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Welcome to the statistics and pharmacometrics themed issue

CPT Pharmacometrics Syst Pharmacol. 2021 Apr;10(4):273-274. doi: 10.1002/psp4.12625.

NO ABSTRACT

PMID:33951754 | DOI:10.1002/psp4.12625

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Antipsychotics are related to psychometric conversion to psychosis in ultra-high-risk youth

Early Interv Psychiatry. 2021 May 5. doi: 10.1111/eip.13158. Online ahead of print.

ABSTRACT

BACKGROUND: The prescription of antipsychotics outside overt psychotic conditions remains controversial, especially in youth where it is relatively widespread. Furthermore, some studies seem to indicate that antipsychotic exposure in individuals at ultra-high-risk (UHR) for psychosis is associated with higher conversion rates. This study was set up to test whether the inter-current prescription of antipsychotics in UHR patients was related to the psychometric threshold for a diagnosis of psychosis.

METHODS: The 24-item Brief Psychiatric Rating Scale (BPRS) was used to quantify treatment response up to 2 years in 125 UHR participants. Standard psychometric criteria were used to quantify conversion to psychosis. Kaplan-Mayer and Cox proportional hazard survival analysis were applied to determine the impact of having or not received the prescription of an antipsychotic drug.

RESULTS: Over the study period 30 (24%) subjects received the prescription of an antipsychotic. In the sample, there were 31 participants (25%) who had reached the psychometric threshold for conversion to psychosis after 2 years of treatment. UHR people who received a prescription of antipsychotics during the first 2 years of treatment were statistically more likely to reach the psychometric threshold for conversion to psychosis on the BPRS: Hazard ratio = 3.03 (95%CI: 1.49-6.16); p = .003.

CONCLUSION: This finding supports the hypothesis that the prescription of antipsychotics within UHR cohorts is to be considered a red flag for higher incipient risk of conversion to psychosis.

PMID:33951751 | DOI:10.1111/eip.13158

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Impact of study design and statistical model in pharmacogenetic studies with gene-treatment interaction

CPT Pharmacometrics Syst Pharmacol. 2021 Apr;10(4):340-349. doi: 10.1002/psp4.12624.

ABSTRACT

Gene-treatment interactions, just like drug-drug interactions, can have dramatic effects on a patient response and therefore influence the clinician decision at the patient’s bedside. Crossover designs, although they are known to decrease the number of subjects in drug-interaction studies, are seldom used in pharmacogenetic studies. We propose to evaluate, via realistic clinical trial simulations, to what extent crossover designs can help quantifying the gene-treatment interaction effect. We explored different scenarios of crossover and parallel design studies comparing two symptom-modifying treatments in a chronic and stable disease accounting for the impact of a one gene and one gene-treatment interaction. We varied the number of subjects, the between and within subject variabilities, the gene polymorphism frequency and the effect sizes of the treatment, gene, and gene-treatment interaction. Each simulated dataset was analyzed using three models: (i) estimating only the treatment effect, (ii) estimating the treatment and the gene effects, and (iii) estimating the treatment, the gene, and the gene-treatment interaction effects. We showed how ignoring the gene-treatment interaction results in the wrong treatment effect estimates. We also highlighted how crossover studies are more powerful to detect a treatment effect in the presence of a gene-treatment interaction and more often lead to correct treatment attribution.

PMID:33951752 | DOI:10.1002/psp4.12624

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Nevin Manimala Statistics

Preoperative Parameters to Predict the Development of Symptomatic Lymphoceles after Radical Prostatectomy

Urol Int. 2021 May 5:1-8. doi: 10.1159/000514041. Online ahead of print.

ABSTRACT

INTRODUCTION: Symptomatic lymphoceles (SLs) represent the most common complication after radical prostatectomy (RP) and pelvic lymph node dissection (PLND). To date, preoperative risk factors are missing.

METHODS: Clinical and pathological data of 592 patients who underwent RP and PLND were evaluated. Included parameters were age, BMI, prostate-specific antigen (PSA), PSA ratio, PSA density, number of resected and/or positive lymph nodes, previous abdominal surgery/pelvic radiotherapy, anticoagulation, and surgical approach.

