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Background: Persistent breathlessness is debilitating and increases in prevalence with advanced age and at end of life. This study aimed to evaluate any relationship between self-reported global impressions of change (GIC) in perceived health and breathlessness in older men. Design: Cross-sectional study of 73-year-old Swedish men in the VAScular and Chronic Obstructive Lung disease study. A postal survey included items on perceived changes in health and breathlessness (GIC scales) and breathlessness (assessed using the modified Medical Research Council [mMRC] breathlessness scale, Dyspnea-12 and Multidimensional Dyspnea Scale) since age 65. Results: Of 801 respondents, breathlessness (mMRC ?2) was reported by 17.9%, worsening breathlessness by 29.1%, and worsening perceived health by 51.3%. Worsening breathlessness was strongly correlated with worsening perceived health (Pearson's correlation coefficient of 0.68 [p?0.001] and Kendall's ? of 0.56 [p?

Aim: The aim of this study was to assess the Personalized Insomnia Intensity Goal (PIIG), the achievement of Personalized Goal Response (PGR), and Patient Global Impression (PGI) after a comprehensive symptom management.Patients and Methods: Advanced cancer patients admitted to palliative care units rated pain and symptoms intensity and their PIIG by using the Edmonton Symptom Assessment Score (ESAS) (T0). In patients with significant levels of insomnia, the achievement of target expected (PIIG) was measured (patient goal response, PIGR), as well the patient global impression (PGI), by the minimal clinically important difference (MCID), after a comprehensive symptom management (T7).Results: Three hundred ninety-seven patients with a level of insomnia of ≥ 3 on ESAS were analyzed in this study. The mean values of PIIG at T0 and T7 were 1.2 (SD 1.5) and 0.9 (SD 1.4), respectively. Most patients (n = 406, 89.8%) indicated a PIIG of ≤ 3 as a target at T0. Such target was significantly lower at T7 (p = < 0.0005). PGI, expressed as MCID, was perceived with a mean decrease in insomnia intensity of - 2.3. In a minority of patients (n = 26; 5.8%) insomnia worsened, with a MCID of 0.50 (SD 2.8). Higher insomnia intensity at T0 and lower insomnia intensity at T7 were independently related to PGI. PIGR was achieved in 87.9% of patients. PIGR was associated with PIIG at T0, and inversely associated to insomnia intensity at T0 and T7, and PIIG at T7.Conclusion: PGIR and PGI seem to be relevant for evaluating the effects of a comprehensive management of insomnia, suggesting therapeutic decisions according to PIIG. Some factors influencing the individual target and clinical response have been detected. [ABSTRACT FROM AUTHOR]

Background: The aim of this study was to assess the patients' global impression (PGI) after symptom management, as well as the achievement of personalized symptom goals (PSG). The secondary outcome was to assess related factors. Subjects, Materials, and Methods: Advanced cancer patients admitted to palliative care units rated symptom intensity by using the Edmonton Symptom Assessment Score (ESAS) at admission and then after 1 week. For each symptom, patient‐reported PGI and PSG, as well as the rate of PSG response, were evaluated. Results: Eight hundred seventy‐six patients were taken into consideration for this study. A mean of 1.71–2.16 points was necessary to perceive a bit better improvement of symptom intensity. Most patients had a PSG of ≤3. A statistically significant number of patients achieved their PSG after starting palliative care. Patients with high intensity of ESAS items at admission achieved a more favorable PGI response. In the multivariate analysis, symptom intensity and PSG were the most frequent factors independently associated to a best PGI, whereas high levels of Karnofsky had a lower odd ratio. Conclusion: PSG and PGI seem to be relevant for patients' assessment and decision‐making process, translating in terms of therapeutic intervention. Some factors may be implicated in determining the individual target and clinical response. Implications for Practice: Personalized symptom goals and global impression of change are relevant for patients' assessment and decision‐making process, translating in terms of therapeutic intervention. Some factors may be implicated in determining the individual target and clinical response. A better characterization of personalized symptom goals (PSG) and factors associated with PSG and patients' global impression (PGI) after symptom management would help clinicians to personalize treatment. This article characterizes PGIs after 1 week of palliative care and assesses PSG in advanced cancer patients admitted to a palliative care unit. [ABSTRACT FROM AUTHOR]

