26.C. Workshop: How to evaluate digital health: three examples based on the model of Continuous eHealth Evaluation

2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
◽  
Keyword(s):  
Public Health ◽  
Iterative Process ◽  
Development Process ◽  
Digital Health ◽  
Evaluation Studies ◽  
Real Life ◽  
Health Innovations ◽  
Real Life Setting ◽  
Starting Point

Abstract Despite the common advantages of digital health, such as the increase of quality of care and the decrease in healthcare costs, the implementation of these innovations into public health are lacking. A positive impact in daily clinical practice is important for the successful implementation of digital health [1, 2]. Still it is difficult to assess the true impact of digital health in a real-life setting as proper evaluation studies are challenging [3-5]. Within a clinical setting the focus of these evaluations are mainly on clinical effectiveness or quality of care. But these kinds of evaluations are only feasible when the technology is mature and no further development is needed. This is also indicated by the most popular method for the evaluation of digital health, based on the Health Technology Assessment (HTA) model. This method, the Model for Assessment of Telemedicine (MAST) [6-8], is only applicable for fully mature technologies. Unfortunately, MAST does not specify when a technology is mature enough. Resulting in evaluations of immature technologies in clinical trials. In our opinion, the maturity of the technology can be assessed based on the Technology Readiness Levels (TRLs). With TRLs we can clearly communicate whether a technology, such as a digital health intervention, is ready for use in daily clinical practice. An understanding of both the performance and the intended use of the technology is required to establish TRL and should be the starting point for every evaluation. The objective of this workshop is to present our model for continuous eHealth evaluation [9] and to demonstrate it based on three evaluation studies of new developed digital health innovations for public health. All three innovations are still under development and have different TRLs. This will help other researchers to plan their evaluation studies with health technologies in an early phase of development. In our opinion the evaluation of digital health should be a continuous and iterative process, aligned to the progress in the development process itself. The presentations will each focus on the evaluation of a new digital innovation with real end-users and in a real-life setting. These evaluations are based on our model for continuous eHealth evaluation and will be presented as three separate cases. We will conduct a 60-minutes interactive workshop, which starts with an overview presentation (15 minutes) of our model for continuous eHealth evaluation. Next, three presentations (3x 10 minutes) on the evaluation of the three new digital health innovation will follow. The workshop ends with a plenary discussion (15 minutes) to discuss our view on the evaluation of digital health (model for continuous eHealth evaluation) and the development of the digital health innovations with the attendees. Key messages The evaluation of digital health is challenging but the maturity of the technology must be the starting point of every digital health evaluation. The evaluation of digital health should be a continuous and iterative process, aligned to the progress in the development process itself.

scholarly journals How Sexuality Education Programs Have Been Evaluated in Low- and Lower-Middle-Income Countries? A Systematic Review

2020 ◽  
Vol 17 (21) ◽  
pp. 8183
Author(s):  
Olena Ivanova ◽  
Masna Rai ◽  
Kristien Michielsen ◽  
Sónia Dias
Keyword(s):  
Public Health ◽  
Sexuality Education ◽  
Program Effectiveness ◽  
Sexual Debut ◽  
Controlled Trial ◽  
Evaluation Studies ◽  
Middle Income ◽  
Middle Income Countries ◽  
Quasi Experimental

Background: Complex sexual and reproductive health interventions, such as sexuality education (SE), contain multiple components and activities, which often requires a comprehensive evaluation design and adaptation to a specific context. In this review, we synthetize available scientific literature on types of evaluation designs used for SE programs in low- and lower-middle-income countries. Methods: Two databases yielded 455 publications, from which 20 articles met the inclusion criteria. Narrative synthesis was used to summarize the findings. Evaluation approaches were compared to recommended evaluation frameworks. The quality of articles was assessed by using MMAT 2018. Results: A total of 15 interventions employed in 10 countries were evaluated in the 20 selected articles, with the quality of publications being moderate to high. Randomized controlled trial was the predominant study design, followed by quasi-experimental design. There were seven process evaluation studies, using mixed methods. Main outcomes reported were of public health or behavioral nature—condom use, sexual debut or delay, and number of sexual partners. By comparing evaluation designs to recommended frameworks, few studies fulfilled at least half of the criteria. Conclusions: Evaluations of SE are largely dominated by quantitative (quasi-)experimental designs and use of public health outcomes. To improve understanding of SE program effectiveness, it is important to assess the quality of the program development, its implementation, and its impact, using existing evaluation frameworks and recommendations.

