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Nevin Manimala Statistics

A Tale of Two D-Dimers: Comparison of Two Assay Methods to Evaluate Deep Vein Thrombosis or Pulmonary Embolism

J Emerg Med. 2022 Sep 9:S0736-4679(22)00279-7. doi: 10.1016/j.jemermed.2022.04.006. Online ahead of print.

ABSTRACT

BACKGROUND: D-dimer testing rules out deep vein thrombosis (DVT) and pulmonary embolism (PE) in low-risk emergency department (ED) patients. Most research has measured fibrin-equivalent units (FEUs), however, many laboratories measure D-dimer units (DDUs).

OBJECTIVE: Our aim was to determine whether either DDU measurements or FEU measurements can rule out DVT/PE using traditional or age-related cutoff values.

METHODS: We performed a de-identified multicenter retrospective evaluation of D-dimer in nonpregnant adult ED patients to evaluate for DVT/PE. DDUs were multiplied by 2 to determine equivalent FEUs prior to analysis. Sensitivity measurements for D-dimer were calculated for FEUs, DDUs, combined FEU/DDUs, and multiple age-adjusted values.

RESULTS: We identified 47,088 ED patients with a D-dimer laboratory value (27,307 FEUs/19,781 DDUs) and 1623 DVT/PEs. The median combined FEU/DDU D-dimer was 400 ng/mL FEUs (interquartile range [IQR] 300-900 ng/mL FEUs) for patients without a DVT/PE vs 2530 ng/mL FEU (IQR 1094-6000 ng/mL FEUs) with a DVT/PE (p < 0.001), overall sensitivity of 87.3% (95% confidence interval [CI] 87.0-87.6%) and negative predictive value of 99.3% (95% CI 99.2-99.4%). Individually, FEUs performed better than DDUs, with sensitivities of 88.0% (95% CI 85.8-89.9%) and 86.1% (95% CI 83.1-88.7%), respectively; however, this difference was not statistically significant. Combined age-adjusted performance had a sensitivity of 90.3% (95% CI 88.3-92.0%); however, a new DDU-only age-adjusted criteria had the highest sensitivity of 91.1% (95% CI 87.9-93.6%).

CONCLUSIONS: Our undifferentiated D-dimer measurements had a slightly lower sensitivity to rule out DVT/PE than reported previously. Our data support using either DDU or FEU measurements for all ages or when using various age-adjusted criteria to rule out DVT/PE.

PMID:36096961 | DOI:10.1016/j.jemermed.2022.04.006

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Nevin Manimala Statistics

Therapy with voretigene neparvovec. How to measure success?

Prog Retin Eye Res. 2022 Sep 9:101115. doi: 10.1016/j.preteyeres.2022.101115. Online ahead of print.

ABSTRACT

Retinal gene supplementation therapy such as the first approved one, voretigene neparvovec, delivers a functioning copy of the missing gene enabling the protein transcription in retinal cells and restore visual functions. After gene supplementation for the genetic defect, a complex network of functional regeneration is the consequence, whereas the extent is very individualized. Diagnostic and functional testings that have been used routinely by ophthalmologists so far to define the correct diagnosis, cannot be applied in the new context of defining small, sometimes subtle changes in visual functions. New view on retinal diagnostics is needed to understand this processes that define safety and efficacy of the treatment. Not only does vision have many aspects that must be addressed by specific evaluations and imaging techniques, but objective readouts of local retinal function for rods and cones separately have been an unmet need until recently. A reliable test-retest variability is necessary in rare diseases such as inherited retinal dystrophies, because statistics are often not applicable due to a low number of participants. Methods for a reliable individual evaluation of the therapy success are needed. In this manuscript we present an elaboration on retinal diagnostics combining psychophysics (eg. full-field stimulus threshold or dark adapted perimetry) as well as objective measures for local retinal function (eg. photopic and scotopic chromatic pupil campimetry) and retinal imaging for a meaningful workflow to apply in evaluation of the individual success in patients receiving gene therapy for photoreceptor diseases.

PMID:36096933 | DOI:10.1016/j.preteyeres.2022.101115

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Nevin Manimala Statistics

Visceral obesity as a risk factor of incisional hernia after single-port laparoscopic gynecologic surgery

Asian J Surg. 2022 Sep 9:S1015-9584(22)01199-X. doi: 10.1016/j.asjsur.2022.08.085. Online ahead of print.

ABSTRACT

OBJECTIVE: We aimed to evaluate associations between abdominal fat distribution (AFD) parameters and incisional hernia (IH) in patients who underwent transumbilical single-port laparoscopic surgery (SPLS) for gynecological disease.

