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INTRODUCTION: The use of pressurised metered-dose inhalers (pMDIs) and asthma exacerbations necessitating healthcare reviews contribute substantially to the global carbon footprint of healthcare. It is possible that a reduction in carbon footprint could be achieved by switching patients with mild asthma from salbutamol pMDI reliever-based therapy to inhaled corticosteroid-formoterol dry powder inhaler (DPI) reliever therapy, as recommended by the Global Initiative for Asthma. METHODS: This post hoc analysis included all 668 adult participants in the Novel START trial, who were randomised 1:1:1 to treatment with as-needed budesonide/formoterol DPI, as-needed salbutamol pMDI or maintenance budesonide DPI plus as-needed salbutamol pMDI. The primary outcome was carbon footprint of asthma management, expressed as kilograms of carbon dioxide equivalent emissions (kgCO2e) per person-year. Secondary outcomes explored the effect of baseline symptom control and adherence (maintenance budesonide DPI arm only) on carbon footprint. RESULTS: As-needed budesonide/formoterol DPI was associated with 95.8% and 93.6% lower carbon footprint compared with as-needed salbutamol pMDI (least-squares mean 1.1 versus 26.2â kgCO2e; difference -25.0, 95% CI -29.7 to -20.4; p<0.001) and maintenance budesonide DPI plus as-needed salbutamol pMDI (least-squares mean 1.1 versus 17.3â kgCO2e; difference -16.2, 95% CI -20.9 to -11.6; p<0.001), respectively. There was no statistically significant evidence that treatment differences in carbon footprint depended on baseline symptom control or adherence in the maintenance budesonide DPI arm. CONCLUSIONS: The as-needed budesonide/formoterol DPI treatment option was associated with a markedly lower carbon footprint than as-needed salbutamol pMDI and maintenance budesonide DPI plus as-needed salbutamol pMDI.
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Asma , Broncodilatadores , Budesonida , Huella de Carbono , Inhaladores de Polvo Seco , Fumarato de Formoterol , Humanos , Asma/tratamiento farmacológico , Femenino , Adulto , Masculino , Persona de Mediana Edad , Budesonida/administración & dosificación , Administración por Inhalación , Fumarato de Formoterol/administración & dosificación , Broncodilatadores/administración & dosificación , Broncodilatadores/uso terapéutico , Albuterol/administración & dosificación , Albuterol/uso terapéutico , Inhaladores de Dosis Medida , Resultado del Tratamiento , Combinación Budesonida y Fumarato de Formoterol/administración & dosificación , Combinación Budesonida y Fumarato de Formoterol/uso terapéutico , Método Doble Ciego , AncianoRESUMEN
INTRODUCTION: It is recognized that for individuals living with endometriosis, receiving a diagnosis is psychosocially beneficial, but little is known about whether this is influenced by the way in which the disease is diagnosed. The primary objective of this study was to determine the impact of the diagnostic test method (clinical, diagnostic imaging, or diagnostic laparoscopy) of endometriosis on the individual's sense of control over their disease and their perceived access to social supports. The secondary objectives were to identify the impact of the diagnostic method on perceived social support, and to explore if there was a difference in the diagnostic method utilization between countries. MATERIAL AND METHODS: This retrospective cohort study reports on data collected using the Endometriosis Health Profile-30 (EHP-30) section of a previously published larger survey conducted between May and July 2020. Women aged 18-55 years who had received a diagnosis of endometriosis were recruited by social media platforms. The two domains of interest on the EHP-30 were control and powerlessness and social support. Scores on these domains were analyzed with diagnosis method as the variable of interest. RESULTS: In all, 1634 valid survey responses were received. There was a small statistically significant difference found between control and powerlessness scores for patients that received a diagnosis via imaging (ultrasound/MRI; n = 120) vs clinical diagnosis (n = 121) (p = 0.049). However, this did not reach clinical significance when covariates were controlled for (p = 0.054). No other comparisons reached statistical significance. CONCLUSIONS: The diagnostic method of endometriosis does not appear to have a clinically significant impact on an individual's sense of control over their disease nor their access to social supports. However, further research into these domains to delineate the true impact of the diagnostic method is required.
