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Nevin Manimala Statistics

Assessment of “Spin” in Published Plastic Surgery Randomized Controlled Trials with Statistically Non-significant Primary Outcomes – A Systematic Review

Plast Reconstr Surg. 2022 Nov 29. doi: 10.1097/PRS.0000000000009937. Online ahead of print.

ABSTRACT

BACKGROUND: “Spin” refers to a manipulation of language that implies benefit for an intervention when none may exist. Randomized clinical trials (RCTs) in other fields have been demonstrated to employ spin, which can mislead clinicians to use ineffective or unsafe interventions. This study’s objective was to determine the strategies, severity, and extent of spin in plastic surgery RCTs with non-significant primary outcomes.

METHODS: A literature search of the top 15 plastic surgery journals using MEDLINE was performed (2000-2020). Parallel 1:1 RCTs with a clearly identified primary outcome showing statistically non-significant results (p ≥ .05) were included. Screening, data extraction, and spin analysis were performed by two independent reviewers. The spin analysis was then independently assessed in duplicate by two plastic surgery residents with graduate level training in clinical epidemiology.

RESULTS: From 3,497 studies identified, 92 RCTs were included in this study. Spin strategies were identified in 78 RCTs (85%), including 64 Abstracts (70%) and 77 Main Texts (84%). Severity of spin was rated moderate or high in 43 Abstract Conclusions (47%) and 42 Main Text Conclusions (46%). The most identified spin strategy in the Abstract was claiming equivalence for statistically non-significant results (26%), and in the Main Text was focusing on another objective (24%).

CONCLUSIONS: This study suggests that 85% of statistically non-significant RCTs in plastic surgery employ spin. Readers of plastic surgery research should be aware of strategies, whether intentional or unintentional, used to manipulate language in reports of statistically non-significant RCTs when applying research findings to clinical practice.

PMID:36442055 | DOI:10.1097/PRS.0000000000009937

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Nevin Manimala Statistics

Diagnostic accuracy of the Child and Adolescent Symptom Inventory (CASI-4R) substance use subscale in detecting substance use disorders in youth

Psychol Assess. 2022 Nov 28. doi: 10.1037/pas0001182. Online ahead of print.

ABSTRACT

Identifying substance use disorders (SUDs) early and accurately improves case formulation and treatment. Previous studies have investigated validity and reliability of the Child and Adolescent Symptom Inventory (CASI) for anxiety, mood, and behavior problems. The present study’s aim was to test if the embedded CASI Substance Use (SU) subscale can discriminate adolescents and young adults (AYA) with and without a SUD diagnosis accurately enough to justify clinical application within an evidence-based assessment framework. N = 479 outpatient AYA (age 14-21) and their caregivers completed K-SADS-PLW semistructured diagnostic interviews; caregivers completed the CASI and adolescents completed a parallel version, the Youth (self-report) Inventory (YI). K-SADS-PLW indicated that 33 youth met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria for SUDs. Receiver Operating Characteristic (ROC) analyses found that both CASI and YI Substance Use subscale scores significantly identified K-SADS-diagnosed SUDs in AYA: Caregiver area under curve (AUC) = .91, p < .0005; YI(AUC) = .90, p < .0005. There was no significant difference in diagnostic accuracy between informants. Both subscales showed diagnostic and clinical utility in identifying AYA SUDs in outpatient mental health settings. Findings suggest that the CASI-4R subscale could be a helpful screening instrument for AYA SUDs. A case vignette illustrates the clinical application of study findings. Future research should examine rapport as a moderator of reporting accuracy, and replicate use of these measures under varying clinical scenarios. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

PMID:36442043 | DOI:10.1037/pas0001182

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Nevin Manimala Statistics

Variance, skewness and multiple outcomes in described and experienced prospects: Can one descriptive model capture it all?

J Exp Psychol Gen. 2022 Nov 28. doi: 10.1037/xge0001323. Online ahead of print.

