Effectiveness of electronic reminders to improve medication adherence in tuberculosis patients: a cluster-randomised trial – Data Codebook

Persistent identifier

10.17037/DATA.4

Description

An anonymised dataset of 4,292 TB patients who gave informed consent to participate in a pragmatic, cluster-randomised trial of 36 districts/counties (clusters) within the provinces of Heilongjiang, Jiangsu, Hunan, and Chongqing, China between June 2011 and March 2012. Dataset contains variables on stratified randomisation and cluster code, socio-demographic information, TB treatment outcomes, adherence outcomes, medication monitor problems, mobile phone problems, and the type of patient treatment management initiated (if at all).

Codebook

Variables in the data set are grouped as follows:

  1. Randomisation arm, variables used in stratified randomisation, cluster code
  2. Socio-demographic variables measured at study enrolment
  3. TB treatment outcomes
  4. Adherence outcomes (based on electronic data from the medication monitor and pill count)
  5. Medication monitor problems
  6. Mobile phone problems
  7. Whether intensive management or directly observed therapy was initiated (intervention arm only)
Variable Name Variable description Answer Label Answer Code Notes Variable Type
studynumber Patient ID (unlinked)       Numeric
inanalysis Inclusion in analysis       Numeric
    In analysis 1    
    Excluded 8    
    Not TB 9    
province China province       Numeric
    Heilongjiang 2    
    Jiangsu 3    
    Hunan 4    
    Chongqing 5    
countyid county/district code       Numeric
arm Trial arm       Numeric
    control 1    
    mobile phone 2    
    medication monitor 3    
    combined mobile phone and medication monitor 4    
strata urban/rural strata for the cluster       Numeric
    rural 0    
    urban 1    
gender Patient gender       Numeric
    male 1    
    female 2    
agecat_calc Patient age category (years)       Numeric
    <30 1    
    30-39 2    
    40-59 3    
    60+ 4    
occupation_calc Patient occupation        
    Student 1    
    Worker 2    
    Migrant Worker 3    
    Farmer 4    
    Unemployed/Houseworker 5    
    Other 6    
educationlevel Patient educational attainment level       Numeric
    Illiterate 1    
    Lower middle school 2    
    Upper middle school 3    
    University or more 4    
married_calc Patient marital status       Numeric
    Unmarried 1    
    First marriage 2    
    other 3    
residence Patient residence location       Numeric
    Living in household registration place 1    
    Living in a place other than household registration place 2    
incomcat_calc total household income in last calendar year       Numeric
    <20,000RMB 0    
    >=20,000RMB 1    
distTBcl_calc distance to local TB clinic in km from the home of the patient       Numeric
    Under 10 1    
    10 to 29 2    
    30 to 39 3    
    40 or more 4    
distsuperv_calc distance to supervision facility in km from the home of the patient       Numeric
    1 or less 1    
    2 2    
    3 or over 3    
medinsur_calc medical insurance held by patient       Numeric
    Rural co-op 1    
    Urban workers 2    
    No insurance 3    
    Other 4    
smeartest pre-treatment smear result of the patient       Numeric
    Positive 1    
    Negative 2    
outcome_lostfup TB treatment outcome - patient lost to follow-up     Note: those missing data on this outcome are: 61 patients reassessed as not having TB by their managing doctor: 58 patients switched to a different treatment model due to hospitalisation or travel; 188 patients with outcome of side effect13 with outcome of treatment failure; 27 with outcome of death; 5 patients with outcome of transferred out; and 1 patient with missing outcome. Numeric
    No 0    
    Yes 1    
outcome_poor TB treatment outcome - patient poor outcome yes/no     Note: those missing data on this outcome are: 61 patients reassessed as not having TB by their managing doctor: 58 patients switched to a different treatment model due to hospitalisation or travel; 188 patients with outcome of side effect; 5 patients with outcome of transferred out; and 1 patient with missing outcome. Numeric
    No 0    
    Yes 1    
miss3dose Percentage of months at least 20% of doses not taken - pill count or monitor       Integer
miss7dose Percentage of months at least 47% of doses not taken - pill count or monitor       Integer
pillcount Percentage of months at least 20% of doses not taken - pill count only       Integer
totalmissed_cm Percentage of doses not taken by patient - pill count or monitor       Integer
totalmissed_pc Percentage of doses not taken by patient - pill count only       Integer
totalmissed_cm10 binary categories of % of doses not taken by patient - pill count or monitor     Note: those missing data on these adherence outcomes are: 61 patients reassessed as not having TB by their managing doctor: 58 patients switched to a different treatment model due to hospitalisation or travel; and 35 patients who had no adherence data. Numeric
