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Concept: Statistical significance

489

Background Concerns persist regarding the effect of current surgical resident duty-hour policies on patient outcomes, resident education, and resident well-being. Methods We conducted a national, cluster-randomized, pragmatic, noninferiority trial involving 117 general surgery residency programs in the United States (2014-2015 academic year). Programs were randomly assigned to current Accreditation Council for Graduate Medical Education (ACGME) duty-hour policies (standard-policy group) or more flexible policies that waived rules on maximum shift lengths and time off between shifts (flexible-policy group). Outcomes included the 30-day rate of postoperative death or serious complications (primary outcome), other postoperative complications, and resident perceptions and satisfaction regarding their well-being, education, and patient care. Results In an analysis of data from 138,691 patients, flexible, less-restrictive duty-hour policies were not associated with an increased rate of death or serious complications (9.1% in the flexible-policy group and 9.0% in the standard-policy group, P=0.92; unadjusted odds ratio for the flexible-policy group, 0.96; 92% confidence interval, 0.87 to 1.06; P=0.44; noninferiority criteria satisfied) or of any secondary postoperative outcomes studied. Among 4330 residents, those in programs assigned to flexible policies did not report significantly greater dissatisfaction with overall education quality (11.0% in the flexible-policy group and 10.7% in the standard-policy group, P=0.86) or well-being (14.9% and 12.0%, respectively; P=0.10). Residents under flexible policies were less likely than those under standard policies to perceive negative effects of duty-hour policies on multiple aspects of patient safety, continuity of care, professionalism, and resident education but were more likely to perceive negative effects on personal activities. There were no significant differences between study groups in resident-reported perception of the effect of fatigue on personal or patient safety. Residents in the flexible-policy group were less likely than those in the standard-policy group to report leaving during an operation (7.0% vs. 13.2%, P<0.001) or handing off active patient issues (32.0% vs. 46.3%, P<0.001). Conclusions As compared with standard duty-hour policies, flexible, less-restrictive duty-hour policies for surgical residents were associated with noninferior patient outcomes and no significant difference in residents' satisfaction with overall well-being and education quality. (FIRST ClinicalTrials.gov number, NCT02050789 .).

Concepts: Psychology, Patient, Hospital, Surgery, Statistical significance, Physician, Perception, Resident

462

A focus on novel, confirmatory, and statistically significant results leads to substantial bias in the scientific literature. One type of bias, known as “p-hacking,” occurs when researchers collect or select data or statistical analyses until nonsignificant results become significant. Here, we use text-mining to demonstrate that p-hacking is widespread throughout science. We then illustrate how one can test for p-hacking when performing a meta-analysis and show that, while p-hacking is probably common, its effect seems to be weak relative to the real effect sizes being measured. This result suggests that p-hacking probably does not drastically alter scientific consensuses drawn from meta-analyses.

Concepts: Scientific method, Statistics, Mathematics, Statistical significance, Science, Effect size, Meta-analysis, Statistical power

393

This randomized controlled trial was performed to investigate whether placebo effects in chronic low back pain could be harnessed ethically by adding open-label placebo (OLP) treatment to treatment as usual (TAU) for 3 weeks. Pain severity was assessed on three 0- to 10-point Numeric Rating Scales, scoring maximum pain, minimum pain, and usual pain, and a composite, primary outcome, total pain score. Our other primary outcome was back-related dysfunction, assessed on the Roland-Morris Disability Questionnaire. In an exploratory follow-up, participants on TAU received placebo pills for 3 additional weeks. We randomized 97 adults reporting persistent low back pain for more than 3 months' duration and diagnosed by a board-certified pain specialist. Eighty-three adults completed the trial. Compared to TAU, OLP elicited greater pain reduction on each of the three 0- to 10-point Numeric Rating Scales and on the 0- to 10-point composite pain scale (P < 0.001), with moderate to large effect sizes. Pain reduction on the composite Numeric Rating Scales was 1.5 (95% confidence interval: 1.0-2.0) in the OLP group and 0.2 (-0.3 to 0.8) in the TAU group. Open-label placebo treatment also reduced disability compared to TAU (P < 0.001), with a large effect size. Improvement in disability scores was 2.9 (1.7-4.0) in the OLP group and 0.0 (-1.1 to 1.2) in the TAU group. After being switched to OLP, the TAU group showed significant reductions in both pain (1.5, 0.8-2.3) and disability (3.4, 2.2-4.5). Our findings suggest that OLP pills presented in a positive context may be helpful in chronic low back pain.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

