Iron deficiency without anemia and iron deficiency anemia are common and frequently overlooked complications of inflammatory bowel disease. Despite the frequency and impact of iron deficiency in inflammatory bowel dis...Iron deficiency without anemia and iron deficiency anemia are common and frequently overlooked complications of inflammatory bowel disease. Despite the frequency and impact of iron deficiency in inflammatory bowel disease, there are gaps in our understanding about its incidence, prevalence and natural history and, consequently, patients may be undertreated. Medical registries have a key role in collecting data on the disease's natural history, the safety and effectiveness of drugs in routine clinical practice, and the quality of care delivered by healthcare services. Even though iron deficiency impacts inflammatory bowel disease patients and healthcare systems substantially, none of the established European inflammatory bowel disease registries systematically collects information on iron parameters and related outcomes. Collection of robust iron parameter data from patient registries is one way to heighten awareness about the importance of iron deficiency in this disease and to generate data to improve the quality of patient care, patient outcomes, and thus quality of life. This objective could be achieved through collection of specific laboratory, clinical, and patientreported measurements that could be incorporated into existing registries. This review describes the status of current European inflammatory bowel disease registries and the data they generate, in order to highlight their potential role in collecting iron data, to discuss how such information gathering could contribute to our understanding of iron deficiency anemia, and to provide practical information in regard to the incorporation of accumulated iron parameter data into registries.展开更多
Objective:This report presents an overview on the progress of clinical trials in Indonesia based on database assessment from clinical trial registries.Methods:Study records that were registered up to December 26,2018,...Objective:This report presents an overview on the progress of clinical trials in Indonesia based on database assessment from clinical trial registries.Methods:Study records that were registered up to December 26,2018,were extracted from three clinical trial registries(ClinicalTrials.gov,ISRCTN registry,and EudraCT)and a clinical trial register(WHO International Clinical Trials Registry Platform(ICTRP))with the keyword“Indonesia”.A total of 505 records comprised of 402 interventional studies and 103 observational studies were found and analyzed.Results:The top five noncommunicable diseases(NCDs)studied were cancers,diabetes,cardiac diseases,hypertension,and gastrointestinal diseases,while the top five infectious diseases(IDs)were malaria,tuberculosis,vaccines for IDs,HIV,and dengue.Remarkably,the proportion of regional studies(within Indonesia only)was higher than that of multiregional studies(including areas outside of Indonesia)in general.This trend became most apparent after the issuance of national regulations on Material Transfer Agreements(MTA)and other rules.Upon closer scrutiny,regional clinical trials and multiregional clinical trials(MRCTs)in Indonesia differed in terms of sponsorship,target population and size,interventions,and study phases.Conclusions:The total number of clinical trials in Indonesia is increasing and is mainly attributed to the growing number of regional clinical trials sponsored from within the country.Interrelated factors have shaped the characteristics of these as compared to the dwindling number of MRCTs.Establishment of a national level of management is an option that can better facilitate both MRCTs as well as regional clinical trials,to better address the national health issues,and to cope with the regulations.展开更多
Objective： The National Central Cancer Registry （NCCR） collected cancer registration data in 2009 from local cancer registries in 2012, and analyzed to describe cancer incidence and mortality in China. Methods： On...Objective： The National Central Cancer Registry （NCCR） collected cancer registration data in 2009 from local cancer registries in 2012, and analyzed to describe cancer incidence and mortality in China. Methods： On basis of the criteria of data quality from NCCR, data submitted from 104 registries were checked and evaluated. There were 72 registries＇ data qualified and accepted for cancer registry annual report in 2012. Descriptive analysis included incidence and mortality stratified by area （urban/rural）, sex, age group and cancer site. The top 10 common cancers in different groups, proportion and cumulative rates were also calculated. Chinese population census in 1982 and Segi＇s population were used for age-standardized incidence/mortality rates. Results： All 72 cancer registries covered a total of 85,470,522 population （57,489,009 in urban and 27,981,513 in rural areas）. The total new cancer incident cases and cancer deaths were 244,366 and 154,310, respectively. The morphology verified cases accounted for 67.23%, and 3.14% of incident cases only had information from death certifications. The crude incidence rate in Chinese cancer registration areas was 285.91/100,000 （males 317.97/100,000, females 253.09/100,000）, age-standardized incidence rates by Chinese standard population （ASIRC） and by world standard population （ASIRW） were 146.87/100,000 and 191.72/100,000 with the cumulative incidence rate （0-74 age years old） of 22.08%. The cancer incidence and ASIRC were 303.39/100,000 and 150.31/100,000 in urban areas whereas in rural areas, they were 249.98/100,000 and 139.68/100,000, respectively. The cancer mortality in Chinese cancer registration areas was 180.54/100,000 （224.20/100,000 in males and 135.85/100,000 in females）, age-standardized mortality rates by Chinese standard population （ASMRC） and by world standard population （ASMRW） were 85.06/100,000 and 115.65/100,000, and the cumulative incidence rate （0-74 age years old） was 12.94%. The cancer mortality and ASMRC were 181.86/100,000 and 80.86/100,000 in urban areas, whereas in rural areas, they were 177.83/100,000 and 94.40/100,000 respectively. Lung cancer, gastric cancer, colorectal cancer, liver cancer, esophageal cancer, pancreas cancer, encephaloma, lymphoma, female breast cancer and cervical cancer, were the most common cancers, accounting for 75% of all cancer cases in urban and rural areas. Lung cancer, gastric cancer, liver cancer, esophageal cancer, colorectal cancer, pancreatic cancer, breast cancer, encephaloma, leukemia and lymphoma accounted for 80% of all cancer deaths. The cancer spectrum showed difference between urban and rural areas, males and females. The main cancers in rural areas were cancers of the stomach, followed by esophageal cancer, lung cancer, liver cancer and colorectal cancer, whereas the main cancer in urban areas was lung cancer, followed by liver cancer, gastric cancer and colorectal cancer. Conclusions： The coverage of cancer registration population has been increasing and data quality is improving. As the basis of cancer control program, cancer registry plays an important role in making anti- cancer strategy in medium and long term. As cancer burdens are different between urban and rural areas in China, prevention and control should be implemented based on practical situation.展开更多
