Category: Statistics

Arch Orthop Trauma Surg. 2021 Aug 17. doi: 10.1007/s00402-021-04120-7. Online ahead of print.

ABSTRACT

INTRODUCTION: Complex orthopaedic procedures, such as iliosacral screw (ISS) fixations, can take advantage of surgical navigation technology to achieve accurate results. Although the impact of surgical navigation on outcomes has been studied, no studies to date have quantified how the design of the targeting display used for navigation affects ISS targeting performance. However, it is known in other contexts that how task information is displayed can have significant effects on both accuracy and time required to perform motor tasks, and that this can be different among users with different experience levels. This study aimed to investigate which visualization techniques helped experienced surgeons and inexperienced users most efficiently and accurately align a surgical tool to a target axis.

METHODS: We recruited 21 participants and conducted a user study to investigate five proposed 2D visualizations (bullseye, rotated bullseye, target-fixed, tool-fixed in translation, and tool-fixed in translation and rotation) with varying representations of the ISS targets and tool, and one 3D visualization. We measured the targeting accuracy achieved by each participant, as well as the time required to perform the task using each of the visualizations.

RESULTS: We found that all 2D visualizations had equivalent translational and rotational errors, with mean translational errors below 0.9 mm and rotational errors below 1.1[Formula: see text]. The 3D visualization had statistically greater mean translational and rotational errors (4.29 mm and 5.47[Formula: see text], p < 0.001) across all users. We also found that the 2D bullseye view allowed users to complete the simulated task most efficiently (mean 30.2 s; 95% CI 26.4-35.7 s), even when combined with other visualizations.

CONCLUSIONS: Our results show that 2D bullseye views helped both experienced orthopaedic trauma surgeons and inexperienced users target iliosacral screws accurately and efficiently. These findings could inform the design of visualizations for use in a surgical navigation system for screw insertions for both training and surgical practice.

PMID:34402930 | DOI:10.1007/s00402-021-04120-7

Abdom Radiol (NY). 2021 Aug 17. doi: 10.1007/s00261-021-03224-3. Online ahead of print.

ABSTRACT

PURPOSE: To compare the diagnostic performance of ¹⁸F-fluorodeoxyglucose-PET/MRI and MRI in the diagnosis of pelvic recurrence of rectal cancer.

METHODS: All PET/MRIs of patients in the follow-up of rectal cancer performed between 2011 and 2018 at our institution were retrospectively reviewed. Recurrence was confirmed/excluded either by histopathology or imaging follow-up (> 4 months). Four groups of readers (groups 1/2: one radiologist each, groups 3/4: one radiologist/one nuclear medicine physician) independently interpreted MRI and PET/MRI. The likelihood of recurrence was scored on a 5-point-scale. Inter-reader agreement, sensitivity, specificity, PPV/NPV and accuracy were assessed. ROC curve analyses were performed.

RESULTS: Fourty-one PET/MRIs of 40 patients (mean 61 years ± 10.9; 11 women, 29 men) were included. Sensitivity of PET/MRI in detecting recurrence was 94%, specificity 88%, PPV/NPV 97% and 78%, accuracy 93%. Sensitivity of MRI was 88%, specificity 75%, PPV/NPV 94% and 60%, accuracy 85%. ROC curve analyses showed an AUC of 0.97 for PET/MRI and 0.92 for MRI, but the difference was not statistically significant (p = 0.116). On MRI more cases were scored as equivocal (12% versus 5%). Inter-reader agreement was substantial for PET/MRI and MRI (0.723 and 0.656, respectively).

CONCLUSION: ¹⁸F-FDG-PET/MRI and MRI are accurate in the diagnosis of locally recurrent rectal cancer. Sensitivity, specificity, PPV, NPV and accuracy are comparable for both modalities, but PET/MRI increases readers’ confidence levels and reduces the number of equivocal cases.

PMID:34402948 | DOI:10.1007/s00261-021-03224-3

Arch Orthop Trauma Surg. 2021 Aug 17. doi: 10.1007/s00402-021-04100-x. Online ahead of print.

