PP290 Ongoing Swedish Initiatives To Improve The Potential For Real World Data Assessment Of Medical Devices

2021 ◽  
Vol 37 (S1) ◽  
pp. 32-32
Author(s):  
Amanda Hansson Hedblom ◽  
Rhodri Saunders
Keyword(s):  
Medical Device ◽  
National Health ◽  
Medical Devices ◽  
Laboratory Data ◽  
Register Data ◽  
Real World Data ◽  
Patient Reported ◽  
The Impact ◽  
Health Registers

IntroductionIn 2020, the Swedish regions cemented a national managed-introduction project for medical devices, to ensure equal, cost-effective, and appropriate use. Health technology assessment (HTA) is an important component of the project. Swedish national health registers have world-class coverage and completeness but may lack information enabling adequate evaluation of medical devices. This study reviews the current situation and ongoing initiatives. Additionally, the potential for medical device health economics and outcomes research (HEOR) using Swedish registers is assessed.MethodsA review of Swedish national health registers was undertaken, focusing on available data, and contextualized for the purpose of HEOR for medical devices. Additionally, the review included an evaluation of the Swedish reimbursement authority's (The Dental and Pharmaceutical Benefits Agency, TLV) ongoing initiatives to improve the potential to follow-up the impact of the technologies they assess and develop value-based pricing schemes.ResultsFive registers were deemed the most relevant national health registers for device research. They include high-quality longitudinal data and are linkable on a per-patient basis. For devices, main limitations include limited data on specialized outpatient care, lags in updating certain registers, lack of laboratory data, and challenges in identifying the specific device used. Reports indicate that certain limitations are being addressed, including pilot-studies investigating the opportunity for automated reporting of data from regional systems, and app-collected patient-reported health data.ConclusionsSwedish registers provide comprehensive sources for HEOR studies, but limitations related to the assessment of medical device impact remain. As is common with register data reporting grouped diagnoses and interventions, specific devices are not directly identifiable in the national health registers. For some devices, this might be addressable through linkage with other data-sources. Swedish authorities are undertaking several initiatives that will likely improve the potential for HTA and follow-up of medical devices using national health register data.

The effect of surgery in tenosynovial giant cell tumours as measured by patient-reported outcomes on quality of life and joint function

2019 ◽  
Vol 101-B (3) ◽  
pp. 272-280 ◽  
Author(s):  
F. G. M. Verspoor ◽  
M. J. L. Mastboom ◽  
G. Hannink ◽  
W. T. A. van der Graaf ◽  
M. A. J. van de Sande ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Giant Cell ◽  
Diffuse Type ◽  
Joint Function ◽  
Population Means ◽  
Sf 36 ◽  
Patient Reported ◽  
The Impact

Aims The aim of this study was to evaluate health-related quality of life (HRQoL) and joint function in tenosynovial giant cell tumour (TGCT) patients before and after surgical treatment. Patients and Methods This prospective cohort study run in two Dutch referral centres assessed patient-reported outcome measures (PROMs; 36-Item Short-Form Health Survey (SF-36), visual analogue scale (VAS) for pain, and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)) in 359 consecutive patients with localized- and diffuse-type TGCT of large joints. Patients with recurrent disease (n = 121) and a wait-and-see policy (n = 32) were excluded. Collected data were analyzed at specified time intervals preoperatively (baseline) and/or postoperatively up to five years. Results A total of 206 TGCT patients, 108 localized- and 98 diffuse-type, were analyzed. Median age at diagnosis of localized- and diffuse-type was 41 years (interquartile range (IQR) 29 to 49) and 37 years (IQR 27 to 47), respectively. SF-36 analyses showed statistically significant and clinically relevant deteriorated preoperative and immediate postoperative scores compared with general Dutch population means, depending on subscale and TGCT subtype. After three to six months of follow-up, these scores improved to general population means and continued to be fairly stable over the following years. VAS scores, for both subtypes, showed no statistically significant or clinically relevant differences pre- or postoperatively. In diffuse-type patients, the improvement in median WOMAC score was statistically significant and clinically relevant preoperatively versus six to 24 months postoperatively, and remained up to five years’ follow-up. Conclusion Patients with TGCT report a better HRQoL and joint function after surgery. Pain scores, which vary hugely between patients and in patients over time, did not improve. A disease-specific PROM would help to decipher the impact of TGCT on patients’ daily life and functioning in more detail. Cite this article: Bone Joint J 2019;101-B:272–280.

scholarly journals Allograft Subsidence Decreases Postoperative Segmental Lordosis With Minimal Effect on Global Alignment Following ACDF

