ABSTRACT
Overall survival (OS) is considered the standard clinical endpoint to support effectiveness claims in new drug applications globally, particularly for lethal conditions such as cancer. However, the source and reliability of OS in the setting of clinical trials have seldom been doubted and discussed. This study first raised the common issue that data integrity and reliability are doubtful when we collect OS information or other time-to-event endpoints based solely on simple follow-up records by investigators without supporting material, especially since the 2019 COVID-19 pandemic. Then, two rounds of discussions with 30 Chinese experts were held and 12 potential source scenarios of three methods for obtaining the time of death of participants, including death certificate, death record and follow-up record, were sorted out and analysed. With a comprehensive assessment of the 12 scenarios by legitimacy, data reliability, data acquisition efficiency, difficulty of data acquisition, and coverage of participants, both short-term and long-term recommended sources, overall strategies and detailed measures for improving the integrity and reliability of death date are presented. In the short term, we suggest integrated sources such as public security systems made available to drug inspection centres appropriately as soon as possible to strengthen supervision. Death certificates provided by participants' family members and detailed standard follow-up records are recommended to investigators as the two channels of mutual compensation, and the acquisition of supporting materials is encouraged as long as it is not prohibited legally. Moreover, we expect that the sharing of electronic medical records and the legal disclosure of death records in established health registries can be realized with the joint efforts of the whole industry in the long-term. The above proposed solutions are mainly based on the context of China and can also provide reference for other countries in the world. © 2022 The Authors
ABSTRACT
Summary Overall survival (OS) is considered the standard clinical endpoint to support effectiveness claims in new drug applications globally, particularly for lethal conditions such as cancer. However, the source and reliability of OS in the setting of clinical trials have seldom been doubted and discussed. This study first raised the common issue that data integrity and reliability are doubtful when we collect OS information or other time-to-event endpoints based solely on simple follow-up records by investigators without supporting material, especially since the 2019 COVID-19 pandemic. Then, two rounds of discussions with 30 Chinese experts were held and 12 potential source scenarios of three methods for obtaining the time of death of participants, including death certificate, death record and follow-up record, were sorted out and analysed. With a comprehensive assessment of the 12 scenarios by legitimacy, data reliability, data acquisition efficiency, difficulty of data acquisition, and coverage of participants, both short-term and long-term recommended sources, overall strategies and detailed measures for improving the integrity and reliability of death date are presented. In the short term, we suggest integrated sources such as public security systems made available to drug inspection centres appropriately as soon as possible to strengthen supervision. Death certificates provided by participants’ family members and detailed standard follow-up records are recommended to investigators as the two channels of mutual compensation, and the acquisition of supporting materials is encouraged as long as it is not prohibited legally. Moreover, we expect that the sharing of electronic medical records and the legal disclosure of death records in established health registries can be realized with the joint efforts of the whole industry in the long-term. The above proposed solutions are mainly based on the context of China and can also provide reference for other countries in the world.
ABSTRACT
BACKGROUND: Pregnant women in the era of the COVID-19 pandemic were listed as one of the vulnerable groups at risk of being infected with COVID-19 because during pregnancy there were changes in gestational physiology and immunological changes in the body’s system. Changes in the immune system that occur during pregnancy can make pregnant women more susceptible to coronavirus infection and more at risk of experiencing severe and fatal disease symptoms. AIM: The purpose of this study was to analyze the effect of self-screening on behavior to prevent the risk of being exposed to COVID-19 in pregnant women. METHODS: This type of research is experimental using a randomized controlled trial research design. This research was conducted for 2 weeks in August–September 2021. The population of this study was pregnant women in Surabaya. The sampling technique used consecutive sampling technique and was divided into two groups, namely, the intervention group with 39 respondents and the control group with 39 respondents. Data analysis used the Wilcoxon signed ranks test with a significance value of p < 0.05. The questionnaire used in this study was designed using a reference and behavioral theory approach with a reliability of 0.89 and a validity test that obtained a Cronbach alpha value of 0.86. RESULTS: The average behavior to prevent the risk of being exposed to COVID-19 before conducting a selfscreening intervention in the intervention group was 1.92 (the behavior to prevent the risk of being exposed to COVID-19 was sufficient) and in the control group was 1.85 (the behavior to prevent the risk of being exposed to COVID-19 was sufficient) with p = 0.596 which means there is no difference in the average behavior to prevent the risk of being exposed to COVID-19, while after being given the self-screening intervention the average prevention behavior in the intervention group is 2.46 (the behavior to prevent the risk of being exposed to COVID-19 is good) and in the control group is 2.05 (the behavior of preventing the risk of being exposed to COVID-19 is good) with p = 0.000 which means that there is a difference in the average behavior of preventing the risk of being exposed to COVID-19 in the intervention group and the control group after being given a self-screening intervention. CONCLUSION: In general, this study proves that self-screening can foster behavior to prevent the risk of being exposed to COVID-19 in pregnant women.
ABSTRACT
Purpose of Study Prior to the COVID-19 pandemic, we initiated a randomized clinical trial for childhood obesity. The trial consented 131 and randomized 104;6-12 year old patients who reside in rural regions in 4 member states (DE, NE, SC, and WV) of the ECHO IDeA States Pediatric Clinical Trials Network (ISPCTN) Approximately 6 weeks into the 10-week recruitment period, the trial was forced to pause all study activity due to the COVID-19 pandemic. This pause necessitated a substantial revision in recruitment and study methods to using virtual procedures. This descriptive paper outlines ways to recruit and manage clinical trial participants using technology to obtain informed consent, obtain height and weight measurements by video, and maintain participant engagement throughout the duration of the trial. Methods Used We reviewed multiple data sources to describe the transition to virtual study procedures. These include research electronic data capture (REDCap) surveys conducted both during the pause and at the completion of the study to identify readiness for each site to conduct virtual recruitment and other study procedures as well as at the end of the study to identify issues that each site encountered during the virtual phase of the project. We also reviewed meeting notes and study enrollment figures. Summary of Results The IRB approved study changes allowed for variability between clinical sites in terms of virtual communication platforms and methods for participant consent and height/weight assessment. Identified advantages of the study included ability to conduct visits during all times of the day or evening, and reduced travel requirements. Challenges included poor Internet reliability in some rural areas;additional participant contacts for consent and eligibility screening;shipping delays of materials;reliance on family to perform height and weight measures;increased costs for materials and shipping. Despite the added challenges, all sites were able to meet the study enrollment objectives. Flexibility was key in implementation of virtual procedures given the variations in site resources. Conclusions While each study site had certain challenges unique to their location during the pandemic, we also identified several common issues with the transition to remote procedures. Lessons learned from this study can assist other study groups in navigating challenges, especially when recruiting and implementing studies with a difficult to reach rural and underserved populations or during challenging events like the pandemic.