Category: Statistics

Biom J. 2023 Jan 15:e2200102. doi: 10.1002/bimj.202200102. Online ahead of print.

ABSTRACT

When comparing the performance of two or more competing tests, simulation studies commonly focus on statistical power. However, if the size of the tests being compared are either different from one another or from the nominal size, comparing tests based on power alone may be misleading. By analogy with diagnostic accuracy studies, we introduce relative positive and negative likelihood ratios to factor in both power and size in the comparison of multiple tests. We derive sample size formulas for a comparative simulation study. As an example, we compared the performance of six statistical tests for small-study effects in meta-analyses of randomized controlled trials: Begg’s rank correlation, Egger’s regression, Schwarzer’s method for sparse data, the trim-and-fill method, the arcsine-Thompson test, and Lin and Chu’s combined test. We illustrate that comparing power alone, or power adjusted or penalized for size, can be misleading, and how the proposed likelihood ratio approach enables accurate comparison of the trade-off between power and size between competing tests.

PMID:36642800 | DOI:10.1002/bimj.202200102

J Genet Couns. 2023 Jan 15. doi: 10.1002/jgc4.1670. Online ahead of print.

ABSTRACT

A growing percentage of genetic counselors are employed in roles that do not involve direct patient care, commonly in commercial diagnostic laboratories. This study aimed to assess characteristics of laboratory and industry (LI) roles and perceptions of the genetic counseling community’s views towards such roles. Members of NSGC and ABGC were invited to participate in this study. Data analysis included descriptive and inferential statistics and select participant quotes are included to highlight key points identified by statistical analyses. Three hundred twenty-six genetic counselors who self-identified as currently or previously working within an LI role responded to the survey. Over 40% of participants reported feeling that they were not perceived positively by colleagues outside of LI settings, and 54% felt that GC colleagues in non-LI roles provided mostly negative commentary about LI GC roles. Over 90% of individuals felt that their employer was a factor in the way they were perceived by others and that this factor carried a bigger weight than job title, work setting, or even professional responsibilities. Qualitative responses from open-ended text questions suggest that while perceptions toward LI roles have improved over time, commentary regarding the “dark side” of genetic counseling persists. To promote the continued, unified growth of the genetic counseling profession and other healthcare professions, it is necessary to address this source of intra-professional conflict.

PMID:36642782 | DOI:10.1002/jgc4.1670

Drug Saf. 2023 Jan 16. doi: 10.1007/s40264-022-01267-z. Online ahead of print.

ABSTRACT

INTRODUCTION AND OBJECTIVE: Receipt of opioid agonist treatment during early and late pregnancy for opioid use disorder may relate to varying perinatal risks. We aimed to assess the effect of time-varying prenatal exposure to opioid agonist treatment using buprenorphine or methadone on adverse neonatal and pregnancy outcomes.

METHODS: We conducted a retrospective cohort study of pregnant women with opioid use disorder using Rhode Island Medicaid claims data and vital statistics during 2008-16. Time-varying exposure was evaluated in early (0-20 weeks) and late (≥ 21 weeks) pregnancy. Marginal structural models with inverse probability of treatment weighting were applied.

RESULTS: Of 400 eligible pregnancies, 85 and 137 individuals received buprenorphine and methadone, respectively, during early pregnancy. Compared with 152 untreated pregnancies with opioid use disorders, methadone exposure in both periods was associated with an increased risk of preterm birth (adjusted odds ratio [aOR]: 2.52; 95% confidence interval [CI] 1.07-5.95), low birth weight (aOR: 2.99; 95% CI 1.34-6.66), neonatal intensive care unit admission (aOR, 5.04; 95% CI 2.49-10.21), neonatal abstinence syndrome (aOR: 11.36; 95% CI 5.65-22.82), respiratory symptoms (aOR, 2.71; 95% CI 1.17-6.24), and maternal hospital stay > 7 days (aOR, 14.51; 95% CI 7.23-29.12). Similar patterns emerged for buprenorphine regarding neonatal abstinence syndrome (aOR: 10.27; 95% CI 4.91-21.47) and extended maternal hospital stay (aOR: 3.84; 95% CI 1.83-8.07). However, differences were found favoring the use of buprenorphine for preterm birth versus untreated pregnancies (aOR: 0.17; 95% CI 0.04-0.77), and for several outcomes versus methadone.

CONCLUSIONS: Methadone and buprenorphine prescribed for the treatment of opioid use disorder during pregnancy are associated with varying perinatal risks. However, buprenorphine may be preferred in the setting of pregnancy opioid agonist treatment. Further research is necessary to confirm our findings and minimize residual confounding.