2021 ◽  
pp. 219256822098827
Author(s):  
Zachariah W. Pinter ◽  
Anthony Mikula ◽  
Matthew Shirley ◽  
Ashley Xiong ◽  
Scott Wagner ◽  
...  
Keyword(s):  
Global Alignment ◽  
Minimal Effect ◽  
Cervical Alignment ◽  
Entire Cohort ◽  
Patient Reported ◽  
Cage Subsidence ◽  
Student’S T ◽  
Segmental Lordosis ◽  
The Impact

Study Design: Retrospective cohort study. Objective: Studies investigating the impact of interbody subsidence in ACDF suggest a correlation between subsidence and worse radiographic and patient-reported outcomes. The purpose of this study was to assess whether allograft subsidence assessed on CT is associated with worse cervical alignment. Methods: We performed a retrospective review of a prospective cohort of patients undergoing 1 to 3 level ACDF. Cervical alignment was assessed on standing radiographs performed preoperatively, less than 2 months postoperatively, and greater than 6 months postoperatively. Allograft subsidence was assessed on CT scan performed at least 6 months postoperatively. Patients with at least 1 level demonstrating greater than 4mm of cage subsidence were classified as severe subsidence. Student’s t-test was used to compare all means between groups. Results: We identified 66 patients for inclusion, including 56 patients with non-severe subsidence and 10 patients with severe subsidence. For the entire cohort, there was a significant increase in C2-7 Lordosis (p = 0.005) and Segmental Lordosis (p < 0.00 001) from preoperative to early postoperative. On comparison of severely and non-severely subsided levels, severely subsided levels demonstrated a significantly greater loss of segmental lordosis from early to mid-term follow-up than non-severely subsided levels (-4.89 versus -2.59 degrees, p < 0.0001), manifesting as a significantly lower segmental lordosis at >6 months postoperative (0.54 versus 3.82 degrees, p < 0.00 001). There were no significant differences in global cervical alignment parameters between patients with severe and non-severe subsidence. Conclusions: Severe subsidence is associated with a significant increase in loss of segmental lordosis, but has minimal effect on global cervical alignment parameters.

T3 Are Burns a Chronic Condition: Examining Physical and Mental Functioning up to 20 Years After Injury

2021 ◽  
Vol 42 (Supplement_1) ◽  
pp. S2-S3
Author(s):  
Callie Abouzeid ◽  
Audrey E Wolfe ◽  
Gretchen J Carrougher ◽  
Nicole S Gibran ◽  
Radha K Holavanahalli ◽  
...  
Keyword(s):  
Mental Health ◽  
Hospital Stay ◽  
National Database ◽  
Time Points ◽  
Patient Reported ◽  
Burn Survivors ◽  
Population Demographic ◽  
The Impact ◽  
Over Time

Abstract Introduction Burn survivors often face many long-term physical and psychological symptoms associated with their injury. To date, however, few studies have examined the impact of burn injuries on quality of life beyond 2 years post-injury. The purpose of this study is to examine the physical and mental well-being of burn survivors up to 20 years after injury. Methods Data from the Burn Model System National Database (1997–2020) were analyzed. Patient-reported outcome measures were collected at discharge with a recall of preinjury status, and then at 5, 10, 15, and 20 years after injury. Outcomes examined were the Physical Component Summary (PCS) and Mental Component Summary (MCS) of the Short Form-12. Trajectories were developed using linear mixed methods model with repeated measures of PCS and MCS scores over time and controlling for demographic and clinical variables. The model fitted score trajectory was generated with 95% confidence intervals to demonstrate score changes over time and associations with covariates. Results The study population included 420 adult burn survivors with a mean age of 42.4 years. The population was mainly male (66%) and white (76.4%) with a mean burn size of 21.5% and length of hospital stay of 31.3 days. Higher PCS scores were associated with follow-up time points closer to injury, shorter hospital stay, and younger age. Similarly, higher MCS scores were associated with earlier follow-up time points, shorter hospital stay, female gender, and non-perineal burns. MCS trajectories are demonstrated in the Figure. Conclusions Burn survivors’ physical and mental health worsened over time. Such a trend is different from previous reported results for mental health in the general population. Demographic and clinical predictors of recovery over time are identified.

