scholarly journals Pharmacoepidemiology for nephrologists (part 1): concept, applications and considerations for study design

2020 ◽  
Author(s):  
Marco Trevisan ◽  
Edouard L Fu ◽  
Yang Xu ◽  
Kitty Jager ◽  
Carmine Zoccali ◽  
...  
Keyword(s):  
Drug Safety ◽  
Kidney Diseases ◽  
Routine Care ◽  
Healthcare Data ◽  
Randomized Controlled ◽  
Drug Utilization Research ◽  
Study Designs ◽  
Trial Evidence ◽  
Limited Generalizability

Abstract Randomized controlled trials on drug safety and effectiveness are the foundation of medical evidence, but they may have limited generalizability and be unpowered to detect rare and long-term kidney outcomes. Observational studies in routine care data can complement and expand trial evidence on the use, safety and effectiveness of medications and aid with clinical decisions in areas where evidence is lacking. Access to routinely collected large healthcare data has resulted in the proliferation of studies addressing the effect of medications in patients with kidney diseases and this review provides an introduction to the science of pharmacoepidemiology to critically appraise them. In this first review we discuss the concept and applications of pharmacoepidemiology, describing methods for drug-utilization research and discussing the strengths and caveats of the most commonly used study designs to evaluate comparative drug safety and effectiveness.

Effect of biologic disease-modifying anti-rheumatic drugs targeting remission in axial spondyloarthritis: systematic review and meta-analysis

Rheumatology ◽  
2020 ◽  
Vol 59 (11) ◽  
pp. 3158-3171
Author(s):  
Ana Rita Cruz-Machado ◽  
Santiago Rodrigues-Manica ◽  
Joana Leite Silva ◽  
Irina Alho ◽  
Constança Coelho ◽  
...  
Keyword(s):  
Disease Activity Score ◽  
Axial Spondyloarthritis ◽  
Meta Analysis ◽  
Unmet Need ◽  
Inactive Disease ◽  
Biologic Dmards ◽  
Randomized Controlled ◽  
Secondary Endpoints ◽  
Study Designs

Abstract Objectives To assess the efficacy of biologic DMARDs (bDMARDs) in achieving Assessment of Spondyloarthritis International Society partial remission (ASAS-PR) and/or Ankylosing Spondylitis Disease Activity Score inactive disease (ASDAS-ID), as remission-like surrogates, in axial SpA (axSpA). Methods Data from randomized controlled trials (RCTs), including long-term extensions, were included. A systematic literature review was performed using the MEDLINE database (first search May 2018, updated February 2020) and PICO criteria according to Patients—adults with radiographic or non-radiographic axSpA; Intervention—any bDMARD; Comparator—placebo and/or any different drug; Outcomes—ASAS-PR and/or ASDAS-ID as primary or secondary endpoints. Meta-analysis was performed after assessment of the homogeneity of study designs, populations and outcomes. Results After screening 155 references, a total of 22 RCTs and 28 long-term extensions were retrieved. ASAS-PR was the dominant remission-like definition used. Concerning TNF inhibitors, 14/17 RCTs provided evidence of efficacy in reaching remission at different time points: 12, 16, 24 and 28 weeks (ASAS-PR in 16–62% of patients and ASDAS-ID in 24–40% of patients). With a limited number of studies available, IL-17A inhibitors exhibited remission rates of 15–21% for ASAS-PR and 11–16% for ASDAS-ID at week 16. A meta-analysis regarding ASAS-PR was performed considering RCTs with a similar duration (12, 16 or 24 weeks). The relative risk for achieving remission was 3.864 (95% CI 2.937, 5.085). Conclusion bDMARDs have a clear impact in axSpA remission evaluated by ASAS-PR. Nevertheless, these data show an unmet need for improved reporting of remission-like outcomes.

scholarly journals Reduction of the long-term use of proton pump inhibitors by a patient-oriented electronic decision support tool (arriba-PPI): study protocol for a randomized controlled trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Anja Rieckert ◽  
Annette Becker ◽  
Norbert Donner-Banzhof ◽  
Annika Viniol ◽  
Bettina Bücker ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Decision Support ◽  
Controlled Trial ◽  
Decision Support Tool ◽  
Routine Care ◽  
Electronic Decision Support ◽  
Support Tool ◽  
Randomized Controlled ◽  
Cluster Randomized

Abstract Background Proton pump inhibitors (PPIs) are increasingly being prescribed, although long-term use is associated with multiple side effects. Therefore, an electronic decision support tool with the aim of reducing the long-term use of PPIs in a shared decision-making process between general practitioners (GPs) and their patients has been developed. The developed tool is a module that can be added to the so-called arriba decision support tool, which is already used by GPs in Germany in routine care. In this large-scale cluster-randomized controlled trial we evaluate the effectiveness of this arriba-PPI tool. Methods The arriba-PPI tool is an electronic decision support system that supports shared decision-making and evidence-based decisions around the long-term use of PPIs at the point of care. The tool will be evaluated in a cluster-randomized controlled trial involving 210 GP practices and 3150 patients in Germany. GP practices will be asked to recruit 20 patients aged ≥ 18 years regularly taking PPIs for ≥ 6 months. After completion of patient recruitment, each GP practice with enrolled patients will be cluster-randomized. Intervention GP practices will get access to the software arriba-PPI, whereas control GPs will treat their patients as usual. After an observation period of six months, GP practices will be compared regarding the reduction of cumulated defined daily doses of PPI prescriptions per patient. Discussion Our principal hypothesis is that the application of the arriba-PPI tool can reduce PPI prescribing in primary care by at least 15% compared to conventional strategies used by GPs. A positive result implies the implementation of the arriba-PPI tool in routine care. Trial registration German Clinical Trials Register, DRKS00016364. Registered on 31 January 2019.

