Feasibility study on elimination of all oral opioids following bariatric surgery.

BACKGROUND: The bariatric population is at increased risk for developing chronic opioid dependence. The practice of prescribing oral opioids for analgesia in postoperative ambulatory settings is a known risk factor for developing chronic opioid dependence. The use of oral opioids following minimally invasive bariatric surgery may not be necessary. OBJECTIVES: To determine whether there is any measurable impact on patient care metrics (length of stay, inpatient delta pain score, 30-day emergency department presentations, and 30-day readmissions) when eliminating the use of oral opioids for postoperative analgesia following laparoscopic Roux-en-Y gastric bypass (LRYGB) and laparoscopic sleeve gastrectomy (SG). SETTING: Retrospective cohort study of data collected at a single bariatric center. METHODS: A cohort of 189 consecutive patients received oral opioids in the immediate postoperative setting, in addition to a prescription for oral opioids at the time of discharge following LRYGB and SG. A second cohort of 136 consecutive patients did not receive oral opioids at any point following surgery. A descriptive bivariate analysis was performed to examine the relationships between cohort characteristics and treatment type. A multivariable linear regression analysis and a logistic regression analysis were conducted to assess the association of treatment type with clinical outcomes of interest. RESULTS: The oral opioid-free cohort received significantly fewer morphine milligram equivalents during their postoperative hospital admission (P < .001). There were no differences in lengths of stay, 30-day emergency department presentations, or 30-day readmissions. Patients in the oral opioid-free cohort reported lower average delta pain scores (P < .001). CONCLUSION: Eliminating the use of oral opioids for analgesia following LRYGB and SG does not negatively impact patient care metrics and may improve patient-reported analgesia, as reflected by a significant difference in delta pain scores averages. Elimination of oral opioids from all postoperative analgesia regimens is feasible.

Mesh Complication Rates Following Pelvic Radiation Therapy in Women With History of Synthetic Midurethral Sling Implantation.

OBJECTIVE: To estimate the risk of mesh complications in women with and without subsequent pelvic and abdominal radiation therapy (RT). METHODS: We identified women within a large health care organization who underwent mesh-augmented surgery for pelvic floor disorders between 2008 and 2014 and subsequently received RT prior to 2018. We compared them to a randomly selected group of women who underwent similar mesh-augmented pelvic reconstructive surgery without RT in a 1:4 ratio. Mesh complications were identified through chart review corroborated with the ninth and tenth revisions of the International Classification of Diseases and Current Procedural Terminology codes for mesh complications. Mesh complications between groups were compared using survival analysis and Cox proportional hazards models. RESULTS: We identified 36 women with RT and compared them with 144 women without RT. Indications for mesh implantation and concomitant vaginal procedures were similar between the groups. The majority of mesh implants (94.4%) were midurethral slings. Twelve mesh complications (6.7%) were identified, with similar rates in the RT (8.3%) and no-RT (6.2%) groups (P = 0.65). The risk of mesh complications did not differ between groups when compared using the Cox proportional hazards model, controlling for age, body mass index, diabetes, menopausal status, and smoking (hazard ratio, 1.19; 95% confidence interval, 0.802-1.787). CONCLUSIONS: There was no difference in the occurrence of mesh-related complications between women with and without RT. Abdominopelvic RT may not substantially increase the risk of mesh complications following placement of a synthetic sling for stress urinary incontinence. The need for future RT may only be a minor factor in counseling patients on the risks of mesh implants for pelvic floor disorders.

Breast cancer risk after hysterectomy with and without salpingo-oophorectomy for benign indications.