Concepts: Low back pain, Randomized controlled trial, Statistical significance, Pharmaceutical industry, Clinical research, Placebo, Acupuncture, Effect size

345

Recent advances in Bayesian hypothesis testing have led to the development of uniformly most powerful Bayesian tests, which represent an objective, default class of Bayesian hypothesis tests that have the same rejection regions as classical significance tests. Based on the correspondence between these two classes of tests, it is possible to equate the size of classical hypothesis tests with evidence thresholds in Bayesian tests, and to equate P values with Bayes factors. An examination of these connections suggest that recent concerns over the lack of reproducibility of scientific studies can be attributed largely to the conduct of significance tests at unjustifiably high levels of significance. To correct this problem, evidence thresholds required for the declaration of a significant finding should be increased to 25-50:1, and to 100-200:1 for the declaration of a highly significant finding. In terms of classical hypothesis tests, these evidence standards mandate the conduct of tests at the 0.005 or 0.001 level of significance.

Concepts: Scientific method, Statistics, Statistical significance, Statistical hypothesis testing, Falsifiability, Bayesian inference, Statistical power, United States Declaration of Independence

260

This study documents reporting errors in a sample of over 250,000 p-values reported in eight major psychology journals from 1985 until 2013, using the new R package “statcheck.” statcheck retrieved null-hypothesis significance testing (NHST) results from over half of the articles from this period. In line with earlier research, we found that half of all published psychology papers that use NHST contained at least one p-value that was inconsistent with its test statistic and degrees of freedom. One in eight papers contained a grossly inconsistent p-value that may have affected the statistical conclusion. In contrast to earlier findings, we found that the average prevalence of inconsistent p-values has been stable over the years or has declined. The prevalence of gross inconsistencies was higher in p-values reported as significant than in p-values reported as nonsignificant. This could indicate a systematic bias in favor of significant results. Possible solutions for the high prevalence of reporting inconsistencies could be to encourage sharing data, to let co-authors check results in a so-called “co-pilot model,” and to use statcheck to flag possible inconsistencies in one’s own manuscript or during the review process.

Concepts: Statistics, Statistical significance, Ronald Fisher, Statistical hypothesis testing, P-value, Statistical power, Hypothesis testing, Counternull

252

Over the past ten years, unconventional gas and oil drilling (UGOD) has markedly expanded in the United States. Despite substantial increases in well drilling, the health consequences of UGOD toxicant exposure remain unclear. This study examines an association between wells and healthcare use by zip code from 2007 to 2011 in Pennsylvania. Inpatient discharge databases from the Pennsylvania Healthcare Cost Containment Council were correlated with active wells by zip code in three counties in Pennsylvania. For overall inpatient prevalence rates and 25 specific medical categories, the association of inpatient prevalence rates with number of wells per zip code and, separately, with wells per km2 (separated into quantiles and defined as well density) were estimated using fixed-effects Poisson models. To account for multiple comparisons, a Bonferroni correction with associations of p<0.00096 was considered statistically significant. Cardiology inpatient prevalence rates were significantly associated with number of wells per zip code (p<0.00096) and wells per km2 (p<0.00096) while neurology inpatient prevalence rates were significantly associated with wells per km2 (p<0.00096). Furthermore, evidence also supported an association between well density and inpatient prevalence rates for the medical categories of dermatology, neurology, oncology, and urology. These data suggest that UGOD wells, which dramatically increased in the past decade, were associated with increased inpatient prevalence rates within specific medical categories in Pennsylvania. Further studies are necessary to address healthcare costs of UGOD and determine whether specific toxicants or combinations are associated with organ-specific responses.

