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Biomedical subjects

K Campion

Publications and source records attributed to K Campion.

10 recordsLinked to original sources
PubMed1997

Multiple sclerosis.

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Disease Progression↗
PubMed1994

The PACE pilot study: 12-month results and implications for future primary prevention trials in the elderly. (Prevention with low-dose Aspirin of Cardiovascular disease in the Elderly)

OBJECTIVE: To document compliance with medication, drop-out and drop-in rates, and baseline cardiovascular event rates during the pilot phase of the PACE (Prevention with low-dose Aspirin of Cardiovascular disease in the Elderly) study. DESIGN: Randomized, double-blind, placebo-controlled trial of low-dose aspirin therapy. SETTING: Community-based, in general practices and residential retirement villages, in Victoria, Australia. SUBJECTS: Four hundred persons aged 70 years and older (53% females), ambulatory and living independently, who volunteered to participate. None had significant vascular disease, peptic ulceration, hemorrhagic symptoms, or were currently taking non-steroidal anti-inflammatory drugs. MAIN OUTCOME MEASURES: Compliance with medication (assessed by pill count and platelet function tests), self-reported drop-out and drop-in rates, and incidence of cardiovascular events reported by participants and their general practitioners during a 12-month period. RESULTS: Two fatal cardiovascular events, three non-fatal coronary events, and eight non-fatal cerebrovascular events were observed during the 12-month period. These incidence figures were approximately 15%, 15%, and 40%, respectively, of those in the general population of the same age and sex, based on morbidity data available from the Australian Bureau of Statistics. Compliance to medication was excellent (87%), and premature withdrawal (other than for a study end point) was limited to 14.5%. Secondary 'softer' endpoints, such as transient ischaemic attack and unstable angina, necessitated patient withdrawal from randomized therapy and possibly contributed to the small number of primary 'hard' end points observed. The projected power of the main study to detect a 20% treatment effect on overall cardiovascular mortality in 15,000 subjects over a 4-year period may, therefore, be substantially reduced. CONCLUSIONS: These results suggest that any future primary prevention study of cardiovascular disease in the elderly examining the effect of low-dose aspirin on overall cardiovascular mortality will likely need to use much larger numbers of patients or use a combined end point of fatal and non-fatal ischemic events.

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PubMed1993

Adverse effects of low-dose aspirin in a healthy elderly population.

The adverse effects of low-dose aspirin (100 mg daily) in the elderly were studied over a 12-month period in a double-blind, randomized, placebo-controlled trial of 400 subjects who were 70 years of age or older and had no preexisting major vascular diseases at the time of entry. Subjects were randomized so that 200 subjects received low-dose enteric-coated aspirin (100 mg daily) and 200 subjects received placebo. Compliance with medication, assessed by pill count, was 86%. Gastrointestinal symptoms were reported by 18% (n = 36) of participants receiving aspirin and 13% (n = 26) of those receiving placebo. Clinically evident gastrointestinal bleeding occurred in 3% (n = 6) of subjects receiving aspirin and none receiving placebo. Aspirin-treated subjects had a significant decrease in mean hemoglobin levels of 0.33 gm/dl during the 12-month study period, which was significantly greater than the decrease in the placebo-treated group (0.11 gm/dl; p < 0.05). These rates of unwanted symptoms are comparable with previous studies that used higher doses of aspirin. Until the risk-benefit trade-off from the use of low-dose aspirin in the elderly is established with an appropriate clinical trial, caution should be exercised when this compound is used for primary prevention of cardiovascular disease in this age group.

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PubMed1992

Haematological profile of healthy elderly Australians.

OBJECTIVE: To determine normal values for haematological parameters in healthy elderly persons, and document any changes in these over a 12 month period. DESIGN: The study was conducted as part of a randomised controlled trial of low-dose aspirin for primary prevention of cardiovascular disease in the elderly. All participants (380) had a full blood examination performed at entry, which was repeated after 12 months. The baseline results for all patients and the 12 month findings in a cohort of 162 persons allocated placebo were used in the present study. SETTING: Community-based (general practices and residential retirement villages). SUBJECTS: Persons aged 70 years and over (53% females) who were ambulatory, living independently, and volunteered to participate. None had significant vascular disease, peptic ulceration, haemorrhagic symptoms or were currently taking non-steroidal anti-inflammatory drugs. MAIN OUTCOME MEASURES: Full blood examination (excluding white cell differential counts) performed with a Technicon H1 analyser. RESULTS: The mean haemoglobin level +/- standard deviation (SD) was 14.69 +/- 1.10 g/dL (for men) and 13.72 +/- 1.05 g/dL (for women). Significant differences (P less than 0.001) in packed cell volume, red cell and platelet counts were observed between the two sexes. No clinically significant change was observed in any of the parameters over a 12 month period. CONCLUSIONS: Haematological reference values for healthy elderly Australians are consistent with normal values reported in younger populations for both sexes. As a result recommendations are provided for normal reference values among this group in an Australian setting.

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PubMed1991

Comparison of recruitment strategies for a large-scale clinical trial in the elderly.

Formal evaluation of recruitment strategies for clinical trials conducted in the community setting, rather than in hospitals, is limited despite recruitment rates and costs having significant implications for the planning of large trials. As part of the development of a large-scale primary prevention trial of low-dose aspirin in 15,000 elderly persons (aged 70 years and above) to be undertaken in a community setting, a pilot study involving 400 participants was carried out to evaluate different recruitment strategies. Three techniques were compared: recruiting from the electoral roll (by individual invitation using direct mail), local community approach (through retirement villages, local media, elderly community groups), and using general/family practice (identifying persons over 70 within a practice and direct mail invitation to participate). Screening of potential participants was carried out by a trained trial nurse with limited involvement only of medical practitioners. The target recruitment figure was achieved in 4 months using the equivalent of 1.5 full-time nurses. General practice was the most effective method utilized, with a yield of one participant recruited per six approached at an estimated cost of A$48.36 per recruited participant. This compares with yield rates of 1 per 29 (for the local community approach) and 1 per 17 for the electoral roll, and costs per participant of A$42.54 and A$59.37 respectively. Other less tangible benefits of general practice include the greater cooperation of primary care practitioners in patient follow-up and end-point ascertainment.

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