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1.
Eur Respir J ; 2024 Apr 12.
Artículo en Inglés | MEDLINE | ID: mdl-38609096

RESUMEN

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 therapy to inhaled corticosteroid-formoterol dry powder inhaler (DPI) reliever therapy, as recommended by the Global Initiative for Asthma (GINA). 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 26.2 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 17.3 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.

2.
Cephalalgia ; 44(3): 3331024231209326, 2024 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-38529897

RESUMEN

PURPOSE: Visual snow syndrome comprises a whole-field static-like visual disturbance, with increased awareness of entopic phenomena, an inability to suppress the 'just seen' and photophobia. Visual snow syndrome is often associated with other problems such as headache, tinnitus, and anxiety. The earliest reported case of a patient experiencing symptoms consistent with visual snow syndrome dates only to 1995. This paper seeks to find patterns of experience in the medical literature of the past that are reminiscent of visual snow syndrome, to challenge the view that it is in any sense a novel disorder. Descriptions of subjective visual sensations such as experienced by patients suffering from visual snow syndrome were sought in treatises, textbooks and other literature generated by leading figures in 19th-century ophthalmology, physiology and physics. CONCLUSION: While retrospective diagnosis of modern illness categories in historical medical literature is an enterprise fraught with pitfalls, it is nonetheless possible to see patterns of experience in the 19th-century medical literature that are strongly reminiscent of visual snow syndrome.


Asunto(s)
Trastornos de la Percepción , Trastornos de la Visión , Humanos , Estudios Retrospectivos , Trastornos de la Visión/complicaciones , Trastornos de la Percepción/complicaciones , Fotofobia , Cefalea/complicaciones
3.
Asia Pac J Clin Nutr ; 33(2): 200-212, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38794980

RESUMEN

BACKGROUND AND OBJECTIVES: Very-low calorie diets (VLCD) achieve weight loss and remission of Type 2 diabetes (T2DM), but efficacy and acceptability in non-European populations is less clear. This feasibility study examines the impact of 10% weight loss through VLCD on metabolic and body composition outcomes in a multi-ethnic cohort of Aotearoa New Zealand (AoNZ) men with prediabetes/early T2DM, and VLCD tolerability/cultural acceptability. METHODS AND STUDY DESIGN: Participants followed a VLCD intervention (mean energy 3033kJ/day) until achievement of 10% weight loss. An oral glucose tolerance test (OGTT), hyperinsulinaemic isoglycaemic clamp with stable isotopes, hood calorimetry and dual-energy Xray absorptiometry (DXA) were undertaken before and after intervention. Qualitative data on VLCD tolerability/cultural acceptability were collected. RESULTS: Fifteen participants were enrolled; nine achieved 10% weight loss. In this group, mean HbA1c reduced by 4.8mmol/mol (2.4-7.1) and reverted to normoglycaemia in n=5/9; mean body weight reduced by 12.0 kg (11.0-13.1) and whole-body glucose disposal improved by 1.5 mg kgFFM-1 min-1 (0.7-2.2). Blood pressure and fasting triglycerides improved significantly. No changes in hepatic glu-cose metabolism were found. In all participants who attended completion testing, HbA1c reduced by 3.4mmol/mol (SD 3.5) and total weight by 9.0kg (SD 5.7). The intervention was highly tolerable/culturally acceptable however challenges with fulfilment of cultural obligations were described. CONCLUSIONS: Results support VLCD use in AoNZ however further work to investigate ethnic differences in physiological response to VLCDs and to optimise protocols for multi-ethnic populations are required.


