Category: Statistics

Eur Urol Oncol. 2023 Dec 23:S2588-9311(23)00290-0. doi: 10.1016/j.euo.2023.11.024. Online ahead of print.

ABSTRACT

BACKGROUND: In the HERO study, relugolix demonstrated sustained testosterone suppression superior to that of leuprolide acetate (97% vs 89%; difference 7.9% [95% confidence interval, 4.1-12%; p < 0.001]).

OBJECTIVE: To analyze testosterone recovery in a prespecified subset of men from the HERO study not indicated to continue androgen deprivation therapy.

DESIGN, SETTING, AND PARTICIPANTS: Men (N = 934) were randomized (2:1) to receive relugolix 120 mg orally daily or leuprolide acetate injections every 12 wk for 48 wk.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Testosterone recovery was assessed in 184 men who completed 48 wk of treatment. During the 90-d recovery period, assessments included time to testosterone recovery (>280 ng/dl; ≥80% of baseline testosterone), serum levels of prostate-specific antigen and pituitary hormones, and adverse events.

RESULTS AND LIMITATIONS: The cumulative incidence rate of testosterone recovery to >280 ng/dl at 90 d following drug discontinuation was significantly higher in the relugolix cohort (n = 137) than in the leuprolide acetate cohort (n = 47; 54% vs 3.2%; nominal p = 0.002). The median time to testosterone recovery was faster following relugolix treatment than with leuprolide acetate treatment (86.0 d vs 112.0 d). Compared with leuprolide acetate, more men treated with relugolix achieved ≥80% of baseline testosterone levels (39% vs 2.1%). Men ≤65 yr and those with baseline testosterone greater than the median had a higher incident rate of testosterone recovery. Adverse events were generally similar between treatment groups. One limitation is the short testosterone recovery follow-up period.

CONCLUSIONS: Oral relugolix had faster and more complete recovery of testosterone to normal levels after treatment discontinuation than leuprolide acetate in a subset of men from the HERO study. The clinical implications of a faster testosterone recovery with relugolix may be significant for men being treated with androgen deprivation therapy and influence treatment decisions.

PATIENT SUMMARY: The male hormone testosterone is reduced during androgen deprivation therapy for prostate cancer. Reduced testosterone levels cause side effects, impacting patient quality of life. When treatment is stopped, the side effects lessen over time as the levels of testosterone come back to pretreatment range (testosterone recovery). In this study, we found that the time to testosterone recovery was faster with relugolix than with leuprolide acetate.

PMID:38143206 | DOI:10.1016/j.euo.2023.11.024

J Voice. 2023 Dec 23:S0892-1997(23)00388-0. doi: 10.1016/j.jvoice.2023.12.004. Online ahead of print.

ABSTRACT

Electroglottography (EGG) is a technology developed for measuring the vocal fold contact area during human voice production. Although considered subjective and unreliable as a sole diagnostic method, with the correct application of relevant computational methods, it can constitute a most promising non-invasive voice disorder diagnostic tools in a form of a digital vocal tract pathology classifier. The aim of the following study is to gather and evaluate currently existing digital voice quality assessment systems and vocal tract abnormality classification systems that rely on the use of electroglottographic bio-impedance signals. To fully comprehend the findings of this review, first the subject of EGG is introduced. For that, we summarise most relevant existing research on EGG with a particular focus on its application in diagnostics. Then, we move on to the focal point of this work, which is describing and comparing the existing EGG-based digital voice pathology classification systems. With the application of PRISMA model, 13 articles were chosen and analysed in detail. Direct comparison between chosen studies brought us to pivotal conclusions, which have been described in Section 5 of this report. Meanwhile, certain limitations arising from the literature were identified, such as questionable understanding of the nature of EGG bio-impedance signals. The appropriate recommendations for future work were made, including the application of different methods for EGG feature extraction, as well as the need for continuous EGG datasets development containing signals gathered in various conditions and with different equipments.

PMID:38143204 | DOI:10.1016/j.jvoice.2023.12.004

Vaccine. 2023 Dec 23:S0264-410X(23)01488-3. doi: 10.1016/j.vaccine.2023.12.042. Online ahead of print.

ABSTRACT

BACKGROUND: Adults who are hesitant toward routinely recommended vaccines for adults may also be hesitant toward COVID-19 vaccines. However, the distribution and differences in hesitancy between routinely recommended vaccines and COVID-19 vaccines, and the association of hesitancy regarding routinely recommended vaccines and hesitancy with COVID-19 vaccination status and intent, is unknown.

METHODS: Using the Research and Development Survey (RANDS) during COVID-19, Round 3, a probability-sampled, nationally representative, web and phone survey fielded from May 17 – June 30, 2021 (n = 5,434), we examined the distribution and difference in prevalence of hesitancy towards COVID-19 and vaccines in general, beliefs associated with vaccine hesitancy, and factors impacting plans to be vaccinated against COVID-19.

