Jolanda De Vries

Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomised trial

BACKGROUND Percutaneous vertebroplasty is increasingly used for treatment of pain in patients with osteoporotic vertebral compression fractures, but the efficacy, cost-effectiveness, and safety of the procedure remain uncertain. We aimed to clarify whether vertebroplasty has additional value compared with optimum pain treatment in patients with acute vertebral fractures. METHODS Patients were recruited to this open-label prospective randomised trial from the radiology departments of six hospitals in the Netherlands and Belgium. Patients were aged 50 years or older, had vertebral compression fractures on spine radiograph (minimum 15% height loss; level of fracture at Th5 or lower; bone oedema on MRI), with back pain for 6 weeks or less, and a visual analogue scale (VAS) score of 5 or more. Patients were randomly allocated to percutaneous vertebroplasty or conservative treatment by computer-generated randomisation codes with a block size of six. Masking was not possible for participants, physicians, and outcome assessors. The primary outcome was pain relief at 1 month and 1 year as measured by VAS score. Analysis was by intention to treat. This study is registered at ClinicalTrials.gov, number NCT00232466. FINDINGS Between Oct 1, 2005, and June 30, 2008, we identified 431 patients who were eligible for randomisation. 229 (53%) patients had spontaneous pain relief during assessment, and 202 patients with persistent pain were randomly allocated to treatment (101 vertebroplasty, 101 conservative treatment). Vertebroplasty resulted in greater pain relief than did conservative treatment; difference in mean VAS score between baseline and 1 month was -5·2 (95% CI -5·88 to -4·72) after vertebroplasty and -2·7 (-3·22 to -1·98) after conservative treatment, and between baseline and 1 year was -5·7 (-6·22 to -4·98) after vertebroplasty and -3·7 (-4·35 to -3·05) after conservative treatment. The difference between groups in reduction of mean VAS score from baseline was 2·6 (95% CI 1·74-3·37, p<0·0001) at 1 month and 2·0 (1·13-2·80, p<0·0001) at 1 year. No serious complications or adverse events were reported. INTERPRETATION In a subgroup of patients with acute osteoporotic vertebral compression fractures and persistent pain, percutaneous vertebroplasty is effective and safe. Pain relief after vertebroplasty is immediate, is sustained for at least a year, and is significantly greater than that achieved with conservative treatment, at an acceptable cost. FUNDING ZonMw; COOK Medical.

Psychometric qualities of a brief self-rated fatigue measure : The Fatigue Assessment Scale

OBJECTIVE The main aim of this study was to examine the dimensionality and psychometric qualities of a new 10-item fatigue measure, the Fatigue Assessment Scale (FAS). METHODS As part of a longitudinal study, the respondents, all workers with at least 20 working hours per week, completed the FAS, four related fatigue measures, a depression questionnaire, and an emotional stability scale. RESULTS The FAS had a high internal consistency. The pattern of correlations and factor analysis showed good convergent and divergent validity. The FAS correlated strongly with the other fatigue scales. In a factor analysis of the five fatigue questionnaires, the FAS had the highest factor loading on a clear one-factor solution. Moreover, factor analyses revealed that fatigue, on the one hand, and depression and emotional stability, on the other hand, are separate constructs. Finally, it was shown that 8 out of the 10 FAS items were unbiased concerning gender; two had a uniform bias. CONCLUSIONS The FAS represents a potentially valuable assessment instrument with promising internal consistency reliability and validity. Gender bias in the FAS does not have consequences for use of the FAS.

