scholarly journals Perceived functioning, well-being and psychiatric symptoms in patients with stable schizophrenia treated with long-acting risperidone for 1 year

2005 ◽  
Vol 187 (2) ◽  
pp. 131-136 ◽  
Author(s):  
W. Wolfgang Fleischhacker ◽  
Jonathan Rabinowitz ◽  
Georg Kemmler ◽  
Mariëlle Eerdekens ◽  
Angelika Mehnert
Keyword(s):  
Mental Component Summary ◽  
Psychiatric Symptoms ◽  
Short Form ◽  
Mental Component Summary Score ◽  
Well Being ◽  
Psychotic Symptoms ◽  
Open Label ◽  
Sf 36 ◽  
Patient Reported ◽  
Long Acting

BackgroundThe extent to which antipsychotics improve patients' well-being is uncertain.AimsTo examine psychopathology and patient-rated functioning and well-being in patients treated with risperidone.MethodIn a 1-year, open-label, international multicentre trial of long-acting risperidone in 615 stable adult patients with schizophrenia, self-rated functioning and well-being were measured every 3 months using the Short Form 36-item questionnaire (SF–36). Psychopathology was quantified using the Positive and Negative Syndrome Scale (PANSS).ResultsSignificant improvements were found on the SF–36 mental component summary score and vitality and social functioning scales. PANSS and mental component summary scores were moderately correlated.ConclusionsPatient-reported functioning and well-being appear to differ from investigator-rated psychotic symptoms. Patient-rated well-being should be assessed with symptoms to help measure treatment outcomes.

Development and Testing of the UK SF-12

1997 ◽  
Vol 2 (1) ◽  
pp. 14-18 ◽  
Author(s):  
Crispin Jenkinson ◽  
Richard Layte
Keyword(s):  
Health Status ◽  
Short Form ◽  
Community Sample ◽  
Mental Component Summary Score ◽  
Well Being ◽  
Summary Score ◽  
Sf 36 ◽  
Patient Groups ◽  
The Uk ◽  
Component Scores

Objectives: The 36 item short form health survey (SF-36) has proved to be of use in a variety of settings where a short generic health measure of patient-assessed outcome is required. This measure can provide an eight dimension profile of health status, and two summary scores assessing physical function and mental well-being. The developers of the SF-36 in America have developed algorithms to yield the two summary component scores in a questionnaire containing only one-third of the original 36 items, the SF-12. This paper documents the construction of the UK SF-12 summary measures from a large-scale dataset from the UK in which the SF-36, together with other questions on health and lifestyles, was sent to randomly selected members of the population. Using these data we attempt here to replicate the findings of the SF-36 developers in the UK setting, and then to assess the use of SF-12 summary scores in a variety of clinical conditions. Methods: Factor analytical methods were used to derive the weights used to construct the physical and mental component scales from the SF-36. Regression methods were used to weight the 12 items recommended by the developers to construct the SF-12 physical and mental component scores. This analysis was undertaken on a large community sample ( n = 9332), and then the results of the SF-36 and SF-12 were compared across diverse patient groups (Parkinson's disease, congestive heart failure, sleep apnoea, benign prostatic hypertrophy). Results: Factor analysis of the SF-36 produced a two factor solution. The factor loadings were used to weight the physical component summary score (PCS-36) and mental component summary score (MCS-36). Results gained from the use of these measures were compared with results gained from the PCS-12 and MCS-12, and were found to be highly correlated (PCS: ρ = 0.94, p < 0.001; MCS: ρ = 0.96, p < 0.001), and produce remarkably similar results, both in the community sample and across a variety of patient groups. Conclusions: The SF-12 is able to produce the two summary scales originally developed from the SF-36 with considerable accuracy and yet with far less respondent burden. Consequently, the SF-12 may be an instrument of choice where a short generic measure providing summary information on physical and mental health status is required. Crispin Jenkinson DPhil, Deputy Director

Improved patient-reported health impact of multiple sclerosis: The ENABLE study of PR-fampridine

