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1.
Rev Med Interne ; 44(6): 274-281, 2023 Jun.
Article in French | MEDLINE | ID: mdl-37024357

ABSTRACT

RATIONALE: Objective structured clinical examinations (OSCEs) were introduced to evaluate students not only on their knowledge, but also on their clinical skills and attitudes. The objectives were to study the correlation between OSCE scores and scores obtained to traditional knowledge examinations and to analyse factors associated with better OSCE performance in DFASM1 and 2 students at Dijon university hospital. METHODS: This was a prospective observational study conducted among all fourth and fifth year medical students in Dijon. The scores on the OSCE elective tests (2022) and the average score on the knowledge tests (2021-2022) were collected and their correlation measured. A questionnaire asked students about their demographic characteristics, their investment in formative and practicum OSCEs, their level of empathy (Jefferson questionnaire) and their personality traits (NEO-Pi-R). RESULTS: Of 549 students, 513 completed all tests. Scores on OSCE and faculty knowledge tests were correlated (r=0.39, P<0.001). Of these, 111 (20%) students responded to the questionnaire, and 97 were analized. We did not observe any significant difference between students who performed better on OSCEs than on knowledge tests and those who did not, regarding their age, their investment in formative tests, their personality traits or their level of empathy. CONCLUSION: Our results underline the need to optimize the evaluation of empathy and clinical skills in OSCE tests, using new tools, in order to better discriminate between students on these skills.


Subject(s)
Students, Medical , Humans , Educational Measurement/methods , Physical Examination/methods , Hospitals, University , Faculty , Clinical Competence
2.
Rev Med Interne ; 43(11): 640-644, 2022 Nov.
Article in French | MEDLINE | ID: mdl-36068122

ABSTRACT

INTRODUCTION: Colchicine is a narrow therapeutic margin drug that does not have the adverse effects of corticosteroids and immunosuppressants. Its use in non-severe ocular inflammatory disease excluding Behcet's disease has not been studied. METHODS: We included patients seen in the internal medicine department of Dijon University Hospital consecutively between September 2020 and September 2021 if they had received colchicine during their pathology. Patients with suspected Behçet's disease were excluded. Treatment efficacy was studied in patients with at least one year of disease progression who had received more than one year of colchicine. Successful treatment was defined as a 50 % reduction in the number of annual relapses on colchicine. RESULTS: Sixteen patients were included (9 women and 7 men). They had recurrent anterior uveitis (n=10), recurrent scleritis (n=5) and intermediate uveitis. Opthalmological involvement was neither severe nor complicated. All patients combined, the annual relapse ratio (ARR) decreased from 1.8 (0.8-3.5) to 0.3 (0-1.6), (P=0.06). Colchicine was considered effective in three of 10 analyzable patients. In only one patient, treatment was stopped for adverse effects after six weeks. CONCLUSION: In view of the interesting benefit-risk ratio of colchicine, it seems appropriate to focus on this molecule in non-granulomatous anterior uveitis and non-severe recurrent scleritis.


Subject(s)
Behcet Syndrome , Scleritis , Uveitis, Anterior , Uveitis , Male , Humans , Female , Behcet Syndrome/complications , Behcet Syndrome/diagnosis , Behcet Syndrome/drug therapy , Colchicine/adverse effects , Scleritis/diagnosis , Scleritis/drug therapy , Scleritis/etiology , Vision Disorders , Uveitis, Anterior/complications , Uveitis, Anterior/drug therapy , Recurrence , Inflammation/complications , Uveitis/diagnosis , Uveitis/drug therapy , Uveitis/etiology
3.
Genet Med ; 23(12): 2433-2442, 2021 12.
Article in English | MEDLINE | ID: mdl-34385668

