Isabelle Guillemin

Comprehensive evaluation of bladder and urethral dysfunction symptoms: development and psychometric validation of the Urinary Symptom Profile (USP) questionnaire.

OBJECTIVES To develop and validate a standardized tool assessing urinary symptoms among men and women with stress, urge, frequency, or urinary obstructive symptoms for use in clinical practice to complement clinical measures and diagnosis. METHODS After development by an advisory committee and comprehension testing with patients, the Urinary Symptoms Profile (USP) item content and validity were evaluated by clinicians. Patients with urinary symptoms (n = 253) and without symptoms (n = 75) completed the final questionnaire at day 0 and day 7. Psychometric properties were assessed, including construct and clinical validity, reliability, and predictive ability for detection of and differentiation between urinary disorders. RESULTS Principal Component Analysis with Varimax Rotation confirmed the final USP structure of 13 items in 3 dimensions: stress urinary incontinence (SUI), overactive bladder (OAB), and low stream (LS). Internal consistency reliability (Cronbachs alpha ranging from 0.69 to 0.94) and concurrent validity (Spearman correlation coefficients between International Consultation on Incontinence Questionnaire and SUI and OAB dimensions of 0.73 and 0.62, respectively) were good. Test-retest reproducibility over 7 days was excellent in stable patients (Intraclass Correlation Coefficients from 0.84 to 0.91). USP clinical validity was demonstrated by comparing micturition diary with USP scores. USP dimension scores were excellent predictors of urinary disorder presence and identification. CONCLUSIONS USP is the first valid and reliable questionnaire providing comprehensive evaluation of all urinary disorders and their severity in both men and women with SUI, OAB, and LS. It allows the screening and contributes to the differential diagnosis of these symptoms. The USP is a valuable tool for use in clinical practice.

Evaluation of the reliability and validity of the Medical Outcomes Study sleep scale in patients with painful diabetic peripheral neuropathy during an international clinical trial

BackgroundSleep is an important element of functioning and well-being. The Medical Outcomes Study Sleep Scale (MOS-Sleep) includes 12 items assessing sleep disturbance, sleep adequacy, somnolence, quantity of sleep, snoring, and awakening short of breath or with a headache. A sleep problems index, grouping items from each of the former domains, is also available. This study evaluates the psychometric properties of MOS-Sleep Scale in a painful diabetic peripheral neuropathic population based on a clinical trial conducted in six countries.MethodsClinical data and health-related quality of life data were collected at baseline and after 12 weeks of follow-up. Overall, 396 patients were included in the analysis. Psychometric properties of the MOS-Sleep were assessed in the overall population and per country when the sample size was sufficient. Internal consistency reliability was assessed by Cronbachs alpha; the structure of the instrument was assessed by verifying item convergent and discriminant criteria; construct validity was evaluated by examining the relationships between MOS-Sleep scores and sleep interference and pain scores, and SF-36 scores; effect-sizes were used to assess the MOS-Sleep responsiveness. The study was conducted in compliance with United States Food and Drug Administration regulations for informed consent and protection of patient rights.ResultsCronbachs alpha ranged from 0.71 to 0.81 for the multi-item dimensions and the sleep problems index. Item convergent and discriminant criteria were satisfied with item-scale correlations for hypothesized dimensions higher than 0.40 and tending to exceed the correlations of items with other dimensions, respectively. Taken individually, German, Polish and English language versions had good internal consistency reliability and dimension structure. Construct validity was supported with lower sleep adequacy score and greater sleep problems index scores associated with measures of sleep interference and pain scores. In addition, correlations between the SF-36 scores and the MOS-Sleep scores were low to moderate, ranging from -0.28 to -0.53. Responsiveness was supported by effect sizes > 0.80 for patients who improved according to the mean sleep interference and pain scores and clinician and patient global impression of change (p < 0.0001).ConclusionThe MOS-Sleep had good psychometric properties in this painful diabetic peripheral neuropathic population.Trial registrationAs this study was conducted from 2000 to 2002 (i.e., before the filing requirement came out), no trial registration number is available.

Measurement of health-related quality of life with glaucoma: validation of the Glau-QoL© 36-item questionnaire

Purpose:  To validate a glaucoma‐specific health‐related quality of life (HRQoL) questionnaire: the Glau‐QoL©.

