Denial and Defensiveness in the Place of Fact and Reason: Rejoinder to Smith and Lovaas

1997 ◽  
Vol 22 (4) ◽  
pp. 219-230 ◽  
Author(s):  
Frank M. Gresham ◽  
Donald L. Macmillan
Keyword(s):  
Outcome Measure ◽  
Physical Punishment ◽  
National Institutes Of Health ◽  
Random Assignment ◽  
Statistical Regression ◽  
Educational Placement ◽  
Methodological Rigor ◽  
Experimental Validity ◽  
Methodological Problems ◽  
Hearing Officers

The Smith and Lovaas (1997) rebuttal to our article (Gresham & MacMillan, 1997) is defensive, factually inaccurate, and often trivial in its attempts to distract readers from the more important issues of methodological rigor and experimental validity. Smith and Lovaas inaccurately claim that the EIP studies incorporated all six features outlined by the National Institutes of Health for scientifically sound outcome studies and still do not admit to any methodological problems with the lack of random assignment, instrumentation, statistical regression, and use of educational placement as an outcome measure. More important for schools and fair hearing officers, Smith and Lovaas do not adequately address the issues of external validity or generalizability of their findings across sites, subjects, parents, treatment implementers, and to settings in which physical punishment cannot be used. We indicate that the EIP results are indeed promising; however, the evidence presented to date is not as compelling as Smith and Lovaas suggest. Smith and Lovaas's inability to concede any methodological limitations of the EIP studies should give the parental, educational, and research communities reason for concern.

scholarly journals Detection of Dermal Alpha-Synuclein Deposits as a Biomarker for Parkinson’s Disease

2021 ◽  
pp. 1-11
Author(s):  
Kathrin Doppler
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Immunohistochemical Staining ◽  
Outcome Measure ◽  
Alpha Synuclein ◽  
Good Sensitivity ◽  
Promising Tool ◽  
Skin Biopsies ◽  
Methodological Problems ◽  
Sensitivity Specificity

Alpha-synuclein deposits are detectable in skin biopsies of patients with Parkinson’s disease and other synucleinopathies like multiple system atrophy by immunohistochemical staining. As they are easily to obtain, they appear a promising tool for the pre-mortem histopathological confirmation of the disease and as a potential outcome measure in studies targeting alpha-synuclein aggregates. Good sensitivity, specificity, and practicability are the most important requirements of a biomarker. The review gives an overview on all three aspects, addresses methodological problems and the lack of standardized procedures as a major problem and gives an outlook on the future of skin biopsy as a potential diagnostic tool in synucleinopathies.

Relative Deprivation Revisited: A Response to Miller, Bolce, and Halligan

1979 ◽  
Vol 73 (1) ◽  
pp. 103-112 ◽  
Author(s):  
Faye Crosby
Keyword(s):  
Relative Deprivation ◽  
Urban Riots ◽  
Methodological Rigor ◽  
J Curve ◽  
Methodological Problems ◽  
Curve Theory

This article challenges some of the conclusions drawn in “The J-Curve Theory and the Black Urban Riots,” by Abraham Miller, Louis Bolce and Mark Halligan (1977). Miller et al. reject relative deprivation theory and J-curve theory as valid explanations of black urban rioting. In my argument that Miller et al. are not justified in rejecting relative deprivation theory, I shall review four versions of relative deprivation theory to show how Miller et al. misrepresent the theory and to point out methodological problems with their operationalization of theoretical variables. Because these operationalization problems are far from atypical, I conclude with a call for greater methodological rigor.

scholarly journals Can quality improvement improve the quality of care? A systematic review of reported effects and methodological rigor in plan-do-study-act projects

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Søren Valgreen Knudsen ◽  
Henrik Vitus Bering Laursen ◽  
Søren Paaske Johnsen ◽  
Paul Daniel Bartels ◽  
Lars Holger Ehlers ◽  
...  
Keyword(s):  
Systematic Review ◽  
Quality Improvement ◽  
Small Scale ◽  
Clinical Practices ◽  
Methodological Rigor ◽  
Full Analysis ◽  
Methodological Problems ◽  
Key Features ◽  
The Individual ◽  
Almost All

