Category: Statistics

JAMA Netw Open. 2024 Nov 4;7(11):e2447649. doi: 10.1001/jamanetworkopen.2024.47649.

ABSTRACT

IMPORTANCE: Cancer and its care impose significant time commitments on patients and care partners. The oncology community has only recently conceptualized these commitments and the associated burden as the “time toxicity” of cancer care. As the concept gains traction, there is a critical need to fundamentally understand the perspectives of multiple stakeholders on the time burdens of cancer care.

OBJECTIVES: To explore time-consuming aspects of cancer care that were perceived as burdensome, identify the individuals most affected by time burdens of cancer care, and evaluate the consequences of these time burdens.

DESIGN, SETTING, AND PARTICIPANTS: Participants in this qualitative analysis were recruited from a National Cancer Institute-designated cancer center in Minnesota, where semistructured qualitative interviews were conducted from February 1 to October 31, 2023. Purposive and criterion sampling methods were used to recruit patients (adults with advanced stage gastrointestinal cancer receiving systemic cancer-directed treatment), care partners (patient-identified informal [unpaid] partners), and clinicians (physicians, physician assistants, nurse practitioners, nurses, social workers, and schedulers). Data were analyzed from February 2023 to February 2024.

MAIN OUTCOMES AND MEASURES: Thematic analysis was conducted with a hybrid (inductive and deductive methods) approach. Themes, subthemes, and illustrative quotations are presented.

RESULTS: Interviews included 47 participants (16 patients [8 aged ≤60 years; 12 women (75.0%)], 15 care partners [12 aged ≤60 years; 9 women (60.0%)], and 16 clinicians [11 women (68.7%)]). A total of 31 subthemes were identified that were grouped into 5 themes. Theme 1 captured time burdens due to health care outside the home (eg, travel, parking, and waiting time), while theme 2 identified the often invisible tasks performed at home (eg, handling insurance and medical bills, receiving formal home-based care). Theme 3 explored how care partners are affected alongside patients (eg, burdens extending to the wider network of family, friends, and community) and theme 4 represented the consequences of time burdens (eg, demoralization, seemingly short visits turned into all-day affairs). Finally, theme 5 referenced positive time spent in clinical interactions and hope for change (eg, patients value meaningful care, the “time toxicity” label is a spark for change).

CONCLUSIONS AND RELEVANCE: This qualitative analysis identifies key sources and effects of time toxicity, as well as the populations affected. The results of this study will guide the oncology community to map, measure, and address future time burdens.

PMID:39602118 | DOI:10.1001/jamanetworkopen.2024.47649

JAMA Netw Open. 2024 Nov 4;7(11):e2448003. doi: 10.1001/jamanetworkopen.2024.48003.

ABSTRACT

IMPORTANCE: Seasonal influenza is associated with substantial disease burden. The relationship between census tract-based social vulnerability and clinical outcomes among patients with influenza remains unknown.

OBJECTIVE: To characterize associations between social vulnerability and outcomes among patients hospitalized with influenza and to evaluate seasonal influenza vaccine and influenza antiviral utilization patterns across levels of social vulnerability.

DESIGN, SETTING, AND PARTICIPANTS: This retrospective repeated cross-sectional study was conducted among adults with laboratory-confirmed influenza-associated hospitalizations from the 2014 to 2015 through the 2018 to 2019 influenza seasons. Data were from a population-based surveillance network of counties within 13 states. Data analysis was conducted in December 2023.

EXPOSURE: Census tract-based social vulnerability.

MAIN OUTCOMES AND MEASURES: Associations between census tract-based social vulnerability and influenza outcomes (intensive care unit admission, invasive mechanical ventilation and/or extracorporeal membrane oxygenation support, and 30-day mortality) were estimated using modified Poisson regression as adjusted prevalence ratios. Seasonal influenza vaccine and influenza antiviral utilization were also characterized across levels of social vulnerability.

