ABSTRACT
BACKGROUND: While healthcare utilization data are useful for postmarketing surveillance of drug safety in pregnancy, the start of pregnancy and gestational age at birth are often incompletely recorded or missing. Our objective was to develop and validate a claims-based live birth gestational age algorithm. METHODS: Using the Medicaid Analytic eXtract (MAX) linked to birth certificates in three states, we developed four candidate algorithms based on: preterm codes; preterm or postterm codes; timing of prenatal care; and prediction models - using conventional regression and machine-learning approaches with a broad range of prespecified and empirically selected predictors. We assessed algorithm performance based on mean squared error (MSE) and proportion of pregnancies with estimated gestational age within 1 and 2 weeks of the gold standard, defined as the clinical or obstetric estimate of gestation on the birth certificate. We validated the best-performing algorithms against medical records in a nationwide sample. We quantified misclassification of select drug exposure scenarios due to estimated gestational age as positive predictive value (PPV), sensitivity, and specificity. RESULTS: Among 114,117 eligible pregnancies, the random forest model with all predictors emerged as the best performing algorithm: MSE 1.5; 84.8% within 1 week and 96.3% within 2 weeks, with similar performance in the nationwide validation cohort. For all exposure scenarios, PPVs were >93.8%, sensitivities >94.3%, and specificities >99.4%. CONCLUSIONS: We developed a highly accurate algorithm for estimating gestational age among live births in the nationwide MAX data, further supporting the value of these data for drug safety surveillance in pregnancy. See video abstract at, http://links.lww.com/EDE/B989 .
Subject(s)
Live Birth , Medicaid , Infant, Newborn , United States/epidemiology , Female , Pregnancy , Humans , Gestational Age , Birth Certificates , AlgorithmsABSTRACT
PURPOSE: Perinatal epidemiology studies using healthcare utilization databases are often restricted to live births, largely due to the lack of established algorithms to identify non-live births. The study objective was to develop and validate claims-based algorithms for the ascertainment of non-live births. METHODS: Using the Mass General Brigham Research Patient Data Registry 2000-2014, we assembled a cohort of women enrolled in Medicaid with a non-live birth. Based on ≥1 inpatient or ≥2 outpatient diagnosis/procedure codes, we identified and randomly sampled 100 potential stillbirth, spontaneous abortion, and termination cases each. For the secondary definitions, we excluded cases with codes for other pregnancy outcomes within ±5 days of the outcome of interest and relaxed the definitions for spontaneous abortion and termination by allowing cases with one outpatient diagnosis only. Cases were adjudicated based on medical chart review. We estimated the positive predictive value (PPV) for each outcome. RESULTS: The PPV was 71.0% (95% CI, 61.1-79.6) for stillbirth; 79.0% (69.7-86.5) for spontaneous abortion, and 93.0% (86.1-97.1) for termination. When excluding cases with adjacent codes for other pregnancy outcomes and further relaxing the definition, the PPV increased to 80.6% (69.5-88.9) for stillbirth, 86.6% (80.5-91.3) for spontaneous abortion and 94.9% (91.1-97.4) for termination. The PPV for the composite outcome using the relaxed definition was 94.4% (92.3-96.1). CONCLUSIONS: Our findings suggest non-live birth outcomes can be identified in a valid manner in epidemiological studies based on healthcare utilization databases.
Subject(s)
Abortion, Spontaneous , Pregnancy , Female , Humans , Abortion, Spontaneous/epidemiology , Stillbirth/epidemiology , Pregnancy Outcome/epidemiology , Algorithms , Databases, FactualABSTRACT
PURPOSE: Current algorithms to evaluate gestational age (GA) during pregnancy rely on hospital coding at delivery and are not applicable to non-live births. We developed an algorithm using fertility procedures and fertility tests, without relying on delivery coding, to develop a novel GA algorithm in live-births and stillbirths. METHODS: Three pregnancy cohorts were identified from 16 health-plans in the Sentinel System: 1) hospital admissions for live-birth, 2) hospital admissions for stillbirth, and 3) medical chart-confirmed stillbirths. Fertility procedures and prenatal tests, recommended within specific GA windows were evaluated for inclusion in our GA algorithm. Our GA algorithm was developed against a validated delivery-based GA algorithm in live-births, implemented within a sample of chart-confirmed stillbirths, and compared to national estimates of GA at stillbirth. RESULTS: Our algorithm, including fertility procedures and 11 prenatal tests, assigned a GA at delivery to 97.9% of live-births and 92.6% of stillbirths. For live-births (n = 4 701 207), it estimated GA within 2 weeks of a reference delivery-based GA algorithm in 82.5% of pregnancies, with a mean difference of 3.7 days. In chart-confirmed stillbirths (n = 49), it estimated GA within 2 weeks of the clinically recorded GA at delivery for 80% of pregnancies, with a mean difference of 11.1 days. Implementation of the algorithm in a cohort of stillbirths (n = 40 484) had an increased percentage of deliveries after 36 weeks compared to national estimates. CONCLUSIONS: In a population of primarily commercially-insured pregnant women, fertility procedures and prenatal tests can estimate GA with sufficient sensitivity and accuracy for utility in pregnancy studies.
