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Official websites use. Share sensitive information only on official, secure websites. A panel of 54 global experts in the field of TB care, public health, microbiology, and pharmacology were identified; 46 participated in a Delphi process. A 5-point Likert scale was used to score draft standards. The final document represents the broad consensus and was approved by all 46 participants. Seven clinical standards were defined: Standard 1, all patients adult or child who have symptoms and signs compatible with PTB should undergo investigations to reach a diagnosis; Standard 2, adequate bacteriological tests should be conducted to exclude drug-resistant TB; Standard 3, an appropriate regimen recommended by WHO and national guidelines for the treatment of PTB should be identified; Standard 4, health education and counselling should be provided for each patient starting treatment; Standard 5, treatment monitoring should be conducted to assess adherence, follow patient progress, identify and manage adverse events, and detect development of resistance; Standard 6, a recommended series of patient examinations should be performed at the end of treatment; Standard 7, necessary public health actions should be conducted for each patient. We also identified priorities for future research into PTB. These consensus-based clinical standards will help to improve patient care by guiding clinicians and programme managers in planning and implementation of locally appropriate measures for optimal person-centred treatment for PTB. Keywords: pulmonary TB, management, diagnosis, treatment, education, rehabilitation, clinical standards. According to WHO estimates, there were 9. In , the gap between diagnosed and reported patients vs. Access to rapid diagnosis with drug susceptibility testing DST results and effective treatment is essential to control TB. However, this is not possible unless symptoms and signs indicating pulmonary TB PTB are correctly identified based on knowledge of the most common risk factors for TB disease, followed by appropriate diagnostics. If PTB is microbiologically confirmed, rapid molecular DST is essential for selecting an appropriate treatment regimen. An effective regimen requires the use of effective drugs at correct dosages for the appropriate duration of treatment. To prevent the selection for drug-resistant mycobacteria, optimal treatment of drug-susceptible TB DS-TB requires three or more effective drugs in the intensive phase and two or more effective drugs in the continuation phase, along with adequate exposure to these drugs. Treatment adherence is a well-known challenge for a successful outcome. It is important to know why some patients discontinue treatment or take irregular treatment. Specific evidence in some areas is still limited. The clinical standards presented here are based on the best available evidence and will be updated in due course to capture new evidence as it accumulates. The clinical standards are not intended to create discrimination. Differences in capacity and access to technology between high- and low-resource healthcare facilities mean that some settings or services may not be able to meet all standards. Nevertheless, these standards can contribute to ensuring the highest standard of care for all patients with PTB. Every individual child and adult with symptoms and signs compatible with PTB should undergo the necessary diagnostic investigations Standard 1. All patients with symptoms and signs compatible with PTB should undergo bacteriological tests Standard 2. At the end of treatment for PTB, a set of checks should be performed for each patient Standard 6. A panel of global experts was identified to represent the main scientific societies, associations and groups active in TB. Of the 54 experts initially invited, six did not respond after one reminder. Of these, 46 provided valid answers. A 5-point Likert scale was used 5: high agreement; 1: low agreement. Based on this substantial agreement, the expert panel jointly developed a draft document. Every individual child or adult with symptoms and signs compatible with PTB should be examined and undergo the recommended investigations. All individuals with presumed PTB should be examined and undergo investigations as part of the diagnostic process, based and organised according to the availability of services and resources so that treatment can be started. The complete list of recommended investigations to assess the presence of PTB are given in Table 1. Known symptoms and signs highly associated with PTB are cough, haemoptysis, fever, night sweats, fatigue, loss of appetite and weight loss; in children, failure to thrive and decreased playfulness are also symptoms. Except for weight loss or failure to thrive, the duration of these symptoms and signs is less important. Cases will be missed if cut-off values for duration are established. Further history and examination should include assessing comorbid medical conditions associated with unfavourable treatment outcomes and increased morbidity and mortality in TB patients. These include malnutrition, HIV infection, DM, chronic kidney diseases, liver disease hepatitis B and C , alcohol abuse and social deprivation. CXR is the most common diagnostic tool for TB in children, and often supports the diagnosis of intrathoracic TB, including mediastinal lymphadenopathy and pleural effusions. Microbiological confirmation of PTB should be determined by examining respiratory samples e. Instructions on sputum collection should be provided to adults and older children when securing an early morning sputum sample, plus a second spot sputum or two spot sputum samples separated in time. If the initial sputum samples are negative, sputum induction can be performed to obtain better specimens. If intubated or if bronchoscopy is done, tracheal aspirates or bronchoalveolar lavage, respectively, should be obtained to obtain samples for microbiology for confirmation and to exclude other pathologies including cancer. All patients with symptoms and signs compatible with PTB should undergo a set of bacteriological tests. Following the examinations done under Standard 1, adequate bacteriological analysis should be conducted in a timely manner to both confirm cases and perform DST. All patients should undergo molecular Mycobacterium tuberculosis complex identification and DST as the initial diagnostic test. All patients should have specimens sent for