PMID:36642778 | DOI:10.1007/s40264-022-01267-z

Environ Sci Pollut Res Int. 2023 Jan 16. doi: 10.1007/s11356-023-25175-6. Online ahead of print.

ABSTRACT

The energy green consumption revolution (EGCR) is the highest priority in the Chinese government’s energy revolution agenda. The purpose of this study is to provide a comprehensive and objective evaluation of the China’s EGCR progressing from 2011 to 2019. In this study, an integrated economic-social-energy-environmental EGCR evaluation framework is built, and the entropy-weighted TOPSIS method with four customized equations is used to calculate and analyze the EGCR index. The study finds that the EGCR index at the national level fluctuates between 0.290 and 0.302, showing a stagnant and regressive trend. At the regional and provincial levels, the EGCR index for eastern China remains at high level, floating above 0.4 and no further growing trend has been indicated. As for the eastern China, Beijing is the only city has high-level EGCR index and is able to maintain positive growth trend. The EGCR index in central, western, and northeastern China is at a low level, fluctuating below 0.4. This result is mainly caused by the fact that the majority of these regions are still constrained by the fossil fuel-dominated social, economy, energy, and environment structures. Therefore, the research findings not only provide supportive evidence for the Chinese government to recognize the progressing of EGCR, but also offer statistical basis over formulating and updating EGCR policies at a timely manner.

PMID:36642773 | DOI:10.1007/s11356-023-25175-6

Skeletal Radiol. 2023 Jan 16. doi: 10.1007/s00256-023-04281-z. Online ahead of print.

ABSTRACT

OBJECTIVE: The accessory sacroiliac joint (ASIJ) is the most common sacroiliac joint anatomical variant; however, its literature-reported prevalence is inconsistent. Previous CT-based studies of the ASIJ have used thick axial slices, which may not adequately detail ASIJ anatomy. The aims of this study are to (1) evaluate ASIJ prevalence and radiographic features in a large age- and sex-balanced cohort using thin-section CT and (2) determine associations between ASIJ anatomy, patient features, and treatment strategies.

MATERIALS AND METHODS: Thin-section CTs (0.75 to 2.00 mm) of the pelvis from 800 patients were reviewed by two musculoskeletal radiologists. Degree of degenerative change and ankylosis at ASIJs were detailed. The EMR was used to capture demographics, lower back or sacroiliac joint symptoms, and treatments.

RESULTS: The ASIJ was present in 25.8% of patients and bilateral in 53.3% of those with any ASIJ. ASIJs were more common at the S2 than S1 neural foramen level (75.7% and 27.2%). There was a statistically significant difference between age and presence of any ASIJ anatomy (mean (SD) 69.0 (19.8) with ASIJ versus 55.9 (22.1) years without ASIJ). Degenerative changes and ankylosis were found in 93.5% and 20.3% of ASIJs, respectively. There was a higher odds ratio of having received a sacroiliac joint corticosteroid injection in those with ASIJ anatomy.

CONCLUSION: Radiologists should be familiar with the ASIJ and consider its age-related association, propensity to show ASIJ degenerative change, and ability to serve as a potential pain generator. Steroid injections may be considered for diagnostic and therapeutic purposes.

PMID:36642769 | DOI:10.1007/s00256-023-04281-z

Int Orthop. 2023 Jan 16. doi: 10.1007/s00264-023-05687-z. Online ahead of print.

ABSTRACT

PURPOSE: The reason for graft failure after anterior cruciate ligament reconstruction (ACLR) is multifactorial. Controversies remain regarding the predominant factor and incidence of failure aetiology in the literature. This review aimed to provide a meta-analysis of the literature to evaluate the relative proportion of various failure modes among patients with ACLR failure.

METHODS: The PubMed, Embase, Cochrane Library, Web of Science, and EBSCO databases were searched for literature on ACLR failure or revision from 1975 to 2021. Data related to causes for ACLR surgical failure were extracted, and a random effects model was used to pool the results, which incorporates potential heterogeneity. Failure modes were compared between different populations, research methods, graft types, femoral portal techniques, and fixation methods by subgroup analysis or linear regression. Funnel plots were used to identify publication bias and small-study effects.

