Tag: statistics

Photodermatol Photoimmunol Photomed. 2021 Jun 22. doi: 10.1111/phpp.12709. Online ahead of print.

ABSTRACT

BACKGROUND: Photodynamic therapy for hidradenitis suppurativa (HS) is a therapeutic alternative with a good safety profile, but its effectiveness has yet to be demonstrated.

OBJECTIVES: To demonstrate the effectiveness of PDT with intralesional methylene blue in HS lesions.

METHODS: A retrospective cross-sectional study was performed. Forty-one patients were treated with intralesional methylene blue and a diode lamp. Follow-up was carried out at 1 and 6 months after therapy. Efficacy was determined by the diameter reduction of the lesion measured by high-frequency ultrasound.

RESULTS: A reduction of ≥75% in the maximum diameter was recorded in 58.5% of the lesions, while 22% showed a reduction between 50 and 75%, and 19.5% showed a reduction of <50 %. Recurrence rate was 12,5%. The lesions treated in patients with typical forms of HS (Canoui-Poitrine phenotype I) had a better therapeutic response. No statistically significant differences were found in terms of lesion location or concomitant treatment.

CONCLUSION: This therapy may potentially be a cost-effective and well-tolerated local therapy for Hurley I-II patients with superficial abscesses and fistulas.

PMID:34157160 | DOI:10.1111/phpp.12709

Photodermatol Photoimmunol Photomed. 2021 Jun 22. doi: 10.1111/phpp.12710. Online ahead of print.

ABSTRACT

BACKGROUND: Currently, sunscreens’ sun protection factor (SPF) and ultraviolet (UV) A protection are tested separately under indoor conditions, without considering external conditions that may affect performance. Studies are often conducted in Caucasian individuals; other racial groups may respond differently.

METHODS: An outdoor, double-blind, intra-individual study was performed in 63 healthy Chinese and Caucasian volunteers in Singapore. Subjects underwent one outdoor sun exposure lasting 2-3 hours. ISO reference products P3 (SPF 15), P5 (SPF 30) and P8 (SPF 50+) applied at 2 mg/cm² were compared against each other and against an untreated exposed area (positive control) and an unexposed area (negative control). Endpoints were investigator global assessment (IGA) of erythema at 24 hours, IGA of pigmentation at 1 week, and colorimetry (a*, L* and ITA) at 24 hours and 1 week.

RESULTS: Clinical erythema and pigmentation scores were statistically significantly different among the three sunscreens, with the highest SPF product providing the highest protection, confirming the discriminatory capacity of the model used. Colorimetric assessment correlated well with clinical evaluation.

CONCLUSION: This study confirmed the feasibility of ranking sunscreens (at 2 mg/cm² ) based on clinical effects of high-intensity outdoor solar radiation. Larger studies are needed to look at differences in erythema and pigmentation reactions between Chinese and Caucasian individuals, which could be relevant for photoprotection.

PMID:34157168 | DOI:10.1111/phpp.12710

Adv Nutr. 2021 Jun 22:nmab071. doi: 10.1093/advances/nmab071. Online ahead of print.

ABSTRACT

Lutein, zeaxanthin, and meso-zeaxanthin are the only carotenoids found in the human macula and may have a role in visual function. These carotenoids are reported to protect the retina, and thus vision, as antioxidants and by acting as a blue light filter. Our objective was to determine a minimum concentration of lutein/zeaxanthin intake that is associated with a statistically significant and/or clinically important change in macular pigment optical density (MPOD) among adults with healthy eyes. We searched Ovid MEDLINE, CENTRAL, and the Commonwealth of Agriculture Bureau for English-language studies through to July 2020. Two reviewers screened results to identify studies that evaluated supplements or dietary sources of lutein/zeaxanthin on MPOD among adults with healthy eyes. One reviewer extracted data and assessed strength of evidence, which was confirmed by a second reviewer. Two independent reviewers assessed the risk of bias. Meta-analyses were stratified by total lutein/zeaxanthin dose. We included 46 studies (N = 3189 participants; mean age = 43 y; 42% male). There was no statistically significant change in MPOD among studies evaluating <5 mg/d of total lutein/zeaxanthin intake which primarily assessed dietary interventions for 3-6 mo (pooled mean difference, 0.02; 95% CI: -0.01 to 0.05). The pooled mean increase in MPOD was 0.04 units (95% CI: 0.02 to 0.07) among studies evaluating 5 to <20 mg/d of lutein/zeaxanthin and was 0.11 units (95% CI: 0.06 to 0.16) among studies evaluating ≥20 mg/d of lutein/zeaxanthin for 3-12 mo. MPOD increased with lutein/zeaxanthin intake, particularly at higher doses, among adults with healthy eyes. The effects of lutein/zeaxanthin intake at doses <5 mg/d or from dietary sources is less clear. Increased lutein/zeaxanthin intake can help with maintaining ocular health. Future research is needed to determine the minimum dose and duration of lutein/zeaxanthin intake that is associated with a clinically important change in MPOD or visual function.