mycobacterial culture and phenotypic DST, if needed. Solid or liquid culture is the conventional diagnostic tool for growth of acid-fast bacilli AFB , including M. All patients should have molecular mycobacterial identification and DST as the initial diagnostic test. If available, cultures should be submitted for DST and whole or next genome sequencing. Next-generation sequencing NGS , either by whole-genome sequencing WGS or targeted amplicon sequencing is an important tool to inform clinical and public health practice. Targeting only genes where mutations are associated with resistance to anti-TB drugs amplicons needs less bacterial DNA than WGS and can be used for rapid molecular prediction of resistance against all anti-TB drugs when AFB are visible on sputum smear microscopy. All patients diagnosed with PTB should be offered effective treatment as soon as practically possible to improve prognosis as well as to limit transmission. Patient history, including drug allergies and concomitant medications, is important to avoid significant adverse events and drug-drug interactions. DR-TB treatment is not part of this standard. Daily dosing is recommended throughout the course to prevent acquired resistance. There are several formulations available, including single-drug formulations and fixed-dose combinations FDC. Some of the latter are child-friendly formulations with dispersible tablets at lower milligram contents. Despite the long duration of anti-TB treatment and variable responses to treatments, recommendations for treatment durations are currently standardised. Biomarkers to individualise the duration of anti-TB therapies are currently under evaluation. Monitoring to evaluate treatment response in patients with PTB is recommended; patients should have a repeat sputum for smear and culture at Month 2. Ideally, 4 months of treatment after culture conversion should be administered. E not always included, especially if susceptibility to R and H was confirmed. A person-centred approach including education and allowing for informed decisions regarding treatment options is recommended. To aid early recognition of drug adverse effects and reporting to healthcare providers, the major adverse effects of the TB drugs should be explained. TB is heavily impacted by social determinants of health, and it is associated with catastrophic costs for the patients and their families, which may reduce treatment adherence. Therefore, the healthcare team should inform patients about their rights and facilitate access to locally available social protection initiatives e. Furthermore, the counselling and education session may be an opportunity to promote other healthy lifestyle behaviours, including good nutrition or smoking cessation, discuss how to combine treatment intake with daily activities to improve treatment adherence, and to highlight or better manage risk factors predisposing to TB disease e. Basic principles of TB disease transmission, epidemiology, clinical aspects, treatment and prevention ;. Recognition of signs and symptoms of post-TB lung disease, which might require further investigation and rehabilitation. Rationale for public health actions, including screening of contacts and wider investigations in the event of outbreaks. Recommendations on how to deliver an effective health education and counselling session are summarised in Table 4. Structured and comprehensive educational programmes are an integral and essential component of the management of PTB treatment. Education should be delivered by professionals who are competent in the relevant subject areas and trained to deliver educational sessions. Educational materials and technological support used to deliver them needs to be evaluated in the setting-specific context. Basic principles of TB disease transmission, epidemiology, clinical aspects, treatment and prevention. Recognising signs and symptoms at the end of treatment, which might require further investigation and rehabilitation. Treatment monitoring should be conducted during the whole course of treatment and include the assessment of treatment adherence. As part of a person-centred approach to adherence, an individual strategy should be used. Weight should be assessed at each visit. Furthermore, follow-up of sputum smear and culture, where available, is important to monitor treatment success or failure, including in children if PTB was bacteriologically confirmed. If there is no sputum culture conversion after 2 months, DST should be repeated. A clear relationship between drug exposure, pathogen susceptibility and treatment response has been demonstrated in both DS- and DR-TB. TDM is not currently recommended for all TB patients on treatment, mainly because of availability, time and financial costs, rather than its potential benefit. TDM is at present recommended for certain patient groups: 1 patients who are taking several concomitant medications so as to reduce toxicity, 2 patients with inadequate treatment response i. At the end of treatment for PTB a set of examinations should be performed for each patient. However, many patients will be unable to produce adequate sputum specimens at this stage, and some national programmes do not recommend a final bacteriological examination when patients show clinical and radiological improvement. A CXR will allow identification of lung sequelae and when severely abnormal, a chest CT scan should be performed if available and affordable to better characterise the lung sequelae and allow better evaluation in the future. Patients should be followed for at least 6 months after treatment completion, particularly if there is post-TB lung disease, such as bronchiectasis, persisting opacification or lung nodules and rehabilitation may be necessary. Because TB is a notifiable infectious disease, there are a series of public health actions to be carried out whenever an individual is diagnosed with the disease. This work is important to support TB surveillance and should be done according to international guidelines and national statutory legislation. Understanding patient delay time from symptom onset to first attempt to seek medical care and service delay time from first attempt to seek medical care and date of treatment start is important to inform targeted public health action to reduce barriers and delays to diagnosis through improved awareness, referral pathways and contact investigations. This is of particular importance for vulnerable household contacts such as children