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Loddon Mallee healthcare worker COVID-19 study—protocol for a prospective cohort study examining the health and well-being of rural Australian healthcare workers during the COVID-19 pandemic

Introduction The COVID-19 pandemic is creating immense psychosocial disturbance. While global, broad-based research is being conducted, little is known about the effects of the COVID-19 pandemic on health and well-being or how protective and resilience factors influence the human response in Australian rural and regional communities. Rural and regional communities often have less resources to deal with such public health emergencies and face additional environmental adversity. Healthcare workers, including those in rural and regional areas, have felt the immediate impacts of COVID-19 in a multitude of ways and these impacts will continue for years to come. Therefore, this study aims to describe and understand the impacts of the COVID-19 pandemic on the rural and regional healthcare workforce within the Loddon Mallee region, Victoria, Australia. Methods and analysis This prospective cohort of rural and regional healthcare workers will be recruited and followed over 3 years to examine the effects of the COVID-19 pandemic on their health and well-being. Self-administered online questionnaires will be administered every 6 months for a 36-month period. Multiple outcomes will be assessed; however, the primary outcomes are emotional health and well-being and psychological resilience. Emotional health and well-being will be measured using validated instruments that will assess multiple domains of the emotional health and well-being continuum. Linear and logistic regression and latent growth curve modelling will be used to examine the association between baseline and follow-up participant emotional health, well-being and resilience while adjusting for potentially time-varying confounding variables. Participant characteristics measured at baseline will also be tested for association with incident health, morbidity, mortality and health service utilisation outcomes at follow-up. Ethics and dissemination Ethical approval has been obtained through the Bendigo Health Human Research Ethics Committee. The study findings will be disseminated through international conferences, international peer-reviewed journals and social media. Trial registration number ACTRN12620001269921.

1. literature review. First, the authors state "little is known about the effects of the COVID-19 pandemic on health and well-being or how protective and resilience factors influence the human response". There are hundreds of papers published on the topic of mental health of general public and healthcare workers under the COVID1-9 pandemic. Most of the papers include sample in both urban and rural settings, and some papers, as many papers used representative samples in certain region and hence by definition include both urban and rural populations. The authors need to build upon prior work to make more accurate claims.

Motivation
Understandably the authors care about the Loddon Mallee region in Victoria. Still scientifically, what are the rationales of studying healthcare workers the Loddon Mallee region in Victoria? Is that representative of rural regions in Australia? Or it is special in certain ways that are scientifically interesting.

Confounding variables
The proposal mentioned it is going to include a number of confounding variables but fails to specify any. This issue is especially programmatic given hundreds of studies on the topic of mental health of general public and healthcare workers under the COVID1-9 pandemic. The proposal needs to build upon prior works.
The amount of outcome variables/items is huge and presents a huge burden to the healthcare workers in the targeted sample.

COVID situation in 3 years
It is very uncertain to forecast the COVID situation in the Loddon Mallee region. Most rural Australia do not suffer from COVID-19 crisis, and it is hard to know the situation with the roll-out of vaccines, so the feasibility of the study is up in the air. 'Although there are data on the impacts of the COVID-19 pandemic on healthcare workers from other countries that include metropolitan, regional, and rural populations 1-6 , there is a scarcity of data on regional and rural populations in Australia. To the best of the authors knowledge, at the time of writing, three relevant COVID-19-related healthcare worker studies have been published in Australia 7-9 and only one of these included healthcare workers from rural and regional communities 9 .
We have also updated the Abstract and Rationale sections to reflect these changes. Please see all changes within the manuscript in red text.

Motivation
Understandably the authors care about the Loddon Mallee region in Victoria. Still Based on workforce data obtained from the Victorian Knowledge bank 10  that the study would focus on the Loddon Mallee region as it consists of a mix of large regional and smaller rural health services and has a broadly similar demographic profile to the rest of the Victorian rural and regional healthcare workforce in terms of age, gender, and profession.
The following text about the representativeness of the Loddon Mallee healthcare workforce has been added to the description of the setting: 'The Loddon Mallee region was chosen for this study as it consists of a mix of large regional and smaller rural health services and has a broadly similar demographic profile to the rest of the Victorian rural and regional healthcare workforce in terms of age, gender, and profession 10 .

