scholarly journals The German RECAP questionnaire: linguistic validation and cognitive debriefing in German adults with self-reported atopic eczema and parents of affected children

2021 ◽  
Vol 5 (1) ◽  
Author(s):  
Michaela Gabes ◽  
Christina Tischer ◽  
Anne Herrmann ◽  
Laura Howells ◽  
Christian Apfelbacher
Keyword(s):  
Atopic Eczema ◽  
Content Validity ◽  
Qualitative Content Analysis ◽  
Recall Period ◽  
Measurement Properties ◽  
German Population ◽  
German Version ◽  
Health Measurement ◽  
Response Options ◽  
Patient Reported

Abstract Background Recap of atopic eczema (RECAP) is a patient-reported outcome measure (PROM) assessing eczema control. Long-term control of eczema is one of the four core outcome domains for atopic eczema trials. This instrument has been recently developed in the UK. Objective This study aimed to translate the English RECAP into German and test its content validity in a German population with self-reported atopic eczema. Methods A six-step procedure including two forward and one backward translations, two consensus decisions and an expert review was performed to obtain a German version of RECAP. We conducted semi-standardized cognitive interviews with adults with atopic eczema (n = 7) and parents having children affected by this disease (n = 5). A “think-aloud” method was used and aspects of comprehensibility, comprehensiveness and relevance according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) criteria were examined. Interviews were coded using qualitative content analysis. Results No particular linguistic problems were encountered during forward-backward translation. Minor wording changes were made as required. The title was adjusted to a more familiar German term of the disease (which is ‘Neurodermitis’). The recall period was rephrased from ‘over the last week’ to ‘over the last seven days’ since there was a different cultural understanding of the time frame. Regarding content validity, the items of the German RECAP were considered to be comprehensible, comprehensive and relevant for the participants and parents of affected children. The participants understood the instruction and considered the one-week recall period and the response options as appropriate. Conclusions A German version of RECAP that is linguistically equivalent to the original version is now available but further assessment of its measurement properties is needed.

scholarly journals Treatment Outcome Measurement Instruments for Port Wine Stains: A Systematic Review of Their Measurement Properties

Dermatology ◽  
2020 ◽  
pp. 1-17
Author(s):  
M. Ingmar van Raath ◽  
Sandeep Chohan ◽  
Albert Wolkerstorfer ◽  
Chantal M.A.M. van der Horst ◽  
Jacqueline Limpens ◽  
...  
Keyword(s):  
Systematic Review ◽  
Content Validity ◽  
Outcome Measurement ◽  
Measurement Properties ◽  
Minimal Important Change ◽  
Port Wine ◽  
Measurement Instruments ◽  
Health Measurement ◽  
Patient Reported

<b><i>Background:</i></b> A plethora of outcome measurement instruments (OMIs) are being used in port wine stain (PWS) studies. It is currently unclear how valid, responsive, and reliable these are. <b><i>Objectives:</i></b> The aim of this systematic review was to appraise the content validity and other measurement properties of OMIs for PWS treatment to identify the most appropriate instruments and future research priorities. <b><i>Methods:</i></b> This study was performed using the updated Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) methodology and adhered to PRISMA guidelines. Comprehensive searches in Medline and Embase were performed. Studies in which an OMI for PWS patients was developed or its measurement properties were evaluated were included. Two investigators independently extracted data and assessed the quality of included studies and instruments to perform qualitative synthesis of the evidence. <b><i>Results:</i></b> In total, 1,034 articles were screened, and 77 full-text articles were reviewed. A total of 8 studies were included that reported on 6 physician-reported OMIs of clinical improvement and 6 parent- or patient-reported OMIs of life impact, of which 3 for health-related quality of life and 1 for perceived stigmatization. Overall, the quality of OMI development was inadequate (63%) or doubtful (37%). Each instrument has undergone a very limited evaluation in PWS patients. No content validity studies were performed. The quality of evidence for content validity was very low (78%), low (15%), or moderate (7%), with sufficient comprehensibility, mostly sufficient comprehensiveness, and mixed relevance. No studies on responsiveness, minimal important change, and cross-cultural validity were retrieved. There was moderate- to very low-quality evidence for sufficient inter-rater reliability for some clinical PWS OMIs. Internal consistency and measurement error were indeterminate in all studies. <b><i>Conclusions:</i></b> There was insufficient evidence to properly guide outcome selection. Additional assessment of the measurement properties of OMIs is needed, preferentially guided by a core domain set tailored to PWS.

