Inequities in coronavirus disease 2019 (COVID-19) Vaccination Rates Among Adolescents in Massachusetts: A Cross-sectional Study.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic has disproportionately affected more socioeconomically disadvantaged persons and areas. We sought to determine how certain sociodemographic factors were correlated to adolescents' COVID-19 vaccination rates in towns and cities ("communities") in the Commonwealth of Massachusetts. METHODS: Data on COVID-19 vaccination rates were obtained over a 20-week period from 30 March 2021 to 10 August 2021. Communities' adolescent (ages 12-19) vaccination rates were compared across quintiles of community-level income, COVID-19 case rate, and proportion of non-Hispanic Black or Hispanic individuals. Other variables included population density and earlier COVID-19 vaccination rates of adolescents and adults, averaged from 30 March to 11 May to determine their effects on vaccination rates on 10 August. Linear and logistic regression was used to estimate individual effects of variables on adolescent vaccination rates. RESULTS: Higher median household income, lower proportion of Black or Hispanic individuals, higher early adolescent COVID-19 vaccination rates, and higher early adult COVID-19 vaccination rates were associated with higher later adolescent COVID-19 vaccination rates. Income per $10 000 (adjusted odds ratio [aOR] = 1.01 [95% confidence interval [CI] = 1.01-1.02]), proportion of Hispanic individuals (aOR = 1.33 [95% CI: 1.13-1.56]), early adolescent COVID-19 vaccination rates (aOR = 5.28 [95% CI: 4.67-5.96]), and early adult COVID-19 vaccination rates (aOR = 2.31 [95% CI: 2.02-2.64]) were associated with higher adolescent COVID-19 vaccination on 10 August, whereas proportion of Black individuals approached significance (aOR = 1.26 [95% CI: .98-1.61]). CONCLUSIONS: Vaccination efforts for adolescents in Massachusetts should focus on boosting vaccination rates early in communities with the lowest incomes and greatest proportion of Hispanic individuals and consider targeting communities with a greater proportion of Black individuals.

Improving Rates of Influenza Vaccination Through Electronic Health Record Portal Messages, Interactive Voice Recognition Calls and Patient-Enabled Electronic Health Record Updates: Protocol for a Randomized Controlled Trial.

BACKGROUND: Clinical decision support (CDS), including computerized reminders for providers and patients, can improve health outcomes. CDS promoting influenza vaccination, delivered directly to patients via an electronic health record (EHR) patient portal and interactive voice recognition (IVR) calls, offers an innovative approach to improving patient care. OBJECTIVE: To test the effectiveness of an EHR patient portal and IVR outreach to improve rates of influenza vaccination in a large multispecialty group practice in central Massachusetts. METHODS: We describe a nonblinded, randomized controlled trial of EHR patient portal messages and IVR calls designed to promote influenza vaccination. In our preparatory phase, we conducted qualitative interviews with patients, providers, and staff to inform development of EHR portal messages with embedded questionnaires and IVR call scripts. We also provided practice-wide education on influenza vaccines to all physicians and staff members, including information on existing vaccine-specific EHR CDS. Outreach will target adult patients who remain unvaccinated for more than 2 months after the start of the influenza season. Using computer-generated randomization and a factorial design, we will assign 20,000 patients who are active users of electronic patient portals to one of the 4 study arms: (1) receipt of a portal message promoting influenza vaccines and offering online appointment scheduling; (2) receipt of an IVR call with similar content but without appointment facilitation; (3) both (1) and (2); or (4) neither (1) nor (2) (usual care). We will randomize patients without electronic portals (10,000 patients) to (1) receipt of IVR call or (2) usual care. Both portal messages and IVR calls promote influenza vaccine completion. Our primary outcome is percentage of eligible patients with influenza vaccines administered at our group practice during the 2014-15 influenza season. Both outreach methods also solicit patient self-report on influenza vaccinations completed outside the clinic or on barriers to influenza vaccination. Self-reported data from both outreach modes will be uploaded into the EHR to increase accuracy of existing provider-directed EHR CDS (vaccine alerts). RESULTS: With our proposed sample size and using a factorial design, power calculations using baseline vaccination rate estimates indicated that 4286 participants per arm would give 80% power to detect a 3% improvement in influenza vaccination rates between groups (α=.05; 2-sided). Intention-to-treat unadjusted chi-square analyses will be performed to assess the impact of portal messages, either alone or in combination with the IVR call, on influenza vaccination rates. The project was funded in January 2014. Patient enrollment for the project described here completed in December 2014. Data analysis is currently under way and first results are expected to be submitted for publication in 2016. CONCLUSIONS: If successful, this study's intervention may be adapted by other large health care organizations to increase vaccination rates among their eligible patients. CLINICALTRIAL: ClinicalTrials.gov NCT02266277; https://clinicaltrials.gov/ct2/show/NCT02266277 (Archived by WebCite at http://www.webcitation.org/6fbLviHLH).

