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Accuracy of digital chest x-ray analysis with artificial intelligence software as a triage and screening tool in hospitalized patients being evaluated for tuberculosis in Lima, Peru.

Tuberculosis (TB) transmission in healthcare facilities is common in high-incidence countries. Yet, the optimal approach for identifying inpatients who may have TB is unclear. We evaluated the diagnostic accuracy of qXR (Qure.ai, India) computer-aided detection (CAD) software versions 3.0 and 4.0 (v3 and v4) as a triage and screening tool within the FAST (Find cases Actively, Separate safely, and Treat effectively) transmission control strategy. We prospectively enrolled two cohorts of patients admitted to a tertiary hospital in Lima, Peru: one group had cough or TB risk factors (triage) and the other did not report cough or TB risk factors (screening). We evaluated the sensitivity and specificity of qXR for the diagnosis of pulmonary TB using culture and Xpert as primary and secondary reference standards, including stratified analyses based on risk factors. In the triage cohort (n=387), qXR v4 sensitivity was 0.91 (59/65, 95% CI 0.81-0.97) and specificity was 0.32 (103/322, 95% CI 0.27-0.37) using culture as reference standard. There was no difference in the area under the receiver-operating-characteristic curve (AUC) between qXR v3 and qXR v4 with either a culture or Xpert reference standard. In the screening cohort (n=191), only one patient had a positive Xpert result, but specificity in this cohort was high (>90%). A high prevalence of radiographic lung abnormalities, most notably opacities (81%), consolidation (62%), or nodules (58%), was detected by qXR on digital CXR images from the triage cohort. qXR had high sensitivity but low specificity as a triage in hospitalized patients with cough or TB risk factors. Screening patients without cough or risk factors in this setting had a low diagnostic yield. These findings further support the need for population and setting-specific thresholds for CAD programs.

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Complicated grief and its relationship with anxiety, depression, and suicidal ideation in older adults in the context of the COVID-19 pandemic in Peru: a cross-sectional analysis

BackgroundComplicated grief (CG) resulting from poor adaptation to the death of a close person may have been related with the presence of other mental health problems in older adults in Peru during the COVID-19 pandemic. Our study aimed to assess the association between CG and anxiety, depression, and suicidal ideation in older adults in Peru in the context of the COVID-19 pandemic.MethodsWe conducted a cross-sectional analysis using data from the “Socioemotional evaluation form” applied in 2020 to mental health problems in older adults attending the Peruvian Social Security (EsSalud). For our study, we included older adults who reported the death of a close person during the last six months when this assessment was performed. CG, depression, anxiety, and suicidal ideation were initially evaluated using validated questionnaires. The association between CG and the presence of mental health problems was calculated through multivariate analysis, where prevalence ratios (PR) were estimated with 95% confidence intervals (CI).ResultsOf the 249 older adults included, 175 (70.3%) were female with a median age of 71 years (interquartile range: 9), and 35 (14.1%) reported the presence of CG. It was found that CG in this population was associated with the presence of anxiety (PR: 1.35, 95% CI: 0.98 to 1.85), depression (PR: 1.44, 95% CI: 1.06 to 1.95), and suicidal ideation (PR: 2.84, 95% CI: 1.06 to 7.59).ConclusionsCG is related to the presence of mental health problems in older adults in Peru. It is essential to implement measures that facilitate the prevention and proper management of this condition in this population, especially in the context of high population mortality such as the COVID-19 pandemic.

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Assessment and personalised advice for fatigue in systemic lupus erythematosus using an innovative digital tool: the Lupus Expert system for the Assessment of Fatigue (LEAF) study

BackgroundFatigue is reported as the most prevalent symptom by patients with systemic lupus erythematosus (SLE). Fatigue management is complex due to its multifactorial nature. The aim of the study was to assess the usefulness of an innovative digital tool to manage fatigue in SLE, in a completely automated manner.MethodsThe «Lupus Expert System for Assessment of Fatigue» (LEAF) is free digital tool which measures the intensity and characteristics of fatigue and assesses disease activity, pain, insomnia, anxiety, depression, stress, fibromyalgia and physical activity using validated patient-reported instruments. Then, LEAF automatically provides personalised feedback and recommendations to cope with fatigue.ResultsBetween May and November 2022, 1250 participants with SLE were included (95.2% women, median age 43yo (IQR: 34–51)). Significant fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue <34) was reported by 78.9% of patients. In univariate analysis, SLE participants with fatigue were more likely to be women (p=0.01), perceived their disease as more active (p<0.0001), had higher levels of pain (p<0.0001), anxiety (p<0.0001), depression (p<0.0001), insomnia (p<0.0001), stress (p<0.0001) and were more likely to screen for fibromyalgia (p<0.0001), compared with patients without significant fatigue. In multivariable analysis, parameters independently associated with fatigue were insomnia (p=0.0003), pain (p=0.002), fibromyalgia (p=0.008), self-reported active SLE (p=0.02) and stress (p=0.045). 93.2% of the participants found LEAF helpful and 92.3% would recommend it to another patient with SLE.ConclusionFatigue is commonly severe in SLE, and associated with insomnia, pain, fibromyalgia and active disease according to patients’ perspective. Our study shows the usefulness of an automated digital tool to manage fatigue in SLE.