Objective： Annual cancer incidence and mortality in 2008 were provided by National Central Cancer Registry in China, which data were collected from population‐based cancer registries in 2011. Methods： There were 56...Objective： Annual cancer incidence and mortality in 2008 were provided by National Central Cancer Registry in China, which data were collected from population‐based cancer registries in 2011. Methods： There were 56 registries submitted their data in 2008. After checking and evaluating the data quality, total 41 registries＇ data were accepted and pooled for analysis. Incidence and mortality rates by area （urban or rural areas） were assessed, as well as the age‐ and sex‐specific rates, age‐standardized rates, proportions and cumulative rate. Results： The coverage population of the 41 registries was 66,138,784 with 52,158,495 in urban areas and 13,980,289 in rural areas. There were 197,833 new cancer cases and 122,136 deaths in cancer with mortality to incidence ratio of 0.62. The morphological verified rate was 69.33%, and 2.23% of cases were identified by death certificate only. The crude cancer incidence rate in all areas was 299.12/100,000 （330.16/100,000 in male and 267.56/100,000 in female） and the age‐standardized incidence rates by Chinese standard population （ASIRC） and world standard population （ASIRW） were 148.75/100,000 and 194.99/100,000, respectively. The cumulative incidence rate （0-74 years old） was of 22.27%. The crude incidence rate in urban areas was higher than that in rural areas. However, after adjusted by age, the incidence rate in urban was lower than that in rural. The crude cancer mortality was 184.67/100,000 （228.14/100,000 in male and 140.48/100,000 in female）, and the age‐standardized mortality rates by Chinese standard population （ASMRC） and by world population were 84.36/100,000 and 114.32/100,000, respectively. The cumulative mortality rate （0-74 years old） was of 12.89%. Age‐adjusted mortality rates in urban areas were lower than that in rural areas. The most common cancer sites were lung, stomach, colon‐rectum, liver, esophagus, pancreas, brain, lymphoma, breast and cervix which accounted for 75% of all cancer incidence. Lung cancer was the leading cause of cancer death, followed by gastric cancer, liver cancer, esophageal cancer, colorectal cancer and pancreas cancer, which accounted for 80% of all cancer deaths. The cancer spectrum varied by areas and sex in rural areas, cancers from digestive system were more common, such as esophageal cancer, gastric cancer and liver cancer, while incidence rates of lung cancer and colorectal cancer were much higher in urban areas. In addition, breast cancer was the most common cancer in urban women followed by liver cancer, gastric cancer and colorectal cancer. Conclusion： Lung cancer, gastric cancer, colorectal cancer, liver cancer, esophageal cancer and female breast cancer contributed to the increased incidence of cancer, which should be paid more attention to in further national cancer prevention and control program. Different cancer control strategies should be carried out due to the varied cancer spectrum in different groups.展开更多
Background:Cancer incidence rate has been increasing in recent years,and it has improved people’s living and financial burden.The incidence and mortality of malignant tumors in the Heilongjiang cancer registry area i...Background:Cancer incidence rate has been increasing in recent years,and it has improved people’s living and financial burden.The incidence and mortality of malignant tumors in the Heilongjiang cancer registry area in 2016 were analyzed,which provided a scientific basis for the prevention and treatment of malignant tumors in Heilongjiang.Methods:The incidence and death data of tumors were collected from 10 tumor registration areas in Heilongjiang Province in 2016.According to the stratification of urban and rural areas and gender,the crude rate,standard rate,accumulative rates(0–74 years old)were calculated.The China 2000 population census data and Segi’s standard population were used for calculating age-standardized rates.Results:The incidence rate of malignant tumors in the Heilongjiang cancer registry area was 286.05/100,000 in 2016,age-standardized incidence rates by standard Chinese population and by standard world population were 168.11/100,000 and 164.69/100,000 with the cumulative incidence rate(0–74 years old)of 18.55%.The incidence of malignant tumors in urban areas was 313.60/100,000,and that in rural areas was 212.26/100,000.The frequency of malignant tumors in males was 295.94/100,000,higher than that in females(276.40/100,000).Lung cancer had the highest incidence followed by breast cancer,colorectal cancer,liver cancer and thyroid cancer.The mortality rate of malignant tumors in Heilongjiang cancer registration areas was 183.56/100,000,age-standardized mortality rates by standard Chinese population and by standard world population were 99.89/100,000 and 99.78/100,000 with the cumulative mortality rate(0–74 years old)of 10.95%.The mortality rate of malignant tumors in urban areas was 194.69/100,000,and that in rural areas was 153.73/100,000.The mortality rate of the male malignant tumor was 222.55/100,000,higher than that of a female malignant tumor(145.51/100,000).Lung cancer had the highest mortality followed by liver cancer,colorectal cancer,gastric cancer and breast cancer.Conclusion:Lung cancer,liver cancer,breast cancer and colorectal cancer were the most common cancers in Heilongjiang Province,which should be taken as the key cancer species for prevention and treatment.The incidence of thyroid cancer is higher in Heilongjiang Province,but the mortality rate is lower,which also needs attention.展开更多
BACKGROUND Colorectal cancer(CRC)is a global health concern,with advanced-stage diagnoses contributing to poor prognoses.The efficacy of CRC screening has been well-established;nevertheless,a significant proportion of...BACKGROUND Colorectal cancer(CRC)is a global health concern,with advanced-stage diagnoses contributing to poor prognoses.The efficacy of CRC screening has been well-established;nevertheless,a significant proportion of patients remain unscreened,with>70%of cases diagnosed outside screening.Although identifying specific subgroups for whom CRC screening should be particularly recommended is crucial owing to limited resources,the association between the diagnostic routes and identification of these subgroups has been less appreciated.In the Japanese cancer registry,the diagnostic routes for groups discovered outside of screening are primarily categorized into those with comorbidities found during hospital visits and those with CRC-related symptoms.AIM To clarify the stage at CRC diagnosis based on diagnostic routes.METHODS We conducted a retrospective observational study using a cancer registry of patients with CRC between January 2016 and December 2019 at two hospitals.The diagnostic routes were primarily classified into three groups:Cancer screening,follow-up,and symptomatic.The early-stage was defined as Stages 0 or I.Multivariate and univariate logistic regressions were exploited to determine the odds of early-stage diagnosis in the symptomatic and cancer screening groups,referencing the follow-up group.The adjusted covariates were age,sex,and tumor location.RESULTS Of the 2083 patients,715(34.4%),1064(51.1%),and 304(14.6%)belonged to the follow-up,symptomatic,and cancer screening groups,respectively.Among the 2083 patients,CRCs diagnosed at an early stage were 57.3%(410 of 715),23.9%(254 of 1064),and 59.5%(181 of 304)in the follow-up,symptomatic,and cancer screening groups,respectively.The symptomatic group exhibited a lower likelihood of early-stage diagnosis than the follow-up group[P<0.001,adjusted odds ratio(aOR),0.23;95%confidence interval(95%CI):0.19-0.29].The likelihood of diagnosis at an early stage was similar between the follow-up and cancer screening groups(P=0.493,aOR for early-stage diagnosis in the cancer screening group vs follow-up group=1.11;95%CI=0.82-1.49).CONCLUSION CRCs detected during hospital visits for comorbidities were diagnosed earlier,similar to cancer screening.CRC screening should be recommended,particularly for patients without periodical hospital visits for comorbidities.展开更多
