scholarly journals Visual Participatory Analysis: A Qualitative Method for Engaging Participants in Interpreting the Results of Randomized Controlled Trials of Health Interventions

2020 ◽  
Vol 15 (1) ◽  
pp. 18-36 ◽  
Author(s):  
Jenevieve Mannell ◽  
Katy Davis ◽  
Kohenour Akter ◽  
Hannah Jennings ◽  
Joanna Morrison ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Qualitative Method ◽  
Controlled Trial ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Valuable Method ◽  
Unique Method ◽  
Quantitative Results ◽  
Participant Perspectives ◽  
Participatory Analysis

This article contributes to the field of mixed methods by introducing a new method for eliciting participant perspectives of the quantitative results of randomized controlled trials. Participants are rarely asked to interpret trial results, obscuring potentially valuable information about why a trial either succeeds or fails. We introduce a unique method called visual participatory analysis and discuss the insights gained in its use as part of a trial to prevent risk and reduce the prevalence of diabetes in Bangladesh. Findings highlight benefits such as elucidating contextualized explanations for null results and identifying causal mechanisms, as well as challenges around communicating randomized controlled trial methodologies to lay audiences. We conclude that visual participatory analysis is a valuable method to use after a trial.

scholarly journals The Timing of Initiating Complementary Feeding in Preterm Infants and Its Effect on Overweight: A Systematic Review

2018 ◽  
Vol 72 (4) ◽  
pp. 307-315 ◽  
Author(s):  
Karin M. Vissers ◽  
Edith J.M. Feskens ◽  
Johannes B. van Goudoever ◽  
Arieke J. Janse
Keyword(s):  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Preterm Infants ◽  
Complementary Feeding ◽  
Controlled Trial ◽  
Controlled Trials ◽  
Z Score ◽  
Term Infants ◽  
Randomized Controlled ◽  
Significant Difference

Background: What is the appropriate time to start complementary feeding for preterm infants? The answer to this question is yet under debate. The timing of initiating complementary feeding may be associated with overweight in term infants. This systematic review aimed to study the effect of the timing of initiating complementary feeding on overweight in preterm infants. Predefined search items included preterm infants, complementary feeding, overweight, and their synonyms. Summary: The search identified 15,749 articles, of which 5 articles were included. Three studies presented data of randomized controlled trials and 2 studies were cohort studies. Two randomized controlled trials found no significant difference in body mass index (BMI) Z-score between the intervention groups at 12 months of age. One randomized controlled trial presented a significant greater mean rate of growth in length per week until 12 months in the preterm weaning strategy-group compared with the current best practices. One observational study concluded that each month the infants received complementary food later, the Z-score for length and weight was reduced by 0.1. Key Messages: No clear conclusion could be drawn from the included studies. This review illustrates the need for further research to access the effect of the timing of initiating complementary feeding on overweight in preterm infants.

Evaluating the reporting of adverse events in controlled clinical trials conducted in 2010–2015 on migraine drug treatments

Cephalalgia ◽  
2018 ◽  
Vol 38 (12) ◽  
pp. 1885-1895
Author(s):  
Peer Tfelt-Hansen ◽  
Janus Kaufmann Lindqvist ◽  
Thien Phu Do
Keyword(s):  
Adverse Events ◽  
Randomized Controlled Trials ◽  
International Headache Society ◽  
Controlled Trial ◽  
Migraine Treatment ◽  
Controlled Trials ◽  
Acute Administration ◽  
Drug Trials ◽  
Randomized Controlled ◽  
Number Of Patients

Background In 2008, the International Headache Society published guidelines on the “evaluation and registration of adverse events in clinical drug trials on migraine”. They listed seven recommendations for reporting adverse events in randomized controlled trials on migraine. The present study aimed to evaluate adherence to these recommendations, and based on the results, to recommend improvements. Methods We searched the PubMed/MEDLINE database to identify controlled trials on migraine drugs published from 2010 to 2015. For each trial, we noted whether five of the recommended parameters were presented. In addition, we noted whether adverse events were reported in abstracts. Results We identified 73 trials; 51 studied acutely administered drugs and 22 studied prophylactic drugs for migraine. The number of patients with any adverse events were reported in 74% of acute-administration and 86% of prophylactic drug trials. Only 30 (41%) of the 73 studies reported adverse events with data in the abstracts, and 27 (37%) abstracts did not mention adverse events. Conclusion Adverse events, both frequency and symptoms, should be reported to allow a fair judgement of benefit/tolerability ratio when randomized controlled trials in migraine treatment are published. Clinically significant adverse events should be included in the abstract of every randomized controlled trial in migraine treatment.

scholarly journals Does pregabalin effectively and safely relieve postoperative pain in patients undergoing pulmonary resections?

