Category: Statistics

AIDS Behav. 2022 Jan 24. doi: 10.1007/s10461-021-03550-z. Online ahead of print.

ABSTRACT

Sauti ya Vijana is a mental health and life skills intervention delivered by young adult group leaders for the improvement of HIV outcomes in young people living with HIV in Tanzania. This pilot randomized controlled trial estimated exploratory intervention effectiveness compared to standard of care. YPLWH (N = 105) were randomized to receive intervention or SOC. The mean age of participants was 18.1 years and 53% were female. Mean scores on mental health measures (Patient Health Questionnaire [PHQ-9], Strengths and Difficulties Questionnaire [SDQ], UCLA Trauma) were asymptomatic to mild in both study arms through 30-month follow-up with a non-significant fluctuation of 1-2 points. The mean self-reported adherence was higher in the intervention arm across all time points (but the confidence interval contained the null at all time points except 6 months). Risk ratio of virologic suppression (HIV RNA < 400 copies/mL) in the intervention arm compared to SOC was 1.15 [95% CI = 0.95, 1.39]) at 6-months, 1.17 [95% CI: 0.92, 1.48] at 12-months, and 0.99 [95% CI 0.76, 1.31] at 18-months. Though these findings were not powered for statistical significance, the trends in HIV outcomes suggest that SYV holds promise for improving antiretroviral therapy (ART) adherence and virologic suppression in YPLWH.

PMID:35067831 | DOI:10.1007/s10461-021-03550-z

Gastric Cancer. 2022 Jan 24. doi: 10.1007/s10120-021-01273-7. Online ahead of print.

ABSTRACT

BACKGROUND: The numbers of Helicobacter pylori (HP)-infected individuals and deaths due to gastric cancer are decreasing in Japan. We aimed to determine whether the serological test for chronic gastritis (the ABC method) is still useful for gastric cancer risk stratification in the 2010s and to analyze risk factors for developing gastric cancer in Japan.

METHODS: In this prospective study, we monitored 20773 individuals for the incidence of gastric cancer from 2010 to 2019. The relationships between blood sampling results, physical examination, and lifestyle in 2010 and the cumulative incidence of gastric cancer were analyzed.

RESULTS: A total of 19343 participants who met the study criteria were analyzed. Overall, 0.08% of participants in group A (9/11717), 0.63% in group B (28/4452), 2.05% in group C (43/2098), 1.52% in group D (1/66), and 0.30% in group E (3/1010) developed gastric cancer. Cox hazard analysis showed that age ≥ 50 years; groups B, C, and D according to the ABC method; and current smoking habits were independent risk factors for gastric cancer. The hazard ratios (HRs) of the incidence of gastric cancer were 6.7 in group B and 21.7 in groups C and D, while the HRs of group E was 2.8, which was not significantly different from that of group A. The incidence of gastric cancer was not statistically significantly different between those with and without successful HP eradication in groups B, C, and D during follow-up.

CONCLUSIONS: The ABC method was still useful for gastric cancer risk stratification in the 2010s.

PMID:35067826 | DOI:10.1007/s10120-021-01273-7

J Egypt Natl Canc Inst. 2022 Jan 24;34(1):4. doi: 10.1186/s43046-022-00105-8.

ABSTRACT

BACKGROUND: Ear keloids are abnormal continuously growing healing process following cutaneous injury. Surgical excision is the standard treatment strategy; however, 50-80% of cases develop recurrence. Adjuvant radiotherapy (RT) is commonly offered with a marked decrease in the recurrence rate. The variation in RT protocols used in different studies leads to a bias of results analysis. The aim is to present our experience of using surgical excision with postoperative radiotherapy for recurrent ear keloids. Also, studying different variables especially dose and keloid size that affects recurrence rate. Radiotherapy complications were reported and assessed.

PATIENTS AND METHODS: Keloids between 2006 and 2021 were retrospectively reviewed. Fifty-five ear keloids out of 83 cases who received RT after surgical excision were included in the study. Different dose regimens including 13 Gy/1fx, 8 Gy/1fx, 10 Gy/2fx, 15 Gy/3fx, and other fractionated regimens were used. The Median follow-up period was 35 months. Recurrence-free rate (RFR), side effects, and prognostic factors were assessed.