The Agatsuma et al’s study shows that despite the evidence of the benefits of an early colorectal cancer(CRC)diagnosis,through screening in asymptomatic subjects,up to 50%of candidates reject this option and many of ...The Agatsuma et al’s study shows that despite the evidence of the benefits of an early colorectal cancer(CRC)diagnosis,through screening in asymptomatic subjects,up to 50%of candidates reject this option and many of those affected are diagnosed later,in advanced stages.The efficacy of screening programs has been well-established for several years,which reduces the risk of CRC morbidity and mortality,without taking into account the test used for screening,or other tools.Nevertheless,a significant proportion of patients remain unscreened,so understanding the factors involved,as well as the barriers of the population to adherence is the first step to possibly modify the participation rate.These barriers could include a full range of social and political aspects,especially the type of financial provision of each health service.In Japan,health services are universal,and this advantageous situation makes it easier for citizens to access to these services,contributing to the detection of various diseases,including CRC.Interestingly,the symptomatic CRC group had a lower early-stage diagnosis rate than the patients detected during follow-up for other comorbidities,and symptomatic and cancer screening groups showed similar early-stage diagnosis.展开更多
近日,《临床肝胆病杂志》被开放学术资源库ROAD(Directory of Open Access Scholarly Resources)收录,标志着本刊开放获取政策和规范与国际标准进一步接轨。ROAD是ISSN国际中心在联合国教科文组织支持下设立的科学学术开放存取资源库,于...近日,《临床肝胆病杂志》被开放学术资源库ROAD(Directory of Open Access Scholarly Resources)收录,标志着本刊开放获取政策和规范与国际标准进一步接轨。ROAD是ISSN国际中心在联合国教科文组织支持下设立的科学学术开放存取资源库,于2013年底启用,是ISSN国际数据库书目记录的一个子集,书目记录由ISSN网络(包括93个国家中心和ISSN国际中心)制作,并得到来自索引库及相关目录[开放存取期刊目录(DOAJ)、Latindex计划、“The Keepers Registry”(保管机构登记处服务)]的元数据以及相关绩效指数(Scopus)的补充。加入ROAD必须遵守严格的标准,涉及期刊定位、学术内容、同行评审、伦理规则、许可声明、编辑责任和可及性等指标。展开更多
Background: Hemodialysis is the most widely used renal replacement therapy in developing countries such as Cote d’Ivoire. Objective: To study the outcome of chronic hemodialysis patients in public centres in Abidjan ...Background: Hemodialysis is the most widely used renal replacement therapy in developing countries such as Cote d’Ivoire. Objective: To study the outcome of chronic hemodialysis patients in public centres in Abidjan using data from the Renal Registry of Cote d’Ivoire (2RCI). Method: This was a prospective analytical cohort study of End Stage Kidney Disease (ESKD) patients undergoing iterative hemodialysis in the network of public hemodialysis centres in Abidjan and who had been registered in the 2RCI register by September 2018. Results: Our study involved 363 cases out of 379 patients registered in the 2RCI registry database in 2018. The mean age of the patients was 47.3 ± 12.1 years, with a male predominance (sex ratio 1.97). In 70.24% of cases, they had no health insurance. The average duration of dialysis for our patients was 6.94 ± 4.1 years, with extremes of 2 and 28 years. This duration was less than 5 years in 44.3% of cases, between 6 and 10 years in 42.9% and more than 10 years in 12.6% of cases. The comorbidities found were hypertension in 95.6% of cases, diabetes in 7.8% and HIV in 4.6%. Anemia was found in 68% of cases and stroke in 8.6%. During the study period, 161 deaths were observed, representing a mortality rate of 44.35%. Acute lung oedema (29.8%), stroke (6.8%) and other cardiovascular diseases (19.3%) were the main causes of death. In multivariate analysis, factors such as age ≥ 65 years (HR = 3.66;CI 95% = 1.55 - 8.67;p = 0.003), “married/coupled” status (HR = 2.02;CI 95% = 1.24 - 3.31;p = 0.005) and normal weight at the start of dialysis (OR = 9.59, CI95% = 4.19 - 21.95;p = 0.001) were associated with the risk of death. Conclusion: Hemodialysis is performed in Abidjan on young patients. The mortality rate after three years of dialysis is very high. Hence the need to pursue the policy of decentralizing public centres and optimizing access to dialysis in terms of quality and quantity in order to improve patient survival.展开更多
Background: Hand injuries are very common and responsible for a significant number of emergency department (ED) visits, most of which are not to hand specialists [1]. The functionality and outcome of hand injuries can...Background: Hand injuries are very common and responsible for a significant number of emergency department (ED) visits, most of which are not to hand specialists [1]. The functionality and outcome of hand injuries can vary significantly depending on the mechanism and pattern of injuries, which is why it is imperative for emergency physicians to recognize the complexities, and the potential repercussion of missed injuries in such cases. Objective: The aim of this study is to provide epidemiological information on hand injuries and their patterns. The objective is 1) to assess whether most hand injuries are superficial (simple), or involve underlying deeper structures (complex) and 2) to assess whether most hand injuries presented to the emergency department were managed by the emergency physician or plastic/orthopaedic surgeon. Methods: This retrospective single-centre observational study conducted at an emergency department in a tertiary care hospital in Mumbai, India collected data from hand trauma patients using a standardized documentation form. Demographic data, trauma-related data, and disposition plans were analysed. Results: A total of 489 cases sustained hand injuries over a period of one year. The patients were predominantly males in the 20 - 30 year age group and injuries were mainly sustained over the right hand. Most of the injuries were sustained at home (42%). The most common mechanism (34%) was sharp object injury (including needle-stick and other sharps in hospital), followed by blunt injury (30%). Among grievous hand injuries, door jamb was a mechanism noted in 11% of patients, accounting for 50% of all crush injuries. Lacerations were the most common pattern (24.7%) noticed, followed closely by fractures (23.3%). Digits II - IV were injured most commonly (54%), followed by carpals (14%) and the thumb (10%). Nearly 80% of the hand injuries were managed by emergency physicians alone, with 61% of cases involving superficial structures. Though 14% of the cases required plastic surgery intervention, the initial evaluation of all these patients was performed by the emergency physician. Conclusions: Our study highlights the burden of hand injuries on the emergency physician, as well as the odds of missed injuries, directly indicating the necessity of a thorough anatomical knowledge of the structures of the hand, and in turn, a proper physical examination. A dedicated registry for hand trauma would help quantify the mechanism and pattern of injuries, and formulate preventive strategies.展开更多
