Value-based medicine: concepts and application

Bae, Jong Myon

doi:10.4178/epih/e2015014

Cited by 78 publications

(78 citation statements)

References 43 publications

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“…Она содержит 5 факторов (обременительность и выраженность симптомов болезни, эмоциональное состояние, функциональные ограничения, оценка режима и оценка результата лечения), фактически оценивающих 4 сферы (физиологической, психологической, продуктивности деятельности, сфера лечения) и 8 подсфер (физиологические симптомы, влияние заболевания на социальную активность, эмоциональные симптомы, ограничива- Обсуждение Одной из важнейших целей ценностной медицины является поиск путей, обеспечивающих выбор, с учетом мнения пациента, наиболее эффективного и наименее затратного метода поведенческого, медикаментозного и интервенционного лечения. Так как результат любого вмешательства не описывается лишь наличием или отсутствием заболевания, необходимо иметь валидный и надежный инструмент для оценки КЖ, особенно, в группах пациентов с распространенными и социально-значимыми заболеваниями [13]. Разработанный авторами в несколько этапов ПИСП является валидным, надежным и чувствительным инструментом для оценки КЖ исключительно для пациентов с АГ без ассоциированных клинических состояний (так называемая неосложненная АГ).…”

Section: материал и методыunclassified

Hypertension specific patient-reported outcome measure. Part III: validation, responsiveness and reliability assessment

et al. 2020

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Aim. Health-related quality of life in patients with arterial hypertension (HTN) is still determined by only generic patient-reported outcome measures (PROMs), although disease-specific ones are more reliable and highly valid. Previously, we reported the results of development and item-selection process of the new Russian HTN-specific PROM. The purpose of this last stage was to confirm validity, reliability, responsiveness and sensitivity of the scale and to present its final version.Material and methods. Analysis was done using data from a mass survey of patients with Grades 1-3 HTN (n=359, aged 25 to 91 y. o.) and healthy volunteers (n=48, aged 23 to 65 y.o), 407 returned questionnaires. We conducted two exploratory factor analyses (EFA) with the intermediate version of the PROM (80 questions, 20 of them HTN-specific). The Cattel’s scree test was used to select the optimal number of factors. After removing the items with a low factor loadings, a confirmatory factor analysis (CFA) was performed to assess the model’s fitindexes adequacy. The core indexes to be measured were SRMR, RMSEA, CFI. Finally, the PROM’s reliability (Cronbach’s α and McDonald’s ω) and criterion validity (responsiveness) were evaluated.Results. Both EFA with oblique and varimax rotation showed 35 questions have factor loadings ≥0,5 and assigned to one of 5 factors. The basic structure of the PROM was retained for further CFA. Most of indices of fit measured met the requirements: SRMR was 0,08, RMSEA was 0,07 (90% CI (0,07-0,08)) and CFI was 0,08, which confirms the construct validity. Both Cronbach’s α and MacDonald’s ω of each of the domains were ≥0,80 and the whole scale was 0,89 confirming satisfactory reliability. Scores of the questionnaire were positively correlated with the severity of HTN (p<0,001 for Grades 1-3 HTN) and between HTN and non-HTN patients (p=0,01 and 0,04 in psychologic and social domains respectively).Conclusion. Sequentially addressing of exploratory and confirmatory factor analyses and assessment of reliability and responsiveness allowed to form the final version of the patient-reported outcome measure for arterial hypertension. The new Russian-language questionnaire is a useful and feasible tool for routine practice and clinical trials.

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Section: материал и методыunclassified

Hypertension specific patient-reported outcome measure. Part III: validation, responsiveness and reliability assessment

et al. 2020

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“…And patients’ individuality strongly influences, if not determines, treatment decisions. Evidence per se is not enough, and one has to consider how patients envision the outcomes related to current standard of care (SOC) practices (efficacy, quality of life, safety) to make clinical judgments and decisions, including the decision to enroll in a clinical trial . In this aspect, the individualized approach of POTs, with recruitment usually based on biomarkers, is associated with high expectancies of success and lower tolerance of uncertainty for a given study outcome.…”

Section: Precision Oncology Trials and Their Challengesmentioning

confidence: 99%

Personalizing Precision Oncology Clinical Trials in Latin America: An Expert Panel on Challenges and Opportunities

et al. 2019

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The participation of patients in precision oncology trials needs to fulfill molecular‐based selection criteria. This strongly limits accrual, and as a consequence, screening successes have decreased, costs have increased, and fewer subjects are enrolled. To achieve narrowed targets, studies have been forced to be multicenter and multinational to reach a larger pool of candidates. However, this globalization faces many challenges, as, for example, in the case of precision oncology trials. These trials have a complex structure that is dependent upon a high‐tech infrastructure and knowledge in a dynamic environment. Given the movement of precision clinical cancer research to regions other than Europe and the U.S., it is important to evaluate the feasibility of performing such trials in lower‐middle‐ and low‐income countries. Here we critically discuss the advantages of conducting precision oncology clinical trials in Latin America and make suggestions on how to overcome the main challenges involved. Implications for Practice Precision clinical trials in oncology are studies that require candidates to have tumors with specific molecular alterations, which are considered the target for the trial experimental therapy. Because many molecular alterations are rare, fewer patients are enrolled. This has led to trials being forced to be multicenter and multinational, including trials in Latin America. This article discusses the challenges and opportunities to conduct precision oncology trials in Latin America, aiming to help sponsors and investigators to solve complex issues that ultimately lead to more of such trials being run in the region, potentially benefiting more Latin American patients with cancer.

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“…Probably everyone would agree with purpose and contents of the statements mentioned above - but is this not a current trend of many other disciplines, anyway? Different terms like ‘Self-Responsibility', ‘Person-Centeredness' [9], ‘Comprehensive Care', ‘Personalized Health Care' [10], ‘Preventive Health Care', ‘Individualized Medicine', ‘Value-Based Health Care' [11], etc. embrace the same transformation taking place in medicine and health care.…”

Section: Tablementioning

confidence: 99%

From Complementary to Integrative Medicine and Health: Do We Need a Change in Nomenclature?

Melchart

2018

Complement Med Res

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Value-based medicine: concepts and application

Cited by 78 publications

References 43 publications

Hypertension specific patient-reported outcome measure. Part III: validation, responsiveness and reliability assessment

Hypertension specific patient-reported outcome measure. Part III: validation, responsiveness and reliability assessment

Personalizing Precision Oncology Clinical Trials in Latin America: An Expert Panel on Challenges and Opportunities

From Complementary to Integrative Medicine and Health: Do We Need a Change in Nomenclature?

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