scholarly journals Using patient-centered end-points in older adults participating in clinical trials

2016 ◽  
Vol 2 (1) ◽  
Author(s):  
Arduino A. Mangoni ◽  
Kimberley Ruxton
Keyword(s):  
Clinical Trials ◽  
Patient Group ◽  
Older Patients ◽  
Prognostic Index ◽  
Well Being ◽  
Functional Independence ◽  
Individual Variability ◽  
Patient Centered ◽  
End Points ◽  
The Impact

Conventional end-points, primarily based on the pharmacodynamic effects of a specific drug, are used to assess the efficacy of pharmacological treatment in clinical trials. However, their application and interpretation in complex frail older patients, a patient group with high inter-individual variability, multiple coexisting disease states and prescribed medications, is becoming increasingly questionable. National surveys and qualitative studies have convincingly shown that the maintenance of functional independence is key to self-rated health and well being in old age. Therefore, the use of unconventional, patientcentered, end-points focused on functional status and perceived health seems appropriate, in combination with conventional end-points, to comprehensively investigate the impact of pharmacological treatments in this patient group. The recent availability of objective, quantifiable, and robust scoring tools, such as the multidimensional prognostic index, to assess key functional domains and clinical outcomes offers a unique opportunity to adequately characterize patient-centered endpoints in future clinical trials in older patients.

scholarly journals Opportunities and challenges of incorporating clinical outcome assessments in brain tumor clinical trials

2018 ◽  
Vol 6 (2) ◽  
pp. 81-92 ◽  
Author(s):  
Emanuela Molinari ◽  
Tito R Mendoza ◽  
Mark R Gilbert
Keyword(s):  
Clinical Trials ◽  
Brain Tumor ◽  
Clinical Outcome ◽  
Clinical Trial Design ◽  
Well Being ◽  
Successful Implementation ◽  
Outcome Assessments ◽  
Tumor Studies ◽  
Clinical Outcome Assessments ◽  
The Impact

Abstract Regulatory agencies have progressively emphasized the importance of assessing broader aspects of patient well-being to better define therapeutic gain. As a result, clinical outcome assessments (COAs) are increasingly used to evaluate the impact, both positive and negative, of cancer treatments and in some instances have played a major factor in the regulatory approval of drugs. Challenges remain, however, in the routine incorporation of these measures in cancer clinical trials, particularly in brain tumor studies. Factors unique to brain tumor patients such as cognitive decline and language dysfunction may hamper their successful implementation. Study designs often relegated these outcome measures to exploratory endpoints, further compromising data completion. New strategies are needed to maximize the complementary information that COAs could add to clinical trials alongside more traditional measures such as progression-free and overall survival. The routine incorporation of COAs as either primary or secondary objectives with attention to minimizing missing data should define a novel clinical trial design. We provide a review of the approaches, challenges, and opportunities for incorporating COAs into brain tumor clinical research, providing a perspective for integrating these measures into clinical trials.

scholarly journals Multidimensional aspects related to shiftworkers' health and well-being

2004 ◽  
Vol 38 (suppl) ◽  
pp. 86-91 ◽  
Author(s):  
Giovanni Costa
Keyword(s):  
Family Relations ◽  
Biological Rhythms ◽  
Well Being ◽  
Individual Variability ◽  
Human Dimensions ◽  
Individual Characteristics ◽  
Social Conditions ◽  
Specific Work ◽  
The Impact ◽  
Health And Well Being

