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PubMedDate not supplied

Development of an oncology services performance improvement team.

Baystate Medical Center is a 750-bed tertiary-care referral center in western Massachusetts. In 1995 Baystate reorganized the structure of its quality assurance (QA) program from an individual departmentally based QA committee structure to a series of multidisciplinary service-line performance improvement teams. The new approach sought to implement total quality management techniques that had been proven effective in major industrial settings but were not widely applied in the healthcare sector. The oncology services performance improvement team is cochaired by an attending surgical oncologist and the nursing supervisor of a dedicated inpatient oncology unit. Its membership comprises a broad spectrum of oncology subspecialists and allied support staff. The team supports multiple performance improvement initiatives, including analyses of various cancer-related outcomes (e.g., patient satisfaction, morbidity and mortality data) and peer review analysis. Systems issues not falling under the aegis of the oncology services team are referred to other service-line teams. The performance improvement activities are carefully designed to meet the needs of the facility's patient population and the accreditation requirements of the Joint Commission on Accreditation of Healthcare Organizations and the American College of Surgeons Commission on Cancer.

Accreditation↗
PubMed2000

ESHRE guidelines for good practice in IVF laboratories. Committee of the Special Interest Group on Embryology of the European Society of Human Reproduction and Embryology.

Education has always been a priority for the European Society of Human Reproduction and Embryology (ESHRE). Many efforts have been dedicated to promoting knowledge of techniques, procedures and strategies in order to ensure use of the highest quality practices in reproductive medicine. The need to develop a set of guidelines was a logical consequence that found its first expression in 1990, when Focus on Reproduction (vol. 1, pp. 10-38) published the first guidelines which were distributed among the membership. Five years later a new, more complete edition with several novel techniques and developments appeared in Human Reproduction (vol. 10, pp. 1246-1271). Both have proved to be invaluable references. Five more years have now passed. The necessity to produce current guidelines for good IVF laboratory practice has provided the strongest motivation. This originated from the increasing awareness that embryologists have a duty to prevent unintentional incidents that might result from poor practice in the laboratory. Therefore, the Embryology Special Interest Group (SIG) undertook to draw up guidelines aimed at giving support and guidance to the laboratory staff. All the aspects required to provide a safe working system were taken into consideration by members of the SIG and their effort produced this document. We hope that it will assist staff in achieving the best clinical outcome for their patients.

Cryopreservation↗
PubMed1993

Operational and policy considerations of data monitoring in clinical trials: the Diabetes Control and Complications Trial experience.

Many clinical trials incorporate a system for monitoring emerging data that utilizes a committee composed of individuals who are independent of the investigators conducting the study. Although this is a common practice, there is a paucity of publications examining the operating methods of these groups. This paper describes the composition, functions, and procedures of the Data, Safety and Quality Review Group (DSQ) of the Diabetes Control and Complications Trial (DCCT). The DSQ is not masked to emerging data and the voting membership is made up of individuals with a wide diversity of expertise that reflects the needs of the trial. There are also nonvoting exofficio members who represent other components of the study organization. In addition to data monitoring, the DSQ provides external review of coordinating center operations. A distinctive aspect of the DCCT's DSQ is the creation of a free-standing operations manual for the DSQ's use during the trial and the involvement of the study investigators in developing certain sections of this document. Utilizing a process that allowed participation of the investigators was considered critical to achieving a mutual understanding regarding the planned uses and interpretations of the study data prior to the study's completion so as to minimize the chances of major disagreements regarding the conclusions drawn. Equally important, the existence of such a manual provides documentable reassurance to all interested parties that both scientific integrity and patient safety are being closely watched and gives the study investigators confidence that the results of the study will be scientifically credible and clinically important.

Clinical Trials as Topic↗
PubMed1993

Nurses on hospital IRBs: a critical voice in protecting human subjects.

The nature and extent of nurses' participation on hospital institutional review boards (IRBs) has not previously been investigated. This descriptive study provides some insights into the characteristics of nurses serving on IRBs and describes the IRBs on which they serve. The nurses are typically master's-prepared nurse managers who have served as volunteer or appointed members of the IRB for an average of 2.67 years. The IRBs have an interdisciplinary membership, and differ widely in structure and procedure, but generally, they conform to the requirements specified in the National Research Act for IRBs. The findings of this study have implications for nursing administration, practice, research, and education.