scholarly journals Validation of a menstrual pictogram and a daily bleeding diary for assessment of uterine fibroid treatment efficacy in clinical studies

2020 ◽  
Vol 4 (1) ◽  
Author(s):  
Claudia Haberland ◽  
Anna Filonenko ◽  
Christian Seitz ◽  
Matthias Börner ◽  
Christoph Gerlinger ◽  
...  
Keyword(s):  
Uterine Fibroid ◽  
Full Range ◽  
Intraclass Correlation ◽  
Phase Iii ◽  
Measurement Properties ◽  
Retest Reliability ◽  
Response Options ◽  
Patient Global Impression ◽  
Patient Reported ◽  
Test Retest Reliability

Abstract Background To evaluate the psychometric and measurement properties of two patient-reported outcome instruments, the menstrual pictogram superabsorbent polymer-containing version 3 (MP SAP-c v3) and Uterine Fibroid Daily Bleeding Diary (UF-DBD). Test-retest reliability, criterion, construct validity, responsiveness, missingness and comparability of the MP SAP-c v3 and UF-DBD versus the alkaline hematin (AH) method and a patient global impression of severity (PGI-S) were analyzed in post hoc trial analyses. Results Analyses were based on data from up to 756 patients. The full range of MP SAP-c v3 and UF-DBD response options were used, with score distributions reflecting the cyclic character of the disease. Test-retest reliability of MP SAP-c v3 and UF-DBD scores was supported by acceptable intraclass correlation coefficients when stability was defined by the AH method and Patient Global Impression of Severity (PGI-S) scores (0.80–0.96 and 0.42–0.94, respectively). MP SAP-c v3 and UF-DBD scores demonstrated strong and moderate-to-strong correlations with menstrual blood loss assessed by the AH method. Scores increased in monotonic fashion, with greater disease severities, defined by the AH method and PGI-S scores; differences between groups were mostly statistically significant (P < 0.05). MP SAP-c v3 and UF-DBD were sensitive to changes in disease severity, defined by the AH method and PGI-S. MP SAP-c v3 and UF-DBD showed a lower frequency of missing patient data versus the AH method, and good agreement with the AH method. Conclusions This evidence supports the use of the MP SAP-c v3 and UF-DBD to assess clinical efficacy endpoints in UF phase III studies replacing the AH method.

scholarly journals Apathy Measures in Older Adults and People with Dementia: A Systematic Review of Measurement Properties Using the COSMIN Methodology

2021 ◽  
pp. 1-13
Author(s):  
Clare Burgon ◽  
Sarah Elizabeth Goldberg ◽  
Veronika van der Wardt ◽  
Catherine Brewin ◽  
Rowan H. Harwood
Keyword(s):  
Systematic Review ◽  
Older Adults ◽  
Rating Scale ◽  
Measurement Properties ◽  
Evaluation Procedure ◽  
Measurement Instruments ◽  
Health Measurement ◽  
Eligibility Criteria ◽  
People With Dementia ◽  
Patient Reported

<b><i>Background:</i></b> Apathy is highly prevalent in dementia and is also seen in mild cognitive impairment and the general population. Apathy contributes to failure to undertake daily activities and can lead to health problems or crises. It is therefore important to assess apathy. However, there is currently no gold standard measure of apathy. A comprehensive systematic review of the measurement properties of apathy scales is required. <b><i>Methods:</i></b> A systematic review was registered with PROSPERO (ID: CRD42018094390). MEDLINE, Embase, PsycINFO, and CINAHL were searched for studies that aimed to develop or assess the validity or reliability of an apathy scale in participants over 65 years, living in the community. A systematic review was conducted in line with the COnsensus-based Standards for the selection of health Measurement INstruments procedure for reviewing patient-reported outcome measures. The studies’ risk of bias was assessed, and all relevant measurement properties were assessed for quality. Results were pooled and rated using a modified Grading of Recommendations Assessment, Development, and Evaluation procedure. <b><i>Results:</i></b> Fifty-seven publications regarding 18 measures and 39 variations met the eligibility criteria. The methodological quality of individual studies ranged from inadequate to very good and measurement properties ranged from insufficient to sufficient. Similarly, the overall evidence for measurement properties ranged from very low to high quality. The Apathy Evaluation Scale (AES) and Lille Apathy Rating Scale (LARS) had sufficient content validity, reliability, construct validity, and where applicable, structural validity and internal consistency. <b><i>Conclusion:</i></b> Numerous scales are available to assess apathy, with varying psychometric properties. The AES and LARS are recommended for measuring apathy in older adults and people living with dementia. The apathy dimension of the commonly used Neuropsychiatric Inventory should be limited to screening for apathy.

