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Table 1 Description of intervention versus standard of care (control) arms

From: Evaluation of a medication monitor-based treatment strategy for drug-sensitive tuberculosis patients in China: study protocol for a cluster randomised controlled trial

Service contents

Intervention arm

Control arm

Supervision method for daily dosing

Patient receives daily reminders for drug intake by the MERM through a buzzer sound and green light, which are active for 5 min then silent for 5 mins, and then is repeated twice. If the MERM is opened during this period, then the alarm is cancelled until the next day. The time of the reminder is set by the doctor at enrolment and can be changed at subsequent follow-up visits.

Patients choose one of the three methods of adherence supervision in consultation with their doctor at the start of treatment: direct observation by (1) healthcare worker or (2) family member; or self-administered.

Follow-up visit reminder

A yellow light on the MERM is used to remind patients to attend their monthly follow-up visit. The light comes on daily, at an agreed time, for 30 mins, for 3 days before their scheduled visit date.

A pictogram label on the MERM indicates that sputum should be collected at clinic visits at 2, 5, and 6 months.

No reminder.

Pictogram labels are not used on the MERM for patients in the control arm.

Monthly follow-up patient visit to the doctor

The TB doctor at the county (district) level exports data on date/time of the box being opened from the MERM and a graphical display of the dosing history for the last month is generated.

The doctor shows the graphical display to the patient, and discusses the patient’s drug-intake summary and the importance of timely drug-intake. A printed copy of graphical display summary is given to the patient, where feasible.

Based on the MERM data from the last month, the doctor determines whether an adjustment to the way of managing patient medication is required. Actions are described below.

Patients are seen at the monthly follow-up visits by the TB doctor at the county (district) level.

If the TB treatment record card indicates doses have been missed, the doctor asks the patient about why drugs have been missed and discusses the importance of timely and regular drug intake.

The doctor does not have access to the MERM data.

Judgment and handling of missing doses

The doctor assesses adherence using data from the MERM, excluding time periods when the patient had been in hospital or travelling. If:

< 20% doses missed: reasons for doses missed are ascertained and the patient educated about keeping healthy. No change to the management of the patient.

20–50% doses missed (first occasion): Township doctors are asked to visit the patient every 2 weeks and village doctors are asked to visit the patient every week to support medication adherence.

> 50% doses missed or 20–50% doses missed (second occasion): management mode is changed to “taking medicine in the presence of medical staff”, namely, village doctors are required to directly supervise patients to take medicine daily.

No specific requirement.

Doctor to patient visit

(1) The CDC doctor visits each patient once during the intensive and continuous phases. At the visit, the patient's adherence and the use of MERM is discussed. If the patient is reluctant to take treatment, the reason is identified and information is given to the patient on keeping healthy.

(2) Doctors from community service centres visit the patient once a month to confirm use of the MERM and monitor adverse reactions. Any errors in using the MERM or any serious adverse reactions are immediately reported to the organisation for TB prevention at the county (district) level.

Standard NTP practice:

(1) The CDC doctor visits each patient once during the intensive and continuous phases. The doctor asks about the patient’s drug adherence, gives advice about timely and regular drug intake, and educates the patient about keeping healthy.

(2) Doctors from community service centres visit patients who are self-supervised/family member supervision every 10 days in the intensive phase, and once a month in the continuous phase.

  1. CDC Center for Disease Control, MERM medication event reminder monitor, NTP National Tuberculosis Programme
  2. In both arms the following occurs:
  3. If a patient does not attend the scheduled follow-up visit, the hospital/dispensary doctor, nurse or other staff member contacts the patient (using patient or family member phone) and asks them to return to the hospital/dispensary for follow-up. If a patient does not attend a follow-up visit 3 days after the scheduled date, the hospital/dispensary doctor informs the CDC, who in turn informs the village doctor. The village doctor is required to visit the patient and supervise them to visit the designated medical institution to get medications or receive sputum examination within 24 h after receiving the follow-up notification