OBJECTIVE: To investigate the accuracy of anthropometric indices as a screening tool for predicting MetS among apparently healthy individuals in Karachi, Pakistan.
METHODS: A community-based cross-sectional survey was conducted in Karachi, Pakistan, from February 2022 to August 2022. A total of 1,065 apparently healthy individuals aged 25 years and above were included. MetS was diagnosed using International Diabetes Federation guidelines. Anthropometric indices were defined based on body mass index (BMI), neck circumference (NC), mid-upper arm circumference (MUAC), waist circumference (WC), waist to height ratio (WHtR), conicity index, reciprocal ponderal index (RPI), body shape index (BSI), and visceral adiposity index (VAI). The analysis involved the utilization of Pearson's correlation test and independent t-test to examine inferential statistics. The receiver operating characteristic (ROC) analysis was also applied to evaluate the predictive capacities of various anthropometric indices regarding metabolic risk factors. Moreover, the area under the curve (AUC) was computed, and the chosen anthropometric indices' optimal cutoff values were determined.
RESULTS: All anthropometric indices, except for RPI in males and BSI in females, were significantly higher in MetS than those without MetS. VAI [AUC 0.820 (95% CI 0.78-0.86)], WC [AUC 0.751 (95% CI 0.72-0.79)], WHtR [AUC 0.732 (95% CI 0.69-0.77)], and BMI [AUC 0.708 (95% CI 0.66-0.75)] had significantly higher AUC for predicting MetS in males, whereas VAI [AUC 0.693 (95% CI 0.64-0.75)], WHtR [AUC 0.649 (95% CI 0.59-0.70)], WC [AUC 0.646 (95% CI 0.59-0.61)], BMI [AUC 0.641 (95% CI 0.59-0.69)], and MUAC [AUC 0.626 (95% CI 0.57-0.68)] had significantly higher AUC for predicting MetS in females. The AUC of NC for males was 0.656 (95% CI 0.61-0.70), while that for females was 0.580 (95% CI 0.52-0.64). The optimal cutoff points for all anthropometric indices exhibited a high degree of sensitivity and specificity in predicting the onset of MetS.
CONCLUSION: BMI, WC, WHtR, and VAI were the most important anthropometric predictors for MetS in apparently healthy individuals of Pakistan, while BSI was found to be the weakest indicator.
MATERIALS AND METHODS: A literature search of PubMed, MEDLINE, Web of Science, and Scopus databases and a manual search of articles from 2009 to 2021 for randomized controlled trials (RCTs) and clinical efficacy trials (nonrandomized) were performed. Methodological quality and risk of bias (RoB) of included papers was assessed using Cochrane Collaboration Risk of Bias Tool 2.0 for RCTs and ROBINS-I (Risk Of Bias In Non-randomized Studies of Interventions) tool for nonrandomized studies.
RESULTS: A total of 352 titles and abstracts were reviewed. Eight RCTs and three clinical efficiency studies were included in this review. The masking effects of the demineralized enamel lesion were reported immediately after resin infiltration, and the color stability of this material was up to 24 months, with no adverse effects noted. For RCTs, four studies were classified as "some concerns" and four were as "low RoB." For nonrandomized studies, all of the studies presented an overall moderate RoB.
CONCLUSION: Resin infiltration achieves the best esthetic outcomes compared with microabrasion and remineralization therapy. Color stability was achieved with this material for up to 24 months and no adverse effects were noted. Factors contributing to the esthetic outcomes of the resin include the elimination of the hypermineralized surface layer, the homogeneity of the resin itself, and polishing after resin infiltration. Longitudinal follow-up and improved control of confounding variables should characterize future high-quality systematic reviews.
OBJECTIVE: The objective of this study was to summarise the protocol and statistical analysis plan for the Mega-ROX Sepsis trial.
DESIGN SETTING AND PARTICIPANTS: The Mega-ROX Sepsis trial is an international randomised clinical trial that will be conducted within an overarching 40,000-patient registry-embedded clinical trial comparing conservative and liberal ICU oxygen therapy regimens. We anticipate that between 10,000 and 13,000 patients with sepsis who are receiving unplanned invasive mechanical ventilation in the ICU will be enrolled in this trial.
MAIN OUTCOME MEASURES: The primary outcome is in-hospital all-cause mortality up to 90 days from the date of randomisation. Secondary outcomes include duration of survival, duration of mechanical ventilation, ICU length of stay, hospital length of stay, and the proportion of patients discharged home.
