Patient preference for chronic obstructive pulmonary disease (COPD) treatment inhalers: a discrete choice experiment in France

Objectives: Understanding inhaler preferences may contribute to improving adherence in COPD patients and improving long-term outcomes. This study aims to identify and quantify preferences for convenience-related inhaler attributes in French moderate-to-severe COPD patients, with discrete choice experiment (DCE) methodology.

Methods: Attributes were defined from a literature search, clinician and patient interviews: shape, dose insertion, dose preparation, dose release, dose confirmation, dose counter and reusability. An online DCE was conducted in respondents with self-reported COPD stage 2–4 recruited through a panel. The study questionnaire included twelve choice scenarios per respondent and questions on patient characteristics, treatment and disease severity. Statistical analyses used a mixed logit regression model with random effects. Utility scores were estimated for four types of inhalers: Inhaler A – soft mist inhaler; Inhaler B – reusable soft mist inhaler; Inhaler C – multi-dose dry powder inhaler; and Inhaler D – single dose dry powder inhaler.

Results: The study was completed by 153 patients (50 females); respondents were 50.4?years old on average; 13 different inhaler devices were reported. The most preferred inhaler is L-shaped, has dose preparation with capsule insertion and a dose counter, and is reusable. Inhaler profiles A and B had the highest utilities (mean of 1.2533 and 0.9578 respectively) compared to inhaler C (0.6315) and D (0.2200).

Conclusions: This study showed statistically significant results that the strongest drivers of preference in French users of inhalation devices for COPD are shape, dose counter and reusability. Convenience-related characteristics are important to patients and should be taken into account by clinicians prescribing these devices.     

Detection and characterization of MRI breast lesions using deep learning

Purpose

The purpose of this study was to assess the potential of a deep learning model to discriminate between benign and malignant breast lesions using magnetic resonance imaging (MRI) and characterize different histological subtypes of breast lesions.

Interpersonal positive reframing in the daily lives of couples coping with breast cancer

Abstract

Objectives: This study examined word use as an indicator of interpersonal positive reframing in daily conversations of couples coping with breast cancer and as a predictor of stress.

Design: The Electronically Activated Recorder (EAR) and Linguistic Inquiry and Word Count (LIWC) were used to examine naturally occurring word use conceptually linked to positive reframing (positive emotion, negative emotion, and cognitive processing words).

Sample: Fifty-two couples coping with breast cancer.

Methods: Couples wore the EAR, a device participants wear, that audio-recorded over one weekend (>16,000 sound files), and completed self-reports of positive reframing (COPE) and stress (Perceived Stress Scale). LIWC, a software program, measured word use.

Findings: Both partners’ word use (i.e., positive emotion and cognitive processing words) was associated with their own reported positive reframing, and spouses’ word use was also indicative of patients’ positive reframing. Results also revealed that, in general, words indicating positive reframing predicted lower levels of stress.

Conclusions: Findings supported the hypothesis that partners—and particularly spouses of breast cancer patients—may assist each other’s coping by positively reframing the cancer experience and other negative experiences in conversation.     

Validación del instrumento Informed Choice para medir la decisión informada de mamografía en mujeres chilenas usuarias de atención primaria

ObjetivoAdaptar y validar el instrumento Informed Choice (IC) para la decisión de mamografía al contexto chileno.DiseñoEstudio transversal, analítico, de adaptación y validación psicométrica.EmplazamientoCentro de atención primaria del sector sur oriente de Santiago de Chile.Métodos1) traducir y contra-traducir IC; 2) realizar un grupo focal para la relevancia cultural/lingüística; 3) examinar la validez del contenido; 4) pilotar el instrumento; 5) aplicar para validación. Para la consistencia interna se usó el alfa de Cronbach, prueba de esfericidad de Bartlett y la medida de Kaiser-Meyer-Olkin para determinar correlaciones entre las variables y análisis factorial.ResultadosSe construyeron 3 versiones del IC, modificándose según la opinión de usuarios y expertos. La validación se llevó a cabo en una muestra de 70 mujeres. La edad media fue de 54,4 años, el 47,1% de educación secundaria completa y el 92,9% al menos se había realizado alguna vez una mamografía. Se realizó análisis factorial del IC y se eliminó uno de sus ítems. El alfa de Cronbach final fue 0,79.ConclusiónEl uso de instrumentos de medición requiere de su validación previa ya que la versión original puede variar de acuerdo al contexto cultural donde será aplicado y las necesidades locales particulares. El proceso de validación del IC permite contar con un instrumento confiable para medir la decisión de las mujeres que deben realizarse la mamografía en la dimensión conocimiento, actitud e intención hacia el examen.Palabras clave: Toma de decisiones en salud, Cáncer de mama, Mamografía     

