Category: Statistics

Korean J Ophthalmol. 2021 Jun;35(3):235-241. doi: 10.3341/kjo.2021.0010. Epub 2021 Jun 4.

ABSTRACT

PURPOSE: To evaluate the safety and efficacy of preservative-free (PF) latanoprost in glaucoma patients.

METHODS: In this prospective, open-label, observational study, a total of 27 primary open-angle glaucoma patients who used benzalkonium chloride-preserved prostaglandin analogues for at least 6 months were enrolled. After changing the eye drops to PF lataprost, the intraocular pressure (IOP) and ocular surface symptoms and signs were evaluated in all patients on days 0 (first visit, D0), 45 (D45), and 90 (D90).

RESULTS: Mean IOP remained stable during the study period (14.0 ± 2.4 mmHg at D0, 13.9 ± 2.0 mmHg at D45, 13.7 ± 2.2 mmHg at D90; p = 0.603). Mean deviation, pattern standard deviation, and best-corrected visual acuity were similar before and after eye drops replacement. Bulbar conjunctival hyperemia, corneal staining, and conjunctival staining were significantly decreased over 90 days (p = 0.025, p < 0.001, p = 0.020, respectively). The ocular surface disease index score showed a statistically significant improvement from 26.4 ± 18.5 at D0 to 19.8 ± 17.0 at D45 and 15.7 ± 15.6 at D90 (p < 0.001). In the evaluation of ocular tolerability, burning symptoms and dryness were significantly decreased (p = 0.001, p = 0.040).

CONCLUSIONS: The effects of PF latanoprost on reducing IOP were comparable with those of benzalkonium chloride-preserved prostaglandin analogues, but side effects on the ocular surface were much less pronounced when PF latanoprost was used. With this efficacy, PF latanoprost could slow the progression of glaucoma by increasing patient compliance.

PMID:34120423 | DOI:10.3341/kjo.2021.0010

Int J Clin Pract. 2021 Jun 13:e14522. doi: 10.1111/ijcp.14522. Online ahead of print.

ABSTRACT

OBJECTIVE: To generate real-world evidence (RWE) from the United States to assess the impact of pill burden and the importance of achieving stable daily dose of sertraline (time taken, number of dose adjustments needed) on adherence/persistence and healthcare resource utilization (HCRU).

METHODS: Retrospective analysis of the PharMetrics® Plus database (Oct/1/2012-Mar/31/2020) in the United States. Eligible patients had major depressive disorder (MDD) or obsessive-compulsive disorder (OCD) and ≥1 claim for sertraline during index period (Apr/1/2013-Mar/31/2019, allowing 6-months prior, 1-year post-index follow-up). Patients who achieved stable daily dose of sertraline (>90-days on same dose) were categorized into five cohorts, depending on pill burden/daily dose: Cohort 1: 1×50mg/day; Cohort 2: 1×100mg/day; Cohort 3: 2×50mg/day; Cohort 4: 1.5×100mg/day; Cohort 5: 3×50mg/day. Impact of pill burden on adherence/persistence and HCRU were assessed among cohorts using logistic regression analysis, and between patients who did vs. did not stabilize on therapy. P<0.05 was considered significant for all analyses.

RESULTS: Of 224,412 eligible patients, 108,729 stabilized on sertraline (50, 100, 150mg/day) and formed Cohorts 1-5. Stabilized patients on lower pill burden had statistically higher adherence and were more likely to remain persistent throughout 1-year post-index period vs. patients on higher pill burden but same overall dose (100mg/day [Cohort 2 vs. 3]; 150mg/day [Cohort 4 vs. 5]; respectively). Patients who did not stabilize had significantly lower adherence/persistence vs. patients who achieved stable daily dose (Cohorts 1-5 combined). Persistence improved when stable daily dose was achieved quickly (within 1-4 months) and efficiently (within 1-3 dose adjustments). Probability of HCRU increased for patients who did not stabilize on their initial prescription.

CONCLUSION: Simplifying treatment regimen and decreasing pill burden improved adherence and/or persistence with sertraline therapy (100 or 150mg/day). Patients achieving stable daily dose of sertraline in an efficient and timely manner were more likely to remain persistent throughout 1-year follow-up.

PMID:34120397 | DOI:10.1111/ijcp.14522

Dent Traumatol. 2021 Jun 13. doi: 10.1111/edt.12687. Online ahead of print.