2019 ◽  
Vol 29 (4) ◽  
pp. 555-560 ◽  
Author(s):  
Shuangjiang Li ◽  
Wenbiao Zhang ◽  
Shan Cheng ◽  
Yongjiang Li
Keyword(s):  
Randomized Controlled Trial ◽  
Postoperative Pain ◽  
Randomized Controlled Trials ◽  
Controlled Trial ◽  
Perioperative Period ◽  
Control Group ◽  
Controlled Trials ◽  
Clinical Question ◽  
Randomized Controlled ◽  
Study Type

Summary A best evidence topic in thoracic surgery was written according to a structured protocol. The question addressed was whether pregabalin could effectively and safely reduce postoperative pain in patients undergoing pulmonary resections. Altogether 23 papers were found using the reported search, of which 6 randomized controlled trials represented the best evidence to answer the clinical question. The authors, journal, date and country of publication, patient group studied, study type, relevant outcomes and results of these papers are tabulated. Five of 6 randomized controlled trials demonstrated that the application of oral pregabalin during the perioperative period could effectively reduce postoperative pain after pulmonary resections without compromising patients’ safety. One randomized controlled trial reported no difference in the postoperative pain levels between the pregabalin group and the control group. The rates of adverse effects were generally found to be decreased in patients who received pregabalin compared to the patients who received routine analgesia, although 2 studies reported significantly higher incidences of mild drowsiness and dizziness among the pregabalin-treated patients. Currently available evidence supports that the perioperative administration of pregabalin can effectively and safely relieve postoperative pain for patients undergoing pulmonary resections.

Person-Centered Research: A novel approach to Randomized Controlled Trials

2018 ◽  
Vol 6 (2) ◽  
pp. 209
Author(s):  
Reza A Badian ◽  
Brendan McCormack ◽  
Vibeke Sundling
Keyword(s):  
Randomized Controlled Trial ◽  
Randomized Controlled Trials ◽  
Study Design ◽  
Controlled Trial ◽  
Controlled Trials ◽  
Evidence Based ◽  
Randomized Controlled ◽  
Centered Care ◽  
Based Medicine ◽  
Novel Design

Introduction: Integrating person-centered values with randomized controlled trials methodology is a novel idea. Person-centeredness is gaining steadily more prominence and attention in healthcare and health-related policy and research. Randomized controlled trials are considered as the gold standard in evidence-based medicine for evaluating the effects of treatment or determining the causal effect. A wide array of study designs is available, but there is a lack of designs with both strong person-centered principles and a strong position with respect to the level of evidence. In this paper we intend to introduce a novel design to fill such a gap.Aims and objectives: The aim of this paper is to introduce a novel study design where essential values of person-centered care (PCC) are integrated with randomized controlled trial (RCT) methodology into a novel study design termed a person-centered randomized controlled trial (PC-RCT).Methods: In this paper we discuss the importance and role of evidence in clinical research, levels of evidence, as well as the significance of study design in evidence-based medicine. Moreover, we discuss randomized controlled trials that are considered the gold standard to achieve high quality evidence. In this paper we will explain what the concept of person-centered care is and discuss the values associated with person-centeredness.The theoretical and methodological considerations that are relevant in applying this concept will be discussed before presenting how we intend to incorporate person-centered values into a randomized controlled trial in a novel study design that is both person-centered and randomized controlled (PC-RCT). Different aspects of this proposed novel study design will be discussed, including the theory and methods underlying this new proposed design, its novelty, different stages and practical steps involved in this proposed design. Challenges, drawbacks and possible solutions for addressing challenges of this novel design will be explored, focusing on the construct, dynamics, advantages, disadvantages and novelty of PC-RCT design.Conclusion: This paper presents how person-centered values and traditional randomised controlled trial principal values are integrated into one study design where the strengths of both concepts are merged into one. The proposed novel study design has stronger person-centered characteristics and is solid in its RCT features. This design ensures that participants have much more active participation in decision-making and gain more choice in their treatment. The proposed novel study design in this paper has clearly an important role to play in satisfying the need for a study design that can address both the need for rendering higher levels of evidence as well as simultaneously securing greater integration of person-centered values in the same study design.