scholarly journals A systematic review of the measurement properties of patient reported outcome measures used for adults with an ankle fracture

2019 ◽  
Vol 3 (1) ◽  
Author(s):  
Rebecca McKeown ◽  
David R. Ellard ◽  
Abdul-Rasheed Rabiu ◽  
Eleni Karasouli ◽  
Rebecca S. Kearney
Keyword(s):  
Systematic Review ◽  
Construct Validity ◽  
Outcome Measures ◽  
Ankle Fracture ◽  
Methodological Quality ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Measurement Properties ◽  
Health Measurement ◽  
Patient Reported

Abstract Background Ankle fractures are painful and debilitating injuries that pose a significant burden to society and healthcare systems. Patient reported outcome measures (PROMs) are commonly used outcome measures in clinical trials of interventions for ankle fracture but there is little evidence on their validity and reliability. This systematic review aims to identify and appraise evidence for the measurement properties of ankle specific PROMs used in adults with an ankle fracture using Consensus Based Standards for the Selection of Health Measurement Instrument (COSMIN) methodology. Methods We searched MEDLINE, Embase and CINAHL online databases for evidence of measurement properties of ankle specific PROMs. Articles were included if they assessed or described the development of the PROM in adults with ankle fracture. Articles were ineligible if they used the PROM to assess the measurement properties of another instrument. Abstracts without full articles and conference proceedings were ineligible, as were articles that adapted the PROM under evaluation without any formal justification of the changes as part of a cross-cultural validation or translation process. Two reviewers completed the screening. To assess methodological quality we used COSMIN risk of bias checklist and summarised evidence using COSMIN quality criteria and a modified Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Two reviewers assessed the methodological quality and extracted the data for a sample of articles. Results The searches returned a total of 377 articles. From these, six articles were included after application of eligibility criteria. These articles evaluated three PROMs: A-FORM, OMAS and AAOS. The A-FORM had evidence of a robust development process within the patient population, however lacks post-formulation testing. The OMAS showed sufficient levels of reliability, internal consistency and construct validity. The AAOS showed low quality evidence of sufficient construct validity. Conclusions There is insufficient evidence to support the recommendation of a particular PROM for use in adult ankle fracture research based on COSMIN methodology. Further validation of these outcome measures is required in order to ensure PROMs used in this area are sufficiently valid and reliable to assess treatment effects. This would enable high quality, evidenced-based management of adults with ankle fracture.

scholarly journals Patient-Reported Outcome Measures for Post-mastectomy Breast Reconstruction: A Systematic Review of Development and Measurement Properties

2020 ◽  
Vol 28 (1) ◽  
pp. 386-404 ◽  
Author(s):  
C. F. Davies ◽  
R. Macefield ◽  
K. Avery ◽  
J. M. Blazeby ◽  
S. Potter
Keyword(s):  
Systematic Review ◽  
Breast Reconstruction ◽  
Content Validity ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Measurement Properties ◽  
Future Studies ◽  
Patient Reported ◽  
Eortc Qlq

Abstract Background Breast reconstruction (BR) is performed to improve outcomes for patients undergoing mastectomy. A recently developed core outcome set for BR includes six patient-reported outcomes that should be measured and reported in all future studies. It is vital that any instrument used to measure these outcomes as part of a core measurement set be robustly developed and validated so data are reliable and accurate. The aim of this systematic review is to evaluate the development and measurement properties of existing BR patient-reported outcome measures (PROMs) to inform instrument selection for future studies. Methods A PRISMA-compliant systematic review of development and validation studies of BR PROMs was conducted to assess their measurement properties. PROMs with adequate content validity were assessed using three steps: (1) the methodological quality of each identified study was assessed using the COSMIN Risk of Bias checklist; (2) criteria were applied for assessing good measurement properties; and (3) evidence was summarized and the quality of evidence assessed using a modified GRADE approach. Results Fourteen articles reported the development and measurement properties of six PROMs. Of these, only three (BREAST-Q, BRECON-31, and EORTC QLQ-BRECON-23) were considered to have adequate content validity and proceeded to full evaluation. This showed that all three PROMs had been robustly developed and validated and demonstrated adequate quality. Conclusions BREAST-Q, BRECON-31, and EORTC QLQ-BRECON-23 have been well-developed and demonstrate adequate measurement properties. Work with key stakeholders is now needed to generate consensus regarding which PROM should be recommended for inclusion in a core measurement set.