RESULTS: Among 57 964 sampled cases, the median (IQR) age was 71 (58-82) years; 55.5% (95% CI, 51.5%-56.0%) were female; 5.2% (5.0%-5.4%) were Asian or Pacific Islander, 18.3% (95% CI, 18.0%-18.6%) were Black or African American, and 64.6% (95% CI, 64.2%-65.0%) were White; and 6.6% (95% CI, 6.4%-68%) were Hispanic or Latino and 74.7% (95% CI, 74.3%-75.0%) were non-Hispanic or Latino. High social vulnerability was associated with higher prevalence of invasive mechanical ventilation and/or extracorporeal membrane oxygenation support (931 of 13 563 unweighted cases; adjusted prevalence ratio [aPR], 1.25 [95% CI, 1.13-1.39]), primarily due to socioeconomic status (790 of 11 255; aPR, 1.31 [95% CI, 1.17-1.47]) and household composition and disability (773 of 11 256; aPR, 1.20 [95% CI, 1.09-1.32]). Vaccination status, presence of underlying medical conditions, and respiratory symptoms partially mediated all significant associations. As social vulnerability increased, the proportion of patients receiving seasonal influenza vaccination declined (-19.4% relative change across quartiles; P < .001) as did the proportion vaccinated by October 31 (-6.8%; P < .001). No differences based on social vulnerability were found in in-hospital antiviral receipt, but early in-hospital antiviral initiation (-1.0%; P = .01) and prehospital antiviral receipt (-17.3%; P < .001) declined as social vulnerability increased.

CONCLUSIONS AND RELEVANCE: In this cross-sectional study, social vulnerability was associated with a modestly increased prevalence of invasive mechanical ventilation and/or extracorporeal membrane oxygenation support among patients hospitalized with influenza. Contributing factors may have included worsened baseline respiratory health and reduced receipt of influenza prevention and prehospital or early in-hospital treatment interventions among persons residing in low socioeconomic areas.

PMID:39602116 | DOI:10.1001/jamanetworkopen.2024.48003

JAMA Netw Open. 2024 Nov 4;7(11):e2448010. doi: 10.1001/jamanetworkopen.2024.48010.

ABSTRACT

IMPORTANCE: Patients with a non-English language preference served within English-dominant health care settings are at increased risk of adverse events that may be associated with communication barriers and inequitable access to care.

OBJECTIVE: To investigate the association of non-English language preference with surgical wait time and postoperative outcomes in older patients undergoing hip fracture repair.

DESIGN, SETTING, AND PARTICIPANTS: This population-based, retrospective cohort study was conducted using linked databases to measure surgical wait time and postoperative outcomes among older adults (aged ≥66 years) in Ontario, Canada, who underwent hip fracture surgery between January 1, 2017, and December 31, 2022. Propensity-based overlap weighting accounting for baseline patient characteristics was used to compare primary and secondary outcomes.

EXPOSURE: Non-English language preference.

MAIN OUTCOMES AND MEASURES: The primary outcome was surgical delay beyond 24 hours. Secondary outcomes included time to surgery, surgical delay beyond 48 hours, postoperative medical complications, length of stay, discharge destination, 30-day mortality, and 30-day hospital readmission.

RESULTS: Among 35 238 patients who underwent hip fracture surgery, 28 815 individuals (81.8%) were English speakers (mean [SD] age, 84.4 [8.0] years; 19 965 female [69.3%]) and 6423 individuals (18.2%) were non-English speakers (mean [SD] age, 85.5 [7.0] years; 4556 female [70.9%]). The median (IQR) wait time for surgery was similar for English (24 [16-41] hours) and non-English (25 [16-42] hours) speakers. There was no significant difference in surgical delay beyond 24 hours between English-speaking and non-English-speaking patients (3321 patients [51.7%] vs 14 499 patients [50.3%]; adjusted relative risk [aRR], 1.00; 95% CI, 0.98-1.03). Compared with English speakers, patients with a non-English language preference had increased risk of delirium (4207 patients [14.6%] vs 1209 patients [18.8%]; aRR, 1.10; 95% CI, 1.03-1.17), myocardial infarction (150 patients [0.5%] vs 43 patients [0.7%]; aRR, 1.52; 95% CI, 1.04-2.22), longer length of stay (median [IQR], 10 [6-17] vs 11 [7-20] days; aRR per 1-day increase, 1.11; 95% CI, 1.06-1.15), and more frequent discharge to a nursing home (1814 of 26 673 patients surviving to discharge [6.8%] vs 413 of 5903 patients surviving to discharge [7.0%]; aRR, 1.13; 95% CI, 1.01-1.27).

CONCLUSIONS AND RELEVANCE: In this study of older adults with hip fracture, non-English language preference was associated with increased risk of delirium, myocardial infarction, longer length of stay, and discharge to a nursing home. These findings suggest inequities in hip fracture care for patients with a non-English language preference.

PMID:39602115 | DOI:10.1001/jamanetworkopen.2024.48010

JAMA Otolaryngol Head Neck Surg. 2024 Nov 27. doi: 10.1001/jamaoto.2024.3963. Online ahead of print.

ABSTRACT

IMPORTANCE: Genome-wide association studies have identified germline variants associated with the development of papillary thyroid carcinoma (PTC) that can be used to construct a polygenic score (PGS). It is important to determine whether patients with higher germline genetic risk, as summarized using PGS, present with more aggressive disease and/or develop worse clinical outcomes.

