Registry Records Research Articles

Evolving Interoperability Across a State Public Health Immunization Registry and Electronic Health Records.

The critical need for system interoperability and robust information infrastructure in public health was highlighted during the COVID-19 pandemic. An assessment of the evolving interoperability between immunization information system (IIS) in a state-based public health agency and electronic health records (EHRs) including pandemic-driven evolution/use was conducted. The Minnesota Immunization Information Connection (MIIC), the IIS for Minnesota (US) supports interoperability with EHRs using HL7v2.5.1 standards-based queries. Structured interviews were conducted with 28 experts across 12 healthcare systems and public health clinics (n=286 sites) between April - July 2022. Though all reported use of MIIC, most (83%) had MIIC integration within their EHRs, and high EHR queries to MIIC (∼6 million/month), numerous organizational/technical barriers were identified including standard vaccine-naming need in EHRs, app access issues, limited resources and informatics-staff shortage in public health. Results underscore vital role of IIS, on-going interoperability evaluation to address issues and promote standards-based bi-directional EHR-IIS data exchanges.

Survival analysis of breast cancer patients luminal subtype B on lymphovascular invasion (LVI), tumor-infiltrating lymphocyte (TIL), and expression of mammaglobin A

Background: With 1 in 10 women receiving a new cancer diagnosis each year, breast cancer is the most frequent cancer among women. Luminal B breast cancer incidence rates are rising in non-Hispanic white women aged 55 to 69 in Asia/Pacific and Indonesia subtype across all age groups. In Bali, Luminal B is the most prevalent subtype with the greatest fatality rate. This study aims to prove the survival analysis of Luminal B subtype breast cancer patients based on lymphovascular invasion (LVI), tumor-infiltrating lymphocyte (TIL), and mammaglobin A expression. Methods: This study is a survival analysis using nested and prospective cohort methods. Retrospective data were taken from the Cancer Registry and Medical Records (MR) of patients in Sanglah General Hospital, mammaglobin results (Paraffin block test) on anatomical pathology analysis. Statistical Kaplan Meier and Cox Proportional hazard calculations performed with the SPSS program were significant (p<0.05). Results: The number of research subjects was 60, with 32 subjects dying and 28 still alive until the data collection was completed. There was no difference in age between the two groups. The mean of all ages is 50.12 ± 9.93 years. Positive LVI has 9 months median survival (95% CI 8-10) with p= 0.013 risk 2,797 times. TIL high (positive 2- positive 3) median survival 8 months (95% CI 6.3-9.7) with p=0.003 and risk 3,151 times. Strong expression of mammaglobin A (3-4) had a median survival of 12 months (95% CI 4.4-19.5 months; p=0.015) and risk 3.34 times. Conclusion: LVI, TIL, and mammaglobin A expression significantly affected poor survival in the breast cancer Luminal B subtype.

Risk of Adverse Financial Events in Patients With Cancer: Evidence From a Novel Linkage Between Cancer Registry and Credit Records.

Although financial toxicity is a growing cancer survivorship issue, no studies have used credit data to estimate the relative risk of financial hardship in patients with cancer versus individuals without cancer. We conducted a population-based retrospective matched cohort study using credit reports to investigate the impact of a cancer diagnosis on the risk of adverse financial events (AFEs). Western Washington SEER cancer registry (cases) and voter registry (controls) records from 2013 to 2018 were linked to quarterly credit records from TransUnion. Controls were age-, sex-, and zip code-matched to cancer cases and assigned an index date corresponding to the case's diagnosis date. Cases and controls experiencing past-due credit card payments and any of the following AFEs at 24 months from diagnosis or index were compared, using two-sample z tests: third-party collections, charge-offs, tax liens, delinquent mortgage payments, foreclosures, and repossessions. Multivariate logistic regression models were used to evaluate the association of cancer diagnosis with AFEs and past-due credit payments. A total of 190,722 individuals (63,574 cases and 127,148 controls, mean age 66 years) were included. AFEs (4.3% v 2.4%, P < .0001) and past-due credit payments (2.6% v 1.9%, P < .0001) were more common in cases than in controls. After adjusting for age, sex, average baseline credit line, area deprivation index, and index/diagnosis year, patients with cancer had a higher risk of AFEs (odds ratio 1.71; 95% CI, 1.61 to 1.81; P < .0001) and past-due credit payments (odds ratio 1.28; 95% CI, 1.19 to 1.37; P < .0001) than controls. Patients with cancer were at significantly increased risk of experiencing AFEs and past-due credit card payments relative to controls. Studies are needed to investigate the impact of these events on treatment decisions, quality of life, and clinical outcomes.

