SARCOPENIA: HAVE WE REACHED THE CONSENSUS?

2012 ◽  
pp. 1-4
Author(s):  
L.-K. CHEN
Keyword(s):  
Clinical Trials ◽  
Older People ◽  
Working Group ◽  
Physical Disabilities ◽  
Adverse Outcomes ◽  
Economic Losses ◽  
International Consensus ◽  
International Working Group ◽  
Age Related ◽  
The Impact

Sarcopenia, the age-related loss of skeletal muscle mass, may cause substantial social and economic losses due to its associations with a number of adverse outcomes in the older people, such as falls, hip fractures, physical disabilities, institutionalizations and death (1-5). Although the impact of sarcopenia to the health of older people has been demonstrated, extensive research works are still needed to reach an international consensus with regard to its diagnosis and treatment. The International Working Group of Sarcopenia successfully invited geriatricians and scientists in this domain and formulated recommendations for clinical trials of sarcopenia in Toulouse, France (6). The International Working Group of Sarcopenia reviewed current evidences in definitions, diagnosis, biomarkers and clinical implications of sarcopenia, to provide some critical information for the study design of clinical trials of sarcopenia. Although the International Working Group of Sarcopenia has developed consensus in many dimensions of clinical trials of sarcopenia, some controversies remained unclear still which deserve more works in the future. Some controversies were summarized as below:

scholarly journals BIOMARKERS OF SARCOPENIA IN CLINICAL TRIALS RECOMMENDATIONS FROM THE INTERNATIONAL WORKING GROUP ON SARCOPENIA

2012 ◽  
pp. 1-9
Author(s):  
M. CESARI ◽  
R.A. FIELDING ◽  
M. PAHOR ◽  
B. GOODPASTER ◽  
M. HELLERSTEIN ◽  
...  
Keyword(s):  
Skeletal Muscle ◽  
Clinical Trials ◽  
Working Group ◽  
Task Force ◽  
Scientific Progress ◽  
Health Priorities ◽  
International Working Group ◽  
Age Related ◽  
The Subject ◽  
Preliminary Phase

Sarcopenia, the age-related skeletal muscle decline, is associated with relevant clinical and socioeconomic negative outcomes in older persons. The study of this phenomenon and the development of preventive/therapeutic strategies represent public health priorities. The present document reports the results of a recent meeting of the International Working Group on Sarcopenia (a task force consisting of geriatricians and scientists from academia and industry) held on June 7-8, 2011 in Toulouse (France). The meeting was specifically focused at gaining knowledge on the currently available biomarkers (functional, biological, or imaging-related) that could be utilized in clinical trials of sarcopenia and considered the most reliable and promising to evaluate age-related modifications of skeletal muscle. Specific recommendations about the assessment of aging skeletal muscle in older people and the optimal methodological design of studies on sarcopenia were also discussed and finalized. Although the study of skeletal muscle decline is still in a very preliminary phase, the potential great benefits derived from a better understanding and treatment of this condition should encourage research on sarcopenia. However, the reasonable uncertainties (derived from exploring a novel field and the exponential acceleration of scientific progress) require the adoption of a cautious and comprehensive approach to the subject.

scholarly journals Sleep disordered breathing at the extremes of age: the elderly

Breathe ◽  
2016 ◽  
Vol 12 (1) ◽  
pp. 50-60 ◽  
Author(s):  
Alison McMillan ◽  
Mary J. Morrell
Keyword(s):  
Risk Factors ◽  
Older People ◽  
Sleep Disordered Breathing ◽  
Treatment Options ◽  
Current Evidence ◽  
List Type ◽  
Pressure Therapy ◽  
Age Related ◽  
The Impact ◽  
Disordered Breathing

Key pointsSleep disordered breathing (SDB) is common and its prevalence increases with age. Despite this high prevalence, SDB is frequently unrecognised and undiagnosed in older people.There is accumulating evidence that SDB in older people is associated with worsening cardio- cerebrovascular, cognitive and functional outcomes.There is now good evidence to support the use of continuous positive airway pressure therapy in older patients with symptomatic SDB.Educational aimsTo highlight the prevalence and presentation of sleep disordered breathing (SDB) in older people.To inform readers about the risk factors for SDB in older people.To explore the impact of SDB in older people.To introduce current evidence based treatment options for SDB in older people.Sleep disordered breathing (SBD) increases in prevalence as we age, most likely due to physiological and physical changes that occur with ageing. Additionally, SDB is associated with comorbidity and its subsequent polypharmacy, which may increase with increasing age. Finally, the increased prevalence of SDB is intrinsically linked to the obesity epidemic. SDB is associated with serious outcomes in younger people and, likewise, older people. Thus, identification, diagnosis and treatment of SDB is important irrelevant of age. This article reviews the age-related changes contributing to SDB, the epidemiology and the risk factors for SDB in older people, the association of SDB with adverse outcomes, and diagnostic and treatment options for this population.

