Current medical research and opinion
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Multicenter Study
Effect of preoperative moderate-dose statin and duration on acute kidney injury after cardiac surgery: a retrospective cohort study.
The impact of preoperative statin use on postoperative acute kidney injury (AKI) is uncertain. We aimed to examine the association of statin therapy before cardiac surgery with postoperative AKI. ⋯ Preoperative moderate-dose statin was significantly related to a decreased risk of postoperative AKI, especially in patients who received statins for a longer duration. Further large-scale multicenter randomized controlled trials are needed to ascertain the impact of statin dose, duration, and timing on postoperative AKI in cardiac surgery patients.
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Clinical Trial
CercaTest RedTM, a novel urine-based point-of-care test for the detection of preeclampsia.
Preeclampsia (PE) poses a serious threat to the health of the pregnant woman and her developing fetus due to the difficulty in diagnosing the condition. The disease can develop and worsen suddenly without noticeable signs and symptoms. Thus, there is an urgent need for a simple Point of Care Test (POCT) that improves accessibility to testing and can be used as an aid in the diagnosis of PE. CercaTest Red is a noninvasive detection kit for impending preeclampsia using urine from pregnant women. This is especially pertinent for women who have limited access to secondary/tertiary healthcare as those in remote settings, low-income countries or simply lack of out of hours laboratory services. ⋯ This test is easy to use, cost-effective and portable with short turnaround time and no laboratory instrument requirement. In the future, the test may have the potential to become quantitative using spectroscopy (Chinese Clinical Trial Registry No. ChiCTR1800017692).
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Time To Discontinuation (TTD) is defined as the time from the start of treatment to the end of treatment, usually occurring due to loss of efficacy or occurrence of adverse events. It has become an important surrogate efficacy endpoint especially in real-world studies due to its correlation with endpoints such as Progression Free Survival (PFS). The aim of the study is to conduct a literature review of all studies reporting TTD in first-line therapy of Non-Small Cell Lung Cancer (NSCLC). ⋯ Studies reporting TTD are increasing, most notably real-world studies. Given the increasing importance of TTD as an efficacy endpoint, it becomes critical to measure and monitor it in various therapeutic settings such as NSCLC. This is the first study to review all TTD values of drugs used in first-line NSCLC.
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Randomized Controlled Trial
Tislelizumab in advanced/metastatic esophageal squamous cell carcinoma: health related quality of life in Asian patients.
Post-hoc analysis examined health-related quality of life and esophageal squamous cell carcinoma (ESCC) symptoms in the Asian subgroup of patients in RATIONALE-302 (NCT03430843). ⋯ Overall, the health-related quality of life and ESCC-related symptoms of patients receiving tislelizumab in the Asian subgroup remained stable or improved, while patients receiving investigator-chosen chemotherapy experienced worsening. These results in Asian patients corroborate the findings in the intent-to-treat population, suggesting tislelizumab is a potential new second-line treatment option for patients with advanced or metastatic ESCC.
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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.