Publication Rate and Consistency of Registered Trials of Motor-Based Stroke Rehabilitation

To determine the publication rate of motor-rehabilitation trials poststroke and the consistency between registry records and their corresponding main publications in trial design, primary objectives and outcomes, eligibility criteria, and sample size. We searched 18 clinical trial registries to identify randomized controlled trials of motor-based stroke rehabilitation registered after July 2005 and completed before April 2017. Eligible trials included adults with stroke, with at least one outcome measure related to motor function. Information in the registry records was compared with that of their main publications, if any. Three hundred twenty-three trials met our eligibility criteria; we were unable to find a peer-reviewed publication reporting the main findings for 46% (150/323) of these. Of the 169 trials with peer-reviewed articles published in English, 141 (83%) were consistent with the registry record in trial design, 100 (59%) were consistent in primary objectives, 71 (42%) were consistent in primary outcomes, 28 (17%) were consistent in eligibility criteria, and 74 (44%) were consistent in sample size. Approximately half of motor-based stroke rehabilitation trials were not published, even more than 3 years after the end of the trial. When main publications were found, they substantially deviated from information in the registry record. These findings highlight the importance of trial registries for identifying unpublished stroke rehabilitation trials and of searching trial registries when conducting systematic reviews and meta-analysis to help ensure that reviews are unbiased.

Epidemiological Analysis of Type II Diabetes Mellitus among Hail Residents, Saudi Arabia

Type II diabetes is a global health concern. This epidemic is elevating in increasing rates in Saudi Arabia. Thus, the study investigates a number of risk factors of Type II diabetes in Hail region, one of Saudi Arabia’s highest regions in diabetes records among adults. Data are collected using diabetic subjects from the Diabetes Registry Records in King Khalid Hospital at the city of Hail, Saudi Arabia, where 200 subjects’ records from 2014 to 2018 were included. A binary logistic regression was utilized to assess the association between age, gender, obesity, hypertension, family history, hypercholesterolemia, and hyperglyceridemia as risk factors and Type II diabetes. Some risk factors yielded statistical significant associations such as age (OR = 486.00 for 61 and older; OR = 468.00 for 51 - 60; and OR = 130.50 for 41 - 50; p-values ≤ 0.01), obesity (OR = 3.088; p-value ≤ 0.01), and hypertension (OR = 8.476; p-value ≤ 0.01), while gender, family history, hypercholesterolemia, and hyperglyceridemia were insignificant risk factors in our study. Proper intervention measures targeting diabetes risk factors may tackle or delay this public health issue.

CREATE: A New Data Resource to Support Cardiac Precision Health

BackgroundThe initiatives of precision medicine and learning health systems require databases with rich and accurately captured data on patient characteristics. We introduce the Clinical Registry, AdminisTrative Data and Electronic Medical Records (CREATE) database, which includes linked data from 4 population databases: Alberta Provincial Project for Outcome Assessment in Coronary Heart Disease (APPROACH; a national clinical registry), Sunrise Clinical Manager (SCM) electronic medical record (city-wide), the Discharge Abstract Database (DAD), and the National Ambulatory Care Reporting System (NACRS). The intent of this work is to introduce a cardiovascular-specific database for pursuing precision health activities using big data analytics. MethodsWe used deterministic data linkage to link SCM electronic medical record data to APPROACH clinical registry data using patient identifier variables. The APPROACH-SCM data set was subsequently linked to DAD and NACRS to obtain inpatient and outpatient cohort data. We further validated the quality of the linkage, where applicable, in these databases by comparing against the Alberta Health Insurance Care Plan registry database. ResultsWe achieved 99.96% linkage across these 4 databases. Currently, there are 30,984 patients with 35,753 catheterizations in the CREATE database. The inpatient cohort contained 65.75% (20,373/30,984) of the patient sample, whereas the outpatient cohort contained 29.78% (9226/30,984). The infrastructure and the process to update and expand the database has been established. ConclusionsCREATE is intended to serve as a database for supporting big data analytics activities surrounding cardiac precision health. The CREATE database will be managed by the Centre for Health Informatics at the University of Calgary, and housed in a secure high-performance computing environment.

