diff --git a/safer_projects/introduction.md b/safer_projects/introduction.md index c548875..70c0650 100644 --- a/safer_projects/introduction.md +++ b/safer_projects/introduction.md @@ -23,7 +23,18 @@ This page provides an introduction to our work on the SAFER Programme. The [SAFER Programme](https://www.safer.phpc.cam.ac.uk/) is nvestigating whether using ECG devices to screen for atrial fibrillation (AF) is effective and cost-effective in reducing the incidence of stroke. It is being conducted by researchers in the Department of Public Health and Primary Care at the University of Cambridge. Many thousands of participants have taken part in the research programme. +### SAFER Phases + The Programme consists of three phases: -- The Feasibility Study -- The Remote Feasibility Study -- The Trial + +- The Feasibility study: (_a.k.a Feas1_) A study in 10 GP Practices, including a face-to-face appointment, which 2,141 participants took part in. This has finished, confirming that it is feasible to deliver an AF screening programme in general practice, and that high numbers of patients accept an offer of AF screening and go on to complete the screening process. +- The Remote Feasibility study: (_a.k.a Feas2_) When the COVID-19 pandemic struck, it became clear that screening could not be delivered in the practice. An additional feasibility study was conducted with participants from 3 GP Practices, in which the screening was delivered remotely. +- Trial, including an internal pilot study: Expected to enrol many 10,000s of participants from 100s of GP Practices, a third of whom will be offered screening. They will be followed up for an average of 5 years. + +### The Screening Process + +The three main steps of the screening process which I?ll refer to are: + +- **ECGs recorded at home:** Firstly, participants are sent a handheld device which takes 30-second ECG recordings between two thumbs. Participants are asked to record an ECG 4 times per day, for 3 weeks, producing approximately 84 ECGs per participant. +- **Automated analysis:** Secondly, the ECG recordings are automatically analysed to identify any that may contain AF. +- **Clinical review:** Thirdly, those ECGs which may contain AF are sent for clinical review to make a final diagnosis. Any participants diagnosed with AF then discuss possible anticoagulation with their GP. \ No newline at end of file diff --git a/safer_projects/reading_material.md b/safer_projects/reading_material.md index bb60a07..f6f8545 100644 --- a/safer_projects/reading_material.md +++ b/safer_projects/reading_material.md @@ -21,9 +21,9 @@ This page provides a background reading material relating to our work on the SAF ## Initial Reading for SAFER Student Projects -This page some recommended reading for projects within the SAFER Programme. Do be selective about which articles to read - there is certainly no need to read them all. In addition, be selective about which parts of the articles to read - for instance, simply reading the abstract may be sufficient in some cases. +This page provides some recommended reading for projects within the SAFER Programme. Do be selective about which articles to read - there is certainly no need to read them all. In addition, be selective about which parts of the articles to read - for instance, simply reading the abstract may be sufficient in some cases. -**PDFs** of documents which are not available online are provided [here](https://universityofcambridgecloud-my.sharepoint.com/:f:/r/personal/pc657_cam_ac_uk/Documents/SAFER_Engineering_Resources/SAFER_student_projects/Project_Resources/Reading_Materials). _NB: to open links on this page, right click and open in a new tab._ +**PDFs** of documents which are not available online are provided [here](https://universityofcambridgecloud-my.sharepoint.com/:f:/r/personal/pc657_cam_ac_uk/Documents/SAFER_Engineering_Resources/SAFER_student_projects/Project_Resources/Reading_Materials). --- @@ -50,7 +50,7 @@ The following are recommended for initial reading on screening for AF: - **The ECG recording device:** Have a look at Zenicor's device [here](https://peterhcharlton.github.io/info/tools/reading/af_screening.html#zenicors-handheld-ecg-device) to get an idea of the device used in these studies. -## Additional Topics +## ECG Interpretation and Analysis Whilst the above topics are likely to be of some relevance, the following topics may or may not be relevant. Do be selective. diff --git a/safer_projects/safer_data.md b/safer_projects/safer_data.md index 3fa0b13..a5a3701 100644 --- a/safer_projects/safer_data.md +++ b/safer_projects/safer_data.md @@ -19,41 +19,15 @@ This page provides information on data collected during the SAFER Programme. --- -## Data Collection - -### Recording ECGs - -Participants of the SAFER programme are asked to use a handheld ECG device to record 30-second, single-lead ECGs at home. They record approximately 4 ECGs per day for approximately 3 weeks, providing around 84 ECGs per participant. - -_The handheld ECG device_ - -The device being used is the [Zenicor-EKG](https://zenicor.com/zenicor-ekg/) device (see [here](https://zenicor.com/wp-content/uploads/2014/08/MG_1945_low-300x200.jpg) for a picture of the device). This device was previously used in the STROKESTOP studies. - -### Automated analysis of ECGs - -ECGs are analysed using [Cardiolund's ECG analysis