Optimizing timing of adolescent vaccines: Impact of initiating HPV vaccination before Tdap or meningococcal vaccination on timely completion of the HPV vaccine series.

To explore the impact on timely series completion of initiating the HPV vaccine series prior to other vaccines in the adolescent platform (Tdap or meningococcal vacccines), we created a cohort of children aged 9 in 2015 who were continuously enrolled through the age of 13 (2019) from a national administrative database of employee-sponsored insurance in the United States (MarketScan). Logistic regressions were used to predict the odds of HPV vaccine series completion among those who started the series prior to, concurrent with, or after receiving Tdap or meningococcal vaccination. The cohort included 100,857 eligible children. Compared with adolescents who received their HPV and Tdap or HPV and meningococcal vaccinations concurrently, those who received HPV prior to other vaccines had higher completion (aOR = 1.38 for Tdap, aOR 1.62 for meningococcal), while those who received their HPV vaccination after other vaccines had lower odds of HPV vaccine series completion (aOR = 0.68 for Tdap, aOR = 0.62 for meningococcal). Other factors associated with series completion included female sex, residing in an urban (vs. rural) area, residing in the Northeast, and receiving primary care from a pediatrician (vs. family medicine physician). These data indicate that beginning the HPV vaccine series prior to the adolescent platform may improve on-time series completion.

The Determining Effective Testing in Emergency Departments and Care Coordination on Treatment Outcomes (DETECT) for Hepatitis C (Hep C) Linkage-to-Care Trial: rationale and design of an emergency department-based randomized clinical trial of linkage-to-care strategies for hepatitis C.

BACKGROUND: Hepatitis C (HCV) poses a major public health problem in the USA. While early identification is a critical priority, subsequent linkage to a treatment specialist is a crucial step that bridges diagnosed patients to treatment, cure, and prevention of ongoing transmission. Emergency departments (EDs) serve as an important clinical setting for HCV screening, although optimal methods of linkage-to-care for HCV-diagnosed individuals remain unknown. In this article, we describe the rationale and design of The Determining Effective Testing in Emergency Departments and Care Coordination on Treatment Outcomes (DETECT) for Hepatitis C (Hep C) Linkage-to-Care Trial. METHODS: The DETECT Hep C Linkage-to-Care Trial will be a single-center prospective comparative effectiveness randomized two-arm parallel-group superiority trial to test the effectiveness of linkage navigation and clinician referral among ED patients identified with untreated HCV with a primary hypothesis that linkage navigation plus clinician referral is superior to clinician referral alone when using treatment initiation as the primary outcome. Participants will be enrolled in the ED at Denver Health Medical Center (Denver, CO), an urban, safety-net hospital with approximately 75,000 annual adult ED visits. This trial was designed to enroll a maximum of 280 HCV RNA-positive participants with one planned interim analysis based on methods by O'Brien and Fleming. This trial will further inform the evaluation of cost effectiveness, disparities, and social determinants of health in linkage-to-care, treatment, and disease progression. DISCUSSION: When complete, the DETECT Hep C Linkage-to-Care Trial will significantly inform how best to perform linkage-to-care among ED patients identified with HCV. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT04026867 Original date: July 1, 2019 URL: https://clinicaltrials.gov/ct2/show/NCT04026867.

Underscreening, overscreening, and guideline-adherent cervical cancer screening in a national cohort.

OBJECTIVE: To explore rates of under- and overscreening for cervical cancer among a national cohort. METHODS: The MarketScan database, a national administrative database of employee-sponsored insurance, was queried for elements relevant to cervical cancer screening among women aged 21-65 with 6 years of continuous enrollment (2015-2019). Average-risk women were defined as those without high-risk medical conditions or abnormal screening histories, and without evidence of hysterectomy with removal of the cervix for benign indications. Average-risk women were considered adequately screened if they had Pap tests alone at 2.5-3.5 year intervals, or HPV tests or co-tests at 4.5-5.5 year intervals. Logistic regressions were used to predict the odds of receiving guideline-adherent screening, underscreening, and overscreening. RESULTS: Among 1,872,809 eligible patients, 1,471,063 (78.5%) qualified for routine screening. Of these, only 18.1% received guideline-adherent screening, and 25.4% were unscreened during the 6-year period. Younger women (aged 21-39) were more likely to be overscreened [OR 1.46]. Older women (aged 50-64) were more likely to be underscreened or unscreened during the study period [OR 2.54]. Guideline-adherent screening was highest with HPV testing alone (80%) followed by co-testing (44%), and lowest with cytology alone (15%). A total of 329,062 women in this general population sample (18%) met high-risk criteria that required increased frequency of screening. CONCLUSIONS: High rates of both underscreening and overscreening indicate a need for additional strategies to improve guideline-adherent care. CLINICAL TRIAL REGISTRATION: N/A.

