Category: Statistics

Wounds. 2023 Jul;35(7):E229-E235.

ABSTRACT

INTRODUCTION: Podiatric infections are common in patients with and without diabetes. Biofilm detection would aid in determining the severity of foot infections and preventive strategies to manage them.

OBJECTIVE: The authors studied the clinicomicrobiological profile of podiatric infections.

MATERIALS AND METHODS: Organisms from podiatric specimens were identified and the antibiotic susceptibility of the organisms determined using standard microbiological methods. Organisms were screened for biofilm production using the microtiter plate method. Staphylococcus aureus isolates were screened for ica, cna, and hlg genes by multiplex PCR.

RESULTS: A total of 117 patients were included in the study, and specimens from 71 patients were culture positive (60.6%). Gram-negative bacteria were predominant (n = 88 [73.3%]). S aureus (n = 32 [26.7%]) was the most common isolate. The rate of biofilm production was 54.2%. Pseudomonas aeruginosa was the most prevalent biofilm producer (82.8%). The study revealed a statistically significant association of biofilm formation with MDR, MRSA, and prior antibiotic therapy with multiple (≥4) antibiotics.

CONCLUSION: Isolation of MRSA or MDR strain from diabetic foot infections could alert the clinician to the possibility of treatment failure with a single drug regimen owing to associated biofilm production. Detection of biofilm producers and subsequent early debridement and/or cleaning of wounds might prevent chronic infection.

PMID:37523740

Cancer Nurs. 2023 Jul 31. doi: 10.1097/NCC.0000000000001273. Online ahead of print.

ABSTRACT

BACKGROUND: Identification of factors associated with quality of life (QOL) among cancer survivors is crucial for identifying potential targets for intervention.

OBJECTIVES: We aimed to provide evidence of factors associated with the QOL among posttreatment cancer survivors in Korea.

METHODS: We performed a systematic literature search from January 2000 to September 2022 using PubMed, EMBASE, CINAHL, PsycINFO, and Korean databases (RISS, SCIENCEON). We evaluated study quality using the Joanna Briggs Institute Quality Appraisal Checklists for Analytical Cross-sectional Studies and performed statistical analysis using the R 3.0 software (R Foundation for Statistical Computing, Vienna, Austria) package. We analyzed the pooled effect sizes of potential QOL correlates by the random-effects model.

RESULTS: This meta-analysis included 31 studies with 8934 participants. The pooled estimates were significantly large for economic status (r = -0.53); significantly medium for fatigue (r = -0.39), anxiety (r = -0.29), depression (r = -0.42), self-efficacy (r = 0.37), and social support (r = 0.30); and significantly small for education level (r = -0.18), job status (r = -0.09), cancer stage (r = -0.20), and time since diagnosis (r = -0.26).

CONCLUSIONS: Low education level, having no job, low economic status, advanced cancer stage, short disease period, fatigue, anxiety, and depression were significantly associated with worse QOL, whereas self-efficacy and social support were significantly associated with better QOL.

IMPLICATIONS FOR PRACTICE: The findings have potential implications for identifying “at-risk survivors” of deteriorated QOL and for suggesting powerful strategies (eg, enhancing self-efficacy or social support) for improving QOL.

PMID:37523733 | DOI:10.1097/NCC.0000000000001273

Int J Radiat Biol. 2023 Jul 31:1-11. doi: 10.1080/09553002.2023.2232009. Online ahead of print.

ABSTRACT

Purpose: The application of high-intensity focused ultrasound (HIFU) in hepatocellular carcinoma (HCC) was promising. However, whether the effect of HIFU is comparable with that of transarterial chemoembolization (TACE) has not been determined.Materials and methods: PubMed, Embase, Cochrane Library, Web of Science, WanFang Data, CqVip, CNKI, and CBM databases were searched for randomized controlled trials (RCTs), cohort studies, and case-control studies. The methodological quality of each study was evaluated. When there is no statistical heterogeneity, the fixed effect model would be used to merge data. Otherwise, the random effect model would be utilized. Sensitivity analyses were conducted by excluding one study each time. Subgroup analyses were conducted based on age, sex, tumor number, relative number of the patients with Child-Pugh C grade in each group, the percentage of patients with Child-Pugh C grade in the whole study, and tumor load. Publication bias was evaluated by Egger’s test and Begg’s test.Results: Six cohort studies including 188 patients from HIFU group and 224 patients from TACE group were obtained for further analysis. The meta-analysis suggested HIFU and TACE showed no differences in postoperative 1-year overall survival (OS) rate, tumor response (including complete response, partial response, stable disease, and progressive disease), and postoperative complications. Moreover, compared with TACE, HIFU showed higher postoperative 6-month and 2-year OS rates. Subgroup analyses, meta regression analysis and sensitivity analyses indicated the findings above were reliable. Additionally, no potential publication bias was detected.Conclusion: For HCC, when compared with TACE, HIFU might show comparable safety but better effect. Considering the limitations of current studies, more well-designed studies are needed to validate our conclusion.