Ziv-aflibercept (Z) in combination with FOLFIRI for second-line treatment of patients (pts) with metastatic colorectal cancer (mCRC): Interim safety data from the global aflibercept safety and quality-of-life program in pts pretreated with bevacizumab (B).

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 556-556 ◽  
Author(s):  
David Raymond Ferry ◽  
Alberto F. Sobrero ◽  
Roberto Bordonaro ◽  
Salvatore Siena ◽  
Filippo Pietrantonio ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Safety Data ◽  
Real Life ◽  
The United States ◽  
Open Label ◽  
Real Life Setting ◽  
Safety Population ◽  
Previously Treated ◽  
Initial Starting

556 Background: In the VELOUR study, adding Z (known as aflibercept outside the United States) to FOLFIRI resulted in improved OS, PFS, and RR in mCRC pts who had received prior oxaliplatin. Prior treatment with B (~30% of the ITT population) did not appear to impact the safety profile of Z. Results from VELOUR supported initiation of the global Aflibercept Safety and Quality-of-Life (QoL) Program composed of two clinical studies (ASQoP [NCT01571284]; AFEQT [NCT01670721]) to capture QoL and safety data from a population similar to that of VELOUR in a real-life setting. We report early safety data from this interim analysis in pts pretreated with B. Methods: ASQoP and AFEQT are single-arm, open-label trials evaluating safety and QoL of Z in mCRC pts previously treated with an oxaliplatin-containing regimen. Eligible pts receive Z (4 mg/kg) q2wks on day 1 of each cycle followed by FOLFIRI until disease progression, unacceptable toxicity, death, or investigator/pt decision. Initial starting doses and subsequent modifications are at treating physicians’ discretion. The percentage of pts with grade (G) 3/4 adverse events (AEs) in the combined safety population of ASQoP and AFEQT in B-pretreated pts is compared with that of B-pretreated pts in VELOUR. Results: At data cut-off, the safety population comprised 116 pts with ≥1 completed treatment cycle; 67 (57.8%) were pretreated with B. At least 1 G3/4 AE was experienced by 49.3% of pts vs 82.5% in VELOUR. Most G3/4 AEs were G3. There were no reports of G4 hypertension or proteinuria. Conclusions: Thisinterim safety analysis from ASQoP/AFEQT in pts pretreated with B has identified no new safety signals for Z and a trend toward decreased incidence of G3/4 events. The early analysis provides additional safety data and suggests an acceptable toxicity profile in this real-life setting. Clinical trial information: NCT01571284. [Table: see text]

Impact on OS of 2nd and 3rd generation TKI in EGFR mt+ and ALK+ patients: Results of the NOWEL network.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e20560-e20560 ◽  
Author(s):  
Julia Roeper ◽  
Maria Netchaeva ◽  
Anne Christina Lueers ◽  
Ursula Stropiep ◽  
Cora Hallas ◽  
...  
Keyword(s):  
Real Life ◽  
Stage Iv ◽  
Cancer Centers ◽  
Real Life Setting ◽  
Effective Choice ◽  
Detection Of Mutations ◽  
The Impact ◽  
Choice Of Therapy ◽  
Generation Sequencing

