Category: Nevin Manimala

JAMA Health Forum. 2023 May 5;4(5):e230894. doi: 10.1001/jamahealthforum.2023.0894.

ABSTRACT

IMPORTANCE: Prioritization and funding for health initiatives, including biomedical innovation, may not consistently target unmet public health needs.

OBJECTIVE: To (1) develop a quantitative, databased framework to identify and prioritize opportunities for biomedical product innovation investments based on a multicriteria decision-making model (MCDM) that includes comprehensive measures of public health burden and health care costs, and (2) pilot test the model.

DESIGN, SETTING, AND PARTICIPANTS: The Department of Health and Human Services (HHS) convened public and private experts to develop a model, select measures, and complete a longitudinal pilot study to identify and prioritize opportunities for investment in biomedical product innovations that have the greatest public health benefit. Cross-sectional and longitudinal data (2012-2019) for 13 pilot medical disorders were obtained from the Institute for Health Metrics Global Burden of Disease database (IHME GBD) and the National Center for Health Statistics (NCHS).

MAIN OUTCOME MEASURES: The main outcome measure was an overall gap score reflecting high public health burden (composite measure of mortality, prevalence, years lived with disability, and health disparities), or high health care costs (composite measure of total, public, and out-of-pocket health spending) relative to low biomedical innovation. Sixteen innovation metrics were selected to reflect the pipeline of biomedical products from research and development to market approval. A higher score indicates a greater gap. Normalized composite scores were calculated for public health burden, cost, and innovation investment using the MCDM Technique for Order of Preference by Similarity to Ideal Solution method.

RESULTS: Among the 13 conditions tested in the pilot study, diabetes (0.61), osteoarthritis (0.46), and drug-use disorders (0.39) had the highest overall gap score reflecting high public health burden, or high health care costs relative to low biomedical innovation in these medical disorders. Chronic kidney disease (0.05), chronic obstructive pulmonary disease (0.09), and cirrhosis and other liver diseases (0.10) had the least amount of biomedical product innovation despite similar public health burden and health care cost scores.

CONCLUSIONS: In this cross-sectional pilot study, we developed and implemented a data-driven, proof-of-concept model that can help identify, quantify, and prioritize opportunities for biomedical product innovation. Quantifying the relative alignment between biomedical product innovation, public health burden, and health care cost may help identify and prioritize investments that can have the greatest public health benefit.

PMID:37145687 | DOI:10.1001/jamahealthforum.2023.0894

Urol Pract. 2021 May;8(3):374-379. doi: 10.1097/UPJ.0000000000000212. Epub 2020 Nov 30.

ABSTRACT

INTRODUCTION: We sought to determine the accuracy of self-reported urology applicant match data and determine which factors were most influential on successful application outcomes.

METHODS: A publicly accessible Google spreadsheet entitled “Urology Residency Applicant Spreadsheet” containing self-reported urology residency applicant characteristics and match outcomes was analyzed for differences across the years 2017+2018 (pre-aggregated)-2020. These data were compared to published data from the American Urological Association and the Association of American Medical Colleges. Statistical modeling of the self-reported data was performed to determine which applicant characteristics were predictive of match outcomes.

RESULTS: Averages of self-reported data were similar to published match data with a bias towards more competitive applicants. The factors associated with increased interview offer rate were: Step 1 score, Step 2 score, number of research items, class quartile, and Alpha Omega Alpha membership. Logistic regression modeling correctly predicted an applicant matching to their first-choice program with 74.7% accuracy, with significant negative predictors being the number of programs to which the applicant applied and interviews offered from waitlist or cancellations, and positive predictors being the number of interview offers received.

CONCLUSIONS: Many applicants “apply broadly” with the goal of improving their match outcomes, but we found that applying to more programs is associated with a decreased likelihood of the applicant matching to their first-choice program. Applicant characteristics such as United States Medical Licensing Examination® scores were not related to first-choice match, suggesting that program selection, among other factors, is vital in the match process.

