Tag: statistics

Fetal Diagn Ther. 2022 Mar 10. doi: 10.1159/000523996. Online ahead of print.

ABSTRACT

INTRODUCTION: Cervical length is an important predictor of spontaneous preterm birth. So far, the best way to measure cervical length has not been established. We aimed to compare the incidence of short cervical length between three methods of cervical length measurement with and without inclusion of cervico-isthmic complex (CIC) (six methods in total) and to determine the positive predictive value for spontaneous preterm birth.

MATERIAL AND METHODS: We performed a prospective single center cohort study in women with a singleton pregnancy between August 2014 and December 2018. During the routine fetal anomaly scan (18-22 weeks), women were offered transvaginal ultrasound for cervical length measurement to screen for the risk of spontaneous preterm birth. Each cervix was measured in six different ways: single-line, two-line and tracing method between the internal and external os of the cervix with and without CIC. We evaluated the predictive value of the different measurements for spontaneous delivery before 37 weeks using positive predictive values.

RESULTS: Our final study population comprised 1,691 women. The overall rate of preterm birth < 37 weeks was 8.0% (4.6% spontaneous, 3.4% iatrogenic preterm birth). The mean gestational age was 19+6 weeks. The different techniques resulted in significant different cervical lengths, showing a maximum difference of > 8 mm between the techniques (41.04 mm (SD 7.1) with one-line without CIC and 49.18 (SD 9.05) mm with trace with CIC) with an incidence of short cervical length below < 25mm ranging from 0.4 to 1.1% (P=0.18). The positive predictive values for spontaneous preterm birth < 37 weeks ranged from 42.9 to 20.0% .

CONCLUSION: Different measurement methods for cervical length resulted in statistically significant differences in measured cervical length. Depending on the chosen cut-off this translates to different incidences of short cervical length, and influences the number of women designated as high risk for preterm birth and receiving treatment. For interpretation and comparability between (inter-)national studies, it is important to adequately report on the employed technique.

PMID:35272290 | DOI:10.1159/000523996

Int J Pediatr Otorhinolaryngol. 2022 Mar 4;156:111093. doi: 10.1016/j.ijporl.2022.111093. Online ahead of print.

ABSTRACT

OBJECTIVE: Intracranial complications of sinusitis and acute otitis media (AOM) are rare but life-threatening events. In children with suppurative intracranial complications, concurrent neurosurgical and otolaryngological (ORL) intervention has been recommended to optimize outcomes. The aim of this study was to investigate outcomes following concurrent neurosurgical and ORL intervention.

METHODS: A retrospective cohort study of children undergoing neurosurgical intervention for intracranial complications of sinusitis or AOM in two neurosurgical centres in Ireland was conducted.

RESULTS: 65 children were identified. Mean age was 11.9 years. The most prevalent symptoms were headache, pyrexia, altered level of consciousness, facial swelling, and vomiting. Subdural empyema (n = 24, 36.9%) and extradural abscess (n = 17, 26.2%) were the most common complications. 54 underwent same admission ORL intervention; 47 (87%) were performed concurrently or earlier. For rhinogenic infections, 35 (64.8%) underwent endoscopic sinus surgery (ESS), 13 (24.1%) underwent frontal sinus trephine, and 5 (9.3%) underwent maxillary sinus washout alone. For otogenic infections, 10 (90.9%) underwent mastoidectomy and 7 (63.6%) underwent tympanostomy tube placement. 19 (29.2%) had post-operative neurological deficits, of which 2 (3.1%) were permanent. Streptococcus intermedius was the most common pathogen (n = 30, 46.2%). Concurrent intervention reduced the prevalence of residual collection (p = 0.018) and the need for revision neurosurgical intervention (p = 0.039) for sinogenic complications. The same trends did not achieve statistical significance for the otogenic group. Mortality was 0%.

CONCLUSION: Intracranial complications of sinusitis and AOM are best managed in a specialist centre with multidisciplinary input. Concurrent ORL and neurosurgical intervention reduces abscess recurrence and requirement for revision neurosurgery in sinogenic complications and should represent the standard of care. ESS is the ORL modality of choice in experienced hands.

PMID:35272257 | DOI:10.1016/j.ijporl.2022.111093

Complement Ther Clin Pract. 2022 Mar 5;47:101571. doi: 10.1016/j.ctcp.2022.101571. Online ahead of print.

