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1.
J Med Internet Res ; 26: e52143, 2024 Sep 09.
Article in English | MEDLINE | ID: mdl-39250789

ABSTRACT

BACKGROUND: Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) are associated with high mortality, morbidity, and poor quality of life and constitute a substantial burden to patients and health care systems. New approaches to prevent or reduce the severity of AECOPD are urgently needed. Internationally, this has prompted increased interest in the potential of remote patient monitoring (RPM) and digital medicine. RPM refers to the direct transmission of patient-reported outcomes, physiological, and functional data, including heart rate, weight, blood pressure, oxygen saturation, physical activity, and lung function (spirometry), directly to health care professionals through automation, web-based data entry, or phone-based data entry. Machine learning has the potential to enhance RPM in chronic obstructive pulmonary disease by increasing the accuracy and precision of AECOPD prediction systems. OBJECTIVE: This study aimed to conduct a dual systematic review. The first review focuses on randomized controlled trials where RPM was used as an intervention to treat or improve AECOPD. The second review examines studies that combined machine learning with RPM to predict AECOPD. We review the evidence and concepts behind RPM and machine learning and discuss the strengths, limitations, and clinical use of available systems. We have generated a list of recommendations needed to deliver patient and health care system benefits. METHODS: A comprehensive search strategy, encompassing the Scopus and Web of Science databases, was used to identify relevant studies. A total of 2 independent reviewers (HMGG and CM) conducted study selection, data extraction, and quality assessment, with discrepancies resolved through consensus. Data synthesis involved evidence assessment using a Critical Appraisal Skills Programme checklist and a narrative synthesis. Reporting followed PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. RESULTS: These narrative syntheses suggest that 57% (16/28) of the randomized controlled trials for RPM interventions fail to achieve the required level of evidence for better outcomes in AECOPD. However, the integration of machine learning into RPM demonstrates promise for increasing the predictive accuracy of AECOPD and, therefore, early intervention. CONCLUSIONS: This review suggests a transition toward the integration of machine learning into RPM for predicting AECOPD. We discuss particular RPM indices that have the potential to improve AECOPD prediction and highlight research gaps concerning patient factors and the maintained adoption of RPM. Furthermore, we emphasize the importance of a more comprehensive examination of patient and health care burdens associated with RPM, along with the development of practical solutions.


Subject(s)
Machine Learning , Pulmonary Disease, Chronic Obstructive , Humans , Monitoring, Physiologic/methods , Pulmonary Disease, Chronic Obstructive/diagnosis , Pulmonary Disease, Chronic Obstructive/physiopathology , Quality of Life , Telemedicine
2.
Heliyon ; 10(15): e35047, 2024 Aug 15.
Article in English | MEDLINE | ID: mdl-39165969

ABSTRACT

This study harnessed bivariate correlational analysis, multiple linear regression analysis and tree-based regression analysis to examine the relationship between laser process parameters and the final material properties (bulk density, saturation magnetization (M s ), and coercivity (H c )) of Fe-based nano-crystalline alloys fabricated via laser powder bed fusion (LPBF). A dataset comprising of 162 experimental data points served as the foundation for the investigation. Each data point encompassed five independent variables: laser power (P), laser scan speed (v), hatch spacing (h), layer thickness (t), and energy density (E), along with three dependent variables: bulk density, M s , and H c . The bivariate correlational analysis unveiled that bulk density exhibited a significant correlation with P, v, h, and E, whereas M s and H c displayed significant correlations exclusively with v and P, respectively. This divergence may stem from the strong influence of microstructure on magnetic properties, which can be impacted not only by the laser process parameters explored in this study but also by other factors such as oxygen levels within the build chamber. Furthermore, our statistical analysis revealed that bulk density increased with rising P, h, and E, while decreased with higher v. Regarding the magnetic properties, a high M s was achievable through low v, while low H c resulted from high P. It was concluded that P and v were considered as the primary laser process parameters, influencing h and t due to their control over the melt-pool size. The application of multiple linear regression analysis allowed the prediction of the bulk density by using both laser process parameters and energy density. This approach offered a valuable alternative to time-consuming and costly trial-and-error experiments, yielding a low error of less than 1 % between the mean predicted and experimental values. Although a slightly higher error of approximately 6 % was observed for M s , a clear association was established between M s and v, with lower v values corresponding to higher M s values. Additionally, a further comparison was conducted between multiple linear regression and three tree-based regression models to explore the effectiveness of these approaches.

