Chronic Obstructive Pulmonary Disease Self-Management in Three Low- and Middle-Income Countries: A Pilot Randomized Trial.

Objectives: Chronic obstructive pulmonary disease (COPD) disproportionately affects low- and middle-income countries. Health systems are ill prepared to manage the increase in COPD cases. Methods: We performed a pilot effectiveness-implementation randomized field trial of a community health worker (CHW)-supported, 1-year self-management intervention in individuals with COPD grades B-D. The study took place in low-resource settings of Nepal, Peru, and Uganda. The primary outcome was the St. George's Respiratory Questionnaire (SGRQ) score at 1 year. We evaluated differences in moderate to severe exacerbations, all-cause hospitalizations, and the EuroQol score (EQ-5D-3 L) at 12 months. Measurements and Main Results: We randomly assigned 239 participants (119 control arm, 120 intervention arm) with grades B-D COPD to a multicomponent, CHW-supported intervention or standard of care and COPD education. Twenty-five participants (21%) died or were lost to follow-up in the control arm compared with 11 (9%) in the intervention arm. At 12 months, there was no difference in mean total SGRQ score between the intervention and control arms (34.7 vs. 34.0 points; adjusted mean difference, 1.0; 95% confidence interval, -4.2, 6.1; P = 0.71). The intervention arm had a higher proportion of hospitalizations than the control arm (10% vs. 5.2%; adjusted odds ratio, 2.2; 95% confidence interval, 0.8, 7.5; P = 0.15) at 12 months. Conclusions: A CHW-based intervention to support self-management of acute exacerbations of COPD in three resource-poor settings did not result in differences in SGRQ scores at 1 year. Fidelity was high, and intervention engagement was moderate. Although these results cannot differentiate between a failed intervention or implementation, they nonetheless suggest that we need to revisit our strategy. Clinical trial registered with www.clinicaltrials.gov (NCT03359915).

Home-Based Respiratory Physiotherapy and Telephone-Based Psychological Support for COVID-19 Survivors in Peru: Protocol for a Randomized Controlled Trial.

BACKGROUND: Both pulmonary and mental health are affected following hospitalization for COVID-19 pneumonia. Pulmonary rehabilitation therapy has demonstrated benefits in improving mental health, but no validated combined programs that include mental health have been proposed. OBJECTIVE: This article presents the design of a trial that aimed to assess whether the participation in a combined rehabilitation program that includes home-based respiratory physiotherapy and telephone-based psychological support is associated with a greater improvement of pulmonary and mental health outcomes 7-12 weeks after COVID-19 hospitalization discharge compared with posthospital usual care provided by a public Peruvian hospital. METHODS: WAYRA (the word for air in the Quechua language) was an open-label, unblinded, two-arm randomized controlled trial. We recruited 108 participants aged 18-75 years who were discharged from the hospital after COVID-19 pneumonia that required >6 liters/minute of supplemental oxygen during treatment. Participants were randomly assigned at a 1:1 ratio to receive the combined rehabilitation program or usual posthospital care provided by a public Peruvian hospital. The intervention consisted of 12 at-home respiratory rehabilitation sessions and 6 telephone-based psychological sessions. The primary outcome was the 6-minute walk distance. Secondary outcomes included lung function, mental health status (depression, anxiety, and trauma), and quality of life. Outcomes were assessed at baseline (before randomization) and at 7 and 12 weeks after hospital discharge to assess the difference between arms. RESULTS: This study was funded by the Peruvian National Council of Science Technology and Technology Innovation in July 2020. Ethics approval was obtained on September 2, 2020. Recruitment and data collection occurred between October 2020 and June 2021. Results are expected to be published by the end of 2022. CONCLUSIONS: WAYRA was the first randomized controlled trial evaluating combined pulmonary-mental health rehabilitation for hospitalized COVID-19 survivors in resource-limited settings, potentially providing a foundation for the cost-effective scale-up of similar multidisciplinary rehabilitation programs. TRIAL REGISTRATION: ClinicalTrials.gov NCT04649736; https://clinicaltrials.gov/ct2/show/NCT04649736. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/36001.

Availability, affordability and access to essential medications for asthma and chronic obstructive pulmonary disease in three low- and middle-income country settings.