PMID:37523652 | DOI:10.1080/09553002.2023.2232009

J Glaucoma. 2023 Jul 25. doi: 10.1097/IJG.0000000000002278. Online ahead of print.

ABSTRACT

PRECIS: In this study, in patients with pseudoexfoliation syndrome or glaucoma, changes in intraocular pressure and pupil size after %1 tropicamide used for pupil dilation, compared to healthy patients, were quantitatively demonstrated up to 4 hours after dilation.

PURPOSE: To evaluate pharmacological dilatation with one drop of 1% tropicamide on pupillary diameter and intraocular pressure (IOP) changes in patients with pseudoexfoliation syndrome (PXS) and glaucoma (PXG).

METHODS: Eighty-two patients with PXS, 78 Patients with PXG, and 35 healthy subjects were included in the study. PXG and PXS were diagnosed based on IOP assessment, corneal pachymetry, optic disc examination, visual field testing, and peripapillary retinal nerve fiber analysis. IOP and the diameter of pupil size were measured before dilatation and at post dilatation 1st hour, 2nd, and 4th hours.

RESULTS: The mean pupillary diameter values at post-dilatation 2nd and 4th hours were statistically significantly different between the patients with PXS and PXG (P<0.001, for each). Also, there were significant differences between PXS group and control group in terms of the mean pupillary diameter values at pre-dilatation and post-dilatation at 1st hour and post-dilatation 2nd hour(P=0.007, P<0.001 respectively). The mean pupillary diameter at all times was statistically significantly different between PXG and control groups (P<0.001 for each). Significant IOP increases were observed in all groups after dilatation. The mean IOP at pre-dilatation and post-dilatation 4th hour were statistically significantly different between PXG and PXS groups (P=0.042, P<0.001, respectively). Whereas the mean IOP at pre-dilatation, post-dilatation 1st hour, post-dilatation 2nd hour, and post-dilatation 4th hour were statistically significantly different between PXG and control group (P<0.001 for each).

CONCLUSION: Significant IOP increases have been observed in our study with 1% tropicamide in the PXG and PXS groups, with the peak effect at the 2nd hour in the post-dilatation period. Furthermore, the mean pupil diameter was found to be significantly lower in PXG patients compared to the control group.

PMID:37523644 | DOI:10.1097/IJG.0000000000002278

J Glaucoma. 2023 Jul 21. doi: 10.1097/IJG.0000000000002273. Online ahead of print.

ABSTRACT

PURPOSE: To characterize treatment patterns for newly-diagnosed glaucoma in sub-Saharan Africa (SSA).

METHODS: This was a multicenter cross-sectional study of adults newly diagnosed with glaucoma at 27 eye care centers in 10 African countries. In addition to demographic and clinical data, physician treatment recommendations (medication, laser, surgery, or no treatment) were recorded. Statistical analyses were performed using STATA version 14.0.

RESULTS: Data from 1201 patients were analyzed. Physicians were most likely to recommend primary medical therapy upon diagnosis of glaucoma (69.4%), with laser (13.2%), surgery (14.9%), and no treatment (2.5%) recommended to the remaining patients. All sites had medical therapy available and most (25/27, 92.6%) could provide surgical treatment; only 16/27 (59.3%) sites offered laser, and at these sites, 30.8% of eyes were recommended to undergo primary laser procedures. As glaucoma severity increased, laser was recommended less, surgery more, and medications unchanged. Patient acceptance of medical therapy was 99.1%, laser 88.3%, and surgery 69.3%.

CONCLUSIONS: Medical therapy for first-line glaucoma management is preferred by most physicians in SSA (69%). Laser therapy may be underutilized at centers where it is available. These findings underscore the need for comparative studies of glaucoma treatments in SSA to inform the development of evidence-based treatment guidelines and of programs to reduce glaucoma blindness in SSA. Strategic approaches to glaucoma therapy in SSA must address the question of whether medical therapy is the most optimal first line approach in this setting.

PMID:37523638 | DOI:10.1097/IJG.0000000000002273

J Glaucoma. 2023 Jul 20. doi: 10.1097/IJG.0000000000002271. Online ahead of print.

ABSTRACT

PRECIS: This retrospective study found a statistically significant reduction in mean intraocular pressure and number of medications after intracameral Bimatoprost SR injection in patients with glaucoma. A history of selective laser trabeculoplasty did not impact treatment outcomes.

