Category: Statistics

Medicina (B Aires). 2024;84(3):407-414.

ABSTRACT

INTRODUCTION: 90% of cases of acute low back pain have no specific underlying cause. International guidelines are available to help identify those individuals who require specialized care. However, in our country, there is a limited emphasis on primary healthcare, with the primary focus on hospital-based care. The aim of this study is to provide an overview of the diagnostic and therapeutic resources utilized in the initial care of patients experiencing low back pain at their first consultation with a specialist physician.

METHODS: Descriptive and cross-sectional study, with prospective data collection through a questionnaire administered to patients experiencing low back pain during their first visit to a specialist’s office.

RESULTS: A total of 44 patients were included, with an average age of 53 years; 50% sought medical attention for chronic pain. Informal referrals were associated with the referring physician’s specialty (non-orthopedic), patients with a higher number of emergency department visits, and longer waiting times to obtain the consultation; 52% of patients arrived with at least one complementary study.

CONCLUSION: Most of the referrals were appropriate; however, informal referrals were more common. Only 1/5 of the patients underwent an physical examination, and less than 30% of those with red flag symptoms presented with suitable complementary studies. The median waiting time for the consultation was 24 days.

PMID:38907954

Sleep Breath. 2024 Jun 22. doi: 10.1007/s11325-024-03076-3. Online ahead of print.

ABSTRACT

PURPOSE: This study aimed to evaluate the accuracy of a Bluetooth position monitor called NaTu sensor and its mobile phone application for detecting sleep position among patients with obstructive sleep apnea (OSA) during polysomnography (PSG).

METHODS: A cross-sectional study was conducted on adults with suspected of having OSA who underwent PSG. Sleep positions were recorded simultaneously using a video-validated PSG position sensor and the NaTu sensor. The area under the Receiver Operator Characteristic curve (ROC AUC), sensitivity, and specificity values were calculated to evaluate the validity of the NaTu sensor.

RESULTS: Ninety participants (56.7% male) were included, with median age of 40.0 years and body mass index of 29.4 kg/m². The mean AHI was 58.4 ± 31.2 events/hour, categorizing the severity of OSA as mild (5.6%), moderate (18.9%), and severe (75.5%). Sleep positions (supine, lateral right, lateral left) identified by the NaTu sensor closely agreed with the video-validated PSG. The kappa statistic demonstrated almost perfect agreement (k = 0.95, P < 0.001) for overall position recording. The ROC AUC for identifying supine, lateral right, and lateral left positions ranged from 0.974 to 0.981, with sensitivity ranging from 95.1% to 99.1% and specificity from 96.5% to 99.6%.

CONCLUSION: Our wearable sensor monitoring significantly agrees with video-validated PSG in identifying sleep positions. This device is reliable and accurate for position monitoring and could be an alternative tool for monitoring positions in in-lab PSG, home sleep apnea testing, or tracking positional treatment at home.

REGISTRATION: Thaiclinicaltrials.org with number TCTR20210701008.

PMID:38907950 | DOI:10.1007/s11325-024-03076-3

Drug Saf. 2024 Jun 22. doi: 10.1007/s40264-024-01449-x. Online ahead of print.

ABSTRACT

BACKGROUND: The safety profile of COVID-19 vaccines in immunocompromised patients has not been comprehensively evaluated.

AIM: To measure the frequency of patient-reported adverse drug reactions (ADRs) related to the first/second/booster dose of COVID-19 vaccine in immunocompromised subject versus matched cohort. As a secondary objective, the time course, evaluated as time to onset (TTO) and time to recovery (TTR), of COVID-19 vaccine-related ADRs was explored.

METHODS: A prospective cohort study, based on electronic questionnaires filled by vaccinees from 11 European countries in the period February 2021 to February 2023 was conducted. All immunocompromised vaccinees who provided informed consent and registered to the project’s web-app within 48 h after first/booster vaccine dose administration of any EMA-authorised COVID-19 vaccine were recruited. Participants filled baseline and up to six follow-up questionnaires (FU-Qs) over 6 months from vaccination, collecting information on suspected COVID-19 vaccine-related ADRs. As a control group, non-immunocompromised vaccinees from the same source population were 1:4 matched by sex, age, vaccine dose, and brand. A descriptive analysis of demographic/clinical characteristics of vaccinees was conducted. Heatmaps of the frequency of solicited ADRs, stratified by gender and vaccine brand, were generated. Median TTO/TTR of reported ADRs were visualised using violin/box-plots.

