Use of Multinational Randomized Clinical Trials in Economic Evaluations of Health Care

2016 ◽  
pp. 335-352
Keyword(s):  
Health Care ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Economic Evaluations

scholarly journals Approach to the most prevalent oral disorders among the elderly: an integrative review focusing on primary health care

2017 ◽  
Vol 20 (3) ◽  
pp. 430-440
Author(s):  
Helena Pereira Rodrigues da Silva ◽  
Bárbara Koppe ◽  
Myrian Câmara Brew ◽  
Giordano Santana Sória ◽  
Caren Serra Bavaresco
Keyword(s):  
Health Care ◽  
Clinical Trials ◽  
Primary Health Care ◽  
Randomized Clinical Trials ◽  
Oral Candidiasis ◽  
The Elderly ◽  
Integrative Review ◽  
Root Caries ◽  
Geriatric Dentistry ◽  
Primary Health

Abstract Objective: an integrative review of the treatment of oral candidiasis, root caries and xerostomia among the elderly population, focusing on Primary Health Care, was carried out. Method: scientific articles were collected from the MEDLINE/PUBMED database using the keywords "Geriatric dentistry" and "Oral health", crossed with corresponding descriptors, together with specific terms for the pathologies studied, and with “the clinical trial” filter activated. The abstracts of the articles were read by three researchers. Result: oral candidiasis: six randomized clinical trials and one quasi-experimental design study, on the treatment of prosthetic stomatitis by medication and/or the disinfection of dentures by different techniques, were identified; root caries: three randomized clinical trials were included, which tested the use of mouthwash with chlorhexidine solution and oral hygiene instruction associated or otherwise with other drugs; and xerostomia: two articles were analyzed using various medications, and the functional massage of the salivary glands and associated muscles. Conclusion: The results demonstrate a variety of treatment options for the studied clinical situations, although these should be adapted to the characteristics of the services and the population, as standard treatment in Primary Health Care has not been established. Strategies based on soft technologies, such as health education, seem to provide good results. The present study provides additional knowledge for health professionals in search of more resolutive and qualified dental care for the elderly in primary health care.

scholarly journals Health Canada & Canadian Society for Pharmaceutical Sciences - Use of Real World Data/Evidence to Inform Regulatory Decision Making

2020 ◽  
Vol 23 ◽  
pp. 1s-47s
Author(s):  
Real World Data Workshop Group CSPS/Health Canada
Keyword(s):  
Health Care ◽  
Decision Making ◽  
Clinical Trials ◽  
Real World ◽  
Randomized Clinical Trials ◽  
Regulatory Agencies ◽  
Real World Data ◽  
World Data ◽  
Regulatory Decision ◽  
Health Canada

Real world data (RWD) and real world evidence (RWE) are playing increasing roles in health-care decisions. Real world data are routinely employed to support reimbursement and coverage decisions for drugs and devices. More recently, clinical trials incorporating pragmatic designs and observational studies are considered to supplement traditional clinical trials (e.g., randomized clinical trials). Regulatory agencies and large co-operative groups including academia and industry are exploring whether leveraging big databases such as electronic medical records and claims databases can be used to garner clinical insights extending beyond those gained from randomized controlled studies. Whether RWE can ultimately replace or improve traditional clinical trials is the big question. The workshop held on December 3, 2019 at Health Canada included presenters from regulatory agencies, industry and academia. Health Canada, US FDA and European Medicine Agency presented current thinking, draft frameworks and guidance available in the public domain. While the three agencies might be at different stages of utilizing RWE for regulatory decision making, the consensus is not whether RWE would be used but when and how it can be incorporated into regulatory decision making while maintaining a high evidentiary bar. The complexity of data sourcing, curating databases, aligning on common data models, illustrated by high-profile work conducted as part of Sentinel, DSEN, OHDSI and Duke-Margolis initiatives, was presented and discussed during the workshop, creating great learning opportunities for the attendees. The design and analysis of RWE studies were compared and contrasted to those of RCTs. While there are gaps, they are closing quickly as novel analytical methods are employed and innovative ways of curating data, including natural language processing and artificial intelligence, are explored.   This proceeding contains summaries of information presented by the speakers, including current highlights about the use of RWE in regulatory decision making. In the world where the uptake of “big data” in everyday life is happening at unprecedented speed, we can expect RWE to be a fast-moving area and with the potential for big impact in health-care decision making in the years to come.

scholarly journals How Safe is the use of Antiseptics and Disinfectants in Children?