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Endometriosis , Humanos , Femenino , Endometriosis/diagnóstico , Endometriosis/complicaciones , Calidad de Vida , Estudios Retrospectivos , Control Interno-Externo , Apoyo SocialRESUMEN
STUDY OBJECTIVE: Externally validate the American Association of Gynecologic Laparoscopists (AAGL) staging system against surgical complexity and compare diagnostic accuracy with revised American Society for Reproductive Medicine (rASRM) stage, as was done in original publication. DESIGN: Retrospective, diagnostic accuracy study. SETTING: Multicenter (Sydney, Australia). PATIENTS: A total of 317 patients (January 2016-October 2021) were used in the final analysis. INTERVENTIONS: A database of patients with coded surgical data was analyzed. MEASUREMENTS AND MAIN RESULTS: Three independent observers assigned an AAGL surgical stage (1-4) as the index test and surgical complexity level (A-D) as the reference standard. Results from the most accurate of the 3 observers were used in the final analysis. The weighted kappa score for the overall performance of AAGL stage and rASRM to predict AAGL level was 0.48 and 0.48, respectively (no difference). This represents weaker agreement with AAGL level than was observed in the reference paper, which reported a weighted kappa of 0.62. Diagnostic accuracy (sensitivity, specificity, positive predictive value, and negative predictive value) for stage 1 to predict level A was 98.5%, 64.3%, 66.3%, and 98.3%; stage 2 to predict level B 31.2%, 90.5%, 27.0%, and 92.1 %; stage 3 to predict level C 12.3%, 94.1%, 59.3%, and 60.7%; stage 4 to predict level D 95.65%, 88.10%, 38.60%, and 99.62%. Area under the receiver operating characteristic curve for A vs B/C/D (cut point 9) was 0.87, A/B vs C/D (cut point 16) was 0.78, and A/B/C vs D (cut point 22) was 0.94. CONCLUSION: There was weak to moderate agreement between AAGL stage and AAGL surgical complexity level. Across all key indicators, the AAGL system did not perform as well in this external validation, nor did it outperform rASRM as it did in the reference paper. Results suggest the system is not generalizable.
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Endometriosis , Laparoscopía , Humanos , Femenino , Estados Unidos , Endometriosis/diagnóstico , Endometriosis/cirugía , Estudios Retrospectivos , Curva ROC , AustraliaRESUMEN
PURPOSE OF STUDY: To explore the experiences, patient interactions and knowledge regarding the use of cannabis as a medicine in New Zealand doctors in an oncology setting. STUDY DESIGN: An observational cross-sectional survey undertaken between November 2019 and January 2020 across four secondary-care hospital oncology departments within New Zealand (Auckland, Wellington, Christchurch and Dunedin). Participants were a convenience sample of doctors; consultants, registrars, medical officers of special status and house surgeons working in oncology departments. Of 53 individuals approached, 45 participated (85% Response Rate). The primary outcome was reporteddoctor-patient interactions. Secondary outcomes included knowledge of cannabis-based products, their efficacy, prescribing regulations and educational access. RESULTS: Of 44 doctors, 37 (84%, 95% CI: 70 to 93) reported patient requests to prescribe cannabis-based products and 43 (98%, 95% CI: 88 to 100) reported patients using illicit cannabis for medical symptoms. Primary request reasons were pain, nausea/vomiting and cancer treatment. 33/45 (73%, 95% CI: 58 to 85) cited knowledge of at least one cannabis-based product and 27/45 (60%, 95% CI: 44 to 74) indicated at least one condition that had evidence of efficacy. 36/44 (82%, 95% CI: 67 to 92) expressed future prescribing concerns but all were willing to use a cannabis-based product developed with traditional medical provenance. CONCLUSION: In the oncology setting, patients are asking doctors about symptomatic and curative treatment with cannabis-based products. Doctors are not biased against the use of products showing medical provenance; however, NZ-specific clinical and regulatory guidelines are essential to support patient discussions and appropriate prescribing.