    <10% 0    
    10%+ 1    
monitorproblem any problem with the medication monitor?        
    None 1 Note: those missing data on this variable are: 61 patients reassessed as not having TB by their managing doctor and 58 patients switched to a different treatment model due to hospitalisation or travel. Numeric
    Recorded by monitor 2    
    Reported by doctor 3    
    Both 4    
medmonproblem1 did the doctor report a medication monitor problem at least once?       Numeric
    Yes 1    
    No -    
medmonproblemcausedoctor1 cause of failure 1st occasion: Doctor set incorrectly       Numeric
    Yes 1    
    No -    
medmonproblemcausepatient1 cause of failure 1st occasion: Patient used incorrectly       Numeric
    Yes 1    
    No -    
medmonproblemcausefailure1 cause of failure 1st occasion: Medication monitor failure       Numeric
    Yes 1    
    No -    
medmonproblemcausepower1 cause of failure 1st occasion: No power       Numeric
    Yes 1    
    No -    
medmonproblemcauseother1 cause of failure 1st occasion: Other       Numeric
    Yes 1    
    No -    
medmonproblemsolved1 was the medication monitor problem solved 1st occasion?       Numeric
    No 0    
    Yes 1    
medmonreplaced1 was the medication monitor replaced 1st occasion     Note: those missing data on these variables are: 61 patients reassessed as not having TB by their managing doctor; and 58 patients switched to a different treatment model due to hospitalisation or travel; and all patients without any medication monitor problems. Numeric
    Yes 1    
    No -    
medmonproblem2 did the doctor report a medication monitor problem at least twice?       Numeric
    Yes 1    
    No -    
medmonproblemcausedoctor2 cause of failure 2nd occasion: Doctor set incorrectly       Numeric
    Yes 1    
    No -    
medmonproblemcausepatient2 cause of failure 2nd occasion: Patient used incorrectly       Numeric
    Yes 1    
    No -    
medmonproblemcausefailure2 cause of failure 2nd occasion: Medication monitor failure       Numeric
    Yes 1    
    No -    
medmonproblemcausepower2 cause of failure 2nd occasion: No power       Numeric
    Yes 1    
    No -    
medmonproblemcauseother2 cause of failure 2nd occasion: Other       Numeric
    Yes 1    
    No -    
medmonproblemsolved2 was the medication monitor problem solved 2nd occasion?       Numeric
    No 0    
    Yes 1    
medmonreplaced2 was the medication monitor replaced 2nd occasion     Note: those missing data on these variables are: 61 patients reassessed as not having TB by their managing doctor; and 58 patients switched to a different treatment model due to hospitalisation or travel; and all patients without at least two medication monitor problems. Numeric
    Yes 1    
    No -    
medmonproblem3 did the doctor report a medication monitor problem at least three times?       Numeric
    Yes 1    
    No -    
medmonproblemcausedoctor3 cause of failure 3rd occasion: Doctor set incorrectly       Numeric
    Yes 1    
    No -    
medmonproblemcausepatient3 cause of failure 3rd occasion: Patient used incorrectly       Numeric
    Yes 1    
    No -    
medmonproblemcausefailure3 cause of failure 3rd occasion: Medication monitor failure       Numeric
    Yes 1    
    No -    
medmonproblemcausepower3 cause of failure 3rd occasion: No power       Numeric
    Yes 1    
    No -    
medmonproblemcauseother3 cause of failure 3rd occasion: Other       Numeric
    Yes 1    
    No -    
medmonproblemsolved3 was the medication monitor problem solved 3rd occasion?       Numeric
    No 0    
    Yes 1    
medmonreplaced3 was the medication monitor replaced 3rd occasion     Note: those missing data on these variables are: 61 patients reassessed as not having TB by their managing doctor; and 58 patients switched to a different treatment model due to hospitalisation or travel; and all patients without at least three medication monitor problems. Numeric
    Yes 1    
    No      
medmonproblem4 did the doctor report a medication monitor problem at least four times?       Numeric
    Yes 1    
    No -    
medmonproblemcausedoctor4 cause of failure 4th occasion: Doctor set incorrectly       Numeric
    Yes 1    
    No -    
medmonproblemcausepatient4 cause of failure 4th occasion: Patient used incorrectly       Numeric
    Yes 1    
    No -    
medmonproblemcausefailure4 cause of failure 4th occasion: Medication monitor failure       Numeric
    Yes 1    
    No -    
medmonproblemcausepower4 cause of failure 4th occasion: No power       Numeric
    Yes 1    
    No -    
medmonproblemcauseother4 cause of failure 4th occasion: Other       Numeric
    Yes 1    
    No -    
medmonproblemsolved4 was the medication monitor problem solved 4th occasion?     Note: those missing data on these variables are: 61 patients reassessed as not having TB by their managing doctor and 58 patients switched to a different treatment model due to hospitalisation or travel; and all patients without four medication monitor problems. Numeric
