Category: Statistics

Eur Urol. 2021 Nov 14:S0302-2838(21)02117-5. doi: 10.1016/j.eururo.2021.10.016. Online ahead of print.

ABSTRACT

BACKGROUND: The taxanes docetaxel and cabazitaxel prolong overall survival for men with metastatic castration-resistant prostate cancer (mCRPC), with cabazitaxel approved in the postdocetaxel setting only. Recent data suggest they have similar efficacy but a different safety profile in the first-line mCRPC setting.

OBJECTIVE: To assess patient preference between docetaxel and cabazitaxel among men who received one or more doses of each taxane and did not experience progression after the first taxane.

DESIGN, SETTING, AND PARTICIPANTS: Chemotherapy-naïve patients with mCRPC were randomized 1:1 to receive docetaxel (75 mg/m² every 3 wk × 4 cycles) followed by cabazitaxel (25 mg/m² every 3 wk × 4 cycles) or the reverse sequence. Randomization was stratified by prior abiraterone or enzalutamide use.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary endpoint was patient preference, assessed via a dedicated questionnaire after the second taxane. Secondary endpoints included reasons for patient preference, prostate-specific antigen response, radiological progression-free survival, and overall survival. This clinical trial is registered at ClinicalTrials.gov as NCT02044354.

RESULTS AND LIMITATIONS: Of 195 men randomized, 152 met the prespecified modified intent-to-treat criteria for analysis. Overall, 66 patients (43%) preferred cabazitaxel, 40 (27%) preferred docetaxel, and 46 (30%) had no preference (p = 0.004, adjusted for treatment period effect). More patients preferred treatment period 1 (43%, 95% confidence interval [CI] 36-52%) versus period 2 (27%, 95% CI 20-34%). Patient preference for cabazitaxel was mainly related to less fatigue (72%), better quality of life (64%), and other adverse events (hair loss, pain, nail disorders, edema). Adverse events were consistent with the known safety profile of each drug.

CONCLUSIONS: A significantly higher proportion of chemotherapy-naïve men with mCRPC who received both taxanes preferred cabazitaxel over docetaxel. Less fatigue and better quality of life were the two main reasons driving patient choice.

PATIENT SUMMARY: Men with metastatic castration-resistant prostate cancer preferred cabazitaxel over docetaxel for chemotherapy, mainly because of less fatigue and better quality of life.

PMID:34789394 | DOI:10.1016/j.eururo.2021.10.016

J Am Pharm Assoc (2003). 2021 Nov 2:S1544-3191(21)00448-9. doi: 10.1016/j.japh.2021.10.029. Online ahead of print.

ABSTRACT

BACKGROUND: Students in health professions, including student pharmacist, are at an increased risk of psychological distress. Unfortunately, effective efforts to combat burnout for student pharmacists are still lacking in the literature and create a void in schools and colleges of pharmacy that seek to assist their students.

OBJECTIVES: The objective of this study was to explore how increasing positive out-of-class interactions between the student pharmacists and faculty members affect burnout, especially in work exhaustion and interpersonal disengagement. Professional fulfillment was also assessed as a primary outcome.

METHODS: The institutional review board approved this study consisting of 4 faculty members and 12 students. After providing informed consent, the participants were assigned to one of 4 groups. Each group included 1 faculty member and 3 students. At the start of the study, each participant completed a modified Stanford Professional Fulfillment Index questionnaire to measure baseline burnout characteristics and initial level of professional fulfillment. For 8 weeks, the groups met weekly to discuss a topic related to burnout and professional fulfillment. After 8 weeks, each participant completed the postquestionnaire. Wilcoxon signed-rank tests were performed to the mean scores (pre vs. post) in each of the 3 constructs. The statistical significance was set at P < 0.05.

RESULTS: The results of the Wilcoxon signed-rank analysis showed a statistically significant difference in the burnout constructs, work exhaustion and interpersonal disengagement. There was not a statistically significant change in professional fulfillment.

