WhiMSICAL Frequently Asked Questions

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Frequently asked questions

Contents

  1. What safeguards are there to protect the privacy and security of the personal medical details entered into the WhiMSICAL Database?

  2. What questions are asked in the questionnaire and how does it work?

  3. What do the main WhiMSICAL screenshots for WM patients look like?

  4. How do I get started?

  5. What are the tips for completion of Question 3?

  6. What are the tips for completion of consent form?

  7. What are the tips for completion of Question 19 Pathology Test Results?

  8. What are the tips for completion of Question 19 Bone Marrow Biopsy results?

  9. How frequently should I update my details in WhiMSICAL database?

  10. Where do I go for enquiries and support?

1. What safeguards are there to protect the privacy and security of the personal medical details entered into the WhiMSICAL Database?

 CART-Wheel data management is undertaken by BioGrid Australia. Privacy and data security are described in detail at: 

https://www.cart-wheel.org/page/43/data-security-of-cart-wheel-database

 Principal features of the data security are:

  • Data is stored on secure servers that can only be accessed by authorised BioGrid Australia administrative staff. 

  • Only authorised researchers with approval from an accredited Human Research Ethics Committee for their research study are permitted to access coded (i.e. with personal identifying information removed) data from CART-Wheel by using BioGrid-supplied authentication details.

  •  Participant identifiers are stored separately (on separate server) from clinical information and are inaccessible to researchers.

  • To ensure privacy and security of data, regular monitoring and management of systems, updating of security patches and external audits take place. 

  • BioGrid Australia complies with and exceeds the International Standard ISO 27005 regarding risk assessment of data security.

If you wish to be further assured on data security arrangements, please contact CART-WHEEL directly at contact@cart-wheel.org .

 2.   What questions are asked and how does the questionnaire work

To give you a feeling for what you are being asked and how the questionnaire works a demonstration is provided by CART-WHEEL at    www.cart-wheel.org/page/32/demonstration-of-patient-questionnaire  

A list of the 20 Questions in the Questionnaire is shown the Content below. Screenshots for each question are provided in the link above.

3.   What do the main WhiMSICAL screenshots for WM patients look like when completed?

Examples are provided for completed screens covering Diagnosis, Treatments and Pathology tests and graphs.

 4. How do I get started?

Introductory comments on Questionnaire

It will be useful before you start the questionnaire to have:

  •  A copy of your pathology report with the specific name of your rare cancer/ tumor
  • Information about the hospitals or medical centres where you have been treated
  • The names of the treatments that you have received

If you do not have all the required information immediately available, you can update your answers to those questions at a later date.

Your information will be entered via a secure connection and cannot be seen by anyone else.

At the end of the questionnaire you will be able to print out a summary of questions and your responses for your record.

Entering the data requires WM patients to spend anywhere from half an hour to multiple hours depending upon how long they have had WM and how many treatments they have had.

It is suggested you start by entering only readily available details.

Login again later to enter details such as test results and BMB details.

The time spent in recording your details is valuable for WM research and well worth the effort.

Note throughout that CART-WHEEL uses the word “tumor” to refer to cancer of any part of the body, including blood and lymph glands

Start with easy small steps and come back later and do more

 

Register (Create CART-WHEEL account https://www.cart-wheel.org/  )

The setup of a CART-WHEEL account includes creating a username and a password  (as shown below) to use to login to the questionnaire.  This gives an option to save information at any time and to log in later to update the information.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Suggested Question sequence and priorities

Start by entering details in the following Questions:

  1. Personal
  2. Contact
  3. Diagnosis ( see additional more tip details below regarding Question 3 Diagnosis)

Then complete “Consent”  (See separate faq 6 below regarding Completing Consent) by selecting the tab “My Consent Details” (as shown above)

Following completion of Questions 1-3 and Consent give priority in data entry to:

  • Question 9 Treatments  
  • Question 19.1 Symptoms  
  • Question 19.5 Pathology test results particularly your IgM and haemoglobin details at diagnosis, at start and completion of each treatment course and your most current data     

Then as it suits you later, slowly work through the rest of the Questionnaire     

5. What are the tips for completion Question 3 on Diagnosis?

Question 3 completion is important as it enables CART-WHEEL to identify Waldenström’s Macroglobulinemia patients and to generate the specifically WM applicable Question 19 Pathology Test Results.

