scholarly journals Discovering Composite Lifestyle Biomarkers With Artificial Intelligence From Clinical Studies to Enable Smart eHealth and Digital Therapeutic Services

2021 ◽  
Vol 3 ◽  
Author(s):  
Sofoklis Kyriazakos ◽  
Aristodemos Pnevmatikakis ◽  
Alfredo Cesario ◽  
Konstantina Kostopoulou ◽  
Luca Boldrini ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Clinical Studies ◽  
Environmental Data ◽  
Therapeutic Area ◽  
Real World Data ◽  
Smart Services ◽  
Novel Treatments ◽  
Continuous Activity ◽  
Therapeutic Services

Discovery of biomarkers is a continuous activity of the research community in the clinical domain that recently shifted its focus toward digital, non-traditional biomarkers that often use physiological, psychological, social, and environmental data to derive an intermediate biomarker. Such biomarkers, by triggering smart services, can be used in a clinical trial framework and eHealth or digital therapeutic services. In this work, we discuss the APACHE trial for determining the quality of life (QoL) of cervical cancer patients and demonstrate how we are discovering a biomarker for this therapeutic area that predicts significant QoL variations. To this extent, we present how real-world data can unfold a big potential for detecting the cervical cancer QoL biomarker and how it can be used for novel treatments. The presented methodology, derived in APACHE, is introduced by Healthentia eClinical solution, and it is beginning to be used in several clinical studies.

scholarly journals 4505 Implementation of Real-World Data and Real-World Evidence in Clinical Studies

2020 ◽  
Vol 4 (s1) ◽  
pp. 114-114
Author(s):  
Jessica Pham ◽  
Eunjoo Pacifici
Keyword(s):  
Infectious Diseases ◽  
Real World ◽  
Clinical Studies ◽  
Treatment Effectiveness ◽  
Drug Product ◽  
Therapeutic Area ◽  
Real World Data ◽  
World Data ◽  
Real World Evidence ◽  
Product Effectiveness

OBJECTIVES/GOALS: Real-world studies have been gaining momentum in providing evidence of treatment effectiveness and hold great potential for facilitating the drug regulatory process. The U.S. Food and Drug Administration (FDA) has recognized this by providing a framework for using real-world data (RWD) to generate real-world evidence (RWE). The objective of this study is to assess the current level of RWE implementation in clinical studies. METHODS/STUDY POPULATION: Using keywords relevant to RWE, we reviewed studies on drugs, biologics, and medical devices published on PubMed in 2018. Information regarding the therapeutic area of focus, intervention type, study design, primary outcome, and data source was recorded. Further analyses of the three main therapeutic areas of study (oncology, cardiology, and infectious diseases) were performed to determine how RWE was being utilized. In addition, a broad “real-world” search was performed on Clinicaltrials.gov, from which we extracted relevant observational and Phase I, II, II/III, III, III/IV, and IV studies. A supplemental PubMed search was used to evaluate published studies in order to identify which field these trials were concentrated in and the outcome of interest.” RESULTS/ANTICIPATED RESULTS: After application of “real-world” search terms to PubMed, 995 hits were generated and of these, 311 studies were excluded. More than half of the studies were observational and retrospective in nature (64%) with 70% examining drug/biologic outcomes. RWE data sources were largely dominated by medical records and claims data. The primary uses of RWE across oncology, cardiology, and infectious diseases included supporting drug product effectiveness, assessing safety, and evaluating treatment patterns. Of the 207 RWE studies identified on ClinicalTrials.gov, 66 were cancer randomized controlled trials (RCTs), a majority of which were used for post-marketing safety evaluations. Further research will be conducted to determine the precise role of RWE in all studies (e.g. historical comparator, label expansion). DISCUSSION/SIGNIFICANCE OF IMPACT: By examining the use of RWE in regulatory decision making, we can inform stakeholders of the extent to which robust RWE studies complement evidence generated by RCTs. Thought to reflect a product’s performance in a broader and more diverse population, RWE can provide greater insight to clinical trial conduct and ultimately transform patient outcomes.