ABSTRACT

BACKGROUND/AIMS: Traumatic dental injuries (TDI) are complex problems where lack of proper care may result in serious complications. The need to improve the management of TDI is a frequently addressed concern. Methods of improvement in their diagnosis and management are continuously evolving. The interactive Internet tool, the Dental Trauma Guide (DTG), helps to simplify diagnostic and management dilemmas. However, it is not a freely available tool. The aim of the current study was to assess the knowledge and diagnostic skills of undergraduate dental students with access to the DTG compared with students without such access, in order to validate and promote this tool in dental education.

MATERIALS AND METHODS: Two groups of students were randomly selected where one group of final year dental undergraduate students were exposed to lectures, demonstrations, discussions and tutorials on the management of TDI according to the standard undergraduate curriculum in Sri Lanka. Another test group of 21 students were provided with access to DTG during their training in paediatric dentistry. At the end of the study period, students were assessed on their knowledge of TDI using MCQs (Multiple Choice Questions) and OSCEs (Objective Structured Clinical Examination), based on the DTG.

RESULTS: The students with access to the DTG were more knowledgeable in providing the correct answers to three out of the seven OSCE questions. Evaluation based on the MCQs did not reveal a significant difference (p = .913). However, users of the DTG showed a statistically significant difference with better overall knowledge based on their answers (p = .028). Following this period of evaluation, all of the students were provided with access to the DTG to supplement their learning experience.

CONCLUSION: The Dental Trauma Guide is a useful supplementary tool for undergraduate students to arrive at a correct diagnosis and treatment plan for TDI.

PMID:34120401 | DOI:10.1111/edt.12687

Pediatr Transplant. 2021 Jun 13:e14065. doi: 10.1111/petr.14065. Online ahead of print.

ABSTRACT

BACKGROUND: The number of programs offering a PTH fellowship has grown rapidly over the last 10 years. This study aimed to describe the clinical, didactic, procedural, and research experiences of recent PTH fellowship graduates. In addition, we sought to understand graduates’ post-fellowship professional responsibilities and their perception about the utility of the PTH fellowship.

METHODS: An anonymous survey was distributed from February to October 2020 through REDCap to all recent graduates (2015-2019) of an ACGME-approved PTH fellowship program. The survey consisted of 49 questions focused on the PTH fellowship experience. Results were summarized using descriptive statistics.

RESULTS: Thirty-eight of 43 graduates (88%) responded to the survey representing 12 PTH fellowship programs. The didactic experience varied; 97% received pathology lectures, 81% radiology lectures, 54% organ allocation lectures, 54% procedural lectures, 57% immunology lectures, and 43% live donation lectures. During the PTH fellowship, the majority of fellows performed >10 liver biopsies (82%) and >5 variceal bandings (58%); however, 63%, 32%, 8%, and 8% never performed paracentesis, variceal sclerotherapy, variceal banding, and liver biopsies, respectively. The majority of fellows (95%) completed a research project during PTH fellowship. Currently, 84% of graduates are employed at a transplant academic institution. All graduates recommended the fellowship.

CONCLUSIONS: There is variability in the didactic, clinical, and procedural training among PTH fellowship programs. Although uniformly viewed as a beneficial fellowship year, there is an opportunity to collaborate to create a more standardized training experience.

PMID:34120405 | DOI:10.1111/petr.14065

Int J Clin Pract. 2021 Jun 13:e14524. doi: 10.1111/ijcp.14524. Online ahead of print.

ABSTRACT

INTRODUCTION: In this study, it is planned to compare the RT-PCR test, which is the gold standard in the diagnosis of COVID-19, with Thorax computed tomography (CT) and rapid antibody test results.

METHODS: Patients who were admitted to the emergency service of İzmir Çiğli Training and Research Hospital between 01.04.2020 and 31.05.2020 and who were suspected of having COVID-19 infection were included in the study. The medical records of the patients were retrospectively analyzed through the hospital data processing database. Age, gender, hospitalization, status of home quarantine, real-time reverse transcription-polymerase chain reaction (RT-PCR), thorax CT and rapid antibody test results of the patients were examined. The relationship between RT-PCR, thorax CT and rapid antibody test results were compared statistically.

