Category: Statistics

Clin Pharmacol Ther. 2022 Feb 16. doi: 10.1002/cpt.2560. Online ahead of print.

ABSTRACT

As the scientific research community along with health care professionals and decision-makers around the world fight tirelessly against the COVID-19 pandemic, the need for comparative effectiveness research (CER) on preventive and therapeutic interventions for COVID-19 is immense. Randomized controlled trials markedly underrepresent the frail and complex patients seen in routine care, and they do not typically have data on long-term treatment effects. The increasing availability of electronic health records (EHRs) for clinical research offers the opportunity to generate timely real-world evidence reflective of routine care for optimal management of COVID-19. However, there are many potential threats to the validity of CER based on EHR data that are not originally generated for research purposes. To ensure unbiased and robust results, we need high-quality healthcare databases, rigorous study designs, and proper implementation of appropriate statistical methods. We aimed to describe opportunities and challenges in EHR-based CER for COVID-19-related questions and to introduce best practices in pharmacoepidemiology to minimize potential biases. We structured our discussion into the following topics: 1) Study population identification based on exposure status; 2) Ascertainment of outcomes; 3) Common biases and potential solutions; and 4) Data operational challenges specific to COVID-19 CER using EHR. We provide structured guidance for the proper conduct and appraisal of drug and vaccine effectiveness and safety research using EHR data for the pandemic. This manuscript is endorsed by the International Society for Pharmacoepidemiology (ISPE).

PMID:35170021 | DOI:10.1002/cpt.2560

Atten Percept Psychophys. 2022 Feb 15. doi: 10.3758/s13414-021-02407-w. Online ahead of print.

ABSTRACT

An ensemble or statistical summary can be extracted from facial expressions presented in different spatial locations simultaneously. However, how such complicated objects are represented in the mind is not clear. It is known that the aftereffect of facial expressions, in which prolonged viewing of facial expressions biases the perception of subsequent facial expressions of the same category, occurs only when a visual representation is formed. Using this methodology, we examined whether an ensemble can be represented with visualized information. Experiment 1 revealed that the presentation of multiple facial expressions biased the perception of subsequent facial expressions to less happy as much as the presentation of a single face did. Experiment 2 compared the presentation of faces comprising strong and weak intensities of emotional expressions with an individual face as the adaptation stimulus. The results indicated that the perceptual biases were found after the presentation of four faces and a strong single face, but not after the weak single face presentation. Experiment 3 employed angry expressions, a distinct category from the test expression used as an adaptation stimulus; no aftereffect was observed. Finally, Experiment 4 clearly demonstrated the perceptual bias with a higher number of faces. Altogether, these results indicate that an ensemble average extracted from multiple faces leads to the perceptual bias, and this effect is similar in terms of its properties to that of a single face. This supports the idea that an ensemble of faces is represented with visualized information as a single face.

PMID:35169990 | DOI:10.3758/s13414-021-02407-w

J Racial Ethn Health Disparities. 2022 Feb 15. doi: 10.1007/s40615-022-01260-3. Online ahead of print.

ABSTRACT

This study provides a culturally sensitive quantitative investigation aimed at assessing the post-traumatic symptomatology, post-migratory difficulties, and resilience of 36 Nigerian male asylum seekers hosted in the province of Caserta, South Italy. A survey composed by the Harvard Trauma Questionnaire-Revised (HTQ-R), the Post-Migratory Checklist (PLMD), and the Connor-Davidson Resilience Scale (CD-RISC) was administered to participants. Descriptive and correlation analyses were made in order to describe the mental health risk and protective factors and understand the relation between these. A linear regression analysis was used to evaluate the influence of post-migratory difficulties and resilience on PTSD. Stratified bivariate analyses were also computed to detect PTSD group and no-PTSD group differences about post-migration difficulties and resilience levels. Regression analysis showed that PMLD numbers significantly increased the risk of having PTSD. No significant effect emerged for the level of resilience. Statistically significant differences between the PTSD group and non-PTSD group in relation to post-migratory difficulties were also found. No differences in the resilience factors emerged. The results offer a glimpse into a specific ethnic group of asylum seekers and its mental health risks and protective factors, taking into consideration the specificities of their past and current life-story experiences. Clinical implications for professionals working in the field of forced migration will be outlined.

