Research in obstetrics and gynecology (OB/GYN) increasingly relies on "big data" and observational study designs. There is a gap in practitioner-relevant guides to interpret and critique such ...research.
This guide is an introduction to interpreting research using observational data and provides explanations and context for related terminology. In addition, it serves as a guide for critiquing OB/GYN studies that use observational data by outlining how to assess common pitfalls of experimental and observational study designs. Lastly, the piece provides a compendium of observational data resources commonly used within OB/GYN research.
Review of literature was conducted for the collection of definitions and examples of terminology related to observational data research. Data resources were collected via Web search and researcher recommendations. Next, each data resource was reviewed and analyzed for content and accessibility. Contents of data resources were organized into summary tables and matched to relevant literature examples.
We identified 26 observational data resources frequently used in secondary analysis for OB/GYN research. Cost, accessibility considerations for software/hardware capabilities, and contents of each data resource varied substantially.
Observational data sources can provide researchers with a variety of options in tackling their research questions related to OB/GYN practice, patient health outcomes, trends in utilization of medications/procedures, or prevalence estimates of disease states. Insurance claims data resources are useful for population-level prevalence estimates and utilization trends, whereas electronic health record-derived data and patient survey data may be more useful for exploring patient behaviors and trends in practice.
Purpose
Abuse‐deterrent formulation (ADF) opioid analgesics have been developed as a means to address prescription opioid abuse. ADF opioid use in clinical practice is not well described in the ...literature. This study characterizes ADF opioid prescribing patterns in 3 diverse states.
Methods
This study used data from prescription drug monitoring programs (PDMPs) in California, Florida, and Kentucky. The sample includes all ADF opioid prescriptions for patients ≥18 years old during the study period (CY 2018). Standardized prescribing rates were calculated by age, sex, and county rurality. The ADF opioid prescribing rate was calculated per 1,000 adult recipients of opioid analgesics.
Findings
The rate of ADF prescribing per 1,000 adult recipients of opioid analgesics was nearly twice as high in Florida (14.57; 95% CI: 14.44‐14.69) than in California (8.30; 95% CI: 8.22‐8.37) or Kentucky (8.20; 95% CI: 8.01‐8.39). ADF prescribing rates were highest among adults ages 55‐74 years and among males. ADF opioid prescribing in rural counties represented a greater proportion of total patients using opioid analgesics than in metro counties in California (RR 1.40; CI: 1.28‐1.53). Opposite and less pronounced variation was observed in Kentucky (RR 0.93; 95% CI: 0.88‐0.98), and a significant difference was not observed in Florida (RR 0.68; 95% CI: 0.38‐1.19).
Conclusions
There were significant differences in the ADF prescribing rates among the 3 states and in rural versus metro counties within 2 states. ADF opioid prescribing by age and sex showed similar trends within states. Further research is needed to elucidate contextual factors which may lead to prescribing variation.
We propose an approach to identify high health care utilizers using residuals from a regression-based health care utilization adjustment model to analyze the variations in health care expenditures. ...Using a large administrative claims dataset from a state public insurance program, we show that the residuals can identify a group of patients with high residuals whose demographics and categorization of comorbidities are similar to other patients but who have a significant amount of unexplained health care utilization. Additionally, these high utilizers persist from year to year. Correlation analysis with
Potentially Preventable Events (PPE) software shows that a portion of this utilization may be preventable. In addition, these residuals can be useful in predicting future PPEs and hence may be useful in identifying impactable high utilizers.
Background and aims
One‐third of opioid (OPI) overdose deaths involve concurrent benzodiazepine (BZD) use. Little is known about concurrent opioid and benzodiazepine use (OPI–BZD) most associated ...with overdose risk. We aimed to examine associations between OPI–BZD dose and duration trajectories, and subsequent OPI or BZD overdose in US Medicare.
Design
Retrospective cohort study.
Setting
US Medicare.
Participants
Using a 5% national Medicare data sample (2013–16) of fee‐for‐service beneficiaries without cancer initiating OPI prescriptions, we identified 37 879 beneficiaries (age ≥ 65 = 59.3%, female = 71.9%, white = 87.6%, having OPI overdose = 0.3%).
Measurements
During the 6 months following OPI initiation (i.e. trajectory period), we identified OPI–BZD dose and duration patterns using group‐based multi‐trajectory models, based on average daily morphine milligram equivalents (MME) for OPIs and diazepam milligram equivalents (DME) for BZDs. To label dose levels in each trajectory, we defined OPI use as very low (< 25 MME), low (25–50 MME), moderate (51–90 MME), high (91–150 MME) and very high (>150 MME) dose. Similarly, we defined BZD use as very low (< 10 DME), low (10–20 DME), moderate (21–40 DME), high (41–60 DME) and very high (> 60 DME) dose. Our primary analysis was to estimate the risk of time to first hospital or emergency department visit for OPI overdose within 6 months following the trajectory period using inverse probability of treatment‐weighted Cox proportional hazards models.
