scholarly journals A pilot study on the validity and psychometric properties of the electronic EQ-5D-5L in routine clinical practice

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Cindy Lo Kuen Lam ◽  
Emily Tsui Yee Tse ◽  
Carlos King Ho Wong ◽  
Joyce Sau Mei Lam ◽  
Sikky Shiqi Chen ◽  
...  

Abstract Background Electronic measurement of health-related quality of life (HRQOL) may facilitate timely and regular assessments in routine clinical practice. This study evaluated the validity and psychometric properties of an electronic version of the EQ-5D-5L (e-EQ-5D-5L) in Chinese patients with chronic knee and/or back problems. Methods 151 Chinese subjects completed an electronic version of the Chinese (Hong Kong) EQ-5D-5L when they attended a primary care or orthopedics specialist out-patient clinic in Hong Kong. They also completed the Chinese Western Ontario and McMaster University Osteoarthritis Index (WOMAC), a Pain Rating Scale, and a structured questionnaire on socio-demographics, co-morbidities and health service utilization. 32 subjects repeated the e-EQ-5D-5L two weeks after the baseline. 102 subjects completed e-EQ-5D-5L and 99 completed the Global Rating on Change Scale at three-month clinic follow up. Construct validity was assessed by the association of EQ-5D-5L scores with external criterion of WOMAC scores. We tested mean differences of WOMAC scores between adjacent response levels of the EQ-5D-5L dimensions by one-way ANOVA, test–retest reliability by intra-class correlation, sensitivity by known group comparisons and responsiveness by changes in EQ-5D-5L scores over 3 months. Results There was an association between EQ-5D-5L and WOMAC scores. Mean WOMAC scores increased with the increase in adjacent response levels of EQ-5D-5L dimensions. Test–retest intraclass correlation coefficient (ICC) of EQ-5D-5L utility and EQ-VAS scores were 0.76 and 0.83, respectively, indicating good reliability. There were significant differences in the proportions reporting limitations in the EQ-5D-5L dimensions, the utility and VAS scores between the mild and severe pain groups (utility = 0.28, p = 0.001; VAS = 11.46, p < 0.001), and between primary care and specialist out-patient clinic patients (utility = 0.15, p = 0.001; VAS = 10.21, p < 0.001), supporting sensitivity. Among those reporting ‘better’ global health at three-months, their EQ-5D-5L utility and EQ-VAS scores were significantly increased from baseline (utility = 0.18, p < 0.001; VAS = 10.75, p = 0.005). Conclusions The electronic version of the EQ-5D-5L is valid, reliable, sensitive and responsive in the measurement of HRQOL in Chinese patients with chronic knee or back pain in routine clinical practice.

2017 ◽  
Vol 23 (1) ◽  
pp. 136-143 ◽  
Author(s):  
Iñaki Martín-Lesende ◽  
Estibalitz Orruño ◽  
Maider Mateos ◽  
Elizabete Recalde ◽  
José Asua ◽  
...  

2020 ◽  
Vol 38 (2) ◽  
pp. 193-199
Author(s):  
Robyn L. Shepardson ◽  
Mark R. Minnick ◽  
Jennifer S. Funderburk

RMD Open ◽  
2020 ◽  
Vol 6 (1) ◽  
pp. e000928 ◽  
Author(s):  
Dafna Gladman ◽  
Peter Nash ◽  
Hitoshi Goto ◽  
Julie A Birt ◽  
Chen-Yen Lin ◽  
...  

