Patient Clinical Global Impression Research Articles

Exploring the relation between clinician ratings and patient-reported experience and outcomes

Abstract Background Patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) are increasingly recognized as important ways for patients to be more actively involved in their treatment and enhance shared decision-making. Objective The current study investigated the associations between PROMs, PREMs and various symptoms measures reported by clinicians and psychiatric patients. Method One hundred and twenty people admitted to a psychiatric hospital completed two PREMs, one PROM (the shortened version of the Manchester Short Assessment of Quality of Life scale) and Effects of Symptoms on Daily Functioning (the Sheehan Disability Scale), the Patient Clinical Global Impression and the Modified Colorado Symptom Index. Their psychiatrists rated them using the Global Assessment of Functioning scale, the Health of the Nation Outcome Scales and the Therapist Clinical Global Impression. Results There was a strong correlation between patient’s evaluation of their quality of life (PROM), experience of their care (PREM) and the overall severity of their condition and their progress. The pattern of correlation between patients’ and clinicians’ measures revealed a three-layer structure representing a continuum from inner experience to external presentation of experiences. Conclusion Together these findings help identify and emphasize various domains of subjective experiences and their relation to external ratings.

An Internally Validated Nomogram for Predicting the Likelihood of Improvement of Clinical Global Impression in Patients With Lifelong Premature Ejaculation Treated With Dapoxetine

BackgroundAlthough the introduction of dapoxetine has ushered in a new era in the treatment of premature ejaculation, many patients with lifelong premature ejaculation (LPE) exhibit an unimproved clinical global impression even after treatment with dapoxetine. AimTo investigate independent predictors of the improvement of Clinical Global Impression (iCGI) in patients with LPE treated with dapoxetine and develop a nomogram to predict a patient's likelihood of achieving iCGI. MethodsData of 243 patients with LPE diagnosed at Xijing Hospital (Xi'an, China) and Northwest Women's and Children's Hospital (Xi'an, China) from January 2019 to May 2020 were analyzed. Independent predictors of iCGI were identified, and a nomogram was developed using R software based on a multivariate logistic regression model. The predictive accuracy of the nomogram was measured using the area under the receiver operating characteristic curve. The nomogram was calibrated by comparing predictions with observations. Main Outcome MeasuresThe primary outcome was the patient-rated Clinical Global Impression of Change scale score after a 4-week course of dapoxetine treatment, which was collected via an online questionnaire. A Clinical Global Impression of Change score of ≥1 was defined as iCGI in this study. ResultsPatients with LPE with at least a bachelor's degree, a self-reported intravaginal ejaculation latency time of >1 minute, and an International Index of Erectile Function question 5 score of ≥3 were independent factors associated with achieving iCGI, whereas a Premature Ejaculation Diagnostic Tool question 1 score of ≥2 was an independent factor negatively associated with achieving iCGI. The predictive accuracy of the nomogram, which was developed by integrating all variables with independent predictive significance, was 0.710 (95% confidence interval: 0.702–0.718). In addition, the calibration plot demonstrated excellent agreement between predictions and observations. Clinical ImplicationsIf the predictive performance of our nomogram is further proven in multiple external validations, it can be used to select suitable patients for dapoxetine treatment, thereby reducing the number of patients discontinuing treatment. Strengths & LimitationsThis study developed the first nomogram for predicting the likelihood of achieving iCGI in patients with LPE treated with dapoxetine. However, our nomogram was not externally validated using independent cohorts from other institutions. ConclusionThis study identified several independent predictors of iCGI in patients with LPE treated with dapoxetine. An effective nomogram was developed to predict their likelihood of achieving iCGI. External validations using data of Western patients with LPE are required to test the broader applicability of this Chinese patient-based tool.Hou G, Gao M, Zhang L, et al. An Internally Validated Nomogram for Predicting the Likelihood of Improvement of Clinical Global Impression in Patients With Lifelong Premature Ejaculation Treated With Dapoxetine. J Sex Med 2020;17:2341–2350.

Objective and Subjective Measures of Premature Ejaculation: How Closely Do They Correspond and How Well Are the Subjective Measures Recalled?

BackgroundClinical trials evaluating new treatments for premature ejaculation (PE) should ideally include both objective end points and patient reported outcomes (PROs), but there is no consensus currently over the optimal measures or combination of outcomes. In addition, many PROs use a 1-month recall period, despite concerns about potential recall bias. AimsData from a clinical trial of men with lifelong PE were used to examine the consistency of 2 core items of the Premature Ejaculation Profile (PEP), a widely used PRO for assessing subjective aspects of PE. The specific aim was to assess the level of agreement between the original 1-month recall version compared with a new event-based version of the scale in men meeting current definitions of lifelong PE. A further aim was to investigate the convergent validity between an objective end point of intravaginal ejaculatory latency time (IELT), subjective PEP responses, and a patient's Clinical Global Impression of Change (CGIC) measure. MethodsFor assessment of consistency of PEP responses (short-term [ie, sexual event driven] vs 1-month recall), descriptive statistics, correlation coefficients (Pearson and Spearman), and Bland-Altman plots are presented for each time interval. For assessment of convergent validity, descriptive statistics and correlation coefficients (Pearson and Spearman) are presented for each assessment with geometric mean IELT values. Results are also depicted graphically. Geometric mean IELT over the last 4 weeks of treatment and change from baseline (absolute and fold change) were estimated via a general linear model for each category of change in PEP and CGIC, adjusting for baseline IELT. OutcomesPEP items administered via 1-month recall and short-term event-driven responses gave virtually identical results. There was a strong correlation (very good convergent validity) between IELT and responses to PEP and the CGIC. Clinical translationMen with lifelong PE can accurately recall their level of sexual functioning over the previous month. The PEP and CGIC are appropriate instruments to measure the subjective response of men with PE to new treatments. Strengths and limitationsOur analyses address gaps in previously published research on PE assessment methodology. Men with acquired PE, men without partners, and men in homosexual relationships were not studied. ConclusionsIn a clinical trial setting, PEP and CGIC are appropriate end points and are likely the optimal combination of PROs for use with IELT to enable a global assessment of patient response to new PE treatments.Althof S, Rosen R, Harty B, et al. Objective and Subjective Measures of Premature Ejaculation: How Closely Do They Correspond and How Well Are the Subjective Measures Recalled? J Sex Med 2020;17:634–644.