RESULTS: A total of 181 patients, 115 (63.5%) male and 66 (36.5%) female, with an average age of 56.4 ± 18.06 years were included in the study. The nasopharyngeal swab PCR result obtained at the first admission of the patients to the emergency department was positive in 71 (39.2%) patients. Rapid antibody tests performed at hospital admission were positive in 57 (31.5%) patients. Thorax CT was performed in 173 (95.6%) patients who applied to the emergency department, and 112 (64.7%) of them had findings that could be compatible with COVID-19. According to the thorax CT findings in patients, sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) for detecting COVID-19 infection were respectively; 76.1%, 43.1%, 48.2% and 72.1% (ĸ: 0.176, p <0.001). According to the rapid antibody test results, sensitivity, specificity, PPV and NPV for detecting COVID-19 infection were 57.5%, 85.5%, 71.9% and 75.8%, respectively (ĸ: 0.448, p <0.001). In our study, the mortality rate for COVID-19 was found to be 2.8%.

CONCLUSION: Rapid antibody test and thorax CT examinations were found to have low diagnostic value in patients who admitted to the emergency department of our hospital and whose first RT-PCR SARS-CoV-2 test was positive. Studies involving larger patient groups are needed for their use alone in diagnosis and screening.

PMID:34120388 | DOI:10.1111/ijcp.14524

Int J Clin Pract. 2021 Jun 13:e14520. doi: 10.1111/ijcp.14520. Online ahead of print.

ABSTRACT

AIMS: Recurrent pregnancy loss (RPL) is usually defined by two or more consecutive clinical miscarriages, which causes psychological trauma for couples. In this study, we aimed to investigate the predictive role of Fibrinogen to albumin ratio (FAR) in patients with RPL.

METHODS: Pregnant women in their first trimester of pregnancy were included in the study and divided in to two groups as RPL patients (n:44) and patients with no previous recurrent miscarriage (n:60) as control group. Demographical parameters and routine blood parameters (fibrinogen, D-dimer, fibrinogen to albumin ratio (FAR), neutrophil to lymphocyte ratio (NLR), platelet count, main platelet volume (MPV), and red cell distribution width (RDW) values) were compared between the RPL group and the control group.

RESULTS: The groups were determined to be statistically different in regards to gravidity and parity (p<0.001). The difference between the groups was statistically different in regards to fibrinogen (mg/dl), albumin (g/dl), FAR (%), NLR (%), RDW-coefficient of variation (CV) (%), RDW-standard deviation (SD) (fL), and platelet counts (10^-3 / uL). However, MPV (fL) and D-dimer (ug/L) levels were similar in both groups. The receiver operating characteristic (ROC) curve analysis revealed that the NLR levels were 84.1% sensitive and 75% specific with a cut-off value of 4.27 and the FAR levels were 79.5% sensitive and 88.3% specific with a cut-off value of 105.69 for predicting RPL.

CONCLUSION: Our results indicate that the FAR and NLR levels seem to be effective parameters for predicting RPL with high sensitivity and specificity.

PMID:34120391 | DOI:10.1111/ijcp.14520

Alcohol Clin Exp Res. 2021 Jun 12. doi: 10.1111/acer.14649. Online ahead of print.

ABSTRACT

BACKGROUND: Posttraumatic Stress Disorder (PTSD) often co-occurs with increased alcohol consumption (AC) and alcohol use disorder (AUD), however it is unknown whether the same etiologic influences underlying PTSD-AUD comorbidity are those underlying PTSD and AC.

METHODS: This study used large-scale genome wide association study (GWAS) data to test if PTSD and drinks per week [DPW]/AUD are causally related to one another, and if so, if PTSD precedes DPW/AUD and/or vice versa, using Mendelian Randomization on European ancestry GWAS summary statistics from the Psychiatric Genomics Consortia (PGC; PTSD), GWAS & Sequencing Consortium of Alcohol and Nicotine Use (GSCAN; DPW), and Million Veteran Program (MVP; AUD).

RESULTS: PTSD exerted a potentially causal effect on AUD (beta= 0.039, se= 0.014, p= 0.005), but not on DPW (beta= 0.002, se= 0.003, p= 0.414). Additionally, neither DPW (beta= 0.019, se= 0.041, p= 0.637) nor AUD (beta= 8.87×10^-4 , se= 0.001, p= 0.441) exerted a causal effect on PTSD.

CONCLUSIONS: These findings are consistent with the self-medication model, in which individuals misuse alcohol as a way of coping with aversive trauma-related symptoms. These findings extend latent and molecular findings of shared and correlated risk between PTSD and alcohol phenotypes. Given the health behaviors associated with these phenotypes, these findings are important in that they suggest groups on which to prioritize prevention efforts. Further, they provide a rationale for future pre-clinical and clinical studies examining the biological mechanisms by which PTSD may impact AUD.

