Category: Statistics

Clin Breast Cancer. 2021 Mar 17:S1526-8209(21)00059-8. doi: 10.1016/j.clbc.2021.03.004. Online ahead of print.

ABSTRACT

Women with early-stage breast cancer have an excellent prognosis with current therapy, but could presumably be treated less invasively, without the need for surgery. The primary goal of this meta-analysis was to examine whether thermal ablation is an effective method to treat early-stage breast cancer. Studies reporting on complete ablation rate after thermal ablation as a treatment of small breast cancers (≤ 2 cm) were included. Methodologic quality of included studies was assessed using MINORS criteria. Complete ablation rates are given as proportions, and meta-regression and subgroup analyses were performed. The overall complete ablation rate in 1266 patients was 86% and was highest after radiofrequency ablation (RFA) (92%). Local recurrence rates varied from 0% to 3%, with a median follow-up of 15 to 61 months. Overall, complication rates were low (5%-18% across techniques) and were highest after high-intensity focused ultrasound ablation and lowest after cryoablation. Cosmetic outcome was good to excellent in at least 85% of patients but was reported infrequently and long-term results of cosmetic outcome after thermal ablation and radiotherapy are still lacking. Thermal ablation techniques treating early-stage breast cancer (≤ 2 cm) are safe and effective based on complete ablation rate and short-term local recurrence rates. Especially, RFA, microwave ablation, and cryoablation are promising techniques as an alternative to surgical resection without jeopardizing current treatment effectiveness or safety. Owing to great heterogeneity in the included studies, a formal recommendation on the best technique is not possible. These findings warrant the design of large randomized controlled trials comparing thermal ablation and breast-conserving surgery in the treatment of T1 breast cancer.

PMID:33840627 | DOI:10.1016/j.clbc.2021.03.004

Brachytherapy. 2021 Apr 8:S1538-4721(21)00045-3. doi: 10.1016/j.brachy.2021.02.008. Online ahead of print.

ABSTRACT

PURPOSE: To determine if Live Implant Dosimetry (LIDO) utilizing intraoperative transrectal ultrasound (TRUS) is equivalent to postimplant CT dosimetry (either day 0 or day 30) in patients with localized prostate cancer (PC) treated with low dose rate (LDR) prostate seed brachytherapy.

METHODS AND MATERIALS: The treated population consisted of 628 men with localized (T1-T2) PC. All d’Amico risk categories (low, intermediate, and high) were included, and 437 patients were treated with monotherapy (160 Gy) [low and low tier intermediate], and the remainder (191) [high tier intermediate and high risk] with an implant boost (106 Gy) post external beam radiation, to a volume including the prostate and seminal vesicles (46 Gy). LIDO with intraoperative TRUS, postimplant CT (day 0 and day 30) were performed in all cases. Prostate volumes (V), V₁₀₀ (prostate) and dose (D) D₉₀ (prostate), D₃₀ (urethra), and Rectum D_2cc, were recorded. No urinary catheter was used on Day 30 CT.

RESULTS: More than 91.33% of monotherapy patients reached the target D₉₀ according to LIDO while only 82.99% of Day 0 CT and 92.82% of Day 30 CT achieved target D₉₀. When considering V₁₀₀, monotherapy patients recorded target dosimetry in 90.93%, 82.31%, and 92.02% of cases assessed by LIDO, Day 0 CT and Day 30 CT, respectively. Strong correlations are observed in D₉₀, Rectum D_2cc and Urethra D₃₀ across imaging modalities but V₁₀₀ and V₁₅₀ were poorly correlated due to the relative quantification of this parameter and high degree of error in measurement. Of all monotherapy patients with satisfactory dosimetry on LIDO, 94.82% reached target D₉₀ at day 30 CT and 94.19% reached target V₁₀₀.