2015 ◽  
Vol 22 (7) ◽  
pp. 944-954 ◽  
Author(s):  
Richard Macdonell ◽  
Guy Nagels ◽  
David-Axel Laplaud ◽  
Carlo Pozzilli ◽  
Brigit de Jong ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Psychological Health ◽  
Short Form ◽  
Real Life ◽  
Health Impact ◽  
The United States ◽  
Prolonged Release ◽  
Open Label ◽  
Sf 36 ◽  
Patient Reported

Background: Multiple sclerosis (MS) is a debilitating disease that negatively impacts patients’ lives. Objective: ENABLE assessed the effect of long-term prolonged-release (PR) fampridine (dalfampridine extended release in the United States) treatment on patient-perceived health impact in patients with MS with walking impairment. Methods: ENABLE was a 48-week, open-label, Phase 4 study of PR-fampridine 10 mg twice daily. Patients who showed any improvement in Timed 25-Foot Walk walking speed at weeks 2 and 4 and any improvement in 12-item MS Walking Scale score at week 4 remained on treatment. The primary endpoint was change from baseline in 36-Item Short-Form Health Survey (SF-36) physical component summary (PCS) score. Results: At week 4, 707/901 (78.5%) patients met the criteria to remain on treatment. Patients on treatment demonstrated significant and clinically meaningful improvements in SF-36 PCS scores from baseline (mean change (95% confidence interval)) to week 12 (4.30 (3.83, 4.78); p < 0.0001), week 24 (3.75 (3.23, 4.27); p < 0.0001), week 36 (3.46 (2.95, 3.97); p < 0.0001), and week 48 (3.24 (2.72, 3.77); p < 0.0001). Significant improvements from baseline were also demonstrated in secondary health measures in patients on treatment. Conclusion: PR-fampridine improved patient-perceived physical and psychological health impact of MS measured in a real-life setting.

scholarly journals Changes in attitude towards LAI antipsychotic maintenance treatment: A two-year follow-up study

2018 ◽  
Vol 53 ◽  
pp. 58-65 ◽  
Author(s):  
Francesco Pietrini ◽  
Giulio D’Anna ◽  
Lorenzo Tatini ◽  
Gabriela Alina Talamba ◽  
Costanza Andrisano ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Maintenance Treatment ◽  
Subjective Experience ◽  
Open Label ◽  
Sf 36 ◽  
Patient Reported ◽  
Long Acting ◽  
Prospective Longitudinal

AbstractBackground:To present real-world evidence on the effects of switching from oral to long-acting injectable (LAI) antipsychotic maintenance treatment (AMT) in a sample of clinically stable patients with schizophrenia, with regard to subjective experience of treatment, attitude towards drug and quality of life.Methods:50 clinically stable adult schizophrenic outpatients were recruited. At the time of enrolment (T0), all patients were under a stabilized therapy with a single oral second-generation antipsychotic (SGA) and were switched to the equivalent maintenance regimen with the long-acting formulation of the same antipsychotic. 43 patients completed the 24-month prospective, longitudinal, open-label, observational study. Participants were assessed at baseline (T0), after 12 (T1) and 24 months (T2), using psychometric scales (PANSS, YMRS and MDRS) and patient-reported outcome measures (SWN-K, DAI-10 and SF-36).Results:The switch to LAI-AMT was associated with a significant clinical improvement at T1 and T2 compared to baseline (T0). All of the psychometric indexes, as well as patients’ subjective experience of treatment (SWN-K), and quality of life (SF-36) showed a significant improvement after one year of LAI-AMT, with stable results after two years. Patients’ attitude towards drug (DAI-10) increased throughout the follow-up period, with a further improvement during the second year.Conclusions:The switch to LAI-AMT may help to address the subjective core of an optimal recovery in stabilized schizophrenic patients. A sustained improvement in patients’ attitude towards drug may help to achieve patient’s compliance. The size of this study needs to be expanded to produce more solid and generalizable results.

scholarly journals Novel Oral Testosterone Formulation Improves Male Well Being Without Compromising International Prostate Symptom Scores