Patients’ Experience and Perception of Hospital-Treated Clostridium difficile Infections: a Qualitative Study

BackgroundClostridium difficile is the leading cause of antibiotic-associated diarrhea and an important source of nosocomial infection. Clinical manifestations can range from mild diarrhea to lethal pseudomembranous colitis. Little is known about the burden of C. difficile infections (CDI) in patients.ObjectiveThis qualitative study explored the impact of hospital-treated CDI on patients’ lives from the first occurrence of CDI symptoms, through their hospital stay, and after discharge.MethodsSemi-structured interviews with 12 US and 12 French patients who had experienced CDI were conducted using an interview guide that was developed on the basis of a thorough literature review. Transcripts from these interviews were analyzed to identify concepts related to the research question.FindingsCDI affected numerous aspects of patients’ lives. Patients reported that the continuous, watery, and uncontrollable diarrhea characteristic of CDI had the most impact on their daily lives. Diarrhea prevented them from participating in usual daily activities; this caused the collapse of their social lives. Patients felt humiliated and embarrassed. Patients’ emotional distress worsened once hospitalized; they reported feelings of loneliness and worry when placed in isolation. From discharge to the time of the interview, patients reported both psychological and physical improvement. However, despite continuing improvement, most patients reported persistent worry and fear of recurrent episodes, and they were thus more careful about their diet and hygiene.ConclusionAs one patient in this study explained, CDI is “the worst of everything that I’ve had.” The emotional distress and extreme physical exhaustion associated with CDI result in a traumatic and frightening experience for patients. This trauma persists after recovery and includes lingering fears of a recurrent episode.

Living with Merkel Cell Carcinoma (MCC): Development of a Conceptual Model of MCC Based on Patient Experiences

BackgroundMerkel cell carcinoma (MCC) is a rare and aggressive skin cancer with limited treatment options at advanced stages. There is a paucity of data available regarding the impact of MCC and its management on patients’ lives. This study aimed to address this gap by interviewing patients with metastatic MCC entering a trial of an immunotherapy (avelumab).MethodsIn a single-arm, open-label, international, phase 2 trial in patients with stage IV, chemotherapy-refractory, histologically confirmed MCC, patients were invited to participate in semi-structured phone interviews. These were conducted before avelumab administration. Interview transcripts were analysed qualitatively to identify concepts important to patients relating to their experience of metastatic MCC and its management.ResultsNineteen patients were interviewed. Most reported MCC to be painless and asymptomatic. They reported being often misdiagnosed and described a long process before receiving the correct diagnosis. They also reported a feeling of “shock” after being informed of the severity and seriousness of their cancer. Overall, patients did not report impaired physical and cognitive capacities or impact on daily lives, either before or after diagnosis. However, patients and their relatives reported feelings of “worry” and “fear” about the unknown outcome of the disease. Chemotherapy and radiotherapy negatively affected patients physically and psychologically in their everyday lives.ConclusionsMCC disease was not perceived by the interviewed patients to result in severe functional limitations or to severely impact everyday activities, but was associated with substantial negative psychological impact. In contrast, chemotherapy and radiotherapy for MCC are highly debilitating and disrupt patients’ lives.ClinicalTrials.gov identifierNCT02155647.

P02-30 Improving the diagnosis of fibromyalgia (FM) in Europe: Identification of factors that aid in the detection of FM

Aim Prior to facing the challenges of FM management, an initial diagnosis must be made. To guide general practitioners (GPs) in the early detection of FM in Europe, we developed an easy-to-use screening tool specific to FM. Method A European multidisciplinary expert group was constituted with the aim of providing clinical expertise, defining methodology, and identifying key issues around the detection of FM. Three conceptual models describing factors that may contribute to the identification of FM patients were derived from; a) a comprehensive literature review, 2) clinician focus groups (N=6), and 3) face-to-face interviews with German, French, and English-speaking patients (N=29) conducting by psychologists to explore their attitudes and perceptions of the disease. A FM screening tool was developed in all three languages and tested for comprehension and applicability in FM-diagnosed and FM-suspected patients. Results The models derived from the literature, clinician focus groups, and FM patient interviews showed high consistency. The resulting FM screening tool is comprised of 14 questions that describe patients’ pain, fatigue, associated symptoms, impact on everyday life, personal history, and attitudes towards their FM. Conclusion Based on this qualitative study, the detection of FM is likely to require the assessment of multiple psychological factors in addition to symptoms, including patient reporting of personal history and patient behaviour. The quantitative validation of these findings is currently underway.