Agile Transformation in Clinical Research

Pavlović, Katarina; Berić, Ivana; Berezljev, Ljiljana

doi:10.18485/epmj.2018.8.1.8

Cited by 2 publications

(4 citation statements)

References 7 publications

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“…EPI-ASTHMA will be managed combining traditional management methodologies with an ‘agile’ approach 27 using the SCRUM framework on Jira software. This combination is expected to fulfil the need to make the study adaptable and to anticipate future needs that are important and can be forgotten due to the dimension of the study.…”

Section: Discussionmentioning

confidence: 99%

“…To mitigate these risks, an experienced contracted research organisation that knows the specificities of each administration/health unit is supporting us through all the process. EPI-ASTHMA will be managed combining traditional management methodologies with an 'agile' approach 27 using the SCRUM framework on Jira software. This combination is expected to fulfil the need to make the study adaptable and to anticipate future needs that are important and can be forgotten due to the dimension of the study.…”

Section: Discussionmentioning

confidence: 99%

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EPI-ASTHMA study protocol: a population-based multicentre stepwise study on the prevalence and characterisation of patients with asthma according to disease severity in Portugal

et al. 2022

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IntroductionIn Portugal as in other countries, data on the epidemiology of asthma are mainly grounded in questionnaire studies. Additionally, the detailed characterisation of asthma in terms of disease severity, control and phenotypes remain scarce. Studies assessing the prevalence of asthma and its subgroups using accurate methods are needed. This study aims to determine the prevalence of asthma, difficult-to-treat asthma and severe asthma, and to evaluate sociodemographic and clinical characteristics of those patients, in mainland Portugal.Methods and analysisA population-based nationwide study with a multicentre stepwise approach will be conducted between 2021 and 2023 in 38 primary care centres of the Portuguese National Health Service. The stepwise approach will comprise four stages: Stage 0—telephone call invitation to adult subjects (≥18 years) randomly selected (n~15 000); stage 1—telephone screening interview assessing the participants’ respiratory symptoms (n~7500); stage 2—diagnostic visit, including physical examination, diagnostic tests (eg, spirometry, fraction of exhaled nitric oxide, blood eosinophil count) and patient-reported outcome measures for diagnostic confirmation of those identified with possible asthma at stage 1 (n~1800); stage 3—further evaluation of patients with asthma and of patients with difficult-to-treat asthma and severe asthma, after 3 months (n~460). At stage 3, data will be collected from a review of the patient’s electronic health records, a follow-up telephone call and the CARATm (Caracteristicas Auto-reportadas de Asma em Tecnologias Móveis) app database. The prevalence of asthma, difficult-to-treat asthma and severe asthma will be determined as the percentage of patients with asthma confirmed from the overall population (stage 1). For the analysis of factors associated with asthma, difficult-to-treat asthma and severe asthma, logistic regression models will be explored.Ethics and disseminationEthical approvals for the study were obtained from the ethics committee of the local health unit of Matosinhos, Porto (38/CES/JAS), Alto Minho (38/2021/CES) and the regional health administration of Lisbon-Vale do Tejo (035/CES/INV/2021). Results will be published in peer-reviewed journals.Trial registration numberNCT05169619.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

EPI-ASTHMA study protocol: a population-based multicentre stepwise study on the prevalence and characterisation of patients with asthma according to disease severity in Portugal

et al. 2022

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“…We have combined traditional management methodologies with an “agile” approach 18 in which all issues, documentation, timelines and task distributions have been reported. This management combination is expected to fulfill the purpose of making the study adaptable and to anticipate future needs, preventing omissions forgetting and to avoid previous flaws in the future that are important and can have an impact on the outcomes due to the dimension of the study.…”

Section: Discussionmentioning

confidence: 99%

“…We also combined traditional management methodologies with an “agile” approach. 18 The agile project management, originated in software development, is used in a growing number of areas. 19 The agile approach is useful in complex projects, that are subject to environmental change and a wide array of uncertainties.…”

Section: Methodsmentioning

confidence: 99%

Prevalence and Characterisation of Patients with Asthma According to Disease Severity in Portugal: Findings from the EPI-ASTHMA Pilot Study

João¹,

Jácome²,

Brito³

et al. 2022

JAA

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To assess the feasibility of the procedures of EPI-ASTHMA. EPI-ASTHMA is a population-based multicentre stepwise study about the prevalence and characterisation of patients with asthma based on disease severity in Portugal. Methods: A pilot study of EPI-ASTHMA was conducted with adults from three primary care centres. We followed a stepwise approach comprising 4 stages: stage 0-invitation phone call (n ~1316); stage 1-telephone interview (n ~658); stage 2-clinical assessment with physical examination, diagnostic tests, and patient-reported outcome measures, to confirm the diagnosis of those with possible asthma at stage 1 (n ~160); stage 3-characterization of a subgroup of asthma patients by collecting data through a telephone interview, patient file review and CARATm app (n ~40), after 3-months. The frequency of asthma was calculated in relation to the entire study population (stage 1) and the frequency of difficult-to-treat/severe asthma in relation to the number of asthma patients (stage 3). Results: From 1305 adults invited, 892 (68%) accepted to participate (stage 0) and 574 (64%; 53[42-67] y; 43% male) were interviewed (stage 1). From those, 148 (26%;[60][61][62][63][64][65][66][67][68] y; 43% male) were assessed at stage 2, and 46 (31%; 51[39-67] y; 44% male) were diagnosed with asthma. Half of these patients (n = 23) accepted to install the app. Stage 3 was completed by 41 (93%) patients, of whom 31 (83%) had asthma confirmed by their file review. A total of 8% of participants had asthma, of those 17% had difficult-to-treat and 5% severe asthma. Conclusion: Attained recruitment rates and the quality of the results confirmed the feasibility of the EPI-ASTHMA stepwise approach. This pilot study provided insight into the improvement of the procedures to be generalized across the country.

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Agile Transformation in Clinical Research

Cited by 2 publications

References 7 publications

EPI-ASTHMA study protocol: a population-based multicentre stepwise study on the prevalence and characterisation of patients with asthma according to disease severity in Portugal

EPI-ASTHMA study protocol: a population-based multicentre stepwise study on the prevalence and characterisation of patients with asthma according to disease severity in Portugal

Prevalence and Characterisation of Patients with Asthma According to Disease Severity in Portugal: Findings from the EPI-ASTHMA Pilot Study

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