3.
BMC Endocr Disord ; 24(1): 134, 2024 Aug 01.
Article in English | MEDLINE | ID: mdl-39090697

ABSTRACT

BACKGROUND: Use of Continuous Subcutaneous Insulin Infusion (CSII) has been shown to improve glycemic outcomes in Type 1 Diabetes (T1D), but high costs limit accessibility. To address this issue, an inter-operable, open-source Ultra-Low-Cost Insulin Pump (ULCIP) was developed and previously shown to demonstrate comparable delivery accuracy to commercial models in standardised laboratory tests. This study aims to evaluate the updated ULCIP in-vivo, assessing its viability as an affordable alternative for those who cannot afford commercially available devices. METHODS: This first-in-human feasibility study recruited six participants with T1D. During a nine-hour inpatient stay, participants used the ULCIP under clinical supervision. Venous glucose, insulin, and ß-Hydroxybutyrate were monitored to assess device performance. RESULTS: Participants displayed expected blood glucose and blood insulin levels in response to programmed basal and bolus insulin dosing. One participant developed mild ketosis, which was treated and did not recur when a new pump reservoir was placed. All other participants maintained ß-Hydroxybutyrate < 0.6 mmol/L throughout. CONCLUSION: The ULCIP safely delivered insulin therapy to users in a supervised inpatient environment. Future work should focus on correcting a pump hardware issue identified in this trial and extending device capabilities for use in closed loop control. Longer-term outpatient studies are warranted. TRIAL REGISTRATION: The trial was prospectively registered with the Australian New Zealand Clinical Trials Registry (ACTRN12623001288617) on the 11 December 2023.


Subject(s)
Blood Glucose , Diabetes Mellitus, Type 1 , Feasibility Studies , Hypoglycemic Agents , Insulin Infusion Systems , Insulin , Humans , Insulin Infusion Systems/economics , Diabetes Mellitus, Type 1/drug therapy , Diabetes Mellitus, Type 1/blood , Diabetes Mellitus, Type 1/economics , Male , Female , Insulin/administration & dosage , Insulin/economics , Adult , Blood Glucose/analysis , Hypoglycemic Agents/administration & dosage , Hypoglycemic Agents/economics , Middle Aged
4.
Hum Vaccin Immunother ; 20(1): 2377904, 2024 Dec 31.
Article in English | MEDLINE | ID: mdl-39016172

ABSTRACT

A panel of 24 international experts met in July 2022 to discuss challenges associated with pertussis detection, monitoring, and vaccination in adults; conclusions from this meeting are presented. There has been a shift in the epidemiology of pertussis toward older children and adults. This shift has been attributed to the waning of infection- or vaccine-induced immunity, newer detection techniques causing detection bias, and possibly the replacement of whole-cell pertussis with acellular vaccines in high-income countries, which may lead to immunity waning more quickly. The burden of adult pertussis is still likely under-ascertained due to widespread under-recognition by healthcare professionals (HCPs), under-diagnosis, and under-reporting in this age group. Non-standardized testing guidance and varied case definitions have contributed to under-reporting. Key barriers to HCP engagement with the tetanus, diphtheria, and pertussis (Tdap) vaccine include low awareness, lack of time/funding, and lack of motivation due to low prioritization of Tdap.


Subject(s)
Vaccination , Whooping Cough , Humans , Whooping Cough/prevention & control , Whooping Cough/epidemiology , Whooping Cough/diagnosis , Adult , Diphtheria-Tetanus-acellular Pertussis Vaccines/immunology , Diphtheria-Tetanus-acellular Pertussis Vaccines/administration & dosage , Pertussis Vaccine/immunology , Pertussis Vaccine/administration & dosage , Public Health Administration/methods , Public Health
5.
BMC Pulm Med ; 24(1): 331, 2024 Jul 10.
Article in English | MEDLINE | ID: mdl-38982423