PMID:35169994 | DOI:10.1007/s40615-022-01260-3

J Cancer Surviv. 2022 Feb 16. doi: 10.1007/s11764-022-01188-x. Online ahead of print.

ABSTRACT

PURPOSE: Young adults (YAs) diagnosed with cancer face high financial burden at a time in their lives when they are financially vulnerable. Some turn to medical crowdfunding, that is, using social media and other means to raise funds or resources to offset medical and usual life expenses. Major research gaps exist regarding the experiences of those who pursued crowdfunding. Thus, the study purpose was to describe the perceptions of, and experiences with, medical crowdfunding among a sample of YA cancer survivors.

METHODS: In February 2021, we distributed an online survey to YAs with a history of a cancer diagnosis, who had received grants from an organization that offers financial assistance. We calculated descriptive statistics on the crowdfunding sample and employed thematic analysis to analyze the open-ended questions.

RESULTS: In this sample (N = 113), 46 YA cancer survivors had engaged in medical crowdfunding and shared their perceptions and experiences. Our central theme, “The Crowdfunding Compromise” captures the trade-offs participants faced, which included subthemes of “crowdfunding as useful/helpful,” “factors associated with crowdfunding success,” and “questioning the why?”.

CONCLUSIONS: Among YA cancer survivors, medical crowdfunding brings shame and stigma in addition to financial support. YA cancer survivors demonstrate resilience in their attempts to find individual solutions to financial problems created by unchecked health care costs, the US health insurance infrastructure, and lack of legislation.

IMPLICATIONS FOR CANCER SURVIVORS: This study fills an important gap in understanding individual-level crowdfunding experiences. Implications include system-level approaches to addressing cancer-related financial burden and potential worsening of existing disparities through medical crowdfunding.

PMID:35169983 | DOI:10.1007/s11764-022-01188-x

J Cancer Surviv. 2022 Feb 15. doi: 10.1007/s11764-022-01176-1. Online ahead of print.

ABSTRACT

PURPOSE: Though prior studies have observed significant association between e-cigarette use and mental health outcomes including depression in the general population, the relationship between e-cigarette use and clinical depression in the cancer survivor subpopulation is unknown. The purpose of this study was to examine the cross-sectional association between e-cigarette use and self-reported clinical depression among cancer survivors.

METHODS: Pooled data from the 2017 and 2018 Behavioral Risk Factor Surveillance Survey were used. Multivariable logistic regression was used to analyze the independent association between e-cigarette use and self-reported clinical depression in a sample of 7,498 cancer survivors.

RESULTS: Among cancer survivors in this study, 22.1% reported a history of clinical diagnosis of depression. The overall prevalence rates for current and former e-cigarette use were 2.6% and 10.5%, respectively. Analysis showed 51.3% of current users, 40% of former users, and 19.1% of those who had never used e-cigarettes self-reported a history of clinical depression. In the multivariable analysis, the odds of self-reported clinical depression were significantly higher for survivors who were current users (OR = 2.85; 95% CI: 1.38-5.90) and former users (OR = 1.63; 95% CI: 1.05-2.55) compared to never e-cigarette users.

CONCLUSION: Findings from this study suggest a statistically significant association between e-cigarette use and depression in cancer survivors. Future studies should focus on examining the longitudinal association between e-cigarette use and depression in cancer survivors.

IMPLICATIONS FOR CANCER SURVIVORS: Study findings reemphasized the need for interventions to support cancer survivors with evidence-based treatments for depression as well as the need for clinicians to screen for psychological distress and/or e-cigarette use and make appropriate recommendations.

PMID:35169981 | DOI:10.1007/s11764-022-01176-1

Surg Technol Int. 2022 Feb 16;40:sti40/1493. Online ahead of print.

