19 research outputs found
Measuring health-related quality of life (HRQoL) and quality-adjusted life years (QALY) in the critical care setting
Cost-utility analysis provides a means to determine the health benefit and economic burden of different health-care interventions. In cost-utility analyses, the benefit of care is measured in quality-adjusted life years (QALYs) gained. The calculation of QALYs requires knowledge of the change in health-related quality of life (HRQoL) and assumptions concerning when the benefit of care materialises and how long the benefit lasts. The gold standard for QALY calculations has not yet been defined and, as a consequence, the HRQoL instruments and calculation methods used vary from study to study.
The aim of the current study was to clarify how much the differences in the components used for the calculation of QALYs are reflected in the end result, i.e., the number of QALYs gained in the critical care setting. The detailed aims were to study 1) the effect of the instrument used (the EQ-5D or the 15D) on the HRQoL score and the measured changes in it; 2) the effects of the baseline HRQoL and the assumptions concerning the progress of recovery on the number of QALYs; 3) how to estimate life expectancy in the critical care setting, and 4) which factors have an effect on the follow-up HRQoL.
The results are based on two study populations. The first population comprises patients having been treated in an intensive care or high-dependency unit (n = 3600), and whose HRQoL was assessed using the EQ-5D and 15D HRQoL instruments 6 and 12 months after treatment. The second population consists of patients having underone treatment in a cardiac surgery intensive care unit (n = 980), and whose HRQoL was assessed using the 15D HRQoL instrument at baseline, when placed on a waiting list for surgery and 6 months after treatment.
The results of the studies show that the HRQoL index score is dependent on the instrument used. The distribution of the patients HRQoL scores differed between instruments. The differences are explained, inter alia, by the ceiling effect of the EQ-5D i.e., for a significant proportion of the respondents, the instrument produced the best possible HRQoL score of 1 and by the negative scores of the EQ-5D i.e., for health states worse than death. The 15D produced higher mean HRQoL scores than the EQ-5D. The 15D was able to distinguish between a greater number of health states than the EQ-5D, thus showing a better discriminatory power.
The choice of instrument was also reflected in the change observed in HRQoL. The two instruments classified patients according to the change in HRQoL (improved, remained stable, deteriorated) in a similar manner only in approximately half of the cases. The 15D was more sensitive to detecting a change than the EQ-5D. Consequently, both its discriminatory power and responsiveness to change were better than those for the EQ-5D.
The assumptions concerning the progression of recovery and the baseline HRQoL score had an effect on the number of QALYs gained both within and between instruments and, consequently, on the cost per QALY ratio. The EQ-5D and the 15D performed differently under different calculation assumptions. The greatest difference in the number of QALYs gained was caused by the negative HRQoL scores observed with the EQ-5D enabling the accrual of more than 1 QALY per year.
Patients having been treated in an intensive care unit showed long-lasting excess mortality and, as a consequence, a reduced life expectancy. By contrast, in cardiac surgery patients, the life expectancy was similar to or even better than that of the general population. In patient groups with excess mortality, neither the follow-up time nor the life expectancy of the general population can be regarded as optimal indicators for the duration of the benefit of care. In those patient groups, life expectancy should be extrapolated in relation to the observed excess mortality.
In cardiac surgery patients, factors predicting mortality and morbidity are not able to accurately predict the follow-up HRQoL. Instead, patient experiences, such as restlessness and pain during intensive care, predicted poor post-treatment HRQoL. Given that these results are novel, future studies should be directed to patient experiences during treatment. They may be confounding factors in analyses concerning treatment effectiveness, and also diminish the effectiveness of treatment.
