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Preparing Studies for Statistical Analysis
Published in Lynne M. Bianchi, Research during Medical Residency, 2022
Luke J. Rosielle, Lynne M. Bianchi
Effect sizes are a critical factor in assessing the clinical significance of a study. An intervention may show a statistically significant effect, but this effect, as indicated by the effect size, might be so small that it is clinically insignificant. In clinical research, the effect size should represent a clinically meaningful difference. For example, a treatment that reduces the length of hospital stay by 30 minutes is unlikely to be considered clinically meaningful, even if it is statistically significant. However, a treatment that reduces length of hospital stay by 30 hours may be. It is up to the investigators and those to whom the results are communicated to decide whether an effect size is sufficiently large enough to warrant a change in policy or procedure. Box 7.2 includes some standard guidelines for “small,” “medium,” and “large” effects.
How to Develop and Write Hypotheses
Published in Lisa Chasan-Taber, Writing Grant Proposals in Epidemiology, Preventive Medicine, and Biostatistics, 2022
Clinical significance is a more subjective term and is based on the expert opinion of key leaders in the field and/or upon the prior literature. For example, consider that you conducted a study of the impact of prenatal exercise on birth weight. Let's assume that you found a 50 g difference in birth weight between exercisers (exposed group) and non-exercisers (unexposed group), which was statistically significant at p = 0.01. However, obstetricians may not consider a 50 g difference in birth weight to be clinically significant; that is, such a small difference in birth weight may not impact the current or future health of the baby. On the flip side, let's assume that you found a 200 g difference in birth weight that was not statistically significant (e.g., p = 0.25). Such a difference may be viewed as clinically significant but, due to your small sample size, was not statistically significant.
Career Opportunities in Industrial Clinical Research
Published in Gary M. Matoren, The Clinical Research Process in the Pharmaceutical Industry, 2020
As the need for sophisticated, controlled clinical studies has increased in the past several years, so has the need increased for sophisticated Biostatisticians with understanding of clinical frames of reference [13,14,29-32]. Hence, Biostatisticians should not only have basic understanding of life sciences and/or biological sciences but also have competent knowledge or experimental clinical research design. In this regard, it is important for Statisticians to understand the difference between "statistical significance" and "clinical significance." A particular finding may be statistically significant at a particular confidence interval (p value) but not be clinically significant, and vice versa [33].
Short and long-term effectiveness of external shock wave therapy for chronic pelvic pain syndrome in men
Published in Arab Journal of Urology, 2023
Kareim Khalafalla, Ahmed Albakr, Walid El Ansari, Ahmad Majzoub, Haitham Elbardisi, Khalid AlRumaihi, Mohamed Arafa
Certainly, compared to pre-treatment levels, urinary symptoms showed intial statistically significant improvement at week 0 after treatment completion that were not sustained on the longer term (at 12 and 26 weeks). Our observed short-term ESWT effect on urinary symptoms concurs with others, where urinary symptom scores, urine flowmetry and postvoiding residual exhibited temporary early improvement after ESWT that were not statistically maintained on longer follow up [10,12,13]. We are unable to speculate the reason behind such ‘waning’ of ESWT’s effect on voiding symptoms. An important point here is the difference between statistical significance vs clinical significance. We found a significant 1.19-point improvement at week 0 compared to pre-treatment level. Nevertheless, at weeks 12 and 26 weeks the score did not regress to its baseline pre-treatment levels, but rather, still showed improvements of 0.75/0.76 points (on a 5-point scale) which despite their statistical insignificance, in our view, represent clinically significant improvements that would definitely reflect in better quality of life of patients, particularly given the number of individuals suffering CP/CPPS. Further research would benefit to undertake evaluations of the natural history of the urinary symptoms among CP/CPPS patients, as well as longer term objective measurement of ESWT’s effects on urine flow and urodynamics.
Measuring static muscular strength among female operatives: a cross-sectional comparison in different handicraft occupations
Published in International Journal of Occupational Safety and Ergonomics, 2021
Ashish Kumar Singh, Makkhan Lal Meena, Himanshu Chaudhary
Many researchers in the past have misunderstood the statistical and clinical outcomes, and mistakenly relate statistical significance to clinical relevance [70]. Measures including clinical significance, effect sizes, confidence intervals and magnitude-based inferences could be used to determine clinical relevance. The minimal clinically important difference (MCID) was used to evaluate the clinical relevance of the results obtained during the present study. A mean difference between the different groups that are higher than a MCID of 2 should be clinically relevant [71]. The MCID was calculated by multiplying the pooled baseline standard deviation scores by 0.2 [72]. It was quite surprising that even though the difference in static muscle strength values in the right and left hands was statistically significant, none of them was found clinically significant.
Reproductive history and osteoarthritis in the Women’s Health Initiative
Published in Scandinavian Journal of Rheumatology, 2021
A Wang, N Zawadzki, H Hedlin, E LeBlanc, N Budrys, L Van Horn, M Gass, L Westphal, ML Stefanick
We also found that a number of reproductive factors were not associated with self-reported OA in the WHI, including age at menopause, first birth, and first pregnancy; the literature findings on these associations have been inconsistent, although a systematic review of 16 studies found that there was no association between female hormonal aspects and OA of the hand, hip, and knee (24). In our study, we did not find any clinically significant associations for OA and reproductive factors, with odds ratios very close to 1 for all variables studied (see Table 3 and Table 4). The definition of clinical significance varies depending on the field and variables of interest, but is typically closer to the range of an effect size of at least 5–10%, which is larger than the findings in our study. Other articles cited on this subject (19, 20, 33-36) have typically reported effect sizes greater than 5%. This disparity may be due to our large sample size as well as our ability to control for a comprehensive set of confounders and reproductive factors, including hysterectomy and oophorectomy status.