Health-related quality of life in Huntington's disease: a comparison of two generic instruments, SF-36 and SIP

Whereas several clinical endpoints in monitoring the response to treatment in patients with Huntington's disease (HD) have been explored, there has been a paucity of research in the quality of life in such patients. The aim of this study was to validate the use of two generic health-related quality of life instruments (the Short Form 36 health survey questionnaire [SF-36] and the Sickness Impact Profile [SIP]) and to evaluate their psychometric properties. We found that both instruments demonstrated acceptable convergent validity and reliability for patients and carers. However, there was an advantage in using the SF-36 because of its more robust construct validity and test-retest reliability; furthermore, motor symptoms appeared to influence some strictly nonmotor dimensions of the SIP. On a pragmatic level, the SF-36 is shorter and quicker to administer and, therefore, easier for patients at various stages of the disease to complete. Thus, the SF-36 would appear to be the recommended instrument of choice for patients with HD and their carers, although further work needs to be done to investigate the sensitivity of this instrument longitudinally. (C) 2004 Movement Disorder Society.

Modelling of the natural chlorine cycling in a coniferous stand: implications for chlorine-36 behaviour in a contaminated forest environment

Considered as one of the most available radionuclide in soileplant system, 36Cl is of potential concern for long-term management of radioactive wastes, due to its high mobility and its long half-life. To evaluate the risk of dispersion and accumulation of 36Cl in the biosphere as a consequence of a potential contamination, there is a need for an appropriate understanding of the chlorine cycling dynamics in the ecosystems. To date, a small number of studies have investigated the chlorine transfer in the ecosystem including the transformation of chloride to organic chlorine but, to our knowledge, none have modelled this cycle. In this study, a model involving inorganic as well as organic pools in soils has been developed and parameterised to describe the biogeochemical fate of chlorine in a pine forest. The model has been evaluated for stable chlorine by performing a range of sensitivity analyses and by comparing the simulated to the observed values. Finally a range of contamination scenarios, which differ in terms of external supply, exposure time and source, has been simulated to estimate the possible accumulation of 36Cl within the different compartments of the coniferous stand. The sensitivity study supports the relevancy of the model and its compartments, and has highlighted the chlorine transfers affecting the most the residence time of chlorine in the stand. Compared to observations, the model simulates realistic values for the chlorine content within the different forest compartments. For both atmospheric and underground contamination scenarios most of the chlorine can be found in its organic form in the soil. However, in case of an underground source, about two times less chlorine accumulates in the system and proportionally more chlorine leaves the system through drainage than through volatilisation.

Self-reported symptoms and motor tests via telemetry in a 36-month levodopa-carbidopa intestinal gel infusion trial

Objective To investigate if a home environment test battery can be used to measure effects of Parkinson’s disease (PD) treatment intervention and disease progression. Background Seventy-seven patients diagnosed with advanced PD were recruited in an open longitudinal 36-month study at 10 clinics in Sweden and Norway; 40 of them were treated with levodopa-carbidopa intestinal gel (LCIG) and 37 patients were candidates for switching from oral PD treatment to LCIG. They utilized a mobile device test battery, consisting of self-assessments of symptoms and objective measures of motor function through a set of fine motor tests (tapping and spiral drawings), in their homes. Both the LCIG-naïve and LCIG-non-naïve patients used the test battery four times per day during week-long test periods. Methods Assessments The LCIG-naïve patients used the test battery at baseline (before LCIG), month 0 (first visit; at least 3 months after intraduodenal LCIG), and thereafter quarterly for the first year and biannually for the second and third years. The LCIG-non-naïve patients used the test battery from the first visit, i.e. month 0. Out of the 77 patients, only 65 utilized the test battery; 35 were LCIG-non-naïve and 30 LCIG-naïve. In 20 of the LCIG-naïve patients, assessments with the test battery were available during oral treatment and at least one test period after having started infusion treatment. Three LCIG-naïve patients did not use the test battery at baseline but had at least one test period of assessments thereafter. Hence, n=23 in the LCIG-naïve group. In total, symptom assessments in the full sample (including both patient groups) were collected during 379 test periods and 10079 test occasions. For 369 of these test periods, clinical assessments including UPDRS and PDQ-39 were performed in afternoons at the start of the test periods. The repeated measurements of the test battery were processed and summarized into scores representing patients’ symptom severities over a test period, using statistical methods. Six conceptual dimensions were defined; four subjectively-reported: ‘walking’, ‘satisfied’, ‘dyskinesia’, and ‘off’ and two objectively-measured: ‘tapping’ and ‘spiral’. In addition, an ‘overall test score’ (OTS) was defined to represent the global health condition of the patient during a test period. Statistical methods Change in the test battery scores over time, that is at baseline and follow-up test periods, was assessed with linear mixed-effects models with patient ID as a random effect and test period as a fixed effect of interest. The within-patient variability of OTS was assessed using intra-class correlation coefficient (ICC), for the two patient groups. Correlations between clinical rating scores and test battery scores were assessed using Spearman’s rank correlations (rho). Results In LCIG-naïve patients, mean OTS compared to baseline was significantly improved from the first test period on LCIG treatment until month 24. However, there were no significant changes in mean OTS scores of LCIG-non-naïve patients, except for worse mean OTS at month 36 (p<0.01, n=16). The mean scores of all subjectively-reported dimensions improved significantly throughout the course of the study, except ‘walking’ at month 36 (p=0.41, n=4). However, there were no significant differences in mean scores of objectively-measured dimensions between baseline and other test periods, except improved ‘tapping’ at month 6 and month 36, and ‘spiral’ at month 3 (p<0.05). The LCIG-naïve patients had a higher within-subject variability in their OTS scores (ICC=0.67) compared to LCIG-non-naïve patients (ICC=0.71). The OTS correlated adequately with total UPDRS (rho=0.59) and total PDQ-39 (rho=0.59). Conclusions In this 3-year follow-up study of advanced PD patients treated with LCIG we found that it is possible to monitor PD progression over time using a home environment test battery. The significant improvements in the mean OTS scores indicate that the test battery is able to measure functional improvement with LCIG sustained over at least 24 months.