CONCLUSIONS: LIDO and CT are both effective tools for assessing postimplant dosimetry. Patients with satisfactory LIDO dosimetry are highly likely to have equivalent dosimetry on CT at follow-up, indicating that postimplant CT may be eliminated in PC a patients implanted with this technique.

PMID:33840634 | DOI:10.1016/j.brachy.2021.02.008

J Prosthodont Res. 2021 Apr 9. doi: 10.2186/jpr.JPR_D_20_00306. Online ahead of print.

ABSTRACT

PURPOSE: The purpose of this study was to evaluate the long-term color stability of light-polymerized resin luting agents stored in different beverages.

METHODS: Eleven shades of two light-polymerized resin luting agents, Choice2 (A1, A2, B1, TRANSLUCENT, MILKY OPAQUE, and MILKY BRIGHT) and BeautiCem Veneer (H-Value, M-Value, L-Value, Ivory-D, Ivory-L) were selected in this study. Disk-shaped specimens were fabricated with 1.3 mm thickness and 15.0 mm diameter. A total of 198 specimens, 18 for each shade, were prepared and randomly divided into six storage conditions (purified water, coffee, cola, tea, red wine, and air). All shades of specimens were three times measured at three random locations (n = 9) at 24 h storage in air after specimen preparation and then measured after immersion at 1, 3, 6, 9, and 12 mos. using a colorimeter. Then, the color difference (ΔE) between the specimens at 24 h after preparation and after storage in each liquid for 12 mos. was calculated. Statistical analysis was performed using Steele-Dwass multiple comparison test of the ΔE values or one-way ANOVA and Tukey’s honest significant difference test.

RESULTS: For all immersion conditions, ΔE was significantly higher than air (control). The ΔE of the shades in the various storage conditions showed no significant difference between Purified Water-Cola and Coffee-Tea. Comparisons of the color components L*, a*, and b* for each shade showed different behaviors among the shades.

CONCLUSIONS: The results suggest that the color stability of light-polymerized resin luting agents may differ between different shades and beverages.

PMID:33840707 | DOI:10.2186/jpr.JPR_D_20_00306

J Orthop Trauma. 2021 Apr 5. doi: 10.1097/BOT.0000000000002135. Online ahead of print.

ABSTRACT

OBJECTIVES: To identify the incidence of distal articular fractures in a series of distal third tibia shaft fractures and to report the utility of both computed tomography (CT) scans and RIDEFAST ratios5 for identification of articular involvement.

DESIGN: Retrospective cohort.

SETTING: Level 1 trauma center.

PATIENTS: 417 distal third tibia shaft fractures.

INTERVENTION: Intramedullary nail or plate fixation.

MAIN OUTCOME MEASURES: Type of articular fracture, time of diagnosis, and RIDEFAST ratios.

RESULTS: 101 of the 417 distal third fractures (24%) had a fracture of the distal tibia articular surface. Of these 101 fractures, 41 (41%) represented an extension of the primary fracture line and 60 (59%) were separate malleolar fractures. 95 of the 101 articular fractures (94%) were identified preoperatively, and 6 were identified intra-operatively (6%). Of the 95 fractures identified preoperatively, 87 (92%) were identified on plain radiographs and 8 (8%) by CT scan. 35 preoperative CT scans were performed on distal third tibia shaft fractures in search of an intra-articular fracture. In 27 patients (77%), no articular fracture was present, representing an overall yield of 23% among CT scans performed to rule out an articular fracture in distal third tibia shaft fractures. RIDEFAST ratios for all 101 distal tibia shaft fractures with articular involvement and 100 fractures with no articular involvement were not significantly different (p>0.05) using both coronal and sagittal plane measurements.

CONCLUSIONS: CT scans performed on distal third tibia shaft fractures in search of articular fractures had a low yield (23%). Widespread use of CT scan to diagnose fractures of the distal tibia articular surface in the setting of distal tibia shaft fractures does not appear warranted. We found no statistically significant differences in RIDEFAST ratios between fractures with and without articular involvement, indicating that more work is necessary before RIDEFAST can be used to reliably rule out articular involvement in this setting.