RESULTS: Fifty-nine patients (10%) developed an SL, of which 57 underwent open retropubic radical prostatectomy (RRP) and 2 underwent robot-assisted radical prostatectomy (RARP). Multivariate logistic regression revealed the following parameters as statistically significant risk factors: PSA (odds ratio [OR] = 2.23; 95% CI [1.25; 5.04], p = 0.04), number of resected lymph nodes (OR = 1.47; 95% CI [1.10; 1.97], p < 0.01), previous abdominal surgery (OR = 2.58; 95% CI [1.38; 4.91], p < 0.01), and surgical approach (OR = 0.08; 95% CI [0.01; 0.27], p < 0.01). Previous oral anticoagulation showed almost statistically significant results (OR = 2.39 [0.92; 5.51], p = 0.05).

CONCLUSION: The risk for SL might be predictable considering preoperative risk factors such as PSA, previous abdominal surgery and anticoagulation. To avoid SL, RARP should be the procedure of choice. If RRP is considered, patients at risk for SL may benefit from peritoneal fenestration during RP.

PMID:33951669 | DOI:10.1159/000514041

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Maternal Serum Placental Protein-13 Levels in the Prediction of Pregnancies with Abnormal Invasive Placentation

Z Geburtshilfe Neonatol. 2021 May 5. doi: 10.1055/a-1475-5413. Online ahead of print.

ABSTRACT

OBJECTIVE: To evaluate whether placental protein-13 (PP-13) measured in the serum of pregnant women could predict abnormal invasive placentation (AIP) detected by color Doppler ultrasound (US) and magnetic resonance imaging scan in addition to the routine US scan during the third trimester.

MATERIALS AND METHODS: The prospective case-control study included patients subdivided in 2 groups: 42 pregnant women with a singleton pregnancy at 28-32 weeks of gestation with only suspected AIP, and 32 healthy pregnant women. The serum PP-13 levels were measured in both groups using an enzyme-linked immunosorbent assay (ELISA) method and statistically compared. The cases of AIP were confirmed by placental histopathological examination and/or the uterus removed by hysterectomy after elective caesarean section.

RESULTS: Serum PP-13 levels of pregnant women with AIP were significantly higher (p<0.001) than those of controls (650.32±387.33 vs. 231.43±94.33). Statistical analysis of maternal serum PP-13 levels above the threshold of 312 pg/ml (measured in the early third trimester) predicted AIP with 76.2% sensitivity and 75% specificity.

CONCLUSION: Maternal serum PP-13 may have a role in the pathophysiology of AIP owing to its high serum value in the AIP group. The maternal serum dosage of PP-13 levels could improve pregnancy management in those patients suspected of having AIP.

PMID:33951735 | DOI:10.1055/a-1475-5413

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Predicting risk of erectile dysfunction in patients with nonalcoholic fatty liver disease

Andrologia. 2021 May 5:e14091. doi: 10.1111/and.14091. Online ahead of print.

ABSTRACT

Nonalcoholic fatty liver disease (NAFLD) is one of the risk factors for erectile dysfunction (ED). We aimed to predict the risk of ED in patients with NAFLD. The study included 146 male patients complaining impotence admitted to the urology outpatient clinic aged 24-80 years without a history of alcohol use who underwent abdominal ultrasonography between February 2018 and January 2019. 106 patients with NAFLD and 40 men without NAFLD were included in the study. Clinical and laboratory parameters, ED status according to International Index of Erectile Function-5 were compared between patients with and without NAFLD. The mean age of patients was 51.47 ± 10.34 years. NAFLD was detected in 72.6% of the patients. No statistically significant difference was found regarding mean age, BMI, IIEF-5 scores, DM status, serum glucose levels (p > .05). Fasting insulin levels, hypertension (HT), insulin resistance (IR) and ED status of the patients with NAFLD were significantly higher than patients without NAFLD (p < .05). NAFLD was found to be a significantly independent associated with ED. We also found that patients with NAFLD have risk of ED 2.92 times higher than without NAFLD (OR: 2.92). For the patients presenting with erectile dysfunction, hepatic steatosis should also be considered.