Subject(s)
Live Birth , Stillbirth , Electronics , Female , Fertility , Gestational Age , Humans , Live Birth/epidemiology , Pregnancy , Stillbirth/epidemiologyABSTRACT
PURPOSE: To develop and validate an International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM)-based algorithm to identify cases of stillbirth using electronic healthcare data. METHODS: We conducted a retrospective study using claims data from three Data Partners (healthcare systems and insurers) in the Sentinel Distributed Database. Algorithms were developed using ICD-10-CM diagnosis codes to identify potential stillbirths among females aged 12-55 years between July 2016 and June 2018. A random sample of medical charts (N = 169) was identified for chart abstraction and adjudication. Two physician adjudicators reviewed potential cases to determine whether a stillbirth event was definite/probable, the date of the event, and the gestational age at delivery. Positive predictive values (PPVs) were calculated for the algorithms. Among confirmed cases, agreement between the claims data and medical charts was determined for the outcome date and gestational age at stillbirth. RESULTS: Of the 110 potential cases identified, adjudicators determined that 54 were stillbirth events. Criteria for the algorithm with the highest PPV (82.5%; 95% CI, 70.9%-91.0%) included the presence of a diagnosis code indicating gestational age ≥20 weeks and occurrence of either >1 stillbirth-related code or no other pregnancy outcome code (i.e., livebirth, spontaneous abortion, induced abortion) recorded on the index date. We found ≥90% agreement within 7 days between the claims data and medical charts for both the outcome date and gestational age at stillbirth. CONCLUSIONS: Our results suggest that electronic healthcare data may be useful for signal detection of medical product exposures potentially associated with stillbirth.
Subject(s)
International Classification of Diseases , Stillbirth , Algorithms , Databases, Factual , Female , Humans , Infant , Pregnancy , Retrospective Studies , Stillbirth/epidemiologyABSTRACT
RESEARCH QUESTION: An important discussion point before chemotherapy is ovarian toxicity, a side-effect that profoundly affects young women with cancer. Their quality of life after successful treatment, including the ability to conceive, is a major concern. We asked whether serum anti-Müllerian hormone (AMH) measurements before chemotherapy for two most common malignancies are predictive of long-term changes in ovarian reserve? DESIGN: A prospective cohort study measured serum AMH in 66 young women with lymphoma and breast cancer, before and at 1 year and 5 years after chemotherapy, compared with 124 healthy volunteers of the same age range (18-43 years). Contemporaneously, patients reported their menses and live births during 5-year follow-up. RESULTS: After adjustment for age, serum AMH was 1.4 times higher (95% CI 1.1 to 1.9; P < 0.02) in healthy volunteers than in cancer patients before chemotherapy. A strong correlation was observed between baseline and 5-year AMH in the breast cancer group (P < 0.001, regression coefficientâ¯=â¯0.58, 95% CI 0.29 to 0.89). No significant association was found between presence of menses at 5 years and serum AMH at baseline (likelihood ratio test from logistics regression analysis). CONCLUSIONS: Reproductive-age women with malignancy have lower serum AMH than healthy controls even before starting chemotherapy. Pre-chemotherapy AMH was significantly associated with long-term ovarian function in women with breast cancer. At key time points, AMH measurements could be used as a reproductive health advisory tool for young women with cancer. Our results highlight the unsuitability of return of menstruation as a clinical indicator of ovarian reserve after chemotherapy.