ABSTRACT

INTRODUCTION: High tibial osteotomy (HTO) is a valid and joint preserving surgical technique to treat medial degenerative osteoarthritis (OA) in young and active patients. A recent study shows that patients’ expectations of osteotomy around the knee are high, but OA progression and potential conversion to a total knee arthroplasty (TKA) were underestimated. The aim of this study was to investigate surgeons’ expectations of HTO and to compare the results to the patients’ expectations and actual outcomes reported in the literature.

METHODS: 461 surgeons were questioned online using the ‘Hospital for Special Surgery Knee Surgery Expectations Survey (HFSS-KSES)’ and a ten-item non-validated questionnaire to investigate the expectations of HTO. Two subgroups were formed to investigate differences regarding the surgeons’ experience. Statistical analysis was performed using IBM SPSS Statistics.

RESULTS: Surgeons’ expectations of HTO were rated between very and little important with pain reduction being the most important item on the HFSS-KSES. Furthermore, ‘improving the ability to walk’, ‘to perform daily activities’, ‘having confidence in the knee’, and ‘avoiding future degeneration’ were rated of high importance. An important difference regarding the experience was the lower expectations on delay/prevention of TKA of less-experienced surgeons.

CONCLUSION: Surgeons’ expectations of HTO are high but nevertheless different to the patients’ expectations reported in the literature. Also, expectations for the delay/prevention of TKA differed regarding the experience of surgeons. While pain reduction represents one of the most important items for surgeons and patients, the expected outcome regarding the delay/prevention of a TKA and returning to sports differs to the patients’ expectations and to the actual outcome reported in the literature. This should be considered when performing the preoperative informed consent.

PMID:34402929 | DOI:10.1007/s00402-021-04100-x

Clin Res Cardiol. 2021 Aug 17. doi: 10.1007/s00392-021-01920-0. Online ahead of print.

ABSTRACT

Heart transplantation (HTx) is a valid therapeutic option for end-stage heart failure secondary to cardiac sarcoidosis (CS) or giant-cell myocarditis (GCM). However, post-HTx outcomes in patients with inflammatory cardiomyopathy (ICM) have been poorly investigated. We searched PubMed, Scopus, Science Citation Index, EMBASE, and Google Scholar, screened the gray literature, and contacted experts in the field. We included studies comparing post-HTx survival, acute cellular rejection, and disease recurrence in patients with and without ICM. Data were synthesized by a random-effects meta-analysis. We screened 11,933 articles, of which 14 were considered eligible. In a pooled analysis, post-HTx survival was higher in CS than non-CS patients after 1 year (risk ratio [RR] 0.88, 95% confidence interval [CI] 0.60-1.17; I² = 0%) and 5 years (RR 0.72, 95% CI 0.52-0.91; I² = 0%), but statistically significant only after 5 years. During the first-year post-HTx, the risk of acute cellular rejection was similar for patients with and without CS, but after 5 years, it was lower in those with CS (RR 0.38, 95% CI 0.03-0.72; I² = 0%). No difference in post-HTx survival was observed between patients with and without GCM after 1 year (RR 1.16, 95% CI 0.05-2.28; I² = 0%) or 5 years (RR 0.98, 95% CI 0.42-1.54; I² = 0%). During post-HTx follow-up, recurrence of CS and GCM occurred in 5% and 8% of patients, respectively. Post-HTx outcomes in patients with CS and GCM are comparable with cardiac recipients with other heart failure etiologies. Patients with ICM should not be disqualified from HTx.

PMID:34402927 | DOI:10.1007/s00392-021-01920-0

J Crohns Colitis. 2021 Aug 17:jjab133. doi: 10.1093/ecco-jcc/jjab133. Online ahead of print.

ABSTRACT

BACKGROUND AND AIMS: Report results from VISIBLE 2, a randomised, double-blind, placebo-controlled phase 3 trial evaluating a new subcutaneous [SC] vedolizumab formulation as maintenance treatment in adults with moderately to severely active Crohn’s disease [CD].