ABSTRACT

PURPOSE: PIK3CA pathogenic variants in the PIK3CA-related overgrowth spectrum (PROS) activate phosphoinositide 3-kinase signaling, providing a rationale for targeted therapy, but no drug has proven efficacy and safety in this population. Our aim was to establish the six-month tolerability and efficacy of low-dose taselisib, a selective class I PI3K inhibitor, in PROS patients. METHODS: Patients over 16 years with PROS and PIK3CA pathogenic variants were included in a phase IB/IIA multicenter, open-label single-arm trial (six patients at 1 mg/day of taselisib, then 24 at 2 mg/day). The primary outcome was the occurrence of dose limiting toxicity (DLT). Efficacy outcomes were the relative changes after treatment of (1) tissue volume at affected and unaffected sites, both clinically and on imaging; (2) cutaneous vascular outcomes when relevant; (3) biologic parameters; (4) quality of life; and (5) patient-reported outcomes. RESULTS: Among 19 enrolled patients, 2 experienced a DLT (enteritis and pachymeningitis) leading to early trial termination (17 treated, 10 completed the study). No serious adverse reaction occurred in the 1 mg cohort (n = 6). No significant reduction in affected tissue volume was observed (mean -4.2%; p = 0.81; SD 14.01). Thirteen (76.4%) participants reported clinical improvement (pain reduction, chronic bleeding resolution, functional improvement). CONCLUSION: Despite functional improvement, the safety profile of low-dose taselisib precludes its long-term use.


Subject(s)
Klippel-Trenaunay-Weber Syndrome , Syzygium , Adult , Humans , Imidazoles , Mutation , Oxazepines , Phosphatidylinositol 3-Kinases/genetics , Quality of Life
4.
Int J Infect Dis ; 105: 256-260, 2021 Apr.
Article in English | MEDLINE | ID: mdl-33508478

ABSTRACT

BACKGROUND: Debate continues regarding the usefulness and benefits of wide prescription of antibiotics in patients hospitalized with coronavirus disease 2019 (COVID-19). METHODS: All patients hospitalized in the Infectious Diseases Department, Dijon University Hospital, Dijon, France between 27 February and 30 April 2020 with confirmed COVID-19 were included in this study. Clinical, biological and radiological data were collected, as well as treatment and outcome data. An unfavourable outcome was defined as death or transfer to the intensive care unit. Patient characteristics and outcomes were compared between patients who did and did not receive antibiotic therapy using propensity score matching. FINDINGS: Among the 222 patients included, 174 (78%) received antibiotic therapy. The univariate analysis showed that patients who received antibiotic therapy were significantly older, frailer and had more severe presentation at admission compared with patients who did not receive antibiotic therapy. Unfavourable outcomes were more common in patients who received antibiotic therapy [hazard ratio (HR) 2.94, 95% confidence interval (CI) 1.07-8.11; P = 0.04]. Multi-variate analysis and propensity score matching indicated that antibiotic therapy was not significantly associated with outcome (HR 1.612, 95% CI 0.562-4.629; P = 0.37). CONCLUSION: Antibiotics were frequently prescribed in this study and this was associated with more severe presentation at admission. However, antibiotic therapy was not associated with outcome, even after adjustment. In line with recent publications, such data support the need to streamline antibiotic therapy in patients with COVID-19.


Subject(s)
Anti-Bacterial Agents/therapeutic use , COVID-19 Drug Treatment , SARS-CoV-2 , Aged , Aged, 80 and over , Female , France/epidemiology , Hospitalization , Hospitals, University , Humans , Male , Middle Aged , Prognosis , Propensity Score
5.
J Visc Surg ; 158(4): 305-311, 2021 08.
Article in English | MEDLINE | ID: mdl-33446466

ABSTRACT

BACKGROUND: We know that inflammation is related to colorectal cancer prognosis and to the onset of postoperative infections. OBJECTIVE: This study aimed to understand the relationship between preoperative inflammation and the prognosis of colorectal cancer and to elucidate whether the impact of inflammation on cancer prognosis was related to an increased risk of surgical infection or was independent of it. METHODS: Patients who underwent elective colorectal cancer surgery between November 2011 and April 2014 were included in a prospective database (IMACORS). Preoperative c reactive protein was collected for each patient. Patients were followed up according to the French national guidelines. A cut-off of preoperative CRP of 5mg/L was chosen. Clinical characteristics were compared according to CRP using Chi2 and Mann-Whitney tests. The Overall Survival (OS) and Disease-Free-Survival (DFS) were compared by Kaplan-Meier curves. A Cox proportional hazards regression model was applied to perform a multivariate analysis of OS and DFS's predictors. RESULTS: A total of 254 patients were included. The median age was 68 years old. The median follow up was 41.8 months. The overall median preoperative CRP was 5mg/L. Preoperative CRP was significantly associated with N status; CRP being significantly higher among patients with colonic cancer and with patients who didn't receive a neoadjuvant treatment. Multivariate analyse revealed that preoperative CRP is an independent prognostic factor of OS and DFS respectively (HR=2.34 (1.26-4.31), P=0.006 and HR=1.83 (1.15-2.90), P=0.01). CONCLUSION: Preoperative inflammation measured by CRP is independently related with overall and disease-free survival of colorectal cancer.