RESULTS: Reported hesitancy towards COVID-19 vaccines (42.2%) was 6-percentage points higher than hesitancy towards vaccines in general (35.7%). Populations who were most hesitant toward COVID-19 vaccines were younger adults, non-Hispanic Black adults, adults with lower education or income, and adults who were associated with a religion. Beliefs in the social benefit and the importance of vaccination, and the belief that COVID-19 vaccines lower risk for infection, were strongly associated with COVID-19 vaccination and intent to be vaccinated.

CONCLUSIONS: Vaccine hesitancy for both COVID-19 vaccines and vaccines in general is common. Health providers and public health officials should utilize strategies to address vaccine hesitancy, including providing strong clear recommendations for needed vaccines, addressing safety and effectiveness concerns, and utilizing trusted messengers such as religious and community leaders to improve vaccine confidence.

PMID:38143200 | DOI:10.1016/j.vaccine.2023.12.042

HPB (Oxford). 2023 Dec 13:S1365-182X(23)02010-5. doi: 10.1016/j.hpb.2023.12.003. Online ahead of print.

ABSTRACT

BACKGROUND: The surgical decision making for pancreatic adenocarcinoma is complex. Although practice guidelines exist for many scenarios, these do not cover many common eventualities that may be encountered during these cases. We sought to identify the practice pattern variations amongst pancreatic surgeons in response to commonly experienced clinical scenarios.

METHODS: A multiple-choice questionnaire was distributed to all full members of the IHPBA. Participant demographics, training history, and clinical practice information were obtained. The survey provided various operative scenarios and participants were asked how they would likely proceed. Responses were collected and stored anonymously in a secure database. Statistical analysis was performed using Stata 16.0.

RESULTS: 164 responses were submitted. Most of the respondents were male and had been in practice for over 10 years. The median age range was 40-50 years old. When asked about staging laparoscopy, the majority performed it selectively. For most respondents a pathological aorto-caval nodes was a reason to abort the procedure but most would have continued in the setting of a positive hepatic artery node. When encountering a single Segment 2 liver metastasis, participants who practiced in Europe were significantly more likely to resect and proceed compared to those in Asia and North America. Participants who had undergone only a Surgical Oncology fellowship were most likely to abort. With respect to direct colonic invasion, most participants would resect the specimen en bloc. Respondents who participated in fewer that 20 PDAC operations/year were most likely to abort.

CONCLUSIONS: Surgical decision making in PDAC surgery is complex and there is significant disagreement on the correct management. While formal guidelines cannot exist for all situations, this survey highlights the need for consensus on commonly encountered operative scenarios.

PMID:38143165 | DOI:10.1016/j.hpb.2023.12.003

Brachytherapy. 2023 Dec 23:S1538-4721(23)01679-3. doi: 10.1016/j.brachy.2023.10.006. Online ahead of print.

ABSTRACT

PURPOSE: In low-dose-rate brachytherapy, iodine-125 seeds are implanted based on a treatment plan, generated with respect to different dose constraints. The quality of the dose distribution depends on a precise seed placement, however, during treatment planning the impact on the dose parameters when certain seeds fail to be placed precisely is not clear.

METHODS AND MATERIALS: We developed a method using automatic differentiation to calculate gradients of dose parameters with regard to the seeds’ positions. Thus, we understand their sensitivity with respect to the seed placement. A statistical analysis is performed on a data set with 35 prostate brachytherapy patients.

RESULTS: The most sensitive seeds regarding the dosimetric parameters of both rectum and urethra are close to the corresponding organ. Their gradient directions are mainly orthogonal to their surfaces. However, not all seeds close to the surface are equally sensitive with regard to the dose parameter. The most sensitive seeds regarding the prostate’s dose parameters are distributed throughout the prostate and the direction of the gradients are mainly parallel to its surface. A linear regression with respect to different patient parameters shows that dose constraints which are barely fulfilled have large gradients and thus are additionally sensitive to misplacement.

CONCLUSION: Automatic differentiation can be used to analyze dose parameter sensitivity with respect to seed placement. Integrating this into treatment planning systems is valuable as it speeds up the planning procedure, making it more robust and less dependent on user experience while showing the operating physician which needle placements require greater accuracy than others.

PMID:38143161 | DOI:10.1016/j.brachy.2023.10.006

J Craniomaxillofac Surg. 2023 Nov 28:S1010-5182(23)00233-0. doi: 10.1016/j.jcms.2023.11.005. Online ahead of print.

