We investigate rates of pathologic complete response (pCR) and tumor expression of ER, PgR, HER2 discordance after neoadjuvant chemotherapy using Japanese breast cancer registry data.
Records of more ...than 300 000 breast cancer cases treated at 800 hospitals from 2004 to 2013 were retrieved from the breast cancer registry. After data cleanup, we included 21 755 patients who received neoadjuvant chemotherapy and had no distant metastases. pCR was defined as no invasive tumor in the breast detected during surgery after neoadjuvant chemotherapy. HER2 overexpression was determined immunohistochemically and/or using fluorescence in situ hybridization.
pCR was achieved in 5.7% of luminal tumors (n = 8730), 24.6% of HER2-positive tumors (n = 4403), and 18.9% of triple-negative tumors (n = 3660). Among HER2-positive tumors, pCR was achieved in 31.6% of ER-negative tumors (n = 2252), 17.0% of ER-positive ones (n = 2132), 31.4% of patients who received trastuzumab as neoadjuvant chemotherapy (n = 2437), and 16.2% of patients who did not receive trastuzumab (n = 1966). Of the 2811 patients who were HER2-positive before treatment, 601 (21.4%) had HER2-negative tumors after neoadjuvant chemotherapy, whereas 340 (3.4%) of the 9947 patients with HER2-negative tumors before treatment had HER2-positive tumors afterward. Of the 10 973 patients with ER-positive tumors before treatment, 499 (4.6%) had ER-negative tumors after neoadjuvant chemotherapy, whereas 519 (9.3%) of the 5607 patients who were ER-negative before treatment had ER-positive tumors afterward.
We confirmed that loss of HER2-positive status can occur after neoadjuvant treatment in patients with primary HER2-positive breast cancer. We also confirmed that in practice, differences in pCR rates between breast cancer subtypes are the same as in clinical trials. Our data strongly support the need for retest ER, PgR, HER2 of surgical sample after neoadjuvant therapy in order to accurately determine appropriate use of targeted therapy.
Measurement and feedback of clinical performance is one of the important activities in clinical database. In addition, clinical database is used for developing medical guidelines, research for public ...policy and clinical research, and also various kinds of information can be provided to the public. On the other hand, risk adjustment for data analysis is a key issue in the clinical database. From these viewpoints, this article described the activities for quality improvement, examples of research, and planning of clinical research using the clinical database.
Clinical database needs quality control and quality assurance of data. Medical staffs of facilities in clinical database need to confirm definitions of data submitted to clinical database and ...criteria of registered cases, and decide how to entry data before data entry. Especially good communication between surgeons and data managers becomes an important factor of data quality in facilities. Also, we need quality improvement initiatives based on high quality data. Clinical database has to assurance data quality. The indicators of data quality are, for examples, completeness of registration and accuracy of data entry and data quality is evaluated on data verification between data of clinical database and medical records in facilities. From these viewpoints, this article described about work flow of registry for participating facilities and medical staffs.
Quality management is necessary for establishing useful clinical database in cooperation with healthcare professionals and facilities. The ways of management are 1) progress management of data entry, ...2) liaison with database participants (healthcare professionals), and 3) modification of data collection form. In addition, healthcare facilities are supposed to consider ethical issues and information security for joining clinical databases. Database participants should check ethical review boards and consultation service for patients.
Data entry system should be constructed considering utility, accuracy, propriety, and feasibility. The methods for developing useful and accurate clinical databases are 1)system development based on ...the concept of "error proofing", 2)system test by real users, 3)guidances for participants, and 4)incentive for accurate data entry. In terms of propriety, to gain patient's consent on data collection and to publicly announce objectives and methods of clinical database are necessary. Confidentiality and anonymization of data are also important. Balancing efficacy and propriety for maximization of patients' and societal benefit is one of the important responsibilities of database management organizations. In addition, assessment of data quality such as audit and feedback is useful for enhancing accuracy and reliability of clinical databases.
We discussed clarification of research purposes and designing of data collection form in large clinical databases. Research purposes are 1)assessment of healthcare quality, 2)evaluation of diagnosis ...and treatment, and 3)evaluation of health policy. In designing clinical databases, the researchers should consider the following themes;assurance of clinical utility, international collaboration, alleviation of data entry burden and assurance of scientific accuracy.
The aim and features of clinical database Okubo, Suguru; Miyata, Hiroaki; Tomotaki, Ai ...
Kyobu geka. The Japanese journal of thoracic surgery
66, Številka:
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Journal Article
Clinical database is a project aiming at quality improvement in medicine. It combines systematic collection of clinical data, analysis and feedback to medical practitioners. Medical professionals can ...clarify their challenges and deal with quality improvement based on feedback. Large and comprehensive clinical databases have been founded in many countries recently. The databases can be used for various purposes; quality indicator, support tool for medical decision-making, policy decision-making and evaluation, clinical research and public reporting. Administrators must pay attention to scientific, ethical and political perspectives. In this manuscript, the authors discussed definitions and issues of large clinical databases.
