Bladder symptoms such as urinary urgency, frequency, and incontinence are common in people with multiple sclerosis (MS). These symptoms, which often result from neurogenic detrusor overactivity (NDO), can have a major impact on patients' day-to-day lives. However, in many cases they are over-looked in the clinical management of MS. The objective of this study was to develop and validate a reliable, sensitive, and specific screening tool for patients with bladder problems related to MS. We performed a literature review and then conducted a content validation study followed by a multisite observational study of a new screening tool, the Actionable Bladder Symptom Screening Tool (ABSST). All ABSST domains as well as the total score met the threshold for good internal consistency (Cronbach α ≥ 0.70), with a Cronbach α value of 0.95 for the total score and values ranging from 0.85 to 0.90 for the three domains. The validity of the ABSST was demonstrated by high correlation of the domains and total score with the Overactive Bladder Questionnaire Short Form (OAB-q SF) Symptom Severity and Total Health-Related Quality of Life (HRQOL) scores (Spearman correlation coefficient ≥ 0.782). The predictive validity of the ABSST total score to identify patients who might receive a recommendation to see a urologist was strong. This new instrument, which was developed with input from clinicians as well as MS patients, meets the current content validity and psychometric testing thresholds established by the US Food and Drug Administration, with high sensitivity and specificity.
BackgroundThe majority of multiple sclerosis (MS) patients develop some form of lower urinary tract dysfunction, usually as a result of neurogenic detrusor overactivity (NDO). Patients identify urinary incontinence as one of the worst aspects of this disease. Despite the high prevalence of NDO, urological evaluation and treatment are significantly under-accessed in this population. The objectives of this study were: 1) to adapt the previously validated Actionable Bladder Symptom Screening Tool (ABSST) to a short form for ease and brevity of application in a clinical setting that is clinically meaningful; and 2) to develop a scoring algorithm that would be interpretable in terms of referring/considering precise diagnosis and treatment.MethodsA US-based, non-randomized, multi-center, stand-alone observational study was conducted to assess the psychometric properties of the ABSST among patients who have MS with and without NDO. Mixed psychometric methods (e.g., classical statistics (Psychometric theory (3rd ed.). New York: McGraw-Hill; 1994) and item response methods (Applying the Rasch Model: Fundamental Measurement in the Human Sciences. New Jersey: Lawrence Earlbaum Associates; 2001)) were used to evaluate the predictive and clinical validity of the shortened form. The latter included clinicians flagging clinically meaningful items and associated response options which would indicate the need for further evaluation or treatment.ResultsA total of 151 patients, all with MS and with and without NDO, were recruited by 28 clinicians in various US geographical locations. Approximately 41% of patients reported a history of or currently having urinary incontinence and/or urinary urgency. The prediction model across the entire range of classification thresholds was evaluated, plotting the true positive identification rate against the false positive rate (1-Specificity) for various cut scores. In this study, the cut-point or total score of greater than or equal to 6 had a sensitivity of approximately 85%, and specificity of approximately 93% (i.e., 85% patients would warrant being referred to a urologist and 93% of the patients whose symptoms would not warrant urologist referral).ConclusionsOverall the short form ABSST demonstrated sensitivity and specificity as it maintained the integrity of the longer form tool. Concurrent validity for each subscale as well as predictive and concurrent validity of the total shortened instrument was demonstrated. This instrument provides a new method for assessing bladder problems among MS patients, and may facilitate earlier and more precise diagnosis, treatment, and/or referral to a specialist.
Introduction and hypothesisThe Actionable Bladder Symptom Screening Tool (ABSST) was initially developed to identify patients with multiple sclerosis (MS) who could benefit from lower urinary tract assessment and treatment. Assessment of the measurement properties of the ABSST, including its ability to identify patients experiencing bladder symptoms related to overactive bladder (OAB), was undertaken in a general female population.MethodsOne hundred women completed the ABSST, OAB Questionnaire Short Form (OAB-q SF), and a patient global impression of severity (PGI-S) scale. Half of the sample had urgency urinary incontinence (UUI), while the other half did not. Descriptive statistics, reliability, and validity were examined, as was sensitivity and specificity of the previous cut-off score established in MS.ResultsFifty-three women with UUI/OAB and 47 controls took part (71.0 % Caucasian). Patients with UUI/OAB were older (54.6 vs 40.4 years), had a higher body mass index (31.1 vs 26.4 kg/m2), and more comorbid conditions. The Cronbach’s alpha reliability of ABSST was 0.90. High correlations with OAB-q SF Symptom Bother and Health Related Quality of Life (r = 0.83 and −0.81 respectively) supported concurrent validity. Using the PGI-S severity scores as a reference, the ABSST was able to distinguish patients with differing severity levels (known-group validity). Physician assessment of the need for further evaluation/treatment showed sensitivity (79 %) and specificity (98 %), supporting a cut-off score of ≥3.ConclusionsThe previous MS ABSST scoring algorithm was validated in a non-neurogenic female population. ABSST is a reliable, valid, and sensitive tool for screening women with UUI/OAB.
A183by the patient preference to different characteristics of ESA treatments. Patients had to complete a questionnaire at baseline and around 6-month. Questionnaire was developed using a CBC analysis method with the following hypothesis: 1) 7 ESA characteristics; 2) from 2 to 3 levels per characteristics; 3) each possible answer includes 1 level for 2 characteristics; 4) 2 choices per question; 5) and 6) 7 questions per CBC questionnaire. The number of combinations between all characteristics and levels was 288, and 20 questionnaires have been generated in order to mix all possible treatment characteristics and levels. Patients only had to answer one questionnaire and a randomization has been used to obtain equal number of respondents for each questionnaire. CBC analysis was planned and performed for subgroup of patients already receiving ESA or not. RESULTS: A total of 790 patients were included, 609 questionnaires were analyzed at baseline. Fifty-five percent of patients were already treated by ESA, among them the most important characteristic was the planned frequency of administration for 31%, followed by the importance of the treatment efficacy for 20%, the pain at injection site for 11%. But when asking a direct question to patient on which characteristic was the most important, 82% of them answered treatment efficacy, 5% for pain at injection site and frequency of injection. Similar results were found for ESA naïve patients. CONCLUSIONS: The CBC analysis revealed that frequency of injections is underestimated by patients and should be taken into account by physicians when choosing an ESA treatment.
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