ObjectivesThis study assessed the psychometric properties of the fatigue numeric rating scale (NRS) and sought to establish values for clinically meaningful change (responder definition).MethodsUsing disease-specific clinician-reported and patient-reported data from two randomised clinical trials of patients with psoriatic arthritis (PsA), the fatigue NRS was evaluated for test–retest reliability, construct validity and responsiveness. A responder definition was also explored using anchor-based and distribution-based methods.ResultsTest–retest reliability analyses supported the reproducibility of the fatigue NRS in patients with PsA (intraclass correlation coefficient=0.829). Mean (SD) values at baseline and week 2 were 5.7 (2.2) and 5.7 (2.4), respectively. Supporting construct validity of the fatigue NRS, moderate-to-large correlations with other assessments measuring similar concepts as measured by Sackett’s conventions were demonstrated. Fatigue severity was reduced when the underlying disease activity was improved and reductions remained consistent at week 12 and 24. A 3-point improvement was identified as being optimal for demonstrating a level of clinically meaningful improvement in fatigue NRS after 12–24 weeks of treatment.ConclusionsFatigue NRS is a valid and responsive patient-reported outcome instrument for use in patients with PsA. The established psychometric properties from this study support the use of fatigue NRS in clinical trials and in routine clinical practice. Robust validation of reliability for use in routine clinical practice in treating patients with active PsA in less active disease states and other more diverse ethnic groups is needed.


Author(s):  
Ю.А. Лушпаева

Целью исследования было выявление возможных проблем диагностики, междисциплинарного взаимодействия и причины дефектов терапии пациентов с остеоартритом на амбулаторном приеме, а также оценка эффективности и безопасности применения в рутинной клинической практике у пациентов с остеоартритом коленных суставов препарата, основой которого является биоактивный концентрат мелких морских рыб. Проанализированы результаты амбулаторного приема ревматолога и истории болезни 2312 пациентов с направительным диагнозом «остеоартрит» различной локализации. Оказалось, что из всех обратившихся к ревматологу пациентов с направительным диагнозом «остеоартрит» 47% направлений можно расценить как безосновательные. Было обнаружено, что 45% пациентов даже при установленном достоверном диагнозе «остеоартрит» на амбулаторном приеме терапия назначалась не в полном объеме и не соответствовала рекомендациям по ведению данной категории больных. После двух курсов (в течение года) лечения препаратом на основе биоактивного концентрата мелких морских рыб эффектом от терапии были удовлетворены 67% пациентов с остеоартритом коленных суставов, отметившие снижение интенсивности боли, улучшение функции суставов и качества жизни. В группе наблюдения не было зарегистрировано нежелательных явлений. Несмотря на то, что в настоящее время проблема остеоартрита хорошо освещена, в реальной клинической практике на этапе первичного звена врачи нередко сталкиваются со сложностями решения как диагностических, так и терапевтических задач. В связи с этим возникает острая необходимость в пересмотре и адаптации к рутинной амбулаторной практике междисциплинарных алгоритмов ведения больных остеоартритом, с определением порога вмешательства врача первичного звена и специалиста. Существует также необходимость в разработке и внедрении в рутинную клиническую практику оптимизированных шкал/опросников для динамической оценки качества жизни пациентов с остеоартритом коленных суставов. Проведенное исследование демонстрирует достаточно высокую эффективность, безопасность и доступность препарата на основе биоактивного концентрата мелких морских рыб, а лечение данным препаратом может широко применяться в комплексной терапии остеоартрита коленных суставов. The purpose of the study was to identify the problems of diagnosis, interdisciplinary interaction and the causes of defects in the treatment of patients with osteoarthritis on an outpatient basis, as well as to assess the efficacy and safety of using the medicine from bioactive concentrate of small marine fish, in routine clinical practice in patients with knee osteoarthritis. The results of an out-patient reception hours with a rheumatologist and case histories of 2312 patients with a referral diagnosis of osteoarthritis of various localization were analyzed. It turned out that 47% of all referrals to a rheumatologist with a referral diagnosis of osteoarthritis can be regarded as unfounded. It was found that 45% of patients, even with an established reliable diagnosis of osteoarthritis, on an outpatient basis, therapy was not prescribed in full and did not comply with the recommendations for the management of this category of patients. After 2 courses (within a year) of treatment with a drug based on a bioactive concentrate of small marine fish, 67% of patients with osteoarthritis of the knee joints were satisfied with the effect of therapy, noting a decrease in pain intensity, an improvement in knee joint function and quality of life. No adverse events were reported in the observation group. Despite the fact that at present the problem of osteoarthritis is well covered, in real clinical practice at the stage of primary care physicians often face difficulties in solving both diagnostic and therapeutic problems. In this regard, there is an urgent need to revise and adapt to the routine outpatient practice of interdisciplinary algorithms for managing patients with osteoarthritis, with the determination of the intervention threshold of a primary care physician and a specialist physician. However, there is a need to develop and introduce into routine clinical practice optimized scales/questionnaires for dynamic assessment of the quality of life of patients with knee osteoarthritis. The study demonstrates a fairly high efficacy, safety and availability of a drug based on a bioactive concentrate of small marine fish, and treatment with this drug can be widely used in the complex therapy of osteoarthritis of the knee joints.