The impact of shift and night work on health shows a high inter- and intra-individual variability, both in terms of kind of troubles and temporal occurrence, related to various intervening factors dealing with individual characteristics, lifestyles, work demands, company organisation, family relations and social conditions. The way we define "health" and "well-being" can significantly influence appraisals, outcomes and interventions. As the goal is the optimisation of shiftworkers' health, it is necessary to go beyond the health protection and to act for health promotion. In this perspective, not only people related to medical sciences, but many other actors (ergonomists, psychologists, sociologists, educators, legislators), as well as shiftworkers themselves. Many models have been proposed aimed at describing the intervening variables mediating and/or moderating the effects; they try to define the interactions and the pathways connecting risk factors and outcomes through several human dimensions, which refer to physiology, psychology, pathology, sociology, ergonomics, economics, politics, and ethics. So, different criteria can be used to evaluate shiftworkers' health and well-being, starting from biological rhythms and ending in severe health disorders, passing through psychological strain, job dissatisfaction, family perturbation and social dis-adaptation, both in the short- and long-term. Consequently, it appears rather arbitrary to focus the problem of shiftworkers' health and tolerance only on specific aspects (e.g. individual characteristics), but a systemic approach appears more appropriate, able to match as many variables as possible, and aimed at defining which factors are the most relevant for those specific work and social conditions. This can support a more effective and profitable (for individuals, companies, and society) adoption of preventive and compensative measures, that must refer more to "countervalues" rather than to "counterweights".

scholarly journals Using the multidimensional prognostic index for treatment decisions and monitoring in frail older patients

2017 ◽  
Vol 3 (3) ◽  
Author(s):  
Arduino A. Mangoni
Keyword(s):  
Clinical Guidelines ◽  
Older Patients ◽  
Management Strategies ◽  
Treatment Strategies ◽  
Prognostic Index ◽  
End Points ◽  
Disease States ◽  
Safe Management ◽  
Limited Life ◽  
Poor Functional Status

The routine applicability of clinical guidelines and disease-specific end-points in frail older patients is problematic because of the exclusion of this group from clinical trials, their limited life expectancy, the co-existence of multiple disease states and poor functional status, and the presence of complex drug-drug and drug-disease interactions. In this context, the use of patient-centred end-points that include measures of quality of life might be particularly useful for designing tailored treatment strategies, monitor progress and, ultimately, improve outcomes. The multidimensional prognostic index, an objective, quantifiable, and validated scoring system based on core domains of the comprehensive geriatric assessment, might represent an important tool for the development of clinical guidelines that take into account measures of frailty and patientcentred end-points. However, research is warranted to investigate whether this approach leads to more effective and safe management strategies in old age.

scholarly journals Komunitas Masyarakat Dan Perawatan Kesehatan Dalam Peningkatan Kualitas Hidup

2020 ◽  
Vol 10 (1) ◽  
pp. 11-24
Author(s):  
Agustinus Hermino
Keyword(s):  
Quality Of Life ◽  
Health Care ◽  
Health Care Quality ◽  
Health Sector ◽  
Well Being ◽  
Individual Variability ◽  
Care Quality ◽  
Global Era ◽  
The Impact

