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IntroductionFirst-episode psychosis (FEP) affects 3% of the population worldwide, mainly young adults. International guidelines for FEP are based on the principles of intensive case management (CM). To improve the relevance of CM and thus patient engagement and functional outcomes, goals of care must be not solely clinical, but placed within an individualized ’recovery’ perspective, considering the patient‘s point of view. The use of clinical tools co-constructed by end-users and adapted to recovery objectives seems essential.MethodsWe used a ’user-centered design’ iterative co-building methodology. In the first phase, 4 workshops were conducted to develop the application with end-users. A thematic content analysis was carried out after the workshops to optimize the specifications of a beta version of the mobile application. Direct interviews were conducted after testing the beta version of PLAN-e-PSY and a qualitative analysis was carried out.Results2 patients, 2 case managers, a caregiver, a peer-worker, a developer and an ergonomist participated in the workshops. The architecture and contents of the application were defined. Participants also worked together to define the application’s graphics charter and ergonomics. Interviews conducted with 3 CMs, 2 peer workers, a caregiver and a patient at the end of the beta test helped improve the application and revealed that the beta version of PLAN-e-PSY was easy to use (4.5/5) and perceived as useful (3.5/5).DiscussionParticipatory action research carried out in partnership with end-users enabled us to construct an application relevant to patients, their families and professionals. We hypothesized that it would contribute to improving CM and thus patient engagement and functional outcomes.ConclusionA funded randomized controlled trial involving 168 patients will assess the application’s effectiveness in FEP care facilities.

IntroductionThe prognosis of first episode psychosis (FEP), which is a severe disorder, can be notably impaired by patients’ disengagement from healthcare providers. Coordinated specialty care with case management is now considered as the gold standard in this population, but there are still challenges for engagement with subsequent functional impairments. Youth-friendly and patient-centred clinical approaches are sought to improve engagement in patients with FEP. Mobile applications are widely used by young people, including patients with FEP, and can increase the youth friendliness of clinical tools. We hypothesise that a co-designed mobile application used during case management can improve functioning in patients with FEP as compared with usual case management practices.Methods and analysisA mobile case management application for planning and monitoring individualised care objectives will be co-designed with patients, caregivers and health professionals in a recovery-oriented approach. The application will be compared with usual case management practices in a multicentre, two-arm and parallel groups clinical trial. Patients will be recruited by specialised FEP teams. Impact on functioning will be assessed using the Personal and Social Performance Scale; the variation between baseline and 12 months in each group (control and active) will be the primary outcome.Ethics and disseminationThis study has been approved by the Inserm Institutional Review Board IRB00003888 (Comité d’évaluation éthique de l’INSERM, reference number 20-647). The results of the study will be published in a peer-reviewed journal and presented at national and international conferences. We will also communicate the results to patients and family representatives’ associations. An optimised version of the application will be then disseminated through the French FEP network (Transition Network).Trial registration numberClinicalTrials.gov: NCT04657380

Background One out of three patients with schizophrenia failed to respond adequately to antipsychotics and continue to experience debilitating symptoms such as auditory hallucinations and negative symptoms. The development of additional therapeutic approaches for these persistent symptoms constitutes a major goal for patients. Here, we develop a randomized-controlled trial testing the efficacy of high-frequency transcranial random noise stimulation (hf-tRNS) for the treatment of resistant/persistent symptoms of schizophrenia in patients with various profiles of symptoms, cognitive deficits and illness duration. We also aim to investigate the biological and cognitive effects of hf-tRNS and to identify the predictors of clinical response. Methods In a randomized, double-blind, 2-arm parallel-group, controlled, multicentre study, 144 patients with schizophrenia and persistent symptoms despite the prescription of at least one antipsychotic treatment will be randomly allocated to receive either active ( n = 72) or sham ( n = 72) hf-tRNS. hf-tRNS (100–500 Hz) will be delivered for 20 min with a current intensity of 2 mA and a 1-mA offset twice a day on 5 consecutive weekdays. The anode will be placed over the left dorsolateral prefrontal cortex and the cathode over the left temporoparietal junction. Patients’ symptoms will be assessed prior to hf-tRNS (baseline), after the 10 sessions, and at 1-, 3- and 6-month follow-up. The primary outcome will be the number of responders defined as a reduction of at least 25% from the baseline scores on the Positive and Negative Syndrome Scale (PANSS) after the 10 sessions. Secondary outcomes will include brain activity and connectivity, source monitoring performances, social cognition, other clinical (including auditory hallucinations) and biological variables, and attitude toward treatment. Discussion The results of this trial will constitute a first step toward establishing the usefulness of hf-tRNS in schizophrenia whatever the stage of the illness and the level of treatment resistance. We hypothesize a long-lasting effect of active hf-tRNS on the severity of schizophrenia symptoms as compared to sham. This trial will also have implications for the use of hf-tRNS as a preventive intervention of relapse in patients with schizophrenia. Trial registration ClinicalTrials.gov NCT02744989. Prospectively registered on 20 April 2016

