Clinical Research Nurses Research Articles

From delegation to specialization: nurses and clinical trial co-ordination.

This paper considers an area of clinical research that has been delegated by physician-researchers to nurses and others in the United States, that of clinical trials co-ordination. It uses interviews with nurse trial co-ordinators to explore the occupational processes by which the boundaries of work enactment and the definition of work have been established by nurses and others. It then discusses the occupational processes that have been established to formalize a role for nurses in clinical research. It raises the question of (and offers speculation on) whether specialization alone will distinguish nursing from other occupational groups engaged in clinical research work.

Recognizing Nurses' contributions to the clinical research process

A survey of the clinical research nurses (CRNs) associated with the Pediatric Pulmonary and Cardiovascular Complications of Vertically Transmitted HIV Infection Study was conducted to delineate the nurses' roles. The diversity of activities reported by the CRNs are presented, categorized, and compared to those stated in the protocol job descriptions. Additional dimensions of the multifaceted CRN role are identified. Aspects of the nurses' role associated with special needs of the study cohort and related implications are discussed.

Payment for Routine Postoperative Patient-controlled Analgesia

David C. Mackey, M.D., Consultant in Anesthesiology and Medicine, Department of Anesthesiology and Critical Care Medicine, Mayo Clinic Jacksonville, 4500 San Pablo Road, Jacksonville, Florida 32224–1865.M. Kathleen Ebener, R.N., M.S.N., Clinical Research Nurse, St. Luke's Hospital, 4205 Belford Road, Jacksonville, Florida 32216–5898.In Reply:--Waun states that management of patient-controlled analgesia (PCA) by anesthesiologists fragments perioperative care and increases cost. Our contentions are merely that PCA may not be markedly safer or less complicated to manage than epidural analgesia and that the best-qualified personnel should manage PCA therapy. The application of multidisciplinary expertise of different physician and allied health providers, using an integrated teamwork approach, is one of the great advances of modern medicine and does not necessarily imply a fragmented and uncoordinated approach to patient care.There is no reason why highly motivated surgeons cannot learn to manage PCA well, but in practice, they are less likely to be either as knowledgeable or as available to patients on the hospital wards as their anesthesiologist colleagues. In addition, any labor-intensive service, such as a very busy PCA service, is unlikely to arouse adequate interest from extremely busy health-care practitioners unless there is reasonable reimbursement for it. We wish this were not true, but it is. Too much of our medical care is driven by economics. We would like to be able to improve postoperative pain management solely on the basis of appeals to our colleagues for "empathetic and compassionate relief of postoperative pain"; it is unfortunate that improving reimbursement will be much more effective.David C. Mackey, M.D., Consultant in Anesthesiology and Medicine, Department of Anesthesiology and Critical Care Medicine, Mayo Clinic Jacksonville, 4500 San Pablo Road, Jacksonville, Florida 32224–1865.M. Kathleen Ebener, R.N., M.S.N., Clinical Research Nurse, St. Luke's Hospital, 4205 Belford Road, Jacksonville, Florida 32216–5898.

Ectopic Pregnancy: A Nursing Approach to Excess Risk Among Minority Women

Ectopic pregnancy rates have quadrupled during the last decade. Although maternal mortality has been reduced for white women, largely because of rapid pregnancy testing and improved ultrasonography, the death rate for minority women is almost twice that of white women, and minority adolescents are almost five times as likely to die of ectopic pregnancy. In this article, causative factors are identified, and the potential for race, gender, and age bias in diagnosis and treatment is discussed. Involvement by nurses in preventive programs, clinical research, and advocacy for policy change may help reduce ectopic pregnancy mortality rates.

