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Funder: Medical Research Council, BACKGROUND: Access to affordable inhaled medicines for chronic respiratory diseases (CRDs) is severely limited in low- and middle-income countries (LMICs), causing avoidable morbidity and mortality. The International Union Against Tuberculosis and Lung Disease convened a stakeholder meeting on this topic in February 2022.METHODS: Focused group discussions were informed by literature and presentations summarising experiences of obtaining inhaled medicines in LMICs. The virtual meeting was moderated using a topic guide around barriers and solutions to improve access. The thematic framework approach was used for analysis.RESULTS: A total of 58 key stakeholders, including patients, healthcare practitioners, members of national and international organisations, industry and WHO representatives attended the meeting. There were 20 pre-meeting material submissions. The main barriers identified were 1) low awareness of CRDs; 2) limited data on CRD burden and treatments in LMICs; 3) ineffective procurement and distribution networks; and 4) poor communication of the needs of people with CRDs. Solutions discussed were 1) generation of data to inform policy and practice; 2) capacity building; 3) improved procurement mechanisms; 4) strengthened advocacy practices; and 5) a World Health Assembly Resolution.CONCLUSION: There are opportunities to achieve improved access to affordable, quality-assured inhaled medicines in LMICs through coordinated, multi-stakeholder, collaborative efforts.

BACKGROUND: Optimal drug dosing is important to ensure adequate response to treatment, prevent development of drug resistance and reduce drug toxicity. The aim of these clinical standards is to provide guidance on ‘best practice´ for dosing and management of TB drugs.METHODS: A panel of 57 global experts in the fields of microbiology, pharmacology and TB care were identified; 51 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 participants.RESULTS: Six clinical standards were defined: Standard 1, defining the most appropriate initial dose for TB treatment; Standard 2, identifying patients who may be at risk of sub-optimal drug exposure; Standard 3, identifying patients at risk of developing drug-related toxicity and how best to manage this risk; Standard 4, identifying patients who can benefit from therapeutic drug monitoring (TDM); Standard 5, highlighting education and counselling that should be provided to people initiating TB treatment; and Standard 6, providing essential education for healthcare professionals. In addition, consensus research priorities were identified.CONCLUSION: This is the first consensus-based Clinical Standards for the dosing and management of TB drugs to guide clinicians and programme managers in planning and implementation of locally appropriate measures for optimal person-centred treatment to improve patient care.

The extent of short-acting βData on disease characteristics/asthma treatments were collected from patients (≥12 years) using electronic case report forms. Patients were classified by investigator-defined asthma severity (guided by the 2017 Global Initiative for Asthma) and practice type (primary/specialist care). Multivariable regression models analyzed associations between SABA prescriptions and outcomes.Data from 1778 patients (mean age, 43.7 years) were analyzed. Most patients were female (62.4%) and had moderate-to-severe asthma (63.3%), with 57.1 and 42.9% of patients treated in specialist and primary care, respectively. Asthma was partly controlled/uncontrolled in 66.2% of patients, with 57.9% experiencing ≥1 severe exacerbation in the previous 12 months. Overall, 46.5% of patients were prescribed ≥3 SABA canisters in the preceding 12 months (over-prescription); 26.2% were prescribed ≥10 canisters. SABAs were purchased over-the-counter by 32.6% of patients, of whom 79.3% had received SABA prescriptions; 71.9% and 40.1% for ≥3 and ≥10 canisters, respectively. Higher SABA prescriptions (vs. 1-2 canisters) were associated with increased incidence rate of severe exacerbations and lower odds of having at least partly controlled asthma (except 3-5 canisters).Findings from this African cohort of the SABINA III study indicate that SABA over-prescription and SABA over-the-counter purchase are common and associated with poor asthma-related outcomes. This highlights the need for healthcare providers/policymakers to align clinical practices with the latest treatment recommendations.