Background: The clinical response after comprehensive symptom management is difficult to determine in terms of a clinically important difference. Moreover, therapies should try to reach the threshold perceived by the individual patient for the determination of a favorable response to a treatment.Measures: The Edmonton Symptom Assessment Score (ESAS) was measured at admission (T0), and seven days after starting palliative care (T7). Patient Global Impression and Goal Response after one week of palliative care and its relation with the Personalized Dyspnea Goal were measured at T7.Intervention: Patients admitted to palliative care units underwent a comprehensive symptom assessment by a specialist palliative care team. At T0, patients were asked about their Personalized Dyspnea Intensity Goal on ESAS. One week later (T7), after a comprehensive palliative care treatment, Personalized Dyspnea Intensity Goals were measured again. Patients were considered to have achieved a Patient Dyspnea Goal Response if dyspnea intensity (measured at T7) was equal or less than their expected Personalized Dyspnea Intensity Goal. At the same interval (T7), Patient Global Impression (improvement or deterioration) was measured.Outcomes: 279 patients were analyzed in this study. The mean Personalized Dyspnea Intensity Goal at T0 and T7 were 0.97 (SD 1.3), and 0.71 (SD 2.1), respectively. 263 patients (94.2%) indicated a Personalized Dyspnea Intensity Goal of ≤3 as a target at T0. Patients perceived a bit better, a better improvement, and a much better improvement with a mean decrease in dyspnea intensity of -2.1, -3.5, and -4.3 points on the dyspnea intensity scale, respectively. In 60 patients (21.5%), dyspnea intensity did not change, and in 4.7%, dyspnea intensity worsened. Patients perceived a Minimal Clinically Important Difference (little worse) with a mean increase in dyspnea intensity of 0.10, and they perceived a worse with a mean increase of 1.7 points. Higher dyspnea intensity at T0 and lower dyspnea intensity at T7 were independently related to Patient Global Impression. At T7, 93 (33.3%) patients achieved their Personalized Goal Response, based on Personalized Dyspnea Intensity. Patient Dyspnea Goal Response was associated with Memorial Delirium Assessment Scale score and Personalized Dyspnea Intensity Goal at T0, and inversely associated with dyspnea intensity at T0 and T7, and lower Karnofsky level. For Patient Dyspnea Goal Response, no significant differences among categories of dyspnea intensity were found (P>0.05).Conclusion: Patient Dyspnea Goal Response and Patient Global Impression seem to be relevant for evaluating the effects of a comprehensive management of symptoms, including dyspnea, assisting decision making process. Some factors may be implicated in determining the individual target and clinical response. A personalized symptom goal may translate in terms of therapeutic intervention, according to the achievement of the patients' expectations. High values of dyspnea intensity, a lower Karnofsky level, as well as high level of Dyspnea Intensity Goal (that is less patients' expectations) favor the achievement of the target. [ABSTRACT FROM AUTHOR]

Background: Pain intensity and patients' impression of global improvement are widely used patient-reported outcome measures (PROMs) in clinical practice and research. They are commonly assessed using the Numerical Pain Rating Scale (NPRS) and Global Rating of Change (GROC) questionnaires. The GROC is essential as an anchor for evaluating the psychometric properties of PROMs. Both of these PROMs are translated to many languages and have shown excellent psychometric properties. Their availability in Nepali would facilitate pain research and cross-cultural comparison of research findings. Therefore, the objectives of this study were to translate and cross-culturally adapt the NPRS and GROC into Nepali and to assess the psychometric properties of the Nepali version of the NPRS (NPRS-NP).Methods: After translating and cross-culturally adapting the NPRS and GROC into Nepali using recommended guidelines, NPRS-NP was administered to 104 individuals with musculoskeletal pain twice. The Nepali version of the GROC (GROC-NP) was administered at the follow-up for anchor-based assessment. (1) Test-retest reliability and minimum detectable change (MDC) among the stable group, (2) construct validity (by single sample t-test within the improved group and independent sample t-test between groups), and (3) concurrent validity were assessed. Receiver operating characteristic (ROC) curves were plotted to determine the responsiveness of the NPRS-NP using the area under the curve (AUC), and minimum important changes (MIC) for small, medium and large improvements.Results: Significant cultural adaptations were required to obtain relevant Nepali versions of both the NPRS and GROC. The NPRS-NP showed excellent test-retest reliability and a MDC of 1.13 points. NPRS-NP demonstrated a good construct validity by significant within-group difference in mean of NPRS score- t(63)= 7.57, P < 0.001 and statistically significant difference of mean score- t(98)= -4.24, P < .001 between the stable and improved groups. It demonstrated moderate concurrent correlation with the GROC-NP; r = 0.43, P < 0.01. Responsiveness of the NPRS-NP was shown at three levels with AUC = 0.68-0.82, and MIC = 1.17-1.33.Conclusions: The NPRS and GROC were successfully translated and culturally adapted into Nepali. The NPRS-NP demonstrated good reliability, validity and responsiveness in assessing musculoskeletal pain intensity in a Nepali population. [ABSTRACT FROM AUTHOR]

