Keywords
COVID-19, Coronavirus, cohort study, follow up study, general practice, primary care
This article is included in the Coronavirus (COVID-19) collection.
COVID-19, Coronavirus, cohort study, follow up study, general practice, primary care
COVID-19 was declared a global pandemic on 11th March 20201. As of the 14th August 2020, there were over 20 million reported cases of COVID-19 worldwide, and more than 750,000 people are believed to have died with confirmed infection2. In Ireland, the total number of confirmed cases is currently 26,929 with 1,774 related deaths. The current median age of people in Ireland infected with COVID-19 is 47, 56.5% of those infected are female, and as is the case globally, infected persons most at risk of suffering severe illness and/or death have been elderly persons and individuals with underlying health conditions3. While the pandemic has impacted considerably on healthcare throughout Ireland, this has been especially so in the North Dublin area4.
The effects of COVID-19 and the COVID-19 pandemic more generally are many and diverse. Patients with COVID-19 infection present with a range of symptoms including fever, cough, shortness of breath, and fatigue. Severe cases of COVID-19 infection have caused considerable damage to various internal bodily structures and functions, resulting in the onset of multiple issues including acute respiratory stress disorder (ARDS), acute heart, liver, and kidney injury, and septic shock5–7. Moreover, it is likely that many discharged COVID-19 patients will have experienced health problems due to intensive care treatment. Prolonged stays in intensive care have been linked to a range of physical and psychological problems including decreased muscle strength, impaired mobility, and cognitive impairment7. It is also likely that because of COVID-19 related fears, grievances, and traumas, patients, their families, and the general population will need care for various mental health problems including anxiety, depression, and post-traumatic stress8–11.
The medium and long-term effects of the COVID-19 pandemic on health are still unclear. To address the needs of patients experiencing long-term health complications, appropriate long-term care plans are necessary. This study aims to examine the medium and long-term health effects of the COVID-19 pandemic in North Dublin. Using a sample of patients attending general practices in the area, the study will observe the pandemic’s effects on general health, mental health, quality of life, substance use behaviour, health service utilisation, and patients’ communities. The study can inform health policies that seek to attenuate the adverse impacts of the COVID pandemic on population health in Ireland and internationally.
This study will be conducted in line with recommendations outlined by the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) checklist for cohort studies. The STROBE checklist is a widely used and trusted framework for ensuring high scientific standards in the conducting of studies of this nature12.
The study will be conducted at 12 general practices in North Dublin and will involve the eight-week time period from 16/3/20, the Monday of the first week when national guidelines recommended that patients with possible symptoms of COVID-19 infection contact their GP and when GPs could refer patients for testing if specific criteria were met. Practices will be recruited from the professional networks of the research team and recruitment will purposefully seek to ensure the sample is representative of practices in the area in terms of practice size.
Upon agreeing to participate in the study, practices will be asked to review their practice records for the eight-week time period from 8/3/20 to identify patients with a presumptive diagnosis (i.e. experiencing symptoms consistent with COVID-19 infection) or confirmed cases of COVID-19. In the first instance, they will be asked to provide brief practice reports outlining information on the total number / demographic characteristics of those who attended during this time. Practices will be asked to assign a diagnostic code indicating those patients who were either ‘a presumptive diagnosis’ or a ‘confirmed case’ of COVID-19, using relevant diagnostic codes from the International Classification of Disease13. All adult (aged 18 years or more) patients who contacted practices during the eight-week time period starting 16/03/2020 who were diagnosed as either a confirmed or presumptive diagnosis of COVID-19 and who have the capacity to provide informed consent will be eligible for the study.
It is estimated that the prevalence of mental health disorders among patients attending general practice in Europe pre-COVID-19 is 29%14–16. Based on this estimate of mental health disorders among patients attending general practice, we estimate that a sample size of 360 will detect a 29% prevalence of mental health disorders, with a margin of error of +/-5% at a 95% confidence level. Allowing for attrition during recruitment17, to reach a target of 360 patients, we will over-sample. Thus, we expect to achieve a sample of 40 patients per practice (total N=480).