Short-acting β

The extent of short-acting β2-agonist (SABA) overuse in Africa remains poorly documented. As part of the SABA use IN Asthma (SABINA) III study, we assessed SABA prescriptions/clinical outcomes in 3 African countries. Data on disease characteristics/asthma treatments were collected from patients (≥12 years) using electronic case report forms. Patients were classified by investigator-defined asthma severity (guided by the 2017 Global Initiative for Asthma) and practice type (primary/specialist care). Multivariable regression models analyzed associations between SABA prescriptions and outcomes. Data from 1778 patients (mean age, 43.7 years) were analyzed. Most patients were female (62.4%) and had moderate-to-severe asthma (63.3%), with 57.1 and 42.9% of patients treated in specialist and primary care, respectively. Asthma was partly controlled/uncontrolled in 66.2% of patients, with 57.9% experiencing ≥1 severe exacerbation in the previous 12 months. Overall, 46.5% of patients were prescribed ≥3 SABA canisters in the preceding 12 months (over-prescription); 26.2% were prescribed ≥10 canisters. SABAs were purchased over-the-counter by 32.6% of patients, of whom 79.3% had received SABA prescriptions; 71.9% and 40.1% for ≥3 and ≥10 canisters, respectively. Higher SABA prescriptions (vs. 1–2 canisters) were associated with increased incidence rate of severe exacerbations and lower odds of having at least partly controlled asthma (except 3–5 canisters). Findings from this African cohort of the SABINA III study indicate that SABA over-prescription and SABA over-the-counter purchase are common and associated with poor asthma-related outcomes. This highlights the need for healthcare providers/policymakers to align clinical practices with the latest treatment recommendations.

Tuberculosis is unique among the major infectious diseases in that it lacks accurate rapid point-of-care diagnostic tests. Failure to control the spread of tuberculosis is largely due to our inability to detect and treat all infectious cases of pulmonary tuberculosis in a timely fashion, allowing continued Mycobacterium tuberculosis transmission within communities. Currently recommended gold-standard diagnostic tests for tuberculosis are laboratory based, and multiple investigations may be necessary over a period of weeks or months before a diagnosis is made. Several new diagnostic tests have recently become available for detecting active tuberculosis disease, screening for latent M. tuberculosis infection, and identifying drug-resistant strains of M. tuberculosis. However, progress toward a robust point-of-care test has been limited, and novel biomarker discovery remains challenging. In the absence of effective prevention strategies, high rates of early case detection and subsequent cure are required for global tuberculosis control. Early case detection is dependent on test accuracy, accessibility, cost, and complexity, but also depends on the political will and funder investment to deliver optimal, sustainable care to those worst affected by the tuberculosis and human immunodeficiency virus epidemics. This review highlights unanswered questions, challenges, recent advances, unresolved operational and technical issues, needs, and opportunities related to tuberculosis diagnostics.

Kenya, a country with a high burden of tuberculosis (TB) and human immunodeficiency virus (HIV) infection. To assess the prevalence of TB infection, bacille Calmette-Guérin (BCG) coverage and the annual risk of tuberculosis infection (ARTI), and to compare estimates with previous findings. A sample of primary school children aged 6-14 years from the same study districts sampled in previous surveys were tuberculin skin tested using the Mantoux method from September 2004 to July 2007. The prevalence of TB infection was estimated by the mirror method, with the mode at 17 mm. Of the 94 771 registered children, 76 676 (80.9%) completed the survey investigations, 12 107 (15.8%) of whom had no BCG scar. The prevalence of TB infection was estimated at 10.2%, with a corresponding ARTI of 1.1%. The ARTI obtained from the current survey is comparable to that of the 1994-1996 survey and higher than that of the 1986-1990 survey. The BCG coverage was comparable with the 1994-1996 survey and higher than in the 1986-1990 survey. TB transmission in Kenya has remained the same over the last decade, which suggests that activities undertaken by the TB control programme have been sufficient to hold TB transmission steady, but insufficient to reduce it