To present the advances of evidence-based medicine and clinical research methodology in integrative oncology,we conducted a literature review of real-world studies of traditional Chinese medicine(TCM)in cancer care an...To present the advances of evidence-based medicine and clinical research methodology in integrative oncology,we conducted a literature review of real-world studies of traditional Chinese medicine(TCM)in cancer care and summarized the available evidence.Pragmatic randomized controlled trials(pRCTs)and clinical registry studies are becoming more popular as they could compensate for the limitations of RCTs.Many RCTs of TCM for cancer treatment as well as systematic reviews have been published.The most investigated therapies are based on acupuncture,Chinese herbal compounds,and Chinese patent medicines.Acupuncture has a significant advantage in relieving cancer-related symptoms.Published studies focus more on improving clinical symptoms and laboratory indicators.However,the patient's quality of life deserves more attention.展开更多
Objectives: Senegal, with the support of WHO, had begun the establishment of a National Cancer Registry in 2009, although it had been at a standstill since 1969;the objective of this work was to test the reliability o...Objectives: Senegal, with the support of WHO, had begun the establishment of a National Cancer Registry in 2009, although it had been at a standstill since 1969;the objective of this work was to test the reliability of data collection tools and feasibility stages necessary for the validation of media before the establishment of a national cancer registry. Methodology: We conducted a non-exhaustive preliminary study over a period of three months from the first of January to 31 March 2010 at four major hospitals in Dakar at the time. Results: Two hundred and eighty-nine cases had been identified: 44% of men (n = 127) and 56% of women (n = 162) with a sex ratio of 0.8. The ages ranged from 20 to 90 years with an average of 50 years. The main diagnostic mode was essentially histological, with 76% of cases (n = 219). The most frequent locations were: ORL (ENT meaning Ear, Nose and Throat) with 25% of cases, liver 7% and bronchopulmonary 4.5% of cases. In men, liver cancer was the most common location and women for cervical cancer with 16%. Squamous cell carcinoma was the most common histological type with 68% of cases followed by adenocarcinoma with 22% of cases. Thirty-eight percent of patients were classified as stage III and IV. A quarter of our patients had received palliative treatment. In contrast, 15 (15%) had received chemotherapy and 4% had received radiotherapy. Data collection was satisfactory. Conclusion: Cancer is a reality in Senegal but it remains underdiagnosed. The materials made it possible to make the cancer registry effective throughout the country.展开更多
Background: Breast cancer mortality remains high in the majority of developing countries. The Ministry of Health has established two population-based cancer registries in Benin: the first one in Cotonou in 2014 and th...Background: Breast cancer mortality remains high in the majority of developing countries. The Ministry of Health has established two population-based cancer registries in Benin: the first one in Cotonou in 2014 and the second one in Parakou in 2017. However, there is a scarcity of data on breast cancer survival and prognosis in Benin Republic. Objective: This study sought to investigate epidemiological, diagnostic, and survival aspects of breast cancer in Parakou, based on data from its population-based cancer registry from 2017 to 2021. Method: For descriptive and analytical purposes, we used a retrospective cohort design. From January 24, 2022 to August 31, 2022, data were collected in all health facilities covered by the Parakou population-based cancer registry using an individual questionnaire. Survival and prognosis analysis were performed using KAPLAN MEIER method and David COX proportional hazard model respectively. Result: A total of 81 patients have been included in this study. The incidence rate of breast cancer in Parakou was 17.5 per 100,000 person-years with a mortality rate of 2.76 per 100,000 person-years. The median age at diagnosis was 44.50 years with extremes ranging from 19 to 76 years and a predominance of 40 - 50 years age group. The median survival time was estimated at 30 months with an overall 5-year survival of 47%. Young age at diagnosis (p-value = 0.002) and advanced stage at diagnosis (p-value = 0.000) had a negative impact on survival in women. The combination of surgery and chemotherapy improved survival (p-value = 0.018). Conclusion: Breast cancer is still a public health issue in Parakou. It comes out mandatory that resources be made available to make screening, early diagnosis and appropriate treatment of breast cancer affordable.展开更多
BACKGROUND Traditionally, the mortality rate at 1-year post hip fracture was quoted as approximately 30% of all hip fractures. There have been recent improvements in hip fracture care in the main driven by national hi...BACKGROUND Traditionally, the mortality rate at 1-year post hip fracture was quoted as approximately 30% of all hip fractures. There have been recent improvements in hip fracture care in the main driven by national hip fracture registries with reductions in 30-d mortality rates reported.AIM To address recent 1-year post hip fracture mortality rates in the literature.METHODS Systematic literature review, national hip fracture registries/databases, local studies on hip fracture mortality, 5 years limitation(2013-2017), cohorts > 100,studies in English. Outcome measure: Mortality rate at 1-year post hip fracture.RESULTS Recent 1-year mortality rates were reviewed using the literature from 8 National Registries and 36 different countries. Recently published 1-year mortality rates appear lower than traditional figures and may represent a downward trend.CONCLUSION There appears to be a consistent worldwide reduction in mortality at 1-year post hip fracture compared to previously published research. Globally, those which suffer hip fractures may currently be benefiting from the results of approximately 30 years of national registries, rigorous audit processes and international collaboration. The previously quoted mortality rates of 10% at 1-mo and 30% at 1-year may be outdated.展开更多
Drug use during pregnancy is not common.Drug-induced liver injury(DILI)is a potential complication that is rare but can adversely affect both the mother and the fetus.Although many drugs can directly cause hepatotoxic...Drug use during pregnancy is not common.Drug-induced liver injury(DILI)is a potential complication that is rare but can adversely affect both the mother and the fetus.Although many drugs can directly cause hepatotoxicity,idiosyncratic liver injury is common in pregnancy.Underreporting of adverse drug reactions,lack of adequate literature regarding drug safety in pregnancy,and the inherent difficulty in diagnosing DILI during pregnancy make the management of this condition challenging.This review attempts to describe the existing literature regarding DILI in pregnancy,which is mainly in the form of case reports;several studies have looked at the safety of antithyroid drugs,antiretroviral drugs,and paracetamol,which have an indication for use in pregnancy;the relevant data from these studies with regard to DILI has been presented.In addition,the review describes the diagnosis of DILI,grading the disease severity,assessment of causality linking the drug to the adverse event,regulatory guidelines for evaluating the potential of drugs to cause liver injury,efforts to ensure better participation of women in clinical trials and studies in pregnant women population in particular,and the challenges involved in generating adequate research evidence.The establishment of DILI registries in various countries is an encouraging development;however,there is a need for promoting active,spontaneous reporting of adverse events during pregnancy to ensure rapid generation of evidence regarding the safety of a drug in pregnant women.展开更多