Asunto(s)
Restricción Calórica , Diabetes Mellitus Tipo 2 , Estudios de Factibilidad , Estado Prediabético , Humanos , Diabetes Mellitus Tipo 2/dietoterapia , Masculino , Estado Prediabético/dietoterapia , Estado Prediabético/terapia , Nueva Zelanda , Persona de Mediana Edad , Restricción Calórica/métodos , Estudios de Cohortes , Adulto , Anciano , Composición Corporal , Pérdida de Peso , Glucemia
4.
Aust Crit Care ; 37(2): 354-368, 2024 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-37684157

RESUMEN

INTRODUCTION: Impairments after critical illness, termed the post-intensive care syndrome, are an increasing focus of research in Australasia. However, this research is yet to be cohesively synthesised and/or summarised. OBJECTIVE: The aim of this scoping review was to explore patient outcomes of survivorship research, identify measures, methodologies, and designs, and explore the reported findings in Australasia. INCLUSION CRITERIA: Studies reporting outcomes for adult survivors of critical illness from Australia and New Zealand in the following domains: physical, functional, psychosocial, cognitive, health-related quality of life (HRQoL), discharge destination, health care use, return to work, and ongoing symptoms/complications of critical illness. METHODS: The Joanna Briggs Institute scoping review methodology framework was used. A protocol was published on the open science framework, and the search used Ovid MEDLINE, Scopus, ProQuest, and Google databases. Eligible studies were based on reports from Australia and New Zealand published in English between January 2000 and March 2022. RESULTS: There were 68 studies identified with a wide array of study aims, methodology, and designs. The most common study type was nonexperimental cohort studies (n = 17), followed by studies using secondary analyses of other study types (n = 13). HRQoL was the most common domain of recovery reported. Overall, the identified studies reported that impairments and activity restrictions were associated with reduced HRQoL and reduced functional status was prevalent in survivors of critical illness. About 25% of 6-month survivors reported some form of disability. Usually, by 6 to12 months after critical illness, impairments had improved. CONCLUSIONS: Reports of long-term outcomes for survivors of critical illness in Australia highlight that impairments and activity limitations are common and are associated with poor HRQoL. There was little New Zealand-specific research related to prevalence, impact, unmet needs, ongoing symptoms, complications from critical illness, and barriers to recovery.


Asunto(s)
Calidad de Vida , Supervivencia , Adulto , Humanos , Enfermedad Crítica/psicología , Nueva Zelanda , Australia , Unidades de Cuidados Intensivos
5.
N Engl J Med ; 382(5): 405-415, 2020 01 30.
Artículo en Inglés | MEDLINE | ID: mdl-31995686

RESUMEN

BACKGROUND: Whether conservative management is an acceptable alternative to interventional management for uncomplicated, moderate-to-large primary spontaneous pneumothorax is unknown. METHODS: In this open-label, multicenter, noninferiority trial, we recruited patients 14 to 50 years of age with a first-known, unilateral, moderate-to-large primary spontaneous pneumothorax. Patients were randomly assigned to immediate interventional management of the pneumothorax (intervention group) or a conservative observational approach (conservative-management group) and were followed for 12 months. The primary outcome was lung reexpansion within 8 weeks. RESULTS: A total of 316 patients underwent randomization (154 patients to the intervention group and 162 to the conservative-management group). In the conservative-management group, 25 patients (15.4%) underwent interventions to manage the pneumothorax, for reasons prespecified in the protocol, and 137 (84.6%) did not undergo interventions. In a complete-case analysis in which data were not available for 23 patients in the intervention group and 37 in the conservative-management group, reexpansion within 8 weeks occurred in 129 of 131 patients (98.5%) with interventional management and in 118 of 125 (94.4%) with conservative management (risk difference, -4.1 percentage points; 95% confidence interval [CI], -8.6 to 0.5; P = 0.02 for noninferiority); the lower boundary of the 95% confidence interval was within the prespecified noninferiority margin of -9 percentage points. In a sensitivity analysis in which all missing data after 56 days were imputed as treatment failure (with reexpansion in 129 of 138 patients [93.5%] in the intervention group and in 118 of 143 [82.5%] in the conservative-management group), the risk difference of -11.0 percentage points (95% CI, -18.4 to -3.5) was outside the prespecified noninferiority margin. Conservative management resulted in a lower risk of serious adverse events or pneumothorax recurrence than interventional management. CONCLUSIONS: Although the primary outcome was not statistically robust to conservative assumptions about missing data, the trial provides modest evidence that conservative management of primary spontaneous pneumothorax was noninferior to interventional management, with a lower risk of serious adverse events. (Funded by the Emergency Medicine Foundation and others; PSP Australian New Zealand Clinical Trials Registry number, ACTRN12611000184976.).