ABSTRACT

BACKGROUND: Coronavirus disease 2019 (COVID-19) is a viral pneumonia that can result in serious respiratory illness. It is associated with extensive systemic inflammation, changes to the lung extracellular matrix, and long-term lung impairment such as interstitial lung disease (ILD). In this study, the aim was to investigate whether tissue remodelling, wound healing, and neutrophil activity is altered in patients with COVID-19 and how these relate to the development of post-COVID ILD. METHOD: Serum samples were collected from 63 patients three months after discharge as part of the Research Evaluation Alongside Clinical Treatment study in COVID-19 (REACT COVID-19), 10 of whom developed ILD, and 16 healthy controls. Samples were quantified using neo-epitope specific biomarkers reflecting tissue stiffness and formation (PC3X, PRO-C3, and PRO-C6), tissue degradation (C1M, C3M, and C6M), wound healing (PRO-FIB and X-FIB), and neutrophil activity (CPa9-HNE and ELP-3). RESULTS: Mean serum levels of PC3X (p < 0.0001), PRO-C3 (p = 0.002), C3M (p = 0.009), PRO-FIB (p < 0.0001), CPa9-HNE (p < 0.0001), and ELP-3 (p < 0.0001) were significantly elevated in patients with COVID-19 compared to healthy controls. Moreover, PC3X (p = 0.023) and PRO-C3 (p = 0.032) were significantly elevated in post-COVID ILD as compared to COVID-19. CONCLUSION: Serological biomarkers reflecting type III collagen remodelling, clot formation, and neutrophil activity were significantly elevated in COVID-19 and type III collagen formation markers were further elevated in post-COVID ILD. The findings suggest an increased type III collagen remodelling in COVID-19 and warrants further investigations to assess the potential of tissue remodelling biomarkers as a tool to identify COVID-19 patients at high risk of developing ILD.


Subject(s)
Biomarkers , COVID-19 , Lung Diseases, Interstitial , SARS-CoV-2 , Humans , COVID-19/complications , COVID-19/blood , Male , Biomarkers/blood , Female , Lung Diseases, Interstitial/blood , Lung Diseases, Interstitial/physiopathology , Middle Aged , Aged , Wound Healing , Case-Control Studies , Neutrophils , Adult
6.
J Infect Dis ; 2024 Jun 05.
Article in English | MEDLINE | ID: mdl-38836471

ABSTRACT

BACKGROUND: We determined the relationships between cytokine expression in sputum and clinical data to characterise and understand Chronic Obstructive Pulmonary Disease (COPD) exacerbations in COPD patients. METHODS: We measured 30 cytokines in 936 sputum samples, collected at stable state (ST) and exacerbation (EX) visits from 99 participants in the Acute Exacerbation and Respiratory InfectionS in COPD (AERIS) study (NCT01360398, www.clinicaltrials.gov). We determined their longitudinal expression and examined differential expression based on disease status or exacerbation type. RESULTS: Of the cytokines, 17 were suitable for analysis. As for disease states, in EX sputum samples, IL-17A, TNF-α, IL-1ß, and IL-10 were significantly increased compared to ST sputum samples, but a logistic mixed model could not predict disease state. As for exacerbation types, bacteria-associated exacerbations showed higher expression of IL-17A, TNF-α, IL-1ß, and IL-1α. IL-1α, IL-1ß, and TNF-α were identified as suitable biomarkers for bacteria-associated exacerbation. Bacteria-associated exacerbations also formed a cluster separate from other exacerbation types in principal component analysis. CONCLUSIONS: Measurement of cytokines in sputum from COPD patients could help identify bacteria-associated exacerbations based on increased concentrations of IL-1α, IL-1ß, or TNF-α. This finding may provide a point-of-care assessment to distinguish a bacterial exacerbation of COPD from other exacerbation types.

7.
Int J Sports Med ; 2024 Aug 30.
Article in English | MEDLINE | ID: mdl-38897227

ABSTRACT

Biceps femoris long head (BFLH) aponeurosis size was compared between legs with and without prior hamstring strain injury (HSI) using two approaches: within-group (injured vs. uninjured legs of previous unilateral HSI athletes) and between-group (previously injured legs of HSI athletes vs. legs of No Prior HSI athletes). MRI scans were performed on currently healthy, competitive male athletes with Prior HSI history (n=23;≥1 verified BFLH injury; including a sub-group with unilateral HSI history; most recent HSI 1.6±1.2 years ago) and pair-matched athletes with No Prior HSI history (n=23). Anonymized axial images were manually segmented to quantify BFLH aponeurosis and muscle size. Prior unilateral HSI athletes' BFLH aponeurosis maximum width, aponeurosis area, and aponeurosis:muscle area ratio were 14.0-19.6% smaller in previously injured vs. contralateral uninjured legs (paired t-test, 0.008≤P≤0.044). BFLH aponeurosis maximum width and area were also 9.4-16.5% smaller in previously injured legs (n=28) from Prior HSI athletes vs. legs (n=46) of No Prior HSI athletes (unpaired t-test, 0.001≤P≤0.044). BFLH aponeurosis size was smaller in legs with prior HSI vs. those without prior HSI. These findings suggest BFLH aponeurosis size, especially maximum width, could be a potential cause or consequence of HSI, with prospective evidence needed to support or refute these possibilities.

