Improving access to affordable quality-assured inhaled medicines in low- and middle-income countries.

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.

Household air pollution and COPD: cause and effect or confounding by other aspects of poverty?

SETTING: Household air pollution (HAP) and chronic obstructive pulmonary disease (COPD) are both major public health problems, reported to cause around 4 million and 3 million deaths every year, respectively. The great majority of these deaths, as well as the burden of disease during life is felt by people in low- and middle-income countries (LMICs).OBJECTIVE and DESIGN: The extent to which HAP causes COPD is controversial; we therefore undertook this review to offer a viewpoint on this from the Global Initiative for COPD (GOLD).RESULTS: We find that while COPD is well-defined in many studies on COPD and HAP, there are major limitations to the definition and measurement of HAP. It is thus difficult to disentangle HAP from other features of poverty that are themselves associated with COPD. We identify other limitations to primary research studies, including the use of cross-sectional designs that limit causal inference.CONCLUSION: There is substantial preventable morbidity and mortality associated with HAP, COPD and poverty, separately and together. Although it may not be possible to define clear causal links between HAP and COPD, there is a clear urgency to reduce the avoidable burden of disease these inflict on the world´s poor.

The GOLD Summit on chronic obstructive pulmonary disease in low- and middle-income countries.

Chronic obstructive pulmonary disease (COPD) is one of the top three causes of death worldwide, but governments and non-governmental organisations have not given its prevention and treatment the priority it requires. This is particularly true in low- and middle-income countries, where most of the people suffering from this disease live. The United Nations (UN) has targeted a reduction of premature deaths from non-communicable diseases (NCDs) by a third by 2030; however, a coordinated UN/World Health Organization (WHO) strategy to address the burden of COPD (one of the most important NCDs) is still lacking. To explore the extent of the problem and inform the development of policies to improve the situation, the Board of Directors of the Global Initiative for Chronic Obstructive Lung Disease (GOLD) held a 1-day Summit. The key themes that emerged were the need to ensure accurate data on prevalence, raise awareness of the disease among the public, healthcare professionals and governments, including the fact that COPD aetiology goes beyond smoking (and other inhaled pollutants) and includes poor lung development in early life, and ensure that spirometry and both pharmacological and non-pharmacological therapies are available and affordable. Here, we present the actions that must be taken to address the impact of COPD. We believe that the WHO is particularly well-positioned to co-ordinate an attack on COPD, and GOLD will do all it can to help and rally support.

Clinician Perceptions of 4 Hearing Protection Devices.

Common equipment in the dental operatory generate cumulative noise at sufficient decibel levels that can damage hearing. Although noise exposure in the dental office is typically intermittent, dentists and other dental care providers have been shown to be at risk of hearing loss. This article provides dentist-generated insight to use when incorporating hearing protection devices during dental practice. Four hearing protection devices (HPDs) were provided to 15 dentists in randomized sequence for evaluation. Perceptions were gathered via questionnaires and analyzed to determine mean ratings and product preferences. Battery requirements of electronic HPDs were also examined. Qualitative assessments of the HPDs evaluated are presented, including dentist preferences and recommendations. There were statistically significant differences ( P ≤ 0.0031) among the HPDs in terms of ease of insertion, aesthetics, ability to hear while using a handpiece, and the openness of the ear. Battery life was not found to differ between the 2 electronic HPDs evaluated. Dentists most highly valued ease of hearing, ability to communicate, and comfort while wearing HPDs. The DI-15 High-Fidelity Electronic Earplugs HPD was ranked the highest, followed by Music PRO Electronic Earplugs. Battery longevity for these electronic HPDs was similar under all tested conditions studied. Knowledge Transfer Statement: Dentists should understand the potential ramifications of hearing loss and be aware that there are commercially available hearing protection products that preserve the ability to communicate with patients and coworkers.

Budesonide/formoterol vs. salmeterol/fluticasone in COPD: a systematic review and adjusted indirect comparison of pneumonia in randomised controlled trials.

