The Impact of Community Generated PPE During the SARS-COV-2 Pandemic in Southeast Alabama and Gulfport Mississippi.

Background: The early stages of the SARS-COV-2 pandemic left many hospital systems devoid of personal protective equipment. Community-driven groups manufactured Personal Protective Equipment (PPE) as a form of temporary replacement until supply could increase to frontline healthcare workers. The purpose of this study was to survey hospital systems in Alabama and Mississippi who requested and received PPE to determine recipient opinions concerning community involvement. Methods: A 15-question Qualtrics survey was distributed to hospital systems who requested and received community-generated PPE (CGPPE) from the group known as Alabama Fighting COVID. 275 responses were gathered over a period of 6 months. Results: Survey data showed that most respondents from healthcare and healthcare-associated professions responded that wearing community generated personal protective equipment provided them with the perception of added protection (55.31% of participants selected either "Agree" or "Strongly Agree"), and that it improved their outlook and desire to work during the pandemic (51.77% of participants selected either "Agree" or "Strongly Agree"). Conclusions: Most respondents reported that wearing community generated personal protective equipment not only provided them with the perception of added protection, but that it improved their outlook and desire to work during the pandemic. With these responses in mind, our study raises questions concerning whether local CGPPE distribution could improve well-ness outcomes of healthcare workers (HCWs) not only in relation to decreased viral transmission, but also in favorable psychosocial health assessments. Further implications for research concerning community involvement during future medical crises are indicated, especially with the current rise of the delta variant strain.

Run-Reversal Equilibrium for Clinical Trial Randomization.

In this paper, we describe a new restricted randomization method called run-reversal equilibrium (RRE), which is a Nash equilibrium of a game where (1) the clinical trial statistician chooses a sequence of medical treatments, and (2) clinical investigators make treatment predictions. RRE randomization counteracts how each investigator could observe treatment histories in order to forecast upcoming treatments. Computation of a run-reversal equilibrium reflects how the treatment history at a particular site is imperfectly correlated with the treatment imbalance for the overall trial. An attractive feature of RRE randomization is that treatment imbalance follows a random walk at each site, while treatment balance is tightly constrained and regularly restored for the overall trial. Less predictable and therefore more scientifically valid experiments can be facilitated by run-reversal equilibrium for multi-site clinical trials.

Sensitivity designs for preventing bias replication in randomized clinical trials.

It is common, after a trial is completed, to employ sensitivity analyses to test the extent to which the results depend on various assumptions or conventions. There is a comparable benefit to employing sensitivity designs when planning a trial, so that features that cannot be varied at the analysis stage can instead be varied (e.g., across centres of a multi-centre trial) during the design stage. Design features amenable to such variation include: (1) the specific randomization methods, (2) the duration of follow-up and (3) the use or non-use of a surrogate endpoint as a replacement for a clinical endpoint. Generally, all centres in a given trial, and all trials in a given program, will employ identical protocols. This means that all will be vulnerable to the same types of biases, meaning that a single bias can by itself render all results unreliable. But by varying the randomization techniques, duration and primary endpoint, one can vary also the biases to which the site-specific results are vulnerable. This means that, if a significant result is found, then one can state that either the treatment worked or there were numerous biases (not just one) at play. This of course makes the attribution of the results to the treatments much more plausible and makes the findings much more robust to violations of assumptions.

Resource use and costs of treatment with anticoagulation and antiplatelet agents: results of the WATCH trial economic evaluation.

BACKGROUND: The Warfarin and Antiplatelet Therapy in Chronic Heart Failure (WATCH) trial revealed no significant differences among 1587 symptomatic heart failure patients randomized to warfarin, clopidogrel, or aspirin in time to all-cause death, nonfatal myocardial infarction, or nonfatal stroke. We compared within-trial medical resource use and costs between treatments. METHODS AND RESULTS: We assigned country-specific costs to medical resources incurred during follow-up. Annualized rates of hospitalizations, inpatient and outpatient procedures, and emergency department visits did not differ significantly between groups. Annualized total costs averaged $5901 (95% confidence interval [CI], $4776-$7520) for the aspirin group, $5646 (95% CI, $4903-$6584) for the clopidogrel group, and $5830 (95% CI, $4838-$7400) for the warfarin group. CONCLUSIONS: Consistent with clinical findings, our analyses did not identify significant cost differences between treatments.

A model of patient choice with mid-therapy information.

For many treatments, a patient's prognosis may be refined by conducting a mid-therapy assessment (MTA). When therapy lasts some time, an MTA predicts a patient's ultimate outcome based on early signs of response. The availability and timing of such assessments also serve as a mechanism by which policy makers can influence patients' treatment-initiation decisions. In this article, we examine how patients evaluate treatment options using MTAs of treatment effectiveness and discuss the policy implications of patient decision making in such contexts. To this end, we use indifference-curve analysis to characterize trade-offs between potential treatment success versus potential adverse effects in therapeutic situations where patients are encouraged to consider their own motivations for initiating treatment. Treatment initiation for chronic hepatitis C virus (HCV) infection is used for illustration, but the analysis can be easily adapted to a variety of clinical scenarios.Analysis shows that the existence of MTAs influences patients' initial treatment decisions by affecting the expectations of treatment success and adverse effects. Earlier MTAs have lower sensitivity and higher specificity, and the prior expectation of adverse effects is accordingly lower for two reasons. First, the lower chance for a false signal of treatment response and the higher chance for a false signal of no response make it more likely that the patient receives a signal leading to discontinuation. Second, if a signal to discontinue is received, fewer weeks of adverse effects have been endured before discontinuation occurs. Both factors make the expected burden of adverse effects lower when the MTA occurs earlier. Later MTAs have higher sensitivity and lower specificity, both of which serve to increase the probability of treatment completion, causing a higher prior likelihood of treatment success.These findings indicate that treatment demand may be increased by changing the timing of MTAs, depending on the information content of the alternative mid-therapy signals and the nature of patient preferences. In HCV infection and other diseases, clinical practice guidelines for conducting MTAs might be modified to better achieve public health or other policy objectives by studying the economics of patient choice.

Trends in health care resource use for hepatitis C virus infection in the United States.

Chronic hepatitis C virus (HCV) infection affects approximately 3 million people in the United States and places tremendous demands on the health care system. As many observers have predicted, the disease burden continues to grow as the infected population ages. In this study, we analyzed inpatient data from the Healthcare Cost and Utilization Project, outpatient data from the National Ambulatory Medical Care Survey, and drug data from the Verispan Source Prescription Audit. We examined recent growth in the use of health care resources among HCV patients by age group and found average annual increases of 25% to 30% for hospitalizations, charges, hospital days, and physician visits. Corresponding time-trend coefficients were positive (P < .001). From 1994 to 2001, the HCV burden increased among patients aged 40 to 60 years, reflecting the natural history of disease progression. In sensitivity analysis, HCV outcome growth rates remained significant, unless more than 3 out of 4 cases were initially underreported. Also, patients co-infected with HIV and HCV in 2001 constituted 7.5 times as many hospitalizations and incurred 2.9 times the charges in 1994, relative to all HIV hospitalizations and charges. Our findings highlight the urgency concerning HCV outcomes. In conclusion, as patients continue to age and disease burden progresses, suboptimal decisions regarding HCV treatments will bring increasing opportunity costs for the health care system and society.

Threshold denial rates in prior authorization prescription programs.

In this special report, the economics of prior authorization is examined with a focus on the break-even rate that requests are denied. Using a simple theoretical model, comparative static results are derived and used to consider the cost-effectiveness implications of future changes in prior authorization policies.