Is the trend of increasing use of patient‑reported outcome measures in medical device studies the sign of shift towards value‑based purchasing in Europe?

Background The recent update of the European Union’s (EU) regulation on public procurement has created new opportunity for progress in the purchasing of medical devices by shifting towards focus on value from one purely on price. Patientreported outcome measures (PROMs) may serve as additional tools for manufacturers to demonstrate value beyond traditional metrics of safety and performance and to diferentiate their products in a market of increasing competition. The aim of our study was to investigate the extent to which PROMs are included in registered device studies in the EU and interpret the results in the context of the purchasing of medical devices. Methods Twelve device groups were searched in clinical trial registries to determine the frequency distribution of PROMs in related studies. Results Results indicate that clinical studies of the selected device categories are done predominately in the western EU nations and are increasingly including PROMs. In the United Kingdom 121 (65%) study, out of 186 included PROMs, and in Germany, 92 (52%) out of 178 between 1998 and 2018. Few device studies were done in the Central and Eastern European region, and out of 76 studies 27 (35%) included PROMs. Since there is no requirement to include PROMs in device studies for regulatory purposes, it seems probable that their increasing use is driven by competitive market pressures. Conclusion The trend of increasing use of PROMs might be driven by the demand of purchasers to demonstrate value of devices, but is manifested at diferent levels in various regions of the EU

Validity and reliability of the 9‑item Shared Decision Making Questionnaire (SDM‑Q‑9) in a national survey in Hungary

Background The nine-item Shared Decision Making Questionnaire (SDM-Q-9) is one of the most frequently applied instruments for assessing patients’ involvement in medical decision-making. Our objectives were to develop a Hungarian version of SDM-Q-9, to evaluate its psychometric properties and to compare its performance between primary and specialised care settings. Methods In 2019, a sample of adults (n=537) representative of the Hungarian general population in terms of age, gender and geographic region completed an online survey with respect to a recent health-related decision. Outcome measures included SDM-Q-9 and Control Preferences Scale-post (CPSpost). Item characteristics, internal consistency reliability and the factor structure of SDM-Q-9 were determined. Results The overall ceiling and foor efects for SDM-Q-9 total scores were 12.3% and 2.2%, respectively. An excellent internal consistency reliability (Cronbach’s alpha 0.925) was demonstrated. Exploratory factor analysis resulted in a onefactor model explaining 63.5% of the variance of SDM-Q-9. A confrmatory factor analysis supported the acceptability of this model. Known-groups validity was confrmed with CPSpost categories; mean SDM-Q-9 total scores were higher in the ‘Shared decision’ category (72.6) compared to both ‘Physician decided’ (55.1, p=0.0002) and ‘Patient decided’ (57.2, p=0.0086) categories. In most aspects of validity and reliability, there was no statistically signifcant diference between primary and specialised care. Conclusions The overall good measurement properties of the Hungarian SDM-Q-9 make the questionnaire suitable for use in both primary and specialised care settings. SDM-Q-9 may be useful for health policies targeting the implementation of shared decision-making and aiming to improve efciency and quality of care in Hungary

Csontpótló anyagok összehasonlító mikrokeménység vizsgálata

A periprotetikus csontpótló anyagokat gyakran teherviselő felületeken is alkalmazzuk például csípő vagy térdízület esetén ezért fontos szempont, hogy azok megfelelő mechanikai tulajdonságokkal rendelkezzenek. A biokompatibilis anyagok mechanikai vizsgálatában a Vickers-féle mikrokeménységmérés széleskörben elterjedt módszer, amely a csontpótló anyagok tanulmányozásában is hasznos eredményekkel szolgálhat. Kísérleteinkben három, klinikai alkalmazás tekintetében azonos indikációval rendelkező csontpótló anyag mikrokeménység vizsgálatát végeztük el. A liofilizált szivacsos humán csont allograft (allograft), liofilizált szivacsos szarvasmarha csontgraft (BioOss), valamint porózus szerkezetű béta-trikálcium-foszfát (ß-TCP) mintákból arannyal bevont csiszolatokat készítettünk, majd és Buehler típusú berendezés segítségével megállapítottuk a mikrokeménységet. Annak ellenére, hogy a három minta közül szubjektíven a ß-TCP volt a leginkább törékeny, a Vickers-féle mikrokeménység mérések szerint jelentősen keményebbnek bizonyult, mint a természetes eredetű csontpótlók. A liofilizált szarvasmarha és a liofilizált humán allograft hasonló keménységgel jellemezhető. Összefoglalva megállapíthatjuk, hogy a biológiai eredetű mineralizált csontgraftokhoz látszólag hasonló mesterséges ß-TCP jelentősen keményebb, ridegebb szerkezetű, amely valószínűleg azt eredményezi, hogy élő szövetbe ültetve könnyebben törik

