were not described for patients with PH.ObjectiveTo evaluate the psychometric properties (validity, reliability, and responsiveness) of different STS protocols in patients with PH.Methods and analysesThis is a systematic review protocol that will include studies using STS in patients with PH. Searches will be conducted on PubMed/MEDLINE, EMBASE, SciELO, Cochrane Central Register of Controlled Trials (CENTRAL), and Web of Science databases following PICOT mnemonic strategy and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P). Rayyan software will be used for study selection. The Risk of bias will be assessed using the Consensus‐Based Standards for the Selection of Health Measurement Instruments (COSMIN) tool, while the quality of evidence will be assessed using the modified Grading of Recommendations, Assessment, Development, and Evaluation (GRADE). Two researchers will independently conduct the study, and a third researcher will be consulted in case of disagreement. The psychometric properties will be evaluated according to the COSMIN. This protocol was registered in the International Prospective Register of Systematic Reviews (PROSPERO, no. CRD42021244271).ConclusionThis systematic review will attempt to identify and show the available evidence on STS for different groups of PH and report validity, reliability, and responsiveness of different protocols.

Measuring negative emotional responses to climate change among young people in survey research: a systematic review protocol

IntroductionMany young people report experiencing negative emotional responses to their awareness of climate change and the threats it poses to their future. With that, an increasing number of survey instruments...

EHealth literacy measurement tools: a systematic review protocol

BackgroundImproving eHealth literacy (eHL) is one of the biggest challenges currently facing the global healthcare community. Indeed the use of digital services has the potential to engage patients in care as well as improve the effectiveness of chronic disease self-management, it remains highly dependent on a patient’s specific skills and experiences in the health care systems. Although eHealth literacy has gained momentum in the past decade, it remains an underresearched area, particularly eHealth literacy measurement. The aim of the review is to identify patient-reported outcome measures (PROMs) of eHealth literacy for adult populations and to summarize the evidence on their psychometric properties.MethodsWe will conduct a systematic literature review of the tools used to measure eHealth literacy for adult population. The search strategy aims to find published studies. A three-step search strategy will be used in this review. Published studies will be searched in CINAHL, PubMed, PsycINFO, and Web of Science from inception until end. Grey literature will be searched to find theses. Database search strategies will be formulated and tested with the assistance of an expert Health Sciences Librarian. The selection of studies will be done by two independent reviewers. Disagreements will be resolved through consensus, and a third reviewer will solve discrepancies. Furthermore, two reviewers will independently evaluate the methodological rigor of the instruments development and testing and assign a grade using the standardized Consensus-based Standards for the Selection of Health Measurement Instruments (COSMIN) checklist. Disagreements will be discussed with a third reviewer, expert in psychometrics.Extracted data will be aggregated and analyzed to produce a set of synthesized findings that will be used to develop evidence-informed recommendations in regard of eHL instruments. We will present a synthesis of all instruments, their psychometric properties, and make recommendations for eHL instrument selection in practice. Reporting will be informed by the Preferred Reporting Items for Systematic Reviews and Meta-Analysis and a PRISMA flow diagram.DiscussionThis systematic review will summarize the evidence on the psychometric properties of PROMs instruments used to measure eHL and will help clinicians, managers, and policy-makers to select an appropriate instrument.Systematic review registrationPROSPERO CRD42021232765

Psychometric Properties of the Hospital Anxiety and Depression Scale in Individuals With Chronic Obstructive Pulmonary Disease: Protocol for a Systematic Review.

