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Facilitators and barriers to adolescent participation in a TB clinical trial. 青少年参与结核病临床试验的促进因素和障碍。
IF 3.4 3区 医学 Q2 INFECTIOUS DISEASES Pub Date : 2024-05-01 DOI: 10.5588/ijtld.23.0519
J M Mangan, K N C Hedges, M M Salerno, K Tatum, B Bouwkamp, M W Frick, L McKenna, G Muzanyi, M Engle, J Coetzee, J Yvetot, M Elskamp, D Lamunu, M E Theunissen Tizora, D Namutamba, R E Chaisson, S Swindells, P Nahid, S E Dorman, E Kurbatova

BACKGROUNDThe inclusion of adolescents in TB drug trials is essential for the development of safe, child-friendly regimens for the prevention and treatment of TB. TB Trials Consortium Study 31/AIDS Clinical Trials Group A5349 (S31/A5349) enrolled adolescents as young as 12 years old. We assessed investigator and coordinator described facilitators and barriers to adolescent recruitment, enrollment, and retention.METHODSInterviews were conducted with six investigators from sites that enrolled adolescent participants and six investigators from non-enrolling sites. Additionally, two focus groups were conducted with study coordinators from enrolling sites and two focus groups with non-enrolling sites. Discussions were transcribed, analyzed, summarized, and summaries were reviewed by Community Research Advisors Group members and research group representatives for content validity.RESULTSInvestigators and coordinators attributed the successful enrollment of adolescents to the establishment and cultivation of external partnerships, flexibility to accommodate adolescents' schedules, staff engagement, recruitment from multiple locations, dedicated recruitment staff working onsite to access potential participants, creation of youth-friendly environments, and effective communications. Non-enrolling sites were mainly hindered by regulations. Suggestions for improvement in future trials focused on study planning and site preparations.CONCLUSIONProactive partnerships and collaboration with institutions serving adolescents helped identify and reduce barriers to their inclusion in this trial..

背景将青少年纳入结核病药物试验对于开发安全、适合儿童的结核病预防和治疗方案至关重要。结核病试验联盟第 31 项研究/艾滋病临床试验组 A5349(S31/A5349)招募了年仅 12 岁的青少年。我们对研究者和协调者描述的青少年招募、入组和保留的促进因素和障碍进行了评估。方法对招募了青少年参与者的研究机构的六名研究者和未招募青少年参与者的研究机构的六名研究者进行了访谈。此外,还与来自注册机构的研究协调员和来自非注册机构的研究协调员分别进行了两次焦点小组讨论。研究人员和协调人员将青少年的成功注册归功于外部合作伙伴关系的建立和培养、适应青少年日程安排的灵活性、员工的参与、从多个地点进行招募、专职招募人员在现场工作以接触潜在参与者、创造对青少年友好的环境以及有效的沟通。非招募地点主要受到规章制度的限制。对未来试验的改进建议主要集中在研究规划和试验场地的准备工作上。
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引用次数: 0
Pulse oximetry has limited utility in identifying potential patients for long-term oxygen therapy. 脉搏血氧仪在确定可能接受长期氧疗的患者方面作用有限。
IF 3.4 3区 医学 Q2 INFECTIOUS DISEASES Pub Date : 2024-05-01 DOI: 10.5588/ijtld.23.0491
C J Crooks, J West, J R Morling, M Simmonds, I Juurlink, S Cruickshank, S Briggs, S Hammond-Pears, D Shaw, T R Card, A W Fogarty
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引用次数: 0
Factors associated with referrals for directly observed treatment and unsuccessful treatment. 与转诊接受直接观察治疗和治疗不成功相关的因素。
IF 4 3区 医学 Q2 INFECTIOUS DISEASES Pub Date : 2024-05-01 DOI: 10.5588/ijtld.23.0396
Y D González Diaz, D Palma, H Vargas-Leguás, T Rodrigo, I Molina-Pinargorte, X Casas, N Forcada, J Santiago, N Altet, J-P Millet

