Tag: pubmed

Thorax. 2021 Oct 27:thoraxjnl-2021-217782. doi: 10.1136/thoraxjnl-2021-217782. Online ahead of print.

ABSTRACT

RATIONALE: Inhaled tobramycin and oral azithromycin are common chronic therapies in people with cystic fibrosis and Pseudomonas aeruginosa airway infection. Some studies have shown that azithromycin can reduce the ability of tobramycin to kill P. aeruginosa. This trial was done to test the effects of combining azithromycin with inhaled tobramycin on clinical and microbiological outcomes in people already using inhaled tobramycin. We theorised that those randomised to placebo (no azithromycin) would have greater improvement in forced expiratory volume in one second (FEV₁) and greater reduction in P. aeruginosa sputum in response to tobramycin.

METHODS: A 6-week prospective, randomised, placebo-controlled, double-blind trial testing oral azithromycin versus placebo combined with clinically prescribed inhaled tobramycin in individuals with cystic fibrosis and P. aeruginosa airway infection.

RESULTS: Over a 6-week period, including 4 weeks of inhaled tobramycin, the relative change in FEV₁ did not statistically significantly differ between groups (azithromycin (n=56) minus placebo (n=52) difference: 3.44%; 95% CI: -0.48 to 7.35; p=0.085). Differences in secondary clinical outcomes, including patient-reported symptom scores, weight and need for additional antibiotics, did not significantly differ. Among the 29 azithromycin and 35 placebo participants providing paired sputum samples, the 6-week change in P. aeruginosa density differed in favour of the placebo group (difference: 0.75 log₁₀ CFU/mL; 95% CI: 0.03 to 1.47; p=0.043).

CONCLUSIONS: Despite having greater reduction in P. aeruginosa density in participants able to provide sputum samples, participants randomised to placebo with inhaled tobramycin did not experience significantly greater improvements in lung function or other clinical outcomes compared with those randomised to azithromycin with tobramycin.

PMID:34706982 | DOI:10.1136/thoraxjnl-2021-217782

Neurology. 2021 Oct 27:10.1212/WNL.0000000000012826. doi: 10.1212/WNL.0000000000012826. Online ahead of print.

ABSTRACT

BACKGROUND AND OBJECTIVES: The mortality from Parkinson’s disease (PD) and its long-term trends in the United States remains unknow. This study aimed to describe the trends in PD mortality in the United States from 1999 to 2019.

METHODS: We used data from the National Vital Statistics System, a nationwide, population-based, death registry, to determine national trends in PD mortality, in overall and by age, sex, race/ethnicity, urban-rural classification and geographic location. Analyses focused on the data from 479,059 deaths due to PD from 1999 to 2019. Joinpoint regression was performed to examine temporal trends in age-standardized death rates.

RESULTS: The age-adjusted mortality from PD increased from 5.4 (95% CI, 5.3-5.5) per 100,000 population in 1999 to 8.8 (95% CI, 8.7-8.9) per 100,000 population in 2019, with an average annual percent change of 2.4% (95% CI, 1.8%-3.0%). From 1999 to 2019, PD mortality increased significantly across all age groups, both sexes, various racial/ethnic groups and different urban-rural classifications. The US states and District of Columbia with reported death rates experienced an increase in PD mortality. Significant differences by sex and race/ethnicity were noted. Age-adjusted PD mortality rates were twice as high in men as in women, and were greater in Whites than other racial/ethnic groups.

DISCUSSION: From 1999 to 2019, the mortality from PD in the United States has increased significantly. The increase was regardless of age, sex, race/ethnicity, urban-rural classification and geographic location. A comprehensive evaluation of long-term trends in PD mortality is important for health care priority setting.

PMID:34706971 | DOI:10.1212/WNL.0000000000012826

Thorax. 2021 Oct 27:thoraxjnl-2021-217072. doi: 10.1136/thoraxjnl-2021-217072. Online ahead of print.

ABSTRACT

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is characterised by symptomatic dyspnoea and reduced exercise tolerance, in part as a result muscle weakness, for which inspiratory muscle training (IMT) may be useful. Excess mucus hypersecretion commonly coexists in COPD and may lead to reduce ventilation, further impacting on breathlessness. Devices for sputum clearance may be employed to aid mucus expectoration. This trial aimed to explore the effectiveness of a combined IMT and high-frequency airway oscillating (HFAO) device in the management of dyspnoea.

METHODS: This was a double-blinded, randomised sham-controlled trial which recruited symptomatic patients with COPD. Patients were randomised to either a HFAO device (Aerosure) or sham device for 8 weeks, three times a day. The primary outcome was the Chronic Respiratory Questionnaire dyspnoea (CRQ-D) domain. Pre-specified subgroup analyses were performed including those with respiratory muscle weakness, excessive sputum and frequent exacerbators.