Content validity, construct validity, and reliability of the WHOQOL-Bref in a population of Dutch adult psychiatric outpatients

In this study, the psychometric properties of a quality of life scale, the WHOQOL-Bref, were examined in a population of 533 Dutch adult psychiatric outpatients. Participants underwent two semistructured interviews in order to obtain Axis-I and II diagnoses, according to DSM-IV. Besides the WHOQOL-Bref they also completed questionnaires for measuring psychopathological symptoms (SCL-90) and perceived social support (PSSS). Scores on 25 of the 26 questions of the WHOQOL-Bref had a good distribution. Similar to previous findings, exploratory factor analysis revealed a four-factor structure. A priori expected associations were found between the domains of the WHOQOL-Bref, on the one hand, and dimensions of the SCL-90 and the PSSS-score, on the other hand, indicating good construct validity. The internal consistency of the four domains of the WHOQOL-Bref ranged from 0.66 to 0.80. Domain scores of the WHOQOL-Bref correlated around 0.92 with the WHOQOL-100 domain scores. Relatively low correlations were found between demographic characteristics (age and sex) and WHOQOL-Bref domain scores. It is concluded that the content validity, construct validity, and the reliability of the WHOQOL-Bref in a population of adult Dutch psychiatric outpatients are good. The WHOQOL-Bref, therefore, is an adequate measure for assessing quality of life at the domain level in a population of adult psychiatric outpatients.

Subjective cognitive dysfunction in breast cancer patients: a systematic review

Objective: Results from studies examining subjective cognitive dysfunctioning (SCD) in breast cancer (BC) patients are unclear. Therefore, this review examined (i) the prevalence of SCD, (ii) the differences between (treatment) groups in SCD, (iii) the course of SCD, (iv) the relationship of SCD with psychological factors, and (v) the relationship between SCD and objective cognitive dysfunctioning (OCD).

Examination of the Dimensionality of Fatigue

Summary: This paper reports on two studies. The goal of Study I was to examine the dimensionality of existing fatigue scales. The aims of Study II were to construct a new self-report fatigue instru...

Quality of life and related concepts in parkinson's disease : A systematic review

Several studies have investigated the quality of life (QOL) of patients with Parkinsons disease (PD). The purpose of this study was to review the conceptual and methodological quality of quality of life (QOL) studies among patients with PD and to identify factors associated with poor (HR)QOL. Computerized bibliographic databases were screened for publications from 1960 to January 2007. According to a list of predefined criteria, the methodological quality of the 61 studies, was moderate. The term ‘QOL’ was often used inappropriately. In fact, almost all studies in this review actually assessed health status (HS) instead of QOL. The functioning of patients with PD on physical, social, and emotional domains is affected by PD. Their HS seems to be lower when compared to healthy persons or patients with other chronic diseases. HS studies augment the insight in self‐perceived functioning. Therefore, HS is conceived as a valuable construct. However, QOL is also an important factor in health care. Attention towards QOL is needed in order to draw valid conclusions regarding a persons subjective experience of well‐being in a broad sense. In order to accomplish this, future studies should apply the QOL concept with more rigor, should use an adequate operational definition, and should employ sound measures.

The World Health Organization Quality of Life Assessment Instrument (WHOQOL-100): Validation Study with the Dutch Version

In this study, we examine the reliability and validity of a new quality-of-life (QoL) instrument, the Field Trial Version of the World Health Organization Quality of Life assessment instrument (WHOQOL-100). Two-hundred-and-twenty persons, 147 healthy individuals, and 73 chronic fatigue syndrome (CFS) patients completed the WHOQOL-100 and a test battery of related measures. The WHOOQL-100 has a fairly good internal consistency and a good validity.

Everyday Cognitive Failure in Sarcoidosis: The Prevalence and the Effect of Anti-TNF-α Treatment