OBJECTIVETo describe the characteristics of people indicated for directly observed treatment (DOT) in Spain, and the factors associated with unsuccessful treatment.METHODSThis was a multicentre observational study based on a prospective follow-up of patients over 18 years old diagnosed with TB between 2006 and 2019 from the registry of the Programa Integrado de Investigación en Tuberculosis (PII-TB). Sociodemographic and clinical variables were collected. Adjusted odds ratios (aORs) were calculated for the indication of DOT and for having an unsuccessful treatment.RESULTSA total of 7,883 patients were included. The indication of DOT was associated with being homeless (aOR 5.93, 95% CI 3.03-11.59), inactivity status (aOR 2.55, 95% CI 2.02-3.23), alcohol consumption (aOR 1.94, 95% CI 1.51-2.48), parenteral drug use (aOR 1.77, 95% CI 1.06-2.95) and HIV diagnosis (aOR 1.96, 95% CI 1.16-3.29). Unsuccessful treatment was associated with having an HIV diagnosis (aPR 2.31, 95% CI 1.31-4.08), having a worse clinical and radiological evolution (clinical progression: APR 15.59, 95% CI 8.21-29.60; radiological progression: aPR 12.84, 95% CI 6.46-25.52), need for hospitalisation (aPR 1.73, 95% CI 1.10-2.73), unsatisfactory tolerability (aPR 2.82, 95% CI 1.49-5.29), the existence of difficulties in understanding the prescribed treatment (aPR 1.92, 95% CI 1.21-3.06), as well as worse treatment satisfaction (aPR 7.27, 95% CI 4.32-12.24).CONCLUSIONThe prioritisation of vulnerable populations is a key aspect to carry out the new Global Plan to End TB 2023-2030. In these groups DOT indication should be increased to ensure adherence and patient follow-up and outcomes..

目的描述西班牙接受直接观察治疗(DOT)者的特征,以及与治疗不成功相关的因素。方法这是一项多中心观察性研究,基于对 2006 年至 2019 年期间从结核病综合研究计划(PII-TB)登记处确诊的 18 岁以上结核病患者的前瞻性随访。研究收集了社会人口学和临床变量。结果共纳入 7883 名患者。DOT 的适应症与无家可归(aOR 5.93,95% CI 3.03-11.59)、不活动状态(aOR 2.55,95% CI 2.02-3.23)、饮酒(aOR 1.94,95% CI 1.51-2.48)、使用肠外药物(aOR 1.77,95% CI 1.06-2.95)和 HIV 诊断(aOR 1.96,95% CI 1.16-3.29)有关。治疗不成功与以下因素有关:HIV 诊断(aPR 2.31,95% CI 1.31-4.08)、临床和放射学进展恶化(临床进展:APR 15.59,95% CI 1.31-4.08):APR15.59,95% CI 8.21-29.60;放射学进展:aPR 12.84,95% CI 6.46-25.52)、需要住院(aPR 1.73,95% CI 1.10-2.73)、耐受性不满意(aPR 2.82,95% CI 1.49-5.29)、难以理解处方治疗(aPR 1.结论:优先考虑易感人群是实施新的《2023-2030 年终结结核病全球计划》的一个关键方面。在这些人群中,应增加直接观察治疗的适应症,以确保患者坚持治疗,并对患者进行随访和取得疗效。
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引用次数: 0
Alpha-1 deficiency in severe asthma patients. 严重哮喘患者的α-1 缺乏症。
IF 4 3区 医学 Q2 INFECTIOUS DISEASES Pub Date : 2024-05-01 DOI: 10.5588/ijtld.23.0493
M Zappa, S Grossi, P Pignatti, L Pini, R Centis, G B Migliori, F Ardesi, G Sotgiu, A G Corsico, A Spanevello, D Visca