Can the diagnosis of pelvic inflammatory disease be excluded without a bimanual examination?

Now that urine-based tests are available for detection of Chlamydia and gonorrhea, we sought to determine whether history alone could be used to exclude pelvic inflammatory disease (PID) and thus preclude a bimanual examination. The study design was a retrospective chart review. The study population included females aged 15-24 years diagnosed with PID. Outcome measures were documentation of screening symptoms (abdominal pain, dyspareunia, or abnormal vaginal bleeding) in the medical record. Our primary analysis was sensitivity of screening symptoms for identifying patients with PID. At least 1 of the 3 screening symptoms was reported by 93% of the PID group. If absence of all 3 screening symptoms were used as a screening instrument to exclude a bimanual examination, many women with lower genital tract symptoms could be evaluated noninvasively. However, this approach could result in delayed diagnosis of PID in a small number of patients. Before this strategy is adopted, a large prospective study is needed.

Changes in brain natriuretic peptide and norepinephrine over time and mortality and morbidity in the Valsartan Heart Failure Trial (Val-HeFT).

BACKGROUND: Neurohormones are considered markers of heart failure progression. We examined whether changes in brain natriuretic peptide (BNP) and norepinephrine (NE) over time are associated with corresponding changes in mortality and morbidity in the Valsartan Heart Failure Trial. METHODS AND RESULTS: Plasma BNP and NE were measured before randomization and during follow-up in approximately 4300 patients in the Valsartan Heart Failure Trial. The relation between baseline BNP and NE and all-cause mortality and first morbid event (M&M) was analyzed in subgroups, with values above and below the median, and by quartiles. The change and percent change from baseline to 4 and 12 months in BNP and NE were also analyzed by quartiles for subsequent M&M. Risk ratios for M&M were calculated using a Cox proportional hazard model. Risk ratio of M&M for patients with baseline BNP or NE above the median was significantly higher than that for patients with values below the median. Baseline BNP and NE in quartiles also showed a quartile-dependent increase in M&M. BNP had a stronger association with M&M than NE. Patients with the greatest percent decrease in BNP and NE from baseline to 4 and 12 months had the lowest whereas patients with greatest percent increase in BNP and NE had the highest M&M. CONCLUSIONS: Not only are plasma BNP and NE important predictors of heart failure M&M, but changes in these neurohormones over time are associated with corresponding changes in M&M. These data further reinforce their role as significant surrogate markers in HF and underscore the importance of including their measurement in HF trials.

Internal thoracic artery grafts for the entire heart at a mean of 12 years.