SETTING: Three busy laboratories in Nairobi, Kenya. OBJECTIVES: To determine the performance of an affordable fluorescence system (FluoreslenS) for tuberculosis microscopy, and to test an auramine-smear rechecking system. DESIGN: Alternating routine use of Ziehl-Neelsen (ZN) and fluorescence microscopy (FM) was performed to compare detection and errors found while rechecking. RESULTS: Overall, 19.5% of 25,250 ZN and 23% of 21,104 FM smears were positive (P < 10(-3)). The proportional increment of FM over ZN was 18% (range -6%-29%), with one centre detecting fewer positives (non-significant, NS). The average error frequencies were comparable (1.8% vs. 2.6% false-negative and 0.2% vs. 0.4% high false-positive for ZN and FM, respectively, NS). The superior performance of controllers and the overall equal ZN/FM quality in the laboratories could be demonstrated only after converting error percentages to relative sensitivity (RS). CONCLUSIONS: FM with the FluoreslenS system considerably improved sensitivity without loss of specificity in two of the busy routine laboratories, but the system is not sufficiently practical or user-friendly. Rechecking by FM can be done using guidelines for ZN smears, provided that routine ZN confirmation of positives is omitted. Calculation of RS allows an objective comparison of microscopy quality, independent of the variable prevalence of positives and sample size.

Objective: To determine the prevalence of myocoplasma pneumoniae in nasopharyngeal aspirates of children under five years of age sufferning from pneumonia. Design: Cross-sectional survey. Methods: Two primer sets targeting the genes coding for adhesion protein and 16S rRNA were used in PCR and M. pneumoniae specific antibodies were detected using commercial article agglutination kit. Microbiological investigations to isolate common acute respiratory infectious pathogens were also carried out. Results: M. pneumoniae was detected in nasopharyngeal aspirates of 33.7% of the cases by PCR while serology was positive in only 4.1%. M. pneumoniae alone (single detection) was detected in 25% of the cases while 75% occurred with other acute respiratory infectious (ARI) pathogens. However, the results did not correlate with clinical outcome or the severity of pneumonia. No significant aetiology was found in 28% of the cases investigated, however microbiological investigations by culture revealed the presence of other aetiological agents as follows: Streptococcus pneumoniae (26%), Klebsiella pneumoniae (1%), Staphylococcus aureus (3%), E. coli (2%), parainfluenza viruses (5%), Salmonella(1%), adenovirus (4%), RSV (22%) and Candida spp(13%), Micoplasma pneumoniae was more prevalent in children aged between six months and three years. Cases of M. pneumoniae PCR positive and S. pneumoniae exhibited similar seasonal distribution with peaks in May and September. However, there was no relationship between M. pneumoniae PCR positive and the severity of pneumonia. Conclusion: More investigation is required to establish the significance of atypical pathogens in respiratory infections in Kenya. (East African Medical Journal: 2002 79(6): 317-322)

(East African Medical Journal: 2001 78(3): 113-114)

Nairobi, the capital of Kenya.To promote standardised tuberculosis (TB) care by private health providers and links with the public sector.A description of the results of interventions aimed at engaging private health providers in TB care and control in Nairobi. Participating providers are supported to provide TB care that conforms to national guidelines. The standard surveillance tools are used for programme monitoring and evaluation.By the end of 2006, 26 of 46 (57%) private hospitals and nursing homes were engaged. TB cases reported by private providers increased from 469 in 2002 to 1740 in 2006. The treatment success rate for smear-positive pulmonary TB treated by private providers ranged from 76% to 85% between 2002 and 2005. Of the 1740 TB patients notified by the private sector in 2006, 732 (42%) were tested for human immunodeficiency virus (HIV), of whom 372 (51%) were positive. Of the 372 HIV-positive TB patients, 227 (61%) were provided with cotrimoxazole preventive treatment (CPT) and 136 (37%) with antiretroviral treatment (ART).Private providers can be engaged to provide TB-HIV care conforming to national norms. The challenges include providing diagnostics, CPT and ART and the capacity to train and supervise these providers.

BACKGROUND: The aim of these clinical standards is to provide guidance on ‘best practice´ for diagnosis, treatment and management of drug-susceptible pulmonary TB (PTB).METHODS: 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.RESULTS: 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.CONCLUSION: 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.