Subject(s)
Colonic Neoplasms , Colorectal Neoplasms , Aged , C-Reactive Protein , Colorectal Neoplasms/complications , Colorectal Neoplasms/surgery , Disease-Free Survival , Humans , Inflammation , Prognosis , Retrospective Studies
6.
Lupus ; 28(14): 1628-1639, 2019 Dec.
Article in English | MEDLINE | ID: mdl-31674267

ABSTRACT

OBJECTIVES: To quantify changes in generic patient-reported outcomes against clinically meaningful, disease activity measures in systemic lupus erythematosus (SLE). METHODS: Using BLISS-52 trial data (867 SLE patients), we estimated the mean difference in change of patient-reported outcome scores (Medical Outcomes Study SF-36 and FACIT-fatigue) in relation to disease activity (SELENA-SLEDAI, SELENA-SLEDAI flare index, SLE responder index and British Isles Lupus Assessment Group (BILAG)), considering all study visits by the mean of multivariate mixed models. Predefined disease activity criteria were used to define for improvement and worsening. RESULTS: Mean changes in physical component summary/mental component summary and FACIT-fatigue in response to changes in SELENA-SLEDAI and SELENA-SLEDAI flare index were significantly lower than 2.5. New SELENA-SLEDAI flare index flare led to a significant change in all patient-reported outcome scores, except role emotional. Mean improvement in patient-reported outcomes with achievement of SLE responder index ranged between +6.2 (physical function) and +11.3 (bodily pain) for SF-36 domains, + 3.4 and +3.3 for mental component summary and physical component summary, and was +4.2 for FACIT-fatigue. When considering disease activity changes by organ system, changes in BILAG (constitutional) was independently associated with significant changes in FACIT-fatigue and all SF-36 domains (except physical function), changes in BILAG (musculoskeletal and hematological) were independently associated with significant changes in patient-reported outcome scores, except for role emotional (musculoskeletal) and general health/mental health (hematological). Mean changes in every SF-36 domain varied (and was >5) with SLE responder index attainment. CONCLUSIONS: Knowledge of changes in patient-reported outcomes, against clinically meaningful changes in SLE disease activity measures, is crucial for designing of clinical trials, interpretation of results and shared decision-making for patient care.


Subject(s)
Lupus Erythematosus, Systemic/physiopathology , Lupus Erythematosus, Systemic/psychology , Patient Reported Outcome Measures , Quality of Life , Adult , Antibodies, Monoclonal, Humanized/therapeutic use , Female , Humans , Lupus Erythematosus, Systemic/drug therapy , Male , Middle Aged , Severity of Illness Index , Young Adult
7.
Lupus ; 28(13): 1534-1540, 2019 Nov.
Article in English | MEDLINE | ID: mdl-31635557