RESULTS: A total of 773 immunocompromised vaccines were included in the analyses. Most participants were females (F/M ratio: 2.1 and 1.6) with a median age of 56 (43-74) and 51 (41-60) years, at the first vaccination cycle and booster dose, respectively. Injection-site pain and fatigue were the most frequently reported ADRs in immunocompromised vaccinees with higher frequency than matched control, especially after the first dose (41.2% vs 37.8% and 38.2% vs 32.9%, respectively). For both cohorts, all solicited ADRs were more frequently reported in females than males, and in those who had received a first dose of the Vaxzevria vaccine. Dizziness was the most frequently reported unsolicited ADR after the first dose in both groups (immunocompromised subjects: 2.5% and matched controls: 2.1%). At the booster dose, lymphadenopathy (3.9%) and lymphadenitis (1.8%) were the most reported unsolicited ADRs for immunocompromised subjects and matched controls, respectively. A very low number of subjects reported adverse event of special interest (AESI) (2 immunocompromised, 3 matched controls) and serious ADRs (5 immunocompromised, 5 matched controls). A statistically significant difference among study cohorts was observed for median TTO after the booster dose, and for median TTR after the first vaccination cycle and booster dose (p < 0.001).

CONCLUSION: The overall safety profile of COVID-19 vaccines in immunocompromised people was favourable, with minor differences as compared to non-immunocompromised vaccinees. Participants mostly experienced mild ADRs, mainly reported after the first dose of Vaxzevria and Jcovden vaccines. Serious ADRs and AESI were rare.

PMID:38907947 | DOI:10.1007/s40264-024-01449-x

Diabetes Ther. 2024 Jun 22. doi: 10.1007/s13300-024-01609-3. Online ahead of print.

ABSTRACT

INTRODUCTION: The triglyceride-glucose index (TyG) has been identified as a dependable and simple indicator marker of insulin resistance (IR). Research has demonstrated a correlation between macrovascular complications and TyG. However, limited research exists regarding the relationship between TyG and diabetic microvascular complications. Consequently, the objective of this study is to investigate the association between TyG and diabetic kidney disease (DKD) and diabetic peripheral neuropathy (DPN).

METHODS: This is a cross-sectional, observational study. A total of 2048 patients from Tongren Hospital, Shanghai Jiao Tong University School of Medicine were enrolled. The primary outcomes are DKD and DPN. Quantile regression analysis was employed to investigate the implicit factors of TyG quartiles. Subsequently, based on implicit factors, logistic regression models were constructed to further examine the relationship between TyG and DKD and DPN.

RESULTS: In the baseline, TyG exhibited higher values across patients with DKD, DPN, and co-existence of DKD and DPN (DKD + DPN) in type 2 diabetes (T2D). Univariate logistic regressions demonstrated a significant association between an elevated TyG and an increased risk of DKD (OR = 1.842, [95% CI] 1.317-2.578, P for trend < 0.01), DPN (OR = 1.516, [95% CI] 1.114-2.288, P for trend < 0.05), DKD + DPN (OR = 2.088, [95% CI] 1.429-3.052, P for trend < 0.05). Multivariable logistic regression models suggested a statistically significant increase in the risk of DKD (OR = 1.581, [95% CI] 1.031-2.424, p < 0.05), DKD + DPN (OR = 1.779, [95% CI] 1.091-2.903, p < 0.05) after adjusting the implicit factors of TyG quartiles. However, no significant relationship was observed between TyG and DPN in the multivariable regression analysis.

CONCLUSIONS: Elevated TyG was significantly associated with an increased risk of DKD in T2D, but no significant relationship was shown with DPN. This finding provided further evidence for the clinical significance of integrating TyG into the initial assessment of diabetic microvascular complications.

PMID:38907937 | DOI:10.1007/s13300-024-01609-3

Methods Mol Biol. 2024;2809:171-192. doi: 10.1007/978-1-0716-3874-3_12.

ABSTRACT

To optimize outcomes in solid organ transplantation, the HLA genes are regularly compared and matched between the donor and recipient. However, in many cases a transplant cannot be fully matched, due to widespread variation across populations and the hyperpolymorphism of HLA alleles. Mismatches of the HLA molecules in transplanted tissue can be recognized by immune cells of the recipient, leading to immune response and possibly organ rejection. These adverse outcomes are reduced by analysis using epitope-focused models that consider the immune relevance of the mismatched HLA.PIRCHE, an acronym for Predicted Indirectly ReCognizable HLA Epitopes, aims to categorize and quantify HLA mismatches in a patient-donor pair by predicting HLA-derived T cell epitopes. Specifically, the algorithm predicts and counts the HLA-derived peptides that can be presented by the host HLA, known as indirectly-presented T cell epitopes. Looking at the immune-relevant epitopes within HLA allows a more biologically relevant understanding of immune response, and provides an expanded donor pool for a more refined matching strategy compared with allele-level matching. This PIRCHE algorithm is available for analysis of single transplantations, as well as bulk analysis for population studies and statistical analysis for comparison of probability of organ availability and risk profiles.