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Cannabis , Conocimientos, Actitudes y Práctica en Salud , Marihuana Medicinal/uso terapéutico , Neoplasias/tratamiento farmacológico , Relaciones Médico-Paciente , Médicos/psicología , Adulto , Anciano , Actitud del Personal de Salud , Estudios Transversales , Femenino , Humanos , Masculino , Medicina , Persona de Mediana Edad , Nueva ZelandaRESUMEN
PURPOSE OF THE STUDY: To evaluate documentation of a target oxygen saturation (SpO2) range and ability to achieve this range in acutely unwell inpatients. STUDY DESIGN: In this single-centre audit, patients with discharge diagnoses of pneumonia, heart failure and exacerbation of asthma or COPD admitted to Wellington Regional Hospital, New Zealand between 1 June 2019 and 31 August 2019 who received oxygen were identified. In those with a documented target SpO2 range, the proportion of SpO2 measurements in the observation chart which were within, above and below range were determined as well as the maximum and minimum SpO2. Regression analysis was performed to determine whether these outcomes were influenced by the prescribed range, high-dependency care or the number of adjustments to oxygen administration. RESULTS: 268 admissions were screened. Of the 100 eligible admissions who received oxygen, a target SpO2 range was documented in 62. The mean (SD) proportion of SpO2 measurements within range was 56.2 (30.6)%. A hypercapnic target SpO2 range was associated with a higher probability of an SpO2 above range; multivariate OR 5.34 (95% CI 1.65 to 17.3, p=0.006) and a lower probability of an SpO2 below range; multivariate OR 0.25 (95% CI 0.08 to 0.80) p=0.02. The mean (SD) maximum SpO2 was similar in those with a target range of 92%-96% versus a hypercapnic range; 96.2 (3.0)% and 95.2 (3.4)%, respectively. CONCLUSIONS: Oxygen prescription and delivery in this clinical setting was suboptimal. SpO2 values above the designated range are common, particularly in patients with a hypercapnic target range.
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Saturación de Oxígeno , Oxígeno , Documentación , Hospitalización , Humanos , Pacientes Internos , OximetríaRESUMEN
Drawing has played a key role in the development and dissemination of Medicine and Surgery, such as to share anatomy, pathology, and techniques for clinical interventions. While many of the visuals used in medicine today are created by medical illustration professionals, and by imaging techniques such as photography and radiography; many doctors continue to draw routinely in their clinical practice. This is known to be valued by patients, for example when making informed decisions about care. We surveyed doctors in New Zealand online regarding their use of drawing to explore the prevalence of this practice. 472 complete responses were obtained over 3 months. There were very high rates of drawing among responding doctors practicing in both medical and surgical specialties. Reasons for drawing are explored and included professional, collegial, and patient communication, supporting informed consent, clinical documentation, and for planning procedures. Widespread use of drawing in clinical practice, almost non-existent training or support for this in digital workflows, and high interest in resources to develop clinical drawing skills, suggest unmet training needs for this practical clinical communication tool.
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Comunicación , Consentimiento Informado , Competencia Clínica , Humanos , Prevalencia , Encuestas y CuestionariosRESUMEN
Healthcare research is traditionally published in academic papers, coded in scientific language, and locked behind paywalls - an inaccessible form for many. Sharing research results with participants and the public in an appropriate, accessible manner, is an ethical practice directed in research guidance. Evidence-based recommendations for the medium used are scant, but science communication advice advocates principles which may be fulfilled well by the medium of comics. We report a randomised crossover study conducted online, comparing participant preferences for research results shared in the medium of a comic, a traditional lay text summary, and the control approach of a scientific abstract. 1236 respondents read all three summaries and ranked their most and least preferred formats. For the most preferred summary, the comic was chosen by 716 (57.9%), lay summary by 321 (26.0%), and scientific abstract by 199 (16.1%) respondents. For the least preferred summary the scientific abstract was chosen by 614 (49.7%), lay summary by 380 (30.7%) and comic by 242 (19.6%). Review of free-text responses identified key reasons for the majority preferring the comic over the others, which included finding this easier to read and understand, more enjoyable to consume, and more satisfactory as a medium of communication.
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Comunicación , Estudios Cruzados , HumanosRESUMEN
BACKGROUND: Both inadequate and excessive administration of oxygen to acutely unwell patients results in risk of harm. Guidelines recommend titration of oxygen to achieve a target oxygen saturation (SpO2) range. Information regarding whether this is being achieved is limited. METHODS: In this two-centre non-interventional study we used continuous pulse oximetry in acutely unwell medical patients over a 24-h period to determine the proportion of time spent with SpO2 within the prescribed target range and whether this is influenced by the target range, age, care in a high-dependency area and the number of oxygen adjustments. RESULTS: Eighty participants were included in the analysis. The mean (SD) proportion of time spent in target range was 55.6% (23.6), this was lower in those with a reduced hypercapnic target range (88-92% or below) compared to those with a range of 92-96%; difference - 13.1% (95% CI - 3.0 to - 23.2), P = 0.012. The proportion of time spent above range was 16.2% (22.9); this was higher in those with a reduced hypercapnic range; difference 21.6% (31.4 to 12), P < 0.001. The proportion of time below range was 28.4% (25.2); there was no difference between target ranges. The proportion of time spent in range was higher for those in a high dependency area in the multivariate model; difference 15.5% (95% CI 2.3 to 28.7), P = 0.02. CONCLUSIONS: Medical patients receiving oxygen in a ward setting spend significant periods of time with SpO2 both above and below the prescribed target range while receiving oxygen therapy.