Latar belakang: Seiring dengan perkembangan jaman, dalam beberapa tahun terakhir ini banyak perhatian yang difokuskan pada eksplorasi dampak penyakit fisik dan mental pada kualitas hidup seseorang baik secara individu maupun masyarakat secara keseluruhan. Sifat subyektif dari 'kualitas hidup' individu, merupakan konsep yang dinamis untuk diukur dan didefinisikan, tetapi bahwa secara umum dapat dipandang sebagai konsep multidimensi yang menekankan pada persepsi diri dari keadaan pikiran seseorang saat iniTujuan: penulisan ini bertujuan untuk memberikan pemahaman tentang peran masyarakat dalam memahani pentingnya kesehatan di era global ditinjau dari perspektif akademis. Pada sektor kesehatan pemahaman kesehatan menjadi sangat pentingnya karena akan menunjukkan pada kualitas hidup seseorang, tetapi hal ini tidak cukup secara individu karena diperlukan pemahaman secara menyeluruh terhadap masyarakat tentang makna kesehatan dan perawatan kesehatan.Metode: penulisan ilmiah ini adalah dengan melakukan analisa akademis dari dari berbagai sumber rujukan relevan sehingga menemukan makna teoritis baru dalam rangka menjawab tantangan yang terjadi di masyarakat.Hasil: Berdasarkan berbagai sumber rujukan yang ada, dapat disimpulkan bahwa kesehatan merupakan gaya hidup yang bertujuan untuk mencapai kesejahteraan fisik, emosional, intelektual, spiritual, dan lingkungan. Penggunaan langkah-langkah kesehatan dapat meningkatkan stamina, energi, dan harga diri, kemudian meningkatkan kualitas hidup. Dengan demikian maka konsep kesehatan memungkinkan adanya variabilitas individu. Kesehatan dapat dianggap sebagai keseimbangan aspek fisik, emosional, psikologis, sosial dan spiritual dari kehidupan seseorang. Kata kunci: masyarakat, perawatan kesehatan, kualitas hidup Society Community and Health Care in Improving Quality of LifeAbstract Background: Along with the development of the era, in recent years there has been a lot of attention focused on exploring the impact of physical and mental illness on the quality of life of a person both individually and as a whole. The subjective nature of an individual's 'quality of life' is a dynamic concept to measure and define, but that in general can be seen as a multidimensional concept that emphasizes self-perception of one's current state of mindAim: purpose of this study is to provide an understanding the role of community in understanding the importance of health in the global era from an academic perspective. In the health sector understanding of health is very important because it will show the quality of life of a person, but this is not enough individually because a comprehensive understanding of the meaning of health and health care is needed. Method: The method of scientific writing is to carry out academic analysis from various relevant reference sources, and find new theoretical meanings in order to answer the challenges that occur in society. Keyword: Community, Society,Health Care, Quality oflife Resullt : Based on various academic reference, it can be concluded that health is a lifestyle that aims to achieve physical, emotional, intellectual, spiritual, and environmental well-being. The use of health measures can increase stamina, energy, and self-esteem, then improve the quality of life. Thus the concept of health allows for individual variability. Health can be considered as a balance of physical, emotional, psychological, social and spiritual aspects of one's life. Keywords: community, health care, quality of life 

Dare voce ai pazienti nella ricerca sulle malattie rare e sui famaci orfani / Giving patients a voice in the rare diseases and orphan drugs research

2018 ◽  
Vol 67 (1) ◽  
pp. 25-40
Author(s):  
Elena Mancini ◽  
Roberta Martina Zagarella
Keyword(s):  
Clinical Trials ◽  
Rare Diseases ◽  
Patient Reported Outcomes ◽  
Narrative Medicine ◽  
Orphan Drugs ◽  
New Drugs ◽  
Patient Centered ◽  
Patient Reported ◽  
Critical Issues ◽  
The Impact

L’articolo ha l’obiettivo di mettere in luce potenzialità e criticità dell’inclusione della prospettiva dei pazienti nella ricerca sulle malattie rare e sui farmaci orfani. A tal fine, nella prima parte, si propone un’analisi epistemologica dell’utilizzo dei racconti dell’esperienza individuale della malattia nella ricerca scientifica e nei trial clinici, facendo emergere, anche attraverso gli strumenti della medicina narrativa, le sfide teoriche e operative poste dall’inclusione della soggettività del paziente e del vissuto di malattia nonché l’importanza della valorizzazione della prospettiva del paziente, sia in generale sia nella ricerca sulle malattie rare e sui farmaci orfani. Nella seconda parte, il testo analizza in particolare il ruolo degli esiti riportati dai pazienti o Patient Reported Outcomes (PROs), misure per la valutazione complessiva della salute basate sulla prospettiva dei pazienti stessi, incentrandosi sulla sperimentazione clinica nel campo delle malattie rare. In questo contesto, infatti, i racconti di malattia, raccolti e valorizzati da fonti istituzionali e associazioni di pazienti, hanno contribuito a far emergere importanti questioni critiche e difficoltà nell’impiego di outcome centrati sul paziente nello sviluppo di nuovi farmaci e trattamenti, generando una serie di documenti e raccomandazioni relative al loro utilizzo per il benessere della comunità dei malati rari. ---------- This paper aims to highlight the potentiality and criticality of including patients’ perspective in rare diseases and orphan drugs research. In the first part, we propose an epistemological analysis of individual narrations of disease experience as they are used in scientific research and clinical trials. With the help of narrative medicine approach, this analysis points out theoretical and operational challenges of a perspective that includes patient’s subjectivity and illness experience. Furthermore, it reveals the significance of patients’ standpoints in general and in rare diseases as well as in the orphan drugs research. The second part of our article focuses on the role of the Patient reported Outcomes (PROs) – which are measures for the health’s overall assessment based on patient’s perspective – by investigating the impact on clinical trials for rare diseases. In this context, illness stories, which are collected and promoted by institutional sources and patients’ associations, contribute to underline important critical issues at stake in the employment of patient-centered outcomes both in new drugs and in the treatments development. Moreover, these stories are crucial to elaborate documents and recommendations concerning the use of PROs for the rare patients’ community welfare.