Background: Cognitive symptoms, such as concentration problems, are frequently recorded by sarcoidosis patients. Objectives: The aim of this study was to assess the prevalence of perceived everyday cognitive failure in sarcoidosis patients and healthy controls. Furthermore, the effect of treatment on cognitive functioning was examined. Methods: The study included 343 sarcoidosis patients (44.6% females; age 49.3 ± 11.0 years). They completed the Cognitive Failure Questionnaire (CFQ) and Fatigue Assessment Scale (FAS) at baseline and the 6-month follow-up to evaluate the effect of treatment on cognitive functioning. The control group consisted of 343 age- and sex-matched healthy controls. Results: The mean CFQ score was significantly higher in sarcoidosis patients (37.3 ± 16.1) compared with the controls (31.3 ± 10.1; p < 0.0001).A high CFQ sore (≧43) was found in 35.0% of the patients and only 14.3% of the controls. No relation with disease severity and duration, or disease location was found. The proportion of patients receiving treatment did not differ among the groups with high and normal CFQ score. At the 6-month follow-up, only patients recently treated with anti-TNF-α therapy (n = 42) demonstrated a significant improvement in the CFQ score (Δ –7.07 ± 7.23) compared with the untreated patients (Δ –0.08 ± 9.35) and patients treated with prednisone with or without methotrexate (Δ 1.67 ± 9.22; p < 0.0001). After adjustment for the concomitant decrease in fatigue, the effect of anti-TNF-α therapy remained high and significant. Conclusions: Subjective cognitive failure is a substantial problem in sarcoidosis patients regardless of disease severity. Anti-TNF-α therapy had a positive effect on cognition, fatigue and other symptoms of sarcoidosis.

Sarcoidosis-associated fatigue

Sarcoidosis-associated fatigue is globally recognised as a disabling symptom. Fatigue has been reported in up to 50–70% of sarcoidosis patients, causing impaired quality of life. The aetiology of this troublesome problem remains elusive and is usually multifactorial. Fatigue can be a consequence of treatment itself, including as a complication of corticosteroid therapy. The diagnosis of sarcoidosis-associated fatigue requires an extensive evaluation to identify and treat potentially reversible causes. Granuloma formation and cytokine release may be involved in its aetiology. However, despite adequate sarcoidosis treatment, many patients continue to experience fatigue. Comorbidities associated with sarcoidosis, including depression, anxiety, hypothyroidism and altered sleep patterns, may all contribute to fatigue. Despite an exhaustive search for treatable clinical causes of fatigue, most patients’ complaints of fatigue are not correlated with clinical parameters of disease activity. Recent studies have demonstrated the effectiveness of various neurostimulants, including methylphenidate, for the treatment of sarcoidosis-associated fatigue. These and other agents may be useful adjuncts for the treatment of sarcoidosis-associated fatigue. Obviously, there is a need for studies evaluating the causes and new therapeutic options of sarcoidosis-associated fatigue. Psychological interventions should also be examined.

Sarcoidosis: assessment of disease severity using HRCT

The value of high-resolution computed tomography (HRCT) in diagnosing and assessing inflammatory activity in sarcoidosis is well established. The aim of the present study was to address the intra- and inter-observer agreements of the HRCT score by Oberstein et al. [8], and to evaluate the relationship between HRCT findings and disease severity expressed in respiratory functional impairment in sarcoidosis. The clinical records of 80 known sarcoidosis patients visiting the outpatient clinic between January 2000 and August 2001, who underwent a HRCT as well as lung function tests (including exercise testing), were reviewed. Two readers scored the first 60 HRCT images twice. Weighted kappa and intra-class correlation coefficient were used to assess the reliability of the HRCT scoring system. Spearmans rank correlation coefficients and multiple regression analyses were performed to evaluate the relationship between HRCT findings (first reading, reader A) and respiratory functional impairment. Intra- and inter-reader reliability demonstrated good agreement. All HRCT subscores, except enlargement of lymph nodes, were correlated to the FEV1, FVC, DLco, Pao2max (all p<0.05) and A-aPo2 max (p<0.001). Furthermore, HRCT abnormalities, but not the chest radiographic stage, were strongly associated with functional parameters. Abnormal changes of lung parenchyma, established by HRCT features, were associated with respiratory functional impairment in sarcoidosis. Moreover, compared with the radiographic stages, HRCT findings appeared to be much more sensitive in depicting respiratory disability, especially abnormal gas exchange.