Asunto(s)
Tratamiento Conservador , Drenaje , Neumotórax/terapia , Adolescente , Adulto , Tubos Torácicos , Drenaje/métodos , Femenino , Estudios de Seguimiento , Humanos , Tiempo de Internación , Masculino , Persona de Mediana Edad , Readmisión del Paciente/estadística & datos numéricos , Neumotórax/diagnóstico por imagen , Complicaciones Posoperatorias , Radiografía Torácica , Recurrencia , Resultado del Tratamiento , Espera Vigilante , Adulto Joven
6.
Neuropediatrics ; 54(3): 174-181, 2023 06.
Artículo en Inglés | MEDLINE | ID: mdl-36539215

RESUMEN

BACKGROUND: There is a paucity of high-quality evidence of the efficacy and safety of cannabis-based medicinal products in treatment of treatment-resistant epilepsy (TRE) in children. METHODS: A case series of children (<18 years old) with TRE from the UK Medical Cannabis Registry was analyzed. Primary outcomes were ≥50% reduction in seizure frequency, changes in the Impact of Pediatric Epilepsy Score (IPES), and incidence of adverse events. RESULTS: Thirty-five patients were included in the analysis. Patients were prescribed during their treatment with the following: CBD isolate oils (n = 19), CBD broad-spectrum oils (n = 17), and CBD/Δ9-THC combination therapy (n = 17). Twenty-three (65.7%) patients achieved a ≥50% reduction in seizure frequency. 94.1% (n = 16) of patients treated with CBD and Δ9-THC observed a ≥50% reduction in seizure frequency compared to 31.6% (n = 6) and 17.6% (n = 3) of patients treated with CBD isolates and broad-spectrum CBD products, respectively (p< 0.001). Twenty-six (74.3%) adverse events were reported by 16 patients (45.7%). The majority of these were mild (n = 12; 34.2%) and moderate (n = 10; 28.6%). CONCLUSION: The results of this study demonstrate a positive signal of improved seizure frequency in children treated with Cannabis-based medicinal products (CBMPs) for TRE. Moreover, the results suggest that CBMPs are well-tolerated in the short term. The limitations mean causation cannot be determined in this open-label, case series.


Asunto(s)
Cannabis , Epilepsia Refractaria , Epilepsia , Marihuana Medicinal , Niño , Humanos , Adolescente , Marihuana Medicinal/efectos adversos , Dronabinol/uso terapéutico , Epilepsia Refractaria/tratamiento farmacológico , Epilepsia/tratamiento farmacológico , Convulsiones/tratamiento farmacológico , Reino Unido
7.
Postgrad Med J ; 99(1172): 542-545, 2023 Jun 15.
Artículo en Inglés | MEDLINE | ID: mdl-37319153

RESUMEN

Surveys are quick and easy to produce. This paper outlines some of the many problems that should be anticipated.


Asunto(s)
Encuestas y Cuestionarios , Humanos
8.
Postgrad Med J ; 2023 Apr 10.
Artículo en Inglés | MEDLINE | ID: mdl-37035929

RESUMEN

Surveys are quick and easy to produce. This paper outlines some of the many problems that should be anticipated.

