Tag: statistics

BMJ Open. 2022 Sep 2;12(9):e063455. doi: 10.1136/bmjopen-2022-063455.

ABSTRACT

OBJECTIVES: There are indications that the COVID-19 pandemic has had a profound negative effect on psychological well-being. Here, we investigated this hypothesis using longitudinal data from a large global cohort of runners, providing unprecedented leverage for understanding how the temporal development in the pandemic pressure relates to well-being across countries.

DESIGN: Prospective cohort study.

SETTING: Global.

PARTICIPANTS: We used data from the worldwide Garmin-RUNSAFE cohort that recruited runners with a Garmin Connect account, which is used for storing running activities tracked by a Garmin device. A total of 7808 Garmin Connect users from 86 countries participated.

PRIMARY AND SECONDARY OUTCOME MEASURES: From 1 August 2019 (prepandemic) to 31 December 2020, participants completed surveys every second week that included the five-item WHO Well-Being Index (WHO-5). Pandemic pressure was proxied by the number of COVID-19-related deaths per country, retrieved from the Coronavirus Resource Centre at Johns Hopkins University. Panel data regression including individual- and time-fixed effects was used to study the association between country-level COVID-19-related deaths over the past 14 days and individual-level self-reported well-being over the past 14 days.

RESULTS: The 7808 participants completed a total of 125 409 WHO-5 records over the study period. We found a statistically significant inverse relationship between the number of COVID-19-related deaths and the level of psychological well-being-independent of running activity and running injuries (a reduction of 1.42 WHO-5 points per COVID-19-related death per 10 000 individuals, p<0.001).

CONCLUSIONS: This study suggests that the COVID-19 pandemic has had a negative effect on the psychological well-being of the affected populations, which is concerning from a global mental health perspective.

PMID:36194449 | DOI:10.1136/bmjopen-2022-063455

Mol Pharm. 2022 Oct 4. doi: 10.1021/acs.molpharmaceut.2c00337. Online ahead of print.

ABSTRACT

Static light scattering (SLS) was used to characterize five monoclonal antibodies (MAbs) as a function of total ionic strength (TIS) at pH values between 5.5 and 7.0. Second osmotic virial coefficient (B₂₂) values were determined experimentally for each MAb as a function of TIS using low protein concentration SLS data. Coarse-grained molecular simulations were performed to predict the B₂₂ values for each MAb at a given pH and TIS. To include the effect of charge fluctuations of titratable residues in the B₂₂ calculations, a statistical approach was introduced in the Monte Carlo algorithm based on the protonation probability based on a given pH value and the Henderson-Hasselbalch equation. The charged residues were allowed to fluctuate individually, based on the sampled microstates and the influence of electrostatic interactions on net protein-protein interactions during the simulations. Compared to static charge simulations, the new approach provided improved results compared to experimental B₂₂ values at pH conditions near the pK_a of titratable residues.

PMID:36194430 | DOI:10.1021/acs.molpharmaceut.2c00337

JAMA Netw Open. 2022 Oct 3;5(10):e2233636. doi: 10.1001/jamanetworkopen.2022.33636.

ABSTRACT

IMPORTANCE: In 2016, the Centers for Medicare and Medicaid Services cut payments for robotic prostatectomy performed for Medicare beneficiaries. Although regulations mandate that billing for urethral suspension is only acceptable for preexisting urinary incontinence, reductions in reimbursement may incentivize billing for the use of this procedure in other scenarios.

OBJECTIVE: To assess trends and geographic variations in payments for urethral suspension with robotic prostatectomy in the context of Medicare payment policy.

DESIGN, SETTING, AND PARTICIPANTS: This US population-based retrospective cohort study analyzed data from the IBM MarketScan Commercial Claims and Encounters and Medicare Supplemental Database for men with employer-based insurance (primary commercial or Medicare supplemental coverage) who underwent robotic prostatectomy (Current Procedural Terminology [CPT] code 55866) between 2009 and 2019.

EXPOSURES: Time period and metropolitan statistical area of patient residence.

MAIN OUTCOMES AND MEASURES: Payment for urethral suspension (CPT code 51990) with robotic prostatectomy.