National survey on the effect of oncology drug shortages in clinical practice: A Hematology Oncology Pharmacy Association (HOPA) survey.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e13609-e13609
Author(s):  
Sarah Hudson-Disalle ◽  
David L. DeRemer ◽  
Larry W Buie ◽  
Mark Hamm ◽  
Jeffrey Pilz ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Supportive Care ◽  
Cancer Patients ◽  
Medication Errors ◽  
The United States ◽  
Adverse Outcomes ◽  
Common Disease ◽  
Drug Shortages ◽  
Oncology Drug ◽  
The Impact

e13609 Background: Drug shortages are a clear and growing challenge. Prominent shortages included oncology medications and supportive care products essential for the care of cancer patients. Oncology drug shortages often result in disruptions in the timing of chemotherapy treatments, alterations in the dose or regimen administered, or even missed doses when alternative agents are unavailable. The purpose of this survey was to characterize the impact of oncology drug shortages across the United States, including the experiences of health care organizations, resource implications, and the impact on patient safety, patient care, and clinical trials. Methods: A 34-item online survey was distributed to HOPA membership of the Hematology Oncology Pharmacy Association to gather information on shortages of oncology drugs (i.e., all drugs essential in the care of cancer patients, including supportive care agents. Results: Sixty-eight organizations completed the survey; almost all completed by pharmacists, and analysis completed. Sixty-three percent of institutions reported one or more drugs shortages a month, with a 34.33% increase in 2019 from 2018. Sixty four percent of responded had incurred increased costs from oncology drugs shortages, with 7% noting reimbursement issues when switched to brand name therapies due to shortages. Treatment delays, reduced doses or alternative regimens were reported by 74.63% of respondents. The most common disease states which causes a dose delay of treatment included Acute Lymphocytic Leukemia, Lymphoma and Multiple Myeloma with dose reductions noted in 36.36%, 36.36 and 15.91%. The top five oncology drugs on shortage included epirubicin, flutamide, decitabine, mechlorethamine, dactinomycin with the top 5 supportive care drugs on shortage being noted as hydrocortisone, bivalirudin, promethazine, mycophenolate sodium and scopolamine. Respondents noted medication errors related to oncology drug shortages at 4.48%, with noted errors including incorrect conversion from iv to oral etoposide and incorrect EMR drug builds. Oncology Drug shortages impacted clinical trials in 13.4% of respondents in which 54.55% of respondents noting patients not being enrolled in clinical trials. Conclusions: A survey of US oncology pharmacists and technicians indicated that oncology drug shortages occurred frequently in 2020. Shortages led to delays in chemotherapy and changes in treatment or omission, complicated clinical research and increased the risk of medication errors and adverse outcomes.

Research trials in the older stroke patient

2020 ◽  
pp. 437-450
Author(s):  
Kailash Krishnan ◽  
Nikola Sprigg
Keyword(s):  
Clinical Trials ◽  
Older People ◽  
Stroke Patient ◽  
Oral Anticoagulants ◽  
Intravenous Thrombolysis ◽  
Lipid Lowering ◽  
Good Communication ◽  
Decompressive Hemicraniectomy ◽  
The Impact

‘Research trials in the older stroke patient’ examines the challenges of research in older people, the phenomenon of ageism, the impact of frailty, trials of acute treatments like intravenous thrombolysis and endovascular therapy, acute lowering of blood pressure, and decompressive hemicraniectomy. Trials looking at secondary prevention, including cardioembolism, role of the newer oral anticoagulants (DOACs), carotid endarterectomy, lipid lowering, antihypertensive therapy, are examined. The broader issue of difficulties in recruiting older people to stroke trials and the potential solutions are discussed. Until recently most participants in clinical trials of stroke have been relatively young with little or no comorbidity. With a group growing more than any other, it becomes a priority to understand the challenges in recruiting and retaining older patients into clinical trials. Barriers to recruitment relate to both researchers and participants; solutions include good communication, logistical support, and innovative study design and sampling. Further research will hopefully narrow the gap to those seen in real-world clinical practice.