INTRODUCTION: Despite the rising burden of chronic respiratory disease globally, and although many respiratory medications are included in the World Health Organization Essential Medications List (WHO-EML), there is limited information concerning the availability and affordability of treatment drugs for respiratory conditions in low- and middle-income countries (LMICs). METHODS: All public and private pharmacies in catchment areas of the Global Excellence in COPD outcomes (GECo) study sites in Bhaktapur, Nepal, Lima, Peru, and Nakaseke, Uganda, were approached in 2017-2019 to assess pricing and availability of medications for the management of asthma and COPD. RESULTS: We surveyed all 63 pharmacies in respective study areas in Nepal (95.2% private), 104 pharmacies in Peru (94.2% private) and 53 pharmacies in Uganda (98.1% private). The availability of any medication for respiratory disease was higher in private (93.3%) compared to public (73.3%) pharmacies. Salbutamol (WHO-EML) monotherapy in any formulation was the most commonly available respiratory medication among the three sites (93.7% Nepal, 86.5% Peru and 79.2% Uganda) while beclomethasone (WHO-EML) was only available in Peru (33.7%) and Nepal (22%). LABA-LAMA combination therapy was only available in Nepal (14.3% of pharmacies surveyed). The monthly treatment cost of respiratory medications was lowest in Nepal according to several cost metrics: the overall monthly cost, the median price ratio comparing medication costs to international reference prices at time of survey in dollars, and in terms of days' wages of the lowest-paid government worker. For the treatment of intermittent asthma, defined as 100 mcg Salbutamol/Albuterol inhaler, days' wages ranged from 0.47 days in Nepal and Peru to 3.33 days in Uganda. CONCLUSION: The availability and pricing of respiratory medications varied across LMIC settings, with medications for acute care of respiratory diseases being more widely available than those for long-term management.

Challenges in the Implementation of Chronic Obstructive Pulmonary Disease Guidelines in Low- and Middle-Income Countries: An Official American Thoracic Society Workshop Report.

There is a substantial burden of chronic respiratory diseases, including chronic obstructive pulmonary disease (COPD), in low- and middle-income countries (LMICs). LMICs have particular challenges in delivering cost-effective prevention, diagnosis, and management of COPD. Optimal care can be supported by effective implementation of guidelines. This American Thoracic Society workshop considered challenges to implementation of COPD guidelines in LMICs. We make 10 specific recommendations: 1) relevant organizations should provide LMIC-specific COPD management guidance; 2) patient and professional organizations must persuade policy-makers of the importance of lung function testing programs in LMICs; 3) healthcare education and training should emphasize the early-life origins of COPD; 4) urgent action is required by governments to reduce airborne exposures, including exposures to tobacco smoke and indoor and outdoor air pollution; 5) guidance for COPD in LMICs should explicitly link across Essential Medicine Lists and the World Health Organization package of essential noncommunicable disease interventions for primary health care in low-resource settings and should consider availability, affordability, sustainability, and cost-effective use of medicines; 6) the pharmaceutical industry should work to make effective COPD and tobacco-dependence medicines globally accessible and affordable; 7) implementation of locally adapted, cost-effective pulmonary rehabilitation programs should be an international priority; 8) the World Health Organization Global Action Plan for the Prevention and Control of Noncommunicable Diseases should specify how improvements in respiratory health will be achieved; 9) research funders should increase the proportion of funding allocated to COPD in LMICs; and 10) the respiratory community should leverage the skills and enthusiasm of earlier-career clinicians and researchers to improve global respiratory health.

Gaps in COPD Guidelines of Low- and Middle-Income Countries: A Systematic Scoping Review.

BACKGROUND: Guidelines are critical for facilitating cost-effective COPD care. Development and implementation in low-and middle-income countries (LMICs) is challenging. To guide future strategy, an overview of current global COPD guidelines is required. RESEARCH QUESTION: We systematically reviewed national COPD guidelines, focusing on worldwide availability and identification of potential development, content, context, and quality gaps that may hamper effective implementation. STUDY DESIGN AND METHODS: Scoping review of national COPD management guidelines. We assessed: (1) global guideline coverage; (2) guideline information (authors, target audience, dissemination plans); (3) content (prevention, diagnosis, treatments); (4) ethical, legal, and socio-economic aspects; and (5) compliance with the eight Institute of Medicine (IOM) guideline standards. LMICs guidelines were compared with those from high-income countries (HICs). RESULTS: Of the 61 national COPD guidelines identified, 30 were from LMICs. Guidelines did not cover 1.93 billion (30.2%) people living in LMICs, whereas only 0.02 billion (1.9%) in HICs were without national guidelines. Compared with HICs, LMIC guidelines targeted fewer health-care professional groups and less often addressed case finding and co-morbidities. More than 90% of all guidelines included smoking cessation advice. Air pollution reduction strategies were less frequently mentioned in both LMICs (47%) and HICs (42%). LMIC guidelines fulfilled on average 3.37 (42%) of IOM standards, compared with 5.29 (66%) in HICs (P < .05). LMICs scored significantly lower compared with HICs regarding conflicts of interest management, updates, articulation of recommendations, and funding transparency (all, P < .05). INTERPRETATION: Several development, content, context, and quality gaps exist in COPD guidelines from LMICs that may hamper effective implementation. Overall, COPD guidelines in LMICs should be more widely available and should be transparently developed and updated. Guidelines may be further enhanced by better inclusion of local risk factors, case findings, and co-morbidity management, preferably tailored to available financial and staff resources.

