Biomedical subjects
Ed Juszczak
Publications and source records attributed to Ed Juszczak.
Developing the BALANCE trail--the role of the pilot study and start-up phase.
OBJECTIVES: The initial design of the BALANCE (Bipolar Affective disorder: Lithium / ANtiConvulsant Comparative Evaluation) Trial of maintenance treatment for bipolar disorder was based on the experience of previous trials in bipolar disorder and psychiatry and on the methods developed for large randomized trials in other areas of medicine. This report describes the adaptations to the initial design and trial procedures following the initial phases of the study. The rationale for the trial and full protocol have been published elsewhere. METHODS: A pilot study and start-up phase were used to check the tolerability of the interventions, refine the trial design and develop trial procedures that are acceptable to both clinicians and patients. RESULTS: Changes to the procedures included: the dropping of masking of allocated treatment from clinicians and participants; introduction of the use of postal delivery to supply medication; and dispensing with the proposed schedule of regular follow up appointments. In addition, support was made available to participating psychiatrists who often had limited experience of participating in randomized trials. CONCLUSIONS: Pilot studies and start-up phases are essential to refine clinical trial design and allow development of procedures that are both methodologically rigorous and flexible and robust enough to promote recruitment and follow up. BALANCE is now actively recruiting in the UK and USA.
A 3-month, randomized, placebo-controlled, neuroleptic discontinuation study in 100 people with dementia: the neuropsychiatric inventory median cutoff is a predictor of clinical outcome.
BACKGROUND: Although few placebo-controlled neuroleptic discontinuation studies have been conducted in people with dementia, such studies are essential to inform key clinical decisions. METHOD: A 3-month, double-blind, placebo-controlled, neuroleptic discontinuation study (June 2000 to June 2002) was completed in 100 care-facility residents with probable or possible Alzheimer's disease (according to National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association criteria) who had no severe behavioral disturbances and had been taking neuroleptics for longer than 3 months. The Neuropsychiatric Inventory (NPI) was used to measure changes in behavioral and psychiatric symptoms. Quality of life was evaluated using Dementia Care Mapping. RESULTS: Eighty-two patients completed the 1-month assessment (36 placebo, 46 active). The number of participants withdrawing overall (N = 14 [30%] placebo, N = 14 [26%] active treatment) and because of exacerbation of behavioral symptoms (N = 6 [13%] placebo, N = 5 [9%] active treatment) was similar in the neuroleptic- and placebo-treated patients. As hypothesized, patients with baseline NPI scores at or below the median (< or = 14) had a particularly good outcome, with a significantly greater reduction of agitation in the patients receiving placebo (Mann-Whitney U test, z = 2.4, p =.018), while patients with higher baseline NPI scores were significantly more likely to develop marked behavioral problems if discontinued from neuroleptics (chi(2) = 6.8, p =.009). There was no overall difference in the change of quality of life parameters between groups. DISCUSSION: A standardized evaluation with an instrument such as the NPI may be a clinical indicator of which people with dementia are likely to benefit from discontinuation of neuroleptic treatment.
Distant past exercise in women: measures may be reliable, but are they valid?
INTRODUCTION/PURPOSE: Methods to measure lifetime physical activity have been described together with evidence suggesting that they are reliable. We present study findings that challenge the validity of such measures. METHODS: One hundred twenty-seven women aged 50-70 interviewed (31 cases, 96 controls) during a pilot case-control study about risk factors for osteoarthritis of the knee. Interviews used a life course approach with visual cues. Information obtained on past physical activity: (i) Total METs for a large range of activities within each decade between age 10 and age 50, (ii) 10-point rating scales representing level of physical activity during each decade between age 10 and age 50, and (iii) lifetime hours' participation in competitive sports. RESULTS: Any statistical correspondence between METs and activity rating scales was best in relation to women's activity when in their teens (Spearman rank correlation r = 0.40). The highest correlation thereafter related to the most recent decade (r = 0.25), which was low, but there was little or no linear association between MET values and the activity ratings when women were in their 20s or 30s. Around one fifth (20.4%) of women who reported no competitive sports participation during their teens and 18.5% who reported none during their 20s also reported total METs corresponding to the top quartile of physical activity during those periods of their lives. CONCLUSION: Retrospective reports from women of distant past activity levels will likely yield different information depending on the form of questioning. It is unclear which method, if any, is accurate and unbiased. The validity of each method is therefore also questionable.
Evaluation of the Dartmouth COOP charts in a large-scale community survey in the United Kingdom.
BACKGROUND: The aim of this study was to gain population norms for the COOP Charts in a large community sample, and to explore the construct validity, and whether the inclusion of the illustrations influences response rates. METHODS: A postal survey was carried out using a questionnaire booklet, containing the COOP Charts and a number of other items concerned with lifestyles and illness, sent to 6007 randomly selected subjects over the age of 18 years. Respondents were randomized to receiving the questionnaire booklet with a copy of the COOP Charts including illustrations, or the same booklet but including the COOP items without illustrations. The sample was drawn from the Family Health Services Authority (FHSA) computerized register for Oxfordshire. Outcome measures were scores for the eight dimensions of the COOP Charts. RESULTS: The survey achieved an adjusted response rate of 56.72 per cent. There was no difference in response rate or scores on the eight dimensions of the COOP Charts when broken down by those who received the illustrated Charts or simply the items from the measure without illustrations. Normative data for the COOP Charts are reported, broken down by age, sex, social class and whether respondent reported chronic illness or not. CONCLUSION: The illustrations included in the original charts do not appear to influence response rates, or responses given to the questions. The evidence suggests that items of the COOP Charts provide a short and comprehensive survey of health status. The normative data provided in this paper may further facilitate their validation and use.
The prevalence of foot problems in older women: a cause for concern.
BACKGROUND: Painful feet are an extremely common problem amongst older women. Such problems increase the risk of falls and hamper mobility. The aetiology of painful and deformed feet is poorly understood. METHODS: Data were obtained during a pilot case-control study about past high heel usage in women, in relation to osteoarthritis of the knee. A total of 127 women aged 50-70 were interviewed (31 cases, 96 controls); case-control sets were matched for age. The following information was obtained about footwear: (1) age when first wore shoes with heels 1, 2 and 3 inches high; (2) height of heels worn for work; (3) maximum height of heels worn regularly for work, going out socially and for dancing, in 10-year age bands. Information about work-related activities and lifetime occupational history was gathered using a Life-Grid. The interview included a foot inspection. RESULTS: Foot problems, particularly foot arthritis, affected considerably more cases than controls (45 per cent versus 16 per cent, p = 0.001) and was considered a confounder. Cases were therefore excluded from subsequent analyses. Amongst controls, the prevalence of any foot problems was very high (83 per cent). All women had regularly worn one inch heels and few (8 per cent) had never worn 2 inch heels. Foot problems were significantly associated with a history of wearing relatively lower heels. Few work activities were related to foot problems; regular lifting was associated with foot pain (p = 0.03). CONCLUSION: Most women in this age-group have been exposed to high-heeled shoes over many years, making aetiological research difficult in this area. Foot pain and deformities are widespread. The relationship between footwear, occupational activities and foot problems is a complex one that deserves considerably more research.