algorithm](https://peterhcharlton.github.io/info/tools/reading/af_screening.html#cardiolunds-ecg-parser-algorithm). This algorithm applies the binary classifications (known as tags) to each ECG signal, which are descirbed [here](https://cardiolund.com/ecg-parser/). - -Selected tags are used to identify ECGs which exhibit signs of possible AF, and therefore warrant manual review. - -### Participant-level diagnoses - -Participants who have at least one ECG exhibiting signs of possible AF are sent for manual review by one or more reviewers (details of this process are provided [here](https://universityofcambridgecloud-my.sharepoint.com/:t:/r/personal/pc657_cam_ac_uk/Documents/SAFER_Engineering_Resources/SAFER_study_methods/Clinical%20review.md?csf=1&web=1&e=qCcgKp), and details of the tags used to identify signs of possible AF are provided [here](https://universityofcambridgecloud-my.sharepoint.com/:t:/r/personal/pc657_cam_ac_uk/Documents/SAFER_Engineering_Resources/SAFER_study_methods/Use%20of%20algorithm%20tags.md?csf=1&web=1&e=NcchiT)). - -Each participant is assigned a participant-level diagnosis. - -### ECG-level labels - -During the process of reviewing participants, cardiologists may label individual ECGs on an ad-hoc basis. Labels include: AF, non-AF, and poor quality. - ## Data processing The SAFER data are extensively processed to produce a clean dataset for analysis. The variables available are listed [here](https://universityofcambridgecloud-my.sharepoint.com/:b:/r/personal/pc657_cam_ac_uk/Documents/SAFER_Engineering_Resources/SAFER_student_projects/Project_Resources/SAFER_variables.pdf?csf=1&web=1&e=0Lq9Vq). -## Accessing the data +## Data Access Users must sign a _Data Sharing Agreement_ to access the data, which is submitted for review by the SAFER Team. Please ask me for a copy of the _Data Sharing Agreement_. -## Files +## File Structure and Formatting ### Participant- and recording-level data diff --git a/safer_projects/safer_methods.md b/safer_projects/safer_methods.md index 26b903e..c1f2a06 100644 --- a/safer_projects/safer_methods.md +++ b/safer_projects/safer_methods.md @@ -19,20 +19,42 @@ This page provides information on the methods used in the SAFER Studies and Tria --- -## SAFER Methods +## Recording ECGs + +Participants of the SAFER programme are asked to use a handheld ECG device to record 30-second, single-lead ECGs at home. They record approximately 4 ECGs per day for approximately 3 weeks, providing around 84 ECGs per participant. + +_The handheld ECG device_ + +The device being used is the [Zenicor-EKG](https://zenicor.com/zenicor-ekg/) device (see [here](https://zenicor.com/wp-content/uploads/2014/08/MG_1945_low-300x200.jpg) for a picture of the device). This device was previously used in the STROKESTOP studies. + +## Labelling ECGs + +### Automated analysis of ECGs + +ECGs are analysed using [Cardiolund's ECG analysis algorithm](https://peterhcharlton.github.io/info/tools/reading/af_screening.html#cardiolunds-ecg-parser-algorithm). This algorithm applies binary classifications (known as tags) to each ECG signal, which are descirbed [here](https://cardiolund.com/ecg-parser/). + +Selected tags are used to identify ECGs which exhibit signs of possible AF, and therefore warrant manual review. The use of algorithm tags is detailed [here](https://universityofcambridgecloud-my.sharepoint.com/:t:/r/personal/pc657_cam_ac_uk/Documents/SAFER_Engineering_Resources/SAFER_study_methods/Use%20of%20algorithm%20tags.md?csf=1&web=1&e=tsnrFN). + +### Participant-level diagnoses + +Participants who have at least one ECG exhibiting signs of possible AF are sent for manual review by one or more reviewers (details of this process are provided [here](https://universityofcambridgecloud-my.sharepoint.com/:t:/r/personal/pc657_cam_ac_uk/Documents/SAFER_Engineering_Resources/SAFER_study_methods/Clinical%20review.md?csf=1&web=1&e=qCcgKp), and details of the tags used to identify signs of possible AF are provided [here](https://universityofcambridgecloud-my.sharepoint.com/:t:/r/personal/pc657_cam_ac_uk/Documents/SAFER_Engineering_Resources/SAFER_study_methods/Use%20of%20algorithm%20tags.md?csf=1&web=1&e=NcchiT)). + +Each participant is assigned a participant-level diagnosis. + +### ECG-level labels + +During the process of reviewing participants, cardiologists may label individual ECGs on an ad-hoc basis. Labels include: AF, non-AF, and poor quality. ### Reviewing ECGs Details of how ECGs were reviewed in the SAFER Programme to allocate diagnoses are provided [here](https://universityofcambridgecloud-my.sharepoint.com/:t:/r/personal/pc657_cam_ac_uk/Documents/SAFER_Engineering_Resources/SAFER_study_methods/Clinical%20review.md?csf=1&web=1&e=mcAfBi). -### ISRCTN Numbers +## ISRCTN Numbers + +The SAFER registration numbers are as follows: |---|---| | Study Phase | ISRCTN number | |---|---| | Feasibility Study ( _Feas1_ ) | [16939438](https://www.isrctn.com/ISRCTN16939438) | -| Trial ( _including the Pilot_ ) | [72104369](https://www.isrctn.com/ISRCTN72104369) | - -### Use of algorithm tags - -The use of algorithm tags is detailed [here](https://universityofcambridgecloud-my.sharepoint.com/:t:/r/personal/pc657_cam_ac_uk/Documents/SAFER_Engineering_Resources/SAFER_study_methods/Use%20of%20algorithm%20tags.md?csf=1&web=1&e=tsnrFN). +| Trial ( _including the Pilot_ ) | [72104369](https://www.isrctn.com/ISRCTN72104369) | \ No newline at end of file