What is a COPD-Like Spirometry Test Result in Resource Constrained Settings?

The diagnosis of chronic obstructive pulmonary disease (COPD), a global health problem, is challenging in resource-constrained settings. Spirometry with an obstructive pattern after the administration of bronchodilators is required for the diagnosis of COPD. Existing COPD treatment guidelines, largely derived from studies performed in populations of cigarette-smokers, recommend pharmacologic interventions with a tendency to include new-and expensive-drugs as first line agents. As the different factors that cause nonsmokers to develop COPD lead to different phenotypes of disease, COPD severity and treatment efficacy cannot be extrapolated to be the same as in the population of smokers. In so doing, current global initiatives may carry risks when trying to over simplify diagnostic approaches and push for standardization of treatment algorithms that are not context-specific. Future work to mitigate the global burden of COPD needs to address the need for new epidemiological data, especially in areas where tobacco use is less prevalent and environmental factors such as domestic air pollution is common.

The health and social implications of household air pollution and respiratory diseases.

Approximately three billion individuals are exposed to household air pollution (HAP) from the burning of biomass fuels worldwide. Household air pollution is responsible for 2.9 million annual deaths and causes significant health, economic and social consequences, particularly in low- and middle-income countries. Although there is biological plausibility to draw an association between HAP exposure and respiratory diseases, existing evidence is either lacking or conflicting. We abstracted systematic reviews and meta-analyses for summaries available for common respiratory diseases in any age group and performed a literature search to complement these reviews with newly published studies. Based on the literature summarized in this review, HAP exposure has been associated with acute respiratory infections, tuberculosis, asthma, chronic obstructive pulmonary disease, pneumoconiosis, head and neck cancers, and lung cancer. No study, however, has established a causal link between HAP exposure and respiratory disease. Furthermore, few studies have controlled for tobacco smoke exposure and outdoor air pollution. More studies with consistent diagnostic criteria and exposure monitoring are needed to accurately document the association between household air pollution exposure and respiratory disease. Better environmental exposure monitoring is critical to better separate the contributions of household air pollution from that of other exposures, including ambient air pollution and tobacco smoking. Clinicians should be aware that patients with current or past HAP exposure are at increased risk for respiratory diseases or malignancies and may want to consider earlier screening in this population.

Los derechos humanos y el consentimiento informado en la práctica clínica: Más allá del derecho a la salud / Human rights and informed consent in clinical practice: Beyond the right to health

Proporcionar una atención médica es un proceso complejo que requiere de un estricto respeto de los derechos humanos. En países como el Perú, a pesar de contar con normas y leyes específicas, el ejercicio de la autonomía del paciente no es común y, ciertamente, el paternalismo y la beneficencia son priorizados al momento de tomar decisiones médicas. En este tipo de realidad, exigir a los profesionales de la salud que se respeten los derechos fundamentales de las personas debe ser considerado crucial, mucho más que en las sociedades donde los ciudadanos están realmente empoderados. Pero para lograr el pleno respeto a los derechos humanos, especialmente en la prestación de un servicio de salud, existe la necesidad de ir mucho más allá de la defensa de una legislación apropiada y de marcos normativos. En este artículo se argumenta que la violación de ciertos derechos, como el proceso de consentimiento informado, por parte de los proveedores del cuidado de la salud, se evidencia en cómo estos profesionales, especialmente médicos formados en la tradición occidental, establecen prioridades y llegan a juicios morales. En este escenario hay que considerar la necesidad de un cambio en la manera en la que se entienden los derechos humanos para mejorar el respeto hacia ellos durante las atenciones de salud.

Providing medical care is us a complex process that requires a strict respect for human rights. In countries like Peru, despite of having regulations and specific laws, patient´s autonomy is not a common currency and certainly paternalism and beneficence generally overrule in physicians decision making. In this type of reality the requirement to health care professionals for respecting fundamental rights should be considered crucial, far more than in societies where citizens are really empowered. But to achieve the full respect of human rights, especially when providing a health care service, there is the need to go much further than just advocating for appropriate legislation and regulatory frameworks. In this article I argue that the violation of certain rights as the informed consent process by health care providers, is rooted in how these professionals, specially medical doctors trained in the western tradition, establish priorities and arrive to moral judgments. In this scenario I consider the need of a change in the way the Human Rights framework is being used to improve fundamental rights respect in health care.