Patient Global Impression Scale Research Articles

Effectiveness of Vortioxetine in Patients with Major Depressive Disorder Associated with Chronic Pain: An Observational Study in a Spanish Population.

Chronic pain (CP) and depression/anxiety often coexist, worsening each other's symptoms. Treating this comorbidity is challenging. Tricyclic antidepressants and serotonin noradrenaline reuptake inhibitors are the first-line treatment options for this comorbidity, although sometimes they are not effective and/or well tolerated by patients, and there is little clinical evidence that selective serotonin reuptake inhibitors are useful for controlling CP. The antidepressant vortioxetine, with a multimodal mechanism that may help reduce pain, has proven clinical efficacy in patients with major depressive disorder (MDD). This study investigated vortioxetine's effectiveness for MDD and CP in clinical practice. This was a 3-month, multicenter, prospective, open-label, non-interventional pharmacoepidemiologic study. Patients (n = 64) with MDD (9-item Patient Health Questionnaire [PHQ-9] score ≥ 15) and CP (visual analogue scale [VAS] score ≥ 4) were treated with vortioxetine for 3months (initiated with 10mg/day, with flexible dosing thereafter [5-20mg/day]). VAS, Clinical Global Impression (CGI), and Patient Global Impression (PGI) scales were used at baseline and at 1 and 3months. Brief Pain Inventory (BPI), PHQ-9 scale, and Satisfaction with Medicines Questionnaire (SATMED-Q) were used at baseline and at 3months. Adverse Events (AEs) were recorded. Descriptive statistics, chi-square tests, and Student's t-tests were used for paired data. MDD patients showed a statistically significant improvement in VAS from baseline (mean [standard deviation (SD)]: 7.42 [0.69]) to 1month (mean [SD]: 6.1 [0.81], P < 0.001) and 3months (mean [SD]: 5.09 [1.26], P < 0.0001). Similarly, BPI and PHQ-9 scores showed significant improvement from baseline (mean [SD]: 6.20 [0.80] and 16.63 [1.47], respectively) to 3months (mean [SD]: 4.73 [0.98] and 7.30 [2.60], P < 0.0001, respectively). Patients showed clinical improvement with CGI and PGI scales and reported being satisfied with the treatment in the SATMED-Q. A few mild EAs were registered. Vortioxetine can relieve depressive and pain symptoms, with a good safety profile, in patients with MDD and CP.

Image-guided programming deep brain stimulation improves clinical outcomes in patients with Parkinson’s disease

Deep brain stimulation (DBS) is an effective treatment for patients with Parkinson’s disease (PD). However, some patients may not respond optimally to clinical programming adjustments. Advances in DBS technology have led to more complex and time-consuming programming. Image-guided programming (IGP) could optimize and improve programming leading to better clinical outcomes in patients for whom DBS programming is not ideal due to sub-optimal response. We conducted a prospective single-center study including 31 PD patients with subthalamic nucleus (STN) DBS and suboptimal responses refractory to clinical programming. Programming settings were adjusted according to the volumetric reconstruction of the stimulation field using commercial postoperative imaging software. Clinical outcomes were assessed at baseline and at 3-month follow-up after IGP, using motor and quality of life (QoL) scales. Additionally, between these two assessment points, follow-up visits for fine-tuning amplitude intensity and medication were conducted at weeks 2, 4, 6, and 9. After IGP, twenty-six patients (83.9%) experienced motor and QoL improvements, with 25.8% feeling much better and 38.7% feeling moderately better according to the patient global impression scale. Five patients (16.1%) had no clinical or QoL changes after IGP. The MDS-UPDRS III motor scale showed a 21.9% improvement and the DBS-IS global score improved by 41.5%. IGP optimizes STN-DBS therapy for PD patients who are experiencing suboptimal clinical outcomes. These findings support using IGP as a standard tool in clinical practice, which could save programming time and improve patients’ QoL.