9.
N Engl J Med ; 380(21): 2020-2030, 2019 05 23.
Artículo en Inglés | MEDLINE | ID: mdl-31112386

RESUMEN

BACKGROUND: In double-blind, placebo-controlled trials, budesonide-formoterol used on an as-needed basis resulted in a lower risk of severe exacerbation of asthma than as-needed use of a short-acting ß2-agonist (SABA); the risk was similar to that of budesonide maintenance therapy plus as-needed SABA. The availability of data from clinical trials designed to better reflect clinical practice would be beneficial. METHODS: We conducted a 52-week, randomized, open-label, parallel-group, controlled trial involving adults with mild asthma. Patients were randomly assigned to one of three treatment groups: albuterol (100 µg, two inhalations from a pressurized metered-dose inhaler as needed for asthma symptoms) (albuterol group); budesonide (200 µg, one inhalation through a Turbuhaler twice daily) plus as-needed albuterol (budesonide maintenance group); or budesonide-formoterol (200 µg of budesonide and 6 µg of formoterol, one inhalation through a Turbuhaler as needed) (budesonide-formoterol group). Electronic monitoring of inhalers was used to measure medication use. The primary outcome was the annualized rate of asthma exacerbations. RESULTS: The analysis included 668 of 675 patients who underwent randomization. The annualized exacerbation rate in the budesonide-formoterol group was lower than that in the albuterol group (absolute rate, 0.195 vs. 0.400; relative rate, 0.49; 95% confidence interval [CI], 0.33 to 0.72; P<0.001) and did not differ significantly from the rate in the budesonide maintenance group (absolute rate, 0.195 in the budesonide-formoterol group vs. 0.175 in the budesonide maintenance group; relative rate, 1.12; 95% CI, 0.70 to 1.79; P = 0.65). The number of severe exacerbations was lower in the budesonide-formoterol group than in both the albuterol group (9 vs. 23; relative risk, 0.40; 95% CI, 0.18 to 0.86) and the budesonide maintenance group (9 vs. 21; relative risk, 0.44; 95% CI, 0.20 to 0.96). The mean (±SD) dose of inhaled budesonide was 107±109 µg per day in the budesonide-formoterol group and 222±113 µg per day in the budesonide maintenance group. The incidence and type of adverse events reported were consistent with those in previous trials and with reports in clinical use. CONCLUSIONS: In an open-label trial involving adults with mild asthma, budesonide-formoterol used as needed was superior to albuterol used as needed for the prevention of asthma exacerbations. (Funded by AstraZeneca and the Health Research Council of New Zealand; Novel START Australian New Zealand Clinical Trials Registry number, ACTRN12615000999538.).


Asunto(s)
Albuterol/administración & dosificación , Asma/tratamiento farmacológico , Broncodilatadores/administración & dosificación , Budesonida/administración & dosificación , Fumarato de Formoterol/administración & dosificación , Administración por Inhalación , Agonistas de Receptores Adrenérgicos beta 2/administración & dosificación , Agonistas de Receptores Adrenérgicos beta 2/efectos adversos , Adulto , Anciano , Albuterol/efectos adversos , Broncodilatadores/efectos adversos , Budesonida/efectos adversos , Quimioterapia Combinada , Femenino , Fumarato de Formoterol/efectos adversos , Humanos , Masculino , Inhaladores de Dosis Medida , Persona de Mediana Edad
10.
Thorax ; 77(6): 563-572, 2022 06.
Artículo en Inglés | MEDLINE | ID: mdl-34593615

RESUMEN

BACKGROUND: International asthma guidelines recommend against epinephrine (adrenaline) administration in acute asthma unless associated with anaphylaxis or angio-oedema. However, administration of intramuscular epinephrine in addition to nebulised selective ß2-agonist is recommended for acute severe or life-threatening asthma in many prehospital guidelines. We conducted a systematic review to determine the efficacy of epinephrine in comparison to selective ß2-agonist in acute asthma. METHODS: We included peer-reviewed publications of randomised controlled trials (RCTs) that enrolled children or adults in any healthcare setting and compared epinephrine by any route to selective ß2-agonist by any route for an acute asthma exacerbation. The primary outcome was treatment failure, including hospitalisation, need for intubation or death. RESULTS: Thirty-eight of 1140 studies were included. Overall quality of evidence was low. Seventeen studies contributed data on 1299 participants to the meta-analysis. There was significant statistical heterogeneity, I2=56%. The pooled Peto's OR for treatment failure with epinephrine versus selective ß2-agonist was 0.99 (0.75 to 1.32), p=0.95. There was strong evidence that recruitment age group was associated with different estimates of the odds of treatment failure; with studies recruiting adults-only having lower odds of treatment failure with epinephrine. It was not possible to determine whether epinephrine in addition to selective ß2-agonist improved outcomes. CONCLUSION: The low-quality evidence available suggests that epinephrine and selective ß2-agonists have similar efficacy in acute asthma. There is a need for high-quality double-blind RCTs to determine whether addition of intramuscular epinephrine to inhaled or nebulised selective ß2-agonist improves outcome. PROSPERO REGISTRATION NUMBER: CRD42017079472.


