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- Zhang, JR, et al.
(author)
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Systematic bias between blinded independent central review and local assessment: literature review and analyses of 76 phase III randomised controlled trials in 45 688 patients with advanced solid tumour
- 2018
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In: BMJ open. - : BMJ. - 2044-6055. ; 8:9, s. e017240-
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Journal article (peer-reviewed)abstract
- Unbiased assessment of tumour response is crucial in randomised controlled trials (RCTs). Blinded independent central review is usually used as a supplemental or monitor to local assessment but is costly. The aim of this study is to investigate whether systematic bias existed in RCTs by comparing the treatment effects of efficacy endpoints between central and local assessments.DesignLiterature review, pooling analysis and correlation analysis.Data sourcesPubMed, from 1 January 2010 to 30 June 2017.Eligibility criteria for selecting studiesEligible articles are phase III RCTs comparing anticancer agents for advanced solid tumours. Additionally, the articles should report objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS) or time to progression (TTP); the treatment effect of these endpoints, OR or HR, should be based on central and local assessments.ResultsOf 76 included trials involving 45 688 patients, 17 (22%) trials reported their endpoints with statistically inconsistent inferences (p value lower/higher than the probability of type I error) between central and local assessments; among them, 9 (53%) trials had statistically significant inference based on central assessment. Pooling analysis presented no systematic bias when comparing treatment effects of both assessments (ORR: OR=1.02 (95% CI 0.97 to 1.07), p=0.42, I2=0%; DCR: OR=0.97 (95% CI 0.92 to 1.03), p=0.32, I2=0%); PFS: HR=1.01 (95% CI 0.99 to 1.02), p=0.32, I2=0%; TTP: HR=1.04 (95% CI 0.95 to 1.14), p=0.37, I2=0%), regardless of funding source, mask, region, tumour type, study design, number of enrolled patients, response assessment criteria, primary endpoint and trials with statistically consistent/inconsistent inferences. Correlation analysis also presented no sign of systematic bias between central and local assessments (ORR, DCR, PFS: r>0.90, p<0.01; TTP: r=0.90, p=0.29).ConclusionsNo systematic bias could be found between local and central assessments in phase III RCTs on solid tumours. However, statistically inconsistent inferences could be made in many trials between both assessments.
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- Chen, XK, et al.
(author)
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Traditional Baduanjin exercise through the eyes of patients with chronic heart failure: A qualitative content analysis study
- 2023
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In: Frontiers in cardiovascular medicine. - : Frontiers Media SA. - 2297-055X. ; 9, s. 1049036-
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Journal article (peer-reviewed)abstract
- Baduanjin (eight silken movements) is a traditional Chinese exercise that can be used as cardiac rehabilitation therapy for patients with chronic heart failure (CHF) especially when other forms of rehabilitation are scarce or unaffordable. This study explores the experiences of Chinese patients with CHF who undertook Baduanjin exercise at home as part of a pilot trial in Guangzhou, China.MethodsWe conducted seven qualitative interviews with participants who had participated in the intervention arm of a pilot randomized controlled trial (RCT) (n = 8). For data collection, we used a semi-structured interview guide with both open-ended, and follow-up questions. We audio recorded the interviews, transcribed them verbatim, and then analyzed them with content analysis.ResultsParticipants’ experiences of doing Baduanjin were classified into three categories: (1) improving practice (2) factors facilitating good exercise adherence, and (3) feeling good. Participants reported that the exercises were easy but that the correct Baduanjin execution and coordination between the mind, movements, and breathing were only achievable through practice. In addition, the training benefits which they perceived were the predominant motivation for patients to keep practicing. Finally, trust in Baduanjin, personal attitudes toward health, flexibility in practice times, as well as social support helped the participants to achieve good adherence to home-based training.ConclusionThis study’s findings indicate that Baduanjin could be a cardiac rehabilitation exercise modality for patients with CHF in China, especially in a home-based setting.
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