Background
Metabolic bone disease (MBD) is a common disorder in extremely low‐birth‐weight (ELBW) infants. However, no studies have investigated whether high‐dose calcium (Ca) and phosphorus (P) ...supplementation by parenteral nutrition (PN) prevents MBD in ELBW infants. This study aimed to identify the effect of PN on MBD in ELBW infants.
Methods
We retrospectively analyzed ELBW infants who were admitted between April 2011 and March 2017. ELBW infants were divided into the low‐P group (n = 22) and the high‐P group (n = 26) according to the dose of parenteral P supply. Biochemical and radiological markers of MBD and treatments were analyzed.
Results
Mean daily parenteral intake of Ca and P in the first week was significantly higher in the high‐P group than in the low‐P group (both P ≤ .001). Serum alkaline phosphatase (ALP) levels were significantly higher in the low‐P group than in the high‐P group in the first month. ELBW infants in the low‐P group received alfacalcidol much more frequently than those in the high‐P group. There was a trend of a higher rate of x‐ray changes in the low‐P group than in the high‐P group. No infants developed bone fractures.
Conclusion
Appropriate P intake by PN is required to ensure high Ca intake, reduce ALP levels in the first month, and prevent MBD from hyperparathyroidism and does not worsen x‐ray findings in ELBW infants.
Aims/Introduction
It was reported that fetuses secrete endogenous incretin; however, the stimulants of fetal incretin secretion are not fully understood. To investigate the association between the ...passage of amniotic fluid through the intestinal tract and fetal secretion of incretin, we analyzed umbilical cord incretin levels of infants with duodenum atresia.
Materials and Methods
Infants born from July 2017 to July 2019 (infants with duodenum atresia and normal term or preterm infants) were enrolled. We measured and compared the concentrations of glucagon‐like peptide‐1 (GLP‐1) and gastric inhibitory peptide/glucose‐dependent insulinotropic polypeptide (GIP) in the umbilical vein and preprandial blood samples after birth.
Results
A total of 98 infants (47 term, 46 preterm and 5 with duodenum atresia) were included. In patients with duodenum atresia, umbilical vein GLP‐1 and GIP levels were the same as those in normal infants. In postnatal samples, there were positive correlations between the amount of enteral feeding and preprandial serum concentrations of GLP‐1 (r = 0.47) or GIP (r = 0.49).
Conclusions
Our results show that enteral feeding is important for secretion of GLP‐1 and GIP in postnatal infants, whereas the passage of amniotic fluid is not important for fetal secretion of GLP‐1 and GIP. The effect of ingested material passing through the digestive tract on incretin secretion might change before and after birth. Other factors might stimulate secretion of GLP‐1 and GIP during the fetal period.
Enteral feeding is important for secretion of glucagon‐like peptide‐1 and gastric inhibitory peptide/glucose‐dependent insulinotropic polypeptide in postnatal infants, whereas the passage of amniotic fluid is not important for fetal secretion of glucagon‐like peptide‐1 and inhibitory peptide/glucose‐dependent insulinotropic polypeptide. The effect of ingested material passing through the digestive tract on incretin secretion might change before and after birth.
Background
Few studies have investigated the developmental prognosis of very‐low‐birthweight (VLBW) infants with congenital heart diseases (CHDs). This study aimed to determine the mortality and ...morbidity, including the developmental prognosis, of VLBW infants with CHD.
Methods
This single‐center, retrospective cohort study included VLBW infants admitted to the neonatal intensive care unit from January 2006 to December 2011. Perinatal records were reviewed for CHD diagnosis, treatment details, comorbidities, mortality, and long‐term neurodevelopmental outcomes. The characteristics and neurological developmental quotients at around the age of 3 years were compared among the following three groups of VLBW infants with CHDs: biventricular circulation without intervention (without surgery), biventricular circulation with intervention (catheter intervention or one‐stage surgery), and single‐ventricular circulation (Fontan‐type multiple‐stage surgery).
Results
Among a total of 449 VLBW infants admitted during this period, 45 (10.0%) infants had CHDs, including 25 infants with congenital abnormalities (chromosomal abnormalities and/or multiple anomalies). All 13 infants who died before discharge had congenital abnormalities. The incidence rates of comorbidities were not higher in VLBW infants with CHDs than in those without CHDs. The developmental quotients of the no‐surgery, catheter intervention or one‐stage surgery, and Fontan‐type multiple‐stage surgery groups were 87.2 ± 10.9, 91.3 ± 4.7, and 63.7 ± 8.6, respectively.
Conclusions
The neurological development at around the age of 3 years in VLBW infants with biventricular circulation was in the borderline‐to‐normal range; however, that in infants with single‐ventricular circulation was poor. Further studies are needed to comprehend the neurological development of VLBW infants with CHDs better.
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