Thoughtful selection and use of scientific terms in clinical research: the case of ‘pragmatic’ trials

2021 ◽  
pp. jim-2021-001789
Author(s):  
Rafael Dal-Ré ◽  
Robert J Mentz ◽  
Frits R Rosendaal
Keyword(s):  
Clinical Practice ◽  
Clinical Research ◽  
Controlled Trial ◽  
International Committee ◽  
Decision Makers ◽  
Pragmatic Trials ◽  
Short Period ◽  
Usual Clinical Practice ◽  
Explanatory Trials ◽  
Technical Terms

Clinical research is a discipline prone to the use of technical terms that may be particularly at risk for misunderstanding given the complex interpretation that is required. In this century, what is happening with the word ‘pragmatic’ when describing a randomized controlled trial (RCT) with medicines deserves a public reflection. Explanatory trials are conducted in ideal conditions to assess the comparative efficacy of interventions and are useful to explain whether interventions work. Pragmatic trials are those conducted in a way that resembles usual clinical practice conditions to assess the comparative effectiveness of interventions in a manner directly applicable for decision-makers. This, however, did not prevent 36% of authors of placebo-controlled, or prelicensing trials to identify their medicines RCTs as pragmatic in the title of their articles. The current situation is such that scientific literature has accepted that ‘pragmatic’ can convey the original meaning—that obtained in trials mimicking usual clinical practice—and a distorted one—that is focused on streamlining any trial procedure. Those involved in clinical trials should emphasize the importance of precision in the use of terms when describing RCTs through standardized solutions when possible. Unless clinical trial stakeholders agree when it would be correct to label an RCT as pragmatic, in a short period of time the term will be in danger of becoming meaningless. It is suggested that the Enhancing the Quality and Transparency of Health Research (EQUATOR) network, the Consolidated Standards of Reporting Trials (CONSORT) group and the International Committee of Medical Journal Editors (ICMJE) could address this topic and provide a consensus way forward.

In real clinical practice osteoporosis drugs are taken for a very short period: analysis of persistence in the campania region

2013 ◽  
Author(s):  
Giovanni Iolascon ◽  
Annarita Capaldo ◽  
Valentina Orlando ◽  
Enrica Menditto ◽  
Francesca Gimigliano
Keyword(s):  
Clinical Practice ◽  
Campania Region ◽  
Period Analysis ◽  
Short Period ◽  
Real Clinical Practice

Temporal trends in surgical procedures for pediatric hydrocephalus: an analysis of the Hydrocephalus Clinical Research Network Core Data Project

2020 ◽  
pp. 1-8
Author(s):  
Mandeep S. Tamber ◽  
John R. W. Kestle ◽  
Ron W. Reeder ◽  
Richard Holubkov ◽  
Jessica Alvey ◽  
...  
Keyword(s):  
Clinical Research ◽  
Temporal Trends ◽  
Patient Characteristics ◽  
Research Network ◽  
Third Ventriculostomy ◽  
Study Cohort ◽  
Core Data ◽  
Pediatric Hydrocephalus ◽  
Short Period ◽  
New Procedures