Spa-therapy can improve quality of life in chronic musculoskeletal disorder subjects: a narrative review

2020 ◽  
Vol 96 (2) ◽  
pp. 3-6
Author(s):  
M.C. Maccarone ◽  
G. Magro ◽  
U. Solimene ◽  
S. Masiero
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Thermal Environment ◽  
Narrative Review ◽  
Spa Therapy ◽  
Age Related ◽  
Therapy Interventions ◽  
The Impact

Chronic Musculoskeletal Disorders (MSDs) are age-related conditions, linked to functional impairment and decreased quality of life (QoL). As a result of the increased life expectancy in Europe, great attention has been focused on investigating the impact of these diseases on QoL. Thermal environment is a suitable place for providing interventions (mud therapy, bath, exercise, etc.) for chronic MSD patients. Our narrative review aims to assess if Spa therapy may improve QoL in patients with chronic MSDs. We searched randomized clinical trials and clinical trials screening PubMed and Google Scholar databases from 2016 up to March 2020. We included 14 trials testing Spa therapy interventions concerning osteoarthritis, rheumatoid arthritis, chronic shoulder pain and fibromyalgia. In conclusion, even though limitations must be considered, evidence shows that Spa therapy, especially in combination with rehabilitation approach, can significantly improve QoL of patients with chronic MSDs.

Socio-economic disadvantage and poverty

2020 ◽  
pp. 105-114
Author(s):  
Alisoun Milne
Keyword(s):  
Older People ◽  
Later Life ◽  
Poverty Line ◽  
Developed Countries ◽  
Economic Disadvantage ◽  
Fundamental Building Block ◽  
Age Related ◽  
The Uk ◽  
State Pension ◽  
The Impact

Chapter 5 is the first of three chapters exploring the impact of age related risks affecting particular sub populations of older people. Socioeconomic disadvantage in later life tends to reflect a lifecourse status. It amplifies what is already present. In 2016/17 one million older people were living in poverty; an additional 1.2 million were living just above the poverty line. These numbers are rising. Those aged 85 years or over, frail older people, older women and single older people are particularly at risk. Poor older people are also more likely to live in poor housing and be exposed to fuel poverty. Being poor - and its concomitants - compromises mental health in a number of profound ways. It undermines an older person’s capacity to make choices, retain independence, save for a crisis, maintain social contacts and be digitally included. It is linked with worry, loss of control over life and shame. Poor older people are at heightened risk of isolation and loneliness, stress, anxiety and depression. The UK has a weak policy record, compared with other developed countries, of sustainably and coherently addressing poverty in later life. One of the cornerstones of doing so is a continued commitment to the basic state pension as a fundamental building block of a secure old age. Addressing poor housing is also pivotal.

The impact of data errors on the outcome of randomized clinical trials

2017 ◽  
Vol 14 (5) ◽  
pp. 499-506 ◽  
Author(s):  
Marc Buyse ◽  
Pierre Squifflet ◽  
Elisabeth Coart ◽  
Emmanuel Quinaux ◽  
Cornelis JA Punt ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Clinical Trials ◽  
Metastatic Colorectal Cancer ◽  
Randomized Clinical Trials ◽  
Systematic Errors ◽  
Age Related Macular Degeneration ◽  
Random Errors ◽  
Significant Treatment ◽  
Age Related ◽  
The Impact

Background/aims Considerable human and financial resources are typically spent to ensure that data collected for clinical trials are free from errors. We investigated the impact of random and systematic errors on the outcome of randomized clinical trials. Methods We used individual patient data relating to response endpoints of interest in two published randomized clinical trials, one in ophthalmology and one in oncology. These randomized clinical trials enrolled 1186 patients with age-related macular degeneration and 736 patients with metastatic colorectal cancer. The ophthalmology trial tested the benefit of pegaptanib for the treatment of age-related macular degeneration and identified a statistically significant treatment benefit, whereas the oncology trial assessed the benefit of adding cetuximab to a regimen of capecitabine, oxaliplatin, and bevacizumab for the treatment of metastatic colorectal cancer and failed to identify a statistically significant treatment difference. We simulated trial results by adding errors that were independent of the treatment group (random errors) and errors that favored one of the treatment groups (systematic errors). We added such errors to the data for the response endpoint of interest for increasing proportions of randomly selected patients. Results Random errors added to up to 50% of the cases produced only slightly inflated variance in the estimated treatment effect of both trials, with no qualitative change in the p-value. In contrast, systematic errors produced bias even for very small proportions of patients with added errors. Conclusion A substantial amount of random errors is required before appreciable effects on the outcome of randomized clinical trials are noted. In contrast, even a small amount of systematic errors can severely bias the estimated treatment effects. Therefore, resources devoted to randomized clinical trials should be spent primarily on minimizing sources of systematic errors which can bias the analyses, rather than on random errors which result only in a small loss in power.

scholarly journals Tackling Diversity in Prostate Cancer Clinical Trials: A Report From the Diversity Working Group of the IRONMAN Registry