scholarly journals Clinical Applications of Mobile Health Wearable–Based Sleep Monitoring: Systematic Review (Preprint)

2019 ◽  
Author(s):  
Elise Guillodo ◽  
Christophe Lemey ◽  
Mathieu Simonnet ◽  
Michel Walter ◽  
Enrique Baca-García ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Sleep Disorders ◽  
Mobile Health ◽  
Selection Criterion ◽  
Feasibility Studies ◽  
Well Being ◽  
Clinical Applications ◽  
Cochrane Library ◽  
Sleep Monitoring ◽  
The Impact

BACKGROUND Sleep disorders are a major public health issue. Nearly 1 in 2 people experience sleep disturbances during their lifetime, with a potential harmful impact on well-being and physical and mental health. OBJECTIVE The aim of this study was to better understand the clinical applications of wearable-based sleep monitoring; therefore, we conducted a review of the literature, including feasibility studies and clinical trials on this topic. METHODS We searched PubMed, PsycINFO, ScienceDirect, the Cochrane Library, Scopus, and the Web of Science through June 2019. We created the list of keywords based on 2 domains: wearables and sleep. The primary selection criterion was the reporting of clinical trials using wearable devices for sleep recording in adults. RESULTS The initial search identified 645 articles; 19 articles meeting the inclusion criteria were included in the final analysis. In all, 4 categories of the selected articles appeared. Of the 19 studies in this review, 58 % (11/19) were comparison studies with the gold standard, 21% (4/19) were feasibility studies, 15% (3/19) were population comparison studies, and 5% (1/19) assessed the impact of sleep disorders in the clinic. The samples were heterogeneous in size, ranging from 1 to 15,839 patients. Our review shows that mobile-health (mHealth) wearable–based sleep monitoring is feasible. However, we identified some major limitations to the reliability of wearable-based monitoring methods compared with polysomnography. CONCLUSIONS This review showed that wearables provide acceptable sleep monitoring but with poor reliability. However, wearable mHealth devices appear to be promising tools for ecological monitoring.

scholarly journals Beyond Survival in AL amyloidosis: Identifying and Satisfying Patients’ Needs

Hemato ◽  
2022 ◽  
Vol 3 (1) ◽  
pp. 38-46
Author(s):  
Hamza Hassan ◽  
Vaishali Sanchorawala
Keyword(s):  
Cell Clone ◽  
Symptom Burden ◽  
Well Being ◽  
Future Research ◽  
Al Amyloidosis ◽  
Patient Centered ◽  
Related Quality ◽  
Health Related ◽  
Delays In Diagnosis ◽  
The Impact