BACKGROUND: Breast cancer risk has been extensively studied in women with genetic predisposition, that is, mutations in breast cancer genes 1 and 2. Although there are guidelines for performing bilateral salpingo-oophorectomies in individuals with specific genetic risks, oophorectomies are also performed in many women considered to be at average risk of developing breast cancer. The risk of breast cancer in women with average risk who undergo hysterectomy with bilateral salpingo-oophorectomy for benign indications is less clear. OBJECTIVE: This study aimed to estimate breast cancer risk after hysterectomy with and without concomitant bilateral salpingo-oophorectomy for benign indications. STUDY DESIGN: From 2001 to 2015, women aged 18 years and older from Kaiser Permanente Northern California who underwent hysterectomy alone and hysterectomy with bilateral salpingo-oophorectomy were identified using the International Classification of Diseases, Ninth Revision, procedure and Current Procedural Terminology codes. Women with a breast cancer gene mutation and previous history of breast cancer or gynecologic cancer were excluded. Descriptive and bivariate analyses were used to describe and compare demographic and clinical characteristics. Breast cancer incidence rates were calculated per 100,000 person-years. Survival analysis and Cox proportional hazard models were conducted to compare the risk of developing breast cancer. RESULTS: Of 49,215 women who underwent hysterectomy, 19,826 had hysterectomy with bilateral salpingo-oophorectomy. Whites, Hispanics, blacks, Asians, and other or unknown comprised 51.2%, 20.3%, 12.7%, 10.4%, and 5.3% of the study population, respectively. The average age of women with hysterectomy alone was 45.5 years compared with 50.8 years for those who had hysterectomy with bilateral salpingo-oophorectomy. During the study period, 915 women received a diagnosis of breast cancer. Age-specific breast cancer incidence rates were higher in women older than 60 years with oophorectomy than hysterectomy alone (471.2 [95% confidence interval, 386.2-556.2] vs 463.0 [95% confidence interval, 349.6-576.5], respectively). After controlling for age, race, income, and Charlson Comorbidity Index, women with bilateral salpingo-oophorectomy had a 14% lower risk of breast cancer than women with hysterectomy alone (hazard ratio, 0.86; 95% confidence interval, 0.75-0.98). All-cause mortality was higher with oophorectomy than hysterectomy alone (64.4% vs 35.6%, P<.0001, respectively). CONCLUSION: Women with concurrent bilateral salpingo-oophorectomy for benign indications had a lower risk of breast cancer than those who had hysterectomy alone. However, all-cause mortality was higher in women with oophorectomy. Perimenopausal patients undergoing hysterectomy for benign indications should be counseled on the risks and benefits of oophorectomy at the time of surgery.

Knowledge, Attitudes, and Perceptions About Medicolegal Education: A Survey of OB/GYN Residents.

INTRODUCTION: Medicolegal concerns affect the career decisions of obstetrics/gynecology (OB/GYN) residents; however, their exposure to medicolegal education during residency training is virtually unknown. OBJECTIVE: To assess the knowledge, attitudes, and perceptions of medicolegal concepts among OB/GYN residents. METHODS: All residents in an accredited residency training program in OB/GYN in the United States during the 2017-2018 academic year were invited to complete an anonymous online survey. RESULTS: Of the 5152 OB/GYN residents invited to complete the survey; nearly 17% (n = 866) responded. Basic medicolegal knowledge was poor. Almost 60% of respondents (n = 500) could not identify malpractice as a form of tort liability. Among respondents, 44% (n = 378) reported receiving no medicolegal education during residency, 21% (n = 181) were unsure, and 34% (n = 293) reported receiving some education. Of those who reported receiving medicolegal education, the majority, 66% (n = 549), received it informally: by "word of mouth" or by "observing colleagues." Most (67%, n = 571) of the residents did not believe they had adequate exposure to medicolegal topics, and 19% (n = 163) were unsure. Ninety-two percent of residents (n = 782) reported concerns about being sued, and 67% (n = 571) believed that formal instruction during residency training may prevent lawsuits. CONCLUSION: Exposure to medicolegal topics during OB/GYN residency training is very limited and unstructured. This study showed that residents desire a more formalized medicolegal curriculum during postgraduate training and that implementation may have several benefits.

Clinical implications and economic impact of accuracy differences among commercially available blood glucose monitoring systems.

