Category: Statistics

JAMA Netw Open. 2023 Dec 1;6(12):e2348692. doi: 10.1001/jamanetworkopen.2023.48692.

ABSTRACT

IMPORTANCE: The effect of testosterone replacement therapy (TRT) on the risk of prostate cancer and other adverse prostate events is unknown.

OBJECTIVE: To compare the effect of TRT vs placebo on the incidences of high-grade prostate cancers (Gleason score ≥4 + 3), any prostate cancer, acute urinary retention, invasive prostate procedures, and pharmacologic treatment for lower urinary tract symptoms in men with hypogonadism.

DESIGN, SETTING, AND PARTICIPANTS: This placebo-controlled, double-blind randomized clinical trial enrolled 5246 men (aged 45-80 years) from 316 US trial sites who had 2 testosterone concentrations less than 300 ng/dL, hypogonadal symptoms, and cardiovascular disease (CVD) or increased CVD risk. Men with prostate-specific antigen (PSA) concentrations greater than 3.0 ng/mL and International Prostate Symptom Score (IPSS) greater than 19 were excluded. Enrollment took place between May 23, 2018, and February 1, 2022, and end-of-study visits were conducted between May 31, 2022, and January 19, 2023.

INTERVENTION: Participants were randomized, with stratification for prior CVD, to topical 1.62% testosterone gel or placebo.

MAIN OUTCOMES AND MEASURES: The primary prostate safety end point was the incidence of adjudicated high-grade prostate cancer. Secondary end points included incidence of any adjudicated prostate cancer, acute urinary retention, invasive prostate surgical procedure, prostate biopsy, and new pharmacologic treatment. Intervention effect was analyzed using a discrete-time proportional hazards model.

RESULTS: A total of 5204 men (mean [SD] age, 63.3 [7.9] years) were analyzed. At baseline, the mean (SD) PSA concentration was 0.92 (0.67) ng/mL, and the mean (SD) IPSS was 7.1 (5.6). The mean (SD) treatment duration as 21.8 (14.2) months in the TRT group and 21.6 (14.0) months in the placebo group. During 14 304 person-years of follow-up, the incidence of high-grade prostate cancer (5 of 2596 [0.19%] in the TRT group vs 3 of 2602 [0.12%] in the placebo group; hazard ratio, 1.62; 95% CI, 0.39-6.77; P = .51) did not differ significantly between groups; the incidences of any prostate cancer, acute urinary retention, invasive surgical procedures, prostate biopsy, and new pharmacologic treatment also did not differ significantly. Change in IPSS did not differ between groups. The PSA concentrations increased more in testosterone-treated than placebo-treated men.

CONCLUSIONS AND RELEVANCE: In a population of middle-aged and older men with hypogonadism, carefully evaluated to exclude those at high risk of prostate cancer, the incidences of high-grade or any prostate cancer and other prostate events were low and did not differ significantly between testosterone- and placebo-treated men. The study’s findings may facilitate a more informed appraisal of the potential risks of TRT.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03518034.

PMID:38150256 | DOI:10.1001/jamanetworkopen.2023.48692

JAMA Netw Open. 2023 Dec 1;6(12):e2349305. doi: 10.1001/jamanetworkopen.2023.49305.

ABSTRACT

IMPORTANCE: Although substantial research has reported grave population-level psychiatric sequelae of the COVID-19 pandemic, evidence pertaining to temporal changes in schizophrenia spectrum disorders in the US following the pandemic remains limited.

OBJECTIVE: To examine the monthly patterns of emergency department (ED) visits for schizophrenia spectrum disorders after the onset of the COVID-19 pandemic.

DESIGN, SETTING, AND PARTICIPANTS: This observational cohort study used time-series analyses to examine whether monthly counts of ED visits for schizophrenia spectrum disorders across 5 University of California (UC) campus health systems increased beyond expected levels during the COVID-19 pandemic. Data included ED visits reported by the 5 UC campuses from 2016 to 2021. Participants included persons who accessed UC Health System EDs had a diagnosis of a psychiatric condition. Data analysis was performed from March to June 2023.

EXPOSURES: The exposures were binary indicators of initial (March to May 2020) and extended (March to December 2020) phases of the COVID-19 pandemic.

MAIN OUTCOMES AND MEASURES: The primary outcome was monthly counts of ED visits for schizophrenia spectrum disorders. International Statistical Classification of Diseases and Related Health Problems, Tenth Revision diagnosis codes, categorized within Clinical Classification Software groups, were used to identify ED visits for schizophrenia spectrum disorders and all other psychiatric ED visits, from the University of California Health Data Warehouse database, from January 2016 to December 2021. Time-series analyses controlled for autocorrelation, seasonality, and concurrent trends in ED visits for all other psychiatric conditions.