BACKGROUND: There is consensus today that the long-term results of bypassing the left anterior descending artery with an internal thoracic artery (ITA) graft are superior to those of a saphenous vein graft. Our hypothesis for this study was that three-vessel revascularization with only ITA grafts would also give excellent results. METHODS: Using our previously described techniques to enhance the length of ITA grafts by skeletonization and high mediastinal mobilization, we were able to perform tension-free, three-vessel revascularization using only ITA grafts in 125 (83%) of a consecutive series of 150 patients with three-vessel occlusive coronary disease. We followed 100% of these 125 exclusive ITA graft patients (average of 3.9 anastomoses per patient) to their time of death (59; 47.2%) or current living status (66; 52.8%). RESULTS: Combined intraoperative graft flows averaged 225 mL/min. Of the 125 patients in this study (average age, 63.5 years), 121 (96.8%) lived beyond 40 days. Of these 121 patients, 55 (45%) died at a mean of 7 years postoperatively and 66 (55%) are still living at a mean of 12.1 years. Of these 121 patients, 112 (93%) had angina at baseline. Of these 112, 92 (85%) were angina free at a mean of 9.1 years postoperatively. Freedom from infarction was 100% at 5 years and 97% at 10 years. Freedom from reintervention was 90% at a mean of 9.8 years. CONCLUSIONS: Use of ITA grafts for three-vessel coronary revascularization provides excellent results and is both practical and appropriate for many patients.

Self-designing two-stage trials to minimize expected costs.

In the design of clinical trials, the sample size for the trial is traditionally calculated from estimates of parameters of interest, such as the mean treatment effect, which can often be inaccurate. However, recalculation of the sample size based on an estimate of the parameter of interest that uses accumulating data from the trial can lead to inflation of the overall Type I error rate of the trial. The self-designing method of Fisher, also known as the variance-spending method, allows the use of all accumulating data in a sequential trial (including the estimated treatment effect) in determining the sample size for the next stage of the trial without inflating the Type I error rate. We propose a self-designing group sequential procedure to minimize the expected total cost of a trial. Cost is an important parameter to consider in the statistical design of clinical trials due to limited financial resources. Using Bayesian decision theory on the accumulating data, the design specifies sequentially the optimal sample size and proportion of the test statistic's variance needed for each stage of a trial to minimize the expected cost of the trial. The optimality is with respect to a prior distribution on the parameter of interest. Results are presented for a simple two-stage trial. This method can extend to nonmonetary costs, such as ethical costs or quality-adjusted life years.

Epidemic crack cocaine use linked with epidemics of genital ulcer disease and heterosexual HIV infection in the Bahamas: evidence of impact of prevention and control measures.

BACKGROUND: Epidemic freebase/crack cocaine use began in the Bahamas in 1982, closely followed by epidemics of genital ulcer disease (GUD) and HIV infection. Numbers of new clients receiving ambulatory treatment for cocaine use in Nassau peaked in 1984. GOAL: To assess interrelations among epidemics of crack use, GUD, and HIV infection. STUDY DESIGN: The study was designed for review and comparison of temporal trends in ambulatory and inpatient treatment of cocaine users and in numbers of cases of sexually transmitted disease (STD) and HIV infection in the Bahamas. A retrospective case-control study of cocaine use and STDs was performed at the Comprehensive Dermatovenereology Clinic in Nassau. RESULTS: Ambulatory visits and inpatient admissions for cocaine use peaked in 1984 and 1987, respectively. GUD cases increased 12-fold in the Bahamas from 1983 to the period of 1985-1987 and then declined. At the Comprehensive Dermatovenereology Clinic, gonorrhea cases outnumbered bacterial GUD cases approximately 10:1 in 1982 and 1983, but the latter increased to outnumber gonorrhea cases in 1985 and 1987-1988. Annual HIV seroprevalences at new-problem visits rose from less than 0.3% in 1986 to 12.9% by 1994 and then leveled off. Cocaine use among patients seen with STD from 1985 through 1990 was significantly associated with GUD (odds ratio [OR], 3.3; 95% CI, 2.1-5.1), secondary syphilis (OR 5.5; 95% CI, 2.4-12.6), and HIV infection (OR, 8.1; 95% CI, 4.3-15.2). CONCLUSIONS: In temporally linked successive epidemics of cocaine use, GUD, and HIV infection, case-control analyses confirmed the association of cocaine use with GUD and with HIV infection. Declining GUD and HIV seroprevalence stabilization followed declines in cocaine use and implementation of syndromic management of GUD, as well as intensified partner-notification efforts.