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Oximetría/métodos , Terapia por Inhalación de Oxígeno/efectos adversos , Saturación de Oxígeno/fisiología , Oxígeno/administración & dosificación , Enfermedad Aguda , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Hipercapnia/epidemiología , Hipercapnia/terapia , Masculino , Nueva Zelanda/epidemiología , Terapia por Inhalación de Oxígeno/métodos , Enfermedad Pulmonar Obstructiva Crónica/epidemiología , Enfermedad Pulmonar Obstructiva Crónica/terapia , TiempoRESUMEN
'Public engagement' describes a collaborative relationship between scientists and the public we serve. This has the potential to improve clinical research and is encouraged by key research funding bodies, however the objective evidence base for effective approaches remains limited. Social media algorithms determine what content users see and are known to weight post media differently. While visual content is understood to improve reach and engagement broadly, less is known about which kinds of visuals are most effective for engaging people with clinical research. We present a five year retrospective analysis of public engagement with Facebook posts made by an independent medical research institute, classified by their visual media content. Inclusion of visual post media was associated with positive effects on both reach and engagement. We present medium and strong evidence that this effect was most pronounced for comics compared to other visual media types. This data evidences objective value of using comics and other visual media for public engagement with clinical research. The metrics evaluated are easily accessible on many social media platforms meaning this approach could readily be applied by other researchers to measure the impact of their public engagement efforts, and inform science communication strategies and resource allocation.
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Medios de Comunicación Sociales , Comunicación , Humanos , Estudios RetrospectivosRESUMEN
An independent online Public Health survey regarding the COVID-19 pandemic was conducted during an Alert Level 4 lockdown, the highest possible, in New Zealand. An illustrated and curiosity-driven public engagement campaign was designed to advertise survey participation, and performance compared with a standard approach using randomised controlled A/B Split tests. The 'Caretoon' approach featured comic illustrations, appealed to goodwill and was intended to pique curiosity. This linked to an illustrated version of the survey which, upon completion, gave a personalised comic summary showing how respondent's answers compared with national averages. The standard ad and survey were not illustrated with comics, and did not provide a personalised comic summary on completion. Both approaches were cost- and time-effective, together resulting in 18,788 responses over six days. The Caretoon approach outperformed the standard approach in terms of the number of people reached, engaged, survey link clicks, gender and ethnic diversity amongst respondents, and cost-effectiveness of advertising. This came at the expense of a small reduction in the proportion of completed surveys and male respondents. The research evidences objective value of public engagement activity, comics and curiosity as tools which can support Public Health research on a national scale.
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Recursos Audiovisuales , COVID-19/epidemiología , Control de Enfermedades Transmisibles/organización & administración , Comunicación en Salud/métodos , Conductas Relacionadas con la Salud , Humanos , Internet , Pandemias , SARS-CoV-2 , Factores SocioeconómicosRESUMEN
AIM: To better understand the reasons for reduced hospital admissions to a hospital general medicine service during COVID-19 lockdowns. METHODS: A statistical model for admission rates to the General Medicine Service at Wellington Hospital, Aotearoa New Zealand, since 2015 was constructed. This model was used to estimate changes in admission rates for transmissible and non-transmissible diagnoses during and following COVID-19 lockdowns for total admissions and various sub-groups. RESULTS: For the 2020 lockdown (n=734 admissions), the overall rate ratio of admissions was 0.71 compared to the pre-lockdown rate. Non-transmissible diagnoses, which constitute 87% of admissions, had an admission rate ratio of 0.77. Transmissible diagnoses, constituting 13% of admissions, had an admission rate ratio of 0.44. Reductions in admissions did not exacerbate existing ethnic disparities in access to health services. The lag in recovery of admission rates was more pronounced for transmissible than non-transmissible diagnoses. The 2021 lockdown (n=105 admissions) followed this pattern, but was of shorter duration with small numbers, and therefore measures were frequently not statistically significant. CONCLUSIONS: The biggest relative reduction in hospital admission was due to a reduction in transmissible illness admissions, likely due to COVID-related public health measures. However, the biggest reduction in absolute terms was in non-transmissible illnesses, where hospital avoidance may be associated with increased morbidity or mortality.