RESULTS: We identified 87 774 men with prostate cancer treated with robotic prostatectomy; 3352 (3.8%) had undergone urethral suspension. The mean (SD) patient age was 59.7 (6.5) years; 16 870 patients (19.2%) had Medicare supplemental coverage. From 2015 to 2016, median payments for robotic prostatectomy changed by -$358 (-17.0%) for Medicare beneficiaries vs -$9 (0%) for commercially insured patients. With urethral suspension vs without, median (IQR) episode payments for robotic prostatectomy were higher for commercially insured men ($3678 [$3090-$4503] vs $3322 [$2601-$4306]) and Medicare beneficiaries ($2927 [$2450-$3909] vs $2379 [$2014-$3512]). Compared with men treated between 2013 and 2015, those treated between 2016 and 2017 were twice as likely to undergo urethral suspension (8.5% vs 4.1%; odds ratio, 2.17 [95% CI, 1.96-2.38]). The proportion of patients who underwent urethral suspension was stable for 2018 to 2019 and 2016 to 2017 (8.5% vs 9.0%; odds ratio, 1.06 [95% CI, 0.96-1.18]). From 2015 to 2019, the proportion of patients who underwent urethral suspension was highest in Charleston, South Carolina (92.0%), Knoxville, Tennessee (66.0%), and Columbia, South Carolina (58.0%). These regions neighbored high-volume areas without patients who underwent prostatectomy with urethral suspension (eg, 146 patients in Greenville, South Carolina, and 173 in Nashville, Tennessee).

CONCLUSIONS AND RELEVANCE: In this study, urethral suspension was associated with increased costs for patients with both commercial insurance and Medicare. Patients treated between 2016 and 2017 were more likely than those treated between 2013 and 2015 to undergo this procedure. Geographic variation in use exceeded what was expected for the preexisting condition for which billing is permitted for Medicare beneficiaries. Policy statements from professional societies highlighting appropriate billing for urethral suspension may have tempered, but not reversed, the broad adoption of this procedure.

PMID:36194414 | DOI:10.1001/jamanetworkopen.2022.33636

J Am Coll Health. 2022 Oct 4:1-12. doi: 10.1080/07448481.2022.2128684. Online ahead of print.

ABSTRACT

Objective: To describe the changes in sleep health domains and examine the associations between the repeated measures and intraindividual variability (IIV) of these domains and perceived stress. Participants: A diverse racial and ethnic group of first-year college students (N = 23, 78.3% female, aged 17-18) attending in-person classes during the COVID-19 pandemic. Methods: Sleep health domains were determined using 7-day wrist actigraph and daily sleep diaries, and perceived stress scale was completed at 1-month intervals across 3 months. Results: Sleep timing, regularity, and alertness during daytime demonstrated statistically significant changes between three timepoints. Greater stress was associated with more irregularity (B = 2.25 [.87-3.62], p < .001), more dissatisfaction in sleep (B = .04 [.02-.19], p < .01), alertness during daytime (B = .18 [.05-.31], p < .001), and greater IIV (ie, fluctuations) in sleep satisfaction (B = .083 [.02, .15], p < .01). Conclusion: These findings offer insights for future researchers to facilitate intervention development to promote mental and sleep health among college students.

PMID:36194424 | DOI:10.1080/07448481.2022.2128684

Int Angiol. 2022 Oct 4. doi: 10.23736/S0392-9590.22.04937-9. Online ahead of print.

ABSTRACT

BACKGROUND: Peripheral artery disease is widespread in Western societies affecting around 13% of the population above 50 years of age. Despite recent improvements of endovascular treatment, open surgical bypass is still recommended as the treatment of choice for long segment TASC D lesions. The DETOUR procedure was introduced as an endovascular alternative in cases of long-segment superficial femoral artery occlusion. This unconventional technique raises several questions regarding the effect of the bypass graft on femoral venous physiology.

METHODS: We conducted a 3-year follow up study of subjects enrolled and treated in the prospective, multi-center DETOUR study at the Pauls Stradins clinical university hospital, Riga, Latvia. In total, 52 consecutive patients (54 procedures) were enrolled in this study from 2015 until 2019. We performed Venous Clinical Severity Score (VCSS) and Villalta (VS) score assessments, duplex ultrasound measuring femoral and popliteal vein diameters, venous occlusion plethysmography and digital photoplethysmography to assess and compare venous physiology at baseline and at follow-up visits every 6 months.

RESULTS: At baseline mean femoral vein diameter was 11.1mm (SD=1.5). At 36-months following intraluminal stent graft placement, mean femoral vein diameter was 11.1 mm (SD=1.7) with no evidence of enlargement of the femoral vein (p=0.2). Popliteal vein diameter was not significantly changed during 24-months of follow up (p=0.12) but showed a small (0.02mm) statistically significant decrease in diameter at 36-months compared to baseline. During the study period, only one patient (1.9%) developed clinically significant ipsilateral DVT 1-month after surgery. Clinically silent femoral venous thrombosis was documented in 8 legs during 36 month follow up. In one case the thrombus was occlusive and in 7 cases the thrombus was non-occlusive. At baseline, 48 of 52 patients (92%) had no or minor venous symptoms ((VCSS 0-2) with clinically significant venous symptoms in only 4 patients ((VCSS ≥3). At one-month follow-up, the venous clinical severity score increased in all patients compared to baseline. At 6-month follow up, the VCSS had returned to baseline in the majority of patients with no significant changes during the 3-year follow up period. At baseline, all patients had a Villalta score of 0-2 indicating minor or no venous symptoms (mean 0.4 (SD 0.7)). At the 1-month follow-up visit 3 patients (5.8%) had a VS ≥ 3 (two patients had a score of 3 and one patient a score of 4), indicating significant venous symptoms. At the 6-month visit and thereafter, all the VS in all patients had returned to baseline. Transvenous endovascular procedure did not significantly alter venous physiology in treated leg.