PMID:38907898 | DOI:10.1007/978-1-0716-3874-3_12

Methods Mol Biol. 2024;2809:101-113. doi: 10.1007/978-1-0716-3874-3_7.

ABSTRACT

HLA somatic mutations can alter the expression and function of HLA molecules, which in turn affect the ability of the immune system to recognize and respond to cancer cells. Therefore, it is crucial to accurately identify HLA somatic mutations to enhance our understanding of the interaction between cancer and the immune system and improve cancer treatment strategies. ALPHLARD-NT is a reliable tool that can accurately identify HLA somatic mutations as well as HLA genotypes from whole genome sequencing data of paired normal and tumor samples. Here, we provide a comprehensive guide on how to use ALPHLARD-NT and interpret the results.

PMID:38907893 | DOI:10.1007/978-1-0716-3874-3_7

Methods Mol Biol. 2024;2809:77-85. doi: 10.1007/978-1-0716-3874-3_5.

ABSTRACT

Human leukocyte antigen (HLA) imputation is an essential step following genome-wide association study, particularly when putative associations in HLA genes are identified, to fully understand the genetic basis of human traits. Different HLA imputation methods have been developed, each with its own advantages, and recent methods have been improved in terms of imputation accuracy and computational costs. Here, I describe Deep*HLA, a recently published method that employs deep learning algorithms to accurately impute HLA alleles from regional single nucleotide variants. Deep*HLA was trained and benchmarked on two reference panels of different ancestries. Deep*HLA achieved high imputation accuracy with relatively mild reduced imputation accuracy for rare alleles. I provide a detailed protocol for running Deep*HLA, including instructions for data preprocessing, model training, and imputation. Deep*HLA is implemented in Python 3 and is freely available.

PMID:38907891 | DOI:10.1007/978-1-0716-3874-3_5

Eur J Clin Pharmacol. 2024 Jun 22. doi: 10.1007/s00228-024-03706-5. Online ahead of print.

ABSTRACT

PURPOSE: We aimed to estimate the absolute (incidence) and relative (hazard ratio; HR) risk of agranulocytosis associated with metamizole in comparison with non-steroidal antiinflammatory drugs (NSAIDs).

METHODS: A cohort study of new users of metamizole versus NSAIDs was performed with BIFAP (Pharmacoepidemiologic Research Database in Public Health Systems; Spain). Patients aged ≥ 2 years in 2005-2022 were followed up from the day after their first metamizole or NSAID dispensation till the end of the treatment period to identify patients hospitalized due to idiosyncratic agranulocytosis. Incidence rate (IR) and adjusted HR of agranulocytosis with metamizole versus NSAID were estimated assuming the onset date of agranulocytosis was the date of hospitalization sensitivity analysis or 7 days before (main analysis). In secondary analyses, we used (1) opioids-paracetamol as negative control and (2) any hospitalized neutropenia as outcome (assuming the onset was 7 days before).

RESULTS: The cohorts included 444,972 new users of metamizole, 3,814,367 NSAID, and 3,129,221 opioids-paracetamol on continuous treatment during a median of 37-40 days. Overall, 26 hospitalized agranulocytosis occurred, 5 in the first week (and so removed in main analysis) and 21 thereafter. IR of agranulocytosis was 14.20 (N = 5 cases) and 8.52 (N = 3), 1.95 (N = 6) and 1.62 (N = 5), and 4.29 (N = 15) and 3.72 (N = 13)/10⁷ person-weeks of continuous treatment using the date of hospitalization or 7 days before, respectively. Two, 0 and 2 of cases identified in both analyses had neoplasia in every cohort, respectively. HR of agranulocytosis associated with metamizole was 7.20 [95% CI: 1.92-26.99] and 4.40 [0.90-21.57] versus NSAID, and 3.31 [1.17-9.34] and 2.45 [0.68-8.83] versus opioid-paracetamol, respectively. HR of neutropenia with metamizole was 2.98 [1.57-5.65] versus NSAID.