The survivorship needs of patients with light-chain (AL) amyloidosis are complex, as is the diagnosis and treatment itself. Early diagnosis is critical in improving patient outcomes; however, given the nonspecific nature of the symptoms, most patients with AL amyloidosis require evaluation by multiple specialists, resulting in significant delays in diagnosis of up to 3 years. An early and accurate diagnosis can help reduce the psychological toll of the patient’s journey to diagnosis. Given the high symptom burden and complex process of diagnosis, it is not surprising that patients with AL amyloidosis report worse health-related quality of life than the general population. Organ dysfunction associated with AL amyloidosis also may make the treatment directed towards plasma cell clone difficult to tolerate, leading to morbidity and mortality. Furthermore, supportive care requires an integrated, multidimensional and patient-centered approach to improve survival and feelings of well-being, as organ responses lag behind hematologic responses. The impact of AL amyloidosis is often devastating for the patient and may last beyond the effects of treatment. Future research is needed to study and assess the needs of survivors of AL amyloidosis utilizing valid, reliable and standardized measures.

Type of tissue biopsy and outcomes in diffuse large B-cell lymphoma (DLBCL).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e13569-e13569
Author(s):  
Sanjal Desai ◽  
Raphael Mwangi ◽  
Rebecca L. King ◽  
Matthew J. Maurer ◽  
James Robert Cerhan ◽  
...  
Keyword(s):  
Clinical Trials ◽  
High Risk ◽  
International Prognostic Index ◽  
Prognostic Index ◽  
B Cell Lymphoma ◽  
Initial Diagnosis ◽  
Molecular Testing ◽  
Tissue Biopsy ◽  
The Impact ◽  
Biopsy Method

e13569 Background: Progress in understanding the molecular biology of DLBCL has led to development of complex molecular classifications that rely on sequencing methods. These molecular clusters are defined by activation of distinct pathways and may aid in selecting targeted therapy. In the molecular era, tissue requirements in clinical trials have increased to ensure sufficient tissue for molecular testing, potentially resulting in bias for enrollment of patients with larger excisional biopsies (EB). We examined the impact of tissue biopsy method on outcomes of DLBCL in a prospective observational study. Methods: Consecutive adult patients with DLBCL within 9 months from their initial diagnosis were enrolled into the Molecular Epidemiology Resource (MER) of the University of Iowa/Mayo Clinic Lymphoma Specialized Program of Research Excellence (SPORE). Demographics, clinical variables, type of tissue biopsy (EB vs. core needle biopsy (CNB)) for initial diagnosis and initial treatment were recorded at baseline. Pts were contacted every 6 months from the date of diagnosis for first 3 years and then annually thereafter. Study objectives were event free survival (EFS) and overall survival (OS) by tissue biopsy method. Results: A total of 1061 patients with newly diagnosed DLBCL, from 2002 to 2015, were included. The table lists baseline characteristics of the cohort. 593 (56%) pts underwent EB and 468 (44%) underwent CNB for initial diagnosis. A significantly higher proportion of patients receiving CNB had performance status >=2, advanced stage, high risk disease by international prognostic index (IPI), abnormal lactate dehydrogenase. Median time from diagnosis to treatment initiation (DTI) was significantly shorter in the CNB group (13 days) than EB group (19 days). 2-year EFS (60% vs 75%, HR 0.75 (0.6-0.9), p <0.01) was significantly lower in CNB than EB group. There was a trend towards lower OS (75% vs 80%, HR: 0.8 (0.6-0.95), p =0.049) in CNB than EB group. Conclusions: Patients undergoing CNB are more likely to have higher risk disease, shorter DTI and survival compared to those undergoing EB. A need for large amount of diagnostic tissue in biomarker driven clinical trials may result in disproportional exclusion of high risk DLBCL pts who have inferior outcomes after standard treatment and could potentially benefit from novel agents, resulting in overperformance of the control arm. The need for tissue must be carefully balanced against resulting selection bias.[Table: see text]

scholarly journals Applying Data Warehousing to a Phase III Clinical Trial From the Fondazione Italiana Linfomi Ensures Superior Data Quality and Improved Assessment of Clinical Outcomes