QALY is not a universal measure, but is dependent on the HRQoL instrument used and on how the factors to be taken into account in the calculation of QALYs are chosen and defined. Furthermore, factors external to the interventions under evaluation, such as the patient s psychological experiences during treatment, may have an effect on the follow-up HRQoL. The ranking of different interventions in terms of their effectiveness calls for standardisation in the calculation of QALYs and more information on the effect of patient experiences during treatment on the follow-up HRQoL âTerveydenhuollon resurssit tulee kohdistaa hoitomuotoihin, joilla saavutetaan eniten terveyttĂ€ suhteessa kĂ€ytettyihin voimavaroihin. Yleisesti hyvĂ€ksytty tapa arvioida hoidolla saavutetut hyödyt on laskea saavutetut laatupainotetut lisĂ€elinvuodet (QALY). QALYjen laskemiseen tarvitaan tieto terveyteen liittyvĂ€stĂ€ elĂ€mĂ€nlaadusta, siihen hoidon tuottamasta muutoksesta sekĂ€ oletus toipumisen kulusta ja hoidon tuottaman hyödyn kestosta. QALYjen laskemiselle ei toistaiseksi ole kultaista standardia, minkĂ€ seurauksena kĂ€ytetyt elĂ€mĂ€nlaatumittarit ja laskentatavat vaihtelevat. TĂ€mĂ€n tutkimuksen tarkoituksena on selvittÀÀ elĂ€mĂ€nlaatumittarin ja erilaisten laskentaoletusten vaikutus saavutettujen QALYjen mÀÀrÀÀn, ja siten arvioon hoidon vaikuttavuudesta.
Terveyteen liittyvÀÀ elÀmÀnlaatua mitattiin EQ-5D:llÀ ja 15D:llÀ teho- ja valvontaosastoilla hoidetuilta potilailta (n=3600) kuusi ja 12 kuukautta hoidon jÀlkeen, ja sydÀnkirurgian teho-osastolla hoidetuilta potilailta (n=980) 15D:llÀ hoitojonoon asettamisen yhteydessÀ ja kuusi kuukautta hoidon jÀlkeen.
Tutkimuksen tuloksena todettiin, ettÀ terveyteen liittyvÀn elÀmÀnlaadun lukema oli riippuvainen kÀytetystÀ elÀmÀnlaatumittarista. EQ-5D:llÀ havaittiin kattoefekti, eli varsin suuri osa vastaajista sai mittarilla maksimiarvon 1. EQ-5D tuotti myös negatiivisia elÀmÀnlaadun tiloja, jotka kuvastavat kuolemaa heikompaa elÀmÀnlaatua. 15D tuotti keskimÀÀrÀisesti korkeampia elÀmÀnlaadun lukemia kuin EQ-5D, mutta sillÀ ei ollut samanlaista kattoefektiÀ. 15D pystyi tunnistamaan useampia elÀmÀnlaadun tiloja kuin EQ-5D, joten sen erottelukyky oli parempi.
KÀytetty elÀmÀnlaatumittari vaikutti terveyteen liittyvÀssÀ elÀmÀnlaadussa havaittuun muutokseen eli potilaan kokemukseen siitÀ, onko hÀnen elÀmÀnlaatunsa parantunut, ennallaan vai heikentynyt. 15D oli herkempi havaitsemaan muutosta elÀmÀnlaadussa kuin EQ-5D, joten sen erottelukyky ja muutosvaste olivat paremmat. ElÀmÀnlaadun muutoksen mittarit luokittelivat yhtenevÀsti noin puolessa tapauksista.
Oletukset toipumisen kulusta ja lÀhtötilanteen arvioinnissa kÀytetty elÀmÀnlaatulukema vaikuttivat merkittÀvÀsti saavutettujen QALYjen mÀÀrÀÀn niin mittarien sisÀisessÀ kuin niiden vÀlisessÀkin vertailussa. Suurimman eron saavutettujen QALYjen mÀÀrÀssÀ aiheuttivat EQ-5D:n negatiiviset elÀmÀnlaatulukemat, jotka mahdollistavat enemmÀn kuin yhden laatupainotetun elinvuoden kertymisen vuoden aikana.
Tehohoitopotilailla todettiin vÀestöön verrattuna pitkÀaikainen ylikuolleisuus ja sen seurauksena alentunut elinajanodote. SydÀnkirurgisilla potilailla elinajanodote vastasi vÀestön elinajanodotetta, tai oli jopa sitÀ pidempi. TautiryhmissÀ, joissa havaitaan ylikuolleisuutta, seuranta-aika ja vÀestön elinajanodote eivÀt ole optimaalisia hoidon hyödyn keston lukemia.