RESULTS: The study data comprised a total of 377 872 psychiatric ED visits, with 37 815 visits for schizophrenia spectrum disorders. The prepandemic monthly mean (SD) number of ED visits for schizophrenia spectrum disorders was 519.9 (38.1), which increased to 558.4 (47.6) following the onset of the COVID-19 pandemic. Results from time series analyses, controlling for monthly counts of ED visits for all other psychiatric conditions, indicated 70.5 additional ED visits (95% CI, 11.7-129.3 additional visits; P = .02) for schizophrenia spectrum disorders at 1 month and 74.9 additional visits (95% CI, 24.0-126.0 visits; P = .005) at 3 months following the initial phase of the COVID-19 pandemic in California.

CONCLUSIONS AND RELEVANCE: This study found a 15% increase in ED visits for schizophrenia spectrum disorders within 3 months after the initial phase of the pandemic in California across 5 UC campus health systems, underscoring the importance of social policies related to future emergency preparedness and the need to strengthen mental health care systems.

PMID:38150255 | DOI:10.1001/jamanetworkopen.2023.49305

JAMA Netw Open. 2023 Dec 1;6(12):e2349544. doi: 10.1001/jamanetworkopen.2023.49544.

ABSTRACT

IMPORTANCE: Empirical antibiotic prescribing in nursing homes (NHs) is often suboptimal. The potential for antibiograms to improve empirical antibiotic decision-making in NHs remains poorly understood.

OBJECTIVE: To determine whether providing NH clinicians with a urinary antibiogram improves empirical antibiotic treatment of urinary tract infections (UTIs).

DESIGN, SETTING, AND PARTICIPANTS: This was a survey study using clinical vignettes. Participants were recruited via convenience sampling of professional organization listservs of NH clinicians practicing in the US from December 2021 through April 2022. Data were analyzed from July 2022 to June 2023.

INTERVENTIONS: Respondents were randomized to complete vignettes using a traditional antibiogram (TA), a weighted-incidence syndromic combination antibiogram (WISCA), or no tool. Participants randomized to antibiogram groups were asked to use the antibiogram to empirically prescribe an antibiotic. Participants randomized to the no tool group functioned as controls.

MAIN OUTCOMES AND MEASURES: Empirical antibiotic selections were characterized as microbiologically (1) active and (2) optimal according to route of administration and spectrum of activity.

RESULTS: Of 317 responses, 298 (95%) were included in the analysis. Duplicate responses (15 participants), location outside the US (2 participants), and uninterpretable responses (2 participants) were excluded. Most respondents were physicians (217 respondents [73%]) and had over 10 years of NH practice experience (155 respondents [52%]). A mixed-effects logistic model found that use of the TA (odds ratio [OR], 1.41; 95% CI, 1.19-1.68; P < .001) and WISCA (OR, 1.54; 95% CI, 1.30-1.84; P < .001) were statistically superior to no tool when choosing an active empirical antibiotic. A similarly constructed model found that use of the TA (OR, 1.94; 95% CI, 1.42-2.66; P < .001) and WISCA (OR, 1.7; 95% CI, 1.24-2.33; P = .003) were statistically superior to no tool when selecting an optimal empirical antibiotic. Although there were differences between tools within specific vignettes, when compared across all vignettes, the TA and WISCA performed similarly for active (OR, 1.09; 95% CI, 0.92-1.30; P = .59) and optimal (OR, 0.87; 95% CI, 0.64-1.20; P = .69) antibiotics.

CONCLUSIONS AND RELEVANCE: Providing NH clinicians with a urinary antibiogram was associated with selection of active and optimal antibiotics when empirically treating UTIs under simulated conditions. Although the antibiogram format was not associated with decision-making in aggregate, context-specific effects may have been present, supporting further study of syndromic antibiograms in clinical practice.

PMID:38150250 | DOI:10.1001/jamanetworkopen.2023.49544

JAMA Netw Open. 2023 Dec 1;6(12):e2350237. doi: 10.1001/jamanetworkopen.2023.50237.

ABSTRACT

IMPORTANCE: The National Cancer Database (NCDB) is an invaluable and widely used resource for cancer research, but the current state of representation of different racial and ethnic groups compared with the United States Cancer Statistics (USCS) database is unknown.

OBJECTIVE: To examine whether Hispanic and American Indian or Alaska Native individuals have lower representation in the NCDB compared with the USCS database.