Adult↗
PubMedDate not supplied

Ensuring universal access to quality laboratory services: CLMA White Paper. National Affairs Committee, Clinical Laboratory Management Association.

As part of its National Affairs Plan, approved in 1991, CLMA committed to publishing periodic position, or "white," papers to explore contemporary public policy issues in laboratory services administration. As CLMA's first white paper, this article is an in-depth analysis of the historical and economic background to today's clinical laboratory industry in the United States. It provides the logic and rationale behind CLMA's position statement on Health-Care Reform and the Clinical Laboratory. The statement has been formally adopted by consensus and has been widely circulated to both Congress and our membership. It will help form the policy basis for the development of the Association's legislative agenda on health-care reform. The principles are intended to be universal and apply not only to U.S. reform efforts at the national level, but also to states and other nations.

Chronology as Topic↗
PubMed2002

Independent practice associations in New Zealand: a study of governance structures and process.

AIMS: To describe the governance structures and processes of four primary care organisations (PCOs) and to evaluate member general practitioners' (GPs) perceptions of the effectiveness of these structures and processes. METHODS: A sample of four PCOs was chosen in 1999, including three independent practitioner associations (IPAs), and a member organisation of CareNet. The chief executive officer of each PCO was interviewed, and the 245 member practitioners were surveyed with a written questionnaire. RESULTS: The response rate to the GP survey was 78.4%. A two tier governance structure was identifiable for all four PCOs: policy board or steering committee, and working committees. In addition each utilised a peer group review process to provide input to some administrative functions. The CareNet PCO emphasised reduced bureaucracy and a loose administrative structure and process. There was a high level of respondent satisfaction (>90%) with their PCO governance processes. CONCLUSIONS: Governance structures and processes have developed within the four PCOs that reflect the needs of member practitioners and according to the requirements of each district and PCO membership. A high level of member satisfaction with their PCO, its governance and processes, was evident.

Attitude of Health Personnel↗
PubMed1990

Conducting a third-party reimbursement survey: experience of the Connecticut Nutrition Services Payment Systems Committee.

Third-party reimbursement (TPR) has emerged as a crucial issue for dietetics in the past decade. To investigate the level of TPR being obtained by individuals receiving nutrition services from registered dietitians in ambulatory settings, the Connecticut Nutrition Services Payment Systems (NSPS) Committee conducted an audit. Sixty survey packets were distributed to consulting dietitians in private practice and to dietitians in outpatient nutrition clinics. Twenty dietitians participated in the audit process, providing 99 client responses to the survey. Sixty-seven percent of clients submitted the charges for nutrition services to their insurance companies, but only 17% received reimbursement for the claims submitted. This audit process raised the level of awareness of the state membership regarding the need to aggressively pursue TPR for nutrition services at all levels, and it provided a model for dietitians to use to conduct periodic audits and assess TPR being received by their clients.

Connecticut↗
PubMedDate not supplied

Moral and ethical dilemmas in critically ill newborns: a 20-year follow-up survey of Massachusetts pediatricians.

OBJECTIVE: To replicate the 1987 survey, referring to the original 1977 study, regarding opinions about treatment for critically ill neonates. STUDY DESIGN: A long-term follow-up survey of American Academy of Pediatrics Massachusetts membership, maintaining the 1987 instrument, was initiated. RESULTS: A notable demographic shift in respondents from a majority of male practitioners in 1977 (89.6%), to 73% in 1987, to more equal numbers of men and women in 1997 (55% and 45%, respectively; p < 0.001; 1987 vs 1997) was apparent. Pediatricians' attitude changes over the 20-year period were relatively modest and were statistically associated with active medical intervention. In 1997, 75% of respondents rejected review committees as mediators, a marked change from 1987. Regardless of healthcare maintenance organization affiliations, 95% indicated that restrictive fiscal policies would not affect decision-making. CONCLUSION: This study indicates stability and consensus in pediatricians' attitudes toward active intervention for critically ill neonates compared with 1977 and 1987 surveys and reveals several claims to professional autonomy.