BackgroundIn individuals with chronic obstructive pulmonary disease (COPD), anxiety and depression contribute to increased mortality and exacerbations, decreased physical functioning, and deteriorated health-related quality of life. The Hospital Anxiety and Depression Scale (HADS) is a patient-reported tool developed to measure symptoms of anxiety and depression in clinical settings. The HADS has been frequently used with individuals with COPD; however, its measurement properties lack critical appraisal in this population.ObjectiveThis review aims to summarize and critically appraise the validity, reliability, and responsiveness of the HADS in individuals with COPD.MethodsFive electronic databases (MEDLINE, Embase, Scopus, PsychINFO, and Web of Science) will be systematically searched. Articles will be included if they assessed the measurement properties of the HADS in COPD; were published in a peer-reviewed journal; and were written in English. The COSMIN (Consensus-based Standards for the Selection of Health Measurement Instruments) guidelines will be used to assess the methodological quality and level of evidence in the selected studies.ResultsTo date, 12 articles met the inclusion criteria and will be included in the systematic review. The results of the psychometric properties of HADS will be qualitatively summarized and compared against the criteria for good measurement properties. The overall quality of evidence will be graded using the modified Grading of Recommendations, Assessment, Development and Evaluation approach. We expect to complete the systematic review by December 2022.ConclusionsThis systematic review will be the first to evaluate the psychometric properties of the HADS in individuals with COPD. Given the negative impact of anxiety and depression on physical functioning and health-related quality of life, this systematic review provides an opportunity to use the HADS as a validated measurement tool for the assessment and treatment of anxiety and depression in individuals with COPD.Trial RegistrationPROSPERO CRD42022302064; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=302064International Registered Report Identifier (IRRID)PRR1-10.2196/37854

Patient-Reported Outcome Measures in Cardiovascular Disease: An Evidence Map of the Psychometric Properties of Health Status Instruments.

Patient-reported outcomes (PROs) are important measures of treatment effect and can be used to inform the approval of cardiovascular drugs and devices by the U.S. Food and Drug Administration (FDA). To catalogue the health status patient-reported outcome measures (PROMs) validated in cardiovascular diseases (CVDs), describe their psychometric properties, and assess adherence with both FDA recommendations and the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) framework. MEDLINE, EMBASE, CINAHL, and Allied and Complementary Medicine Database from inception to August 2022. Studies that developed and/or validated health status PROMs in CVD populations. Two study authors extracted data on CVD type, PROM psychometric properties, and adherence to FDA recommendations. The risk of bias informing the development or validation of PROMs was assessed using the COSMIN framework. Fifty health status PROMs (described in 83 studies) were identified, of which 45 were disease specific and 5 were generic. Eleven (22%) of the 50 PROMs validated in CVDs had minimally important differences (MIDs) established, and 8 (16%) reported on the validation of all psychometric properties recommended by the FDA. By COSMIN standards, only 2 PROMs (4%) had all of their psychometric properties rated as sufficient in quality, and 32 PROMs (64%) had less than 50% of psychometric properties rated as sufficient. The quality of reporting varied across included studies. Of 50 PROMs validated in CVDs, only a small minority reported on the validation of all FDA-recommended psychometric properties, had psychometric properties rated as sufficient by COSMIN, or had MIDs established. Given the use of PROMs to guide FDA approvals of drugs and devices in CVDs, there is a need for better adherence to quality standards in PROM validation. None.

Measurement properties of the HOOS-PS in revision total hip arthroplasty: a validation study on validity, interpretability, and responsiveness in 136 revision hip arthroplasty patients.

Background and purposeTo determine whether the Hip disability and Osteoarthritis Outcome Score-Physical function Short-form (HOOS-PS) is able to appropriately evaluate physical function in revision hip arthroplasty patients, this study assesses psychometric properties of the Dutch HOOS-PS in this patient population.Patients and methodsWe assessed psychometric properties of the HOOS-PS following the Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) criteria. Content validity, including comprehensibility, comprehensiveness, and relevance of the items, was assessed using cognitive debriefing interviews in hip revision patients (n = 8) and orthopedic surgeons specialized in revision surgery (n = 7). Construct validity, responsiveness, and interpretability (floor/ceiling effects) were assessed in revision hip arthroplasty patients (baseline n = 136, follow-up n = 67). We formulated hypotheses a priori to assess construct validity and responsiveness using the EuroQol 5-Dimensions Health Questionnaire, Numeric Rating scale for pain, and Oxford Hip Score as comparators. All questionnaires were measured at baseline and 1 year postoperatively.ResultsWe found insufficient content validity of the HOOS-PS, as relevance and comprehensibility of the items scored < 85% on the COSMIN criteria for revision hip arthroplasty patients. Construct validity was sufficient as all hypotheses were confirmed (≥ 75% COSMIN criteria). Interpretability was sufficient (< 15% COSMIN criteria) and responsiveness was insufficient (< 75% COSMIN criteria).InterpretationThe Dutch HOOS-PS is not able to sufficiently evaluate physical function in revision hip arthroplasty patients. Minor changes in the items are needed for the HOOS-PS to become sufficiently content valid, because the HOOS-PS lacks relevant items and comprehensiveness.