e20560 Background: Available clinical research data shows that early mutation testing for patients with NSCLC stage IV could lead to an effective choice of therapy for patients with proven mutations. Targeted therapies achieve a higher ORR, PFS, OS and a better quality of life than chemotherapy in mt+ patients. With the advent of 2nd and 3rd generation TKI´s effective in 1st generation TKI resistant tumors, we wanted to study the impact of these drugs on the outcome of patients in a real life setting in 3 lung cancer centers. Methods: 1383 patients from the three cancer centers diagnosed with NSCLC stage IV (UICC 7) were examined. Methods for the detection of mutations included Sanger Sequencing, hybridization based COBAS testing as well as hybrid cage next generation sequencing. Results: 880/1383 (64%) consecutive patients with non-squamous cell NSCLC from the cancer centers were studied for the presence of tumor mutations, especially for EGFR and ALK mutations. The EGFR mutation rate was 16.6% (141/880), and the ALK-translocation rate 3.8% (24/635). Median OS in EGFR mt+ patients was 31 (n = 78) vs. 32 (n = 38) vs. 16 (n = 14) months respectively (center 1 vs. center 2 vs. center 3). Median OS in ALK mt+ patients was 25 (n = 17) months in center 1 and 11 (n = 5) months in center 2 (p < 0.05). Use of 3rd generation TKI Osimertinib (n = 17) lead to a significantly higher OS (n = 17, median OS 67 mo) than the use of only 1st and 2nd generation TKI (n = 113, median OS 24 mo, p < 0.000). Similarly, use of 2nd and 3rd generation ALKi impacted significantly on median OS: Crizotinib alone n = 7, 17 months, Crizotinib followed by Ceritinib and/or Brigatinib (n = 9) median OS not reached, p < 0.001. Conclusions: Smalldifferences in OS were observed, depending on the treatment centers, but the use of multiple EGFR and ALK-I impacted highly significantly on the outcome of patients with EGFR and ALK-alterations in a real life setting.

scholarly journals Acoustic Coordinated Reset Neuromodulation in a Real Life Patient Population with Chronic Tonal Tinnitus

2015 ◽  
Vol 2015 ◽  
pp. 1-8 ◽  
Author(s):  
Christian Hauptmann ◽  
Armin Ströbel ◽  
Mark Williams ◽  
Nitesh Patel ◽  
Hannes Wurzer ◽  
...  
Keyword(s):  
Real Life ◽  
Negative Influence ◽  
Tinnitus Questionnaire ◽  
Open Label ◽  
Safety And Efficacy ◽  
Life Conditions ◽  
Real Life Setting ◽  
Clinically Significant ◽  
Coordinated Reset

Purpose. Primary tinnitus has a severe negative influence on the quality of life of a significant portion of the general population. Acoustic coordinated reset neuromodulation is designed to induce a long-lasting reduction of tinnitus symptoms. To test acoustic coordinated reset neuromodulation as a treatment for chronic, tonal tinnitus under real life conditions, an outpatient study “RESET Real Life” was commissioned by ANM GmbH. Herein we present the results of this study.Methods. In a prospective, open-label, nonrandomized, noncontrolled multicenter clinical study with 200 chronic tinnitus patients, tinnitus questionnaire TBF-12 and Global Clinical Improvement-Impression Scale (CGI-I7) are used to study the safety and efficacy of acoustic coordinated reset neuromodulation. 189 patients completed the last 12-month visit, 11 patients dropped out (8 because of nontreatment related reasons; 2 because tinnitus did not change; and 1 because tinnitus got louder).Results. Acoustic coordinated reset neuromodulation caused a statistically and clinically significant decrease in TBF-12 scores as well as in CGI-I7 after 12 months of therapy under real life conditions. There were no persistent adverse events reported that were related to the therapy.Conclusion. The field study “RESET Real Life” provides evidence for safety and efficacy of acoustic coordinated reset neuromodulation in a prospective, open-label, real life setting.

Long-term treatment of chronic migraine with OnabotulinumtoxinA: efficacy, quality of life and tolerability in a real-life setting

2016 ◽  
Vol 123 (5) ◽  
pp. 533-540 ◽  
Author(s):  
Katja Kollewe ◽  
Claus M. Escher ◽  
Dirk U. Wulff ◽  
Davood Fathi ◽  
Lejla Paracka ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Chronic Migraine ◽  
Real Life ◽  
Term Treatment ◽  
Real Life Setting ◽  
Long Term Treatment

scholarly journals Mitigating Long-Term COVID-19 Consequences on Brain Health

2021 ◽  
Vol 12 ◽  
Author(s):  
Ryan C. N. D'Arcy ◽  
Jagdeep K. Sandhu ◽  
Shawn Marshall ◽  
Markus Besemann
Keyword(s):  
Risk Factors ◽  
Nervous System ◽  
Digital Health ◽  
Objective Evaluation ◽  
Health Impacts ◽  
Brain Health ◽  
Health Innovations ◽  
Starting Point ◽  
The Brain

COVID-19 is increasingly being linked to brain health impacts. The emerging situation is consistent with evidence of immunological injury to the brain, which has been described as a resulting “brain fog.” The situation need not be medicalized but rather clinically managed in terms of improving resilience for an over-stressed nervous system. Pre-existing comparisons include managing post-concussion syndromes and/or brain fog. The objective evaluation of changes in cognitive functioning will be an important clinical starting point, which is being accelerated through pandemic digital health innovations. Pre-morbid brain health can significantly optimize risk factors and existing clinical frameworks provide useful guidance in managing over-stressed COVID-19 nervous systems.