ABSTRACT

BACKGROUND: LupusPRO is a SLE specific patient reported outcomes measure developed and validated in the USA. This study aimed to validate the Hindi version of LupusPRO in systemic lupus erythematosus (SLE) patients in India. METHODS: Disease activity and damage were assessed using SELENA-SLEDAI and SLICC/ACR damage Index respectively. Demographic and clinical features were recorded. The Hindi Version of LupusPRO and 36-Item Short Form Health Survey (SF-36) were administered for assessment of quality of life. Depression, anxiety and fatigue were assessed using Patient Health Questionnaire 9 (PHQ9), Generalized Anxiety Disorder 7 (GAD7) and Fatigue Severity Scale (FSS) respectively. Internal consistency reliability, test-retest reliability, convergent and discriminant validity (against corresponding domains of the SF-36, fatigue, depression and anxiety), criterion validity (against disease activity and damage) and known group validity were tested. RESULTS: A total of 144 (140 females) patients with SLE with a mean age of 32.48 ± 7.26 years participated in the study. The median (interquartile range) SELENA SLEDAI was 2 (5.5). The internal consistency reliability of the LupusPRO domains was >0.7 for most domains (except for lupus symptoms, lupus medication, procreation and social support).We noted good convergent validity of LupusPRO domains with corresponding domains of SF-36, pain vitality with fatigue (FSS) and emotional health domain with depression (PHQ9) and anxiety (GAD7). Criterion validity of lupus symptoms with disease activity was observed. Known group validity of the LupusPRO domains with patient reported health status was observed. Confirmatory factor analysis showed a good fit. CONCLUSION: The Hindi LupusPRO has fair psychometric properties among Indian patients with SLE.


Subject(s)
Lupus Erythematosus, Systemic/physiopathology , Patient Reported Outcome Measures , Quality of Life , Surveys and Questionnaires , Adult , Cross-Cultural Comparison , Cross-Sectional Studies , Female , Humans , India , Lupus Erythematosus, Systemic/psychology , Male , Psychometrics , Reproducibility of Results , Severity of Illness Index
8.
Rev Med Interne ; 40(9): 570-573, 2019 Sep.
Article in French | MEDLINE | ID: mdl-30955904

ABSTRACT

BACKGROUND: Behçet's disease (BD) is a recurrent multisystemic disease responsible for occlusive vasculitis with arterial, venous and capillary involvement. The aim of this study was to determine the frequency and the features associated with the use of biotherapy in the management of patients followed in our department for BD. METHODS: This is a retrospective study of patients medical records followed for BD in a department of internal medicine from January 2005 to August 2018. RESULTS: A total of 41 patients were included with a mean age at diagnosis of 42.5±12.1 years (range 16 to 63) and a sex ratio men/women of 1.05. Oral and/or genital aphtosis was present in 70.7% of the patients. Other lesions were: ocular (78.0%), articular (46.3%), cutaneous (41.5%), central neurological (34.1%), vascular (26.8%), digestive (7.3%), pericardial (2.4%) and epididymal (2.4%). A biotherapy, interferon α and monoclonal antibodies, was used in 15 patients (36.6%), after failure of conventional treatments. The monoclonal antibodies were anti-TNFα (infliximab, adalimumab, certolizumab and golimumab) except in one patient for whom ustekinumab was used. Biotherapy was used in 46.9% of the patients with ocular involvement and never used in those patients without ocular involvement (P=0.01). CONCLUSION: Biotherapy is effective and represents a solution to the failures of conventional treatments in severe forms of Behçet's disease with ocular involvement.


Subject(s)
Behcet Syndrome/drug therapy , Biological Therapy , Adolescent , Adult , Biological Therapy/statistics & numerical data , Female , Hospital Departments , Humans , Internal Medicine , Male , Middle Aged , Retrospective Studies , Young Adult
10.
Support Care Cancer ; 26(12): 4121-4131, 2018 Dec.
Article in English | MEDLINE | ID: mdl-29872944

ABSTRACT

PURPOSE: Family caregivers play an important role in caring for patients with advanced cancer. To become competent, individuals must draw on and mobilise an adequate combination of resources. Our goal was to identify the skills developed by caregivers of patients with advanced cancer and the associated resources mobilised. We chose to do it with partners of patients with colon cancer. METHODS: The study used a cross-sectional qualitative design based on 20 individual interviews and a focus group. Partners were recruited from patients treated in three hospitals of France. Semi-structured interviews were conducted until data saturation was achieved. Each interview was transcribed verbatim, and thematic analyses were performed to extract significant themes and subthemes. RESULTS: Results from the individual and focus group interviews showed that the skills implemented by the partners (in domains of social relationships and health, domestic, organisational, emotional and well-being dimensions) were singular constructs, dependant on if resources (personal, external and schemes) may have been missing and insufficient. In addition, partners may have had these resources but not mobilised them. CONCLUSION: The identification of the skills and associated resources could allow healthcare professionals better identifying and understanding of the difficulties met by partners in taking care of patients. This could enable them to offer appropriate support to help the caregivers in their accompaniment.