ABSTRACT

We determined the scope of five decision models of choices across four environmental niches defined by whether outcome probabilities are described (risk) or experienced by sampling (uncertainty) and whether lotteries are simple (one or two outcomes per prospect) or complex (three or four). The majority of participants chose in accordance with cumulative prospect theory only in simple environments involving decisions from description (75%). In complex environments involving decisions from description and experience, however, skewness-preference models were more prevalent (57% and 68%, respectively). Consequently, in niches outside of simple lotteries under risk, rank dependence and nonlinear probability weighting failed to accurately describe the majority of choices. Exploiting elicited subjective beliefs in decisions from experience, we found that experienced (sampled) outcome likelihoods outperformed elicited beliefs in predicting choices and found scant evidence for two-stage models of decisions under uncertainty. Finally, we found statistically significant evidence that 90% of participants chose as if they relied on different models across environments; nonetheless, assuming as if participants used a single model across all environments to predict out-of-sample choice only minimally reduced prediction accuracy. We discuss the implications of model mimicry and task diagnosticity in light of these results in terms of both economic and statistical significance, both for model comparisons and inference. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

PMID:36442037 | DOI:10.1037/xge0001323

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Nevin Manimala Statistics

The social network: How people infer relationships from mutual connections

J Exp Psychol Gen. 2022 Nov 28. doi: 10.1037/xge0001330. Online ahead of print.

ABSTRACT

People infer that individuals are socially related if they have overlapping preferences, beliefs, and choices. Here we examined whether people also infer relationships by attending to social network information. In five preregistered experiments, participants were shown the social networks of two target people and their friends or acquaintances within a group, and judged if the targets were socially related to one another. In the first three experiments, adults (total N = 528) were more likely to judge that individuals were friends when a high rather than low proportion of their friendships were mutual. Adults also considered other factors when inferring friendships, such as the number of friends each individual had. In the final two experiments, 5-7-year-olds (total N = 135) were also sensitive to the proportion of mutual relationships. Together, our work suggests that people use proportional information and statistical inferences when assessing whether individuals are socially related. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

PMID:36442033 | DOI:10.1037/xge0001330

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Nevin Manimala Statistics

Notes on demand: Conceptual and empirical benefits of applying Rachlin’s discounting equation to demand data

Psychol Addict Behav. 2022 Nov 28. doi: 10.1037/adb0000889. Online ahead of print.

ABSTRACT

OBJECTIVE: Howard Rachlin wrote extensively on how value diminishes in a hyperbolic form, and he contributed to understanding choice processes between different commodities as a molar pattern of behavior. The field of behavioral economic demand has been dominated by exponential decay functions, indicating that decreases in consumption of a commodity are best fit by exponential functions. Because of the success of Rachlin’s equation at describing how hyperbolic decay affects the value of a commodity across various factors (e.g., delay, probability, social distance), we attempted to extend his equation to behavioral economic demand data for alcohol and opioids.

METHOD: Rachlin’s discounting equation was applied to estimate consumption on alcohol purchase task data and nonhuman drug demand data. We compared results of his equation to the exponentiated demand equation using both a mixed-effects modeling approach and a two-stage approach.

RESULTS: Rachlin’s equation provided better fits to consumption data than the exponentiated equation for both mixed-effects and two-stage modeling. We also found that traditional demand metrics, such as Pmax, can be derived analytically when using Rachlin’s equation. Certain metrics derived from Rachlin’s equation appeared to be related to clinical covariates in ways similar to the exponentiated equation.

CONCLUSIONS: Rachlin’s equation better described demand data than did the exponentiated equation, indicating that demand for a commodity may decrease hyperbolically rather than exponentially. Other benefits of his equation are that it does not have the same pitfalls as the current exponential equations and is relatively straightforward in its conceptualization when applied to demand data. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

PMID:36442017 | DOI:10.1037/adb0000889

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Nevin Manimala Statistics

Correction to Krieglmeyer and Sherman (2012)

J Pers Soc Psychol. 2022 Dec;123(6):1406. doi: 10.1037/pspa0000332.

