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Table 2 Schedule of examinations during treatment and follow-up phases of the study

From: Non-inferiority stepped wedge cluster randomized controlled trial on all-oral shorter regimens for rifampicin resistant/multidrug-resistant TB in Pakistan – a study protocol

 

Investigation/Observation

Baseline assessment & screening

Treatment Phase (M = Month)

Post-treatment Follow-Up

M T

1

M T

2

M T

3

M T

4

M T

5

M T

6

M T

7

M T

8

MT 9/11

MF 6

MF 12

Clinical evaluation

Demographics, Medical History

X

           

Written informed consent

X

           

Clinical Examination

X

X

X

X

X

X

X

X

X

X

X

X

Treatment adherence

 

X

X

X

X

X

X

X

X

X

  

Concomitant treatment

 

X

X

X

X

X

X

X

X

X

X

 

Adverse events

 

X

X

X

X

X

X

X

X

X

X

 

Bacteriology

Y

Sputum smear

X

X

X

X

X

.X

X

X

X

X

X

X

Sputum culture

X

X

X

X

X

X

X

X

X

X

X

X

DST (FQ)

X

           

Laboratory tests

Hemoglobin/platelets count/White blood count

X

X

X

X

X

X

X

X

X

X

  

Serum liver enzymes

X

X

X

X

X

X

X

X

X

X

  

Serum creatinine (at baseline and if clinically indicated or ECG abnormalities)

X

           

Serum potassium (at baseline and if clinically indicated or ECG abnormalities)

X

           

Pregnancy test (female)

X

           

HIV testing

X

           

Other

ECG

X

Xβ

X

X

X

X

X

X

X

X

  

Visual acuity & BPNS(Note: for patients receiving Lzd and high-dose INH/EMB)

X

(X)

(X)

(X)

(X)

(X)

(X)

(X)

(X)

(X)

  

Chest X-ray

X

           

Disability assessment

X

        

X

 

X

 

Health Related Quality of Life assessment

X

   

X

    

X

 

X

  1. βBaseline ECG should be obtained and additional ECGs conducted at week 1 and 2 after starting treatment and thereafter monthly throughout treatment