PMID:33951744 | DOI:10.1111/and.14091

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Influence Factors of Sexual Intercourse Frequency in Infertile Couples without Sexual Dysfunction in Southwest China: A Retrospective Study

Urol Int. 2021 May 5:1-7. doi: 10.1159/000513320. Online ahead of print.

ABSTRACT

INTRODUCTION: The aim of this study was to investigate the sexual intercourse frequency (SIF) of infertile couples without sexual dysfunction and analyze its related influencing factors.

MATERIALS AND METHODS: We retrospectively analyzed the data of a total number of 4,923 infertile couples without sexual dysfunction who received treatment in our assisted reproductive center from October 2016 to October 2018. Both partners of couples were inquired about their information of demographic statistics, occupations, lifestyles, education backgrounds, psychological characteristics, and testostrone levels of male patients. The multivariable linear regression analysis was applied to evaluate the influence of various variables on SIF.

RESULTS: The median (interquartile range) SIF of infertile couples without sexual dysfunction was 7 (6.5-8) times per month. Lower academic qualification and younger age were predictive of increased SIF in both partners. The SIF of Chinese Han women and Chinese Zang women is higher than that of other ethnic groups. Men with lower testosterone (<10 nmol/L) were associated with lower SIF. The BMI, occupation, alcohol consumption, races of both partners of couples, and smoking status of males were not associated with SIF. Multivariable linear regression analysis indicated that only the age and the education level of men played an important role in SIF, and educational level of men had the greatest impact, followed by men’s age.

CONCLUSION: In our study, we analyzed demographics data, occupational characteristics, and lifestyle behaviors of both partners, as well as men’s testosterone levels; we also reported the related SIF. According to our research, men’s education level was the most important factor in predicting SIF, followed by men’s age. Testosterone levels of men do not appear to play a substantial role in predicting SIF in infertile couples.

PMID:33951657 | DOI:10.1159/000513320

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Impact of Autologous Transobturator Sling Surgery on Female Sexual Function: A Comparative Study with Mesh Used Mid-Urethral Sling Surgeries

Urol Int. 2021 May 5:1-7. doi: 10.1159/000514415. Online ahead of print.

ABSTRACT

INTRODUCTION: To avoid mesh-related complications, autologous transobturator-tape (a-TOT) technique is a viable option in stress urinary incontinence (SUI) surgery. The method differs from TOT and retropubic tape (RT) in the usage of autologous tissue. We hypothesized that a-TOT improves female sexual dysfunction (FSD) more than TOT and RT.

METHODS: This is a retrospective cohort study. Patients who underwent a-TOT, TOT, and RT surgeries were surveyed regarding the cure of SUI, complications, and FSD parameters. The groups were compared according to baseline and postoperative data.

RESULTS: A-TOT, TOT, and RT groups included 37, 69, and 36 patients, respectively. The median follow-up time was 19 months. The groups were similar in terms of preoperative characteristics. The objective cure, subjective cure, and overall complication rates were comparable among the groups (p > 0.05). A-TOT group had significant improvements in mean female sexual function index (FSFI) scores, TOT group deteriorated, and RT group remained stable (p = 0.001, p = 0.001, and p = 0.226, respectively). The postoperative mean total FSFI scores were 25.73 ± 2.46, 23.17 ± 3.35, and 21.53 ± 2.47 for the a-TOT, TOT, and RT groups, respectively. The a-TOT group had better results than the TOT and RT groups (p < 0.05 and p < 0.05), and besides, the difference between the TOT and RT groups was statistically significant (p < 0.05). According to percentage changes in domain scores following the operations, the a-TOT group had significantly better results in desire, arousal, lubrication, satisfaction, and pain domains than the TOT group (p < 0.05) as well as better desire, arousal, and pain domains (p < 0.05) than the RT group.