LEVEL OF EVIDENCE: Diagnostic Level III. See Instructions for Authors for a complete description of levels of evidence.

PMID:33840735 | DOI:10.1097/BOT.0000000000002135

Braz J Phys Ther. 2021 Mar 26:S1413-3555(21)00024-1. doi: 10.1016/j.bjpt.2021.03.001. Online ahead of print.

ABSTRACT

BACKGROUND: Neuromuscular electrical stimulation (NMES) is an important therapeutic tool for rehabilitation. However, best stimulation parameters remain to be determined.

OBJECTIVE: To determine the influence of different electrical stimulation currents and phase durations on torque, efficiency, and discomfort.

METHODS: Using a cross-over design, kHz frequency alternating currents (KFAC) and pulsed currents (PC) with narrow (200 µs) or wide (500 µs) phase durations were randomly applied on knee extensor muscles of healthy participants with a minimum of seven days between sessions. The NMES-evoked torque, NMES-efficiency, and discomfort (visual 0-10 cm analogue scale) were measured for each stimulation intensity increments (10 mA). Statistics were conducted using a three-way analysis of variances (phase duration x current x intensity), followed by Tukey post-hoc.

RESULTS: Twenty-four males (age 22.3 ± 3.5years) were included. No effect of NMES current was observed for torque, efficiency, and discomfort. For wide phase durations (500 µs), torque significantly increased for all stimulation intensities. For narrow phase durations (200 µs) evoked torque significantly increased only after 40% of maximal stimulation intensity. Phase durations of 500 µs produced greater torque than 200 µs. Discomfort was greater with 500 µs when compared to 200 µs. Submaximal relative torque, for example 40% of maximum voluntary contraction (MVC), was obtained with ∼ 60% and ∼ 80% of the maximal current intensity for 500 µs and 200 µs, respectively.

CONCLUSION: KFAC and PC current applied with the same phase duration induced similar relative submaximal and maximum evoked-torque, efficiency, and perceived discomfort. However, currents with 500 µs induced higher evoked-torque, current efficiency, and perceived discomfort.

PMID:33840592 | DOI:10.1016/j.bjpt.2021.03.001

Acad Radiol. 2021 Apr 8:S1076-6332(21)00103-3. doi: 10.1016/j.acra.2021.03.005. Online ahead of print.

ABSTRACT

RATIONALE AND OBJECTIVES: Celiac plexus and retrocrural splanchnic nerve (CP/RSN) blocks are widely used for cancer-related abdominal pain, but there is limited literature on their efficacy for non-cancer related pain. Our aim was to determine the indications and effectiveness of CT-guided CP/RSN blocks performed on patients with abdominal pain from non-cancer related sources.

MATERIALS AND METHODS: CT-guided CP/RSN blocks for non-cancer related abdominal pain from 2011-2020 were retrospectively reviewed for patient demographics, procedure details, duration of pain relief, and complications. Effective blocks were defined as patient-reported pain relief or decrease in opioid use lasting 2 or more days for temporary blocks and 14 or more days for permanent blocks.

RESULTS: Of 72 CT-guided CP/RSN blocks for non-cancer related abdominal pain, 48 (67%) were effective for a mean of 51 days (median 14, range 2-700). Of the 18 permanent blocks, 9 (50%) were effective for a mean of 111 days (median 90, range 14-390). Of the 54 temporary blocks, 39 (72%) were effective for a mean of 37 days (median 9, range 2-700). Indications included postural orthostatic tachycardia syndrome/dysautonomia (77% effective, 20/26), pancreatitis (86% effective, 12/14), postsurgical pain (62% effective, 8/13), median arcuate ligament syndrome (70% effective, 7/10), chronic pain syndrome (20% effective, 1/5), gastroparesis (80% effective, 4/5), and renal cystic disease (33% effective, 1/3). For postural orthostatic tachycardia syndrome /dysautonomia, pancreatitis, post-surgical pain, and MALS, there were no statistically significant differences in effectiveness between celiac vs. splanchnic blocks in groups matched by indication and intended duration (temporary/permanent).