OBJECTIVE: To assess whether germline risk defined by PGS is associated with clinicopathologic features and survival outcomes for patients with PTC.

DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study included patients with newly diagnosed PTC who presented to The University of Texas MD Anderson Cancer Center for treatment between 1999 and 2014, with a median follow-up of 12 years. Data were analyzed from December 2023 to April 2024.

EXPOSURE: Germline risk, as defined by PGS.

MAIN OUTCOMES AND MEASURES: Genomic DNA was extracted from buffy coat cells isolated from peripheral blood samples, and genotyping for germline polymorphisms was performed. Germline risk for PTC was estimated with a previously validated PGS calculated from 10 single-nucleotide variations identified through genome-wide association studies. Stage; PTC-specific survival, defined as the time from PTC diagnosis to death caused by PTC; and overall survival, defined as the time from PTC diagnosis to death by any cause, were analyzed.

RESULTS: A total of 366 patients were included in the study (261 women [71.3%]; mean [SD] age at diagnosis, 44.3 [13.8] years). There was a statistically significant association between higher PGS and multifocality (β [SE], 0.40 [0.23]; P = .045) and cervical lymph node involvement (N stage) (β [SE], 0.62 [0.35]; P = .009) at diagnosis. PGS was associated with PTC-specific survival (hazard ratio, 2.66; 95% CI, 1.03-6.85; P = .04), but this association was not independent of age and overall stage. There was not a statistically significant association between PGS and overall survival.

CONCLUSIONS AND RELEVANCE: Findings of this cohort study suggest that patients with a higher germline risk of PTC, as estimated by PGS, present with more aggressive clinicopathologic features. These results contribute to the current understanding of inherited risk in PTC and how germline variants could potentially contribute to disease presentation and clinical outcomes.

PMID:39602114 | DOI:10.1001/jamaoto.2024.3963

JAMA Health Forum. 2024 Nov 1;5(11):e244216. doi: 10.1001/jamahealthforum.2024.4216.

ABSTRACT

IMPORTANCE: In response to the growing opioid crisis, states implemented opioid prescribing limits to reduce exposure to opioid analgesics. Research in other clinical contexts has found that these limits are relatively ineffective at changing opioid analgesic prescribing.

OBJECTIVE: To examine the association of state-level opioid prescribing limits with opioid prescribing within the 30-day postpartum period, as disaggregated by type of delivery (vaginal vs cesarean) and opioid naivete.

DESIGN, SETTING, AND PARTICIPANTS: This retrospective, observational cohort study used commercial claims data from January 1, 2014, to December 31, 2021, from 49 US states and a difference-in-differences staggered adoption estimator to examine changes in postpartum opioid prescribing among all deliveries to enrollees between the ages of 18 and 44 years in the US.

EXPOSURES: The implementation of a state opioid prescribing limit between 2017 and 2019.

MAIN OUTCOMES AND MEASUREMENTS: The primary outcomes for this analysis were the number of prescriptions for opioid analgesics, proportion of prescriptions with a supply greater than 7 days, and milligrams of morphine equivalent (MMEs) per delivery between 3 days before and 30 days after delivery.

RESULTS: A total of 1 572 338 deliveries (enrollee mean [SD] age, 30.20 [1.59] years) were identified between 2014 and 2021, with 32.3% coded as cesarean deliveries. A total of 98.4% of these were to opioid-naive patients. The mean MMEs per delivery was 310.79, with higher rates in earlier years, states that had an opioid prescribing limit, and cesarean deliveries. In a covariate-adjusted difference-in-differences regression analysis, opioid prescribing limits were associated with a decrease of 148.70 MMEs per delivery (95% CI, -657.97 to 360.57) compared with states without such limits. However, these changes were not statistically significant. The pattern of results was similar among other opioid-prescribing outcomes and types of deliveries.

CONCLUSIONS AND RELEVANCE: The results of this cohort study suggest that opioid prescribing limits are not associated with changes in postpartum opioid prescribing regardless of delivery type or opioid naivete, which is consistent with research findings on these limits in other conditions or settings. Future research could explore what kinds of prevention mechanisms reduce the risk of opioid prescribing during pregnancy and postpartum.

PMID:39602107 | DOI:10.1001/jamahealthforum.2024.4216

Orthod Craniofac Res. 2024 Nov 27. doi: 10.1111/ocr.12874. Online ahead of print.

