Tag: statistics

Heart Lung. 2021 Oct 29;51:25-31. doi: 10.1016/j.hrtlng.2021.07.005. Online ahead of print.

ABSTRACT

BACKGROUND: Fixed-dose combination (FDC) of Aclidinium (ACL) and Formoterol (FOR) is a maintenance therapy for patients with stable chronic obstructive pulmonary disease (COPD). Although the effect of combination of long-acting beta-agonists (LABA) and long-acting muscarinic antagonists (LAMA) is less compared with the statistical sum of the effects of LABA and LAMA alone, the effect of combination of LABA and LAMA is significantly higher than that of either of the two. Thus, the resulting therapeutic effect in pulmonary function, improvement of dyspnea, quality of life, and incidence of adverse events was analyzed to explore the efficacy of FDC and monotherapy of either ACL or FOR in stable COPD patients.

METHODS: Methods Chronic obstructive pulmonary disease (COPD), aclidinium or LAMA, formoterol or LABA, randomized controlled trials, or RCT were used as keywords in the search for studies in PubMed, EMBASE, Cochrane Library, Reference List, and Clinicaltrails.gov databases. Studies that evaluated efficacy and side effects of Fixed-dose combination of Aclidinium/Formoterol and Monotherapy of Aclidinium or Formoterol in COPD published between the establishment period of the database and June 2020 were retrieved. Two independent reviewers extracted the data; Revman 5.3 software was used for data analysis with dose efficacy and side effects were presented as mean difference at 95% confidence interval. Notably, ACL 400 mg / FOR 12ug and ACL 400 mg / 6ug were used as subgroup analysis.

RESULTS: A total of 6 studies with 7,081 patients were enrolled for analysis. The trough forced expiratory volume in 1 second (FEV1) mean difference (MD) for FDC was 0.01 (95% CI, – 0.01 to 0.03); St George’s respiratory COPD specific questionnaire (SGRQ) MD for FDC was – 0.76 (95% CI, – 1.81 to 0.29); transitional dyspnea index (TDI) MD for FDC was 0.33 (95% CI, 0.06 to 0.60) compared to that of ACL. Furthermore, trough FEV1 MD for FDC was 0.05 (95% CI, 0.03 to 0.06); SGRQ MD for FDC was – 1.52 (95% CI, – 2.57 to-0.47); TDI MD for FDC was 0.43 (95% CI, 0.15 to 0.70) compared to that of the FOR. The evidence for each result was accurate and the results were unaffected by the duration of the study.

CONCLUSION: The findings of this study showed that, unlike monotherapies, FDC significantly improves lung function, dyspnea, and quality of life. In addition, FDC significantly improves dyspnea compared to ACL alone.

PMID:34731694 | DOI:10.1016/j.hrtlng.2021.07.005

Eur J Obstet Gynecol Reprod Biol. 2021 Oct 22;267:73-78. doi: 10.1016/j.ejogrb.2021.10.018. Online ahead of print.

ABSTRACT

OBJECTIVES: The primary objectives of this study were to estimate blood loss, operation time and cost differences in patients undergoing vaginal hysterectomy (VH) versus laparoscopically-assisted vaginal hysterectomy (LAVH). The secondary objectives were to determine differences in hospital stay, need for postoperative analgesia, intra- and immediate post-operative complications, and the rate of conversion to laparotomy. VH was hypothesized to be the preferred route for hysterectomy for benign uterine conditions.

STUDY DESIGN: A randomized control study was undertaken at the Department of Obstetrics and Gynaecology of the Charlotte Maxeke Johannesburg Academic Hospital and included the women admitted between January 2017 and December 2019 for hysterectomy due to benign conditions, meeting the inclusion criteria (vaginally accessible uterus, estimated uterine size ≤ 12 weeks of gestation or ≤ 280 g on ultrasound examination and pathology confined to the uterus). Surgical procedures were performed by the residents in training under the supervision of specialists with large experience. The patient demographic characteristics, uterine weight, operative time, estimated blood loss(expressed as the difference between preoperative and postoperative day one serum haemoglobin),direct surgery-associated costs, intra- and immediate post-operative complications and the length of hospital stay were recorded and comparatively analysed among patients randomly placed in VH and LAVH group.

