Tag: statistics

Breast Cancer Res Treat. 2021 Aug 3. doi: 10.1007/s10549-021-06341-1. Online ahead of print.

ABSTRACT

PURPOSE: Studies that report equivalent oncologic outcomes of sentinel lymph node biopsy (SLNB) alone versus axillary lymph node dissection (ALND) for T1-2N1mi breast cancers are heavily weighted with patients who received breast-conserving surgery (BCS). The impact of omitting ALND in N1mi patients treated with mastectomy is not well studied. It is also unknown if these patients would benefit from post-mastectomy radiotherapy (PMRT). This study reports the outcomes of patients with T1-2N1mi breast cancer treated by mastectomy without axillary therapy.

METHODS: Patients who had T1-2N1mi breast cancer and underwent mastectomy from January 1998 to December 2018 were identified from our multi-institutional prospective database. Axillary recurrence rate (ARR), disease-free survival (DFS), and overall survival (OS) are reported.

RESULTS: 260 patients with pT1-2N1mi breast cancer who had mastectomy were identified. They had either SLNB (35.4%) or ALND (64.6%). Majority of these patients received adjuvant systemic therapy (93.8%). 77 (29.6%) patients received radiotherapy, 31 after SLNB and 46 after ALND. At median follow-up of 61 months, ARR was 1.1% (n = 1) in the SLNB only group, vs. 0.6% (n = 1) in the ALND group (p = 0.752). DFS and OS were not significantly different between patients with SLNB alone versus ALND (p = 0.40 and p = 0.27, respectively). Among 92 patients who had SLNB only, no DFS or OS difference was observed with the use of PMRT.

CONCLUSION: In T1-2N1mi patients with mastectomy and SLNB, axillary recurrences were rare. No statistically significant differences were noted between patients with SLNB, ALND, or PMRT. Our findings suggest that these patients may be safely treated without axillary therapy.

PMID:34342766 | DOI:10.1007/s10549-021-06341-1

Lasers Med Sci. 2021 Aug 3. doi: 10.1007/s10103-021-03391-1. Online ahead of print.

ABSTRACT

Conventional therapies have aimed to try to help individuals suffering with dentine hypersensitivity (DH/DHS). A relatively new approach, laser therapy claims to be beneficial while having immediate and long-lasting effect. Therefore, our analysis aims to explore the immediate and 1-month efficacy of near-infrared laser (NIR) therapy in treating dentinal hypersensitivity. A systematic literature search conducted in databases, and analysis was undertaken utilizing a meta-analysis approach. Randomized controlled clinical trials comparing near-infrared lasers and placebo/no treatment in patients (> 18 years) were included. The risk of bias for included studies was assessed using Cochrane RoB tool (for randomized studies). Random effects meta-analyses model of standardized mean differences and 95% confidence intervals were performed using RevMan 5.4 software. A comprehensive electronic and manual search yielded a total of 1081 potential articles. Following the implementation of the inclusion and exclusion criteria, a total of 6 studies were included in the analysis. Near-infrared laser therapy led to statistical significant reduction in immediate and 1-month follow-up VAS (visual analog scale) scores compared to placebo/no treatment (p < 0.05). Statistical heterogeneity across the studies was high (I²-96%). The findings suggest that near-infrared laser therapy does have a significant immediate effect in reducing dentine hypersensitivity compared to placebo/no treatment. Furthermore, this effect is not diminished and endured at 1-month follow-up.

PMID:34342772 | DOI:10.1007/s10103-021-03391-1

Eur J Orthop Surg Traumatol. 2021 Aug 3. doi: 10.1007/s00590-021-03058-1. Online ahead of print.

ABSTRACT

PURPOSE: Gastrocnemius flaps provide reliable reconstructive solutions to soft-tissue loss of the knee and proximal tibia following orthopedic procedures. While this technique has been used and studied, little is known about its prophylactic application. Single-stage and delayed approaches were compared with respect to the timing of débridement, complications, and relationship between microorganisms and complications.

METHODS: Gastrocnemius flaps for soft-tissue defects of the knee joint were retrospectively reviewed. Success of the flap procedure was defined as a healed soft-tissue envelope, no evidence of infection, a good blood supply to the flap, and adherence of the flap to its bed. Independent sample t test was used to compare the corresponding parameters (level of statistical significance was 0.05).