8.
Heliyon ; 10(10): e31201, 2024 May 30.
Article in English | MEDLINE | ID: mdl-38803869

ABSTRACT

Background: Acute exacerbations of COPD (AECOPD) are episodes of breathlessness, cough and sputum which are associated with the risk of hospitalisation, progressive lung function decline and death. They are often missed or diagnosed late. Accurate timely intervention can improve these poor outcomes. Digital tools can be used to capture symptoms and other clinical data in COPD. This study aims to apply machine learning to the largest available real-world digital dataset to develop AECOPD Prediction tools which could be used to support early intervention and improve clinical outcomes. Objective: To create and validate a machine learning predictive model that forecasts exacerbations of COPD 1-8 days in advance. The model is based on routine patient-entered data from myCOPD self-management app. Method: Adaptations of the AdaBoost algorithm were employed as machine learning approaches. The dataset included 506 patients users between 2017 and 2021. 55,066 app records were available for stable COPD event labels and 1263 records of AECOPD event labels. The data used for training the model included COPD assessment test (CAT) scores, symptom scores, smoking history, and previous exacerbation frequency. All exacerbation records used in the model were confined to the 1-8 days preceding a self-reported exacerbation event. Results: TheEasyEnsemble Classifier resulted in a Sensitivity of 67.0 % and a Specificity of 65 % with a positive predictive value (PPV) of 5.0 % and a negative predictive value (NPV) of 98.9 %. An AdaBoost model with a cost-sensitive decision tree resulted in a a Sensitivity of 35.0 % and a Specificity of 89.0 % with a PPV of 7.08 % and NPV of 98.3 %. Conclusion: This preliminary analysis demonstrates that machine learning approaches to real-world data from a widely deployed digital therapeutic has the potential to predict AECOPD and can be used to confidently exclude the risk of exacerbations of COPD within the next 8 days.

9.
PLoS One ; 19(5): e0304429, 2024.
Article in English | MEDLINE | ID: mdl-38781164

ABSTRACT

[This corrects the article DOI: 10.1371/journal.pone.0057413.].

10.
Hum Vaccin Immunother ; 20(1): 2324547, 2024 Dec 31.
Article in English | MEDLINE | ID: mdl-38564339

ABSTRACT

Pertussis has several notable consequences, causing economic burden, increased strain on healthcare facilities, and reductions in quality of life. Recent years have seen a trend toward an increase in pertussis cases affecting older children and adults. To boost immunity, and protect vulnerable populations, an enduring approach to vaccination has been proposed, but gaps remain in the evidence surrounding adult vaccination that are needed to inform such a policy. Gaps include: the true incidence of pertussis and its complications in adults; regional variations in disease recognition and reporting; and incidence of severe disease, hospitalizations, and deaths in older adults. Better data on the efficacy/effectiveness of pertussis vaccination in adults, duration of protection, and factors leading to poor vaccine uptake are needed. Addressing the critical evidence gaps will help highlight important areas of unmet need and justify the importance of adult pertussis vaccination to healthcare professionals, policymakers, and payers.


Subject(s)
Diphtheria-Tetanus-acellular Pertussis Vaccines , Whooping Cough , Child , Humans , Aged , Adolescent , Whooping Cough/epidemiology , Whooping Cough/prevention & control , Quality of Life , Vaccination , Incidence
11.
BMJ Open ; 14(2): e078171, 2024 Feb 20.
Article in English | MEDLINE | ID: mdl-38382954