Psychometric properties of performance-based measures of physical function administered via telehealth among people with chronic conditions: A systematic review.

Telehealth could enhance rehabilitation for people with chronic health conditions. This review examined the psychometric properties of performance-based measures of physical function administered via telehealth among people with chronic health conditions using the Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) approach. This systematic review was registered with Prospero (Registration number: CRD42021262547). Four electronic databases were searched up to June 2022. Study quality was evaluated by two independent reviewers using the COSMIN risk of bias checklist. Measurement properties were rated by two independent reviewers in accordance with COSMIN guidance. Results were summarised according to the COSMIN approach and the modified GRADE approach was used to grade quality of the summarised evidence. Five articles met the eligibility criteria. These included patients with Parkinson's Disease (n = 2), stroke (n = 1), cystic fibrosis (n = 1) and chronic heart failure (n = 1). Fifteen performance-based measures of physical function administered via videoconferencing were investigated, spanning measures of functional balance (n = 7), other measures of general functional capacity (n = 4), exercise capacity (n = 2), and functional strength (n = 2). Studies were conducted in Australia (n = 4) and the United States (n = 1). Reliability was reported for twelve measures, with all twelve demonstrating sufficient inter-rater and intra-rater reliability. Criterion validity for all fifteen measures was reported, with eight demonstrating sufficient validity and the remaining seven demonstrating indeterminate validity. No studies reported data on measurement error or responsiveness. Several performance-based measures of physical function across the domains of exercise capacity, strength, balance and general functional capacity may have sufficient reliability and criterion validity when administered via telehealth. However, the evidence is of low-very low quality, reflecting the small number of studies conducted and the small sample sizes included in the studies. Future research is needed to explore the measurement error, responsiveness, interpretability and feasibility of these measures administered via telehealth.

Self-report instruments for measuring patient dignity: A psychometric systematic review.

To synthesize and evaluate the psychometric properties of self-report instruments that measure patient dignity. A psychometric systematic review. A comprehensive search of studies published from inception until February 17, 2022, was performed using PubMed, Embase, CINAHL, Web of Science, and Scopus. The methodological quality of the psychometric studies was evaluated following the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines. Eleven self-report instruments that evaluate dignity were identified. For most instruments, psychometric properties, including reliability, cross-cultural validity, responsiveness, and measurement error, had not been adequately examined. The Patient Dignity Inventory (PDI), the Jacelon's Attributed Dignity Scale (JADS), and the Inpatient Dignity Scale (IPDS) had acceptable content validity, structure validity, and internal consistency to measure dignity among adult patients under palliative care, community-dwelling older adults, and inpatients receiving daily care. The PDI, the JADS, and the IPDS are recommended for future clinical practice and research to measure dignity among adult patients under palliative care, community-dwelling older adults, and inpatients receiving daily care. Early identification of patients' dignity-related problems in nursing care can prevent negative health outcomes and help develop a timely intervention to promote patients' health and recovery. Given that the psychometric properties of the existing self-report dignity instruments have not been systematically assessed, the present review utilized comprehensive methods according to COSMIN to evaluate and determine the most appropriate measure for research and practice. The PDI, the JADS, and the IPDS demonstrated satisfactory psychometric properties and are, thus, recommended for clinical and research applications. Nursing professionals can employ these instruments to assess and promptly identify dignity issues among both young and older adults in hospitals and communities.

