scholarly journals Validity arguments for patient-reported outcomes: justifying the intended interpretation and use of data

2021 ◽  
Vol 5 (1) ◽  
Author(s):  
Melanie Hawkins ◽  
Gerald R. Elsworth ◽  
Sandra Nolte ◽  
Richard H. Osborne
Keyword(s):  
Literature Review ◽  
Patient Reported Outcomes ◽  
Measurement Instrument ◽  
Self Report ◽  
Validity Evidence ◽  
Measurement Instruments ◽  
Validity Testing ◽  
Patient Reported ◽  
Intended Interpretation ◽  
Interpretive Argument

Abstract Background Contrary to common usage in the health sciences, the term “valid” refers not to the properties of a measurement instrument but to the extent to which data-derived inferences are appropriate, meaningful, and useful for intended decision making. The aim of this study was to determine how validity testing theory (the Standards for Educational and Psychological Testing) and methodology (Kane’s argument-based approach to validation) from education and psychology can be applied to validation practices for patient-reported outcomes that are measured by instruments that assess theoretical constructs in health. Methods The Health Literacy Questionnaire (HLQ) was used as an example of a theory-based self-report assessment for the purposes of this study. Kane’s five inferences (scoring, generalisation, extrapolation, theory-based interpretation, and implications) for theoretical constructs were applied to the general interpretive argument for the HLQ. Existing validity evidence for the HLQ was identified and collated (as per the Standards recommendation) through a literature review and mapped to the five inferences. Evaluation of the evidence was not within the scope of this study. Results The general HLQ interpretive argument was built to demonstrate Kane’s five inferences (and associated warrants and assumptions) for theoretical constructs, and which connect raw data to the intended interpretation and use of the data. The literature review identified 11 HLQ articles from which 57 sources of validity evidence were extracted and mapped to the general interpretive argument. Conclusions Kane’s five inferences and associated warrants and assumptions were demonstrated in relation to the HLQ. However, the process developed in this study is likely to be suitable for validation planning for other measurement instruments. Systematic and transparent validation planning and the generation (or, as in this study, collation) of relevant validity evidence supports developers and users of PRO instruments to determine the extent to which inferences about data are appropriate, meaningful and useful (i.e., valid) for intended decisions about the health and care of individuals, groups and populations.

scholarly journals PROPRIEDADES PSICOMÉTRICAS DE INSTRUMENTOS DE MEDIDAS: BASES CONCEITUAIS E MÉTODOS DE AVALIAÇÃO - PARTE I

2018 ◽  
Vol 26 (4) ◽  
Author(s):  
Maria Elena Echevarría-Guanilo ◽  
Natália Gonçalves ◽  
Priscila Juceli Romanoski
Keyword(s):  
Patient Reported Outcomes ◽  
Measurement Instruments ◽  
Health Measurement ◽  
Patient Reported ◽  
Selection Of

RESUMO Objetivo: apresentar e discutir bases conceituais e métodos de avaliações que fundamentam importantes propriedades de instrumentos de medidas. Método: estudo teórico embasado na literatura internacional e nacional e nos instrumentos Consensus-based Standards for the selection of health Measurement Instruments e Evaluating the Measurement of Patient-Reported Outcomes que contemplam conceitos de avaliação de instrumentos para apreciação de resultados relatados pelo paciente. Inicialmente são apresentados e discutidos os conceitos de confiabilidade, responsividade e interpretabilidade, citados exemplos das principais formas de avaliação dessas propriedades. Resultados: pode-se perceber que ainda há divergências em algumas descrições conceituais. Entretanto, os autores ressaltam a importância da confiabilidade para avaliar o instrumento de medida. Destaca-se a importância do conhecimento do Modelo Conceitual, das propriedades de medidas e dos diferentes métodos de avaliação para garantir, principalmente em estudo de validação de instrumentos, resultados confiáveis e válidos. Conclusões: a discussão apresentada sobre a confiabilidade, responsividade e interpretabilidade contribui para os profissionais de saúde no conhecimento teórico e senso crítico na escolha de instrumentos e na condução de análises sobre essas propriedades de medida.

scholarly journals Comparative Effectiveness Study of Home-Based Interventions to Prevent CA-MRSA Infection Recurrence