ABSTRACT

We treated a small cohort of venous ulcers that were very unresponsive to standard and advanced therapies with autologous cultured bone marrow-derived mesenchymal stem cells (MSCs). This pilot clinical trial was randomized, controlled, and double-blinded. Subjects were treated with either normal saline (Group A), fibrin spray alone (Group B), or MSCs in fibrin (1 million cells/cm2 of wound bed surface) (Group C). The control and test materials were applied to the wound using a double-barreled syringe with thrombin and fibrinogen (with or without MSCs) in each barrel, or saline alone in both barrels. The MSCs were separated, cultured in vitro, and expanded in a dedicated Good Manufacturing Practice (GMP) facility from 30-50 ml of bone marrow aspirate obtained from the iliac crest in Group C subjects. To ensure that the study remained controlled and blinded, subjects who were randomized to one of the two control arms (saline or fibrin) underwent sham bone marrow aspiration performed by a hematologist who anesthetized the iliac crest area down to and pushing against the periosteum, but without penetrating the bone marrow. Therefore, both the clinician who evaluated wound progress and the study subjects had no knowledge of whether bone aspiration was actually performed and what treatment had been applied to the wound. The study was performed after full FDA investigational new drug (IND) approval. The primary endpoint was the rate of healing (wound closure as linear healing from the wound margins in cm/week), as measured by the Gilman equation. One-way ANOVA was used to calculate the statistical significance of differences between the mean healing rates of each of the 3 treatment groups every 4 weeks and over the 24 weeks of treatment. Overall, treatment with MSCs accelerated the healing rate by about 10-fold compared to those in the saline and fibrin control groups. Although the total number of patients in this pilot study was small (n=11), the statistical significance was surprisingly promising: p<0.01 and f-ratio of 15.9358. No serious adverse events were noted. This small but carefully performed prospective, controlled, randomized, and double-blinded pilot study in a rare population of totally unresponsive patients adds to previous reports showing the promise of MSCs in the treatment of chronic wounds and provides proof of principle for how to approach this type of very demanding clinical and translational research.

PMID:35168289

Angle Orthod. 2022 Mar 1;92(2):173-179. doi: 10.2319/032921-246.1.

ABSTRACT

OBJECTIVES: To compare the treatment and posttreatment effects of Invisalign aligners that incorporated SmartForce features and attachments to traditional fixed appliances.

MATERIALS AND METHODS: This randomized controlled trial included 66 patients, 32 aligners, and 34 fixed-appliance patients. The median ages of the aligner and braces patients were 26.7 (interquartile range [IQR]: 9.8) and 25.9 (IQR: 16.6) years, respectively. Pretreatment occlusion was assessed using the ABO Discrepancy Index. Posttreatment (T1) and 6-month retention (T2) occlusions were quantified using the ABO Objective Grading System (OGS) scores.

RESULTS: The braces group finished treatment significantly (P < .001) earlier (0.4 years) than the aligner group. The median DI scores for the aligner and braces groups were 4.5 and 7.0, respectively, which was a statistically significant (P = .015), but clinically insignificant, difference. There were no statistically significant between-group differences for the total OGS scores or any of the individual component scores at debond (T1) or after 6 months of retention (T2). During the posttreatment period, alignment and overjet worsened significantly in the aligner group, while buccolingual inclinations and occlusal relations improved. Over the same period, alignment worsened in the braces group and buccolingual inclinations improved. There was no statistically significant between-group difference in posttreatment changes of the total OGS scores.

CONCLUSIONS: While patients with simple malocclusions require 4.8 months longer treatment times with aligners than traditional braces, the treatment and 6-month posttreatment occlusal outcomes are similar.

PMID:35168256 | DOI:10.2319/032921-246.1

Handchir Mikrochir Plast Chir. 2022 Feb;54(1):58-64. doi: 10.1055/a-1718-3494. Epub 2022 Feb 15.

ABSTRACT

BACKGROUND: As distal radius fractures as well as diagnostic and therapeutic options vary widely, there is an enormous potential for deficient convalescence and subsequent patient dissatisfaction. The aim of this study is the evaluation of malpractice in distal radius fracture management, which could help to draw conclusions regarding optimization and prevention as well as raising patient satisfaction and minimizing subsequent costs.

MATERIAL AND METHODS: Files and patient data of all distal radius fracture complaints regarding one public hospital operator in a period between 2007 and 2017 were reviewed and subjected to descriptive statistics.