AIMS: This analysis was designed to provide a comparison between budesonide/formoterol and salmeterol/fluticasone for the relative incidence of pneumonia adverse events, pneumonia serious adverse events and pneumonia-related mortality in patients being treated for chronic obstructive pulmonary disease. METHODS: An initial literature search revealed no suitable head-to-head trials between budesonide/formoterol and salmeterol/fluticasone and therefore a systematic review was conducted to find randomised controlled trials providing data for input into an adjusted indirect comparison of the two combination treatments using placebo as a common comparator. The Bucher adjusted indirect comparison method was used to calculate odds ratios and 95% confidence intervals. RESULTS: Eight salmeterol/fluticasone trials and four budesonide/formoterol trials were identified as being relevant for the analyses. The proportion of patients experiencing a pneumonia adverse event was significantly lower with budesonide/formoterol than salmeterol/fluticasone (odds ratio, 0.47; 95% confidence interval, 0.28-0.80). The proportion of patients experiencing a pneumonia serious adverse event was also significantly lower with budesonide/formoterol than salmeterol/fluticasone (odds ratio, 0.41; 95% confidence interval, 0.19-0.86). However, there were too few events to draw any firm conclusions on pneumonia-related mortality. CONCLUSIONS: The results of the indirect comparison support the hypothesis that budesonide/formoterol is associated with fewer pneumonia events than salmeterol/fluticasone in chronic obstructive pulmonary disease. The limitations of the analysis are that the results from a single study, TORCH, have a large bearing on the overall findings of the analysis, and that there is heterogeneity in the length and the dosing of the included studies, although it does not appear that heterogeneity affected the reported results. Another important limitation is the lack of predefined diagnostic standards for pneumonia in these studies.

Barriers to advance care planning in chronic obstructive pulmonary disease.

The English End of Life Care Strategy promises that all patients with advanced, life limiting illness will have the opportunity to participate in Advance Care Planning (ACP). For patients with Chronic Obstructive Pulmonary Disease (COPD), the barriers to this being achieved in practice are under-explored. Five focus groups were held with a total of 39 health care professionals involved in the care of patients with COPD. Participants reported that discussions relating to ACP are very rarely initiated with patients with COPD and identified the following barriers: inadequate information provision about the likely course of COPD at diagnosis; lack of consensus regarding who should initiate ACP and in which setting; connotations of comparing COPD with cancer; ACP discussions conflicting with goals of chronic disease management; and a lack of understanding of the meaning of 'end of life' within the context of COPD. The findings from this study indicate that, for patients with COPD, significant service improvement is needed before the objective of the End of Life Care Strategy regarding patient participation in end of life decision-making is to be achieved. Whilst the findings support the Strategy's recommendations regarding an urgent for both professional education and increased public education about end of life issues, they also indicate that these alone will not be enough to effect the level of change required. Consideration also needs to be given to the integration of chronic disease management and end of life care and to developing definitions of end of life care that fit with concepts of 'continuous palliation'.

Stratification of COPD patients by previous admission for targeting of preventative care.

BACKGROUND: Hospital admissions for exacerbations of chronic obstructive pulmonary disease (COPD) impact considerably on disease evolution and healthcare provision. Building on previous studies, this study postulated that COPD patients could be stratified by risk of admission to determine which groups provide the greatest burden on resources, and how interventions should be targeted to prevent admissions. METHODS: COPD admissions during 1997-2003 in three Strategic Health Authorities in England were analysed (n=80,291). Patients admitted during winter (1 November-31 March) were stratified into three groups according to the number of admissions during the previous year: 0 (NIL), 1-2 (MOD) or >or=3 (FRQ). Winter weeks were classified as "average", "above average", "high", or "very high" risk, compared with the long-term mean. RESULTS: The risk of admission during winter for FRQ and MOD patients was 40% and 12% respectively. NIL patients contributed to 70% of winter admissions, and 90% of the variation between "average" and "very high" weeks, versus 9% and 1% for MOD and FRQ. CONCLUSIONS: Patients with no previous admissions have lower individual risk, but contribute to a high overall utilisation of health care resources and should be targeted to prevent admissions. Focusing upon high-risk patients (frequent attenders or more severe) may only reduce a small proportion of admissions, and therefore clinicians should ensure that all COPD patients receive appropriate therapy to reduce risk of exacerbations.

Confidence and understanding among general practitioners and practice nurses in the UK about diagnosis and management of COPD.

