Medical Device Incident Reports by Professional Users in Finland 2014-2021.

Medical Device incident reporting is a legal obligation for professional users in Finland. We analyzed all medical device incident reports recorded into the national incident repository from January 2014 to August 2021. Among the total 5,897 records, annual numbers of incident reports varied between 463 and 1,190.

Electronic Health Records on the Top of Medical Device Incident Reports.

Medical Device incident reporting is a legal obligation for professional users in Finland. We analyzed all medical device incident reports recorded into the national incident repository from January 2014 to August 2021. Almost 30% of the total of 5,897 recorded incidents were caused by top ten devices, of which electronic health records were the most common (332 incidents).

Large-scale decontamination of disposable FFP2 and FFP3 respirators by hydrogen peroxide vapour, Finland, April to June 2020.

BackgroundThe shortage of FFP2 and FFP3 respirators posed a serious threat to the operation of the healthcare system at the onset of the COVID-19 pandemic.AimOur aim was to develop and validate a large-scale facility that uses hydrogen peroxide vapour for the decontamination of used respirators.MethodsA multidisciplinary and multisectoral ad hoc group of experts representing various organisations was assembled to implement the collection and transport of used FFP2 and FFP3 respirators from hospitals covering 86% of the Finnish population.

Treatment of gynecological malignancies: long-term follow-up of health-related quality of life and healthcare costs.

To assess long-term health-related quality of life (HRQoL) and treatment-related costs in gynecological cancer patients, and to compare HRQoL between cancer types and to age-standardized general female population. A prospective 8-10-year follow-up of 218 patients treated in Helsinki University Hospital in 2002-2004. The most common malignancies were uterine, ovarian and cervical cancers.

Effectiveness of peer support on health-related quality of life in recently diagnosed breast cancer patients: a randomized controlled trial.

Purpose: Breast cancer is the most common cancer of Finnish women. Peer support could be a way to help breast cancer patients to deal with the disease but studies on its effectiveness have produced conflicting results. The aim of this randomized controlled trial was to study the effectiveness of peer support on health-related quality of life (HRQoL) of breast cancer patients.

Estimating the minimum important change in the 15D scores.

Purpose: To facilitate the interpretation of empirical results produced by the 15D, a generic, preference-based instrument for measuring health-related quality of life (HRQoL), a subjective five-category global assessment scale (GAS) was used as an external anchor to determine the minimum important change (MIC) in the 15D scores.

Methods: Altogether 4,903 hospital patients representing sixteen disease entities and having the 15D score at baseline repeated the HRQoL assessment at 6 months after treatment and answered the question: compared to the situation before treatment, my overall health status is now (1) much better, (2) slightly better, (3) much the same, (4) slightly worse, (5) much worse. Regression analysis was used to estimate the MIC for improvement/deterioration, defined as the lower/upper limit of 99.

Can factors related to mortality be used to predict the follow-up health-related quality of life (HRQoL) in cardiac surgery patients?

Background: Optimal selection of patients and choice of treatment methods in cardiac surgery calls for methods to predict outcome both in terms of mortality and health-related quality of life (HRQoL). Our target was to evaluate whether indicators predicting mortality can also be used to predict follow-up HRQoL.

Methods: Preoperative and intensive care-related data of 571 elective cardiac surgery patients treated in the Helsinki University Central Hospital were used to predict, in a stepwise (forward) binary logistic regression, the probability of being dead at six months after operation.

Effect of health-related quality-of-life instrument and quality-adjusted life year calculation method on the number of life years gained in the critical care setting.

Objectives: Health-related quality of life (HRQoL) and quality-adjusted life-years (QALYs) gained are basic elements in the cost-utility evaluations of health care. Different HRQoL instruments produce different scores for the same patient, and thus also a different number of QALYs. We examined the effect of these factors on the number of QALYs gained and the cost per QALY in the critical care setting.

Comparison of two utility instruments, the EQ-5D and the 15D, in the critical care setting.

Purpose: Reliable measures are required for proper cost-utility analysis after critical care. No gold standard is available, but the EQ-5D health-related quality of life instrument (HRQoL) has been proposed. Our aim was to compare the EQ-5D with another utility measure, the 15D, after critical illness.