CONCLUSIONS: CT-guided CP/RSN blocks can effectively manage non-cancer related abdominal pain, though there is discrepancy in efficacy between temporary and permanent blocks.

PMID:33840601 | DOI:10.1016/j.acra.2021.03.005

J Arthroplasty. 2021 Mar 18:S0883-5403(21)00285-0. doi: 10.1016/j.arth.2021.03.035. Online ahead of print.

ABSTRACT

BACKGROUND: Vancomycin is often used as antimicrobial prophylaxis in patients undergoing total hip or knee arthroplasty. Vancomycin requires longer infusion times to avoid associated side effects. We hypothesized that vancomycin infusion is often started too late and that delayed infusion may predispose patients to increased rates of surgical site infections and prosthetic joint infections.

METHODS: We reviewed clinical data for all primary total hip arthroplasty (THA) and total knee arthroplasty (TKA) patients at our institution between 2013 and 2020 who received intravenous vancomycin as primary perioperative gram-positive antibiotic prophylaxis. We calculated duration of infusion before incision or tourniquet inflation, with a cutoff of 30 minutes defining adequate administration. Patients were divided into two groups: 1) appropriate administration and 2) incomplete administration. Surgical factors and quality outcomes were compared between groups.

RESULTS: We reviewed 1047 primary THA and TKA patients (524 THAs and 523 TKAs). The indication for intravenous vancomycin usage was allergy (61%), methicillin-resistant staphylococcus aureus colonization (17%), both allergy and colonization (14%), and other (8%). 50.4% of patients began infusion >30 minutes preoperatively (group A), and 49.6% began infusion <30 minutes preoperatively (group B). Group B had significantly higher rates of readmissions for infectious causes (3.6 vs 1.3%, P = .017). This included a statistically significant increase in confirmed prosthetic joint infections (2.2% vs 0.6%, P = .023). Regression analysis confirmed <30 minutes of vancomycin infusion as an independent risk factor for PJI when controlling for comorbidities (OR 5.22, P = .012).

CONCLUSION: Late infusion of vancomycin is common and associated with increased rates of infectious causes for readmission and PJI. Preoperative protocols should be created to ensure appropriate vancomycin administration when indicated.

PMID:33840539 | DOI:10.1016/j.arth.2021.03.035

Foot Ankle Surg. 2021 Apr 1:S1268-7731(21)00077-1. doi: 10.1016/j.fas.2021.03.024. Online ahead of print.

ABSTRACT

BACKGROUND: The main goal of the surgical correction of the hallux valgus is the morphological correction associated with the functional rebalancing of the first ray. The aim of this triple-blinded, randomized controlled study was to show the efficacy of piezosurgery in performing distal linear osteotomy of the first metatarsal bone in HV correction, in terms of clinical and radiological outcomes at 1-year final follow up.

METHODS AND MATERIALS: This study was performed collecting prospectively pre-operative and post-operative data for all patients. 34 patients were included in the trial and were randomly allocated (1:1) in a Piezoelectric Group (PG) that involved the use of piezoelectric tools and in a Control Group (CG) that provided for the use of a traditional oscillating saw. In both groups, all patients were treated with a distal linear osteotomy of the first metatarsal bone. Clinical and radiographic assessments were performed.

RESULTS: The AOFAS score between the two groups was similar pre-operatively and during the follow-up period, with a slight superiority in the PG at each evaluation. The osteotomy surgical time was registered for both groups. Among the endpoints of the study, the radiological bone healing time was independently assessed by a radiologist that reported a lower mean value in the piezoelectric group compared with the control group.