ABSTRACT

INTRODUCTION: Multiple automated insulin delivery (AID) systems have become commercially available following randomised controlled trials demonstrating benefits in people with type 1 diabetes (T1D). However, their real-world utility may be undermined by user-associated burdens, including the need to carbohydrate count and deliver manual insulin boluses. There is an important need for a 'fully automated closed loop' (FCL) AID system, without manual mealtime boluses. The (Closed Loop Open SourcE In Type 1 diabetes) trial is a randomised trial comparing an FCL AID system to the same system used as a hybrid closed loop (HCL) in people with T1D, in an outpatient setting over an extended time frame. METHODS AND ANALYSIS: Randomised, open-label, parallel, non-inferiority trial comparing the Android Artificial Pancreas System (AAPS) AID algorithm used as FCL to the same algorithm used as HCL. Seventy-five participants aged 18-70 will be randomised (1:1) to one of two treatment arms for 12 weeks: (a) FCL-participants will be advised not to bolus for meals and (b) HCL-participants will use the AAPS AID algorithm as HCL with announced meals. The primary outcome is the percentage of time in target sensor glucose range (3.9-10.0 mmol/L). Secondary outcomes include other glycaemic metrics, safety, psychosocial factors, platform performance and user dietary factors. Twenty FCL arm participants will participate in a 4-week extension phase comparing glycaemic and dietary outcomes using NovoRapid (insulin aspart) to Fiasp (insulin aspart and niacinamide). ETHICS AND DISSEMINATION: Approvals are by the Alfred Health Ethics Committee (615/22) (Australia) and Health and Disability Ethics Committees (2022 FULL 13832) (New Zealand). Each participant will provide written informed consent. Data protection and confidentiality will be ensured. Study results will be disseminated by publications, conferences and patient advocacy groups. TRIAL REGISTRATION NUMBERS: ACTRN12622001400752 and ACTRN12622001401741.


Subject(s)
Blood Glucose , Diabetes Mellitus, Type 1 , Hypoglycemic Agents , Insulin Infusion Systems , Insulin , Pancreas, Artificial , Humans , Diabetes Mellitus, Type 1/drug therapy , Diabetes Mellitus, Type 1/therapy , Adult , Hypoglycemic Agents/therapeutic use , Hypoglycemic Agents/administration & dosage , Insulin/administration & dosage , Insulin/therapeutic use , Blood Glucose/analysis , Young Adult , Middle Aged , Adolescent , Algorithms , Female , Aged , Male , Blood Glucose Self-Monitoring , Randomized Controlled Trials as Topic , Equivalence Trials as Topic
12.
Am J Respir Crit Care Med ; 209(10): 1208-1218, 2024 05 15.
Article in English | MEDLINE | ID: mdl-38175920

ABSTRACT

Rationale: Chronic obstructive pulmonary disease (COPD) due to tobacco smoking commonly presents when extensive lung damage has occurred. Objectives: We hypothesized that structural change would be detected early in the natural history of COPD and would relate to loss of lung function with time. Methods: We recruited 431 current smokers (median age, 39 yr; 16 pack-years smoked) and recorded symptoms using the COPD Assessment Test (CAT), spirometry, and quantitative thoracic computed tomography (QCT) scans at study entry. These scan results were compared with those from 67 never-smoking control subjects. Three hundred sixty-eight participants were followed every six months with measurement of postbronchodilator spirometry for a median of 32 months. The rate of FEV1 decline, adjusted for current smoking status, age, and sex, was related to the initial QCT appearances and symptoms, measured using the CAT. Measurements and Main Results: There were no material differences in demography or subjective CT appearances between the young smokers and control subjects, but 55.7% of the former had CAT scores greater than 10, and 24.2% reported chronic bronchitis. QCT assessments of disease probability-defined functional small airway disease, ground-glass opacification, bronchovascular prominence, and ratio of small blood vessel volume to total pulmonary vessel volume were increased compared with control subjects and were all associated with a faster FEV1 decline, as was a higher CAT score. Conclusions: Radiological abnormalities on CT are already established in young smokers with normal lung function and are associated with FEV1 loss independently of the impact of symptoms. Structural abnormalities are present early in the natural history of COPD and are markers of disease progression. Clinical trial registered with www.clinicaltrials.gov (NCT03480347).