RESULTS: 104 participants (68% men, mean (SD) age 69.75 years (7.41), forced expiratory volume in 1 s per cent predicted 48.22% (18.75)) were recruited to this study with 96 participants completing. No difference in CRQ-D was seen between groups (0·28, 95% CI -0.19 to 0.75, p=0.24), though meaningful improvements were seen over time in both groups (mean (SD) HFAO 0.45 (0.78), p<0.01; sham 0.73 (1.09), p<0.01). Maximal inspiratory pressure significantly improved in the HFAO group over sham (5.26, 95% CI 0.34 to 10.19, p=0.05). Similar patterns were seen in the subgroup analysis.

CONCLUSION: There were no statistical differences between the HFAO and the sham group in improving dyspnoea measured by the CRQ-D.

TRIAL REGISTRATION NUMBER: ISRCTN45695543.

PMID:34706980 | DOI:10.1136/thoraxjnl-2021-217072

BMJ Open. 2021 Oct 27;11(10):e052856. doi: 10.1136/bmjopen-2021-052856.

ABSTRACT

OBJECTIVE: To evaluate whether the COVID-19 experts who appear most frequently in media have high citation impact for their research overall, and for their COVID-19 peer-reviewed publications in particular and to examine the representation of women among such experts.

DESIGN: Cross-linking of data sets of most highly visible COVID-19 media experts with citation data on the impact of their published work (career-long publication record and COVID-19-specific work).

SETTING: Cable news appearance in prime-time programming or overall media appearances.

PARTICIPANTS: Most highly visible COVID-19 media experts in the USA, Switzerland, Greece and Denmark.

INTERVENTIONS: None.

OUTCOME MEASURES: Citation data from Scopus along with discipline-specific ranks of overall career-long and COVID-19-specific impact based on a previously validated composite citation indicator.

RESULTS: We assessed 76 COVID-19 experts who were highly visible in US prime-time cable news, and 50, 12 and 2 highly visible experts in media in Denmark, Greece and Switzerland, respectively. Of those, 23/76, 10/50, 2/12 and 0/2 were among the top 2% of overall citation impact among scientists in the same discipline worldwide. Moreover, 37/76, 15/50, 7/12 and 2/2 had published anything on COVID-19 that was indexed in Scopus as of 30 August 2021. Only 18/76, 6/50, 2/12 and 0/2 of the highly visible COVID-19 media experts were women. 55 scientists in the USA, 5 in Denmark, 64 in Greece and 56 in Switzerland had a higher citation impact for their COVID-19 work than any of the evaluated highly visible media COVID-19 experts in the respective country; 10/55, 2/5, 22/64 and 14/56 of them were women.

CONCLUSIONS: Despite notable exceptions, there is a worrisome disconnect between COVID-19 claimed media expertise and scholarship. Highly cited women COVID-19 experts are rarely included among highly visible media experts.

PMID:34706959 | DOI:10.1136/bmjopen-2021-052856

BMJ Open. 2021 Oct 27;11(10):e053124. doi: 10.1136/bmjopen-2021-053124.

ABSTRACT

INTRODUCTION: Communicable disease epidemics and pandemics magnify the health inequities experienced by marginalised populations. People who use substances suffer from high rates of morbidity and mortality and should be a priority to receive palliative care, yet they encounter many barriers to palliative care access. Given the pre-existing inequities to palliative care access for people with life-limiting illnesses who use substances, it is important to understand the impact of communicable disease epidemics and pandemics such as COVID-19 on this population.

METHODS AND ANALYSIS: We will conduct a scoping review and report according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews reporting guidelines. We conducted a comprehensive literature search in seven bibliographical databases from the inception of each database to August 2020. We also performed a grey literature search to identify the publications not indexed in the bibliographical databases. All the searches will be rerun in April 2021 to retrieve recently published information because the COVID-19 pandemic is ongoing at the time of this writing. We will extract the quantitative data using a standardised data extraction form and summarise it using descriptive statistics. Additionally, we will conduct thematic qualitative analyses and present our findings as narrative summaries.

ETHICS AND DISSEMINATION: Ethics approval is not required for a scoping review. We will disseminate our findings to healthcare providers and policymakers through professional networks, digital communications through social media platforms, conference presentations and publication in a scientific journal.

PMID:34706961 | DOI:10.1136/bmjopen-2021-053124

BMJ Open. 2021 Oct 27;11(10):e052135. doi: 10.1136/bmjopen-2021-052135.

ABSTRACT

OBJECTIVES: Measures to limit the spread of infection during the COVID-19 global pandemic have made engaging and involving members of the community in global health research more challenging. This research aimed to explore how global health researchers adapted to the imposed pandemic measures in low and middle income countries (LMICs) and how they overcame challenges to effective community engagement and involvement (CEI).

