Category: Statistics

J Glob Antimicrob Resist. 2024 Mar 30:S2213-7165(24)00058-4. doi: 10.1016/j.jgar.2024.03.009. Online ahead of print.

ABSTRACT

OBJECTIVE: This study aims to estimate the overall in vitro activity of bedaquiline (BDQ) against clinical isolates of Mycobacterium abscessus complex (MABS) and Mycobacterium avium complex (MAC), considering BDQ as a repurposed drug for non-tuberculous mycobacteria (NTM) infections.

METHODS: We conducted a systematic review of publications in PubMed/ MEDLINE, Web of Science, and Embase up to April 15, 2023. Studies were included if they followed the Clinical and Laboratory Standards Institute (CLSI) criteria for drug susceptibility testing (DST). Using a random effects model, we assessed the overall in vitro BDQ resistance rate in clinical isolates of MABS and MAC. Sources of heterogeneity were analyzed using Cochran’s Q and the I² statistic. All analyses were performed using CMA V3.0.

RESULTS: A total of 24 publications (19 reports for MABS and 11 for MAC) were included. Using 1 μg/mL and 2 μg/mL as the breakpoint for BDQ resistance, the pooled rates of in vitro BDQ resistance in clinical isolates of MABS were found to be 1.8% (95% confidence interval [CI], 0.7-4.6%) and 1.7% (95% CI, 0.6-4.4%), respectively. In the case of MAC, the pooled rates were 1.7% (95% CI, 0.4-6.9%) and 1.6% (95% CI, 0.4-6.8%) for 1 μg/mL and 2 μg/mL, respectively.

CONCLUSION: This study reports the prevalence of BDQ resistance in clinical isolates of MABS and MAC. The findings suggest that BDQ holds potential as a repurposed drug for treating MABS and MAC infections.

PMID:38561143 | DOI:10.1016/j.jgar.2024.03.009

Transplant Cell Ther. 2024 Mar 30:S2666-6367(24)00301-4. doi: 10.1016/j.jtct.2024.03.028. Online ahead of print.

ABSTRACT

BACKGROUND: While curing a patient’s underlying disease is the primary goal of physicians performing hematopoietic cell transplantation (HCT), the ultimate objective is to provide patients with optimal post-HCT quality of life. For many survivors, this includes returning to work (RTW).

OBJECTIVE: We conducted a survey of one- to five-year post-HCT survivors at our center to evaluate their perspective on facilitators and barriers to RTW as well as to gauge interest in potentially useful RTW support interventions.

STUDY DESIGN: Survivors aged 18 to 65 years (n=994) were sent an annual survey that included 36 supplementary questions about post-HCT RTW. Survey questions were selected from published national cancer survivor surveys and then modified specifically for HCT survivors.

RESULTS: 344 (35%) survivors with a mean age of 53 years completed the survey, of whom 272 (79%) had worked prior to their diagnosis. Of those 272 patients, 145 (53%) were working currently and another 22 (8%) had attempted to go back to work following HCT but were not presently working. We found that having had an allogeneic vs autologous HCT (p=0.006) was associated with a decreased likelihood of currently working, whereas frequent employer communication (> once a month) (p=0.070) and having a more supportive employer (p=0.036) were associated with a greater chance of currently working. Of survivors currently working, 45% reported that they had made one or more changes to their work schedule (e.g., flexible schedule or part-time work) or environment (e.g., work from home) upon RTW. Ninety-five percent of responders reported that they could have benefited from RTW support provided by the transplant center, but only 13% indicated that they had received it. Education on RTW challenges, information on disability benefits, and access to physical therapy were among the most requested support interventions.

CONCLUSION: To improve post-HCT quality of life for survivors open to assistance, providers should address work status and goals, recognize barriers to successful return, and offer RTW support including working directly with employers. Allogeneic HCT survivors are particularly vulnerable to failing attempts to RTW and should be the target of retention interventions. A previously published manuscript on RTW guidance for providers of stem cell transplant patients endorsed by the American Society of Transplant and Cellular Therapy is available Open Access and can be used as a tool to counsel and support these patients.

PMID:38561139 | DOI:10.1016/j.jtct.2024.03.028

Radiother Oncol. 2024 Mar 30:110264. doi: 10.1016/j.radonc.2024.110264. Online ahead of print.

ABSTRACT

BACKGROUND: High-level evidence on hypofractionated proton therapy (PT) for localized and locally advanced prostate cancer (PCa) patients is currently missing. The aim of this study is to provide a systematic literature review to compare the toxicity and effectiveness of curative radiotherapy with photon therapy (XRT) or PT in PCa.