P9.48: A Systematic Review of the Use of Patient-Reported Outcome Measures (PROMs) in Adults Undergoing Liver Transplantation

Background: Improved survival rates of liver transplantation (LT) (~80% 5-year survival) has shifted the focus towards reducing symptom burden and improving quality of life, which can be assessed using patient-reported outcome measures (PROMs). This study systematically reviewed measurement properties of PROMs to serve as an evidence base for the selection of suitable PROMs and offer new benchmarks for value-based health-care in LT. Methods: MEDLINE, EMBASE, PubMed and COCHRANE databases were searched for relevant articles. Studies were included if they reported PROMs in LT candidates and/or recipients. Articles including patients <16 years only and clinician-assessed instruments were excluded. The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist was used to asses methodological quality of included studies and measurement properties. Results: The full-texts of 185 out of 2040 studies were reviewed. The Short-Form-36 (SF-36) (n=86 studies) and Hospital Anxiety and Depression Scale (HADS) (n=16 studies) were the most commonly reported generic instruments in this population. Only 15 studies provided original measurement properties for 24 PROMs. Both SF-36 (n=2 studies) and HADS (n=2 studies) showed high quality evidence for sufficient internal consistency (Cronbach’s alpha >7.8 and >7.3, respectively), but indeterminate reliability. The Liver Disease Quality of Life Questionnaire and its short version ((SF-)LDQOL) were the most used disease-specific PROMs reported in LT candidates (n=8 studies), and showed moderate quality evidence for sufficient internal consistency and construct validity in 2 studies. Five individual studies reported newly developed PROMs for LT recipients, often incorporating questions from existing instruments. These showed generally high quality evidence and sufficient internal consistency. Conclusion: In addition to well-established PROMs (SF-36 and HADS), we conclude that the (SF-)LDQOL is the most promising for the detection of disease-specific changes in LT candidates. However, this instrument should be evaluated further for LT recipients.

Conceptualisation and psychometric evaluation of positive psychological outcome measures used in adolescents and young adults living with HIV: a mixed scoping and systematic review protocol

IntroductionSub-Saharan Africa bears the greatest burden of HIV. Concomitant mental disorders are common, necessitating the integration of mental healthcare into routine HIV care. Consequently, it is necessary to holistically evaluate...

Technologies for the Instrumental Evaluation of Physical Function in Persons Affected by Chronic Obstructive Pulmonary Disease: A Systematic Review.

Several systems, sensors, and devices are now available for the instrumental evaluation of physical function in persons with Chronic Obstructive Pulmonary Disease (COPD). We aimed to systematically review the literature about such technologies. The literature search was conducted in all major scientific databases, including articles published between January 2001 and April 2022. Studies reporting measures derived from the instrumental assessment of physical function in individuals with COPD were included and were divided into application and validation studies. The quality of validation studies was assessed with the Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) risk of bias tool. From 8752 articles retrieved, 21 application and 4 validation studies were included in the systematic review. Most application studies employed accelerometers, gait analysis systems, instrumented mattresses, or force plates to evaluate walking. Surface electro-myography or near-infrared spectroscopy were employed in four studies. Validation studies were heterogeneous and presented a risk of bias ranging from inadequate to doubtful. A variety of data regarding physical function can be retrieved from technologies used in COPD studies. However, a general lack of standardization and limitations in study design and sample size hinder the implementation of the instrumental evaluation of function in clinical practice.

A Systematic Review of Psychometric Properties of Knee-Related Outcome Measures Translated, Cross-Culturally Adapted, and Validated in Arabic Language.

During the previous two decades, patient-reported outcome measures (PROMs) have been well tested, and the tools were validated in different languages across the globe. This systematic review aimed to identify the knee disease-specific outcome tools in Arabic and evaluate their methodological quality of psychometric properties of the most promising tools based on the COSMIN checklist and PRISMA guidelines. Articles published in English, from the inception of databases until the date of search (10 August 2022), were included. Articles without at least one psychometric property (reliability, validity, and responsiveness) evaluation, and articles other than in the English language, were excluded from the study. The key terms [“Arabic” AND “Knee” AND (“Questionnaire” OR “Scale”)] were used in three databases, i.e., PubMed, Scopus, and Web of Science (WoS) in the advanced search strategy. Key terms were either in the title or abstract for PubMed. Key words were in the topic (TS) for WoS. COSMIN (COnsensus-based Standards for the selection of health Measurement Instruments) risk of bias checklist was used to evaluate the methodological quality of psychometric properties of the Arabic knee-related outcome measures. A total of 99 articles were identified in PubMed, SCOPUS, and WoS. After passing inclusion and exclusion criteria, 20 articles describing 22 scales from five countries were included in this review. The instruments validated in the Arabic language are Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), knee injury and osteoarthritis outcome score (KOOS), knee outcome survey- activities of daily living scale (KOS-ADLS), Oxford knee score (OKS), anterior knee pain scale, osteoarthritis of knee and hip health-related quality of life (OAKHQoL) scale, Lysholm knee score (LKS), international documentation committee subjective knee form (IKDC), intermittent and constant osteoarthritis pain (ICOAP) questionnaire, Kujala patellofemoral pain scoring system (PFPSS), anterior knee pain scale (AKPS) and osteoarthritis quality of life questionnaire (OAQoL),. All were found to have good test-retest reliability (Intra Correlation Coefficient), internal consistency (Cronbach’s alpha), and construct validity (Visual Analog Scale, Short Form-12, RAND-36, etc.). Of 20 instruments available to assess self-reported knee symptoms and function, 12 were validated in the Saudi Arabian population. Among them, KOS-ADLS is the best PROM to be used in various knee conditions, followed by KOOS and WOMAC. The assessed methodological quality of evidence says that the knee Arabic PROMs are reliable instruments to evaluate knee symptoms/function.

