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Final Trial Report of Sentinel-Node Biopsy versus Nodal Observation in Melanoma
Published in Niall MH McLeod, Peter A Brennan, 50 Landmark Papers every Oral & Maxillofacial Surgeon Should Know, 2020
This is the only large multicentre randomised controlled study investigating SNLB in cutaneous melanoma. Its aim was to establish whether SNLB confers a survival advantage. In the interim report,6 it was evident that there was no difference in melanoma-specific survival and the authors subsequently undertook a subset analysis. Their post hoc data showed an improvement in survival in SNLB-positive patients when compared to the therapeutic nodal dissection patients in the Observation Group. This post hoc analysis was widely criticised at the time.
Special Issues and Resolutions
Published in Mark Chang, John Balser, Jim Roach, Robin Bliss, Innovative Strategies, Statistical Solutions and Simulations for Modern Clinical Trials, 2019
Mark Chang, John Balser, Jim Roach, Robin Bliss
In preclinical and clinical experiments, sometimes unexpected events happen, such as sudden deaths as discussed in Section 9.6. There are ways to statistically analyze whether the events are likely a result of the medical intervention or not. However, such a post hoc analysis should be used with caution.
Orthomolecular Parenteral Nutrition Therapy
Published in Aruna Bakhru, Nutrition and Integrative Medicine, 2018
Arturo O'Byrne-Navia, Arturo O'Byrne-De Valdenebro
The treatment was well tolerated in both doses, without any statistically significant difference in comparison to the placebo group, both in the clinical and laboratory evaluations. This reflected the findings from previous studies (Hauser et al. 2009, Mischley et al. 2013) regarding the excellent profile of tolerability of Glutathione in Parkinson's disease patients. Aside from that, the authors report a slight clinical improvement according to the UPDRS symptoms scores in the two treatment groups over the placebo group. This trend persisted in the post hoc analysis of the results after the exclusion of the patients who changed medications throughout the study. According to their findings, which included a clinical response superior to placebo, without ignoring the fact of power limitations of this experimental design, Mischley et al. suggest the use of a delayed-start trial (or a similar) design in future investigations to determine a potential neuroprotective effect of intranasal Glutathione in Parkinson's disease. A compilation of the interesting works of Dr. Mischley can be found for further reading in her PhD thesis (Mischley et al. 2016).
The impact of personal protective factors on quality of life after traumatic brain injury
Published in Brain Injury, 2023
Amanda Gahlot, Nancy Chiaravalloti, Yael Goverover
In an effort to understand the pattern of results, one might hypothesize that the observation of impaired SA related to higher QOL may reflect the use of denial as a coping strategy (41,42). The post hoc analysis partially supported this proposed explanation of study results. That is, individuals who over-estimated their performance reported higher QOL than those with accurate SA. Individuals deemed to be ‘over-estimators’ may perceive they were performing better than reality, therefore reporting an inaccurate rating on some QOL questions, such as ‘does your health limit you in certain activities?’ Unfortunately, very few participants underestimated their performance precluding the examination of the role of under-estimation in this relationship. Another possible insight might be found in the significant, negative relationship between SA and emotional functioning, as measured by depressive symptomatology. As one becomes more self-aware of their performance and impairments, they may become more depressed, impacting reports of QOL. This finding is also consistent with prior research (14,38,43).
Concussed Neural Signature is Substantially Different than Fatigue Neural Signature in Non-concussed Controls
Published in Journal of Motor Behavior, 2023
Gustavo Sandri Heidner, Caitlin O’Connell, Zachary J. Domire, Patrick Rider, Chris Mizelle, Nicholas P. Murray
Data were inspected for normality using the Zskewness and Zkurtosis scores (Ghasemi & Zahediasl, 2012; Mishra et al., 2019). The normality tests had a level of significance set at α = 0.001. Non-parametric data sets were treated with a natural logarithmic (Ln) function and re-tested for normality. Two four-way ANOVAs were conducted to investigate the differences within and between groups. The dependent variable was mean natural log of absolute spectral power. The independent variables were condition (EC, EO, SS, SL, US, VR, VB), time/group (pre-/post-fatigue, post-fatigue/concussed), brain region (Frontal, Motor Cortex, Temporal, Central Sulcus, Sensorimotor Cortex, Parietal, Occipital), and frequency band (alpha, theta). The first univariate design was strictly within-subjects repeated-measures model and analyzed the pre- and post-fatigue protocol in the non-concussed group across all conditions, brain regions, and frequency bands. Post-hoc analysis was done through a means and confidence intervals approach. The second univariate design was a between-subjects comparison of the post-fatigue non-concussed group and the concussed group baseline, also across all conditions, brain regions, and frequency bands. Tukey’s HSD post-hoc test and equality of means with Bonferroni correction were used to investigate main effects and interactions. The level of significance for these tests was set at α = 0.05.
Switching to risankizumab from ustekinumab or adalimumab in plaque psoriasis patients improves PASI and DLQI outcomes for sub-optimal responders
Published in Journal of Dermatological Treatment, 2022
Bruce Strober, April Armstrong, Simone Rubant, Manish Patel, Tianshuang Wu, Huzefa Photowala, Jeffrey Crowley
There are limitations inherent to this post-hoc analysis. Patients switched from UST to RZB in the single-arm, open-label extension and thus, there is no comparator for how patients do on continuous UST treatment compared to switching to RZB. However, our results still demonstrate a numerical improvement for patients after their switch. For the ADA to RZB switch population, a smaller patient population switched from ADA to RZB, and these patients had a shorter duration of follow-up. However, IMMvent directly assessed the switch from ADA to RZB compared to continuous ADA treatment in intermediate responders and was adequately powered to assess for superiority. In this direct comparator analysis, switching to RZB was superior for patients with an intermediate response than patients remaining on ADA after rerandomization (7).