OBJECTIVEAnalysis of temporal trends in patient populations and procedure types may provide important information regarding the evolution of hydrocephalus treatment. The purpose of this study was to use the Hydrocephalus Clinical Research Network’s Core Data Project to identify meaningful trends in patient characteristics and the surgical management of pediatric hydrocephalus over a 9-year period.METHODSThe Core Data Project prospectively collected patient and procedural data on the study cohort from 9 centers between 2008 and 2016. Logistic and Poisson regression were used to test for significant temporal trends in patient characteristics and new and revision hydrocephalus procedures.RESULTSThe authors analyzed 10,149 procedures in 5541 patients. New procedures for hydrocephalus (shunt or endoscopic third ventriculostomy [ETV]) decreased by 1.5%/year (95% CI −3.1%, +0.1%). During the study period, new shunt insertions decreased by 6.5%/year (95% CI −8.3%, −4.6%), whereas new ETV procedures increased by 12.5%/year (95% CI 9.3%, 15.7%). Revision procedures for hydrocephalus (shunt or ETV) decreased by 4.2%/year (95% CI −5.2%, −3.1%), driven largely by a decrease of 5.7%/year in shunt revisions (95% CI −6.8%, −4.6%). Concomitant with the observed increase in new ETV procedures was an increase in ETV revisions (13.4%/year, 95% CI 9.6%, 17.2%). Because revisions decreased at a faster rate than new procedures, the Revision Quotient (ratio of revisions to new procedures) for the Network decreased significantly over the study period (p = 0.0363). No temporal change was observed in the age or etiology characteristics of the cohort, although the proportion of patients with one or more complex chronic conditions significantly increased over time (p = 0.0007).CONCLUSIONSOver a relatively short period, important changes in hydrocephalus care have been observed. A significant temporal decrease in revision procedures amid the backdrop of a more modest change in new procedures appears to be the most notable finding and may be indicative of an improvement in the quality of surgical care for pediatric hydrocephalus. Further studies will be directed at elucidation of the possible drivers of the observed trends.

scholarly journals Hybrid Tele and In-Clinic Occupation Based Intervention to Improve Women’s Daily Participation after Breast Cancer: A Pilot Randomized Controlled Trial

2021 ◽  
Vol 18 (11) ◽  
pp. 5966
Author(s):  
Khawla Loubani ◽  
Rachel Kizony ◽  
Uzi Milman ◽  
Naomi Schreuer
Keyword(s):  
Breast Cancer ◽  
Cognitive Abilities ◽  
Controlled Trial ◽  
Intervention Group ◽  
Performance Measure ◽  
Control Group ◽  
Activity Levels ◽  
Emotional Symptoms ◽  
Short Period ◽  
Secondary Outcomes

Background: Women after breast cancer (BC) cope with decreased daily participation and quality of life (QOL) due to physical, cognitive, and emotional symptoms. This study examined a hybrid occupation-based intervention, Managing Participation with Breast Cancer (MaP-BC), to improve daily participation in their meaningful activities. Methods: Thirty-five women after BC phase were randomly allocated to the MaP-BC intervention (n = 18) or control (n = 17) group (standard care only). Assessments were administered at baseline (T1), 6-week (T2), and 12-week (T3) post-T1. Main outcome: perceived performance and performance-satisfaction with meaningful activities according to the Canadian Occupational Performance Measure. Secondary outcomes: retained activity levels (Activity Card Sort), QOL (Functional Assessment of Cancer Therapy-Breast), cognitive abilities (Montreal Cognitive Assessment and Behavior Rating Inventory of Executive Function), and upper-extremity functioning (Disability of Arm, Shoulder, Hand). Results showed significant interaction (group x time) effects for the primary outcome in performance, F(2,66) = 29.54, p = 0.001, ɳP2 = 0.472, and satisfaction, F(2,66) = 37.15, p = 0.000, ɳP2 = 0.530. The intervention group improved more in performance, t = 5.51, p = 0.0001, d = 1.298, and satisfaction, t = −5.32, p = 0.0001, d = 1.254, than the control group between T1 and T2. Secondary outcomes demonstrated within-group improvements. Conclusion: MaP-BC, a comprehensive occupation-based hybrid intervention tailored to women’s functional daily needs after BC, improved participation in meaningful activities within a short period.