PCR37 Understanding Symptoms and Meaningful Change in Patient Global Impression Scales for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer (adv/met NSCLC): A Qualitative Research Study

PCR37 Understanding Symptoms and Meaningful Change in Patient Global Impression Scales for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer (adv/met NSCLC): A Qualitative Research Study

The Use of Platelet-rich Plasma as a Novel Nonsurgical Treatment of the Female Stress Urinary Incontinence: A Prospective Pilot Study

The aim of the study was to evaluate the efficacy and safety of platelet-rich plasma (PRP) for the treatment of stress urinary incontinence (SUI). This was a prospective observational pilot study conducted in a tertiary referral unit, enrolling women with SUI booked for SUI surgery. A total of 20 consecutive women met the inclusion criteria and attended all follow-ups. All participants underwent 2 PRP injections into the lower one third of the anterior vaginal wall at 4- to 6-week intervals. At baseline, they underwent urodynamic studies, a 1-hour pad test, and completed the International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms and King's Health Questionnaire. At follow-up visits (1, 3, and 6 months), patients underwent the 1-hour pad test and completed the King's Health Questionnaire, International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms, and Patient Global Impression Scale of Improvement. Primary outcome was to evaluate posttreatment SUI. Secondary outcomes included assessment of patient-reported questionnaires, assessment of urine loss (1-hour pad test), and the level of discomfort during injections (visual analog scale score). Statistical analysis was performed before PRP and 1, 3, and 6 months after the last treatment. A significant improvement in SUI symptoms was observed 3 months after treatment with a further improvement at 6 months. A mean reduction of 50.2% in urine loss was observed in the 1-hour pad test. At the 6-month follow-up, 80.0% of women reported to be at least improved. No adverse effects were observed. Platelet-rich plasma injections were both effective and safe at least in the short term and could be offered as an alternative outpatient procedure for the treatment of SUI. However, these encouraging findings warrant further investigation with randomized controlled trials.

Randomized Prospective Study in Patients With Complex Regional Pain Syndrome of the Upper Limb With High-Frequency Spinal Cord Stimulation (10-kHz) and Low-Frequency Spinal Cord Stimulation

ObjectiveThe objective of this prospective randomized study of cases and controls was to evaluate the efficacy of treatment with low-frequency spinal cord stimulation (LF-SCS) and 10 kHz spinal cord stimulation (10-kHz SCS) in patients diagnosed with complex regional pain syndrome type I (CRPS) with upper limb involvement. Materials and MethodsFifty patients were randomized to receive conventional treatment or SCS with a commercially available low-frequency or 10-kHz system. Patients were assessed at 1, 3, 6, and 12 months. The primary endpoint was at 12-months post permanent implantation of the SCS devices. Outcome measures assessed included: Numerical Rating Scale (NRS), 12-Item Short-Format Health Survey (SF-12), Oswestry Disability Index (ODI), Study Sleep Scale medical outcomes (MOS-SS), Douleur Neuropathique 4 questions pain questionnaire (DN4), Patient Global Impression Scale on the impact of treatment improvement (PGI-I), Clinician Global Impression Scale on the impact of improving the patient (CGI-I). ResultsForty-one patients were finally included in the analysis, 19 patients in the conventional treatment group, 12 in the LF-SCS group, and 10 in the 10-kHz SCS group. At the primary endpoint, patients treated with LF-SCS presented improvements in the NRS and DN4 outcomes around 2.4 and 1.5 times above the minimal clinically important difference (MCID) thresholds. At the primary endpoint, patients treated with 10-kHz SCS presented improvements in the NRS and DN4 outcomes around 2 and 1.4 times above the MCID thresholds. ConclusionsPatients experienced considerable improvement after SCS. The results show that LF-SCS has very good results when compared with conventional treatment. The results obtained with 10-kHz SCS are encouraging, with the advantages of the absence of paresthesia making it an alternative in the treatment of CRPS.

