Association of Aspirin Use with Mortality Risk Among Older Adult Participants in the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial

Loomans-Kropp HA1, Pinsky P, Cao Y, Chan AT, Umar A. JAMA Netw Open. 2019 Dec 2;2(12):e1916729. [CrossRef] [PubMed]

Aspirin use has been associated with reduced risk of cancer mortality, particularly of the colorectum. However, aspirin efficacy may be influenced by biological characteristics, such as obesity and age. With the increasing prevalence of obesity and conflicting data regarding the effect of aspirin in older adults, the authors evaluated aspirin use among participants aged 65 years and older in the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial at baseline (November 8, 1993, to July 2, 2001) and follow-up (2006-2008). The majority endpoints were all-cause, any cancer, GI cancer, or colorectal cancer (CRC) mortality. Multivariable hazard ratios (HRs) and 95% CIs were calculated using time-varying Cox proportional hazards regression modeling, adjusting for additional factors. Compared with no use, aspirin use 1 to 3 times per month was associated with reduced risk of all-cause mortality (HR, 0.84; 95% CI, 0.80-0.88; P < .001) and cancer mortality (HR, 0.87; 95% CI, 0.81-0.94; P < .001). Aspirin use 3 or more times per week was associated with decreased risk of mortality of all causes (HR, 0.81; 95% CI, 0.80-0.83; P < .001), any cancer (HR, 0.85; 95% CI, 0.81-0.88; P < .001), GI cancer (HR, 0.75; 95% CI, 0.66-0.84; P < .001), and CRC (HR, 0.71; 95% CI, 0.61-0.84; P < .001). When stratified by BMI (calculated as weight in kilograms divided by height in meters squared), aspirin use 3 or more times per week among individuals with BMI 20 to 24.9 was associated with reduced risk of all-cause mortality (HR, 0.82; 95% CI, 0.78-0.85; P < .001) and any cancer mortality (HR, 0.86; 95% CI, 0.79-0.82; P < .001). Among individuals with BMI 25 to 29.9, aspirin use 3 or more times per week was associated with reduced risk of all-cause mortality (HR, 0.82; 95% CI, 0.79-0.85; P < .001), any cancer mortality (HR, 0.86; 95% CI, 0.81-0.91; P < .001), GI cancer mortality (HR, 0.72; 95% CI, 0.60-0.86; P < .001), and CRC mortality (HR, 0.66; 95% CI, 0.51-0.85; P = .001). The authors conclude that aspirin use 3 or more times per week was associated with a reduction in all-cause, cancer, GI cancer and CRC mortality in older adults.

Dissecting Racial Bias in an Algorithm Used to Manage the Health of Populations

Obermeyer Z, Powers B, Vogeli C, Mullainathan S. Science. 2019;366:447-53. [CrossRef]

Insurance companies often use commercial algorithms to guide health decisions. The authors found evidence of racial bias in one widely used algorithm. At a given risk score, Black patients are considerably sicker than White patients, as evidenced by signs of uncontrolled illnesses. Remedying this disparity would increase the percentage of Black patients receiving additional help from 17.7 to 46.5%. The bias arises because the algorithm predicts health care costs rather than illness, but unequal access to care means that we spend less money caring for Black patients than for White patients. Thus, despite health care cost appearing to be an effective proxy for health by some measures of predictive accuracy, large racial biases arise. Reformulating the algorithm so that it no longer uses costs as a proxy for needs eliminates the racial bias in predicting who needs extra care.

Dog Ownership and Cardiovascular Health: Results from the Kardiovize 2030 Project

Maugeri A, Medina-Inojosa JR, Kunzova S, Barchitta M, Agodi A, Vinciguerra M, Lopez-Jimenez F. Mayo Clin Proc Innov Qual Outcomes. 2019 Aug 23;3(3):268-275. [CrossRef] [PubMed]