BACKGROUND: Despite accuracy standards, there are performance differences among commercially available blood glucose monitoring (BGM) systems. The objective of this analysis was to assess the potential clinical and economic impact of accuracy differences of various BGM systems using a modeling approach. METHODS: We simulated additional risk of hypoglycemia due to blood glucose (BG) measurement errors of five different BGM systems based on results of a real-world accuracy study, while retaining other sources of glycemic variability. Using data from published literature, we estimated an annual additional number of required medical interventions as a result of hypoglycemia. We based our calculations on patients with type 1 diabetes mellitus (T1DM) and T2DM requiring multiple daily injections (MDIs) of insulin in a U.S. health care system. We estimated additional costs attributable to treatment of severe hypoglycemic episodes resulting from BG measurement errors. RESULTS: Results from our model predict an annual difference of approximately 296,000 severe hypoglycemic episodes from BG measurement errors for T1DM (105,000 for T2DM MDI) patients for the estimated U.S. population of 958,800 T1DM and 1,353,600 T2DM MDI patients, using the least accurate BGM system versus patients using the most accurate system in a U.S. health care system. This resulted in additional direct costs of approximately $339 million for T1DM and approximately $121 million for T2DM MDI patients per year. CONCLUSION: Our analysis shows that error patterns over the operating range of BGM meter may lead to relevant clinical and economic outcome differences that may not be reflected in a common accuracy metric or standard. Further research is necessary to validate the findings of this model-based approach.

Economic burden of resected squamous cell carcinoma of the head and neck in a US managed-care population.

BACKGROUND: Squamous cell carcinoma of the head and neck (SCCHN) places a high burden on society and poses complex challenges to healthcare providers. METHODS: Retrospective claims-based analysis of commercially insured patients identified between 01-31-04 and 12-31-07 with diagnostic evidence of cancer of the lip, tongue, oral cavity, pharynx, or larynx who underwent surgical resection during identification period. Outcomes included treatment patterns, healthcare utilization, and costs. All study variables were analyzed descriptively. RESULTS: Among the 1104 patients in the final study sample, 71.9% were male, with mean age 56.6 years. On average, patients were followed for 830 days (range of mean days: 805 for lip or tongue cancer to 847 for pharyngeal cancer). About half received radiation therapy during follow-up, whereas only 16.2% received chemotherapy. Patients with pharyngeal cancer were most likely to undergo chemotherapy. After their index surgery, 57.9% of patients had ≥1 inpatient stay, 44.9% had ≥1 ER visit, and all had ≥1 ambulatory visit. The percentage with ≥1 inpatient stay post-index was highest among patients with pharyngeal cancer (73.0%) and lowest in the laryngeal cancer cohort (49.5%). Mean number of hospitalized days, ER visits, and ambulatory visits was 0.45, 0.69, and 27.4, respectively, per-patient per-year. Overall, patients incurred ~$94 million in cost following index surgery ($85,000 per-person, on average). Mean total healthcare cost was $34,450 per-patient per-year, the bulk of which comprised medical expenses ($32,401). The highest mean healthcare cost was incurred by the pharyngeal cancer cohort ($40,214). CONCLUSIONS: Patients with resected SCCHN incur substantial healthcare costs and have high utilization rates. Results of this analysis are primarily applicable to resected SCCHN in a managed-care setting, and therefore may not be generalizable to the entire US population. Furthermore, disease stage is an important factor impacting outcomes, but these analyses did not stratify patients according to disease stage.

Impact of Treatment by NCQA-Certified Physicians on Diabetes-Related Outcomes.

