HOITOSUOSITUSTEN KIELI: LÄÄKETIETEEN TULOSTEN TULKINTA JA KÄYTETTÄVYYS

Lääketieteellisen tutkimuksen tuoma uusi tieto on runsasta ja tutkimusraporttien kielihankalaa käytännön lääkärille. Tutkimustietoa kerätään järjestelmällisiin katsauksiinja niiden perusteella laaditaan toimintasuosituksia lääkäreille. Suositusten laatuja käyttökelpoisuus riippuvat monista asioista, joista yksi on katsausten ja suositustenraportoinnin laatu. Alkuperäisen tutkimustiedon merkitykset, hoidon tehoa jasen todennäköisyyttä kuvaavat kielelliset valinnat ovat moninaisia ja lukijat tulkitsevatniitä vaihtelevalla tavalla. Teen nyt katsauksen lääketieteen alan kirjallisuuteen,joka käsittelee tutkimustiedon viestintään vaikuttavia tekijöitä. Osa tekijöistä liittyylukijaan, osa tekstin kirjoittajaan ja itse tekstiin. Annan myös esimerkin lääkehoidonvaikuttavuuden ilmaisuista tenniskyynärpään hoitosuosituksissa ja samasta aiheestatehdyissä katsauksissa. Suositusten tekstuaalisten ominaisuuksien havaitseminen jasen kautta syvempi ymmärtäminen voi edistää parempien ja käytettävämpien suositustentekoa ja lääkäreiden sitoutumista toimimaan niiden mukaisesti.Avainsanat: Lääketiede, tekstiketjut, tieteen kieli, hoitosuositukset, lääkärit, potilaat.Key words: Meta-Analysis, guidelines, evidence based medicine

Hospital-based health technology assessment (HTA) in Finland : a case study on collaboration between hospitals and the national HTA unit

Background: This study examines, as a part of the European Union funded Adopting Hospital Based Health Technology Assessment (AdHopHTA) project, the results and barriers of collaboration between Finnish hospitals and the national health technology assessment (HTA) agency, Finohta. A joint collaborative HTA program has existed since 2006 between the Finnish hospitals and the national agency. Methods: A case study method was used. Information about the collaboration between Finnish hospitals and Finohta was retrieved from interviews and publications, and categorised per theme. Hypotheses and indicators of successful collaboration were determined beforehand and reflected on the observations from the interviews and literature. Results: Overall, 48 collaborative HTA reports have been performed during 7 years of collaboration. However, there were no clear indications that the use of HTA information or the transparency of decision-making regarding new technologies would have increased in hospitals. The managerial commitment to incorporate HTAs into the decision-making processes in hospitals was still low. The quality of the collaborative HTA reports was considered good, but their applicability in the hospital setting limited. There were differing expectations about the timing and relevance of the content. Signs of role conflict and mistrust were observed. Conclusions: Despite collaborative efforts to produce HTAs for hospitals, the impact of HTA information on hospital decision-making appears to remain low. The difficulties identified in this case study, such as lack of managerial commitment in hospitals, can hopefully be better addressed in the future with the guidance and tools having been developed in the AdHopHTA project. Collaboration between hospitals and national HTA agencies remains important for the efficient sharing of skills and resources.Peer reviewe

Testing the HTA Core Model: Experiences from two pilot projects

Objectives: The aim of this study was to analyze and describe process and outcomes of two pilot assessments based on the HTA Core Model, discuss the applicability of the model, and explore areas of development. Methods: Data were gathered from HTA Core Model and pilot Core HTA documents, their validation feedback, questionnaires to investigators, meeting minutes, emails, and discussions in the coordinating team meetings in the Finnish Office for Health Technology Assessment (FINOHTA). Results: The elementary structure of the HTA Core Model proved useful in preparing HTAs. Clear scoping and good coordination in timing and distribution of work would probably help improve applicability and avoid duplication of work. Conclusions: The HTA Core Model can be developed into a platform that enables and encourages true HTA collaboration in terms of distribution of work and maximum utilization of a common pool of structured HTA information for national HTA report