Magnitude and meaningfulness of change in SF-36 scores in four types of orthopedic surgery

Background: The Medical Outcomes General Health Survey (SF-36) is a widely used health status measure; however, limited evidence is available for its performance in orthopedic settings. The aim of this study was to examine the magnitude and meaningfulness of change and sensitivity of SF-36 subscales following orthopedic surgery.

Methods: Longitudinal data on outcomes of total hip replacement (THR, n = 255), total knee replacement (TKR, n = 103), arthroscopic partial meniscectomy (APM, n = 74) and anterior cruciate ligament reconstruction (ACL, n = 62) were used to estimate the effect sizes (ES, magnitude of change) and minimal detectable change (sensitivity) at the group and individual level. To provide context for interpreting the magnitude of changes in SF-36 scores, we also compared patients' scores with age and sex-matched population norms. The studies were conducted in Sweden. Follow-up was five years in THR and TKR studies, two years in ACL, and three months in APM.

Results: On average, large effect sizes (ES≥0.80) were found after orthopedic surgery in SF-36 subscales measuring physical aspects (physical functioning, role physical, and bodily pain). Small (0.20–0.49) to moderate (0.50–0.79) effect sizes were found in subscales measuring mental and social aspects (role emotional, vitality, social functioning, and mental health). General health scores remained relatively unchanged during the follow-up. Despite improvements, post-surgery mean scores of patients were still below the age and sex matched population norms on physical subscales. Patients' scores on mental and social subscales approached population norms following the surgery. At the individual level, scores of a large proportion of patients were affected by floor or ceiling effects on several subscales and the sensitivity to individual change was very low.

Conclusion: Large to moderate meaningful changes in group scores were observed in all SF-36 subscales except General Health across the intervention groups. Therefore, in orthopedic settings, the SF-36 can be used to show changes for groups in physical, mental, and social dimensions and in comparison with population norms. However, SF-36 subscales have low sensitivity to individual change and so we caution against using SF-36 to monitor the health status of individual patients undergoing orthopedic surgery.

Quality of life assessment in the community-dwelling elderly : validation of the Assessment of Quality of Life (AQoL) instrument and comparison with the SF-36

Measurement of Health-Related Quality of Life (HRQoL) of the elderly requires instruments with demonstrated sensitivity, reliability, and validity, particularly with the increasing proportion of older people entering the health care system. This article reports the psychometric properties of the 12-item Assessment of Quality of Life (AQoL) instrument in chronically ill community-dwelling elderly people with an 18-month follow-up. Comparator instruments included the SF-36 and the OARS. Construct validity of the AQoL was strong when examined via factor analysis and convergent and divergent validity against other scales. Receiver Operator Characteristic (ROC) curve analyses and relative efficiency estimates indicated the AQoL is sensitive, responsive, and had the strongest predicative validity for nursing home entry. It was also sensitive to economic prediction over the follow-up. Given these robust psychometric properties and the brevity of the scale, AQoL appears to be a suitable instrument for epidemiologic studies where HRQoL and utility data are required from elderly populations.

Impact of positively- versus negatively-worded items on the factor structure of three psychological measures: W-BQ22, W-BQ12 & SF-36

Background: The 22-item Well-being Questionnaire (W-BQ22) (Bradley, 1994) includes Anxiety, Depression, Energy and Positive Well-being subscales. However, the constructs of anxiety and depression could not be easily distinguished from each other. Consequently, the W-BQ12 was designed to include just three subscales, Negative Well-being (including only negatively-worded anxiety and depression items), Energy (2 positively- and 2 negativelyworded items) and Positive Well-being (all positively-worded items). The SF-36 (Ware & Sherbourne, 1983), a widely used health status measure, includes a 4-item vitality subscale (2 positively- and 2 negatively-worded items) and a 5-item mental health scale (2 positively worded and 3 negatively-worded items).

Method: Factor structures of W-BQ22, W-BQ12 and SF-36 were compared using data from 789 outpatients with diabetes.

Results: W-BQ22 factor analysis showed negatively-worded anxiety and depression items loading together, while positively-worded depression items loaded with positive well-being items and separately from positively-worded anxiety items. W-BQ12 loaded as intended on 3 factors, with negatively-worded anxiety and depression items loading together on one factor: negative well-being. The four energy items (2 positively- and 2 negatively-worded) loaded together (factor 3) and the four positive well-being items loaded together (factor 1). Unforced factor analysis of the SF-36 produced 5 factors and split the mental health and vitality items into two components, which could only be defined in terms of positive and negative wording. A forced 8-factor solution produced similar results, with the mental health and vitality items being split into two components according to their positive or negative wording. A forced 2-factor solution brought mental health/vitality items together, separate from physical health items.

Conclusion: The previously unrecognised influence of positive and negative wording on factor structure is clearly shown here to be of importance in conceptualising and designing measures of psychological well-being to be used with people with diabetes and may be of relevance for other populations.