Microhardness testing of comparable bone substitutes

A periprotetikus csontpótló anyagokat gyakran teherviselő felületeken is alkalmazzuk például csípő vagy térdízület esetén ezért fontos szempont, hogy azok megfelelő mechanikai tulajdonságokkal rendelkezzenek. A biokompatibilis anyagok mechanikai vizsgálatában a Vickers-féle mikrokeménységmérés széleskörben elterjedt módszer, amely a csontpótló anyagok tanulmányozásában is hasznos eredményekkel szolgálhat. Kísérleteinkben három, klinikai alkalmazás tekintetében azonos indikációval rendelkező csontpótló anyag mikrokeménység vizsgálatát végeztük el. A liofilizált szivacsos humán csont allograft (allograft), liofilizált szivacsos szarvasmarha csontgraft (BioOss), valamint porózus szerkezetű béta-trikálcium-foszfát (β-TCP) mintákból arannyal bevont csiszolatokat készítettünk, majd és Buehler típusú berendezés segítségével megállapítottuk a mikrokeménységet. Annak ellenére, hogy a három minta közül szubjektíven a β-TCP volt a leginkább törékeny, a Vickers-féle mikrokeménység mérések szerint jelentősen keményebbnek bizonyult, mint a természetes eredetű csontpótlók. A liofilizált szarvasmarha és a liofilizált humán allograft hasonló keménységgel jellemezhető. Összefoglalva megállapíthatjuk, hogy a biológiai eredetű mineralizált csontgraftokhoz látszólag hasonló mesterséges β-TCP jelentősen keményebb, ridegebb szerkezetű, amely valószínűleg azt eredményezi, hogy élő szövetbe ültetve könnyebben törik. DOI: 10.17489/biohun/2013/2/02Bone-substitute materials are often employed in areas around load-bearing surfaces of implants, for example hip joints and ligaments around knees. It is important these materials have appropriate mechanical properties. Among mechanical tests, the Vickers microhardness measurement gives useful insights into bone-substitute materials. In these experiments microhardness was tanulmánytested for three bone-substitute materials used in similar clinical settings. Gold-coated samples of lyophilised trabecular human bone allograft, lyophilised trabecular bovine bone graft (BioOss), and porous-structured beta-tricalcium-phosphate (β-TCP) were measured for microhardness. Vickers-type microhardness measures ranked the β-TCP an order of magnitude harder than thenatural-source bone substitutes. The unusually high microhardness value of the β-TCP wasexplicable in terms of material-structure differences. The natural-origin bone substitutes are composite materials in which elastic protein fi lament cages hold inorganic calcium and magnesium during bone formation. In contrast, synthetic β-TCP is a single-phase dense material andlacks protein fi laments, explaining why its microhardness is an order of magnitude higher. To sum up, it was possible to establish that in comparison to mineralised, biological-origin bone grafts, artifi cial β-TCP was signifi cantly harder and brittler, probably meaning that when embeddedin living tissue it breaks more easily

In Vivo Evaluation of an Injectable Premixed Radiopaque Calcium Phosphate Cement

In this work a radiopaque premixed calcium phosphate cement (pCPC) has been developed and evaluated in vivo. Radiopacity was obtained by adding 0–40 % zirconia to the cement paste. The effects of zirconia on setting time, strength and radiopacity were evaluated. In the in vivo study a 2 by 3.5 mm cylindrical defect in a rat vertebrae was filled with either the pCPC, PMMA or bone chips. Nano-SPECT CT analysis was used to monitor osteoblast activity during bone regeneration. The study showed that by adding zirconia to the cement the setting time becomes longer and the compressive strength is reduced. All materials evaluated in the in vivo study filled the bone defect and there was a strong osteoblast activity at the injury site. In spite of the osteoblast activity, PMMA blocked bone healing and the bone chips group showed minimal new bone formation. At 12 weeks the pCPC was partially resorbed and replaced by new bone with good bone ingrowth. The radiopaque pCPC may be considered to be used for minimal invasive treatment of vertebral fractures since it has good handling, radiopacity and allows healing of cancellous bone in parallel with the resorption of the cement

