scholarly journals Event detection using population-based health care databases in randomized clinical trials: a novel research tool in interventional cardiology

2013 ◽  
pp. 357 ◽  
Author(s):  
Leif Thuesen ◽  
Lisette Jensen ◽  
Hans Henrik Tilsted ◽  
Maeng ◽  
Christian Terkelsen ◽  
...  
Keyword(s):  
Health Care ◽  
Clinical Trials ◽  
Event Detection ◽  
Randomized Clinical Trials ◽  
Interventional Cardiology ◽  
Population Based ◽  
Research Tool

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.

Comparative Effectiveness of Rituximab-Based Immunochemotherapy in Waldenstrom's Macroglobulinemia (WM)

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 2986-2986 ◽  
Author(s):  
Adam J Olszewski ◽  
Steven P Treon ◽  
Jorge J Castillo
Keyword(s):  
Clinical Trials ◽  
Comparative Effectiveness ◽  
Research Funding ◽  
Randomized Clinical Trials ◽  
Single Agent ◽  
The United States ◽  
Population Based ◽  
First Line ◽  
Prophylactic Measures ◽  
Significant Difference

Abstract Background: Waldenström macroglobulinemia (WM) is difficult to study in randomized clinical trials because of its rarity, and higher incidence among older patients (pts). The most recent published trial focusing on WM (Leblond et al., J Clin Oncol 2013) compared chlorambucil with fludarabine-treatments no longer in common use. Recent data (Olszewski et al., Oncologist 2016) show that over 80% of WM pts in the United States are now treated with rituximab (R) alone or in combination with chemotherapy, although the effect of R on overall survival (OS) in WM has not been shown in clinical trials (Buske et al., Leukemia, 2009). Our objective was to provide comparative evidence of therapeutic efficacy for R-based immunochemotherapy in WM by applying causal inference methods to population-based, observational data. Methods: Using Medicare claims from 1999-2013, linked to the Surveillance, Epidemiology and End Results registry data, we identified WM patients (pts) >65 years old, who initiated first-line chemotherapy with or without R, with purine analogues (PUR, fludarabine or cladribine) and/or classic alkylating agents (ALK, chlorambucil or cyclophosphamide). Pts receiving both fludarabine and cyclophosphamide were grouped as PUR. Factors associated with treatment selection were studied in multivariable mixed-effects logistic models. We then conducted 3 separate comparative analyses: 1) regimens with R versus without R, 2) R monotherapy versus combination immunochemotherapy, and 3) PUR- versus ALK-based regimens. In each case, we balanced baseline characteristics (age, sex, race, socioeconomic status, comorbidities, performance status, time from diagnosis), and indicators of WM severity previously validated to correlate with OS (anemia, transfusions, plasmapheresis) using propensity score analysis, to minimize indication bias and simulate a randomized experiment. We then compared OS and select adverse events within 90 days of treatment (hospitalization, transfusion, or plasmapheresis) using survival or log-binomial models weighted by inverse probability of treatment (IPT), reporting hazard ratio (HR) or relative risk (RR) with 95% confidence intervals (CI). Results: Among 1,310 pts (median age 78 years, 43% women), 54% received first-line R monotherapy, 12% R+PUR, 12% R+ALK, 14% PUR-(without R)- and 8% ALK-(without R)-based regimen. Receipt of R was more likely among pts with metropolitan residence, diagnosis after 2003, and baseline neuropathy, and significantly varied by treating physician (intra-class correlation, 45%, CI 25-66%, P<.0001). Unadjusted 5-year OS was 42.0% (CI, 36.1-47.8) for chemotherapy without R, 51.9% (CI, 46.0-57.6) for chemotherapy with R, and 50.6% (CI, 46.4-54.7) for R alone. In each comparative analysis, we achieved adequate balance of confounding variables using propensity scores. In the IPT-weighted outcome models, OS was significantly better for pts who received R as part of their therapy compared with those who did not (HR, 0.77; CI, 0.64-0.93; P=.0058; Fig. A), without difference in the studied toxicities. Within 3 months of starting therapy, there was an overall 20.4% frequency of transfusion, 9.6% of hospitalization, and 4.4% of plasmapheresis. The RR for plasmapheresis after R-based regimen was 1.09 (CI, 0.63-1.90, P=.76). There was no significant difference in OS between pts receiving R alone or in combination with chemotherapy (HR, 0.90, CI, 0.74-1.08, P=.25, Fig. B), but the risk of transfusions (RR, 0.71; CI, 0.56-0.88; P=.002) and hospitalizations (RR, 0.52; CI, 0.34-0.79; P=.002) was lower after single-agent R. Furthermore, there was no evident difference between PUR- or ALK-based regimens in OS (HR, 1.13, CI, 0.90-1.42, P=.30, Fig. C), or in the studied toxicities. Conclusions: This population-based, comparative effectiveness study provides evidence of OS benefit of R (as monotherapy or combination immunochemotherapy) for Medicare beneficiaries (>65 years old) with WM. Toxicity of single-agent R was lower compared with combination regimens, without a difference in survival, thus confirming its utility as a treatment option for older pts who do not have a strong indication for cytotoxic therapy. Acknowledging likely pre-selection on the basis of (unrecorded) IgM levels, and possible uncaptured prophylactic measures, R-based therapy did not appear to result in a higher risk of plasmapheresis or hospitalization. Figure Figure. Disclosures Olszewski: TG Therapeutics: Research Funding; Genentech: Research Funding; Bristol-Myers Squibb: Consultancy. Treon:Pharmacyclics: Consultancy, Research Funding; Janssen: Consultancy. Castillo:Janssen: Honoraria; Millennium: Research Funding; Pharmacyclics: Honoraria; Abbvie: Research Funding; Otsuka: Consultancy; Biogen: Consultancy.