Subject(s)
Anti-Mullerian Hormone/blood , Breast Neoplasms/blood , Lymphoma/blood , Ovarian Reserve/physiology , Adolescent , Adult , Age Factors , Anti-Mullerian Hormone/analysis , Breast Neoplasms/pathology , Cohort Studies , Female , Follow-Up Studies , Humans , Lymphoma/pathology , Ovarian Function Tests/methods , Predictive Value of Tests , Reproduction/physiology , Young AdultABSTRACT
INTRODUCTION: Pediatric bladder and bowel dysfunction (BBD) is a common problem in children. However, the current ability to diagnosis and quantify pediatric BBD is limited as only a few validated instruments exist. In addition, the current questionnaires are limited by their lack of psychometric processing and methods of validation. To address these issues, the authors developed a new questionnaire to objectively diagnose pediatric BBD symptoms. This study aimed to evaluate the performance of this newly devised objective instrument in diagnosing and quantifying the symptomatology of BBD in children. MATERIALS AND METHODS: An 18-item, 5-point questionnaire was developed using both a literature review and expert opinions. The total questionnaire score could range from 0 to 72. Questions were subgrouped into six symptom categories: (1) nocturnal enuresis, (2) lower urinary tract symptoms, (3) urinary holding, (4) infrequent urination, (5) bowel symptoms, and (6) daytime urinary incontinence. The questionnaire also assessed the degree of bother associated with the symptoms. Patients were divided into cases and controls, and these two groups were compared. DISCUSSION/RESULTS: A total of 1265 new patients (758 cases and 507 controls) completed the new BBD questionnaire. The mean age of the whole study cohort was 9.5 years (range, 3-19 years). The total mean questionnaire score was significantly higher at 23 (3-58) in the cases, compared with 8 (0-35) in the controls (p < 0.001) (Summary Figure). Reliability analysis of the 18-item instrument showed a Cronbach's alpha reliability coefficient of 0.80 for the scale. CONCLUSIONS: This new instrument provides a valid and reliable method for diagnosis of pediatric BBD and classification of patients into subcategories of BBD based on their specific symptoms.
Subject(s)
Constipation/diagnosis , Enuresis/diagnosis , Mass Screening/methods , Psychometrics/methods , Surveys and Questionnaires , Urinary Incontinence/diagnosis , Adolescent , Child , Child, Preschool , Constipation/epidemiology , Enuresis/epidemiology , Female , Follow-Up Studies , Humans , Male , Morbidity/trends , Reproducibility of Results , Retrospective Studies , United States/epidemiology , Urinary Incontinence/epidemiology , Young AdultABSTRACT
OBJECTIVE: To evaluate stroke risk among users of typical antipsychotics compared to users of atypical antipsychotics in a non-elderly and non-demented US population. METHODS: New users of antipsychotics aged 18-64 years without dementia were identified via electronic health care data from 13 health plans participating in the Sentinel System from January 2001 to September 2015. The risk of hospitalized stroke events, identified via ICD-9-CM diagnostic criteria, was compared between typical and atypical antipsychotic users using 1:1 matching on propensity score. Adjusted hazard ratios (HRs) and 95% CIs during the entire follow-up period and during 1- to 15-day and 16- to 90-day risk windows were estimated. The risk associated with haloperidol use was estimated separately. RESULTS: A total of 45,495 typical antipsychotic users were matched 1:1 to atypical antipsychotic users. While unmatched HRs suggest an increased stroke risk among typical antipsychotic users compared to atypical antipsychotic users, no increased risk was observed after matching during the entire follow-up period (HR = 0.87; 95% CI, 0.54-1.41), the 1- to 15-day risk window (HR = 1.16; 95% CI, 0.41-3.32), or the 16- to 90-day risk window (HR = 0.52; 95% CI, 0.20-1.36). The adjusted HR for haloperidol was 1.31 (95% CI, 0.54-3.21). CONCLUSION: These findings were not suggestive of an increased stroke risk in typical antipsychotic users compared to atypical antipsychotic users in a non-elderly and non-demented population.
Subject(s)
Antipsychotic Agents , Stroke , Adult , Antipsychotic Agents/adverse effects , Antipsychotic Agents/classification , Antipsychotic Agents/therapeutic use , Depressive Disorder/drug therapy , Depressive Disorder/epidemiology , Electronic Health Records/statistics & numerical data , Female , Humans , International Classification of Diseases , Male , Middle Aged , Pharmacovigilance , Prevalence , Quality Assurance, Health Care/methods , Risk Assessment/methods , Risk Factors , Schizophrenia/drug therapy , Schizophrenia/epidemiology , Sex Factors , Stroke/diagnosis , Stroke/epidemiology , Stroke/etiologyABSTRACT
BACKGROUND: Suicidal outcomes, including ideation, attempt, and completed suicide, are an important drug safety issue, though few epidemiological studies address the accuracy of suicidal outcome ascertainment. Our primary objective was to evaluate validated methods for suicidal outcome classification in electronic health care database studies. METHODS: We performed a systematic review of PubMed and EMBASE to identify studies that validated methods for suicidal outcome classification published 1 January 1990 to 15 March 2016. Abstracts and full texts were screened by two reviewers using prespecified criteria. Sensitivity, specificity, and predictive value for suicidal outcomes were extracted by two reviewers. Methods followed PRISMA-P guidelines, PROSPERO Protocol: 2016: CRD42016042794. RESULTS: We identified 2202 citations, of which 34 validated the accuracy of measuring suicidal outcomes using International Classification of Diseases (ICD) codes or algorithms, chart review or vital records. ICD E-codes (E950-9) for suicide attempt had 2-19% sensitivity, and 83-100% positive predictive value (PPV). ICD algorithms that included events with 'uncertain' intent had 4-70% PPV. The three best-performing algorithms had 74-92% PPV, with improved sensitivity compared with E-codes. Read code algorithms had 14-68% sensitivity and 0-56% PPV. Studies estimated 19-80% sensitivity for chart review, and 41-97% sensitivity and 100% PPV for vital records. CONCLUSIONS: Pharmacoepidemiological studies measuring suicidal outcomes often use methodologies with poor sensitivity or predictive value or both, which may result in underestimation of associations between drugs and suicidal behaviour. Studies should validate outcomes or use a previously validated algorithm with high PPV and acceptable sensitivity in an appropriate population and data source.