In order to assess the confidence of healthcare professionals in diagnosing and managing COPD telephone interviews were conducted with 60 practice nurses and 46 general practitioners (GPs) in 2001 and 61 nurses and 39 GPs in 2005. The nurses all ran respiratory clinics. 80% of GPs were confident about diagnosing COPD and this had increased from 52% in 2001. Fifty five percent of nurses were confident and there was no change from 2001. In 2005, 79% of GPs and 70% of nurses were confident about differentiating asthma and COPD. Smoking history, breathlessness, age of onset, lack of response to asthma therapy and cough were reported as features differentiating COPD from asthma. Most respondents stated that spirometry is essential to diagnose COPD and in 2005 nearly all practices had access to a spirometry service. GPs were more confident about interpreting spirometry results in 2005 than nurses and their confidence had increased significantly from 2001. In 2005, nearly all respondents had heard of pulmonary rehabilitation, and significantly more had a programme in their area in 2005 than 2001 (69% vs. 49% p=0.05). Fifty four percent of GPs were confident about which patients to refer for long term oxygen therapy in 2005 but nurses were less confident. There had not been any significant change between 2001 and 2005. In 2005 only 35% of respondents had access to a pulse oximeter. When presented with case scenarios, GPs self-reported confidence was not reflected in their diagnoses or investigation and management strategies and they seem to favour cardiac over respiratory diagnoses.

Evaluating the effectiveness of combination therapy to prevent COPD exacerbations: the value of NNT analysis.

The effective prevention of exacerbations in patients with chronic obstructive pulmonary disease (COPD) has the potential to improve patients' health-related quality of life, reduce rates of hospitalisation and mortality and lower healthcare costs. Several pharmacological agents, including inhaled corticosteroid/long-acting beta2-agonist combination therapies, have demonstrated beneficial effects on COPD exacerbations. The number needed to treat (NNT) analysis is a simple, concise method that allows physicians to quantify directly the benefits that alternative treatment options have on disease outcomes in terms of the number of patients who need to be treated before a benefit is observed. This review evaluates the applicability and clinical relevance of NNT analysis for determining the effectiveness of combination therapies against COPD exacerbations, focusing on budesonide/ formoterol in the same inhaler. Physicians are encouraged to consider NNT data within the context of their limitations and in conjunction with other analytical methods when selecting treatments for patients with COPD.

Living with severe chronic obstructive pulmonary disease (COPD): perceptions of patients and their carers. An interpretative phenomenological analysis.

BACKGROUND: A study designed to explore the experiences of patients with severe chronic obstructive pulmonary disease (COPD) and their carers, particularly with regard to ongoing and palliative care needs. METHODS: The participants were nine men and one woman with severe COPD and the carers of eight of the men, in East Devon, UK. Semi-structured interviews were undertaken, transcribed and analysed using interpretative phenomenological analysis (IPA). RESULTS: The emergent themes were of losses, adaptation, relationships with health professionals and effect on carer. Losses reflected the loss of personal liberty and dignity and of previous expectations of the future. Adaptation included strategies to cope with the effects of the disease. Relationships related to both positive and negative aspects of contact with health professionals. There was appreciation for continuity of care and reassurance. The effect on the carer was evident particularly as they had to take on multiple roles. They also experienced some of the same losses as the patient and appeared enmeshed with the illness. CONCLUSIONS: This study confirmed the inexorable decline in activities of daily life and social isolation for patients with severe COPD. Adaptive strategies were common and some positive aspects were identified. Support from the primary health care team was appreciated. The strain on carers was very apparent. The concept of a more structured sharing of information and a surveillance role mediated by health care professionals known to the patient and carer would be a pragmatic approach to improving care.

Symptoms are an important outcome in chronic obstructive pulmonary disease clinical trials: results of a 3-month comparative study using the Breathlessness, Cough and Sputum Scale (BCSS).

