PROSTATE PATHOLOGY REPORTING STUDY
UPDATE May 2022: The surveys have now closed. A big thank you to all who took part. For those who volunteered to help in the interview stage, this has now received eithcal approval and is about to launch - we will be in touch shortly to invite you to take part. See more details below.
Background: Prostate cancer is the most common cancer in men and the demand for detailed prostate pathology diagnostics is significant. Men suspected of having prostate cancer usually have a biopsy to confirm the presence of cancer and the biopsy is examined by a pathologist and a written report of their findings included in the patient's notes. Men who opt to have their prostate removed surgically (for cancer or other reasons such as benign enlargement causing symptoms) will also have the prostate examined and reported on by a pathologist.
Pathology Reports: In the UK prostate specimens (biopsies or surgically removed tissue) are examined and reported by pathologists following guidelines set out by the Royal College of Pathologists (RCPath). These guidelines suggest that reports include a number of diagnostic and prognostic features, such as tumour grade (Gleason grade), tumour size, extent of spread, and other details.
The Project: This study aims to improve reporting of prostate cancer by establishing what pathologists are reporting and what the clinical teams (urological surgeons and oncologists) think about those reports. To do this, surgeons, oncologists, and pathologists will be invited to complete a survey - there will be separate surveys for pathologists and surgeons/oncologists with slightly different wordings. The survey will be followed up with focused interview of those who volunteer. It is hoped that the surveys will help inform pathologists how to stream-line reports to increase the efficiency and speed of pathology services, and in turn help improve patient care.
Ethical Approval: The project has been reviewed and approved by the Oxford University Medical Sciences Division Research Ethics Committee (CUREC / MS IDREC): sugeon/oncologists application number R74574/RE002, (approved 4/5/22) and the pathologists application number R77044/RE002 (approved 4/5/22).
Participation: Participation in the is by invitation only. If you have been invited to participate and would like to preview or re-review the background and consent information (including if you would like to withdraw your participation) please see the text set out below.
The following is a copy of the participant information and consent form:
PARTICIPANT INFORMATION SHEET
Study Title: PROSTATE HISTOPATHOLOGY REPORTING INTERVIEW
Please read this section carefully.
You may ask any questions before deciding to take part by contacting the researcher (details below).
The Researcher is Richard Colling, who is attached to the Nuffield Department of Surgical Sciences at the University of Oxford. This project is being completed under the supervision of Prof Carl Heneghan and Dr Annette Pluddemann (Principal Investigator).
A copy of this participant information sheet can be provided on request.
Why is this research being conducted?
The aim of this part of the study is to follow up on our previous survey and to find out more detail about your views on prostate histopathology reporting practices. This will hopefully allow us to improve the content of histopathology reports.
Why have I been invited to take part?
You have been identified to take part either because you kindly indicated that you would like to volunteer in the previous survey on this topic, or because you have agreed directly with the researchers personally. We very much appreciate your interest in participating.
Do I have to take part?
No, participation is voluntary. Please read through this information before agreeing to participate (if you wish to). If you do decide to take part, you may withdraw at any point before the analysis and publication (this is expected to be within two years after the interview) - including before finishing this form, as well as after submitting this form and before, during, and after the interview. You can withdraw for any reason, without needing to give a reason. You can opt out while completing this form by closing the browser and the responses will not be recorded. If you have finished and the answers are submitted along with an email address, you may withdraw at any time by contacting the investigators (details below) and your data will be deleted.
What will happen to me if I take part in the research?
If you wish to take part and continue with this short survey you will be asked a short series of brief and generic questions about you. Your full consent to take part will be also be recorded in the following pages.
At the end of this short survey you will also be asked if you would like to take part in any future research on this topic.
Once you have completed this short survey you will then be contacted within a few days via email (you will be asked to supply an email address in a moment) to arrange the interview time and date.
The interview will take place via Microsoft (MS) Teams and a calendar invitation will be sent to you. No face to face / in person interviews or telephone interviews will be conducted. You will meet with the interviewer (Richard Colling) via MS Teams at the arranged time online. When you join the interview the initial conversation will not be recorded. You can join with your camera on or off as to your preference. The interviewer will have their camera turned on. At the start of the interview this study information will be briefly recapped and a consent form will be completed. The consent form will be shared with you via email.
When you are ready, the interview will begin. Cameras will be turned off and the audio will be recorded. You will be asked a series of questions about your views on prostate pathology reports and you will have time to give answers. Questions that would identify you will not be asked. The interview is hoped to last no more than 1 hour. You can pause or leave the interview at any time should you need to for any reason (without needing to give a reason). If you need to take a short break, please let the interviewer know and the recording will be paused for a period.