Subject(s)
Algorithms , Outcome Assessment, Health Care/classification , Suicidal Ideation , Suicide/statistics & numerical data , Validation Studies as Topic , Databases, Factual/statistics & numerical data , Epidemiologic Research Design , Humans , International Classification of Diseases , Observational Studies as Topic , Predictive Value of TestsABSTRACT
PURPOSE: Mortality data within the Sentinel Death Tables remain generally uncharacterized. Assessment of mortality data within Sentinel will help inform its utility for medical product safety studies. METHODS: To determine if Sentinel contains sufficient all-cause and cause-specific mortality events to power postmarketing safety studies. We calculated crude rates of all-cause mortality and suicide and proportional mortality from suicide from 2004 to 2012 in seven Sentinel data partners. Results were stratified by data partner, sex, age group, and calendar year and compared with national estimates from Centers for Disease Control and Prevention Wide-ranging ONline Data for Epidemiologic Research. We performed sample size estimations for all-cause mortality and 10 leading causes of death. RESULTS: We observed 479 694 deaths, including 5811 suicides, during 68 million person-years of follow-up. Pooled mean death and suicide rates in the data partners were 710 and 8.6 per 100 000 person-years, respectively (vs 810 and 11.8 nationally). The mean proportional mortality from suicide among the data partners was 1.2%, compared with 1.5% nationally. National trends of decreasing overall mortality and increasing proportional mortality for suicide were reflected within Sentinel. We estimated that detecting hazard ratios of 1.25 and 3 would require 16 442 and 460 exposed patients, respectively, for overall mortality, and 1.3 million and 37 411, respectively, for suicide. CONCLUSIONS: This was the first study to investigate mortality data in the Sentinel death tables. We found that all-cause mortality appeared well powered for use as a safety outcome and cause-specific mortality outcomes may be adequately powered in certain circumstances. Further investigation into the quality of the Sentinel death data is needed.
Subject(s)
Adverse Drug Reaction Reporting Systems/statistics & numerical data , Centers for Disease Control and Prevention, U.S./statistics & numerical data , Mortality , Suicide/statistics & numerical data , Adult , Female , Follow-Up Studies , Humans , Male , Middle Aged , Proportional Hazards Models , United States/epidemiology , Young AdultABSTRACT
INTRODUCTION/BACKGROUND: Metachronous contralateral inguinal hernias (MCH) occur in approximately 10% of pediatric patients following unilateral inguinal hernia repairs (UIHR). Laparoscopic evaluation of the contralateral internal ring is a method of identifying high-risk individuals for prophylactic contralateral exploration and repair. OBJECTIVE: The objective of this study was to assess variation in utilization of diagnostic laparoscopy, and report costs associated with the evaluation of a contralateral patent processus vaginalis during hernia repair in pediatric hospitals. STUDY DESIGN: The Pediatric Health Information System database was searched to identify outpatient surgical encounters for pediatric patients with a diagnosis of inguinal hernia during a 1-year period (2014). Records were identified that contained diagnostic codes for unilateral or bilateral inguinal hernia in combination with a procedure code for open hernia repair with or without diagnostic laparoscopy. RESULTS: After exclusions there were 3952 hernia repairs performed at 30 hospitals; median age was 4 years (IQR 1-7), 78.8% were male, and 64.9% Caucasian. Three-quarters (76.7%) had UIHR, 8.6% had unilateral repairs with laparoscopy (UIHRL), 12.2% had bilateral inguinal hernia repairs (BIHR), and 2.4% had bilateral repairs with laparoscopy (BIHRL). Where laparoscopy was used, 78% resulted in a unilateral repair and 22% in a bilateral procedure. The percent of patients undergoing laparoscopy varied from 0 to 57% among hospitals, and 0-100% among surgeons. Pediatric surgeons were more than three times more likely to perform a diagnostic laparoscopy compared with pediatric urologists. Median adjusted costs were $2298 (IQR 1659-2955) for UIHR, $2713 (IQR 1873-3409) for UIHRL, $2752 (IQR 2230-3411) for BIHR, and $2783 (IQR 2233-3453) for BIHRL. Median costs varied over two-fold among hospitals ($1310-4434), and over four-fold among surgeons ($948-5040). DISCUSSION: Data suggested that <10% of patients with clinically unilateral inguinal hernias developed MCH. A negative diagnostic laparoscopy ensured that 0.9-1.31% developed MCH. However, up to 30% of patients underwent contralateral exploration/repair when diagnostic laparoscopy was used. The current study found increased costs associated with the use of laparoscopy, with considerable variation in costs among surgeons and hospitals. These data elucidate competing financial and clinical consequences associated with the use of diagnostic laparoscopy with clinically unilateral hernias. CONCLUSIONS: Variation existed in the use of laparoscopy during inguinal hernia repairs and associated costs within the current sample from children's hospitals in the United States. The additional costs of laparoscopic evaluation must be considered against the clinical utility and therapeutic consequences of identifying individuals with a higher risk of metachronous contralateral inguinal hernia.