English

BACKGROUND Accidental and intentional poisoning are major preventable contributors to death and illness. According to World Health Organization (WHO) estimates, 0.3 million people die every year due to various poisoning agents. Earlier the initial resuscitation, gastric decontamination, and use of specific antidotes, better the outcome. In order to improve clinical management, proper planning and prevention is. This study was conducted in a tertiary care hospital to evaluate the pattern of acute poisoning cases in that region. METHODS This is a retrospective study conducted among 57 patients with poisoning admitted over a 2-year period. Data was collected from ICU registry and Medical Records Department, ESIC MH. RESULTS Females represented 59.6 % (n = 57). Most of our patients were in the age group 18 – 28 yrs. (35.08 %). Notably majority of the cases had consumed organophosphorus compounds (25 patients, 43.85 %) and tablets (22 patients, 38.60 %). Majority (22 patients, 38.59 %) stayed at ICU for less than three days; overall mortality from all poisoning was low (2 patients, 3.50 %). CONCLUSIONS Use of organophosphorus compound and tablets for intentional poisoning continues to be pervasive in India. Education on poison, counselling and strict pesticide and drugs regulation laws will reduce the incidence of this public health problem. KEYWORDS Organophosphorus Compound, Poisoning, Mortality

Validity of self-reported cancer: Comparison between self-report versus cancer registry records in the Geelong Osteoporosis Study

BackgroundDetermining the validity of self-reported data is important. The aim of this study was to assess the validity of self-reported cancer and investigate factors associated with accurate reporting in men and women. MethodsStudy participants (n = 1727) from the Geelong Osteoporosis Study, located in south-eastern Australia, were utilised. Self-reported cancer data were compared to Victorian Cancer Registry records. Age, socioeconomic status (SES), education and time between cancer diagnosis and study appointment were investigated as factors associated with accuracy of self-report. ResultsThere were 142 participants who self-reported a cancer and 135 with a VCR record. Comparing self-report to any registry record, sensitivity was 63.7 %, specificity 96.5 %, PPV 60.6 %, NPV 96.9 %, and overall agreement ĸ0.588. Comparing exact-match records, sensitivity was 58.8 %, specificity 95.5 %, PPV 49.3 %, NPV 96.9 % and overall agreement ĸ0.499. In logistic regression models, post-secondary education was independently associated with accuracy of any (OR 1.72, 95 % CI 1.10−2.70) and exact-match (OR 1.59, 95 % CI 1.05−2.42) self-report, compared to cancer registry record. For any cancer, being aged >70 years was inversely associated with accuracy (OR 0.24, 95 % CI 0.15−0.38). Likewise, for matched cancer reporting, those aged 60−70 years (OR 0.51, 95 %CI 0.30−0.88) and >70 years (OR 0.23, 95 % CI 0.15−0.35) were less accurate. No other significant associations were detected. ConclusionResults suggest moderate agreement between self-report and registry data for any cancer among men and women. However, when comparing self-report to registry data for exact-match cancer type, level of overall agreement deteriorated. Self-report cancer data may be acceptable for determining a history of cancer, although, is less accurate in identifying history of specific cancer types documented in registry-based data.