scholarly journals Improving Power and Accuracy in Randomized Controlled Trials of Pain Treatments by Accounting for Concurrent Analgesic Use: Statistical Simulations and Analyses of Randomized Controlled Trial Data

2021 ◽  
Author(s):  
Pradeep Suri ◽  
Patrick J Heagerty ◽  
Anna Korpak ◽  
Mark P Jensen ◽  
Laura S Gold ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Pain Intensity ◽  
Rating Scale ◽  
Controlled Trial ◽  
Simulated Data ◽  
Alternative Methods ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Analytic Methods ◽  
Analgesic Use

The 0 to 10 numeric rating scale (NRS) of pain intensity is a standard outcome in randomized controlled trials (RCTs) of pain treatments. For individuals taking analgesics, there may be a disparity between 'observed' pain intensity (the NRS, irrespective of concurrent analgesic use), and 'underlying' pain intensity (what the NRS would be had concurrent analgesics not been taken). Using a contemporary causal inference framework, we compare analytic methods that can potentially account for concurrent analgesic use, first in statistical simulations, and second in analyses of real (non-simulated) data from an RCT of lumbar epidural steroid injections (LESI). The default analytic method was ignoring analgesic use, which is the most common approach in pain RCTs. Compared to ignoring analgesic use and other analytic methods, simulations showed that a quantitative pain and analgesia composite outcome based on adding 1.5 points to observed pain intensity for those who were taking an analgesic (the QPAC1.5) optimized power and minimized bias. Analyses of real RCT data supported the results of the simulations, showing greater power with analysis of the QPAC1.5 as compared to ignoring analgesic use and most other methods examined. We propose alternative methods that should be considered in the analysis of pain RCTs.

scholarly journals Assessing the impact of retraction on the citation of randomized controlled trial reports: an interrupted time-series analysis

2018 ◽  
Vol 24 (1) ◽  
pp. 44-51 ◽  
Author(s):  
Andrew Mott ◽  
Caroline Fairhurst ◽  
David Torgerson
Keyword(s):  
Time Series ◽  
Randomized Controlled Trial ◽  
Randomized Controlled Trials ◽  
Controlled Trial ◽  
Interrupted Time Series ◽  
Controlled Trials ◽  
Interrupted Time Series Analysis ◽  
Randomized Controlled ◽  
Before And After ◽  
The Impact

Objectives To assess the impact of retraction on the citation of randomized controlled trials. Methods We used an interrupted time-series with matched controls. PubMed, CINHAL, Google and the Retraction Watch Database were searched. We identified retracted publications reporting the results of randomized controlled trials involving human participants with two years of available data before and after retraction. We obtained monthly citation counts across all articles for the 24 months before and after retraction, from Web of Science. We used a Poisson segmented regression to detect changes in the level and trend of citation following retraction. We also undertook a matched control analysis of unretracted randomized controlled trials and a sensitivity analysis to account for cases of large-scale, well-advertised fraud. Results We identified 387 retracted randomized controlled trial reports, of which 218 (56.3%) were included in the interrupted time-series analysis. A reduction of 22.9% (95% CI 4.0% to 38.2%, p = 0.02) was observed in the number of citations in the month after retraction, and a further reduction of 1.9% (95% CI 0.4% to 3.5%, p = 0.02) per month in the following 24 months, relative to the expected trend. There was no evidence of a statistically significant reduction among the matched controls. Authors with a large number of retractions saw a 48.2% reduction at the time of retraction (95% CI 17.7% to 67.3%, p = 0.01). Other cases had a more gradual reduction with no change at the time of retraction and a 1.8% reduction per month in the following 24 months (95% CI 0.2% to 3.4%, p = 0.03). Conclusions Retractions of randomized controlled trial reports can be effective in reducing citations. Other factors, such as the scale of the retractions and media attention, may play a role in the effectiveness of the reduction.

scholarly journals The randomised controlled trial in medical research: using bibliometric methods to identify core journals