RESULTS: A total of 39 studies were analyzed, including 33 cohort studies and six registry-based studies reporting 6578 failures. The results showed that among patients with ACLR failure or revision, traumatic reinjury was the most common failure mode with a rate of 40% (95% CI: 35-44%), followed by technical error (34%, 95% CI: 28-42%) and biological failure (11%, 95% CI: 7-15%). Femoral tunnel malposition was the most common cause of the technical error (29%, 95% CI: 18-41%), with more than two times higher occurrence than tibial tunnel malposition (11%, 95% CI: 6-16%). Traumatic reinjury was the most common factor for ACLR failure in European populations and in recent studies, while technical errors were more common in Asian populations, earlier studies, and surgery performed using the transtibial (TT) portal technique. Biological factors were more likely to result in ACLR failure in hamstring (HT) autografts compared to bone-patellar tendon-bone (BPTB) autografts.

CONCLUSION: Trauma is the most important factor leading to surgical failure or revision following ACLR. Technical error is also an important contributing factor, with femoral tunnel malposition being the leading cause of error resulting in failure.

PMID:36642768 | DOI:10.1007/s00264-023-05687-z

Graefes Arch Clin Exp Ophthalmol. 2023 Jan 16. doi: 10.1007/s00417-023-05977-7. Online ahead of print.

ABSTRACT

PURPOSE: This comprehensive prospective study aimed to investigate the bacterial contamination of antibiotic steroid eye ointments and drops frequently used by eye patients.

METHOD: In this comprehensive prospective study, a total of 410 multi-use topical eye medications containing 15 different ingredients from 22 pharmaceutical companies used by 185 patients were analyzed. Four groups were formed as follows: group 1: antibiotic ointments (n: 109); group 2: antibiotic drops (n: 103); group 3: steroid ointments (n: 67); and group 4: steroid drops (n: 131). Topical multi-use eye drops and ointments used by patients at home for at least 1 week were randomly collected. The caps and contents were separately bacteriologically examined in a chocolate agar medium.

RESULTS: Our study detected bacterial contamination in 23 containers (5.6%) of the total 410 topical drugs. According to the groups, bacterial contamination was detected in 10 of 67 (14.9%) steroid ointments, 6 of 109 (5.5%) antibiotic ointments, 4 of 131(3.1%) steroid drops, and 3 of 103 (2.9%) antibiotic drops. While the bacterial contamination rate in ointments was 9.1%, this rate was 3% in drops. The difference between them was statistically significant (p = 0.015). According to the post-hoc pairwise comparisons, the difference between steroid drops and steroid ointment (p = 0.0023) was statistically significant. Among all drugs, contamination was detected in 12 of the 93 (12.9%) containers used after keratitis, conjunctivitis, and inflammatory conditions. It was determined that preservatives statistically reduced bacterial growth on the cap. The preservatives did not have a statistically significant effect on the bacterial contamination of the contents compared to the caps. While all contaminations were detected in illiterate and primary school graduates, no contamination was seen in the drugs used by any secondary school or university graduate.

CONCLUSION: Our study detected contamination in all topical ophthalmic drug groups. Contamination rates were found to be higher in ointments and steroids. Bacterial contamination was also seen in drugs containing preservatives. We should be careful in the use of topical medications. We do not recommend the bilateral use of ointments and drops in infected eyes, such as those with keratitis, or after intraocular surgeries, such as those for cataracts.

PMID:36642767 | DOI:10.1007/s00417-023-05977-7

Metab Brain Dis. 2023 Jan 16. doi: 10.1007/s11011-022-01150-x. Online ahead of print.

ABSTRACT

To 1) investigate the morphological brain-tissue changes in patients with dialysis- and non-dialysis-dependent chronic kidney disease (CKD); 2) analyze the effects of CKD on whole-brain cortical thickness, cortical volume, surface area, and surface curvature; and 3) analyze the correlation of these changes with clinical and biochemical indices. This study included normal controls (NCs, n = 34) and patients with CKD who were divided into dialysis (dialysis-dependent chronic kidney disease [DD-CKD], n = 26) and non-dialysis (non-dialysis patients who underwent cranial magnetic resonance imaging scans [NDD-CKD], n = 26) groups. Cortical thickness, volume, surface area, and surface curvature in each group were calculated using FreeSurfer software. Brain morphological indicators with statistical differences were correlated with clinical and biochemical indicators. Patients with CKD exhibited a significant and widespread decrease in cortical thickness and volume compared with NCs. Among the brain regions associated with higher neural activity, patients with CKD exhibited more significant morphological changes in the paracentral gyrus, transverse temporal gyrus, and lateral occipital cortex than in other brain regions. Cortical thickness and volume in patients with CKD correlated with blood pressure, lipid, hemoglobin, creatinine, and urea nitrogen levels. The extent of brain atrophy was further increased in the DD-CKD group compared with that in the NDD-CKD group. Patients with CKD potentially exhibit a certain degree of structural brain-tissue imaging changes, with morphological changes more pronounced in patients with DD-CKD, suggesting that blood urea nitrogen and dialysis may be influential factors in brain morphological changes in patients with CKD.