METHODS: Following open-label vedolizumab 300 mg intravenous induction therapy at Weeks 0 and 2, Week 6 clinical responders (≥70-point decrease in CD Activity Index [CDAI] score from baseline) were randomised 2:1 to receive double-blind maintenance vedolizumab 108 mg SC or placebo every 2 weeks until Week 50. Assessments at Week 52 included clinical remission [primary endpoint; CDAI≤150], enhanced clinical response [≥100-point decrease in CDAI from baseline], corticosteroid-free clinical remission among patients using a corticosteroid at baseline, clinical remission in anti-tumour necrosis factor [anti-TNF]-naïve patients, and safety.

RESULTS: Following vedolizumab intravenous induction, 275 patients were randomised to vedolizumab SC and 135 to placebo maintenance. At Week 52, 48.0% of patients receiving vedolizumab SC versus 34.3% receiving placebo were in clinical remission [p=0.008]. Enhanced clinical response at Week 52 was achieved by 52.0% versus 44.8% of patients receiving vedolizumab SC versus placebo, respectively [p=0.167]. At Week 52, 45.3% and 18.2% of patients receiving vedolizumab SC and placebo, respectively, were in corticosteroid-free clinical remission, and 48.6% of anti-TNF-naïve patients receiving vedolizumab SC and 42.9% receiving placebo were in clinical remission. Injection site reaction was the only new safety finding observed for vedolizumab SC [2.9%].

CONCLUSIONS: Vedolizumab SC is an effective and safe maintenance therapy in patients with CD who responded to two infusions of vedolizumab intravenous induction therapy.

PMID:34402887 | DOI:10.1093/ecco-jcc/jjab133

J Orofac Orthop. 2021 Aug 17. doi: 10.1007/s00056-021-00340-z. Online ahead of print.

ABSTRACT

PURPOSE: The goal of this study was to compare the shear bond strength (SBS) and failure modes of three different adhesive resins following the use of two different dental curing light units.

METHODS: A total of 160 human premolars were randomly divided into four groups (N = 40 for each): group 1, Transbond™ XT (3M Unitek, Monrovia, CA, USA) adhesive paste; group 2, Heliosit Orthodontic paste with no primer; group 3, Maxcem Elite (Kerr, Orange, CA, USA) self-adhesive resin with prior etching; group 4, Maxcem Elite self-adhesive resin with no etching. Each group was further divided into 2 subgroups: half (named “a”) were cured with VALO LED (Ultradent Products, South Jordan, UT, USA), and the other half (named “b”) with the Elipar LED unit (3M Unitek LED, Monrovia, CA, USA). The brackets were submitted to SBS testing 24 h after bonding. Adhesive Remnant Index (ARI) scores and bonding time were also measured. Two-way analysis of variance (ANOVA) and Kruskal-Wallis tests were used for statistical analysis.

RESULTS: No significant differences in SBS were observed when comparing the two different LED devices within the same bonding material. The mean SBS of group 1 was significantly higher compared to groups 2, 3, and 4 (p < 0.001). Mean SBS values of groups 2 and 3 were significantly higher than that of group 4 (p < 0.001). ARI scores were significantly different in groups 4a and 4b compared to the other groups (p < 0.05). Group 4a showed significantly lower bonding time/tooth compared to the other groups except to groups 3a and 4b (p < 0.001).

CONCLUSIONS: Decreasing curing time using high-power LED device did not significantly affect SBS. However, the composite type did affect SBS.

PMID:34402921 | DOI:10.1007/s00056-021-00340-z

Brief Bioinform. 2021 Aug 17:bbab326. doi: 10.1093/bib/bbab326. Online ahead of print.

ABSTRACT

Genotype imputation is a statistical method for estimating missing genotypes from a denser haplotype reference panel. Existing methods usually performed well on common variants, but they may not be ideal for low-frequency and rare variants. Previous studies showed that the population similarity between study and reference panels is one of the key factors influencing the imputation accuracy. Here, we developed an imputation reference panel reconstruction method (RefRGim) using convolutional neural networks (CNNs), which can generate a study-specified reference panel for each input data based on the genetic similarity of individuals from current study and references. The CNNs were pretrained with single nucleotide polymorphism data from the 1000 Genomes Project. Our evaluations showed that genotype imputation with RefRGim can achieve higher accuracies than original reference panel, especially for low-frequency and rare variants. RefRGim will serve as an efficient reference panel reconstruction method for genotype imputation. RefRGim is freely available via GitHub: https://github.com/shishuo16/RefRGim.