SydÀnkirurgisilla potilailla tehohoidon aikainen levottomuus ja kivuliaisuus ennustivat hoidon jÀlkeistÀ alentunutta elÀmÀnlaatua, joten potilaan hoidon aikaiset kokemukset saattavat heijastua hoidon vaikuttavuuteen. Koska tulokset ovat uusia, tulee tutkimusta suunnata potilaan hoidon aikaisiin kokemuksiin, ja pyrkiÀ tunnistamaan terveyteen liittyvÀÀ elÀmÀnlaatua heikentÀviÀ tekijöitÀ, jotta niihin voitaisiin puuttua.
TÀmÀn tutkimuksen johtopÀÀtöksenÀ voidaan todeta, ettÀ QALY ei ole universaali mittayksikkö, vaan riippuvainen kÀytetystÀ elÀmÀnlaatumittarista ja siitÀ, miten laskennassa huomioon otettavat osatekijÀt on mÀÀritelty ja valittu. LisÀksi arvioitavien hoitomuotojen ulkopuoliset tekijÀt, kuten potilaan hoidonaikaiset kokemukset, saattavat vaikuttaa koettuun elÀmÀnlaadun muutoksen. Eri hoitomuotojen asettaminen paremmuusjÀrjestykseen vaikuttavuuden suhteen edellyttÀÀ laatupainotettujen elinvuosien laskennan standardointia. Potilaiden hoidonaikaisten kokemusten vaikutuksesta elÀmÀnlaadun muutokseen tarvitaan lisÀtietoa
Electronic Health Records on the Top of Medical Device Incident Reports
Publisher Copyright: © 2022 European Federation for Medical Informatics (EFMI) and IOS Press.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). High number of incidents caused by electronic health records arouses safety concerns. A further analysis is required to explore the causes of findings.Peer reviewe
Medical Device Incident Reports by Professional Users in Finland 2014 2021
Publisher Copyright: © 2022 The authors and IOS Press.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. Approximately 80% of the medical device incident reports were near misses, 18.7% were person injuries and 1.3% deaths. The number of annual medical device incident reports between hospital districts varied more than expected when related to the population of catchment area. There was a tendency towards lesser reports per population from smaller hospital districts. In conclusion, medical device incident reporting activity of the professional user varied both annually and geographically. A high number of incidents caused person injuries or even death, which arouses safety concerns. A further analysis is required to explore the causes behind our findings.Peer reviewe
Advances in Informatics, Management and Technology in Healthcare
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. Approximately 80% of the medical device incident reports were near misses, 18.7% were person injuries and 1.3% deaths. The number of annual medical device incident reports between hospital districts varied more than expected when related to the population of catchment area. There was a tendency towards lesser reports per population from smaller hospital districts. In conclusion, medical device incident reporting activity of the professional user varied both annually and geographically. A high number of incidents caused person injuries or even death, which arouses safety concerns. A further analysis is required to explore the causes behind our findings
Suomen tekonivelrekisteri 40 vuotta laadun tukena
âą Implanttirekisteri on maailman kolmanneksi vanhin edelleen toiminnassa oleva kliininen kansallinen laaturekisteri.âą Implanttirekisteri on ortopedien ja THL:n yhteistyönĂ€ uudistettu vastaamaan 2020-luvun tarpeita.âą Implanttirekisteriin perustuvia tutkimusraportteja julkaistiin 17 kappaletta pelkĂ€stÀÀn vuosina 2019â2020. Moni tieteellinen julkaisumme on merkittĂ€vĂ€sti muuttanut hoitokĂ€ytĂ€ntöjĂ€.</p
Suomen tekonivelrekisteri 40 vuotta laadun tukena
Vertaisarvioitu. English summary.âą Implanttirekisteri on maailman kolmanneksi vanhin edelleen toiminnassa oleva kliininen kansallinen laaturekisteri. âą Implanttirekisteri on ortopedien ja THL:n yhteistyönĂ€ uudistettu vastaamaan 2020-luvun tarpeita. âą Implanttirekisteriin perustuvia tutkimusraportteja julkaistiin 17 kappaletta pelkĂ€stÀÀn vuosina 2019â2020. Moni tieteellinen julkaisumme on merkittĂ€vĂ€sti muuttanut hoitokĂ€ytĂ€ntöjĂ€.Peer reviewe