文摘Iron deficiency without anemia and iron deficiency anemia are common and frequently overlooked complications of inflammatory bowel disease. Despite the frequency and impact of iron deficiency in inflammatory bowel disease, there are gaps in our understanding about its incidence, prevalence and natural history and, consequently, patients may be undertreated. Medical registries have a key role in collecting data on the disease's natural history, the safety and effectiveness of drugs in routine clinical practice, and the quality of care delivered by healthcare services. Even though iron deficiency impacts inflammatory bowel disease patients and healthcare systems substantially, none of the established European inflammatory bowel disease registries systematically collects information on iron parameters and related outcomes. Collection of robust iron parameter data from patient registries is one way to heighten awareness about the importance of iron deficiency in this disease and to generate data to improve the quality of patient care, patient outcomes, and thus quality of life. This objective could be achieved through collection of specific laboratory, clinical, and patientreported measurements that could be incorporated into existing registries. This review describes the status of current European inflammatory bowel disease registries and the data they generate, in order to highlight their potential role in collecting iron data, to discuss how such information gathering could contribute to our understanding of iron deficiency anemia, and to provide practical information in regard to the incorporation of accumulated iron parameter data into registries.
文摘Objective:This report presents an overview on the progress of clinical trials in Indonesia based on database assessment from clinical trial registries.Methods:Study records that were registered up to December 26,2018,were extracted from three clinical trial registries(ClinicalTrials.gov,ISRCTN registry,and EudraCT)and a clinical trial register(WHO International Clinical Trials Registry Platform(ICTRP))with the keyword“Indonesia”.A total of 505 records comprised of 402 interventional studies and 103 observational studies were found and analyzed.Results:The top five noncommunicable diseases(NCDs)studied were cancers,diabetes,cardiac diseases,hypertension,and gastrointestinal diseases,while the top five infectious diseases(IDs)were malaria,tuberculosis,vaccines for IDs,HIV,and dengue.Remarkably,the proportion of regional studies(within Indonesia only)was higher than that of multiregional studies(including areas outside of Indonesia)in general.This trend became most apparent after the issuance of national regulations on Material Transfer Agreements(MTA)and other rules.Upon closer scrutiny,regional clinical trials and multiregional clinical trials(MRCTs)in Indonesia differed in terms of sponsorship,target population and size,interventions,and study phases.Conclusions:The total number of clinical trials in Indonesia is increasing and is mainly attributed to the growing number of regional clinical trials sponsored from within the country.Interrelated factors have shaped the characteristics of these as compared to the dwindling number of MRCTs.Establishment of a national level of management is an option that can better facilitate both MRCTs as well as regional clinical trials,to better address the national health issues,and to cope with the regulations.
文摘Objective： The National Central Cancer Registry （NCCR） collected cancer registration data in 2009 from local cancer registries in 2012, and analyzed to describe cancer incidence and mortality in China. Methods： On basis of the criteria of data quality from NCCR, data submitted from 104 registries were checked and evaluated. There were 72 registries＇ data qualified and accepted for cancer registry annual report in 2012. Descriptive analysis included incidence and mortality stratified by area （urban/rural）, sex, age group and cancer site. The top 10 common cancers in different groups, proportion and cumulative rates were also calculated. Chinese population census in 1982 and Segi＇s population were used for age-standardized incidence/mortality rates. Results： All 72 cancer registries covered a total of 85,470,522 population （57,489,009 in urban and 27,981,513 in rural areas）. The total new cancer incident cases and cancer deaths were 244,366 and 154,310, respectively. The morphology verified cases accounted for 67.23%, and 3.14% of incident cases only had information from death certifications. The crude incidence rate in Chinese cancer registration areas was 285.91/100,000 （males 317.97/100,000, females 253.09/100,000）, age-standardized incidence rates by Chinese standard population （ASIRC） and by world standard population （ASIRW） were 146.87/100,000 and 191.72/100,000 with the cumulative incidence rate （0-74 age years old） of 22.08%. The cancer incidence and ASIRC were 303.39/100,000 and 150.31/100,000 in urban areas whereas in rural areas, they were 249.98/100,000 and 139.68/100,000, respectively. The cancer mortality in Chinese cancer registration areas was 180.54/100,000 （224.20/100,000 in males and 135.85/100,000 in females）, age-standardized mortality rates by Chinese standard population （ASMRC） and by world standard population （ASMRW） were 85.06/100,000 and 115.65/100,000, and the cumulative incidence rate （0-74 age years old） was 12.94%. The cancer mortality and ASMRC were 181.86/100,000 and 80.86/100,000 in urban areas, whereas in rural areas, they were 177.83/100,000 and 94.40/100,000 respectively. Lung cancer, gastric cancer, colorectal cancer, liver cancer, esophageal cancer, pancreas cancer, encephaloma, lymphoma, female breast cancer and cervical cancer, were the most common cancers, accounting for 75% of all cancer cases in urban and rural areas. Lung cancer, gastric cancer, liver cancer, esophageal cancer, colorectal cancer, pancreatic cancer, breast cancer, encephaloma, leukemia and lymphoma accounted for 80% of all cancer deaths. The cancer spectrum showed difference between urban and rural areas, males and females. The main cancers in rural areas were cancers of the stomach, followed by esophageal cancer, lung cancer, liver cancer and colorectal cancer, whereas the main cancer in urban areas was lung cancer, followed by liver cancer, gastric cancer and colorectal cancer. Conclusions： The coverage of cancer registration population has been increasing and data quality is improving. As the basis of cancer control program, cancer registry plays an important role in making anti- cancer strategy in medium and long term. As cancer burdens are different between urban and rural areas in China, prevention and control should be implemented based on practical situation.
