Patient reported outcomes and quality of life in Chinese patients with implantable cardioverter defibrillators✰

Guo, Xijuan; Tripp, Connor; Huber, Nichelle L.; Hou, Chenping; Lü, Rong; Li, Jing; Liang, Tao; Sears, Samuel F.

doi:10.1016/j.hrtlng.2020.05.003

Cited by 5 publications

(8 citation statements)

References 25 publications

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“…9,31 Some Chinese researchers have also recognized the great potential of PROs and have begun to independently design novel PRO instruments [32][33][34][35] and apply them in clinical practice. 36,37 The findings of this survey are concordant with our hypothesis that phase 3 and phase 4 trials typically involve more PRO measures. PRO items were included in 12.9% of phase 4 clinical trials, suggesting that researchers may be willing to pay more attention to patients' feelings when the trial is not aimed only at marketing.…”

Section: Discussionsupporting

confidence: 85%

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Application of Patient-Reported Outcome Measurements in Clinical Trials in China

Zhou

Yao

et al. 2022

JAMA Netw Open

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IMPORTANCE Regulatory authorities, industry peers, and international health policies have emphasized the value of assessing patient-reported outcomes (PROs) in clinical studies. Despite the increase in the number of clinical studies in the last decade in China, little is known about the extent of the use of PROs. OBJECTIVETo evaluate the application and characteristics of PRO instruments as primary and secondary outcomes in randomized clinical trials in China. DESIGN, SETTING, AND PARTICIPANTSA cross-sectional study of interventional clinical trials conducted in China from January 1, 2010, to December 31, 2020, was performed. Data obtained from the Chinese Clinical Trial Registry and ClinicalTrials.gov databases were evaluated. MAIN OUTCOMES AND MEASURESTrials were categorized according to those that (1) precisely listed PRO tools as outcomes, (2) mentioned patient subjective feelings in outcomes but did not clarify which tools were used for assessment, and (3) did not mention any PRO measurements. Data on study phase, setting, participant age, and sex were extracted from trials that considered patient feelings, along with the target diseases and names of the PRO tools. RESULTS Among a total of 34 033 trials, 6915 (20.3%) listed the explicit PRO instruments used and 3178 (9.3%) included PRO in their outcomes but did not include the names of the assessment tools.From more than 32 million people included in the registered trials, data on 1.5 million (4.7%) patients were scientifically collected by PRO instruments, and subjective feelings were assessed for 693 867 (2.1%) participants. Pain (16.8%), cancer (15.6%), and musculoskeletal symptoms (13.3%) were the most common conditions for which PROs were precisely collected by tools. The most common tools for PRO measurements were the visual analog scale, Short-Form 36, and Hamilton Depression Scale. CONCLUSIONS AND RELEVANCEIn this cross-sectional study, the use of PROs increased during the study period in clinical trials conducted in China. However, patient opinion appears to still be rarely measured. The application of PRO is geographically unevenly distributed. Development of PRO instruments, especially those suitable for the Chinese population, may be useful. Further expansion of PROs with respect to the scope of diseases is needed to avoid missing important data.

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Section: Discussionsupporting

confidence: 85%

“…However, a positive sign is that some researchers have begun to focus on the development and evaluation of new PRO scales . Some Chinese researchers have also recognized the great potential of PROs and have begun to independently design novel PRO instruments and apply them in clinical practice …”

Section: Discussionmentioning

confidence: 99%

Application of Patient-Reported Outcome Measurements in Clinical Trials in China

Zhou

Yao

et al. 2022

JAMA Netw Open

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“… 19 , 20 Para o construto ansiedade relacionada ao CDI, os escores médios obtidos variaram de 23,5 a 23,9, denotando um nível leve de ansiedade, à semelhança de um estudo transversal que reportou escores médios de 22,1 pontos. 8 Para a aceitação do dispositivo, os escores obtidos de 72,6 a 74,7, em 30 e 180 dias, respectivamente, mostraram um nível adequado de aceitação, semelhante a estudos prévios, que reportaram pontuações que variaram de 64,7 a 66,5. 8 , 21 …”

