Prospective Cohort of People Starting Treatment for Tuberculosis Disease in France (FrenchTB)

Definite cure (microbiological): negative cultures (or direct examination) of respiratory specimens on two occasions during follow-up, in the last month of treatment and on an intermediate specimen, in a participant who has completed treatment and has never met the definition of treatment failure.

Probable cure: clinical and radiological improvement of tuberculosis-related symptoms in a participant who has completed treatment and never met the definition of treatment failure.

Assessed by the conversion (negativation) of cultures specimens on two occasions during follow-up, in the last month of treatment and on an intermediate specimen, in a participant who has completed treatment and has never met the definition of treatment failure.

Number of Positive culture after 5 months of treatment

Number of deaths directly related to tuberculosis in the year following diagnosis

Number of interrupted treatments before the end of the planned duration and not resumed (for a reason other than a rejected tuberculosis diagnosis

Number of treatment ongoing at 12 months because interrupted for more than two months or modified for resistance, side effects/intolerance, initial failure

Number of transfers or loss of follow-up

Occurrence and causes of death after tuberculosis diagnosis after inclusion and causes

Recurrence of positive culture of respiratory samples after the end of treatment and after cultures become negative during treatment

Rate of persistent respiratory symptoms such as coughing, dyspnoea, chest pain and/or wheezing

Oxygen saturation 88% or lower and PaO2 lower 60 mmHg in ambient air at a distance from an acute episode

and/or impaired lung function as measured by spirometry (FEV1 or FVC <80% of the theoretical value or FEV1/FVC ratio <0.70) iv) and/or radiological sequelae defined as the persistence of pulmonary parenchymal abnormalities (nodules, cavities, reticulations, etc.). The anomalies should not be linked to an obvious cause unrelated to tuberculosis (COPD).

The 3 components of the St Georges's Respiratory Questionnaire (SGRQ): symptoms (frequency and severity), activity (effects on and adjustment of everyday activities), and psychosocial impact. The total score has a maximum of 100 points, with values ranging from 0 to 100.

Functional evaluation measured by the 6-minute walk test

Spirometry - FEV1/FVC ratio of greater than 0.70 and both FEV1 and FVC above 80% of the predicted value

Pulse oximetry

Imaging (scanner)

Chest X-ray2.Other imaging for extrapulmonary involvement

Psycho-trauma screening (PC-PTSD-5) - 20-item questionnaire, corresponding to the DSM-5 symptom criteria for PTSD. The self-report rating scale is 0-4 for each symptom, reflecting a change from 1-5 in the DSM-IV version.

Anxiety questionnaire (GAD-7) - Score 5-9: Mild Anxiety. Score 10-14: Moderate Anxiety. Score greater than 15: Severe Anxiety. EQ-5D-5L - The UI is calculated from patient scoring of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). For each dimension, participants are asked to mark between 1: 'no problems' to 5: 'unable to/extreme problems'. Depression (PHQ-9) -Total scores of 5, 10, 15 and 20 represent the thresholds for mild, moderate, moderately severe and severe depression, respectively. Note: Question 9 is a single screening question on suicide risk.

Psycho-trauma screening (PC-PTSD-5) - 20-item questionnaire, corresponding to the DSM-5; .symptom criteria for PTSD. The self-report rating scale is 0-4 for each symptom, reflecting a change from 1-5 in the DSM-IV version.Hunger scale (HHS) - rating scale from 0 to 10, where 0 is painful hunger and 10 is painful fullness.

Stigma scale - Responses to each item are measured on a five-point scale (ranging from zero 'strongly disagree' to four 'strongly agree'). Higher scores indicate higher levels of depression stigma.

Alcohol questionnaire (AUDIT-C) - scored on a scale of 0-12 (scores of 0 reflect no alcohol use). In men, a score of 4 or more is considered positive; in women, a score of 3 or more is considered positive. Generally, the higher the AUDIT-C score, the more likely it is that the patient's drinking is affecting his/her health and safety. Tobacco questionnaire (Fagerström) - Test for Nicotine Dependence, the three yes/no items are scored 0 (no) and 1 (yes). The three multiple-choice items are scored from 0 to 3. The items are summed to yield a total score of 0-10.

Psychoactive substances questionnaire (CAGE-AID) - Item responses on the CAGE are scored 0 or 1, with a higher score an indication of alcohol problems. A total score of 2 or greater is considered clinically significant. A score of 2 to 3 indicates a high index of suspicion and a score of 4 is virtually diagnostic for alcoholism.

Questionnaire

PRECAR score

Questionnaire

Neurocognitive scores - Rankin (MR,) - Measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.

is a 6 point disability scale with possible scores ranging from 0 to 5. A separate category of 6 is usually added for patients who expire.