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Manual data entry system

User manual for the EQUAL Data entry system
This manual describes the functions of the EQUAL data entry system. It elaborates on the actions of the different buttons and by using screenshots attention will be paid to those items in the system that may require some additional information or instructions. The screenshots can be enlarged by clicking them on this page.
In case of content related questions for example regarding specific items in the CRF, please contact the national coordinating center for help or advice:

For technical problems, you can directly contact Martijn Leegte and Lara Heuveling from Nefrovisie

1. Login

The data entry system is located at: https://survey.nefrovisie.nl/mrIWeb/mrIWeb.dll?I.Project=EQUAL_DASHBOARD

As soon as the EQUAL contact person or coordinator in your center requested access for the users in your centre, you will receive instructions by email. 

Screen 1: Loginlogin
You can access the EQUAL data entry system by entering your email address and password (screen 1). A function will soon be implemented which allows you to change your password (not implemented yet). In case you forgot your password, use the “forgot password”-link. Enter your email address and click “request password”(screen 2). Your password will be send to your e-mailbox immediately.

Screen 2: Forgot password forget password

 2. Dashboard

After logging into the data entry system, you will reach the dashboard (Screen 3). Via this dashboard the following actions can be taken.

2.1 Register a new patient

2.2 Enter a CRF for a patient

2.3 Fill in a questionnaire about reasons (not) to start dialysis

2.4 Register a mutation/change for a patient (in development)

The language is displayed based on the official language of your country. You can change the language on the dashboard by clicking the flag of your preferred language. Language settings are not automatically stored by opening a new form, but the same option is present on other forms.

NB: As soon as a patient is included in the EQUAL Study, make sure you register this patient via the dashboard (2.1 “Register a new patient”). Only after registering the patient documents (CRF, mutation form and other questionnaires) will be made available by the data entry system.

Screen 3: Dashboard dashboard

2.1 Register a new patient

Click ‘register a new patient’ in the navigation bar to register a new patient who was recently included in the EQUAL Study. A list of patient IDs available for your center is displayed (screen 4).

Screen 4: Register patientregister patient

Click ‘register patient’ next to the patient ID that was allocated to the new patient. The registration form (screen 5) will subsequently open in a new window.

Screen 5: Registration form reg_form

There is a check built in to make sure you are registering the correct patient ID. The patient ID should therefore be entered manually and should match the patient ID printed on top of the page.

Dates can be entered using several formats (dd-mm-yyyy or dd/mm/yyyy). You can also use the calendar tool which accessible by clicking the -button. After completing the registration form click the button ‘register patient’.  From this moment onwards, other forms for this patient will be made available instantly. In case the patient ID is not visible on the other forms right away, you may need to refresh the page using F5 on your keyboard.  

NB: the button ‘close window’ in the upper right corner closes the window without saving any data.

2.2 Enter a CRF for a patient

If you want to enter clinical data for a patient click ‘Enter CRF’ in the navigation bar or the menu of the data entry system. An overview of all registered patients with an empty or incomplete CRF will be displayed. By clicking one of the red circles, you will be directed to this tab in the CRF.

As soon as all tabs of the CRF are completed and the tab “complete form” is finalized, this measurement for this patient will be removed from the list and you can not open it yourself again. If a change is required you can contact Nefrovisie.

By clicking ‘view completed forms (answer summaries)’ above the table, it is also possible to generate an overview of all patients with completed CRFs.

2.2.1 CRF – general notes

Navigation bar
The EQUAL CRF consists of separate tabs as displayed in the navigation bar (screen 6). Please note that entered data will not be stored when navigating through these tabs in the navigation bar, so make sure to use one of the save buttons first.

Screen 6: Navigation bar CRF navbar

You can request an overview regarding all entered data for a patient so far, by using the link ‘Show report’ in the tab ‘Complete form’. By using this link, a form is displayed presenting missing answers and all data included so far. (see 2.2.8 and screen 14)

“Save and go to next tab” button: Once all data on a tab are completely entered, use the ‘save and go to next tab’-button. Every tab contains several built-in checks to screen the entered data for inconsistencies and plausibility. For example, one of the checks calculates whether the patient is ≥ 65 years of age based on the entered date of birth.

By using ‘Save and go to next tab’ button, the built-in checks are being activated and all data for this tab will be stored. If all questions are entered correctly, the navigation bar will show a green tick. If an answer is still missing or incorrect, a warning occurs so you can correct it accordingly.

If a tick does not appear while you are certain this tab is completed correctly, please contact Nefrovisie.

 “Save (no checks)” button: This button can be used for example when you are called away when entering the data for a patient, or you have to quit because of any other reason before the tab is completed. This button saves all the entered data so far, but the built-in checks are not activated. After using this button, a tick will not appear in the navigation bar, and this page will not be considered as complete, even though the page is completely entered correctly. The only way to finalize a page is to go back in the tab and use the “save and continue to next tab”-button.

“Close window” button: With this button, the window closes and all unsaved data will be lost.

Below, an overview is presented describing the points of attention for each tab within the CRF.

2.2.2 CRF – demographics

Screen 7: CRF-demographics CRF_demographics

Dates can be entered using several formats (dd-mm-yyyy or dd/mm/yyyy). You can also use the calendar tool which accessible by clicking the -button.