INTRODUCTIONAlpha-1 antitrypsin (AAT) deficiency, an autosomal co-dominant condition, decreases protein concentration and activity at both serum and tissue levels. Few studies investigated whether the type of SERPINA1 gene phenotype in patients with severe asthma can influence symptoms and disease control during follow-up.OBJECTIVETo assess whether the presence of a non-MM genotype of SERPINA1 in patients with severe asthma is associated with disease control, systemic and airway inflammation, lung function and comorbidities prevalence compared to severe asthma patients with a homozygous genotype (MM).METHODSAsthmatic patients belonging to Global Initiative for Asthma (GINA) step 5 were retrospectively analysed in an Italian reference asthma clinic. We collected clinical, biological and functional variables at baseline and for the three following years.RESULTSOut of 73 patients enrolled, 14 (19.18%) were non-MM and 59 (80.8%) were MM. Asthmatics with non-MM genotype had lower serum AAT concentration (P = 0.004) and higher emphysema prevalence than the MM group (P = 0.003) at baseline. During follow up, only MM patients showed a significant improvement of both ACQ-6 score (P < 0.0001) and eosinophilic systemic inflammation (P < 0.0001).CONCLUSIONSOur findings emphasise the importance of a screening for AAT deficiency in severe asthma, as alleles mutation may influence patient's follow-up..

简介α-1 抗胰蛋白酶(AAT)缺乏症是一种常染色体共显性疾病,会降低血清和组织水平的蛋白质浓度和活性。很少有研究调查严重哮喘患者的 SERPINA1 基因表型类型是否会影响随访期间的症状和疾病控制。目的评估与同基因型(MM)的重症哮喘患者相比,重症哮喘患者的 SERPINA1 非 MM 基因型是否与疾病控制、全身和气道炎症、肺功能和合并症发生率有关。方法在一家意大利哮喘参考诊所对哮喘全球倡议(GINA)第 5 阶段的哮喘患者进行回顾性分析。结果在 73 名入选患者中,14 人(19.18%)为非 MM,59 人(80.8%)为 MM。与 MM 组相比,非 MM 基因型哮喘患者的血清 AAT 浓度较低(P = 0.004),肺气肿发生率较高(P = 0.003)。结论我们的研究结果强调了筛查严重哮喘患者 AAT 缺乏症的重要性,因为等位基因突变可能会影响患者的后续治疗。
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引用次数: 0
Characteristics of TB cases without documented sputum culture in the United States, 2011-2021. 2011-2021 年美国无痰培养记录肺结核病例的特征。
IF 4 3区 医学 Q2 INFECTIOUS DISEASES Pub Date : 2024-05-01 DOI: 10.5588/ijtld.23.0432
L H Rautman, J S Kammerer, B J Silk, V C Marconi, M E Youngblood, J A Edwards, J M Wortham, J L Self

BACKGROUNDCulture-based diagnostics are the gold standard for diagnosing pulmonary TB (PTB). We characterized culture practices by comparing cases with documented sputum culture to those without.METHODSUsing multivariable logistic regression, we examined associations between PTB case characteristics and no documented sputum culture reported to the U.S. National TB Surveillance System during 2011-2021.RESULTSAmong 69,538 PTB cases analyzed, no sputum culture attempt was documented for 5,869 (8%). Non-sputum culture specimens were documented for 54%, 80%, and 89% of cases without documented sputum culture attempts among persons aged <15 years, 15-64, and 65+ years, respectively; bronchial fluid and lung tissue were common non-sputum specimens among cases in persons >15 years old. Having no documented sputum culture was associated with age <15 years (aOR 23.84, 99% CI 20.09-28.27) or ≥65 years (aOR 1.22, 99% CI 1.07-1.39), culture of a non-sputum specimen (aOR 6.57, 99% CI 5.93-7.28), residence in a long-term care facility (aOR 1.58, 99% CI 1.23-2.01), and receiving TB care outside of a health department (aOR 1.79, 99% CI 1.61-1.98).CONCLUSIONSInability to obtain sputum from children and higher diagnostic suspicion for disease processes that require tissue-based diagnostics could explain these findings..