PMID:37145662 | DOI:10.1097/UPJ.0000000000000212

Urol Pract. 2021 May;8(3):355-359. doi: 10.1097/UPJ.0000000000000219. Epub 2021 Feb 8.

ABSTRACT

INTRODUCTION: We evaluated the adherence of urologists within an integrated health care system to Choosing Wisely®, an initiative aimed at avoiding unnecessary medical tests. In urology, 2 of the guidelines state bone scans and pelvic computerized tomography scans are unnecessary in low risk prostate cancer.

METHODS: We performed a retrospective study on patients diagnosed with low risk prostate cancer between January 1, 2010 and December 31, 2017 at Kaiser Permanente Southern California. All demographics and imaging data were obtained. Patients with symptoms concerning for metastatic disease or with other malignancies were excluded by chart review. Statistical analysis was employed to compare the use of bone scans and computerized tomography scans in this population before and after the Choosing Wisely guidelines were published.

RESULTS: Of the 6,996 patients, 121 (1.7%) and 96 (1.4%) underwent a bone scan and computerized tomography scan, respectively. A Cochran-Armitage test showed no change after implementation of the statements. Logistic regression analysis revealed that for every point increase in prostate specific antigen, the odds ratio was 1.09 for ordering both a bone scan and computerized tomography scan. When compared to Whites, the odds ratio of having a bone scan and computerized tomography scan were 0.35 and 0.37 for Blacks, 0.30 and 0.38 for Hispanics, and 0.47 and 0.61 for Asians, respectively.

CONCLUSIONS: Over the study period, there were low rates of inappropriate imaging for low risk prostate cancer. There was no change in trend after publication of the Choosing Wisely. Higher prostate specific antigen levels and White ethnicity were predictors for ordering inappropriate imaging.

PMID:37145659 | DOI:10.1097/UPJ.0000000000000219

Urol Pract. 2021 May;8(3):337-340. doi: 10.1097/UPJ.0000000000000218. Epub 2021 Feb 4.

ABSTRACT

INTRODUCTION: Vasectomy is the most effective form of permanent male contraception. Although vasectomy techniques and outcomes have steadily improved, postvasectomy semen analysis compliance remains a significant challenge. The aim of this study was to assess if home testing improved postvasectomy semen analysis compliance.

METHODS: Data were collected prospectively but retrospectively reviewed between 2007 and 2019 from a single surgeon’s high volume practice. Subjects were divided into 2 groups based on postvasectomy semen analysis method (home vs office) and further subdivided by compliance status. Patients were considered compliant if they provided at least 1 semen sample postvasectomy. Statistical analysis was completed to determine factors predictive of compliance.

RESULTS: A total of 364 patients were included. Median age for the home group vs the office group was similar (42 years [IQR 39-46] vs 41 years [IQR 38-46]). Median number of children for both groups was 2 (IQR 2-3). In all, 109 men (30.0%) opted for at-home testing. No significant difference in compliance was found (59.6% of home test vs 58.8% of laboratory patients, p=0.89). No statistically significant difference in patient demographics (age, partner age, number of children, smoking and alcohol) was observed, and there were no demographic factors predicting compliance with regression modeling.

CONCLUSIONS: At-home semen analysis kits did not significantly improve compliance. Clinicians should be aware that this may be a reasonable alternative for those who are unable to obtain a postvasectomy semen analysis in-office. Contact of the female partner instead may improve postvasectomy semen analysis compliance as the female partner has a stake in ensuring postvasectomy semen analysis azoospermia.

PMID:37145658 | DOI:10.1097/UPJ.0000000000000218

Urol Pract. 2021 May;8(3):367-372. doi: 10.1097/UPJ.0000000000000210. Epub 2021 Mar 26.

ABSTRACT

INTRODUCTION: The arrival of coronavirus disrupted health care systems and forced delays in cancer treatment. We explored the experience of urologists who had to delay their patients’ cancer care.