Retrospective Study of the Clinicopathological Characteristics of 31 Cases of Primary Mucinous Tumors of the Ovary at a Tertiary Care Center

This retrospective analysis aimed to evaluate the clinicopathological characteristics of primary mucinous tumors of the ovary (MOT) treated at a tertiary care center. Demographic, clinicopathological, treatment and follow-up details of all patients with primary MOT treated from June 2015 till August 2019 were extracted from institutional cancer registry and Electronic Medical Records, after obtaining necessary clearance from institutional ethical committee, and institutional review board. The details obtained were tabulated and analyzed. Thirty-one patients were identified to have primary MOT: 20 cystadenomas, 10 carcinomas (mOC) and one borderline (mBOT). MOT was frequently noted between the fourth to sixth decades. Abdominal distension was the most common symptom at presentation. In total, 70% of cystadenomas were less than 15 cm, while 90% of mOC were 15 cm and above. In total, 95% cystadenomas were unilateral, while all cases of mBOT and mOC were unilateral. mOC showed elevated CA 125 in 42.86% cases, elevated CEA in 42.86% cases and elevated CA 19–9 in 75% cases. Imaging showed 30% of mOC as benign cysts and 42.1% of cystadenomas as complex cyst. Frozen section correctly diagnosed cystadenomas and mBOT, and two mOC were underdiagnosed as borderline. All had upfront surgery. Of cystadenomas, 11 underwent salpingoovariotomy, and nine had hysterectomy and salpingoovariotomy. All the mOC and mBOT underwent staging laparotomy. Three cases of mOC had a fertility preserving approach. No cases had positive lymph nodes, and appendix showed normal histology. In total, 40% were stage 1a, 30% 1C1 and 30% IC3. Two patients received postoperative chemotherapy. Differentiation between benign MOT and mOC is crucial. A multidisciplinary approach, involving clinician, radiologist and pathologist, helps in clinching the diagnosis. mOC present at a younger age and fertility-sparing procedures are reasonable options in early-stage MOT.

Retrospective Study of the Clinicopathological Characteristics of Adult Granulosa Cell Tumour of the Ovary at a Tertiary Care Centre

This retrospective analysis aimed to evaluate the clinicopathological characteristics of adult granulosa cell tumours (AGCT) treated at a tertiary care centre. Demographic, clinicopathological, treatment and follow-up details of all patients with AGCT treated from January, 2003 till July, 2014 were extracted from institutional cancer registry and Electronic Medical Records, after obtaining necessary clearance from institutional ethical committee, and institutional review board. The details obtained were tabulated and analyzed. Thirty-three patients were identified to have AGCT; 24 at initial diagnosis and nine at recurrence. Mean age at diagnosis among patients seen at initial diagnosis and those at recurrence was 50.42 years versus 40.78 years, while mean tumour size was 11.9 cm and 14.8 cm respectively. Abdominal pain was most common symptom at presentation. All patients had upfront surgery. Of the 24 cases seen initially, 16 had staging surgery; among whom six were second surgery, one in the fertility sparing group, and five in the non-sparing group. None were upstaged. Complete resection was feasible in all 16. Three cases had fertility preserving surgery. Among the patients who had staging surgery, 81.25% were stage I and the rest stage IIb. Six patients received postoperative chemotherapy. The mean follow-up period was 42.08 months. Mean time to relapse among the nine recurrent cases was 92.79 months. All patients had intra-abdominal recurrence, pelvis and omentum being the most common sites. Resection of metastatic sites was done in all nine cases. Three patients received preoperative chemotherapy and one received postoperative radiotherapy. The mean overall survival was 170.18 months. Complete resection of tumour is feasible both in primary and recurrent cases. Fertility preserving surgery may be offered to women with early-stage disease who opt to retain fertility. Long term follow-up with pelvic and whole abdominal surveillance is necessary.

The duty to employ the head and deputy head of Public Registry Office in light of the provisions of the new act of Public Registry Records Law of 28 November 2014

In the new act of Public Registry Records Law of 28 November 2014, despite introducing a lot of changes, the legislator has maintained adherence to the principle according to which a borough leader is the head of Public Registry Office. What has also been kept is the duty to employ another person on the post of the head of Public Registry Office in the districts inhabited by more than 50 thousand people while the obligatory employment of the deputy head of Public Registry Office in those districts has been given up. However minor the change seems to be, it brings about the situation in which all the opinion discrepancies that has existed for many years concerning the question whether a borough leader employing another person on the post of the head of Public Registry Office maintains the rights in the scope of registering the marital status or not. This is why the author makes a thorough analysis of new solutions looking for answers to the following questions: what guided the legislator in making those changes, what doubts can they raise and what results can they have in practice? Since activities in the scope of registering marital status are of utmost legal importance, the author demands the legislator should finally regulate the issues so that they are explicit. Due to that fact she is not passive herself and suggests de lege ferenda bold legal solutions which would enable to eliminate them.