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COVID-19 , Admisión del Paciente , Humanos , COVID-19/epidemiología , COVID-19/prevención & control , Nueva Zelanda/epidemiología , Admisión del Paciente/estadística & datos numéricos , Admisión del Paciente/tendencias , Hospitalización/estadística & datos numéricos , SARS-CoV-2 , Masculino , Femenino , Cuarentena , Control de Enfermedades Transmisibles , Pandemias , Persona de Mediana EdadRESUMEN
Objective: The objective of this study was to determine whether automated titration of the fraction of inspired oxygen (FiO2) increases the time spent with oxygen saturation (SpO2) within a predetermined target SpO2 range compared with manually adjusted high-flow oxygen therapy in postoperative cardiac surgical patients managed in the intensive care unit (ICU). Design: Single-centre, open-label, randomised clinical trial. Setting: Tertiary centre ICU. Participants: Recently extubated adults following elective cardiac surgery who required supplemental oxygen. Interventions: Automatically adjusted FiO2 (using an automated oxygen control system) compared with manual FiO2 titration, until cessation of oxygen therapy, ICU discharge, or 24 h (whichever was sooner). Main outcome measures: The primary outcome was the proportion of time receiving oxygen therapy with the SpO2 in a SpO2 target range of 92-96 %. Results: Among 65 participants, the percentage of time per patient spent in the target SpO2 range was a median of 97.7 % (interquartile range: 87.9-99.2 %) and 91.3 % (interquartile range: 77.1-96.1 %) in the automated (n = 28) and manual (n = 28) titration groups, respectively. The estimated effect of automated FiO2, compared to manual FiO2 titration, was to increase the percentage of time spent in the target range by a median of 4.8 percentage points (95 % confidence interval: 1.6 to 10.3 percentage points, p = 0.01). Conclusion: In patients recently extubated after cardiac surgery, automated FiO2 titration significantly increased time spent in a target SpO2 range of 92-96 % compared to manual FiO2 titration.
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Background: A non-invasive ventilation (NIV) mask has been designed to deliver NIV with expiratory washout (EW) to improve efficacy of ventilation by optimizing clearance of expired gases from the anatomic dead-space. This study compared the performance and comfort of a novel investigational mask with EW with a conventional mask during NIV therapy.Methods: In this pilot cross-over study, participants with severe stable chronic obstructive pulmonary disease (COPD) attended a single visit to receive bi-level NIV through two masks; the investigational mask with EW, and a conventional mask. The order of mask use was randomly allocated, and each mask was used for 60-minutes with a 30-to-60-minute washout in between. The primary outcome was transcutaneous carbon dioxide (PtCO2) at 60 minutes. Other physiologic and NIV device variables were also assessed.Results: The mean difference [95% CI] in the PtCO2 between the investigational and conventional masks at 60 minutes, adjusted for baseline, was -0.74 mmHg [-2.81 to 1.33, P=0.45]. The investigational mask with EW elicited a lower tidal volume (-128.7 mL [-190.0 to -67.3], P<0.001) and minute ventilation (-2.28 L·min-1 [-3.12 to -1.43], P<0.001), and a higher leak (7.96 L·min-1 [4.39 to 11.54], P<0.001), than the conventional mask. There were no significant differences in other physiological responses or ratings of dyspnoea or comfort.Conclusions: NIV therapy delivered using a novel mask with EW was similarly effective at reducing PtCO2, while the delivered tidal volume and minute ventilation were significantly lower, when compared to a conventional mask in participants with severe COPD.
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Background: In New Zealand a progressive increase in budesonide/formoterol dispensing, accompanied by a reduction in dispensing of short-acting ß2-agonists (SABAs), inhaled corticosteroids (ICSs), and other ICS/long-acting ß2-agonists (ICSs/LABAs), occurred in the 18-month period following publication of the 2020 New Zealand asthma guidelines, which recommended budesonide/formoterol anti-inflammatory reliever therapy. Objective: Our aim was to investigate more recent trends in asthma medication use and asthma hospital discharges in New Zealand. Methods: New Zealand national dispensing data for inhalers for the period from January 2010 to December 2022 were reviewed for patients aged 12 years and older. Monthly rates of dispensing of budesonide/formoterol, ICSs, other ICS/LABAs, and SABAs were displayed graphically by locally weighted scatterplot smoother plots. The rates of dispensing and hospital discharge for asthma were compared between the past 6 months for which dispensing data were available (July-December 2022) and the corresponding period from July to December 2019. Results: There has been a progressive increase in dispensing of budesonide/formoterol since 2019, with a 108% increase between the period from July to December 2019 and the period from July to December 2022 in adolescents and adults. In contrast, there was a reduction in rates of dispensing of other ICS/LABAs, ICSs, and SABAs by 3%, 18%, and 5%, respectively. During this period, there was a 17% reduction in hospital discharges for asthma. Conclusion: There has been a further widespread uptake of ICS/formoterol reliever and/or maintenance therapy in adolescents and adults with asthma in New Zealand. The changes in prescribing practice have been temporally associated with a reduction in hospital admissions for asthma.