Adult↗
PubMed2003

Congress, health care, and congressional caucuses: an examination of the Diabetes Caucus.

Caucuses have become a critical feature of the congressional landscape, yet are neglected in the literature on health-policy making in Congress. The principal goal of the article is to use the Diabetes Caucus as a case study to highlight this significant yet underappreciated political actor in the health-policy realm in Congress. The exploration, which draws on information gathered from thirty-two interviews with members of the Diabetes Caucus and their staff, will contribute to an increased understanding of both Congress's operations in the health area and the potential impact of caucuses on health-policy making. The article emphasizes particular characteristics relating to the membership and objectives of the Diabetes Caucus. In addition, the study stresses that the group had the requisite political momentum to achieve legislative successes when a policy window opened in the 105th Congress because it served much like, in the terminology of John Kingdon, a "policy entrepreneur".

Advisory Committees↗
PubMed2004

Small group processes relevant to data monitoring committees in controlled clinical trials: an overview of reviews.

BACKGROUND: The quality of the decisions reached by data monitoring committees (DMCs) is crucial. The aim of this paper is to identify factors that may make errors more or less likely in small, task-oriented, decision-making expert groups and to consider the implications of these factors for data monitoring committees. METHODS: A systematic overview was carried out of reviews of empirical studies of small group processes and decision errors in small, task-oriented decision-making groups in laboratory or real-world settings, published between 1950 and 2002 (n = 57 included reviews). RESULTS: These reviews suggest that a number of factors may increase the likelihood that small groups will make poor and potentially erroneous decisions. The most important of these, in terms of empirical support, are: biased or overly directive leadership, expression of a limited range of opinions during group discussion, poor procedures for identifying or appraising the available information, and presentation of the available information in a way that is likely to result in biased perception of it. CONCLUSIONS: The main implications for DMCs relate to membership, the role of the chairperson, the information provided for DMCs and training for DMC members. Selection methods that encourage a degree of diversity within the DMC are recommended. Chairs of DMCs should be experienced members, who have the skills to facilitate a discussion, can manage conflict effectively and can be impartial. Adherence to a prespecified analysis plan is recommended to reduce the risk of error associated with strong evidence or excess information. Training in the use of methodical decision-making procedures, education about the factors that influence decision quality and an opportunity to participate in mock DMC discussions may be of benefit for new members.

Clinical Trials Data Monitoring Committees↗
PubMed2004

Systematic qualitative review of the literature on data monitoring committees for randomized controlled trials.

AIMS: To systematically review the published literature on data monitoring committees (DMCs) for randomized controlled trials (RCT) and summarize information and opinions on best practice. This was part of the DAMOCLES project. METHODS: A systematic and comprehensive search of five online bibliographic databases was performed, identifying 4007 potentially relevant articles. These were assessed in two stages by the authors. The 84 most relevant articles were agreed and were supplemented with extracts from 16 books: ultimately, 100 sources were reviewed. A series of 23 questions plus subquestions were developed to structure the data extraction and interpretation process. RESULTS: Much has been written about DMCs but by a rather small community of authors. The papers included some results of surveys, but were mainly opinion pieces based on the authors' beliefs, practices and experiences. There is a lack of empirical evidence for many aspects of DMCs. There was a great range of detail in the literature relating to the prespecified questions. It was generally agreed that interim monitoring of accumulating data was necessary in some form for most trials. Questions such as membership of the DMC featured widely in the literature with opinions and practice ranging from 3-20 members, of whom between none and all should be independent. There was a consensus that formal statistical methods should be used as tools to guide decision making rather than as hard rules. Conversely, topics such as the training and experience required for DMC membership were discussed in very few papers. CONCLUSIONS: There is a consensus in the published literature in a number of areas, although there are many different models for structure and functions of a DMC. While uncertainty remains about some issues, it is strongly recommended that an explicit set of guidelines (Charter) is prepared for each DMC prior to the start of the trial specifying clearly how it will operate.