RESULTS: Of 43 flaps (43 patients), 18 were performed during a single-stage procedure along with the orthopedic procedure and 25 were delayed. Success of the single-stage (100%) and delayed flaps (88%) was not significantly different (p = 0.083). Complication rate did not differ significantly for single-stage (11%) and delayed flaps (24%) (p = 0.272). We were unable to establish a relationship between complications and microorganisms.

CONCLUSION: Results indicate both approaches are reliable. Single-stage gastrocnemius flaps may eliminate the need for a second surgery.

LEVEL OF EVIDENCE: Level III (Therapeutic, Retrospective cohort).

PMID:34342731 | DOI:10.1007/s00590-021-03058-1

Clin Rheumatol. 2021 Aug 3. doi: 10.1007/s10067-021-05870-w. Online ahead of print.

ABSTRACT

INTRODUCTION/OBJECTIVE: Antineutrophil cytoplasmic antibodies (ANCA) serology can aid in the diagnosis and classification of ANCA-associated vasculitides (AAV). However, it is often ordered in patients without clinical manifestations of vasculitis. In this retrospective chart review, we aim to better understand the clinical practices on ANCA testing.

METHODS: We retrospectively reviewed patients’ charts for the indications and diagnostic outcomes of ANCA tests. All ANCA tests ordered at two Canadian hospitals (a community hospital and an academic tertiary hospital) between January and December 2016 were included in the study. Descriptive statistics are used.

RESULTS: A total of 302 ANCA tests were included. The majority (n = 198, 65.6%) were ordered without an indication for testing. For those patients with at least 1 clinical manifestation of AAV (n = 104), 25% were ANCA positive and 18.3% resulted in a diagnosis of AAV. In comparison, among those without a clinical manifestation of AAV (n = 198), only 1.5% were ANCA positive and none was diagnosed with AAV. All patients diagnosed with AAV had at least 1 indication for ANCA testing. The three most common clinical presentations in patients with a final diagnosis of AAV were glomerulonephritis (81.8%), pulmonary hemorrhage (45.5%), and multiple lung nodules (31.8%).

CONCLUSION: To our knowledge, this is the first study that evaluates patients with both positive and negative ANCA test results in an inpatient setting. We demonstrated a low rate of ANCA positivity and AAV diagnosis in patients without clinical manifestations of AAV. Overall, there is a high rate of ANCA testing without an indication at our academic institution. This over-testing may be curbed by strategies such as a gating policy, culture changes, and clinician education. Key Points • AAV is a clinical-pathological diagnosis, and despite the usefulness of ANCA testing, it does not confirm nor rule out AAV. • ANCA testing for the diagnosis of AAV is generally only indicated when there is a clear manifestation of AAV. • Although patients with AAV may occasionally present without classic signs and symptoms, the diagnostic utility of ANCA serology in this setting is low, and testing is more likely to result in a false-positive or false-negative test. • If clinical suspicion remains high despite negative ANCA testing, clinicians should seek consultation with a rheumatologist.

PMID:34342740 | DOI:10.1007/s10067-021-05870-w

Curr Oncol Rep. 2021 Aug 3;23(10):117. doi: 10.1007/s11912-021-01110-1.

ABSTRACT

PURPOSE OF REVIEW: This review aims to clarify the current role of minimally invasive surgery in the treatment of rectal cancer, highlighting short- and long-term outcomes from the latest trials and studies.

RECENT FINDINGS: Data from previous trials has been conflicting, with some failing to demonstrate non-inferiority of laparoscopic surgical resection of rectal cancer compared to an open approach and others demonstrating similar clinical outcomes. Robot-assisted surgery was thought to be a promising solution to the challenges faced by laparoscopic surgery, and even though the only randomized controlled trial to date comparing these two techniques did not show superiority of robot-assisted surgery over laparoscopy, more recent retrospective data suggests a statistically significant higher negative circumferential resection margin rate, decreased frequency of conversion to open, and less sexual and urinary complications. Minimally invasive surgery techniques for resection of rectal cancer, particularly robot-assisted, offer clear short-term peri-operative benefits over an open approach; however, current data has yet to display non-inferiority in terms of oncological outcomes.

PMID:34342706 | DOI:10.1007/s11912-021-01110-1

Acta Neurochir (Wien). 2021 Aug 3. doi: 10.1007/s00701-021-04931-y. Online ahead of print.

ABSTRACT

BACKGROUND: In the aging society, many patients with movement disorders, pain syndromes, or psychiatric disorders who are candidates for deep brain stimulation (DBS) surgery suffer also from cardiovascular co-morbidities that require chronic antiplatelet or anticoagulation treatment. Because of a presumed increased risk of intracranial hemorrhage during or after surgery and limited knowledge about perioperative management, chronic antiplatelet or anticoagulation treatment often has been considered a relative contraindication for DBS. Here, we evaluate whether or not there is an increased risk for intracranial hemorrhage or thromboembolic complications in patients on chronic treatment (paused for surgery or bridged with subcutaneous heparin) as compared to those without.