PURPOSE: To determine outcomes of Bimatoprost sustained release (Bimatoprost SR) on intraocular pressure (IOP) and number of topical IOP lowering medications in patients with glaucoma. A secondary objective was to determine the outcomes of Bimatoprost SR in patients with a prior history of selective laser trabeculoplasty (SLT).

METHODS: Retrospective case series. One hundred and eighteen eyes from 84 patients that received Bimatoprost SR by 6 glaucoma specialists at Wills Eye Hospital from March 2020 to September 2021 were examined. The intervention was a single injection of intracameral Bimatoprost SR. Main outcome measures included IOP and number of medications.

RESULTS: The mean most recent follow-up time for all eyes was 27.8±18.6 weeks. Mean post-treatment IOP at most recent follow-up of 16.6±5.3 mmHg was significantly lower than mean under therapy pre-treatment IOP of 18.5±5.7 mmHg for all eyes (P<0.01). Mean post-treatment number of medications at most recent follow-up of 1.3±1.3 decreased compared to number of pre-treatment medications of 2.1±1.4 for all eyes (P<0.01). Analysis of multilevel models controlling for demographic variables demonstrated a statistically significant reduction in IOP and number of medications post-treatment (P<0.01). A prior history of SLT (n=54) had no impact on treatment for both IOP and number of medications (P>0.1 for both).

CONCLUSIONS: Intracameral Bimatoprost SR reduced IOP and decreased the number of medications. Prior history of SLT did not impact Bimatoprost SR treatment outcomes.

PMID:37523637 | DOI:10.1097/IJG.0000000000002271

J Glaucoma. 2023 Jul 20. doi: 10.1097/IJG.0000000000002262. Online ahead of print.

ABSTRACT

PRCIS: Our results demonstrate that, among randomized clinical trials examining the use of surgical treatments for glaucoma, the majority were not registered. Publication bias was less likely. More than one third of registered trials presented outcome reporting bias.

PURPOSE: Despite the optimum of quality evidence provided by randomized controlled trials (RCTs), biases may be introduced and hinder their application. The primary objective of this study was to investigate outcome reporting bias (ORB) and publication bias (PB) in RCTs assessing surgical treatments of glaucoma, as well as their registration status.

METHODS: A literature review was conducted in MEDLINE, EMBASE and CENTRAL databases. Inclusion criteria were RCTs published in English between 2007 and 2021 that focused on surgical treatments of patients of all ages with glaucoma or elevated intraocular pressure. Exclusion criteria included cadaveric and animal studies. Registration status was correlated with entries from clinical trial registries. PB was determined by the proportion of trials presenting statistically significant results. ORB was evaluated by comparing the study’s primary outcome with that listed in the trial registry. Trials quality was assessed using the Jadad score.

RESULTS: After deleting duplicates, 7,561 citations were screened. 161 RCTs were eligible and included between 13 and 556 participants. Ninety one percent studied an adult population and 71% included patients suffering from primary open-angle glaucoma. Among included studies, 63% were not registered and 47% had statistically significant results. An upward trend in registration was observed with time. However, 37% of the studies showed discrepancies between objectives in cited clinical trial registries and the published results.

CONCLUSION: Publication bias in surgical glaucoma trials was not obvious. Among the minority of trials that were registered, more than a third presented outcome reporting bias. Unregistered trials had lower quality. RCT registration is crucial for transparent interpretation of studies, improved patient care in surgery and informed decision-making.

PMID:37523630 | DOI:10.1097/IJG.0000000000002262

J Glaucoma. 2023 Jul 19. doi: 10.1097/IJG.0000000000002269. Online ahead of print.

ABSTRACT

PRCIS: The change in glaucoma surgical volumes due to the COVID-19 pandemic was not uniform across procedure types and unequal between rural and urban practice locations.

PURPOSE: To quantify the impact of the COVID-19 pandemic on surgical volumes performed by fellowship-trained glaucoma subspecialists.

METHODS: This retrospective cohort analysis of the CMS Medicare Public Use File extracted all glaucoma surgeries including micro-invasive glaucoma surgeries, trabeculectomy, goniotomy, lasers, and cataract surgery performed by fellowship-trained glaucoma surgeons in rural and urban areas between 2016 and 2020. Predicted estimates of 2020 surgical volumes were created utilizing linear squares regression. Percent change between predicted and observed 2020 surgical volume estimates was analyzed. Statistical significance was achieved at P<0.05.