scholarly journals Topical Honey in the Management of Pediatric Peritoneal Dialysis Exit Sites

2016 ◽  
Vol 36 (6) ◽  
pp. 684-687 ◽  
Author(s):  
Thomas A. Forbes ◽  
Loren Shaw ◽  
Catherine Quinlan
Keyword(s):  
Peritoneal Dialysis ◽  
Controlled Trial ◽  
Evidence Base ◽  
Exit Site ◽  
Exit Site Infection ◽  
Randomized Controlled ◽  
Mupirocin Resistance ◽  
Trial Evidence ◽  
Medical Grade

International guidelines in peritoneal dialysis (PD) advocate for regular application of topical mupirocin in chronic PD exit-site care. A strong evidence base links this treatment to reduced rates of exit-site infections and peritonitis. However, emerging reports of increasing mupirocin resistance and gram-negative infections are threatening the long-term viability of topical antibiotic ointments as a prophylactic treatment. Medical grade honey has multiple proven antibacterial and wound healing properties. High-quality randomized controlled trial evidence (the HONEYPOT trial), however, does not support the use of topical medical-grade honey over antibiotic ointments for the prevention of exit-site infection and peritonitis in adults. Pediatric representation in these studies is low, and these findings may not extrapolate to the pediatric context, which has a higher incidence of PD-related infection and a lower prevalence of diabetes.We present a series of 8 pediatric patients treated with topical Medihoney (Comvita, Paengaroa, New Zealand) in the context of poor exit-site condition, persistent infection, and recurrent granuloma where the addition of honey was felt to produce remarkable improvement in exit-site status.Medihoney is the first-line prophylactic exit-site ointment in PD exit sites at our institution and has been implicated in the salvage of peritoneal access in some patients. No exclusively pediatric studies have been performed; however, existing literature suggests a beneficial effect in promoting healing of infected wounds with a lower risk of developing antimicrobial resistance.

Juvederm Vollure XC is Safe and Effective for Long-Term Correction of Nasolabial Folds: Results from a Multicenter, Randomized, Controlled Study

2017 ◽  
Vol 1 ◽  
pp. s78
Author(s):  
Steven Dayan ◽  
Corey S Maas ◽  
Pearl E Grimes ◽  
Kenneth Beer ◽  
Gary Monheit ◽  
...  
Keyword(s):  
Randomized Controlled Study ◽  
Controlled Study ◽  
Randomized Controlled ◽  
Nasolabial Folds

Abstract Not AvailableDisclosures: Study supported by Allergan.

Threatening Conditions and Challenges in the Modern Living of the Old People in Republic of Macedonia

2016 ◽  
Vol 2 (2) ◽  
pp. 110
Author(s):  
Hava Rexhep
Keyword(s):  
Kidney Diseases ◽  
Methodological Approach ◽  
Research Problem ◽  
Functional Dependency ◽  
Old People ◽  
Stomach Diseases ◽  
Social Challenge ◽  
The Social ◽  
Build System

The aging is not only a personal but also a social challenge from several aspects, several dimensions; a challenge aiming to build system approaches and solutions with a long term importance. Aims: the main aim of this research is to investigate the conditions and challenges in the modern living of the old people, primarily in terms of the social care. However, this research is concentrated on a big group of the population and their challenges are the most intensive in the modern living. The investigation of the conditions and challenges in the aging are basis and encouragement in realizing the progressive approaches in order to improve the modern living of the old people. The practical aim of the research is a deep investigation and finding important data, analyzing the basic indicators of the conditions, needs and challenges in order to facilitate the old population to get ready for the new life. Methods and techniques: Taking into consideration the complexity of the research problem, the basic methodological approach is performed dominantly by descriptive-analytical method. The basic instrument for getting data in the research is the questionnaire with leading interview for the old people. Results: The research showed that the old people over 70-79 years old in a bigger percentage manifested difficulties primarily related to the functional dependency, respectively 39,33 % of the participants in this category showed concern about some specific functional dependency from the offered categories. The percentage of the stomach diseases with 38,33 % is important, as well as the kidney diseases with 32,83% related to the total population and the category of the old people over 80. Conclusion: The old people very often accept the life as it is, often finding things fulfilled with tolerance and satisfaction. However the health problems of the old people are characterized with a dominant representation. The chronic diseases and the diseases characteristic for the aging are challenge in organizing adequate protection which addresses to taking appropriate regulations, programs and activities.

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