Section: Discussionunclassified

“… 8 Para a aceitação do dispositivo, os escores obtidos de 72,6 a 74,7, em 30 e 180 dias, respectivamente, mostraram um nível adequado de aceitação, semelhante a estudos prévios, que reportaram pontuações que variaram de 64,7 a 66,5. 8 , 21 …”

Section: Discussionunclassified

“…A identificação de fatores que possam discriminar subgrupos com maior risco de apresentar desfechos psicossociais desfavoráveis ainda foi pouco explorada na literatura e os resultados variam consideravelmente entre os estudos. Até o presente momento, a ocorrência de terapias de choque do CDI, 7 condições psicológicas pré-existentes como depressão, 8 personalidade do tipo D 9 e transtorno de ansiedade generalizada, 4 sexo feminino, 10 idade superior a 60 anos, 11 a falta de suporte social 9 e de conhecimento sobre a doença e o dispositivo 12 foram os principais fatores associados ao impacto negativo do CDI sob a perspectiva dos pacientes.…”

Section: Introductionunclassified

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Preditores de Qualidade de Vida, Ansiedade e Aceitação em Pacientes com Cardioversor-Desfibrilador Implantável

Silva,

Saucedo

et al. 2024

Arq. Bras. Cardiol.

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Resumo Fundamento O cardioversor-desfibrilador implantável (CDI) pode causar níveis elevados de ansiedade e depressão, resultando em efeitos negativos na qualidade de vida. Objetivos Avaliar a qualidade de vida, a ansiedade e a aceitação do CDI por meio de instrumentos de medida padronizados e identificar preditores de melhores respostas para cada um dos desfechos estudados. Método Coorte prospectiva com pacientes submetidos a implante inicial de CDI ou reoperação para a manutenção do dispositivo. Os desfechos do estudo incluíram: qualidade de vida, ansiedade e aceitação do CDI. A mudança nos escores (30 e 180 dias) foi avaliada por meio da diferença mínima importante (DMI). Foi utilizada a análise univariada e o modelo de regressão logística multivariada para a identificação de preditores de melhores respostas, adotando-se o nível de significância de 5%. Resultados De janeiro/2020 a junho/2021 foram incluídos 147 pacientes, com idade média de 55,3 ± 13,4 anos e predomínio do sexo masculino (72,1%). A DMI para qualidade de vida, a ansiedade e a aceitação do CDI foram observadas em 33 (22,4%), 36 (24,5%) e 43 (29,3%) pacientes, respectivamente. Idade igual ou maior que 60 anos (OR=2,5; IC 95%=1,14-5,53; p=0,022), ausência de fibrilação atrial (OR=3,8; IC 95%=1,26-11,63; p=0,017) e sexo feminino (OR=2,2; IC 95%=1,02-4,97; p=0,045) foram preditores independentes de melhores respostas para qualidade de vida, ansiedade e aceitação do CDI, respectivamente. Conclusão A identificação de preditores para melhores escores de qualidade de vida, ansiedade e aceitação do dispositivo pode subsidiar a implementação de cuidados específicos para os pacientes com maiores chances de apresentar resultados desfavoráveis.

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Development of a patient and clinician co-led education program to promote living well with an implantable cardioverter defibrillator: Insights from a pilot project

et al. 2022

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Patient reported outcomes and quality of life in Chinese patients with implantable cardioverter defibrillators✰

Cited by 5 publications

References 25 publications

Application of Patient-Reported Outcome Measurements in Clinical Trials in China

Application of Patient-Reported Outcome Measurements in Clinical Trials in China

Preditores de Qualidade de Vida, Ansiedade e Aceitação em Pacientes com Cardioversor-Desfibrilador Implantável

Development of a patient and clinician co-led education program to promote living well with an implantable cardioverter defibrillator: Insights from a pilot project

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