RESULTS: A total of 35 cases with complaints regarding medical treatment, communication and long-term effects were identified, broken down into key issues and analyzed by means of descriptive statistics.

CONCLUSION: Complications and long-term effects of distal radius fractures are not completely avoidable. It is possible, however, to prevent lack of communication and treatment delays. To achieve increased patient satisfaction, it is essential to reflect on diagnostic, therapeutic and interpersonal strategies.

PMID:35168269 | DOI:10.1055/a-1718-3494

Angle Orthod. 2022 Mar 1;92(2):220-225. doi: 10.2319/042421-330.1.

ABSTRACT

OBJECTIVES: To analyze adaptational changes in clear aligner fit after intraoral usage at different sets of time.

MATERIALS AND METHODS: Eight Invisalign appliances (Align Technology, San Jose, California, USA) were collected after intraoral usage. Acrylic imprints of the lower incisor region were constructed for each appliance at T0 (unused appliance). Two appliances were then used intra-orally for each of the following defined periods of time: 3 days, 7 days, 10 days, or 15 days. Used aligners were adapted on its T0 imprint and both were sectioned buccolingually from the distal surfaces of each incisor at the attachment area. Eight surfaces were collected for each set of time (n = 32 surfaces). Microphotographs of obtained sections and micrometric measurements of aligner fit were recorded at five different levels using scanning electron microscopy (SEM). Mean values of the fit changes (gap width) and group comparisons were statistically analyzed using analysis of variance and Tukey’s post hoc tests. Significance level was set at P < .05.

RESULTS: Highly significant differences in aligner fit were found at the different time points assessed (P < .001) with the least mean gap width at 15 days (176 ± 98 μm) and the highest at 7 days (269 ± 145 μm). Significant differences in aligner fit at different attachment levels were also found (P < .01) with the least mean gap width at the middle of the labial surface of the attachment (187 ± 118 μm).

CONCLUSIONS: The 15-day period of intraoral aligner wear might still be recommended as it showed the best adaptation and least gap width between the aligner and the attachment.

PMID:35168255 | DOI:10.2319/042421-330.1

Int J Sports Physiol Perform. 2022 Feb 15:1-6. doi: 10.1123/ijspp.2021-0097. Online ahead of print.

ABSTRACT

PURPOSE: To assess the relationship between external and internal load during official women’s rugby seven matches.

METHODS: Six backs (age = 24.2 [3.2] y; height = 161.5 [7.3] cm; body mass = 59.5 [5.0] kg; playing experience = 5.3 [1.5] y) and 8 forwards (age = 22.4 [2.7] y; height = 167.0 [4.8] cm; body mass = 70.6 [5.6] kg; playing experience = 5.0 [1.5] y) belonging to the women’s rugby seven Brazilian national team were monitored across 3 international tournaments during the 2019-20 season, with 2 players excluded from the analysis since they did not participate in any investigated match. Total distance (TD), distance during high-intensity running 18.1 to 20.0 km·h-1 and >20 km·h-1 (sprinting), number of accelerations >1.8 m·s-2 (ACC), and of decelerations <1.8 m·s-2 were used as match load volume measures, while their relative values (TD per minute, high-intensity running per minute, sprinting per minute, ACC per minute, and decelerations per minute) were used as external load match intensity measures. Internal load intensity and volume were assessed using the session rating of perceived exertion (sRPE) and its value multiplied by match duration (sRPE-ML), respectively. Spearman correlations and linear mixed models were used to assess the relationships between internal and external load measures.

RESULTS: A very large relationship (ρ = .830, P < .001) was found between sRPE-ML and TD, with linear mixed models showing that TD statistically affected sRPE-ML (P < .001). Linear mixed models analysis showed that ACC per minute was also affecting the sRPE-ML (P = .017), while sprinting (P = .007) and ACC per minute (P = .005) were the only 2 measures statistically affecting sRPE. However, weak relationships (trivial to large) were found for these and all other measures.

CONCLUSIONS: These results highlight that TD is the main external load measure able to anticipate the internal load responses measured via sRPE-ML in elite women’s rugby sevens.

PMID:35168199 | DOI:10.1123/ijspp.2021-0097