Antibiotics ◽  
2021 ◽  
Vol 10 (9) ◽  
pp. 1105
Author(s):  
Jonathan N. Tobin ◽  
Suzanne Hower ◽  
Brianna M. D’Orazio ◽  
María Pardos de la Gándara ◽  
Teresa H. Evering ◽  
...  
Keyword(s):  
Staphylococcus Aureus ◽  
Patient Reported Outcomes ◽  
Health Workers ◽  
Home Visits ◽  
Self Report ◽  
Household Member ◽  
Surveillance Culture ◽  
Home Based ◽  
Patient Reported ◽  
Household Members

Recurrent skin and soft tissue infections (SSTI) caused by Community-Associated Methicillin-Resistant Staphylococcus aureus (CA-MRSA) or Methicillin-Sensitive Staphylococcus aureus (CA-MSSA) present treatment challenges. This community-based trial examined the effectiveness of an evidence-based intervention (CDC Guidelines, topical decolonization, surface decontamination) to reduce SSTI recurrence, mitigate household contamination/transmission, and improve patient-reported outcomes. Participants (n = 186) were individuals with confirmed MRSA(+)/MSSA(+) SSTIs and their household members. During home visits; Community Health Workers/Promotoras provided hygiene instructions; a five-day supply of nasal mupirocin; chlorhexidine for body cleansing; and household disinfecting wipes (Experimental; EXP) or Usual Care Control (UC CON) pamphlets. Primary outcome was six-month SSTI recurrence from electronic health records (EHR). Home visits (months 0; 3) and telephone assessments (months 0; 1; 6) collected self-report data. Index patients and participating household members provided surveillance culture swabs. Secondary outcomes included household surface contamination; household member colonization and transmission; quality of life; and satisfaction with care. There were no significant differences in SSTI recurrence between EXP and UC in the intent-to-treat cohort (n = 186) or the enrolled cohort (n = 119). EXP participants showed reduced but non-significant colonization rates. EXP and UC did not differ in household member transmission, contaminated surfaces, or patient-reported outcomes. This intervention did not reduce clinician-reported MRSA/MSSA SSTI recurrence. Taken together with other recent studies that employed more intensive decolonization protocols, it is possible that a promotora-delivered intervention instructing treatment for a longer or repetitive duration may be effective and should be examined by future studies.

scholarly journals Engagement and Participant Experiences With Consumer Smartwatches for Health Research: Longitudinal, Observational Feasibility Study (Preprint)

2019 ◽  
Author(s):  
Anna L Beukenhorst ◽  
Kelly Howells ◽  
Louise Cook ◽  
John McBeth ◽  
Terence W O'Neill ◽  
...  
Keyword(s):  
Data Collection ◽  
Knee Osteoarthritis ◽  
Patient Reported Outcomes ◽  
Health Data ◽  
Self Report ◽  
Sensor Data ◽  
Battery Life ◽  
Activity Data ◽  
Technical Problems ◽  
Patient Reported

BACKGROUND Wearables provide opportunities for frequent health data collection and symptom monitoring. The feasibility of using consumer cellular smartwatches to provide information both on symptoms and contemporary sensor data has not yet been investigated. OBJECTIVE This study aimed to investigate the feasibility and acceptability of using cellular smartwatches to capture multiple patient-reported outcomes per day alongside continuous physical activity data over a 3-month period in people living with knee osteoarthritis (OA). METHODS For the KOALAP (Knee OsteoArthritis: Linking Activity and Pain) study, a novel cellular smartwatch app for health data collection was developed. Participants (age ≥50 years; self-diagnosed knee OA) received a smartwatch (Huawei Watch 2) with the KOALAP app. When worn, the watch collected sensor data and prompted participants to self-report outcomes multiple times per day. Participants were invited for a baseline and follow-up interview to discuss their motivations and experiences. Engagement with the watch was measured using daily watch wear time and the percentage completion of watch questions. Interview transcripts were analyzed using grounded thematic analysis. RESULTS A total of 26 people participated in the study. Good use and engagement were observed over 3 months: most participants wore the watch on 75% (68/90) of days or more, for a median of 11 hours. The number of active participants declined over the study duration, especially in the final week. Among participants who remained active, neither watch time nor question completion percentage declined over time. Participants were mainly motivated to learn about their symptoms and enjoyed the self-tracking aspects of the watch. Barriers to full engagement were battery life limitations, technical problems, and unfulfilled expectations of the watch. Participants reported that they would have liked to report symptoms more than 4 or 5 times per day. CONCLUSIONS This study shows that capture of patient-reported outcomes multiple times per day with linked sensor data from a smartwatch is feasible over at least a 3-month period. INTERNATIONAL REGISTERED REPORT RR2-10.2196/10238