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BACKGROUND: Closed-loop oxygen control systems automatically adjust the fraction of inspired oxygen (FiO2) to maintain oxygen saturation (SpO2) within a predetermined target range. Their performance with low and high-flow oxygen therapies, but not with non-invasive ventilation, has been established. We compared the effect of automated oxygen on achieving and maintaining a target SpO2 range with nasal high flow (NHF), bilevel positive airway pressure (bilevel) and continuous positive airway pressure (CPAP), in stable hypoxaemic patients with chronic cardiorespiratory disease. METHODS: In this open-label, three-way cross-over trial, participants with resting hypoxaemia (n=12) received each of NHF, bilevel and CPAP treatments, in random order, with automated oxygen titrated for 10 min, followed by 36 min of standardised manual oxygen adjustments. The primary outcome was the time taken to reach target SpO2 range (92%-96%). Secondary outcomes included time spent within target range and physiological responses to automated and manual oxygen adjustments. RESULTS: Two participants were randomised to each of six possible treatment orders. During automated oxygen control (n=12), the mean (±SD) time to reach target range was 114.8 (±87.9), 56.6 (±47.7) and 67.3 (±61) seconds for NHF, bilevel and CPAP, respectively, mean difference 58.3 (95% CI 25.0 to 91.5; p=0.002) and 47.5 (95% CI 14.3 to 80.7; p=0.007) seconds for bilevel and CPAP versus NHF, respectively. Proportions of time spent within target range were 68.5% (±16.3), 65.6% (±28.7) and 74.7% (±22.6) for NHF, bilevel and CPAP, respectively.Manually increasing, then decreasing, the FiO2 resulted in similar increases and then decreases in SpO2 and transcutaneous carbon dioxide (PtCO2) with NHF, bilevel and CPAP. CONCLUSION: The target SpO2 range was achieved more quickly when automated oxygen control was initiated with bilevel and CPAP compared with NHF while time spent within the range across the three therapies was similar. Manually changing the FiO2 had similar effects on SpO2 and PtCO2 across each of the three therapies. TRIAL REGISTRATION NUMBER: ACTRN12622000433707.
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Presión de las Vías Aéreas Positiva Contínua , Estudios Cruzados , Hipoxia , Ventilación no Invasiva , Terapia por Inhalación de Oxígeno , Saturación de Oxígeno , Humanos , Masculino , Femenino , Terapia por Inhalación de Oxígeno/métodos , Hipoxia/terapia , Hipoxia/etiología , Persona de Mediana Edad , Ventilación no Invasiva/métodos , Anciano , Presión de las Vías Aéreas Positiva Contínua/métodos , Oxígeno/administración & dosificación , Enfermedades Cardiovasculares/terapia , AdultoRESUMEN
BACKGROUND: Eczema is a chronic, relapsing skin condition commonly managed by emollients and topical corticosteroids. Prevalence of use and demand for effective botanical therapies for eczema is high worldwide, however, clinical evidence of benefit is limited for many currently available botanical treatment options. Robustly-designed and adequately powered randomised controlled trials (RCTs) are essential to determine evidence of clinical benefit. This protocol describes an RCT that aims to investigate whether a manuka oil based emollient cream, containing 2% ECMT-154, is a safe and effective topical treatment for moderate to severe eczema. METHODS: This multicentre, single-blind, parallel-group, randomised controlled trial aims to recruit 118 participants from community pharmacies in Aotearoa New Zealand. Participants will be randomised 1:1 to receive topical cream with 2% ECMT-154 or vehicle control, and will apply assigned treatment twice daily to affected areas for six weeks. The primary outcome is improvement in subjective symptoms, assessed by change in POEM score. Secondary outcomes include change in objective symptoms assessed by SCORAD (part B), PO-SCORAD, DLQI, and treatment acceptability assessed by TSQM II and NRS. DISCUSSION: Recruitment through community pharmacies commenced in January 2022 and follow up will be completed by mid-2023. This study aims to collect acceptability and efficacy data of manuka oil based ECMT-154 for the treatment of eczema. If efficacy is demonstrated, this topical may provide an option for a novel emollient treatment. The community-based design of the trial is anticipated to provide a generalisable result. ETHICS AND DISSEMINATION: Ethics approval was obtained from Central Health and Disability Ethics Committee (reference: 2021 EXP 11490). Findings of the study will be disseminated to study participants, published in peer-reviewed journal and presented at scientific conferences. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12621001096842. Registered on August 18, 2021 ( https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=382412&isReview=true ). PROTOCOL VERSION: 2.1 (Dated 18/05/2022).