RESULTS: In 2020, fellowship trained glaucoma surgeons operated mostly in urban areas (N=810, 95%). A 29% and 31% decrease in predicted cataract surgery volumes in urban and rural areas was observed. Glaucoma surgeries experienced a 36% decrease from predicted estimates (N=56,781). MIGS experienced a 86% and 75% decrease in rural and urban areas respectively. Trabeculectomy in rural areas experienced a 16% increase relative to predicted estimates while urban areas experienced a decrease of 3% (P>0.05). The number of goniotomies decreased by 10% more in rural areas than in urban areas (-22% and -12%, respectively). Laser procedures decreased by 8% more in urban areas than in rural areas (-18% and -10%, respectively).

CONCLUSIONS: Among glaucoma-trained surgeons, glaucoma surgeries experienced a greater volume loss than cataract surgeries. In urban US areas, relative reductions in MIGS and goniotomy volumes in urban areas may have been compensated by greater laser and trabeculectomy volumes. Trabeculectomies in rural areas was the only group exceeding predicted estimates. Glaucoma subspecialists may utilize these findings when planning for future events and in overcoming any remaining unmet need in terms of glaucoma care.

PMID:37523625 | DOI:10.1097/IJG.0000000000002269

J Clin Oncol. 2023 Jul 31:JCO2300045. doi: 10.1200/JCO.23.00045. Online ahead of print.

ABSTRACT

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.ARST1321 was a phase II study designed to compare the near complete pathologic response rate after preoperative chemoradiation with/without pazopanib in children and adults with intermediate-/high-risk chemotherapy-sensitive body wall/extremity non-Rhabdomyosarcoma Soft Tissue Sarcoma (ClinicalTrials.gov identifier: NCT02180867). Enrollment was stopped early following a predetermined interim analysis that found the rate of near complete pathologic response to be significantly greater with the addition of pazopanib. As a planned secondary aim of the study, the outcome data for this cohort were analyzed. Eight-five eligible patients were randomly assigned to receive (regimen A) or not receive (regimen B) pazopanib in combination with ifosfamide and doxorubicin + preoperative radiotherapy followed by primary resection at week 13 and then further chemotherapy at week 25. As of December 31, 2021, at a median survivor follow-up of 3.3 years (range, 0.1-5.8 years), the 3-year event-free survival for all patients in the intent-to-treat analysis was 52.5% (95% CI, 34.8 to 70.2) for regimen A and 50.6% (95% CI, 32 to 69.2) for regimen B (P = .8677, log-rank test); the 3-year overall survival was 75.7% (95% CI, 59.7 to 91.7) for regimen A and 65.4% (95% CI, 48.1 to 82.7) for regimen B (P = .1919, log-rank test). Although the rate of near complete pathologic response was significantly greater with the addition of pazopanib, outcomes were not statistically significantly different between the two regimens.

PMID:37523624 | DOI:10.1200/JCO.23.00045

Surg Laparosc Endosc Percutan Tech. 2023 Jul 14. doi: 10.1097/SLE.0000000000001203. Online ahead of print.

ABSTRACT

BACKGROUND: Parastomal hernia repairs (PHRs) are often complex and challenging, even for experienced abdominal wall surgeons. Although the ideal therapeutic option in the setting of a parastomal hernia is to restore intestinal continuity, this is often not feasible, and numerous techniques have been described for PHR. Current guidelines recommend using mesh for elective PHR, but there is a scarcity of evidence comparing different PHR techniques. We aimed to report a meta-analysis comparing the outcomes of the “Sugarbaker” and “Keyhole” mesh configuration in PHR.

METHODS: A literature search of PubMed, Embase, Scopus, and Cochrane Library databases was performed to identify studies comparing Sugarbaker and Keyhole mesh configuration in PHR. Postoperative outcomes were assessed by means of pooled analysis and meta-analysis. Statistical analysis was performed using RevMan 5.4. Heterogeneity was assessed with I2 statistics.

RESULTS: A total of 3247 studies were screened, and 27 were fully reviewed. Ten studies and 632 patients were included in the meta-analysis. Three hundred five patients (48.3%) with Keyhole and 327 patients (51.7%) with Sugarbaker mesh configuration. Four hundred thirty-three patients (68.5%) underwent laparoscopic PHR with intraperitoneal onlay mesh. Sugarbaker mesh configuration was associated with lower hernia recurrence compared with Keyhole (odds ratio: 0.39; 95% CI: 0.19-0.83; P = 0.01; I2 = 46%). No differences were seen in overall complications, reoperations, stoma outlet obstruction, mesh infection, and postoperative bleeding.

CONCLUSION: PHR with Sugarbaker mesh configuration is associated with decreased hernia recurrence compared with Keyhole and had similar rates of overall complications, reoperations, stoma outlet obstruction, mesh infection, and postoperative bleeding.

PMID:37523583 | DOI:10.1097/SLE.0000000000001203