ABSTRACT

AIM: To investigate the effectiveness of dry-needling(DN) together with exercise therapy on pain, ultrasonographic parameters of myofascial trigger points(MTrPs), and upper trapezius(UT) muscles, and neck disability in patients with myofascial pain syndrome.

MATERIAL AND METHODS: This was a single-blind, prospective, randomized, and controlled trial. Participants aged 18-45 years with persistent neck pain for >3 months caused by the active MTrPs in the UT muscles were included. The exercise therapy was performed 3 times/week for 3 months. DN therapy was applied once a week, for a total of three sessions. The pain intensity, ultrasonographic measurements of the thickness of the UT muscle, and diameter of the MTrPs in the UT muscle were the primary outcomes. The secondary outcome was the neck disability.

RESULTS: Seventy participants were randomized into two groups: the dry-needling together with exercise group(DNG, n = 35) and the exercise-only group(EG, n = 35). A total of 8 participants dropped out of the study, and the study was completed with 62 participants(DNG = 33; EG = 29). There was a significant difference in terms of VAS(at night, at rest, and during activity)(p < 0.001) at post-treatment and after 3 months, the thickness of UT muscle(p = 0.004), and diameter of MTrP(p = 0.021) at post-treatment between the groups. No statistical differences were identified in terms of NDI(p = 0.065).

CONCLUSION: This study demonstrated the effects of DN applied together with exercise therapy on reduction of the pain intensity at short(post-treatment) and mid-term(after 3 months), and the ultrasonographic parameters of MTrPs and UT muscles at short-term(post-treatment).

PMID:35272249 | DOI:10.1016/j.ctcp.2022.101571

Anat Sci Educ. 2022 Mar 10. doi: 10.1002/ase.2177. Online ahead of print.

ABSTRACT

Health concerns during the Covid-19 pandemic required the adaptation of a lecture-laboratory course in ultrasound imaging for graduate students from an in-person to a live, remote learning format. The adaptation of in-person lectures to live, remote delivery was achieved by using videoconferencing. The adaptation of in-person laboratory sessions to live, remote instruction was achieved in the first half of the course by providing a hand-held ultrasound instrument to each student who performed self-scanning at their remote locations, while the instructor provided live instruction using videoconferencing. In the second half of the course, the students transitioned to using cart-based, hospital-type instruments and self-scanning in the ultrasound laboratory on campus. The aim of this study was to measure the success of this adaptation to the course by comparing assessment scores of students in the live, remote course with assessment scores of students in the in-person course offered in the previous year. There were no statistically significant differences in the assessment scores of students in the two courses. The adaptation of a course in ultrasound imaging from an in-person to a live, remote learning format during the Covid-19 pandemic described here suggests that contrary to the prevailing view, ultrasound imaging can be taught to students without in-person instruction. The adapted course can serve as a model for teaching ultrasound where instructors and learners are physically separated by constraints other than health concerns during a pandemic.

PMID:35271761 | DOI:10.1002/ase.2177

Med Phys. 2022 Mar 10. doi: 10.1002/mp.15596. Online ahead of print.

ABSTRACT

PURPOSE: A novel phantom-imaging platform, a set of software tools, for automated and high precision imaging of the American College of Radiology (ACR) PET phantom for PET/MR and PET/CT systems is proposed.

METHODS: The key feature of this platform is the vector graphics design which facilitates the automated measurement of the knife-edge response function and hence image resolution, using composite volume of interest (VOI) templates in a 0.5 mm resolution grid applied to all inserts of the phantom. Furthermore, the proposed platform enables the generation of an accurate μ-map for PET/MR systems with a robust alignment based on two-stage image registration using specifically designed PET templates. The proposed platform is based on the open-source NiftyPET software package used to generate multiple list-mode data bootstrap realisations and image reconstructions to determine the precision of the two-stage registration and any image-derived statistics. For all the analyses, iterative image reconstruction was employed with and without modelled shift-invariant point spread function (PSF) and with varying iterations of the ordered subsets expectation maximisation (OSEM) algorithm. The impact of the activity outside the field of view (FOV) was assessed using two acquisitions of 30 minutes each, with and without the activity outside the FOV.