2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. A760-A760
Author(s):  
Om P Dhingra ◽  
James Bernstein ◽  
Shaina D Barnes ◽  
Hannah VanLaanen ◽  
Natasha Wadlington ◽  
...  
Keyword(s):  
Sleep Disturbances ◽  
Short Form ◽  
Controlled Trial ◽  
Group Versus ◽  
Well Being ◽  
Male Hypogonadism ◽  
Meaningful Improvement ◽  
Testosterone Undecanoate ◽  
Sf 36 ◽  
Patient Reported

Abstract Introduction: Male hypogonadism results from insufficient secretion of testosterone (T) and is characterized by low serum T concentrations. Common symptoms of hypogonadism include decreased libido, impotence, weakness, low energy, depression and/or loss of motivation, memory and concentrating issues, and sleep disturbances. Several forms of T replacement are available. Testosterone undecanoate (TU) is a testosterone prodrug available in oral formulations. A novel TU formulation, SOV2012-F1, has been submitted for FDA consideration under the name KYZATREX®. While TU efficacy is measured by serum total T, patientfocused endpoints such as Patient Reported Outcomes (PROs) are valuable indicators of well-being and psychosexual symptom abatement. Methods: A Phase 3, randomized, multicenter, open-label, active-controlled trial, comparing SOV2012F1 (testosterone undecanoate capsules) (n=214) with AndroGel® (1.62% topical testosterone gel) (n=100) enrolled males aged 18 to 65 years with hypogonadism (serum total T levels ≤281 ng/dL). A key exploratory endpoint was change from Baseline (ΔBL) after 52 weeks of treatment in the following PROs: International Prostate Symptom Score (IPSS), Psychosexual Daily Questionnaire (PDQ), Short Form Health Survey 36 item (SF-36), and the International Index of Erectile Function (IIEF). Results: Total or overall scores for all PROs (IPSS, PDQ, SF-36 and IIEF) showed increased improvement in the SOV2012-F1 group relative to the Androgel group, and all but IPSS demonstrated improvement relative to BL. For IPSS, due to the potential that T could worsen urinary symptoms, the ΔBL would ideally be small to reflect minimal impact. Change for the SOV2012-F1 and AndroGel groups was, respectively, 0.6 and 1.0. Further, the IPSS total score was not significantly different from BL in the patients receiving SOV20212-F1 (p = 0.5659). For PDQ, a clinically meaningful improvement of sexual desire in hypogonadal men age ≥65 years is ≥0.7; mean ΔBL was 1.6 in the SOV2012-F1 group versus 1.4 in the AndroGel group. In the SF-36, the mean ΔBL total score was 83.7 in the SOV2012-F1 group and 70.2 in the AndroGel group. Further, post hoc analysis of the Health Change category found a significant (p ≤ 0.05) improvement in patient perspectives on health over the course of the study. The overall satisfaction score of the IIEF trended towards significance for the SOV2012-F1 group with a mean ΔBL score of 2.3 versus and 1.6 in the AndroGel group. The ΔBL for the 4 domains of male sexual function were small and consistent between the SOV2012-F1 and AndroGel groups. Comparable results were noted for Early Withdrawals and All Subjects across all PROs. Conclusion: Treatment with SOV2012-F1 for 52 weeks exceeded AndroGel patient satisfaction as measured by PROs including IPSS, PDQ, SF-36 and IIEF, demonstrating clinical distinction. Further analysis of SOV2012-F1 will be forthcoming.

scholarly journals Quality of Life in Hypoparathyroidism Improves With rhPTH(1-84) Throughout 8 Years of Therapy

2019 ◽  
Vol 104 (7) ◽  
pp. 2748-2756 ◽  
Author(s):  
Gaia Tabacco ◽  
Yu-Kwang Donovan Tay ◽  
Natalie E Cusano ◽  
John Williams ◽  
Beatriz Omeragic ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Short Form ◽  
Calcium Supplementation ◽  
Bodily Pain ◽  
Well Being ◽  
Reference Population ◽  
Open Label ◽  
Sf 36