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Eccema , Farmacias , Humanos , Emolientes/uso terapéutico , Nueva Zelanda , Índice de Severidad de la Enfermedad , Australia , Eccema/tratamiento farmacológico , Ensayos Clínicos Controlados Aleatorios como Asunto , Estudios Multicéntricos como AsuntoRESUMEN
Background: Asthma is the most common chronic childhood respiratory condition globally. Inhaled corticosteroid (ICS)-formoterol reliever-based regimens reduce the risk of asthma exacerbations compared with conventional short-acting ß2-agonist (SABA) reliever-based regimens in adults and adolescents. The current limited evidence for anti-inflammatory reliever therapy in children means it is unknown whether these findings are also applicable to children. High-quality randomised controlled trials (RCTs) are needed. Objective: The study aim is to determine the efficacy and safety of budesonide-formoterol reliever alone or maintenance and reliever therapy (MART) compared with standard therapy: budesonide or budesonide-formoterol maintenance, both with terbutaline reliever, in children aged 5 to 11â years with mild, moderate and severe asthma. Methods: A 52-week, multicentre, open-label, parallel group, phase III, two-sided superiority RCT will recruit 400 children aged 5 to 11â years with asthma. Participants will be randomised 1:1 to either budesonide-formoterol 100/6â µg Turbuhaler reliever alone or MART; or budesonide or budesonide-formoterol Turbuhaler maintenance, with terbutaline Turbuhaler reliever. The primary outcome is moderate and severe asthma exacerbations as rate per participant per year. Secondary outcomes are asthma control, lung function, exhaled nitric oxide and treatment step change. Assessment of Turbuhaler technique and cost-effectiveness analysis are also planned. Conclusion: This will be the first RCT to compare the efficacy and safety of a step-wise budesonide-formoterol reliever alone or MART regimen with conventional inhaled ICS or ICS-long-acting ß-agonist maintenance plus SABA reliever in children. The results will provide a much-needed evidence base for the treatment of asthma in children.
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Purpose: The anatomical distribution of deep endometriosis (DE) is essential in treating patients with symptoms associated with the disease. There is an evidence gap in correlating clinical features and symptoms with disease patterns. The study aimed at determining DE anatomic distribution based on advanced transvaginal ultrasound and describe the relationship with symptoms obtained with the World Endometriosis Foundation Questionnaire. Methods: A cross-sectional study included 549 ultrasound results and 370 questionnaire responses between July 2018 and January 2021. Descriptive statistics are presented. Continuous variables were compared by a simple t-test and ANOVA and categorical variables by the chi-squared test. Logistic regression and R2 values summarised the relationship between positive ultrasound and possible predictor variables (software SAS version 9.4). Results: The anatomical locations with signs of endometriosis on ultrasound were the right uterosacral ligament (USL) 23.3% (n = 128), left USL 21.3% (n = 117) and bowel 19.1% (n = 105). Endometriomas in the right and left ovaries (14%, n = 77, and 14.7%, n = 81 respectively), superficial endometriosis in 15.5% (n = 85), torus uterinus in 11.7% (n = 64), Pouch of Douglas (POD) in 9.7% (n = 53), rectovaginal septum in 4.2% (n = 23), vaginal fornix in 3.5% (n = 19). A negative 'sliding-sign' was noted in 25.3% (n = 139), and ovarian medial immobility was noted frequently (left 20.2%, n = 111 and right 16.9%, n = 93). Dyspareunia, dysmenorrhoea, infertility and family history were associated with endometriosis lesions (P < 0.05). Prediction models based on symptomatology presented low discriminatory power. Discussion: This large real-life cohort associating the description of the anatomical distribution of endometriosis as seen on advanced TVS in symptomatic patients confirmed that uterosacral ligaments, torus uterinus, ovaries and bowel represent the most common anatomical sites of endometriosis. Also, the dynamic abnormalities elicited via ultrasound, such as the uterus 'sliding-sign' and ovarian mobility, remain common. The knowledge of the general locations of identifiable endometriosis on ultrasound and the dynamic abnormalities is essential to sonologists and sonographers in implementing advanced TVS protocols to detect endometriosis. In addition, the different presentations of dyspareunia can be associated with USL and bowel endometriosis. Subfertility might also be associated with USL, ovarian and bowel endometriosis. Nevertheless, prediction models showed suboptimal results. Conclusions: Endometriosis is mainly distributed in USLs, bowel and ovaries. POD obliteration is frequent. Symptoms can be associated with anatomic locations; however, prediction models showed low clinical applicability.