METHODS: Out of a series of 465 patients undergoing functional stereotactic neurosurgery, 34 patients were identified who were on chronic treatment before and after receiving DBS. In patients with antiplatelet treatment, medication was stopped in the perioperative period. In patients with vitamin K antagonists or novel oral anticoagulants (NOACs), heparin was used for bridging. All patients had postoperative stereotactic CT scans, and were followed up for 1 year after surgery.

RESULTS: In patients on chronic antiplatelet or anticoagulation treatment, intracranial hemorrhage occurred in 2/34 (5.9%) DBS surgeries, whereas the rate of intracranial hemorrhage was 15/431 (3.5%) in those without, which was statistically not significant. Implantable pulse generator pocket hematomas were seen in 2/34 (5.9%) surgeries in patients on chronic treatment and in 4/426 (0.9%) without. There were only 2 instances of thromboembolic complications which both occurred in patients without chronic treatment. There were no hemorrhagic complications during follow-up for 1 year.

CONCLUSIONS: DBS surgery in patients on chronic antiplatelet or anticoagulation treatment is feasible. Also, there was no increased risk of hemorrhage in the first year of follow-up after DBS surgery. Appropriate patient selection and standardized perioperative management are necessary to reduce the risk of intracranial hemorrhage and thromboembolic complications.

PMID:34342730 | DOI:10.1007/s00701-021-04931-y

Eur J Pediatr. 2021 Aug 3. doi: 10.1007/s00431-021-04214-9. Online ahead of print.

ABSTRACT

The association of proadrenomedullin and neonatal sepsis has been examined in numerous studies. The object of our meta-analysis is to evaluate differences in proadrenomedullin among neonates with sepsis and health neonates. We systematically searched the following databases: MEDLINE, Clinicaltrials.gov, Cochrane Central Register of Controlled Trials (CENTRAL), Google Scholar, and WHO (International Clinical Trials Register Platform) using a structured algorithm. Statistical analysis was conducted using Revman 5.3 and R software. Included studies in the meta-analysis were assessed using the Newcastle-Ottawa scale. Proadrenomedullin levels were found significantly higher in neonates with sepsis than healthy neonates with an SMD equal with 3.07 [95% CI 1.71, 4.42 (p < 10^-5, I² = 98%)]. The optimal cutoff point of pro-ADM was calculated at 17.559 with a sensitivity of 0.879 (0.458; 0.984) and a specificity of 0.994 (0.820; 1.000), and an AUC of 0.905. Subgroup analysis, leave-one-out meta-analysis, and meta-regression were performed in an effort to lower inter-study heterogeneity. Sensitivity analysis was conducted by excluding high risk of bias studies and those contributing to the overall heterogeneity shown by the Baujat plot. Publication bias was assessed using a funnel plot and the trim-and-fill method. Certainty assessment was evaluated using the GRADE score.Conclusion: The findings of our meta-analysis suggest that proadrenomedullin is elevated in neonates with sepsis. However, future prospective cohort studies need to be conducted in order to assess its diagnostic accuracy. What is Known: • Proadrenomedullin has been found increased in adult patients with infectious diseases such as community acquired pneumonia. • Proadrenomedullin plays a major role in the pathophysiology of sepsis in adults. What is New: • Proadrenomedullin is increased in neonates with sepsis. • Future cohort studies need to be conducted in order to elucidate the value of proadrenomedullin in a safer way.

PMID:34342678 | DOI:10.1007/s00431-021-04214-9

Environ Manage. 2021 Aug 3. doi: 10.1007/s00267-021-01514-6. Online ahead of print.

