Innovating in Medical Device (MD) industry is challenging. This study aims to develop and validate an evidence-based framework that helps innovators of small and large enterprises (SEs and LEs) ...assess their readiness for successful MD development and deployment. We conducted a key-informant process (stage 1) where 25 international experts identified a list of emergent Health Technology Assessment (HTA) themes they believed were essential to company success. A sample of 22 European and US selected companies (13 SEs and 9 LEs) then reached a consensus on a list of key themes through a robust Delphi process (stage 2). Finally, we constructed (stage 3) and validated (stage 4) the checklist for SEs and LEs. The checklist for SEs and LEs included 21 and 15 items (i.e., fundamental Yes/No questions) with nine overlapping criteria for both SEs and LEs. In both groups, MD success was driven by three major item categories: (i) R&D assessment strategy; (ii) device-outcome measures; (iii) company profiling. Alongside the retrospective validation study, we collected 40 case studies on MDs (23 successes and 17 failures) across the selected enterprises. The retrospective validation provided the proportion of successful and failed case studies that met the 'MeDKET' criteria. We discovered that early HTA plays a pivotal role in MD industry success with different implications based on enterprise size. This study is the first of its kind to provide a holistic picture of the perceived role of early-stage HTA in MD industry success.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Individuals with chronic lung disease (eg, cystic fibrosis (CF)) often receive antimicrobial therapy including aminoglycosides resulting in ototoxicity. Extended high-frequency audiometry has ...increased sensitivity for ototoxicity detection, but diagnostic audiometry in a sound-booth is costly, time-consuming and requires a trained audiologist. This cross-sectional study analysed tablet-based audiometry (Shoebox MD) performed by non-audiologists in an outpatient setting, alongside home web-based audiometry (3D Tune-In) to screen for hearing loss in adults with CF.
Hearing was analysed in 126 CF adults using validated questionnaires, a web self-hearing test (0.5 to 4 kHz), tablet (0.25 to 12 kHz) and sound-booth audiometry (0.25 to 12 kHz). A threshold of ≥25 dB hearing loss at ≥1 audiometric frequency was considered abnormal. Demographics and mitochondrial DNA sequencing were used to analyse risk factors, and accuracy and usability of hearing tests determined.
Prevalence of hearing loss within any frequency band tested was 48%. Multivariate analysis showed age (OR 1.127; (95% CI: 1.07 to 1.18; p value<0.0001) per year older) and total intravenous antibiotic days over 10 years (OR 1.006; (95% CI: 1.002 to 1.010; p value=0.004) per further intravenous day) were significantly associated with increased risk of hearing loss. Tablet audiometry had good usability, was 93% sensitive, 88% specific with 94% negative predictive value to screen for hearing loss compared with web self-test audiometry and questionnaires which had poor sensitivity (17% and 13%, respectively). Intraclass correlation (ICC) of tablet versus sound-booth audiometry showed high correlation (ICC >0.9) at all frequencies ≥4 kHz.
Adults with CF have a high prevalence of drug-related hearing loss and tablet-based audiometry can be a practical, accurate screening tool within integrated ototoxicity monitoring programmes for early detection.
ObjectivesThis study investigated the barriers and facilitators to the adoption of point-of-care tests (POCTs).DesignQualitative study incorporating a constant comparative analysis of stakeholder ...responses to a series of interviews undertaken to design the Point-of-Care Key Evidence Tool.SettingThe study was conducted in relation to POCTs used in all aspects of healthcare.ParticipantsForty-three stakeholders were interviewed including clinicians (incorporating laboratory staff and members of trust POCT committees), commissioners, industry, regulators and patients.ResultsThematic analysis highlighted 32 barriers in six themes and 28 facilitators in eight themes to the adoption of POCTs. Six themes were common to both barriers and facilitators (clinical, cultural, evidence, design and quality assurance, financial and organisational) and two themes contained facilitators alone (patient factors and other (non-financial) resource use).ConclusionsFindings from this study demonstrate the complex motivations of stakeholders in the adoption of POCT. Most themes were common to both barriers and facilitators suggesting that good device design, stakeholder engagement and appropriate evidence provision can increase the likelihood of a POCT device adoption. However, it is important to realise that while the majority of identified barriers may be perceived or mitigated some may be absolute and if identified early in device development further investment should be carefully considered.