A Comparison of Mortality-to-Incidence Ratio with Survival Analyses in Assessing Racial Breast Cancer Disparities Across South Carolina Counties

Abstract The mortality-to-incidence rate ratio (MIR) provides a population-based measure of survival which accounts for incidence. The use of MIR as a surveillance tool has shown that South Carolina (SC) exhibits more extreme racial differences in cancer incidence, mortality and MIR than other states or the nation. We assessed the effectiveness of MIR as a proxy for 5-year survival time (5YST) among breast cancer (BrCa) patients in South Carolina. Methods: The 5YST was computed from data on BrCA cases which were obtained retrospectively from the SC Central Cancer Registry from 2002 to 2010. The MIR was computed from Cancer incidence and mortality data which were obtained from the SC Community Access Network (SCAN). The underlying data for SCAN were generated from the SC Central Cancer Registry and SC DHEC Vital Records and used to construct MIRs. ArcGIS 10.2 was utilized to map BrCA MIRs by race for 46 counties within SC. Seven categories of MIR were derived using the national MIR for BrCA as reference. 5YST was computed for all BrCA cases in each county utilizing SAS software and this was mapped with MIR per county. Exploratory and geographically weighted regression analyses were conducted in ArcGIS to determine the relationship between MIR and MST. Results: A total of 2155 breast cancer patients (nWhites = 1557/72%; nBlacks = 598/28%) were reported in the study period. A visual inspection of the MIR maps by race showed that Blacks were in the highest MIR category while the MIR by 5YST map showed that higher MIR was likely associated with lower 5YST. By contrast, the MIRs for Whites were more evenly represented over the seven categories. Overall, the 5YST was 92.8% among blacks and 95.6% among whites. Assessment of MIR with MST in ArcGIS utilizing exploratory ArcGIS regression showed that there was statistically significant Global Moran's I p value indicative of clustering. Conclusions: The MIR proved useful for identifying disparities in BrCA incidence and mortality among Black and White women in SC. Cancer surveillance programs may use the MIR to monitor disparities across racial/ethnic groups and geographic regions going forward. MIRs have the potential to serve as an indicator of the long-term success of cancer surveillance programs.

Cancer mortality disparities among New York City's Upper Manhattan neighborhoods.

The East Harlem (EH), Central Harlem (CH), and Upper East Side (UES) neighborhoods of New York City are geographically contiguous to tertiary medical care, but are characterized by cancer mortality rate disparities. This ecological study aims to disentangle the effects of race and neighborhood on cancer deaths. Mortality-to-incidence ratios were determined using neighborhood-specific data from the New York State Cancer Registry and Vital Records Office (2007-2011). Ecological data on modifiable cancer risk factors from the New York City Community Health Survey (2002-2006) were stratified by sex, age group, race/ethnicity, and neighborhood and modeled against stratified mortality rates to disentangle race/ethnicity and neighborhood using logistic regression. Significant gaps in mortality rates were observed between the UES and both CH and EH across all cancers, favoring UES. Mortality-to-incidence ratios of both CH and EH were similarly elevated in the range of 0.41-0.44 compared with UES (0.26-0.30). After covariate and multivariable adjustment, black race (odds ratio=1.68; 95% confidence interval: 1.46-1.93) and EH residence (odds ratio=1.20; 95% confidence interval: 1.07-1.35) remained significant risk factors in all cancers' combined mortality. Mortality disparities remain among EH, CH, and UES neighborhoods. Both neighborhood and race are significantly associated with cancer mortality, independent of each other. Multivariable adjusted models that include Community Health Survey risk factors show that this mortality gap may be avoidable through community-based public health interventions.

Long-term follow-up of the potential benefits of early nutritional intervention in adults with upper gastrointestinal cancer: a pilot randomised trial.