The need to manage the key symptoms of chronic obstructive pulmonary disease (COPD) (breathlessness, cough and sputum) is an important treatment objective. Viozan (sibenadet HCl, AR-C68397AA) is a novel dual D2 dopamine receptor, beta2-adrenoceptor agonist, which combines conventional bronchodilatory activity with the sensory nerve modulation afforded by dopamine agonism. The efficacy of this agent in relieving patient symptoms has been determined in a series of large-scale clinical studies; the results of a 3-month, placebo-controlled multi-centre study are reported. Effect on patient symptoms was determined using a novel patient-reported assessment instrument, the Breathlessness, Cough and Sputum Scale (BCSS). Patients with smoking-related COPD were required to complete a 2-week baseline period before being randomized to one of three treatment groups; sibenadet (500 microg three times daily) plus placebo (twice daily); salmeterol (50 microg twice daily) plus placebo (three times daily); placebo (twice daily) plus a second placebo (three times daily). All treatments were delivered via pressurized metered dose inhaler (pMDI) for 12 weeks. From enrolment, patients were required to complete daily diary cards to record symptoms of breathlessness, cough and sputum, medication use and adverse events. The primary outcome measure was the difference between the mean BCSS total score measured over the baseline period and the mean BCSS total score in the final 4 weeks of the treatment period. Secondary measures included assessment of lung function, rescue medication use, exacerbations, health-related quality of life, opinion of efficacy and safety. Although an initial reduction in BCSS total score (indicating symptom improvement) was seen with sibenadet therapy, this effect was not maintained for the study duration. Salmeterol therapy, however, resulted in a sustained reduction in BCSS total score. No notable benefit over placebo was seen in lung function, exacerbations or health-related quality of life with either active treatment. While the results of this study failed to demonstrate sustained efficacy with sibenadet therapy, they do indicate the value of symptom assessment in the clinical evaluation of new drugs for the treatment of COPD.

Attack context: an important mediator of the relationship between psychological status and asthma outcomes.

BACKGROUND: The importance of psychosocial variables in asthma is increasingly recognised, although attempts to relate these to asthma outcomes often produce only weak relationships. This study aimed to identify whether such relationships might be obscured by the effects of recent asthma experience on psychological status. METHODS: An adult community sample of 37 patients who had suffered a recent attack of asthma and 37 with stable asthma were given measures of panic fear and control confidence. The relationship with subsequent emergency service use was examined using two way ANOVA and correlational analyses. Covariate influences (psychiatric morbidity, age, sex, treatment level, asthma duration, social status) were considered. RESULTS: Control confidence predicted emergency service use in different ways for recent attack and stable asthma patients. This interaction was highly significant (F(1,69) = 10.32, p<0.005) with high confidence relating to an increased risk of an attack in the recent attack group and low confidence relating to increased risk for the stable asthma group. There was also an interaction between panic fear and attack context (F(1,69) = 11.05, p<0.005) with low panic fear resulting in more attacks for recent attack cases. CONCLUSIONS: Attack context (having a recent attack) is an important mediator of psychological status. Strong cognitive/affective responses to attacks may motivate improved self-care and this represents a window of opportunity for self-care interventions. Weak cognitive/affective responses to attacks may reflect denial and require different intervention approaches. For those with recently stable asthma the relationships are qualitatively and quantitatively different, and the implications for intervention are also discussed.

A comparison of professionals' and patients' understanding of asthma: evidence of emerging dualities?

Despite an increase in the provision of services to patients with asthma, morbidity from the disease remains high. Recent research (outside asthma) has raised the possibility that patients may develop a conceptualisation of illnesses which is not entirely compatible with the prevailing biomedical view. This paper compares the way in which health care professionals and patients with asthma described various aspects of the illness, using an approach which considered the type of knowledge which might be used to construct the respective conceptualisations of asthma. A qualitative method is empliyed, using focus groups. Eight focus groups were convened, four of professionals and four of patients with asthma. Following the initial data analysis, the results were reviewed linguistically, with particular attention to the use of metaphor.The health care professionals and patients participating in this study agreed broadly in their explanations of the aetiology and drug treatment of asthma. The data suggest lack of congruence in the development of treatment strategies and locus of control. Health care professionals and patients in this study used linguistically different metaphors to represent the disease: the former more frequently used metaphors evoking on-going processes, the latter visualising the chest (in their use of metaphor) as a static container, emptying and filling throughout the course of the disease. Two commentaries from philosophical and anthropological literature are considered in order to offer theoretical accounts relevant to this interpretation. The data suggest an emerging duality in the approach to treatment plans, in the roles played by professionals and patients with asthma, and in the different types of knowledge used by professionals and patients to construct their respective working models of asthma.