Findings
We identified nine distinct OPI–BZD trajectories: group A: very low OPI (early discontinuation)–very low declining BZD (n = 10 598; 28.0% of the cohort); B: very low OPI (early discontinuation)–very low stable BZD (n = 4923; 13.0%); C: very low OPI (early discontinuation)–medium BZD (n = 4997; 13.2%); D: low OPI–low BZD (n = 5083; 13.4%); E: low OPI–high BZD (n = 3906; 10.3%); F: medium OPI–low BZD (n = 3948; 10.4%); G: very high OPI–high BZD (n = 1371; 3.6%); H: very high OPI–very high BZD (n = 957; 2.5%); and I: very high OPI–low BZD (n = 2096; 5.5%). Compared with group A, five trajectories (32.3% of the study cohort) were associated with increased 6‐month OPI overdose risks: E: low OPI–high BZD hazard ratio (HR) = 3.27, 95% confidence interval (CI) = 1.61–6.63; F: medium OPI–low BZD (HR = 4.04, 95% CI = 2.06–7.95); G: very high OPI–high BZD (HR = 6.98, 95% CI = 3.11–15.64); H: very high OPI–very high BZD (HR = 4.41, 95% CI = 1.51–12.85); and I: very high OPI–low BZD (HR = 6.50, 95% CI = 3.15–13.42).
Conclusions
Patterns of concurrent opioid and benzodiazepine use most associated with overdose risk among fee‐for‐service US Medicare beneficiaries initiating opioid prescriptions include very high‐dose opioid use (MME > 150), high‐dose benzodiazepine use (DME > 40) or medium‐dose opioid with low‐dose benzodiazepine use.
Polysubstance use and the associated adverse consequences such as the ongoing and exponential increases in drug overdose deaths are major public health threats in the United States. There has been a ...substantial prevalence of driving under the influence of drugs (4.9% drivers in the United States) and drug-involved collisions (10.2% in Kentucky). In this study, 26 drugs including stimulants, opioids, and antipsychotics were measured in raw wastewater collected from two rest areas and a commercial truck service facility along two interstate highways in Kentucky. Methamphetamine, amphetamine, and cocaine were detected in all wastewater samples (n = 56) at both rest areas (I-24 E and I-24 W) and a commercial truck serving facility (I-75 N/S). Methamphetamine was discharged significantly higher at the rest areas (108 and 239 mg/d/1000 people at I-24 E and I-24 W, respectively); however, prescription opioids including tramadol, hydrocodone, and morphine as well as temazepam (benzodiazepine) and citalopram (antidepressant) were significantly discharged higher at the commercial truck service facility. Xylazine, a veterinary sedative, was also quantified for the first time in greater than 33% of collected wastewater samples. To the authors’ knowledge, this is the first quantitative study of drugs discharged at rest area facilities along interstate highways.
To investigate the effects of precursor chemical regulation aimed at reducing cocaine production on cocaine-related maternal and newborn hospital stays in the United States.
We analyzed monthly ...counts of maternal and neonatal stays from January 2002 through December 2013 by using a quasi-experimental interrupted time series design. We estimated the preregulation linear trend, postregulation change in linear trend, and abrupt change in level.
The number of monthly cocaine-related maternal and neonatal stays decreased by 221 and 128 stays, respectively, following the cocaine precursor regulation change. We also observed a further decline in per-month maternal and neonatal stays of 18 and 8 stays, respectively.
A supply-side disruption in the United States cocaine market was associated with reduced hospital stays for 2 vulnerable populations: pregnant women and newborns. Results support findings that federal precursor regulation can positively reduce cocaine availability in the United States.
Purpose of Review
Effective responses to the US opioid overdose epidemic rely on accurate and timely drug overdose mortality data, which are generated from medicolegal death investigations (MDI) and ...certifications of overdose deaths. We identify nuances of MDI and certification of overdose deaths that can influence drug overdose mortality surveillance, as well as recent research, recommendations, and epidemiological tools for improved identification and quantification of specific drug involvement in overdose mortality.
Recent Findings
Death certificates are the foundation of drug overdose mortality surveillance. Accordingly, counts and rates of specific drug involvement in overdose deaths are only as accurate as the drug listed on death certificates. Variation in systematic approaches or jurisdictional office policy in drug overdose death certification can lead to bias in mortality rate calculations. Recent research has examined statistical adjustments to improve underreported opioid involvement in overdose deaths. New cause-of-death natural language text analysis tools improve quantification of specific opioid overdose mortality rates. Enhanced opioid overdose surveillance, which combines death certificate data with other MDI-generated data, has the potential to improve understanding of factors and circumstances of opioid overdose mortality.
Summary
The opioid overdose crisis has brought into focus some of the limitations of US MDI systems for drug overdose surveillance and has given rise to a sense of urgency regarding the pressing need for improvements in our MDI data for public health action and research. Epidemiologists can stimulate positive changes in MDI data quality by demonstrating the critical role of data in guiding public health and safety decisions and addressing the challenges of accurate and timely overdose mortality measures with stakeholders. Education, training, and resources specific to drug overdose surveillance and analysis will be essential as the nation’s overdose crisis continues to evolve.