scholarly journals Patient-reported outcome measures in community-acquired pneumonia: a systematic review of application and content validity

2019 ◽  
Vol 6 (1) ◽  
pp. e000398 ◽  
Author(s):  
Melanie Lloyd ◽  
Emily Callander ◽  
Amalia Karahalios ◽  
Lucy Desmond ◽  
Harin Karunajeewa
Keyword(s):  
Outcome Measures ◽  
Content Validity ◽  
Short Form ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Community Acquired Pneumonia ◽  
Current Evidence ◽  
Measurement Instruments ◽  
Health Measurement ◽  
Patient Reported

IntroductionPatient-reported outcome measures (PROMs) are a vital component of patient-centred care. Community-acquired pneumonia (CAP) is a significant contributor to morbidity, mortality and health service costs globally, but there is a lack of consensus regarding PROMs for this condition.MethodsWe searched MEDLINE, EMBASE and Cochrane Collaboration for studies, both interventional and observational, of adult recovery from CAP that applied at least one validated PROM instrument and were published before 31 December 2017. The full text of included studies was examined and data collected on study design, PROM instruments applied, constructs examined and the demographic characteristics of the populations measured. For all CAP-specific PROM instruments identified, content validity was assessed using the COnsensus based Standards for selection of health Measurement INstruments guidelines (COSMIN).ResultsForty-two articles met the inclusion criteria and applied a total of 17 different PROM instruments including five (30%) classified as CAP specific, six (35%) as generic and six (35%) that measured functional performance or were specific to another disease. The 36-Item Short Form Survey (SF-36) was the most commonly used instrument (15 articles). Only one of 11 (9%) patient cohorts assessed using a CAP-specific instrument had a mean age ≥70 years. The CAP-Sym and CAP-BIQ questionnaires had sufficient content validity, though the quality of evidence for all CAP-specific instruments was rated as very low to low.DiscussionPROM instruments used to measure recovery from CAP are inconsistent in constructs measured and have frequently been developed and validated in highly selective patient samples that are not fully representative of the hospitalised CAP population. The overall content validity of all available CAP-specific instruments is unclear, particularly in the context of elderly hospitalised populations. Based on current evidence, generic health instruments are likely to be of greater value for measuring recovery from CAP in this group.

scholarly journals Measurement Properties of Existing Patient-Reported Outcome Measures on Medication Adherence: Systematic Review (Preprint)

2020 ◽  
Author(s):  
Yu Heng Kwan ◽  
Si Dun Weng ◽  
Dionne Hui Fang Loh ◽  
Jie Kie Phang ◽  
Livia Jia Yi Oo ◽  
...  
Keyword(s):  
Systematic Review ◽  
Medication Adherence ◽  
Outcome Measures ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Measurement Properties ◽  
Cochrane Library ◽  
Health Measurement ◽  
Patient Reported ◽  
Adherence Scale

BACKGROUND Medication adherence is essential for improving the health outcomes of patients. Various patient-reported outcome measures (PROMs) have been developed to measure medication adherence in patients. However, no study has summarized the psychometric properties of these PROMs to guide selection for use in clinical practice or research. OBJECTIVE This study aims to evaluate the quality of the PROMs used to measure medication adherence. METHODS This study was guided by the PRISMA (Preferred Reporting Items for Systematic Review and Meta-Analysis) guidelines. Relevant articles were retrieved from the EMBASE, PubMed, Cochrane Library, Web of Science, and CINAHL (Cumulative Index to Nursing and Allied Health Literature) databases. The PROMs were then evaluated based on the COnsensus-based Standards for the selection of health Measurement Instruments (COSMIN) guidelines. RESULTS A total of 121 unique medication adherence PROMs from 214 studies were identified. <i>Hypotheses testing for construct validity</i> and <i>internal consistency</i> were the most frequently assessed measurement properties. PROMs with at least a <i>moderate</i> level of evidence for ≥5 measurement properties include the Adherence Starts with Knowledge 20, Compliance Questionnaire-Rheumatology, General Medication Adherence Scale, Hill-Bone Scale, Immunosuppressant Therapy Barrier Scale, Medication Adherence Reasons Scale (MAR-Scale) revised, 5-item Medication Adherence Rating Scale (MARS-5), 9-item MARS (MARS-9), 4-item Morisky Medication Adherence Scale (MMAS-4), 8-item MMAS (MMAS-8), Self-efficacy for Appropriate Medication Adherence Scale, Satisfaction with Iron Chelation Therapy, Test of Adherence to Inhalers, and questionnaire by Voils. The MAR-Scale revised, MMAS-4, and MMAS-8 have been administered electronically. CONCLUSIONS This study identified 121 PROMs for medication adherence and provided synthesized evidence for the measurement properties of these PROMs. The findings from this study may assist clinicians and researchers in selecting suitable PROMs to assess medication adherence.