IntroductionProstate multiparametric MRI (mpMRI) has shown good sensitivity in detecting cancers with an International Society of Urological Pathology (ISUP) grade of ≥2. However, it lacks specificity, and its inter-reader reproducibility remains moderate. Biomarkers, such as the Prostate Health Index (PHI), may help select patients for prostate biopsy. Computer-aided diagnosis/detection (CAD) systems may also improve mpMRI interpretation. Different prototypes of CAD systems are currently developed under the Recherche Hospitalo-Universitaire en Santé / Personalized Focused Ultrasound Surgery of Localized Prostate Cancer (RHU PERFUSE) research programme, tackling challenging issues such as robustness across imaging protocols and magnetic resonance (MR) vendors, and ability to characterise cancer aggressiveness. The study primary objective is to evaluate the non-inferiority of the area under the receiver operating characteristic curve of the final CAD system as compared with the Prostate Imaging-Reporting and Data System V.2.1 (PI-RADS V.2.1) in predicting the presence of ISUP ≥2 prostate cancer in patients undergoing prostate biopsy.MethodsThis prospective, multicentre, non-inferiority trial will include 420 men with suspected prostate cancer, a prostate-specific antigen level of ≤30 ng/mL and a clinical stage ≤T2 c. Included men will undergo prostate mpMRI that will be interpreted using the PI-RADS V.2.1 score. Then, they will undergo systematic and targeted biopsy. PHI will be assessed before biopsy. At the end of patient inclusion, MR images will be assessed by the final version of the CAD system developed under the RHU PERFUSE programme. Key secondary outcomes include the prediction of ISUP grade ≥2 prostate cancer during a 3-year follow-up, and the number of biopsy procedures saved and ISUP grade ≥2 cancers missed by several diagnostic pathways combining PHI and MRI findings.Ethics and disseminationEthical approval was obtained from the Comité de Protection des Personnes Nord Ouest III (ID-RCB: 2020-A02785-34). After publication of the results, access to MR images will be possible for testing other CAD systems.Trial registration numberNCT04732156.

Background Traumatic exposure is a frequent issue in patients visiting emergency departments (EDs). Some patients will subsequently develop post-traumatic stress disorder (PTSD) while other will not. The problem is under-diagnosed in EDs and no standardized management is provided to prevent PTSD. Most studies focused on a particular group of trauma whereas we need a global approach to further develop interventions for detecting and treating patients at high risk. We aim to assess the prevalence of traumatic exposure and situation at high risk of further PTSD and identify pre and peri-traumatic biopsychosocial factors predisposing individuals to PTSD in the general context of EDs. Methods This comprehensive multicenter study will have two steps. The first step will be a cross-sectional study on moderate and high risk of PTSD prevalence among EDs visitors with a recent history of trauma. All patients aged 18–70 years, presenting with a recent history of trauma (< 1 month) in one of the six EDs in the Auvergne-Rhône-Alpes region (≈1/10° of the French population) will be included over a 1-month period and approximately 1500 subjects are expected in this cross-sectional step. The risk of PTSD will be assessed using the Impact of Event Scale Revised (IES-R). Self-administered questionnaires will be used to measure acute stress (IES–R), and a number of potential bio-psycho-social risk factors. Demographic and physical health-related data will be collected from medical file. Second step will be a prospective cohort study within a sub-sample of 400 patients enrolled in step 1, randomly selected with stratification on sex, age, ED, and IES–R score. At 3 months, PTSD will be defined by a ≥ 33 score at PTSD Check List for DSM–5 (PCL–5) through a telephone interview. We will evaluate definite PTSD biopsychosocial predictive factors using a multivariate logistic regression model and describe evolution of PTSD at 3 months. Discussion This is the first study to assess PTSD predictors prospectively with a biopsychosocial approach within a cohort representative of EDs visitors. The results will inform the development of dedicated interventions to decrease the risk of subsequent PTSD. Trial registration ClinicalTrials.gov: NCT03615014 ; ISSUE protocol 2nd version was approved on 07/08/2018.

