Tag: statistics

JAMA Surg. 2023 Apr 12. doi: 10.1001/jamasurg.2023.0652. Online ahead of print.

ABSTRACT

IMPORTANCE: Each year, the National Cancer Database (NCDB) collects and analyzes data used in reports to support research, quality measures, and Commission on Cancer program accreditation. Because data models used to generate these reports have been historically stable, year-to-year variances have been attributed to changes within the cancer program rather than data modeling. Cancer submissions in 2020 were anticipated to be significantly different from prior years because of the COVID-19 pandemic. This study involved a validation analysis of the variances in observed to expected 2020 NCDB cancer data in comparison with 2019 and 2018.

OBSERVATIONS: The NCDB captured a total of 1 223 221 overall cancer cases in 2020, a decrease of 14.4% (Δ = -206 099) compared with 2019. The early months of the COVID-19 pandemic (March-May 2020) coincided with a nadir of cancer cases in April 2020 that did not recover to overall prepandemic levels through the remainder of 2020. In the early months of the COVID-19 pandemic, the proportion of early-stage disease decreased sharply overall, while the proportion of late-stage disease increased. However, differences in observed to expected stage distribution in 2020 varied by primary disease site. Statistically significant differences in the overall observed to expected proportions of race and ethnicity, sex, insurance type, geographic location, education, and income were identified, but consistent patterns were not evident.

CONCLUSIONS AND RELEVANCE: Historically stable NCDB data models used for research, administrative, and quality improvement purposes were disrupted during the first year of the COVID-19 pandemic. NCDB data users will need to carefully interpret disease- and program-specific findings for years to come to account for pandemic year aberrations when running models that include 2020.

PMID:37043215 | DOI:10.1001/jamasurg.2023.0652

JAMA Netw Open. 2023 Apr 3;6(4):e237699. doi: 10.1001/jamanetworkopen.2023.7699.

ABSTRACT

IMPORTANCE: High-risk medical devices approved by the US Food and Drug Administration (FDA) can undergo modifications to their original premarket approval (PMA) via 1 of 5 types of supplements. Only panel track supplements (approximately 1%) require clinical data for approval. The association between device modifications and risk to patient safety has not previously been analyzed.

OBJECTIVE: To determine the association between PMA supplements and the risk of any device recall and high-risk (class 1) recall.

DESIGN, SETTING, AND PARTICIPANTS: In this cohort study, the FDA database was queried for original devices approved via PMA from January 1, 2008, through December 31, 2019. Supplement and recall data were obtained for these devices from January 1, 2008, through December 31, 2021, giving a minimum 2-year follow-up after initial approval. Data were analyzed from July 6 to August 6, 2022. Retrospective, time-to-event analysis investigated the association between the number and type of supplements and risk of recall.

EXPOSURES: Supplements submitted by manufacturers for FDA approval to modify devices.

MAIN OUTCOMES AND MEASURES: A mixed-effects Cox proportional hazards regression model with frailty terms was used, modeling device recall as an outcome variable during the observation period. A second model was performed for class 1 (high-risk) recall. Explanatory variables are the number of supplements, number of panel track supplements, and cardiovascular devices. Multivariable analysis was performed to identify independent risk factors for recall with hazard ratios (HRs) as the main end point.

RESULTS: A total of 373 original PMA devices with 10 776 associated supplements were included in the analysis. A median 2.5 (IQR, 1.2-5.0) supplements per device were approved annually. Cardiovascular devices contributed 138 supplements (37.0%), followed by microbiology with 45 (12.1%). No other specialty contributed more than 10%. Multivariable analysis demonstrated that each increase of 1 supplement per year was associated with increased risk of recall (HR, 1.28 [95% CI, 1.15-1.44]; P < .001). For class 1 recall, increased number of supplements (HR, 1.32 [95% CI, 1.06-1.64]; P = .01) and cardiovascular vsnoncardiovascular classification of devices (HR, 3.51 [95% CI, 1.15-10.72]; P = .03) were significantly associated with an increased risk of recall.

CONCLUSIONS AND RELEVANCE: The findings of this cohort study suggest that PMA supplements are associated with an approximately 30% increased risk of any recall and class 1 recall. The FDA processes for approving modifications to high-risk medical devices should be reevaluated to optimize patient safety and public health.

PMID:37043202 | DOI:10.1001/jamanetworkopen.2023.7699

JAMA Netw Open. 2023 Apr 3;6(4):e237894. doi: 10.1001/jamanetworkopen.2023.7894.