The Determining Effective Testing in Emergency Departments and Care Coordination on Treatment Outcomes (DETECT) for Hepatitis C (Hep C) Screening Trial: rationale and design of a multi-center pragmatic randomized clinical trial of hepatitis C screening in emergency departments.

BACKGROUND: Early identification of HCV is a critical health priority, especially now that treatment options are available to limit further transmission and provide cure before long-term sequelae develop. Emergency departments (EDs) are important clinical settings for HCV screening given that EDs serve many at-risk patients who do not access other forms of healthcare. In this article, we describe the rationale and design of The Determining Effective Testing in Emergency Departments and Care Coordination on Treatment Outcomes (DETECT) for Hepatitis C (Hep C) Screening Trial. METHODS: The DETECT Hep C Screening Trial is a multi-center prospective pragmatic randomized two-arm parallel-group superiority trial to test the comparative effectiveness of nontargeted and targeted HCV screening in the ED with a primary hypothesis that nontargeted screening is superior to targeted screening when identifying newly diagnosed HCV. This trial will be performed in the EDs at Denver Health Medical Center (Denver, CO), Johns Hopkins Hospital (Baltimore, MD), and the University of Mississippi Medical Center (Jackson, MS), sites representing approximately 225,000 annual adult visits, and designed using the PRECIS-2 framework for pragmatic trials. When complete, we will have enrolled a minimum of 125,000 randomized patient visits and have performed 13,965 HCV tests. In Denver, the Screening Trial will serve as a conduit for a distinct randomized comparative effectiveness trial to evaluate linkage-to-HCV care strategies. All sites will further contribute to embedded observational studies to assess cost effectiveness, disparities, and social determinants of health in screening, linkage-to-care, and treatment for HCV. DISCUSSION: When complete, The DETECT Hep C Screening Trial will represent the largest ED-based pragmatic clinical trial to date and all studies, in aggregate, will significantly inform how to best perform ED-based HCV screening. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT04003454 . Registered on 1 July 2019.

Eligibility for cervical cancer screening exit: Comparison of a national and safety net cohort.

OBJECTIVE: To determine eligibility for discontinuation of cervical cancer screening. METHODS: Women aged 64 with employer-sponsored insurance enrolled in a national database between 2016 and 2018, and those aged 64-66 receiving primary care at a safety net health center in 2019 were included. Patients were evaluated for screening exit eligibility by current guidelines: no evidence of cervical cancer or HIV-positive status and no evidence of cervical precancer in the past 25 years, and had evidence of either hysterectomy with removal of the cervix or evidence of fulfilling screening exit criteria, defined as two HPV screening tests or HPV plus Pap co-tests or three Pap tests within the past 10 years without evidence of an abnormal result. RESULTS: Of the 590,901 women in the national claims database, 131,059 (22.2%) were eligible to exit due to hysterectomy (1.6%) or negative screening (20.6%). Of the 1544 women from the safety net health center, 528 (34.2%) were eligible to exit due to hysterectomy (9.3%) or negative screening (24.9%). Most women did not have sufficient data available to fulfill exit criteria: 382,509 (64.7%) in the national database and 875 (56.7%) in the safety net hospital system. Even among women with 10 years of insurance claims data, only 41.5% qualified to discontinue screening. CONCLUSIONS: Examining insurance claims in a national database and electronic medical records at a safety net institution led to remarkably similar findings: two thirds of women fail to qualify for screening exit. Additional steps to ensure eligibility prior to screening exit may be necessary to decrease preventable cervical cancers among women aged >65. CLINICAL TRIAL REGISTRATION: N/A.

Payments for outpatient joint replacement surgery: A comparison of hospital outpatient departments and ambulatory surgery centers.