Subject(s)
Caregivers/psychology , Clinical Competence , Colonic Neoplasms/therapy , Health Personnel/psychology , Adult , Cross-Sectional Studies , Emotions , Female , Focus Groups , France , Health Resources , Humans , Male , Middle Aged , Qualitative Research
11.
Rev Neurol (Paris) ; 174(5): 337-341, 2018 May.
Article in French | MEDLINE | ID: mdl-29704959

ABSTRACT

Behçet's disease is a rare multisystemic vasculitis with an etiology that is still unknown. Neurological manifestations may be seen in approximately 5-15% of patients, and both parenchymal and extraparenchymal neurological involvement has been described. When cerebral venous thrombosis (CVT) is the main extraparenchymal manifestation of Behçet's disease, the condition is then dubbed "angio-Behçet's syndrome". However, arterial involvement is extremely rare, with only one reported case of vasculo-neuro-Behçet's disease, characterized by both venous and intracranial arterial involvement - until now. This report is of two patients diagnosed with Behçet's disease characterized by the concomitant presence of both cerebral arterial manifestations and CVT.


Subject(s)
Behcet Syndrome/physiopathology , Cerebral Arteries/physiopathology , Cerebral Veins/physiopathology , Adult , Behcet Syndrome/drug therapy , Cerebral Angiography , Female , Fibrinolytic Agents/therapeutic use , Humans , Intracranial Thrombosis/drug therapy , Intracranial Thrombosis/physiopathology , Magnetic Resonance Angiography , Magnetic Resonance Imaging , Male , Treatment Outcome , Venous Thrombosis/drug therapy , Venous Thrombosis/physiopathology , Young Adult
12.
Rev Med Interne ; 39(9): 711-720, 2018 Sep.
Article in French | MEDLINE | ID: mdl-29496270

ABSTRACT

Scleritis is an inflammatory disease of the sclera; outer tunic of the eye on which the oculomotor muscles are inserted. It can be associated with a systemic disease up to one time out of 3. These associated diseases are mainly rheumatoid arthritis, vasculitis, including granulomatosis with polyangiitis in the first line and spondyloarthropathies. Before mentioning such an etiology, it is necessary to eliminate an infectious cause, mainly herpetic, which is regularly underestimated. The classification of scleritis is clinical. We distinguish between anterior scleritis and posterior scleritis. Anterior scleritis is diffuse or nodular, usually of good prognosis. Anterior necrotizing scleritis with inflammation is often associated with an autoimmune disease, necrotizing scleritis without inflammation usually reflects advanced rheumatoid arthritis. The treatment of these conditions requires close collaboration between internists and ophthalmologists to decide on the use of corticosteroid therapy with or without immunosuppressors or biotherapies.


Subject(s)
Autoimmune Diseases , Health Knowledge, Attitudes, Practice , Inflammation , Internal Medicine/methods , Physicians , Scleritis , Autoimmune Diseases/complications , Autoimmune Diseases/diagnosis , Autoimmune Diseases/therapy , Diagnostic Techniques, Ophthalmological , Humans , Inflammation/complications , Inflammation/diagnosis , Inflammation/therapy , Scleritis/diagnosis , Scleritis/etiology , Vasculitis/complications , Vasculitis/diagnosis , Vasculitis/therapy
13.
Rev Med Interne ; 39(5): 332-338, 2018 May.
Article in French | MEDLINE | ID: mdl-29397233

ABSTRACT

Hyper-IgE may be found under many pathological conditions. The role of IgE is essentially associated with the occurrence of allergic manifestations, which may be accompanied by an increase of their serum levels. Elevation of total IgE has also been reported in association with certain rare genetic immune deficiencies called hyper-IgE syndromes. Other circumstances such as infectious diseases, tumors or autoimmune diseases may also be accompanied by an excessive synthesis of IgE. Considering the diversity of these situations, discussion of the prognostic value of total IgE is useful to the internist.