ABSTRACT

IMPORTANCE: The aerosol box has been used during the management of patients with COVID-19 to reduce health care practitioner (HCP) exposure during aerosol-generating medical procedures (AGMPs). Little is known about the effect of aerosol box use on HCP contamination and AGMP procedure time.

OBJECTIVE: To investigate whether use of an aerosol box during AGMPs reduces HCP contamination or influences the time to successful completion and first-pass success rate for endotracheal intubation (ETI) and laryngeal mask airway (LMA) insertion.

DESIGN, SETTING, AND PARTICIPANTS: This multicenter, simulation-based, randomized clinical trial was conducted from May to December 2021 at tertiary care pediatric hospitals. Participant teams performed 3 simulated patient scenarios: bag-valve-mask ventilation, ETI, and LMA insertion. During the scenarios, aerosols were generated using Glo Germ. Teams of 2 HCPs were randomly assigned to control (no aerosol box) or intervention groups (aerosol box). Statistical analysis was performed from July 2022 to February 2023.

INTERVENTIONS: The aerosol box (or SplashGuard CG) is a transparent, plastic barrier covering the patient’s head and shoulders with access ports allowing HCPs to manage the airway.

MAIN OUTCOMES AND MEASURES: The primary outcome was surface area of contamination (AOC) on participants. Secondary outcomes were time to successful completion and first-pass success rates for ETI and LMA insertion.

RESULTS: A total of 64 teams (128 participants) were enrolled, with data from 61 teams (122 participants) analyzed. Among the 122 participants analyzed, 79 (64.8%) were female and 85 (69.7%) were physicians. Use of an aerosol box was associated with a 77.5% overall decreased AOC to the torso (95% CI, -86.3% to -62.9%; P < .001) and a 60.7% overall decreased AOC to the facial area (95% CI, -75.2% to -37.8%; P < .001) in airway HCPs. There was no statistically significant difference in surface contamination after doffing personal protective equipment between groups. Time to completing ETI was longer in the aerosol box group compared with the control group (mean difference: 10.2 seconds; 95% CI, 0.2 to 20.2 seconds; P = .04), but there was no difference between groups for LMA insertion (mean difference: 2.4 seconds; 95% CI, -8.7 to 13.5 seconds; P = .67).

CONCLUSIONS AND RELEVANCE: In this randomized clinical trial of aerosol box use in AGMPs, use of an aerosol box reduced contamination deposition on HCPs’ torso and face predoffing; the use of an aerosol box delayed time to successful intubation. These results suggest that the incremental benefits of reduced surface contamination from aerosol box use should be weighed against delayed time to complete intubation, which may negatively affect patient outcome.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04880668.

PMID:37043197 | DOI:10.1001/jamanetworkopen.2023.7894

Fam Med. 2023 Apr;55(4):225-232. doi: 10.22454/FamMed.2023.486345. Epub 2023 Feb 13.

ABSTRACT

BACKGROUND AND OBJECTIVES: Training models in the Length of Training Pilot (LOTP) vary. How innovations in training length affect patient visits and resident perceptions of continuity is unknown.

METHODS: We analyzed resident in-person patient encounters (2013-2014 through 2018-2019) for each postgraduate year (PGY) and total visits at graduation derived from the Accreditation Council for Graduate Medical Education reports for each LOTP program. We collected data on residents’ perceptions of continuity from annual surveys (2015-2019). We analyzed continuous variables using independent samples t tests with unequal variance and categorical variables using χ2 tests in comparing 3-year (3YR) versus 4-year (4YR) programs.

RESULTS: PGY-1 and PGY-2 residents in 4YR programs saw statistically more patients than their counterparts in 3YR programs. In PGY3, 3YR program residents had statistically higher visit volume compared to 4YR program residents. Visits conducted in PGY4 ranged from 832 to 884. The additional year of training resulted in approximately 1,000 more total patient visits. Most residents in 3YR and 4YR programs rated their continuity clinic experience as somewhat or very adequate (range 86.3% to 93.7%), which did not statistically differ according to length of training.

CONCLUSIONS: Resident visits were significantly different at each PGY level when comparing 3YR and 4YR programs in the LOTP and the additional year of training resulted in about 1,000 more total visits. Resident perspectives on the adequacy of their continuity clinic experience appeared to not be affected by length of training. Future research should explore how the volume of patient visits performed in residency affects scope of practice and clinical preparedness.

PMID:37043182 | DOI:10.22454/FamMed.2023.486345

Int Urol Nephrol. 2023 Apr 12. doi: 10.1007/s11255-023-03551-y. Online ahead of print.

