Trends in randomized controlled trials in ENT: a 30-year review

1997 ◽  
Vol 111 (7) ◽  
pp. 611-613 ◽  
Author(s):  
K. W. Ah-See ◽  
N. C. Molony ◽  
A. G. D. Maran
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Randomized Controlled Trials ◽  
Gold Standard ◽  
Controlled Trials ◽  
Evidence Based ◽  
Controlled Clinical Trials ◽  
Medline Search ◽  
Randomized Controlled Clinical Trials ◽  
Randomized Controlled

AbstractThere is a growth in the demand for clinical practice to be evidence based. Recent years have seen a rise in the number of randomized controlled clinical trials (RCTS). Such trials while acknowledged as the gold standard for evidence can be difficult to perform in surgical specialities. We have recently identified a low proportion of RCTS in the otolaryngology literature. Our aim was to identify any trend in the number of published RCTS within the ENT literature over a 30-year period and to identify which areas of our speciality lend themselves to this form of study design. A Medline search of 10 prominent journals published between 1966 and 1995 was performed. Two hundred and ninety-six RCTS were identified. Only five were published before 1980. Two hundred (71 per cent) of RCTS were in the areas of otology and rhinology. An encouraging trend is seen in RCTS within ENT literature.

scholarly journals A Description of the Trials, Reviews, and Practice Guidelines Indexed in the PEDro Database

2008 ◽  
Vol 88 (9) ◽  
pp. 1068-1077 ◽  
Author(s):  
Christopher G Maher ◽  
Anne M Moseley ◽  
Cathie Sherrington ◽  
Mark R Elkins ◽  
Robert D Herbert
Keyword(s):  
Clinical Practice ◽  
Physical Therapy ◽  
Randomized Controlled Trials ◽  
Systematic Reviews ◽  
Clinical Practice Guidelines ◽  
Practice Guidelines ◽  
Controlled Trials ◽  
Evidence Based ◽  
Randomized Controlled ◽  
History Of

This perspective provides an overview of the randomized controlled trials, systematic reviews, and evidence-based clinical practice guidelines in physical therapy. Data from the Physiotherapy Evidence Database (PEDro) are used to describe key events in the history of physical therapy research and the growth of evidence of effects of interventions used in the various subdisciplines of physical therapy. The 11,494 records that were identified reveal a rich history of physical therapy research dating back to the first trial in 1929. Most of the randomized controlled trials, systematic reviews, and evidence-based clinical practice guidelines in physical therapy have been published since the year 2000. This rapid growth presents a challenge for physical therapists who want to keep up to date in clinical practice.

scholarly journals Factors in Randomized Controlled Trials Reported to Impact the Implementation of Patient-Reported Outcome Measures Into Routine Care: Protocol for a Systematic Review (Preprint)

2019 ◽  
Author(s):  
Natasha Anne Roberts ◽  
Kimberly Alexander ◽  
David Wyld ◽  
Monika Janda
Keyword(s):  
Systematic Review ◽  
Clinical Practice ◽  
Randomized Controlled Trials ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Controlled Trials ◽  
Evidence Based ◽  
Randomized Controlled ◽  
Patient Reported ◽  
Implementation Factors

BACKGROUND Patient-reported outcome measures (PROMs) are tools that enable patients to directly report their own assessments of well-being, or symptoms, in a structured and consistent way. Despite the usefulness of PROMs in optimizing health outcomes, their use in clinical practice is not routine. PROMs are complex to integrate into the clinical setting, with many elements potentially impacting on the success of implementation. For this reason, a protocol has been developed to guide a systematic review to collate information on implementation as presented in the randomized controlled trials (RCTs) to date. OBJECTIVE The primary objective of this systematic review is to identify and synthesize factors available from RCT data about the fidelity of PROM interventions in clinical practice. The secondary objective will be an assessment of how implementation factors impact fidelity outcomes. METHODS Preferred Reporting Items for Systematic Reviews and Meta-Analyses reporting standards will be followed. MEDLINE, EMBASE, and the Cumulative Index to Nursing and Allied Health Literature via OvidSP will be accessed using a defined search strategy. Grey literature and ClinicalTrials.gov will be reviewed for unpublished studies. Data extraction will be done to identify fidelity and factors impacting implementation, summarized using a narrative synthesis. An evidence-based implementation science framework will assist in identifying potential elements of importance and their effect on the process and outcomes of implementation. A meta-analysis to assess the impact of implementation factors will be attempted. A Cochrane risk of bias tool will be used. RESULTS This protocol has received funding, and searches of databases will commence at the end of May 2019. It is planned that this systematic review will be finalized for publication in (December) 2019. CONCLUSIONS Applying an implementation science evidence-based framework to the published literature may identify factors present in the data that impact on the implementation of PROMs into routine clinical care. This systematic review aims to improve understanding of how these factors impact the fidelity of this intervention, so that PROMs can be more effectively used in the care of patients. This systematic review can also offer more detailed information about the process and outcomes of successful implementation of PROMs.