RESULTS AND CONCLUSIONS: Mega-ROX Sepsis will compare the effect of conservative vs. liberal oxygen therapy on 90-day in-hospital mortality in adults with sepsis who are receiving unplanned invasive mechanical ventilation in the ICU. The protocol and a prespecified approach to analyses are reported here to mitigate analysis bias.
DESIGN SETTING AND PARTICIPANTS: This international, multicentre, observational pharmacokinetic study will comprise adult critically ill patients prescribed antifungal agents including fluconazole, voriconazole, posaconazole, isavuconazole, caspofungin, micafungin, anidulafungin, and amphotericin B for the treatment or prophylaxis of invasive fungal disease. A minimum of 12 patients are targeted for enrolment for each antifungal agent, across 12 countries and 30 intensive care units to perform descriptive pharmacokinetics. Pharmacokinetic sampling will occur during two dosing intervals (occasions): firstly, between days 1 and 3, and secondly, between days 4 and 7 of the antifungal course, collecting three samples per occasion. Patients' demographic and clinical data will be collected.
MAIN OUTCOME MEASURES: The primary endpoint of the study is attainment of pharmacokinetic/pharmacodynamic target exposures that are associated with optimal efficacy. Thirty-day mortality will also be measured.
RESULTS AND CONCLUSIONS: This study will describe whether contemporary antifungal drug dosing achieves drug exposures associated with optimal outcomes. Data will also be used for the development of antifungal dosing algorithms for critically ill patients. Optimised drug dosing should be considered a priority for improving clinical outcomes for critically ill patients with fungal infections.
OBJECTIVE: The objective of this study was to summarise the protocol and statistical analysis plan for the Mega-ROX Brains trial.
DESIGN SETTING AND PARTICIPANTS: Mega-ROX Brains is an international randomised clinical trial, which will be conducted within an overarching 40,000-participant, registry-embedded clinical trial comparing conservative and liberal ICU oxygen therapy regimens. We expect to enrol between 7500 and 9500 participants with nonhypoxic ischaemic encephalopathy acute brain injuries and conditions who are receiving unplanned invasive mechanical ventilation in the ICU.
MAIN OUTCOME MEASURES: The primary outcome is in-hospital all-cause mortality up to 90 d from the date of randomisation. Secondary outcomes include duration of survival, duration of mechanical ventilation, ICU length of stay, hospital length of stay, and the proportion of participants discharged home.
RESULTS AND CONCLUSIONS: Mega-ROX Brains will compare the effect of conservative vs. liberal oxygen therapy regimens on 90-day in-hospital mortality in adults in the ICU with acute brain injuries and conditions. The protocol and planned analyses are reported here to mitigate analysis bias.
TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry (ACTRN 12620000391976).
METHODS: This was a prospective observational study carried out at a tertiary referral centre. POAG patients on topical antiglaucoma medications and planned for phaco-ECP were recruited. WDT was performed before surgery and 6 weeks postoperatively by drinking 10 mL/kg of water in 5 min followed by serial IOP by Goldmann applanation tonometry measurements at 15, 30, 45, and 60 min. Mean IOP, IOP fluctuation (difference between highest and lowest IOP), IOP reduction, and factors affecting IOP fluctuation were analysed.
RESULTS: Twenty eyes from 17 patients were included. Baseline IOP was similar before (14.7 ± 2.7 mm Hg) and after (14.8 ± 3.4 mm Hg, p = 0.90) surgery. There was no difference in mean IOP (17.6 ± 3.4 mm Hg vs. 19.3 ± 4.7 mm Hg pre- and postoperative, respectively, p = 0.26) or peak IOP (19.37 ± 3.74 mm Hg vs. 21.23 ± 5.29 mm Hg, p = 0.25), albeit a significant reduction in IOP-lowering medications (2.2 ± 1.15 vs. 0.35 ± 0.93, p < 0.001) postoperatively. IOP fluctuation was significantly greater (6.4 ± 3.2 mm Hg vs. 4.6 ± 2.1 mm Hg, p = 0.015) with more eyes having significant IOP fluctuation of ≥6 mm Hg (11 eyes [55%] vs. 4 eyes [20%], p < 0.001) postoperatively. Factors that were significantly associated with increased postoperative IOP fluctuations were higher preoperative IOP fluctuation (β = 0.69, 95% CI 0.379-1.582, p = 0.004) and more number of postoperative antiglaucoma medications (β = 0.627, 95% CI 0.614-3.322, p = 0.008).
CONCLUSION: Reducing aqueous production with phaco-ECP does not eliminate IOP fluctuation in POAG patients. The increase in postoperative IOP fluctuation suggests increased outflow resistance after phaco-ECP.
