Serum Isoform [−2]proPSA Derivatives Significantly Improve Prediction of Prostate Cancer at Initial Biopsy in a Total PSA Range of 2–10 ng/ml: A Multicentric European Study

Background

Strategies to reduce prostate-specific antigen (PSA)–driven prostate cancer (PCa) overdiagnosis and overtreatment seem to be necessary.

Objective

To test the accuracy of serum isoform [−2]proPSA (p2PSA) and its derivatives, percentage of p2PSA to free PSA (fPSA; %p2PSA) and the Prostate Health Index (PHI)—called index tests—in discriminating between patients with and without PCa.

Design, setting, and participants

This was an observational, prospective cohort study of patients from five European urologic centers with a total PSA (tPSA) range of 2–10 ng/ml who were subjected to initial prostate biopsy for suspected PCa.

Outcome measurements and statistical analysis

The primary end point was to evaluate the specificity, sensitivity, and diagnostic accuracy of index tests in determining the presence of PCa at prostate biopsy in comparison to tPSA, fPSA, and percentage of fPSA to tPSA (%fPSA) (standard tests) and the number of prostate biopsies that could be spared using these tests. Multivariable logistic regression models were complemented by predictive accuracy analysis and decision curve analysis.

Results and limitations

Of >646 patients, PCa was diagnosed in 264 (40.1%). Median tPSA (5.7 vs 5.8 ng/ml; p = 0.942) and p2PSA (15.0 vs 14.7 pg/ml) did not differ between groups; conversely, median fPSA (0.7 vs 1 ng/ml; p < 0.001), %fPSA (0.14 vs 0.17; p < 0.001), %p2PSA (2.1 vs 1.6; p < 0.001), and PHI (48.2 vs 38; p < 0.001) did differ significantly between men with and without PCa. In multivariable logistic regression models, p2PSA, %p2PSA, and PHI significantly increased the accuracy of the base multivariable model by 6.4%, 5.6%, and 6.4%, respectively (all p < 0.001). At a PHI cut-off of 27.6, a total of 100 (15.5%) biopsies could have been avoided. The main limitation is that cases were selected on the basis of their initial tPSA values.

Conclusions

In patients with a tPSA range of 2–10 ng/ml, %p2PSA and PHI are the strongest predictors of PCa at initial biopsy and are significantly more accurate than tPSA and %fPSA.

Trial registration

The study is registered at http://www.controlled-trials.com, ref. ISRCTN04707454.     

Risk factors for dislocation arthropathy after Latarjet procedure: a long-term study

Purpose

The purpose of this study was to analyse the long-term incidence of dislocation arthropathy after a modified Latarjet procedure for glenohumeral instability.

Methods

Long-term follow-up information was obtained from a consecutive series of patients who had undergone a modified Latarjet procedure by one surgeon between 1986 and 1999. Multivariable regression analysis was performed to examine the relation between the development of a dislocation arthropathy and patients and surgery-related factors.

Results

There were 117 patients (117 shoulders) for evaluation, (35 women and 82 men) with a mean age 28.4 ± 8.5 (range, 16–55). The mean follow-up was 16.2 years (range, ten to 22.2 years). Signs of dislocation arthropathy were found in 36 % of patients, graded as Samilson 1 in 30 %, Samilson 2 in 3 %, and 3 % Samilson 3 in 3 % of patients. Risk factors for dislocation arthropathy included surgery in patients older than 40 years of age (64.3 vs. 34.4 %; adjusted RR 2.2, 95 % CI 1.7–2.9) and lateral positioning of the transferred coracoid process in relation to the glenoid rim (82.4 vs. 30.4 %; adjusted RR 2.3, 95 % CI 1.7–3.2). Patients with hyperlaxity developed less dislocation arthropathy (15 vs. 42.5 %; adjusted RR 0.4, 95 % CI 0.1–0.95).

Conclusion

The development of dislocation arthropathy after the Latarjet procedure remains a source of concern in the long term. It correlates with surgery after the age of 40 and lateral coracoid transfer in relation to the glenoid rim. On the other hand, hyperlaxity seems to have a protective effect on the development of dislocation arthropathy.     