Malignant gastrointestinal stromal tumors treated with imatinib in France: Results in unselected patients

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e22177-e22177
Author(s):  
A. Mathieu-Boue ◽  
O. Bouché ◽  
A. Cioffi ◽  
M. Rios ◽  
F. Duffaud ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Disease Onset ◽  
Initial Dosage ◽  
Real Life ◽  
Published Data ◽  
Case Report Form ◽  
Primary Tumors ◽  
Real Life Setting

e22177 Background: GISTs are rare tumors of the GI tract. In France, their incidence is estimated to be 9- 12/106 inhabitants/year. Imatinib (IM) has been approved to treat unresectable and/or metastatic Kit-positive GISTs since 2002 but information on routine use, safety and efficacy in unselected “real life” setting is lacking. An observational cohort (EPIGIST) in France was designed to provide data on survival, safety and treatment patterns and quality of life. Methods: EPIGIST is a nationwide multi-center, observational study on GIST patients (pts) treated with IM for the first time between the availability on the French Market and the end of the 2008. Centers were randomly selected in national files of oncologists, gastrointestinal surgeons and gastrointestinal specialists. The planned follow-up duration was three years. A case report form (CRF) had to be completed at inclusion and during each follow-up visits. Quality of life was assessed using QLQ-C30 and SF36 questionnaires. Results: 29 on 51 selected centers enrolled at least one pt and 127 pts were included (as of 12/2008), The median age of disease onset was 59 years (range 29 - 85) with 48% pts>50 years. 63% were symptomatic at diagnosis; 69% were fully active (grade 0 on the ECOG index). Primary tumors were most often gastric (34%), or from jejunum/ileum (24%). At diagnosis 84% of pts had a tumor size over 5cm. 64% of patients had surgery of the primary tumor before starting IM. For 86% of the pts, IM was given at an in initial dosage of 400 mg, 8% at 300 mg and 6% at 800mg. Compliance was superior to 90% for all pts. With a median follow-up of 1.72 years (CI95%: [1.08;1.95]), two-years overall survival from first treatment with IM was 88.1% (CI95%: [65.3%-96.3%]). Conclusions: EPIGIST is still an ongoing survey. Current results confirm previous published data on survival in GIST treated with IM in an unselected cohort of patients outside of a clinical trial. [Table: see text]

Aflibercept (Z) in combination with FOLFIRI for second-line treatment of patients (pts) with metastatic colorectal cancer (mCRC): Safety and quality of life (QoL) data from the Spanish subgroup of the Aflibercept Safety and Quality-of-Life Program (ASQoP).

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 751-751
Author(s):  
Fernando Rivera ◽  
Eduardo Polo Marques ◽  
Enrique Aranda ◽  
Carlos Fernandez-Martos ◽  
Adelaida La Casta Munoa ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Real Life ◽  
Open Label ◽  
Utility Index ◽  
Real Life Setting ◽  
Safety Population ◽  
Eortc Qlq C30 ◽  
Report Data ◽  
Eortc Qlq