Abstract Context Calcium and vitamin D treatment does not improve reduced quality of life (QOL) in hypoparathyroidism. Recombinant human (rh) PTH(1-84) therapy improves QOL metrics for up to 5 years. Data on QOL beyond this time point are not available. Objectives To evaluate the effects of 8 years of rhPTH(1-84) therapy on QOL and factors associated with long-term benefit. Design Prospective, open-label trial. Setting Referral center. Patients Twenty patients with hypoparathyoidism. Main Outcome Measures RAND 36-Item Short Form Health Survey (SF-36). Results rhPTH therapy led to substantial improvement in five of the eight SF-36 domains [vitality, social functioning (SF), mental health (MH), bodily pain (BP) and general health] and three of these domains (SF, MH, BP) were no longer lower than the reference population. The improvement in the mental component summary (MCS) score was sustained through 8 years, while the physical component summary (PCS) score improved through 6 years. A lower baseline QOL score was associated with greater improvement. A threshold value &lt;238 (MCS) and &lt;245 (PCS) predicted long-term improvement in 90% and 100% of the cohort, respectively. In patients whose calcium supplementation was reduced, MCS and PCS scores improved more than those whose supplementation did not decline to the same extent. Improvement in PCS was greater in patients whose calcitriol dosage was reduced and duration of disease was shorter. Conclusions rhPTH(1-84) improves long-term well-being in hypoparathyroidism. The improvements are most prominent in those with impaired SF-36 at baseline and those whose requirements for conventional therapy decreased substantially.

scholarly journals Patient-reported Outcomes in a Randomized Trial of Etanercept in Psoriatic Arthritis

2010 ◽  
Vol 37 (6) ◽  
pp. 1221-1227 ◽  
Author(s):  
PHILIP J. MEASE ◽  
J. MICHAEL WOOLLEY ◽  
AMITABH SINGH ◽  
WAYNE TSUJI ◽  
MELEANA DUNN ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Pain Assessment ◽  
Patient Reported Outcomes ◽  
Short Form ◽  
Health Assessment ◽  
Open Label ◽  
Double Blind ◽  
Etanercept Treatment ◽  
Sf 36 ◽  
Patient Reported

Objective.To evaluate the effects of etanercept treatment on patient-reported outcomes (PRO) in patients with psoriatic arthritis (PsA).Methods.A 24-week double-blind comparison to placebo was followed by a 48-week open-label phase in which all eligible patients received etanercept. PRO were measured using the Stanford Health Assessment Questionnaire Disability Index (HAQ-DI), the Medical Outcomes Study Short-Form (SF-36), the EQ-5D visual analog scale (VAS), and the American College of Rheumatology (ACR) patient pain assessment.Results.Beginning at Week 4 and continuing through Week 24 of double-blind treatment, patients treated with etanercept had significantly higher mean percentage improvement in HAQ-DI relative to baseline than patients given placebo (53.6% vs 6.4% at Week 24; p < 0.001). After 48 weeks of open-label treatment with etanercept, the mean percentage change from study baseline was 52.8% for the original etanercept group and 46.9% for the original placebo group, with 41.2% of patients overall achieving a HAQ-DI of 0. Mean changes relative to baseline for SF-36 physical component summary scores, EQ-5D VAS, and ACR pain assessment were also significant in the double-blind period for etanercept compared with placebo (p < 0.001 for all 3 measures). Patients taking placebo achieved similar improvements once they began treatment with etanercept in the open-label period.Conclusion.Patients with PsA treated with etanercept reported significant improvements in physical function that were almost 10 times the improvement seen with placebo and were maintained for up to 2 years. Almost half of patients treated with etanercept reported no disability by the end of the study.

Quality of life of patients with Sjogren’s disease with ongoing therapy with diseasemodifying antirheumatic drugs

2020 ◽  
pp. 33-38
Author(s):  
E. Yu. Gan ◽  
L. P. Evstigneeva
Keyword(s):  
Quality Of Life ◽  
Short Form ◽  
Life Quality ◽  
Well Being ◽  
Disease Modifying Antirheumatic Drugs ◽  
Antirheumatic Drugs ◽  
Sf 36 ◽  
Disease Modifying ◽  
Sjögren’S Disease