文摘Objective： Annual cancer incidence and mortality in 2008 were provided by National Central Cancer Registry in China, which data were collected from population‐based cancer registries in 2011. Methods： There were 56 registries submitted their data in 2008. After checking and evaluating the data quality, total 41 registries＇ data were accepted and pooled for analysis. Incidence and mortality rates by area （urban or rural areas） were assessed, as well as the age‐ and sex‐specific rates, age‐standardized rates, proportions and cumulative rate. Results： The coverage population of the 41 registries was 66,138,784 with 52,158,495 in urban areas and 13,980,289 in rural areas. There were 197,833 new cancer cases and 122,136 deaths in cancer with mortality to incidence ratio of 0.62. The morphological verified rate was 69.33%, and 2.23% of cases were identified by death certificate only. The crude cancer incidence rate in all areas was 299.12/100,000 （330.16/100,000 in male and 267.56/100,000 in female） and the age‐standardized incidence rates by Chinese standard population （ASIRC） and world standard population （ASIRW） were 148.75/100,000 and 194.99/100,000, respectively. The cumulative incidence rate （0-74 years old） was of 22.27%. The crude incidence rate in urban areas was higher than that in rural areas. However, after adjusted by age, the incidence rate in urban was lower than that in rural. The crude cancer mortality was 184.67/100,000 （228.14/100,000 in male and 140.48/100,000 in female）, and the age‐standardized mortality rates by Chinese standard population （ASMRC） and by world population were 84.36/100,000 and 114.32/100,000, respectively. The cumulative mortality rate （0-74 years old） was of 12.89%. Age‐adjusted mortality rates in urban areas were lower than that in rural areas. The most common cancer sites were lung, stomach, colon‐rectum, liver, esophagus, pancreas, brain, lymphoma, breast and cervix which accounted for 75% of all cancer incidence. Lung cancer was the leading cause of cancer death, followed by gastric cancer, liver cancer, esophageal cancer, colorectal cancer and pancreas cancer, which accounted for 80% of all cancer deaths. The cancer spectrum varied by areas and sex in rural areas, cancers from digestive system were more common, such as esophageal cancer, gastric cancer and liver cancer, while incidence rates of lung cancer and colorectal cancer were much higher in urban areas. In addition, breast cancer was the most common cancer in urban women followed by liver cancer, gastric cancer and colorectal cancer. Conclusion： Lung cancer, gastric cancer, colorectal cancer, liver cancer, esophageal cancer and female breast cancer contributed to the increased incidence of cancer, which should be paid more attention to in further national cancer prevention and control program. Different cancer control strategies should be carried out due to the varied cancer spectrum in different groups.
文摘Background:Cancer incidence rate has been increasing in recent years,and it has improved people’s living and financial burden.The incidence and mortality of malignant tumors in the Heilongjiang cancer registry area in 2016 were analyzed,which provided a scientific basis for the prevention and treatment of malignant tumors in Heilongjiang.Methods:The incidence and death data of tumors were collected from 10 tumor registration areas in Heilongjiang Province in 2016.According to the stratification of urban and rural areas and gender,the crude rate,standard rate,accumulative rates(0–74 years old)were calculated.The China 2000 population census data and Segi’s standard population were used for calculating age-standardized rates.Results:The incidence rate of malignant tumors in the Heilongjiang cancer registry area was 286.05/100,000 in 2016,age-standardized incidence rates by standard Chinese population and by standard world population were 168.11/100,000 and 164.69/100,000 with the cumulative incidence rate(0–74 years old)of 18.55%.The incidence of malignant tumors in urban areas was 313.60/100,000,and that in rural areas was 212.26/100,000.The frequency of malignant tumors in males was 295.94/100,000,higher than that in females(276.40/100,000).Lung cancer had the highest incidence followed by breast cancer,colorectal cancer,liver cancer and thyroid cancer.The mortality rate of malignant tumors in Heilongjiang cancer registration areas was 183.56/100,000,age-standardized mortality rates by standard Chinese population and by standard world population were 99.89/100,000 and 99.78/100,000 with the cumulative mortality rate(0–74 years old)of 10.95%.The mortality rate of malignant tumors in urban areas was 194.69/100,000,and that in rural areas was 153.73/100,000.The mortality rate of the male malignant tumor was 222.55/100,000,higher than that of a female malignant tumor(145.51/100,000).Lung cancer had the highest mortality followed by liver cancer,colorectal cancer,gastric cancer and breast cancer.Conclusion:Lung cancer,liver cancer,breast cancer and colorectal cancer were the most common cancers in Heilongjiang Province,which should be taken as the key cancer species for prevention and treatment.The incidence of thyroid cancer is higher in Heilongjiang Province,but the mortality rate is lower,which also needs attention.
基金the Foundation for Cancer Research supported by Kyoto Preventive Medical Center and the Japan Society for the Promotion of Science(JSPS)Grants-in-Aid KAKENHI,No.JP 22K21080.