Subject(s)
Immunoglobulin E/blood , Job Syndrome/diagnosis , Cytokines/blood , Humans , Internal Medicine , Job Syndrome/therapy
14.
Lupus ; 27(6): 982-990, 2018 May.
Article in English | MEDLINE | ID: mdl-29451066

ABSTRACT

BACKGROUND: The Multidimensional Health Assessment Questionnaire (MDHAQ) is a patient-reported outcome (PRO) tool that includes the Routine Assessment of Patient Index Data 3 (RAPID3), an index that can be calculated at the point of care. The objective of this study was to perform psychometric analyses of MDHAQ/RAPID3 to study its measurement properties in systemic lupus erythematosus (SLE). METHODS: The MDHAQ was completed by 161 SLE patients in routine care, along with LupusPRO (a disease-specific PRO). The SLE disease-specific activity index (SELENA-SLEDAI) and damage (SDI) were assessed. Data from 70 patients with rheumatoid arthritis who had completed MDHAQ during their routine medical care were used as controls to compare the results of Physical Function (FN) domain exploratory factor analysis. Internal consistency reliability (ICR) for FN items was calculated using Cronbach's α. Validity of MDHAQ/RAPID3 was evaluated for content validity and construct validity. Responsiveness of the RAPID3 to changes in disease activity anchors was assessed. RESULTS: The ICR of the 10 physical function items on Cronbach's α was 0.88. Exploratory factor analysis revealed cross-loadings of three FN items. RAPID3 showed a strong correlation with LupusPRO health-related quality of life score (rho -0.68 (p < 0.001)), indicating convergent validity. RAPID3 scores did not correlate with disease activity indices or SDI. After adjustment for fibromyalgia status, a weak correlation with the Physician's Global Assessment (PGA) (rho = 0.31, p = 0.008) was noted. RAPID3 could differentiate between SLE patients based on flare status. RAPID3 was not responsive to changes in PGA, SELENA-SLEDAI or SELENA-Flare Index. CONCLUSIONS: MDHAQ/RAPID3 has fair reliability and validity in SLE.

15.
Rev Med Interne ; 39(2): 107-116, 2018 Feb.
Article in French | MEDLINE | ID: mdl-28457682

ABSTRACT

Systemic lupus erythematosus (SLE) is a chronic disease that considerably hampers patient's daily living. Qualitative studies with patients' interviews have been conducted to describe the experiences and perspectives of adults living with SLE. Among existing generic and disease-specific quality of life (QOL) questionnaires, none succeeded to exhaustively measure patient's preoccupations. However, these tools are useful to quantify the burden of the disease. Social precariousness, socioeconomic status and education level are intimately correlated to QOL measures, either generic or disease-specific. Musculoskeletal disease activity is also associated with a lower QOL. Using disease-specific tools may be useful because of a better aptitude to record an improvement in health status. Moreover, using generic and disease-specific questionnaires together may help to identify factors associated with a lower quality of life but not related to SLE from the patient's perspective (such as smoking or obesity). Developing new ways of recording QOL data in the future may help to evaluate the real benefit of using QOL scales in daily practice.


Subject(s)
Lupus Erythematosus, Systemic/psychology , Patient Reported Outcome Measures , Quality of Life , Adult , Humans , Risk Factors , Surveys and Questionnaires
16.
Lupus ; 26(4): 396-402, 2017 Apr.
Article in English | MEDLINE | ID: mdl-27587460