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BACKGROUND: In June 2020, the New Zealand (NZ) adolescent and adult asthma guidelines recommended budesonide/formoterol, taken as maintenance and/or reliever therapy, as the preferred therapeutic approach. OBJECTIVE: To investigate whether these recommendations were associated with changes in clinical practice indicated by asthma medication use trends. METHODS: NZ national dispensing data for inhaler medications from January 2010 to December 2021 were reviewed. Monthly "dispensings" of inhaled budesonide/formoterol, inhaled corticosteroid (ICS), other ICS/long-acting ß2-agonists (LABA), and inhaled short-acting ß2-agonists (SABA), for the 12+ age group, were displayed graphically with piecewise regression used to produce plots of rates by time with a July 1, 2020, break point. The number of dispensings in the last 6 months that data were available (July-December 2021) was compared with the corresponding period, July-December 2019. RESULTS: Budesonide/formoterol dispensing increased markedly after July 1, 2020 (regression coefficient 41.1 inhalers dispensed/100,000 population per month [95% confidence interval (CI): 36.3-45.6, P < .0001]; 64.7% increase in the number of dispensings between July-December 2019 and July-December 2021), in contrast to "other ICS/LABA" (regression coefficient: -15.9 [95% CI: -22.2 to -9.6, P < .0001]; -1.7% decrease) and SABA (regression coefficient: -14.7 [95% CI: -29.7 to 0.3, P = .055]; -10.6% decrease), respectively. CONCLUSION: In NZ, a progressive increase in budesonide/formoterol dispensing, accompanied by a reduction in SABA and "other ICS/LABA" dispensing, occurred after publication of the 2020 NZ asthma guidelines. While acknowledging the limitations in the interpretation of temporal associations, these findings suggest that the transition to ICS/formoterol reliever-based therapy can be achieved if recommended and promoted as the preferred therapeutic approach in national guidelines.
Asunto(s)
Antiasmáticos , Asma , Adulto , Adolescente , Humanos , Nueva Zelanda/epidemiología , Asma/tratamiento farmacológico , Asma/epidemiología , Fumarato de Formoterol/uso terapéutico , Combinación Budesonida y Fumarato de Formoterol/uso terapéutico , Corticoesteroides/uso terapéutico , Budesonida/uso terapéutico , Administración por Inhalación , Etanolaminas/uso terapéutico , Antiasmáticos/uso terapéutico , Combinación de MedicamentosRESUMEN
AIM: To explore the prevalence of ongoing symptoms and laboratory abnormalities in confirmed cases of COVID-19 from the first wave within the Greater Wellington Region, after at least 12 months post infection. METHOD: COVID-19 cases were obtained from EpiSurv. Eligible participants electronically completed questionnaires (Overall Health Survey, Patient Health Questionnaire-9 [PHQ-9], Generalised Anxiety Disorder-7 [GAD-7], Pittsburgh Sleep Quality Index, EuroQol 5 Dimension 5 Level [EQ-5D-5L], Fatigue Severity Scale [FSS], WHO Symptom Questionnaire, Modified Medical Research Council Dyspnoea Scale [mMRC Dyspnoea Scale]). Blood samples were analysed for cardiac, endocrine, haematological, liver, antibody, and inflammatory markers. RESULTS: Forty-two of 88 eligible cases undertook the study. Participants were enrolled at a median 628.5 days from symptom onset. Fifty-two point four percent felt that their current overall health was worse than it was prior to contracting COVID-19. Ninety percent of participants reported at least two ongoing symptoms since their acute illness. Between 45-72% of participants reported each of anxiety, depression, dyspnoea, pain/discomfort, and sleep difficulties, assessed using the GAD-7, PHQ-9, mMRC Dyspnoea Scale, EQ-5D-5L and FSS questionnaires respectively. There were minimal laboratory abnormalities. CONCLUSION: There is a high prevalence of ongoing symptoms following the first wave of COVID-19 infection in Aotearoa New Zealand. At a median of 1.7 years post infection, there is a wide spectrum of symptoms and symptom severity, although as an observational, cross-sectional study a causal relationship between symptoms or their severity and COVID-19 infection cannot be firmly established.