2021 ◽  
pp. 495-505
Author(s):  
Rana R. McKay ◽  
Theresa Gold ◽  
Jelani C. Zarif ◽  
Ilkania M. Chowdhury-Paulino ◽  
Adam Friedant ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Trials ◽  
Race And Ethnicity ◽  
Working Group ◽  
Advanced Prostate Cancer ◽  
Unmet Need ◽  
Minority Populations ◽  
Eligibility Criteria ◽  
Patient Reported ◽  
The Impact

Prostate cancer disproportionately affects racial and ethnic minority populations. Reasons for disparate outcomes among minority patients are multifaceted and complex, involving factors at the patient, provider, and system levels. Although advancements in our understanding of disease biology have led to novel therapeutics for men with advanced prostate cancer, including the introduction of biomarker-driven therapeutics, pivotal translational studies and clinical trials are underrepresented by minority populations. Despite attempts to bridge the disparities gap, there remains an unmet need to expand minority engagement and participation in clinical trials to better define the impact of therapy on efficacy outcomes, quality of life, and role of biomarkers in diverse patient populations. The IRONMAN registry (ClinicalTrials.gov identifier: NCT03151629 ), a global, prospective, population-based study, was borne from this unmet medical need to address persistent gaps in our knowledge of advanced prostate cancer. Through integrated collection of clinical outcomes, patient-reported outcomes, epidemiologic data, and biospecimens, IRONMAN has the goal of expanding our understanding of how and why prostate cancer outcomes differ by race and ethnicity. To this end, the Diversity Working Group of the IRONMAN registry has developed informed strategies for site selection, recruitment, engagement and retention, and trial design and eligibility criteria to ensure broad inclusion and needs awareness of minority participants. In concert with systematic strategies to tackle the complex levels of disparate care, our ultimate goal is to expand minority engagement in clinical research and bridge the disparities gap in prostate cancer care.

scholarly journals Impact of Social Restriction Imposed by 2019-ncov Pandemic on the Mobility of Older People: A Scope Review Protocol

2020 ◽  
Author(s):  
Sarah Bandeira ◽  
Patricia Batista ◽  
Cristina Cristóvão Ribeiro Silva ◽  
Ruth Caldeira Melo ◽  
Monica Rodrigues Perracini
Keyword(s):  
Older People ◽  
Latin American ◽  
Health Care Providers ◽  
Adverse Outcomes ◽  
Care Providers ◽  
Targeted Interventions ◽  
Thomson Reuters ◽  
Social Restriction ◽  
The Impact ◽  
At Home

Abstract Background The 2019‑nCoV pandemic represents a high risk for older people that sustain higher mortality rates compared to young adults. Limited social contact and restriction of mobility in the community (stay-at-home precautions) are recognised as measures to prevent SARS-CoV-2 infection among older people. The impact of these measures on health, physical function and emotional wellbeing are numerous, and might result in long-term adverse outcomes such as disability, falls and limited mobility. Thus, the objective of this scope review is to map the estimated impact of measures of social restrictions on the mobility of older people living in the community and to systematize the existing recommendations, anticipating possible intervention strategies gaps.Methods The search will be carried out using a standardized protocol in Latin American and Caribbean Literature on Health Sciences (LILACS), consulted by the Virtual Health Library (VHL), and the Cumulative Index to Nursing and Allied Health Literature (CINAHL), Medical Literature Analysis and Retrieval System Online (MEDLINE), via PubMed; Web of Science, via Main Collection (Thomson Reuters Scientific) and SCOPUS. Documents and reports with recommendations from governmental and nongovernmental organizations will be consulted. Complete studies available in the English, Spanish or Portuguese languages included in the different methodological approaches (original articles, literature reviews, editorials and guidelines) that necessarily address the recommendations of social restriction measures for preventing Covid-19 disease and their impacts on mobility of older people will be included. Two reviewers will select the studies based on their titles and abstracts. The manuscripts and documents selected for full reading will be analysed by reviewers concerning the eligibility criteria. When disagreements occurred in any phase of the selection process, a third reviewer will be included for a consensus analysis. Data will be extracted using a template form and the PRISMA-ScR checklist will be used to guarantee quality and transparency. Results will be presented as a narrative summary, including tables and figures.Discussion Globally, recommendations to stay-at-home and social distancing are substantially affecting health and wellbeing of older people. Preserving mobility is crucial to active and healthy ageing. The evidence summarized in the selected studies will be analysed in order to answer the research questions. The results of this review will help clinical practitioners, health care providers and policy makers to estimate the impact of measures to protect older people from 2019‑nCoV and to identify gaps and anticipate needs for targeted interventions to prevent mobility decline. Systematic review registrationsubmitted on 10-09-2020 in https://osf.io/registries

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