RESULTS: The overall 2-year RFR was 88 ± 5%. The 2-year RFR was 83 ± 8% for dose regimens with biological effective dose (BED) ≤ 40 and 92 ± 5% for regimens with BED > 40 Gy with an insignificant p value. The 2-year RFR was 74 ± 10% compared to 97 ± 3% for keloids > 2 cm and keloids ≤ 2 cm respectively (p value 0.02). The higher dose used for keloids with > 2 cm size significantly improved RFR. The orthovoltage therapy showed marginally better 2-year RFR compared to electron beam therapy; however, statistically insignificant (p value 0.09). The side effects were minimal with no reported second malignancy or serious G3-4 complications.

CONCLUSION: Excision followed by RT is a safe and effective treatment for recurrent ear keloids. Low and modest radiation doses are effective; however, a higher dose is recommended for keloids > 2 cm. We recommend a prospective larger-scale study to test the effect of dose and keloid size on the treatment results.

PMID:35067821 | DOI:10.1186/s43046-022-00105-8

Lasers Med Sci. 2022 Jan 24. doi: 10.1007/s10103-021-03474-z. Online ahead of print.

ABSTRACT

Stress urinary incontinence (SUI) is a common health problem that affects roughly 35% of women in the reproductive period. A prospective uncontrolled study was conducted to assess the long-term efficacy and safety of a non-ablative Er:YAG laser treatment of SUI. Forty-three patients participated in the study. All women underwent three sessions of IncontiLase® procedure, and efficacy of laser treatment was assessed by 1-h pad test, 24-h pad test, 3-day voiding diary, and ICIQ-UI SF questionnaire at multiple follow-ups. Statistical analysis was performed using one-way repeated measures ANOVA. Patients were questioned about discomfort during treatment and any adverse events following the laser procedures. All outcome measures showed a significant change over a period of the entire clinical trial. Eighteen-month follow-up revealed a fading of the effect, which was alleviated by single-session maintenance treatments every 6 months. There were no serious adverse events reported during the study. All reported side effects were mild and transient. The application of non-ablative Er:YAG laser for SUI treatment significantly improves the SUI symptoms. High improvement rates and patient satisfaction can be maintained with single-session maintenance treatments performed every 6 months. Long-term safety profile of multiple non-ablative Er:YAG laser treatment is shown. NCT04348994, 16.04.2020, retrospectively registered.

PMID:35067817 | DOI:10.1007/s10103-021-03474-z

Clin Oral Investig. 2022 Jan 24. doi: 10.1007/s00784-021-04348-y. Online ahead of print.

ABSTRACT

OBJECTIVES: The purpose of this in vitro study was to investigate the effects of various surface treatment methods on the shear bond strength of self-adhesive resin cement to polymer-infiltrated materials.

MATERIALS AND METHODS: One hundred twenty-eight polymer-infiltrated specimens (n = 32) for four different computer aided design-computer-aided manufacturing (CAD-CAM) materials, polyether ether ketone (PEEK) (PE), polyether ketone ketone (PEKK) (PK), composite resin nanoceramic (Cerasmart) (CS), and polymer-infiltrated ceramic network (PICN) (VITA ENAMIC) (VE) were milled from CAD-CAM blocks. They were divided into two groups (n = 16) in terms of surface treatments: airborne-particle abraded (AA) or silica-coated (SC) and two subgroups (n = 8) according to adhesive application or no adhesive. The surface roughness, contact angle, and shear bond strength (SBS) values of specimens were measured. Data were analyzed with Shapiro-Wilk test, the generalized linear models’ method, and Bonferroni corrected t test (α ˂ 0.05).

RESULTS: No statistically significant differences were found between the groups in terms of surface roughness and SBS values (P > 0.05). A statistically significant effect of the main adhesive interaction on the bond strength was found independent of the material and surface treatments (P < 0.001). While the average bond strength of the non-adhesive was 4.9 MPa, the average of the adhesive applied was 9.1 MPa. On the other hand, there is a statistically significant difference between the means of the contact angle values (P ˂ 0.001). While the highest mean contact angle value was 117.1 ± 14.8° obtained from the non-adhesive PK in the AA group, the lowest mean contact angle value 22.6 ± 4.3° was obtained from the VE without adhesive in the SC group.

CONCLUSIONS: Roughness and SBS values were similar between groups after surface treatments. Adhesive application increased the SBS values. Surface treatments were found to have an effect on the contact angle.

