Most Bothersome Symptom Research Articles

Patient-reported most bothersome symptoms in OAB: post hoc analysis of data from a large, open-label trial of solifenacin

In overactive bladder (OAB), subjects' most bothersome symptom (MBS) may influence treatment-related outcomes. We evaluated effects of solifenacin on patient-reported outcomes (PROs) in subjects stratified by their MBS at baseline. In a 12-week, open-label study, the effects of solifenacin on PROs were assessed using visual analog scales (VAS), the OAB questionnaire (OAB-q), and the patient perception of bladder condition (PPBC). Statistics were descriptive. Subjects' baseline MBS were frequency (27%), urge urinary incontinence (UUI; 26%), urgency (23%), and nocturia (15%); VAS scores were worse for MBS. By study end, participants' MBS showed the largest solifenacin-related VAS improvements. The UUI subgroup showed the largest VAS, OAB-q, and PPBC improvements. Solifenacin improved overall and symptom-specific bother, HRQL, and perception of their bladder condition in MBS subgroups, with larger improvements in subjects' MBS. Those with UUI as MBS showed greater improvement in most outcomes.

Impact and Outcomes of an Iyengar Yoga Program in a Cancer Centre

Individuals have increasingly sought complementary therapies to enhance health and well-being during cancer, although little evidence of their effect is available. We investigated how an Iyengar yoga program affects the self-identified worst symptom in a group of participants. Whether quality of life, spiritual well-being, and mood disturbance change over the Iyengar yoga program and at 6 weeks after the program. How, from a participant's perspective, the Iyengar yoga program complements conventional cancer treatment. This pre-post instrumental collective case study used a mixed methods design and was conducted at a private Iyengar yoga studio. The sample consisted of 24 volunteers (23 women, 1 man; 88% Caucasian; mean age: 49 years) who were currently on treatment or who had been treated for cancer within the previous 6 months, and who participated in ten 90-minute weekly Iyengar yoga classes. The main outcome measures were most-bothersome symptom (Measure Your Medical Outcome Profile 2 instrument), quality of life and spiritual well-being (Functional Assessment of Chronic Illness Therapy-General subscale and Spiritual subscale), and mood disturbance (Profile of Mood States-Short Form). Participant perspectives were obtained in qualitative interviews. Statistically significant improvements were reported in most-bothersome symptom (t((23)) = 5.242; p < 0.001), quality of life (F((2,46)) = 14.5; p < 0.001), spiritual well-being (F((2,46)) = 14.4; p < 0.001), and mood disturbance (F((2,46)) = 10.8; p < 0.001) during the program. At follow-up, quality of life (t((21)) = -3.7; p = 0.001) and mood disturbance (t((21)) = 2.4; p = 0.025) significantly improved over time. Categorical aggregation of the interview data showed that participants felt the program provided them with various benefits not included on the outcomes questionnaires. Over the course of the Iyengar Yoga for Cancer program, participants reported an improvement in overall well-being. The program was also found to present participants with a holistic approach to care and to provide tools to effectively manage the demands of living with cancer and its treatment.

Randomized, multicenter, double-blind, placebo-controlled trial to evaluate the efficacy and safety of synthetic conjugated estrogens B for the treatment of vulvovaginal atrophy in healthy postmenopausal women

To evaluate the safety and efficacy of synthetic conjugated estrogens B (SCE-B; 0.3 mg/d) for 12 weeks in the treatment of vulvovaginal atrophy in symptomatic, postmenopausal women. Prospective, randomized, multicenter, double-blind, placebo-controlled trial. Forty-two participating sites in the United States. Postmenopausal women with at least one moderate to severe symptom of vaginal atrophy. Daily oral administration, in a randomized, placebo-controlled setting, of SCE-B (0.3 mg) or of placebo for 12 weeks. Mean changes in vaginal maturation index, percentage of parabasal and superficial cells, vaginal pH, and severity of the most bothersome symptom (MBS) between baseline and predetermined time points were assessed. Safety and tolerability were evaluated. A total of 310 women (mean age, 58.6 y) were enrolled. Synthetic conjugated estrogens B yielded statistically significantly greater differences in vaginal maturation index and vaginal pH from baseline to the end of treatment. Vaginal dryness (44.4%) and pain during intercourse (30.2%) were the symptoms most commonly identified as the MBS. A statistically significant mean reduction in the severity of the MBS was noted for SCE-B. There were no clinically significant differences observed between the two groups for findings related to safety. Synthetic conjugated estrogens B (0.3 mg/d) was effective in treating vulvovaginal atrophy in symptomatic postmenopausal women. Significant improvement was seen in vaginal maturation index, vaginal pH, and severity of MBS from baseline to the end of treatment.

Solifenacin treatment for overactive bladder in Hispanic patients: patient-reported symptom bother and quality of life outcomes from the VESIcare® Open-Label Trial

The primary goal of overactive bladder (OAB) treatment is to reduce symptoms and improve health-related quality of life (HRQoL). Although trials open enrolment to everyone, most OAB studies feature Caucasians. Here we present Hispanic data. VESIcare Open-Label Trial was a 12-week, open-label, flexible-dosing study in patients with OAB symptoms for >or=3 months. All patients started on solifenacin 5 mg/day, with a dosing option of 5 or 10 mg/day at weeks 4 and 8. Three patient-reported outcome (PRO) measures assessed symptom improvement and treatment satisfaction: the Patient Perception of Bladder Condition (PPBC) scale, a Visual Analogue Scale (VAS), the Overactive Bladder Questionnaire (OAB-q). 94/2205 patients in the full population were Hispanic. Urgency was most frequently reported at baseline (93.6%), followed by frequency (91.5%), nocturia (84.0%) and urge incontinence (UI) (67.0%). Frequency was reported as the most bothersome symptom (MBS) by a higher proportion of Hispanics than the full population (40.4% vs. 28.1%). UI was reported as the MBS by a smaller proportion of Hispanics (18.1% vs. 27.3%). Patients reporting moderate-to-severe problems related to bladder condition at baseline reported improvement to 'some minor problems' at week 12. Over 72.0% of patients experienced PPBC score improvement. Both groups reported significant improvements in urgency, UI, frequency and nocturia on the VAS (all p<0.001) and all OAB-q domains (all p<0.001) at week 12. Although numbers were small, Hispanics receiving solifenacin for OAB reported improvement from baseline in symptom bother and HRQoL, as assessed by three independent PRO measures.

To What Extent Do Geriatricians Document the Most Bothersome Symptoms of Patients with Advanced Dementia?

To assess whether geriatricians documented the bothersome symptoms of patients with advanced dementia, proxy reports of the most-bothersome symptoms affecting those patients (as elicited in research interviews) were compared with what geriatricians who had seen those patients in a proximate clinic visit documented in the medical record. Retrospective chart review. Outpatient geriatrics clinic at the University of Chicago. Fifty-seven pairs of patients with dementia (Functional Assessment Staging Tool stage 6 or 7) and their proxies. Clinic notes were reviewed for documentation of patients' bothersome symptoms that proxies reported during research interviews. Proxy reports had been recorded in the previously established Palliative Excellence in Alzheimer Care Efforts database. The most-bothersome symptom was documented at least once in 84.2% (48/57) of clinic notes. The second-most-bothersome symptom was documented in 70.3% (26/37) of clinic notes. Most symptoms were documented in the Assessment and Plan section of the note. Geriatricians identified and documented the vast majority of bothersome symptoms, as reported by proxies, of patients with moderate to severe dementia.