Use of Patient and Investigator Global Impression Scales: A Review of Food and Drug Administration–Approved Labeling, 2009 to 2019

ObjectiveIdentify disease categories in which single-item global impression (GI) scales were included in product labeling of new drugs approved by the US Food and Drug Administration (FDA) in January 2009-December 2019 and review the characteristics of GIs included in product labeling of new FDA-approved drugs (January 2017-December 2019). MethodsFDA Clinical Outcome Assessment (COA) Compendium was reviewed for drug labels that included GIs for drugs approved in 2009-2016. The indication, year of approval, ICD-10 code, and GI respondent were noted. A manual review of labels of FDA-approved drugs (2017-2019) was undertaken to identify GIs included in the labels. Corresponding drug approval packages were reviewed to identify details of any regulatory reviewer comments related to GIs. GI characteristics were noted from the drug label or the review documents, including the respondent, type of measure (static or dynamic), item wording, concept assessed, and response options. ResultsProduct labeling containing GIs was most common in diseases related to the skin, nervous system, behavioral disorders, and the musculoskeletal system. GIs were included in 30/77 (39.0%) drug labels in the four disease categories. ConclusionIn the past 10 years, GIs have been included as endpoint measures in confirmatory clinical trials and have generated evidence of treatment benefit in diseases related to the skin, nervous system, behavioral disorders, and the musculoskeletal system. GIs frequently provide important insights into the patient experience. Before GIs are included in clinical trials to assess treatment benefit, it is important to ensure that they are valid, reliable, and responsive.

Effects of three contraceptive methods on depression and sexual function: An ancillary study of the ECHO randomized trial

ObjectiveTo compare the effects of depot medroxyprogesterone acetate (DMPA‐IM), levonorgestrel (LNG) implant, and copper intrauterine device (IUD) on mood and sexual function.MethodsAt the Effective Care Research Unit in South Africa, women already randomized in the ECHO Trial to the three methods were asked to participate in this study. Participants were interviewed at 3 and 12 months after enrollment using the Beck Depression Inventory and Arizona Sexual Experiences Scale, and at 12 months using the WHO‐5 Wellbeing Index and the Patient Global Impression scale.ResultsA total of 605 women participated. There was little difference in depression at 3 months across the three study groups. Contrary to our hypothesis, at 12 months, depression was lowest among DMPA‐IM users (16/167, 9.6%) and highest among IUD users (28/158, 17.7%) (p = 0.032). There was little difference in sexual function at any time‐point. More women in the DMPA‐IM group felt “very much better” on the PGI scale than in the IUD and LNG implant groups (p = 0.003).ConclusionDepression may be less likely with DMPA‐IM than with the other methods 1 year after initiation. Major differences in sexual functioning are unlikely. Unhappiness related to not using DMPA‐IM, the most popular method in our setting, may have skewed results.Trial registration number: PACTR201706001651380.

Vibegron improves quality-of-life measures in patients with overactive bladder: Patient-reported outcomes from the EMPOWUR study.