RESULTS: A total of 227 women were included (151 patients underwent VH and 76 LAVH, upon 2:1 randomization, performed on this way to reflect the previous pattern of operating of the unit). The patients were matched with respect to age, parity and body mass index. No significant differences between two groups were found in mean uterine weight and also in mean serum haemoglobin shift, intra- and immediate post-operative complications, and convalescence period duration. There were statistically significant differences in operating time and in cost between the two procedures. On average, LAVH took longer than VH to be performed (62.8 ± 9.3 vs 29.9 ± 6.6 min, p < 0.0001) and it was more costly, mainly due to the longer operating time and required disposables. An amount of 15698.20 South African Rand (ZAR) or 1145.85 United States Dollar (USD) more were needed to perform LAVH in comparison to VH. All VHs and LAVHs were successfully accomplished without major complications or conversation to laparotomy.

CONCLUSION: Our data indicate that VH is a feasible and safe alternative for a large group of women with benign pathology and non-prolapsed uteri, being a faster and less costly procedure than LAVH.

PMID:34731640 | DOI:10.1016/j.ejogrb.2021.10.018

J Speech Lang Hear Res. 2021 Nov 3:1-31. doi: 10.1044/2021_JSLHR-21-00176. Online ahead of print.

ABSTRACT

Purpose This study investigated within-language and between-language associations between phonological memory, vocabulary, and grammar in French-English (n = 43) and Spanish-English (n = 25) bilingual children at 30, 36, and 48 months. It was predicted that phonological memory would display both within-language and between-language relations to language development and that these relations would be stronger at the youngest age. Method Bilingual children participated in free-play sessions in both of their languages at each age, from which vocabulary and grammatical information (number of different words and mean length of utterance) was extracted. Vocabulary information was also obtained from parent inventories completed when the children were 30 months and a standardized receptive vocabulary test administered at 36 and 48 months. The children were also administered nonword repetition tests in both of their languages at each age. Results Mixed logistic regression indicated that phonological memory was associated with vocabulary and grammar within the same language and phonological memory in the other language. In two of the four statistical models, phonological memory exhibited positive between-language relations, and in one model, it exhibited negative between-language relations to language development. Results also indicated that within-language and between-languages effects remained constant, or between-language associations decreased during the age range studied. Conclusion Overall, the findings provide some support for cross-language associations between phonological memory and lexical and grammatical skills.

PMID:34731575 | DOI:10.1044/2021_JSLHR-21-00176

J Speech Lang Hear Res. 2021 Nov 3:1-15. doi: 10.1044/2021_JSLHR-20-00651. Online ahead of print.

ABSTRACT

Purpose This study aimed to provide detailed descriptive information about the speech of a heterogeneous cohort of children with autism spectrum disorder (ASD) and to explore whether subgroups exist based on this detailed speech data. High rates of delayed and disordered speech in both low-verbal and high-functioning children with ASD have been reported. There is limited information regarding the speech abilities of young children across a range of functional levels. Method Participants were 23 children aged 2;0-6;11 (years;months) with a diagnosis of ASD. Comprehensive speech and language assessments were administered. Independent and relational speech analyses were conducted from single-word naming tasks and spontaneous speech samples. Hierarchical clustering based on language, nonverbal communication, and spontaneous speech descriptive data was completed. Results Independent and relational speech analyses are reported. These variables are used in the cluster analyses, which identified three distinct subgroups: (a) children with high language and high speech ability (n = 10), (b) children with low expressive language and low speech ability but higher receptive language and use of gestures (n = 3), and (c) children with low language and low speech development (n = 10). Conclusions This is the first study to provide detailed descriptive speech data of a heterogeneous cohort of children with ASD and use this information to statistically explore potential subgroups. Clustering suggests a small number of children present with low levels of speech and expressive language in the presence of better receptive language and gestures. This communication profile warrants further exploration. Replicating these findings with a larger cohort of children is needed. Supplemental Material https://doi.org/10.23641/asha.16906978.

PMID:34731586 | DOI:10.1044/2021_JSLHR-20-00651

J Occup Health. 2021 Jan;63(1):e12288. doi: 10.1002/1348-9585.12288.

ABSTRACT

OBJECTIVES: Excess salt intake is a major risk factor for hypertension and cardiovascular disease. Modifying workplace environments has been recognized to be important for reducing salt intake. However, studies examining the effects of improving the workplace environment regarding salt reduction are limited. This study aimed to evaluate the effects of workplace dietary intervention on employees’ salt intake and sodium-to-potassium (Na/K) ratio.