BACKGROUND: The National Committee for Quality Assurance supports high-quality care for patients through the Diabetes Recognition Program (DRP). The DRP recognizes physicians and practices that are providing high-quality diabetes care as determined by 10 key measures. OBJECTIVE: To examine the impact of treatment by DRP-certified physicians compared with non-DRP-certified physicians on patient outcomes. METHODS: This retrospective claims analysis was conducted from January 1, 2007, through November 30, 2007, using a large US database of approximately 14 million commercially insured members. Physicians with DRP certification (N = 1188) were identified and matched 1:1 to physicians without DRP certification based on physician specialty, location (state) of practice, size of potential patient population, and number of patients with type 2 diabetes treated by the physician. Patients were included if they had type 2 diabetes and had been treated by a physician in the DRP group (N = 3836) or in the comparison group (N = 4175). Primary outcomes were medication use, medical resource utilization, and expenditures. Per-patient per-year (PPPY) medical and pharmacy utilization measures were analyzed using Poisson regression; PPPY expenditures were estimated using a generalized linear model with gamma distribution. RESULTS: Multivariate analysis showed that patients treated by DRP-certified physicians had more postindex diabetes-related office visits (mean PPPY, 4.69 vs 4.44, respectively; P <.001) and outpatient visits (mean PPPY, 0.93 vs 0.85, respectively; P <.001) than patients treated by non-DRP-certified physicians, but fewer emergency department visits (mean PPPY, 0.04 vs 0.07, respectively; P <.001) and inpatient visits (mean PPPY, 0.08 vs 0.10, respectively; P = .02). Prescribing rates for oral antihyperglycemic drugs and statins were higher among DRP-certified physicians than non-DRP-certified physicians. Total diabetes-related healthcare expenditures were lower for patients with type 2 diabetes managed by DRP-certified physicians compared with those managed by non-DRP-certified physicians (mean PPPY, $3424 vs $4097, respectively; P = .03). CONCLUSION: Significant differences in oral antihyperglycemic and statin drug use, and diabetes-related emergency department and inpatient visits and expenditures, were observed in this study between DRP-certified and non-DRP-certified physicians, showing overall improved outcomes for patients managed by DRP-certified physicians.

Improved A1C by switching to continuous subcutaneous insulin infusion from injection insulin therapy in type 2 diabetes: A retrospective claims analysis.

AIMS: This study was a real-world, retrospective evaluation of the clinical effectiveness of switching to continuous subcutaneous insulin infusion (CSII) among managed care enrollees with type 2 diabetes for whom multiple daily injections (MDI) had presumably failed. METHODS: Administrative claims with integrated A1C values from a large and geographically diverse health plan were analyzed. RESULTS: Statistically significant A1C reductions (from the baseline period to follow-up period, mean follow-up 17 months) were achieved with CSII. Among subjects using a long-acting and rapid-acting insulin regimen at baseline, A1C decreased to mean follow-up A1C by 0.8% and to minimum follow-up A1C by 1.2% (p<0.001). The proportion of subjects at target (A1C<7%) increased significantly from baseline to follow-up (8.4-22.9% [using mean A1C] and 32.8% [using minimum A1C]; both p<0.001). The rate of severe hypoglycemic events was similar from baseline to follow-up. CONCLUSIONS: CSII was associated with significant reductions in A1C without an increase in hypoglycemic events in insulin-taking people with type 2 diabetes, including subjects previously using a long-acting and rapid-acting insulin regimen.

Resource utilization with insulin pump therapy for type 2 diabetes mellitus.

OBJECTIVES: To evaluate the effects of switching from multiple daily injection (MDI) therapy to insulin pump therapy, also called continuous subcutaneous insulin infusion (CSII), on antidiabetic drug and healthcare resource utilization. STUDY DESIGN: This study was a retrospective analysis of administrative claims data from a large geographically diverse health plan in the United States from January 1, 2005, through April 30, 2008. METHODS: Changes in antidiabetic drug use, antidiabetic drug switching and augmentation, and healthcare utilization during the baseline period and after CSII initiation were assessed using paired t test. RESULTS: There were 3649 possible subjects, of whom 943 met the criteria for analysis. The mean number of antidiabetic drugs used decreased by 46% after CSII initiation, and the mean reduction in antidiabetic drug utilization was 0.67; both were statistically significant. More than one-third of subjects who were taking antidiabetic drugs before CSII initiation discontinued oral therapy after CSII initiation. The number of subjects using multiple antidiabetic drugs significantly decreased after CSII initiation by 58%, and rates of switching or augmenting significantly decreased from 42% at baseline to 25% after CSII initiation.The rates of emergency department visits and inpatient admissions significantly decreased, and the rate of ambulatory visits significantly increased. CONCLUSIONS: CSII was associated with significant decreases in antidiabetic drug and healthcare resource utilization, contributing to stability of care. The evidence from this study indicates that CSII should be considered as an option for patients with type 2 diabetes mellitus who are using MDI and are experiencing a high degree of antidiabetic drug and healthcare resource utilization.