Asunto(s)
Antiasmáticos , Asma , Enfermedad Aguda , Administración por Inhalación , Agonistas Adrenérgicos beta/uso terapéutico , Adulto , Asma/tratamiento farmacológico , Broncodilatadores/uso terapéutico , Niño , Epinefrina/uso terapéutico , Humanos , Sulfato de Magnesio/uso terapéutico , Ensayos Clínicos Controlados Aleatorios como Asunto
11.
Thorax ; 2022 Jul 18.
Artículo en Inglés | MEDLINE | ID: mdl-35851045

RESUMEN

OBJECTIVE: To compare bronchodilator response after to salbutamol and budesonide/formoterol in adults with stable asthma. METHODS: A double-blind, cross-over, single-centre, placebo-controlled, non-inferiority trial. Adults with stable asthma were randomised to different orders of two treatment regimens: two actuations of placebo via MDI and one actuation of budesonide/formoterol 200/6 µg via turbuhaler; and one actuation of placebo turbuhaler and two actuations of salbutamol 100 µg via MDI. The primary outcome measure was FEV1 after 2 min. Secondary outcome measures included FEV1, mBorg Dyspnoea Scale score and visual analogue score for breathlessness over 30 min. RESULTS: Forty-nine of 50 potential participants were randomised. One participant withdrew following the first intervention visit and another could not be randomised due to COVID-19 restrictions. The mean (SD) change from baseline FEV1 2 min after treatment administration for budesonide/formoterol and salbutamol was 0.08 (0.14) L, n=49, and 0.17 (0.18) L, n=48, respectively, mean (95% CI) paired difference of -0.097 L (-0.147 to -0.047), p=0.07, against a non-inferiority bound of -0.06 L. In the secondary analysis, FEV1 over 30 min was lower for budesonide/formoterol compared with salbutamol, difference (95% CI): -0.10 (-0.12 to -0.08) L, p<0.001. There were no differences in Visual Analogue Scale score or mBorg Dyspnoea Scale score between treatments. CONCLUSION: The results do not support the primary hypothesis of non-inferiority at the boundary of -0.06 L for the difference between budesonide/formoterol 200/6 µg compared with salbutamol 200 µg for FEV1 at 2 min, and could be consistent with inferiority with a p value of 0.07. For the secondary analysis of FEV1 measurements over time, the FEV1 was higher with salbutamol. TRIAL REGISTRATION NUMBER: Australian and New Zealand Clinical Trials Registry (ACTRN 12619001387112).

12.
Eur Respir J ; 2022 Feb 03.
Artículo en Inglés | MEDLINE | ID: mdl-35115339

RESUMEN

OBJECTIVE: To determine the comparative bronchodilator, systemic beta2-agonist, cardiovascular and adverse effects of salbutamol 200 µg and budesonide/formoterol 200/6 µg when taken repeatedly in stable asthma. METHODS: This open-label, cross-over, single-centre, controlled trial, randomised adults with asthma to different orders of two treatment regimens: salbutamol 200 µg via MDI at t=0, 30, 60, 90 min, then salbutamol 2.5 mg via nebuliser at t=120, 140, 160 and 420 min; or budesonide/formoterol 200/6 µg one actuation via Turbuhaler at t=0, 30, 60, 90 min, two actuations at t=120, 140, 160 and 420 min. The primary outcome measure was FEV1 after 180 min. Secondary outcomes included repeat measures of FEV1, serum potassium, heart rate, and adverse events RESULTS: Of 39 patients randomised, two withdrew due to adverse events (QTCF prolongation and T wave abnormalities) after the first intervention with salbutamol. The mean (sd) change from baseline FEV1 180 min after randomisation for salbutamol and budesonide/formoterol regimens was 0.71 (0.46) L, N=38, and 0.58 (0.45) L, N=37, respectively; with a mean (sd) paired difference of -0.10 (0.40) L, N=37, and a model-based estimated difference (95% CI) -0.12 (-0.25 to 0.02) L, p=0.088. In the main secondary analysis, salbutamol resulted in significantly greater FEV1 from 30 to 240 min, but lesser FEV1 at 360 and 420 min. Salbutamol resulted in a significantly lower serum potassium, and a higher heart rate and number of adverse events. CONCLUSION: The comparative bronchodilator responses of repeated administration of salbutamol 200 µg dose-1 and budesonide/formoterol 200/6 µg differed depending on the time of measurement. Salbutamol caused greater systemic beta2-agonist and cardiovascular effects and more adverse events.