2021 ◽  
Vol 5 (3) ◽  
pp. RV6-RV9
Author(s):  
Abdullah Hosseni ◽  
Nirmal Thapa ◽  
Priya T.
Keyword(s):  
Health Care ◽  
Clinical Trials ◽  
Health Care Professionals ◽  
Healthcare Professionals ◽  
Pediatric Patients ◽  
Randomized Clinical Trials ◽  
Research Work ◽  
Toxic Effects ◽  
Safety And Efficacy ◽  
Wide Range

A wide range of antiseptic preparations and disinfectants have been used in varying concentrations and combinations in children but much research work regarding their safety and efficacy is not available. The aim of this review is to expand and broaden the pre-existing guidelines useful to the health care professionals so that antisepsis in the pediatric field can be performed appropriately, and at the same time, guarantee safety for children. Previously published studies were also assessed while writing this review. As per the data, there may be several local and systemic toxic effects related to the use of antiseptics and disinfectants in children. Properly designed large multicenter randomized clinical trials are required to direct the healthcare professionals regarding the most appropriate and safe antiseptic and disinfectant to use in pediatric patients.

scholarly journals Evaluation of Journal Registration Policies and Prospective Registration of Randomized Clinical Trials of Nonregulated Health Care Interventions

2019 ◽  
Vol 179 (5) ◽  
pp. 624 ◽  
Author(s):  
Marleine Azar ◽  
Kira E. Riehm ◽  
Nazanin Saadat ◽  
Tatiana Sanchez ◽  
Matthew Chiovitti ◽  
...  
Keyword(s):  
Health Care ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Health Care Interventions

scholarly journals Religious and spiritual interventions in mental health care: a systematic review and meta-analysis of randomized controlled clinical trials

2015 ◽  
Vol 45 (14) ◽  
pp. 2937-2949 ◽  
Author(s):  
J. P. B. Gonçalves ◽  
G. Lucchetti ◽  
P. R. Menezes ◽  
H. Vallada
Keyword(s):  
Mental Health ◽  
Systematic Review ◽  
Health Care ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Extensive Literature ◽  
Spiritual Interventions ◽  
Comparison Groups ◽  
The Impact

Background.Despite the extensive literature assessing associations between religiosity/spirituality and health, few studies have investigated the clinical applicability of this evidence. The purpose of this paper was to assess the impact of religious/spiritual interventions (RSI) through randomized clinical trials (RCTs).Method.A systematic review was performed in the following databases: PubMed, Scopus, Web of Science, PsycINFO, Cochrane Collaboration, Embase and SciELO. Through the use of a Boolean expression, articles were included if they: (i) investigated mental health outcomes; (ii) had a design consistent with RCTs. We excluded protocols involving intercessory prayer or distance healing. The study was conducted in two phases by reading: (1) title and abstracts; (2) full papers and assessing their methodological quality. Then, a meta-analysis was carried out.Results.Through this method, 4751 papers were obtained, of which 23 remained included. The meta-analysis showed significant effects of RSI on anxiety general symptoms (p < 0.001) and in subgroups: meditation (p < 0.001); psychotherapy (p = 0.02); 1 month of follow-up (p < 0.001); and comparison groups with interventions (p < 0.001). Two significant differences were found in depressive symptoms: between 1 and 6 months and comparison groups with interventions (p = 0.05). In general, studies have shown that RSI decreased stress, alcoholism and depression.Conclusions.RCTs on RSI showed additional benefits including reduction of clinical symptoms (mainly anxiety). The diversity of protocols and outcomes associated with a lack of standardization of interventions point to the need for further studies evaluating the use of religiosity/spirituality as a complementary treatment in health care.

Digital mHealth and Virtual Care Monitoring and Support in Pandemics: Part 2 - A Rapid Review Assessing Strategies during COVID-19 (Preprint)

2021 ◽  
Author(s):  
Alessandro Cau ◽  
Alison Müller ◽  
Samia El Joueidi ◽  
Ka Hong Chan ◽  
Jay JH Park ◽  
...  
Keyword(s):  
Health Care ◽  
Clinical Trials ◽  
Mobile Phone ◽  
Chronic Diseases ◽  
Systematic Reviews ◽  
Health Care Professionals ◽  
Randomized Clinical Trials ◽  
Contact Tracing ◽  
Rapid Review ◽  
Virtual Care