Confounding variables
The proposal mentioned it is going to include a number of confounding variables but fails to specify any. This issue is especially programmatic given hundreds of studies on the topic of mental health of general public and healthcare workers under the COVID1-9 pandemic.
The proposal needs to build upon prior works.
The protocol describes the general aims of the study and associated research questions. As there are multiple research questions that will be examined using this data, each question will have its own set of

COVID situation in 3 years
It is very uncertain to forecast the COVID situation in the Loddon Mallee region. We expect that this will be much lower in healthcare workers as English fluency is essential for employment in a healthcare setting. However, we acknowledge that this may be an obstacle to participation for some people and we have included this as a potential limitation in the discussion section.
The following text has been added to the statistical analysis section: 'Non-English-speaking people were excluded from the study, however the prevalence of this is very low in the The sample size is 4000 and it is not mentioned whether more participants would be recruited to compensate for loss to follow up.
We agree that loss to follow up can be expected in any cohort study. To reduce loss to follow up, study participants will be offered an incentive at each followup timepoint in the form of a random draw to win a grocery voucher. A fridge magnet will also be provided to each participant as a reminder that they are a valued study participant. So that we are able to maintain contact with participants, the fridge magnet will also remind participants to contact the study team if they change their contact details. Participants will also be sent a newsletter every six months as a way of regularly engaging with participants, and as a means of updating them on important study developments and findings.
The following text has been added to the section that describes participant follow-up: To reduce loss to follow up, study participants will be offered an incentive at each follow-up timepoint in the form of a random draw to win a grocery voucher. A fridge magnet will also be provided to each participant as a reminder that they are a valued study participant.
So that we are able to maintain contact with participants, the fridge magnet will also remind participants to contact the study team if they change their contact details. Participants will also be sent a newsletter every six months as a way of regularly engaging with participants, and as a means of updating them on important study developments and findings.
Ignoring attrition or restricting analysis to participants only with complete follow data leads to biased effect estimates. Depending on the research question, linear Issue Response mixed models will be used under the assumption of an immortal cohort with data missing at random (MAR).
However, this is not appropriate if the data is missing not at random (MNAR). Therefore, a sensitivity analysis will be performed based on the assumption that data could be MNAR. In this case a linearincrement model or joint modelling of longitudinal outcome and time to death will be used. Under the assumption of a mortal cohort, inverse probability weighting or multiple imputation will be used.
The following text has been added to the statistical analysis section: 'Depending on the research question, loss to follow up will be addressed using linear mixed models under the assumption of an immortal cohort with data missing at random (MAR). However, this is not appropriate if the data is missing not at random (MNAR). Therefore, a sensitivity analysis will be performed based on the assumption that data could be MNAR. In this case a linear-increment model or joint modelling of longitudinal outcomes and time to death will be used.
Under the assumption of a mortal cohort, inverse probability weighting or multiple imputation will be used 11 .' 3. The exclusion criteria does not mention any thing about those healthcare workers who resign or get transferred during the study period.
Participants who change employment or resign will remain part of the cohort as these are considered important outcomes to document. We will collect full contact details of study participants so that we are able to make contact if they change their employment or resign. The primary contact will be through email, however if people do not respond we will use postal or telephone contact to ensure that we maintain contact with study participants. As described above a study fridge magnet will also remind participants to contact the study team if they change their contact details.

Issue Response
Participants will also be asked at each questionnaire to update their contact details if they have changed. Thank you for this helpful suggestion. However, the vaccination roll-out in Victoria has commenced since the manuscript was submitted. Questions regarding vaccination status and intent are included in the next questionnaire.

Editorial comments
Please revise the 'Strengths and limitations' section of your manuscript The strengths and limitation section following the abstract has been revised as suggested.
Please provide copies of the surveys that were created for this study as supplementary files.
A copy of Questionnaire 1 (baseline) has been provided as a supplementary file.
Please include the planned start and end dates for the study in the methods section.
The planned start and finish date has been added to the methods section as suggested.
Please remove table 1 uploaded separately and place it inside your main document where it was first cited.
The suggested change has been made.
Please embed your corresponding author's email address in your main document file as shown in scholar one.
The corresponding author's email address has been embedded as requested.