scholarly journals Developing fit-for-purpose self-report instruments for assessing consumer responses to tobacco and nicotine products: the ABOUT™ Toolbox initiative

F1000Research ◽  
2018 ◽  
Vol 7 ◽  
pp. 1878 ◽  
Author(s):  
Christelle Chrea ◽  
Catherine Acquadro ◽  
Esther F. Afolalu ◽  
Erica Spies ◽  
Thomas Salzberger ◽  
...  
Keyword(s):  
Public Health ◽  
Wide Spectrum ◽  
Medical Product ◽  
Consumer Perception ◽  
Self Report ◽  
Measurement Instruments ◽  
Patient Reported ◽  
Fit For Purpose ◽  
And Behavior ◽  
The Impact

Background. Determining the public health impact of tobacco harm reduction strategies requires the assessment of consumer perception and behavior associated with tobacco and nicotine products (TNPs) with different exposure and risk profiles. In this context, rigorous methods to develop and validate psychometrically sound self-report instruments to measure consumers’ responses to TNPs are needed. Methods. Consistent with best practice guidelines, including the U.S. Food and Drug Administration’s “Guidance for Industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims,” scientifically designed, fit-for-purpose, reliable, and valid instruments are now being applied to tobacco regulatory research. Results. This brief report presents the ABOUT™ Toolbox (Assessment of Behavioral OUtcomes related to Tobacco and nicotine products) initiative. This communication: (1) describes the methodological steps followed for the development and validation of the measurement instruments included in the ABOUT™ Toolbox, (2) presents a summary of the high-priority tobacco-related domains that are currently covered in the ABOUT™ Toolbox (i.e., risk perception, dependence, product experience, health and functioning, and use history), and (3) details how the measurement instruments are made accessible to the scientific community. Conclusions. By making the ABOUT™ Toolbox available to the tobacco research and public health community, we envision a rapidly expanding knowledge base, with the goals of (1) supporting consumer perception and behavior research to allow comparisons across a wide spectrum of TNPs, (2) enabling public health and regulatory communities to make better-informed decisions for future regulation of TNPs, and (3) enhancing surveillance activities associated with the impact of TNPs on population health.

scholarly journals A Narrative Literature Review of Bias in Collecting Patient Reported Outcomes Measures (PROMs)

2021 ◽  
Vol 18 (23) ◽  
pp. 12445
Author(s):  
Michela Luciana Luisa Zini ◽  
Giuseppe Banfi
Keyword(s):  
Literature Review ◽  
Response Bias ◽  
Patient Reported Outcomes ◽  
Selection Process ◽  
Medical Specialty ◽  
Recall Bias ◽  
Language Bias ◽  
Pubmed Database ◽  
Patient Reported ◽  
Narrative Literature Review

There is a growing interest in the collection and use of patient reported outcomes because they not only provide clinicians with crucial information, but can also be used for economic evaluation and enable public health decisions. During the collection phase of PROMs, there are several factors that can potentially bias the analysis of PROM data. It is crucial that the collected data are reliable and comparable. The aim of this paper was to analyze the type of bias that have already been taken into consideration in the literature. A literature review was conducted by the authors searching on PubMed database, after the selection process, 24 studies were included in this review, mostly regarding orthopedics. Seven types of bias were identified: Non-response bias, collection method related bias, fatigue bias, timing bias, language bias, proxy response bias, and recall bias. Regarding fatigue bias and timing bias, only one study was found; for non-response bias, collection mode related bias, and recall bias, no agreement was found between studies. For these reasons, further research on this subject is needed in order to assess each bias type in relation to each medical specialty, and therefore find correction methods for reliable and comparable data for analysis.

Sign in / Sign up

Export Citation Format

Share Document