BackgroundQuality of life (QOL) can be significantly impacted by symptoms of overactive bladder (OAB). Vibegron is a highly selective β3‐adrenergic receptor agonist that showed efficacy in treatment of symptoms of OAB in the randomised, double‐blind, placebo‐ and active‐controlled phase 3 EMPOWUR trial. Here we report patient‐reported QOL outcomes from the EMPOWUR trial.MethodsPatients were randomly assigned 5:5:4 to receive vibegron 75 mg, placebo or tolterodine 4 mg extended release, respectively, for 12 weeks. Patients completed the OAB questionnaire (OAB‐q) at baseline and at week 12 and the patient global impression (PGI) scales for severity, control, frequency and leakage at baseline and at weeks 4, 8 and 12. Change from baseline at week 12 and responder rates (OAB‐q: patients achieving a ≥10‐point improvement; PGI: patients reporting best possible response) were assessed. Vibegron was compared with placebo, and no comparisons were made between vibegron and tolterodine.ResultsOf the 1518 patients randomised, 1463 (placebo, n = 520; vibegron, n = 526; tolterodine, n = 417) had evaluable data for efficacy measures and were included in the analysis. Mean baseline OAB‐q and PGI scores were comparable among treatment groups. At week 12, patients receiving vibegron had greater improvements from baseline in OAB‐q subscores of coping, concern, sleep, health‐related QOL total and symptom bother (P < .01 each) compared with patients receiving placebo; a greater proportion of patients receiving vibegron vs placebo were responders in the OAB‐q coping (P < .05) and symptom bother scores (P < .0001). Compared with placebo, a greater proportion of patients who received vibegron achieved the best response on all PGI end‐points at week 12 (P < .05 each) and were classified as responders (P < .05 each).ConclusionsIn the 12‐week EMPOWUR trial, treatment with vibegron was associated with significantly greater and clinically meaningful improvement in OAB‐q and PGI scores compared with placebo, consistent with improvements in OAB symptoms.Clinical trial registrationClinicalTrials.gov identifier number NCT03492281.

PNS227 Response SETS within Patient Global Impression Measures: Challenges and Recommendations for Development

Patient Global Impression (PGI) instruments are used to assess aspects of a patient’s experience with a given health condition or treatment. Respondents typically evaluate disease activity or severity, or change in health status, choosing among discrete response options on an ordinal scale with positive and negative extremes. Despite their simplicity, common issues in PGI translation and comprehension can interfere in the accurate assessment of a PGI’s target construct, as well as their ability to pool data collected across languages or countries. This research reviews these common problems in PGI translation and presents recommendations for resolving them. A convenience sample of 8 recent cognitive debriefing projects including PGIs was compiled and patient feedback on response options, suggestions for translation revisions, and terminology preferences was extracted for review. Overall, debriefing results from 85 language-country pairs were analyzed, each containing 5 patient interviews (N = 425). Our results indicate that 7-point PGI scales are problematic across many languages, and difficulty frequently arises in distinguishing between conceptually similar response options (e.g., “a little better” vs “moderately better”; “minimally” vs “mildly”). Regardless of response set length, common response options such as “moderate”, “worst imaginable”, and “quite a bit” were conceptually unclear across languages (particularly Indian and Nordic languages, as well as Russian variants), and more descriptive language was typically preferred by patients. Another frequent issue was misinterpretation of “global” in the instrument title, predominantly in variants of English and Romance languages. Based on these data, RWS Life Sciences recommends avoidance of large and conceptually similar response sets, along with standardization and simplification of the terminology used in PGIs. Unclear wording and overly dense response sets interfere in the collection of accurate data on patient experience, especially in the context of global studies on patients from diverse language and educational backgrounds.

Obstructive sleep apnea in people with intellectual disabilities: adherence to and effect of CPAP.

Obstructive sleep apnea (OSA) is common in people with intellectual disabilities (ID), but in practice continuous positive airway pressure (CPAP) is often deemed unfeasible. We investigated adherence to and effect of CPAP in patients with ID and OSA. Patients with ID were started on CPAP using an intensive training program. Acceptable adherence was defined as use of ≥ 4h/night during ≥ 70% of the nights. Treatment effect was measured with a patient global impression scale and customized questionnaires. Reasons for not starting CPAP, factors influencing treatment, and reasons for terminating CPAP were explored. Of 39 patients with ID, 87% after 8-10weeks and 70% at 8months still used CPAP, of whom 74% and 77% showed acceptable adherence. Baseline apnea-hypopnea (AHI) index decreased from 41.2/h to 5.3/h after 8-10weeks (p < 0.001), and 4.3/h after 8months (p < 0.001). At 8-10weeks and after 8months, there was an improvement in the most restrictive reported complaint (both p < 0.0005), difficulty waking up (p < 0.01; p < 0.0005), handling behavior (p < 0.03; p < 0.02), presence of irritability (p < 0.01), and sleepiness (p < 0.05). The expectation that CPAP would not be tolerated was the main reason for not starting. CPAP use in the first 2weeks predicted adherence at 8-10weeks and 8months (r = 0.51, p < 0.01; r = 0.69, p < 0.01). Of 13 patients who terminated CPAP, the reasons for termination included behavioral problems, comorbid insomnia, anxiety, discomfort, or other side effects. With adequate guidance, CPAP is both feasible and effective in people with ID and OSA.