under the age of 5. Ideally, co-existing comorbidities should also be recorded because of their role in the potential treatment outcome, and to improve TB awareness and communication across different clinical specialities. The WHO has introduced definitions of outcomes, which have been recently revised. For example, patients undergoing pulmonary rehabilitation offer the possibility of a post-treatment follow-up, as they remain in care and are therefore accessible after completing their anti-TB treatment. Standard 7 calls for the need to update the TB register if any change occurs in the final outcome cure or treatment completion , e. Communication between the clinical staff and the TB register is encouraged. An additional element of Standard 7 is represented by the importance of prioritising patients with severe post-TB lung disease and disability for access to social protection schemes. This can be based on existing national legislation or facilitated through advocacy to reform or revise legislation in line with Pillar 2 of the WHO End TB Strategy. Finally, in the case of patients moving to different countries, effective trans-border communication is encouraged to provide timely exchange of clinical documents necessary for case referral and ensure optimal continuum of care. There are multiple research priorities for PTB. Also, current drugs, such as RIF at a higher dose, should be further investigated. Shorter treatment regimens, preferably with a lower pill burden, which are better tolerated, less toxic and require less monitoring, and which are safe in children, during pregnancy and for people living with HIV, should be developed. Several experts propose a universal drug regimen for both DS- and DR-TB, which may facilitate programmatic implementation; however, growing drug resistance may hamper its effectiveness in the medium term. Treatment research should also focus on better ways to support and enable patients to safely complete treatment as prescribed. This includes differentiated models of care or tailor-made approaches. Third, research into reducing implementation gaps and improving patient management algorithms is also needed. Further research priorities include a randomised controlled trial to evaluate TDM, use of inhaled antimicrobial treatment for PTB, and host-directed therapies. Research to better understand post-TB lung disease and mitigation strategies is also urgently needed. For any person with signs and symptoms of PTB, adequate and timely clinical, radiological and micro-biological assessment is necessary. Health education and counselling at the start and during treatment can improve treatment adherence and outcomes. Strengthening public health action, most commonly initiated by treating clinicians, is essential to improve TB control and drive elimination. The standards presented here aim to guide best practice and ensure that PTB is diagnosed as early as possible and treated in the best way possible. The authors would also like to thank M van den Boom for his useful comments on the manuscript. CO received speaking fees from Qiagen Hilden, Germany outside this work. ST has received honoraria from Janssen and Qiagen outside the scope of this work. As a library, NLM provides access to scientific literature. Int J Tuberc Lung Dis. Show available content in en fr. Find articles by O W Akkerman. Find articles by R Duarte. Find articles by S Tiberi. Find articles by H S Schaaf. Find articles by C Lange. Find articles by J W C Alffenaar. Find articles by J Denholm. Find articles by A C C Carvalho. Find articles by M S Bolhuis. Find articles by S Borisov. Find articles by J Bruchfeld. Find articles by A M Cabibbe. Find articles by J A Caminero. Find articles by I Carvalho. Find articles by J Chakaya. Find articles by R Centis. Find articles by M P Dalcomo. Find articles by M Dedicoat. Find articles by K Dheda. Find articles by K E Dooley. Find articles by J Furin. Find articles by N A H van Hest. Find articles by B C de Jong. Find articles by X Kurhasani. Find articles by S Mpagama. Find articles by M Munoz Torrico. Find articles by E Nunes. Find articles by C W M Ong. Find articles by D J Palmero. Find articles by R Ruslami. Find articles by A M I Saktiawati. Find articles by C Semuto. Find articles by D R Silva. Find articles by R Singla. Find articles by I Solovic. Find articles by S Srivastava. Find articles by J E M de Steenwinkel. Find articles by A Story. Find articles by M G G Sturkenboom. Find articles by M Tadolini. Z F Udwadia 62 P. Find articles by Z F Udwadia. Find articles by A R Verhage. Find articles by J P Zellweger. Find articles by G B Migliori. Open in a new tab. Components of the health education and counselling session for PTB patients. Set of examinations to be performed at the end of treatment of each patient with PTB. Clinical assessment Clinical history Symptom assessment Clinical examination Imaging Chest radiography Computed tomography if chest radiography is severely abnormal or low dyspnoea score Microbiological evaluation If available Sputum specimen for smear microscopy and mycobacterial culture — DST if culture-positive if possible Subjective evaluation Dyspnoea score Functional evaluation if dyspnoea is present Six-minute walk test Spirometry Body plethysmography Diffusion capacity assessment DLCO, KCO Tidal volume Pulse oximetry Arterial blood gas analysis in case of low peripheral oxygen saturation Cardiopulmonary exercise testing Plan a follow-up 6 months after TB treatment completion to evaluate for relapse, bronchiectasis, persisting opacification or nodules which might indicate need for rehabilitation. Similar articles. Add to Collections. Create a new collection. Add to an existing collection. Choose a collection Unable to load your collection due to an error Please try again. Add Cancel. Mainly sputum, but any possible respiratory specimen in children e. Clinical history Symptom assessment Clinical examination. Chest radiography Computed tomography if chest radiography is severely abnormal or low dyspnoea score. If available Sputum specimen for smear microscopy and mycobacterial culture — DST if culture-positive if possible. Functional evaluation if dyspnoea is present. Plan a follow-up 6 months after TB treatment completion to evaluate for relapse, bronchiectasis, persisting opacification or nodules which might indicate need for rehabilitation.

Clinical standards for drug-susceptible pulmonary TB

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