This study aimed to evaluate the long-term survival of all patients who participated in a pilot randomised trial of an early nutritional intervention for adults with upper gastrointestinal cancer. It also sought to identify factors that predicted patient mortality. All participants (n=21) who were randomised into the original study were followed for a maximum of 5years and 2months (final follow-up April 2016). The primary outcome measure was time from date of recruitment until date of death, ascertained by the Victorian Cancer Registry and/or Monash Health Scanned Medical Records. Secondary analyses were conducted to identify factors that adversely affected survival. At the end of the follow-up period, three patients were alive in the nutrition intervention group whilst only two patients were living from the standard care group. Visual evaluation of the Kaplan-Meier survival curves demonstrated a possible survival benefit from being exposed to the intervention between 6months and 1.4years post-recruitment, though this benefit dissipated soon after. The intervention was not associated with increased survival in univariate analyses, but was after adjustment for other factors found to adversely impact on survival (adjusted hazard ratio 0.12 (95% CI 0.02-0.72) p=0.02). These factors were being a smoker (14.2 (1.43 to 140.67), p=0.02); low baseline physical functioning (1.11 (1.01 to 1.21), p=0.03); high baseline fatigue (1.09 (1.02-1.16), p=0.007); and high baseline dyspnoea (1.08 (1.02-1.13), p=0.003). Early and intensive nutrition intervention may increase the survival of people with upper gastrointestinal cancer.

Racial disparities in endometrial cancer mortality-to-incidence ratios among Blacks and Whites in South Carolina.

Endometrial cancer (EC) exhibits striking racial disparities with higher mortality in Blacks compared to Whites. The mortality-to-incidence ratio (MIR) provides a population-based measure of survival which accounts for incidence. The objective of this study was to map EC MIRs by race for eight health regions within South Carolina (SC) and chart EC incidence by race and grade across the four cancer stages. Cancer incidence and mortality data were obtained from the SC Community Access Network (SCAN), the online data query system provided by the SC Department of Health and Environmental Control (DHEC). The underlying data for SCAN were generated from the SC Central Cancer Registry and SC DHEC Vital Records and used to construct MIRs. ArcGIS 10.1 was used to map EC MIRs by race for eight health regions within SC. Four categories of MIR were derived using the national MIR for EC among Whites as the reference category. Blacks had higher levels of poorly differentiated tumors across all stages and higher incidence and mortality rates. In all eight health regions, Blacks were in the highest MIR category. By contrast, the MIRs for Whites were more evenly represented over the four categories. The MIR proved useful for identifying disparities in EC incidence and mortality among Black and White women in SC. Cancer surveillance programs may use the MIR to monitor disparities across racial/ethnic groups and geographic regions going forward. MIRs have the potential to serve as an indicator of the long-term success of cancer surveillance programs.

Abstract A35: Association between calcium and beta-carotene intake and risk of prostate cancer in Seoul Male Cohort Study

Abstract Prostate cancer is a 5th common cancer among Korean male population, but the incidence is increasing rapidly (12.1% per year). The 5-year relative survival of prostate cancer in Korea is relatively poor (80.1% for 2001-2005 incident cases) compared to other developed countries (99.4%, 2001-2007 incident cases in SEER U.S.A), probably due to later stage at diagnosis. Dietary factors are strongly related to the risk of prostate cancer. Calcium and beta-carotene has been suggested to have a positive and an inverse association with the risk of prostate cancer, respectively. However, several recent studies showed no association with dietary calcium and either no or a positive association with bet-carotene, especially among smokers. We aimed to test the association between calcium and beta-carotene intake and the risk of prostate cancer in a Korean male population. Seoul Male Cohort was established in 1993. Members were recruited from the male beneficiaries of the Korean Health Insurance Company, who were aged 40-59 and living in Seoul. A lifestyle questionnaire survey was conducted through mailing. Dietary intake was measured using a quantitative food frequency questionnaire with 88 food items. Nutrient intake was calculated and the amount was categorized into quartiles (q1-the lowest quartile, q4-the highest quartile). Cancer occurrence was identified through data linkage to the Korean Central Cancer Registry and Korean Death Records. A total of 14,533 members were followed up until December 31, 2008, and 123 incident prostate cancer cases were identified. Multivariable hazard ratios (aHR) and 95% confidence intervals (95%CI) were calculated using Cox's regression model. There was no significant difference between prostate cancer patients and non-cancer cohort members in terms of initial age, family history, body mass index, alcohol intake, and smoking, whereas prostate cancer patients had higher education (p&amp;lt;0.036). Higher calcium intake was not associated with prostate cancer (q4 vs. q1, aHR=0.98, 95%CI = 0.51-1.88, ptrend=0.81). Moderate, but not significant, risk increase by beta-carotene intake was observed (q4 vs. q1, aHR=1.60, 95%CI = 0.93-2.77, ptrend=0.06). Baseline smoking rate among cohort members was high (76%). Therefore, we observed the same result in a subgroup analysis with smokers only. In conclusion, calcium intake did not increase the risk of prostate cancer, and beta-carotene intake may increase the risk of prostate cancer in a Korean male population. Citation Format: Myung-Hee Shin, Jong-Myon Bae, Moo-Song Lee, Dong-Hyun Kim, Zhong-Min Li, Yoon-Ok Ahn. Association between calcium and beta-carotene intake and risk of prostate cancer in Seoul Male Cohort Study. [abstract]. In: Proceedings of the Thirteenth Annual AACR International Conference on Frontiers in Cancer Prevention Research; 2014 Sep 27-Oct 1; New Orleans, LA. Philadelphia (PA): AACR; Can Prev Res 2015;8(10 Suppl): Abstract nr A35.