Atomoxetine improves sleepiness and global severity of illness but not the respiratory disturbance index in mild to moderate obstructive sleep apnea with sleepiness

Background and purpose Norepinephrine reuptake inhibitors such as protriptyline have been shown to improve sleepiness in sleep apnea, with or without improvement in the respiratory disturbance index (RDI). This study was performed to evaluate whether the selective norepinephrine reuptake inhibitor atomoxetine improves sleepiness, the clinical global impression (CGI) of severity of illness, and the RDI in patients with mild to moderate obstructive sleep apnea with excessive sleepiness. Methods Patients aged 18–60 years with RDI (including apneas, hypopneas with desaturations and hypopneas with arousals) > 5/h sleep, apnea–hypopnea index (AHI; including apneas, hypopneas with 4% desaturations, but not apneas with arousals) < 15/h sleep, and excessive sleepiness (Epworth Sleepiness Scale [ESS] ⩾ 10) received open-label treatment with atomoxetine 40–80 mg HS for 4 weeks, with repeat polysomnography at the end of treatment. Of 20 patients screened, 17 started treatment and 15 completed treatment. Results ESS improved from 15.3 to 10.5 and CGI improved from 4.3 to 3.1 (both significant at p < 0.01), but there was no significant change in RDI. ESS and CGI improved in a linear fashion across the weeks of treatment. Sleep efficiency and % stage rapid eye movement (REM) sleep were decreased, and % stage 1, awakenings and wake after sleep onset were increased. Conclusions Atomoxetine improved sleepiness and the CGI in patients with mild to moderate obstructive sleep apnea with sleepiness. However, it did not improve the RDI.

Meta-analysis: the efficacy of nootropic agent Cerebrolysin in the treatment of Alzheimer’s disease

To determine the therapeutic effect of nootropic agent Cerebrolysin on patients with mild to moderate Alzheimer's disease (AD), we searched the Cochrane Library, Medline, PubMed, and Chinese Biomedical Literature Analysis and Retrieval System for Compact Disc (CBMDISC), and communicated with EBEWE Pharmaceutical Ltd, for randomized trials comparing Cerebrolysin with placebo in AD. Available data on clinical global impression, cognitive performance and activities of daily living were extracted from 6 randomized double-blind placebo-controlled clinical trials and combined with standard meta-analysis methods. An infusion with Cerebrolysin for 4 weeks (30 ml Cerebrolysin daily on five consecutive days of each week) led to a significant improvement of the clinical global impression. Compared with placebo, log(OR) was 1.1799, and 95% confident interval was 0.7463-1.6135 (P < 0.05), indicating that Cerebrolysin could significantly improve the clinical global impression in patients with mild to moderate AD. However, more convincing evidences are needed for the efficacy of Cerebrolysin on the cognitive performance and activities of daily living.

Efficacy on menopausal neurovegetative symptoms and some plasma lipids blood levels of an herbal product containing isoflavones and other plant extracts

Objectives To assess the efficacy of a product containing isoflavones and other plant extracts (BIO) on whole menopausal symptomatology and plasma lipids profile. Methods Multicente, randomized, double blind, placebo controlled clinical investigation on 125 menopausal women randomly assigned to two groups treated for 6 months with placebo or one tablet daily of an herbal product containing 72 mg/dose of isoflavones of different plants origin and other plant extracts (BIO). Primary end-point: Kupperman Menopause Index (KI) variations; secondary end-point: activity on plasma lipids profile and clinical global impression (CGI) on efficacy and tolerability by investigators and patients. The usual parametric test (paired Student t test) was performed to evaluate the significance. In case of non-applicability of parametric tests, the non-parametric Mann–Whitney U test was used. The differences where considered significant at p < 0.05 level. Results At the end of treatment in both groups KI showed a significant decrease ( p < 0.001). However, in the BIO group the KI reduction was significantly higher ( p = 0.0265) than in the placebo group after 4 and 6 months of treatment. In the BIO treated patients the LDL cholesterol showed a borderline but not significant reduction compared to placebo ( p = 0.0608) and triglyceride (TG) a significant ( p = 0.0151) decrease compared to placebo. The investigator's and patient's CGI on BIO group where superior as compared to placebo. Clinical tolerability was good in booth groups. Conclusion On the basis of positive effects on KI and lipids profile as well as of good clinical tolerability, BIO can be considered one of the possible alternative therapy for conventional HRT.