METHODS: Medical records of 2116 patients who underwent SPLS for gynecological disease at Daejeon St. Mary’s Hospital between March 2014 and February 2021 were reviewed. Among 21 (1.0%) patients who developed IH requiring surgical treatment after SPLS, 18 had preoperative abdominopelvic computed tomography (CT) images. As a control group, we randomly selected 72 patients who did not develop IH and who had undergone preoperative abdominopelvic CT scan, matched to test patients by type of surgery. Total fat area (TFA), visceral fat area (VFA), subcutaneous fat area (SFA), visceral-to-subcutaneous fat ratio (VSR), and waist circumference (WC) were measured at the level of the third lumbar vertebral body on the preoperative abdominopelvic CT images, using National Institutes of Health (NIH) ImageJ version 1.53 k.

RESULTS: Receiver operating curve analysis showed that VFA has the highest predictive value for IH among AFD parameters (AUC = 0.749, 95% CI 0.630-0.869, p < 0.001). Univariate analysis showed that age, BMI, hypertension, dyslipidemia, TFA, VFA, VSR and WC were significant factors for IH. In multivariate analysis, only high VFA was identified as an independent risk factor for IH (HR 6.18, 95% CI 1.13-33.87, p = 0.04), whereas BMI, TFA, SFA, VSR, and WC failed to show statistical significance.

CONCLUSION: We could find high VFA as an independent risk factor of IH in patients who underwent SPLS for gynecologic disease.

PMID:36096929 | DOI:10.1016/j.asjsur.2022.08.085

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Nevin Manimala Statistics

Salivary orosomucoid 1 as a biomarker of hepatitis B associated hepatocellular carcinoma

Sci Rep. 2022 Sep 12;12(1):15347. doi: 10.1038/s41598-022-18894-2.

ABSTRACT

Saliva is rich in proteins, DNA, RNA and microorganisms, and can be regarded as a biomarker library. In order to explore a noninvasive and simple means of early screening for liver cancer, proteomics was used to screen salivary markers of hepatitis B associated liver cancer. We used mass spectrometry coupled isobaric tags for relative and absolute quantitation (iTRAQ)-technology to identify differentially expressed proteins (DEPs). Western blot, immunohistochemistry and enzyme linked immunosorbent assay were used to detect marker expression of in tissues and saliva. Statistical analysis was used to analyze the diagnostic efficacy of the markers was analyzed through statistical analyses. By comparing the hepatocellular carcinoma (HCC) group with non-HCC groups, we screened out 152 salivary DEPs. We found orosomucoid 1(ORM1) had significantly higher expression in saliva of HCC patients compared with non-HCC groups (p < 0.001) and the expression of ORM1 in liver cancer tissues was significantly higher than that in adjacent normal tissues (p < 0.001). The combination of salivary ORM1 and alpha-fetoprotein (AFP) showed reasonable specificities and sensitivities for detecting HCC. In a word, salivary ORM1 as a new biomarker of hepatitis B associated hepatocellular carcinoma, combination of salivary ORM1 and AFP as an improved diagnostic tool for hepatocellular carcinoma.

PMID:36096917 | DOI:10.1038/s41598-022-18894-2

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Nevin Manimala Statistics

Author Correction: Statistical evaluation of proxies for estimating the rainfall erosivity factor

Sci Rep. 2022 Sep 12;12(1):15325. doi: 10.1038/s41598-022-19412-0.

NO ABSTRACT

PMID:36096916 | DOI:10.1038/s41598-022-19412-0

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Nevin Manimala Statistics

An in vitro evaluation of 2 methods for retrieving fractured abutment screw fragments from the intaglio of 4 different implant systems

J Prosthet Dent. 2022 Sep 9:S0022-3913(22)00466-8. doi: 10.1016/j.prosdent.2022.07.005. Online ahead of print.

ABSTRACT

STATEMENT OF PROBLEM: When an abutment screw fractures, there is no standardized technique for retrieving it from the intaglio of the dental implant.

PURPOSE: The purpose of this in vitro study was to assess the relative efficacy of a commercially available screw fragment retrieval kit with a range of standard dental instruments in regard to success and retrieval time. In addition, the effects of other variables on the success rate of screw fragment retrieval and the retrieval time required were also investigated. Finally, the integrity of the intaglio screw channel of the dental implant was also assessed following retrieval.

MATERIAL AND METHODS: The abutment screws from 4 dental implant systems: Osseotite Certain, Ø4.1 mm (Zimmer Biomet); Osseotite External hexagonal connection micromini, Ø3.25 mm (Zimmer Biomet); Standard Plus Tissue Level, Ø4.8 mm (Institut Straumann AG); and Brånemark Mark III TiUnite, Ø4.1 mm (Nobel Biocare) had notches placed between the first and second coronal threads before being placed in their respective abutments, positioned in the dental implants (n=128), and tightened until the screws fractured. The dental implant specimens were placed in maxillary and mandibular casts at the lateral incisor and first molar sites on both sides. The casts were placed in mannequin heads on a dental chair and assigned to 2 experienced and 2 inexperienced operators who used 2 different retrieval kits to retrieve the screw fragments. Chisquared tests were used to determine the association between the success rate of screw fragment retrieval and the other factors recorded (α=.05), and a binary logistic regression was used to determine the association between the retrieval event and all of the independent variables. Regression models were developed to determine the factors effecting retrieval time.