ABSTRACT

PURPOSE: Renin-angiotensin system hyperactivation in autosomal-dominant polycystic kidney disease (ADPKD) patients leads to early hypertension. Cystic enlargement probably causes parenchymal hypoxia, renin secretion, and endothelial dysfunction. Sympathetic and parasympathetic balance is altered in this condition, especially during the night, also affecting blood pressure circadian rhythm. Aim of this study was to evaluate sympathetic/parasympathetic balance using heart rate variability (HRV) parameters and find a correlation between HRV and renal damage progression, as total kidney volume enlargement, in ADPKD patients.

METHODS: Sixteen adult ADPKD patients were enrolled in the study. Eleven patients (68.8%) were male, and the median age was 42 years (IQR 36-47.5). HRV parameters were calculated using 24 h-ECG Holter. A kidney magnetic resonance imaging (MRI) scan 3 Tesla was performed to evaluate total kidney volume (TKV) and total fibrotic volume (TFV).

RESULTS: A statistically significant positive linear correlation was observed between length of kidneys and frequency domain parameters as low frequency (LF) (r = 0.595, p < 0.05) and LFday (r = 0.587, p < 0.05). Moreover, a statistically significant positive linear correlation exists between high frequency (HF) and TFV (r = 0.804, p < 0.01) or height-adjusted (ha) TFV (r = 0.801, p < 0.01). Finally, we found a statistically significant positive linear correlation between HFnight and TKV (r = 0.608, p < 0.05), ha-TKV (r = 0.685, p < 0.01), TFV (r = 0.594, p < 0.05), and ha-TFV (r = 0.615, p < 0.05).

CONCLUSION: We suppose that the increase in TKV and TFV could lead to a parasympathetic tone hyperactivation, probably in response to hypoxic stress and vasoconstriction due to cystic enlargement.

PMID:37043156 | DOI:10.1007/s11255-023-03551-y

Eur J Epidemiol. 2023 Apr 12. doi: 10.1007/s10654-023-00998-2. Online ahead of print.

ABSTRACT

Excess death estimates have great value in public health, but they can be sensitive to analytical choices. Here we propose a multiverse analysis approach that considers all possible different time periods for defining the reference baseline and a range of 1 to 4 years for the projected time period for which excess deaths are calculated. We used data from the Human Mortality Database on 33 countries with detailed age-stratified death information on an annual basis during the period 2009-2021. The use of different time periods for reference baseline led to large variability in the absolute magnitude of the exact excess death estimates. However, the relative ranking of different countries compared to others for specific years remained largely unaltered. The relative ranking of different years for the specific country was also largely independent of baseline. Averaging across all possible analyses, distinct time patterns were discerned across different countries. Countries had declines between 2009 and 2019, but the steepness of the decline varied markedly. There were also large differences across countries on whether the COVID-19 pandemic years 2020-2021 resulted in an increase of excess deaths and by how much. Consideration of longer projected time windows resulted in substantial shrinking of the excess deaths in many, but not all countries. Multiverse analysis of excess deaths over long periods of interest can offer an approach that better accounts for the uncertainty in estimating expected mortality patterns, comparative mortality trends across different countries, and the nature of observed mortality peaks.

PMID:37043153 | DOI:10.1007/s10654-023-00998-2

Support Care Cancer. 2023 Apr 12;31(5):256. doi: 10.1007/s00520-023-07717-3.

ABSTRACT

Early-stage Hodgkin lymphoma has become one of the most curable hematologic malignancies. Depending upon the disease location, possible toxicities, and patient preference, chemotherapy alone with ABVD remains an accepted treatment modality for this disease. There remains a paucity of data regarding the longitudinal trajectory of health-related quality of life (HRQoL) in patients treated for HL. The impact of disease and treatment on HRQoL is increasingly important to understand as the number of long-term survivors increases. We report the longitudinal HRQoL using data prospectively collected from diagnosis up to 10 years post-treatment in the ABVD arm of the HD.6 randomized controlled trial for early-stage HL patients (N=169). We analyzed HRQoL using the EORTC QLQ-C30 collected at baseline, 3 months, 6 months, and 12 months after completion of chemotherapy and yearly up to year 10. Clinically and statistically significant improvements were noted for specific domains including emotional (3 months post-treatment), social (12 months post-treatment) and financial functioning (2 years post-treatment), and the specific symptom of fatigue (6 months post-treatment) during the follow-up period. To our knowledge, this is the first prospective, longitudinal analysis of HRQoL specifically among patients with early-stage HL treated with ABVD therapy alone. Although improvements were noted, sustained clinically and statistically significant improvements were noted only in select symptoms emphasizing the need to better understand and optimize HRQoL among this patient group.

PMID:37043087 | DOI:10.1007/s00520-023-07717-3

J Anesth. 2023 Apr 12. doi: 10.1007/s00540-023-03192-6. Online ahead of print.

