Category: Statistics

J Speech Lang Hear Res. 2021 Aug 31:1-10. doi: 10.1044/2021_JSLHR-21-00082. Online ahead of print.

ABSTRACT

Purpose The aim of this study was to use the Daily Phonotrauma Index (DPI) to quantify group-based changes in the daily voice use of patients with phonotraumatic vocal hyperfunction (PVH) after receiving voice therapy as the sole treatment. This is part of an ongoing effort to validate an updated theoretical framework for PVH. Method A custom-designed ambulatory voice monitor was used to collect 1 week of pre- and posttreatment data from 52 female patients with PVH. Normative weeklong data were also obtained from 52 matched controls. Each week was represented by the DPI, which is a combination of neck-surface acceleration magnitude skewness and the standard deviation of the difference between the first and second harmonic magnitudes. Results Compared to pretreatment, the DPI statistically decreased towards normal in the patient group after treatment (Cohen’s d = -0.25). The posttreatment patient group’s DPI was still significantly higher than the control group (d = 0.68). Conclusions The DPI showed the pattern of improved ambulatory voice use in a group of patients with PVH following voice therapy that was predicted by the updated theoretical framework. Per the prediction, voice therapy was associated with a decreased potential for phonotrauma in daily voice use, but the posttreatment patient group data were still significantly different from the normative control group data. This posttreatment difference is interpreted as reflecting the impact on voice use of the persistence of phonotrauma-induced structural changes to the vocal folds. Further validation of the DPI is needed to better understand its potential clinical use.

PMID:34463536 | DOI:10.1044/2021_JSLHR-21-00082

Inquiry. 2021 Jan-Dec;58:469580211036283. doi: 10.1177/00469580211036283.

ABSTRACT

PURPOSE: The study aimed to determine the impact of pharmacist-led interventions on diabetes management at a community pharmacy in Pakistan.

METHODS: A one-month follow-up, randomized controlled trial (RCT) was carried out between December 1, 2016 and June 30, 2017. Sampling population consisted of patients diagnosed with type 2 diabetes mellitus (T2DM). The study population was randomized to a control group or an intervention group to determine the impact of a community pharmacist intervention on glycemic control fasting blood glucose (FBG) and random blood glucose (RBG), medication adherence (MMAS), and health-related quality of life (HRQoL) (EQ-5D-3L). Both non-pharmacological and pharmacological interventional tools were used that consist of array of charts and verbal communication by pharmacist. Outcomes for continuous variables were analyzed using paired sample t-test for time effect and one sample t-test to evaluate the study group effect. Independent sample t-test was used to compare each independent variable with dependent variable. A P-value of <.05 was considered statistically significant.

RESULTS: The control and intervention groups showed significant improvement (P-value < .05) in glycemic control, medication adherence, and HRQoL. However, the difference between the control and intervention groups was not statistically significant in terms of blood glucose levels and HRQoL (time trade off, TTO). There was a clinically significant association between pharmacist intervention and predefined glycemic control among the study participants (FBG: P-value < .001 and RBG: P-value = .04). A clinically significant association was also found between pharmacist intervention and medication adherence at the end of the trial compared with baseline values (P-value < .001). Similarly, a clinically significant association was found between pharmacist intervention and predefined HRQoL [TTO: P-value = .002 and EQ-VAS: P-value = .001].

CONCLUSION: A significant proportion of T2DM patients in the intervention group achieved predefined glycemic control, medication adherence, and health related quality of life.

PMID:34463538 | DOI:10.1177/00469580211036283

ACR Open Rheumatol. 2021 Aug 31. doi: 10.1002/acr2.11338. Online ahead of print.

ABSTRACT

OBJECTIVE: Voclosporin, a novel calcineurin inhibitor approved for the treatment of adults with lupus nephritis (LN), improved complete renal response rates in patients with LN in a phase 2 trial. This study aimed to evaluate the efficacy and safety of voclosporin for the treatment of LN.

