[Psychometric validation of Convergence criteria PP]. / Validation psychométrique des critères de Convergences PP.

CONTEXT: The PP Convergences criteria group together 10 of the most significant clinical criteria for sensitization in the context of chronic pelvic pain. They are the result of a consensus of experts and represent to date the only clinical evaluation guide to identify patients with pelvic perineal pain in whom a pelvic sensitization component can be evoked. OBJECTIVE: This work concerns the psychometric validation of these criteria. The aim is to answer 3 questions: 1) is the instrument reliable (i.e., sensitive, specific and accurate)?; 2) can we define a screening score for pelvic-perineal pain by sensitization from the CPP criteria?; 3) can combinations of criteria be defined to predict pelvic-perineal sensitization from the CPP criteria? METHODOLOGY AND SUBJECTS: In total, 308 patients with pelviperineal pain were recruited during their medical consultation. PROCEDURE: Fifteen expert physicians were asked to judge the presence or absence of the 10 CPP criteria and to make a diagnosis of the presence or absence of pelviperineal sensitization in their patient. RESULTS: ROC curve analysis indicated that a score of 5 was the closest to a perfect score with a sensitivity of 95% and a specificity of 87%. They also indicate that the CPP criteria have a very good sensitivity (97%) and specificity (91%) and present globally a good reproducibility on all the criteria (Kappa>0.6). Finally, the statistical analyses reveal that the most discriminating criterion for predicting sensitization is Q8 (pain persisting after sexual activity). CONCLUSION: The CPP criteria represent a very good screening tool for pelvic sensitization. The score of 5 corresponds to the score at which the patient has sufficient clinical criteria to be classified as sensitized. LEVEL OF EVIDENCE: 4.

Impact of total thyroidectomy on quality of life at 6 months: the prospective ThyrQoL multicentre trial.

OBJECTIVE: This study is to determine the impact of complications after total thyroidectomy on health-related quality of life (HR-QoL) and to identify significant predictive factors of HR-QoL changes. HR-QoL is usually impaired in patients with thyroid diseases compared to the general population. Thyroidectomy is largely performed in the case of benign thyroid benign and can be associated with long-term complications (vocal cord palsy, hypoparathyroidism). DESIGN: The prospective ThyrQoL multicenter trial (NCT02167529) included 800 patients who underwent total thyroidectomy for benign or malignant non-extensive disease in seven French referral hospitals between 2014 and 2016. METHODS: HR-QoL was assessed using the MOS 36-item short form health survey (SF-36) self-questionnaire with a 6-month follow-up. RESULTS: We observed a significant improvement of HR-QoL 6 months after surgery (P < 0.0001). Postoperative complications were associated with a non-significant impairment of HR-QoL. In multivariable analysis, Graves' disease was associated with a significant improvement of HR-QoL (OR = 2.39 [1.49; 3.84]) and thyroid malignant disease with an impairment of HR-QoL (OR = 1.44 [0.99; 2.08]) after thyroidectomy. CONCLUSION: We observed a significant improvement of HR-QoL 6 months after total thyroid surgery for benign thyroid disease.

[Validity and reproducibility of two direct observation assessment forms for evaluation of internal medicine residents' clinical skills]. / Validité et reproductibilité de deux grilles d'observation des compétences cliniques des internes en DES de médecine interne.

INTRODUCTION: The revision of the French medical studies' third cycle ought to be competency-based. In internal medicine, theoretical and practical knowledge will be assessed online with e-learning and e-portfolio. In parallel, a reflection about clinical skills assessment forms is currently ongoing. In this context, our aim was to assess the reproducibility and validity of two assessment forms based on direct clinical observation. METHOD: A prospective and multicentric study has been conducted from November 2015 to October 2016 aiming at evaluating the French translations of the MINI-Clinical Examination Exercice (MINI-CEX) and the Standardized Patient Satisfaction Questionnaire (SPSQ). Included residents have been assessed 2 times over a period of 6 months by the same binoma of judges. RESULTS: Nineteen residents have been included. The inter-judge reproducibility was satisfactory for the MINI-CEX: intraclass coefficients (ICC) between 0.4 and 0.8 and moderate for the SPSQ: ICC between 0.2 and 0.7 with a good internal coherence for both questionnaires (Cronbach between 0.92 and 0.94). Significant differences between the distributions of the scores given by the judges and a significant inter-center variability have been found. CONCLUSION: If the absolute value of the scores should not be taken into account in the evaluation process given its high variability, it could be of interest for the follow-up of the progression in the competencies. These forms could support the residents' debriefing based on the general trends given by the scores.

