Perpetual Observational Study (POS) of Acute Respiratory Infections (ARI) in Primary Care Settings (PC) Across Europe
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,000
- 试验地点
- 3
- 主要终点
- Overall illness severity rating
研究概览
简要总结
Acute respiratory infection (ARI) is the commonest reason for consulting in community care. Furthermore, new and re-emerging pathogens are often first noticed in primary care (PC). The POS-ARI-PC study is a long-term study, with the aim of describing the nature of ARI in adults and children presenting to PC across Europe. The POS-ARI-PC study will provide critically important data on the presentation and management of ARI, and build a research-ready infrastructure for studies related to the treatment, diagnosis, and prevention of ARI in primary care settings. Additional observational studies will be embedded and use the infrastructure developed in POS-ARI-PC.
详细描述
The main aim for POS-ARI-PC is to provide a platform for continuous data capture for patients with ARI presenting to primary care settings across Europe, covering cases caused by known and emerging respiratory pathogens with epidemic and pandemic potential, in order to generate observational evidence to inform care and maintain study- readiness for RCT evaluations. The POS-ARI-PC platform will thereby support the efficient set-up of new clinical studies and trials, which will be embedded into the platform.
We have developed two overarching protocols for the POS-ARI-PC. The POS-ARI-PC AUDIT protocol allows for a flexible annual anonymous prospective audit-type registration to describe the presentation and management of patients presenting in primary care with ARI. This provides the infrastructure for patient sampling and follow-up, and in which randomisation can be activated for platform trials to evaluate a range of interventions that can be added and replaced over time. This has resulted in the POS-ARI-PC CORE protocol.
POS-ARI-PC AUDIT:
This is a flexible annual anonymous prospective audit-type registration to describe the presentation and management of patients presenting in primary care with ARI. POS-ARI-PC AUDIT will be delivered through a prospective, multi-country, audit-type anonymous registration of presentation and management of approximately 2,000 patients presenting to PC annually across Europe. This audit will benchmark the case mix and care of patients consulting in PC. These can include general practice, urgent care centres, accident and emergency and other acute services in hospitals, for adult and paediatric patients, both in and out of office hours.
POS-ARI-PC CORE:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •POS-ARI-PC AUDIT:
- •Inclusion Criteria:
- •Eligible patients will be of any age consulting (telephone, video, face-to-face) with a participating health care facility with:
- •Symptoms suggestive of an acute lower RTI with cough as predominant symptom and with illness duration less than 28 days, AND/OR
- •Symptoms suggestive of an acute upper RTI with sore throat and/or coryza as predominant symptom and with illness duration of less than 14 days AND/OR
- •Patients otherwise suspected of COVID-19, influenza or RSV.
排除标准
- •Patients will not be eligible for if they have withdrawn their consent for anonymous data collection for research by their health care facility.
- •POS-ARI-PC CORE:
- •Inclusion criteria:
- •Eligible patients will be of any age consulting (telephone, video, face to face) with a participating primary health care facility with:
- •Symptoms suggestive of an acute lower respiratory infection with cough as the predominant symptom, with illness duration less than 28 days, AND/OR
- •Symptoms suggestive of an acute upper respiratory infection with sore throat and/or coryza as the predominant symptom, with illness duration of less than 14 days AND/OR
- •Other symptoms suggestive of COVID-19, Influenza, RSV AND
- •Participant or legal guardian(s) willing and able to provide informed consent and comply with study procedures
- •Exclusion criteria:
- •Patients will not be eligible if:
- •According to the judgement of the recruiting clinician, they will not be able comply with study procedures, for example because they do not understand the language in which the study is being conducted locally (and have no one to help and translate for them); have a serious psychiatric disorder; or are terminally ill
- •Symptoms of presumed non-infective origin
- •Participant requires admission to hospital on the day of inclusion
- •Additional in/exclusion criteria might apply to embedded studies and will be described in the SSA or ISA.
