Questions and Answers from the BPaL OR Project
Implementation Review- Philippines

Question

Answer

Dr Maria Marissa I. Golla (De La Salle Medical and Health Sciences Institute - DLSMHSI):

Last year we had only one potential patient for referral to BPaL OR. Unfortunately, due to the distance of travel from Cavite to Batangas, the patient was not willing and we enrolled patient under ITR.

1. Travel allowance or transportation provided?

2. Meal allowance included?

3. Possible to refer DSTB patient allergic to first line drugs and does not want long treatment?

Dr Irene Flores (Principal Investigator - PI):

·       On the allowance or financial support, it’s the same for all PMDT patients. They will be given a daily allowance for the whole duration of treatment c/o PBSP. All other needs like transportation and other medicine, we can refer to RTBMAC for approval and we can also coordinate with the LGU.

·       For the DSTB case, unfortunately we cannot enroll the patient in the operational research because the patient needs to be RR detected in Xpert.

Dr Maria Marissa I. Golla (DLSMHSI):

How long is the timeline? We aim to enroll a bacteriologically confirmed DRTB patient within 7 days of diagnosis. What if due to the Covid pandemic screening at OR site was not possible within 7 days and at the end patient is not eligible. How is the reporting?

Lovely Ducusin (Ilocos Training and Research Medical Center – ITRMC):

·       They will still be eligible for enrollment for BPal.  We can use the RR-TB GX result of the previous treatment and as long as the patient has not reached 1 month of exposure to Bdq, Lzd, Pa po doc. If the patient was exposed already to the said medicines for more than a month, they will be excluded from the OR (unless proven susceptible). We have a reporting for this and this will be reflected in Form 1.

Dr Maria Marissa I. Golla (DLSMHSI): So we enroll the patient first to ITR and refer if willing to participate for BPaL screening. Timeline is within a month if not eligible to continue ITR.

If changed to BPaL, add to OR and number of study participation in front of usual enrollment ID number. Did I correctly understand this?

Dr Irene Flores (PI):

·       We have to check first if patient is eligible for screening based on inclusion criteria (FQ-resistance, treatment intolerance or non-response). If eligible, we can already screen the patient regarding BPaL OR c/o the OR site team. If the patient agrees then the OR site can enroll the patient.

Marichu Naje (RTBMAC Region V):

If we refer the patient to the Ophthalmologist, can this be considered as a special diagnostic procedure that can be paid for by PBSP?

Dr Irene Flores (PI):

·       Yes, as long as it is properly requested to PBSP and approval is given.

Dr JoAn TuY (Lung Center of the Philippines):

If the outcome of the patient is pending for the time being, and the patient would be asking a medical certificate or abstract for some reason, what would we put as outcome?

Dr Irene Flores (PI):

·       For the purpose of medical certificate alone, we can mention that the patient has completed treatment but to declare an outcome, we would have to wait for the culture results at 5^th or 6^th month.

Dr Mamel Quelapio (LIFT-TB Consultant):

·       (Agree with Dr Flores) It can be indicated that the patient is clinically well.

Manuel Franco (Mayor Hilarion A. Ramiro Sr. Medical Center – MHARSMC):

Does erythropoietin play a role in decreasing hemoglobin levels during the treatment?

Dr Irene Flores (PI):

·       Yes, even in the PMDT Implementing Guidelines, we can use erythropoietin for patients with anemia secondary to myelosuppression.

Manuel Franco (MHARSMC):

Can erythropoietin substitute blood transfusion in this case (Patient #2)?

Dr Irene Flores (PI):

·       The Hemoglobin level is already grade 4 in the severity grading scale, blood transfusion is needed in this case. Even in other cases of anemia, blood transfusion is indicated for Hgb of <70g/l.

·       If symptomatic, blood transfusion is indicated even if Hgb is >70, for all cases of anemia.

Manuel Franco (MHARSMC):

What if the patient is affiliated with a religion that does not allow blood transfusion?

Dr Irene Flores (PI):

·       If the patient refuses blood transfusion because of religious belief then we cannot force the patient to do it in which case s/he should be asked to sign a waiver for the refusal.

Dr Mamel Quelapio (LIFT-TB Consultant):

·       In the context of BPaL, if the patient refuses blood transfusion and he is already in the 3^rd month of treatment, the BPaL regimen can be continued but Lzd would definitely have to be discontinued.

If the patient is finished with 6 months treatment and still waiting for the 5/6th months culture results, what should be indicated as treatment outcome?

Dr Irene Flores (PI):

·       Temporarily put “pending.”

For Lzd dose reduction, when can we say this is a permanent reduction or a temporary one?

Dr Mamel Quelapio (LIFT-TB Consultant):

·       If there are no plans to resume back to the higher dose, consider this permanent. (Note that this indicator is being modified.)

For symptoms of possible AESIs like optic neuritis, what would be the basis for classifying the condition as AESI?

Dr Irene Flores (PI):

·       We have to follow the Ophthalmologist’s  report in classifying the condition as AESI.

How to decide if the OR site can end the treatment of the patient at 6months if the TBC on the 4th month is still pending or contaminated?

Dr Irene Flores (PI):

·       Evaluate whether the patient is clinically improved in terms of symptoms and comparative reading of chest X-rays at baseline and 6 months. 

In case, where the dose of Lzd was not resumed to usual dose 1200 and visual symptom remained stable but did not worsen, how should the outcome be considered?

Dr Irene Flores (PI):

·       It should be declared as unresolved or unknown.

Dr Mamel Quelapio (LIFT-TB Consultant):

·       If the visual exam is clear that the VA did not return to the previous reading, I think this will fall under “unresolved” rather than unknown.