Purpose:To evaluate changes in pain intensity and activity limitation, at group and individual levels, and their associations with the global impression of change after multimodal rehabilitation in patients with back pain. Method:Patients with long-term back pain (n = 282) participated in a 4-week programme with a follow-up after 6 months. Visual analogue scales (VAS) were used to rate pain intensity and activity limitation. Global impression of change (GIC) was rated on a 7-category scale. The sign test, the Svensson method and the Spearman rank correlation were used for analyses. Results:Significantly lower ratings in pain and activity limitation at follow-up were found at group level. However, a large individual variability was found by the Svensson method. The correlations between GIC and changes in pain and activity limitation werers  = 0.49 andrs  =  0.50, respectively. A rated GIC of at least “much better” on group level showed changes of  ≥20 mm on the VAS. Conclusions:At group level, lower VAS ratings were found in patients with back pain. However, a large individual variability in pain and activity limitation was also found resulting in low to moderate associations between GIC and the change in VAS ratings. The large individual variability might be due to the impreciseness in the ratings on the VAS. We have presented a critical discussion of statistical methods in connection with the VAS.Implications for RehabilitationThe use of VAS as a rating instrument may be questioned, especially for perceived pain intensity which is a too complex experience to be rated on a line without any visible categories.Single ratings of pain intensity should preferably be complemented with the ratings of activity limitation in patients with long-term back pain.Global impression of change is a suggested inclusive rating after rehabilitation.The improvement desired by the patient should preferably be determined before rehabilitation. [ABSTRACT FROM PUBLISHER]

Abstract: Clinical trials on the treatment of pain syndromes have adopted Patient Global Impression of Change (PGIC) as a primary outcome. However, little is known about how change in clinical status influences these ratings. The present study examined relationships between changes in pain, depressed mood, physical functioning, vitality, sleep disturbance, cognitive complaints, and PGIC ratings among 1260 participants with fibromyalgia (FM) who completed one of two trials examining the safety and efficacy of milnacipran. Many of the relationships between change in clinical status and PGIC ratings were stronger among persons who rated themselves as improved (responders) versus those reporting no change or a worsening of their condition (non-responders). Among non-responders, simultaneous regression analysis revealed that greater degrees of depressed mood and pain, and poorer physical function were significantly associated with worse PGIC ratings. Among responders, improvements in pain were significantly associated with better PGIC ratings, along with improvements in vitality, sleep, physical function, and cognitive complaints. These findings underscore the complexity of global ratings in FM patients, and suggest the association between clinical status and PGIC ratings varies as a function of perceived treatment response. Several domains were associated with PGIC ratings, highlighting the need to assess multiple outcomes in clinical trials of treatments for FM. [Copyright &y& Elsevier]

Introduction: The Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) was modified for use in mild cognitive impairment (MCI) trials and tested in the ADCS MCI randomized clinical trial of donepezil, vitamin E, and placebo. We assessed feasibility for its use by determining whether or not: (I) it distinguished a medication effect at 6 months and 12 months, (2) baseline demographic or clinical characteristics predicted change, (3) there was an association between MCI-CGIC and change in other clinical measures in order to evaluate external or concurrent validity. Methods: We used a generalized estimating equations approach for ordinal outcome data to test the effects of treatment, baseline characteristics, and change in clinical measures on the MCI-CGIC over 12 months, and ordinal logistic regression to assess the association between MCI-CGIC and change in clinical measures at 6 months and 12 months. Results: On the MCI-CGIC overall, 12.9% and 10.6% were rated as having improved, and 3 1.6% and 39.8% as having worsened over 6 months and 12 months, respectively. The MCI-CGIC did not distinguish the donepezil or vitamin E groups from placebo at 6 and 12 months treatment. Variables at screening or baseline that were associated with worse CGIC scores over 6 and 12 months included white race, greater years of education, worse depression, dementia severity rating, cognitive, and daily activities scores, and lower memory domain scores on a neuropsychological battery. Rate of worsening on the MCI-CGIC over 12 months was associated with change on the Alzheimer Disease Assessment Scale-cognitive and on executive function. Worsening at 6 months and 12 months, separately, were associated with the corresponding change in Alzheimer Disease Assessment Scale-cognitive, Activities of Daily Living, Beck Depression Inventory, Mini-Mental State Examination, Clinical Dementia Rating sum of boxes, memory, and executive function. Conclusions: Change detected by the MCI-CGIC was associated with baseline clinical severity and with change in clinical ratings over 6 and 12 months, supporting the validity of a COIC approach in MCI. The effect size of the donepezil-placebo difference was similar to that of other outcomes at 12 months. About 40% of MCI patients were judged worse and about 11% improved, consistent with clinical experience and other ratings. [ABSTRACT FROM AUTHOR]