    No 0    
    Yes 1    
medmonreplaced4 was the medication monitor replaced 4th occasion       Numeric
    Yes 1    
    No -    
mobileproblem1 did the doctor report a mobile phone problem at least once?       Numeric
    Yes 1    
    No -    
mobileproblemcausepatient1 cause of failure 1st occasion: Patient used incorrectly       Numeric
    Yes 1    
    No -    
mobileproblemcausenetwork1 cause of failure 1st occasion: Network failure       Numeric
    Yes 1    
    No -    
mobileproblemcausenomoney1 cause of failure 1st occasion: No money       Numeric
    Yes 1    
    No -    
mobileproblemcauseother1 cause of failure 1st occasion: Other       Numeric
    Yes 1    
    No -    
mobileproblemsolved1 was the mobile phone problem solved 1st occasion?     Note: those missing data on these variables are: 61 patients reassessed as not having TB by their managing doctor; and 58 patients switched to a different treatment model due to hospitalisation or travel; all patients in the control arm or the medication monitor arm; and all patients without any mobile phone problems. Numeric
    No 0    
    Yes 1    
mobileproblem2 did the doctor report a mobile phone problem at least twice?       Numeric
    Yes 1    
    No -    
mobileproblemcausepatient2 cause of failure 2nd occasion: Patient used incorrectly       Numeric
    Yes 1    
    No -    
mobileproblemcausenetwork2 cause of failure 2nd occasion: Network failure       Numeric
    Yes 1    
    No -    
mobileproblemcausenomoney2 cause of failure 2nd occasion: No money       Numeric
    Yes 1    
    No -    
mobileproblemcauseother2 cause of failure 2nd occasion: Other       Numeric
    Yes 1    
    No -    
mobileproblemsolved2 was the mobile phone problem solved 2nd occasion?     Note: those missing data on these variables are: 61 patients reassessed as not having TB by their managing doctor; and 58 patients switched to a different treatment model due to hospitalisation or travel; all patients in the control arm or the medication monitor arm; and all patients without at least two mobile phone problems. Numeric
    No 0    
    Yes 1    
mobileproblem3 did the doctor report a mobile phone problem at least three times?       Numeric
    Yes 1    
    No -    
mobileproblemcausepatient3 cause of failure 3rd occasion: Patient used incorrectly       Numeric
    Yes 1    
    No -    
mobileproblemcausenetwork3 cause of failure 3rd occasion: Network failure       Numeric
    Yes 1    
    No -    
mobileproblemcausenomoney3 cause of failure 3rd occasion: No money       Numeric
    Yes 1    
    No -    
mobileproblemcauseother3 cause of failure 3rd occasion: Other       Numeric
    Yes 1    
    No -    
mobileproblemsolved3 was the mobile phone problem solved 3rd occasion?     Note: those missing data on these variables are: 61 patients reassessed as not having TB by their managing doctor; and 58 patients switched to a different treatment model due to hospitalisation or travel; all patients in the control arm or the medication monitor arm; and all patients without at least three mobile phone problems. Numeric
    No 0    
    Yes 1    
mobileproblem4 did the doctor report a mobile phone problem at least four times?       Numeric
    Yes 1    
    No -    
mobileproblemcausepatient4 cause of failure 4th occasion: Patient used incorrectly       Numeric
    Yes 1    
    No -    
mobileproblemcausenetwork4 cause of failure 4th occasion: Network failure       Numeric
    Yes 1    
    No -    
mobileproblemcausenomoney4 cause of failure 4th occasion: No money       Numeric
    Yes 1    
    No -    
mobileproblemcauseother4 cause of failure 4th occasion: Other       Numeric
    Yes 1    
    No -    
mobileproblemsolved4 was the mobile phone problem solved 4th occasion?     Note: those missing data on these variables are: 61 patients reassessed as not having TB by their managing doctor; and 58 patients switched to a different treatment model due to hospitalisation or travel; all patients in the control arm or the medication monitor arm; and all patients without at least four mobile phone problems. Numeric
    No 0    
    Yes 1    
mobileproblem5 did the doctor report a mobile phone problem at least five times?       Numeric
    Yes 1    
    No -    
mobileproblemcausepatient5 cause of failure 5th occasion: Patient used incorrectly       Numeric
    Yes 1    
    No -    
mobileproblemcausenetwork5 cause of failure 5th occasion: Network failure       Numeric
    Yes 1    
    No -    
mobileproblemcausenomoney5 cause of failure 5th occasion: No money       Numeric
    Yes 1    
    No -    
mobileproblemcauseother5 cause of failure 5th occasion: Other       Numeric
    Yes 1    
    No -    
mobileproblemsolved5 was the mobile phone problem solved 5th occasion?     Note: those missing data on these variables are: 61 patients reassessed as not having TB by their managing doctor; and 58 patients switched to a different treatment model due to hospitalisation or travel; all patients in the control arm or the medication monitor arm; and all patients without at least five mobile phone problems. Numeric