Background An increased number of resources are allocated on cancer biomarker discovery, but very few of these biomarkers are clinically adopted. To bridge the gap between Biomarker discovery and ...clinical use, we aim to generate the Biomarker Toolkit, a tool designed to identify clinically promising biomarkers and promote successful biomarker translation. Methods All features associated with a clinically useful biomarker were identified using mixed-methodology, including systematic literature search, semi-structured interviews, and an online two-stage Delphi-Survey. Validation of the checklist was achieved by independent systematic literature searches using keywords/subheadings related to clinically and non-clinically utilised breast and colorectal cancer biomarkers. Composite aggregated scores were generated for each selected publication based on the presence/absence of an attribute listed in the Biomarker Toolkit checklist. Results Systematic literature search identified 129 attributes associated with a clinically useful biomarker. These were grouped in four main categories including: rationale, clinical utility, analytical validity, and clinical validity. This checklist was subsequently developed using semi-structured interviews with biomarker experts (n=34); and 88.23% agreement was achieved regarding the identified attributes, via the Delphi survey (consensus level:75%, n=51). Quantitative validation was completed using clinically and non-clinically implemented breast and colorectal cancer biomarkers. Cox-regression analysis suggested that total score is a significant driver of biomarker success in both cancer types (BC: p0.0001, 95.0% CI: 0.869-0.935, CRC: p0.0001, 95.0% CI: 0.918-0.954). Conclusions This novel study generated a validated checklist with literature-reported attributes linked with successful biomarker implementation. Ultimately, the application of this toolkit can be used to detect biomarkers with the highest clinical potential and shape how biomarker studies are designed/performed. Keywords: Breast cancer, Biomarkers, Translational research, Clinical utility, Colorectal cancer
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
ObjectivesThe existing British National Patient Safety Agency (NPSA) safety guideline recommends testing the pH of nasogastric (NG) tube aspirates. Feeding is considered safe if a pH of 5.5 or lower ...has been observed; otherwise chest X-rays are recommended. Our previous research found that at 5.5, the pH test lacks sensitivity towards oesophageal placements, a major risk identified by feeding experts. The aim of this research is to use a decision analytic modelling approach to systematically assess the safety of the pH test under cut-offs 1–9.Materials and methodsWe mapped out the care pathway according to the existing safety guideline where the pH test is used as a first-line test, followed by chest x-rays. Decision outcomes were scored on a 0–100 scale in terms of safety. Sensitivities and specificities of the pH test at each cut-off were extracted from our previous research. Aggregating outcome scores and probabilities resulted in weighted scores which enabled an analysis of the relative safety of the checking procedure under various pH cut-offs.ResultsThe pH test was the safest under cut-off 5 when there was ≥30% of NG tube misplacements. Under cut-off 5, respiratory feeding was excluded; oesophageal feeding was kept to a minimum to balance the need of chest X-rays for patients with a pH higher than 5. Routine chest X-rays were less safe than the pH test while to feed all without safety checks was the most risky.DiscussionThe safety of the current checking procedure is sensitive to the choice of pH cut-offs, the impact of feeding delays, the accuracy of the pH in the oesophagus, as well as the extent of tube misplacements.ConclusionsThe pH test with 5 as the cut-off was the safest overall. It is important to understand the local clinical environment so that appropriate choice of pH cut-offs can be made to maximise safety and to minimise the use of chest X-rays.Trial registration numberISRCTN11170249; Pre-results.
Innovating in Medical Device (MD) industry is challenging. This study aims to develop and validate an evidence-based framework that helps innovators of small and large enterprises (SEs and LEs) ...assess their readiness for successful MD development and deployment. We conducted a key-informant process (stage 1) where 25 international experts identified a list of emergent Health Technology Assessment (HTA) themes they believed were essential to company success. A sample of 22 European and US selected companies (13 SEs and 9 LEs) then reached a consensus on a list of key themes through a robust Delphi process (stage 2). Finally, we constructed (stage 3) and validated (stage 4) the checklist for SEs and LEs. The checklist for SEs and LEs included 21 and 15 items (i.e., fundamental Yes/No questions) with nine overlapping criteria for both SEs and LEs. In both groups, MD success was driven by three major item categories: (i) R&D assessment strategy; (ii) device-outcome measures; (iii) company profiling. Alongside the retrospective validation study, we collected 40 case studies on MDs (23 successes and 17 failures) across the selected enterprises. The retrospective validation provided the proportion of successful and failed case studies that met the 'MeDKET' criteria. We discovered that early HTA plays a pivotal role in MD industry success with different implications based on enterprise size. This study is the first of its kind to provide a holistic picture of the perceived role of early-stage HTA in MD industry success.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Dear Editor,We read with interest the recently published study by Trigueros et al（1）,highlighting the financial and management conditions of femtosecond laser-assisted cataract surgery（FLACS）.The ...authors derived a simulation to estimate.