METHODS: PubMed, Embase, and the Cochrane Library databases were systematically searched up to April 2022. Men with a diagnosis of PCa who underwent curative hypofractionated RT treatment (PT or XRT) were included. Risk of grade (G) ≥ 2 acute and late genitourinary (GU) OR gastrointestinal (GI) toxicity were the primary outcomes of interest. Secondary outcomes were five-year biochemical relapse-free survival (b-RFS), clinical relapse-free, distant metastasis-free, and prostate cancer-specific survival. Heterogeneity between study-specific estimates was assessed using Chi-square statistics and measured with the I2 index (heterogeneity measure across studies).

RESULTS: A total of 230 studies matched inclusion criteria and, due to overlapped populations, 160 were included in the present analysis. Significant lower rates of G ≥ 2 acute GI incidence (2 % vs 7 %) and improved 5-year biochemical relapse-free survival (95 % vs 91 %) were observed in the PT arm compared to XRT. PT benefits in 5-year biochemical relapse-free survival were maintained for the moderate hypofractionated arm (p-value 0.0122) and among patients in intermediate and low-risk classes (p-values < 0.0001 and 0.0368, respectively). No statistically relevant differences were found for the other considered outcomes.

CONCLUSION: The present study supports that PT is safe and effective for localized PCa treatment, however, more data from RCTs are needed to draw solid evidence in this setting and further effort must be made to identify the patient subgroups that could benefit the most from PT.

PMID:38561122 | DOI:10.1016/j.radonc.2024.110264

J Gastrointest Surg. 2024 Mar 30:S1091-255X(24)00391-3. doi: 10.1016/j.gassur.2024.03.029. Online ahead of print.

ABSTRACT

BACKGROUND: Although many guidelines recommend performing lymph node dissection (LND) during surgery for intrahepatic cholangiocarcinoma (ICC), there is no evidence for incidentally detected ICC patients who did not undergo LND. This study aimed to identify the role of lymph node dissection in patients with incidental ICC.

METHODS: The data from 284 patients who had undergone radical surgery for ICC from 2000 to 2020 were retrospectively reviewed. The enrolled patients were divided into three groups according to their T stage (T1 vs. T2 vs. T3+4). Moreover, the patients of each T group were divided into three groups according to their nodal status (N0 vs. N1 vs. Nx) and their survival outcomes were compared.

RESULTS: Survival outcomes of Nx group were statistically similar to that of N0 group in T1 stage (Nx vs. N0: disease-free survival (DFS) (months), 129.0 [75.6-182.4] vs. 125.0 [65.7-184.3], p=0.948; overall survival (OS) (months), 175.0 [153.9-196.1] vs. 173.0 [109.0-237.0], p=0.443). On the other hand, survival outcomes of Nx group in the other T stage (T2 and T3+4) were poorer than that of N0 group and were better than that of N1 group. In addition, in the Nx subgroup analysis according to T stage, T1 group showed significantly better survival outcomes than the other groups. (T1 vs. T2 vs. T3+4: DFS (months), 129.0 [75.9-182.1] vs. 16.0 [9.8-22.2] vs. 13.0 [0.3-25.7], p<0.001; OS (months), 175.0 [153.9-196.1] vs. 53.0 [30.8-75.2] vs. 37.0 [17.6-56.4], p<0.001) CONCLUSION: ICC patients incidentally diagnosed with T2 or above T stage may consider additional LND.

PMID:38561087 | DOI:10.1016/j.gassur.2024.03.029

Int J Infect Dis. 2024 Mar 30:107021. doi: 10.1016/j.ijid.2024.107021. Online ahead of print.

ABSTRACT

OBJECTIVES: Evaluate and compare the efficacy and safety of molnupiravir and favipiravir in outpatients with mild to moderate COVID-19 and at risk of severe COVID-19.

METHODS: In an open-label, parallel-group, multicenter trial in Thailand, participants with moderate COVID-19 and at least one factor associated with severe COVID-19 were randomly assigned 1:1 to receive oral molnupiravir or oral favipiravir (standard of care). Phone calls for remote symptom assessment were made on Days 6, 15 and 29. Participants with worsening symptoms were instructed to return to the hospital. The primary endpoint was pulmonary involvement by Day 29, as evidenced by ≥2 of the following: dyspnea, oxygen saturation <92% or imaging.