    No 0    
    Yes 1    
mobileproblem6 did the doctor report a mobile phone problem at least six times?       Numeric
    Yes 1    
    No -    
mobileproblemcausepatient6 cause of failure 6th occasion: Patient used incorrectly       Numeric
    Yes 1    
    No -    
mobileproblemcausenetwork6 cause of failure 6th occasion: Network failure       Numeric
    Yes 1    
    No -    
mobileproblemcausenomoney6 cause of failure 6th occasion: No money       Numeric
    Yes 1    
    No -    
mobileproblemcauseother6 cause of failure 6th occasion: Other       Numeric
    Yes 1    
    No -    
mobileproblemsolved6 was the mobile phone problem solved 6th occasion?     Note: those missing data on these variables are: 61 patients reassessed as not having TB by their managing doctor; and 58 patients switched to a different treatment model due to hospitalisation or travel; all patients in the control arm or the medication monitor arm; and all patients without at least six mobile phone problems. Numeric
    No 0    
    Yes 1    
mobileproblem7 did the doctor report a mobile phone problem at least seven times?       Numeric
    Yes 1    
    No -    
mobileproblemcausepatient7 cause of failure 7th occasion: Patient used incorrectly       Numeric
    Yes 1    
    No -    
mobileproblemcausenetwork7 cause of failure 7th occasion: Network failure       Numeric
    Yes 1    
    No -    
mobileproblemcausenomoney7 cause of failure 7th occasion: No money       Numeric
    Yes 1    
    No -    
mobileproblemcauseother7 cause of failure 7th occasion: Other       Numeric
    Yes 1    
    No -    
mobileproblemsolved7 was the mobile phone problem solved 7th occasion?     Note: those missing data on these variables are: 61 patients reassessed as not having TB by their managing doctor; and 58 patients switched to a different treatment model due to hospitalisation or travel; all patients in the control arm or the medication monitor arm; and all patients without at least seven mobile phone problems. Numeric
    No 0    
    Yes 1    
mobileproblem8 did the doctor report a mobile phone problem at least eight times?       Numeric
    No 0    
    Yes 1    
mobileproblemcausepatient8 cause of failure 8th occasion: Patient used incorrectly       Numeric
    Yes 1    
    No -    
mobileproblemcausenetwork8 cause of failure 8th occasion: Network failure       Numeric
    Yes 1    
    No -    
mobileproblemcausenomoney8 cause of failure 8th occasion: No money       Numeric
    Yes 1    
    No -    
mobileproblemcauseother8 cause of failure 8th occasion: Other       Numeric
    Yes 1    
    No -    
mobileproblemsolved8 was the mobile phone problem solved 8th occasion?     Note: those missing data on these variables are: 61 patients reassessed as not having TB by their managing doctor; and 58 patients switched to a different treatment model due to hospitalisation or travel; all patients in the control arm or the medication monitor arm; and all patients without at least eight mobile phone problems. Numeric
    No 0    
    Yes 1    
mobileproblem9 did the doctor report a mobile phone problem at least nine times?       Numeric
    Yes 1    
    No -    
mobileproblemcausepatient9 cause of failure 9th occasion: Patient used incorrectly       Numeric
    Yes 1    
    No -    
mobileproblemcausenetwork9 cause of failure 9th occasion: Network failure       Numeric
    Yes 1    
    No -    
mobileproblemcausenomoney9 cause of failure 9th occasion: No money       Numeric
    Yes 1    
    No -    
mobileproblemcauseother9 cause of failure 9th occasion: Other       Numeric
    Yes 1    
    No -    
mobileproblemsolved9 was the mobile phone problem solved 9th occasion?     Note: those missing data on these variables are: 61 patients reassessed as not having TB by their managing doctor; and 58 patients switched to a different treatment model due to hospitalisation or travel; all patients in the control arm or the medication monitor arm; and all patients without nine mobile phone problems. Numeric
    No 0    
    Yes 1    
IM_doctor should switch to intensive management based on data available to doctor       Numeric
    No 0    
    Yes 1    
IM_medmon should switch to intensive management based on medication monitor/pill count       Numeric
    No 0    
    Yes 1    
IM_switched switched to intensive management by doctor       Numeric
    No 0    
    Yes 1    
DOT_doctor should switch to DOT based on data available to doctor       Numeric
    No 0    
    Yes 1    
DOT_medmon should switch to DOT based on medication monitor/pill count       Numeric
    No 0    
    Yes 1    
DOT_switched switched to DOT by doctor     Note: those missing data on these variables are: All patients in arm 1; 48 patients not in arm 1 and reassessed as not having TB by their managing doctor; and 38 patients not in arm 1 and switched to a different treatment model due to hospitalisation or travel. Numeric
    No 0    
    Yes 1