DESIGN: A qualitative two-stage mixed-methods study involving an online survey and a virtual round table.

SETTING: The survey and round table were completed online.

PARTICIPANTS: Of 53 participants, 43 were LMIC-based or UK-based global health researchers and/or CEI professionals, and 10 worked for the National Institute for Health Research or UK Government’s Department of Health and Social Care.

OUTCOME MEASURES: This study aimed to capture data on: the number of CEI activities halted and adapted because of the COVID-19 pandemic; where CEI is possible; how it has been adapted; what the challenges and successes were; and the potential impact of adapted or halted CEI on global health research.

RESULTS: Pandemic control measures forced the majority of researchers to stop or amend their planned CEI activities. Most face-to-face CEI activities were replaced with remote methods, such as online communication. Virtual engagement enabled researchers to maintain already established relationships with community members, but was less effective when developing new relationships or addressing challenges around the inclusion of marginalised community groups.

CONCLUSIONS: COVID-19 has highlighted the need for contingency planning and flexibility in CEI. The redesigning and adopting of remote methods has come with both advantages and disadvantages, and required new skills, access to technology, funding, reliable services and enthusiasm from stakeholders. The methods suggested have the potential to augment or substitute previously preferred CEI activities. The effectiveness and impact of these remote CEI activities need to be assessed.

PMID:34706957 | DOI:10.1136/bmjopen-2021-052135

BMJ Open. 2021 Oct 27;11(10):e049017. doi: 10.1136/bmjopen-2021-049017.

ABSTRACT

OBJECTIVES: There is a controversy about whether both sexes’ response to cardiac resynchronisation therapy (CRT) is similar. We aimed to assess a causal effect of sex on CRT response.

DESIGN: Secondary analysis of a randomised controlled trial (RCT) data. Doubly robust augmented-inverse-probability-weighted (AIPW) estimation of sex effect on CRT response.

SETTING: The SmartDelay Determined Atrioventricular (AV) Optimisation (SMART-AV) RCT.

PARTICIPANTS: The SMART-AV RCT enrolled New York Heart Association class III-IV patients with heart failure (HF) with left ventricular ejection fraction (LVEF) ≤35% despite optimal medical therapy and QRS duration ≥120 ms, in sinus rhythm. After exclusion of those with missing outcome or covariates, 741 participants (age 66±11 years; 33% female; 78% white; LVEF 28%±9%; 58% ischaemic cardiomyopathy; 75% left bundle branch block; left ventricular end-systolic volume index (LVESVI) 65±30 mL/m²) were included.

INTERVENTIONS: Implanted CRT defibrillator with randomly assigned AV delay as either (1) fixed at 120 ms, or (2) echocardiography-determined, or (3) SmartDelay algorithm-programmed.

OUTCOME: A composite of freedom from death and HF hospitalisation and a >15% reduction in LVESVI at 6 month post-CRT was the endpoint.

RESULTS: The primary endpoint was met by 337 patients (45.5%); 134 were women (55.6% response) and 203 were men (40.6% response); p<0.0001. After conditioning for 33 covariates that included baseline demographic, clinical, ECG, echocardiographic and biomarker characteristics, known predictors of CRT response, logistic regression showed a higher probability for composite CRT response for women versus men (OR 1.79; 95% CI 1.08 to 2.98; p<0.0001), whereas AIPW estimation showed no difference in CRT response (average treatment effect 0.88; 95% CI 0.41 to 1.89; p=0.739). After removing colliders from the model, both logistic regression (OR 1.00; 95% CI 0.69 to 1.44) and AIPW (ATE 1.06; 95% CI 0.96 to 1.16) reported similar results.

CONCLUSIONS: Both sexes’ response to CRT is similar. Sex differences in HF substrate, treatment and comorbidities explain sex disparities in CRT outcomes.

TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Identifier; NCT00677014.

PMID:34706949 | DOI:10.1136/bmjopen-2021-049017

BMJ Open. 2021 Oct 27;11(10):e050690. doi: 10.1136/bmjopen-2021-050690.

ABSTRACT

INTRODUCTION: Sweat secretion is controlled by the sympathetic nervous system and is less active during winter than in the summer. Raynaud’s phenomenon is affected by an excessive strain of the sympathetic nerves after exposure to a cold environment, thus reducing the quality of life of patients with collagen disease. Herein, we focus on the eccrine sweat glands that receive both adrenergic and cholinergic innervation. Our hypothesis is that excessive activation of sympathetic nerve in Raynaud’s phenomenon can affect sweating, especially in winter. This study is designed to evaluate the neuroactive sweating responses in patients with collagen disease and to assess its association with skin findings in peripheral circulatory disorders.