PMID:34402866 | DOI:10.1093/bib/bbab326

Arch Pathol Lab Med. 2021 Aug 17. doi: 10.5858/arpa.2020-0686-OA. Online ahead of print.

ABSTRACT

CONTEXT.—: Intraoperative consultation-frozen section diagnosis (FSD)-determines tumor pathology and guides the optimal surgical management of ovarian neoplasms intraoperatively.

OBJECTIVE.—: To evaluate the diagnostic accuracy of the FSD and analyze the discrepancy between the FSD and final diagnosis.

DESIGN.—: This is a retrospective study of 618 ovarian neoplasm FSDs from 2009 to 2018 at a tertiary health care center. The discrepant cases were reviewed and reevaluated by gynecologic and general surgical pathologists. The outcomes of interest were performing unnecessary procedure, returning for a second surgery, and 30-day postoperative mortality.

RESULTS.—: The sensitivity and the positive predictive value of the FSD were lower in borderline tumors than in benign and malignant epithelial ovarian tumors. Major and minor discrepancies were identified in 5.3% (33 of 618) and 12.3% of (76 of 618) cases, respectively. A root cause analysis of the major discrepant cases showed that sampling error accounted for 43% (14 of 33). The discrepancy distributions of gynecologic and general surgical pathologists were statistically similar in the overall cohort (P = .65). The overall κ for diagnostic agreement among gynecologic pathologists, general surgical pathologists, and final diagnosis was 0.18 (0.10-0.26, P < .001), implying only a slight overall agreement. Of the major discrepant cases, only 3 had a clinical implication. One overdiagnosed patient underwent unnecessary procedure and 2 underdiagnosed patients were recommended to return for a second surgery. No patient had 30-day postoperative mortality.

CONCLUSIONS.—: Frozen section diagnosis remains a definitive diagnostic tool in ovarian neoplasms and plays a crucial role in guiding intraoperative surgical management.

PMID:34402886 | DOI:10.5858/arpa.2020-0686-OA

JAMA. 2021 Aug 17;326(7):637-648. doi: 10.1001/jama.2021.9907.

ABSTRACT

IMPORTANCE: The elimination of racial and ethnic differences in health status and health care access is a US goal, but it is unclear whether the country has made progress over the last 2 decades.

OBJECTIVE: To determine 20-year trends in the racial and ethnic differences in self-reported measures of health status and health care access and affordability among adults in the US.

DESIGN, SETTING, AND PARTICIPANTS: Serial cross-sectional study of National Health Interview Survey data, 1999-2018, that included 596 355 adults.

EXPOSURES: Self-reported race, ethnicity, and income level.

MAIN OUTCOMES AND MEASURES: Rates and racial and ethnic differences in self-reported health status and health care access and affordability.

RESULTS: The study included 596 355 adults (mean [SE] age, 46.2 [0.07] years, 51.8% [SE, 0.10] women), of whom 4.7% were Asian, 11.8% were Black, 13.8% were Latino/Hispanic, and 69.7% were White. The estimated percentages of people with low income were 28.2%, 46.1%, 51.5%, and 23.9% among Asian, Black, Latino/Hispanic, and White individuals, respectively. Black individuals with low income had the highest estimated prevalence of poor or fair health status (29.1% [95% CI, 26.5%-31.7%] in 1999 and 24.9% [95% CI, 21.8%-28.3%] in 2018), while White individuals with middle and high income had the lowest (6.4% [95% CI, 5.9%-6.8%] in 1999 and 6.3% [95% CI, 5.8%-6.7%] in 2018). Black individuals had a significantly higher estimated prevalence of poor or fair health status than White individuals in 1999, regardless of income strata (P < .001 for the overall and low-income groups; P = .03 for middle and high-income group). From 1999 to 2018, racial and ethnic gaps in poor or fair health status did not change significantly, with or without income stratification, except for a significant decrease in the difference between White and Black individuals with low income (-6.7 percentage points [95% CI, -11.3 to -2.0]; P = .005); the difference in 2018 was no longer statistically significant (P = .13). Black and White individuals had the highest levels of self-reported functional limitations, which increased significantly among all groups over time. There were significant reductions in the racial and ethnic differences in some self-reported measures of health care access, but not affordability, with and without income stratification.