CONCLUSIONS: This trial has shown that piezoelectric surgery is not inferior to traditional methods from the clinical-functional point of view, but can even lead to an evident reduction of bone healing time with a statistical significance.

LEVEL OF EVIDENCE: Level I.

PMID:33840570 | DOI:10.1016/j.fas.2021.03.024

Cont Lens Anterior Eye. 2021 Apr 8:101438. doi: 10.1016/j.clae.2021.03.005. Online ahead of print.

ABSTRACT

PURPOSE: To evaluate the ocular surface at the microstructural level of adults who habitually undertake indoor-suntanning utilising in vivo confocal microscopy.

METHODS: Participants were prospectively recruited and enrolled into either а study group (n = 75) with a history UV indoor tanning, or a control group (n = 75) with no prior history of artificial tanning. The study group participated in voluntary tanning sessions performed with standard equipment and maintained their usual routine for eye protection. Slit lamp biomicroscopy and in vivo confocal microscopy were performed at baseline before undertaking a series of suntanning sessions (10 sessions of 10 min duration over a 15 day period), within three days after the last session, and four weeks after the last session. Control group participants were examined at baseline and 8 weeks later and did not participate in tanning sessions.

RESULTS: All participants were female with a mean age of 25 ± 4 years and 24 ± 4 years in the study and control groups, respectively. No clinically significant changes were observed in either group over time using slit lamp biomicroscopy (all p ≥ 0.05), however, statistically significant differences were observed between the study and the control group for all corneal layers imaged using confocal microscopy (all p ≤ 0.03). Characteristic cystic conjunctival lesions with dark centres and bright borders were observed in 95% of the study group before and in 100% after the suntanning sessions.

CONCLUSION: Indoor suntanning resulted in statistically significant microstructural changes in the cornea and the bulbar conjunctiva that are undetectable with slit lamp biomicroscopy.

PMID:33840575 | DOI:10.1016/j.clae.2021.03.005

J Arthroplasty. 2021 Mar 19:S0883-5403(21)00287-4. doi: 10.1016/j.arth.2021.03.037. Online ahead of print.

ABSTRACT

BACKGROUND: The aim of the study was to investigate changes in patient-reported outcome measures (PROMs) after revision total knee arthroplasty (rTKA).

METHODS: A total of 10,727 patients undergoing elective rTKA were recruited from the UK National Health Service PROMs data set from 2013 to 2019. PROMs were collected at baseline and six months to assess joint function (Oxford Knee Score, OKS) and quality of life (EQ-5D). Associations with a change in the OKS (COKS) were investigated through multiple linear regression.

RESULTS: The mean COKS was 12.4 (standard deviation 10.7) points. A total of 6776 of 10,329 (65.6%) patients demonstrated increase in the OKS above the minimal important change of 7.5 points. The median change in the EQ-5D utility was 0.227 (interquartile range 0.000 to 0.554). A total of 4917 of 9279 (53.0%) patients achieved a composite endpoint of improvement greater than the minimal important change for joint function and ‘better’ QoL as per the Paretian analysis. A total of 7477 of 10,727 (69.7%) patients reported satisfaction with rTKA. A total of 7947 of 10,727 (74.1%) patients felt surgery was a success. A total of 4888 of 10,632 (46.0%) patients reported one or more adverse events. A higher preoperative OKS was associated with a lower COKS (coefficient -0.63 [95% confidence interval -0.67 to -0.60]). Other factors associated with a lower COKS were postoperative complication(s), age under 60 years, longer duration of knee problems, patients who identified as disabled, problems in EQ-5D dimensions of anxiety/depression and self-care, comorbid conditions (circulatory problems, diabetes, and depression), and earlier year of procedure in the data set.

CONCLUSION: Two-thirds of patients experienced a meaningful improvement in joint function after rTKA. However, there was a high frequency of patient-reported complications. These findings may enable better informed discussion of the risks and benefits of discretionary rTKA.

PMID:33840536 | DOI:10.1016/j.arth.2021.03.037