Do Patient-Reported Quality-of-Life (QoL) Scales Provide an Adequate Assessment of Patients with Cryptoglandular Anal Fistulae? A Systematic Review of Measurement Instruments and Their Content Validity.

Background: Cryptoglandular anal fistulae can significantly affect patient quality of life (QoL), making it essential to ensure that any study of fistula treatment assesses the impact on QoL. The aim of this systematic review was to evaluate the content validity of Patient-Reported Outcome Measures (PROMs) that assess QoL in patients with a fistula. Methods: MEDLINE, EMBASE, PsycINFO, and Scopus were searched and studies assessing the content validity of patient-reported QoL measurement instruments, or PROM development studies in patients with cryptoglandular anal fistulae, were included. Data were extracted from eligible studies to determine the instruments’ relevance, comprehensiveness, and comprehensibility, and their quality was assessed according to COnsensus-based Standards for the Selection of health Measurement Instruments (COSMIN). Results: Two PROM development studies were identified, both of which described the development of a disease-specific QoL measurement instrument for patients with cryptoglandular anal fistulae. The overall content validity of these instruments was inconsistent and supported by very low-quality evidence. There were no studies assessing the content validity of established QoL measurement instruments in patients with fistulae. Conclusions: This systematic review could not establish the content validity of the available QoL PROMs for patients with anal fistulae, due either to the absence of designated content validity studies or a lack of comprehensiveness of the available PROMs. This highlights an important gap in the literature that needs to be addressed to ensure high-quality outcome assessment in patients with fistulae.

Investigating the feasibility of recruitment to an observational, quality-of-life study of patients diagnosed with atrial fibrillation (AF) who have experienced a bleed while anticoagulated: EQUAL-AF feasibility study protocol

BackgroundOral anticoagulation therapies (OATs) are often prescribed in conjunction with medications to restore normal heart rate rhythm which can limit the risk of an atrial fibrillation (AF) related stroke and systemic thromboembolism. However, they are associated with the serious side effect of bleeding. Both clinically relevant nonmajor bleeding (CRNMB) and major bleeding while anticoagulated are believed to have a significant impact on patient quality of life (QoL). There is currently limited research into the effect bleeding has on QoL. The aim of this study is to evaluate the feasibility of identifying and recruiting patients diagnosed with AF, who are taking OATs and have recently experienced a bleed and collecting information on their QoL.MethodsWe will recruit a minimum of 50 patients to this cross-sectional, observational study. We will recruit from general practices, secondary care, and through an online AF forum. We will ask participants to complete three validated patient-reported outcome measures (PROMs), EQ5D, AFEQT, and PACT-Q, approximately 4 weeks following a bleed and again 3 months later. We will randomly select a subset of 10 participants (of those who agree to be interviewed) to undergo a structured interview with a member of the research team to explore the impact of bleeding on their QoL and to gain feedback on the three PROMs used. We will undertake a descriptive analysis of the PROMs and demographic data. We will analyse the qualitative interviews thematically to identify key themes.DiscussionWe aim to establish if it is possible to recruit patients and use PROMs to collect information regarding how patient QoL is affected when they experience either a clinically relevant non-major bleed (CRNMB) or major bleed while taking OATs for the management of AF. We will also explore the appropriateness, or otherwise, of the three identified PROMs for assessing quality of life following a bleed.PROMsThree PROMs were selected following a literature review of similar QoL studies and using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist for comparison. A review of the current literature produced no suitable validated PROM to record QoL experiences in patients who have been diagnosed with AF and have experienced a bleed while anticoagulated. As such, the EQ5D, AFEQT, and PACT-Q (part 2) were deemed most appropriate for use in this feasibility study.Trial registrationThe trial has been adopted onto the NIHR Portfolio (ID no. 47771) and registered with www.ClinicalTrials.gov (no. NCT04921176) retrospectively registered in June 2021.