PMID:34157098 | DOI:10.1093/advances/nmab071

Nutr Rev. 2021 Jun 22:nuab028. doi: 10.1093/nutrit/nuab028. Online ahead of print.

ABSTRACT

CONTEXT: There are only a few systematic reviews on the association of obesity with risk of inflammatory bowel disease (IBD) to date.

OBJECTIVE: The current study was undertaken to systematically review prospective cohort studies on the association between body mass index (BMI) and risk of IBD. It was carried out according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines.

DATA SOURCES: Relevant prospective cohort studies published from 1969 to July 2020 were searched through PubMed, MEDLINE, SCOPUS, EMBASE, and Google Scholar, using suitable keywords.

DATA EXTRACTION: Hazard ratios (HRs) or relative risks (RRs) and 95% confidence intervals (CIs) for IBD or its subtypes across categories of BMI were extracted.

DATA ANALYSIS: The log HRs/RRs, including standard errors, were calculated based on reported HRs or RRs and their 95% CIs, and overall effect size was calculated using a fixed-effects model. All statistical analyses were done using STATA version 14.0 (Stata Corp LP, College Station, TX, USA).

CONCLUSION: Overall, 9 studies were included. Combining findings from 5 studies, a statistically significant 21% lower risk of ulcerative colitis incidence was found in patients with obesity than in those with normal weight (RR, 0.79; 95% CI, 0.68-0.92; I2= 0.0%), but not with risk of ulcerative colitis exacerbation, as found by meta-analysis of 3 studies. Pooling data from 5 studies, no significant differences were seen in the risk of Crohn’s disease incidence between patients in the highest range of BMI and those in the normal range. In addition, no significant nonlinear association was found between BMI and risk of Crohn’s disease (P=0.94). A significant inverse association was found between obesity and total IBD incidence (RR, 0.76; 95% CI, 0.66-0.88; I2=93.2%), but not between increasing BMI and IBD exacerbation, or between increasing BMI and IBD incidence.

PMID:34157115 | DOI:10.1093/nutrit/nuab028

J Clin Endocrinol Metab. 2021 Jun 22:dgab459. doi: 10.1210/clinem/dgab459. Online ahead of print.

ABSTRACT

PURPOSE: Dehydroepiandrosterone sulfate (DHEAS) from the adrenal cortex substantially decreases with age, which may accelerate osteoporosis. However, the association of DHEAS with bone mineral density (BMD) and fracture is inconclusive. We conducted a Mendelian randomization (MR) analysis to investigate the role of DHEAS in age-related changes in BMD and fracture risk.

METHODS: Single nucleotide polymorphisms (SNPs) associated with serum DHEAS concentrations were used as instrumental variables (4 SNPs for main analysis; 4 SNPs for men and 5 SNPs for women in sex-related analysis). Summary statistics were obtained from relevant genome-wide association studies.

RESULTS: A log-transformed unit (μmol/L) increase in serum DHEAS concentrations was associated with SD increase in estimated BMD at the heel (estimate, 0.120; 95% confidence interval [CI], 0.081-0.158; P = 9 × 10 -10), and decreased fracture (odds ratio [OR], 0.989; 95%CI, 0.981-0.996; P = 0.005), consistent with dual-energy X-ray absorptiometry-derived BMD at the femoral neck and lumbar spine. Their associations remained even after adjusting for height, body mass index, testosterone, estradiol, sex hormone-binding globulin, and IGF-1. The association of DHEAS with fracture remained after adjusting for falls, grip strength, and physical activity but was attenuated after adjusting for BMD. The MR-Baysian model averaging analysis showed BMD was the top mediating factor for association of DHEAS with fracture. The association between DHEAS and BMD was observed in men but not in women.

CONCLUSION: DHEAS was associated with increased BMD and decreased fracture. DHEAS may play a protective role in decreasing fracture risk, mainly by increasing bone mass.

PMID:34157116 | DOI:10.1210/clinem/dgab459

Br J Surg. 2021 Jun 22;108(6):702-708. doi: 10.1002/bjs.11998.