METHODS: A quasi-experimental study was conducted. Two small business establishments in Saitama Prefecture, Japan, were allocated as the intervention (n = 69) and comparison (n = 68) workplaces, respectively. The 1-year intervention involving healthy lunch and nutrition education was implemented in the intervention workplace. Spot urine samples, physical assessments, and self-administered questionnaire data were collected at baseline, 6 months, and 1 year after the start of the intervention. Analysis of covariance was conducted to investigate differences in the salt intake or Na/K ratio between the study workplaces at year 1. Educational status and rotating work schedules were included as covariates.

RESULTS: Salt intake in the intervention workplace decreased significantly from 10.7 to 9.3 g (-1.4 g change; 95% confidence interval [CI]: “-2.4, -0.5”). The adjusted difference in changes in salt intake between workplaces was statistically significant (-3.7 g change; 95% CI: “-5.2, -2.3”). Although no significant change was observed in the Na/K ratio in the intervention workplace (3.37-3.08; -0.29 change; 95% CI: “-0.59, 0.01”), the adjusted difference in changes between the workplaces was statistically significant (-0.60 change; 95% CI: “-1.03, -0.17”).

CONCLUSIONS: Providing healthy lunch and nutrition education may be effective approaches to reduce employees’ salt intake and Na/K ratio.

PMID:34731526 | DOI:10.1002/1348-9585.12288

J Cosmet Dermatol. 2021 Nov 3. doi: 10.1111/jocd.14548. Online ahead of print.

ABSTRACT

Vitiligo is a common, psychologically devastating pigmentary disorder. Surgical graftings are used to treat stable vitiligo when medical treatment fails. An automated epidermal micrograft harvesting (AEMH) system was first designated to treat wounds, and very few studies investigated the application of AEMH in vitiligo. In this study, we investigated the efficacy and safety of the AEMH system in patients with stable segmental and nonsegmental vitiligo. The rate of repigmentation and adverse events was recorded bimonthly for at least 12 months. We analyzed the efficacy based on patient characteristics, vitiligo subtypes, and different anatomical locations. A total of 56 depigmented lesions from 34 patients were included. 95.50% of the automated epidermal micrografts were successfully grafted at the recipient sites. There was a significant improvement in Vitiligo Area Scoring Index (VASI) and Dermatologic Life Quality Index (DLQI) in patients treated with AEMH (p < 0.001). The rate of repigmentation by VASI score improves from 96.25 ± 8.59 to 48.30 ± 28.16 after the treatment (p < 0.001). Treatment outcomes were comparable between the patients of segmental and stable nonsegmental vitiligo. The face and neck region achieved a better outcome, followed by the trunk (chest, abdomen, back, and axilla), limbs, and the worse outcome was found in the acral region (p < 0.014). Conclusively, AEMH is an effective treatment procedure with limited adverse events in patients with stable vitiligo. This harvesting method may be a feasible option for vitiligo surgical treatment.

PMID:34731519 | DOI:10.1111/jocd.14548

J Cosmet Dermatol. 2021 Nov 3. doi: 10.1111/jocd.14555. Online ahead of print.

ABSTRACT

OBJECTIVE: To the knowledge of the authors, no data about the reproducibility and accuracy of 3-dimensional surface imaging of the face using a whole-body scanner are available. Thus, the objective of this investigation was to assess the reproducibility of facial scans acquired using a whole-body imaging device.

MATERIAL AND METHODS: This investigation investigated 220 3-D scans of a total of 22 healthy volunteers (with a mean age of 29.36 years). Two consecutive 3-D images using a Vectra WB360 of the volunteers were obtained utilizing a whole-body imaging device. Predefined distances in the face were performed in each scan and compared. Furthermore, surface deviation between two consecutively captured scans was assessed.

RESULTS: The distance with the smallest statistical significance was found to be at the nose with p = 0.998, while the biggest statistical significance was found in the midface with p = 0.658. The area with the biggest surface deviation between the superimposed scans was the neck with a root mean square (RMS) of 1.62 ± 1.71, and the area with the smallest surface deviation was the forehead with a RMS of 0.17 ± 0.05.

