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Biomedical subjects

D Macfarlane

Publications and source records attributed to D Macfarlane.

10 recordsLinked to original sources
PubMed1992

Patient treatment on a compassionate basis: documentation of high adverse drug reaction rate.

The special exception mechanism was established by the Division of Cancer Treatment (DCT), National Cancer Institute (NCI), for the provision of anticancer drugs not yet approved by the Food and Drug Administration (FDA) to patients on a compassionate basis. Strict guidelines have been established for the distribution of drugs through this mechanism and for the reporting of adverse drug reactions (ADRs) with investigational drugs. These guidelines have been used to format the data base which is maintained on all ADRs submitted by investigators. In this paper, the incidence of ADRs with the eleven investigational drugs most frequently administered on special exception protocols was determined for a twelve month time period, January 1, 1985 through December 31, 1985. On special exception protocols, the overall incidence rate of ADRs was significantly greater than that seen on research protocols for the time period. For three drugs, Methyl-G, DBD, and AMSA, the ADR incidence rate was seven to fifteen-fold greater on special exception protocols than on research protocols. In an analysis of all ADRs submitted to the FDA for the twelve months time period, no difference was found in the frequency of distribution of either types of adverse effects or the causal assessments of ADRs on special exception and research protocols.

Antineoplastic Agents↗
PubMed1992

Osteoarthritis.

Explore the source record for details and available documents.

Aged↗
PubMed1991

Quantitative microfocal radiographic assessment of disease and progression in osteoarthritis of the hand.

Macroradiographic examination of the wrists and hands of 32 patients with osteoarthritis (OA) over an 18 month period showed that, compared with healthy control subjects, 44% of the patients had significant joint space narrowing at entry, which increased to 65%. Subchondral cortical thickness was greater in all patients at entry and increased with time. Osteophytes and juxtaarticular radiolucencies were present in all patients at study entry; by the end, osteophytes had increased in number and area, and juxtaarticular radiolucencies in area only. We conclude that in OA of the hand, bony changes have progressed significantly before joint space narrowing.

Aged↗
PubMed1988

AIMS ratings--repeatability.

In the present study, two raters, a psychologist and a nurse, each made five independent ratings of 30 different video-recorded patient-examinations. Having thus excluded patient fluctuation, individual-rater consistency and between-rater agreement over the 6 weeks of the study are examined. While between-rater agreement was apparently being maintained, mean AIMS scores steadily increased. In the hands of these raters, AIMS items 2 and 4 emerged as very reliable, while items 1, 6, and 7 showed high variability. Some patients appeared to be hard to rate. Differences between the study raters and the author JB highlight the issue: how reproducible is an AIMS rating?

Dyskinesia, Drug-Induced↗
PubMed1987

Selection factors in clinical trials: results from the Community Clinical Oncology Program Physician's Patient Log.

Between August 1984 and November 1985, data concerning 44,156 newly diagnosed cancer patients were entered in the Community Clinical Oncology Program Physician's Patient Log. Forty percent (17,773 patients) had a National Cancer Institute-approved protocol available for site and stage of disease. Fifty-six percent of patients with a protocol available were clinically eligible and 19% were entered on protocol. Thus, one-third of clinically eligible patients were entered in the study. Age was a major factor influencing eligibility and entry on study. Eighty percent of patients less than 25 years of age with a protocol available were clinically eligible for clinical trials participation, and 58% were placed on protocol. Patients greater than or equal to 65 years of age with a protocol available were less likely to be clinically eligible (48%) or placed on study (14%). A physician's preference for an alternate treatment and patient refusal for protocol treatment were also important reasons that clinically eligible patients were not registered on protocol. Selection for clinical trials participation affects the characteristics of patients under study and may have an impact on the ability to generalize the results of clinical trials.

Adult↗