ABSTRACT

BACKGROUND: Minimally invasive oesophagectomy has been shown to reduce the risk of pulmonary complications compared with open oesophagectomy, but the effects on health-related quality of life (HRQoL) and oesophageal cancer survivorship remain unclear. The aim of this study was to assess the longitudinal effects of minimally invasive compared with open oesophagectomy for cancer on HRQoL.

METHODS: All patients who had surgery for oesophageal cancer in Sweden from January 2013 to April 2018 were identified. The exposure was total or hybrid minimally invasive oesophagectomy, compared with open surgery. The study outcome was HRQoL, evaluated by means of the European Organisation for Research and Treatment of Cancer questionnaires QLQ-C30 and QLQ-OG25 at 1 and 2 years after surgery. Mean differences and 95 per cent confidence intervals were adjusted for confounders.

RESULTS: Of the 246 patients recruited, 153 underwent minimally invasive oesophagectomy, of which 75 were hybrid minimally invasive and 78 were total minimally invasive procedures. After adjustment for age, sex, Charlson Co-morbidity Index score, pathological tumour stage and neoadjuvant therapy, there were no clinically and statistically significant differences in overall or disease-specific HRQoL after oesophagectomy between hybrid minimally invasive and total minimally invasive surgical technique versus open surgery.

CONCLUSION: In this population-based nationwide Swedish study, longitudinal HRQoL after minimally invasive oesophagectomy was similar to that of the open surgical approach.

PMID:34157084 | DOI:10.1002/bjs.11998

Blood. 2021 Jun 22:blood.2021011719. doi: 10.1182/blood.2021011719. Online ahead of print.

ABSTRACT

Omidubicel is an ex vivo expanded hematopoietic progenitor cell, and non-expanded myeloid and lymphoid cell product derived from a single umbilical cord blood unit. We report results of a phase III trial to evaluate the efficacy of omidubicel compared to standard umbilical cord blood transplantation (UCBT). Between January 2017 and January 2020, 125 patients aged 13-65 with hematologic malignancies were randomized to omidubicel versus standard UCBT. Patients received myeloablative conditioning and graft versus host disease (GvHD) prophylaxis with a calcineurin inhibitor and mycophenolate mofetil. The primary endpoint was time to neutrophil engraftment. The treatment arms were well balanced and racially diverse. Median time to neutrophil engraftment was 12 days (95% CI 10-14 days) and 22 days (95% CI 19-25 days) (p<0.001) for the omidubicel and control arms, respectively. The cumulative incidence of neutrophil engraftment was 96% and 89% for patients receiving omidubicel and control transplants, respectively. The omidubicel arm had faster platelet recovery (55% vs. 35% recovery by 42 days, p=0.028), a lower incidence of first grade 2/3 bacterial or invasive fungal infections (37% vs. 57%, p=0.027), and spent more time out of hospital during the first 100 days following transplant (median 61 vs. 48 days, p=0.005) than controls. Differences in GvHD and survival between the two arms were not statistically significant. Transplantation with omidubicel results in faster hematopoietic recovery and reduced early transplant-related complications as compared to standard UCBT. The results suggest that omidubicel may be considered as a new standard of care for adult patients eligible for UCBT.

PMID:34157093 | DOI:10.1182/blood.2021011719

PLoS One. 2021 Jun 22;16(6):e0253313. doi: 10.1371/journal.pone.0253313. eCollection 2021.

ABSTRACT

BACKGROUND: Over the last three decades, the accessibility and usage of mobile devices have increased among young children. This study’s objective was to develop a validated caregiver-reported digital-screen exposure questionnaire (DSEQ) for children aged 2-5 years.

METHODS: DSEQ was developed in five phases. Phase 1, a draft questionnaire was developed by reviewing the literature on existing tools (n = 2) from 2009-2017. Phase 2, face-to-face interviews with primary caregivers (n = 30) were conducted in a tertiary-care-hospital for acculturation. Nine experts assessed the face and content validity of the draft Hindi and English questionnaire. Phase 3, a pilot study conducted among randomly selected families (n = 40) to evaluate the feasibility of DSEQ in field settings. Phase 4, test-retest reliability was done among 30 primary caregivers selected randomly in another urban cluster. Phase 5, the internal consistency of DSEQ was checked by conducting a cross-sectional study among randomly selected 400 primary caregivers in Chandigarh, North India. IBM SPSS Statistics for Macintosh, version 25.0, was for data management and analysis.