Comparison of noninferiority margins reported in protocols and publications showed incomplete and inconsistent reporting

ObjectivesTo compare noninferiority margins defined in study protocols and trial registry records with margins reported in subsequent publications. Study Design and SettingComparison of protocols of noninferiority trials submitted 2001 to 2005 to ethics committees in Switzerland and The Netherlands with corresponding publications and registry records. We searched MEDLINE via PubMed, the Cochrane Controlled Trials Register (Cochrane Library issue 01/2012), and Google Scholar in September 2013 to identify published reports, and the International Clinical Trials Registry Platform of the World Health Organization in March 2013 to identify registry records. Two readers recorded the noninferiority margin and other data using a standardized data-abstraction form. ResultsThe margin was identical in study protocol and publication in 43 (80%) of 54 pairs of study protocols and articles. In the remaining pairs, reporting was inconsistent (five pairs, 9%), or the noninferiority margin was either not reported in the publication (five pairs, 9%) or not defined in the study protocol (one pair). The confidence interval or the exact P-value required to judge whether the result was compatible with noninferior, inferior, or superior efficacy was reported in 43 (80%) publications. Complete and consistent reporting of both noninferiority margin and confidence interval (or exact P-value) was present in 39 (72%) protocol-publication pairs. Twenty-nine trials (54%) were registered in trial registries, but only one registry record included the noninferiority margin. ConclusionThe reporting of noninferiority margins was incomplete and inconsistent with study protocols in a substantial proportion of published trials, and margins were rarely reported in trial registries.

Colorectal cancer prevention by an optimized colonoscopy protocol in routine practice.

We conducted a retrospective cohort study to investigate the colorectal cancer (CRC) incidence and mortality prevention achievable in clinical practice with an optimized colonoscopy protocol targeting near-complete polyp clearance. The protocol consisted of: (i) telephonic reinforcement of bowel preparation instructions; (ii) active inspection for polyps throughout insertion and circumferential withdrawal; and (iii) timely updating of the protocol and documentation to incorporate the latest guidelines. Of 17,312 patients provided screening colonoscopies by 59 endoscopists in South Carolina, USA from September 2001 through December 2008, 997 were excluded using accepted exclusion criteria. Data on 16,315 patients were merged with the South Carolina Central Cancer Registry and Vital Records Registry data from January 1996 to December 2009 to identify incident CRC cases and deaths, incident lung cancers and brain cancer deaths (comparison control cancers). The standardized incidence ratios (SIR) and standardized mortality ratios (SMR) relative to South Carolina and US SEER-18 population rates were calculated. Over 78,375 person-years of observation, 18 patients developed CRC versus 104.11 expected for an SIR of 0.17, or 83% CRC protection, the rates being 68% and 91%, respectively among the adenoma- and adenoma-free subgroups (all p < 0.001). Restricting the cohort to ensure minimum 5-year follow-up (mean follow-up 6.64 years) did not change the results. The CRC mortality reduction was 89% (p < 0.001; four CRC deaths vs. 35.95 expected). The lung cancer SIR was 0.96 (p = 0.67), and brain cancer SMR was 0.92 (p = 0.35). Over 80% reduction in CRC incidence and mortality is achievable in routine practice by implementing key colonoscopy principles targeting near-complete polyp clearance.