Glioplasticity in irritable bowel syndrome.

BACKGROUND: Growing evidence indicates a wide array of cellular remodeling in the mucosal microenvironment during irritable bowel syndrome (IBS), which possibly contributes to pathophysiology and symptom generation. Here, we investigated whether enteric glial cells (EGC) may be altered, and which factors/mechanisms lead to these changes. METHODS: Colonic mucosal biopsies of IBS patients (13 IBS-Constipation [IBS-C]; 10 IBS-Diarrhea [IBS-D]; 11 IBS-Mixed [IBS-M]) and 24 healthy controls (HC) were analyzed. Expression of S100ß and GFAP was measured. Cultured rat EGC were incubated with supernatants from mucosal biopsies, then proliferation and Ca2+ response to ATP were analyzed using flow cytometry and Ca2+ imaging. Histamine and histamine 1-receptor (H1R) involvement in the effects of supernatant upon EGC was analyzed. KEY RESULTS: Compared to HC, the mucosal area immunoreactive for S100ß was significantly reduced in biopsies of IBS patients, independently of the IBS subtype. IBS-C supernatants reduced EGC proliferation and IBS-D and IBS-M supernatants reduced Ca2+ response to ATP in EGC. EGC expressed H1R and the effects of supernatant upon Ca2+ response to ATP in EGC were blocked by pyrilamine and reproduced by histamine via H1R. IBS supernatants reduced mRNA expression of connexin-43. The S100ß-stained area was negatively correlated with the frequency and intensity of pain and bloating. CONCLUSION AND INFERENCES: Changes in EGC occur in IBS, involving mucosal soluble factors. Histamine, via activation of H1R-dependent pathways, partly mediates altered Ca2+ response to ATP in EGC. These changes may contribute to the pathophysiology and the perception of pain and bloating in patients with IBS.

Cult membership: What factors contribute to joining or leaving?

We assumed that, as in the case of addiction disorders, former cult members exhibit vulnerability and protective factors for cult commitment and membership. Thus, the aim of our study was to identify vulnerability factors that are involved in the commitment and in the retention in the group, as well as protective factors that are involved in the departure. We interviewed 31 former cult members, using semi-structured interviews to evaluate their clinical profile, characteristics of the cultic group and their experience in the group. Cult membership and addictive disorders share some characteristics: persistence despite damage, initial psychological relief, occupation of an exclusive place in the thoughts of members, high psychiatric comorbidity prevalence, high accessibility, leading to social precariousness and the importance of familial support when leaving. Three main axes of improvement were highlighted: regulations concerning cults in order to limit their social presence, which appears to be a vulnerability factor for commitment; social and therapeutic follow-up when a member leaves a group so that social precariousness does not become an obstacle to departure; and familial support to maintain a link with the member, as the intervention of a person from outside of the group is an important protective factor for leaving.

What are the appropriate methods for analyzing patient-reported outcomes in randomized trials when data are missing?

Subjective health measurements using Patient Reported Outcomes (PRO) are increasingly used in randomized trials, particularly for patient groups comparisons. Two main types of analytical strategies can be used for such data: Classical Test Theory (CTT) and Item Response Theory models (IRT). These two strategies display very similar characteristics when data are complete, but in the common case when data are missing, whether IRT or CTT would be the most appropriate remains unknown and was investigated using simulations. We simulated PRO data such as quality of life data. Missing responses to items were simulated as being completely random, depending on an observable covariate or on an unobserved latent trait. The considered CTT-based methods allowed comparing scores using complete-case analysis, personal mean imputations or multiple-imputations based on a two-way procedure. The IRT-based method was the Wald test on a Rasch model including a group covariate. The IRT-based method and the multiple-imputations-based method for CTT displayed the highest observed power and were the only unbiased method whatever the kind of missing data. Online software and Stata® modules compatibles with the innate mi impute suite are provided for performing such analyses. Traditional procedures (listwise deletion and personal mean imputations) should be avoided, due to inevitable problems of biases and lack of power.