13.
Diabetes Obes Metab ; 24(12): 2431-2442, 2022 12.
Artículo en Inglés | MEDLINE | ID: mdl-36064937

RESUMEN

AIM: Very low carbohydrate/ketogenic diets (VLC/KDs) are popular but their role in managing pre-diabetes and type 2 diabetes (T2D) is uncertain. This study uses a systematic review and meta-analysis of randomized controlled trials to estimate the effect of these diets in this population. MATERIALS AND METHODS: A systematic review identified randomized controlled trials of at least 6 months duration comparing efficacy and safety of VLC/KDs (≤50 g carbohydrate or ≤10% total energy from carbohydrate per day) with a control diet (carbohydrate above the VLC/KD threshold) in adults with pre-diabetes or T2D. The primary outcome variable was glycated haemoglobin (HbA1c) after 12 months. The meta-analysis method was inverse variance weighting of mean values for continuous variables. RESULTS: Key word searches identified 2290 studies; 2221 were not in scope. A full text review of 69 studies identified eight meeting inclusion criteria; in total, it involved 606 participants. Six studies reported HbA1c (%) at 12 months; four as change from baseline with a fixed effects estimate (95% confidence interval): VLC/KD minus control of 0.01% (-0.22 to 0.25), p = .91; and two as change from baseline: -0.65% (-0.99; -0.31) [-7.1 mmol/mol (-10.8; -3.4)], p < .001. Serum triglycerides were lower with VLC/KD versus control: -0.28 mmol/L (-0.44 to -0.11), p < .001. High-density lipoprotein was higher with an estimate of 0.04 mmol/L (0.01 to 0.08), p = .03, in the five studies reporting 12-month summary data. CONCLUSIONS: A VLC/KD may cause reductions in HbA1c and triglycerides in those with pre-diabetes or T2D but evidence of an advantage over other strategies is limited. More well-designed studies are required to provide certain evidence.


Asunto(s)
Diabetes Mellitus Tipo 2 , Dieta Cetogénica , Estado Prediabético , Adulto , Humanos , Hemoglobina Glucada/análisis , Dieta Cetogénica/métodos , Ensayos Clínicos Controlados Aleatorios como Asunto , Dieta Baja en Carbohidratos/métodos , Triglicéridos
14.
Headache ; 62(5): 624-633, 2022 05.
Artículo en Inglés | MEDLINE | ID: mdl-35593783

RESUMEN

OBJECTIVE: To assess the long-term efficacy and safety of erenumab in the subgroup of patients with chronic migraine (CM) in whom prior preventive treatments had failed (TF) (≥1, ≥2, and ≥3 TF medication categories) and never failed (preventive naïve or prior preventive treatments had not failed), using the data from a 52-week, open-label treatment period (OLTP) of the parent study. BACKGROUND: Erenumab is a fully human monoclonal antibody that selectively binds to and inhibits the canonical calcitonin gene-related peptide receptor. There are limited long-term data evaluating the efficacy and safety of erenumab in patients with CM in whom prior preventive treatments had failed. METHODS: Patients who had completed the 12-week double-blind treatment period (DBTP) in the parent study were eligible to participate in the 52-week OLTP, during which they received erenumab every 4 weeks. The TF subgroups (≥1, ≥2, and ≥3 TF medication categories) were not mutually exclusive; patients in whom prior preventive treatments from ≥3 medication categories had failed were also counted in the ≥2 and ≥1 medication categories. Endpoints included monthly migraine days (MMD), monthly acute migraine-specific medication days (MSMD), achievement of ≥50%, ≥75%, and 100% reduction from baseline in MMD, and exposure-adjusted patient incidence rates of adverse events (AEs; per 100 patient-years). RESULTS: Erenumab treatment provided sustained mean reductions in MMD and MSMD relative to the parent study baseline throughout the 52 weeks of the OLTP across all TF subgroups. At Week 52, the mean MMD change was -8.6 (SD 6.6) (baseline: 18.4 [SD 4.5] days) in the ≥1 TF subgroup. A post hoc completer analysis (52 weeks [OLTP] erenumab) showed that compared with erenumab 70 mg, the 140 mg dose was associated with numerically greater reductions in the mean MMD (Week 40: -8.6 and -7.2 days; Week 52: -9.7 and -7.9 days [≥1 TF subgroup]) and a higher proportion of patients achieved ≥50%, ≥75%, and 100% response thresholds across all subgroups at Weeks 40 and 52. Overall the exposure-adjusted patient incidence rates of AEs did not increase during the OLTP versus the DBTP (≥1 TF subgroup: 141.9/100 versus 317.9/100 patient-years), and no new safety signals occurred. CONCLUSION: The long-term treatment with erenumab was well tolerated and showed sustained efficacy in patients with CM in whom prior preventive treatments had failed, with numerically greater treatment effects for 140 mg versus 70 mg.