RESULTS: The utility of the platform has been demonstrated by providing a standard and an advanced phantom analysis including the estimation of spatial resolution using all cylindrical inserts. In the imaging planes close to the edge of the axial FOV, we observed deterioration in the quantitative accuracy, reduced resolution (FWHM increased by 1 – 2 mm), reduced contrast and background uniformity due to the activity outside the FOV. Although it slows convergence, the PSF reconstruction had a positive impact on resolution and contrast recovery, but the degree of improvement depended on the regions. The uncertainty analysis based on bootstrap resampling of raw PET data indicated high precision of the two-stage registration.

CONCLUSIONS: We demonstrated that phantom imaging using the proposed methodology with the metric of spatial resolution and multiple bootstrap realisations may be helpful in more accurate evaluation of PET systems as well as in facilitating fine tuning for optimal imaging parameters in PET/MR and PET/CT clinical research studies. This article is protected by copyright. All rights reserved.

PMID:35271742 | DOI:10.1002/mp.15596

Clin Pharmacol Ther. 2022 Mar 10. doi: 10.1002/cpt.2578. Online ahead of print.

ABSTRACT

Asthma is a chronic disease of the lungs characterized by airway inflammation, bronchoconstriction, and increased airway responsiveness. Forced Expiratory Volume in the first second (FEV1) is used as a measure of lung function and to help diagnose and monitor lung diseases including asthma. An exponential longitudinal model has been previously developed to adequately describe the FEV1 response in asthma patients with placebo. This model was the basis of a longitudinal model-based meta-analysis which was undertaken to describe the trough FEV1 responses ranging up to 1 year from nine clinical studies in asthma population (N=3896), following placebo, dual (Fluticasone Furoate/Vilanterol) and triple combinations (Fluticasone Furoate/ Umeclidinium /Vilanterol) given via inhalation. Numerical, graphical and simulation-based diagnostics showed that a Weibull model adequately characterized the longitudinal trough FEV1 response with time. Automatic covariate selection supported by statistically based regression models identified a range of patient characteristics influencing the model parameters. Race was a significant covariate on baseline but not on the parameters that impact the FEV1 trajectory. Based on the trough FEV1, all active treatments were found to be significantly different when compared to placebo and showed clinically meaningful improvement in FEV1. The model was able to predict the longitudinal FEV1 response in Chinese patients with inadequately controlled asthma and was used to provide additional support with respect to the design for a shorter duration Phase 3 study to China National Medical Products Administration (NMPA).

PMID:35271735 | DOI:10.1002/cpt.2578

Arch Pathol Lab Med. 2022 Mar 10. doi: 10.5858/arpa.2021-0223-CP. Online ahead of print.

ABSTRACT

CONTEXT.—: The College of American Pathologists (CAP) updated the Laboratory Accreditation Program Cytopathology Checklist to assist laboratories in meeting and exceeding the Clinical Laboratory Improvement Amendments standards for gynecologic cytologic-histologic correlation (CHC).

OBJECTIVE.—: To survey the current CHC practices.

DESIGN.—: Data were analyzed from a survey developed by the committee and distributed to participants in the CAP Gynecologic Cytopathology PAP Education Program mailing.

RESULTS.—: Worldwide, CHC practice is nearly universally adopted, with an overall rate of 87.0% (568 of 653). CHC material was highly accessible. CHC was commonly performed real time/concurrently at the time the corresponding surgical pathology was reviewed. Investigation of CHC discordances varied with North American laboratories usually having a single pathologist review all discrepant histology and cytology slides to determine the reason for discordance, while international laboratories have a second pathologist review histology slides to determine the reason for discordance. The cause of CHC discordance was primarily sampling issues. The more common statistical metrics for CHC monitoring were the total percentage of cases that correlated with subsequent biopsies, screening error rate by cytotechnologist, and interpretative error rate by cytotechnologist.

CONCLUSIONS.—: Many laboratories have adopted and implemented the CHC guidelines with identifiable differences in practices between North American and international laboratories. We identify the commonalities and differences between North American and international institutional practices including where CHC is performed, how CHC cases are identified and their accessibility, when CHC is performed, who investigates discordances, what discordances are identified, and how the findings affect quality improvement.

PMID:35271691 | DOI:10.5858/arpa.2021-0223-CP

J Am Med Inform Assoc. 2022 Mar 10:ocac034. doi: 10.1093/jamia/ocac034. Online ahead of print.

ABSTRACT

OBJECTIVE: Clinicians spend significant time working in the electronic health record (EHR). The US is an outlier in EHR time, suggesting that EHR-related work may be driven in part by the legal environment and threat of malpractice. To assess this, we evaluate the association between state-level malpractice climate and clinician time spent in the EHR.