An overview of body weight of older persons, including the impact on mortality The national health and nutrition examination survey i-epidemiologic follow-up study

1991 ◽  
Vol 44 (8) ◽  
pp. 743-753 ◽  
Author(s):  
Joan C. Cornoni-Huntley ◽  
Tamara B. Harris ◽  
Donald F. Everett ◽  
Demetrius Albanes ◽  
Marc S. Micozzi ◽  
...  
Keyword(s):  
Body Weight ◽  
National Health ◽  
Older Persons ◽  
Nutrition Examination Survey ◽  
Follow Up Study ◽  
Health And Nutrition ◽  
The Impact

PP096 European Union-Health Technology Assessments For Medical Devices - How To Overcome Reimbursement Divergence

2017 ◽  
Vol 33 (S1) ◽  
pp. 116-117
Author(s):  
Jana Hemmerling ◽  
Karolin Eberle ◽  
Sara Hogger ◽  
Maike Gupta ◽  
Anna Ullraum ◽  
...  
Keyword(s):  
Health Care ◽  
Medical Device ◽  
Medical Devices ◽  
Small Body ◽  
Health Technology ◽  
Surrogate Endpoints ◽  
European Network ◽  
Gemeinsamer Bundesausschuss ◽  
Real World Data ◽  
Clinical Reality

INTRODUCTION:National Health Technology Assessments (HTAs) for medical devices are crucial to regulate the quality and costs of healthcare systems. However, there is diversity in several aspects among European countries. Consequently, controversial results might arise, generating contrary reimbursement decisions. The European Network for Health Technology Assessment (EUnetHTA) is an interface platform for the harmonization of HTA information across Europe. The European Commission expects national uptake of a European HTA. Thus, European HTAs might overcome the diversity of national HTA requirements.METHODS:We aimed to compare German and European HTAs for medical devices regarding processes, methods, timelines, and involvement of medical device companies. Therefore we analyzed guidelines, requirements, and output of EUnetHTA and compared those aspects with the German G-BA (Federal Joint Committee, Gemeinsamer Bundesausschuss) standard and IQWiG (Institute for Quality and Efficiency in Health Care, Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen) methods.RESULTS:We found differences between the European and German HTAs for medical devices regarding timelines, involvement of medical device companies, body of evidence, use of surrogate endpoints, and methodology. European HTAs for medical devices reflect the clinical reality by integrating the existing evidence (including real world data) and by using comprehensive statistical methods for medical devices. In contrast, German HTAs for medical device-based technologies are long lasting and are often restricted to a small body of evidence.CONCLUSIONS:As a conclusion, similar to pharmaceuticals, the European HTA framework might also become a worldwide platform for HTAs of medical device-based technologies with the potential to harmonize reimbursement decisions and patients health care across countries on the basis of clinical reality.

scholarly journals SP9.1.1 The Impact of Anaesthetic Use on Healing in Sub-cutaneous Abscess Management: A Retrospective Before and After Cohort Study

2021 ◽  
Vol 108 (Supplement_7) ◽  
Author(s):  
Hannah Elkadi ◽  
Eleanor Dodd ◽  
Theodore Poulton ◽  
William Bolton ◽  
Joshua Burke ◽  
...  
Keyword(s):  
Wound Healing ◽  
Local Anaesthetic ◽  
Surrogate Endpoints ◽  
Incision And Drainage ◽  
Number Of Patients ◽  
Significant Difference ◽  
Patient Reported ◽  
Before And After ◽  
The Impact

Abstract Aims Despite being the most common surgical procedure, there is wide variation that exists in the management of simple subcutaneous abscesses with no national guideline describing best practice. During the COVID-19 Pandemic national guidelines promoted the use of regional or local anaesthetic (LA) instead of general anaesthesia (GA) to avoid aerosol generating intubation associated with GA. This study aimed to assess the impact of anaesthetic choice in outcomes following incision and drainage of subcutaneous abscesses. Methods Two cohorts of patients undergoing abscess incision and drainage at St. James’ University Hospital Leeds were retrospectively identified over a 14-week period before and after the introduction of the new COVID-19 anaesthetic guidelines. Wound healing surrogate endpoints were used: i) total number of follow up appointments and ii) attendance to healthcare services after 30 days from I&D. Result 133 patients were included. Significantly more procedures were performed under LA after the intervention (84.1% vs 5.7%; p &lt; 0.0001) with a significant reduction in wound packing (68.3% vs 87.1%. p=0.00473). Follow up data found no significant difference in the average number of follow-up appointments (7.46 vs 5.11; p = 0.0731) and the number of patients who required ongoing treatment after 30 days (n = 14 vs n = 14, p = 0.921). Conclusion Drainage of simple subcutaneous abscess under 5 cm is safe under local anaesthetic with no significant difference in surrogate endpoints of wound healing observed in this patient cohort. Recurrent packing may not be required. Future work should explore patient reported measures such as pain management and the health economics of this intervention.

