scholarly journals Unique Opportunities and Challenges From Two Online Psychosocial Randomized Clinical Trials

2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. 82-83
Author(s):  
Carol Musil ◽  
Britney Webster ◽  
Rachel Pruchno
Keyword(s):  
Clinical Trials ◽  
Family Caregiving ◽  
Social Intelligence ◽  
Randomized Clinical Trials ◽  
Psychosocial Interventions ◽  
Retention Strategies ◽  
Daily Diaries ◽  
Advantages And Disadvantages ◽  
Report Data ◽  
Hard To Reach Populations

Abstract Research aimed at testing readily delivered online psychosocial interventions for addressing the needs of custodial grandfamilies (CGF) has been scarce. This symposium reports on two NIH-funded randomized clinical trials (RCT) involving fully online interventions: Study 1 (S1)-dyadic social Intelligence training for custodial grandmothers and their adolescent grandchildren, and Study 2 (S2)-4 week resourcefulness training with daily journaling intervention for grandmothers only. We presented here on the unique advantages and challenges of online RCTs as they apply to CGFs and similar hard-to-reach populations. First, in a cross-study collaboration, Jeanblanc et al. report data from both studies on how COVID-19 influenced coping habits, grandchild’s remote learning, household conflict, uncertainty, and finances. Second, Castro et al. investigate how baseline positive and negative affect were reported in daily diaries completed by both grandmothers and grandchildren across 14 days at pretest in S1. Third, Musil et al. describe the challenges and benefits of using an entirely online design for the distribution and collection of longitudinal data, as exemplified by 4 weeks of qualitative daily journals from S2. Lastly, Webster et al. report on the benefits and challenges of recruitment and retention strategies encountered across S1 and S2. As discussant, Rachel Pruchno considers how the specific methodological advantages and disadvantages of online RCTs covered in the above papers apply to family caregiving research in general.

scholarly journals Evaluating Anti-infective Drugs in the Resistant Pathogen Setting: Can We Use External Controls?

2017 ◽  
Vol 9 (1) ◽  
Author(s):  
Scott R Evans ◽  
John Powers
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Controlled Trial ◽  
Patient Characteristics ◽  
Controlled Trials ◽  
Advantages And Disadvantages ◽  
Lack Of Information ◽  
Study Results ◽  
New Treatments ◽  
The Impact

AbstractDecreased efficacy of antibiotics due to resistant pathogens has created a need for the development of more effective medical interventions. Despite the increasing prevalence of pathogens resistant to one or more drugs, identifying and enrolling participants into clinical trials that evaluate new interventions for the treatment of some diseases can be challenging given the low prevalence of disease in which there are no effective treatments. Thus researchers might be tempted to consider externally-controlled trials that may allow for a reduction of the necessary number of prospectively-identified trial participants, thus easing recruitment burden and resulting in more timely trial completion relative to randomized controlled trials. We discuss advantages and disadvantages in externally controlled trials and review requirements for a valid externally-controlled trial. As ECTs are subject to the bias of observational studies, the criteria for a valid ECT should be carefully evaluated before these designs are implemented. Given considerable variation in study results in the resistant pathogen setting, the lack of information on important patient characteristics that may confound estimates of treatment effects, as well as the improvements in medical practice and evolving antibiotic resistance, the use of ECTs in the resistant pathogen setting, is not recommended. ECTs should be should be limited to specific situations where superiority of the effect of the new intervention is dramatic, the usual course of the disease highly predictable, the endpoints are objective (e. g., all-cause mortality) and the impact of baseline and treatment variables on outcomes is well characterized. Given that the resistant pathogen setting does not satisfy these criteria, we conclude that that randomized clinical trials are needed to evaluate new treatments for resistant pathogens. Innovative approaches to trial design that may ease recruitment burden while evaluating the benefits and harms of new treatments are being developed and utilized.

Psychotherapie ist gut fürs Immunsystem

2020 ◽  
Vol 21 (04) ◽  
pp. 9-9
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Immune System ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Psychosocial Interventions ◽  
System Function ◽  
Psychosoziale Interventionen ◽  
Immune System Function

Shields GS et al. Psychosocial Interventions and Immune System Function: A Systematic Review and Meta-analysis of Randomized Clinical Trials. JAMA Psychiatry 2020; 77: 1–13. doi: 10.1001/jamapsychiatry.2020.0431. Online ahead of print Das Immunsystem spielt nicht nur bei klassischen Infektionskrankheiten eine Rolle, sondern auch z. B. bei Herz-Kreislauf-Krankheiten, Krebs und psychischen Erkrankungen – und damit auch bei jedem zweiten Todesfall. Umgekehrt können psychosoziale Interventionen das Immunsystem beeinflussen. Nach einer großen Meta-Analyse ist der Effekt vergleichbar dem entsprechender Medikamente – aber kostengünstiger und nachhaltiger.