DISCUSSION/CONCLUSIONS: Besides comparable outcomes in SUI treatment, the a-TOT technique provides improvements in female sexual functions while TOT worsens and RT does not change. Favorable outcomes in sexual functions caused by improvements in desire, arousal, satisfaction, and pain domains are observed following the a-TOT technique.

PMID:33951661 | DOI:10.1159/000514415

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Mapping Telemedicine in German Private Practice Urological Care: Implications for Transitioning beyond the COVID-19 Pandemic

Urol Int. 2021 May 5:1-7. doi: 10.1159/000515982. Online ahead of print.

ABSTRACT

BACKGROUND: There are limited data on the use and concern of telemedicine among German urologists, and thus, there are no established guidelines for telemedical diagnosis, treatment, and prevention of urological indications.

METHODS: An anonymized survey was conducted among German private practice urologists during the 2019 coronavirus disease (COVID-19) pandemic. The χ2 test, Mann-Whitney U-test, and Kruskal-Wallis test were used for statistical analysis.

RESULTS: 257 urologists were included in the final analysis. Thirty-five (14.0%) of urologists had used telemedicine as part of their consultation, and 221 (86.0%) had not used telemedicine. There was no difference between telemedicine adoption rates between rural and urban settings. Telemedicine users were significantly more satisfied with the information they had received regarding telemedicine issues. Users saw the greatest barrier to telemedicine that patients do not take up the offer of telemedicine. Nonusers were most concerned with unclear indications for telemedicine followed by lesser reimbursements during telemedicine than in-person visitations. Users were significantly more likely to use telemedicine beyond the COVID-19 pandemic. Urologists, who wanted to use the service in the future, wanted an active support by the German society of urology and guidelines for telemedicine. Last, users and nonusers preferred telemedicine for non-acute chronic diseases and follow-up visitations.

CONCLUSION: Despite the COVID-19 pandemic, telemedicine remains a rarely used service among German private practice urologists. Ultimately, to overcome the current challenges, urologists require an active support for the service through the German Society of Urology and telemedical guidelines.

PMID:33951666 | DOI:10.1159/000515982

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Aspiration Thrombectomy with the Indigo System for Acute Lower Limb Ischemia: preliminary experience and analysis of parameters affecting the outcome

Ann Vasc Surg. 2021 May 2:S0890-5096(21)00367-8. doi: 10.1016/j.avsg.2021.04.016. Online ahead of print.

ABSTRACT

PURPOSE: The purpose of our study is to assess the short-term technical success and the safety of the Indigo System in a series of patients undergoing vacuum-assisted catheter direct thrombus aspiration (IS-CDTA) for acute lower limb ischemia (ALLI) and to evaluate which parameters may affect the outcome.

MATERIALS AND METHODS: All procedures using the IS-CDTA for ALLI, performed in a single-centre Interventional Radiology Unit from February 2016 to March 2020, were retrospectively analysed. Technical success was defined as the achievement of nearly-complete or complete revascularization (TIPI grade 2/3) and considered as a good outcome. Variables potentially correlated with the IS-CDTA outcome were analysed.

RESULTS: 33 procedures were performed in 29 patients. Mean age was 69 years old (range 47 – 88), 24 males (83%) and 5 females (18%). The technical success was 70%. Catheter-directed thrombolysis following IS-CDTA was performed in 23 cases and the overall technical success increased from 70% to 90%, afterwards. The median time between symptoms insurgency and IS-CDTA was significantly shorter in patients with good outcome (10 hours; IQR 2.75-48) compared to those with poor outcome (168 hours; IQR 36-336) (p = 0.003). No statistically significant differences were found between the two groups regarding ATK vs BTK (p=0.34), native vessel vs graft (p=0.25), occlusion nature p=0.28) or Rutherford score (p=0.80).

CONCLUSION: IS-CDTA is a valid option for a rapid and percutaneous treatment of ALLI. Our experience indicates that the time elapsing from the symptoms insurgency and the endovascular procedure is the best positive predictor of the outcome.

PMID:33951530 | DOI:10.1016/j.avsg.2021.04.016