Current medical research and opinion
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Review
Patient-reported outcomes validated in Phase 3 clinical trials: a targeted literature review.
Regulatory guidance advises validation of patient-reported outcome (PRO) instruments prior to use in pivotal clinical studies, which may then be used to generate critical patient-centered evidence and support labelling claims. This targeted literature review aimed to determine if PRO instruments psychometrically validated in a phase 3 trial setting could support label claims from the same phase 3 study (i.e. PRO data were generated as an endpoint). ⋯ These results suggest that quantitative validation of novel PRO instruments, and existing PROs for new indications, can occur within the context of phase 3 trials, and these PROs can also support label claims.
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COVID-19 has had a negative impact on the health care of patients with cardiovascular disease and patients at high risk of cardiovascular disease. The restrictions affecting access to the health care system have conditioned the care received, resulting in poorer control and a higher risk of events. Taking action to improve the care provided during health emergencies is mandatory. ⋯ In addition, primary care and coordination between health care levels should be improved. Moreover, the simplification and optimization of treatment, for example, using the cardiovascular polypill, have led to an improvement in adherence, better control of vascular risk factors, and a reduced risk of events. The present document provides specific recommendations for improving the care provided to patients under a health emergency.
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Review Meta Analysis
Clear cell carcinoma of the ovary and venous thromboembolism: a systematic review and meta-analysis.
As the second most common subtype of Epithelial ovarian cancers (EOCs), ovarian clear cell carcinoma (OCCC) is associated with a high rate of cancer-associated thrombosis. Previous studies revealed the wide range prevalence (6-42%) of venous thromboembolism (VTE) among OCCC patients. This study aimed to determine the prevalence of VTE among OCCC patients as well as factors affecting it. ⋯ Ovarian clear cell carcinoma is associated with a high rate of cancer-associated thrombosis. VTE events in OCCC patients were higher in advanced stages and Japanese women.
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Review Meta Analysis
Clear cell carcinoma of the ovary and venous thromboembolism: a systematic review and meta-analysis.
As the second most common subtype of Epithelial ovarian cancers (EOCs), ovarian clear cell carcinoma (OCCC) is associated with a high rate of cancer-associated thrombosis. Previous studies revealed the wide range prevalence (6-42%) of venous thromboembolism (VTE) among OCCC patients. This study aimed to determine the prevalence of VTE among OCCC patients as well as factors affecting it. ⋯ Ovarian clear cell carcinoma is associated with a high rate of cancer-associated thrombosis. VTE events in OCCC patients were higher in advanced stages and Japanese women.
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The Asia-Pacific region (APAC) represents a unique environment for the publication of biomedical research, particularly industry-funded research. Awareness and adoption of international guidelines on ethical publication practices continues to increase across APAC, but the reframing and expansion of many of the recommendations in the Good Publication Practice (GPP) 2022 guidelines versus GPP3 published in 2015 have important implications for publishing industry-funded biomedical research in the region. ⋯ Overall, this manuscript offers a pragmatic guide for stakeholders in industry-sponsored research on applying GPP 2022 in practice with a focus on effectively integrating these guidelines in an APAC context.