Asunto(s)
Anticuerpos Monoclonales Humanizados , Trastornos Migrañosos , Anticuerpos Monoclonales Humanizados/efectos adversos , Antagonistas del Receptor Peptídico Relacionado con el Gen de la Calcitonina/efectos adversos , Método Doble Ciego , Humanos , Trastornos Migrañosos/tratamiento farmacológico , Trastornos Migrañosos/prevención & control , Resultado del Tratamiento
15.
Clin Rehabil ; 36(2): 240-250, 2022 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-34414801

RESUMEN

OBJECTIVE: To undertake an economic analysis of the Take Charge intervention as part of the Taking Charge after Stroke (TaCAS) study. DESIGN: An open, parallel-group, randomised trial comparing active and control interventions with blinded outcome assessment. SETTING: Community. PARTICIPANTS: Adults (n = 400) discharged to community, non-institutional living following acute stroke. INTERVENTIONS: The Take Charge intervention, a strengths based, self-directed rehabilitation intervention, in two doses (one or two sessions), and a control intervention (no Take Charge sessions). MEASURES: The cost per quality-adjusted life year (QALY) saved for the period between randomisation (always post hospital discharge) and 12 months following acute stroke. QALYs were calculated from the EuroQol-5D-5L. Costs of stroke-related and non-health care were obtained by questionnaire, hospital records and the New Zealand Ministry of Health. RESULTS: One-year post hospital discharge cost of care was mean (95% CI) $US4706 (3758-6014) for the Take Charge intervention group and $6118 (4350-8005) for control, mean (95% CI) difference $ -1412 (-3553 to +729). Health utility scores were mean (95% CI) 0.75 (0.73-0.77) for Take Charge and 0.71 (0.67-0.75) for control, mean (95% CI) difference 0.04 (0.0-0.08). Cost per QALY gained for the Take Charge intervention was $US -35,296 (=£ -25,524, € -30,019). Sensitivity analyses confirm Take Charge is cost-effective, even at a very low willingness-to-pay threshold. With a threshold of $US5000 per QALY, the probability that Take Charge is cost-effective is 99%. CONCLUSION: Take Charge is cost-effective and probably cost saving.


Asunto(s)
Calidad de Vida , Accidente Cerebrovascular , Adulto , Análisis Costo-Beneficio , Humanos , Años de Vida Ajustados por Calidad de Vida , Encuestas y Cuestionarios
16.
Postgrad Med J ; 98(1164): 793-798, 2022 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-34039698

RESUMEN

The essential principles of statistics as applied to surveys, studies, sampling, epidemiology, screening, and trials are described and explained.


Asunto(s)
Estadística como Asunto , Ensayos Clínicos como Asunto , Epidemiología , Humanos , Tamizaje Masivo
17.
Postgrad Med J ; 98(1160): 461-465, 2022 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-33589491

RESUMEN

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.