Subject(s)
Cost-Benefit Analysis , Hernia, Inguinal/surgery , Herniorrhaphy/economics , Herniorrhaphy/methods , Hospitals, Pediatric , Laparoscopy/methods , Adolescent , Age Factors , Child , Child, Preschool , Databases, Factual , Female , Follow-Up Studies , Hernia, Inguinal/diagnosis , Herniorrhaphy/adverse effects , Humans , Infant , Laparoscopy/adverse effects , Length of Stay/economics , Male , Odds Ratio , Postoperative Complications/epidemiology , Postoperative Complications/physiopathology , Retrospective Studies , Risk Assessment , Sex Factors , Treatment Outcome , United StatesABSTRACT
PURPOSE: To compare the use of nonsteroidal anti-inflammatory drugs (NSAIDs) and/or opioids to the use of acetaminophen without NSAIDs or opioids with respect to associations with birth defects. METHODS: We used data from the National Birth Defects Prevention Study (1997-2011). Exposure was self-reported maternal analgesic use from the month before through the third month of pregnancy (periconceptional). Adjusted odds ratios (aORs) were calculated to examine associations with 16 birth defects. RESULTS: Compared to acetaminophen, mothers reporting NSAIDs were significantly more likely to have offspring with gastroschisis, hypospadias, cleft palate, cleft lip with cleft palate, cleft lip without cleft palate, anencephaly, spina bifida, hypoplastic left heart syndrome, pulmonary valve stenosis, and tetralogy of Fallot (aOR range, 1.2-1.6). Opioids were associated with tetralogy of Fallot, perimembranous ventricular septal defect, and ventricular septal defect with atrial septal defect (aOR range, 1.8-2.3), whereas use of both opioids and NSAIDs was associated with gastroschisis, cleft palate, spina bifida, hypoplastic left heart syndrome, and pulmonary valve stenosis (aOR range, 2.0-2.9). CONCLUSIONS: Compared to periconceptional use of acetaminophen, selected birth defects occurred more frequently among infants of women using NSAIDs and/or opioids. However, we could not definitely determine whether these risks relate to the drugs or to indications for treatment.
