The impact of different health dimensions on overall quality of life related to kyphoplasty and non-surgical management.

UNLABELLED: This study uses data from a previously published randomised trial where balloon kyphoplasty was compared to non-surgical management. Of the improved overall quality of life, 60 % was caused by decreased pain. However, ignoring other dimensions of quality of life would underestimate the procedure's effect. INTRODUCTION: Acute back pain has been viewed as the most important factor lowering quality of life (QoL) for patients suffering vertebral fractures. The objective of this study was to quantify the impact of different health dimensions on overall QoL using patient-reported outcome measurements (PROMs) collected in Fracture Reduction Evaluation (FREE) trial. METHODS: The analysis was based on patients included in the 2-year-long randomised controlled FREE trial studying the efficacy and safety of balloon kyphoplasty procedure (BKP) compared to non-surgical management (NSM). The PROMs included were EQ-5D, Short Form (SF)-36, visual analogue scale (VAS) pain and the Roland-Morris Disability Questionnaire (RMDQ). The health dimensional contribution to the overall QoL improvements was analysed by isolating the impact of each dimension on QoL in the SF-36 and EQ-5D, respectively. A correlation analysis of the QoL improvement was performed to investigate the relationships between the four instruments. RESULTS: Changes in pain explained 60 % of the quality-adjusted life years (QALY) gained in BKP vs. NSM followed by self-care (17 %), mobility (16 %) and usual activities (10 %) (EQ-5D). Health dimensions capturing the mental state had little impact on the QALY gained. The SF-36 dimensional analysis showed similar results. The correlation analysis showed that the correlation between VAS pain, RMDQ and QALY improvement was fairly weak. CONCLUSIONS: Changes in the pain dimension of health are the most important drivers for changes of overall QoL in patients treated with BKP or NSM. However, ignoring the impact of other dimensions would lead to an underestimation of the actual improvement in overall QoL.

A conceptual and disease model framework for osteoporotic kyphosis.

UNLABELLED: This paper presents a multi-method research project to develop a conceptual framework for measuring outcomes in studies of osteoporotic kyphosis. The research involved literature research and qualitative interviews among clinicians who treat patients with kyphosis and among patients with the condition. INTRODUCTION: Kyphosis due to at least one vertebral compression fracture is prevalent among osteoporotic patients, resulting in well-documented symptoms and impact on functioning and well-being. A three-part study led to development of a conceptual measurement framework for comprehensive assessment of symptoms, impact, and treatment benefit for kyphosis. METHODS: A literature-based disease model (DM) was developed and tested with physicians (n = 10) and patients (n = 10), and FDA guidelines were used to develop a final disease model and a conceptual framework. RESULTS: The DM included signs, symptoms, causes/triggers, exacerbations, and functional status associated with kyphosis. The DM was largely confirmed, but physicians and patients added several concepts related to impact on functioning, and some concepts were not confirmed and removed from the DM. CONCLUSIONS: This study confirms the need for more comprehensive assessment of health outcomes in kyphosis, as most current studies omit key concepts.

[Normalization of the Brief Repeatable Battery of Neuropsychological tests (BRB-N) for German-speaking regions. Application in relapsing-remitting and secondary progressive multiple sclerosis patients]. / Normierung der Brief Repeatable Battery of Neuropsychological Tests (BRB-N) für den deutschsprachigen Raum Anwendung bei schubförmig remittierenden und sekundär progredienten Multiple-Sklerose-Patienten.

The Brief Repeatable Battery of Neuropsychological Tests (BRB-N) is a neuropsychological screening battery, often applied in multiple sclerosis (MS) patients. It is almost exclusively administered in trials and not in the daily practice routine because of the lack of normative values. Using a stepwise linear regression analysis, the dependence of test results on age, gender, and education of 241 healthy control subjects was investigated. Z-values of -1.68 or less were considered pathological. Based on the normative values, the proportions of cognitively impaired patients with relapsing-remitting MS (RRMS, n=43) and secondary progressive MS patients (SPMS, n=60) were calculated. The regression model explained 2.7-25.0% of the variance of test performances. Cognitive impairment occurred in 38% and in 47% of the RRMS and the SPMS groups, respectively. In both groups attention and concentration impairment was prominent, while in the SPMS group memory was also frequently affected. The proportion of cognitively impaired MS patients reflected the figures that could be found in the literature.

Interferon-beta1b in the treatment of secondary progressive MS: impact on quality of life.

BACKGROUND: The recent randomized, controlled trial of interferon-beta1b (IFN-beta1b) in 718 patients with secondary progressive MS (SP-MS) demonstrated a significant effect on the development of disability as evaluated by the physician. Its effect on patient-reported health-related quality of life (HrQoL) is reported herein. METHODS: In this multicenter, double-blind, randomized, placebo-controlled trial, outpatients with SP-MS scoring between 3.0 and 6.5 on the Expanded Disability Status Scale received either 8 x 10(6) IU of IFN-beta1b or placebo for up to 3 years. A range of outcomes was measured, including HrQoL, which was assessed using the Sickness Impact Profile (SIP), a self-report questionnaire validated for use in MS. Measurements were undertaken at baseline and at 6-monthly intervals thereafter for 36 months. RESULTS: A slight positive effect on the HrQoL of the IFN group in comparison with the placebo group was found, which reached significance in the physical scale of the SIP at 6 and 12 months and at last visit. There was moderate correlation between physician-assessed evaluation of change and patient-reported change. CONCLUSIONS: IFN-beta1b may delay sustained deterioration in patient-reported HrQoL in SP-MS. Methods of interpreting change in HrQoL are currently insufficiently developed to determine how clinically important these changes are for this population.

Interferon beta-1b in secondary progressive multiple sclerosis--outline of the clinical trial.

This manuscript describes the outline of a double-blind, placebo-controlled, (European), multicentre phase III study to evaluate the safety and efficacy of 8 MIU of interferon beta-Ib given subcutaneously every other day for 3 years in patients with secondary progressive multiple sclerosis. The primary efficacy variable of this trial is the time to confirmed neurological deterioration as documented by the Expanded Disability Status Scale. The essentials of the study design are presented, including the rationale for the performance of the study and the selection of both clinical and magnetic resonance imaging outcome parameters.

Terguride in fluctuating parkinsonian patients: a double-blind study versus placebo.

Terguride (TER), a semisynthetic derivative of lisuride, has been found to display dopamine (DA) agonist and DA antagonist effects in animals, depending on the experimental model used. TER (2 mg/day) was compared to placebo in 41 fluctuating Parkinson's disease patients to test its effect on akinesia and dyskinesia. Mean hours "off" decreased at weeks 6 and 12 (p < 0.05) in the TER group but the overall difference from the placebo group was not significant. Only the TER group displayed a decrease over time in mean Columbia University Rating Scale total score "on" and "off" (p = 0.001 and p = 0.03, respectively). Duration of involuntary movements and resulting disability were not significantly different between patients on TER and those on placebo administration. In the overall evaluation, patients preferred TER (p = 0.01). Tolerance of TER was very good in all but one patient whose wearing-off increased; no one dropped out because of side effects. This 3-month double-blind study showed that TER, added to stable doses of L-dopa, may have slight antiparkinsonian efficacy.