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Biomedical subjects

M S McCabe

Publications and source records attributed to M S McCabe.

At least 19 recordsLinked to original sources

Quality-of-life assessment in cancer treatment protocols: research issues in protocol development.

BACKGROUND: Interest in incorporating quality of life as an end point in clinical studies of cancer treatment has intensified in recent years. PURPOSE: We provide practical suggestions that will assist investigators considering including quality-of-life assessment in phase III therapeutic trials. METHODS: We discuss issues important in study planning, including quality-of-life definition, priority studies for quality-of-life assessment, eligibility requirements, and design. CONCLUSIONS: Many of the problems that quality-of-life studies have encountered, from protocol approval to data analysis, could be addressed and alleviated during protocol development. This discussion is intended to assist and stimulate investigators conducting research in this area.

Clinical Protocols

Reimbursement of biotherapy: present status, future directions--perspectives of the hospital-based oncology nurse.

Cancer is a set of diseases that affects one in four Americans and which is too often fatal. For many types of cancer, there is no fully satisfactory treatment. Therefore, investigational therapy provided in a formal, peer-reviewed clinical trial can present the best available treatment for patients with life-threatening malignancies. At a time when clinical cancer research is at a particularly promising point and multiple new biologics are on the horizon, the traditional partnership of the federal government, the pharmaceutical industry, private institutions, and insurers is threatened. The issue of increasing concern is the impact of changes in third-party reimbursement policy on cancer clinical investigation. Although its incidence, magnitude, and geographic distribution have not been specifically defined, this issue is generating serious concern and intense national debate. The growing denials of patient-care costs related to clinical trials serve to threaten patient access to potentially efficacious therapy. The implications of this reimbursement issue are tremendous for both clinical investigation and patient care. The refusal to pay for patient-care costs related to investigational therapy may adversely influence clinical trial design and will certainly affect the speed with which new therapies are developed. When insurers refuse to cover these clinical costs, only affluent individuals have access to the most promising treatments. Nursing actions can positively affect the reimbursement debate. Nurses must develop cost-efficient plans of care and the means to evaluate their effectiveness. Educating patients about and assisting them with reimbursement issues maximizes their prospects for receiving appropriate investigational therapy.(ABSTRACT TRUNCATED AT 250 WORDS)

Clinical Trials as Topic

Building quality of life assessment into cancer treatment studies.

Quality of life is increasingly recognized as an important outcome of cancer treatment. However, quality of life research poses considerable problems in design and implementation. This article provides guidelines for the preparation of phase III therapeutic protocols that include quality of life assessment. The guidelines emphasize the distinct requirements of quality of life research and provide specific recommendations for the questions that need to be addressed in protocol development.

Clinical Trials as Topic

Psychological support for the patient on chemotherapy.

The benefits of chemotherapy are frequently accompanied by side effects that can cause significant toxicity. Specific aspects of treatment contribute to the patient's psychological distress and should be identified by care-givers. Practical support interventions are possible and include both prevention and management techniques. Such strategies should be used in an ongoing manner as part of the professional relationship with the patient and may be enhanced by the inclusion of outside resources.

Antineoplastic Agents

Elliptinium: phase II study in advanced measurable breast cancer.

Eighteen patients with advanced measurable breast cancer were treated with elliptinium acetate 100 mg/m2 x 3 days every 3 weeks. Fourteen of these patients had failed prior chemotherapy. Two patients had an objective tumor response of greater than 4 weeks. Myelosuppression, renal insufficiency and thrombophlebitis were rarely encountered and alopecia was not seen at all. This study demonstrates that elliptinium has minimal activity in recurrent breast cancer with a favorable toxicity profile.

Adenocarcinoma

Psychiatric illness and human renal transplantation.

This study focuses on physiological as well as psychological causes for psychiatric illness in renal transplant recipients. During an 18 month period 20 transplant recipients were evaluated in psychiatric consultation. A variety of psychiatric illnesses were noted with eight having a secondary depression diagnosed according to psychiatric research criteria. Case histories of these patients indicated that corticosteroid and meythyldopa therapy were significant etiologic agents in the development of the depressive syndrome. A step-wise approach to the management of patients with depressed mood or slowed thinking was proposed.