Associations of Frequency and Duration of Patient-Doctor Contact in Hemodialysis Facilities with Mortality

It is unknown whether regular patient-doctor contact (PDC) contributes to better outcomes for patients undergoing hemodialysis. Here, we analyzed the associations between frequency and duration of PDC during hemodialysis treatments with clinical outcomes among 24,498 patients from 778 facilities in the international Dialysis Outcomes and Practice Patterns Study (DOPPS). The typical facility PDC frequency, estimated by facility personnel, was high (more than once per week) for 55% of facilities, intermediate (once per week) for 24%, and low (less than once per week) for 21%. The mean ± SD estimated duration of a typical interaction between patient and physician was 7.7±5.6 minutes. PDC frequency and duration varied across DOPPS phases and countries; the proportion of facilities with high PDC frequency was 17% in the United States and 73% across the other countries. Compared with high PDC frequency, the adjusted hazard ratio (HR) for all-cause mortality was 1.06 (95% confidence interval [CI], 0.96 to 1.17) for intermediate PDC frequency and 1.11 (95% CI, 1.01 to 1.23) for low PDC frequency (P=0.03 for trend). Furthermore, each 5-minutes-shorter duration of PDC was associated with a 5% higher risk for death, on average (HR, 1.05; 95% CI, 1.01 to 1.09), adjusted for PDC frequency and other covariates. Multivariable analyses also suggested modest inverse associations between both PDC frequency and duration with hospitalization but not with kidney transplantation. Taken together, these results suggest that policies supporting more frequent and longer duration of PDC may improve patient outcomes in hemodialysis.Although maintenance hemodialysis (HD) saves lives, survival of patients with ESRD remains poor and is much worse than for the general population.¹ HD facilities differ with respect to provision of important clinical practices;^2,3 among these, differences in patterns of dialysis unit staffing might influence mortality.^4,5 HD patients usually receive thrice-weekly dialysis provided by a multidisciplinary team of health care professionals (doctors, nurses, technicians, dietitians, and social workers). As part of this team, the physician’s role in improving the quality of chronic disease care is considered crucial.^6,7Many health care providers and researchers believe that more frequent and longer patient-doctor contact (PDC) in HD care may improve patient outcomes because it provides physicians with greater opportunity to monitor treatments; enhance communication and build trust with the patient; and detect, prevent, and treat new medical problems.^2,5,8 However, the actual frequency and duration of PDC for HD care have not been reported in many countries, and there is little direct evidence that more frequent and longer PDC contributes to better patient health outcomes. Previous studies from the United States showed that less frequent PDC was associated with lower patient satisfaction, lower patient adherence, lower patient achievement of clinical performance targets, and higher hospitalization, but more frequent PDC was not necessarily related to longer patient survival.^8–10 A recent study based on data from the U.S. Renal Data System (USRDS) also reported no difference in survival for PDC frequency of <4 times per month compared with 4 times per month.¹⁰ However, the study was limited to one country and was unable to evaluate differences in outcomes between 4 times per month and >4 times per month because of limitations of the billing codes and relatively low proportion of high PDC frequency in the United States.This study examined the estimated typical frequency and duration of PDC that occurs at the time of HD treatments and its associations with all-cause mortality as a primary outcome among participants in the Dialysis Outcomes and Practice Patterns Study (DOPPS), an international prospective cohort study of HD patients and facilities. PDC was studied at the facility level, reducing the opportunity for patient-level confounding by indication in this international cohort. Among such patients, a high PDC frequency (>4 times per month) is much more common outside of than in the United States. We also examined the associations of PDC frequency and duration with first hospitalization and kidney transplantation as secondary outcomes. A better understanding of the effect of PDC intensity could have implications for health policy in addition to improving health care delivery and HD patient outcomes.     

Effectiveness of collaborative care for depression in Italy. A randomized controlled trial

Trial design

This was a multicenter cluster-randomized controlled trial.

Participants

A total of 227 patients ≥ 18 years old with a new onset of depressive symptoms who screened positive on the first two items of the Patient Health Questionnaire-9 (PHQ-9) were recruited by primary care physicians (PCPs) of eight health districts of three Italian regions from September 2009 to June 2011.