Subject(s)
Lung , Pulmonary Disease, Chronic Obstructive , Spirometry , Tomography, X-Ray Computed , Adult , Female , Humans , Male , Middle Aged , Young Adult , Disease Progression , Forced Expiratory Volume/physiology , Lung/physiopathology , Lung/diagnostic imaging , Pulmonary Disease, Chronic Obstructive/physiopathology , Pulmonary Disease, Chronic Obstructive/diagnostic imaging , Smokers/statistics & numerical data , Smoking/adverse effects , Smoking/physiopathology , Case-Control Studies
13.
Intern Med J ; 54(2): 307-311, 2024 Feb.
Article in English | MEDLINE | ID: mdl-37605836

ABSTRACT

BACKGROUND AND AIMS: Serum prolactin levels may be elevated by venepuncture stress. We investigated the utility of a rested prolactin sample, obtained through an indwelling venous cannula, in preventing the overdiagnosis of hyperprolactinaemia. METHODS: Patients at our institution undergo serial prolactin sampling, usually over 40 min, when investigating hyperprolactinaemia. We retrospectively reviewed all serial prolactin sampling performed during a 3-year period. Patients with possible medication-induced hyperprolactinaemia and macroprolactin interference were excluded. We assessed the effect of venepuncture-associated stress on hyperprolactinaemia with the main outcome being normalisation of serum prolactin at the end of serial sampling. RESULTS: Ninety-three patients with documented hyperprolactinaemia (range 360-1690 mU/L) were included in the analysis. Prolactin decreased during serial sampling in 73 patients (78%), suggesting a prevalent effect of venepuncture stress. The final prolactin sample was normal in 50 patients (54%), consistent with stress hyperprolactinaemia rather than pathological hyperprolactinaemia. Patients with a referral prolactin result greater than two times the upper reference limit (URL) were less likely (15%) to have a normal prolactin result on serial sampling. Measurement of a single rested prolactin sample from an indwelling cannula showed the same diagnostic utility as serial sampling. CONCLUSION: Serum prolactin results are frequently elevated by the stress of venepuncture. Confirmation of pathological hyperprolactinaemia in a rested sample obtained from an indwelling venous cannula is recommended in patients with mild hyperprolactinaemia, particularly when the referral prolactin is less than two times the URL.


Subject(s)
Hyperprolactinemia , Humans , Hyperprolactinemia/diagnosis , Hyperprolactinemia/chemically induced , Prolactin/adverse effects , Retrospective Studies , Phlebotomy , Referral and Consultation
14.
JCEM Case Rep ; 1(1): luac029, 2023 Jan.
Article in English | MEDLINE | ID: mdl-37908270

ABSTRACT

The presence of macroscopic fat on computed tomography (CT) imaging has been traditionally regarded as an indication that an adrenal lesion is likely to be a benign myelolipoma, for which further investigation is not usually required. Two cases are described where an adrenal lesion was eventually found to be malignant on histology (adrenocortical carcinoma in the first case, undifferentiated sarcoma in the second case), despite the presence of macroscopic fat on CT. In both cases there were other clinical and radiological indicators of potential malignant pathology. These cases add to increasing awareness in the literature that malignant adrenal tumors may rarely contain macroscopic fat, emphasizing a need for clinical vigilance.

15.
Int J Chron Obstruct Pulmon Dis ; 18: 2127-2146, 2023.
Article in English | MEDLINE | ID: mdl-37789931

ABSTRACT

Introduction: COPD is a leading cause of morbidity and mortality globally. Management is complex and costly. Although international quality standards for diagnosis and management exist, opportunities remain to improve outcomes, especially in reducing avoidable hospitalisations. Objective: To estimate the potential health and economic impact of improved adherence to guideline-recommended care for prevalent, on-treatment COPD populations in four high-income settings. Methods: A disease simulation model was developed to evaluate the impact of theoretical improvements to COPD management, comparing outcomes for usual care and policy scenarios for interventions that reduce avoidable hospitalisations: 1) increased attendance (50% vs 31-38%) of early follow-up review after severe exacerbation hospitalisation; 2) increased access (30% vs 5-10%) to an integrated disease management (IDM) programme that provides guideline adherent care. Results: For cohorts of 100,000 patients, Policy 1 yielded additional life years (England: 523; Germany: 759; Canada: 1316; Japan: 512) and lifetime cost savings (-£2.89 million; -€6.58 million; -$40.08 million; -¥735.58 million). For Policy 2, additional life years (2299; 3619; 3656) and higher lifetime total costs (£38.15 million; €35.58 million; ¥1091.53 million) were estimated in England, Germany and Japan, and additional life years (4299) and cost savings (-$20.52 million) in Canada. Scenarios found that the cost impact depended on the modelled intervention effect size. Conclusion: Interventions that reduce avoidable hospitalisations are estimated to improve survival and may generate cost savings. This study provides evidence on the theoretical impact of policies to improve COPD care and highlights priority areas for further research to support evidence-based policy decisions.