OBJECTIVE: To compare commercial insurance payments for outpatient total knee and hip replacement surgeries performed in hospital outpatient departments (HOPDs) and in ambulatory surgery centers (ASCs). DATA SOURCES: A large national claims database that contains information on actual prices paid to providers over the period 2014-2017. DATA COLLECTION: We identified all patients receiving total knee replacement surgery and total hip replacement surgery in HOPDs and in ASCs for each of the 4 years. STUDY DESIGN: For each year, we conducted descriptive and statistical patient-level analyses of the facility component of payments to HOPDs and to ASCs. PRINCIPAL FINDINGS: For each procedure and for each year, ASC payments exceeded HOPD payments by a wide margin; however, the gap across settings declined over time. In 2014, knee replacement payments to HOPDs (n = 67) were $6016 compared to $23 244 in ASCs (n = 68). By 2017, payments to HOPDs (n = 223) had grown to $10 060 compared to $18 234 in ASCs (n = 602). Similarly, for hip replacements, HOPD payments (n = 43) rose from $6980 in 2014 to $11 139 in 2017 (n = 206) and in ASCs fell from $28 485 in 2014 (n = 82) to $18 595 in 2017 (n = 465). CONCLUSIONS: Results suggest that for total joint replacement, common perceptions of cost savings from transition of services from hospitals to ASCs may be misguided.

Patient Outcomes Following Total Joint Replacement Surgery: A Comparison of Hospitals and Ambulatory Surgery Centers.

BACKGROUND: For several years, many orthopedic surgeons have been performing total joint replacements in hospital outpatient departments (HOPDs) and more recently in ambulatory surgery centers (ASCs). In a recent shift, the Centers for Medicare and Medicaid Services began reimbursing for total knee replacement surgery in HOPDs. Some observers have expressed concerns over patient safety for the Medicare population particularly if Centers for Medicare and Medicaid Services extends the policy to include total hip replacement surgery and coverage in ASCs. METHODS: This study used a large claims database of non-Medicare patients to examine inpatient and outpatient total knee replacement and total hip replacement surgery performed on a near-elderly population during 2014-2016. We applied propensity score methods to match inpatients with ASC patients and HOPD patients with ASC patients adjusting for risk using the HHS Hierarchical Condition Categories risk adjustment model. We conducted statistical tests comparing clinical outcomes across the 3 settings and examined relative costs. RESULTS: Readmissions, postsurgical complications, and payments were lower for outpatients than for inpatients. Within outpatient settings, readmissions and postsurgical complications were lower in ASCs than in HOPDs but payments for ASC patients were higher than payments for HOPD patients. CONCLUSION: Our findings support the argument that outpatient total joint replacement is appropriate for select patients treated in both HOPDs and ASCs, although in the commercially insured population, the latter services may come at a cost. Until further study of outpatient total joint replacement in the Medicare population becomes available, how this will extrapolate to the Medicare population is unknown.

Cost-effectiveness of hepatitis C screening and treatment linkage intervention in US methadone maintenance treatment programs.

BACKGROUND: We evaluated the cost-effectiveness of a hepatitis C (HCV) screening and active linkage to care intervention in US methadone maintenance treatment (MMT) patients using data from a randomized trial conducted in New York City and San Francisco. METHODS: We used a decision analytic model to compare 1) no intervention; 2) HCV screening and education (control); and 3) HCV screening, education, and care coordination (active linkage intervention). We also explored an alternative strategy wherein HCV/HIV co-infected participants linked elsewhere. Trial data include population characteristics (67% male, mean age 48, 58% HCV infected) and linkage rates. Data from published sources include treatment efficacy and HCV re-infection risk. We projected quality-adjusted life years (QALYs) and lifetime medical costs using an established model of HCV (HEP-CE). Incremental cost-effectiveness ratios (ICERs) are in 2015 US$/QALY discounted 3% annually. RESULTS: The control strategy resulted in a projected 35% linking to care within 6 months and 31% achieving sustained virologic response (SVR). The intervention resulted in 60% linking and 54% achieving SVR with an ICER of $24,600/QALY compared to no intervention from the healthcare sector perspective and was a more efficient use of resources than the control strategy. The intervention had an ICER of $76,500/QALY compared to the alternative strategy. From a societal perspective, the intervention had a net monetary benefit of $511,000-$975,600. CONCLUSIONS: HCV care coordination interventions that include screening, education and active linkage to care in MMT settings are likely cost-effective at a conventional $100,000/QALY threshold for both HCV mono-infected and HIV co-infected patients.

Obstetric Outcomes After Failed Hysteroscopic and Laparoscopic Sterilization Procedures.

