scholarly journals The effects of industry funding and positive outcomes in the interpretation of clinical trial results: a randomized trial among Dutch psychiatrists

2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Joeri K. Tijdink ◽  
Yvo M. Smulders ◽  
Lex M. Bouter ◽  
Christiaan H. Vinkers
Keyword(s):  
Clinical Trial ◽  
Clinical Relevance ◽  
Positive Outcome ◽  
Negative Outcomes ◽  
Industry Funding ◽  
Perceived Credibility ◽  
Funding Sources ◽  
Study Results ◽  
Scientific Abstract ◽  
Negative Outcome

Abstract Background Most studies are inclined to report positive rather than negative or inconclusive results. It is currently unknown how clinicians appraise the results of a randomized clinical trial. For example, how does the study funding source influence the appraisal of an RCT, and do positive findings influence perceived credibility and clinical relevance? This study investigates whether psychiatrists’ appraisal of a scientific abstract is influenced by industry funding disclosures and a positive outcome. Methods Dutch psychiatrists were randomized to evaluate a scientific abstract describing a fictitious RCT for a novel antipsychotic drug. Four different abstracts were created reporting either absence or presence of industry funding disclosure as well as a positive or a negative outcome. Primary outcomes were the perceived credibility and clinical relevance of the study results (10-point Likert scale). Secondary outcomes were the assessment of methodological quality and interest in reading the full article. Results Three hundred ninety-five psychiatrists completed the survey (completion rate 45%). Industry funding disclosure was found not to influence perceived credibility (Mean Difference MD 0.12; 95% CI − 0.28 to 0.47, p?) nor interpretation of its clinical relevance (MD 0.14; 95% CI − 0.54 to 0.27, p?). A negative outcome was perceived as more credible than a positive outcome (MD 0.81 points; 95% Confidence Interval (CI) 0.43 to 1.18, p?), but did not affect clinical relevance scores (MD -0.14; 95% CI − 0.54 to 0.27). Conclusions In this study, industry funding disclosure was not associated with the perceived credibility nor judgement of clinical relevance of a fictional RCT by psychiatrists. Positive study outcomes were found to be less credible compared to negative outcomes, but industry funding had no significant effects. Psychiatrists may underestimate the influence of funding sources on research results. The fact that physicians indicated negative outcomes to be more credible may point to more awareness of existing publication bias in the scientific literature.

scholarly journals Industry Funding and Cholesterol Research: A Systematic Review

2019 ◽  
pp. 155982761989219
Author(s):  
Neal D. Barnard ◽  
M. Blaire Long ◽  
Jennifer M. Ferguson ◽  
Rosendo Flores ◽  
Hana Kahleova
Keyword(s):  
Systematic Review ◽  
Intervention Studies ◽  
Blood Cholesterol ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Industry Funding ◽  
The Public ◽  
Funding Sources ◽  
Central Register ◽  
Study Results

The effect of diet on blood cholesterol concentrations has become controversial. We assessed whether industry-funded studies were more likely than non–industry-funded studies to report conclusions that were not supported by their objective findings. PubMed and Cochrane Central Register of Controlled Trials searches through March 8, 2019, yielded 211 relevant articles. The percentage of industry-funded studies increased from 0% in the 1950s to 60% for 2010 tp 2019 ( P < .001). Of 94 non–industry-funded intervention studies for which the effect of egg ingestion on cholesterol concentrations could be determined, net cholesterol increases were reported in 88 (93%) studies (51% statistically significant, 21% not significant, 21% significance not reported). Among 59 industry-funded intervention studies, net cholesterol increases were reported in 51 (86%) studies (34% statistically significant, 39% not significant, and 14% significance not reported). No studies reported significant cholesterol decreases. Nonsignificant net cholesterol decreases were reported by 6 (6%) non–industry-funded and 8 (14%) industry-funded studies. However, 49% of industry-funded intervention studies reported conclusions that were discordant with study results (ie, net cholesterol increases were described as favorable in the articles’ stated conclusions), compared with 13% of non–industry-funded studies. Readers, editors, and the public should remain alert to funding sources in interpreting study findings and conclusions.

The Outcome Effect and Professional Skepticism: A Replication and a Failed Attempt at Mitigation

2018 ◽  
Vol 31 (2) ◽  
pp. 135-143 ◽  
Author(s):  
Joseph F. Brazel ◽  
Christine Gimbar ◽  
Eldar M. Maksymov ◽  
Tammie J. Schaefer
Keyword(s):  
Positive Outcome ◽  
Original Study ◽  
Research Note ◽  
Data Availability ◽  
Professional Skepticism ◽  
Initial Effect ◽  
Additional Testing ◽  
Failed Attempt ◽  
Negative Outcome

ABSTRACT In this research note, we replicate Brazel, Jackson, Schaefer, and Stewart's (2016) study of how auditors evaluate skeptical behavior. Like the original study, we find that evaluators reward audit staff who exercise appropriate levels of skepticism and identify a misstatement (positive outcome). However, when no misstatement is identified (negative outcome), evaluators penalize staff who exercise appropriate levels of skepticism. One factor causing this outcome effect may be that exercising skepticism typically causes budget overages due to additional testing. Hence, we examine whether formally attributing the budget overage to skeptical judgments and actions in the audit budget file reduces outcome effects. However, while replicating the initial effect across three separate studies, we have been unable to reduce this effect. Thus, it is clear that the outcome effect in this context is very robust. Data Availability: Contact the authors.

scholarly journals Least Likely Observations in Regression Models for Categorical Outcomes

2002 ◽  
Vol 2 (3) ◽  
pp. 296-300 ◽  
Author(s):  
Jeremy Freese
Keyword(s):  
Logistic Regression ◽  
Regression Models ◽  
Binary Logistic Regression ◽  
Positive Outcome ◽  
Ordinary Least Squares ◽  
Parameter Estimates ◽  
Least Squares Regression ◽  
Binary Logistic Regression Model ◽  
Ordered Logistic Regression ◽  
Negative Outcome

This article presents a method and program for identifying poorly fitting observations for maximum-likelihood regression models for categorical dependent variables. After estimating a model, the program leastlikely will list the observations that have the lowest predicted probabilities of observing the value of the outcome category that was actually observed. For example, when run after estimating a binary logistic regression model, leastlikely will list the observations with a positive outcome that had the lowest predicted probabilities of a positive outcome and the observations with a negative outcome that had the lowest predicted probabilities of a negative outcome. These can be considered the observations in which the outcome is most surprising given the values of the independent variables and the parameter estimates and, like observations with large residuals in ordinary least squares regression, may warrant individual inspection. Use of the program is illustrated with examples using binary and ordered logistic regression.

scholarly journals Diastolic dyssynchrony in patients with LV only fusion pacing CRT without RV lead

2021 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
A Gurgu ◽  
L Petrescu ◽  
C Vacarescu ◽  
CT Luca ◽  
C Mornos ◽  
...  
Keyword(s):  
Lateral Wall ◽  
Positive Outcome ◽  
Type I ◽  
Exercise Tests ◽  
Type Iii ◽  
Funding Sources ◽  
End Diastolic Volume ◽  
Chamber View ◽  
Systolic And Diastolic Function

Abstract Funding Acknowledgements Type of funding sources: None. Background CRT improves both systolic and diastolic function, thus increasing cardiac output. However, less data is available concerning diastolic dyssynchrony and fusion pacing CRT. The aim of our study was to assess the outcome of LV diastolic asynchrony in a population of fusion pacing CRT without right ventricular (RV)  lead. Methods Prospective data were collected from a cohort of patients (pts) with right atrium/left ventricle leads (RA/LV CRT). Baseline and every 6 months follow-up included standard ETT and classical dyssynchrony parameter measurements. Diastolic dyssynchrony was done by offline speckle-tracking derived TDI timing assesment of the simultaneity of E" and A"  basal septal and lateral wall 4 chamber view. New parameters were introduced: E" and respectively A" time (E"T / A"T) as the time difference between E" (respectively A" ) peaks septal and lateral wall. Exercise tests, drugs optimization and device individual programmimg were systematically performed in order to maintain constant fusion and improve CRT response. Patients were divided in three groups: super-responders (SR), responders (R) and non responders (NR). Results Sixty-two pts (35 male) aged 62 ± 11 y.o. with idiopathic DCM implanted with a RA/LV CRT were analyzed: 34%SR / 61%R / 5%NR. Baseline initial characteristics: QRS 164 ± 18 ms; EF 27 ± 5.2; 29% had type III diastolic dysfunction (DD), 63% type II DD, 8% type I DD. Average follow-up was 45 ± 19 months; mean LVEF at the last follow-up was 37 ± 7.9%. The E"T decreased from 90 ± 20 ms to 25 ± 10 ms in SR with significant LV reverse remodelling (LV end-diastolic volume 193.7 ± 81 vs 243.2 ± 82 ml at baseline, p &lt; 0.0028) and lower LV filling pressures (E/E" 13.2 ± 4.6 vs 11.4 ± 4.5, p =0.0295). DD profile improved in 65% of R with a reduction in E/A ratio (1.46 ± 5.3 vs. 0.82 ± 3.9 at baseline, p= 0.4453). Non-sudden cardiac death occurred in 3 NR pts (2%) with type III DD, severe LA volume and larger E" T /A"T (E"T&gt; 85 msec A"T &gt; 30 msec).  Significant cut off value calculated by ROC curve for LV diastolic dyssynchrony is E"T &gt; 80 ms and A"T of &gt; 25 msec. Conclusions Fusion pacing CRT without RV lead showed a positive outcome; improving LV diastolic dyssynchrony in responders and super-responders patients is obvious. Larger randomized studies are needed to define the role of diastolic asynchronism as a predictor of favorable response in fusion pacing. Abstract Figure. Typical TDI patterns in LV fusion pacing

scholarly journals Protocol for a randomised clinical trial of multimodal postconcussion symptom treatment and recovery: the Concussion Essentials study

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e041458
Author(s):  
Vicki Anderson ◽  
Vanessa C Rausa ◽  
Nicholas Anderson ◽  
Georgia Parkin ◽  
Cathriona Clarke ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomised Clinical Trial ◽  
Normal Activity ◽  
Secondary Outcome ◽  
Open Label ◽  
Human Research Ethics ◽  
Postconcussive Symptoms ◽  
Study Results ◽  
Registration Number ◽  
Initial Injury

IntroductionWhile most children recover from a concussion shortly after injury, approximately 30% experience persistent postconcussive symptoms (pPCS) beyond 1-month postinjury. Existing research into the treatment of pPCS have evaluated unimodal approaches, despite evidence suggesting that pPCS likely represent an interaction across various symptom clusters. The primary aim of this study is to evaluate the effectiveness of a multimodal, symptom-tailored intervention to accelerate symptom recovery and increase the proportion of children with resolved symptoms at 3 months postconcussion.Methods and analysisIn this open-label, assessor-blinded, randomised clinical trial, children with concussion aged 8–18 years will be recruited from The Royal Children’s Hospital (The RCH) emergency department, or referred by a clinician, within 17 days of initial injury. Based on parent ratings of their child’s PCS at ~10 days postinjury, symptomatic children (≥2 symptoms at least 1-point above those endorsed preinjury) will undergo a baseline assessment at 3 weeks postinjury and randomised into either Concussion Essentials (CE, n=108), a multimodal, interdisciplinary delivered, symptom-tailored treatment involving physiotherapy, psychology and education, or usual care (UC, n=108) study arms. CE participants will receive 1 hour of intervention each week, for up to 8 weeks or until pPCS resolve. A postprogramme assessment will be conducted at 3 months postinjury for all participants. Effectiveness of the CE intervention will be determined by the proportion of participants for whom pPCS have resolved at the postprogramme assessment (primary outcome) relative to the UC group. Secondary outcome analyses will examine whether children receiving CE are more likely to demonstrate resolution of pPCS, earlier return to normal activity, higher quality of life and a lower rate of utilisation of health services, compared with the UC group.Ethics and disseminationEthics were approved by The RCH Human Research Ethics Committee (HREC: 37100). Parent, and for mature minors, participant consent, will be obtained prior to commencement of the trial. Study results will be disseminated at international conferences and international peer-reviewed journals.Trial registration numberACTRN12617000418370; pre-results.

scholarly journals Clinical trial research on COVID-19 in Germany – a systematic analysis

F1000Research ◽  
2021 ◽  
Vol 10 ◽  
pp. 913
Author(s):  
Julian Hirt ◽  
Abeelan Rasadurai ◽  
Matthias Briel ◽  
Pascal Düblin ◽  
Perrine Janiaud ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Research Agenda ◽  
Randomized Clinical Trials ◽  
Median Number ◽  
First Year ◽  
Industry Funding ◽  
Systematic Analysis ◽  
Clinical Trial Research ◽  
German Contribution

Background: In 2020, the COVID-19 pandemic led to an unprecedented volume of almost 3,000 clinical trials registered worldwide. We aimed to describe the COVID-19 clinical trial research agenda in Germany during the first year of the pandemic. Methods: We identified randomized clinical trials assessing interventions to treat or prevent COVID-19 that were registered in 2020 and recruited or planned to recruit participants in Germany. We requested recruitment information from trial investigators as of April 2021. Results: In 2020, 65 trials were completely (n=27) or partially (n=38) conducted in Germany. Most trials investigated interventions to treat COVID-19 (86.2%; 56/65), in hospitalized patients (67.7%; 44/65), with industry funding (53.8%; 35/65). Few trials were completed (21.5%; 14/65). Overall, 187,179 participants were planned to be recruited (20,696 in Germany), with a median number of 106 German participants per trial (IQR 40 to 345).  From the planned German participants, 13.4%  were recruited (median 15 per trial (IQR 0 to 44). Conclusions: The overall German contribution to the worldwide COVID-19 clinical trial research agenda was modest. Few trials delivered urgently needed evidence. Most trials did not meet recruitment goals. Evaluation and international comparison of the challenges for conducting clinical trials in Germany is needed.

Aluminum foot insoles reduce plantar forefoot pressure and increase foot comfort for motorcyclists

2018 ◽  
Vol 42 (6) ◽  
pp. 606-611 ◽  
Author(s):  
Israel Casado-Hernández ◽  
Ricardo Becerro-de-Bengoa-Vallejo ◽  
Daniel López-López ◽  
Antonio Gómez-Bernal ◽  
Marta Elena Losa-Iglesias
Keyword(s):  
Clinical Trial ◽  
Plantar Pressure ◽  
Clinical Relevance ◽  
Ethylene Vinyl Acetate ◽  
Maximum Pressure ◽  
Foot Pain ◽  
Foot Pressure ◽  
First Metatarsal ◽  
Repetitive Loading ◽  
And Control

Background: Foot pain and paresthesia are common in cycling, due to plantar pressure and repetitive loading. Objectives: The aim was to investigate the effect of foot insoles on plantar pressure of the foot in motorcycling, as well as self-reported comfort. Study design: A randomized crossover clinical trial. Methods: A flexible foot pressure mat (GP MobilData WiFi® Gebiomized®) with different sizes was utilized. Results: Maximum pressure values occurred predominantly in the hallux with 4.90 ± 1.19 N/cm2, followed by second and third metatarsal areas with 4.57 ± 0.73 N/cm2, followed by the first metatarsal area with 4.30 ± 0.96 N/cm2, and followed by the fourth and fifth metatarsal areas with 3.22 ± 0.89 N/cm2 when using the control foot insole and using aluminum foot insole, which reduces maximum pressure to 1.55 ± 0.34, 1.56 ± 0.75, 1.09 ± 0.43, and 1.07 ± 0.59 N/cm2, respectively ( p < 0.001), with an effect size of 3.828, 4.067, 4.315, and 2.847, respectively. Conclusion: The use of an aluminum foot insole significantly reduced maximum pressure during motorcycling. Clinical relevance In this study, an aluminum insole in a motorcycling boot was shown to decrease maximum pressure on the foot. Comfort was significantly higher than that from ethylene vinyl acetate or commercial boot inserts. This increased comfort and decreased pressure should result in increased safety and control for motorcyclists.

Themes and Lessons Learned

2016 ◽  
pp. 337-361
Keyword(s):  
Clinical Trial ◽  
Mixed Methods ◽  
Case Studies ◽  
Quantitative Methods ◽  
Psychotherapy Research ◽  
Positive Outcome ◽  
Lessons Learned ◽  
Qualitative And Quantitative Methods ◽  
Change Mechanisms

Case Studies Within Psychotherapy Trials: Integrating Qualitative and Quantitative Methods presents a specific, mixed-methods approach, called the “Cases Within Trials” (CWT) model, to psychotherapy research, combining the results from a randomized clinical trial (RCT) with systematic case studies involving contrasting outcomes drawn from the experimental condition of the RCT; and a synthesis of the two types of knowledge. Chapters 3–6 of the book present four specific and diverse projects that concretely illustrate the CWT method. In Chapter 8 the editors analyze the four chapters and explore emergent themes in the knowledge gained from them. In the process, the editors systematically compare the positive-outcome and negative-outcome cases across the four projects, highlighting, for example, (a) the importance of contextual variables in creating the conditions for change mechanisms to be activated; (b) the multidimensional, reciprocally interactional nature of the therapy process; and (c) the particular role of therapist responsiveness.

scholarly journals Effects of home-based mirror therapy and cognitive therapeutic exercise on the improvement of the upper extremity functions in patients with severe hemiparesis after a stroke: a protocol for a pilot randomised clinical trial

BMJ Open ◽  
2020 ◽  
Vol 10 (9) ◽  
pp. e035768
Author(s):  
Josefa Gonzalez-Santos ◽  
Raul Soto-Camara ◽  
Paula Rodriguez-Fernández ◽  
Maria Jimenez-Barrios ◽  
Jeronimo Gonzalez-Bernal ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Upper Extremity ◽  
Randomised Clinical Trial ◽  
Therapeutic Exercise ◽  
Mirror Therapy ◽  
Link Type ◽  
Home Based ◽  
Study Results ◽  
Task Oriented