Subject(s)
Abnormalities, Drug-Induced/epidemiology , Acetaminophen/adverse effects , Analgesics, Non-Narcotic/adverse effects , Analgesics, Opioid/adverse effects , Analgesics/adverse effects , Anti-Inflammatory Agents, Non-Steroidal/adverse effects , Cleft Lip/chemically induced , Cleft Palate/chemically induced , Congenital Abnormalities/etiology , Gastroschisis/chemically induced , Acetaminophen/administration & dosage , Adult , Analgesics/administration & dosage , Analgesics, Non-Narcotic/administration & dosage , Analgesics, Opioid/administration & dosage , Anti-Inflammatory Agents, Non-Steroidal/administration & dosage , Case-Control Studies , Cleft Lip/epidemiology , Cleft Palate/epidemiology , Female , Gastroschisis/epidemiology , Humans , Hypospadias/chemically induced , Hypospadias/epidemiology , Male , Mothers , Population Surveillance , Young AdultABSTRACT
Value-based care, which balances high-quality care with the most efficient use of resources, has been considered the next frontier in cancer care and a means to maintain health system sustainability. Created to promote value-based care, Choosing Wisely Canada-modelled after Choosing Wisely in the United States-is a national clinician-driven campaign to identify unnecessary or harmful services that are frequently used in Canada. As part of the campaign, national medical societies have developed recommendations for tests and treatments that clinicians and patients should question. Here, we present baseline indicator findings about current practice patterns associated with 7 cancer-related recommendations from Choosing Wisely Canada and about the effects of those practices on patients and the health care system. Indicator findings point to substantial variations in cancer system performance between Canadian jurisdictions, most notably for breast cancer screening practices, treatment practices for men with low-risk localized prostate cancer, and radiation therapy practices for early-stage breast cancer and bone metastases. Extrapolating indicator findings to the entire country, it was estimated that 740,000 breast and cervical cancer screening tests were performed outside of the recommended age ranges, and within 1 year of diagnosis, 17,000 patients received treatments that could be low-value. A 15% reduction in the use of the 7 screening and treatment practices examined could lead to multiple benefits for patients and the health care system: 9000 false-positive results and 3000 treatments and related side effects could be avoided, and 4500 hours of linear accelerator capacity could be freed up each year. Interjurisdictional performance variations suggest potential differences in clinical practice patterns in the planning and delivery of cancer control services, and in some cases, in disease management outcomes. Although the cancer screening and treatment practices described might be unnecessary for some patients, it is important to realize that they could, in fact, be necessary for other patients. Further research into appropriate rates of use could help to determine how much cancer care represents overuse of practices that are not supported by evidence or underuse of practices that are supported by evidence.
ABSTRACT
Meaningful performance measures are an important part of the toolkit for health system improvement. The Canadian Partnership Against Cancer has been reporting on pan-Canadian cancer system performance indicators since 2009-work that has led to the availability of standardized measures that can help to shed light on the extent of variation and opportunities for quality improvement across the country. Those measures include a core set of system indicators ranging from prevention and screening, through diagnosis and treatment, to survivorship and end-of-life care. Key indicators were calculated and graphed, showing the range from worst to best result for the provinces and territories included in the data. There were often significant differences in cancer system performance between provinces and territories. For example, smoking prevalence rates ranged from 14% to 62%. The 90th percentile wait times from an abnormal breast screen to resolution (without biopsy) ranged from 4 weeks to 8 weeks. The percentage of breast cancer resections that used breast-conserving surgery rather than mastectomy ranged from 38% to 75%. Clinical trial participation rates for adults ranged from 0.2% to 6.6%. Variations in performance indicators between Canadian jurisdictions suggest potential differences in the planning and delivery of cancer control services and in clinical practice patterns and patient outcomes. Understanding sources of variation can help to identify opportunities for improvements in the quality and outcomes of cancer control service delivery in each province and territory.
ABSTRACT
PURPOSE: To examine ondansetron use in pregnancy in the context of other antiemetic use among a large insured United States population of women delivering live births. METHODS: We assessed ondansetron and other antiemetic use among pregnant women delivering live births between 2001 and 2015 in 15 data partners contributing data to the Mini-Sentinel Distributed Database. We identified live birth pregnancies using a validated algorithm, and all forms of ondansetron and other available antiemetics were identified using National Drug Codes or procedure codes. We assessed the prevalence of antiemetic use by trimester, calendar year, and formulation. RESULTS: In over 2.3 million pregnancies, the prevalence of ondansetron, promethazine, metoclopramide, or doxylamine/pyridoxine use anytime in pregnancy was 15.2, 10.3, 4.0, and 0.4%, respectively. Ondansetron use increased from <1% of pregnancies in 2001 to 22.2% in 2014, with much of the increase attributable to oral ondansetron beginning in 2006. Promethazine and metoclopramide use increased modestly between 2001 (13.8%, 3.2%) and 2006 (16.0%, 6.0%) but decreased annually through 2014 (8.0%, 3.2%). Doxylamine/pyridoxine, approved for management of nausea and vomiting in pregnancy in 2013, was used in 1.8% of pregnancies in 2014. For all antiemetics, use was highest in the first trimester. CONCLUSIONS: We observed a marked increase in ondansetron use by study year, prescribed to nearly one-quarter of insured pregnant women in 2014, occurring in conjunction with decreased use of promethazine and metoclopramide. Given the widespread use of ondansetron in pregnancy, data establishing product efficacy and methodologically rigorous evaluation of post-marketing safety are needed. Published 2017. This article is a U.S. Government work and is in the public domain in the USA.