RESULTS: An overall success rate of 88.3% was achieved for screw fragment retrieval. No statistically significant difference (P=1) was found in the relative efficacy of the retrieval kits. Univariate analysis identified a statistically significant association (P<.01) in the success of abutment screw fragment retrieval between the Osseotite Certain and the Osseotite External hexagonal connection micromini implant systems. Gamma regression analysis identified significant differences between the time taken to retrieve the screw fragments and the type of dental implant (P<.001), (P<.01). The time taken to retrieve screw fragments in the maxillary arch was significantly longer than for the mandibular arch (P<.05).

CONCLUSIONS: The commercially available screw fragment retrieval kit and the standard dental instruments were equally effective in retrieving the screw fragments. Less time was required to retrieve screw fragments in the mandibular arch than the maxillary arch. The level of experience of the operator had no effect on the ability to successfully retrieve fractured abutment screws.

PMID:36096913 | DOI:10.1016/j.prosdent.2022.07.005

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Nevin Manimala Statistics

Comparative evaluation of digitally fabricated complete dentures versus conventional complete dentures: A randomized, single-blinded, cross-over clinical trial

J Prosthet Dent. 2022 Sep 9:S0022-3913(22)00339-0. doi: 10.1016/j.prosdent.2022.05.013. Online ahead of print.

ABSTRACT

STATEMENT OF PROBLEM: Clinical trials comparing outcomes associated with digital complete dentures (CDs) fabricated from intraoral scan data with those of CDs fabricated by using the conventional workflow are lacking.

PURPOSE: The purpose of this randomized clinical trial was to evaluate the clinical performance of and patient satisfaction associated with digitally versus conventionally fabricated CDs.

MATERIAL AND METHODS: Eight participants requiring CDs were enrolled in this study. Two sets of CDs were fabricated for each participant. One set was fabricated by using a digital workflow, which involved digital scanning with an intraoral scanner, whereas the other set was made by using the conventional workflow. The participants were given 1 set of CDs for 1 month and another set for the next month. The order of placing CDs was randomly selected for each participant. The internal adaptation, masticatory force, and masticatory efficiency of the CDs in each group were evaluated for objective analysis. Additionally, a questionnaire was provided to the participants, and the responses were evaluated for subjective satisfaction analysis. All parameters were analyzed by using t tests (α=.05).

RESULTS: The internal adaptation did not statistically significantly differ between the conventional and digital CDs with regard to the maxillary arches (P=.406) and mandibular arches (P=.412). The average masticatory force (P=.051) and maximum masticatory force (P=.110) likewise did not statistically significantly differ between the 2 types of CDs. Masticatory efficiency, expressed via the mixing ability index, was statistically better for conventional CDs than the digital CDs (P=.009). No statistically significant differences were observed between the 2 types of CDs in terms of overall patient satisfaction as assessed by using the study questionnaire (P=.172 for maxillary CD and P=.161 for mandibular CD). However, the conventional CDs were statistically significantly better than the digital CDs with regard to subjective satisfaction with pronunciation ability (P=.006).

CONCLUSIONS: The digital CDs were inferior to the conventional CDs in terms of masticatory efficiency and pronunciation. However, internal adaptation and overall patient satisfaction were comparable between conventional and digital CDs. This finding suggests that intraoral scanning and additively manufactured CDs may be suitable for edentulous patients, at least for interim use.

PMID:36096912 | DOI:10.1016/j.prosdent.2022.05.013

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Nevin Manimala Statistics

Automated Classification and Detection of Staphyloma with Ultrasound Images in Pathologic Myopia Eyes

Ultrasound Med Biol. 2022 Sep 9:S0301-5629(22)00462-8. doi: 10.1016/j.ultrasmedbio.2022.06.010. Online ahead of print.

ABSTRACT

The aim of this study was to develop an eyewall curvature- and axial length (AxL)-based algorithm to automate detection (clinician-free) of staphyloma ridge and apex locations using ultrasound (US). Forty-six individuals (with emmetropia, high myopia or pathologic myopia) were enrolled in this study (AxL range: 22.3-39.3 mm), yielding 130 images in total. An intensity-based segmentation algorithm automatically tracked the posterior eyewall, calculating the posterior eyewall local curvature (K) and distance (L) to the transducer and the location of the staphyloma apex. By use of the area under the receiver operator characteristic (AUROC) curve to evaluate the diagnostic ability of eight local statistics derived from K, L and AxL, the algorithm successfully quantified non-uniformity of eye shape with an AUROC > 0.70 for most K-based parameters. The performance of binary classification (staphyloma absence vs. presence) was assessed with the best classifier (the combination of AxL, standard deviation of K and standard deviation of L) yielding a diagnostic validation performance of 0.897, which was comparable to the diagnostic performance of junior clinicians. The staphyloma apex was localized with an average error of 1.35 ± 1.34 mm. Combined with the real-time data acquisition capabilities of US, this method can be employed as a screening tool for clinician-free in vivo staphyloma detection.