Intervention

PCPs of the intervention group received a specific collaborative care program including 2 days of intensive training, implementation of a stepped care protocol, depression management toolkit and scheduled meetings with a dedicated consultant psychiatrist.

Objective

The objective was to determine whether a collaborative care program for depression management in primary care leads to higher remission rate than usual PCP care.

Outcomes

Outcome was clinical remission as expressed on PHQ-9 < 5 at 3 months.

Randomization

An independent researcher used computer-generated randomization to assign involved primary care groups to the two alternative arms.

Blinding

PCPs and research personnel were not blinded.

Results

The 223 PCPs enrolled recruited 227 patients (128 in collaborative care arm, 99 in the usual care arm). At 3 months (n= 210), the proportion of patients who achieved remission was higher, though the difference was not statistically significant, in the collaborative care group. The effect size was of 0.11. When considering only patients with minor/major depression, collaborative care appeared to be more effective than usual care (P= .015).

Conclusions

The present intervention for managing depression in primary care, designed to be applicable to the Italian context, appears to be effective and feasible.     

Parry Romberg Syndrome associated with chronic facial pain

Parry Romberg Syndrome (PRS) is a rare condition of unknown cause and pathophysiology. It is characterized by progressive facial hemiatrophy, and neurological abnormalities are found in 20% of cases. We describe a 50-year-old woman with PRS and severe neurological involvement (lateralised epileptic seizure activity and facial pain refractory to medication). Pain intensity and frequency was reduced and control of epileptic crises was improved using levetiracetam as an additional therapy. In previous published cases associated with facial pain, the most frequent diagnoses were migraine and trigeminal neuralgia. Our findings suggest that in this patient PRS-related persistent pain has peculiar features possibly attributed to the underlying musculoskeletal abnormalities.     

Episodic ataxia and severe infantile phenotype in spinocerebellar ataxia type 14: expansion of the phenotype and novel mutations

Journal of Neurology - Spinocerebellar ataxia type 14 (SCA14) is a dominantly inherited neurological disorder characterized by slowly progressive cerebellar ataxia. SCA14 is caused by mutations in...     

Difference in safety and humoral response to mRNA SARS-CoV-2 vaccines in patients with autoimmune neurological disorders: the ANCOVAX study

Journal of Neurology - Assessing the safety of SARS-CoV-2 mRNA vaccines and the effect of immunotherapies on the seroconversion rate in patients with autoimmune neurological conditions (ANC) is...     

Long-term efficacy of the trans-obturator and retropubic mid-urethral slings for stress urinary incontinence: update from a randomized clinical trial

Purpose

To report the extended long-term results of the use of tension-free vaginal tape(TVT) and trans-obturator tape (TOT) for the treatment of female stress urinary incontinence (SUI).

Methods

A prospective, multicentre randomized clinical trial comparing the use of TVT and TOT was used to evaluate 87 patients. The inclusion criteria were stress or mixed UI associated with urethral hyper mobility (the stress component was clinically predominant), while the exclusion criteria were previous anti-incontinence surgery and/or pelvic organ prolapse. The objective cure criteria were a negative provocative stress test and a negative 1-h pad test, with no further treatment for SUI. The subjective cure criteria were a 3-day voiding diary, quality-of-life questionnaires (UDI6–IIQ7), and patient satisfaction on a scale from 0 to 10.

Results

Eighty-seven patients were evaluated (47 TOT and 40 TVT) at a median follow-up of 100 months. Subjective and objective cure rates were 59.6 and 70.2 % in the TOT group and 75 and 87.5 % in the TVT group. The mid-to-long-term trend was a decreasing continence rate in patients who underwent TOT, compared with a stable rate for TVT. The Kaplan–Meier survival curve showed that continence rate decreased for up to 25 months after surgery, with stabilization thereafter for the TVT group while continuing to drop in the TOT group, with no inter-group difference.

Conclusion

The patients in both groups were highly satisfied at long-term follow-up. The overall continence rate worsened for both groups within 25 months. While the results tend to stabilize in the TVT group, a further decline in the TOT was observed.