OBJECTIVE: To compare obstetric outcomes after failed hysteroscopic and laparoscopic sterilization. METHODS: This retrospective cohort study examined pregnancy outcomes including live birth, preterm birth, stillbirth, spontaneous abortion, therapeutic abortion, ectopic pregnancies, and gestational trophoblastic disease using a commercial claims administrative database for the years 2007-2013. We used a Z-test to compare pregnancy outcomes per 100 person-years based on type of sterilization. Cox proportional hazard models controlled for patient age, geographic region, urbanicity, comorbidities, and insurance type. RESULTS: We evaluated 997 pregnancy outcomes among 817 women from a total of 70,115 women with a history of either hysteroscopic sterilization (n=387 pregnancies/27,724 cases) or laparoscopic sterilization (n=610 pregnancies/42,391 cases). Women undergoing hysteroscopic sterilization were slightly older than, but otherwise similar to, women undergoing laparoscopic sterilization. The most common outcome was live birth, which was more likely after hysteroscopic sterilization compared with laparoscopic sterilization (adjusted hazard ratio 1.32, 95% CI 1.09-1.60). The rate of spontaneous abortion was not statistically significantly different between the two groups. Therapeutic abortion occurred more often after hysteroscopic sterilization (adjusted hazard ratio 1.49, 95% CI 1.10-2.01), whereas ectopic pregnancies occurred less often (adjusted hazard ratio 0.12, 95% CI 0.05-0.29) compared with laparoscopic sterilization. CONCLUSION: Hysteroscopic sterilization is associated with higher rates of live birth and lower rates of ectopic pregnancy compared with laparoscopic sterilization. Spontaneous abortion and preterm birth rates were similar in both groups. These data do not support an adverse effect of hysteroscopic sterilization on subsequent pregnancy outcomes.

Gynecologic Outcomes After Hysteroscopic and Laparoscopic Sterilization Procedures.

OBJECTIVE: To compare rates of gynecologic morbidity after laparoscopic and hysteroscopic sterilization. METHODS: This retrospective cohort study used a commercial claims administrative database, 2007-2013, to compare rates of pregnancy, menstrual dysfunction, pelvic pain, hysteroscopic surgery, and intra-abdominal gynecologic surgery after laparoscopic and hysteroscopic sterilization. Women with 12 or more continuous months of data before and after their index procedure were included. Pregnancy rates after laparoscopic and hysteroscopic sterilization were compared for the entire population of women who underwent hysteroscopic sterilization and the subset who had completed postprocedure hysterosalpingograms. Cox proportional hazard models were calculated controlling for age, comorbidities, U.S. geographic region, metropolitan statistical area designation, and insurance type. RESULTS: A total of 42,391 women underwent laparoscopic and 27,724 underwent hysteroscopic sterilization. The pregnancy rate was higher after hysteroscopic than laparoscopic sterilization (adjusted hazard ratio [HR] 1.20, 95% confidence interval [CI] 1.09-1.33; 2.4% compared with 2.0% risk of pregnancy at 2 years). Only 66.1% (n=18,318) of women who underwent hysteroscopic sterilization received a hysterosalpingogram. This group had similar pregnancy rates as those who underwent laparoscopic sterilization (adjusted HR 0.90, 95% CI 0.80-1.02; 1.8% compared with 2.0% at 2 years). After undergoing hysteroscopic sterilization, more women were diagnosed with menstrual dysfunction (adjusted HR 1.23, 95% CI 1.20-1.27; 26.8% compared with 22.3% at 2 years), and more women underwent hysteroscopic surgeries (adjusted HR 2.05, 95% CI 1.96-2.14; 13.8% compared with 6.4% at 2 years), but fewer women were diagnosed with pelvic pain (adjusted HR 0.83, P<.001; 21.0% compared with 25.6% at 2 years) and fewer women underwent intra-abdominal gynecologic surgeries (adjusted HR 0.95, 95% CI 0.90-0.99; 7.7% compared with 8.1% at 2 years), including hysterectomy (adjusted HR 0.65, 95% CI 0.61-0.69; 10.9% compared with 14.3% at 5 years). CONCLUSION: Hysteroscopic sterilization may be associated with a higher rate of pregnancy, more menstrual dysfunction, more hysteroscopic surgeries, less pelvic pain, and fewer intra-abdominal gynecologic surgeries than laparoscopic sterilization. Pregnancy rates appear to be similar for women who completed their postprocedure hysterosalpingogram, but only 66% of women did so.