METHODS: This cross-sectional study included all children diagnosed with CF in our centre. Data on clinical presentation, genetic mutation, serial spirometry results and complications were collected. Out-of-pocket (OOP) and healthcare costs over 1 year were retrieved for patients who were alive. Cohen's d and odds ratio (OR) were used to determine the effect size.
RESULTS: Twenty-four patients were diagnosed with CF. Five patients died at a median (range) age of 18 (0.3-22) years. F508deletion (c. 1521_1523delCTT) was found in 20% of the alleles, while 89% of the variants were detected in nine patients. Body mass index (BMI) Z score was >-1.96 in 70.6% of patients. Two thirds (68%) were colonised with Pseudomonas aeruginosa, and this was associated with lower weight (P = 0.009) and BMI (P = 0.02) Z scores. Only 18% had FEV1 Z scores >-1.96. Early symptom onset (d = 0.74), delayed diagnosis (d = 2.07), a low FEF25-75 Z score (d = 0.82) and a high sweat conductance (d = 1.19) were associated with death. Inpatient cost was mainly from diagnostic tests, while medications contributed to half of the outpatient cost.
Healthcare utilisation cost was catastrophic, amounting to 20% of the total income.
CONCLUSION: Asian children with CF suffer significant complications such as low weight, low lung function and shortened lifespan. P. aeruginosa colonisation was frequent and associated with poor growth. Healthcare cost to parents was catastrophic.
METHODS: This is a retrospective, descriptive study of patients who presented to the ED between 1 January 2019 and 31 December 2020. Patients diagnosed with mental health-related systematised nomenclature of medicine who visited the ED during this period were identified and were placed into mental health diagnosis categories for analysis. A comparison was made between patients who presented before the pandemic (2019) and during the pandemic (2020).
RESULTS: During the study periods, we identified 1,421 patients, of whom 27 were excluded due to non-mental health-related diagnoses, leaving 1,394 patients for analysis. There was a 36.7% increase in mental health-related ED presentations from 2019 to 2020. The proportion of higher-acuity mental health-related ED attendances and number of suicide attempts also increased.
CONCLUSION: Our study described an increase in the proportion of high-acuity mental health-related ED attendances during the COVID-19 pandemic. Emergency physicians must be cognisant of the effects of the pandemic on mental health. Further research should be conducted to better equip the healthcare system for handling all aspects of the pandemic.
OBJECTIVES: To examine 1. the effects of individual classes of haemostatic therapies, compared with placebo or open control, in adults with acute spontaneous ICH, and 2. the effects of each class of haemostatic therapy according to the use and type of antithrombotic drug before ICH onset.
SEARCH METHODS: We searched the Cochrane Stroke Trials Register, CENTRAL (2022, Issue 8), MEDLINE Ovid, and Embase Ovid on 12 September 2022. To identify further published, ongoing, and unpublished randomised controlled trials (RCTs), we scanned bibliographies of relevant articles and searched international registers of RCTs in September 2022.
SELECTION CRITERIA: We included RCTs of any haemostatic intervention (i.e. procoagulant treatments such as clotting factor concentrates, antifibrinolytic drugs, platelet transfusion, or agents to reverse the action of antithrombotic drugs) for acute spontaneous ICH, compared with placebo, open control, or an active comparator.
DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcome was death/dependence (modified Rankin Scale (mRS) 4 to 6) by day 90. Secondary outcomes were ICH expansion on brain imaging after 24 hours, all serious adverse events, thromboembolic adverse events, death from any cause, quality of life, mood, cognitive function, Barthel Index score, and death or dependence measured on the Extended Glasgow Outcome Scale by day 90.