2006 ◽  
Vol 1 (1) ◽  
pp. 104
Author(s):  
John Loy
Keyword(s):  
Growth Rate ◽  
Drug Therapy ◽  
Randomized Controlled Trials ◽  
Detailed Analysis ◽  
Medical Literature ◽  
Controlled Trial ◽  
The United States ◽  
Growth Patterns ◽  
Controlled Trials ◽  
Randomized Controlled

A review of: Tsay, Migh-yueh, and Yen-hsu Yang. “Bibliometric Analysis of the Literature of Randomized Controlled Trials.” Journal of the Medical Library Association 93.4 (October 2005): 450-58. Objective – To explore the characteristics and distribution of randomized controlled trials (RCTs) in the medical literature. The study aims to identify the growth patterns of the RCT, key subject matter, country and language of publication, and determine a list of core journals which contain a substantial proportion of the RCT literature. Design – Retrospective analysis of RCTs. Setting – Medical journal literature. Subjects – A total of 160,213 articles published between 1965-2001. Detailed analysis of a subset numbering 114,850 articles published from 1990-2001. Methods – The study seeks to identify all RCTs in MEDLINE from 1965-2001, and examines the growth rate of the RCT. The authors then do a more detailed analysis on a subset of data from 1990-2001, using Access database and Excel spreadsheet software, and PERL programming language. The references were analyzed by five fields within MEDLINE; publication type, source, language, country of publication, and descriptor (subject index). Main results – An exponential growth rate for the RCT is demonstrated, suggesting that in the medical literature development has not yet matured and that research using this method continues to grow. A growth rate for the RCT of 11.2% per annum is identified. The most common form of publication is the journal article, making up approximately 98% of the RCT literature. Approximately 75% of the RCTs are multicentre trials indicating that this is the design of choice adopted by researchers. The United States proves to be the greatest source of RCT literature, with 39.9% of journals and 50.6% of articles originating there. After the USA, the most productive countries are England (15.8% of journals and 21.7% articles) and Germany (6.5% journals and 6.1% articles). As might be expected, English is the predominant language providing 92.9% of the total publications. Of the remaining 7%, German is the most common language accounting for 2.2%. The top three areas being researched are: 1. Drug therapy for hypertension - 2291 citations 2. Anticancer drug combinations - 2140 citations 3. Drug therapy and asthma - 1397 citations Bradford’s law of scattering is successfully applied, identifying four zones of journals which each publish approximately 26,000 articles. Conclusion – The results indicate that bibliometric methods can be applied to the medical literature, and highlight those disciplines in which RCTs more often occur. A core list of 42 journal titles is presented, providing busy practitioners with invaluable guidance as to which journals are most likely to publish the greater number of RCTs.

scholarly journals Adjusting for bias in unblinded randomized controlled trials

2016 ◽  
Vol 27 (8) ◽  
pp. 2413-2427 ◽  
Author(s):  
AF Schmidt ◽  
RHH Groenwold
Keyword(s):  
Randomized Controlled Trials ◽  
Instrumental Variable ◽  
Controlled Trial ◽  
Meta Analysis ◽  
Genetic Research ◽  
Risk Difference ◽  
Controlled Trials ◽  
Treatment Allocation ◽  
Randomized Controlled ◽  
Novel Method

It may not always be possible to blind participants of a randomized controlled trial for treatment allocation. As a result, estimators of the actual treatment effect may be biased. In this paper, we will extend a novel method, originally introduced in genetic research, for instrumental variable meta-analysis, adjusting for bias due to unblinding of trial participants. Using simulation studies, this novel method, “Egger Correction for non-Adherence”, is introduced and compared to the performance of the “intention-to-treat,” “as-treated,” and conventional “instrumental variable” estimators. Scenarios considered (time-varying) non-adherence, confounding, and between-study heterogeneity. The effect of treatment on a binary endpoint was quantified by means of a risk difference. In all scenarios with unblinded treatment allocation, the Egger Correction for non-Adherence method was the least biased estimator. However, unless the variation in adherence was relatively large, precision was lacking, and power did not surpass 0.50. As a comparison, in a meta-analysis of blinded randomized controlled trials, power of the conventional IV estimator was 1.00 versus at most 0.14 for the Egger Correction for non-Adherence estimator. Due to this lack of precision and power, we suggest to use this method mainly as a sensitivity analysis.

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