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1. Korean colonoscopy screening pilot study (K-cospi) for screening colorectal cancer: study protocol for the multicenter, community-based clinical trial

Author

Bomi Park, Jae Kwan Jun, Byung Chang Kim, Kui Son Choi, Mina Suh, The Expert Advisory Committee, The Monitoring Committee, Center for Korean Colonoscopy Screening Pilot Study, and The Research Team on the Protocol Development of Pilot study

Subjects
Colonoscopy, Colorectal cancer screening, Protocol, Pilot study, National Cancer Screening Program, Diseases of the digestive system. Gastroenterology, RC799-869
Abstract

Abstract Background The Korean National Cancer Screening Program has been providing annual fecal immunochemical test for colorectal cancer (CRC) to adults aged 50 years and older since 2004. The Korean Colonoscopy Screening Pilot Study was developed to evaluate the effectiveness of colonoscopy screening for CRC incidence and mortality, screening-related complications, and acceptability of colonoscopy as a primary modality for the national CRC screening program. Methods This study and its protocols have been approved by the Korean Public Institutional Review Board and the National Cancer Center Institutional Review Board. We obtain written informed consent from all participants. The target population is males and females aged 50–74 years living within the pilot sites. A total of 26,640 participants will be recruited for colonoscopy screening. Subjects who have been diagnosed with CRC, who are currently undergoing treatment for CRC, or who have undergone colonoscopy screening within the past 5 years are not allowed to participate. All participants need to complete baseline questionnaires. This pilot study is currently conducted by 104 endoscopists from 57 national cancer screening institutions (42 primary, 10 secondary, and 5 tertiary institutions) located in Goyang-si, Gimpo-si, and Paju-si. The number of endoscopists, medical institutions, and districts participating in the pilot study will be expanded, if necessary. Participating endoscopists at each medical institution perform colonoscopy and report the colonoscopy results to a centralized electronic case report system. We conduct a telephone survey after 7 days and 4 weeks post-colonoscopy to assess for procedure-related complications and satisfaction of the participants. In case of abnormal findings from colonoscopy screening, we track the results from follow-up diagnostic tests. Data from this pilot study will be linked to the diagnostic workup results, the Korean Cancer Registry, and death certificate data for analysis of the performance, long-term effects, and cost-effectiveness of colonoscopy. Discussion The results will provide critical information to determine whether the introduction of colonoscopy as the primary modality of the Korean National Cancer Screening Program would be acceptable and feasible. Trial registration Korean Clinical Research Information Service registry, KCT0004142. Registered on 15 July 2019, http://cris.nih.go.kr/cris/en/search/search_result_st01.jsp?seq=16227

Published
2021
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2. Korean colonoscopy screening pilot study (K-cospi) for screening colorectal cancer: study protocol for the multicenter, community-based clinical trial.

Author

Park, Bomi, Jun, Jae Kwan, Kim, Byung Chang, Choi, Kui Son, Suh, Mina, The Expert Advisory Committee, Kim, Young Sun, Kim, Tae Il, Park, Eun-Cheol, Sohn, Dae Kyung, Sohn, JinHee, Youk, Eui Gon, Chang, Woong Ki, Jang, Byung Ik, Jeong, Seung-Yong, Cha, Jae Myung, Han, Jae Yong, The Monitoring Committee, Kim, Hyun Soo, and Shin, Aesun

Subjects
COMMUNITY-based clinical trials, COLORECTAL cancer, EARLY detection of cancer, COLONOSCOPY, PILOT projects
Abstract

Background: The Korean National Cancer Screening Program has been providing annual fecal immunochemical test for colorectal cancer (CRC) to adults aged 50 years and older since 2004. The Korean Colonoscopy Screening Pilot Study was developed to evaluate the effectiveness of colonoscopy screening for CRC incidence and mortality, screening-related complications, and acceptability of colonoscopy as a primary modality for the national CRC screening program.Methods: This study and its protocols have been approved by the Korean Public Institutional Review Board and the National Cancer Center Institutional Review Board. We obtain written informed consent from all participants. The target population is males and females aged 50-74 years living within the pilot sites. A total of 26,640 participants will be recruited for colonoscopy screening. Subjects who have been diagnosed with CRC, who are currently undergoing treatment for CRC, or who have undergone colonoscopy screening within the past 5 years are not allowed to participate. All participants need to complete baseline questionnaires. This pilot study is currently conducted by 104 endoscopists from 57 national cancer screening institutions (42 primary, 10 secondary, and 5 tertiary institutions) located in Goyang-si, Gimpo-si, and Paju-si. The number of endoscopists, medical institutions, and districts participating in the pilot study will be expanded, if necessary. Participating endoscopists at each medical institution perform colonoscopy and report the colonoscopy results to a centralized electronic case report system. We conduct a telephone survey after 7 days and 4 weeks post-colonoscopy to assess for procedure-related complications and satisfaction of the participants. In case of abnormal findings from colonoscopy screening, we track the results from follow-up diagnostic tests. Data from this pilot study will be linked to the diagnostic workup results, the Korean Cancer Registry, and death certificate data for analysis of the performance, long-term effects, and cost-effectiveness of colonoscopy.Discussion: The results will provide critical information to determine whether the introduction of colonoscopy as the primary modality of the Korean National Cancer Screening Program would be acceptable and feasible. Trial registration Korean Clinical Research Information Service registry, KCT0004142. Registered on 15 July 2019, http://cris.nih.go.kr/cris/en/search/search_result_st01.jsp?seq=16227. [ABSTRACT FROM AUTHOR]