CONCLUSIONS: Improving relationships between student pharmacist and faculty through increasing out-of-class interactions benefits individuals who are at risk of experiencing burnout. Future initiatives can focus on effective strategies that target work exhaustion and interpersonal disengagement and build on the social networks that develop in pharmacy school.

PMID:34789404 | DOI:10.1016/j.japh.2021.10.029

Injury. 2021 Oct 31:S0020-1383(21)00907-4. doi: 10.1016/j.injury.2021.10.035. Online ahead of print.

ABSTRACT

AIM OF THE STUDY: The aim of this study is to identify if there is any association between neuromuscular disorders and prosthetic dislocation in patients treated with hip hemiarthroplasty for neck of femur fractures.

PATIENTS AND METHODS: Our study is a retrospective analysis of data collected over 34 years for patients with intracapsular neck of femur fracture who underwent hip hemiarthroplasty. Pathological fractures and patients treated with other treatment modalities were excluded. The study population is composed of four groups; patients with no neuromuscular disorders, patients with Parkinson’s disease, patients with previous stroke, and patients with mental impairment.

RESULTS: A total of 3827 patients were treated with hip hemiarthroplasty. For the 3371 patients with no neuromuscular condition (Group I) the dislocation rate was 1.1%. 219 patients had Parkinsonism (Group II) with a dislocation rate of 3.2%, 104 patients had a previous stroke with weakness on the fracture side with a dislocation rate of 1.0% (Group III), and 984 patients had severe mental impairment with a dislocation rate of 1.8% (Group IV). The increased dislocation rate for those with Parkinson’s disease was statistically significant (p = 0.02) while none of the other neuromuscular conditions were statistically significant.

CONCLUSION: Our study demonstrates an increased risk of dislocation after hemiarthroplasty for patients with Parkinson’s disease in comparison to other groups. No increase was apparent for those with mental impairment or weakness from a previous stroke.

PMID:34789388 | DOI:10.1016/j.injury.2021.10.035

Eur Urol. 2021 Nov 14:S0302-2838(21)02133-3. doi: 10.1016/j.eururo.2021.10.030. Online ahead of print.

ABSTRACT

BACKGROUND: It is hypothesised that simulation enhances progression along the initial phase of the surgical learning curve.

OBJECTIVE: To evaluate whether residents undergoing additional simulation, compared to conventional training, are able to achieve proficiency sooner with better patient outcomes.

DESIGN, SETTING, AND PARTICIPANTS: This international, multicentre, randomised controlled trial recruited 94 urology residents with experience of zero to ten procedures and no prior exposure to simulation in ureterorenoscopy, selected as an index procedure.

INTERVENTION: Participants were randomised to simulation or conventional operating room training, as is the current standard globally, and followed for 25 procedures or over 18 mo.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The number of procedures required to achieve proficiency, defined as achieving a score of ≥28 on the Objective Structured Assessment of Technical Skill (OSATS) scale over three consecutive operations, was measured. Surgical complications were evaluated as a key secondary outcome. This trial is registered at www.isrctn.com as ISCRTN 12260261.

RESULTS AND LIMITATIONS: A total of 1140 cases were performed by 65 participants, with proficiency achieved by 21 simulation and 18 conventional participants over a median of eight and nine procedures, respectively (hazard ratio [HR] 1.41, 95% confidence interval [CI] 0.72-2.75). More participants reached proficiency in the simulation arm in flexible ureterorenoscopy, requiring a lower number of procedures (HR 0.89, 95% CI 0.39-2.02). Significant differences were observed in overall comparison of OSATS scores between the groups (mean difference 1.42, 95% CI 0.91-1.92; p < 0.001), with fewer total complications (15 vs 37; p = 0.003) and ureteric injuries (3 vs 9; p < 0.001) in the simulation group.