MATERIALS AND METHODS: We use EHR metadata from 351 ambulatory care health systems in the United States using Epic from January-August 2019 combined with state-level data on malpractice incidence and payouts. We used descriptive statistics to measure variation in clinician EHR time, including total EHR time, documentation time per day, and after-hours EHR time per day. Multi-variable regression evaluated the association between clinicians in high malpractice states and EHR use.

RESULTS: We found no association between location in a state in the top-quartile of malpractice payouts and time spent in the EHR per day, time spent in the EHR outside of scheduled hours, or time spent documenting per day, except for a subgroup of the clinicians in the highest malpractice specialties, where there was a small increase in EHR time per day (B = 6.08 min, P < 0.001) and time spent documenting notes (B = 2.77 min, P < 0.001).

DISCUSSION: State-level differences in malpractice incidence are unlikely to be a significant driver of EHR work for most clinicians.

CONCLUSION: Policymakers seeking to address EHR documentation burden should examine burden driven by other socio-technical demands on clinician time, such as billing or quality measurement.

PMID:35271723 | DOI:10.1093/jamia/ocac034

PLoS One. 2022 Mar 10;17(3):e0265063. doi: 10.1371/journal.pone.0265063. eCollection 2022.

ABSTRACT

BACKGROUND: Considering perinatal transmission and the high rate of chronic hepatitis B virus (HBV) infection in infants, diagnosis of HBV infection during pregnancy and timely interventions are of great importance. Therefore, this study was performed to investigate the prevalence and genotype distribution of HBV infection and the associated risk factors among pregnant women in the northern shores of the Persian Gulf, South of Iran.

METHODS: Serum samples of 1425 pregnant women were tested for the presence of HBsAg and HBcAb by ELISA (HBsAg one-Version ULTRA and HBc Ab ELISA kits, DIA.PRO, Milan, Italy). The seropositive samples were tested for the presence of HBV DNA by nested PCR, targeting S, X, pre-core (pre-C), and basal core promoter (BCP) regions of the HBV genome. The amplified fragments were sequenced by Sanger dideoxy sequencing technology to evaluate the genotype distribution and mutations of HBV infection by using the MEGA 7 software. The HBV seropositive pregnant women were tested for HCV and HIV coinfections by ELISA (HCV Ab and HIV Ab/Ag ELISA kits, DIA.PRO, Milan, Italy).

RESULTS: Of 1425 participants, 15 pregnant women (1.05%, 95% CI: 0.64%-1.73%) were positive for HBsAg, 41 women (2.88%, 95% CI: 2.10%-3.88%) were positive for HBcAb, and 5 women (0.35%, 95% CI: 0.15% -0.82%) had HBV viremia with genotype D, sub-genotype D3 and subtype ayw2. One of the viremic samples was positive for HBcAb but negative for HBsAg, which is indicative of an occult HBV infection. HBsAg seroprevalence was higher among pregnant women aged 20 to 29 years, women in the third trimester of pregnancy, residents of Khormuj city, Afghan immigrants, illiterate women, and pregnant women with a history of tattoo and HBV vaccination. The highest rate of HBcAb seroprevalence was observed in residents of Borazjan city, Turk ethnicity, the age group >39 years, and those women with more parities and a history of abortion. Nevertheless, HBV seroprevalence among pregnant women was not statistically associated with these variables. In contrast, HBcAb seropositivity was significantly associated with the history of tattoo (P = 0.018). According to mutations analyses, seven amino acid substitutions in the HBsAg, one point mutation in the pre-C region, and five points mutations in the BCP region were detected. Besides, the BCP mutations caused amino acid substitutions in the X protein. Of note, the conversion of Ala → Val at amino acid 168 (A168V) and Thr → Pro at amino acid 127 (T127P) were detected in HBsAg of the occult HBV strain.

CONCLUSION: These results indicate a relatively low prevalence of HBV infection among pregnant women in the South of Iran, while tattooing is a risk factor for exposure to HBV infection. Moreover, all of the HBV-positive pregnant women were asymptomatic and unaware of their infection. Therefore, routine screening for HBV markers during pregnancy, appropriate treatment of HBV-infected women, and HBV vaccination are recommended to decrease mother-to-child transmission of HBV.

PMID:35271684 | DOI:10.1371/journal.pone.0265063