Background In the Lao People's Democratic Republic (Lao PDR), cervical cancer is the third leading cause of women cancer. Aims The objective of this cross‐sectional study was to compare the efficacy of careHPV™ test versus conventional Pap smear or Siriraj liquid‐based cytology in the detection of cervical cancer in women living with human immunodeficiency virus type 1 (HIV‐1). Materials & Methods Overall, 631 women consented to participate. Four cervical specimens were taken for the purpose of conventional Pap smear, Siriraj liquid‐based cytology, careHPV™ test, and HPV‐16 genotyping. The exact McNemar test was used to compare the efficacy and diagnostic performance of the tests. Results Of the 631 women with follow‐up, 331 were human papillomavirus (HPV) negative. High‐grade squamous intraepithelial lesions were found in 37 women, biopsy‐proven high‐grade cervical intraepithelial neoplasia in 50 women, and invasive carcinoma in seven women. The proportion of women with high‐grade cervical lesion or carcinoma detected after abnormal careHPV™ test was higher (6.02%; 95% confidence interval [CI]: 4.4–8.1) than that detected by conventional Pap smear (4.59%; 95% CI: 3.2–6.5). careHPV™ and HPV‐16 genotyping had, respectively, the highest sensitivity (80.8%; 95% CI: 67.4–89.5) and specificity (92.2%; 95% CI: 89.8–94.2). HPV‐16 was the most frequently detected genotype. Conclusions careHPV™ test represents a screening option in Lao PDR, particularly in women living with HIV‐1 because of higher prevalence of chronic HPV in this population. LaoCol study provided health authorities in Lao People's Democratic Republic with a basis for improving their national cervical cancer screening policy and some epidemiological information useful for the establishment of a possible human papillomavirus vaccine prevention policy.

Whether multiparametric MRI improves the detection of clinically significant prostate cancer and avoids the need for systematic biopsy in biopsy-naive patients remains controversial. We aimed to investigate whether using this approach before biopsy would improve detection of clinically significant prostate cancer in biopsy-naive patients. In this prospective, multicentre, paired diagnostic study, done at 16 centres in France, we enrolled patients aged 18–75 years with prostate-specific antigen concentrations of 20 ng/mL or less, and with stage T2c or lower prostate cancer. Eligible patients had been referred for prostate multiparametric MRI before a first set of prostate biopsies, with a planned interval of less than 3 months between MRI and biopsies. An operator masked to multiparametric MRI results did a systematic biopsy by obtaining 12 systematic cores and up to two cores targeting hypoechoic lesions. In the same patient, another operator targeted up to two lesions seen on MRI with a Likert score of 3 or higher (three cores per lesion) using targeted biopsy based on multiparametric MRI findings. Patients with negative multiparametric MRI (Likert score ≤2) had systematic biopsy only. The primary outcome was the detection of clinically significant prostate cancer of International Society of Urological Pathology grade group 2 or higher (csPCa-A), analysed in all patients who received both systematic and targeted biopsies and whose results from both were available for pathological central review, including patients who had protocol deviations. This study is registered with ClinicalTrials.gov, number NCT02485379, and is closed to new participants. Between July 15, 2015, and Aug 11, 2016, we enrolled 275 patients. 24 (9%) were excluded from the analysis. 53 (21%) of 251 analysed patients had negative (Likert ≤2) multiparametric MRI. csPCa-A was detected in 94 (37%) of 251 patients. 13 (14%) of these 94 patients were diagnosed by systematic biopsy only, 19 (20%) by targeted biopsy only, and 62 (66%) by both techniques. Detection of csPCa-A by systematic biopsy (29·9%, 95% CI 24·3–36·0) and targeted biopsy (32·3%, 26·5–38·4) did not differ significantly (p=0·38). csPCa-A would have been missed in 5·2% (95% CI 2·8–8·7) of patients had systematic biopsy not been done, and in 7·6% (4·6–11·6) of patients had targeted biopsy not been done. Four grade 3 post-biopsy adverse events were reported (3 cases of prostatitis, and 1 case of urinary retention with haematuria). There was no difference between systematic biopsy and targeted biopsy in the detection of ISUP grade group 2 or higher prostate cancer; however, this detection was improved by combining both techniques and both techniques showed substantial added value. Thus, obtaining a multiparametric MRI before biopsy in biopsy-naive patients can improve the detection of clinically significant prostate cancer but does not seem to avoid the need for systematic biopsy. French National Cancer Institute.