Abstract 1273: Association between smoking, alcohol, and salty food intake and risk of stomach cancer by topographic location and histological type in Seoul Male Cohort

Abstract Incidence of stomach cancer has been declining in South Korea, but it still remains as the highest among men in the country. Cancers of upper and lower parts of stomach, and diffuse and intestinal type of stomach are thought to have different risk factors. Smoking, alcohol, and salty food intake are consistently associated with the risk of stomach cancer, but possible differential associations by topographic location and histological type are not well established. We evaluated the associations between smoking, alcohol, and salty food intake and the risk of cancers in upper (cardia and fundus), middle (body), and lower parts (antrum) of stomach, and of diffuse and intestinal type of stomach cancer in a prospective cohort study in Korea. Seoul Male Cohort was established in 1993. Members were recruited from the male beneficiaries of the Korean Health Insurance Company, who were aged 40-59 and living in Seoul. A lifestyle questionnaire survey was conducted through mailing. Dietary intake was measured using a quantitative food frequency questionnaire with 88 food items. Cancer occurrence was identified through data linkage to the Korean Central Cancer Registry and Korean Death Records. A total of 14,533 members were followed up until December 31, 2008, and 362 incident stomach cancer cases were identified. Multivariable hazard ratios (aHR) and 95% confidence intervals (95% CI) were calculated using Cox's regression model. None of the smoking, alcohol, and salty food intake was associated with risk of upper stomach cancer. Smoking had strongest association with risk of mid stomach cancer. Men who smoked currently and who stopped smoking for less than 4 years had 2.57 and 3.28 times higher risk of mid stomach cancer than never smokers (95% CI = 1.26-5.26, 1.36-7.96, respectively, ptrend=0.0036). Ex-smokers who stopped smoking for 4 or more years had no increase in risk of mid stomach cancer. Alcohol also had strongest association with risk of mid stomach cancer. The aHR of mid stomach cancer for those who had alcohol more than 45g/day compared to non-drinkers was 2.13 (95% CI = 0.94-4.82, ptrend=0.0353). Salty food and sodium intake had strongest association with risk of lower stomach cancer (Highest vs. lowest quartile, aHR=1.53 (95%CI = 0.93-2.52, ptrend=0.0670) for salty food, aHR=2.25 (95%CI = 1.18- 4.31, ptrend=0.0442) for sodium). Current smoking was strongly associated with both diffuse (aHR=2.44) and intestinal type of stomach cancer (aHR=1.87). Ex-smoking, alcohol, and salty food intake had significant positive association with intestinal type of stomach cancer, but not with diffuse type. In conclusion, smoking, alcohol, and salty food intake were mostly associated with risk of mid and lower stomach cancer and intestinal type of stomach cancer. Citation Format: Myung-Hee Shin, Seon-Mi Hwang, Min-Gew Choi, Duk-Hwan Kim, Jong-Myon Bae, Moo-Song Lee, Dong-Hyun Kim, Zhong-Min Li, Yoon-Ok Ahn. Association between smoking, alcohol, and salty food intake and risk of stomach cancer by topographic location and histological type in Seoul Male Cohort. [abstract]. In: Proceedings of the 105th Annual Meeting of the American Association for Cancer Research; 2014 Apr 5-9; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2014;74(19 Suppl):Abstract nr 1273. doi:10.1158/1538-7445.AM2014-1273

Misdiagnosed Case of Lepromatous Leprosy

Despite of tremendous decrease in cases of leprosy world-wide due to the successful antimycobacterial agents, some areas still remain endemic for this infectious disease globally 1 . The Kingdom of Bahrain and other GCC countries are not considered as endemic areas for leprosy, but the Ministry of Health and National Registry Records show sporadic cases among expatriates 1 .