RESULTS: A valid DSEQ with 86 items under five domains, including sociodemographic, screen-time exposure and home media environment, level of physical activity, media-related behaviors, and parental perceptions was developed. The pilot study showed that it was feasible to use the DSEQ in the field. DSEQ was reliable with kappa value ranging from 0.52 to 1.0, and intra-class coefficient of 0.62-0.99 (p<0.05). A strong internal consistency was observed for three domains including, screen-time exposure and home media environment (Cronbach’s alpha of 0.82), media-related behaviors (Cronbach’s alpha of 0.74) and physical activity (Cronbach’s alpha 0.73).

CONCLUSIONS: The developed DSEQ has good face and content validity and acceptable evidence of internal consistency and test-retest reliability. The DSEQ can be used for measuring digital screen exposure and its correlates among children aged 2 to 5 years.

PMID:34157053 | DOI:10.1371/journal.pone.0253313

Int J Oral Maxillofac Implants. 2021 Jun 22. doi: 10.11607/jomi.8851. Online ahead of print.

ABSTRACT

PURPOSE: The purpose of this study was to compare changes in the physicochemical and biologic characteristics of titanium surfaces through short-term re-hydrophobization for 24 hours and ultraviolet (UV) re-irradiation for 24 hours.

MATERIALS AND METHODS: Photofunctionalization was performed with four 15-W bactericidal lamps at an intensity of 5.0 mW/cm² (wavelength = 254 ± 20 nm) on sandblasted, large-grit, acid-etched (SLA)-treated titanium surfaces, which were stored in a sterilized sealed container for 8 weeks to allow enough biologic aging. The duration of the UV irradiation was as follows: irradiation group-UV irradiated for 24 hours; re-hydrophobization group-UV irradiated for 24 hours and then stored in an ambient sterilized medium; and re-irradiation group-UV irradiated for 24 hours followed by storing for 24 hours in an ambient sterilized medium and then UV re-irradiated for 24 hours. The surface characteristics were evaluated with field emission scanning electron microscopy, x-ray photoelectron spectroscopy (XPS), and water contact angle. Cell viability and morphology were measured using fluorescence staining. Alkaline phosphatase (ALP) assay and alizarin red S staining were performed to evaluate the differentiation of osteogenic cells and the mineralization capability.

RESULTS: Macroroughness and superimposed microroughness were observed on the disk surfaces in all groups as typically seen on SLA surfaces. The water contact angles were measured to be 1.85, 1.48, and 1.18 degrees for the irradiation group, re-hydrophobization group, and re-irradiation group, respectively, indicating superhydrophilicity. There was no difference in the surface elemental ratio or the spectra of XPS, cell viability, or ALP activity. Although the re-irradiation group had the highest total amount of calcium deposition, there was no statistical significance.

CONCLUSION: Within the limitations of the study, improved superhydrophilicity and bioactivity after UV irradiation were maintained during short-term re-hydrophobization and repeated re-irradiation without changing the topography of SLA titanium surfaces.

PMID:34157065 | DOI:10.11607/jomi.8851

Br J Surg. 2021 Jun 22;108(6):613-621. doi: 10.1093/bjs/znab016.

ABSTRACT

INTRODUCTION: Operating room recording, via video, audio and sensor-based recordings, is increasingly common. Yet, surgical data science is a new field without clear guidelines. The purpose of this study is to examine existing published studies of surgical recording modalities to determine which are available for use in the operating room, as a first step towards developing unified standards for this field.

METHODS: Medline, EMBASE, CENTRAL and PubMed databases were systematically searched for articles describing modalities of data collection in the operating room. Search terms included ‘video-audio media’, ‘bio-sensing techniques’, ‘sound’, ‘movement’, ‘operating rooms’ and others. Title, abstract and full-text screening were completed to identify relevant articles. Descriptive statistical analysis was performed for included studies.

RESULTS: From 3756 citations, 91 studies met inclusion criteria. These studies described 10 unique data-collection modalities for 17 different purposes in the operating room. Data modalities included video, audio, kinematic and eye-tracking among others. Data-collection purposes described included surgical trainee assessment, surgical error, surgical team communication and operating room efficiency.

CONCLUSION: Effective data collection and utilization in the operating room are imperative for the provision of superior surgical care. The future operating room landscape undoubtedly includes multiple modalities of data collection for a plethora of purposes. This review acts as a foundation for employing operating room data in a way that leads to meaningful benefit for patient care.

PMID:34157080 | DOI:10.1093/bjs/znab016