A randomized, double-blind, placebo-controlled study of polyunsaturated fatty acids efficacy in adolescents with anorexia nervosa

Objective. Omega–3 polyunsaturated fatty acids (PUFAs) were tested in adolescent depression and in several neurodevelopmental disorders with partial success. Anorexia nervosa (AN) is characterised by deficiencies in fatty food intake and frequent comorbidity, including depressive and cognitive symptoms. Thus supplementation with PUFAs may be beneficial in this group of patients. The aim of the study was to assess whether PUFAs as an add-on treatment is associated with better improvement of body mass index (BMI) and psychopathological symptoms than placebo in patients with AN. Method. 61 female adolescent inpatients with AN were randomly allocated to omega–3 PUFAs supplementation or placebo for 10 weeks. Patients also participated in the behavioural programme and eclectic psychotherapy (treatment as usual, TAU). At baseline and follow-up visits, patients’ BMI and psychopathology were assessed with Clinical Global Impression Scale (CGI), Patient Global Impression Scale (PGI), and Eating Attitude Test (EAT-26). Results. After 10 weeks, both groups showed improvement in all parameters. Improvement in CGI scores was observed greater in placebo vs. PUFA-s group (p = 0.015) while other differences were not statistically significant. Omega–3 PUFAs supplementation appears not to be effective as an add-on treatment in inpatient adolescent girls with anorexia nervosa. Conclusions. The results should be analysed with caution due to small sample size and heterogeneity in TAU. As the TAU turned out to be highly effective, additional therapeutic effect of PUFA might not be visible. Nevertheless, that does not explain the tendency for better improvement in the placebo group.

Agreement between patient global impression scale of improvement, pelvic floor distress inventory and 15D in measuring the outcome of pelvic organ prolapse surgery.

To evaluate the correlation between three commonly used patient-reported outcome measures, two generic and one condition-specific instrument, in assessing the change in health-related quality of life following pelvic organ prolapse surgery. The generic health-related quality of life measure 15-dimensional instrument (15D), Patient Global Impression of Improvement (PGI-I), and prolapse-specific Pelvic Floor Distress Inventory (PDFI-20) were used to assess the effectiveness of pelvic organ prolapse surgery in the national FINPOP study of 3535 surgeries (83% of all pelvic organ prolapse operations) performed in Finland in 2015. Spearman correlations between PGI-I, change in 15D and its dimensions and change in PFDI-20 and its subscales over a 2-year follow-up were investigated. The proportion of concordant ratings was also studied by investigating the proportion of women rated similarly (worse/no change/better/much better) by two instruments according to validated cutoffs. Among 2248 women for whom the 2-year change in all instruments could be measured, changes in PFDI-20 and 15D and its dimensions were weak (ρ < 0.2 for all except excretion; ρ = 0.39 and sexual activity; ρ = 0.27). PFDI-20 change (ρ = 0.39) and its subscales (ρ = 0.19-0.40, all P < .001) were more strongly correlated with PGI-I. The proportion of fully concordant ratings were higher for PFDI-20 and PGI-I (50.6%) than for PFDI-20 and 15D (33.0%). The weak correlations between 15D, PGI-I, and PDFI-20 observed in this study show that the quantified health gains are strongly dependent on the chosen patient-reported outcome measures. This demonstrates the importance of using condition-specific sensitive outcome measures in assessing the impact of surgical treatment in pelvic organ prolapse.