Clinical Trials Data Monitoring Committees↗
PubMed2001

Standards of professional practice: measuring the beliefs and realities of Consultant Dietitians in Health Care Facilities.

A dietetic practice group of the American Dietetic Association (ADA), Consultant Dietitians in Health Care Facilities (CD-HCF), surveyed members (n = 5930) on agreement with the six standards of professional practice and frequency of completing indicators within each standard. Sampling approaches included placing a survey in the publication, The Consultant Dietitian, and disseminating at the following CD-HCF activities: the 1998 business meeting at ADA's Annual Meeting & Exhibition, a multi-state teleconference in December 1998, and conferences held between November 1998 to April 1999. Duplication was monitored using the RD or RD-eligible registration number. The final sample included 553 surveys and represented 10% of the membership. Of the survey responders, 50% were individual consultants and 43% were employees; 88% consulted to facilities providing skilled care (geriatrics/adults) and 48% consulted to intermediate care facilities. With the exception of one, all standards and indicators met acceptance criterion. The standard statement "participation in research to enhance practice" did not attain the validation criterion. Study findings indicated that consulting to a facility conducting nutrition research increased chances of agreement with the research participation standard. The Executive Committee approved all standards, indicators and outcomes as a document defining quality consultation and business services conduct for consultant dietitians in health care facilities.

Attitude of Health Personnel↗
PubMed1997

Marketing authorization of veterinary medicinal products in Poland.

Opening of the European Agency for the Evaluation of Medicinal Products (EMEA) in London (February 1, 1995) has begun harmonization of international requirements in veterinary drug legislation in the European Union (EU). The main objective of this paper is to introduce the principal rules of veterinary drug registration in Poland, a candidate to membership in the EU. In Poland the basic guideline governing quality, production, marketing, and inspection of medicinal products is "The Pharmaceutical Products, Medical Materials, Pharmacies, Wholesaler Outlets, and Pharmacy Inspection Act, dated October 10, 1991." The detailed rules are given in directives of the Minister of Health or the Minister of Agriculture in case of veterinary medicinal products. Since 1993 licensing of drugs in Poland has become a universal procedure for both human and veterinary products. The common Committee of Drug and Medical Materials Registration, which is under control of the Minister of Health and Social Welfare, ensures that the quality, safety (e.g., maximum residue limits and current FAO/WHO and EEC regulations for products used in food-producing animals are accepted), and efficacy are the criteria for the registration process. During 1994-1996 almost 300 veterinary products (more than 200 from the EU) received marketing authorizations in Poland. All these products were evaluated and registered on a similar basis to those in the European Union.

Animals↗
PubMed1996

The identity of psychoanalysis: the question of lay analysis.

This article, besides being a general historical account of the nature and meaning of the almost century-long controversy over "the question of lay analysis," also had a specific context and purpose. The author was invited to give the plenary keynote address to the winter meeting of the American Academy of Psychoanalysis in Santa Barbara, California, on December 9, 1994. After the passage of the Gaskill Committee proposals by the American Psychoanalytic Association in 1986, the alteration of the Regional Association agreement between the American and the International Psychoanalytical Association in 1987, and the settlement of the class-action lawsuit by clinical psychologists against the American and the International in 1988, this controversy over lay analysis had finally been resolved within the International and all its component organizations, including the American. The American Academy of Psychoanalysis, however, is one organization (with some overlap of membership with the American Psychoanalytic Association) that continues to maintain a bar against any members except medically qualified psychoanalysts. The author agreed to give the plenary address with the stipulation, which was accepted, that he could use the occasion to review this long history of the struggle over lay analysis, and to ask the Academy to reconsider its long-standing policies that now make it a lonely holdout against the evolution and resolution that has taken place in the overwhelming balance of organized institutional psychoanalysis worldwide.

Academies and Institutes↗
PubMedDate not supplied

Estimation of food additive intake. Nordic approach.