Subject(s)
Pulmonary Disease, Chronic Obstructive , Humans , Pulmonary Disease, Chronic Obstructive/diagnosis , Pulmonary Disease, Chronic Obstructive/epidemiology , Pulmonary Disease, Chronic Obstructive/therapy , Japan/epidemiology , Hospitalization , Canada/epidemiology , England/epidemiology
16.
J Diabetes Sci Technol ; : 19322968231208216, 2023 Oct 18.
Article in English | MEDLINE | ID: mdl-37850586

ABSTRACT

In an article in Journal of Diabetes Science and Technology, Nanayakkara and colleagues assessed the glycemic efficacy and safety of AndroidAPS, an open-source automated delivery (AID) system, in a crossover randomized controlled trial. Although the trial included only 20 participants during a relatively short 4-week intervention period, glycemic outcomes attained were similar to commercial AID systems and there were no safety concerns. Validation of open-source AID systems in studies such as this should help address clinician hesitancy regarding these systems, and affirms the role of patient-centered innovation and self-management in diabetes care.

17.
ERJ Open Res ; 9(5)2023 Sep.
Article in English | MEDLINE | ID: mdl-37868151

ABSTRACT

Background: Increased serum interleukin (IL)-33 predicts poor outcomes in patients hospitalised with coronavirus disease 2019 (COVID-19). We examined the efficacy and safety of tozorakimab, a monoclonal antibody that neutralises IL-33, in improving outcomes in ACCORD-2 (EudraCT: 2020-001736-95). Methods: ACCORD-2 was an open-label, phase 2a study in adults hospitalised with COVID-19. Patients were randomised 1:1 to tozorakimab 300 mg plus standard of care (SoC) or SoC alone. The primary end-point was time to clinical response (sustained clinical improvement of ≥2 points on the World Health Organization ordinal scale, discharge from hospital or fit for discharge) by day 29. Other end-points included death or respiratory failure, mortality and intensive care unit admission by day 29, and safety. Serum IL-33/soluble stimulated-2 (sST2) complex levels were measured by high-sensitivity immunoassay. Results: Efficacy analyses included 97 patients (tozorakimab+SoC, n=53; SoC, n=44). Median time to clinical response did not differ between the tozorakimab and SoC arms (8.0 and 9.5 days, respectively; HR 0.96, 80% CI 0.70-1.31; one-sided p=0.33). Tozorakimab was well tolerated and the OR for risk of death or respiratory failure with treatment versus SoC was 0.55 (80% CI 0.27-1.12; p=0.26), while the OR was 0.31 (80% CI 0.09-1.06) in patents with high baseline serum IL-33/sST2 complex levels. Conclusions: Overall, ACCORD-2 results suggest that tozorakimab could be a novel therapy for patients hospitalised with COVID-19, warranting further investigation in confirmatory phase 3 studies.