ABSTRACT

Objective The lupus impact tracker (LIT) is a 10-item patient reported outcome tool to measure the impact of systemic lupus erythematosus or its treatment on patients' daily lives. Herein, we describe the responsiveness of the LIT and LupusQoL to changes in disease activity, using the systemic lupus erythematosus responder index (SRI). Methods A total of 325 adult systemic lupus erythematosus patients were enrolled in an observational, longitudinal, multicentre study, conducted across the USA and Canada. Data (demographics, LIT, LupusQoL, BILAG, SELENA-SLEDAI) were obtained three months apart. Modified SRI was defined as: a decrease in SELENA-SLEDAI (4 points); no new BILAG A, and no greater than one new BILAG B; and no increase in the physician global assessment. Standardised response mean and effect size for LIT and LupusQoL domains were calculated among SRI responders and non-responders. Wilcoxon's test was used to compare the LIT and LupusQoL variation by SRI responder status. Results Of the participants 90% were women, 53% were white, 33% were of African descendant and 17% were Hispanic. Mean (SD) age and SELENA-SLEDAI at baseline were 42.3 (16.2) years and 4.3 (3.8), respectively. Mean (SD) LIT score at baseline was 39.4 (22.9). LIT standardised response mean (effect size) among SRI responders and non-responders were -0.69 (-0.36) and -0.20 (-0.12), respectively ( P = 0.02). For LupusQoL, two domains were responsive to SRI: standardised response mean (effect size) for physical health and pain domains were 0.42 (0.23) and 0.65 (0.44), respectively. Conclusions LIT is moderately responsive to SRI in patients with systemic lupus erythematosus. Inclusion of this tool in clinical care and clinical trials may provide further insights into its responsiveness. This is the first systemic lupus erythematosus patient reported outcome tool to be evaluated against composite responder index (SRI) used in clinical trials.


Subject(s)
Lupus Erythematosus, Systemic/psychology , Adolescent , Adult , Aged , Canada , Female , Humans , Longitudinal Studies , Lupus Erythematosus, Systemic/diagnosis , Lupus Erythematosus, Systemic/drug therapy , Male , Middle Aged , Quality of Life , Severity of Illness Index , Surveys and Questionnaires , Treatment Outcome , United States , Young Adult
17.
Lupus ; 25(10): 1111-21, 2016 Sep.
Article in English | MEDLINE | ID: mdl-27497256

ABSTRACT

Therapeutic advances in systemic lupus erythematosus (SLE) are greatly needed. Despite advances in our knowledge of pathogenesis of the disease and targets, treatment remains a significant challenge. Finding effective and relatively safe medications remains one of the top priorities. SLE significantly impairs quality of life (QoL), and patient-reported outcomes (PROs) measure a unique aspect of the disease not captured by disease activity. Inclusion of PRO measurements is encouraged in SLE clinical trials, as they allow capturing benefits of a proposed intervention in language patients can relate to and in areas deemed pertinent and important to and by patients. Availability of patient-reported and patient-centric clinical trials data may facilitate patients in informed and shared decision making, and allow for comparative cost-effectiveness evaluation for future resource allocation and reimbursements. Herein we review clinical trials with biologic therapies wherein PRO tools were included in the study design.


Subject(s)
Biological Products/therapeutic use , Lupus Erythematosus, Systemic/drug therapy , Clinical Trials as Topic , Humans , Patient Reported Outcome Measures , Quality of Life/psychology , Randomized Controlled Trials as Topic
18.
Lupus ; 24(14): 1486-91, 2015 Dec.
Article in English | MEDLINE | ID: mdl-26162686

ABSTRACT

OBJECTIVE: To evaluate the responsiveness of Lupus Impact Tracker (LIT) to changes in physician and patient disease activity assessments over time. METHODS: Available longitudinal data from routine patient care visits on LIT, physician assessed disease activity (physician global assessment (PGA), SELENA-SLEDAI score, SELENA Flare Index (SFI)), and patient-reported changes in systemic lupus erythematosus (SLE) health status were analyzed. Significant, clinically important change (worsening or improvement) in physician disease activity assessment or patient-reported SLE health status were judged using the following criteria: change of 0.3 on PGA, 4 on SELENA-SLEDAI, change in SFI status over time, and change of 2 in either direction in patient-reported SLE health status. Mixed model regression analysis was used to compare changes in LIT using the above criteria. RESULTS: There were 1184 observations with significant changes in physician disease activity or patient-reported measure for 182 patients' data across 1364 visits. Patients' mean (SD) age and SELENA-SLEDAI were 43.5 (13.2) years and 6.4 (7.3) respectively. LIT mean scores decreased by more than 3 with improvement in PGA (standardized response mean -0.26, p < 0.05), while it increased by more than 5 with worsening in SELENA-SLEDAI (standardized response mean 0.42, p = 0.01). Mean change in LIT of greater than ±3 was noted with change in SFI status (p < 0.05). Mean LIT score decreased by greater than 4 and increased by greater than 2 with patient-reported improvement and worsening in SLE health status respectively (p < 0.05). CONCLUSIONS: LIT is responsive to physician-assessed and patient-assessed changes in disease status. A mean LIT change of 2-4 may represent a significant clinical change in LIT. It is an effective tool that may be used by patients and physicians in tracking disease impact in SLE patients.