CONCLUSIONS: Although the number of procedures required to reach proficiency was similar, simulation-based training led to higher overall proficiency scores than for conventional training. Fewer procedures were required to achieve proficiency in the complex form of the index procedure, with fewer serious complications overall.

PATIENT SUMMARY: This study investigated the effect of simulation training in junior surgeons and found that it may improve performance in real operating settings and reduce surgical complications for complex procedures.

PMID:34789393 | DOI:10.1016/j.eururo.2021.10.030

Injury. 2021 Nov 14:S0020-1383(21)00912-8. doi: 10.1016/j.injury.2021.11.007. Online ahead of print.

ABSTRACT

BACKGROUND: The majority of neck of femur (NOF) fractures are treated operatively in the United Kingdom. The literature reports the advantages of operative management for these patients. However, whilst a subset is treated non-operatively, there is currently no clear guidance for the selection and subsequent management of these patients. This study aims to explore the incidence, demographics, inpatient stay, use of imaging and outcomes of patients who have non-operatively managed NOF fractures.

METHODS: A 6-year retrospective review (2013-2019) of all non-operatively managed NOF fractures at a tertiary teaching hospital and major trauma centre was conducted. Electronic patient records, radiographs and National Hip Fracture Database (NHFD) data were used to obtain information. We noted demographic details, fracture classification, rationale for non-operative management, mortality, clinical frailty score (CFS), use of imaging and analgesia requirements. Patients who were repatriated or transferred to other sites for specialist surgery were excluded.

RESULTS: 3.2% (99/3132) of NOF fractures were managed non-operatively. The two commonest reasons for non-operative management were either ‘comfortable mobilisation’ (n = 44) or ‘patient frailty/medically unwell’ (n = 50). 74% (37/50) of the patients in whom operative risk was thought to outweigh benefit died within the 30 days of admission and 1-year mortality for this group was 92% (46/50). Of the “comfortable mobilisation” subgroup only 18% (8/44) of this patient subgroup subsequently required surgical intervention for failed non-operative management. The 30-day mortality for this cohort was 6.8% with a 1-year mortality rate of 25% (11/44).

CONCLUSION: For a select group of patients whose fractures are stable enough to allow them to mobilise comfortably, non-operative management resulted in a 25% 1-year mortality rate and average length of stay of 10.1 days. This is comparable to statistics for overall NOF fracture management in the literature according to the NHFD January 2021 report. 82% of this group of patients were successfully managed without an operation indicating that there is a place for the consideration of non-operative management in a small select subgroup of hip fracture patients with minimally displaced, stable fractures. Further analysis is necessary to assess the functional outcomes of this subgroup, as well as the potential cost implications.

PMID:34789387 | DOI:10.1016/j.injury.2021.11.007

Dtsch Arztebl Int. 2021 Sep 6;118I processed the file.I’m waiting for feedback tomorrow(35-36):587-594. doi: 10.3238/arztebl.m2021.0231.

ABSTRACT

BACKGROUND: Metatarsal fractures are among the most common foot and ankle injuries, with an annual incidence of 6.7 per 100 000 persons. Approximately 30% of metatarsal fractures affect the base of the fifth metatarsal bone. Nevertheless, no evidence-based treatment recommendations are available to date.

METHODS: The three fracture localizations according to Lawrence and Botte (zone I, proximal to the intermetatarsal joint between the fourth and fifth metatarsal bones; zone II, in the area of the joint; zone III, at the distal end of the joint) are analyzed on the basis of a systematic literature search. Studies were included that compared the treatment of two types of fracture in the same manner, or that compared two different treatments for a single type of fracture.

RESULTS: Nine studies compared different treatments of zone I fractures. Two of these were randomized controlled trials (RCTs); in one RCT, patients given functional therapy returned to work much sooner than those treated with immobilization (11 vs. 28 days; p = 0.001), with otherwise similar outcomes. The non-randomized studies revealed a faster return to full function (33 vs. 46 days; p<0.05) with early functional therapy, and similar outcomes for immobilization and surgery. One RCT that compared functional therapy with immobilization for zone II fractures revealed no statistically significant difference. Five studies compared fractures in zones I and II that were treated in the same manner, revealing similar outcomes. One RCT compared surgery and immobilization for zone III fractures: surgery led to statistically significant improvement of the outcome in all of the measured parameters.