CONCLUSIONS: Percutaneous transvenous femoropopliteal bypass provided safe and effective lower-extremity revascularization with minimal effect on long-term venous function. The femoral and popliteal vein remained patent with no compensatory enlargement in response to the presence of the bypass graft within the femoral vein. During 3-year follow up there were no significant changes in venous symptom scores or physiologic function.

PMID:36194385 | DOI:10.23736/S0392-9590.22.04937-9

Clin Transl Oncol. 2022 Oct 4. doi: 10.1007/s12094-022-02963-z. Online ahead of print.

ABSTRACT

PURPOSE: Design and evaluate a knowledge-based model using commercially available artificial intelligence tools for automated treatment planning to efficiently generate clinically acceptable hippocampal avoidance prophylactic cranial irradiation (HA-PCI) plans in patients with small-cell lung cancer.

MATERIALS AND METHODS: Data from 44 patients with different grades of head flexion (range 45°) were used as the training datasets. A Rapid Plan knowledge-based planning (KB) routine was applied for a prescription of 25 Gy in 10 fractions using two volumetric modulated arc therapy (VMAT) arcs. The 9 plans used to validate the initial model were added to generate a second version of the RP model (Hippo-MARv2). Automated plans (AP) were compared with manual plans (MP) according to the dose-volume objectives of the PREMER trial. Optimization time and model quality were assessed using 10 patients who were not included in the first 44 datasets.

RESULTS: A 55% reduction in average optimization time was observed for AP compared to MP. (15 vs 33 min; p = 0.001).Statistically significant differences in favor of AP were found for D98% (22.6 vs 20.9 Gy), Homogeneity Index (17.6 vs 23.0) and Hippocampus D mean (11.0 vs 11.7 Gy). The AP met the proposed objectives without significant deviations, while in the case of the MP, significant deviations from the proposed target values were found in 2 cases.

CONCLUSION: The KB model allows automated planning for HA-PCI. Automation of radiotherapy planning improves efficiency, safety, and quality and could facilitate access to new techniques.

PMID:36194382 | DOI:10.1007/s12094-022-02963-z

Cardiovasc Drugs Ther. 2022 Oct 4. doi: 10.1007/s10557-022-07384-2. Online ahead of print.

ABSTRACT

PURPOSE: To study the effects of a perindopril-based regimen on cardiovascular (CV) outcomes in patients with vascular disease in relation to background statin therapy.

METHODS: A pooled analysis of the randomized ADVANCE, EUROPA, and PROGRESS trials was performed to evaluate CV outcomes in 29,463 patients with vascular disease treated with perindopril-based regimens versus placebo. The primary endpoint was a composite of CV mortality, nonfatal myocardial infarction, and stroke. Multivariable Cox regression analyses were performed to assess the effects of a perindopril-based regimen versus placebo in relation to statin use.

RESULTS: At randomization, 39.5% of the overall combined study population used statins. After a mean follow-up of 4.0 years (SD 1.0), the cumulative event-free survival was highest in the statin/perindopril group and lowest in the no statin/placebo group (91.2% vs. 85.6%, respectively, log-rank p < 0.001). In statin users (adjusted hazard ratio [aHR] 0.87, 95% confidence interval [CI] 0.77-0.98) and non-statin users (aHR 0.80, 95% CI 0.74-0.87), a perindopril-based regimen was associated with a significantly lower risk of the primary endpoint when compared to placebo. The additional treatment effect appeared numerically greater in non-statin users, but the observed difference was statistically nonsignificant.

CONCLUSION: Our data suggest that the treatment benefits of a perindopril-based regimen in patients with vascular disease are independent of statin use.

PMID:36194352 | DOI:10.1007/s10557-022-07384-2

World J Urol. 2022 Oct 4. doi: 10.1007/s00345-022-04174-1. Online ahead of print.

ABSTRACT

PURPOSE: To evaluate the risk of urinary incontinence (UI) after various prostate enucleation procedures (PEP).

METHODS: PubMed was searched from January 2000 to July 2021 for studies investigating UI after PEP. The articles were divided into 5 subgroups: holmium, thulium, greenlight laser, electrocautery, and simple prostatectomy. Meta-analysis was performed to examine rate of stress (SUI), urge (UUI) or unspecified UI at short (< 3 months), intermediate (3-6 months), and long-term (> 6 months). The impact of age, prostate size, surgery time, laser time, postoperative nadir PSA level and technical modifications on UI was analyzed.