BMJ Open ◽  
2019 ◽  
Vol 9 (6) ◽  
pp. e025776 ◽  
Author(s):  
Harma Johanna Alma ◽  
Corina de Jong ◽  
Danijel Jelusic ◽  
Michael Wittmann ◽  
Michael Schuler ◽  
...  

ObjectivesChronic Obstructive Pulmonary Disease (COPD) is a progressive disease. Preventing deterioration of health status is therefore an important therapy goal. (Minimal) Clinically Important Differences ((M)CIDs) are used to interpret changes observed. It remains unclear whether (M)CIDs are similar for both deterioration and improvement in health status. This study investigates and compares these clinical thresholds for three widely-used questionnaires.Design and settingData were retrospectively analysed from an inhouse 3-week pulmonary rehabilitation (PR) randomised controlled trial in the German Klinik Bad Reichenhall (study 1), and observational research in Dutch primary and secondary routine clinical practice (RCP) (study 2).ParticipantsPatients with COPD aged ≥18 years (study 1) and aged ≥40 years (study 2) without respiratory comorbidities were included for analysis.Primary outcomesThe COPD Assessment Test (CAT), Clinical COPD Questionnaire (CCQ) and St George’s Respiratory Questionnaire (SGRQ) were completed at baseline and at 3, 6 and 12 months. A Global Rating of Change scale was added at follow-up. Anchor-based and distribution-based methods were used to determine clinically relevant thresholds.ResultsIn total, 451 patients were included from PR and 207 from RCP. MCIDs for deterioration ranged from 1.30 to 4.21 (CAT), from 0.19 to 0.66 (CCQ), and from 2.75 to 7.53 (SGRQ). MCIDs for improvement ranged from −3.78 to −1.53 (CAT), from −0.50 to −0.19 (CCQ), and from −9.20 to −2.76 (SGRQ). Thresholds for moderate improvement versus deterioration ranged from −5.02 to −3.29 vs 3.89 to 8.14 (CAT), from −0.90 to −0.72 vs 0.42 to 1.23 (CCQ), and from −15.85 to −13.63 vs 7.46 to 9.30 (SGRQ).ConclusionsMCID ranges for improvement and deterioration on the CAT, CCQ and SGRQ were somewhat similar. However, estimates for moderate and large change varied and were inconsistent. Thresholds differed between study settings.Trial registration numberRoutine Inspiratory Muscle Training within COPD Rehabilitation trial: #DRKS00004609; MCID study: #UMCG201500447.


2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Charles C. Guo ◽  
Jolanta Bondaruk ◽  
Hui Yao ◽  
Ziqiao Wang ◽  
Li Zhang ◽  
...  

Abstract Genomic profiling studies have demonstrated that bladder cancer can be divided into two molecular subtypes referred to as luminal and basal with distinct clinical behaviors and sensitivities to frontline chemotherapy. We analyzed the mRNA expressions of signature luminal and basal genes in bladder cancer tumor samples from publicly available and MD Anderson Cancer Center cohorts. We developed a quantitative classifier referred to as basal to luminal transition (BLT) score which identified the molecular subtypes of bladder cancer with 80–94% sensitivity and 83–93% specificity. In order to facilitate molecular subtyping of bladder cancer in primary care centers, we analyzed the protein expressions of signature luminal (GATA3) and basal (KRT5/6) markers by immunohistochemistry, which identified molecular subtypes in over 80% of the cases. In conclusion, we provide a tool for assessment of molecular subtypes of bladder cancer in routine clinical practice.


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