RESULTS: 977 participants (487 molnupiravir, 490 favipiravir) were enrolled from 8 July 2022 to 19 January 2023. 98% had received ≥1 dose of COVID-19 vaccine and 83% ≥3 doses. By Day 29, pulmonary involvement occurred in 0% (0/483) in molnupiravir arm versus 1% (5/482) in favipiravir arm (-1.0%; Newcombe 95.2% CI: -2.4% to -0.0%; p=0.021); all-cause death in 0% (0/483) and <1% (1/482); COVID-19 related hospitalization in <1% (1/483) and 1% (3/482); treatment-related adverse event in 1% (5/483) and 1% (4/486); and serious adverse event in 1% (4/483) and 1% (4/486).

CONCLUSIONS: Favipiravir and molnupiravir had a similar efficacy and safety profile. Whether either of the two reduced the risk of complications during the omicron era in this population with a low risk of pulmonary involvement and a high vaccine coverage remains unclear. There were no differences in any of the safety endpoints.

THAI CLINICAL TRIALS REGISTRY ID: TCTR20230111009.

PMID:38561040 | DOI:10.1016/j.ijid.2024.107021

J Dent. 2024 Mar 30:104968. doi: 10.1016/j.jdent.2024.104968. Online ahead of print.

ABSTRACT

OBJECTIVES: To determine and compare the opportunistic respiratory pathogenic index (ORPI) and prevalence of respiratory pathogens between clean and unclean removable prostheses.

METHODS: A cross-sectional study was conducted among 97 removable prosthesis wearers at a teaching dental hospital. Participants’ prosthesis hygiene was grouped into clean and unclean. After prosthesis plaque samples were sequenced using the Type IIB Restriction-site Associated DNA Sequencing for Microbiome method, the prevalence was assessed for the presence of respiratory pathogens on each sample. The ORPIs for clean and unclean prostheses were quantified based on the sum of the relative abundance of respiratory pathogenic bacteria in a microbiome using a reference database that contains opportunistic respiratory pathogens and disease-associated information.

RESULTS: A total of 30 opportunistic respiratory pathogens were identified on the removable prostheses. Eighty-one (83.5%) removable prostheses harboured respiratory pathogenic bacteria. Stenotrophomonas maltophilia (34.0%), Pseudomonas aeruginosa (27.8%), and Streptococcus agalactiae (27.8%) were the top three prevalent respiratory pathogens detected in plaque samples. There was a significantly higher prevalence of respiratory pathogens residing on unclean than clean prostheses (P = 0.046). However, the ORPIs in both groups showed no statistically significant difference (P = 0.516).

CONCLUSIONS: The ORPIs for both clean and unclean prostheses demonstrated a similar abundance of respiratory pathogens. However, the high prevalence of respiratory pathogens residing on unclean prostheses should not be underestimated. Therefore, maintaining good prosthesis hygiene is still important for overall oral and systemic health, even though the direct link between prosthesis cleanliness and reduced abundance of respiratory pathogens has not been established.

CLINICAL SIGNIFICANCE: The association between the prevalence of respiratory pathogens and unclean removable prostheses has been demonstrated and might increase the theoretical risk of respiratory disease development.

PMID:38561038 | DOI:10.1016/j.jdent.2024.104968

World Neurosurg. 2024 Mar 30:S1878-8750(24)00528-X. doi: 10.1016/j.wneu.2024.03.142. Online ahead of print.

ABSTRACT

BACKGROUND: Bilateral cages are often used for interbody fusion. However, this procedure may not be possible in some cases making unilateral cages a reasonable alternative. The literature remains divided on the clinical and radiological distinctions when comparing unilateral to bilateral cages in lumbar interbody fusion. Thus, this meta-analysis will analyze the clinical and radiographic outcomes between these two groups.

METHODS: PubMed, Cochrane, and Google Scholar (page 1-20) were searched till January 2024. The clinical outcomes evaluated were the incidence of adverse events, surgery-related parameters, and patient reported outcomes.

RESULTS: Lower rates of pseudoarthrosis, subsidence, were reported in the bilateral cages group (p=0.01, p=0.001, respectively) whereas shorter operative time (OR time), and lower estimated blood loss (EBL) were seen in unilateral cage group (p<0.001, and p=0.003). There was no statistically significant difference in the remaining analyzed outcomes.

CONCLUSION: Unilateral cages were shown to be superior due to their reduced OR time and EBL. As for the higher rate of pseudoarthrosis, this outcome may not be related to the cage numbers and it did not affect clinical outcomes. Nevertheless, one must consider other factors such as radiographic sagittal parameters before making a surgical decision.

PMID:38561031 | DOI:10.1016/j.wneu.2024.03.142

World Neurosurg. 2024 Mar 30:S1878-8750(24)00527-8. doi: 10.1016/j.wneu.2024.03.141. Online ahead of print.