scholarly journals Surgical Management of Insertional Achilles Tendinopathy in the Young and Elderly Result in Similar Clinical Outcomes

2020 ◽  
Vol 5 (4) ◽  
pp. 2473011420S0038
Author(s):  
Huai M. Phen ◽  
Wesley J. Manz ◽  
Joel T. Greenshields ◽  
Danielle Mignemi ◽  
Jason T. Bariteau
Keyword(s):  
Linear Regression ◽  
Clinical Outcomes ◽  
Surgical Management ◽  
Surgical Correction ◽  
Physical Component Score ◽  
Achilles Tendinitis ◽  
Sf 36 ◽  
Patient Reported ◽  
The Impact

Category: Other; Ankle Introduction/Purpose: Insertional Achilles tendinitis (IAT) is a common cause of chronic posterior heel pain. Non-operative treatment has demonstrated evidence of success, with similar failure rates in both the young and the elderly. Surgical management can reproducibly improve patients’ pain and functional status. Older patients are considered to be at a higher risk for surgical complications due to associated comorbidities when compared to patients under the age of 60. The aim of this study is to investigate the impact of comorbidities and peri-operative variables on functional patient reported outcomes following surgical treatment of IAT in those over and under the age of 60. Methods: Retrospective review of prospectively collected data pertaining to a consecutive series of adult patients who underwent surgical management of IAT by a single surgeon (J.B.). Patients were separated into those 60 years of age and younger, and those above 60. Patients undergoing concomitant surgical procedures or revisions were excluded. Patient demographics, co- morbidities, perioperative variables, and post-operative complications were collected. Visual Analogue Scale (VAS), Short Form Health Survey Physical Component Score (SF-36 PCS), wound infection, and recurrence were assessed with a minimum follow-up of 12 months. Statistics were obtained using linear regression mixed models, and chi-squared analysis. Results: 38 operative cases were identified including 17 patients over and 21 patients under 60 years of age (mean 66.8 +/- 5.1yrs, 49.1 +/- 8.4yrs, respectively). There were no significant differences in demographics, rates of co-morbidities, or post-operative infection between the two groups. Both young and elderly groups experienced improvements in mean VAS pain scores at 6 months (3.3 and 2.7, respectively, P = 0.416) and 12 months (5.0 and 4.1, respectively, P = 0.322) post-operatively. SF-36 PCS improvements were also observed in both young and elderly cohorts at 6 (mean 22.1 and 9.3, respectively, P = 0.122) and 12 months (mean 30.4 and 20.4, respectively, P = 0.158). Linear regression analysis showed no statistical difference between the presence of co-morbidities, or age, on clinical outcomes. Conclusion: None of the co-morbidities nor peri-operative variables assessed were linked to increased risk of failed surgical correction of IAT in elderly patients, suggesting surgical correction of IAT in geriatric populations is an appropriate and reproducible treatment option. Further higher-powered studies, with longer follow-up times would be of use to better elucidate the influence of co-morbidities on recurrence.

Advancing Medical Technology Using FPGAs

2010 ◽  
Author(s):  
Zach Olson
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
High Performance ◽  
Heart Surgery ◽  
Open Heart Surgery ◽  
Good Alternative ◽  
Real Time Processing ◽  
Precise Control ◽  
Glucose Levels ◽  
The Impact

Field Programmable Gate Arrays (FPGAs) have dramatically changed the design of medical devices in the past decade. FPGAs offer the flexibility of writing software on a standard microprocessor and the reliability and performance of dedicated hardware. In the design of medical devices that previously required the rigorous design of custom circuits or ASIC design, FPGAs are providing a good alternative at a much lower cost for low to mid-volume medical device design. In this session, we will explore how FPGAs relate to medical device technology including real-time processing of data, high performance image processing, precise control, and code reuse from prototype to deployed device. We will explore how this technology was applied to two devices that improve the success of high-risk surgeries. In the first, FPGA technology is used to monitor blood glucose levels in patients during open-heart surgery. The second example is a device that simulates electrical signals from the human nervous system to train neurophysiologists for events that may happen during surgery. We will explore the impact FPGAs have on design cycles, briefly explore the design process, and compare different programming methodologies including C, VHDL, and LabVIEW. Finally, we will discuss the impact of FPGAs with respect to the 510k process.

Sign in / Sign up

Export Citation Format

Share Document