A randomised controlled trial of a mitochondrial therapeutic target for bipolar depression: mitochondrial agents, N-acetylcysteine, and placebo

BackgroundA phasic dysregulation of mitochondrial bioenergetics may operate in bipolar disorder, increased in mania and decreased in depression. We aimed to examine efficacy of two add-on treatments in bipolar depression: N-acetylcysteine (NAC) and NAC with a combination of nutraceutical agents that may increase mitochondrial biogenesis.MethodsA three-arm 16-week, double-blind, randomised, placebo-controlled trial, adjunctive to usual treatment, was conducted. Participants (n = 181) with bipolar disorder and current depressive symptoms were randomised to 2000 mg/day NAC (n = 59), 2000 mg/day NAC with the combination nutraceutical treatment (CT, n = 61), or placebo (n = 61). The primary outcome was change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline to week 16. Young Mania Rating Scale, Clinical Global Impression (CGI)-Improvement and CGI-Severity scales, Patient Global Impression scale, Social and Occupational Functioning Assessment Scale (SOFAS), Longitudinal Interval Follow-Up Evaluation - Range of Impaired Functioning Tool (LIFE-RIFT), and Quality of Life Enjoyment, and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) were secondary outcomes.ResultsOne hundred forty-eight participants had post-randomisation data and were analysed (NAC = 52, CT = 47, Placebo = 49). No between-group differences were found for the rate of change between baseline and 16 weeks on any of the clinical and functioning variables. Improvements in MADRS, BDRS, SOFAS, and LIFE-RIFT scores from baseline to the week 20 post-discontinuation visit were significantly greater in the CT group compared to those in the placebo. At week 20, the CGI-I was significantly lower in the CT group versus placebo. Gastrointestinal symptoms were significantly greater in the NAC than in the placebo group.ConclusionsThese overall negative results, with no significant differences between groups detected at the primary outcome but some positive secondary signals, suggest either delayed benefit of the combination or an improvement of symptoms on withdrawal which warrants further exploration regarding the composition, mechanisms, and application of mitochondrial agents in illnesses characterised by mitochondrial dysfunction.Trial registrationANZCTR (ACTRN12612000830897).

Rotigotine in Parkinson's Disease Patients: What is the Efficient and Tolerable Dose According with the Real Clinical Practice? An Open, Non-Controlled Multicenter Spanish-Study

Patients included in this study showed a significant improvement in regards to the UPDRS motor scale, as well as in the PDQ-8 functional scale and the patient global impression scale at the end of the study. Whereas, the score in global clinical impression as well as in the NPI scale showed no significant statistical improvement at the end of the end of the study.

Patient centric measures for a patient centric era: Agreement and convergent between ratings on The Patient Global Impression of Improvement (PGI-I) scale and the Clinical Global Impressions – Improvement (CGI-S) scale in bipolar and major depressive disorder

BackgroundConcordant with an increased emphasis on consumer engagement, the Patient Global Impression Scale of Improvement (PGI-I) is commonly used as an outcome measure in studies evaluating the efficacy of treatments in medical and psychiatric conditions with subjective symptom domains. The current study evaluated the agreement between PGI-I and Clinician Global Impression Scale of Improvement (CGI-I) ratings and convergent validity of PGI-I among individuals with bipolar or major depressive disorders. MethodData were derived from three double-blind, placebo-controlled, multicentre studies conducted from 2007 to 2015 among adult individuals (N = 472). Clinicians were asked to rate participants symptoms using the CGI-I as well as severity of depression by the Montgomery-Åsberg Depression (MADRS), quality of life (Q-LES-Q), social and occupational functioning (SOFAS), and functional impairment (LIFE–RIFT). Participants were asked to assess their symptom improvement with the PGI-I. Bland-Altman agreement plots and Intra-class correlations were used to evaluate agreement, and Spearman correlation coefficients were implemented to examine convergent validity. Sub-group analyses for disorder type (bipolar and major depression) were performed. ResultsThere was high agreement between the PGI-I and CGI-I ratings across follow-up time points (weeks 2, 4, 6, 8, 12, 16, 20, 24, and 28). Similar results were observed in male only and female only data and after adjustment for age and gender. Both PGI-I and CGI-I ratings were robustly positively correlated with MADRS, and LIFE-RIFT and negatively correlated with SOFAS and Q-LES-Q, supporting the convergent validity of the PGI-I. Sub-group analyses for bipolar and major depressive disorder showed similar findings. ConclusionOur findings support the utility of the PGI-I as a participant rated measure of global improvement among individuals with bipolar or major depressive disorders.

