Tag: statistics

J Rheumatol. 2021 Mar 1:jrheum.201679. doi: 10.3899/jrheum.201679. Online ahead of print.

ABSTRACT

The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA)-Outcome Measures in Rheumatology (OMERACT) Psoriatic Arthritis (PsA) Working Group provided updates at the 2020 GRAPPA annual meeting on its work toward developing a core outcome set for PsA. Working groups were set up for the 4 prioritized domains: enthesitis, fatigue, structural damage, and physical function. Two instruments for measurement of physical function were provisionally endorsed: (1) the Health Assessment Questionnaire-Disability Index and (2) the physical functioning domain in the Medical Outcomes Study 36-item Short Form survey.

PMID:33649070 | DOI:10.3899/jrheum.201679

Cancer Prev Res (Phila). 2021 Mar 1:canprevres.0598.2020. doi: 10.1158/1940-6207.CAPR-20-0598. Online ahead of print.

ABSTRACT

Polyphenon E (Poly E) is a green tea polyphenol preparation whose most active component is epigallocatechin gallate (EGCG). We studied the cancer preventive efficacy and safety of Poly E in subjects with rectal aberrant crypt foci (ACF) which represent putative precursors of colorectal cancers. Eligible subjects had prior colorectal advanced adenomas or cancers, and had > 5 rectal ACF at a pre-registration chromoendoscopy. Subjects (N=39) were randomized to 6-months of oral Poly E (780 mg EGCG) daily or placebo. Baseline characteristics were similar by treatment arm (all P >0.41); 32 of 39 (82%) subjects completed 6-months of treatment. The primary endpoint was percent reduction in rectal ACF at chromoendoscopy comparing before and after treatment. Among 32 subjects (15 Poly E,17 placebo), percent change in rectal ACF number (baseline vs 6-month) did not differ significantly between study arms (3.7% difference of means; P =0.28); total ACF burden was also similar (-2.3% difference of means; P =0.83). Adenoma recurrence rates at 6-months were similar by arm (P >0.35). Total drug received did not differ significantly by study arm; 31 (79%) subjects received >70% of prescribed Poly E. Poly E was well tolerated and adverse events (AEs) did not differ significantly by arm. One subject on placebo had two grade 3 AEs; one subject had grade 2 hepatic transaminase elevations attributed to treatment. In conclusion, Poly E for 6 months did not significantly reduce rectal ACF number relative to placebo. Poly E was well tolerated and without significant toxicity at the dose studied.

PMID:33648940 | DOI:10.1158/1940-6207.CAPR-20-0598

BMJ Glob Health. 2021 Mar;6(3):e003734. doi: 10.1136/bmjgh-2020-003734.

ABSTRACT

PURPOSE: The long-term consequences of parental emigration on offspring self-harm risk is unknown.

METHODS: We investigated the association between experiencing parental emigration in childhood with hospital presentations for self-poisoning in adulthood using a hospital case-control study. Cases were adult self-poisoning patients (≥18 year olds) admitted to the medical toxicology ward Teaching Hospital Peradeniya, Sri Lanka. Sex and age frequency matched controls were recruited from the outpatient department or nearby specialist clinics at the same hospital. Details of parental emigration were collected using a pre-piloted questionnaire. The relationship between parental emigration and self-poisoning in adulthood was estimated using logistic regression models.

RESULTS: 298 cases, and 500 hospital controls were interviewed for the study. We estimate that one in five adults experienced parental emmigration as children (95% CI 17% to 24%). We find limited evidence that children from households with emigrating parents were more likely to experience adverse childhood experiences than those with non-emigrating parents. We found no statistical evidence of an increased risk of self-poisoning in adulthood in individuals who experienced parental emigration (maternal or paternal) during childhood. There was no statistical evidence that the impact differed by the sex of the participant.

CONCLUSION: Adults who experienced parental emigration as children were no more likely to self-poison than adults with non-emigrating parents. Further research using longitudinal data are needed to understand whether any adverse outcomes observed in ‘left-behind’ children are a consequence of parental emigration or due to factors associated but predate the emigration. Prospective data are also important to investigate whether there are any lasting effects on children who experience parental emigration.

PMID:33648980 | DOI:10.1136/bmjgh-2020-003734

Int J Gynecol Cancer. 2021 Mar;31(3):379-386. doi: 10.1136/ijgc-2020-001751.

ABSTRACT

BACKGROUND: Neoadjuvant chemotherapy before fertility-sparing surgery is an accepted option for patients with cervical tumors between 2 cm and 4 cm. There is a paucity of data regarding its role in patients with tumors <2 cm. Our objective was to compare the oncological and obstetrical outcomes between patients who underwent neoadjuvant chemotherapy before cervical conization versus upfront cervical conization in patients with cervical cancer with tumors <2 cm.