- •POS-ARI-PC-001:
- •Symptoms and Duration Symptoms suggestive of an acute lower RTI with new or increased cough as the predominant symptom, with illness duration ≤10 days; AND/OR Symptoms suggestive of an acute upper RTI with sore throat and/or coryza as the predominant symptom, with illness duration ≤10 days;
- •Age Aged 60 years and over OR Aged 50 to 59 years and have a long-term health condition which makes them eligible for the yearly influenza vaccination under the national influenza vaccination programme;
- •Consent Willing and able to provide informed consent and have a swab taken.
- •Exclusion Criteria:
- •As per the POS-ARI-PC CORE Protocol, with one exception: patients needing hospitalisation can be recruited into the study if timing allows. Patients can provide a swab and decide not to participate in the follow-up procedures.
研究组 & 干预措施
POS-ARI-PC
POS-ARI-PC AUDIT:
Anonymous registration of patients of any age presenting at the participating primary care facility with ARI.
POS-ARI-PC CORE:
Patients of any age presenting at the participating primary care facility with ARI.
POS-ARI-PC-001:
Patients 60 and over, or aged 50 to 59 years and have a long-term health condition which makes them eligible for the yearly influenza vaccination under the national influenza vaccination programme, presenting at the participating primary care facility with ARI.
结局指标
主要结局
Overall illness severity rating
时间窗: Baseline (Day 0)
Overall illness severity (clinician's impression) recorded at baseline (mild, moderate or severe) by site study team.
Swab samples taken and retrospective viral/microbiological infection analysis performed (multiplex PCR) to identify potential causative pathogens.
时间窗: Baseline (Day 0)
Participants have a combined oropharyngeal and nasal swab taken at the baseline visit which will be subjected to PCR-based analysis to identify potential causative pathogens.
Proportion undergoing POC (with results) and lab-based investigations
时间窗: Baseline (Day 0) and day 28.
POC investigations recorded at baseline and results recorded at day 28 by site study team.
Details of prescriptions given on presentation of ARI
时间窗: Baseline (Day 0)
Prescriptions given at presentation recorded at Baseline by site study team.
Details of tests ordered on presentation of ARI
时间窗: Baseline (Day 0)
Tests ordered at presentation recorded at Baseline by site study team.
Return to usual daily activities
时间窗: Day 1-14
Participants asked if they have returned to usual activities in daily diary.
Age Bands
时间窗: Baseline (Day 0)
Participant age recorded at baseline by site study team.
Use of over the counter medications
时间窗: Day 1-14
Participants asked if they have used over the counter medication for the RTI in daily diary.
Complications reported associated to ARI presentation
时间窗: Day 28
Recorded at day 28 by a member of the site study team.
Variation in practice and advice from national guidelines, to be fed back to national teams
时间窗: Baseline (Day 0)
Practice and advise recorded at Baseline by site study team.
The proportion with a preliminary diagnosis of various sub-categories of ARI (e.g. LRTI, URTI)
时间窗: Baseline (Day 0)
Working diagnosis recorded at baseline by site study team.
Feeling recovered from RTI
时间窗: Day 1-14
Participants asked if they are feeling recovered from RTI in daily diary.
Use of prescription medication
时间窗: Day 1-14
Participants asked if they have used prescription medication for the RTI in daily diary.
次要结局
- Recommendations on how to improve study processes, recruitment and study communication based on shared understanding and insights from researchers, clinicians, and patients.(After day 28)
- Approval for a study-specific appendix (SSA) or an intervention-specific appendix (ISA) of an embedded (non) randomised study for ARI in primary care associated with this POS, measured using the number of embedded studies to this POS-ARI-PC platform over(Through study completion)
- An understanding of the meaning of study results for European primary care, from the perspectives of clinicians and patients, and recommendations regarding the implementation of findings.(After day 28)
- An understanding of changing health-seeking behaviour, management and expectations to inform clinical studies and trials(After day 28)