If you wish to withdraw your consent, then please state this during the interview, or via email afterwards, and your data will be deleted.
If you leave the interview and it is unclear why (for example this could be because you lose internet connection) the interviewer will stop recording and attempt to reconnect with you. The interviewer may contact you via email to see if you are able to continue or if you wish to re-schedule. If the interviewer leaves the session unexpectedly, this could be for a technical or similar reason, they will either attempt to reconnect, or make contact via email as soon as possible.
If the interview ends early for any reason, and you do not wish to withdraw consent, but cannot continue / re-schedule (e.g. you don’t have time to finish the interview) then your answers up to that point will be included in the future analysis.
What are the possible disadvantages and risks in taking part?
No disadvantages or significant risks are expected from your participation. It is possible that in the unlikely event of a data breach before the end of the study (and your data deleted) that you could be identified by your email address or recorded voice.
Are there any benefits in taking part?
There is no direct or personal benefit to you by participating in the project although it is hoped that this study will improve histopathology reports and thus help improve your clinical work. Expenses or financial (or other) rewards will not be provided.
What information will be collected and why is the collection of this information relevant for achieving the research objectives?
This form will collect some personal identifiable data (name and email address) in order to arrange your interview and collect consent. Some brief questions about your specialty and work will be asked to establish your background. The interview will ask your opinions about prostate histopathology reports and it is hoped that your views will help guide how reports can be improved in the future.
Your interview will be voice/audio recorded. The audio recording is needed so that accurate and representative comments can be recorded in a timely manner that will allow the interview to be as short as possible and allow interaction and engagement with the interviewer. A full or part (anonymous) transcript of the conversation will be generated for analyses in a software program, such as NVIVO. This form data and your interview recording/transcript will be linked via a unique number. Personal identifiable data (other than your voice) will not be collected during the interview. The responses you provide here and at interview (audio and transcripts) will be securely stored online on university servers in a password-protected electronic file and may be anonymously used in academic publications. Your answers will not be linked to your personal details. Your email address will be collected here again and deleted as soon as it is no longer required for the interview research, unless you opt to join future studies. Research data (audio and transcripts) will be stored until the study has concluded. Consent records (this survey data) will be kept for at least three years after publication or public release.
Your IP address will not be stored. We will take all reasonable measures to ensure that data remain confidential. Your personal data (and any link to your responses) will not be made publicly available
Will the research be published? Could I be identified from any publications or other research outputs?
The findings from the research will/may be written up for academic publications, or conference posters/presentations, or a DPhil (PhD) thesis (thesis/ dissertation will be deposited both in print and online in the Oxford University Research Archive where it will be publicly available to facilitate its use in future research). Your comments made public will remain anonymous.
Who is funding the research?
This study is not directly funded, although it is supported by the Oxford University Clarendon Fund.
The University of Oxford is the data controller with respect to your personal data, and as such will determine how your personal data is used in the study. The University will process your personal data for the purpose of the research outlined above. Research is a task that is performed in the public interest. Further information about your rights with respect to your personal data is available at https://compliance.admin.ox.ac.uk/individual-rights.
Who will have access to my data?
The Online Survey Provider Jisc is collecting data (https://www.jisc.ac.uk) here. Details (outlined above) will be stored by Jisc and available to the researchers. Jisc and the University of Oxford will be the data controllers with respect to your personal data (email address, audio recordings) and, as such, will determine how your personal data is used. Please see the privacy notices here [https://www.jisc.ac.uk/website/privacy-notice; https://researchsupport.admin.ox.ac.uk/policy/data]
Who has reviewed this study?
This project has been reviewed by, and received ethics clearance through, the University of Oxford Central University Research Ethics Committee [reference numbers R74574 and R77033 RE002].
FURTHER INFORMATION AND CONTACT DETAILS
Who do I contact if I have a concern or I wish to complain?