METHODS: We conducted a systematic literature review and searched MEDLINE, EMBASE, and CINAHL (from 1995 to March 2020) using the terms: uterine cervix neoplasms, cervical cancer, fertility-sparing surgery, fertility preservation, conization, cone biopsy, and neoadjuvant chemotherapy. We included manuscripts with information on patients with tumor size <2 cm, lymph node status, follow-up, oncological and obstetrical outcome, and toxicity related to neoadjuvant chemotherapy. We excluded review articles or articles with duplicated patient information.

RESULTS: We identified 12 articles, including 579 patients. For final analysis, 261 patients met inclusion criteria. The most common histology was non-squamous cell carcinoma (62%). Median follow-up time was 63.5 (range 7-122) months for the neoadjuvant chemotherapy group and 48 (range 12-184) months for the upfront cervical conization group. There was no difference in either overall survival (neoadjuvant chemotherapy group 100% vs upfront cervical conization 99.7%, p=0.79) or disease-free survival (neoadjuvant chemotherapy 100% vs upfront cervical conization 98.9%, p=0.59) between the groups. Fertility preservation rate was 81.4% versus 99.1% (p<0.001) favoring upfront cervical conization. No statistically significant differences were seen in live birth rate or pregnancy loss. Also, we found that all neoadjuvant chemotherapy patients reported chemotherapy-related toxicity (30.7% grade 3 and 69.2% grade 1-2).

CONCLUSIONS: There was no difference in disease-free survival or overall survival between patients who underwent neoadjuvant chemotherapy followed by conization and upfront cervical conization. Patients who underwent upfront cervical conization had a higher fertility preservation rate.

PMID:33649005 | DOI:10.1136/ijgc-2020-001751

J Craniomaxillofac Surg. 2021 Feb 12:S1010-5182(21)00053-6. doi: 10.1016/j.jcms.2021.02.007. Online ahead of print.

ABSTRACT

The aim of this study was to investigate the impact of a prolonged treatment delay on survival in patients with primary oral squamous cell carcinoma. The investigators hypothesized that treatment delay affects survival, supposing a poor outcome in patients with prolonged treatment initiation. In addition, a critical treatment delay should be defined. Inclusion criteria were a histopathological diagnosis of primary squamous cell carcinoma of the oral cavity and a surgery-based treatment of the tumor. Patients with a history of previously diagnosed malignancies and patients with distant metastasis at the time of diagnosis were excluded from this protocol. Common clinical and histopathological data were assessed retrospectively. Treatment delay was analyzed for the interval between initial presentation and the date of surgery. A total of 484 patients could be included. Considering early-stage patients, the risk of death increases by 1.8% for each day that the treatment delay is prolonged if all other characteristics do not change (p = 0.0035). In patients with advanced disease, a prolonged treatment delay does not affect the risk of death (p = 0.9134). In terms of progression-free survival, treatment delay tends to be associated with a higher risk of recurrence in early-stage disease, but without being statistically significant (p = 0.0718). For patients with early-stage disease, a treatment delay of 20 days is critical regarding overall survival (p = 0.011). For patients with advanced-stage disease, no significant differences have been observed. As patients with early-stage oral squamous cell carcinoma profit from early treatment initiation, we suggest an acceptable maximum treatment delay of no more than 20 days in the surgical management of these patients.

PMID:33648813 | DOI:10.1016/j.jcms.2021.02.007

J Arthroplasty. 2021 Feb 12:S0883-5403(21)00162-5. doi: 10.1016/j.arth.2021.02.023. Online ahead of print.

ABSTRACT

BACKGROUND: Patients with mood disorders undergoing total joint arthroplasty (TJA) are at increased risk for poor outcomes. This study seeks to examine the effect of anxiety disorders on pain following TJA and evaluate if anxiety disorders are a modifiable risk factor.

METHODS: Between March 2019 and July 2020, 319 TJA patients had preoperative anxiety screening using the Generalized Anxiety Disorder 2-item screening tool (GAD-2) and 6-week postoperative Pain Catastrophizing Scale scores. Patients were organized into 4 cohorts based on preoperative selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) use and GAD-2 scores: Group 1: no SSRI/SNRI use and GAD-2 score <3 (control patients); Group 2: SSRI/SNRI use and GAD-2 score <3 (appropriately treated GAD patients); Group 3: no SSRI/SNRI use and GAD-2 score ≥3 (untreated GAD patients); and Group 4: SSRI/SNRI use and GAD-2 score ≥3 (poorly treated GAD patients). The cohorts underwent multivariate linear regression analysis and equivalence testing.