MAIN RESULTS: We included 20 RCTs involving 4652 participants: nine RCTs of recombinant activated factor VII (rFVIIa) versus placebo/open control (1549 participants), eight RCTs of antifibrinolytic drugs versus placebo/open control (2866 participants), one RCT of platelet transfusion versus open control (190 participants), and two RCTs of prothrombin complex concentrates (PCC) versus fresh frozen plasma (FFP) (47 participants). Four (20%) RCTs were at low risk of bias in all criteria. For rFVIIa versus placebo/open control for spontaneous ICH with or without surgery there was little to no difference in death/dependence by day 90 (risk ratio (RR) 0.88, 95% confidence interval (CI) 0.74 to 1.05; 7 RCTs, 1454 participants; low-certainty evidence). We found little to no difference in ICH expansion between groups (RR 0.81, 95% CI 0.56 to 1.16; 4 RCTs, 220 participants; low-certainty evidence). There was little to no difference in all serious adverse events and death from any cause between groups (all serious adverse events: RR 0.81, 95% CI 0.30 to 2.22; 2 RCTs, 87 participants; very low-certainty evidence; death from any cause: RR 0.78, 95% CI 0.56 to 1.08; 8 RCTs, 1544 participants; moderate-certainty evidence). For antifibrinolytic drugs versus placebo/open control for spontaneous ICH, there was no difference in death/dependence by day 90 (RR 1.00, 95% CI 0.93 to 1.07; 5 RCTs, 2683 participants; high-certainty evidence). We found a slight reduction in ICH expansion with antifibrinolytic drugs for spontaneous ICH compared to placebo/open control (RR 0.86, 95% CI 0.76 to 0.96; 8 RCTs, 2866 participants; high-certainty evidence). There was little to no difference in all serious adverse events and death from any cause between groups (all serious adverse events: RR 1.02, 95% CI 0.75 to 1.39; 4 RCTs, 2599 participants; high-certainty evidence; death from any cause: RR 1.02, 95% CI 0.89 to 1.18; 8 RCTs, 2866 participants; high-certainty evidence). There was little to no difference in quality of life, mood, or cognitive function (quality of life: mean difference (MD) 0, 95% CI -0.03 to 0.03; 2 RCTs, 2349 participants; mood: MD 0.30, 95% CI -1.98 to 2.57; 2 RCTs, 2349 participants; cognitive function: MD -0.37, 95% CI -1.40 to 0.66; 1 RCTs, 2325 participants; all high-certainty evidence). Platelet transfusion likely increases death/dependence by day 90 compared to open control for antiplatelet-associated ICH (RR 1.29, 95% CI 1.04 to 1.61; 1 RCT, 190 participants; moderate-certainty evidence). We found little to no difference in ICH expansion between groups (RR 1.32, 95% CI 0.91 to 1.92; 1 RCT, 153 participants; moderate-certainty evidence). There was little to no difference in all serious adverse events and death from any cause between groups (all serious adverse events: RR 1.46, 95% CI 0.98 to 2.16; 1 RCT, 190 participants; death from any cause: RR 1.42, 95% CI 0.88 to 2.28; 1 RCT, 190 participants; both moderate-certainty evidence). For PCC versus FFP for anticoagulant-associated ICH, the evidence was very uncertain about the effect on death/dependence by day 90, ICH expansion, all serious adverse events, and death from any cause between groups (death/dependence by day 90: RR 1.21, 95% CI 0.76 to 1.90; 1 RCT, 37 participants; ICH expansion: RR 0.54, 95% CI 0.23 to 1.22; 1 RCT, 36 participants; all serious adverse events: RR 0.27, 95% CI 0.02 to 3.74; 1 RCT, 5 participants; death from any cause: RR 0.49, 95% CI 0.16 to 1.56; 2 RCTs, 42 participants; all very low-certainty evidence).
AUTHORS' CONCLUSIONS: In this updated Cochrane Review including 20 RCTs involving 4652 participants, rFVIIa likely results in little to no difference in reducing death or dependence after spontaneous ICH with or without surgery; antifibrinolytic drugs result in little to no difference in reducing death or dependence after spontaneous ICH, but result in a slight reduction in ICH expansion within 24 hours; platelet transfusion likely increases death or dependence after antiplatelet-associated ICH; and the evidence is very uncertain about the effect of PCC compared to FFP on death or dependence after anticoagulant-associated ICH. Thirteen RCTs are ongoing and are likely to increase the certainty of the estimates of treatment effect.
METHODS: This narrative review was undertaken to address two main questions - why remove vital pulp tissue in teeth with complex canal anatomy when it can be preserved? And why replace the necrotic pulp in teeth with mature roots with a synthetic material when we can revitalize? This review also aims to discuss anatomical challenges with pulpotomy and revitalization procedures.
RESULTS: Maintaining the vitality of the pulp via partial or full pulpotomy procedures avoids the multiple potential challenges faced by clinicians during root canal treatment. However, carrying out pulpotomy procedures requires a meticulous understanding of the pulp chamber anatomy, which varies from tooth to tooth. Literature shows an increased interest in the application of RPs in teeth with mature roots; however, to date, the relation between the complexity of the root canal system and outcomes of RPs in necrotic multi-rooted teeth with mature roots is unclear and requires further robust comparative research and long-term follow-up.