Adjustment Disorders

Human rights and interviews.

Regulations from the US Department of Health, Education, and Welfare define consent in the conduct of research involving human beings. As requirements expand, these regulations have assumed considerable importance for psychiatric research, including research interviews. The author's experience with one committee on research involving human beings provided the impetus for the present report. Subjects were drawn from a prospective study of couples in a home dialysis program. Thirty couples were systematically interviewed concerning social, personal, medical, and psychiatric history. After completion of the interview, subjects were asked a series of questions concerning their feelings about being interviewed. Although most subjects found the experience to be pleasant, nearly half believed it might upset other patients. However, none believed any long-term harm could come from the conduct of the interview itself. It is therefore concluded that the potential harm of structured interviews in severely medically ill patients and their spouses is essentially nil.

Attitude

ECT versus chlorpromazine in mania.

The efficacy of ECT in the treatment of depression is well recognized. In mania its efficacy is less well acknowledged. This report compares ECT, chlorpromazine, and no active treatment in mania. Twenty-eight control patients diagnosed as manic were selected from consecutive admissions to the University of Iowa Psychiatric Hospital in the period 1935-1941 when there was no active treatment given. Twenty-eight patients treated with ECT were selected from the period 1945-1949, and 28 chlorpromazine-treated patients were selected from the period 1958-1964. Symptoms sufficient to fulfill a research diagnosis of mania had to be documented in the record for all patients. Results compare symptomatology, duration of hospital admission, discharge condition, discharge category, social recovery, and follow-up. Both ECT and chlorpromazine were superior to no active treatment for outcome measures considered. Ten chlorpromazine-treated patients did not respond satisfactorily to the chlorpromazine treatment but recovered with ECT treatment.

Adult

Reactive psychoses and schizophrenia with good prognosis.

Cross-national studies have indicated that American psychiatrists diagnose schizophrenia more often than others. Clinical, genetic, and follow-up studies suggest that many patients diagnosed as having acute schizophrenia might be more appropriately diagnosed as having affective disorder. Forty probands diagnosed in Aarhus, Denmark, as having reactive psychoses are compared with 28 probands diagnosed in St Louis as having schizophrenia with good prognosis. Clinical differences largely reflect diagnostic criteria, with the patients from the St Louis group frequently having diagnosable affective disorder. A smaller proportion, 39% of the patients from St Louis, could be considered for the diagnosis of reactive psychosis. This is additional evidence supporting the use of the diagnostic category, reactive psychoses. Patients ordinarily given the diagnoses acute schizophrenic episode and/or schizo-affective schizophrenia may be more appropriately diagnosed as having (1) affective disorder and (2) reactive psychoses.

Adult

ECT in the treatment of mania: a controlled study.

In a chart review study of manic patients, the author found that ECT remarkably improved outcome variables of condition at discharge, duration of hospitalization, and social recovery in comparison with an untreated matched control group. More conclusive evidence would depend on a prospective trial with random assignment of manic patients to ECT, lithium carbonate, and major tranquilizers and blind evaluation of outcome.

Adolescent

Reactive psychoses. A family study.

Reactive, or psychogenic, psychoses have been given the most attention in the literature by Scandinavian investigators. We defined diagnostic criteria for reactive psychoses emphasizing differences with manic-depressive psychoses and schizophrenia. Forty Danish probands were selected and family history data was obtained by personal interview and record review. In order to compare our results with other investigations, we age corrected family history data. Siblings of reactive probands were found to have significantly more reactive psychoses than siblings of manic-depressives or schizophrenics, and significantly less schizophrenia than siblings of schizophrenics. Although there was some genetic overlap with manic-depressive psychosis, we believe that the findings are sufficiently distinct to warrant the separate diagnostic category of reactive psychoses.

Adolescent

Demographic differences in functional psychoses.

Only Scandinavian investigators have reported on demographic aspects of reactive psychoses. Data from the National Health Service, Denmark, for age at first admission, sex, and length of stay in hospital in reactive, manic-depressive and schizophrenic psychoses are analysed. Differences in sex incidence ratios, age at first admission and length of stay are evident between the three psychoses. The differences noted are considered to provide indirect evidence supporting the separate diagnostic categories.

Adolescent