ABSTRACT

Temporomandibular joint (TMJ) surgery accounts for a significant number of patient episodes in oral and maxillofacial surgery, and treatment effectiveness is commonly assessed using measures of pain and mouth opening. Patient-reported outcome measures (PROMs) enable assessment of the patient’s perspective and perception of the diseases and treatment outcomes. The purpose of this review was to assess the use of PROMs in TMJ surgery. A review of 3 databases (PubMed, OVID, Trip) was carried out to assess the use of PROMs when reporting on TMJ surgical interventions. Studies were limited to the English language, involving humans and at least one surgical intervention of the TMJ. A total of 214 articles met the inclusion and exclusion criteria, of which only 28 used 18 PROMs among them. Half of these PROMs were single-question visual analogue scales or Likert scales on quality of life and disability. The Oral Health Impact Profile and the Helkimo Clinical Dysfunction Index were the second most used (n = 3). PROMs were used most in studies on internal derangement (n = 9) and in cohort study designs (n = 26), but this was not statistically significant. In the majority of research on TMJ surgery, no PROMs are used, and when one is, there is a tendency to use weaker single-question PROMs as opposed to multi-question PROMs to assess outcomes. With the increasing importance of PROMs for assessing patients’ perception of treatment outcomes, further research is needed to establish valid and reproducible PROMs for TMJ surgery.

PMID:38143160 | DOI:10.1016/j.jcms.2023.11.005

Injury. 2023 Nov;54 Suppl 6:110724. doi: 10.1016/j.injury.2023.04.011.

ABSTRACT

INTRODUCTION: hip fracture represents a global health problem, with a high morbidity and mortality rate and an increasing incidence. The treatment of trochanteric fractures is reduction and osteosynthesis, and implant selection depends mainly on the stability of the fracture and lateral wall competence. Lateral wall competence has gained relevance in recent years, which led to the modification of the AO/OTA classification. However, determination of lateral wall integrity is difficult from plain radiographs; the influence of images with traction on its measurement has not been evaluated.

METHODS: prospective concordance study, emergency and post-traction radiographs of 65 patients with trochanteric fracture were evaluated by six orthopedic surgeons independently, measuring the lateral wall, classifying the fracture according to the AO/OTA 2018 classification and selecting the implant for osteosynthesis. A comparison of incompetent to intact lateral wall proportion between each image set was made. Secondary outcomes were the inter-observer correlation of lateral wall measurement and inter-observer agreement of classification and implant choice.

RESULTS: the proportion of patients with an incompetent lateral wall in emergency x-ray was 37.43% (CI 95% 0.326-0.422), while the proportion in post-traction fluoroscopy was 15% (CI 95% 0.115-0.185), with a statistically significant difference (p < 0.001). 40.1% of patients with an incompetent lateral wall changed to an intact one. Inter-observer correlation for the lateral wall thickness was 0.399 (CI 95% 0.292-0.519) in emergency x-ray and 0.658 (CI 95% 0.564-0.748) in post-traction fluoroscopy, with a substantial agreement. Inter-observer agreement for the fracture classification was fair to moderate using emergency x-ray (κ 0.369 95%CI 0.330-0.408) and fair to moderate with post-traction fluoroscopy (κ 0.400, 95% CI 0.334-0.466).

CONCLUSION: traction images significantly change the measurement of the lateral wall in trochanteric fractures, changing from an incompetent to a competent wall in 40% of patients. The correct classification of trochanteric fractures is crucial to make the best decision when deciding which implant to use, and the measurement of the lateral wall is determinant in the actual AO/OTA classification. Therefore, traction images appear as necessary for correct decision-making.

PMID:38143142 | DOI:10.1016/j.injury.2023.04.011

Injury. 2023 Nov;54 Suppl 6:110857. doi: 10.1016/j.injury.2023.110857.

ABSTRACT

INTRODUCTION: Open Tibia fractures are associated with high rates of Fracture Related Infection (FRI). Given the negative outcomes and increased costs related to the latter, several prophylactic local antibiotic delivery methods have been proposed, aiming to decrease the FRI rate. Our objective with this study was to determine the effectiveness of antibiotic-coated intramedullary nails for open tibia FRI prevention.

PATIENTS AND METHODS: We conducted a PRISMA compliant systematic review and meta-analysis. Queries were performed on Embase, PubMed, Lilacs and Cochrane data libraries. Seventeen studies were included for qualitative analysis and 2 studies were amenable for meta-analysis.

RESULTS: Global infection, deep infection and non-union rates were 8.4%, 5.4% and 3.7% in the antibiotic-coated nail group and 22%, 14% and 14% in the non-antibiotic-coated nail group respectively. The meta-analysis showed a protective trend that favored the antibiotic-coated nail group although it didn’t achieve statistical significance: deep infection Relative Risk (RR) (RR = 0.17 CI95% [0.02 – 1.31]); global infection RR = 0.36 CI95% [0.10 – 1.35]) and non-union (RR = 0.14 CI95% [0.02 – 1.22]), CONCLUSIONS: Our findings suggest a favorable trend towards antibiotic-coated nail, with decreased risk of global infection, deep infection and non-union as compared to non-antibiotic-coated nail in patients with open tibia fractures. Nonetheless, higher level evidence studies are required to confirm our findings.

