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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
PubMed1999

The ethical foundation of informed consent in clinical research.

OBJECTIVES: To provide a foundation for understanding the ethical concept of informed consent with particular emphasis on the characteristics and principles that make it a moral imperative. DATA SOURCES: Government reports, published articles, and book chapters from the ethics literature. CONCLUSIONS: Informed consent is central to the conduct of cancer clinical trials and good patient care. It is a thoughtful, collaborative process whereby an individual gives autonomous authorization and the decision of the individual is respected by the health professionals. IMPLICATIONS FOR NURSING PRACTICE: Understanding the theory and practice of informed consent is an essential aspect of the nurses role. There are many challenges to this process in the oncology setting because of the severity of the diseases and the complexity of the research, and nurses must be prepared to assure that informed decision-making takes place.

Clinical Trials as Topic↗
PubMed1997

Detection of single-copy genes in DNA from transgenic plants by nonradioactive Southern blot analysis.

Improvements to the sensitivity, speed, and reproducibility of digoxigenin (DIG)-labeled probes and chemiluminescent substrates makes these compounds increasingly popular to detect nucleic acids. High sensitivity and low background are essential in Southern blot analysis, particularly with plant DNA. This article describes a nonradioactive system to detect single-copy genes in transgenic plants. Labeling using the polymerase chain reaction (PCR) was employed to produce highly sensitive and reusable DIG-labeled probes. The background was reduced by immobilizing the DNA onto nylon filters by alkaline transfer and by minimized gel handling; the signal-to-noise ratio was improved by modification of the detection procedure.

Blotting, Southern↗
PubMed1995

The National Cancer Institute audit of the National Surgical Adjuvant Breast and Bowel Project Protocol B-06.

BACKGROUND: The National Surgical Adjuvant Breast and Bowel Project (NSABP) Protocol B-06, a clinical trial sponsored by the National Cancer Institute (NCI), has provided evidence of the value of lumpectomy and breast irradiation for treating women with breast cancer in an early stage. Publicity generated by the discovery that the study included fraudulent data on patients enrolled by St. Luc Hospital in Montreal aroused concern about the overall accuracy of the data and conclusions. To address this concern, the NCI conducted an audit of other participating institutions. METHODS: In 1994, data on 1554 of the 1809 randomized patients (85.9 percent) enrolled by centers other than St. Luc Hospital were audited at 37 clinical sites in North America. The audit included data on eligibility, survival, disease-free survival, the length of time to a recurrence of cancer in the ipsilateral breast, and documentation of signed informed consent. RESULTS: End points were assessed for all 1554 patients, and eligibility was assessed for 1507 patients; 47 patients were excluded because their forms were not complete or not returned. A total of 1429 patients had their eligibility status verified. Of a total of 7770 data points examined with respect to the number of positive nodes at base line, treatment characteristics, first events (excluding death), recurrence of cancer in the ipsilateral breast, and survival, 7577 (97.5 percent) were verified, 123 (1.6 percent) could not be verified, and 70 (0.9 percent) were discrepant with the NSABP file. Of the 1554 patients, 1340 (86.2 percent) had all audited items (including eligibility) verified, 69 (4.4 percent) had at least one discrepant item, and 113 (7.3 percent) had at least one unverified item (as a result of missing or incomplete data); 32 (2.1 percent) were not assessed for eligibility but had no other discrepant or unverifiable items. Written informed consent was documented for 1098 patients before surgery and 210 after surgery; no date appeared on the signed form for 137. The informed-consent status was not verified for 71 patients and could not be determined for 38. The rates of verification of end-point data and documentation of written informed consent were similar among the total-mastectomy group, the lumpectomy group, and the group treated by lumpectomy and breast irradiation. CONCLUSIONS: The audit confirms the adequacy of the data on which the reanalysis of Protocol B-06 and the results after 12 years of follow-up are based.

Breast Neoplasms↗
PubMed1995

Women's health advocacy: its growth and development in oncology.

Women's health has become a topic of national importance. Advocacy initiatives by consumers, scientists, government officials, health care professionals, industry, and the media have played a role in helping to set this agenda. Much of the current interest in women's health is the result of the women's movement and its interaction with science, medicine, and health care. Emerging consumerism and increasing public knowledge of medical and scientific topics has led to the emergence of patients as individuals seeking to actively make decisions regarding health care options. Nurses should embrace the advocacy movement and, whenever possible, work with patients and their advocates toward their many shared goals.

Consumer Advocacy↗
PubMed1994

Efforts to recruit the economically disadvantaged to national clinical trials.

Clinical trials are vital for the development of state-of-the-art cancer prevention and treatment. A goal for trial recruitment should be to have a representative sample of the total population by gender, race, culture, ethnicity, and socioeconomic status as appropriate. Increased sensitivity to the unique barriers and access to care issues required to achieve a representative sample are necessary. Knowledge and understanding of recruitment problems and strategies to resolve them are developing; however, much more is needed before we can fully address and resolve all of the relevant issues. Nurses have a key role in identification, education, and recruitment of special populations including the SED to clinical trials.

Advertising↗
PubMed1993

Nursing management of the patient receiving Taxol therapy.

Taxol is an important new antitumor agent with demonstrated efficacy in ovarian and breast cancer. Toxicities identified, including cardiac, hypersensitivity reactions, and neurologic, require careful nursing assessment for management, Additional toxicities may be identified as Taxol is combined with other chemotherapeutic agents. Studies to determine the most effective dose and schedule are ongoing. The current evaluation of this new drug presents an important opportunity for nurses to contribute to its development through both clinical and research endeavors. Such contributions will facilitate the optimal nursing care of patients treated with Taxol.

Humans↗
PubMed1992

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↗
PubMed1992

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↗
PubMed1992

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↗
PubMed1991

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↗
PubMed1989

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↗
PubMed1983

Preventing chemotherapy-induced alopecia.

Chemotherapy-induced alopecia is now potentially preventable. Although scalp tourniquets and hypothermia are neither universally applicable nor always successful, they represent simple and relatively inexpensive methods for reducing hair loss. When successful, these techniques help maintain the patient's self-image and thereby diminish the devastating psychologic effects that accompany a diagnosis of cancer.

Alopecia↗