RESULTS: Patients with preoperative GAD-2 scores ≥3 had worse postoperative pain with significantly higher average 6-week postoperative Pain Catastrophizing Scale score than patients with GAD-2 scores <3 (9.90 vs 5.19, P < .001). Patients with appropriately treated GAD and the control group had statistically equivalent postoperative pain, while patients with poorly treated or untreated GAD had worse postoperative pain.

CONCLUSION: Preoperative GAD is a risk factor for poor postoperative pain control but is a modifiable risk factor when patients are appropriately treated. Screening for preoperative GAD with GAD-2 and referral for treatment may improve patient outcomes and reduce opioid consumption following TJA.

PMID:33648840 | DOI:10.1016/j.arth.2021.02.023

Eur Cytokine Netw. 2020 Dec 1;31(4):129-133. doi: 10.1684/ecn.2020.0457.

ABSTRACT

Tuberculosis (TB) is one of the leading infectious causes of death worldwide and despite the progress recently made in TB control at a global level, the decline in its incidence is still slow. It is therefore crucial to evaluate the performance of new tools for monitoring of TB treatment. The aim of this study was to evaluate the response to tuberculosis treatment using the QuantiFERON-TB Gold Plus (QFT-Plus) kit. Blood samples of 100 patients with active TB were taken before treatment and after three months, if treatment was successful and sputum culture was negative. Whole blood was incubated in the presence or absence of the TB antigens, TB1 and TB2-specific antigens, and the production of IFN-γ was determined using the QuantiFERON-TB Gold Plus (QFT-Plus) test. The data were analyzed using SPSS 16 software and statistical significance was assessed at a two-tailed P value of 0.05. The median values of IFN-γ released following stimulation with TB1 peptides decreased slightly after treatment (2.5 IU/mL (IQR: 0.9-5.3), compared to the baseline (3.4 IU/mL (IQR: 0.5-6.6)). Also, with respect to the TB1 antigen, 38 out of 45 patients were positive for the QFT test before treatment (84.4%) and 37 cases after treatment (82.2%). On the other hand, the median values of IFN-γ determined with the TB2 test declined marginally after treatment (2.7 IU/mL; IQR: 0.95-5.8), as compared to pretreatment (3.0 IU/mL; IQR: 0.7-8.9). Thirty-nine out of 45 patients (86.7%) before initiation of treatment and 37 cases following a 3-month treatment (82.2%) were had positive values. Moreover, the median values of IFN-γ of TB2 minus TB1 before and after treatment were 0.17 (IQR: 0-1.0) and 0.03 (IQR: 0.0.48), respectively; however, these differences were not significant (p value=0.29). Conclusion: The results of this study show no significant differences between the IFN-γ release in TB patients prior to and after treatment. However, more extensive studies are needed in different populations with higher sample sizes to validate these results.

PMID:33648920 | DOI:10.1684/ecn.2020.0457

Eur J Dermatol. 2021 Mar 1. doi: 10.1684/ejd.2021.3967. Online ahead of print.

ABSTRACT

BACKGROUND: Organ transplant recipients (OTR) are at marked increased risk of skin cancer and skin infections compared to the general population.

OBJECTIVES: The purpose of this study was to acquire long-term incidence data on commonly occurring skin diseases in four different transplant groups.

MATERIALS & METHODS: This retrospective single-centre cohort study included 621 OTR. By counting defined malignant, inflammatory, infectious or drug-related skin conditions per patient and visit, incidence rates (IR) for the different groups of OTR were calculated as cases per 1000-patient years and cumulative incidences of non-melanoma skin cancer (NMSC), respectively.

RESULTS: Overall, 2,309 non-malignant skin conditions and 340 NMSC were registered. Skin infections were most common (51.4%), followed by inflammatory skin conditions (35.6%) and sun-induced skin damage (32.9%). Kidney transplant recipients (KTR) had a 4.7-fold (95% CI: 2.7-8.0; p < 0.0001), 2.6-fold (95% CI: 1.2-5.3; p = 0.0098) and 5.4-fold (95% CI: 2.8-10.3; – < 0.0001) higher IR for oral candidiasis, oral aphthosis and herpes simplex virus infections, respectively, compared to the other OTR. Pruritus was most commonly reported in liver transplant recipients (95% CI: 1.3-5.3; p = 0.0047). KTR and lung transplant recipients (LuTR) had a 10.7-fold (95% CI:3.6-43.2; p < 0.0001) higher IR of steroid induced acne. KTR had a 1.6-fold (95% CI: 1.1-2.3; p = 0.0096) higher IR of squamous cell carcinoma compared to the other groups. The incidence of basal cell carcinoma was 2.5-fold higher (95% CI: 1.7-3.6; p < 0.0001) in LuTR, compared to the other OTR.