DESIGN, SETTING, AND PARTICIPANTS: This multicenter, retrospective cohort study assessed individuals diagnosed with breast, colorectal, lung, and prostate cancer from January 1, 2004, to December 31, 2006, and January 1, 2017, to December 31, 2019, in the NCDB and USCS databases. Data analysis was performed from September 2022 to October 2023.

EXPOSURE: Time.

MAIN OUTCOMES AND MEASURES: The primary outcome was the absolute percentage change (APC) in capture rate across the study period.

RESULTS: The cohort included 5 175 007 individuals (0.50% American Indian or Alaska Native, 3.10% Asian or Pacific Islander, 12.01% Black, 6.58% Hispanic, and 77.81% White) who were diagnosed with breast, colorectal, lung, and prostate cancer. Capture rates were the lowest for individuals who were Hispanic (40.83% in 2004-2006 and 54.75% in 2017-2019; P < .001) or American Indian or Alaska Native (20.72% in 2004-2006 and 41.41% in 2017-2019; P < .001). The APCs were positive for both racial categories across all 4 cancers. However, overall APCs for Hispanic individuals (13.92%) remained lower than the overall APCs of White individuals (22.23%; P < .001). The APCs were greater for American Indian or Alaska Native individuals than for White individuals for prostate (14.68% vs 11.57%) and breast (21.61% vs 17.90%) cancer (P < .001), but the APCs for American Indian or Alaska Native individuals were lower than for White individuals for lung cancer (24.54% vs 33.03%; P < .001).

CONCLUSIONS AND RELEVANCE: In this cohort study of individuals diagnosed with cancer in the NCDB, Hispanic and American Indian or Alaska Native individuals diagnosed with breast, colorectal, lung, and prostate cancer were undercaptured in the NCDB, but their representation improved over time. Increased study is needed to determine where these populations predominantly seek cancer care.

PMID:38150248 | DOI:10.1001/jamanetworkopen.2023.50237

JAMA Dermatol. 2023 Dec 27. doi: 10.1001/jamadermatol.2023.5226. Online ahead of print.

ABSTRACT

IMPORTANCE: Non-Hispanic American Indian/Alaska Native people have the second highest incidence rate of invasive cutaneous melanoma in the US after non-Hispanic White people.

OBJECTIVE: To examine invasive cutaneous melanoma incidence rates and trends over time among non-Hispanic American Indian/Alaska Native people.

DESIGN, SETTING, AND PARTICIPANTS: This descriptive, observational cross-sectional study used population-based cancer registry data (US Cancer Statistics AI/AN Incidence Analytic Database) linked to the Indian Health Service administrative database to examine incidence rates by age, sex, region, histology, tumor site, stage, and other demographic and clinical characteristics. The study examined trends from 1999 to 2019 time period by age, sex, stage at diagnosis, and region. Non-Hispanic American Indian/Alaska Native people 15 years and older who received a diagnosis of invasive cutaneous melanoma from 1999 to 2019 who were members of federally recognized tribes and resided in Indian Health Service purchased/referred care delivery areas were included in this study to reduce racial misclassification and provide more accurate rates. The data were analyzed in 2022.

EXPOSURES: Demographic and clinical characteristics, such as age, sex, geographic region, histology, stage, and tumor site.

MAIN OUTCOMES AND MEASURES: Invasive cutaneous melanoma incidence rates by age group, sex, region, resident county characteristics (poverty level, rurality, education level, and socioeconomic status), stage at diagnosis, tumor site, and histology. Trends over time by age, sex, region, and stage.

RESULTS: From 1999 to 2019, 2151 non-Hispanic American Indian/Alaska Native people (1021 female individuals [47.5%]) received a diagnosis of incident cutaneous melanoma (rate, 10.7 per 100 000; 95% CI, 10.3-11.2). Rates were higher among male than female individuals (13.0 [95% CI, 12.2-13.8] vs 9.2 [95% CI, 8.6-9.8]) and for people 55 years and older (24.2; 95% CI, 22.8-25.7) compared with those aged 15 to 39 years (3.5; 95% CI, 3.2-3.9). Rates were highest for male individuals 55 years and older (34.5; 95% CI, 31.8-37.3) and people living in the Southern Plains (male individuals: 23.8; 95% CI, 21.5-26.2; female individuals: 15.5; 95% CI, 14.0-17.2) and Pacific Coast region (male individuals: 16.5; 95% CI, 14.5-18.7; female individuals: 12.3; 95% CI, 10.9-13.9). Rates increased among female individuals from 1999 to 2019 (average annual percent change [AAPC], 2.5; P < .001); among regional/distant stage tumors (AAPC, 2.5; P = .01) and people 55 years and older (AAPC, 2.8; P = .001).