Subject(s)
Antiemetics/therapeutic use , Morning Sickness/drug therapy , Ondansetron/therapeutic use , Practice Patterns, Physicians'/trends , Adult , Algorithms , Female , Humans , Morning Sickness/epidemiology , Pilot Projects , Pregnancy , Pregnancy Trimesters , United States/epidemiologyABSTRACT
Evidence shows that continued smoking by cancer patients leads to adverse treatment outcomes and affects survival. Smoking diminishes treatment effectiveness, exacerbates side effects, and increases the risk of developing additional complications. Patients who continue to smoke also have a higher risk of developing a second primary cancer or experiencing a cancer recurrence, both of which ultimately contribute to poorer quality of life and poorer survival. Here, we present a snapshot of smoking behaviours of current cancer patients compared with the non-cancer patient population in Canada. Minimal differences in smoking behaviours were noted between current cancer patients and the rest of the population. Based on 2011-2014 data from the Canadian Community Health Survey, 1 in 5 current cancer patients (20.1%) reported daily or occasional smoking. That estimate is comparable to findings in the surveyed non-cancer patient population, of whom 19.3% reported smoking daily or occasionally. Slightly more male cancer patients than female cancer patients identified as current smokers. A similar distribution was observed in the non-cancer patient population. There is an urgent need across Canada to better support cancer patients in quitting smoking. As a result, the quality of patient care will improve, as will cancer treatment and survival outcomes, and quality of life for these patients.
ABSTRACT
Monitoring and reporting on cancer survival provides a mechanism for understanding the effectiveness of Canada's cancer care system. Although 5-year relative survival for colorectal cancer and lung cancer has been previously reported, only recently has pan-Canadian relative survival by stage been analyzed using comprehensive registry data. This article presents a first look at 2-year relative survival by stage for colorectal and lung cancer across 9 provinces. As expected, 2-year age-standardized relative survival ratios (arsrs) for colorectal cancer and lung cancer were higher when the cancer was diagnosed at an earlier stage. The arsrs for stage i colorectal cancer ranged from 92.2% in Nova Scotia [95% confidence interval (ci): 88.6% to 95.1%] to 98.4% in British Columbia (95% ci: 96.2% to 99.3%); for stage iv, they ranged from 24.3% in Prince Edward Island (95% ci: 15.2% to 34.4%) to 38.8% in New Brunswick (95% ci: 33.3% to 44.2%). The arsrs for stage i lung cancer ranged from 66.5% in Prince Edward Island (95% ci: 54.5% to 76.5%) to 84.8% in Ontario (95% ci: 83.5% to 86.0%). By contrast, arsrs for stage iv lung cancer ranged from 7.6% in Manitoba (95% ci: 5.8% to 9.7%) to 13.2% in British Columbia (95% ci: 11.8% to 14.6%). The available stage data are too recent to allow for meaningful comparisons between provinces, but over time, analyzing relative survival by stage can provide further insight into the known differences in 5-year relative survival. As the data mature, they will enable an assessment of the extent to which interprovincial differences in relative survival are influenced by differences in stage distribution or treatment effectiveness (or both), permitting targeted measures to improve population health outcomes to be implemented.
ABSTRACT
AIM: To describe how the stability of oxygen saturation measured by pulse oximetry (SpO2%) varies within and between infants with bronchopulmonary dysplasia (BPD). METHODS: Clinically stable infants with BPD had SpO2 measured at different inspired oxygen concentrations (FIO2 expressed as %). A computer model of gas exchange, that is, ventilation/perfusion ratio (VA/Q) and shunt, plotted the curve of SpO2 versus FIO2 best fitting these data. The slope of this curve is the change in SpO2 per % change in FIO2, hence SpO2 stability, calculated at each SpO2 from 85% to 95%. RESULTS: Data from 16 infants with BPD previously described were analysed. The dominant gas exchange impairment was low VA/Q (median 0.35, IQR, 0.16-0.4, normal 0.86). Median shunt was 1% (IQR, 0-10.5; normal <2%). Slope varied markedly between infants, but above 95% SpO2 was always <1.5. In infants with least severe BPD (VA/Q ≈0.4, shunt ≤2%) median slope at 85% SpO2 was 5.1 (IQR, 3.7-5.5). With more severe BPD (VA/Q ≤0.3) slope was flatter throughout the SpO2 range. The highest FIO2 for 90% SpO2 was in infants with the lowest VA/Q values. CONCLUSIONS: In infants with BPD, there was large variation in the slope of the curve relating SpO2% to inspired oxygen fraction in the SpO2 range 85%-95%. Slopes were considerably steeper at lower than higher SpO2, especially in infants with least severe BPD, meaning that higher SpO2 target values are intrinsically much more stable. Steep slopes below 90% SpO2 may explain why some infants appear dependent on remarkably low oxygen flows.