PMID:36642760 | DOI:10.1007/s11011-022-01150-x

Int J Legal Med. 2023 Jan 16. doi: 10.1007/s00414-023-02947-w. Online ahead of print.

ABSTRACT

Informed consent is based on basic ethical principles that should be considered when conducting biomedical and behavioral research involving human subjects. These principles-respect, beneficence, and justice-form the foundations of informed consent which in itself is grounded on three fundamental elements: information, comprehension, and voluntary participation. While informed consent has focused on human subjects and research, the practice has been adopted willingly in the forensic science arena primarily to acquire reference samples from family members to assist in identifying missing persons. With advances in molecular biology technologies, data mining, and access to metadata, it is important to assess whether the past informed consent process and in particular associated risks are concomitant with these increased capabilities. Given the state-of-the-art, areas in which informed consent may need to be modified and augmented are as follows: reference samples from family members in missing persons or unidentified human remains cases; targeted analysis of an individual(s) during forensic genetic genealogy cases to reduce an investigative burden; donors who provide their samples for validation studies (to include population studies and entry into databases that would be applied to forensic statistical calculations) to support implementation of procedures and operations of the forensic laboratory; family members that may contribute samples or obtain genetic information from a molecular autopsy; and use of medical and other acquired samples that could be informative for identification purposes. The informed consent process should cover (1) purpose for collection of samples; (2) process to analyze the samples (to include type of data); (3) benefits (to donor, target, family, community, etc. as applicable); (4) risks (to donor, target, family, community, etc. as applicable); (5) access to data/reports by the donor; (6) sample disposition; (7) removal of data process (i.e., expungement); (8) process to ask questions/assessment of comprehension; (9) follow-up processes; and (10) voluntary, signed, and dated consent. Issues surrounding these topics are discussed with an emphasis on addressing risk factors. Addressing informed consent will allow human subjects to make decisions voluntarily and with autonomy as well as secure the use of samples for intended use.

PMID:36642749 | DOI:10.1007/s00414-023-02947-w

Prog Orthod. 2023 Jan 16;24(1):2. doi: 10.1186/s40510-022-00453-0.

ABSTRACT

BACKGROUNDS: The present study was designed to define: (1) which are the less predictable OTM with Invisalign aligners when the treatment plan is designed by expert operators, (2) if the presence and shape of attachments influence the predictability of OTM and (3) if patients’ demographics influence OTM predictability. The sample comprises 79 prospectively recruited patients (mean age 30.8 years; SD 12.0; 23 M, 56 F), treated by expert operators with an average of 27 aligners (SD 15) in the maxillary arch and 25 aligners (SD 11) in the mandibular arch. Post-treatment digital models and final virtual treatment plan models were exported from ClinCheck^® software as STL files and subsequently imported into Geomagic Qualify ^®software, to compare final teeth positions. The differences were calculated and tested for statistical significance for each tooth in the mesial-distal, vestibular-lingual and occlusal-gingival directions, as well as for angulation, inclination and rotation. In addition, the statistical significance of categorical variables was tested.

RESULTS: The lack of correction was significant for all movements and in all group of teeth (P < 0.01) except for the rotation of maxillary first molar. The prescribed OTM, the group of teeth and movement, the frequency of aligner change and the use of attachment influence the outcome. The greatest discrepancies in predicted and achieved tooth position were found for angular movements and rotation of teeth characterized by round-shaped crowns, for a ratio of approximately 0.4° per 1° prescribed. Optimized attachments for upper canines and lower premolar rotation seem not working properly. Second molar movements are mostly unexpressed. Furthermore, changing the aligner every 14 days will reduce the lack of correction of the 12% with respect to 7 days aligner change.

CONCLUSIONS: Predictability of orthodontic movement with aligners still has limitations related to the biomechanics of the system: the shape of some attachments and the characteristics of aligner material need to be redefined. However, the results of this study allow to properly design the virtual treatment plan, revealing how much overcorrection is needed and which attachments are most effective.

PMID:36642743 | DOI:10.1186/s40510-022-00453-0