Adult Onset Nocturnal Enuresis: Identifying Causes, Cofactors and Impact on Quality of Life.

The objectives of the present study were: (i) Evaluate common co-pathologies associated with, and potentially contributing to adult onset Nocturnal enuresis (NE) in a tertiary referral population; and (ii) quantify its impact on QoL with validated questionnaires. Following Institutional Review Board approval, patients with adult onset NE were reviewed with history, physical examination, urodynamic studies, questionnaires: Overactive bladder questionnaire short-form (OAB-qSF), Urogenital Distress Inventory (UDI-6), AUA symptom score (AUA-SS) and Patient Global Impression scale (PGIS). Between 2004 and 2016, 45 NE patients (19 male, 26 female) were identified. Twenty-five patients (56%) had an associated diagnosis of neurogenic bladder (NGB). Five (11%) reported no other LUTS or associated conditions. Forty (89%) had at least one of the following contributing factors: sedative use, OAB (bothersome symptoms based on UDI-6), voiding dysfunction (also based on UDI-6 or AUA-SS), abnormal UDS finding, and/or confirmed obstructive sleep apnea (OSA). Overall, 20% had two contributing factors, and 31% each had three and four factors. Among all patients, 76% reported sedative use and of 36 patients with UDS, 75% had abnormal findings. Of the 41 questionnaire respondents, mean AUA-SS among men was 22.5 (range 8-35) and mean UDI-6 score among women was 9.3 (range 2-16). Mean PGI-S score was 3.1 (range 1-4) and mean Health Related Quality of Life (HRQL) subscale, as part of the OAB-q SF was 44 (range 22-78). Nocturnal enuresis is associated with multiple possible co-factors in all populations with majority reporting use of sedating medications. NE is associated with significant symptom bother and impacts greatly on QoL.

Reliability of the English version of the painDETECT questionnaire

Background: The painDETECT questionnaire (PD-Q) has been used widely for the identification of neuropathic pain (NeP); however, the reliability of the English version of the PD-Q has never been investigated.Objective: This study aimed to determine the reliability of the PD-Q pre- (T0) and immediately post- (T1) clinical consultation and at one-week follow-up (T2).Methods: We recruited 157 patients attending a Neurosurgery Spinal Clinic and Pain Management Department. Minor changes to PD-Q instructions were made to facilitate patient understanding; however, no changes to individual items or scoring were made. Intraclass correlation coefficients (ICCs) were used to assess the reliability of PD-Q total scores between T0–T1 and T0–T2; weighted kappa (κ) was used to assess the agreement of PD-Q classifications (unlikely NeP, ambiguous, likely NeP) between all time-points. To ensure stability of clinical pain, patients scoring ≤2 or ≥6 on the Patient Global Impression Scale (PGIC) at T2 were excluded from the T0–T2 analysis.Results: Accounting for missing data and exclusions (change in PGIC score), data for 136 individuals (mean [SD] age: 56.8 [15.2]; 54% male) was available, of whom n = 129 were included in the T0–T1 and n = 69 in the T0–T2 comparisons. There was almost perfect agreement between the PD-Q total scores at T0–T1 time-points (ICC 0.911; 95% CI: 0.882–0.941) and substantial agreement at T0–T2 (ICC 0.792; 95% CI: 0.703–0.880). PD-Q classifications demonstrated substantial agreement for T0–T1 (weighted κ: 0.771; 95% CI: 0.683–0.858) and for T0–T2 (weighted κ: 0.691; 95% CI: 0.553–0.830). Missing data was accounted in 13% of our cohort and over 42% of our patients drew multiple pain areas on the PD-Q body chart.Conclusion: The English version of the PD-Q is reliable as a screening tool for NeP. The validity of the questionnaire is still in question and has to be investigated in future studies.