背景基于培养的诊断是诊断肺结核(PTB)的金标准。我们将有痰培养记录的病例与无痰培养记录的病例进行了比较,从而确定了培养实践的特点。结果在分析的 69538 例肺结核病例中,有 5869 例(8%)无痰培养记录。在 15 岁人群中,分别有 54%、80% 和 89% 的病例无痰培养记录。没有痰培养记录与年龄有关 结论无法从儿童身上获得痰液以及对需要组织诊断的疾病过程的诊断怀疑度较高可能是这些发现的原因。
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引用次数: 0
Factors associated with patient delay in the diagnosis of TB - a study of health-seeking behaviour. 肺结核患者延误诊断的相关因素--一项关于寻求健康行为的研究。
IF 3.4 3区 医学 Q2 INFECTIOUS DISEASES Pub Date : 2024-05-01 DOI: 10.5588/ijtld.23.0502
M S Marques, T Silva, A Gomes, C Pereira, M Pinto, A Aguiar, R Duarte
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引用次数: 0
Acceptability of clofazimine capsules in children and adolescents with rifampicin-resistant TB. 耐利福平结核病儿童和青少年对氯唑明胶囊的接受程度。
IF 3.4 3区 医学 Q2 INFECTIOUS DISEASES Pub Date : 2024-05-01 DOI: 10.5588/ijtld.23.0517
D T Wademan, Z Saule, A Marthinus, L Viljoen, E Nortier, J Hughes, I Courtney, M Palmer, A J Garcia-Prats, A C Hesseling, G Hoddinott
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引用次数: 0
Point-of-care ultrasound for diagnosing extrapulmonary TB. 用于诊断肺外结核病的护理点超声波。
IF 3.4 3区 医学 Q2 INFECTIOUS DISEASES Pub Date : 2024-05-01 DOI: 10.5588/ijtld.23.0471
L T Allan-Blitz, C Yarbrough, M Ndayizigiye, C Wade, A J Goldsmith, N M Duggan

BACKGROUNDDespite the high morbidity and mortality globally, standard microbiologic diagnosis for TB requires laboratory infrastructure inaccessible in many resource-limited areas and may be insufficient for identifying extrapulmonary disease. Point-of-care (POC) ultrasound facilitates visualization of extrapulmonary manifestations, permitting laboratory-independent diagnosis, but its diagnostic utility remains unclear.METHODSWe conducted a systematic review of five online databases for studies reporting ultrasound findings among cases with and without extrapulmonary TB (EPTB). A minimum of two authors independently screened and reviewed each article, and extracted data elements of interest. We conducted a series of univariate meta-analyses using a random-effects model to calculate the pooled effect estimate and 95% confidence interval (CI) for each outcome: sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV).RESULTSOf 279 articles identified, 6 were included. There were 699 cases of EPTB among 1,633 participants. The pooled sensitivity estimate was 0.72 (95% CI 0.57-0.88). The pooled specificity estimate was 0.77 (95% CI 0.63-0.90). The pooled PPV and NPV estimates were respectively 0.67 (95% CI 0.47-0.87) and 0.85 (95% CI 0.77-0.93).CONCLUSIONPOC ultrasound showed modest test characteristics for diagnosing EPTB, which may constitute an improvement over some currently available diagnostics..

背景尽管结核病在全球的发病率和死亡率都很高,但标准的结核病微生物学诊断需要实验室基础设施,而许多资源有限的地区无法获得这些基础设施,而且可能不足以确定肺外疾病。我们对五个在线数据库中报告肺外结核病(EPTB)病例和非肺外结核病(EPTB)病例超声检查结果的研究进行了系统性回顾。每篇文章至少由两名作者独立筛选和审阅,并提取感兴趣的数据元素。我们使用随机效应模型进行了一系列单变量荟萃分析,以计算出每种结果的集合效应估计值和 95% 置信区间 (CI):灵敏度、特异性、阳性预测值 (PPV) 和阴性预测值 (NPV)。在 1,633 名参与者中有 699 例 EPTB 病例。汇总的灵敏度估计值为 0.72(95% CI 0.57-0.88)。综合特异性估计值为 0.77(95% CI 0.63-0.90)。综合 PPV 和 NPV 估计值分别为 0.67 (95% CI 0.47-0.87) 和 0.85 (95% CI 0.77-0.93)。
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引用次数: 0
SMaRT-PCR: sampling using masks and RT-PCR, a non-invasive diagnostic tool for paediatric pulmonary TB. SMaRT-PCR:使用口罩和 RT-PCR 进行采样,这是一种针对小儿肺结核的无创诊断工具。
IF 4 3区 医学 Q2 INFECTIOUS DISEASES Pub Date : 2024-04-01 DOI: 10.5588/ijtld.23.0291
A Shaikh, K Sriraman, S Vaswani, I Shah, V Poojari, V Oswal, S Mane, S Rajagara, N Mistry