文摘BACKGROUND Colorectal cancer(CRC)is a global health concern,with advanced-stage diagnoses contributing to poor prognoses.The efficacy of CRC screening has been well-established;nevertheless,a significant proportion of patients remain unscreened,with>70%of cases diagnosed outside screening.Although identifying specific subgroups for whom CRC screening should be particularly recommended is crucial owing to limited resources,the association between the diagnostic routes and identification of these subgroups has been less appreciated.In the Japanese cancer registry,the diagnostic routes for groups discovered outside of screening are primarily categorized into those with comorbidities found during hospital visits and those with CRC-related symptoms.AIM To clarify the stage at CRC diagnosis based on diagnostic routes.METHODS We conducted a retrospective observational study using a cancer registry of patients with CRC between January 2016 and December 2019 at two hospitals.The diagnostic routes were primarily classified into three groups:Cancer screening,follow-up,and symptomatic.The early-stage was defined as Stages 0 or I.Multivariate and univariate logistic regressions were exploited to determine the odds of early-stage diagnosis in the symptomatic and cancer screening groups,referencing the follow-up group.The adjusted covariates were age,sex,and tumor location.RESULTS Of the 2083 patients,715(34.4%),1064(51.1%),and 304(14.6%)belonged to the follow-up,symptomatic,and cancer screening groups,respectively.Among the 2083 patients,CRCs diagnosed at an early stage were 57.3%(410 of 715),23.9%(254 of 1064),and 59.5%(181 of 304)in the follow-up,symptomatic,and cancer screening groups,respectively.The symptomatic group exhibited a lower likelihood of early-stage diagnosis than the follow-up group[P<0.001,adjusted odds ratio(aOR),0.23;95%confidence interval(95%CI):0.19-0.29].The likelihood of diagnosis at an early stage was similar between the follow-up and cancer screening groups(P=0.493,aOR for early-stage diagnosis in the cancer screening group vs follow-up group=1.11;95%CI=0.82-1.49).CONCLUSION CRCs detected during hospital visits for comorbidities were diagnosed earlier,similar to cancer screening.CRC screening should be recommended,particularly for patients without periodical hospital visits for comorbidities.
文摘The Agatsuma et al’s study shows that despite the evidence of the benefits of an early colorectal cancer(CRC)diagnosis,through screening in asymptomatic subjects,up to 50%of candidates reject this option and many of those affected are diagnosed later,in advanced stages.The efficacy of screening programs has been well-established for several years,which reduces the risk of CRC morbidity and mortality,without taking into account the test used for screening,or other tools.Nevertheless,a significant proportion of patients remain unscreened,so understanding the factors involved,as well as the barriers of the population to adherence is the first step to possibly modify the participation rate.These barriers could include a full range of social and political aspects,especially the type of financial provision of each health service.In Japan,health services are universal,and this advantageous situation makes it easier for citizens to access to these services,contributing to the detection of various diseases,including CRC.Interestingly,the symptomatic CRC group had a lower early-stage diagnosis rate than the patients detected during follow-up for other comorbidities,and symptomatic and cancer screening groups showed similar early-stage diagnosis.
文摘近日,《临床肝胆病杂志》被开放学术资源库ROAD(Directory of Open Access Scholarly Resources)收录,标志着本刊开放获取政策和规范与国际标准进一步接轨。ROAD是ISSN国际中心在联合国教科文组织支持下设立的科学学术开放存取资源库,于2013年底启用,是ISSN国际数据库书目记录的一个子集,书目记录由ISSN网络(包括93个国家中心和ISSN国际中心)制作,并得到来自索引库及相关目录[开放存取期刊目录(DOAJ)、Latindex计划、“The Keepers Registry”(保管机构登记处服务)]的元数据以及相关绩效指数(Scopus)的补充。加入ROAD必须遵守严格的标准,涉及期刊定位、学术内容、同行评审、伦理规则、许可声明、编辑责任和可及性等指标。
文摘Background: Hemodialysis is the most widely used renal replacement therapy in developing countries such as Cote d’Ivoire. Objective: To study the outcome of chronic hemodialysis patients in public centres in Abidjan using data from the Renal Registry of Cote d’Ivoire (2RCI). Method: This was a prospective analytical cohort study of End Stage Kidney Disease (ESKD) patients undergoing iterative hemodialysis in the network of public hemodialysis centres in Abidjan and who had been registered in the 2RCI register by September 2018. Results: Our study involved 363 cases out of 379 patients registered in the 2RCI registry database in 2018. The mean age of the patients was 47.3 ± 12.1 years, with a male predominance (sex ratio 1.97). In 70.24% of cases, they had no health insurance. The average duration of dialysis for our patients was 6.94 ± 4.1 years, with extremes of 2 and 28 years. This duration was less than 5 years in 44.3% of cases, between 6 and 10 years in 42.9% and more than 10 years in 12.6% of cases. The comorbidities found were hypertension in 95.6% of cases, diabetes in 7.8% and HIV in 4.6%. Anemia was found in 68% of cases and stroke in 8.6%. During the study period, 161 deaths were observed, representing a mortality rate of 44.35%. Acute lung oedema (29.8%), stroke (6.8%) and other cardiovascular diseases (19.3%) were the main causes of death. In multivariate analysis, factors such as age ≥ 65 years (HR = 3.66;CI 95% = 1.55 - 8.67;p = 0.003), “married/coupled” status (HR = 2.02;CI 95% = 1.24 - 3.31;p = 0.005) and normal weight at the start of dialysis (OR = 9.59, CI95% = 4.19 - 21.95;p = 0.001) were associated with the risk of death. Conclusion: Hemodialysis is performed in Abidjan on young patients. The mortality rate after three years of dialysis is very high. Hence the need to pursue the policy of decentralizing public centres and optimizing access to dialysis in terms of quality and quantity in order to improve patient survival.
文摘Background: Hand injuries are very common and responsible for a significant number of emergency department (ED) visits, most of which are not to hand specialists [1]. The functionality and outcome of hand injuries can vary significantly depending on the mechanism and pattern of injuries, which is why it is imperative for emergency physicians to recognize the complexities, and the potential repercussion of missed injuries in such cases. Objective: The aim of this study is to provide epidemiological information on hand injuries and their patterns. The objective is 1) to assess whether most hand injuries are superficial (simple), or involve underlying deeper structures (complex) and 2) to assess whether most hand injuries presented to the emergency department were managed by the emergency physician or plastic/orthopaedic surgeon. Methods: This retrospective single-centre observational study conducted at an emergency department in a tertiary care hospital in Mumbai, India collected data from hand trauma patients using a standardized documentation form. Demographic data, trauma-related data, and disposition plans were analysed. Results: A total of 489 cases sustained hand injuries over a period of one year. The patients were predominantly males in the 20 - 30 year age group and injuries were mainly sustained over the right hand. Most of the injuries were sustained at home (42%). The most common mechanism (34%) was sharp object injury (including needle-stick and other sharps in hospital), followed by blunt injury (30%). Among grievous hand injuries, door jamb was a mechanism noted in 11% of patients, accounting for 50% of all crush injuries. Lacerations were the most common pattern (24.7%) noticed, followed closely by fractures (23.3%). Digits II - IV were injured most commonly (54%), followed by carpals (14%) and the thumb (10%). Nearly 80% of the hand injuries were managed by emergency physicians alone, with 61% of cases involving superficial structures. Though 14% of the cases required plastic surgery intervention, the initial evaluation of all these patients was performed by the emergency physician. Conclusions: Our study highlights the burden of hand injuries on the emergency physician, as well as the odds of missed injuries, directly indicating the necessity of a thorough anatomical knowledge of the structures of the hand, and in turn, a proper physical examination. A dedicated registry for hand trauma would help quantify the mechanism and pattern of injuries, and formulate preventive strategies.