If you have a concern about any aspect of this study, please speak to Richard Colling (01865 221243, Richard.email@example.com) or supervisors Carl Heneghan (https://www.phc.ox.ac.uk/team/carl-heneghan) & Annette Pluddemann (https://www.phc.ox.ac.uk/team/annette-pluddemann) and we will do our best to answer your query. We will acknowledge your concern within 10 working days and give you an indication of how it will be dealt with. If you remain unhappy or wish to make a formal complaint, please contact the Chair of the Research Ethics Committee at the University of Oxford who will seek to resolve the matter as soon as possible:
Medical Sciences Interdivisional Research Ethics Committee; Email: firstname.lastname@example.org; Address: Research Services, University of Oxford, Boundary Brook House, Churchill Drive, Oxford OX3 7GB
Consent to take part in:
PROSTATE HISTOPATHOLOGY REPORTING PRE-INTERVIEW SURVEY AND INTERVIEW
Central University Research Ethics Committee (CUREC) approval reference: R74574 and R77033 RE002
Please tick each box if you agree with the statement
I confirm that I have read and understand the online information sheet version for the above research. I have had the opportunity to consider the information, ask questions and have had these answered satisfactorily.
I understand that my participation is voluntary and that I am free to withdraw at any point before the analysis, without giving any reason.
I understand who will have access to personal data provided, how the data will be stored and what will happen to the data at the end of the project.
I understand that I will not be identifiable from any publications, reports for specific organisations, presentations, posters, thesis resulting from this work.
I consent to being audio recorded.
I agree to the use of quotations in research outputs if I am not identifiable.
I understand how to raise a concern or make a complaint.
I agree to take part.
I agree that my personal contact details can be retained in a secure database so that the researchers can contact me about future studies.
*** SURVEY CLOSED***
The following text is presented at the start of the survey:
You may ask any questions before deciding to take part by contacting the researcher (details below). The Researcher is Richard Colling, who is attached to the Nuffield Department of Surgical Sciences at the University of Oxford. This project is being completed under the supervision of Prof Carl Heneghan and Dr Annette Pluddemann (Principal Investigator).
Do I have to take part? No. Please note that participation is voluntary. Please read through this information before agreeing to participate (if you wish to) by ticking the ‘yes’ box below. If you do decide to take part, you may withdraw at any point for any reason before finishing the survey (including now) by closing the browser and the responses will not be recorded. If you have finished and the answers are submitted along with an email address, you may withdraw at any time by contacting the investigators (details below) and your data will be deleted. If you have not provided an email address your answers once submitted will be anonymous but unfortunately cannot be deleted.
All questions are required however for most we have included a ‘Don’t know’ option for each set of questions should you prefer not to answer a particular question. The first few questions are about your current job role and an answer must be given to identify if you meet the study inclusion criteria, however no identifiable personal data about you is collected at that point.
How will my data be used? The only personal data that will be collected in this survey will be an email address if you wish to provide this. You do not have to provide an email address to complete the survey. The responses you provide will be securely stored online and in a password-protected electronic file and may be anonymously used in academic publications. Your answers will be linked to your email address, if you choose to provide one. Research data (including answers, email addresses, and linked consent records) will be stored for three years after publication or public release.
The contact details we will collect will be linked to your answers. Your contact details could identify you. You do not have to enter any contact details if you do not want to and if you do not the answers you provide will be completely anonymous. If you do leave your contact details and wish to withdraw all your responses (or would just like the contact details deleted) then this will be possible by contacting the investigator (details below).
Your IP address will not be stored. We will take all reasonable measures to ensure that data remain confidential. Your emailed address if provided (and any link to your responses) will not be made publicly available.
Who will have access to my data? The Online Survey Provider Jisc is collecting data (https://www.jisc.ac.uk). Contact details (outlined above) will be stored by Jisc and available to the researchers. Jisc and the University of Oxford will be the data controllers with respect to your personal data (email address) and, as such, will determine how your personal data is used. Please see the privacy notices here:
This survey will be written up for an DPhil (PhD) degree.
Who has reviewed this study? This project has been reviewed by, and received ethics clearance through, the University of Oxford University Medical Science Division Research Ethics Committee (see above).
Who do I contact if I have a concern or I wish to complain? If you have a concern about any aspect of this study, please speak to Richard Colling (01865 221243, email@example.com) or their supervisors Carl Heneghan (https://www.phc.ox.ac.uk/team/carl-heneghan) & Annette Pluddemann (https://www.phc.ox.ac.uk/team/annette-pluddemann) and we will do our best to answer your query. We will acknowledge your concern within 10 working days and give you an indication of how it will be dealt with. If you remain unhappy or wish to make a formal complaint, please contact the Chair of the Research Ethics Committee at the University of Oxford who will seek to resolve the matter as soon as possible: Medical Sciences Interdivisional Research Ethics Committee; Email: firstname.lastname@example.org; Address: Research Services, University of Oxford, Wellington Square, Oxford OX1 2JD