Patient-controlled Analgesia and the Acute Pain Service in the United States

David C. Mackey, M.D., Consultant in Anesthesiology and Medicine, Department of Anesthesiology and Critical Care Medicine, Mayo Clinic Jacksonville, 4500 San Pablo Road, Jacksonville, Florida 32224-1865.M. Kathleen Ebener, R.N., M.S.N., Clinical Research Nurse, St. Luke's Hospital, 4205 Belford Road, Jacksonville, Florida 32216-5898.Bonnie L. Howe, R.N., B.S.N., Acute Pain Service, Department of Anesthesiology and Critical Care Medicine, Mayo Clinic Jacksonville, 4500 San Pablo Road, Jacksonville, Florida 32224-1865.To the Editor:--Correspondence from Ready examined the use of patient-controlled analgesia (PCA) in the United States. [1]As an extension to his useful work, it would be helpful to have additional data regarding PCA management in elderly postoperative patients, who are at greater risk for perioperative problems than the general population.* In Florida, we find little management of postoperative PCA by anesthesiologists. Perhaps this is because of the relatively large percentage of Medicare patients in our state and because of the decision of the Health Care Financing Administration (HCFA) to halt further Medicare reimbursement to Florida anesthesiologists for this service, effective June 1, 1992. The HCFA's position is that surgeons have historically managed patients' postoperative pain and that they should continue to do so "except under special circumstances," with pain management reimbursement thus part of the surgeon's global fee.** Our opinion is that this conclusion by HCFA is erroneous, because no one managed postoperative pain until anesthesiologists recently defined a new standard and began to focus their attention upon it. [2].PCA is commonly thought of as an "autopilot" process, and thus there is no need for specialized acute pain service management. However, is this true? We have believed that PCA was just as management-intensive as epidural analgesia and that anesthesiologists were the ideal providers of PCA because of their knowledge of pain physiology and their command of the analgesic armamentarium, including the utilization of parenteral opioids and the treatment of their side effects and complications. [3]Our impression of PCA management intensity was confirmed by a pilot study: We noted that PCA has just as many side effects and requires just as many ward nurse and acute pain service interventions as does epidural analgesia.*** In addition, the common assumption that PCA possesses less risk than epidural analgesia is unwarranted: There is no evidence that respiratory depression, the most dangerous side effect of opioid administration, occurs less often with PCA relative to epidural administration. [4].No one questions the need for anesthesiologists to manage epidural analgesia, but if PCA is equally problematic and equally management-intensive, anesthesiologists should likewise be reimbursed for this service. And in the case of postoperative epidural analgesia, how much of the overall benefit is derived exclusively from the epidural infusion per se, and how much is the result of other undefined aspects of twice-a-day acute pain service rounds? We do not believe that we are unnecessarily fixated on dollars: The decision of the HCFA not to reimburse anesthesiologists for postoperative PCA pain management has impeded optimal postoperative pain management--anesthesiologists are the optimal providers of PCA, and yet it is realistic to assume that, if they are not reimbursed for this service, they are unlikely to assume its burden. Our department has decided to continue to manage all PCA, including postoperative, because we are convinced that this is what is best for our patients and because our group practice situation allows us to do so with minimal individual financial repercussion. For a variety of reasons, however, many other anesthesiology departments have not been so inclined. For optimal postoperative PCA management, HCFA Medicare reimbursement policies should support the recently published U.S. Department of Health and Human Services acute pain management guidelines, which state that, "in all cases, responsibility for [acute pain management] should be assigned to those most knowledgeable, experienced, interested, and available to deal with the patients' needs in a timely fashion."****David C. Mackey, M.D., Consultant in Anesthesiology and Medicine, Department of Anesthesiology and Critical Care Medicine, Mayo Clinic Jacksonville, 4500 San Pablo Road, Jacksonville, Florida 32224-1865.M. Kathleen Ebener, R.N., M.S.N., Clinical Research Nurse, St. Luke's Hospital, 4205 Belford Road, Jacksonville, Florida 32216-5898.Bonnie L. Howe, R.N., B.S.N., Acute Pain Service, Department of Anesthesiology and Critical Care Medicine, Mayo Clinic Jacksonville, 4500 San Pablo Road, Jacksonville, Florida 32224-1865.(Accepted for publication May 12, 1995.)* Jones RL: Anesthesia risk in the geriatric patient. Probl Anesth 3:527-550, 1989.** Letters from Carrier Medical Directors' Meetings, dated May 29, 1992, and September 29, 1992; Health Care Financing Administration.*** Ebener MK, Howe BL, Mackey DC, Atkinson EJ: Intensity of postoperative pain management: Patient-controlled analgesia (PCA) is equivalent to epidural analgesia. American Pain Society 13th Annual Scientific Meeting, 1994.**** AHCPR Pub. No. 92-0032: Acute pain management: Operative or medical procedures and trauma, Clinical Practice Guideline. Rockville, Agency for Health Care Policy and Research, Public Health Service, U.S. Department of Health and Human Services, 1992, p 71.