ABSTRACT

Reports an error in “Disentangling stereotype activation and stereotype application in the stereotype misperception task” by Regina Krieglmeyer and Jeffrey W. Sherman (Journal of Personality and Social Psychology, 2012[Aug], Vol 103[2], 205-224). In the article (https://doi.org/10.1037/a0028764), there was an error in the data analysis of Experiment 4. The mean proportions of “more threatening” responses in trials with White and Neutral primes in the aggregated data file were not correct. Correction of the error leads to deviations in the descriptive, inferential and modeling statistics (including changes in Figure 6), but does not substantively alter the primary conclusions drawn from the data. The raw data is freely available at osf.io/cp9ga/. The online version of this article has been corrected (The following abstract of the original article appeared in record 2012-14232-001.) When forming impressions about other people, stereotypes about the individual’s social group often influence the resulting impression. At least 2 distinguishable processes underlie stereotypic impression formation: stereotype activation and stereotype application. Most previous research has used implicit measures to assess stereotype activation and explicit measures to assess stereotype application, which has several disadvantages. The authors propose a measure of stereotypic impression formation, the stereotype misperception task (SMT), together with a multinomial model that quantitatively disentangles the contributions of stereotype activation and application to responses in the SMT. The validity of the SMT and of the multinomial model was confirmed in 5 studies. The authors hope to advance research on stereotyping by providing a measurement tool that separates multiple processes underlying impression formation. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

PMID:36442013 | DOI:10.1037/pspa0000332

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Nevin Manimala Statistics

Evaluation of court-initiated randomized controlled trial of online parent programs for divorcing and separating parents

J Fam Psychol. 2022 Nov 28. doi: 10.1037/fam0001049. Online ahead of print.

ABSTRACT

We conducted an evaluation of a court-initiated randomized controlled trial comparing outcomes for parents assigned to either a no-program control group or one of two online parenting programs-Two Families Now (TFN) or Children in Between (CIB)-among 221 parents in initial divorce or separation court cases. We gathered parent report measures of family functioning at study entry, completion of program, and 1-year following study entry. We also gathered and coded court records to capture the content of the document resolving issues and occurrence of relitigation in the following year. All findings became statistically nonsignificant when a Bonferroni correction was employed. Before correction, however, a few statistically significant differences between groups emerged. Immediately following program completion, there were no study condition differences on measures of parental beliefs and intentions regarding parenting. One year following study entry, three statistically significant differences between program and no-program conditions emerged. Those assigned to a program reported significantly less intimate partner abuse and had less relitigation in court than those in the no-program condition, both with small effect sizes. Contrary to hypotheses, parents assigned to a program reported less social support than parents in the no-program condition. Overall, the findings do not provide strong support for the two investigated brief online parenting programs, demonstrating the need for continued rigorous evaluation of online parenting programs for divorcing and separating parents. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

PMID:36441999 | DOI:10.1037/fam0001049

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Nevin Manimala Statistics

COVID-19 pandemic and environment: Not only air pollution

Allergy. 2022 Dec;77(12):3699-3701. doi: 10.1111/all.15394.

NO ABSTRACT

PMID:36441593 | DOI:10.1111/all.15394

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Nevin Manimala Statistics

Effectiveness of Gamification in Knee Replacement Rehabilitation: Protocol for a Randomized Controlled Trial With a Qualitative Approach

JMIR Res Protoc. 2022 Nov 28;11(11):e38434. doi: 10.2196/38434.

ABSTRACT

BACKGROUND: Exergames can provide encouraging exercise options. Currently, there is limited evidence regarding home-based exergaming in the postoperative phase of total knee replacement (TKR).

OBJECTIVE: This study aimed to investigate the effects of a 4-month postoperative home-based exergame intervention with an 8-month follow-up on physical function and symptoms among older persons undergoing TKR compared with home exercise using a standard protocol. In addition, a concurrent embedded design of a mixed methods study was used by including a qualitative component within a quantitative study of exergame effects.