Asunto(s)
Saturación de Oxígeno , Oxígeno , Documentación , Hospitalización , Humanos , Pacientes Internos , Oximetría
18.
Am J Respir Crit Care Med ; 201(12): 1480-1487, 2020 06 15.
Artículo en Inglés | MEDLINE | ID: mdl-31905013

RESUMEN

The stepwise approach to pharmacological treatment in adult asthma mandates that asthma treatment is progressively stepped up to achieve symptom control and reduce the risk of exacerbations and stepped down after a period of prolonged control. This review proposes that in adults without good asthma control, well-controlled asthma can only be achieved in approximately 70% of patients across the strata of severity, and only if there is a progressive increase in inhaled corticosteroid/long-acting ß2 agonist therapy to a maintenance inhaled corticosteroid dose that causes the same magnitude of systemic side effects as oral prednisone at a 5-mg daily dose. Another consideration is that in a person with asthma, there are numerous overlapping disorders that can present with symptoms indistinguishable from asthma, comorbidities that contribute to poor control and lifestyle/environmental factors that require treatment in their own right and that if specifically managed might lead to better outcomes. The disparity between patients' perceptions and guideline assessment of control may be due to partially controlled asthma being associated with near-maximal levels of quality of life, with minimal impairment. Finally, it is widely assumed that asthma symptom control equates to elimination of risk of asthma attacks, an assumption that may not apply to many patients, particularly those with more severe asthma. We propose that further research be undertaken to determine the optimal levels of asthma control and the potential value of different treatment targets, such as control of type-2 airway inflammation, that can be achieved with currently available treatment, based on efficacy, side effects, and cost.


Asunto(s)
Corticoesteroides/uso terapéutico , Agonistas de Receptores Adrenérgicos beta 2/uso terapéutico , Antiasmáticos/uso terapéutico , Asma/tratamiento farmacológico , Guías de Práctica Clínica como Asunto , Administración por Inhalación , Administración Oral , Asma/fisiopatología , Humanos , Calidad de Vida , Índice de Severidad de la Enfermedad
19.
BMC Pulm Med ; 21(1): 332, 2021 Oct 26.
Artículo en Inglés | MEDLINE | ID: mdl-34702236

RESUMEN

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.


Asunto(s)
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 , Tiempo
20.
Clin Rehabil ; 35(7): 1021-1031, 2021 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-33586474

RESUMEN

OBJECTIVE: To use secondary data from the Taking Charge after Stroke study to explore mechanisms for the positive effect of the Take Charge intervention on physical health, advanced activities of daily living and independence for people after acute stroke. DESIGN: An open, parallel-group, randomised trial with two active and one control intervention and blinded outcome assessment. SETTING: Community. PARTICIPANTS: Adults (n = 400) discharged to community, non-institutional living following acute stroke. INTERVENTIONS: One, two, or zero sessions of the Take Charge intervention, a self-directed rehabilitation intervention which helps a person with stroke take charge of their own recovery. MEASURES: Twelve months after stroke: Mood (Patient Health Questionnaire-2, Mental Component Summary of the Short Form 36); 'ability to Take Charge' using a novel measure, the Autonomy-Mastery-Purpose-Connectedness (AMP-C) score; activation (Patient Activation Measure); body mass index (BMI), blood pressure (BP) and medication adherence (Medication Adherence Questionnaire). RESULTS: Follow-up was near-complete (388/390 (99.5%)) of survivors at 12 months. Mean age (SD) was 72.0 (12.5) years. There were no significant differences in mood, activation, 'ability to Take Charge', medication adherence, BMI or BP by randomised group at 12 months. There was a significant positive association between baseline AMP-C scores and 12-month outcome for control participants (1.73 (95%CI 0.90 to 2.56)) but not for the Take Charge groups combined (0.34 (95%CI -0.17 to 0.85)). CONCLUSION: The mechanism by which Take Charge is effective remains uncertain. However, our findings support a hypothesis that baseline variability in motivation, mastery and connectedness may be modified by the Take Charge intervention.


Asunto(s)
Afecto , Motivación , Rehabilitación de Accidente Cerebrovascular , Accidente Cerebrovascular/psicología , Actividades Cotidianas , Anciano , Presión Sanguínea , Índice de Masa Corporal , Femenino , Humanos , Masculino , Cumplimiento de la Medicación , Calidad de Vida
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