Concepts: Medicine, Statistics, Petroleum, Statistical significance, The Association, Multiple comparisons, Natural gas, Bonferroni correction

223

What are the statistical practices of articles published in journals with a high impact factor? Are there differences compared with articles published in journals with a somewhat lower impact factor that have adopted editorial policies to reduce the impact of limitations of Null Hypothesis Significance Testing? To investigate these questions, the current study analyzed all articles related to psychological, neuropsychological and medical issues, published in 2011 in four journals with high impact factors: Science, Nature, The New England Journal of Medicine and The Lancet, and three journals with relatively lower impact factors: Neuropsychology, Journal of Experimental Psychology-Applied and the American Journal of Public Health. Results show that Null Hypothesis Significance Testing without any use of confidence intervals, effect size, prospective power and model estimation, is the prevalent statistical practice used in articles published in Nature, 89%, followed by articles published in Science, 42%. By contrast, in all other journals, both with high and lower impact factors, most articles report confidence intervals and/or effect size measures. We interpreted these differences as consequences of the editorial policies adopted by the journal editors, which are probably the most effective means to improve the statistical practices in journals with high or low impact factors.

Concepts: Statistics, Statistical significance, Ronald Fisher, Statistical hypothesis testing, Effect size, Impact factor, Statistical power, The Lancet

200

Much has been written regarding p-values below certain thresholds (most notably 0.05) denoting statistical significance and the tendency of such p-values to be more readily publishable in peer-reviewed journals. Intuition suggests that there may be a tendency to manipulate statistical analyses to push a “near significant p-value” to a level that is considered significant. This article presents a method for detecting the presence of such manipulation (herein called “fiddling”) in a distribution of p-values from independent studies. Simulations are used to illustrate the properties of the method. The results suggest that the method has low type I error and that power approaches acceptable levels as the number of p-values being studied approaches 1000.

Concepts: Scientific method, Statistics, Statistical significance, Academic publishing, Ronald Fisher, Statistical hypothesis testing, Effect size, P-value

190

Reproducibility is a defining feature of science, but the extent to which it characterizes current research is unknown. We conducted replications of 100 experimental and correlational studies published in three psychology journals using high-powered designs and original materials when available. Replication effects were half the magnitude of original effects, representing a substantial decline. Ninety-seven percent of original studies had statistically significant results. Thirty-six percent of replications had statistically significant results; 47% of original effect sizes were in the 95% confidence interval of the replication effect size; 39% of effects were subjectively rated to have replicated the original result; and if no bias in original results is assumed, combining original and replication results left 68% with statistically significant effects. Correlational tests suggest that replication success was better predicted by the strength of original evidence than by characteristics of the original and replication teams.

Concepts: Scientific method, Psychology, Statistics, Statistical significance, Statistical hypothesis testing, Effect size, Meta-analysis, Statistical power

189

BACKGROUND: Acupuncture is used by patients as a treatment for irritable bowel syndrome (IBS) but the evidence on effectiveness is limited. The purpose of the study was to evaluate the effectiveness of acupuncture for irritable bowel syndrome in primary care when provided as an adjunct to usual care. METHODS: Design: A two-arm pragmatic randomised controlled trial.Setting: Primary care in the United Kingdom.Patients: 233 patients had irritable bowel syndrome with average duration of 13 years and score of at least 100 on the IBS Symptom Severity Score (SSS).Interventions: 116 patients were offered 10 weekly individualised acupuncture sessions plus usual care, 117 patients continued with usual care alone.Measurements: Primary outcome was the IBS SSS at three months, with outcome data collected every three months to 12 months. RESULTS: There was a statistically significant difference between groups at three months favouring acupuncture with a reduction in IBS Symptom Severity Score of -27.43 (95% CI: –48.66 to -6.21, p = 0.012). The number needed to treat for successful treatment (>=50 point reduction in the IBS SSS) was six (95% CI: 3 to 17), based on 49% success in the acupuncture group vs. 31% in the control group, a difference between groups of 18% (95% CI: 6% to 31%). This benefit largely persisted at 6, 9 and 12 months. CONCLUSIONS: Acupuncture for irritable bowel syndrome provided an additional benefit over usual care alone. The magnitude of the effect was sustained over the longer term. Acupuncture should be considered as a treatment option to be offered in primary care alongside other evidenced based treatments.Trial RegistrationCurrent Controlled Trials ISRCTN08827905.

Concepts: Clinical trial, The Canon of Medicine, Randomized controlled trial, Statistical significance, Effectiveness, Avicenna, Irritable bowel syndrome, Flatulence