The example below illustrates how to complete Question 3.

 6. What are the tips for completion of consent form?

Importance of consent form completion (Without this consent form, the information provided cannot be used)

The privacy and confidentiality of your patient details are safeguarded by the comprehensive CART-WHEEL Consent process.

Completing your Consent Form confirms your permission for use of the entered information for the purposes of research.

An important requirement of the Human Research Ethics Committee that protects your rights is that you formally confirm that you understand the purpose of the study.

The importance of Consent and details about the WhiMSICAL database workings are provided in the Participant Information covering:

  • Participants access to Database via the website
  • Ethical and scientific standards for research access to data
  • Ethical guidelines
  • BioGrid Australia data sharing technology company providing secure web-based infrastructure protecting both privacy and intellectual property
  • Levels of consent for use of data
  • How privacy is protected
  • Benefits, risks, further information, problems, voluntary participation and consent withdrawal

Guidance on Completion of the Consent Form

  • CART-WHEEL uses the word “tumor” to refer to cancer of any part of the body, including blood and lymph glands
  • Choose Online option for Consent form as it is easier and quicker
  • Consent to all 5 options to ensure the maximum benefit for research purposes from data provided
  • The sections of the consent form regarding tissue sample specimens and blood samples stored in tissue banks are not relevant to the WhiMSICAL CART-WHEEL Database
  • Complete the Consent without delay so that the details entered are immediately available for research
  • For assistance and any clarification send message towhimsical@iwmf.com

Submit the Consent Form to CART-WHEEL online

Once you are logged into the Questionnaire, select ‘My Consent details’ in the top right of your screen. Select the ‘Add Consent’ button.

This will provide on screen the relevant information to enable you to consent to your participation in CART-WHEEL.

 

 

7. What are the tips for completion of Question 19 Pathology Test Results?

  • Test results are entered in the units provided in the pathology report regardless of the country. 
  • The units for the applicable country are selected using a drop-down menu
  • Entry of those pathology test results around the time of diagnosis, before and after treatment and the most recent are the most important if it is burdensome to enter all. 
  • Don’t worry, if you don’t have all the information handy, just fill in whatever data you do have.
  • Come back later to enter additional results when you have accessed the detail from your treatment centre  
  • Note Abnormal or Paraprotein Band (M-spike) in WhiMSICAL is called Serum Paraprotein Level in Question 19.
  • Note Beta 2-microglobulin is not done as frequently as others.  It is often part of a panel used to determine prognosis and treatment. Beta 2 globulin is very different to Beta 2-microglobulin.

 

8.What are the tips for completion of Question 19 Bone Marrow Biopsy results?

For assistance in determining what detail on the biopsy reports is to be entered, send a message to whimsical@iwmf.com

Aspirate and Trephine Bone Marrow reports should be entered as separate entries. An illustration on this provided below.

The BMB report details are:

“35% lymphoplasmacytic cells on aspirate and a packed trephine which showed 80% of the cells being CD20+ and 15% of the cells CD138+”

 

This example shows how the relevant details on the BMB report as above, are entered in the applicable box for:

  • Trephine
  • Aspirate

and how these details are shown in Pathology Results.

 

 

9. How frequently should I update my details in WhiMSICAL database?

After the initial completion of the Questionnaire it is sufficient to do updates yearly or when there are significant changes to your medical condition or treatment

Entering new pathology test results in question 19 is likely to be the most frequent part for updating. 

The bonus for entering in the latest results into WhiMSICAL is that you immediately have a graph generated showing the trend lines for each of the tests.

The graph trend lines give indications of the need for or benefit from treatment.

 

 

10. Where do I go for enquiries and support?

 Send an email message as follows for: