Treatment Allocation, the Size of Trials and Reporting Results

Keyword(s):  
2009 ◽  
Vol 1 (1) ◽  
pp. 41-49
Author(s):  
Marc Bosiers ◽  
Koen Deloose ◽  
Jurgen Verbist ◽  
Patrick Peeters

Author(s):  
Willemieke P M Dijksterhuis ◽  
Marianne C Kalff ◽  
Anna D Wagner ◽  
Rob H A Verhoeven ◽  
Valery E P P Lemmens ◽  
...  

Abstract Background Biological sex and gender have been reported to impact incidence and overall survival (OS) of curatively treated gastroesophageal cancer. The aim of this study was to compare palliative treatment allocation and OS between women and men with advanced gastroesophageal cancer. Methods Patients with an unresectable (cT4b) or metastatic (cM1) esophageal (including cardia) adenocarcinoma (EAC) or squamous cell carcinoma (ESCC), or gastric adenocarcinoma (GAC) diagnosed in 2015-2018 were identified in the Netherlands Cancer Registry. Treatment allocation was compared using chi-squared tests and multivariable logistic regression analyses, and OS using the Kaplan-Meier method with log-rank test and Cox proportional hazard analysis. All statistical tests were 2-sided. Results Of patients with EAC (n = 3,077), ESCC (n = 794) and GAC (n = 1,836), 18.0%, 39.4% and 39.1% were women, respectively. Women received less often systemic treatment compared to men in EAC (42.7% vs. 47.4%, P = 0.045) and GAC (33.8% vs. 38.8%, P = 0.03), but not in ESCC (33.2% vs. 39.5%, P = 0.07). Women had a lower probability of receiving systemic treatment in GAC in multivariable analyses (odds ratio [OR] = 0.79, 95% confidence interval [CI] = 0.62-1.00), but not in EAC (OR = 0.86, 95%CI = 0.69-1.06) and ESCC (OR = 0.81, 95%CI = 0.57-1.14). Median OS was lower in women with EAC (4.4 vs. 5.2 months, P = 0.04), but did not differ after adjustment for patient and tumor characteristics and systemic treatment administration. Conclusion We observed statistically significant and clinically relevant gender differences in systemic treatment administration and OS in advanced gastroesophageal cancer. Causes of these disparities may be sex-based, i.e. related to tumor biology, as well as gender-based, e.g. related to differences in treatment choices.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Stephanie Jansen-Kosterink ◽  
Lex van Velsen ◽  
Miriam Cabrita

Abstract Background The uptake of complex clinical decision support systems (CDSS) in daily practice remains low, despite the proven potential to reduce medical errors and to improve the quality of care. To improve successful implementation of a complex CDSS this study aims to identify the factors that hinder, or alleviate the acceptance of, clinicians toward the use of a complex CDSS for treatment allocation of patients with chronic low back pain. Methods We tested a research model in which the intention to use a CDSS by clinicians is influenced by the perceived usefulness; this usefulness, in turn is influenced by the perceived service benefits and perceived service risks. An online survey was created to test our research model and the data was analysed using Partial Least Squares Structural Equation Modelling. The study population consisted of clinicians. The online questionnaire started with demographic questions and continued with a video animation of the complex CDSS followed by the set of measurement items. The online questionnaire ended with two open questions enquiring the reasons to use and not use, a complex CDSS. Results Ninety-eight participants (46% general practitioners, 25% primary care physical therapists, and 29% clinicians at a rehabilitation centre) fully completed the questionnaire. Fifty-two percent of the respondents were male. The average age was 48 years (SD ± 12.2). The causal model suggests that perceived usefulness is the main factor contributing to the intention to use a complex CDSS. Perceived service benefits and risks are both significant antecedents of perceived usefulness and perceived service risks are affected by the perceived threat to autonomy and trusting beliefs, particularly benevolence and competence. Conclusions To improve the acceptance of complex CDSSs it is important to address the risks, but the main focus during the implementation phase should be on the expected improvements in patient outcomes and the overall gain for clinicians. Our results will help the development of complex CDSSs that fit more into the daily clinical practice of clinicians.


2021 ◽  
pp. 1-8
Author(s):  
Norin Ahmed ◽  
Jessica K. Bone ◽  
Gemma Lewis ◽  
Nick Freemantle ◽  
Catherine J. Harmer ◽  
...  

Abstract Background According to the cognitive neuropsychological model, antidepressants reduce symptoms of depression and anxiety by increasing positive relative to negative information processing. Most studies of whether antidepressants alter emotional processing use small samples of healthy individuals, which lead to low statistical power and selection bias and are difficult to generalise to clinical practice. We tested whether the selective serotonin reuptake inhibitor (SSRI) sertraline altered recall of positive and negative information in a large randomised controlled trial (RCT) of patients with depressive symptoms recruited from primary care. Methods The PANDA trial was a pragmatic multicentre double-blind RCT comparing sertraline with placebo. Memory for personality descriptors was tested at baseline and 2 and 6 weeks after randomisation using a computerised emotional categorisation task followed by a free recall. We measured the number of positive and negative words correctly recalled (hits). Poisson mixed models were used to analyse longitudinal associations between treatment allocation and hits. Results A total of 576 participants (88% of those randomised) completed the recall task at 2 and 6 weeks. We found no evidence that positive or negative hits differed according to treatment allocation at 2 or 6 weeks (adjusted positive hits ratio = 0.97, 95% CI 0.90–1.05, p = 0.52; adjusted negative hits ratio = 0.99, 95% CI 0.90–1.08, p = 0.76). Conclusions In the largest individual placebo-controlled trial of an antidepressant not funded by the pharmaceutical industry, we found no evidence that sertraline altered positive or negative recall early in treatment. These findings challenge some assumptions of the cognitive neuropsychological model of antidepressant action.


2017 ◽  
Vol 2017 ◽  
pp. 1-7 ◽  
Author(s):  
Anna-Lena Robinson ◽  
Anders Möller ◽  
Yohan Robinson ◽  
Claes Olerud

The currently available data on the distribution of C2 fracture subtypes is sparse. This study was designed to identify the proportions of the second cervical vertebra (C2) fracture subtypes and to present age and gender specific incidences of subgroups. A dataset of all patients treated between 2002 and 2014 for C2 fractures was extracted from the regional hospital information system. C2 fractures were classified into odontoid fractures types 1, 2, and 3, Hangman’s fractures types 1, 2, and 3, and atypical C2 fractures. 233 patients (female 51%, age 72±19 years) were treated for a C2 fracture. Odontoid fractures were found in 183 patients, of which 2 were type 1, 127 type 2, and 54 type 3, while 26 of C2 fractures were Hangman’s fractures and 24 were atypical C2 fractures. In the geriatric subgroup 89% of all C2 fractures were odontoid, of which 71% were type 2 and 29% type 3. There was an increasing incidence of odontoid fractures types 2 and 3 from 2002 to 2014. 40% of C2 fractures were treated surgically. This study presents reliable subset proportions of C2 fractures in a prospectively collected regional cohort. Knowledge of these proportions facilitates future epidemiological studies of C2 fractures.


2014 ◽  
Vol 46 (02) ◽  
pp. 585-602 ◽  
Author(s):  
Li-Xin Zhang ◽  
Feifang Hu ◽  
Siu Hung Cheung ◽  
Wai Sum Chan

The generalized Pólya urn has been extensively studied and is widely applied in many disciplines. An important application of urn models is in the development of randomized treatment allocation schemes in clinical studies. The randomly reinforced urn was recently proposed, but, although the model has some intuitively desirable properties, it lacks theoretical justification. In this paper we obtain important asymptotic properties for multicolor reinforced urn models. We derive results for the rate of convergence of the number of patients assigned to each treatment under a set of minimum required conditions and provide the distributions of the limits. Furthermore, we study the asymptotic behavior for the nonhomogeneous case.


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