CLINICAL RELEVANCE: Since the AA and SC surface treatments used in the study show similar bond strength values, the Cojet system, which is more practical and easier to use, can be preferred as an alternative to AA after restoration production with CAD-CAM as a chairside.

PMID:35067779 | DOI:10.1007/s00784-021-04348-y

Ann Surg Oncol. 2022 Jan 23. doi: 10.1245/s10434-021-11158-9. Online ahead of print.

ABSTRACT

BACKGROUND: This study compared survival between patients who had medullary thyroid cancer (MTC) treated with surgery alone and patients who underwent surgery and radiation (SRT).

METHODS: Patients from the National Cancer Database (NCDB) with a diagnosis of stage 3 or 4 MTC, lymph node disease, and no distant metastases between 2008 and 2016 were studied. Kaplan-Meier analyses and log-rank statistics were used to estimate and compare overall survival between patients treated with surgery alone and those treated with SRT. Mutlivariable Cox proportional hazards models and propensity-matching were used to adjust for confounding and selection bias.

RESULTS: Among 1370 patients, 1112 (81%) received surgery alone, and 258 (19%) received SRT. The hazard ratio for mortality in the SRT group was 1.784 (95% confidence interval [CI] 1.313-2.43) after multivariable adjustment for confounding variables. Furthermore, SRT remained associated with a higher mortality rate (p < 0.008) after propensity-matching in an effort to adjust for selection bias.

CONCLUSIONS: This analysis of NCDB patients showed that SRT is associated with a significantly higher mortality rate among patients treated for stage 3 or 4 IV MTC with positive lymph node disease. Although this observation can be attributed to unmeasured confounders or selection bias, the cause for the profound survival differences deserves prospective evaluation, especially as adjuvant therapies for this disease continue to evolve.

PMID:35067791 | DOI:10.1245/s10434-021-11158-9

Vet Comp Oncol. 2022 Jan 23. doi: 10.1111/vco.12802. Online ahead of print.

ABSTRACT

The human grading system is currently applied to canine meningioma, although it has not been validated in dogs. The present study focused on standardizing the human grading system applied to canine meningioma. Four veterinary neuropathologists graded 186 canine meningiomas as follows: grade I tumor, with <4 mitoses/2.37 mm² ; grade II tumor, with ≥4 mitoses/2.37 mm² , brain invasion or at least 3 of the following criteria: sheeting architecture, hypercellularity, small cells, macronucleoli, necrosis; grade III tumor, with ≥20 mitoses/2.37 mm² or anaplasia. Slides with grading disagreement were reviewed to define a consensus diagnosis and to assess reproducible criteria. Concordance between histologic grade and the consensus diagnosis, as well as intra- and inter-observer agreements for each criterion, were statistically analyzed. Concordance between histologic grade and consensus diagnosis ranged from 59% to 100%, with lower concordance for grade I and II tumors. The lowest inter-observer agreement was recorded for macronucleoli, small cells, hypercellularity and sheeting architecture. Tumor invasion and necrosis displayed fair agreement, while moderate agreement was reached for mitotic grade and anaplasia. The following recommendations were issued to improve reproducibility of canine meningioma grading: 1. Assess mitotic grade in consecutive HPFs within the most mitotically active area; 2. Define invasion as neoplastic protrusions within central nervous tissue without pial lining; 3. Report spontaneous necrosis; 4. Report prominent nucleoli when visible at 100x; 5. Report pattern loss when visible at 100x in > 50% of the tumor; 6. Report necrosis, small cells, hypercellularity and macronucleoli, even when focal; 7. Report anaplasia if multifocal. This article is protected by copyright. All rights reserved.

PMID:35066998 | DOI:10.1111/vco.12802

J Cosmet Dermatol. 2022 Jan 23. doi: 10.1111/jocd.14765. Online ahead of print.

ABSTRACT

BACKGROUND: Epidermal growth factor (EGF) may promote wound healing and decrease laser-induced postinflammatory hyperpigmentation (PIH).

OBJECTIVES: To evaluate the effectiveness of an EGF-containing cream on PIH, post-laser erythema, and transepidermal water loss (TEWL) after 1,064-nm Q-Switched Nd: YAG laser treatment of Hori’s nevus.

