Screening, ethics, and the law.
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Biomedical subjects
Publications and source records attributed to M Law.
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Patients with advanced breast cancer were randomised to 3M (mitozantrone 6.5 mg/m2q 21 days, methotrexate 30 mg/m2q 21 days, mitomycin C 6.5 mg/m2q 42 days) or 2M (as 3M but without mitomycin C). The objective response rates of 30% in 51 evaluable patients receiving 3M and 26% of 54 patients receiving 2M were not significantly different. 4/16 patients not responding to 2M responded to 3M on crossover. Both regimes were well tolerated but there was significantly less haematological toxicity and fewer dose reductions and delays with 2M. We conclude that patients should initially be treated with 2M and that non-responding patients should be crossed to 3M.
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The prevalence of nausea and emesis among a series of out-patients (n = 95) receiving mainly mild-to moderately-emetic cytotoxics, was assessed, along with levels of psychological morbidity. Particular focus was given to the rates of psychologically-based (anticipatory) nausea and emesis. Results indicated that 23% of patients experienced anticipatory nausea and the majority reported that this occurred before at least half of the previous treatment cycles. Both emetic challenge of chemotherapy regimen and younger age were linked to this anticipatory effect. The data clearly indicated that nausea and emesis, both post-treatment and in anticipation of treatment, carried a psychological cost with anxiety being highest in those experiencing anticipatory nausea and/or emesis. The role of anxiety in the aetiology of psychologically-based nausea and emesis was not evaluated and it is considered that a prospective study is needed to clarify the exact contribution of psychological factors in the incidence of both post-treatment and anticipatory side-effects.
In 224 consecutive patients with hormone-resistant prostatic cancer referred to 2 European Cancer Centres for palliation of painful bone metastases the one year survival for all patients was 24% (2-year survival: 7%). The median survival was 8 months. In univariate analyses the following prognostic factors were identified: performance status, serum creatinine, alkaline phosphatase, duration of response to primary hormone treatment, degree of bone scan involvement and hemoglobin. Multivariate analyses confirmed the four first parameters to be independent factors. A prognostic model was established (no or one risk factors vs 2 risk factors vs 3 or 4 risk factors) based on performance status, creatinine, alkaline phosphatase and hormone response duration. The median survival of these groups was 10 months, 6 months and 3 months, respectively. This model proved to be discriminative in an external data set of 214 patients with hormone-resistant prostatic cancer entered in two prospective trials. The above differences in outcome between readily and simply defined prognostic groups are greater than the differences one can realistically hope to produce using new treatment strategies. These prognostic factors should be taken into account both in the design and interpretation of clinical studies dealing with the treatment of hormone-resistant progressing prostatic cancer and painful bone metastases.
PURPOSE: The study purpose was to evaluate aminoglutethimide (AG) as adjuvant therapy in patients with primary node-positive breast cancer in a randomized double-blind placebo-controlled trial. PATIENTS AND METHODS: In a multicenter trial, 354 postmenopausal women with early breast cancer and histologically confirmed positive axillary lymph nodes were randomized after surgery to received aminoplac. Patients were prescribed either AG 250 mg four times per day and hydrocortisone 20 mg twice per day or placebos of identical appearance for 2 years. RESULTS: After a median follow-up of 8.1 years, there has been no overall benefit for AG in terms of either event-free survival or overall survival (OS). However, the results are consistent with interim analyses with a significantly improved event-free survival for patients who received AG for up to 4 years, although this benefit subsequently disappears. Similarly, there is an improved OS for patients who received AG for up to 4 years, but this also subsequently disappears. There was a marginal advantage for estrogen receptor (ER)-positive patients who received AG (n = 74; P = .054). There was no difference in the sites of relapse. There was a significant increase in toxicity for patients who received AG. CONCLUSION: The lack of survival benefit with long-term follow-up for AG may indicate that aromatase inhibitors have less of an impact on early breast cancer than tamoxifen and may imply different biologic mechanisms of action.
The Clinical Observations of Motor and Postural Skills (COMPS) is a screening tool for children with motor incoordination. A study of reliability (test-retest, interrater, and internal consistency) and construct validity with 132 children, both with and without developmental coordination disorder, is reported here. Test-retest reliability over 2 weeks was high: .92 for a group of 48 children. Interrater reliability for occupational therapists experienced in pediatrics was also excellent: .87 for a group of 72 children. Internal consistency of the COMPS was high, particularly when one of the seven items (Schilder's arm extension) was deleted. The test discriminates well between children with and without motor problems and has many properties of a good screening test.
The purpose of this research was to study the effect of intensive neurodevelopmental therapy (NDT) and upper-extremity inhibitive casting, separately or in combination, on hand function, quality of upper-extremity movement and range of motion of 73 children with spastic cerebral palsy aged 18 months to eight years. There was no significant difference between intensive or regular therapy and casting or no casting for hand function, between intensive and regular NDT, or between intensive NDT plus casting and the other groups for quality of movement and range of motion. Casting led to increased quality of movement and wrist extension after six months. Casting with NDT improved the quality of upper-extremity movement and range of motion. There appear to be no immediate benefits from intensive therapy alone.