METHODS: This was a dual-center, nonblinded, two-arm, parallel group randomized controlled trial with an embedded qualitative approach. This study aimed to recruit 100 patients who underwent their first unilateral TKR (aged 60-75 years). Participants were randomized to the exergame or standard home exercise arms. Participants followed a custom-made exergame program independently at their homes daily for 4 months. The primary outcomes at 4 months were function and pain related to the knee using the Oxford Knee Score questionnaire and mobility using the Timed Up and Go test. Other outcomes, in addition to physical function, symptoms, and disability, were game user experience, exercise adherence, physical activity, and satisfaction with the operated knee. Assessments were performed at the preoperative baseline and at 2, 4, and 12 months postoperatively. Exergame adherence was followed from game computers and using a structured diary. Self-reported standard exercise was followed for 4 months of intervention and physical activity was followed for 12 months using a structured diary. Qualitative data on patients’ perspectives on rehabilitation and exergames were collected through laddering interviews at 4 and 12 months.

RESULTS: This study was funded in 2018. Data collection began in 2019 and was completed in January 2022. The COVID-19 pandemic caused an unavoidable situation in the study for recruitment, data collection, and statistical analysis. As of November 2020, a total of 52 participants had been enrolled in the study. Primary results are expected to be published by the end of 2022.

CONCLUSIONS: Our study provides new knowledge on the effects of postoperative exergame intervention among older patients with TKR. In addition, this study provides a new understanding of gamified postoperative rehabilitation, home exercise adherence, physical function, and physical activity among older adults undergoing TKR.

TRIAL REGISTRATION: ClinicalTrials.gov NCT03717727; https://clinicaltrials.gov/ct2/show/NCT03717727.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/38434.

PMID:36441574 | DOI:10.2196/38434

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Nevin Manimala Statistics

First Randomized, Multicenter, Placebo-Controlled Study of Self-Administered Intranasal Etripamil for Acute Conversion of Spontaneous Paroxysmal Supraventricular Tachycardia (NODE-301)

Circ Arrhythm Electrophysiol. 2022 Nov 28:e010915. doi: 10.1161/CIRCEP.122.010915. Online ahead of print.

ABSTRACT

BACKGROUND: Pharmacologic termination of paroxysmal supraventricular tachycardia (PSVT) often requires medically supervised intervention. Intranasal etripamil, is an investigational fast-acting, nondihydropyridine, L-type calcium channel blocker, designed for unsupervised self-administration to terminate atrioventricular nodal-dependent PSVT. Phase 2 results showed potential safety and efficacy of etripamil in 104 patients with PSVT.

METHODS: NODE-301, a phase 3, multicenter, double-blind, placebo-controlled study evaluated the efficacy and safety of etripamil nasal spray administered, unsupervised in patients with symptomatic sustained PSVT. After a medically supervised etripamil test dose while in sinus rhythm, patients were randomized 2:1 to receive etripamil 70 mg or placebo. When PSVT symptoms developed, patients applied a cardiac monitor and attempted a vagal maneuver; if symptoms persisted, they self-administered blinded treatment. An independent Adjudication Committee reviewed continuous electrocardiogram recordings. The primary efficacy endpoint was termination of adjudicated PSVT within 5 hours after study drug administration.

RESULTS: NODE-301 accrued 156 positively adjudicated PSVT events treated with etripamil (n=107) or placebo (n=49). The hazard ratio for the primary endpoint, time-to-conversion to sinus rhythm during the 5-hour observation period, was 1.086 (95% CI, 0.726-1.623; P=0.12). In predefined sensitivity analyses, etripamil effects (compared with placebo) occurred at 3, 5, 10, 20, and 30 minutes (P<0.05). For example, at 30 minutes, there was a 53.7% of SVT conversion in the treatment arm compared to 34.7% in the placebo arm (hazard ratio, 1.87 [95% CI, 1.09-3.22]; P=0.02). Etripamil was well tolerated; adverse events were mainly related to transient nasal discomfort and congestion (19.6% and 8.0%, respectively, of randomized treatment-emergent adverse events.

CONCLUSIONS: Although the primary 5-hour efficacy endpoint was not met, analyses at earlier time points indicated an etripamil treatment effect in terminating PSVT. Etripamil self-administration during PSVT was safe and well tolerated. These results support continued clinical development of etripamil nasal spray for self-administration during PSVT in a medically unsupervised setting.

REGISTRATION: URL: https://www.

CLINICALTRIALS: gov; Unique identifier: NCT03464019.

PMID:36441560 | DOI:10.1161/CIRCEP.122.010915