METHODS AND ANALYSIS: The study will be conducted at a single centre in Japan. Patients with systemic sclerosis, Sjogren’s syndrome, systemic lupus erythematosus, mixed connective tissue disease, and dermatomyositis will be assessed using the quantitative sudomotor axon reflex test. The primary outcomes will be sweat volume and reaction time due to axon reflex and the Raynaud’s condition score. The secondary outcomes will include patient background, skin symptoms (digital ulcers, pernio-like eruptions, subcutaneous calcifications, telangiectasia, nailfold capillary dilatation/bleeding and degree of skin sclerosis) and skin surface temperature. Evaluation will be done two times, during the summer and winter, allowing for the assessment of seasonal differences in sweating responses.

ETHICS AND DISSEMINATION: Ethical approval of this study was certified by the clinical research review board of Nagasaki University Hospital (Reference number: CRB19-001). We will disseminate the findings of this study through peer-reviewed publications and conference presentations.

TRIAL REGISTRATION NUMBER: jRCTs072190009; pre-results.

PMID:34706954 | DOI:10.1136/bmjopen-2021-050690

BMJ Glob Health. 2021 Oct;6(10):e006786. doi: 10.1136/bmjgh-2021-006786.

ABSTRACT

INTRODUCTION: Geographical accessibility is important against health equity, particularly for less developed countries as Nepal. It is important to identify the disparities in geographical accessibility to the three levels of public health facilities across Nepal, which has not been available.

METHODS: Based on the up-to-date dataset of Nepal formal public health facilities in 2021, we measured the geographical accessibility by calculating the travel time to the nearest public health facility of three levels (ie, primary, secondary and tertiary) across Nepal at 1×1 km² resolution under two travel modes: walking and motorised. Gini and Theil L index were used to assess the inequality. Potential locations of new facilities were identified for best improvement of geographical efficiency or equality.

RESULTS: Both geographical accessibility and its equality were better under the motorised mode compared with the walking mode. If motorised transportation is available to everyone, the population coverage within 5 min to any public health facilities would be improved by 62.13%. The population-weighted average travel time was 17.91 min, 39.88 min and 69.23 min and the Gini coefficients 0.03, 0.18 and 0.42 to the nearest primary, secondary and tertiary facilities, respectively, under motorised mode. For primary facilities, low accessibility was found in the northern mountain belt; for secondary facilities, the accessibility decreased with increased distance from the district centres; and for tertiary facilities, low accessibility was found in most areas except the developed areas like zonal centres. The potential locations of new facilities differed for the three levels of facilities. Besides, the majority of inequalities of geographical accessibility were from within-province.

CONCLUSION: The high-resolution geographical accessibility maps and the assessment of inequality provide valuable information for health resource allocation and health-related planning in Nepal.

PMID:34706879 | DOI:10.1136/bmjgh-2021-006786

Heart. 2021 Oct 27:heartjnl-2021-319677. doi: 10.1136/heartjnl-2021-319677. Online ahead of print.

ABSTRACT

OBJECTIVE: Given the paucity of long-term outcome data for complex congenital heart disease (CHD), we aimed to describe the treatment pathways and survival for patients who started interventions for functionally univentricular heart (FUH) conditions, excluding hypoplastic left heart syndrome.

METHODS: We performed a retrospective cohort study using all procedure records from the National Congenital Heart Diseases Audit for children born in 2000-2018. The primary outcome was mortality, ascertained from the Office for National Statistics in 2020.

RESULTS: Of 53 615 patients, 1557 had FUH: 55.9% were boys and 67.4% were of White ethnic groups. The largest diagnostic categories were tricuspid atresia (28.9%), double inlet left ventricle (21.0%) and unbalanced atrioventricular septal defect (AVSD) (15.2%). The ages at staged surgery were: initial palliation 11.5 (IQR 5.5-43.5) days, cavopulmonary shunt 9.2 (IQR 6.0-17.1) months and Fontan 56.2 (IQR 45.5-70.3) months. The median follow-up time was 10.8 (IQR 7.0-14.9) years and the 1, 5 and 10-year survival rates after initial palliation were 83.6% (95% CI 81.7% to 85.4%), 79.4% (95% CI 77.3% to 81.4%) and 77.2% (95% CI 75.0% to 79.2%), respectively. Higher hazards were present for unbalanced AVSD HR 2.75 (95% CI 1.82 to 4.17), atrial isomerism HR 1.75 (95% CI 1.14 to 2.70) and low weight HR 1.65 (95% CI 1.13 to 2.41), critical illness HR 2.30 (95% CI 1.67 to 3.18) or acquired comorbidities HR 2.71 (95% CI 1.82 to 4.04) at initial palliation.

CONCLUSION: Although treatment pathways for FUH are complex and variable, nearly 8 out of 10 children survived to 10 years. Longer-term analyses of outcome based on diagnosis (rather than procedure) can inform parents, patients and clinicians, driving practice improvements for complex CHD.

PMID:34706904 | DOI:10.1136/heartjnl-2021-319677