Nerve-sparing radical hysterectomy in patients with infiltrative cervical cancer

2016 ◽  
pp. 46-51
Author(s):  
T. Dermenzhy ◽  
◽  
V. Svintitskiy ◽  
S. Nespryadko ◽  
L. Legerda ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Radical Hysterectomy ◽  
Contractile Function ◽  
Major Elements ◽  
Control Group ◽  
Nerve Sparing ◽  
Group I ◽  
Hypogastric Plexus ◽  
Prognostic Indexes

The objective: to improve an effectiveness of therapy and quality of life of patients with infiltrative cervical cancer using radical hysterectomy accomplished with nerve-sparing methodology. Patients and Methods: Ninety patients with histologically verified infiltrative cervical cancer were cured with radical hysterectomy (RHE) in the Department of Oncogynecology of National Cancer Institute (Kyiv, Ukraine) in 2012-2016. The age of the patients was from 26 to 65 years (an average age of 42.61±1.06). The patients were distributed in 2 groups: group I treated with nerve-sparing radical hysterectomy (NSRHE), 45 patients, the main group; group II treated with radical hysterectomy (RHE III), the control group, 45 patients. The prognostic indexes in the groups were similar. Results. NSRHE that included the dissection of cardinal ligament, separation of dorsal and anterior layers of uterovesical ligament allowed separate uterine branch of inferior hypogastric plexus, preserve an innervation of urinary bladder and prevent the malfunction of its contractile function at postoperative period. Conclusion. The data of the urodynamic study using cystomanometry performed at pre- and early operative periods have shown that surgical treatment of patients with infiltrative cervical cancer with preservation of the major elements of pelvic autonomic plexuses allows significantly decrease the rate of postoperative urogenical malfunctions. Key words: nerve-sparing radical hysterectomy, cervical cancer, cystomanometry.

MENOPAUSAL HORMONOTHERAPY IN ONCOGYNECOLOGIC PATIENTS

2017 ◽  
Vol 63 (6) ◽  
pp. 843-854
Author(s):  
Olga Novikova ◽  
Yelena Ulrikh ◽  
V. Nosov ◽  
A. Charkhifalakyan
Keyword(s):  
Quality Of Life ◽  
Cervical Cancer ◽  
Endometrial Cancer ◽  
Hormone Replacement Therapy ◽  
Hormone Therapy ◽  
Replacement Therapy ◽  
Hormone Replacement ◽  
Menopausal Hormone Therapy ◽  
Oncological Safety

There is presented the review of domestic and foreign references on the conserved oncological safety of the use of menopausal hormone therapy after treatment for endometrial cancer, cervical cancer, borderline and malignant ovarian tumors, various variants of sarcomas of the uterus, vulva and vaginal cancer. To the opinion of the authors the refusal to prescribe menopausal hormone therapy to patients with oncogynecologic diseases in the anamnesis is usually not justified, the category of patients, to whom hormone replacement therapy is contraindicated, is well described and mentioned in the text. In other cases sex hormones can be used to treat menopausal symptoms and improve the quality of life of patients.

scholarly journals Measuring What Matters for Children: A Systematic Review of Frequently Used Pediatric Generic PRO Instruments

2021 ◽  
Author(s):  
Tasneem Arsiwala ◽  
Nuzhat Afroz ◽  
Kattayoun Kordy ◽  
Christel Naujoks ◽  
Francesco Patalano
Keyword(s):  
Quality Of Life ◽  
Child Health ◽  
Clinical Studies ◽  
Task Force ◽  
Emotional Health ◽  
Research Practices ◽  
European Collaboration ◽  
Patient Reported ◽  
Good Research

Abstract Objective To provide an assessment of the quality of the most frequently used self-reported, generic patient-reported outcome measures (PROMs) that measure health-related quality of life (HRQoL) in children against the good research practices recommended by ISPOR task force for the pediatric population. Method Literature search was conducted on OvidSP database to identify the generic pediatric PROMs used in published clinical studies. The quality of PROMs used in more than ten clinical studies were descriptively evaluated against the ISPOR task force’s good research practices. Results Six PROMs were evaluated, namely Pediatric Quality-of-Life inventory 4.0 (PedsQL), Child Health Questionnaire (CHQ), KIDSCREEN, KINDL, DISABKIDS and Child Health and Illness Profile (CHIP). All PROMs, except KIDSCREEN, had versions for different age ranges. Domains of physical, social, emotional health and school activities were common across all the instruments, while domains of family activities, parent relations, independence, and self-esteem were not present in all. Children’s input was sought during the development process of PROMs. Likert scales were used in all the instruments, supplemented with faces (smileys) in instruments for children under 8 years. KIDSCREEN and DISABKIDS were developed in a European collaboration project considering the cross-cultural impact during development. Conclusion The comparison of the instruments highlights differences in the versions for different pediatric age groups. None of the PROMs fulfill all the good research practices recommended by the ISPOR task force. Further research is needed to define which age-appropriate domains are important for older children and adolescents.