Abstract: Objective: Pain assessment has been shown to be affected by depression, neuroticism, and recall bias. The purpose of this study was to determine whether momentary pain assessment, compared with recalled pain reports, would diminish the influence of neuroticism and depression on the measurement of pain. Methods: Patients with chronic pain (n=66) completed depression (Beck Depression Inventory II) and neuroticism (NEO Personality Inventory) questionnaires, made weekly recall pain ratings, judged their change in pain from 1 week to the next over a 4-week period, and collected momentary reports of pain intensity and pain unpleasantness over a 2-week period. Results: Analyses showed that neuroticism and depression correlated with pain intensity and pain unpleasantness at low levels for both momentary and recalled pain reports. Neuroticism and depression did not influence the accuracy of recalled pain (difference between momentary and recalled data). Both neuroticism and depression were systematically associated with ratings of judged change in pain even when actual changes in pain were controlled. Specifically, for increased levels of baseline depression and neuroticism, patients displayed a pattern of judging recent pain as more severe than pain in the previous week following several weeks of symptom monitoring. Conclusion: There was little evidence for neuroticism and depression affecting either recall or momentary pain ratings or influencing the accuracy of recall ratings. However, neuroticism and depression did influence pain assessment when the task involved rating change in pain—a measure widely used in clinical research. [Copyright &y& Elsevier]

Objective: Intrathecal drug delivery (ITDD) is commonly used for intractable pain management. A paucity of good-quality studies in chronic noncancer patients and concerns over increased dosages have focused interest on different modes of administration. The aim of this international multicenter randomized double-blind crossover trial was to compare the efficacy of the same daily dose of drugs administered by intermittent boluses vs simple continuous infusion., Methods: Eligible patients implanted with a programmable ITDD device were randomized to receive two weeks of either intermittent boluses or a simple continuous flow in period 1, followed by a crossover to the alternative mode of administration. The primary outcome measure was the Patients' Global Impression of Change (PGIC) scale., Results: The mean proportion of positive responders (at least "minimally improved") was 38.4% in the continuous condition vs 37.3% in the bolus (difference in proportions = 1.1%, 95% confidence interval [CI] = -21.8-24.0%, P  = 0.93). The mean PGIC in the continuous condition was 3.8 vs 3.9 in the bolus (mean difference = -0.1, -0.6-0.4, P  = 0.72). Exploratory analyses revealed a tendency for the mean proportion of positive responders to be higher at low vs high flow rates for both bolus and continuous administrations. Two patients were withdrawn from the study due to adverse events during the bolus phase, both with symptoms of increased pain, and one patient with additional symptoms of numbness and urinary retention., Conclusion: The mean PGIC and proportion of positive responders was not substantially different after intermittent bolus vs continuous administration., (© 2016 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com)

Background: Dextromethorphan (DM)/quinidine (Q) is an approved treatment for pseudobulbar affect (PBA) based on trials in amyotrophic lateral sclerosis or multiple sclerosis. PRISM II evaluated DM/Q effectiveness and tolerability for PBA secondary to dementia, stroke, or traumatic brain injury; dementia cohort results are reported., Methods: This was an open-label, multicenter, 90 day trial; patients received DM/Q 20/10 mg twice daily. Primary outcome was change in Center for Neurologic Study-Lability Scale (CNS-LS) score. Secondary outcomes included PBA episode count and Clinical and Patient/Caregiver Global Impression of Change scores with respect to PBA (CGI-C/PGI-C)., Results: 134 patients were treated. CNS-LS improved by a mean (SD) of 7.2 (6.0) points at Day 90/Endpoint (P<.001) vs. baseline. PBA episodes were reduced 67.7% (P<.001) vs. baseline; global measures showed 77.5% CGI-C and 76.5% PGI-C "much"/"very much" improved. Adverse events included headache (7.5%), urinary tract infection (4.5%), and diarrhea (3.7%); few patients dropped out for adverse events (10.4%)., Conclusions: DM/Q significantly reduced PBA symptoms in patients with dementia; reported adverse events were consistent with the known safety profile of DM/Q. Trial Registration clinicaltrials.gov identifier: NCT01799941.