PMID:36096896 | DOI:10.1016/j.ultrasmedbio.2022.06.010

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Nevin Manimala Statistics

Relationship between ER expression by IHC or mRNA with Ki67 response to aromatase inhibition: a POETIC study

Breast Cancer Res. 2022 Sep 12;24(1):61. doi: 10.1186/s13058-022-01556-6.

ABSTRACT

BACKGROUND: In clinical practice, oestrogen receptor (ER) analysis is almost entirely by immunohistochemistry (IHC). ASCO/CAP recommends cut-offs of < 1% (negative) and 1-10% (low) cells positive. There is uncertainty whether patients with ER low tumours benefit from endocrine therapy. We aimed to assess IHC and mRNA cut-points for ER versus biological response of primary breast cancer to 2 weeks’ aromatase inhibitor treatment as measured by change in Ki67.

METHODS: Cases were selected from the aromatase inhibitor treatment group of POETIC. We selected the 15% with the poorest Ki67 response (PR, < 40% Ki67 suppression, n = 230) and a random 30% of the remainder categorised as intermediate (IR, 40-79% Ki67 suppression, n = 150) and good-responders (GR, ≥ 80% Ki67 suppression, n = 230) from HER2 – group. All HER2 + cases available were selected irrespective of their response category (n = 317). ER expression was measured by IHC and qPCR.

RESULTS: ER IHC was available from 515 HER2 – and 186 HER2 + tumours and ER qPCR from 367 HER2 – and 171 HER2 + tumours. Ninety-one percentage of patients with ER IHC < 10% were PRs with similar rates in HER2 – and HER2 + cases. At or above ER IHC 10% substantial numbers of patients showed IR or GR. Similar proportions of patients were defined by cut-points of ER IHC < 10% and ER mRNA < 5 units. In addition, loss of PgR expression altered ER anti-proliferation response with 92% of PgR – cases with ER IHC < 40% being PRs.

CONCLUSIONS: There was little responsiveness at IHC < 10% and no distinction between < 1% and 1-10% cells positive. Similar separation of PRs from IR/GRs was achieved by IHC and mRNA.

PMID:36096872 | DOI:10.1186/s13058-022-01556-6

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Nevin Manimala Statistics

Relationship between embryo development and apoptotic gene expression of cumulus cells in poor responders and polycystic ovary syndrome

Reprod Biomed Online. 2022 Jun 26:S1472-6483(22)00431-X. doi: 10.1016/j.rbmo.2022.06.018. Online ahead of print.

ABSTRACT

RESEARCH QUESTION: Is there a relationship between embryo quality, pregnancy rates and apoptotic gene expression in cumulus cells of oocytes collected from patients with poor ovarian response and polycystic ovary syndrome?

DESIGN: Fifty infertile couples who underwent assisted reproductive technology treatment were included in the study (Approval date 4 February 2020, number 03). The patients were divided into four group: control (n = 9; 90 oocytes), unexplained infertility (n = 8; 86 oocytes), polycystic ovary syndrome (PCOS) (n = 6; 137 oocytes) and poor ovarian response (POR) (n = 27; 124 oocytes). Cumulus cells were isolated individually from 437 oocytes obtained. Intracytoplasmic sperm injection was undertaken on 365 mature oocytes. The embryos were monitored. Caspase-3, Bax and Bcl-2 gene expressions of the cumulus cells were measured by real-time polymerase chain reaction.

RESULTS: A significant and negative correlation was found between Bax and Bcl-2 expressions of the cumulus cells of poor-quality embryos. The increase in Caspase-3 gene expression in the POR group statistically decreases the pregnancy rates. Fertilization and good-quality embryo development of 365 oocytes whose cumulus cells were examined, however, were not associated with apoptotic gene expression. The Bax/Bcl-2 ratio was found to be significantly lower in cumulus cells of mature oocytes.

CONCLUSIONS: Our results demonstrated no significant associations between fertilization, quality embryo development and apoptotic gene expression. Bax expression and the Bax/Bcl-2 ratio are high in immature oocyte cumulus cells has shown us that the apoptotic process may begin when the cumulus-oocyte connection exists.

PMID:36096870 | DOI:10.1016/j.rbmo.2022.06.018