2.2.3 CRF – kidney disease

Screen 8: CRF – Kidney disease CRF_kidney disease

To enter the primary kidney disease code for a patient, start with typing the first few letters. A list appears with all possible diseases including these letters, which is based on the most recent PRD coding system of the ERA-EDTA (http://www.era-edta-reg.org/prd.jsp). You can select the primary kidney disease by clicking the name in the drop-down list or enter the full name of the disease for example when it is not included in the list.

For the dates on this tab, year is mandatory, day and month may remain empty if they are unknown. If also the year is not known, please make an educated guess.

2.2.4 CRF – comorbidity

Screen 9: CRF – comorbidity CRF_comorbidity

This tab contains questions about the presence of comorbidities as defined by the Charlson comorbidity index (definitions in “i-buttons”). Please enter for each type of comorbidity whether it is present/absent/unknown. If a comorbidity is present, also sub-questions should be answered.

NB: If a type of comorbidity is present, information about duration or its first event is requested. If this can not be retrieved from the medical records, make an educated guess or enter -9 (“for how many years”-questions), or 1-1-1900 (“first event”-questions) if this data is permanently missing.

Once this tab is finished click ‘save and go to next tab’. The automatic built-in checks are activated, and the system displays a green tick (if data is fully completed and correct) or displays a warning at the top of the page describing the missing or incorrect items on this tab.

2.2.5 CRF – Diet and medication

Screen 10: CRF – Diet and medication CRF_diet

If the patient received new or additional dietary restrictions since the previous study visit, indicate which restrictions these were. When a protein restriction has been advised, please also enter the details regarding amount of protein.

Dates can be entered using several formats (dd-mm-yyyy or dd/mm/yyyy). You can also select the date by using the calendar tool by clicking the -button.

When entering the first few letters of a medication name, a list of all medications registered to the data entry system appears. You can type in the full name of the medication (for example when it is not included in the list) or select the correct medication name by clicking on the name in the list.

2.2.6 CRF – Physical examination and SGA

Screen 11: CRF – Physical examination and SGACRF_physical
All items are mandatory on this tab. In case certain data can not be retrieved, and they will not become available, enter -9 to indicate a permanently missing value. If you leave the answer field empty, the data entry system can not complete this tab.

For the Subjective Global Assessment please enter all sub-scores and the overall assessment score. In case the SGA was not performed, tick the box “SGA not assessed”.

2.2.7 CRF – Lab

Screen 12: CRF – Lab CRF_lab

The results of blood and urine biochemistry are all mandatory. Please, start with entering the date of the laboratory results. In case an item was not assessed or could not be retrieved from the medical records, enter -9 to indicate a permanent missing value. Only after entering all required data (including -9 for missing values) the tab can be completed and a tick will appear in the navigation bar.

2.2.8 Complete form

As soon as all separate tabs are entered correctly (e.g. all tabs have green ticks in the navigation bar), the CRF can be definitively closed by using the “complete form” tab. After doing this you are not able to open the CRF again yourself, Nefrovisie can re-open the CRF if changes are required.

An overview of all entered data can be requested at all times. To do this, go to the tab ‘complete form’ and click the link ‘Show report’. An overview of all missing answers and completed data so far will open in a new window (screen 14).

Screen 13: CRF – Complete formCRF_complete form
Screen 14: Report form with completed data so far: overview

2.3 Fill in a questionnaire about reasons (not) to start dialysis

Screen 15: doctor questionnaires DR_questionnaire

The doctor questionnaires need to be completed by the treating nephrologists, as they concern the decision-making on whether or not to start with dialysis.

Via the dashboard you can click ‘Doctor questionnaires’. An overview of all registered patients is displayed. By clicking ‘open form’ you access the questionnaire as requested for a patient.

In these questionnaires there are also 2 options to save the data. ‘Save and return later’ can be used to store the data. ‘Save and complete form’ can be used to activate the built-in checks and complete the form. The ‘close window’ button closes the window without saving unsaved data.

At the end of the doctor questionnaires, please enter the name of the nephrologist providing the answers and the date. We may need this information at a later moment when questions arise.

Doctor questionnaire: Reasons to start dialysis
This questionnaire (screen 16) should be completed 1-6 weeks before diaysis initiation. Regarding the first question, multiple signs and symptoms could have been involved, but you should score the importance for the 3 most important items only.
Please indicate in the second question for each row whether this was a reason for changing the moment of starting dialysis and if so, whether this was a reason for starting earlier or later.

Screen 16: Questionnaire: Reasons to start dialysisDR_start dialysis

Doctor questionnaire: Reasons not to start dialysis
The questionnaire “Reasons not to start dialysis” has two moments of admission:
   1) As soon as the eGFR drops 2 and dialysis is not initiated (yet).
   2) At the end of the follow-up period and dialysis is not initiated yet.

Both questions consist of 2 parts. For each row you have to indicate whether the factor is present or not. If so, the strength of this factor in the decision not to start dialysis should be indicated.

Screen 17: Questionnaire reasons not to start dialysisDR_not start

2.4 Register a mutation/change for a patient (in development)

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