Published
2021
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4. Impact of an early childhood intervention on the home environment, and subsequent effects on child cognitive and emotional development: A secondary analysis

Author

Orla Doyle, Sylvana M. Côté, Richard E. Tremblay, Massimiliano Orri, McGill Group for Suicide Studies [Montréal, Canada] (MGSS), Douglas Mental Health University Institute [Montréal], McGill University = Université McGill [Montréal, Canada]-McGill University = Université McGill [Montréal, Canada], Bordeaux population health (BPH), Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), School of Public Health [Montréal, Canada], Université de Montréal (UdeM), School of Public Health, Physiotherapy and Sports Science [Dublin, Irlande], University College Dublin [Dublin] (UCD), Department of Pediatrics [Montréal, Canada], Department of Psychology [Montréal, Canada], UCD School of Economics [Dublin, Irlande], UCD Geary Institute for Public Policy [Dublin, Irlande], We would like to thank the Northside Partnership who provided funding for the Preparing for Life evaluation through The Atlantic Philanthropies and the Department of Children and Youth Affairs, and the Children’s Research Network for providing funding through the Prevention and Early Intervention Grant Scheme (CRN-PEI-2017). We are also grateful to all those who participated in and supported this research, especially the participating families and community organizations, the PFL intervention staff, and the Expert Advisory Committee. Thanks also to Prof. James Heckman, Prof. Colm Harmon, Prof. Cecily Kelleher, Prof. Sharon Ramey, and Prof. Craig Ramey for their guidance and advice throughout the project, and the Early Childhood Research Team at UCD Geary Institute for Public Policy for their contributions to the work., Bodescot, Myriam, University of Montreal [Montréal, Canada], and Université de Montréal. École de santé publique. Département de médecine sociale et préventive

Subjects
Male, Maternal Health, Emotions, [SDV.MHEP.PSM] Life Sciences [q-bio]/Human health and pathology/Psychiatrics and mental health, Social Sciences, Parenting behavior, Pediatrics, 01 natural sciences, law.invention, Families, 010104 statistics & probability, Cognition, Learning and Memory, 0302 clinical medicine, Moderated mediation, Sociology, Randomized controlled trial, Pregnancy, law, Outcome Assessment, Health Care, Early Intervention, Educational, Medicine and Health Sciences, Psychology, 030212 general & internal medicine, Children, Child development, Schools, Multidisciplinary, Parenting, Obstetrics and Gynecology, House Calls, Child, Preschool, Medicine, Female, Research Article, Clinical psychology, Adult, Mediation (statistics), Science, Environment, Education, Young Adult, 03 medical and health sciences, [SDV.MHEP.PED] Life Sciences [q-bio]/Human health and pathology/Pediatrics, Humans, Learning, Cognitive skill, 0101 mathematics, Poverty, Behavior, [SDV.MHEP.PED]Life Sciences [q-bio]/Human health and pathology/Pediatrics, Latent growth modeling, Infant, Newborn, Cognitive Psychology, Infant, Biology and Life Sciences, Age Groups, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, [SDV.MHEP.PSM]Life Sciences [q-bio]/Human health and pathology/Psychiatrics and mental health, People and Places, Cognitive Science, Women's Health, Early childhood intervention, Population Groupings, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Ireland, Neuroscience
Abstract

International audience; The objective of this study was to use secondary data from the Preparing for Life (PFL) trial to test (1) the impact of a prenatal-to-age-five intervention targeting women from a disadvantaged Irish community on the quality of the home environment; (2) whether any identified changes in the home environment explain the positive effects of the PFL program on children's cognitive and emotional development at school entry which have been identified in previous reports of the PFL trial (ES = .72 and .50, respectively). Pregnant women were randomized into a treatment (home visits, baby massage, and parenting program, n = 115) or control (n = 118) group (trial registration: ISRCTN04631728). The home environment was assessed at 6 months, 1½, and 3 years using the Home Observation for Measurement of the Environment (responsiveness, acceptance, organization, learning material, involvement, variety). Cognitive skills were assessed at 5 years using the British Ability Scales. Emotional problems were teacher-reported at 5 years using the Short Early Development Inventory. Latent growth modeling was used to model changes in the home environment, and mediation analyses to test whether those changes explained children outcomes. Compared to controls, treatment children were exposed to more stimulating environments in terms of learning material (B = -1.62, p = 0.036) and environmental variety (B = -1.58, p = 0.009) at 6 months, but these differences faded at 3 years. Treatment families were also more likely to accept suboptimal child behaviors without using punishment (acceptance score, B = 1.49, p = 0.048) and were more organized at 3 years (B = 1.08, p = 0.033). None of the changes mediated children's outcomes. In conclusion, we found that the program positively impacted different home environment dimensions, but these changes did not account for improvements in children's outcomes. Exploratory analyses suggest that the impact of improvements in the home environment on child outcomes may be limited to specific groups of children. Limitations of the study include the potential lack of generalizability to other populations, the inability to assess the individual treatment components, and sample size restrictions which precluded a moderated mediation analysis.

Published
2019
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