[Validation of a questionnaire for standardized-patient assessment of clinical skills]. / Validation d'une grille d'évaluation des compétences cliniques utilisée par des patients standardisés.

BACKGROUND: This study was designed in the context of a new educational program based on standardized-patients (SPs). The study objectives were (1) to evaluate the reliability of the assessment form used by SPs and (2) to compare global ratings to checklists reproducibility. METHOD: History taking, physical examination and communication skills were assessed by SPs at the end of clinical encounters with year 3 medical students, using generic global rating scales and case-specific checklists. The validation process followed four steps: (1) correlation analysis between global rating and their relative checklist of specific items, (2) internal consistency estimation, (3) validation of the questionnaire dimensions, (4) estimation of the reliability of SPs' ratings compared to medical teachers' ratings. RESULTS: A total of 3322 consultations have been performed by 444 year 3 medical students. Statistical analysis showed a good internal reliability (Cronbach α was greater than 0.7) and an acceptable inter-judge reproducibility except for communication skills. Case-specific checklists did not prove to be more reliable than global ratings. Reproducibility was lower with SPs' than with medical teachers' assessment. CONCLUSION: Global rating-based assessment should be preferred to checklists because they are faster and easier to use (shorter duration of SPs training). As SPs proved to be acceptable examiners, no third person seems to be required as external observer.

Identifying trajectory clusters in breast cancer survivors' supportive care needs, psychosocial difficulties, and resources from the completion of primary treatment to 8 months later.

PURPOSE: This study aimed to chart patterns of simultaneous trajectories over 8 months in breast cancer survivors' (BCS) supportive care needs, psychological distress, social support, and posttraumatic growth. Clusters of BCS among these trajectories were identified and characterized. METHODS: Of 426 BCS study participants, 277 (65%) provided full assessments in the last week of primary cancer treatment and 4 and 8 months later. Latent trajectories were obtained using growth mixture modeling for patients who responded to all scores for at least one time point (n = 348). Then, classification of BCS was performed by hierarchical agglomerative clustering on axes derived from a multiple factor analysis of trajectory assignments. Self-esteem, attachment security, and satisfaction with care were assessed at baseline. RESULTS: Four trajectory clusters were identified, including two BCS subgroups (63%) with low needs and low psychological distress. Two others (37%) exhibited high or increasing needs and concerning levels of psychological distress. These latter clusters were characterized by higher insecure attachment, lower satisfaction with care, and either lower education or younger age, and having undergone chemotherapy. CONCLUSION: More than a third of BCS present unfavorable patterns in supportive care needs over 8 months after primary cancer treatment. Identified psychosocial and cancer care characteristics point to targets for enhanced BCS supportive care.

Exploring the impact of staff absenteeism on patient satisfaction using routine databases in a university hospital.

AIM: To explore the influence of staff absenteeism on patient satisfaction using the indicators available in management reports. BACKGROUND: Among factors explaining patient satisfaction, human resource indicators have been studied widely in terms of burnout or job satisfaction, but there have not been many studies related to absenteeism indicators. METHOD: A multilevel analysis was conducted using two routinely compiled databases from 2010 in the clinical departments of a university hospital (France). The staff database monitored absenteeism for short-term medical reasons (5 days or less), non-medical reasons and absences starting at the weekend. The patient satisfaction database was established at the time of discharge. RESULTS: Patient satisfaction related to relationships with staff was significantly and negatively correlated with nurse absenteeism for non-medical reasons (P < 0.05) and with nurse absenteeism starting at weekends (P < 0.05). Patient satisfaction related to the hospital environment was significantly and negatively correlated with nurse assistant absenteeism for short-term medical reasons (P < 0.05). CONCLUSION: Our findings seem to indicate that patient satisfaction is linked to staff absenteeism and should lead to a better understanding of the impact of human resources on patient satisfaction. IMPLICATIONS FOR NURSING MANAGEMENT: To enhance patient satisfaction, managers need to find a way to reduce staff absenteeism, in order to avoid burnout and to improve the atmosphere in the workplace.

Escherichia coli antibiotic resistance in emergency departments. Do local resistance rates matter?