ABSTRACT

PURPOSE: The purpose of this study was to determine the relationship between the uncinate process and vertebral artery from a radiological view and to confirm the surgical safety margin in order to minimize the risk of vertebral artery injury during anterior cervical approaches.

METHODS: We retrospectively reviewed computed tomography angiography of 205 patients by using a contrast-enhanced CTA protocol of the vertebral artery. Four kinds of images were simultaneously reconstructed to measure all the parameters associated with vertebral artery and uncinate process of cervical spine.

RESULTS: The shortest distance from the UP’s tip to the VA’s medial border (p<0.001) was at the C-6 level (2.9±0.9mm on the left and 3.2±1.3 on the right), and the longest distance (p<0.001) was at the C-3 level on both sides. The distance between UP’s tip and the medial border of the ipsilateral VA was statistically significantly different at each cervical level, and the right distance was larger than the left (p<0.05). We found the height of UP gradually increased from C-3 to C5-level and then decreased from C-5 to C-7 level for both sides. The mean distance between the medial borders of left UP and left VA was on average 7.5±1.4mm. The diameter of VA was on average 3.4±0.6mm on the left side and 3.2±0.7mm on the right. The diameter of the VA was statistically significantly different on both sides, and the left side was larger than the right (p<0.05).

CONCLUSIONS: Detailed radiologic anatomy of vertebral artery and uncinate process was reviewed in this study. A deep understanding of the correlation between the uncinate process and vertebral artery is essential to perform anterior cervical spine surgery safely and ensure adequate spinal canal decompression.

PMID:38561028 | DOI:10.1016/j.wneu.2024.03.141

Pediatr Exerc Sci. 2024 Apr 1:1-10. doi: 10.1123/pes.2023-0119. Online ahead of print.

ABSTRACT

PURPOSE: Examine in preschool-aged children: (1) the associations between parental-reported and device-measured outdoor play (OP) and health indicators of physical, cognitive, and social-emotional development and (2) whether associations were independent of outdoor moderate- to vigorous-intensity physical activity (MVPA).

METHODS: This cross-sectional study included 107 participants. Children’s OP was measured via a parental questionnaire and the lux feature of accelerometers. Children’s growth, adiposity, and motor skills were assessed as physical development indicators. Visual-spatial working memory, response inhibition, and expressive language were assessed as cognitive development indicators. Sociability, prosocial behavior, internalizing, externalizing, and self-regulation were assessed as social-emotional development indicators. Regression models were conducted that adjusted for relevant covariates. Additional models further adjusted for outdoor MVPA.

RESULTS: Parental-reported total OP, OP in summer/fall months, and OP on weekdays were negatively associated (small effect sizes) with response inhibition and working memory. After adjusting for outdoor MVPA, these associations were no longer statistically significant. OP on weekdays was negatively associated with externalizing (B = -0.04; 95% confidence interval, -0.08 to -0.00; P = .03) after adjusting for outdoor MVPA. A similar pattern was observed for device-based measured total OP (B = -0.49; 95% confidence interval, -1.05 to 0.07; P = .09).

CONCLUSIONS: Future research in preschool-aged children should take into account MVPA and contextual factors when examining the association between OP and health-related indicators.

PMID:38561002 | DOI:10.1123/pes.2023-0119

Multivariate Behav Res. 2024 Apr 1:1-23. doi: 10.1080/00273171.2024.2318784. Online ahead of print.

ABSTRACT

Researchers are often interested in comparing predictors, a practice commonly done via informal comparisons of standardized regression slopes. However, formal interval-based approaches offer advantages over informal comparison. Specifically, this article examines a delta-method-based confidence interval for the difference between two standardized regression coefficients, building upon previous work on confidence intervals for single coefficients. Using Monte Carlo simulation studies, the proposed approach is evaluated at finite sample sizes with respect to coverage rate, interval width, Type I error rate, and statistical power under a variety of conditions, and is shown to outperform an alternative approach that uses the standard covariance matrix found in regression textbooks. Additional simulations evaluate current software implementations, small sample performance, and multiple comparison procedures for simultaneously testing multiple differences of interest. Guidance on sample size planning for narrow confidence intervals, an R function to conduct the proposed method, and two empirical demonstrations are provided. The goal is to offer researchers a different tool in their toolbox for when comparisons among standardized coefficients are desired, as a supplement to, rather than a replacement for, other potentially useful analyses.

PMID:38560991 | DOI:10.1080/00273171.2024.2318784