METHODS: This is a split-face, double-blinded, randomized, controlled study conducted in 30 subjects with bilateral Hori’s nevus. After laser treatment, participants were randomized to apply EGF cream on one facial side and placebo on the other side for 8 weeks. The incidence and intensity of PIH were assessed by photographs and melanin indexes (MIs) ratio at baseline, Week 2, Week 4, and Week 8. Post-laser erythema and TEWL were measured at baseline, Day 1, Day 3, and Day 7. Side effects and patient satisfaction score were evaluated.

RESULTS: The incidence of PIH was 26.7% in EGF group compared to 20% in placebo. The intensity of PIH was 0.057 (0.033-0.086) and 0.045 (0.027-0.076) in EGF and placebo group, respectively. There was no significant difference in both incidence (p = 0.5) and intensity of PIH (p = 0.145). Post-laser erythema was not statistically different between groups. EGF could alleviate TEWL better than placebo but without statistical significance. Patient satisfaction score was significantly higher in EGF group compared to placebo (p < 0.001).

CONCLUSIONS: The EGF-containing cream could not prevent PIH. It may reduce laser-induced skin barrier damage. Future studies in more subjects are needed.

PMID:35066982 | DOI:10.1111/jocd.14765

Catheter Cardiovasc Interv. 2022 Jan 23. doi: 10.1002/ccd.30088. Online ahead of print.

ABSTRACT

OBJECTIVES: Vascular access site complications increase morbidity and mortality in transcatheter aortic valve replacement (TAVR).

BACKGROUND: Medtronic’s EnVeo PRO® low-profile sheath concept and Edwards’ expandable eSheath® aim to lower vascular trauma and access site complications. This study aims to compare Valve Academic Research Consortium (VARC)-3 defined access-related vascular complications using the two different transcatheter heart valve (THV) delivery concepts.

METHODS: We performed a retrospective, propensity-matched study to compare access site vascular complications in 756 consecutive patients who underwent a transfemoral TAVR using a Medtronic Evolut-R®/Evolut-PRO® or an Edwards Sapien3®/Sapien3ultra® THV.

RESULTS: Propensity score matching resulted in 275 patient pairs. The primary endpoint of major VARC-3 vascular complication was 7.6% in the Medtronic group and 12.7% in the Edwards group (p = 0.066). Minor VARC-3 vascular complications were 9.1% and 8%, respectively (p = 0.76). VARC-3 bleeding complications (8.4% vs. 12.7%, p = 0.129) length of hospital stay (7.6 + 5.4 vs. 7.5 + 3.7 days, p = 0.783) and in-hospital mortality (1.1% vs. 0.4%, p = 0.624) were comparable between both groups.

CONCLUSIONS: In a propensity-matched TAVR population, patients treated with the integrated sheath showed a trend towards fewer major vascular complications than patients treated with an expandable sheath, however, the difference was not statistically significant.

PMID:35066980 | DOI:10.1002/ccd.30088

Eur J Cancer Care (Engl). 2022 Jan 23:e13550. doi: 10.1111/ecc.13550. Online ahead of print.

ABSTRACT

OBJECTIVE: The aim of the research was to determine the effect of education given to the women with hearing impairments on the behaviours of Pap smear test.

METHODS: This study was a controlled trial study with longitudinal design. The sample consisted of 156 women (intervention = 78, control = 78) who registered in hearing-impaired associations in Izmir, Turkey. The education about cervical cancer and Pap smear test was given to intervention group with face-to-face interviews by using Turkish sign language. Three months later, the women were contacted and asked whether they have had a Pap smear test, and the total knowledge score of intervention groups was evaluated.

RESULTS: There was not a statistically significant difference between the mean total score of knowledge about cervical cancer and Pap smear test in intervention (0.6 ± 1.6) and control (1.1 ± 1.9) groups. After 3 months, having a Pap smear test was found to be statistically significantly higher between groups (intervention = 29.5%, control = %1.2), and the mean cervical cancer and Pap smear knowledge score of the intervention group (9.2 ± 1.4) was found to be statistically significantly higher than the score before education (0.6 ± 1.6).

CONCLUSION: Education of cervical cancer and Pap smear test increased knowledge level and behaviour of Pap smear test of the women.

PMID:35066957 | DOI:10.1111/ecc.13550