Standardizing Postoperative Complications—Validating the Clavien-Dindo Complications Classification in Cardiac Surgery

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Bi-allelic pathogenic variations in DNAJB11 cause Ivemark II syndrome,a renal-hepatic-pancreatic dysplasia

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Review of Over 15 Years Postmarketing Safety Surveillance Spontaneous Data for the Human Rotavirus Vaccine (Rotarix) on Intussusception

Introduction

Rotavirus (RV) is the most common cause of acute gastroenteritis in children <5 years of age worldwide, and vaccination reduces the disease burden. Evidence from postmarketing surveillance studies suggested an increased risk of intussusception (IS) in infants post-RV vaccination. An overall positive benefit–risk balance for the human RV vaccine (HRV) Rotarix (GlaxoSmithKline [GSK], Belgium) has been established and recent findings indicate an indirect effect of reduced IS over the long term.

Objective

The aim of this study was to discuss spontaneous data from the GSK worldwide safety database on IS post-Rotarix administration.

Methods

The database was reviewed for all spontaneous IS cases from 2004 to 2020. Additionally, an observed versus expected (O/E) analysis was done for adverse events attributed to IS. Data were reviewed as overall worldwide and stratified by region (Europe/USA/Japan) and dose.

Results

A male predominance of IS patients was observed, consistent with earlier reports. The most frequently reported events in confirmed IS cases (Brighton Collaboration Working Group [BCWG] level 1) with time to onset ≤ 30 days post-vaccination were vomiting (55.8%), haematochezia (47.2%), and crying (21.1%). The observations from the IS spontaneous cases review and results of the O/E analysis are consistent with the known IS safety profile of RV vaccines: a transient increased incidence of IS post-vaccination (primarily in Europe/Japan/worldwide), mostly within 7 days postdose 1.

Conclusion

Since the outcomes of early IS management are favourable over delayed management, healthcare professionals should inform parents about the importance of seeking immediate medical advice in case of unusual behaviour of the vaccinated infant. GSK continues to monitor the IS risk post-Rotarix administration through routine pharmacovigilance activities.

Graphic abstract

     

Cancer-associated thrombosis and drug–drug interactions of antithrombotic and antineoplastic agents

Venous thromboembolism (VTE) is often associated with malignant diseases and notably contributes to morbidity and mortality in patients with cancer. Cancer-associated thrombosis (CAT) brings additional costs to health expenditures and has a negative impact on oncological outcomes. Either the recurrence rate of VTE or bleeding complications are also higher in patients with cancer. Prophylactic anticoagulation has been recommended in peri-surgical periods, inpatient settings, and high-risk ambulatory patients. Although various risk stratification scores are used, none are ideal for identifying patients who can benefit from anticoagulant prophylaxis. New risk scoring systems or biomarkers are needed to identify patients who are more likely to benefit from prophylaxis with low bleeding risk. The questions about the patients who will be given prophylaxis and those who develop thromboembolism, with which drug, and how long they will be treated are still not fully answered. Anticoagulation is the cornerstone of the treatment, but management of CAT remains complex. Low molecular weight heparins and direct oral anticoagulants are effective and safe options for the treatment of CAT. Recognizing adverse effects, drug–drug interactions, and accompanying conditions that cause dose adjustment is crucial. Prevention and treatment of VTE in patients with cancer require a multidisciplinary and patient-based approach.

Plain Language Summary

• Cancer-associated thrombosis is a significant cause of mortality and morbidity in patients with cancer.
• Chemotherapy, surgery, and/or use of central venous access remarkably increase the risk of thrombosis.
• Prophylactic anticoagulation should be considered not only in inpatient follow-up and during peri-surgical period but also ambulatory patients with a high risk of thrombosis.
• Many parameters, such as drug–drug interactions, primary side of cancer, and comorbidities of patients should be considered when selecting anticoagulant drugs.
• More accurate risk stratification scores or biomarkers are still an unmet need.