Oral morphine for cancer pain.

Oral morphine for cancer pain.

Clinical experience of the use of agomelatine in the treatment of patients with depression and chronic brain ischemia

To study the efficacy and tolerability of agomelatine (valdoxan) in treatment of mild depressive states in patients with chronic brain ischemia (CBI). The study comprised 33 patients (23 women, 10 men, average age 54.5 years), including 12 people (36.4%) with CBI, stage I, and 21 (63.6%) with CBI, stage II. All patients had a single depressive episode of mild severity. Diagnosis of affective and cognitive impairment was carried out using clinical and neuropsychological methods (the Hamilton Depression Rating Scale (HDRS-17), the Hospital Anxiety and Depression Scale (HADS), the night sleep questionnaire developed by A.M. Vein, the Mini-mental state examination (MMSE), the modified Mini-Cog method, the Montreal Cognitive Assessment Scale (MoCA), the Clinical Global Impression scale (CGI-S, CGI-I) to assess the degree and dynamics of the disease, the Patient Global Impression (PGI) scale. The survey had been performed after 2,4 and 8 weeks of treatment. Agomelatine (valdoxan) was used 1 time per day in the evening in a dose of 25 mg (1 tablet). Agomelatine improved sleep from the second week of treatment, reduced anxiety symptoms after six weeks and depressive symptoms after eight weeks. The improvement of cognitive functions was noted as well. No side-effects was observed. The results revealed the high antidepressive activity of the drug in treatment of mild depressive states in patients with chronic brain ischemia, the balanced spectrum of effects on anxiety, depression, insomnia, the positive effect on cognitive functions that allows to recommend agomelatine in treatment of patients with CBI.

The effects of gluten-free diet versus hypocaloric diet among patients with fibromyalgia experiencing gluten sensitivity symptoms: Protocol for a pilot, open-label, randomized clinical trial

BackgroundFibromyalgia is a chronic musculoskeletal pain syndrome characterized by a broad spectrum of manifestations. Patients with fibromyalgia frequently suffer from manifestations similar to those experienced by patients with gluten-related disorders raising the possibility that some patients with fibromyalgia could suffer from underlying gluten sensitivity. ObjectiveThis study aims to assess whether avoiding gluten among patients with fibromyalgia and gluten sensitivity is beneficial. MethodsAdult patients with fibromyalgia presenting gluten sensitivity symptoms are randomly allocated to receive gluten-free diet or hypocaloric diet for 24weeks. The primary outcome measure is the mean change in the number of experienced gluten sensitivity symptoms. Secondary outcome measures include the mean changes in the body mass index, Revised Fibromyalgia Impact Questionnaire, Pittsburgh Sleep Quality Index, Brief Pain Inventory, Beck Depression Inventory—II, State-Trait Anxiety Inventory, Short-Form Health Survey and Patient Global Impression Scale of Severity. Other secondary outcome measures include the frequency of potential adverse events and the proportion of responders according to the Patient Global Impression Scale of Improvement. DiscussionPrevious studies assessing dietary interventions in fibromyalgia primarily evaluated their effects on the severity and impact of fibromyalgia symptoms and pain. The current study is the first to evaluate the effects of gluten-free diet on the gluten sensitivity symptoms experienced by patients with fibromyalgia. The results of this study will contribute to a better understanding of the potential role of gluten sensitivity in fibromyalgia.