CONCLUSIONS AND RELEVANCE: In a serial cross-sectional survey study of US adults from 1999 to 2018, racial and ethnic differences in self-reported health status, access, and affordability improved in some subgroups, but largely persisted.

PMID:34402830 | DOI:10.1001/jama.2021.9907

JAMA. 2021 Aug 17;326(7):660-669. doi: 10.1001/jama.2021.7217.

ABSTRACT

IMPORTANCE: Gestational diabetes is associated with adverse maternal and offspring outcomes.

OBJECTIVE: To determine whether rates of gestational diabetes among individuals at first live birth changed from 2011 to 2019 and how these rates differ by race and ethnicity in the US.

DESIGN, SETTING, AND PARTICIPANTS: Serial cross-sectional analysis using National Center for Health Statistics data for 12 610 235 individuals aged 15 to 44 years with singleton first live births from 2011 to 2019 in the US.

EXPOSURES: Gestational diabetes data stratified by the following race and ethnicity groups: Hispanic/Latina (including Central and South American, Cuban, Mexican, and Puerto Rican); non-Hispanic Asian/Pacific Islander (including Asian Indian, Chinese, Filipina, Japanese, Korean, and Vietnamese); non-Hispanic Black; and non-Hispanic White.

MAIN OUTCOMES AND MEASURES: The primary outcomes were age-standardized rates of gestational diabetes (per 1000 live births) and respective mean annual percent change and rate ratios (RRs) of gestational diabetes in non-Hispanic Asian/Pacific Islander (overall and in subgroups), non-Hispanic Black, and Hispanic/Latina (overall and in subgroups) individuals relative to non-Hispanic White individuals (referent group).

RESULTS: Among the 12 610 235 included individuals (mean [SD] age, 26.3 [5.8] years), the overall age-standardized gestational diabetes rate significantly increased from 47.6 (95% CI, 47.1-48.0) to 63.5 (95% CI, 63.1-64.0) per 1000 live births from 2011 to 2019, a mean annual percent change of 3.7% (95% CI, 2.8%-4.6%) per year. Of the 12 610 235 participants, 21% were Hispanic/Latina (2019 gestational diabetes rate, 66.6 [95% CI, 65.6-67.7]; RR, 1.15 [95% CI, 1.13-1.18]), 8% were non-Hispanic Asian/Pacific Islander (2019 gestational diabetes rate, 102.7 [95% CI, 100.7-104.7]; RR, 1.78 [95% CI, 1.74-1.82]), 14% were non-Hispanic Black (2019 gestational diabetes rate, 55.7 [95% CI, 54.5-57.0]; RR, 0.97 [95% CI, 0.94-0.99]), and 56% were non-Hispanic White (2019 gestational diabetes rate, 57.7 [95% CI, 57.2-58.3]; referent group). Gestational diabetes rates were highest in Asian Indian participants (2019 gestational diabetes rate, 129.1 [95% CI, 100.7-104.7]; RR, 2.24 [95% CI, 2.15-2.33]). Among Hispanic/Latina participants, gestational diabetes rates were highest among Puerto Rican individuals (2019 gestational diabetes rate, 75.8 [95% CI, 71.8-79.9]; RR, 1.31 [95% CI, 1.24-1.39]). Gestational diabetes rates increased among all race and ethnicity subgroups and across all age groups.

CONCLUSIONS AND RELEVANCE: Among individuals with a singleton first live birth in the US from 2011 to 2019, rates of gestational diabetes increased across all racial and ethnic subgroups. Differences in absolute gestational diabetes rates were observed across race and ethnicity subgroups.

PMID:34402831 | DOI:10.1001/jama.2021.7217