CONCLUSION: The whole-body imaging device investigated in this study can be utilized to capture the face and provides enough accuracy to compare scans. Even though not directly investigated, it can be hypothesized that the error caused by repositioning the patient between a baseline and a follow-up scan will not be too big to consider measurements performed with the whole-body imaging device as impractical.

PMID:34731521 | DOI:10.1111/jocd.14555

J Oral Rehabil. 2021 Nov 3. doi: 10.1111/joor.13278. Online ahead of print.

ABSTRACT

BACKGROUND: Previous bench-top studies examined the details of the mechanical environment of rigidly-fixed occluding teeth. It was demonstrated that during each chomp, contacting molar teeth experience in-occlusal-plane forces (F_lateral ) that are highly transient in magnitude and direction.

OBJECTIVES: The objectives of this study are to identify F_lateral behaviors that are attributable to the presence of a visco-elastic periodontal ligament (PDL) analogue, and to asses the necessity of incorporating it into future studies.

METHODS: A weighted maxillary molar denture tooth was lowered onto, and raised from, a matching mandibular molar 10 times. The latter was supported by a load cell that continuously measured F_lateral . For statistical purposes, the test was repeated with 21 (n = 21) different occlusal relationships obtained with 0.05 mm incremental shifts of the lower assembly.

RESULTS: Overall, the results are similar to those of rigid attachment but the details of the F_lateral profiles are very different.

CONCLUSION: The PDL plays a major role in the mechanical environment of occlusion, suggesting that, in general (not necessarily always), it should be integrated into studies of occlusion.

PMID:34731498 | DOI:10.1111/joor.13278

Methods Mol Biol. 2022;2390:177-190. doi: 10.1007/978-1-0716-1787-8_7.

ABSTRACT

We describe an approach to early stage drug discovery that explicitly engages with the complexities of human biology. The combined computational and experimental approach is formulated on a conceptual framework in which network biology is used to bridge between individual molecular entities and the cellular phenotype that emerges when those entities interact in a network. Multiple aspects of early stage discovery are addressed including the data-driven elucidation of biological processes implicated in disease, target identification and validation, phenotypic discovery of active molecules and their mechanism of action, and extraction of genetic target support from human population genetics data. Validation is described via summary of a number of discovery projects and details from a project aimed at COVID-19 disease.

PMID:34731469 | DOI:10.1007/978-1-0716-1787-8_7

Int J Dermatol. 2021 Nov 3. doi: 10.1111/ijd.15784. Online ahead of print.

ABSTRACT

BACKGROUND: The term super responders defines a subset of patients with moderate-to-severe psoriasis that present a rapid and higher rate of response to biological treatments in comparison to the general population. Little scientific evidence to explain the behavior and clinical characteristics of these psoriatic patients has been published thus far. Its characterization could be important to improve therapeutic optimization and to identify the profile of patients that will respond efficiently to biological treatments.

OBJECTIVES: The main objective of this study was to evaluate and characterize the proportion of super-responder patients (who achieved PASI = 0 at week 12 and 24) in a total of 87 patients with moderate-to-severe psoriasis treated with guselkumab. Also, our intent was to analyze and evaluate differences in response to guselkumab in absolute PASI, PASI 75, PASI 90, PASI 100, BSA, VAS pruritus, and DLQI between groups.

RESULTS: A total of 14 out of 87 patients treated with guselkumab were characterized as SR. No differences in demographic characteristics were found. The percentage of patients reaching PASI 75, PASI 90, and PASI 100 were numerically greater for SR than N-SR at week 12, 24, 36, and 52. These differences were more pronounced for PASI 100 > PASI 90 > PASI 75. SR performed better and faster to guselkumab treatment as assessed by absolute PASI, BSA, VAS pruritus, and DLQI. Statistically significant differences were found in absolute PASI, BSA, VAS pruritus, and DLQI between groups along the 52 weeks of study. No differences in drug survival were found between groups (P = 0.3326).

CONCLUSION: Our study demonstrated for the first time, in a real clinical practice setting, the presence of a subpopulation of patients that super respond to guselkumab at week 12 and 24 and maintain this efficacy for 52 weeks. Further research must be performed to identify basal specific characteristics of this SR population.

PMID:34731493 | DOI:10.1111/ijd.15784