Health-related quality of life as a potential predictor in chronic obstructive lung disease patients.

Chronic obstructive pulmonary disease is used as an umbrella term for chronic bronchitis and emphysema and is the fourth most common cause of death in North America. Current therapies are based on reducing risk factors as there is no known cure for this disease and hence an important focus of clinical medicine has been the prevention of further decline in physical function and the enhancement of health-related quality of life. The objective of the study is to assess the relationship between the patients' reported health-related quality of life and the severity of disease as measured by clinical indicators. A prospective, nonrandomized, observational study was conducted. The population consisted of subjects presenting to the University of Maryland Medical Center and the Baltimore Veterans Administration outpatient clinic, enrolled according to a convenience, staggered sampling. The Airways obstruction Questionnaire-20, the Medical Outcomes Study short form-12 and the Health Utilities Index instruments were used, and descriptive, as well as multivariate analyses were performed using multivariate linear regression models. The chronic obstructive pulmonary disease cohort was predominantly Caucasian (64%) and male (68%). The disease-specific instrument (Airways obstruction Questionnaire-20) had weak associations with the utility scores as well as a mental component and mild association with a physical component. Results showed a mild association between the disease severity, which is based on the forced expiratory volume in 1 s value, and the health-related quality of life scores. Over a 3-month period, no change was seen in the patient-reported health-related quality of life and the change in health-related quality-of-life scores was not associated with disease severity.

Modeling risk of gastrointestinal events among Medicaid NSAID users using propensity scores.

The purpose of the study is to evaluate the gastrointestinal risk of nonsteroidal anti-inflammatory drugs compared with cyclooxygenase-2 inhibitors in a Medicaid managed care population. Medical and prescription claims were analyzed for all Medicaid-enrollees aged 18 years and older, who received a cyclooxygenase-2 or other prescription nonsteroidal anti-inflammatory drug between January 6, 2000 and January 6, 2002, and who did not use these drugs for at least 6 months prior. A logistic model was developed of the propensity for either treatment and stratified patients by quintiles of their propensity score, adjusting for demographics, indications for nonsteroidal anti-inflammatory drugs and gastrointestinal risks. The rates of gastrointestinal event (ICD-9 codes 531-534,578) among nonsteroidal anti-inflammatory drug and cyclooxygenase-2 users were compared. The model was adjusted for drug exposure which was calculated using the medication possession ratio. Of the total sample, 73% were female, 43% were Caucasian and 29% were older than 50 years. Both the direct and the propensity adjusted model, controlling for gastroprotective agents, and medication possession ratio showed significantly different rates of gastrointestinal events in nonsteroidal anti-inflammatory drug users as compared with cyclooxygenase-2 users (odds ratio = 1.874, 95% confidence interval 1.056, 3.326) and (odds ratio = 2.088, 95% confidence interval 1.061, 4.110) respectively. A significant difference in gastrointestinal event rates was found among patients in this Medicaid population on nonsteroidal anti-inflammatory drug versus cyclooxygenase-2 inhibitors, when the gastroprotective agent use and the medication possession ratio were controlled for. Misclassification bias was accounted for by adjusting for length of drug exposure.

Formulary decision-making considerations: COX-2 inhibitors.

When deciding the formulary status of a drug, Pharmacy & Therapeutics Committees must consider clinical efficacy, safety, financial implications, MCO population demographics, and other formulary options currently available. Differences in safety and effectiveness among drug classes and among drugs in the same class commonly take precedence over all other considerations, including economic ones. Particularly in light of recent events, the case of the cyclooxygenase-2 inhibitors for the treatment of arthritis yields interesting perspectives into formulary decision making.