Individuals in Canada with a disability encounter environmental constraints that limit their active participation in the daily life of our communities. Fundamental inequities in participation and integration continue to exist and there is a need for a concerted effort to eliminate these disabling environments. Several factors, including the built environment, societal production of space, classification of individuals based on norms, the perception of disability as deviance, the power of health disciplines and bureaucracy are examined to determine their contribution to the creation of these disabling environments. Recent modifications to occupational therapy theory and practice, while meaningful, have not fully explored ways in which disabling environments limit occupation. Prevailing ideas about occupation and the environment are examined for their contribution to solving these environmental problems. Principles which can assist occupational therapy intervention directed at changing disabling environments are described. The intent is to define methods of changing disabling environments, based on the desires and active participation of people with disabilities
In 1987, Health and Welfare Canada and the Canadian Association of Occupational Therapists Task Force recommended that work go forward to develop an outcome measure for occupational therapy which reflects the Occupational Performance Model. The first step in this process was to review critically those outcome measures which assess occupational performance and that are currently available in the literature. This paper will present the review process, describe in more detail eight assessments that fulfilled many of the review criteria, discuss the limitations of these measures using the "Guidelines for the Client-centred Practice of Occupational Therapy as the framework, and make recommendations for the development of a new outcome measure for use in occupational therapy.
The Canadian Association of Occupational Therapists, in collaboration with Health and Welfare Canada have developed and published a conceptual model for occupational therapy, the Occupational Performance model. This paper describes the development of an outcome measure, The Canadian Occupational Performance Measure (COPM), which is designed to be used with these guidelines for client-centred clinical practice. The COPM is an outcome measure designed for use by occupational therapists to assess client outcomes in the areas of self-care, productivity and leisure. Using a semi-structured interview, the COPM is a five step process which measures individual, client-identified problem areas in daily function. Two scores, for performance and satisfaction with performance are obtained. This paper describes the rationale and development of the COPM as well as information about its use for therapists.
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Criteria mapping is a flexible and responsive method of chart audit that allows the simultaneous assessment of both the process and the outcome of care by means of health record abstraction. This method of audit is particularly suited to occupational therapy because it includes branching to reflect the sequential judgments of therapists and does not penalize the clinician for omitting unnecessary procedures. The purpose of this study was to determine the utility and reliability of the criteria mapping process in evaluating the quality of care for a self-care disability in an acute care setting. Three occupational therapists and one independent abstractor evaluated 12 charts twice. Intraobserver reliability calculated with intraclass correlation coefficients was .77 for the therapists and .65 for all observers. Interobserver reliability was .73 for the therapists and .72 for all observers. The criteria map provided comprehensive and relevant information about each chart. This paper discusses the implications of these findings for the ongoing monitoring of the quality of care in occupational therapy.
Occupational therapists routinely perform activities of daily living (ADL) assessments. Although the literature contains many ADL scales, few sources summarize and review the measurement properties of such scales. In this paper, standard criteria are used to review scales of basic self-care. Each scale is critically appraised regarding its purpose, clinical utility, construction, standardization, reliability, and validity. Recommendations are made regarding the ADL scales that are most suitable for describing, predicting, or evaluating ADL function. This review is intended to help therapists in selecting the most appropriate ADL measure to use in their clinical practice.
The 1986 position statement by the Board of Trustees fo the Council for Learning Disabilities called for a moratorium on the measurement and training of perceptual and perceptual-motor function as a part of services for children with learning disabilities (LD). Estimates in the literature, however, indicate that approximately 13% of children with LD exhibit motor deficits. Such children with motor or perceptual-motor problems are of ten referred to occupational therapy and found to have sensory integrative (SI) dysfunction; subsequently, they are treated with techniques aimed at remediating perceptual or sensorimotor dysfunction. Because the results of research concerned with the efficacy fo sensorimotor therapy are inconclusive and incomplete at this time, the position statement may be premature. Occupational therapists, however, must be aware of the statement and respond appropriately. In order to respond, they must have a better understanding of the nature of this subgroup of children with LD who have motor problems. the purpose fo this study was to assist in the definition of this population. Eighty children with LD between 5 years and 8 years 11 months were examined. They had been referred for occupational therapy at six centres in Southern Ontario. Results indicated that these children were similar to other children with LD in terms of gender and IQ distribution, developmental history, and academic achievement. The study population, however, tended to have less generalized emotional/behavioral disorder than the general population with LD. As expected, these children also had major deficits in gross and fine motor performance. A focus of the paper is on the importance of sensorimotor deficit for learning and self-concept in the child. Implications for both the position statement and practice and research in occupational therapy are discussed.
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