Psychosocial Interventions to Promote Undetectable HIV Viral Loads: A Systematic Review of Randomized Clinical Trials

2021 ◽  
Author(s):  
Forrest Toegel ◽  
Andrew M. Rodewald ◽  
Matthew D. Novak ◽  
Sarah Pollock ◽  
Meghan Arellano ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Psychosocial Interventions ◽  
Viral Loads

End Points and Trial Design in Geriatric Oncology Research: A Joint European Organisation for Research and Treatment of Cancer–Alliance for Clinical Trials in Oncology–International Society of Geriatric Oncology Position Article

2013 ◽  
Vol 31 (29) ◽  
pp. 3711-3718 ◽  
Author(s):  
Hans Wildiers ◽  
Murielle Mauer ◽  
Athanasios Pallis ◽  
Arti Hurria ◽  
Supriya G. Mohile ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Geriatric Oncology ◽  
New Drugs ◽  
Phase Iii ◽  
Phase Ii Trials ◽  
Global Functioning ◽  
End Points ◽  
Advantages And Disadvantages ◽  
Oncology Research

Selecting the most appropriate end points for clinical trials is important to assess the value of new treatment strategies. Well-established end points for clinical research exist in oncology but may not be as relevant to the older cancer population because of competing risks of death and potentially increased impact of therapy on global functioning and quality of life. This article discusses specific clinical end points and their advantages and disadvantages for older individuals.Randomized or single-arm phase II trials can provide insight into the range of efficacy and toxicity in older populations but ideally need to be confirmed in phase III trials, which are unfortunately often hindered by the severe heterogeneity of the older cancer population, difficulties with selection bias depending on inclusion criteria, physician perception, and barriers in willingness to participate. All clinical trials in oncology should be without an upper age limit to allow entry of eligible older adults. In settings where so-called standard therapy is not feasible, specific trials for older patients with cancer might be required, integrating meaningful measures of outcome. Not all questions can be answered in randomized clinical trials, and large observational cohort studies or registries within the community setting should be established (preferably in parallel to randomized trials) so that treatment patterns across different settings can be compared with impact on outcome. Obligatory integration of a comparable form of geriatric assessment is recommended in future studies, and regulatory organizations such as the European Medicines Agency and US Food and Drug Administration should require adequate collection of data on efficacy and toxicity of new drugs in fit and frail elderly subpopulations.

L-arginine effect on inflammatory mediators: A systematic review of randomized controlled clinical trials

2019 ◽  
pp. 1-9 ◽  
Author(s):  
Seyed Reza Mirhafez ◽  
Mitra Hariri
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Inflammatory Mediators ◽  
Randomized Clinical Trials ◽  
Randomized Controlled Clinical Trials ◽  
Patients With Cancer ◽  
Reactive Protein ◽  
Randomized Controlled ◽  
Human Adults ◽  
Factor Α

Abstract. L-arginine is an important factor in several physiological and biochemical processes. Recently, scientists studied L-arginine effect on inflammatory mediators such as C-reactive protein (CRP), tumor necrosis factor-α (TNF-α) and interleukin-6 (IL-6). We conducted a systematic review on randomized controlled trials assessing L-arginine effect on inflammatory mediators. We searched data bases including Google scholar, ISI web of science, SCOPUS, and PubMed/Medline up to April 2019. Randomized clinical trials assessing the effect of L-arginine on inflammatory mediators in human adults were included. Our search retrieved eleven articles with 387 participants. Five articles were on patients with cancer and 6 articles were on adults without cancer. L-arginine was applied in enteral form in 5 articles and in oral form in 6 articles. Eight articles were on both genders, two articles were on women, and one article was on men. L-arginine could not reduce inflammatory mediators among patients with and without cancer except one article which indicated that taking L-arginine for 6 months decreased IL-6 among cardiopathic nondiabetic patients. Our results indicated that L-arginine might not be able to reduce selected inflammatory mediators, but for making a firm decision more studies are needed to be conducted with longer intervention duration, separately on male and female and with different doses of L-arginine.

Ongoing randomized clinical trials for the treatment of thrombosis in the antiphospholipid syndrome

2001 ◽  
Vol 21 (02) ◽  
pp. 77-81 ◽  
Author(s):  
G. Finazzi
Keyword(s):  
Clinical Trials ◽  
Large Scale ◽  
Low Dose ◽  
Randomized Clinical Trials ◽  
Oral Anticoagulants ◽  
Collaborative Study ◽  
Clinical Problem ◽  
Vascular Events ◽  
Dose Oral ◽  
Adverse Pregnancy

SummaryThrombotic events are a major clinical problem for patients with antiphospholipid antibodies (APA). However, current recommendations for their prevention and treatment are still based on retrospective studies. Data from large scale, prospective clinical trials are required to ultimately identify the optimal management of these patients. To date, at least four randomized studies are underway. The WAPS and PAPRE clinical trials are aimed to establish the correct duration and intensity of oral anticoagulation in APA patients with major arterial or venous thrombosis. The WARSS-APASS is a collaborative study to evaluate the efficacy and safety of aspirin or low-dose oral anticoagulants in preventing the recurrence of ischemic stroke. The recently announced UK Trial compares low-dose aspirin with or without low-intensity anticoagulation for the primary prevention of vascular events in APA-positive patients with SLE or adverse pregnancy history, but still thrombosis-free. It is hoped that the results of these trials will be available soon since clinicians urgently need more powerful data to treat their patients with the APA syndrome.

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