Reliability and validity of a health-related quality of life battery for evaluating outpatient antidepressant treatment.

This study was designed to evaluate the reproducibility, validity and responsiveness of a health-related quality of life (HRQOL) battery that was assembled for the evaluation of antidepressant therapy. The Montgomery-Asberg Depression Rating Scale was used to measure severity of depression. The HRQOL battery contained measures of energy and fatigue, social behaviour, cognitive function, home and work role function, and general well-being (i.e., health perceptions, life satisfaction) selected from previously developed and validated instruments. The clinical investigators and research nurses reported on difficulty in using the HRQOL battery. Most patients were able to complete the questionnaire without problems within 10 min. Reproducibility was very good with intraclass correlation coefficients ranging from 0.74 to 0.97. The HRQOL scales showed evidence of good concurrent validity. The scales were moderately correlated with MADRS scores (r = 0.30-0.62). The magnitude of these correlations indicate that HRQOL scales are related to depression measures, but they are not alternative measures of depression. Changes in MADRS scores were associated with changes in all scales, except for work behaviour, indicating that improvements in depression ratings also resulted in improvements in health status and well-being. The HRQOL scales included in this study were found to be reliable, reproducible, and valid and no appreciable burden was placed on patients or investigators participating in the study. With the exception of the Work Behaviour scale, the HRQOL scales were very responsive to changes in depression severity. This brief HRQOL instrument can provide a comprehensive assessment of the outcomes of antidepressant treatment.

Foreword

Clinical Research Nurse, Nursing Quality Consultant, Department of Medical Research/Patient Care Services, Methodist Hospital of Indiana, Inc., Indianapolis, Indiana, Issue Editor

Proarrhythmia

Clinical Research Nurse VA Wadsworth Hospital Cardiology Department Master's Candidate, UCLA School of Nursing Los Angeles, California Assistant Professor Department of Physiological Nursing University of California, San Francisco Medical Center San Francisco, California

Clinical Research Nurses' Association

Clinical Research Nurses' Association

Approach of the Clinical Research Nurse to Informed Consent

AbstractThe informed consent is an important tool in conducting clinical research as it serves to protect all parties involved in the clinical trial. This fact has been recognized since the early beginnings of research projects. The role of the clinical research nurse (CRN) in procuring informed consent, however, has not been clearly defined or generally accepted at this time. This article will focus on the essential content of the informed consent and the value of the CRN in assuring the completeness and effectiveness of this important document. Included is an example of a consent form which covers the elements of appropriate informed consent as discussed in this article.

FDA Regulatory Affairs: An Overview for Nurses in Clinical Research

AbstractThe role of the nurse in clinical drug trials is evolving into a specialty with the responsibilities becoming increasingly more complex. The clinical research nurse (CRN) requires more definitive guidelines regarding the legal responsibilities of the position. The focus of this article is on the regulations of the Food and Drug Administration (FDA) and its practical implications for the nurse participating in clinical trials. The discussion will encompass compliance according to the FDA regulations governing pre-trial preparation, data acquisition and reporting, obligations after completion of the investigation and the regulatory check list that we have found useful in preparing for an FDA audit.