Abstract
Emerging data demonstrate long-term survival after salvage interventions for local or oligometastatic recurrence after planned curative resection for esophageal cancer, providing rationale ...for postoperative surveillance. However, the impact of intensive surveillance on oncologic outcome is unknown. This multicenter collaborative study aimed to characterize oncologic surveillance protocols across esophageal cancer centers internationally and determine the independent effect of intensive surveillance on oncologic outcome.
Methods
The ENSURE international multicenter study included consecutive patients who underwent surgery with curative intent for cTxNxM0 esophageal cancer from June 2009 to June 2015. Intensive surveillance was defined as use of cross-sectional imaging, at least annually, during the first three postoperative years. The estimated sample size of 4425 provided 90% power to detect a 5% increase in 5-year overall survival (OS, primary outcome measure). Secondary outcome measures included disease-free (DFS) and disease-specific survival (DSS), surveillance strategies, incidence of oligometastatic recurrence, treatment strategies, and HRQOL. The study was registered on ClinicalTrials.gov (NCT03461341).
Results
4597 patients were included. The participating 27 centres undertook mean(SD) 52.3(17.1) esophageal cancer resections annually between 3.5 ± 1.3 attending surgeons. 37%, 11% and 19% centers utilized postoperative surveillance CT, PET-CT and endoscopy, respectively. Among all patients, intensive surveillance was associated with improved OS (HR0.92 0.85–0.99) but not DSS (HR0.93 0.85–1.01) or DFS (HR0.97 0.90–1.04), and on multivariable analysis, intensive surveillance did not provide oncologic benefit (OS HR1.10 0.99–1.22, DSS HR1.12 1.00–1.25), but reduced observed DFS (HR1.19 1.08–1.31). Evaluating surveillance modalities, neither surveillance endoscopy nor laboratory tests improved oncologic outcome, however flexible nasolaryngoscopy was associated with improved OS (HR0.84 0.69–1.0).
Conclusion
ENSURE, the first study powered to assess the impact of postoperative surveillance protocols on oncologic outcome in esophageal cancer, demonstrated no overall survival benefit following intensive imaging surveillance, with reduced observed disease-free survival time. However, routine assessment for secondary aerodigestive malignancies may be of oncologic benefit. The present data do not support the use of intensive imaging surveillance among all patients following esophageal cancer surgery. Further reports detailing subgroup analyses and HRQOL impact are anticipated.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, UILJ, UKNU, UL, UM, UPUK
10.
COVID-19 rapid diagnostics: practice review Reynard, Charles; Allen, Joy A; Shinkins, Bethany ...
Emergency medicine journal,
01/2022, Letnik:
39, Številka:
1
Journal Article
Recenzirano
Odprti dostop
Point-of-care tests for SARS-CoV-2 could enable rapid rule-in and/or rule-out of COVID-19, allowing rapid and accurate patient cohorting and potentially reducing the risk of nosocomial transmission. ...As COVID-19 begins to circulate with other more common respiratory viruses, there is a need for rapid diagnostics to help clinicians test for multiple potential causative organisms simultaneously.However, the different technologies available have strengths and weaknesses that must be understood to ensure that they are used to the benefit of the patient and healthcare system. Device performance is related to the deployed context, and the diagnostic characteristics may be affected by user experience.This practice review is written by members of the UK's COVID-19 National Diagnostic Research and Evaluation programme. We discuss relative merits and test characteristics of various commercially available technologies. We do not advocate for any given test, and our coverage of commercially supplied tests is not intended to be exhaustive.
PDF