ABSTRACT

OBJECTIVE: To compare the three-dimensional root parallelism (mesiodistally and buccolingually) between orthodontic therapy with the Invisalign clear aligners (CA) and fixed appliances (FA) among the first premolar-extraction patients, using cone-beam computed tomography (CBCT).

MATERIALS AND METHODS: Sixty participants with similar American Board of Orthodontics discrepancy index scores as baseline characteristics were included and divided into CA and FA groups (30 per group). Post-treatment mesiodistal and buccolingual root parallelisms were analysed through CBCT using Invivo 6.0.3 software. Descriptive and analytical statistics were performed with a p < 0.05, considered statistically significant.

RESULTS: Mesiodistal dental root parallelism in the U1-U2 and L1-L2 pairings between CA and FA groups were found to be significantly different with inferior parallelism in the CA group (p < 0.05). Conversely, the U3-U5 and L5-L6 pairings exhibited superior parallelism in the CA group (p < 0.05). However, other pairings, including U1-U1, U2-U3, U5-U6, U6-U7, L1-L1, L2-L3, L3-L5, and L6-L7, showed no significant differences in mesiodistal parallelism between groups (p > 0.05). Regarding the buccolingual dental root parallelism, significant differences were also noted in the U5-U6 and L5-L6 pairings with superior parallelism in the CA group (p < 0.05). However, in the U1-U1, U2-U3, U3-U5, U6-U7, L1-L1, L2-L3, L3-L5, and L6-L7 pairings, no significant differences in buccolingual parallelism were observed (p > 0.05).

CONCLUSION: In this study, our findings indicate that in cases involving the extraction of first premolars, Invisalign clear aligners may offer comparable or even superior three-dimensional root parallelism compared to fixed orthodontic appliances, with the exception of the mesiodistal dimension in upper and lower incisors, where their performance is less effective.

PMID:39602097 | DOI:10.1111/ocr.12874

Adv Neonatal Care. 2024 Dec 1;24(6):569-577. doi: 10.1097/ANC.0000000000001204. Epub 2024 Nov 26.

ABSTRACT

BACKGROUND: The challenging transition to parenthood affects both mothers and fathers; yet, the strain intensifies with a premature birth in the neonatal intensive care unit (NICU), underscoring the importance of acknowledging and addressing potential differences in parental roles.

PURPOSE: This paper aimed to investigate how parental role conflicts among mothers and fathers of preterm-born infants hospitalized in German NICUs manifest and investigated potential parental resources.

METHODS: Twenty-four participants, 17 mothers, and seven fathers of very low birth-weight infants were interviewed. A thematic content analysis was performed at a semantic level.

RESULTS: Fathers feel pressured to fulfill the role expectations, often leading to the suppression of paternal feelings and needs. For mothers, deviating from societal expectations regarding their expressive roles can be distressing, as they worry that such deviation might hinder their infants from having a successful start in life. Consulting with healthcare professionals shows to ease challenges for both parental roles.

IMPLICATIONS FOR PRACTICE AND RESEARCH: Maternal and paternal challenges are often rooted in expectations placed on their societal roles. Highlighting these challenges can be essential for increasing awareness and effectively addressing them. Tailored nursing practices may have the potential to facilitate individuals’ navigation of uncertainties and fulfillment of caregiving roles.

PMID:39602093 | DOI:10.1097/ANC.0000000000001204

Adv Neonatal Care. 2024 Dec 1;24(6):517-524. doi: 10.1097/ANC.0000000000001212. Epub 2024 Nov 26.

ABSTRACT

BACKGROUND: In 2020, the rate of newborns diagnosed with neonatal abstinence syndrome (NAS) in the United States was 6.3 for every 1000 newborn hospitalizations. Resources used to care for this population, particularly NICU beds, are being overwhelmed. In 2020, the state of Ohio saw a rate of 9.5 newborns with NAS for every 1000 newborn hospitalizations.

PURPOSE: To determine if using the Eat, Sleep, Console (ESC) model of care to guide management of neonates with NAS instead of the Finnegan Scale would reduce the number of admissions of neonates diagnosed with NAS to the neonatal intensive care unit (NICU).

METHODS: The PDSA (Plan, Do, Study, Act) method was used in the planning and implementation of this pilot quality improvement project. Education regarding the ESC model of care was provided to the Mother/Infant Unit (MIU), with ongoing education and resources provided and readily available on the unit.

RESULTS: Fifteen neonates were managed with ESC. Of the 5 who would have been admitted to the NICU for pharmacological treatment if Finnegan Scores were the determining factor for admission, 2 were discharged home from the MIU having been managed with ESC.

IMPLICATIONS FOR PRACTICE AND RESEARCH: The use of the ESC model of care can be a useful tool in the management and assessment of neonates with NAS. Resource allocation for care of this population must be assessed to provide optimal non-pharmacological interventions.