Investigation of the mechanical and chemical characteristics of nanotubular and nano-pitted anodic films on grade 2 titanium dental implant materials

Abstract Objective The objective of this study was to investigate the reproducibility, mechanical integrity, surface characteristics and corrosion behavior of nanotubular (NT) titanium oxide arrays in comparison with a novel nano-pitted (NP) anodic film. Methods Surface treatment processes were developed to grow homogenous NT and NP anodic films on the surface of grade 2 titanium discs and dental implants. The effect of process parameters on the surface characteristics and reproducibility of the anodic films was investigated and optimized. The mechanical integrity of the NT and NP anodic films were investigated by scanning electron microscopy, surface roughness measurement, scratch resistance and screwing tests, while the chemical and physicochemical properties were investigated in corrosion tests, contact angle measurement and X-ray photoelectron spectroscopy (XPS). Results and discussion The growth of NT anodic films was highly affected by process parameters, especially by temperature, and they were apt to corrosion and exfoliation. In contrast, the anodic growth of NP film showed high reproducibility even on the surface of 3-dimensional screw dental implants and they did not show signs of corrosion and exfoliation. The underlying reason of the difference in the tendency for exfoliation of the NT and NP anodic films is unclear; however the XPS analysis revealed fluorine dopants in a magnitude larger concentration on NT anodic film than on NP surface, which was identified as a possible causative. Concerning other surface characteristics that are supposed to affect the biological behavior of titanium implants, surface roughness values were found to be similar, whereas considerable differences were revealed in the wettability of the NT and NP anodic films. Conclusion Our findings suggest that the applicability of NT anodic films on the surface of titanium bone implants may be limited because of mechanical considerations. In contrast, it is worth to consider the applicability of nano-pitted anodic films over nanotubular arrays for the enhancement of the biological properties of titanium implants

Robot-assisted surgery and artificial intelligence-based tumour diagnostics:social preferences with a representative cross-sectional survey

BackgroundThe aim of this study was to assess social preferences for two different advanced digital health technologies and investigate the contextual dependency of the preferences.MethodsA cross-sectional online survey was performed among the general population of Hungary aged 40 years and over. Participants were asked to imagine that they needed a total hip replacement surgery and to indicate whether they would prefer a traditional or a robot-assisted (RA) hip surgery. To better understand preferences for the chosen method, the willingness to pay (WTP) method was used. The same assessment was conducted for preferences between a radiologist’s and AI-based image analysis in establishing the radiological diagnosis of a suspected tumour. Respondents’ electronic health literacy was assessed with the eHEALS questionnaire. Descriptive methods were used to assess sample characteristics and differences between subgroups. Associations were investigated with correlation analysis and multiple linear regressions.ResultsAltogether, 1400 individuals (53.7% female) with a mean age of 58.3 (SD = 11.1) years filled in the survey. RA hip surgery was chosen by 762 (54.4%) respondents, but only 470 (33.6%) chose AI-based medical image evaluation. Those who opted for the digital technology had significantly higher educational levels and electronic health literacy (eHEALS). The majority of respondents were willing to pay to secure their preferred surgical (surgeon 67.2%, robot-assisted: 68.8%) and image assessment (radiologist: 70.9%; AI: 77.4%) methods, reporting similar average amounts in the first (p = 0.677), and a significantly higher average amount for radiologist vs. AI in the second task (p = 0.001). The regression showed a significant association between WTP and income, and in the hip surgery task, it also revealed an association with the type of intervention chosen.ConclusionsIndividuals with higher education levels seem to accept the advanced digital medical technologies more. However, the greater openness for RA surgery than for AI image assessment highlights that social preferences may depend considerably on the medical situation and the type of advanced digital technology. WTP results suggest rather firm preferences in the great majority of the cases. Determinants of preferences and real-world choices of affected patients should be further investigated in future studies