Purpose of the study. Assessing the association between the life quality of patients with Sjogren’s Disease and ongoing therapy with various disease-modifying antirheumatic drugs.Material and methods. The study was conducted on the basis of the regional rheumatology center of the consultative diagnostic clinic of the Sverdlovsk Regional Clinical Hospital No. 1. This work is based on the results of a simultaneous study of 74 patients with primary Sjogren’s Disease (SD), distributed in three comparison groups receiving various disease-modifying antirheumatic drugs chlorambucil, methotrexate and hydroxychloroquine. The diagnosis of SD was carried out according to European-American criteria AECGC (2002) [18]. In order to analyze the quality of life of patients with SD, the 36-Item Short Form Health Survey (SF‑36) was used. Statistical data processing was carried out using Statistica 7.0 program.Results. Assessment of the quality of life of patients with SD, which is an integrative criterion of human health and well-being, revealed the absence of statistically significant differences (p > 0.05) on eight scales and two health components of the SF‑36 questionnaire in the analyzed groups that differ in the treatment of disease-modifying antirheumatic drugs chlorambucil, methotrexate and hydroxychloroquine.Conclusions. The obtained data indicate an equivalent quality of life in SD patients treated with different disease-modifying antirheumatic drugs methotrexate, chlorambucil and hydroxychloroquine, and therefore hydroxychloroquine can be considered as an alternative basic therapy in patients with SD with certain limitations and contraindications methotrexate and chlorambucil.

Patient-Reported Outcome Measures in Colorectal Surgery: Construction of Core Measures Using Open-Source Research Method

2021 ◽  
pp. 155335062199887
Author(s):  
Alaa El-Hussuna ◽  
Ines Rubio-Perez ◽  
Monica Millan ◽  
Gianluca Pellino ◽  
Ionut Negoi ◽  
...  
Keyword(s):  
Colorectal Surgery ◽  
Outcome Measures ◽  
Short Form ◽  
Wide Spectrum ◽  
Core Outcome Set ◽  
Well Being ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Patient Reported ◽  
Eortc Qlq

Purpose. The primary aim of the study was to review the existing literature about patient-reported outcome measures (PROMs) in colorectal cancer and IBD. The secondary aim was to present a road map to develop a core outcome set via opinion gathering using social media. Method. This study is the first step of a three-step project aimed at constructing simple, applicable PROMs in colorectal surgery. This article was written in a collaborative manner with authors invited both through Twitter via the #OpenSourceResearch hashtag. The 5 most used PROMs were presented and discussed as slides/images on Twitter. Inputs from a wide spectrum of participants including researchers, surgeons, physicians, nurses, patients, and patients’ organizations were collected and analyzed. The final draft was emailed to all contributors and 6 patients’ representatives for proofreading and approval. Results. Five PROM sets were identified and discussed: EORTC QLQ-CR29, IBDQ short health questionnaire, EORTC QLQ-C30, ED-Q5-5L, and Short Form-36. There were 315 tweets posted by 50 tweeters with 1458 retweets. Awareness about PROMs was generally limited. The general psycho-physical well-being score (GPP) was suggested and discussed, and then a survey was conducted in which more than 2/3 of voters agreed that GPP covers the most important aspects in PROMs. Conclusion. Despite the limitations of this exploratory study, it offered a new method to conduct clinical research with opportunity to engage patients. The general psycho-physical well-being score suggested as simple, applicable PROMs to be eventually combined procedure-specific, disease-specific, or symptom-specific PROMs if needed.

scholarly journals A Longitudinal Analysis of SF-36 scores Within the Candrive Cohort: An Example of Survivor Bias

2020 ◽  
Vol 4 (Supplement_1) ◽  
pp. 528-528
Author(s):  
Michel Bedard ◽  
Hillary Maxwell ◽  
Isabelle Gelinas ◽  
Shawn Marshall ◽  
Gary Naglie ◽  
...  
Keyword(s):  
Prospective Studies ◽  
Mental Component Summary ◽  
Well Being ◽  
Early Years ◽  
Driving Cessation ◽  
Completion Status ◽  
Sf 36 ◽  
Survivor Bias ◽  
Study Participants ◽  
Health And Well Being