ABSTRACT

Globally, shifting cultivation is known to be an important driver of tropical deforestation. However, in this paper, we argue that it can be sustainably managed if the environmental boundary conditions, laid by the traditional customs and practices, are fully respected. We narrate an empirical study from the Zunheboto district of Nagaland, India, where we deployed a mixed research method to explore the Indigenous and Local Knowledge and Practices (ILKPs) associated with shifting cultivation (aka Jhum), particularly concerning farm-level practices, forest and biodiversity conservation, and disaster risk reduction measures. The research method included analysis of primary data obtained through Focus Group discussions (FGDs), key informant interviews (n = 21), and a questionnaire survey (n = 153) with Jhum farmers from two different age groups, i.e., below 50 years (middle-aged farmers) and above 50 years (older farmers). From the qualitative inquiry, we identified 15 ILKPs, which were then validated from survey responses. We used the Mann-Whitney U test to examine differences in agreement between two groups of framers. Based on this analysis, we conclude that upholding of the ILKPs holds strong potential for the local implementation of several Sustainable Development Goals (SDGs), particularly, SDG-1(No poverty), SDG-2 (Zero hunger), and SDG-15 (Life on land). However, eight of the identified ILKPs showed a statistically significant difference between older and middle-aged farmers, underlining a declining trend. Finally, we suggest suitable policy measures to mainstream ILKPs to balance the trade-offs in food production and biodiversity conservation, and to ensure the future sustainability of Jhum cultivation in the region and beyond.

PMID:34342685 | DOI:10.1007/s00267-021-01514-6

Heart Vessels. 2021 Aug 3. doi: 10.1007/s00380-021-01915-x. Online ahead of print.

ABSTRACT

Left atrial (LA) function can help predict various cardiovascular events. Catheter ablation for atrial fibrillation (AF) modifies baseline LA function through the maintenance of sinus rhythm and myocardial injury. We investigated the impact of post-ablation LA function on recurrence of AF after ablation and identified the predictors of reduced post-ablation LA function. A total of 616 patients who underwent AF ablation (paroxysmal, N = 310; non-paroxysmal, N = 306) were retrospectively examined with cardiac computed tomography at baseline and 3 months after the final ablation procedure. Post-ablation LA emptying fraction (LAEF_post) was calculated. We evaluated the association between LAEF_post and recurrence of AF after the final ablation procedure. Further, we assessed the predictors of reduced LAEF_post. The recurrence rate of AF was 72.7% after the final ablation procedure [median follow-up 48 months (48.0, 48.0), total number of ablation sessions: 1.4 ± 0.7]. Multivariate analysis revealed that LAEF_post was associated with the recurrence of AF (hazard ratio/10% increase: 0.62, 95% confidence interval: 0.51-0.75, P < 0.0001). LAEF_post had a mild predictive power for recurrence of AF (c-statistics: 0.670, optimal cutoff: 26.36%, P < 0.0001). The recurrence-free proportion among patients with reduced LAEF_post (< 26.36%, N = 100) and those with preserved LAEF_post (≥ 26.36%, N = 516) was 40% and 79%, respectively (P < 0.0001). The predictors of reduced LAEF_post were low pre-ablation LAEF, high pre-ablation LA volume, low body mass index (BMI), and female sex. Further, reduced LAEF_post was associated with the total number of ablation sessions and extra-pulmonary vein LA ablation. In conclusion, reduced LAEF_post was associated with recurrence of AF after ablation. Advanced LA remodeling, low BMI, and female sex could predict reduced LAEF_post. Although additional ablation was associated with reduced LAEF_post, it remains unclear whether reduced LAEF_post resulted from the additional ablation. Reduced LAEF_post might help stratify patients with ablation-refractory AF.

PMID:34342674 | DOI:10.1007/s00380-021-01915-x

Nervenarzt. 2021 Aug 3. doi: 10.1007/s00115-021-01174-1. Online ahead of print.

ABSTRACT

The research domain criteria (RDoC) initiative of the National Institute of Mental Health (NIMH) was presented 12 years ago. The RDoC provides a matrix for the systematic, dimensional and domain-based study of mental disorders that is not based on established disease entities as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM) or the International Classification of Diseases (ICD). The primary aim of RDoC is to understand the nature of mental health and illness in terms of different extents of dysfunction in psychological/biological systems with interconnected diagnoses. This selective review article aims to provide a comprehensive overview of RDoC-based studies that have contributed to a better conceptual organization of mental disorders. Numerous promising and methodologically sophisticated studies on RDoC were identified. The number of scientific studies increased over time, indicating that dimensional research is increasingly being pursued in psychiatry. In summary, the RDoC initiative has a considerable potential to more precisely define the complexity of pathomechanisms underlying mental disorders; however, major challenges (e.g. small and heterogeneous study samples, unclear biomarker definitions and lack of replication studies) remain to be overcome in the future. Furthermore, it is plausible that a diagnostic system of the future will integrate categorical and dimensional approaches to arrive at a stratification that can underpin a precision medical approach in psychiatry.

PMID:34342676 | DOI:10.1007/s00115-021-01174-1