Confirming neuropathic pain in cancer patients: Applying the NeuPSIG grading system in clinical practice and clinical research

Pain ◽  
2014 ◽  
Vol 155 (5) ◽  
pp. 859-863 ◽  
Author(s):  
Matthew R. Mulvey ◽  
Roman Rolke ◽  
Pål Klepstad ◽  
Augusto Caraceni ◽  
Marie Fallon ◽  
...  
Keyword(s):  
Neuropathic Pain ◽  
Clinical Practice ◽  
Clinical Research ◽  
Cancer Patients ◽  
Grading System

scholarly journals Weight Loss and Weight Regain in Usual Clinical Practice: Results From the TARGET-NASH Observational Cohort

2021 ◽  
Author(s):  
Miguel H. Malespin ◽  
Alfred Sidney Barritt ◽  
Stephanie E. Watkins ◽  
Cheryl Schoen ◽  
Monica A. Tincopa ◽  
...  
Keyword(s):  
Weight Loss ◽  
Clinical Practice ◽  
Weight Regain ◽  
Usual Clinical Practice ◽  
Observational Cohort

Collaborative Research: Once More Into the Breach

PEDIATRICS ◽  
1988 ◽  
Vol 82 (3) ◽  
pp. 510-511
Author(s):  
EVAN CHARNEY
Keyword(s):  
Clinical Practice ◽  
Clinical Research ◽  
Collaborative Research ◽  
Molecular Level ◽  
Organ System ◽  
Biomedical Science ◽  
Memorial Hospital ◽  
Narrow Focus ◽  
Higher Power ◽  
Practice Based Research

In this issue, Christoffel and associates1 described a new program of practice-based research involving community pediatricians and the Department of Pediatrics at Children's Memorial Hospital in Chicago. In one sense, all clinical research is practice based and has a long and honorable history in medicine. What has changed is that the gap between those who conduct research and those in clinical practice has widened. As the pathophysiology of diseases is better understood, the frontier of biomedical science has moved from the whole patient to the organ system, the cell, and, now, the molecular level. It is as if each generation of researchers has snapped a progressively higher power lens under the microscope, with a deeper but more narrow focus.

scholarly journals Non-invasive positive pressure ventilation in acute hypercapnic respiratory failure: clinical experience of a respiratory ward

2004 ◽  
Vol 61 (2) ◽  
Author(s):  
R. Scala ◽  
M. Naldi ◽  
I. Archinucci ◽  
G. Coniglio
Keyword(s):  
Clinical Practice ◽  
Respiratory Failure ◽  
Standard Therapy ◽  
Positive Pressure Ventilation ◽  
Controlled Trial ◽  
Positive Pressure ◽  
Hypercapnic Respiratory Failure ◽  
Non Invasive ◽  
Arterial Blood ◽  
Acute Hypercapnic Respiratory Failure

Background: Although a controlled trial demonstrated that non-invasive positive pressure ventilation (NIV) can be successfully applied to a respiratory ward (RW) for selected cases of acute hypercapnic respiratory failure (AHRF), clinical practice data about NIV use in this setting are limited. The aim of this observational study is to assess the feasibility and efficacy of NIV applied to AHRF in a RW in everyday practice. Methods: Twenty-two percent (216/984) of patients consecutively admitted for AHRF to our RW in Arezzo (years: 1996-2003) received NIV in addition to standard therapy, according to pre-defined routinely used criteria. Tolerance, effects upon arterial blood gases (ABG), success rate (avoidance a priori criteria for intubation) and predictors of failure of NIV were analysed. Results: Nine patients (4.2%) were found to be intolerant to NIV, while the remaining 207 (M: 157, F: 50; mean (SD) age: 73.2 (8.9) yrs; COPD: 71.5%) were ventilated for >1 hour. ABG significantly improved after two hours of NIV (pH: 7.32 (0.06) versus median (Interquartiles) 7.28 (7.24-7.31), p<0.0001; PaCO2: 71.9 (13.5) mmHg versus 80.0 (15.2) mmHg, p<0.0001; PaO2/FiO2: 212 (66) versus 184 (150-221), p<0.0001). NIV succeeded in avoiding intubation in 169/207 patients (81.6%) with hospital mortality of 15.5%. NIV failure was independently predicted by Activity of Daily Living score, pneumonia as cause of AHRF and Acute Physiology and Chronic Health Evaluation III score. Conclusions: In clinical practice NIV is feasible, effective in improving ABG and useful in avoiding intubation in most AHRF episodes that do not respond to the standard therapy managed in an RW adequately trained in NIV.

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