18.
Front Pharmacol ; 14: 1221905, 2023.
Article in English | MEDLINE | ID: mdl-37818189

ABSTRACT

Background: Although many acute exacerbations of COPD (AECOPD) are triggered by non-bacterial causes, they are often treated with antibiotics. Preliminary research suggests that the Chinese herbal medicine "Shufeng Jiedu" (SFJD), may improve recovery and therefore reduce antibiotic use in patients with AECOPD. Aims: To assess the feasibility of conducting a randomised placebo-controlled clinical trial of SFJD for AECOPD in UK primary care. Methods: GPs opportunistically recruited patients experiencing an AECOPD. Participants were randomised 1:1 to usual care plus SFJD or placebo for 14 days. Participants, GPs and research nurses were blinded to treatment allocation. GPs could prescribe immediate, delayed or no antibiotics, with delayed prescribing encouraged where appropriate. Participants were asked to complete a participant diary, including EXACT-PRO and CAT™ questionnaires for up to 4 weeks. Outcomes included recruitment rate and other measures of study feasibility described using only descriptive statistics and with no formal comparisons between groups. We also conducted qualitative interviews with recruited and non-recruited COPD patients and clinicians, analysed using framework analysis. Results: Over 6 months, 19 participants (6 SFJD, 13 placebo) were recruited. Sixteen (84%) participants returned diaries or provided a diary by recall. Overall, 1.3 participants were recruited per 1,000 patients on the COPD register per month open. Median duration of treatment was 9.8 days in the intervention group vs 13.3 days in the placebo group. The main reason for discontinuation in both groups was perceived side-effects. in both groups. Point estimates for both the EXACT-PRO and CAT™ outcomes suggested possible small benefits of SFJD. Most patients and clinicians were happy to try SFJD as an alternative to antibiotics for AECOPD. Recruitment was lower than expected because of the short recruitment period, the lower incidence of AECOPD during the COVID-19 pandemic, patients starting antibiotics from "rescue packs" before seeing their GP, and workforce challenges in primary care. Conclusion: Recruitment was impaired by the COVID-19 pandemic. Nevertheless, we were able to demonstrate the feasibility of recruiting and randomising participants and identified approaches to address recruitment challenges such as including the trial medication in COPD patients' "rescue packs" and delegating recruitment to a central trials team. Clinical Trial Registration: Identifier, ISRCTN26614726.

19.
J Endocr Soc ; 7(10): bvad119, 2023 Aug 28.
Article in English | MEDLINE | ID: mdl-37795193

ABSTRACT

Context: The American College of Radiology Thyroid Image Reporting and Data System (ACR TI-RADS) was developed to predict malignancy risk in thyroid nodules using ultrasound features. TI-RADS was derived from a database of patients already selected for fine-needle aspiration (FNA), raising uncertainty about applicability to unselected patients. Objective: We aimed to assess the effect of ACR TI-RADS reporting in unselected patients presenting for thyroid ultrasound in a real-world setting. Methods: Records for all patients presenting for thyroid ultrasonography in Canterbury, New Zealand, were reviewed across two 18-month periods, prior to and after implementation of TI-RADS reporting. Patient outcomes were compared between the 2 periods. Malignancy rates were calculated for nodules 10 mm or larger with a definitive FNA or histology result. Results: A total of 1210 nodules were identified in 582 patients prior to implementation of TI-RADS; 1253 nodules were identified in 625 patients after implementation of TI-RADS. TI-RADS category was associated with malignancy rate (0% in TR1 and TR2, 3% in TR3, 5% in TR4, 12% in TR5; P = .02); however, 63% of nodules were graded TR3 or TR4, for which malignancy rate did not meaningfully differ from baseline risk. After implementation of TI-RADS there was a small reduction in the proportion of patients proceeding to FNA (49% vs 60%; P < .01) or surgery (14% vs 18%; P < .05), with no difference in cancer diagnoses (3% vs 4%, not significant). Conclusion: TI-RADS category is associated with malignancy rate and may alter clinical decision-making in a minority of patients; however, it is nondiscriminatory in the majority of nodules. In this study of unselected patients, nodules classified as TR5 and thus considered "highly suspicious" for cancer had only a modest risk of malignancy.

20.
Diagnostics (Basel) ; 13(18)2023 Sep 15.
Article in English | MEDLINE | ID: mdl-37761330

ABSTRACT

Acute respiratory distress syndrome (ARDS) is a major cause of hypoxemic respiratory failure in adults, leading to the requirement for mechanical ventilation and poorer outcomes. Dysregulated surfactant metabolism and function are characteristic of ARDS. A combination of alveolar epithelial damage leading to altered surfactant synthesis, secretion, and breakdown with increased functional inhibition from overt alveolar inflammation contributes to the clinical features of poor alveolar compliance and alveolar collapse. Quantitative and qualitative alterations in the bronchoalveolar lavage and tracheal aspirate surfactant composition contribute to ARDS pathogenesis. Compared to neonatal respiratory distress syndrome (nRDS), replacement studies of exogenous surfactants in adult ARDS suggest no survival benefit. However, these studies are limited by disease heterogeneity, variations in surfactant preparations, doses, and delivery methods. More importantly, the lack of mechanistic understanding of the exact reasons for dysregulated surfactant remains a significant issue. Moreover, studies suggest an extremely short half-life of replaced surfactant, implying increased catabolism. Refining surfactant preparations and delivery methods with additional co-interventions to counteract surfactant inhibition and degradation has the potential to enhance the biophysical characteristics of surfactant in vivo.

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