IntroductionNeuroplasticity is defined as the capacity of the brain to reorganise new neuronal pathways. Mirror therapy (MT) and cognitive therapeutic exercise (CTE) are two neurorehabilitation techniques based on neuroplasticity and designed to improve the motor functions of the affected upper extremity in patients with severe hemiparesis after a stroke. Home-based interventions are an appropriate alternative to promote independence and autonomy. The objective of this study is to evaluate which of these techniques, MT and CTE, combined with task-oriented training, is more effective in functional recovery and movement patterns of the upper extremities in patients with severe hemiparesis after a stroke.Methods and analysisThis is a home-based, single-blind, controlled, randomised clinical trial with three parallel arms, including 154 patients who had a stroke aged above 18 years. The primary outcome will be the functionality of the affected upper extremity measured using the Fugl-Meyer Assessment. Secondary variables will include cognitive performance, emotional state, quality of life and activities of daily living. During 6 weeks, one of the intervention groups will receive a treatment based on MT and the other one on CTE, both combined with task-oriented training. No additional interventions will be provided to the control group. To assess the progress of patients who had a stroke in the subacute phase, all variables will be evaluated at different visits: initial (just before starting treatment and 4 weeks post-stroke), post-intervention (6 weeks after initial) and follow-up (6 months).Ethics and disseminationThis protocol has been approved by the Institutional Review Board (CEIm-2.134/2.019) and registered at ClinicalTrials.gov (NCT04163666). The results will be disseminated through open-access peer-reviewed journals, conference presentation, broadcast media and a presentation to stakeholders. These study results will provide relevant and novel information on effective neurorehabilitation strategies and improve the quality of intervention programmes aimed at patients after a stroke.Trial registration numberClinicalTrials.gov (NCT04163666).

scholarly journals Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness (BALANCE) randomised clinical trial: study protocol

BMJ Open ◽  
2020 ◽  
Vol 10 (5) ◽  
pp. e038300
Author(s):  
Nick Daneman ◽  
Asgar H Rishu ◽  
Ruxandra L Pinto ◽  
Yaseen M Arabi ◽  
Deborah J Cook ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Antibiotic Treatment ◽  
Treatment Duration ◽  
Bloodstream Infections ◽  
Clinical Effectiveness ◽  
Randomised Clinical Trial ◽  
Prosthetic Material ◽  
Link Type ◽  
Study Results ◽  
Registration Number

IntroductionBloodstream infections are a leading cause of mortality and morbidity; the duration of treatment for these infections is understudied.Methods and analysisWe will conduct an international, multicentre randomised clinical trial of shorter (7 days) versus longer (14 days) antibiotic treatment among hospitalised patients with bloodstream infections. The trial will include 3626 patients across 60 hospitals and 6 countries. We will include patients with blood cultures confirming a pathogenic bacterium after hospital admission. Exclusion criteria will include patient factors (severe immunosuppression), infection site factors (endocarditis, osteomyelitis, undrained abscesses, infected prosthetic material) and pathogen factors (Staphylococcus aureus, Staphylococcus lugdunensis, Candida and contaminant organisms). We will leave the selection of specific antibiotics, doses and route of delivery to the discretion of treating physicians; no placebo control will be used given the diversity of pathogens and sources of bacteraemia. The intervention will be assignment of treatment duration to be 7 versus 14 days. We will minimise selection bias via central randomisation with variable block sizes, with concealed allocation until day 7 of adequate antibiotic treatment. The primary outcome is 90-day survival; we will test whether 7 days is non-inferior to 14 days of treatment, with a non-inferiority margin of 4% absolute mortality. Secondary outcomes include hospital and intensive care unit (ICU) mortality, relapse rates of bacteraemia, hospital and ICU length of stay, mechanical ventilation and vasopressor duration, antibiotic-free days, Clostridium difficile infection, antibiotic allergy and adverse events and colonisation/infection with antibiotic-resistant organisms.Ethics and disseminationThe study has been approved by the ethics review board at each participating site. Sunnybrook Health Sciences Centre is the central ethics committee. We will disseminate study results via the Canadian Critical Care Trials Group and other collaborating networks to set the global paradigm for antibiotic treatment duration for non-staphylococcal Gram-positive, Gram-negative and anaerobic bacteraemia, among patients admitted to hospital.Trial registration numberThe BALANCE (Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness) trial was registered at www.clinicaltrials.gov (registration number: NCT03005145).

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