Abstract A bias inherent to prospective studies is focusing only on individuals who remain in the study; these individuals may differ from those who leave early. To examine this issue, we analyzed SF-36 scores by completion status for individuals enrolled in the seven-year Candrive cohort. The SF-36 provides a self-reported evaluation of health and well-being along two subscales, the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Of 928 participants in the cohort, 887 had at least two consecutive years of data starting at baseline (age=76.17, SD=4.81; 61.9% male). A total of 142 participants had 7 years of data. Study discontinuation (due to withdrawal, driving cessation, or death) happened least in early years, and peaked after 6 years (n=235). When analyzed according to completion status, patterns of change in SF-36 scores varied. For example, participants with 7 years of data had mean PCS scores ranging from 51.41 (SD=7.92) at baseline to 46.93 (SD=9.46) at year 7, a change of 0.75 points per year. For those with only two years of data, scores were lower and dropped from 45.82 (SD=9.98) to 43.59 (SD=10.90), a change of 2.23 points over a single year (p&lt;.001). Differences are also evident for other groups. While the results indicate relative stability of SF-36 scores among participants who remained in the study, participants who dropped out reported greater deterioration in scores. These results highlight important differences between participants based on completion status.

OP443 Evaluating The Value Of Endovascular Innovations For Aortic Valve Replacement Through Clinical Benefits, Patient-reported Outcomes And Resource Consumption.

2021 ◽  
Vol 37 (S1) ◽  
pp. 17-17
Author(s):  
Eduardo Pinar ◽  
Juan García de Lara ◽  
José Hurtado ◽  
Miguel Robles ◽  
Gunnar Leithold ◽  
...  
Keyword(s):  
High Risk ◽  
Aortic Valve ◽  
Short Form ◽  
Systematic Evaluation ◽  
Special Importance ◽  
Economic Modelling ◽  
Sf 36 ◽  
Patient Reported ◽  
Clinical Benefits ◽  
Sapien 3

IntroductionThe use of most recent Transcatheter aortic valve implants (TAVI) in the treatment of symptomatic severe aortic stenosis (SAS) is evolving with expanded indications from inoperable/high-risk to intermediate and low risk patients. Consequently, TAVI outcomes must be monitored to highlight its value under real-world conditions. Our aim was to prospectively evaluate TAVI (SAPIEN 3) outcomes in terms of patient's health-related quality of life (HRQoL), clinical outcomes, and healthcare resource utilization (HRU).MethodsAn observational prospective study including all consecutive patients with SAS undergoing a transcatheter valve implantation with Edwards SAPIEN 3 valve (transfemoral access) was conducted in full accordance with clinical guidelines from the European Society of Cardiology. Patients were evaluated before the intervention (baseline), at discharge, and after one, six and twelve months from the implant. A thoughtful and systematic evaluation of patients’ HRQoL (EQ-5D 5L, the Short Form-36 Health Survey -SF-36- and the Kansas City Cardiomyopathy Questionnaire -KCCQ-), clinical endpoints (that is, cardiovascular mortality, and rates of stroke, major bleeding, myocardial infarction, and re-hospitalization), echocardiographic measurements, and HRU (that is, Length of stay-LOS- in ward/intensive care unit -ICU-) was implemented. Multivariate regression models were applied to test outcomes while controlling key risk factors (that is, patient’ severity at baseline).ResultsA total of seventy-six patients (fifty percent female, fifty-five percent of intermediate-high risk) with a mean age of 82.1 ± 4.78 years were included. Implant success was 97.34% and cardiovascular death was 2.6% at one year. Significant reductions in mean and maximum gradients were achieved and maintained during follow-up. Mean LOS in ward (5.2 ± 4.0days) and ICU (0.22 ± 0.64 days) were low. Statistically significant improvements were detected in the KCCQ overall summary scores, EQ-5D, and SF-36 (Physical component summary) - all adjusted - p < 0.05 - after the intervention.ConclusionsTAVI represents a safe and effective innovation for SAS with clinical benefits translated into significant improvements in terms of HRQoL. Besides, the low HRU provides new insights for health-economic modelling and the optimization of limited resources of special importance under current pandemic situation.

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