CONCLUSIONS AND RELEVANCE: The results of this study suggest that additional studies could potentially identify risk factors among non-Hispanic American Indian/Alaska Native people.

PMID:38150212 | DOI:10.1001/jamadermatol.2023.5226

Photobiomodul Photomed Laser Surg. 2023 Dec 26. doi: 10.1089/photob.2023.0141. Online ahead of print.

ABSTRACT

Background: The current research extends previous laboratory investigations by investigating the effects of low-level laser irradiation (LLLI) on human blood plasma. Total bilirubin is of special importance because of its potential biostimulatory and modulatory actions. Objective: This study aims to analyze changes in total bilirubin content as a consequence of LLLI on human blood plasma. This study aims to determine how changes in exposure duration and laser wavelength affect these adjustments. Methodology: Plasma was isolated from a healthy adult donor’s whole blood using the anticoagulant ethylenediaminetetraacetic acid (EDTA). Plasma samples were exposed to LLLI at 375 and 650 nm for 5, 10, 15, 20, and 25 min. Total bilirubin concentrations were measured both before and after irradiation using spectrophotometric analysis. The difference between 375 and 630 nm lasers was also investigated. Results: Five, 10, 15, 20, and 25 min of exposure to LLLI at 375 and 650 nm wavelengths resulted in statistically significant differences in total bilirubin content (p ˂ 0.05, p ˂ 0.001, p ˂ 0.0001). There was no statistically significant difference in total bilirubin concentration between the 375 and 630 nm lasers. Conclusions: Human blood plasma total bilirubin levels were considerably lower following LLLI at 375 and 630 nm than controls. Multiple exposures provide the same results. These findings demonstrate the role of biostimulation by laser irradiation in blood plasma applications and suggest that low-level laser treatment may control total bilirubin levels, particularly at 375 and 630 nm.

PMID:38150176 | DOI:10.1089/photob.2023.0141

Sports Med. 2023 Dec 27. doi: 10.1007/s40279-023-01977-z. Online ahead of print.

ABSTRACT

There is increasing concern regarding the effects of heading in football on brain health including cognitive, behavioural and neuromotor function, with research suggesting an association between repeated ball-head impacts and neurodegenerative disease. While longitudinal studies to determine the long-term consequences of heading are challenging, there have been short-term ‘acute’ studies conducted, with some studies lacking appropriate methodology to ensure valid results. The Union of European Football Associations (UEFA) established a panel of experts to determine methodological recommendations for the conduct of studies that explore the acute effects of heading (defined as a single session of heading conducted either in a laboratory setting or following match play or a training session). The aim of this panel was to create quality criteria for acute heading studies that will form part of the eligibility assessment when applying for UEFA research funding (although the criteria can be applied to the conduct of acute heading research more widely). This process was deemed necessary to counter studies with poor methodological quality that used heading trials that did not accurately represent player exposure to ball-head impacts through football practice and match play (such as small sample sizes, unrealistically high heading exposure, and a lack of consideration of confounding variables). The panel identified core design decisions that authors should consider when designing and conducting acute heading research, with key methodological requirements for each domain pertaining to participants, heading trials, confounding variables, statistics and dependent/target variables and their measurement. After two rounds of reviews, the final list of quality criteria was agreed by the panel and will be applied to the next round of UEFA grant applications.

PMID:38150166 | DOI:10.1007/s40279-023-01977-z

Int J Colorectal Dis. 2023 Dec 27;39(1):10. doi: 10.1007/s00384-023-04572-w.

ABSTRACT

PURPOSE: This study aims to adapt and validate the Cleveland Clinic Colorectal Cancer Quality of Life Questionnaire (CCF-CaQL) in Turkish, addressing the significant need for reliable, language-specific QoL measures for colorectal cancer (CRC) in Turkiye. This effort fills a critical gap in CRC patient care, enhancing both patient-provider communication and disease-specific QoL assessment.

METHODS: The CCF-CaQL was translated into Turkish, verified for accuracy, and reviewed for clarity and relevance. Eligible patients who underwent colorectal surgery for cancer between July 2021 and July 2022 from six hospitals completed the CCF-CaQL and SF-36 questionnaires. For analysis, confirmatory factor analysis using Smart PLS 4 and descriptive statistics were employed. The questionnaire’s reliability and validity were assessed using Cronbach alpha, composite reliability, and the heterotrait-monotrait (HTMT) ratio, along with multicollinearity checks and factor loadings. Nonparametric resampling was used for precise error and confidence interval calculations, and the Spearman coefficient and split-half method were applied for reliability testing.

