CMS Will Test New Value-Based Primary Care Model

Starting in July 2024, the US Centers for Medicare & Medicaid Services (CMS) will begin piloting the Making Care Primary Model at organizations in 8 states—Colorado, Massachusetts, Minnesota, New Jersey, New Mexico, New York, North Carolina, and Washington. In addition to improving care coordination, helping primary care clinicians connect with specialists, and strengthening connections with community-based organizations, the approach will likely reduce health care costs, the agency said in a statement.

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Luglio 2023

Effectiveness of inactivated COVID-19 vaccines against SARS-CoV-2 infections among healthcare personnel in Pakistan: a test-negative case-control study

Objective
During the COVID-19 pandemic, several vaccines that were efficacious in randomised controlled trials were authorised for mass vaccination. In developing countries, inactivated vaccines were widely administered. While inactivated vaccines have been deemed effective in reducing disease severity, for healthcare personnel (HCP), effectiveness against SARS-CoV-2 infections is essential to reduce the risk to vulnerable patients and ensure a stable healthcare workforce. There are limited studies examining inactivated vaccines’ effectiveness against SARS-CoV-2 variants of concern (VOCs) in real-world settings. We estimated the effectiveness of inactivated vaccines (BBIBP-CorV and CoronaVac) against reverse transcription PCR (RT-PCR)-confirmed SARS-CoV-2 infections among HCP in the setting of emerging SARS-CoV-2 VOCs in Pakistan.

Design
A retrospective matched, test-negative case–control analysis using existing data from an Employee Health database on HCP at a large, private healthcare system in Pakistan.

Participants
4599 HCP were tested between 1 April and 30 September 2021. Each case (PCR positive) was matched to two to six controls (PCR negative) by the date of the RT-PCR test (±7 days) to reduce bias.

Primary and secondary outcome measures
The primary outcome was vaccine effectiveness (VE) against SARS-CoV-2 infection. The secondary outcome was VE against symptomatic SARS-CoV-2 infection. Per cent VE was calculated using (1-OR)*100, with the OR of getting a PCR-confirmed SARS-COV-2 infection estimated using conditional logistic regression, after adjusting for age, gender, work area and history of SARS-CoV-2 infection.

Results
Inactivated vaccines were ineffective against SARS-CoV-2 infections after receiving the first dose (VE 17%, 95% CI –10, 39; p=0.261). They showed modest effectiveness ≥14 days after the second dose against SARS-CoV-2 infections (VE 30%, 95% CI 7, 48; p=0.015) and symptomatic SARS-CoV-2 infections (VE 33%, 95% CI 6, 52; p=0.002).

Conclusions
Inactivated vaccines show modest effectiveness against SARS-CoV-2 infections in the setting of emerging VOCs. This builds a strong case for boosters and/or additional vaccination.

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Giugno 2023

Interpreting a Negative Trial as a Negative Test for Efficacy

As noted in JAMA more than 30 years ago, randomized clinical trials are like diagnostic tests in several ways. Clinical trials are designed to detect hypothesized treatment effects in the same way diagnostic tests are designed to detect an abnormality or target illness. A trial’s statistical power, namely the probability that it can detect the treatment effect given that the hypothesized effect exists, is analogous to a diagnostic test’s sensitivity, namely the probability a positive test result is obtained when the target condition is present. Just as the sensitivity of a diagnostic test can be affected by the severity of illness, an effect called “spectrum bias,” the power of a clinical trial, is strongly influenced by the magnitude of the true treatment benefit associated with the experimental treatment. The specificity of a diagnostic test, namely the fraction of all persons free of disease who have a true-negative test result, is analogous in clinical trial design to 1 −α, where α is the maximum statistically significant 1-tailed P value (eg, .025) defined for the trial (ie, the type I error risk, or the risk of a false-positive result if there is no treatment effect).

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Giugno 2023