RESULTS: Most (69.4%) of 49 articles included employed holmium laser. There was no significant difference in incidence of short-, intermediate-, and long-term UI, SUI and UUI between five sub-groups and within different technical modifications. Although not statistically significant, the incidence of UI was higher (15%) at short-term with green-light and simple prostatectomy (95% CI 9-23 and 1-84), and higher (4%) at intermediate-term with holmium laser (95% CI 2-8). SUI was more prevalent at short-term with holmium laser (4%; 95% CI 2-5%), and at intermediate term with simple prostatectomy (3%; 95% CI 1-14). UUI was higher in the thulium group (10%, 95% CI 7-16). Increased age, surgery time, laser time and prostate size up to 80 cc were associated with higher UI. There was no correlation between postoperative PSA and UI.

CONCLUSIONS: There is no significant difference in incidence of UI, SUI and UUI after various PEP. Patients age, prostate size, surgery and laser time are linearly associated with UI.

PMID:36194286 | DOI:10.1007/s00345-022-04174-1

World J Urol. 2022 Oct 4. doi: 10.1007/s00345-022-04175-0. Online ahead of print.

ABSTRACT

PURPOSE: Preserved sexual function is one of the endpoints of the surgical management of lower urinary tract symptoms suggestive of benign prostatic hyperplasia. Our aim was to investigate the evolution of erectile function (EF) at 3 and 12 months after holmium laser enucleation of the prostate (HoLEP).

METHODS: A multicentric retrospective study was performed including 235 sexually active patients who underwent HoLEP between January 2016 and June 2017. Evaluation of EF was carried out with the five-item version of the International Index of Erectile Function (IIEF-5) completed before surgery and at 3 and 12 months after surgery. A change of more than five points in either direction in the IIEF-5 score compared to baseline was considered as an improvement or impairment of EF.

RESULTS: No significant differences were found between median pre-operative IIEF-5 and median scores at 3 and 12 months (p = 0.15 and p = 0.45). At 3 and 12 post-operative months, respectively, 10% and 13% of patients reported an improvement, whereas 15% and 16% reported an impairment. The reduction in IIEF-5 score was only statistically significant within the sub-group of patients with normal pre-operative EF (p < 0.001). In this sub-group, 15% of patients reported a decrease of more than five points in total IIEF-5 score.

CONCLUSION: This multicentric evaluation confirmed that median IIEF-5 score was not significantly impaired after HoLEP. However, for patients with normal pre-operative EF, a significant decrease in EF after HoLEP was observed. These results may be taken into account when counselling patients before HoLEP.

PMID:36194285 | DOI:10.1007/s00345-022-04175-0

Int Orthop. 2022 Oct 3. doi: 10.1007/s00264-022-05586-9. Online ahead of print.

ABSTRACT

PURPOSE: The objective is to analyse peri-operative blood loss (BL) and hidden blood loss (HBL) rates in spinal deformity complex cases surgery, with a focus on the strategies to prevent major bleeding.

METHODS: We retrospectively analysed surgical and anaesthesiologic data of patients who had been operated for adolescent idiopathic scoliosis (AIS) or adult spinal deformities (ASD) with a minimum of five levels fused. A statistical comparison among AIS, ASD without a pedicle subtraction osteotomy (PSO) (ASD-PSO( -)) and ASD with PSO (ASD-PSO( +)) procedures was performed with a view to identifying patient- and/or surgical-related factors affecting peri-operative BL and HBL.

RESULTS: One-hundred patients were included with a mean 9.9 ± 2.8 fused vertebrae and a mean 264.2 ± 68.3 minutes operative time (OT) (28.3 ± 9 min per level). The mean perioperative BL was 641.2 ± 313.8 ml (68.9 ± 39.5 ml per level) and the mean HBL was 556.6 ± 381.8 ml (60.6 ± 42.8 ml per level), with the latter accounting for 51.5% of the estimated blood loss (EBL). On multivariate regression analysis, a longer OT (p < 0.05; OR 3.38) and performing a PSO (p < 0.05; OR 3.37) were related to higher peri-operative BL, while older age (p < 0.05; OR 2.48) and higher BMI (p < 0.05; OR 2.15) were associated to a more significant post-operative HBL.

CONCLUSION: With the correct use of modern technologies and patient management, BL in major spinal deformity surgery can be dramatically reduced. Nevertheless, it should be kept in mind that 50% of patients estimated losses are hidden and not directly controllable. Knowing the per-level BL allows anticipating global losses and, possibly, the need of allogenic transfusions.

PMID:36194284 | DOI:10.1007/s00264-022-05586-9