Participating general practices will provide researchers with brief practice reports. These reports will contain anonymous aggregated data pertaining to a sample of patients attending the practice since 16/03/2020 with either a presumptive or confirmed case of COVID-19 infection. After at least one month of their initial attendance at the practice, a member of the practice team will contact those patients who meet the eligibility criteria by text message, to ask if they would like to participate in the study’s follow-up procedures. Consenting patients will be contacted by a member of the research team, who will then outline study information and what their participation will involve. At recruitment and at two subsequent time points (6, 12 months) data will be collected using an interviewer administered questionnaire18, and by reviewing each patient’s clinical record (see Figure 1).
Anonymous aggregated data: The anonymous aggregated (i.e. ‘brief practice report’) data will provide details of patients’ demographic profile(s). The data will help us determine what factors are associated with COVID-19 related health issues. The reports will contain various types of information including practice location, the number of patients contacting the practice with COVID-19 infection and/or concerns, patient age, gender, General Medical Services (GMS) status, and physical/mental health history. To establish long-term trends, the reports will be collected at recruitment, and at two follow-up time points. Further, to ensure instrument validity, the reports will be prepared using existing tools within practice management systems, one of which has previously reported on the prevalence of mental health disorders among patients attending general practice19,20.
Interviewer-administered questionnaires: Patient questionnaire responses, including a chart review instrument18, will help us understand whether patients have been experiencing health problems because of the COVID-19 pandemic. Specifically, they will query patients on their age, gender, medical history, general health, mental health, COVID-19 experiences, recent health service experiences, quality of life, substance use behaviour, and their perception of how the COVID-19 pandemic has impacted their community. The questionnaire comprises multiple measures, some of which have been validated and have been frequently used in clinical practice and research settings (i.e. the SF12 Quality of Life Scale21; the PRIME-MD instrument for assessing mental health22; the ‘Impact of Event Scale-Revised’ (IES-R) post-traumatic distress measure23; and the AUDIT-C scale for measuring alcohol use24. Our questionnaire also contains two measures that are study specific. These instruments relate to patients’ experiences of the COVID-19 pandemic, their healthcare experiences during the pandemic, and the pandemic’s impact on their community. As these measures are specific to particular contexts and have been developed in response to an unprecedented public health emergency (i.e. the pandemic), they have not been previously validated. Should a health issue be identified during the interview, appropriate follow up with the person’s general practitioner will be arranged.
Review of clinical records: Using a study specific instrument18, data will be collected on demographic characteristics, the presence of any long-term medical conditions, any recent medical conditions, medicines prescribed.
This study aims to provide an overview of how the COVID-19 pandemic has impacted the physical health, mental health, and wellbeing of patients attending general practices in the North Dublin area. The COVID-19 pandemic has been an unprecedented public health emergency, and so it is not clear how the pandemic will have affected this population. Exploratory statistical analyses will therefore be used to ascertain macro-level practice and patient trends, and to identify unanticipated or noteworthy differences and/or relationships between study variables (e.g. differences between follow-up points and genders in terms of study outcomes, association between health outcomes and COVID-19 diagnostic status). These analyses will likely include a combination of descriptive and inferential statistical methods including frequency, correlation, regression, and between group analysis methods. Statistical tests will be run using IBM SPSS statistical software version 26.
With regards to informed consent, potential participants will be approached by a member of the clinical team and will be provided with information on the study. Potential participants will be contacted initially via text message and if interested, they will be provided with a study information sheet and consent form by post. Those who wish to participate in the study will be asked to indicate their informed consent to participate by signing and returning this consent form18 via prepaid post to the research team. Thus, the researchers will only have access to participants’ contact details when participants themselves agree to provide them via their GPs. We will ensure that this agreement is recorded in written form. Lastly, no individual will be identifiable during dissemination. Only grouped results will be published, and we will ensure that details which may render a study participant identifiable are amended in any publications / presentations that arise. All participants (practices and patients) can withdraw their participation at any time up until the point where their data has been anonymised. At this point it will not be possible to identify and delete their information.
