Drop outs, don’t exist!

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Missed up files do not exist ! (or almost)

Missed up files do not exist ! (or almost)

Drop outs, don’t exist!

During a clinical trial, one of Site Study missions is to ensure the monitoring of patients participating in the study. However, it happens that during the study, patients do not give any news to the center: they are called the “Drop outs” (or “Perdus de vues” in French).

In a trial, the more those drop outs’ number is important, the greater the results will be inaccurate. So to avoid loss of information that could lead to trial invalidation, we will provide you the best ways to find out your patient: drop outs, don’t exist!
If you are Site Study Coordinator, explore these different tracks with the investigator.
If you’re CRA and your investigator and / or Site Study Coordinator informs you that a patient dropped out, suggest them to explore these different tracks:

1. Phone call

As a Site Study Coordinator, you have to make the necessary for your patient to return to his formal visits. If he does not, try at first, to call him to find out why he does not come to the planned visits.

If he does not pick up the phone, see in the folder may be there are names of people close to the patient or a family member you could contact. If the phone number is incorrect, think to use the white pages to try to get a new number or attempt to contact a family member in the same city or in the same department.

2. Town hall

By checking in the medical record, you may find your patient birthplace. The town hall of residence is able to tell you if your patient is possibly died. So you can contact your patient last known residence city Town Hall  whether he is alive or not. If you do not get information from the last known common residence, you can try to contact his birth municipality.
Or you can contact them by an “official” letter, including necessary information (patient Last name and first name, date of birth,investigator name, etc…). This will allow them to find your patient easily. To save time, do not hesitate to pre-fill your letter with the suggestion below.

Madam, Sir,

We are responsible in the XXX service of Professor XXXX to update patient files being monitored in consultation supervision.
We would like to know if he is mentioned in your death records:

Mr. XXX, born on: XXX

You can select below the appropriate item and return the information to your liking:
□ deceased – date of death: __ / __ / ____

□ not declared death to date

Otherwise, you can make a request directly online on some town halls websites or via the form on: https://mdel.mon.service-public.fr/acte-etat-civil.html for french citizens who died in France or on https://pastel.diplomatie.gouv.fr/dali/index2.html for death abroad. It is to be noticed that anyone can apply for a death certificate without justifying.

3. General practitioners and specialists (city surgery)

By going through your medical record, you will notice that a number of practitioners have already met your patient: cardiologists, general practitioners… Contact them all by phone or mail. They will give you valuable information. You could well have elements to find your patient.
EXAMPLE OF MAIL

Dear Doctor,
Following our phone call about Mr. XXX born on XXX, participating in the XXX study, would it be possible for you to provide us with the following information: (address, telephone number, last visit date, death, etc.)

4. Medical analysis laboratories

By well analyzing your medical record, you can also find various analysis laboratories where the patient completed his tests. You can also contact these laboratories to have information on the fate of your patient (did he move? etc.) You can contact them by phone to ask them  further information as you may have done with the town hall and doctors, contact them in a pre-filled mail, asking them the date of the last review and the doctor who prescribe this trial (you will be able to contact him after that).

5. Former hospital

If your patient has done tests in another hospital, you can contact the hospital. Try at first to call the concerned service in order to clarify your information request, and then send them a letter summarizing the discussion on the call made and the type of information you need. Use the opportunity to ask for the name of the patient’s doctor if you do not have it yet. Ask as well information about the medical laboratory where the patient has made his last health checks (laboratory name, city and phone if possible). You may ask them to fax this information to lighten their task. Finally, ask them the patient new address.

EXAMPLE of MAIL

To information request

I am clinical research technician, in charge of monitoring and updating the patients latest news whose records were selected as part of a clinical research on XXX.

Further to our conversation, may I ask you to complete the following items on Mr. XXX born on XXX.

– Patient Address: ……………………………………………………………

XXX
External Contact request

Madam, Sir,

I am clinical research technician, in charge of patients monitoring on XXX clinical research.

Could you provide us with the following information for Mr. XXX born on XXX

  • Doctor (name + city): …………………………………….
  • Last patient’s medical test laboratory (name + city + phone if possible): …..
  • Last patient’s home address: ……………………………………………………………

6. Anticipate

Be attentive to your patient, certain procedures in the clinical studies are sometimes long, and / or painful for him. Take time to talk with your patient, review with him the study purpose, the potential benefits and risks, and what this study could provide to other patients, and to the Research. Transmit this information to your investigator. Understanding your patient feelings better, you may apprehend the early exits of the study and possible drop outs.

To sum up, drop outs research is almost similar to investigate. This is essential to ensure the patient well-being and study operability.

Pharmaspecific provides Study Coordinators for public and private hospitals, you can directly visit our website for further information.

If you liked this article, I invite you to click on “I like” or share with your CRA colleagues and project Manager friends.

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Recherches utilisés pour trouver cet article :consentement patient perdu a vue,justifier perdu de vue dans étude descriptive,recherche clinique et consentement perdu
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