PMID:34120358 | DOI:10.1111/acer.14649

APMIS. 2021 Jun 12. doi: 10.1111/apm.13163. Online ahead of print.

ABSTRACT

BACKGROUND: Research on biofilms is predominantly made in in vitro contexts. However, in vivo observation of biofilms in human chronic infections shows distinct differences compared to in vitro biofilm growth. This could imply the use of an inadequate mental model both in research and healthcare practices. Drawing on knowledge from the cognitive sciences, we hypothesise that the predominance of in vitro research on biofilms is skewed toward a mental model promoting wrong inferences for researchers and healthcare professionals (HCPs) in the in vivo context.

METHODS: To explore the prevalence of such a mental model, we carried out a qualitative image analysis in which biofilm illustrations from a Google image search were coded for typical in vitro or in vivo characteristics. Further, to investigate potential misinformed and unhelpful clinical interventions related to biofilms, we conducted a quantitative questionnaire among HCPs. The questions were designed to test whether knowledge about in vitro biofilms was used in an in vivo context. This questionnaire was analysed through a chi-squared test.

RESULTS: Most biofilm illustrations were consistent with the in vitro model. A statistical analysis of survey responses revealed that HCPs have adequate knowledge about biofilm but often respond incorrectly when asked to apply their knowledge to in vivo contexts.

CONCLUSIONS: The outcome of this research points to a prevalent and consolidated mental model derived from in vitro observations. This model has likely been made dominant by HCPs’ frequent exposure to visual depictions in articles and presentations. The prevalence of the in vitro model sets up the possibility of erroneous claims when the in vitro model is inadequately applied to in vivo contexts. This has potential implications for HCPs working in fields involving biofilm, such as wound care treatment.

PMID:34120370 | DOI:10.1111/apm.13163

Neurogastroenterol Motil. 2021 Jun 13:e14185. doi: 10.1111/nmo.14185. Online ahead of print.

ABSTRACT

BACKGROUND: In children with functional dyspepsia (FD), genes involved in pain modulation may be differentially expressed contributing to chronic pain.

METHODS: Children with suspected FD (cases) and known eosinophilic esophagitis (controls) undergoing esophagogastroduodenoscopy completed the Rome IV Diagnostic, Pain Burden and Frequency Severity-Duration questionnaires. Two antral and two duodenal biopsies were collected and relative fold differences in gene expression for 84 pain-associated genes compared to pain-free controls were calculated.

RESULTS: Sixty-six subjects with FD (postprandial distress syndrome = 34, epigastric pain syndrome = 7, both = 25; 65% female; mean age 13.7 years) and 13 pain-free controls (8% female; mean age 12.7) were studied. There were no significant differences in antral and duodenal eosinophilic counts or distribution between the pain and pain-free groups. Pain severity and burden did not differ significantly between FD subgroups and neither measure significantly correlated with eosinophil counts in the antrum or duodenum. Analysis of 47 antral and 39 duodenal biospecimens revealed 5 candidate genes significantly associated with pain burden: antral EDN1, PTGES3 and duodenal HTR1A, P2Y1, SCN3A (p < 0.01). Subsequent stringent statistical analysis comparing those with significant pain versus no pain revealed antral PTGES3 and duodenal SCN3A were the highest priority candidate genes (p < 0.001).

CONCLUSIONS: Pain burden in pediatric FD may be linked to antral EDN1, PTGES3 and duodenal HTR1A, P2Y1, SCN3A differential expression. These genes are known to be involved in pain conduction, modulation, and neurotransmission, suggesting potential therapeutic targets for managing pain in FD.

PMID:34120385 | DOI:10.1111/nmo.14185

Stat Med. 2021 Jun 13. doi: 10.1002/sim.9094. Online ahead of print.

ABSTRACT

In sequential analysis, hypothesis testing is performed repeatedly in a prospective manner as data accrue over time to quickly arrive at an accurate conclusion or decision. In this tutorial paper, detailed explanations are given for both designing and operating sequential testing. We describe the calculation of exact thresholds for stopping or signaling, statistical power, expected time to signal, and expected sample sizes for sequential analysis with Poisson and binary type data. The calculations are run using the package Sequential, constructed in R language. Real data examples are inspired on clinical trials practice, such as the current efforts to develop treatments to face the COVID-19 pandemic, and the comparison of treatments of osteoporosis. In addition, we mimic the monitoring of adverse events following influenza vaccination and Pediarix vaccination.

PMID:34120357 | DOI:10.1002/sim.9094