基金This study was supported by the Key Project of the National Natural Science Foundation of China(81830115).
文摘To present the advances of evidence-based medicine and clinical research methodology in integrative oncology,we conducted a literature review of real-world studies of traditional Chinese medicine(TCM)in cancer care and summarized the available evidence.Pragmatic randomized controlled trials(pRCTs)and clinical registry studies are becoming more popular as they could compensate for the limitations of RCTs.Many RCTs of TCM for cancer treatment as well as systematic reviews have been published.The most investigated therapies are based on acupuncture,Chinese herbal compounds,and Chinese patent medicines.Acupuncture has a significant advantage in relieving cancer-related symptoms.Published studies focus more on improving clinical symptoms and laboratory indicators.However,the patient's quality of life deserves more attention.
文摘Objectives: Senegal, with the support of WHO, had begun the establishment of a National Cancer Registry in 2009, although it had been at a standstill since 1969;the objective of this work was to test the reliability of data collection tools and feasibility stages necessary for the validation of media before the establishment of a national cancer registry. Methodology: We conducted a non-exhaustive preliminary study over a period of three months from the first of January to 31 March 2010 at four major hospitals in Dakar at the time. Results: Two hundred and eighty-nine cases had been identified: 44% of men (n = 127) and 56% of women (n = 162) with a sex ratio of 0.8. The ages ranged from 20 to 90 years with an average of 50 years. The main diagnostic mode was essentially histological, with 76% of cases (n = 219). The most frequent locations were: ORL (ENT meaning Ear, Nose and Throat) with 25% of cases, liver 7% and bronchopulmonary 4.5% of cases. In men, liver cancer was the most common location and women for cervical cancer with 16%. Squamous cell carcinoma was the most common histological type with 68% of cases followed by adenocarcinoma with 22% of cases. Thirty-eight percent of patients were classified as stage III and IV. A quarter of our patients had received palliative treatment. In contrast, 15 (15%) had received chemotherapy and 4% had received radiotherapy. Data collection was satisfactory. Conclusion: Cancer is a reality in Senegal but it remains underdiagnosed. The materials made it possible to make the cancer registry effective throughout the country.
文摘Background: Breast cancer mortality remains high in the majority of developing countries. The Ministry of Health has established two population-based cancer registries in Benin: the first one in Cotonou in 2014 and the second one in Parakou in 2017. However, there is a scarcity of data on breast cancer survival and prognosis in Benin Republic. Objective: This study sought to investigate epidemiological, diagnostic, and survival aspects of breast cancer in Parakou, based on data from its population-based cancer registry from 2017 to 2021. Method: For descriptive and analytical purposes, we used a retrospective cohort design. From January 24, 2022 to August 31, 2022, data were collected in all health facilities covered by the Parakou population-based cancer registry using an individual questionnaire. Survival and prognosis analysis were performed using KAPLAN MEIER method and David COX proportional hazard model respectively. Result: A total of 81 patients have been included in this study. The incidence rate of breast cancer in Parakou was 17.5 per 100,000 person-years with a mortality rate of 2.76 per 100,000 person-years. The median age at diagnosis was 44.50 years with extremes ranging from 19 to 76 years and a predominance of 40 - 50 years age group. The median survival time was estimated at 30 months with an overall 5-year survival of 47%. Young age at diagnosis (p-value = 0.002) and advanced stage at diagnosis (p-value = 0.000) had a negative impact on survival in women. The combination of surgery and chemotherapy improved survival (p-value = 0.018). Conclusion: Breast cancer is still a public health issue in Parakou. It comes out mandatory that resources be made available to make screening, early diagnosis and appropriate treatment of breast cancer affordable.
文摘BACKGROUND Traditionally, the mortality rate at 1-year post hip fracture was quoted as approximately 30% of all hip fractures. There have been recent improvements in hip fracture care in the main driven by national hip fracture registries with reductions in 30-d mortality rates reported.AIM To address recent 1-year post hip fracture mortality rates in the literature.METHODS Systematic literature review, national hip fracture registries/databases, local studies on hip fracture mortality, 5 years limitation(2013-2017), cohorts > 100,studies in English. Outcome measure: Mortality rate at 1-year post hip fracture.RESULTS Recent 1-year mortality rates were reviewed using the literature from 8 National Registries and 36 different countries. Recently published 1-year mortality rates appear lower than traditional figures and may represent a downward trend.CONCLUSION There appears to be a consistent worldwide reduction in mortality at 1-year post hip fracture compared to previously published research. Globally, those which suffer hip fractures may currently be benefiting from the results of approximately 30 years of national registries, rigorous audit processes and international collaboration. The previously quoted mortality rates of 10% at 1-mo and 30% at 1-year may be outdated.
文摘Drug use during pregnancy is not common.Drug-induced liver injury(DILI)is a potential complication that is rare but can adversely affect both the mother and the fetus.Although many drugs can directly cause hepatotoxicity,idiosyncratic liver injury is common in pregnancy.Underreporting of adverse drug reactions,lack of adequate literature regarding drug safety in pregnancy,and the inherent difficulty in diagnosing DILI during pregnancy make the management of this condition challenging.This review attempts to describe the existing literature regarding DILI in pregnancy,which is mainly in the form of case reports;several studies have looked at the safety of antithyroid drugs,antiretroviral drugs,and paracetamol,which have an indication for use in pregnancy;the relevant data from these studies with regard to DILI has been presented.In addition,the review describes the diagnosis of DILI,grading the disease severity,assessment of causality linking the drug to the adverse event,regulatory guidelines for evaluating the potential of drugs to cause liver injury,efforts to ensure better participation of women in clinical trials and studies in pregnant women population in particular,and the challenges involved in generating adequate research evidence.The establishment of DILI registries in various countries is an encouraging development;however,there is a need for promoting active,spontaneous reporting of adverse events during pregnancy to ensure rapid generation of evidence regarding the safety of a drug in pregnant women.