CONCLUSION: Fractures in zones I and II should be treated with early functional therapy. There seems to be no reason to consider zone I and II fractures as two separate entities, as the outcomes in the two groups are similar. In contrast, fractures in zone III should primarily be treated surgically.

PMID:34789369 | DOI:10.3238/arztebl.m2021.0231

Cortex. 2021 Oct 22:S0010-9452(21)00327-0. doi: 10.1016/j.cortex.2021.10.001. Online ahead of print.

ABSTRACT

The role of the dorsolateral prefrontal cortex (DLPFC) in implicit sequence/statistical learning has received considerable attention in recent cognitive neuroscience research. Studies have used non-invasive brain stimulation methods to test whether the DLPFC plays a role in the incidental acquisition and expression of implicit sequence learning. In a recent study, Prutean et al. has concluded that stimulating the left or the right DLPFC might not affect the expression of implicit sequence learning measured by the Serial Reaction Time (SRT) task. The authors speculated that the previous results revealing improved implicit sequence learning following DLPFC stimulation might have been found because explicit awareness accumulated with the use of Alternating Serial Reaction Time (ASRT) task. Our response presents solid evidence that the ASRT task measures implicit sequence learning that remains unconscious both at the judgment and structural level. Therefore, contrary to the conclusion of Prutean et al., we argue that the DLPFC could have a crucial effect on implicit sequence learning that may be task-dependent. We suggest that future research should focus on the specific cognitive processes that may be differentially involved in the SRT versus ASRT tasks, and test what the role of the DLPFC is in those specific cognitive processes.

PMID:34789384 | DOI:10.1016/j.cortex.2021.10.001

Public Health Nutr. 2021 Nov 18:1-19. doi: 10.1017/S1368980021004602. Online ahead of print.

ABSTRACT

OBJECTIVE: To examine cross-sectional associations between farmers’ market shopping behaviors and objectively measured and self-reported fruit and vegetable (FV) intake among rural North Carolina (NC) and New York City (NYC) shoppers.

DESIGN: Cross-sectional intercept surveys were used to assess self-reported FV intake and three measures of farmers’ market shopping behavior: (1) frequency of purchasing FV, (2) variety of FV purchased, and (3) dollars spent on FV. Skin carotenoids, a non-invasive biomarker for FV intake, were objectively measured using pressure-mediated reflection spectroscopy. Associations between farmers’ market shopping behaviors and FV intake were examined using regression models that controlled for demographic variables (e.g., age, sex, race, smoking status, education, income, and state).

SETTING: Farmers’ markets (n=17 markets) in rural NC and NYC.

PARTICIPANTS: A convenience sample of 645 farmers’ market shoppers.

RESULTS: Farmers’ market shoppers in NYC purchased a greater variety of FV and had higher skin carotenoid scores compared to shoppers in rural NC. Among all shoppers, there was a positive, statistically significant association between self-reported frequency of shopping at farmers’ markets and self-reported as well as objectively assessed FV intake. The variety of FV purchased and farmers’ market spending on FV also were positively associated with self-reported FV intake, but not skin carotenoids.

CONCLUSION: Those who shop for FV more frequently at a farmers’ markets, purchase a greater variety of FV, and spend more money on FV have higher self-reported, and in some cases higher objectively measured FV intake. Further research is needed to understand these associations and test causality.

PMID:34789356 | DOI:10.1017/S1368980021004602

Gut Pathog. 2021 Nov 17;13(1):68. doi: 10.1186/s13099-021-00463-z.