BACKGROUNDKey challenges in paediatric TB diagnosis are invasive sampling and poor sensitivity of standard methods. This study demonstrates the diagnostic potential of non-invasive sampling of bioaerosols from children using SMaRT-PCR, comprising mask sampling combined with reverse transcriptase-polymerase chain reaction (RT-PCR) for TB.METHODSExhaled bioaerosols were captured on modified N-95 masks in a 10-min talk-cough-breathe process from 51 children (30 with TB confirmed using standard sampling methods and 21 without TB) aged 2-15 years. All mask samples were tested using in-house RT-PCR for 16s and rpoB RNA transcripts. Additional mask samples from children with TB were tested using Xpert® MTB/RIF (n = 3) and Xpert® MTB/RIF Ultra (n = 27).RESULTSSMaRT-PCR sensitivity for detecting TB among treatment-naïve children was 96% if 16s or rpoB was present, and 75% if both genes were present, comparable to standard methods (71%) in the same cohort. Specificity was better for both genes, at 95%, than 85% for a single gene detection. Mask sampling with Xpert MTB/RIF or Ultra had a sensitivity of only 13%.CONCLUSIONThis is the first study to provide evidence for testing bioaerosols as a promising alternative for detecting paediatric TB. Sampling is non-invasive and simple, with the potential for point-of-care applications. This pilot study also suggests that RNA transcript-based detection may improve TB diagnostic sensitivity in children; however, further investigation is required to establish its adaptability in clinical settings..

背景:儿科结核病诊断面临的主要挑战是侵入性采样和标准方法灵敏度低。本研究证明了使用 SMaRT-PCR 对儿童生物气溶胶进行非侵入性采样的诊断潜力,SMaRT-PCR 包括口罩采样和结核病反转录聚合酶链反应 (RT-PCR)。方法在 51 名 2-15 岁儿童(30 名使用标准采样方法确诊为结核病,21 名未确诊为结核病)的 10 分钟谈话-咳嗽-呼吸过程中,用改良的 N-95 口罩采集吸入的生物气溶胶。所有口罩样本均通过内部 RT-PCR 检测 16s 和 rpoB RNA 转录本。结果如果 16s 或 rpoB 均存在,则 MaRT-PCR 检测治疗无效儿童结核病的灵敏度为 96%,如果两个基因均存在,则灵敏度为 75%,与同一队列中标准方法的灵敏度(71%)相当。检测两种基因的特异性为 95%,优于检测单一基因的 85%。使用 Xpert MTB/RIF 或 Ultra 进行掩蔽采样的灵敏度仅为 13%。采样是非侵入性的,操作简单,有可能应用于护理点。这项试点研究还表明,基于 RNA 转录物的检测可能会提高儿童结核病诊断的灵敏度;不过,要确定它在临床环境中的适应性,还需要进一步的调查。
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引用次数: 0
Advantages and limitations of virtual multi-disciplinary team meetings on difficult-to-treat mycobacteria. 针对难治分枝杆菌的虚拟多学科团队会议的优势和局限性。
IF 4 3区 医学 Q2 INFECTIOUS DISEASES Pub Date : 2024-04-01 DOI: 10.5588/ijtld.23.0551
V N Dahl, A Burke, A Fløe, J Bruchfeld, T Schön, C M Wejse, A B Andersen, E Svensson, J van Ingen, L Davies Forsman
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引用次数: 0
期刊
International Journal of Tuberculosis and Lung Disease
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