METHODS: This multicenter, double-blind, randomized phase 3 trial was done in 142 hospitals and clinics across 27 countries. Patients with a diagnosis of systemic lupus erythematosus and LN, according to the American College of Rheumatology criteria, who had undergone a kidney biopsy within 2 years that showed class III, IV, or V (alone or in combination with class III or IV) were eligible for this study. Patients were randomly assigned (1:1) to receive oral voclosporin (23.7 mg twice daily) or a placebo, on a background of mycophenolate mofetil (1 g twice daily) and rapidly tapered low-dose oral steroids, by use of an interactive web response system. The primary endpoint was complete renal response at 52 weeks, defined as a composite of urine protein creatinine ratio of 0.5 mg/mg or less, stable renal function (defined as estimated glomerular filtration rate [eGFR] ≥60 ml/min/1.73m² or no confirmed decrease from baseline in eGFR of > 20%), no administration of rescue medication, and no more than 10 mg prednisone equivalent per day for 3 or more consecutive days or 7 or more days during Week 44 through Week 52 (just before the primary endpoint assessment). Safety was also assessed. Efficacy analysis was by intention to treat, and safety analysis was by randomized patients receiving at least one dose of study treatment.

RESULTS: Between April 13, 2017, and October 10, 2019, 179 patients were assigned to the voclosporin group and 178 were assigned to the placebo group. The primary endpoint of complete renal response at Week 52 was achieved in significantly more patients in the voclosporin group than in the placebo group (73 [41%] of 179 patients vs 40 [23%] of 178 patients; odds ratio, 2.65; 95% confidence interval [CI] 1.64-4.27; P < 0·0001). The adverse event profile was balanced between the two groups; serious adverse events occurred in 37 (21%) of 178 patients in the voclosporin group and 38 (21%) of 178 patients in the placebo group. The most frequent serious adverse event involving infection was pneumonia, occurring in seven (4%) patients in the voclosporin group and in eight (4%) patients in the placebo group. A total of six patients died during the study or study follow-up period (one [<1%] patient in the voclosporin group and five [3%] patients in the placebo group). None of the events leading to death were considered by the investigators to be related to the study treatments.

CONCLUSION: Voclosporin in combination with mycophenolate mofetil (MMF) and low-dose steroids led to a clinically and statistically superior complete renal response rate versus MMF and low-dose steroids alone, with a comparable safety profile. This finding is an important advancement in the treatment of patients with active LN.

PMID:34463434 | DOI:10.1002/acr2.11338

Am J Speech Lang Pathol. 2021 Aug 31:1-17. doi: 10.1044/2021_AJSLP-20-00382. Online ahead of print.

ABSTRACT

Purpose Variation within languages, including dialects, takes on an indexical function, marking belonging and connection. Meanwhile, attitudes toward these speech varieties become marked by linguistic bias. Within the speech-language pathology profession, research evidence, assessment tools, and intervention programs have largely been designed for and by the White, English-speaking middle class. As such, linguistic bias with a preference for standardized dialects is prevalent in the training and practice of the speech-language pathology profession, resulting in discriminatory and racialized practices. Method To investigate the influence of linguistic bias upon speech-language pathologists’ (SLPs’) clinical decision making, data were collected from 129 Australian SLPs via an online survey. Inferential statistics were used to investigate the relationship between clinical decision making and SLPs’ attitudes toward nonstandard dialects as well as personal and professional factors. A content analysis of extended responses was conducted to identify themes in clinical decision making. Results SLPs with more years of experience and those who had received professional development were significantly more likely to seek out more information before making a diagnosis, while those with more negative attitudes toward linguistic diversity were significantly more likely to identify a disorder than a difference. SLPs provided a range of justifications for their clinical decision making, but few acknowledged the influence of their own attitudes and bias upon their decision making. Conclusions SLPs’ linguistic bias towards speakers of nonstandard dialects has the potential to impact upon their clinical judgment of difference versus disorder and lead to inequality of service provision for speakers who do not express themselves in standardized forms. Before the profession can truly move toward an antiracist approach of equitable service provision for all, SLPs must engage in critical self-reflection to disrupt the adherence of the speech-language pathology profession to standardized “White” norms of communication.

PMID:34463535 | DOI:10.1044/2021_AJSLP-20-00382

J Midwifery Womens Health. 2021 Aug 31. doi: 10.1111/jmwh.13270. Online ahead of print.