Abstract Background The Plan-Do-Study-Act (PDSA) method is widely used in quality improvement (QI) strategies. However, previous studies have indicated that methodological problems are frequent in PDSA-based QI projects. Furthermore, it has been difficult to establish an association between the use of PDSA and improvements in clinical practices and patient outcomes. The aim of this systematic review was to examine whether recently published PDSA-based QI projects show self-reported effects and are conducted according to key features of the method. Methods A systematic literature search was performed in the PubMed, Embase and CINAHL databases. QI projects using PDSA published in peer-reviewed journals in 2015 and 2016 were included. Projects were assessed to determine the reported effects and the use of the following key methodological features; iterative cyclic method, continuous data collection, small-scale testing and use of a theoretical rationale. Results Of the 120 QI projects included, almost all reported improvement (98%). However, only 32 (27%) described a specific, quantitative aim and reached it. A total of 72 projects (60%) documented PDSA cycles sufficiently for inclusion in a full analysis of key features. Of these only three (4%) adhered to all four key methodological features. Conclusion Even though a majority of the QI projects reported improvements, the widespread challenges with low adherence to key methodological features in the individual projects pose a challenge for the legitimacy of PDSA-based QI. This review indicates that there is a continued need for improvement in quality improvement methodology.

scholarly journals National Institutes of Health Stroke Scale

Stroke ◽  
2020 ◽  
Vol 51 (1) ◽  
pp. 282-290 ◽  
Author(s):  
Vicky Chalos ◽  
Nadinda A.M. van der Ende ◽  
Hester F. Lingsma ◽  
Maxim J.H.L. Mulder ◽  
Esmee Venema ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Endovascular Treatment ◽  
Treatment Effect ◽  
Acute Treatment ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Primary Outcome Measure ◽  
National Institutes Of Health ◽  
Unique Identifier ◽  
Mr Clean

Background and Purpose— The modified Rankin Scale (mRS) at 3 months is the most commonly used primary outcome measure in stroke treatment trials, but it lacks specificity and requires long-term follow-up interviews, which consume time and resources. An alternative may be the National Institutes of Health Stroke Scale (NIHSS), early after stroke. Our aim was to evaluate whether the NIHSS assessed within 1 week after treatment could serve as a primary outcome measure for trials of acute treatment for ischemic stroke. Methods— We used data from 2 randomized controlled trials of endovascular treatment for ischemic stroke: the positive MR CLEAN (Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands; N=500) and the neutral IMS (Interventional Management of Stroke) III trial (N=656). We used a causal mediation model, with linear and ordinal logistic regression adjusted for confounders, to evaluate the NIHSS 24 hours and 5 to 7 days after endovascular treatment as primary outcome measures (instead of the mRS at 3 months) in both trials. Patients who had died before the NIHSS was assessed received the maximum score of 42. NIHSS+1 was then log10-transformed. Results— In both trials, there was a significant correlation between the NIHSS at 24 hours and 5 to 7 days and the mRS. In MR CLEAN, we found a significant effect of endovascular treatment on the mRS and on the NIHSS at 24 hours and 5 to 7 days. After adjustment for NIHSS at 24 hours and 5 to 7 days, the effect of endovascular treatment on the mRS decreased from common odds ratio 1.68 (95% CI, 1.22–2.32) to respectively 1.36 (95% CI, 0.97–1.91) and 1.24 (95% CI, 0.87–1.79), indicating that treatment effect on the mRS is in large part mediated by the NIHSS. In the IMS III trial there was no treatment effect on the NIHSS at 24 hours and 5 to 7 days, corresponding with the absence of a treatment effect on the mRS. Conclusions— The NIHSS within 1 week satisfies the requirements for a surrogate end point and may be used as a primary outcome measure in trials of acute treatment for ischemic stroke, particularly in phase II(b) trials. This could reduce stroke-outcome assessment to its essentials (ie, neurological deficit), and reduce trial duration and costs. Whether and under which conditions it could be used in phase III trials requires a debate in the field with all parties. Clinical Trial Registration— URL: http://www.isrctn.com . Unique identifier: ISRCTN10888758; https://www.clinicaltrials.gov . Unique identifier: NCT00359424.