751 Background: In the VELOUR trial, adding Z to FOLFIRI improves OS, PFS and RR in mCRC pts progressing after oxaliplatin ±biologic agents. The ASQoP trial (NCT01571284) was designed to gather safety and QoL data from mCRC in real-life setting. We report data collected by the Spanish investigators. Methods: ASQoP is single-arm, open-label trial evaluating safety and QoL of Z in mCRC pts as 2nd line. Eligible pts received Z (4mg/kg) q2wks on day 1/cycle, followed by FOLFIRI (dosing was at physician’s discretion) until disease progression, unacceptable toxicity, death, or investigator/pt decision. The EQ-5D was used for utility index (UI) measure and the EORTC QLQ-C30 as generic cancer instrument. QoL population consisted of pts completing the questionnaire at baseline and ≥1 assessment post-baseline and received ≥1 part of 1 dose of study treatment. Results: The safety population comprised 77 pts with ≥1 completed cycle of treatment. Grade (G)3/4 AEs were reported in 72.7% of pts (vs 83.5% in VELOUR), being G3 most commonly reported. There was no G4 hypertension, stomatitis, or proteinuria. G4 Diarrhea was found in 1.3% of pts. Mean baseline UI was 0.7 (95% CI, 0.63-0.78) in 51 pts, and remained relatively stable at cycles 3 (n=39) and 7 (n=24), with a mean (±SD) change from baseline of 0.03 (±0.26) and -0.06 (±0.35), respectively. Mean baseline global health status score was 63.1 (95% CI, 55.8-70.4) in 54 pts, and remained stable up to cycle 9 with a mean (±SD) change from baseline of 4.17 (±38). Conclusions: Thisanalysis has identified no new safety signals and suggests an acceptable toxicity profile with a relatively stable UI and QoL in Spanish mCRC pts in the real-life setting. [Table: see text]

scholarly journals Improving graduate outcomes

2020 ◽  
Vol ahead-of-print (ahead-of-print) ◽  
Author(s):  
Ugochukwu Chinonso Okolie ◽  
Elisha Nwonu Elom ◽  
Paul Agu Igwe ◽  
Michael Olayinka Binuomote ◽  
Chinyere Augusta Nwajiuba ◽  
...  
Keyword(s):  
Teaching And Learning ◽  
Real Life ◽  
Theory And Practice ◽  
Semistructured Interview ◽  
Content Type ◽  
Postgraduate Students ◽  
Effective Implementation ◽  
Life Problems ◽  
Starting Point

PurposeThis study explores how the implementation of problem-based learning (PBL) in technical and vocational education training (TVET) systems of Nigerian higher education (HE) can enhance quality graduate outcomes. The study also explores the issues and challenges of PBL implementation in the TVET system of Nigerian HE.Design/methodology/approachThis study follows the assumptions of qualitative research. The authors interviewed 55 participants and had a focus group with 7 TVET postgraduate students. The 55 interviewees were drawn from TVET teachers (n = 33; 24 males and 9 females), Directors at National Board for Technical Education (n = 4; 3 males and 1 female), Directors of National Directorate of Employment (n = 5; 3 males and 2 females), Directors at the Federal Ministry of Education (n = 3 males), and industry executives (n = 10; 7 males and 3 females). Data were collected through a semistructured interview approach, transcribed and coded using NVivo 12 plus and analyzed through thematic analysis.FindingsThe results show that PBL in the Nigerian TVET system has positive implications for quality TVET graduate outcomes in that it can enable integrating theory and practice, motivate learning, improve students' self-efficacy, allow students to construct learning on their own, enhance graduate competencies and graduate employability. It also revealed six perceived possible major challenges to effective implementation of PBL in the Nigerian TVET system, which includes inadequacy of teaching and learning facilities; corruption in Nigerian education sector; recruitment of unqualified incompetent TVET teachers; difficulties in identifying real-life problems, among others. Participants offered benchmarks and actions and standards for improving the identified challenges, which formed a framework for coping with issues, challenges, and barriers to effective implementation of PBL in the TVET system of Nigerian HE (Table 1).Originality/valueThe results of this study are original and serve as an advocacy for Nigerian HE authorities to explore how PBL can be implemented in the TVET system to improve graduate outcomes. The study serves as a starting point for more research in the domain of improving the quality of TVET programs in Nigerian HE. Industry leaders and policymakers in Nigeria and other developing countries could use the findings from this study to increase HE and industry participation and partnership for quality of TVET program.

Long-term treatment of chronic migraine with onabotulinumtoxinA: Efficacy, quality of life, and tolerability in a real-life setting

Toxicon ◽  
2016 ◽  
Vol 123 ◽  
pp. S50
Author(s):  
Katja Kollewe ◽  
Claus M. Escher ◽  
Dirk U. Wulff ◽  
Davood Fathi ◽  
Lejla Paracka ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Chronic Migraine ◽  
Real Life ◽  
Term Treatment ◽  
Real Life Setting ◽  
Long Term Treatment
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