scholarly journals Factors in Randomized Controlled Trials Reported to Impact the Implementation of Patient-Reported Outcome Measures Into Routine Care: Protocol for a Systematic Review

10.2196/14579 ◽  
2019 ◽  
Vol 8 (11) ◽  
pp. e14579
Author(s):  
Natasha Anne Roberts ◽  
Kimberly Alexander ◽  
David Wyld ◽  
Monika Janda
Keyword(s):  
Systematic Review ◽  
Clinical Practice ◽  
Randomized Controlled Trials ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Controlled Trials ◽  
Evidence Based ◽  
Randomized Controlled ◽  
Patient Reported ◽  
Implementation Factors

Background Patient-reported outcome measures (PROMs) are tools that enable patients to directly report their own assessments of well-being, or symptoms, in a structured and consistent way. Despite the usefulness of PROMs in optimizing health outcomes, their use in clinical practice is not routine. PROMs are complex to integrate into the clinical setting, with many elements potentially impacting on the success of implementation. For this reason, a protocol has been developed to guide a systematic review to collate information on implementation as presented in the randomized controlled trials (RCTs) to date. Objective The primary objective of this systematic review is to identify and synthesize factors available from RCT data about the fidelity of PROM interventions in clinical practice. The secondary objective will be an assessment of how implementation factors impact fidelity outcomes. Methods Preferred Reporting Items for Systematic Reviews and Meta-Analyses reporting standards will be followed. MEDLINE, EMBASE, and the Cumulative Index to Nursing and Allied Health Literature via OvidSP will be accessed using a defined search strategy. Grey literature and ClinicalTrials.gov will be reviewed for unpublished studies. Data extraction will be done to identify fidelity and factors impacting implementation, summarized using a narrative synthesis. An evidence-based implementation science framework will assist in identifying potential elements of importance and their effect on the process and outcomes of implementation. A meta-analysis to assess the impact of implementation factors will be attempted. A Cochrane risk of bias tool will be used. Results This protocol has received funding, and searches of databases will commence at the end of May 2019. It is planned that this systematic review will be finalized for publication in (December) 2019. Conclusions Applying an implementation science evidence-based framework to the published literature may identify factors present in the data that impact on the implementation of PROMs into routine clinical care. This systematic review aims to improve understanding of how these factors impact the fidelity of this intervention, so that PROMs can be more effectively used in the care of patients. This systematic review can also offer more detailed information about the process and outcomes of successful implementation of PROMs. International Registered Report Identifier (IRRID) PRR1-10.2196/14579

scholarly journals Investigator initiated trials versus industry sponsored trials - translation of randomized controlled trials into clinical practice (IMPACT)

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Anette Blümle ◽  
Katharina Wollmann ◽  
Karin Bischoff ◽  
Philipp Kapp ◽  
Szimonetta Lohner ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Randomized Controlled Trials ◽  
Systematic Reviews ◽  
Controlled Trials ◽  
Drug Trials ◽  
Journal Articles ◽  
Randomized Controlled ◽  
Investigator Initiated Trials ◽  
German Contribution

Abstract Background Healthcare decisions are ideally based on clinical trial results, published in study registries, as journal articles or summarized in secondary research articles. In this research project, we investigated the impact of academically and commercially sponsored clinical trials on medical practice by measuring the proportion of trials published and cited by systematic reviews and clinical guidelines. Methods We examined 691 multicenter, randomized controlled trials that started in 2005 or later and were completed by the end of 2016. To determine whether sponsorship/funding and place of conduct influence a trial’s impact, we created four sub-cohorts of investigator initiated trials (IITs) and industry sponsored trials (ISTs): 120 IITs and 171 ISTs with German contribution compared to 200 IITs and 200 ISTs without German contribution. We balanced the groups for study phase and place of conduct. German IITs were funded by the German Research Foundation (DFG), the Federal Ministry of Education and Research (BMBF), or by another non-commercial research organization. All other trials were drawn from the German Clinical Trials Register or ClinicalTrials.gov. We investigated, to what extent study characteristics were associated with publication and impact using multivariable logistic regressions. Results For 80% of the 691 trials, results were published as result articles in a medical journal and/or study registry, 52% were cited by a systematic review, and 26% reached impact in a clinical guideline. Drug trials and larger trials were associated with a higher probability to be published and to have an impact than non-drug trials and smaller trials. Results of IITs were more often published as a journal article while results of ISTs were more often published in study registries. International ISTs less often gained impact by inclusion in systematic reviews or guidelines than IITs. Conclusion An encouraging high proportion of the clinical trials were published, and a considerable proportion gained impact on clinical practice. However, there is still room for improvement. For publishing study results, study registries have become an alternative or complement to journal articles, especially for ISTs. IITs funded by governmental bodies in Germany reached an impact that is comparable to international IITs and ISTs.

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