Changing the treatment paradigm for patients with MDS: How the development of therapeutics influences population-based care in community oncology, the Georgia Cancer Specialists Outcomes Database experience

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 7080-7080
Author(s):  
B. A. Feinberg ◽  
J. Gilmore ◽  
W. Hawke ◽  
T. Gondesen
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Cancer Therapeutics ◽  
Initial Response ◽  
Initial Therapy ◽  
Population Based ◽  
Quality Cancer Care ◽  
Community Oncology ◽  
Treatment Paradigm ◽  
Cancer Specialists

7080 Background: Clinical trials that lead to approval of new cancer therapeutics are based upon rigorous studies of safety & efficacy in a highly-restricted pt population. Community oncology practices are evolving to contribute to our understanding of the population- based effectiveness of these therapeutics by capturing and analyzing outcomes data. Georgia Cancer Specialists, a group practice of 41 hematologists/oncologists has been routinely tracking outcomes data since 1999. We now report outcomes for pts with MDS from our database. MDS was selected since this is a Medicare population, has typically been treated with supportive care only, and 3 new agents, 5-azacytadine (VID), lenalidomide (REV) and decitabine (DAC) have recently been approved allowing assessment of their impact on this cancer population. Methods: The Georgia Cancer Specialists Outcomes Database is an integrated electronic medical records and billing database that captures over 45 parameters on every pt visit at 31 sites. This study is a retrospective, observational study using de-identified pt-level information. Results: We followed 824 MDS pts from Jan-Oct, 2006, with 63% women; mean age 71 yrs; 61% Medicare/Medicaid. Only 7% of pts received at least one MDS-indicated chemotherapeutic. Of these, 44% received VID; 36% REV, and 43% DAC and 18% received at least two. At initial therapy, more REV pts (73%) were transfusion-dependent than VID (20%) and DAC (55%) (p=0.034). Average duration of observed therapy ranged from 2.3–3.25 cycles. A greater proportion of DAC pts (93%) had an improvement in RBC count within the first 4 cycles when compared to VID (44%) and REV (62.5%) (p<0.01). The treatment response profile for platelets was similar for VID and DAC. Conclusions: Practice patterns of elderly pts with MDS are changing as new therapies are adopted in community oncology practice. DAC appears to be very active, with the shortest time to initial response. Rigorous population based outcomes analyses at the practice level is an important component of quality cancer care and must supplement information generated by randomized clinical trials. No significant financial relationships to disclose.

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.

Recruitment in NHLBI population-based studies and randomized clinical trials: Data analysis and survey results

1987 ◽  
Vol 8 (4) ◽  
pp. 141-149 ◽  
Author(s):  
Jeffrey L. Probstfield ◽  
Janet T. Wittes ◽  
Donald B. Hunninghake
Keyword(s):  
Clinical Trials ◽  
Data Analysis ◽  
Randomized Clinical Trials ◽  
Population Based ◽  
Survey Results

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
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