2019 ◽  
pp. 1-15 ◽  
Author(s):  
Gian Maria Zaccaria ◽  
Simone Ferrero ◽  
Samanta Rosati ◽  
Marco Ghislieri ◽  
Elisa Genuardi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Data Quality ◽  
Clinical Outcomes ◽  
Control Strategy ◽  
International Prognostic Index ◽  
Prognostic Index ◽  
Database Management System ◽  
Phase Iii ◽  
End Points

PURPOSE Data collection in clinical trials is becoming complex, with a huge number of variables that need to be recorded, verified, and analyzed to effectively measure clinical outcomes. In this study, we used data warehouse (DW) concepts to achieve this goal. A DW was developed to accommodate data from a large clinical trial, including all the characteristics collected. We present the results related to baseline variables with the following objectives: developing a data quality (DQ) control strategy and improving outcome analysis according to the clinical trial primary end points. METHODS Data were retrieved from the electronic case reporting forms (eCRFs) of the phase III, multicenter MCL0208 trial (ClinicalTrials.gov identifier: NCT02354313 ) of the Fondazione Italiana Linfomi for younger patients with untreated mantle cell lymphoma (MCL). The DW was created with a relational database management system. Recommended DQ dimensions were observed to monitor the activity of each site to handle DQ management during patient follow-up. The DQ management was applied to clinically relevant parameters that predicted progression-free survival to assess its impact. RESULTS The DW encompassed 16 tables, which included 226 variables for 300 patients and 199,500 items of data. The tool allowed cross-comparison analysis and detected some incongruities in eCRFs, prompting queries to clinical centers. This had an impact on clinical end points, as the DQ control strategy was able to improve the prognostic stratification according to single parameters, such as tumor infiltration by flow cytometry, and even using established prognosticators, such as the MCL International Prognostic Index. CONCLUSION The DW is a powerful tool to organize results from large phase III clinical trials and to effectively improve DQ through the application of effective engineered tools.

scholarly journals Patient-Centered Collaborative Care: The Impact of a New Approach to Postpartum Rounds on Residents' Perception of Their Work Environment

2010 ◽  
Vol 2 (1) ◽  
pp. 62-66 ◽  
Author(s):  
Maureen Baldwin ◽  
Jason Hashima ◽  
Jeanne-Marie Guise ◽  
William Thomas Gregory ◽  
Alison Edelman ◽  
...  
Keyword(s):  
Patient Care ◽  
Work Environment ◽  
Collaborative Care ◽  
Improve Patient Care ◽  
Well Being ◽  
Care Patient ◽  
Case Managers ◽  
Patient Centered ◽  
Negative Impacts ◽  
The Impact

Abstract Objective At our institution, traditional postpartum rounds consisted of separate visits from all members of the obstetric team. This led to patient care inefficiencies and miscommunication. In an effort to improve patient care, patient-centered collaborative care (PCCC) was established, whereby physicians, residents, medical students, nurses, case managers, and social workers conduct rounds as a team. The goal of this observational study was to evaluate how PCCC rounds affected resident physicians' assessment of their work environment. Methods Obstetrics and gynecology residents completed a 13-question written survey designed to assess their sense of workflow, education, and workplace cohesion. Surveys were completed before and 6 months after the implementation of PCCC. Responses were compared in aggregate for preintervention and postintervention with Pearson χ2 test. Results Ninety-two percent of the obstetrics residents (n  =  23) completed the preintervention survey, and 79% (n  =  19) completed the postintervention survey. For most measures, there was no difference in resident perception between the 2 time points. After implementation of PCCC rounds, fewer residents felt that rounds were educational (preintervention  =  39%, postintervention  =  7%; P  =  .03). Conclusion Residents did not report negative impacts on workflow, cohesion, or general well-being after the implementation of PCCC rounds. However, there was a perception that PCCC rounds negatively impacted the educational value of postpartum rounds. This information will help identify ways to improve the resident physician experience in the obstetric service while optimizing patient care.

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