CONCLUSIONS: This study provides additional organ-specific incidence data on non-malignant skin diseases and skin cancer in OTR.

PMID:33648926 | DOI:10.1684/ejd.2021.3967

J Prosthet Dent. 2021 Feb 26:S0022-3913(21)00043-3. doi: 10.1016/j.prosdent.2021.01.006. Online ahead of print.

ABSTRACT

STATEMENT OF PROBLEM: The lost-wax technique is commonly used for fabricating partial fixed dental prostheses. The casting patterns can be fabricated by using vat photopolymerization (a type of additive manufacturing), but the adaptation of these casting patterns has not been elucidated.

PURPOSE: The purpose of this in vitro study was to evaluate the effect of build orientation on the adaptation of casting patterns fabricated by digital light projection (DLP).

MATERIAL AND METHODS: A 3-unit partial fixed dental prosthesis with mandibular left second premolar and second molar abutment teeth was scanned and virtually designed with a computer-aided design software program. The cement space was designed to be 30 μm. Specimens were fabricated with 3 build orientations: 0 degrees (with the occlusal surface parallel to the platform), 30 degrees, and 45 degrees (by rotating the file along the long axis). The casting patterns were fabricated by using DLP (Cara Print 4.0) with a photopolymerizable monomer (dima Print Cast Q). Photopolymerization, cleaning, and postpolymerization processes were performed according to the manufacturer’s instructions. The adaptation of the specimens was examined by using a silicone replica method. The vertical marginal discrepancy and axial wall, occlusal, and marginal gaps were measured by using a digital measuring microscope. The effect of build orientation at each cross-sectional area was statistically analyzed by using the Kruskal-Wallis test followed by the pairwise Wilcoxon rank sum test with Bonferroni correction (α=.05).

RESULTS: Excess polymerized resin was observed along the intaglio buccal wall at build orientations of 30 degrees and 45 degrees. Vertical marginal discrepancies in the buccolingual section ranged from -50 to 248 μm, while those in the mesiodistal section ranged from -25 to 182 μm. The gaps in the buccolingual section ranged from 0 to 236 μm, while those in the mesiodistal section ranged from 0 to 177 μm. According to the observation of vertical marginal discrepancies and gaps, the 30-degree specimens inclined during insertion, and the 45-degree specimens were not completely seated. However, the marginal gaps of the 0- and 30-degree specimens were within the clinically acceptable limit of 120 μm.

CONCLUSIONS: The limited data indicated that the build orientation influenced the adaptation of casting patterns for 3-unit partial fixed dental prostheses fabricated by using DLP. A build orientation of 0 degrees is recommended for fabricating casting patterns for 3-unit partial fixed dental prostheses because no excess polymerization of the intaglio buccal wall was observed.

PMID:33648796 | DOI:10.1016/j.prosdent.2021.01.006

Auris Nasus Larynx. 2021 Feb 27:S0385-8146(21)00066-3. doi: 10.1016/j.anl.2021.02.008. Online ahead of print.

ABSTRACT

OBJECTIVE: Retrospective videofluoroscopic swallowing study (VFSS) evaluations of pharyngeal swallowing were used to evaluate the types of dysphagia alleviated by the chin-down maneuver.

MATERIALS AND METHODS: The study population consisted of 64 patients who underwent VFSS evaluations during neutral and chin-down maneuvers presenting specifically penetration or aspiration. The assessment of the VFSS movie clips of each maneuver was performed using parameters of the Modified Barium Swallow Impairment Profile (MBSImP) and the presence and degree of airway invasion(PDAI) by three blinded raters in the following five subcategorized groups, 1. patietns presenting penetration or aspiration during swallow 2. after swallow, patients of 3. head and neck, 4. digestive and 5. neuromuscular disorders, respectively. The scores registered for the two maneuvers were statistically compared. Additionally, we examined statistically which factors had the impact on the improvement of the PDAI using fisher’s exact test.

RESULTS: Compared with the neutral position, PDAI, pharyngeal constriction, anterior hyoid movement, pharyngeal constriction, laryngeal elevation, laryngeal closure, upper esophageal sphincter opening, initiation of the pharyngeal swallow, and pharyngeal clearance in pyriform sinus were significantly (p < 0.01-0.05) improved with the chin-down maneuver. In a subcategory comparison with group 1, 3 and 4, the PDAI improved significantly (p < 0.01) with the chin-down maneuver, in which laryngeal elevation and laryngeal closure had statistically the impact (p < 0.01-0.05) on improvement of PDAI.

CONCLUSION: The chin-down maneuver was most effective in improving swallow function when the impairment included penetration and aspiration during swallow caused by inadequate laryngeal elevation and laryngeal closure.

PMID:33648799 | DOI:10.1016/j.anl.2021.02.008