Content Validity of the LIMB-Q: A Patient-Reported Outcome Instrument for Lower Extremity Trauma Patients

2020 ◽  
Vol 36 (09) ◽  
pp. 625-633
Author(s):  
Lily R. Mundy ◽  
Anne Klassen ◽  
Amanda R. Sergesketter ◽  
Andrew Jordan Grier ◽  
Matthew J. Carty ◽  
...  
Keyword(s):  
Lower Extremity ◽  
Expert Opinion ◽  
Content Validity ◽  
Clinical Care ◽  
Trauma Patients ◽  
Response Options ◽  
Lower Extremity Trauma ◽  
Outcome Instrument ◽  
Extremity Trauma ◽  
Patient Reported

Abstract Background Limb-threatening lower extremity traumatic injuries can be devastating events with a multifaceted impact on patients. Therefore, evaluating patient-reported outcomes (PROs) in addition to traditional surgical outcomes is important. However, currently available instruments are limited as they were not developed specific to lower extremity trauma patients and lack content validity. The LIMB-Q is being developed as a novel PRO instrument to meet this need, with the goal to measure all relevant concepts and issues impacting amputation and limb-salvage patients after limb-threatening lower extremity trauma. Methods This is a qualitative interview-based study evaluating content validity for the LIMB-Q. Patients aged 18 years and older who underwent amputation, reconstruction, or amputation after failed reconstruction were recruited using purposeful sampling to maximize variability of participant experiences. Expert opinion was solicited from a variety of clinical providers and qualitative researchers internationally. Preliminary items and scales were modified, added, or removed based on participant and expert feedback after each round of participant interviews and expert opinion. Results Twelve patients and 43 experts provided feedback in a total of three rounds, with changes to the preliminary instrument made between each round. One scale was dropped after round one, one scale was added after round two, and only minor changes were needed after round three. Modifications, additions and removal of items, instructions, and response options were made after each round using feedback gathered. Conclusion The LIMB-Q was refined and modified to reflect feedback from patients and experts in the field. Content validity for the LIMB-Q was established. Following a large-scale field test, the LIMB-Q will be ready for use in research and clinical care.

scholarly journals PSYCHOMETRIC PROPERTIES OF MEASUREMENT INSTRUMENTS: CONCEPTUAL BASIS AND EVALUATION METHODS - PART II

2019 ◽  
Vol 28 ◽  
Author(s):  
Maria Elena Echevarría-Guanilo ◽  
Natália Gonçalves ◽  
Priscila Juceli Romanoski
Keyword(s):  
Patient Reported Outcomes ◽  
Theoretical Study ◽  
Criterion Validity ◽  
Measurement Properties ◽  
Measuring Instruments ◽  
Measurement Instruments ◽  
Health Measurement ◽  
Patient Reported ◽  
Selection Of

ABSTRACT Objective: to present and discuss conceptual bases and methods for evaluating the content, construct and criterion validity of self-reported measuring instruments. Method: theoretical study based on the concepts of the Consensus-based Standards for the Selection of Health Measurement Instruments and those evaluated in the Evaluating the Measurement of Patient-Reported Outcomes, which includes concepts of instrument assessment to assess patient-reported outcomes. Results: validity is significant for the methodological quality of an instrument; however, it is a relative criterion, since it depends on the adequacy of the instrument to be measured. There are three different validity measurement properties described in the literature: content, construct and criterion validity. Conclusions: as validity is an important property, it is recommended that it be verified in studies that aimed to develop new scales and in those that adapted and validated for another culture or population.

Sign in / Sign up

Export Citation Format

Share Document