RESULTS: In the study involving 244 colorectal cancer patients, confirmatory factor analysis of the CCF-CaQL indicated effective item performance, with one item removed due to lower factor loading. The questionnaire exhibited high internal consistency, evidenced by a Cronbach alpha value of 0.909. Convergent validity was strong, with all average variance extracted (AVE) values exceeding 0.4. Discriminant validity was confirmed with HTMT coefficients below 0.9, and no significant multicollinearity issues were observed (VIF values < 10). Parallel testing with the SF-36 scale demonstrated moderate to very strong correlations, affirming the CCF-CaQL’s comparability in measuring quality of life.

CONCLUSION: The Turkish version of the CCF-CaQL was validated for assessing quality of life in colorectal cancer patients. This validation confirms its reliability and cultural appropriateness for use in Turkiye. The disease-specific nature of the CCF-CaQL makes it a useful tool in clinical and research settings, enhancing patient care by accurately monitoring treatment effects and interventions in the Turkish colorectal cancer patient population.

PMID:38150157 | DOI:10.1007/s00384-023-04572-w

Braz J Microbiol. 2023 Dec 27. doi: 10.1007/s42770-023-01222-9. Online ahead of print.

ABSTRACT

Cordyceps militaris is a fungus with numerous therapeutic properties that has gained worldwide popularity due to its potential health benefits. The fruiting body of this mushroom is highly expensive and takes a longer time to produce, making mycelial a sustainable and cost-effective alternative. The study investigates and optimizes cultural and nutritional conditions to maximize mycelial biomass. The initial optimization was done by the conventional single-factor approach, followed by Plackett-Burman design to screen the most significant variables, with yeast extract, temperature, and glucose being the most significant, contributing 11.58%, 49.74%, and 27.98%, respectively, in mycelial biomass production. These variables were then optimized using response surface methodology (RSM) based on central composite design (CCD). The study observed that temperature and glucose had the highest impact on mycelial biomass, with p-values of 0.0128 and 0.0191, respectively. Under the optimized conditions, temperature 20 °C, glucose 2.5% (w/v), and yeast extract 0.8% (w/v), the maximal yield of mycelial biomass reached 547 ± 2.09 mg/100 mL, which was 1.95-fold higher than the yield in the basal medium. These findings suggest that optimizing the cultural and nutritional conditions can enhance mycelial biomass production of Cordyceps militaris, offering a sustainable and cost-effective source of this valuable fungus.

PMID:38150151 | DOI:10.1007/s42770-023-01222-9

Abdom Radiol (NY). 2023 Dec 27. doi: 10.1007/s00261-023-04138-y. Online ahead of print.

ABSTRACT

PURPOSE: To assess the renal elasticity values using (SWE) and correlate the values with steroid sensitivity to distinguish between steroid-resistant nephrotic syndrome (SRNS) and steroid-sensitive nephrotic syndrome (SSNS) in children.

METHODS: In this IRB-approved cross-sectional study, 83 children (4-14 years) diagnosed with nephrotic syndrome were included from July 2021 to December 2022. SWE measurements were done for each kidney’s upper pole, interpolar region, and lower pole. Mean as well as median SWE were calculated. Correlation of the renal stiffness values was done with different laboratory findings (blood urea, serum creatinine, 24 h urine protein, serum albumin, and serum cholesterol), the grayscale findings (cortical echogenicity, and corticomedullary differentiation), and the final diagnosis of SRNS and SSNS. The statistical tests were done at a significance level of α = 0.05.

RESULTS: The median (IQR) overall SWE of kidneys was higher in SRNS group 12.64 (8.4-19.68) kPa than SSNS group 9.87 (8.20-12.56) kPa. The difference was significant (p = 0.004). At a cut-off of ≥ 10.694 kPa (AUROC- 0.641), the overall SWE predicted SRNS group with a sensitivity of 70% and a specificity of 63%. A significant correlation (p < 0.05) was found between the SWE and 24-h urine protein, cortical echogenicity, and corticomedullary differentiation in SSNS, while only between SWE and corticomedullary differentiation in SRNS.

CONCLUSION: The mean SWE was higher in children with SRNS. While SWE has potential to differentiate SSNS from SRNS, a different study design where SWE is performed at presentation is needed for confirmation.

PMID:38150144 | DOI:10.1007/s00261-023-04138-y