PMID:38143139 | DOI:10.1016/j.injury.2023.110857

Injury. 2023 Nov;54 Suppl 6:110836. doi: 10.1016/j.injury.2023.05.067.

ABSTRACT

Fracture-related infection (FRI) is a common complication following open tibia fracture (OTF), especially in patients with high-energy trauma or comorbidities. The use of gentamicin-coated nail (GCN) has been proposed as a local adjuvant to prevent FRI in high-risk patients.

HYPOTHESIS: The incidence of FRI is expected to be lower in OTF treated with a GCN, alongside with no detrimental effects on fracture healing time.

OBJECTIVES: This study aimed to evaluate the effectiveness of GCNs as a definitive fixation method and prophylaxis for FRI in OTFs. Secondary outcomes included non-union rates and time to healing.

METHODS: The study design was a mixed cohort, including a prospective group of patients treated with GCN (Expert Tibial Nail PROtect™, Depuy Synthes, Johnson&Johnson Company Inc, New Jersey, USA) and a retrospectively evaluated group treated with non-gentamicin-coated nail (NGCN). Patients with at least 12 months of follow-up were included. The treatment protocol consisted of timely administration of antibiotics, surgical debridement, and early soft-tissue coverage. Exclusion criteria included protocol infringement, traumatic amputation, and loss of follow-up. Statistical analysis was performed using Stata v14.0, with a significance level of p < 0.05.

RESULTS: The study included 243 patients, 104 in GCN group and 139 NGCN group. External Fixator use was higher in the NGCN group, but this did not significantly affect the FRI rate. GCN use was associated with a significantly lower incidence of FRI (2.88% GCN group vs. 15.83% NGCN group, OR 0.16, p < 0.01). Furthermore, GCN use was found to be a protective factor against tibial non-union (OR 0.41, p = 0.03). There were no adverse effects attributed to locally administered gentamycin. The NGCN cohort had a higher incidence of polytrauma, although the difference was not statistically significant. A longer time to heal as well as more FRI and Non-union according to the progression in Gustilo-Anderson classification was observed in the GCN group.

CONCLUSION: Our findings suggest that GCN is an effective prophylactic method to reduce the risk of FRI in open tibial fractures at 12-month follow-up, as well as, probably derived from this protective effect, leading to lower fracture consolidation times when compared with cases treated without GCN.

PMID:38143136 | DOI:10.1016/j.injury.2023.05.067

Injury. 2023 Nov;54 Suppl 6:110806. doi: 10.1016/j.injury.2023.05.037.

ABSTRACT

Type I Young and Burgess anterior posterior compression (APC) pelvic injuries have been classically managed non operatively due to theoretical integrity of sacroiliac joint ligaments (SIJL), though examination under anesthesia (EUA) has been proven occult mechanical instability in up to 50% of these injuries. We sought to determine the diagnostic accuracy of magnetic resonance (MRI) for detection of occult instability on APC-I injuries when compared to EUA.

METHODS: Diagnostic test study of prospectively recruited patients admitted with APC-I pelvic injuries between 2015 and 2022. All patients consented to participate in this study were subjected to MRI and EUA. The evaluators of each of these tests were blinded. On MRI evaluation, SIJL were considered compromised when unilateral injury to anterior SIJL was visualized in three or more consecutive images or in bilateral injuries, when injury to the anterior SIJL in two or more consecutive images on each side was observed. Positive EUA was considered a symphyseal diastasis over 25 mm on stress fluoroscopy. Demographic data was collected as recruited and sensitivity, specificity, accuracy, and positive and negative predictive values were calculated. Confidence interval was set at 95%. EUA was considered the gold standard in statistical analysis.

RESULTS: A total of 32 patients mean aged 36 (24-61) years were included. Mean symphyseal diastasis at admission was 17.58 (11 – 25) mm. The median time from injury to EUA was 5 (0-21) days. Positive EUA was observed on 20 patients and 25 patients presented compromised SIJL. MRI presented a sensitivity of 95% (75.13% – 99.87%), specificity of 50% (21.09% – 78.91%), positive-predictive value of 73% (60.61% to 82.93%), negative-predictive value of 87% (48.66% – 98.08%).

CONCLUSION: Injury to SIJL on MRI presented an accuracy of 77% (58.29% – 89.64%) for the detection of occult pelvic instability on EUA.

PMID:38143131 | DOI:10.1016/j.injury.2023.05.037