Patient-reported outcome (PRO) instruments for disease severity and quality of life in patients with atopic dermatitis: a systematic review of English and Chinese literature.

BackgroundMany patient-reported outcome (PRO) on disease severity quality of life (QOL) have been developed for atopic dermatitis (AD) patients. However, none of them on the reliability and validity of the instruments was sufficient for their application in clinical studies. The objective of this study is to identify and assess the quality of recently developed PROs for disease severity and QOL in English and Chinese in AD patients.MethodsWe conducted a systematic review of PROs for disease severity and QOL for AD from PubMed, Web of Science, PsycINFO and ERIC (English literatures), and CNKI and Wanfang Data (Chinese literatures) from September 2010 to December 2021 with string including “atopic dermatitis” and “scaling”. All studies were screened by 2 reviewers. After being removed duplications, the studies developed the instruments for the AD patients, were reported by patients, and assessing the disease severity or QOL were included.ResultsTwenty-six instruments were retrieved. Three single-item Numeric Rating Scale (NRS) and 8 multidimensional instruments assessing disease severity and 15 assessing QOL were found to be originally developed in English (n=23) or Chinese (n=3). After full assessment on the reliability and validity, 3 NRS and 9 multidimensional instruments were recommended. The 3 NRS were Peak Pruritus/Itch NRS, Skin Pain NRS and Sleep Disturbance (SD) NRS. The multidimensional instruments for disease severity included the Patient-Oriented Eczema Measure (POEM), the patient oriented-SCORAD (PO-SCORAD), and Atopic Dermatitis Symptom Score (ADSS), and the instruments for QOLs included Infant’s Dermatology Quality of Life Index (IDQOL), Children’s Dermatology Life Quality Index (CDLQI), Atopic Dermatitis Control Tool (ADCT), PROMIS® Itch Questionnaire Mood and Sleep (PIQ-MS), PROMIS-Sleep Disturbance (PROMIS-SD), and PROMIS-Sleep-Related Impairment (PROMIS-SRI) for QOL. However, none of the Chinese PROs either originally developed or adapted were fully validated.DiscussionSingle-item NRS is a complement to multidimensional PROs in assessing the disease severity of AD. Quality of these instruments vary greatly and only a few instruments that meet the Consensus-based Standards for the Selection of Health Measurement Instruments (COSMIN) standards are recommended. Therefore, standardization of PROs is essential for developing new instruments, and for adapting a PRO in other populations with different culture and languages.

Image analysis systems to calculate the surface area of vitiligo lesions: A systematic review of measurement properties.

Several digital image analysis systems have been developed for surface calculation of vitiligo lesions. Critical assessment of their measurement properties is crucial to support evidence-based recommendations on the most suitable instruments and will reveal the need for future research. A systematic review was performed to systematically summarize, compare, and critically assess the measurement properties of digital and analogue analysis systems for surface calculation of vitiligo lesions following the Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) recommendations. Nineteen clinical trials were selected including 25 different instruments. Manual tracing on transparent sheets (contact planimetry) combined with digital measurement or point counting can be considered as the best validated method for the evaluation of target lesions taking into account the skin curvatures. Two-dimensional digital imaging analysis on photographs seems also robust although confirmatory data of different research groups using the same digital instrument in a wide range of skin types are missing. Analysis based on 3D photography is still in its early stage but is promising for whole-body analysis. However, the reported data on the quality of the instruments for surface area calculation of vitiligo lesions were in general rather limited. Therefore, future high-quality validation studies are required also including full body evaluations.