CONCLUSIONS: Agranulocytosis was very rare but more common (above 4 times more) with metamizole than other analgesics. The impact of the drug-induced agranulocytosis was less precise with metamizole than the comparators due to its lower use, which precluded to find statistical differences in main analysis. The increased risk of hospitalized neutropenias with metamizole supports the link with its severity although triggers unavailable during the follow-up (ex. cytotoxic medication) can not be discarded.

PMID:38907883 | DOI:10.1007/s00228-024-03706-5

Hernia. 2024 Jun 22. doi: 10.1007/s10029-024-03090-0. Online ahead of print.

ABSTRACT

PURPOSE: This study aimed to investigate the surgical outcomes of laparoscopic inguinal hernia repair using an Endoscope Manipulator Robot (EMARO).

METHODS: This retrospective study included 51 patients who underwent laparoscopic inguinal hernia repairs. The transabdominal preperitoneal approach (TAPP) has been used to treat inguinal hernias. The patients were divided into two groups: one group underwent laparoscopic surgery using EMARO (E-TAPP) and the other group underwent conventional laparoscopic surgery (L-TAPP). The EMARO is a pneumatically driven endoscope-holder robot. The surgical outcomes of laparoscopic inguinal hernia repair were compared between the two groups.

RESULTS: Fifteen patients underwent E-TAPP, and 36 underwent L-TAPP. The L-TAPP operation requires two personnel, whereas E-TAPP can be performed by one surgeon. The median operation times of the E-TAPP and L-TAPP groups were 81 min (range, 77-87) and 70 min (range, 60-94), respectively, and the median blood loss was 5 mL (range, 1-5) and 2 mL (range, 1-5). However, these differences were not statistically significant. The setup time for EMARO was approximately 8 min (range, 5-12). No patient experienced recurrence, and the postoperative complication rates were similar between the two groups. The number of patients who used postoperative analgesics in the E-TAPP and L-TAPP groups was four (n = 15) and 22 (n = 36), respectively, with a significant difference between the two groups (p = 0.042).

CONCLUSION: Laparoscopic surgery using EMARO can reduce labor costs and postoperative pain. The surgical outcomes of the E-TAPP group were not inferior to those of the L-TAPP group, and E-TAPP could also be safely performed.

PMID:38907879 | DOI:10.1007/s10029-024-03090-0

Int J Retina Vitreous. 2024 Jun 21;10(1):44. doi: 10.1186/s40942-024-00564-2.

ABSTRACT

Macular holes (MHs), including atraumatic idiopathic and refractory MHs, affect central vision acuity due to full-thickness defects in the retinal tissue. The existing controversy regarding the pathophysiology and management of MHs has significantly improved with the implementation of internal limiting membrane (ILM) surgical techniques and improved MH closure rates. Thus, to determine the effect of ILM techniques on large idiopathic and refractory MH management, the present study systematically reviewed 5910 original research articles extracted from online literature databases, including PubMed, Cochrane, Google Scholar, and Embase, following the PRISMA guidelines. The primary outcome measures were MH closure rate and postoperative visual acuity. A total of 23 randomized controlled trials (RCTs) with adequate patient information and information on the effect of ILM peeling, inverted ILM flaps, autologous retinal transplantation (ART), and ILM insertion techniques on large idiopathic and refractory MH patients were retrieved and analyzed using RevMan software (version 5.3) provided by the Cochrane Collaboration. Statistical risk of bias analysis was also conducted on the selected sources using RoB2, which showed a low risk of bias in the included studies. A meta-analysis indicated that the inverted ILM flap technique had a significantly greater MH closure rate for primary MH than the other treatment methods (OR = 3. 22, 95% CI 1.34-7.43; p = 0.01). Furthermore, the findings showed that the inverted ILM flap group had significantly better postoperative visual acuity than did the other treatment options for patients with idiopathic MH (WMD = – 0.13; 95% CI = 0.22-0.09; p = 0.0002). The ILM peeling technique had the second highest statistical significance for MH closure rates in patients with idiopathic MH (OR = 2. 72, 95% CI: 1.26-6.32; p = 0.016). In refractory MHs, autologous retinal transplant (ART) and multilayer ILM plug (MIP) techniques improve the closure rate and visual function; human amniotic membrane grafting (hAMG) provides a high degree of anatomical outcomes but disappointing visual results. This study demonstrated the reliability and effectiveness of ILM techniques in improving the functional and anatomical outcomes of large idiopathic and refractory MH surgery. These findings will help clinicians choose the appropriate treatment technique for patients with idiopathic and refractory MH.

PMID:38907361 | DOI:10.1186/s40942-024-00564-2