Download Annex 2 Consent Form

Effectiveness and Safety of a Simplified Short Regimen for Multidrug Resistant Tuberculosis Treatment in
Karakalpakstan, Uzbekistan
Joint Ministry of Health, Uzbekistan and Médecins Sans Frontières - Operational Center Amsterdam (MSF-OCA)
PATIENT INFORMED CONSENT
MSF and the Ministry of Health invite you to participate in a project evaluating the effectiveness of a shortened
treatment regimen for Multidrug Resistant Tuberculosis (MDR TB). Please read (or if you prefer, it can be read to you)
the following information so that you can make an informed decision about whether or not to participate in this project.
1.
Multidrug Resistant Tuberculosis (MDR TB)
You have been diagnosed with MDR TB. Tuberculosis is an infectious disease that is typically transmitted via air. When
TB shows resistance to several anti-TB drugs it is called MDR TB. MDR TB requires a long and complex treatment
regimen for longer than 20 months. Adherence to MDR TB treatment is crucial to treat this disease. In addition to being
important for your own health, your adherence to treatment will also reduce the risk that you will transmit the disease
to others.
2.
Purpose of Project
Recently there is some evidence showing that MDR TB can be successfully treated by taking medicine daily for 9-11
months. MSF-OCA and the Ministry of Health are evaluating whether this shorter MDR TB treatment regimen is effective
for patients with MDR TB in Uzbekistan. All patients diagnosed with MDR TB who have not previously had treatment for
MDR TB are eligible to participate in this project.
3.
Methods
If you agree to participate in this project, you will be treated for MDR TB with a shortened treatment regimen lasting 911 months instead of the alternative 20+ month regimen (“current standard MDR TB treatment regimen’). There are
three significant differences between the short course regimen and the current standard regimen: the length of
treatment, the number of drugs in each phase and the types of drugs. All regimens consist of 2 phases, intensive and
continuation. The short course regimen has an intensive phase that lasts for at least 4 months and maximum 6 months
and involves taking 7 drugs 7 days a week, including 1 injection. The continuation phase lasts for 5 months and involves
taking 5 oral drugs daily. The current standard regimen has an intensive phase that lasts for at least 8 months and
involves taking 6 drugs for 6 days per week, including 1 injection. The continuation phase lasts for 12-16 months and
involves taking 3-5 oral drugs daily.
All MDR TB regimens are always taken under strict direct treatment observation (DOT) in a health facility with a
healthcare provider or another place, such as your home. The number of treatment visits to see a doctor and the
number of blood and sputum tests will be the same during the time you take treatment whichever regimen you choose.
The only extra test required will be an electrocardiogram (ECG) which is a non-invasive test that measures the electrical
activity of the heart. This will be done 3 times, all during the first month of treatment.
The project also aims to investigate the relapses of MDR TB after treatment completion. To assist with this, you will be
requested to attend two follow-up appointments with your TB doctor in the year after you finish treatment.
During your care, healthcare workers will collect routine medical information from you for monitoring purposes. If you
agree to be treated with the project regimen, this information will also be used to answer specific scientific research
questions, and to share the experiences of the program publicly with the wider medical community.
If you decide not to participate in the project, you will still be eligible to receive standard MDR TB treatment and your
decision will have no negative consequences for the quality of care you will receive.
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4.
Risks
All anti-TB drugs may cause side effects that may be occasionally severe and will be immediately reported to minimize
their effect on adherence and quality of life. Possible adverse events with the short course regimen include nausea,
vomiting, hearing loss, kidney failure, joint pain and temporary skin discolouration (while taking the treatment). Apart
from the skin discolouration all of these adverse events may also occur with the current standard treatment for MDR TB.
There is limited evidence that this regimen will work for MDR TB patients in Karakalpakstan, however, the treatment
outcome with current standard MDR TB treatment are also very modest. Each patient will be closely monitored by
sputum and blood analyses during the entire course and in case of any unfavourable outcomes, the short course
regimen will be stopped and the current standard 20+ month MDR TB treatment will be commenced. Unfortunately, the
safety of TB medications used to treat drug resistant tuberculosis and their influence on the foetus has not been
established, some medications (capreomycin or prothinamide) are contraindicated during pregnancy.
Pregnancy during the shortened treatment regimen may require the modification of the regimen and significant
extension of the duration of treatment. Therefore, contraception is strongly recommended before commencing and
during the entire shortened treatment regimen.
Two medications used in the regimen (clofazimine and moxifloxacin) may potentially cause a risk of disturbing the
electrical activity of the heart, however, these drugs have been used in the standard MDR TB regimen for several years
without sudden severe adverse effects observed. To avoid potentially dangerous consequences for patients, regular ECG
examinations will be performed in the intervals according to the protocol.
5.
Benefits
The main benefit for participation in the short course regimen is the possibility to treat your MDR TB in a reduced
treatment period of 9-11 months, instead of the current 20+ months. You may also gain satisfaction by participating in a
project designed to evaluate strategies to improve MDR TB care, which may help other MDR TB patients.
6.
Patient rights and confidentiality
You have the right to stop treatment and your participation in the project at any time. Your decision at any time will be
respected and this will not affect the quality of care you will receive. You also have the right to have access to detailed
and honest medical information concerning your treatment and prognosis.
Absolute confidentiality will be guaranteed at all times and all information concerning your treatment will only be
discussed with you or your appointed representative. Your name or identifying information will not be included in any
report, or publication. For analysis of project results, an anonymous identification number will be used. Your name or
identifying information will not be included in any report or publication. All patient information is confidential and will
be stored in a secure and safe manner. Project material is kept for several years after the project is completed and then
destroyed. It will be discarded in accordance with national and MSF regulations.
7.
Patient responsibilities
You are responsible for committing to the full duration of treatment and for taking all prescribed medication. You
should inform the medical team if you need to stop or end treatment for any reason. You are also responsible for
attending the follow up consultation visits and undertaking the monitoring tests recommended by your doctor. Failure
to meet these responsibilities can result in exclusion from the MDR TB treatment program and cessation of treatment.
The schedule and tests during treatment are the same that you would do if you chose not to participate in the study.
After treatment completion we will ask you to visit the clinic at month 6 and 12 respectively.
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8.
Pilot project team contact information
You may have questions about this short course treatment. If you have any questions, you can ask any of our healthcare
staff at any time. If you have questions later, you can call or write to the country project coordinator, MSF, Jay Achar,
Uzbekistan, Karakalpakstan, Nukus, Panaev st #20, 230105 phone number +998-91-377 8652.
9.
Consent statement
I have read this form or it has been read to me. I have had a chance to ask questions about this project, and my
questions have been answered. I understand and agree to my rights and responsibilities contained in the information
sheet. I have been offered a copy of this informed consent to keep if I so wish.
Please check one of the following and sign below:
 I agree to participate in this pilot project.
 I do not agree to participate in this pilot project.
Date:
PATIENT
(if younger than 16 year old consent of parents/ guardian)
STAFF MEMBER OBTAINING CONSENT
Name: __________________________________
Name: _________________________________
Position/role: _____________________________
Signature: _______________________________
Signature: ________________________________
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