Journal of Statistics on Health Decision

Evaluation of cardiovascular disease risk factors with Propensity Score Matching and Coarsened Exact Matching: Nepalese post-seismic observational data

Tiago Adrega — 2021-12-14

A large part of the known results and evidences in medical and social sciences come from a type of studies known as observational studies. This type of studies differ from the usual randomized experiences because, due to several different reasons, the researcher is not able to conduct a randomized experience, controlling for the effects on covariables under investigation to assess for some treatment effects. Some methodologies have been developed in order to reduce the imbalanced in the samples of treated and control units. Propensity Score Matching (PSM) is still one of the most common approaches applied but Coarsened Exact Matching appears to produce better results, most of the times in which it is used. This work illustrates the application of each of the two techniques to a set of data from Nepal population. Non-communicable disease are the leading causes of death in developed and developing countries worldwide. Nepal is an example of this paradigm - from 2005 to 2015, there was an increase in ischemic heart disease and brain vascular disease. The April and May 2015 earthquakes imposed critical social and epidemiological pressures, resulting in critical lifestyle changes, namely regarding cardiovascular disease (CVD) risk factors Some organizations were able to provided support to these people and engaged in various activities aiming to fight against the CVD threat.The aim of this study was to appraise the prevalence of CVD risk factors and health in two cohorts of a native Nepalese population, with a common origin from a remote village that were separated in two groups after the incidents of the May 2015 earthquake. The results obtained from the two approaches are generally in agreement but with CEM there is additional conclusions not perceptible with PSM.

Agreement of Whodas 2.0-12 items Portuguese version applied by telephone or digital media

Daniela Domingues — 2021-12-10

Aims: Analise agreement of WHODAS 2.0-12 items, Portuguese version, applied by telephone or digital media for people aged 50 or more years old.

Method: Face-to-face, telephone and digital media versions were conducted in 31 participants, with an interval of three days between applications. Internal consistency was assessed with Cronbach’s Alpha and an agreement was analyzed with Intraclass Correlation Coefficient and Bland-Altman plots.

Results: The telephonic and digital media versions of the WHODAS 2.0–PT12 has shown good internal consistency. Agreement between face-to-face vs telephone application was ICC=0.99 (CI95%=[0.98-1.00]), and between face-to-face vs digital media was ICC=0.98 (CI95%=[0.96-0.99]). The Bland-Altman plots revealed no systematic bias. Application by telephone or by digital media discriminate different levels of overall functioning, and between institutionalized and non-institutionalized participants.

Conclusions: WHODAS 2.0 - PT12 applied by telephone or digital media to people 50 years of age or older showed excellent agreement with face-to-face administration.

Characterization of the epidemiological curve of the 1st wave of the pandemic - study of the determinants for death and hospitalization due to COVID-19 in Portugal

Francisca Monteiro Freire — 2021-12-14

COVID-19 is an infectious disease caused by the SARS-CoV-2 virus that emerged in China and has since spread rapidly to all countries in the world. The aim of this study is to characterize the peak of the first wave of the pandemic using some demographic and clinical determinants. The database studied contains epidemiological surveillance data of COVID-19 from Portugal until June 30, 2020. The peak of the pandemic was determined considering the number of diagnoses, deaths, and hospitalizations over time, and the estimated period for the first wave was between March 19 and April 24. Logistic regression models were performed to estimate the univariate and multivariate Odds Ratio (OR) and the respective 95% confidence intervals (95% CI) for this period and for each of the variables considered in relation to both study outcomes: mortality (5.8%) and hospitalization (18.8%). The main risk factors considered for the mortality outcome were: Age Group (≥ 80 years: OR = 11.978; 65-79 years: OR = 4.064; Ref. G.: <64 years:), Hospitalization (OR = 6.479) and Comorbidities (OR = 5.735). For the outcome hospitalization, the main risk factors were: Age Group (≥ 80 years: OR =
8.537; 65-79 years: OR = 3.899; Ref. G.: <64 years), male gender (OR= 1.575) and Comorbidities (OR = 5.193). The proposed models presented high area under curves (AUC) results (mortality: AUC=91.05%; and hospitalization: AUC=84.5%), with small amplitudes in the 95% CI. The present study demonstrated that, overall, the major risk factors associated with worse prognostics of COVID-19 were advanced age (over 65 years), and the existence of comorbidities. For the risk of hospitalizations, the male gender was also a significant risk factor.

Tapentadol: review of adverse drug reactions reported to Eudravigilance.

Adela Iutis — 2021-12-14

Background: Adverse drug reactions (ADRs) are a public health problem. Tapentadol is a novel opioid analgesic with a dual mode of action that was approved for acute and chronic pain. This drug has been associated with several ADRs, particularly involving Nervous System Disorders, Psychiatric Disorders, Gastrointestinal Disorders, and General Disorders and Administration Site Condition.

Objective: Since published studies on tapentadol-associated ADRs are limited, the major aim of this study was to characterise ADRs’ reports related to tapentadol included in EudraVigilance (EV).

Methods: The data analysed was retrieved from EV - the European database of suspected ADR reports, between January 1^st, 2017 and October 17^th, 2019. The ADR reports in which tapentadol was not the only reported drug of interest were excluded. We selected 865 cases from a total of 1467 reports identified.

Results: Within the selected ADR reports, the majority referred to cases involving adults. A predominance of female ADR reports (64.05%) was also observed. The five most frequent ADRs reported were nausea (9.36%), dizziness (9.25%), vomiting (4.86%), confusional state (4.62%) and headache (4.51%). Eight cases of serotonin syndrome were reported. Most patients recovered completely. Fatal outcomes were shown to be rare (2.66%).

Conclusions: Pharmacovigilance databases are important tools to evaluate the safety and efficacy profiles of drugs, thus improving patients’ safety and quality of life.

Despite an overall safety profile, the prescription of tapentadol still demands for caution and ongoing monitoring, in order to decrease its known and potential associated ADRs.

The use of health data to foster the development of clinical trials through value-based healthcare in Portugal

Adriana Coutinho Gradim — 2021-12-14

The value-based healthcare (VBH) approach has emerged as an alternative to the traditional management of health systems. However, it is still necessary to evaluate its impacts in several domains, including the management of clinical trials.
This study aims to analyse how the healthcare ecosystem in Portugal is implementing VBH and how that can enhance the management and implementation of clinical trials. For that, interviews were made with elements involved in the implementation of VBH in Portugal, that were complemented with secondary data analysis in order to obtain a preliminary perspective on the subject.
The sources emphasized that, even though it VBH is considered an important development in health management, in Portugal it is still difficult to efficiently collect data from the different elements, especially patient measurements, and that patients still fear the non-clinical use of the data provided.
With this background, in order to fulfill the potential of data to foster clinical trials, there is the need to develop new ways of collecting and managing data from the stakeholders, and there is also the need to have innovative approaches to information sharing to foster innovation and patient participation.
These findings support the broader concept that there is an underlying opportunity to develop integrated information systems where data from patients can be collected, (pseudo) anonymized and used to foster innovation, while, at the same time, creating a symbiosis between the implementation of VBH concepts and the development of clinical trials.
This work can serve as basis for future research regarding the use of data in the health system, aligned with broader initiatives such as the creation of the Portuguese Health Data Lake and the European Health Data Space, aligned with a dynamic clinical trials industry.