ABSTRACT

PURPOSE: To assess the efficacy of pericapsular nerve group (PENG) block combined with lateral femoral cutaneous nerve (LFCN) block in controlling postoperative pain and promoting recovery of lower extremity after total hip arthroplasty (THA), and to compare its effectiveness with supra-inguinal fascia iliaca compartment block (S-FICB).

MATERIALS AND METHODS: 92 patients undergoing THA with general anesthesia were randomly allocated to receive either a PENG with LFCN block (n = 46) using 30 ml 0.33% ropivacaine (20 ml for PENG block, 10 ml for LFCN block), or an S-FICB (n = 46) using 30 ml 0.33% ropivacaine. The primary outcome was the time to first postoperative walk. The secondary outcomes included intraoperative remifentanil consumption, postoperative hip flexion degree and muscle strength of the operative lower limbs in the supine position, pain scores (static and dynamic), rescue analgesia, postoperative nausea and vomiting (PONV), and nerve block-related complications.

RESULTS: The combination of PENG with LFCN blocks resulted in an earlier first postoperative walking time (19.6 ± 9.6 h vs 26.5 ± 8.2 h, P < 0.01), greater postoperative hip flexion degree at 6 h, 24 h and 48 h (all P < 0.01), and higher muscle strength of the operative lower limbs at 6 h after surgery (P = 0.03) compared to S-FICB. The difference in pain scores (static and dynamic) was only statistically significant at 48 h (P < 0.05). There were no differences in the other outcomes.

CONCLUSIONS: PENG with LFCN blocks is more effective than S-FICB in shortening the time to first postoperative walk and preservation hip motion after THA, which makes it a suitable addition to enhanced recovery programs following surgery.

PMID:37043081 | DOI:10.1007/s00540-023-03192-6

Matern Child Health J. 2023 Apr 12. doi: 10.1007/s10995-022-03524-0. Online ahead of print.

ABSTRACT

BACKGROUND: Recent legislative decisions in the United States have encouraged discussion about national parental leave programs. Currently, over 47% of the United States workforce is female. However, the United States is the only nation of the 37 member countries in the Organization for Economic Co-Operation and Development (OECD) to have no national requirement for maternity leave. The first few months of a child’s life are vital to their physical and mental development. Likewise, a gradual return to pre-partum functioning is important for a newly postpartum woman. While it has been shown that maternity leave positively impacts various measures of maternal and infant mental and physical health, we lack consensus on the optimal length of paid or unpaid maternity leave. Accordingly, we conducted a systematic review and meta-analysis to evaluate the optimal length of paid or unpaid maternity leave to encourage maternal and infant mental and physical health in the United States.

METHODS: A systematic review and meta-analysis were conducted to synthesize and critically evaluate the current research investigating the association between maternity leave and maternal and infant mental and physical health using the Preferred Reporting in Systematic Reviews and Meta-Analyses guidelines. Databases EMBASE, PsycInfo, and PubMed were searched using specific inclusion and exclusion criteria. Methodological Index for Non-Randomized Studies scale assessed the methodological quality of the included eligible studies. The magnitude of heterogeneity between-study was tested using The Cochrane χ² test and the Moran’s I² statistic. Possible publication bias was assessed through the funnel plot and the Egger regression test. A p-value of < 0.10 will be considered as an indication for the existence of potential publication bias. All statistical analyses were carried out with Stata software version 15.

RESULTS: A total of 21 studies were analyzed. It was found that longer maternity leave may decrease rates of maternal mental and physical health complaints. It was also found that longer maternity leave leads to more positive mother-child interactions, decreased infant mortality, and longer periods of breastfeeding.

CONCLUSION: Maternity leave of 12 weeks or more confers the greatest benefit for mothers and their infants.

PMID:37043071 | DOI:10.1007/s10995-022-03524-0

Bull Exp Biol Med. 2023 Apr 12. doi: 10.1007/s10517-023-05766-6. Online ahead of print.

ABSTRACT

The frequency of D. melanogaster embryonic death was estimated using the method of dominant lethal mutations after exposure to ionizing γ-radiation and non-ionizing pulsed magnetic field. γ-Radiation had a dose-dependent mutational effect on D. melanogaster. A pronounced increase in embryonic death was observed starting from a dose of 3 Gy and reaches a plateau at 60 Gy due to the maximum death of eggs. When D. melanogaster was exposed to pulsed magnetic field, the effect did not depend on the exposure time; a statistically significant genotoxic effect was detected after 5-h exposure.

PMID:37043061 | DOI:10.1007/s10517-023-05766-6