With respect to confidentiality, anonymised, aggregated practice reports will be collected from participating practices. Furthermore, when collecting data on study participants, an alphanumeric code will be assigned to individual participants (i.e., pseudonymised data). Data will be stored on a password protected computer in the researchers’ offices in the Catherine McAuley Research & Education Centre, Nelson St. Dublin 7.
With respect to data protection, no third party (i.e. persons external to named investigators) will have access to study participants’ information. All electronic data will be stored as pseudonymised data on a secure, password protected server computer hard drive at the UCD School of Medicine Education & Research Centre (i.e. the Catherine McCauley Centre). Further, all hard copy data will be stored in a secure cabinet in a locked room at the same location. All data will be destroyed by the principal investigator after a retention period of three years after study completion. This is to allow dissemination of findings and secondary data analysis by the members of the research team named on this application.
With regards to vulnerable groups, the study aims to examine the impact of COVID-19 on a sample of patients attending general practice in North Dublin. Thus, the study involves interacting with and collecting information on vulnerable participants. However, we expect that participants will be exposed to minimal risk because the study involves gathering information using secondary data collection methods and a telephone-administered questionnaire. Also, with regards to contacting patients for the study’s follow-up procedures, we will only contact patients that: a) are clinically well enough to be contacted, and b) have consented to participate in the study or to be contacted by the research team. All the researchers have educational and/or professional experience in the field of mental health service delivery, have basic skills when it comes to managing mental health issues that may arise during telephone interviews. The questionnaire will also be accompanied by a statement telling patients that if they have further concerns, they should contact their doctor. Should a health issue be identified during the interview, appropriate follow up with the person’s general practitioner will be arranged.
The study has been approved by the UCD Life Sciences Human Research Ethics Committee (reference: LS-20-27-Broughan-Cullen; original approval granted 27/04/20; amendment and extension granted 17/07/20 until 30/06/21).
The project will involve collaboration with the Irish Health Service (HSE) Clinical Programmes, Ireland East Hospital Group, and the Mater Misericordiae University Hospital Dublin. The study is funded by the Health Research Board (HRB). The study will inform health service policies to attenuate the adverse impacts of the COVID-19 pandemic on population health. Outputs such as technical reports for stakeholders will be delivered accordingly. Study reports will also be submitted for publication in scientific journals, and study datasets, as well as related material (e.g. study instruments, recruitment forms) will be made publicly available on the Zenodo open-access repository website.
We are currently recruiting general practices to participate in the study. Once recruited, practices will initiate the collection of service level data, and recruitment of patients on our behalf. The first stage of data collection is expected to occur in October 2020.
Zenodo: Study Protocol: Prospective, observational, cohort study of COVID-19 in General Practice (North Dublin COVID-19 Cohort [‘ANTICIPATE’] Study). https://doi.org/10.5281/zenodo.401517618
This project contains the following extended data within the file ‘ANTICIPATE. GP ARM. Study Instruments, Information Leaflets, and Consent Forms.docx’:
- Study instrument to be used collecting data from clinical records (chart) review
- Study instrument to be used collecting anonymised aggregated data from practices
- Study instrument to be used in patient interviews on recent healthcare experiences
- Patient information leaflet
- General Practitioner information leaflet
- Patient consent form
- General Practitioner patient consent form
Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0).
Is the rationale for, and objectives of, the study clearly described?
Yes
Is the study design appropriate for the research question?
Yes
Are sufficient details of the methods provided to allow replication by others?
Yes
Are the datasets clearly presented in a useable and accessible format?
Not applicable
Competing Interests: No competing interests were disclosed.
Reviewer Expertise: I am a medical doctor in Obstetrics and Gynaecology, currently writing up my PhD entitled improving the prevention of maternal sepsis in global settings. My main area of work is in infection prevention in low resource maternity settings. I have worked on cohort studies previously, including the WHO GLOSS study.
Is the rationale for, and objectives of, the study clearly described?
Partly
Is the study design appropriate for the research question?
Yes
Are sufficient details of the methods provided to allow replication by others?
Yes
Are the datasets clearly presented in a useable and accessible format?
Not applicable
Competing Interests: No competing interests were disclosed.
Reviewer Expertise: health services research, health economics
Alongside their report, reviewers assign a status to the article:
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