In Arizona an automobile license can be obtained which says, “Pets Enrich Our Lives”. This article suggests that pet ownership may have health benefits. The authors studied 1769 subjects (aged from 25 to 64 years; 44.3% males) with no history of cardiovascular disease and compared cardiovascular health (CVH) scores with nonpet owners. Approximately 42% of subjects owned a pet: 24.3% owned a dog and 17.9% owned another animal. Pet owners, and specifically dog owners, were more likely to report physical activity, diet, and blood glucose at ideal level which resulted in higher CVH score than nonpet owners (P=0.006). Compared with owners of other pets, dog owners were more likely to report physical activity and diet at ideal level. The comparison of dog owners with non-dog owners yielded similar results. After adjustment for covariates, dog owners exhibited higher CVH scores than non-pet owners (P=0.005), other pet-owners (0.309; P=0.041), and non-dog owners (P=0.004). The authors conclude that dog owners were more likely to achieve recommended level of behavioral CVH metrics (physical activity and diet) than non-dog owners, which likely translates into better cardiovascular health.

Analysis of Human Performance Deficiencies Associated with Surgical Adverse Events

Suliburk JW, Buck QM, Pirko CJ, Massarweh NN, Barshes NR, Singh H, Rosengart TK. JAMA Netw Open. 2019 Jul 3;2(7):e198067. [CrossRef] [PubMed]

Potentially preventable adverse events remain a formidable cause of patient harm and health care expenditure despite advances in systems-based risk-reduction strategies. The authors analyzed the incidence of human performance deficiencies (HPDs) during the provision of surgical care using a new taxonomy to inform the development and implementation of an HPD classifier tool to categorize HPDs into errors associated with cognitive, technical, and team dynamic functions. The HPD classifier tool was then used to concurrently analyze surgical adverse events in 3 adult hospital affiliates—a level I municipal trauma center, a quaternary care university hospital, and a US Veterans Administration hospital—from January 2, 2018, to June 30, 2018. Surgical trainees presented data describing all adverse events associated with surgical services at weekly hospital-based morbidity and mortality conferences.

A total of 188 adverse events were recorded, including 182 adverse events (96.8%) among 5365 patients who underwent surgical operations and 6 adverse events (3.2%) among patients undergoing nonoperative treatment. Among these 188 adverse events, 106 (56.4%) were associated with HPDs. Among these 106 HPD adverse events over half were attributed to human performance deficiencies in execution, planning or problem solving, communication, teamwork, and rules violation. Among the adverse events listed in Table 1 of the article were surgical site infection and wound dehiscence (12.2%); unexpected bleeding or transfusion (8%); deep venous thrombosis and pulmonary embolism (6.4%); unplanned intubation, pneumonia, and the patient needing a ventilator more than 48 hours after the operation has ended (5.9%), sepsis or septic shock (4.3%).

The authors conclude that human performance deficiencies were identified in more than half of adverse events, most commonly associated with cognitive error in the execution of care. It is unclear how many of these adverse events relate to human performance deficiencies including cognitive error.

New Drugs: Where Did We Go Wrong and What Can We Do Better?

Wieseler B, McGauran N, Kaiser T. BMJ. 2019 Jul 10;366:l4340. [CrossRef] [PubMed]

The authors reviewed the efficacy of new medications approved in Germany. Medicine regulators around the world are pursuing a strategy aimed at accelerating the development and approval of drugs. These approaches are based on the assumption that faster access to new drugs benefits patients. The rhetoric of novelty and innovation creates an assumption that new products are better than existing ones.

But although gaps in the therapeutic armamentarium undoubtedly exist, research covering drug approvals since the 1970s suggests only a limited number of new drugs provide real advances over existing drugs. Most studies put the proportion of true innovation at under 15%, with no clear improvement over time.

In one large study, investigators found that only 54 (25%) of the 216 new drugs entering the German market between 2011 and 2017 were judged to have a considerable, or major, added benefit. For 16% of these new agents, this additional benefit was either minor or could not be quantified. In addition, for 58% of these medications there was no proof of added benefit vs.  standard of care in the approved patient population.

"Rather than waiting for drug companies to decide what to develop, they could define the health system's needs and implement measures to ensure the development of the treatments required," they write, adding that this could include needs-oriented public-private partnerships and not-for-profit drug development.

In response to the article, the Association of Research-Based Pharmaceutical Companies in Germany issued a statement pointing out that the assessment of additional benefit "is not an easy matter — there is not always a 'right' or 'wrong.'"