Ciprofloxacin and cotrimoxazole are recommended to treat uncomplicated pyelonephritis and uncomplicated cystitis, respectively, provided that local resistance rates of uropathogens do not exceed specified thresholds (10 and 20 %, respectively). However, Escherichia coli resistance rates in Emergency Departments (ED) remain poorly described. Our objectives were to assess E. coli ciprofloxacin and cotrimoxazole resistance rates in EDs of a French administrative region, and to determine if resistance rates differ between EDs. This was a retrospective study of E. coli urine isolates sampled in ten EDs between 2007 and 2012. The following risk factors for resistance were tested using logistic regression: ED, sex, age, sampling year, sampling month. A total of 17,527 isolates were included. Ciprofloxacin local resistance rates (range, 5.3 % [95 % CI, 4.0-7.1 %] to 11.7 % [95 % CI, 5.2-23.2 %]) were ≤10 % in nine EDs in 2012. Five EDs were risk factors for ciprofloxacin resistance, as were male sex, age and sampling in April or October. Cotrimoxazole local resistance rates (range, 13.3 % [95 % CI, 6.3-25.1 %] to 20.4 % [95 % CI, 18.9-22.0 %]) were ≤20 % in seven EDs in 2012. Five EDs were risk factors for cotrimoxazole resistance, as were age, sampling between October and December, and sampling in 2011 and 2012. We found a significant variability of E. coli ciprofloxacin and cotrimoxazole resistance rates among EDs of a small region. These differences impact on the feasibility of empirical treatment of urinary tract infections with ciprofloxacin or cotrimoxazole in a given ED. Continuous local survey of antibacterial resistance in ED urinary isolates is warranted to guide antibacterial therapy of urinary tract infections.

Power analysis on the time effect for the longitudinal Rasch model.

Statistics literature in the social, behavioral, and biomedical sciences typically stress the importance of power analysis. Patient Reported Outcomes (PRO) such as quality of life and other perceived health measures (pain, fatigue, stress,...) are increasingly used as important health outcomes in clinical trials or in epidemiological studies. They cannot be directly observed nor measured as other clinical or biological data and they are often collected through questionnaires with binary or polytomous items. The Rasch model is the well known model in the item response theory (IRT) for binary data. The article proposes an approach to evaluate the statistical power of the time effect for the longitudinal Rasch model with two time points. The performance of this method is compared to the one obtained by simulation study. Finally, the proposed approach is illustrated on one subscale of the SF-36 questionnaire.

Evaluation properties of the French version of the OUT-PATSAT35 satisfaction with care questionnaire according to classical and item response theory analyses.

PURPOSE: The present study investigates the properties of the French version of the OUT-PATSAT35 questionnaire, which evaluates the outpatients' satisfaction with care in oncology using classical analysis (CTT) and item response theory (IRT). METHODS: This cross-sectional multicenter study includes 692 patients who completed the questionnaire at the end of their ambulatory treatment. CTT analyses tested the main psychometric properties (convergent and divergent validity, and internal consistency). IRT analyses were conducted separately for each OUT-PATSAT35 domain (the doctors, the nurses or the radiation therapists and the services/organization) by models from the Rasch family. We examined the fit of the data to the model expectations and tested whether the model assumptions of unidimensionality, monotonicity and local independence were respected. RESULTS: A total of 605 (87.4%) respondents were analyzed with a mean age of 64 years (range 29-88). Internal consistency for all scales separately and for the three main domains was good (Cronbach's α 0.74-0.98). IRT analyses were performed with the partial credit model. No disordered thresholds of polytomous items were found. Each domain showed high reliability but fitted poorly to the Rasch models. Three items in particular, the item about "promptness" in the doctors' domain and the items about "accessibility" and "environment" in the services/organization domain, presented the highest default of fit. A correct fit of the Rasch model can be obtained by dropping these items. Most of the local dependence concerned items about "information provided" in each domain. A major deviation of unidimensionality was found in the nurses' domain. CONCLUSIONS: CTT showed good psychometric properties of the OUT-PATSAT35. However, the Rasch analysis revealed some misfitting and redundant items. Taking the above problems into consideration, it could be interesting to refine the questionnaire in a future study.

Increasing use of third-generation cephalosporins for pneumonia in the emergency department: may some prescriptions be avoided?