scholarly journals Sustainable Smart City—Opening a Black Box

2021 ◽  
Vol 13 (2) ◽  
pp. 769
Author(s):  
Mona Treude
Keyword(s):  
Sustainable Development ◽  
Citizen Participation ◽  
Smart City ◽  
Evolutionary Economics ◽  
Smart Cities ◽  
Innovation Process ◽  
Sustainable City ◽  
Smart Services ◽  
Underlying Processes

Cities are becoming digital and are aiming to be sustainable. How they are combining the two is not always apparent from the outside. What we need is a look from inside. In recent years, cities have increasingly called themselves Smart City. This can mean different things, but generally includes a look towards new digital technologies and claim that a Smart City has various advantages for its citizens, roughly in line with the demands of sustainable development. A city can be seen as smart in a narrow sense, technology wise, sustainable or smart and sustainable. Current city rankings, which often evaluate and classify cities in terms of the target dimensions “smart” and “sustainable”, certify that some cities are both. In its most established academic definitions, the Smart City also serves both to improve the quality of life of its citizens and to promote sustainable development. Some cities have obviously managed to combine the two. The question that arises is as follows: What are the underlying processes towards a sustainable Smart City and are cities really using smart tools to make themselves sustainable in the sense of the 2015 United Nations Sustainability Goal 11? This question is to be answered by a method that has not yet been applied in research on cities and smart cities: the innovation biography. Based on evolutionary economics, the innovation biography approaches the process towards a Smart City as an innovation process. It will highlight which actors are involved, how knowledge is shared among them, what form citizen participation processes take and whether the use of digital and smart services within a Smart City leads to a more sustainable city. Such a process-oriented method should show, among other things, to what extent and when sustainability-relevant motives play a role and which actors and citizens are involved in the process at all.

scholarly journals Development and content validity of the Barth Syndrome Symptom Assessment (BTHS-SA) for adolescents and adults

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Chad Gwaltney ◽  
Jonathan Stokes ◽  
Anthony Aiudi ◽  
Iyar Mazar ◽  
Sarah Ollis ◽  
...  
Keyword(s):  
Clinical Studies ◽  
Genetic Disorder ◽  
Signs And Symptoms ◽  
Symptom Assessment ◽  
Barth Syndrome ◽  
Therapeutic Area ◽  
Symptom Experience ◽  
Patient Reported ◽  
Adolescents And Adults ◽  
Syndrome Symptom

Abstract Background Barth Syndrome (BTHS) is a rare genetic disorder that presents as a complex of debilitating symptoms and reduced life expectancy. Well-developed, BTHS-specific assessments measuring primary signs and symptoms of BTHS are not currently available, making it difficult to evaluate treatment effects in BTHS clinical studies. The objective of this research was to develop symptom-focused patient-reported outcome (PRO) measures for use in clinical studies with adolescents and adults with BTHS. Methods Concept elicitation interviews (CEIs) with pediatric (n = 18, age < 16 years) and adult (n = 15, age ≥ 16 years) individuals with BTHS and/or their caregivers were conducted to identify signs and symptoms relevant to BTHS and important to individuals with the condition. Based on CEI results, questionnaire construction activities were conducted to create unique adolescent and adult versions of the Barth Syndrome-Symptom Assessment (BTHS-SA). The questionnaires were evaluated in cognitive debriefing interviews (CDIs) with adolescents (n = 12; age 12- < 16 years) and adults (n = 12; age ≥ 16 years) with BTHS to assess relevance and readability of the tools. Results During the CEIs, a total of 48 and 40 signs and symptoms were reported by the pediatric and adult groups, respectively; 31 were reported by both age groups. Fatigue/tiredness and muscle weakness were the symptoms most frequently reported by both pediatric and adult patients with BTHS as important to improve with an effective treatment. The CEI results informed construction of a nine-item version of the BTHS-SA for adolescents and an eight-item version for adults. Developed for daily administration, each version asks respondents to rate symptom severity “at its worst” over the 24 h prior to administration. CDIs with both adolescents and adults with BTHS demonstrated that each BTHS-SA version was reflective of the disease experience and that respondents could interpret the questionnaire as intended and provide responses that accurately reflected their symptom experience. Conclusions The BTHS-SA adolescent and adult versions are content-valid PRO measures that can be used to evaluate severity of disease-specific symptoms in future clinical trials. Given the lack of available and well-developed assessments in this underserved therapeutic area, these tools fulfill a need for clinical researchers developing treatments for individuals with BTHS.

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