ABSTRACT

BACKGROUND: Poultry necrotic enteritis (NE) is an economically important disease caused by C. perfringens. The disease causing ability of this bacterium is linked with the production of a wide variety of toxins. Among them, necrotic enteritis B-like (NetB) toxin is reported to be involved in the pathogenesis of NE; in addition there is some circumstantial evidence that tpeL toxin may enhance virulence, but this is yet to be definitely shown. The situation becomes more complicated in the presence of a number of predisposing factors like co-infection with coccidia, type of diet and use of high protein diet. These co-factors alter the intestinal environment, thereby favoring the production of more toxins, leading to a more severe disease. The objective of this study was to develop a successful animal model that would induce clinical signs and lesions of NE using C. perfringens type G strains obtained from field outbreaks. A separate trial was simultaneously considered to establish the role of dietary factor with coccidial co-infection in NE.

RESULTS: The results have shown that use of net-B positive C. perfringens without predisposing factors induce moderate to severe NE (Av. Lesion score 1.79 ± 1.50). In a separate trial, addition of fish meal to a feed of C. perfringens challenged birds produced higher number of NE cases (Av. Lesion score 2.17 ± 1.28). However, use of less virulent E. necatrix strain along with fish meal in conjunction with net-B positive strain did not alter the severity of NE lesions in specific pathogen free chicken (Av. Lesion score 2.21 ± 1.13).

CONCLUSIONS: This study suggests that virulent C. perfringens type G strains can induce NE lesions in the absence of other predisposing factors. Birds in the clostridia challenged group showed moderate to severe NE lesions. Use of less virulent coccidia strain contributed to a lesser extent in increasing the severity of disease. Maize based diet along with fishmeal (1:1) increased the severity of lesions but statistically it was non-significant. The NE lesions in all experimental groups were found to be present more frequently in the duodenum. In this way, this study provided an effective model for in vivo production of NE in poultry birds.

PMID:34789342 | DOI:10.1186/s13099-021-00463-z

Diagn Progn Res. 2021 Nov 18;5(1):19. doi: 10.1186/s41512-021-00107-5.

ABSTRACT

BACKGROUND: Chronic kidney disease (CKD) is a well-established complication in people with diabetes mellitus. Roughly one quarter of prevalent patients with diabetes exhibit a CKD stage of 3 or higher and the individual course of progression is highly variable. Therefore, there is a clear need to identify patients at high risk for fast progression and the implementation of preventative strategies. Existing prediction models of renal function decline, however, aim to assess the risk by artificially grouped patients prior to model building into risk strata defined by the categorization of the least-squares slope through the longitudinally fluctuating eGFR values, resulting in a loss of predictive precision and accuracy.

METHODS: This study protocol describes the development and validation of a prediction model for the longitudinal progression of renal function decline in Caucasian patients with type 2 diabetes mellitus (DM2). For development and internal-external validation, two prospective multicenter observational studies will be used (PROVALID and GCKD). The estimated glomerular filtration rate (eGFR) obtained at baseline and at all planned follow-up visits will be the longitudinal outcome. Demographics, clinical information and laboratory measurements available at a baseline visit will be used as predictors in addition to random country-specific intercepts to account for the clustered data. A multivariable mixed-effects model including the main effects of the clinical variables and their interactions with time will be fitted. In application, this model can be used to obtain personalized predictions of an eGFR trajectory conditional on baseline eGFR values. The final model will then undergo external validation using a third prospective cohort (DIACORE). The final prediction model will be made publicly available through the implementation of an R shiny web application.

DISCUSSION: Our proposed state-of-the-art methodology will be developed using multiple multicentre study cohorts of people with DM2 in various CKD stages at baseline, who have received modern therapeutic treatment strategies of diabetic kidney disease in contrast to previous models. Hence, we anticipate that the multivariable prediction model will aid as an additional informative tool to determine the patient-specific progression of renal function and provide a useful guide to early on identify individuals with DM2 at high risk for rapid progression.

PMID:34789343 | DOI:10.1186/s41512-021-00107-5