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Evaluating newly approved drugs in combination regimens for multidrug-resistant tuberculosis with fluoroquinolone resistance (endTB-Q): study protocol for a multi-country randomized controlled trial

BackgroundTreatment for fluoroquinolone-resistant multidrug-resistant/rifampicin-resistant tuberculosis (pre-XDR TB) often lasts longer than treatment for less resistant strains, yields worse efficacy results, and causes substantial toxicity. The newer anti-tuberculosis drugs, bedaquiline and delamanid, and repurposed drugs clofazimine and linezolid, show great promise for combination in shorter, less-toxic, and effective regimens. To date, there has been no randomized, internally and concurrently controlled trial of a shorter, all-oral regimen comprising these newer and repurposed drugs sufficiently powered to produce results for pre-XDR TB patients.MethodsendTB-Q is a phase III, multi-country, randomized, controlled, parallel, open-label clinical trial evaluating the efficacy and safety of a treatment strategy for patients with pre-XDR TB. Study participants are randomized 2:1 to experimental or control arms, respectively. The experimental arm contains bedaquiline, linezolid, clofazimine, and delamanid. The control comprises the contemporaneous WHO standard of care for pre-XDR TB. Experimental arm duration is determined by a composite of smear microscopy and chest radiographic imaging at baseline and re-evaluated at 6 months using sputum culture results: participants with less extensive disease receive 6 months and participants with more extensive disease receive 9 months of treatment. Randomization is stratified by country and by participant extent-of-TB-disease phenotype defined according to screening/baseline characteristics. Study participation lasts up to 104 weeks post randomization. The primary objective is to assess whether the efficacy of experimental regimens at 73 weeks is non-inferior to that of the control. A sample size of 324 participants across 2 arms affords at least 80% power to show the non-inferiority, with a one-sided alpha of 0.025 and a non-inferiority margin of 12%, against the control in both modified intention-to-treat and per-protocol populations.DiscussionThis internally controlled study of shortened treatment for pre-XDR TB will provide urgently needed data and evidence for clinical and policy decision-making around the treatment of pre-XDR TB with a four-drug, all-oral, shortened regimen.Trial registrationClinicalTrials.Gov NCT03896685. Registered on 1 April 2018; the record was last updated for study protocol version 4.3 on 17 March 2023.

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1381. Barriers and Facilitators to Prompt Diagnosis of Tuberculosis in Lima, Peru

Abstract Background Tuberculosis (TB) infectiousness decreases significantly with only a few days of therapy, but delayed diagnosis often leads to late treatment initiation. We conducted a sequential explanatory mixed-methods study to understand the barriers and facilitators to prompt diagnosis and identify areas for improvement. Methods We enrolled 100 adults who started TB therapy in the Carabayllo district of Lima, Peru, between November 2020 and February 2022 and administered a survey about their symptoms and healthcare encounters. We calculated the time from symptom onset to first healthcare visit and to diagnosis. We conducted semi-structured interviews of 26 participants who had a range of delays, investigating their experiences navigating the health system. Interview transcripts were inductively coded for concepts related to diagnostic barriers and facilitators and suggestions for improvement. Results Overall, 38% of patients sought care from public facilities and 42% from the private sector. Only 33% reported being diagnosed with TB on their first visit. The median total diagnostic delay was 9 weeks (interquartile range [IQR] 4–22), with a median of 4 weeks (IQR 0–9) before contact with the health system and of 3 weeks (IQR 0–9) after. There was a median of 3 (IQR 2–4) health visits before diagnosis. Several factors contributed to a delayed diagnosis. Many patients attributed their symptoms to an alternative cause or had misconceptions about the disease, and often postponed seeking care. Once they sought care, the vast majority of patients had multiple encounters, sometimes alternating between the public and private sectors. Having a referral document and being seen by a pulmonologist often expedited the diagnosis. Several patients identified a need for more education about the disease through community campaigns and for better access to pulmonologists. Factors impacting the time to diagnosis of tuberculosis in the Carabayllo district of Lima, Peru Conclusion We identified important diagnostic delays related to both patient- and health system-associated factors. Misinformation about TB, poor accessibility of health services, and the need for multiple encounters to obtain diagnostic tests were major factors leading to delays. Better strategies for community education and integration between the public and private sectors should be priorities in the efforts to combat TB. Disclosures All Authors: No reported disclosures

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Association between polymorphisms of the VKORC1 and CYP2C9 genes and warfarin maintenance dose in Peruvian patients.

The aim of this study was to investigate the association between VKORC1 and CYP2C9 genes polymorphisms and the maintenance dose of warfarin in Peruvian patients. An observational study was conducted on outpatients from the Hospital Grau ESSALUD in Lima, Peru. The participants were selected using nonprobabilistic convenience sampling. Inclusion criteria required patients to have been on anticoagulation therapy for >3months, maintain stable doses of warfarin (consistent dose for at least 3 outpatient visits), and maintain an international normalized ratio within the therapeutic range of 2.5-3.5. DNA samples were obtained from peripheral blood for gene analysis. Seventy patients (mean age of 69.6± 13.4years, 45.7% female) were included in the study. The average weekly warfarin dose was 31.6± 15.2mg. The genotypic frequencies of VKORC1 were as follows: 7.1% (95% confidence interval, 2.4-15.9) for AA; 44.3% (32.4-56.7) for GA; and 48.6% (36.4-60.8) for GG. No deviation from the Hardy-Weinberg equilibrium was observed in the variants studied (P= .56). The mean weekly warfarin doses for AA, GA and GG genotypes were 16.5±2.9, 26.5±9.5 and 37.9± 17.1mg, respectively (P< .001). The genotypic frequencies of CYP2C9 were as follows: 82.8% (72.0-90.8) for CC (*1/*1); 4.3% (1.0-12.0) for CT (*1/*2); and 12.9% (6.1-23.0) for TT (*2/*2). We did not find a significant association between the CYP2C9 gene polymorphism and the dose of warfarin. The AA genotype of the VKORC1 gene was associated with a lower maintenance dose of warfarin in Peruvian patients.

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