Third-generation cephalosporins are used to treat inpatients with community-acquired pneumonia. Some of these prescriptions may be avoided, i.e. replaced by agents less likely to promote ESBL-mediated resistance. Our objectives were to assess the recent trend of third-generation cephalosporins use for pneumonia in the emergency department, and the proportion of avoidable prescriptions. This was a retrospective study of patients treated for community-acquired pneumonia in an emergency department, and subsequently hospitalized in non ICU wards. Third-generation cephalosporin prescriptions were presumed unavoidable if they met both criteria: (i) age ≥ 65 yr or comorbid condition, and (ii) allergy or intolerance to penicillin, or failure of penicillin first-line therapy, or treatment with penicillin in three previous months. Prescriptions were otherwise deemed avoidable. The proportion of patients treated with a third generation cephalosporin increased significantly from 13.9 % (6.9-24.1 %) in 2002 to 29.5 % (18.5-42.6 %) in 2012 (OR = 1.07 [1.01-1.14] , P = 0.02). This increase was independent from other factors associated with the prescription of a third-generation cephalosporin (immunocompromising condition, antibacterial therapy in three previous months, fluid resuscitation and REA-ICU class). Treatment with third-generation cephalosporin was avoidable in 118 out of 147 patients (80.3 % [72.7-86.2 %]). On day 7 after admission in the ED, treatment with third-generation cephalosporins was stopped or de-escalated in, respectively, 17 % and 32 % of patients. Antibiotic stewardship programs should be implemented to restrict the third-generation cephalosporins use for pneumonia in the emergency department.

Effect of stress on clinical reasoning during simulated ambulatory consultations.

BACKGROUND: The goal of this study was to examine the impact of subjective and physiological stress responses on medical students' diagnostic reasoning and communication skills. METHOD: A prospective randomized quantitative study was undertaken, looking at ambulatory consultations in internal medicine. On the first day (baseline day), volunteer year 6 students (n = 41) participated in a simulated ambulatory consultation with standardized patients (SPs). On the second day (study day), one week later, they were randomly assigned to two groups: a low stress (n = 20) and a high stress (n = 21) simulated ambulatory consultation. Stress was measured using validated questionnaires and salivary cortisol. The SPs assessed the students' reasoning and communication. The students completed assessments of their clinical reasoning after the consultations. RESULTS: Although stress measures were all significantly higher in the high-stress condition (all p < 0.05), no differences were found in diagnostic accuracy and justification scores. However, correlational analyses revealed a negative correlation between multiple-stress measures and the students' ability to generate arguments for differential diagnoses. CONCLUSION: Stress was associated with impairments in clinical reasoning, of a nature typically suggestive of premature closure.

Immobilization and the risk of venous thromboembolism. A meta-analysis on epidemiological studies.

BACKGROUND: The thrombogenic burden of immobilization remains unknown especially in the medical setting. Most of epidemiological studies estimating the link between risk factors and venous thromboembolism (VTE) have not been designed to evaluate immobilization. The aim of this work was to estimate the risk of VTE in medical bedridden patients by a systematic review and a meta-analysis. METHODS: A research on PUBMED and EMBASE was carried out to retrieve case-control and cohort studies showing the proportion of bedridden patients with or without VTE. Included studies were assigned in six groups according to the following criteria: 1) their design (cohort or case-control), 2) the targeted population (with or without suspicion of VTE) and 3) the medical setting (ambulatory or hospital). Odd-Ratios and Relative Risk for case-control and cohort studies were calculated using a random effect method. Heterogeneity and publication bias were statistically assessed by the I(2) statistics and funnel plots with Egger's tests. RESULTS: 43 studies were included (24181 patients). The pooled RR ranged from 1.46 to 2.77 in the subgroups of cohort studies (n=36) with an overall RR of 1.86 (1.61-2.14; P<0.001). The pooled OR were 2.79 and 2.47 in the two subgroups of case-control studies (n=7), both statistically significant (overall OR: 2.52; 1.70-3.74; P<0.001). Heterogeneity through studies was demonstrated in four subgroups. Publication bias was only observed in one subgroup. CONCLUSIONS: Among medical patients, immobilization increases the risk of VTE. Nevertheless, a specific role of underlying conditions can not be excluded.