Background: With the development of the sentinel node technique in early-stage cervical cancer, it is imperative to define the clinical significance of micrometastases (MICs) and isolated tumor cells (ITCs). Methods: We included all patients who participated in the Senticol 1 and Senticol 2 studies. We analyzed the factors associated with the presence of low-volume metastasis, the oncological outcomes of patients with MIC and ITC and the correlation of recurrences and risk factors. Results: Twenty-four patients (7.5%) had low-volume metastasis. The risk factors associated with the presence of low-volume metastasis were a higher stage (p = 0.02) and major stromal invasion (p = 0.01) in the univariate analysis. The maximum specificity and sensitivity were found at a cutoff of 8 mm of stromal invasion. In multivariate analysis, the higher stage (p = 0.02) and the positive lymphovascular space invasion (p = 0.02) were significantly associated with the MIC and ITC. Patients with low-volume metastasis had similar disease-free survival (DFS) (92.7%) to node-negative patients (93.6%). The addition of adjuvant treatment in presence of low-volume metastasis did not modify the DFS. Conclusions: These results confirm our previous analysis of Senticol 1: the presence of low-volume metastasis did not decrease the DFS in early-stage cervical cancer patients.

ObjectivesThe aim of this study was to evaluate the impact of micrometastasis and isolated tumor cells on disease recurrence in patients with early-stage cervical cancer.MethodsWe included patients with International Federation of Gynecology and Obstetrics (FIGO) stage IA1 with lymphvascular space invasion, stage IA2, and IB1 who participated in the SENTICOL1 trial. A centralized histologic analysis with re-reading and ultrastaging was performed 3 months after surgery and treatment was not impacted by findings from our study. Patients were followed for 3 years and outcomes were compared according to prognostic factors.ResultsA total of 139 patients were included and 13 recurrences were found. There were two recurrences in patients with positive sentinel lymph node (SLN) (one macrometastases and one micrometastases) and 11 recurrences in patients with negative lymph nodes (sentinel or non-sentinel). Among patients with positive SLN for micrometastases there was only one recurrence. No patient with isolated tumor cells on their lymph nodes experienced a recurrence. There was a significant decrease in disease-free survival in patients aged >50 years (p = 0.01).ConclusionEvidence of micrometastasis or isolated tumor cells in the SLN of untreated patients with early cervical cancer in the SENTICOL1 trial did not impact progression-free survival.

Background: The goal of this study was to identify the risk factors for metastasis in the remaining non-sentinel lymph nodes (SLN) in the case of positive SLN in early-stage cervical cancer. Methods: An ancillary analysis of two prospective multicentric databases on SLN biopsy for cervical cancer (SENTICOL I and II) was performed. Patients with early-stage cervical cancer (FIGO 2018 IA to IIA1), with bilateral SLN detection and at least one positive SLN after ultrastaging, were included. Results: 405 patients were included in SENTICOL I and Il. Fifty-two patients had bilateral SLN detection and were found to have SLN metastasis. After pelvic lymphadenectomy, metastatic involvement of non-SLN was diagnosed in 7 patients (13.5%). Patients with metastatic non-SLN were older (51.9 vs. 40.8 years, p = 0.01), had more often lympho-vascular space invasion (LVSI) (85.7% vs. 35.6%, p = 0.03), and had more often parametrial involvement (42.9% vs. 6.7%, p = 0.003). Multivariate analysis retained age (OR = 1.16, 95% IC = [1.01–1.32], p = 0.03) and LVSI (OR = 25.97, 95% IC = [1.16–582.1], p = 0.04) as independently associated with non-SLN involvement. Conclusions: Age and LVSI seemed to be predictive of non-SLN metastasis in patients with SLN metastasis in early-stage cervical cancer. Larger cohorts are needed to confirm the results and clinical usefulness of such findings.