Subject(s)
Bronchopulmonary Dysplasia , Oximetry/methods , Ventilation-Perfusion Ratio , Bronchopulmonary Dysplasia/blood , Bronchopulmonary Dysplasia/diagnosis , Bronchopulmonary Dysplasia/physiopathology , Humans , Infant, Newborn , Infant, Premature , Oxygen Consumption , Retrospective Studies , Severity of Illness Index , Statistics as TopicABSTRACT
This study sought to investigate whether isolated abnormal strict morphology (<5% normal forms) and very low strict morphology (0-1% normal forms) affects pregnancy rates in intrauterine insemination (IUI). This was a retrospective study performed at an Academic Medical Center/Reproductive Medicine Center. Four hundred and eight couples were included for 856 IUI cycles. 70 IUI cycles were performed in couples with abnormal strict morphology and otherwise normal semen parameters. Outcomes were measured as clinical pregnancy rate per IUI cycle as documented by fetal heart activity on maternal ultrasound. Clinical pregnancy rate did not significantly differ between the group with abnormal strict morphology [11/70 (15.7%)] and the normal morphology group [39/281 (13.9%)]. Additionally, there was no significant difference between the pregnancy rate in the abnormal morphology group compared to that of our overall institutional IUI pregnancy rate [145/856 (16.9%)]. Furthermore, there was no significant difference between pregnancy rate in the very low morphology group [3/14 (21.4%)] compared to those with normal morphology or the overall IUI pregnancy rate. Patients with isolated abnormal strict morphology have clinical pregnancy rates similar to those with normal morphology for IUI. Even in those with very low normal forms, consideration of IUI for assisted reproduction should not be excluded.
Subject(s)
Infertility, Male/therapy , Insemination, Artificial, Homologous , Spermatozoa/pathology , Adult , Female , Humans , Infertility, Male/pathology , Infertility, Male/physiopathology , Male , Predictive Value of Tests , Pregnancy , Pregnancy Rate , Retrospective Studies , Risk Factors , Semen Analysis , Treatment OutcomeABSTRACT
Across Canada, introduction of the Pap test for cervical cancer screening, followed by mammography for breast cancer screening and, more recently, the fecal occult blood test for colorectal cancer screening, has contributed to a reduction in cancer mortality. However, another contribution of screening has been disparities in cancer mortality between certain populations. Here, we explore the disparities associated with breast and cervical cancer screening and preliminary data concerning disparities in colorectal cancer screening. Although some disparities in screening utilization have been successfully reduced over time (for example, mammography and Pap test screening in rural and remote populations), screening utilization data for other populations (for example, low-income groups) clearly indicate that disparities have existed and continue to exist across Canada. Organized screening programs in Canada have been able to successfully engage 80% of women for regular cervical cancer screening and 70% of women for regular mammography screening, but of the women who remain to be reached or engaged in regular screening, those with the least resources, those who are the most isolated, and those who are least culturally integrated into Canadian society as a whole are over-represented. Population differences are also observed for utilization of colorectal cancer screening services. The research literature on interventions to promote screening utilization provides some evidence about what can be done to increase participation in organized screening by vulnerable populations. Adaption and adoption of evidence-based screening promotion interventions can increase the utilization of available screening services by populations that have experienced the greatest burden of disease with the least access to screening services.
ABSTRACT
PURPOSE: The aim of this study was to develop a mother-child linked database consisting of all eligible active duty military personnel, retirees, and their dependents in order to conduct medication-related analyses to improve the safety and quality of care in the Military Health System (MHS). METHODS: Eligible women of reproductive age with at least one pregnancy-related encounter between January 2005 and December 2013 receiving care in the MHS were included in the study population. Building on previously published algorithms, we used pregnancy-related diagnostic and procedure codes, parameterized temporal constraints, and data elements unique to the MHS to identify pregnancies ending in live births, stillbirth, spontaneous abortion, or ectopic pregnancy. Pregnancies ending in live births were matched to presumptive offspring using birth dates and family-based sponsorship identification. Antidepressant and antiepileptic use during pregnancy was evaluated using electronic pharmacy data. RESULTS: Algorithms identified 755,232 women who experienced 1,099,648 complete pregnancies with both pregnancy care encounter and pregnancy outcome. Of the 924,320 live birth pregnancies, 827,753 (90.0%) were matched to offspring. Algorithms also identified 5,663 stillbirths, 11,358 ectopic pregnancies, and 169,665 spontaneous abortions. Among the matched singleton live birth pregnancies, 7.1% of mothers were dispensed an antidepressant at any point during pregnancy, usually a selective serotonin reuptake inhibitor, (75.3%), whereas 1.3% of mothers were dispensed an antiepileptic drug.