METHODS: Urologists who treat prostate, bladder, and renal cancers, selected through purposive sampling, responded to a survey about cancer treatment delay. They were asked about their practice setting, decision making and interactions with patients, and they were asked to reflect on their personal experience. A 0 to 10 point scale, modeled on the National Comprehensive Cancer Network’ Distress Thermometer (NCCN-DT), validated for cancer patients with cancer, was used to estimate physician distress. We used descriptive statistics to analyze survey results.

RESULTS: Of the 64 participating urologists, 98% delayed surgical treatment; fewer delayed cases of advanced cancers (42% for ≥T3/T4 or Gleason ≥8 prostate cancers, 58% for muscle invasive bladder cancer, 61% for ≥T2 renal cancers). They reported feeling anxious (44%) and helpless (29%), and their median distress score was 5 (range 0-10). They relied on their own risk assessments (67%) and consulted colleagues (56%) and national guidelines (53%) when making treatment deferral decisions. They identified a number of concerns as they resumed surgeries.

CONCLUSIONS: Based on a comparison to the NCCN-DT clinical cutoff distress level of 4, urologists experienced moderately high levels of distress as they delayed cancer care during the COVID-19 pandemic and expressed concerns going forward. While the focus on patient care is paramount in a pandemic, it is important to recognize physician distress and develop practical and psychological strategies for distress mitigation.

PMID:37145655 | DOI:10.1097/UPJ.0000000000000210

Urol Pract. 2021 Mar;8(2):303-308. doi: 10.1097/UPJ.0000000000000205. Epub 2020 Oct 28.

ABSTRACT

INTRODUCTION: Excessive trainee debt continues to be a problem. Little is known about how debt influences future practice decisions. We sought to examine the correlation between educational debt and anticipated practice choices and career expectations to better understand the impact of debt on urology trainees to inform urology workforce policy.

METHODS: Data were collected from urology trainees who completed the AUA Annual Census between 2016 and 2018. We examined level of debt among urology trainees against their anticipated practice choices compensation expectation and various debt relief variables.

RESULTS: Among 705 U.S. urology trainees who completed the survey, 22% had no debt, 23% had <$150,000 debt, 27% had $150,000 to $250,000 of debt, and the remaining 27% had >$250,000. Debt level did not appear to significantly affect anticipated future practice setting or the decision to pursue fellowship. Concerning how loan forgiveness influenced practice opportunity, 31% of trainees reported no effect, 42% some effect and 27% great effect. Those trainees with higher level of debt appeared to be more likely to accept a practice opportunity if loan forgiveness was offered (p ≤0.001). Those trainees with higher level of debt were more likely to anticipate higher annual compensation as compared to those with less debt (p=0.001).

CONCLUSIONS: Nearly 70% of those trainees with debt had $150,000 of debt or higher. Our study showed carrying educational debt is statistically associated with trainees’ choice of anticipated practice for better compensation and tuition forgiveness. Workforce policy should consider addressing the financial burden of urology trainees.

PMID:37145622 | DOI:10.1097/UPJ.0000000000000205

J Biopharm Stat. 2023 May 5:1-13. doi: 10.1080/10543406.2023.2206481. Online ahead of print.

ABSTRACT

Estimation of median survival and its 95% confidence interval depends on the choice of the survival function, standard error, and a method for constructing the confidence interval. This paper outlines several available possibilities in SAS® (version 9.4) PROC LIFETEST and compares them on theoretical grounds and using simulated data, with criteria: ability to estimate the 95% CI, coverage probability, interval width, and appropriateness for practical use. Data are generated with varying hazard patterns, N, % censoring, and censoring patterns (early, uniform, late, last visit). LIFETEST was run using the Kaplan-Meier and Nelson-Aalen estimators and the transformations available (linear, log, logit, complementary log-log, and arcsine square root). Using the Kaplan-Meier estimator with the logarithmic transformation as well as with the logit leads to a high frequency of LIFETEST not being able to estimate the 95% CI. The combination of Kaplan-Meier with the linear transformation is associated with poor coverage achieved. For small samples, late/last visit censoring has a negative effect on being able to estimate the 95% CI. Heavy early censoring can lead to low coverage of the 95% CI of median survival for sample sizes up to and including N = 40. The two combinations that are optimal for being able to estimate the 95% CI and having adequate coverage are the Kaplan-Meier estimator with complementary log-log transformation, and the Nelson-Aalen estimator with linear transformation. The former fares best on the third criterion (smaller width) and is also the SAS® default and validates the choice of default.