Subject(s)
Lupus Erythematosus, Systemic/diagnosis , Adult , Dose-Response Relationship, Drug , Female , Health Status , Humans , Longitudinal Studies , Lupus Erythematosus, Systemic/drug therapy , Male , Middle Aged , Outcome Assessment, Health Care/methods , Physicians , Reproducibility of Results , Self Report , Severity of Illness Index , Software
19.
Ann Phys Rehabil Med ; 58(2): 78-85, 2015 Apr.
Article in English | MEDLINE | ID: mdl-25766087

ABSTRACT

INTRODUCTION: CASP specifically assesses post-stroke cognitive impairments. Its items are visual and as such can be administered to patients with severe expressive aphasia. We have previously shown that the CASP was more suitable than the Mini Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA) in aphasic patients. Our objective was to compare the above scales in non-aphasic stroke patients, and assess to what extent the solely visual items of the CASP were problematic in cases of neurovisual impairments. METHODS: Fifty non-aphasic patients admitted to Physical Medicine and Rehabilitation (PM&R) units after a recent left- or right-hemisphere stroke were evaluated with the CASP, MMSE and MoCA. We compared these three scales in terms of feasibility, concordance, and influence of neurovisual impairments on the total score. RESULTS: Twenty-nine men and 21 women were included (mean age 63 ± 14). For three patients, the MoCa was impossible to administer. It took significantly less time to administer the CASP (10 ± 5 min) than the MoCA (11 ± 5 min, P=0.02), yet it still took more time than MMSE administration (7 ± 3 min, P<10(-6)). Neurovisual impairments affected equally the total scores of the three tests. Concordance between these scores was poor and only the CASP could specifically assess unilateral spatial neglect. CONCLUSION: The sole visual format of the CASP scale seems suitable for administration in post-stroke patients.


Subject(s)
Cognition Disorders/diagnosis , Neuropsychological Tests , Stroke/psychology , Adult , Aged , Cognition , Cognition Disorders/psychology , Feasibility Studies , Female , Humans , Male , Middle Aged , Perceptual Disorders , Reproducibility of Results , Time Factors
20.
Ann Phys Rehabil Med ; 57(6-7): 422-35, 2014.
Article in English | MEDLINE | ID: mdl-24953703

ABSTRACT

INTRODUCTION: Post-stroke aphasia makes it difficult to assess cognitive deficiencies. We thus developed the CASP, which can be administered without using language. Our objective was to compare the feasibility of the CASP, the Mini Mental State Examination (MMSE) and the Montreal Cognitive Assessment (MoCA) in aphasic stroke patients. MATERIAL AND METHODS: All aphasic patients consecutively admitted to seven French rehabilitation units during a 4-month period after a recent first left hemispheric stroke were assessed with CASP, MMSE and MoCA. We determined the proportion of patients in whom it was impossible to administer at least one item from these 3 scales, and compared their administration times. RESULTS: Forty-four patients were included (age 64±15, 26 males). The CASP was impossible to administer in eight of them (18%), compared with 16 for the MMSE (36%, P=0.05) and 13 for the MoCA (30%, P=0.21, NS). It was possible to administer the CASP in all of the patients with expressive aphasia, whereas the MMSE and the MoCA could not be administered. Administration times were longer for the CASP (13±4min) than for the MMSE (8±3min, P<10(-6)) and the MoCA (11±5min, P=0.23, NS). CONCLUSION: The CASP is more feasible than the MMSE and the MoCA in aphasic stroke patients.


Subject(s)
Aphasia/psychology , Cognition Disorders/diagnosis , Neuropsychological Tests , Stroke/complications , Aged , Aphasia/etiology , Cognition Disorders/psychology , Feasibility Studies , Female , Humans , Male , Middle Aged , Stroke/psychology , Time Factors
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