National Institutes of Health Stroke Scale as an Outcome in Stroke Research: Value of ANCOVA Over Analyzing Change From Baseline

Stroke ◽  
2022 ◽  
Author(s):  
Eva A. Mistry ◽  
Sharon D. Yeatts ◽  
Pooja Khatri ◽  
Akshitkumar M. Mistry ◽  
Michelle Detry ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Outcome Measure ◽  
National Institutes Of Health ◽  
Strong Assumption ◽  
Stroke Research ◽  
Clinical Trial Simulations ◽  
Final Measurement ◽  
Time Of Presentation ◽  
The Relationship

National Institutes of Health Stroke Scale (NIHSS), measured a few hours to days after stroke onset, is an attractive outcome measure for stroke research. NIHSS at the time of presentation (baseline NIHSS) strongly predicts the follow-up NIHSS. Because of the need to account for the baseline NIHSS in the analysis of follow-up NIHSS as an outcome measure, a common and intuitive approach is to define study outcome as the change in NIHSS from baseline to follow-up (ΔNIHSS). However, this approach has important limitations. Analyzing ΔNIHSS implies a very strong assumption about the relationship between baseline and follow-up NIHSS that is unlikely to be satisfied, drawing into question the validity of the resulting statistical analysis. This reduces the precision of the estimates of treatment effects and the power of clinical trials that use this approach to analysis. ANCOVA allows for the analysis of follow-up NIHSS as the dependent variable while adjusting for baseline NIHSS as a covariate in the model and addresses several challenges of using ΔNIHSS outcome using simple bivariate comparisons (eg, a t test, Wilcoxon rank-sum, linear regression without adjustment for baseline) for stroke research. In this article, we use clinical trial simulations to illustrate that variability in NIHSS outcome is less when follow-up NIHSS is adjusted for baseline compared to ΔNIHSS and how a reduction in this variability improves the power. We outline additional, important clinical and statistical arguments to support the superiority of ANCOVA using the final measurement of the NIHSS adjusted for baseline over, and caution against using, the simple bivariate comparison of absolute NIHSS change (ie, delta).

THE NATIONAL INSTITUTES OF HEALTH CHRONIC PROSTATITIS SYMPTOM INDEX: DEVELOPMENT AND VALIDATION OF A NEW OUTCOME MEASURE

1999 ◽  
Vol 162 (2) ◽  
pp. 369-375 ◽  
Author(s):  
MARK S. LITWIN ◽  
MARY McNAUGHTON-COLLINS ◽  
FLOYD J. FOWLER ◽  
J. CURTIS NICKEL ◽  
ELIZABETH A. CALHOUN ◽  
...  
Keyword(s):  
Chronic Prostatitis ◽  
Outcome Measure ◽  
National Institutes Of Health ◽  
Symptom Index ◽  
Index Development ◽  
Development And Validation

The 1-MeV Electron Microscope Installation at the University of Colorado

1973 ◽  
Vol 31 ◽  
pp. 8-9 ◽  
Author(s):  
Mircea Fotino
Keyword(s):  
Electron Microscopy ◽  
Developmental Biology ◽  
Transmission Electron Microscopy ◽  
Electron Microscope ◽  
National Institutes Of Health ◽  
Experimental Program ◽  
University Of Colorado ◽  
Transmission Electron ◽  
The University ◽  
Research Resources

A new 1-MeV transmission electron microscope (Model JEM-1000) was installed at the Department of Molecular, Cellular and Developmental Biology of the University of Colorado in Boulder during the summer and fall of 1972 under the sponsorship of the Division of Research Resources of the National Institutes of Health. The installation was completed in October, 1972. It is installed primarily for the study of biological materials without many of the limitations hitherto unavoidable in standard transmission electron microscopy. Only the technical characteristics of the installation are briefly reviewed here. A more detailed discussion of the experimental program under way is being published elsewhere.

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