PMID:37144552 | DOI:10.1080/10543406.2023.2206481

J Biopharm Stat. 2023 May 5:1-11. doi: 10.1080/10543406.2023.2208665. Online ahead of print.

ABSTRACT

In phase 2 clinical trials, we expect to make a right Go or No-Go decision during the interim analysis (IA) and make this decision at the right time. The optimal time for IA is usually determined based on a utility function. In most previous research, utility functions aim to minimize the expected sample size or total cost in confirmatory trials. However, the selected time can vary depending on different alternative hypotheses. This paper proposes a new utility function for Bayesian phase 2 exploratory clinical trials. It evaluates the predictability and robustness of the Go and No-Go decision made during the IA. We can make a robust time selection for the IA based on the function regardless of the treatment effect assumptions.

PMID:37144549 | DOI:10.1080/10543406.2023.2208665

Int J Cosmet Sci. 2023 May 5. doi: 10.1111/ics.12866. Online ahead of print.

ABSTRACT

OBJECTIVE: This article measures and discusses the effects of different shower gels on the consumption of water used during a shower.

METHODS: A sensory panel was created for quantifying water consumption associated with the use of shower gels. 15 French panellists were recruited (Age: 59 ± 7, Height: 163 cm ± 9 and Weight: 68 kg ± 20) and trained to assess rinsed skin in a standardized way. Effective panellists were then asked to assess 25 shower gels covering the variety of existing products on the market.

RESULTS: Results showed that the average volume was 4.77 L for heating the water and wetting the body and 4.15 L for rinsing the shower gel off the full body. We observed a significant shower gel effect (p < .0001) with the water volume needed to rinse the 25 shower gels ranging 3.21 L to 5.65 L.

CONCLUSION: This paper demonstrates the impact of shower gel formulation on water consumption during a shower. It thus demonstrates the importance of formulating shower gels to reduce the total amount of water needed to shower. It also introduces the distinction between ‘useful water’ which refers strictly to the volume of water objectively needed to rinse off a product and the ‘used water’ which refers to the total shower volume of water. This distinction helps to better strategize actions in order to reduce water consumption from rinse-off cosmetic products used during showers.

PMID:37144490 | DOI:10.1111/ics.12866

Nucleic Acids Res. 2023 May 5:gkad352. doi: 10.1093/nar/gkad352. Online ahead of print.

ABSTRACT

The study of cellular networks mediated by ligand-receptor interactions has attracted much attention recently owing to single-cell omics. However, rich collections of bulk data accompanied with clinical information exists and continue to be generated with no equivalent in single-cell so far. In parallel, spatial transcriptomic (ST) analyses represent a revolutionary tool in biology. A large number of ST projects rely on multicellular resolution, for instance the Visium™ platform, where several cells are analyzed at each location, thus producing localized bulk data. Here, we describe BulkSignalR, a R package to infer ligand-receptor networks from bulk data. BulkSignalR integrates ligand-receptor interactions with downstream pathways to estimate statistical significance. A range of visualization methods complement the statistics, including functions dedicated to spatial data. We demonstrate BulkSignalR relevance using different datasets, including new Visium liver metastasis ST data, with experimental validation of protein colocalization. A comparison with other ST packages shows the significantly higher quality of BulkSignalR inferences. BulkSignalR can be applied to any species thanks to its built-in generic ortholog mapping functionality.

PMID:37144485 | DOI:10.1093/nar/gkad352