CONCLUSIONS: Whenever indicated, pulpotomy procedures are viable treatment options for vital teeth with mature roots; however, comparative, adequately powered studies with long-term follow-up are needed as a priority in this area. RPs show promising outcomes for necrotic teeth with mature roots that warrant more evidence in different tooth types with long-term follow-ups. CLINICAL RELEVANCE: Clinicians should be aware of the pulp chamber anatomy, which is subject to morphological changes by age or as a defensive mechanism against microbial irritation, before practicing partial and full pulpotomy procedures. RP is a promising treatment option for teeth with immature roots, but more evidence is needed for its applications in teeth with mature roots. A universal consensus and considerably more robust evidence are needed for the standardization of RPs in teeth with mature roots.
OBJECTIVE: This study aims to explore the perceived benefits and challenges, needs and preferences, and willingness of patients with diabetes to use mHealth apps for self-management of diabetes.
METHODS: The study involved one-on-one semistructured online interviews with a total of 15 participants, all of whom were aged 18 years or older and had been diagnosed with diabetes for more than 6 months. An interview guide was developed based on the constructs of the Technology Acceptance Model (TAM), the Health Information Technology Acceptance Model (HITAM), and the aesthetics factor derived from the Mobile Application Rating Scale. All interviews were recorded in audio format and transcribed verbatim. The interview content was then organized and coded using ATLAS.ti version 8. Thematic analysis was conducted in accordance with the recommended guidelines for analyzing the data.
RESULTS: From the interviews with participants, 3 key themes emerged regarding the perceived benefits of using mHealth app support in diabetes self-management. These themes were the ability to track and monitor diabetes control, assistance in making lifestyle modifications, and the facilitation of more informed treatment decision-making for health care professionals. The interviews with participants revealed 4 prominent themes regarding the perceived barriers to using mHealth app support for diabetes self-management. These themes were a lack of awareness about the availability of mHealth support, insufficient support in using mHealth apps, the perception that current mHealth apps do not align with users' specific needs, and limited digital literacy among users. The interviews with participants unveiled 4 key themes related to their needs and preferences concerning mHealth app support for diabetes self-management. These themes were the desire for educational information, user-friendly design features, carbohydrate-counting functionality, and the ability to engage socially with both peers and health care professionals. The majority of participants expressed their willingness to use mHealth apps if they received recommendations and guidance from health care professionals.
CONCLUSIONS: Patients generally perceive mHealth app support as beneficial for diabetes self-management and are willing to use these apps, particularly if recommended by health care professionals. However, several barriers may hinder the utilization of mHealth apps, including a lack of awareness and recommendations regarding these apps from health care professionals. To ensure the effective development of mHealth app support systems for diabetes self-management, it is crucial to implement user-centered design processes that consider the specific needs and preferences of patients. This approach will help create apps that are tailored to the requirements of individuals managing diabetes.
METHODS: In this phase 3, international, randomized trial, we assigned in a 1:1 ratio patients with advanced NSCLC with EGFR exon 20 insertions who had not received previous systemic therapy to receive intravenous amivantamab plus chemotherapy (amivantamab-chemotherapy) or chemotherapy alone. The primary outcome was progression-free survival according to blinded independent central review. Patients in the chemotherapy group who had disease progression were allowed to cross over to receive amivantamab monotherapy.
RESULTS: A total of 308 patients underwent randomization (153 to receive amivantamab-chemotherapy and 155 to receive chemotherapy alone). Progression-free survival was significantly longer in the amivantamab-chemotherapy group than in the chemotherapy group (median, 11.4 months and 6.7 months, respectively; hazard ratio for disease progression or death, 0.40; 95% confidence interval [CI], 0.30 to 0.53; P<0.001). At 18 months, progression-free survival was reported in 31% of the patients in the amivantamab-chemotherapy group and in 3% in the chemotherapy group; a complete or partial response at data cutoff was reported in 73% and 47%, respectively (rate ratio, 1.50; 95% CI, 1.32 to 1.68; P<0.001). In the interim overall survival analysis (33% maturity), the hazard ratio for death for amivantamab-chemotherapy as compared with chemotherapy was 0.67 (95% CI, 0.42 to 1.09; P = 0.11). The predominant adverse events associated with amivantamab-chemotherapy were reversible hematologic and EGFR-related toxic effects; 7% of patients discontinued amivantamab owing to adverse reactions.
CONCLUSIONS: The use of amivantamab-chemotherapy resulted in superior efficacy as compared with chemotherapy alone as first-line treatment of patients with advanced NSCLC with EGFR exon 20 insertions. (Funded by Janssen Research and Development; PAPILLON ClinicalTrials.gov number, NCT04538664.).