The HTA Core Model: A novel method for producing and reporting health technology assessments

Objectives: The aim of this study was to develop and test a generic framework to enable international collaboration for producing and sharing results of health technology assessments (HTAs). Methods: Ten international teams constructed the HTA Core Model, dividing information contained in a comprehensive HTA into standardized pieces, the assessment elements. Each element contains a generic issue that is translated into practical research questions while performing an assessment. Elements were described in detail in element cards. Two pilot assessments, designated as Core HTAs were also produced. The Model and Core HTAs were both validated. Guidance on the use of the HTA Core Model was compiled into a Handbook. Results: The HTA Core Model considers health technologies through nine domains. Two applications of the Model were developed, one for medical and surgical interventions and another for diagnostic technologies. Two Core HTAs were produced in parallel with developing the model, providing the first real-life testing of the Model and input for further development. The results of formal validation and public feedback were primarily positive. Development needs were also identified and considered. An online Handbook is available. Conclusions: The HTA Core Model is a novel approach to HTA. It enables effective international production and sharing of HTA results in a structured format. The face validity of the Model was confirmed during the project, but further testing and refining are needed to ensure optimal usefulness and user-friendliness. Core HTAs are intended to serve as a basis for local HTA reports. Core HTAs do not contain recommendations on technology us

COVID-19 mRNA vaccine induced antibody responses against three SARS-CoV-2 variants

As SARS-CoV-2 has been circulating for over a year, dozens of vaccine candidates are under development or in clinical use. The BNT162b2 mRNA COVID-19 vaccine induces spike protein-specific neutralizing antibodies associated with protective immunity. The emergence of the B.1.1.7 and B.1.351 variants has raised concerns of reduced vaccine efficacy and increased re-infection rates. Here we show, that after the second dose, the sera of BNT162b2-vaccinated health care workers (n = 180) effectively neutralize the SARS-CoV-2 variant with the D614G substitution and the B.1.1.7 variant, whereas the neutralization of the B.1.351 variant is five-fold reduced. Despite the reduction, 92% of the seronegative vaccinees have a neutralization titre of >20 for the B.1.351 variant indicating some protection. The vaccinees’ neutralization titres exceeded those of recovered non-hospitalized COVID-19 patients. Our work provides evidence that the second dose of the BNT162b2 vaccine induces cross-neutralization of at least some of the circulating SARS-CoV-2 variants

COVID-19 mRNA vaccine induced antibody responses against three SARS-CoV-2 variants

As SARS-CoV-2 has been circulating for over a year, dozens of vaccine candidates are under development or in clinical use. The BNT162b2 mRNA COVID-19 vaccine induces spike protein-specific neutralizing antibodies associated with protective immunity. The emergence of the B.1.1.7 and B.1.351 variants has raised concerns of reduced vaccine efficacy and increased re-infection rates. Here we show, that after the second dose, the sera of BNT162b2-vaccinated health care workers (n=180) effectively neutralize the SARS-CoV-2 variant with the D614G substitution and the B.1.1.7 variant, whereas the neutralization of the B.1.351 variant is five-fold reduced. Despite the reduction, 92% of the seronegative vaccinees have a neutralization titre of >20 for the B.1.351 variant indicating some protection. The vaccinees' neutralization titres exceeded those of recovered non-hospitalized COVID-19 patients. Our work provides evidence that the second dose of the BNT162b2 vaccine induces cross-neutralization of at least some of the circulating SARS-CoV-2 variants. Emerging SARS-CoV-2 variants contain mutations in the spike protein that may affect vaccine efficacy. Here, Jalkanen et al. show, using sera from 180 BNT162b2-vaccinated health care workers, that neutralization of SARS-CoV2 variant B.1.1.7 is not affected, while neutralization of B.1.351 variant is five-fold reduced.Peer reviewe