PMID:39602091 | DOI:10.1097/ANC.0000000000001212

Transfus Med. 2024 Nov 27. doi: 10.1111/tme.13115. Online ahead of print.

ABSTRACT

BACKGROUND: Granulocyte transfusions represent a therapeutic option for severely neutropenic patients with bacterial or fungal infections that are otherwise unresponsive to conventional therapy. Prior clinical studies suggest that patients receiving higher granulocyte doses achieve superior outcomes. Consequently, suboptimal donor stimulation and collection leading to lower granulocyte doses likely correlate with worse clinical outcomes.

STUDY DESIGN: A retrospective analysis was conducted on mobilisation data from 312 granulocyte collections from healthy donors between January 2020 and May 2023. This study was performed in a single blood donor center exclusively supporting a comprehensive cancer center. Donors underwent stimulation with 480 mcg of filgrastim (granulocyte colony stimulating factor [G-CSF]) subcutaneously and 8 mg of dexamethasone orally administered 12 to 14 h before collection. The correlation between donor characteristics (age, gender, body weight (BW), body mass index (BMI), baseline haemoglobin (Hgb), and platelet (PLT) counts) and mobilisation efficiency (Δ WBC, defined as post-mobilisation WBC count-baseline WBC count) was examined to identify factors associated with enhanced mobilisation efficiency. Additionally, the impact of multiple donations on Δ WBC in repeat donors was assessed.

RESULTS: The median donor age was 43 years (range 18-81), with 224 male and 88 female donors. Female donors exhibited significantly higher baseline PLT counts and post-mobilisation WBC counts. However, donor gender did not significantly affect Δ WBC. A negative correlation was observed between Δ WBC and age (r = -0.235, p = 0.001), with older donors (61-81 years) exhibiting significantly lower mobilisation efficiency. BW and BMI differences had no significant effect on Δ WBC. A positive correlation was identified between baseline PLT count and Δ WBC (r = 0.140, p = 0.014), with females having significantly higher baseline PLT counts (p = 0.0004). No correlation was found between Δ WBC and baseline Hgb (r = 0.004, p = 0.477). Repeat donors showed no statistically significant change in Δ WBC with subsequent donations, with a mean interval of 136.5 days between collections.

CONCLUSION: Mobilisation efficiency was not impacted by donor BW or BMI suggesting that BW-based G-CSF stimulation is not essential for optimising WBC mobilisation. Rather, a fixed single dose of 480 mcg of G-CSF and 8 mg of dexamethasone was sufficient to mobilise donors, thus reducing the procedural costs and the potential risks for medication-related side effects. The positive correlation found between baseline PLT count and Δ WBC suggests that PLT count could be used as a potential predictor of mobilisation efficiency. Mobilisation response in up to four collections in repeat granulocytes donors was not affected in subsequent donations. However, sample size is a limitation, and more data is needed for a meaningful conclusion of whether frequent granulocyte donations are safe and effective.

PMID:39601217 | DOI:10.1111/tme.13115

Am J Mens Health. 2024 Nov-Dec;18(6):15579883241296881. doi: 10.1177/15579883241296881.

ABSTRACT

Infertility was reported in approximately 15% of all heterozygous couples, with the male factor accounting for nearly half of the cases. This typically occurs due to low sperm production, sperm dysfunction, and sperm delivery obstruction. In this randomized controlled single-blind clinical trial, 90 infertile male subjects diagnosed with oligospermia, hypospermia, asthenozoospermia, or necrozoospermia were recruited. Semen samples were obtained with the masturbation method and an assessment of semen volume, sperm count, and motility was performed. Five milliamps of electrical shock was delivered to the participants through the fertility improvement device. Semen analysis was collected 4 months post-intervention from all subjects. Data were collected and an analysis of pre- and post-intervention results was performed. There was an improvement in the count, volume, and motility of the patient’s sperm after electrical shock treatment compared with the control group. By using the analysis of variance (ANOVA) test, there were statistically significant differences between the first and the second seminal analysis results (<.05). All other results were found to be independently correlated. This study demonstrated that using a painless, convenient at-home device, which is designed to contain all the testis tissue as a cup and then extend to include the scrotal roots reaching the penile root to include the epididymis, could significantly improve sperm motility and count. This device can be utilized to tackle the significant issue of infertility in a cost-effective, safe, and efficacious manner. An ultrasound was done before and after using the device as well as years after with no changes noted.Clinical Trial’s Registration Number: NCT04173052.

PMID:39601214 | DOI:10.1177/15579883241296881