ABSTRACT

INTRODUCTION: Individuals who are incarcerated in the United States often struggle to access family planning care because of the common practice of jails not providing contraceptives on site. However, less is known about the contraceptive needs and preferences, including the desirability of intrauterine devices and implants, among those who are incarcerated.

METHODS: Cross-sectional, in-person surveys were administered to 148 reproductive-age women (aged 18-48) incarcerated at an urban jail in Utah to identify women’s contraceptive needs and preferences while incarcerated. We used summary statistics and logistic regression to investigate relationships between demographic characteristics, the desire to access contraceptive services while incarcerated, and interest in specific contraceptive methods.

RESULTS: Surveys indicate a high interest in accessing contraceptives while in jail (73%). Participants who were more likely to prefer access to contraceptive services in jail were also more likely to be interested in the injectable (odds ratio [OR], 4.75; 95% CI, 1.03-21.94), the implant (OR, 8.44; 95% CI, 1.70-41.99), and intrauterine devices (OR, 10.04; 95% CI, 3.46-29.20) than participants indicating no desire to access contraceptive services while in jail.

DISCUSSION: Jails could be an access point for contraceptive methods requiring health care provider intervention in the state of Utah. However, care must be taken due to broader historical legacies of reproductive coercion in carceral settings.

PMID:34463421 | DOI:10.1111/jmwh.13270

Clin Obes. 2021 Aug 31:e12485. doi: 10.1111/cob.12485. Online ahead of print.

ABSTRACT

This systematic review investigated the effects of weight-loss diets before elective surgery on preoperative weight loss and postoperative outcomes in people with obesity. Electronic databases were searched from inception to May 2021. Inclusion criteria were prospective cohort or randomised controlled studies that compared effects of weight-loss diets to standard care on postoperative outcomes in adults with obesity awaiting surgery. Participants with cancer or undergoing bariatric surgery were excluded. Data on preoperative weight change, length of stay, postoperative complications and patient-reported outcome measures were extracted and synthesised in meta-analyses. One randomised controlled trial involving total knee arthroplasty and two that investigated general surgery were eligible that included 173 participants overall. Each study compared low-calorie diets using meal replacement formulas to usual care. There is very-low-quality evidence of a statistically significant difference favouring the intervention for preoperative weight loss (mean difference [MD] -6.67 kg, 95% confidence interval [CI] -12.09 to -1.26 kg; p = 0.02) and low-quality evidence that preoperative weight-loss diets do not reduce postoperative complications to 30 days (odds ratio [OR] 0.34, 95% CI 0.08-1.42; p = 0.14) or length of stay (MD -3.72 h, 95% CI -10.76 to 3.32; p = 0.30). From the limited data that is of low quality, weight loss diets before elective surgery do not reduce postoperative complications.

PMID:34463422 | DOI:10.1111/cob.12485

J Child Adolesc Psychiatr Nurs. 2021 Aug 31. doi: 10.1111/jcap.12347. Online ahead of print.

ABSTRACT

PROBLEM: The study was conducted to examine the effects of laughter therapy on happiness level and self-esteem in 5th grade students.

METHODS: This study used an experimental study with pretest posttest control group. The study population consisted of 5th grade students studying at a secondary school in Turkey. There were six branches in the 5th grade. Groups were randomly selected from among these 5th grade classes to include 29 students in the intervention group and 32 in the control group. Laughter therapy sessions were applied to the intervention group twice a week for 4 weeks. No intervention was offered to the control group. The data were collected by a questionnaire, the School Children’s Happiness Inventory, and the Coopersmith Self-Esteem Inventory.

RESULTS: It was determined that there was a statistically significant difference between the groups in terms of the School Children’s Happiness Inventory (p < .05) but no significant difference was found according to the groups’ scores on the Coopersmith Self-Esteem Inventory (p > .05).

CONCLUSIONS: In this study, it was determined that laughter therapy increased the happiness level of students yet had no effect on their self-esteem. It is recommended to organize laughter therapy activities in schools to increase the happiness levels of students.

PMID:34463398 | DOI:10.1111/jcap.12347

J Card Surg. 2021 Aug 31. doi: 10.1111/jocs.15963. Online ahead of print.