BACKGROUND As a result of the novel coronavirus 2019 (COVID-19) pandemic, fewer patients are able to communicate with their health care professionals due to widely encouraged physical distancing. This provides a unique opportunity to evaluate and test the effectiveness of virtual care globally, especially mobile phone facilitated health interventions, called mHealth. This review evaluates how this rapidly growing field of virtual care could be effective in a pandemic situation by using mHealth interventions to manage chronic diseases, in addition to filling gaps within the health care system that have arisen due to COVID-19. OBJECTIVE To synthesize the published information regarding mobile phone-based virtual care technologies for mHealth interventions implemented in previous pandemics and chronic care. This information can provide an evidence-base to the patient experience and public health virtual care approaches toward COVID-19 control and health services beyond the pandemic. METHODS For this rapid review, we included systematic reviews (restricted within the past 2 years), randomized control trials, controlled non-randomized clinical trials, prospective and retrospective cohort studies, and case control studies reporting on mHealth and telehealth technologies on chronic, non-communicable diseases and infectious disease outbreaks and patient centered clinical decision support tools (symptom checkers, chatbots, digital self-triage technologies). PubMed and Cochrane Systematic Libraries were searched for studies dated between 1973 (when the first mobile phone was invented) and August 10, 2020. AMSTAR2 was used to evaluate the quality of systematic reviews. RESULTS Of 4083 potentially relevant records, 130 meeting our inclusion criteria for this review. For virtual care and mHealth technologies managing patient care, the general consensus among systematic reviews was that there is mixed evidence evaluating its efficacy in improving overall health outcomes. Clinical trials assessing adherence to chronic diseases management strategies were the most promising. The inconsistency observed regarding the efficacy of mHealth and virtual care interventions stems from research study bias, dependence on self-reporting, small samples sizes, among many other factors. This noted inconsistency extended to mHealth and virtual care interventions used during pandemics, predominantly focusing on HIV. There have been no evaluations investigating the effectiveness of digitalized case contact tracing during a pandemic or support for isolated individuals and/or health care workers. CONCLUSIONS Virtual care technologies could be effective in communicating crucial health care support and advice to patients managing chronic and infectious diseases, as well as individuals in self-isolation. There is no direct evidence regarding the use of virtual care technologies during a respiratory disease-based pandemic; however, reviewing available literature can provide insights into effective virtual care interventions for implementation during a pandemic such as COVID-19. CLINICALTRIAL N/A

scholarly journals Health Canada & Canadian Society for Pharmaceutical Sciences - Use of Real World Data/Evidence to Inform Regulatory Decision Making

2020 ◽  
Vol 23 ◽  
pp. 1s-47s
Author(s):  
Real World Data Workshop Group CSPS/Health Canada
Keyword(s):  
Health Care ◽  
Decision Making ◽  
Clinical Trials ◽  
Real World ◽  
Randomized Clinical Trials ◽  
Regulatory Agencies ◽  
Real World Data ◽  
World Data ◽  
Regulatory Decision ◽  
Health Canada

Real world data (RWD) and real world evidence (RWE) are playing increasing roles in health-care decisions. Real world data are routinely employed to support reimbursement and coverage decisions for drugs and devices. More recently, clinical trials incorporating pragmatic designs and observational studies are considered to supplement traditional clinical trials (e.g., randomized clinical trials). Regulatory agencies and large co-operative groups including academia and industry are exploring whether leveraging big databases such as electronic medical records and claims databases can be used to garner clinical insights extending beyond those gained from randomized controlled studies. Whether RWE can ultimately replace or improve traditional clinical trials is the big question. The workshop held on December 3, 2019 at Health Canada included presenters from regulatory agencies, industry and academia. Health Canada, US FDA and European Medicine Agency presented current thinking, draft frameworks and guidance available in the public domain. While the three agencies might be at different stages of utilizing RWE for regulatory decision making, the consensus is not whether RWE would be used but when and how it can be incorporated into regulatory decision making while maintaining a high evidentiary bar. The complexity of data sourcing, curating databases, aligning on common data models, illustrated by high-profile work conducted as part of Sentinel, DSEN, OHDSI and Duke-Margolis initiatives, was presented and discussed during the workshop, creating great learning opportunities for the attendees. The design and analysis of RWE studies were compared and contrasted to those of RCTs. While there are gaps, they are closing quickly as novel analytical methods are employed and innovative ways of curating data, including natural language processing and artificial intelligence, are explored.   This proceeding contains summaries of information presented by the speakers, including current highlights about the use of RWE in regulatory decision making. In the world where the uptake of “big data” in everyday life is happening at unprecedented speed, we can expect RWE to be a fast-moving area and with the potential for big impact in health-care decision making in the years to come.

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