ABSTRACT

Misapplication of p values can lead to very misleading conclusions. The frequent insignificance of a “significant” p value ¹ provides examples illustrating situations where p values are misused in interpretation and describes alternatives to p values to consider. The concern about p values, and their potential shortcomings and misinterpretations, has been widely discussed and has received a lot of debate from the statistical community. While we agree with much of the content presented in the article, the issue fundamentally represents a misinterpretation of conditional probability, misapplication of measures regarding diagnostic accuracy, and consequently violations of assumptions inherent in experimental design and the validity of many approaches to statistical analysis and inference. One way this can be remedied is through team science, and collaboration between clinical and biostatistical scientists in research.

PMID:34463384 | DOI:10.1111/jocs.15963

Pediatr Dermatol. 2021 Aug 31. doi: 10.1111/pde.14765. Online ahead of print.

ABSTRACT

BACKGROUND/OBJECTIVES: Hidradenitis suppurativa (HS) is understudied in the pediatric population. Adult HS patients are known to have a high comorbidity burden. We aimed to describe physical and psychosocial comorbidities in a cohort of pediatric HS patients.

METHODS: A retrospective chart review of pediatric HS patients at a single academic institution was conducted. Data on patient demographics, disease characteristics, and physical and psychosocial comorbidities in pediatric patients with HS were collected and analyzed.

RESULTS: Seventy-three pediatric patients were included in this study, 81% female. Mean (SD) age of HS disease onset was 12.6 (2.9) years. Comorbid conditions were reported in 68 of 73 (93%) patients. Significantly increased rates of several comorbidities were seen in our cohort as compared to the general US pediatric population. Metabolic and endocrine abnormalities were prevalent, with 52% (22/42) patients with obesity and 10% (6/59) with polycystic ovary syndrome. The most common cutaneous comorbidity was acne vulgaris, seen in 37% (27/73) of patients. Over one quarter (21/73, 29%) of patients had either an anxiety or depression disorder. Almost one-fifth (14/73, 19%) of our cohort had a diagnosis of asthma and other reactive airway diseases. Only one-third (24/73, 33%) of patients had documentation regarding impact of HS on their daily life. Overall, comorbidities largely did not significantly differ based on race, gender, or disease severity.

CONCLUSIONS: Pediatric patients with HS face a high-comorbidity burden, especially with psychiatric conditions. Early identification, including routine mental health screening, and management of comorbidities is warranted in the pediatric HS population.

PMID:34463372 | DOI:10.1111/pde.14765

Magn Reson Med. 2021 Aug 31. doi: 10.1002/mrm.28998. Online ahead of print.

ABSTRACT

PURPOSE: Quantitative assessment of prospective motion correction (PMC) capability at 7T MRI for compliant healthy subjects to improve high-resolution images in the absence of intentional motion.

METHODS: Twenty-one healthy subjects were imaged at 7 T. They were asked not to move, to consider only unintentional motion. An in-bore optical tracking system was used to monitor head motion and consequently update the imaging volume. For all subjects, high-resolution T₁ (3D-MPRAGE), T₂ (2D turbo spin echo), proton density (2D turbo spin echo), and T2∗ (2D gradient echo) weighted images were acquired with and without PMC. The images were evaluated through subjective and objective analysis.

RESULTS: Subjective evaluation overall has shown a statistically significant improvement (5.5%) in terms of image quality with PMC ON. In a separate evaluation of every contrast, three of the four contrasts (T₁ , T₂ , and proton density) have shown a statistically significant improvement (9.62%, 9.85%, and 9.26%), whereas the fourth one ( T2∗ ) has shown improvement, although not statistically significant. In the evaluation with objective metrics, average edge strength has shown an overall improvement of 6% with PMC ON, which was statistically significant; and gradient entropy has shown an overall improvement of 2%, which did not reach statistical significance.

CONCLUSION: Based on subjective assessment, PMC improved image quality in high-resolution images of healthy compliant subjects in the absence of intentional motion for all contrasts except T2∗ , in which no significant differences were observed. Quantitative metrics showed an overall trend for an improvement with PMC, but not all differences were significant.

PMID:34463376 | DOI:10.1002/mrm.28998