Food additive intake has been estimated in Finland by means of a stepwise system using simultaneously two different methods. The first method, based on food consumption and food control analysis, can be classified into the group of Estimated Daily Intake methods (EDI). The second method, a questionnaire to food manufacturers concerning the use of food additives, has been employed five times. Estimates have been timed to reflect legislative changes and their influence on the intake. The intake of most food additives and sweeteners by Finnish diabetic adolescents was well below Acceptable Daily Intakes (ADIs). The average nitrite intake, especially by children and adolescents, was greater. Estimates of nitrite intake by children varied between 39% and 89% of ADIs depending on the method used and the new ADIs given by the Joint FAO/WHO Expert Committee on Food Additives (JECFA). Diabetic children's and the mothers' daily intake of nitrite was shown to be greater when compared with that of non-diabetics and the results of that other Finnish study gives support the evidence that dietary nitrites may be associated with the development of Type I diabetes. New estimates of additive intakes, based on a nationwide control project carried out in 1994, will be worked out. The results will reflect the situation in Finland before EU membership.

Finland↗
PubMed2005

ACCF/ASNC appropriateness criteria for single-photon emission computed tomography myocardial perfusion imaging (SPECT MPI): a report of the American College of Cardiology Foundation Quality Strategic Directions Committee Appropriateness Criteria Working Group and the American Society of Nuclear Cardiology endorsed by the American Heart Association.

Under the auspices of the American College of Cardiology Foundation (ACCF) and the American Society of Nuclear Cardiology (ASNC), an appropriateness review was conducted for radionuclide cardiovascular imaging (RNI), specifically gated single-photon emission computed tomography myocardial perfusion imaging (SPECT MPI). The review assessed the risks and benefits of the imaging test for several indications or clinical scenarios and scored them based on a scale of 1 to 9, where the upper range (7 to 9) implies that the test is generally acceptable and is a reasonable approach, and the lower range (1 to 3) implies that the test is generally not acceptable and is not a reasonable approach. The mid range (4 to 6) implies that the test may be generally acceptable and may be a reasonable approach for the indication. The indications for this review were primarily drawn from existing clinical practice guidelines and modified based on discussion by the ACCF Appropriateness Criteria Working Group and the Technical Panel members who rated the indications. The method for this review was based on the RAND/UCLA approach for evaluating appropriateness, which blends scientific evidence and practice experience. A modified Delphi technique was used to obtain first- and second-round ratings of 52 clinical indications. The ratings were done by a Technical Panel with diverse membership, including nuclear cardiologists, referring physicians (including an echocardiographer), health services researchers, and a payer (chief medical officer). These results are expected to have a significant impact on physician decision making and performance, reimbursement policy, and future research directions. Periodic assessment and updating of criteria will be undertaken as needed.

Coronary Circulation↗
PubMed1993

Michigan drug utilization review and OBRA 90.

The DUR Board's role in the Medicaid DUR process is significant. With the requirements for membership on the DUR Board and the responsibilities directed by OBRA 90, the standards will ensure that they reflect the accepted medical practice and are clinically relevant to the geographical area represented. The DUR Board has the potential to improve drug utilization review and ultimately improve the quality of care. The approval of criteria for both patient retrospective and prospective DUR and the addition of education intervention will help us to improve the quality of care. DSS encourages your input and participation on the DUR regional committees. There are currently three committees that meet monthly and are located in: Detroit, Ann Arbor, Lansing.

Drug Utilization Review↗
PubMed1987

Nurses come together to face ethical issues.

In today's society, the role of the nurse is complex, challenging, and, at times, conflicting. The realities of limited resources, regulations, technology, and professional and personal integrity often given rise to ethical dilemmas and difficult decisions. To deal with these, forums designed specifically for nurses are needed. At Calvary Hospital, Bronx, NY, a Nursing Ethics Group was established to explore ethical choices nurses make daily and to deal with controversies that arise in the care of advanced cancer patients. The Nursing Ethics Group's goal was to promote responsible and ethical nursing practice by increasing awareness of the ethical dimensions of nursing, facilitating communication among nurses, and familiarizing nurses with ethical principles and components of the decision-making process. The group evolved in three phases: exploration of feelings and issues, consideration of an ethical decision-making model, and values clarification. Although membership is open to all, a core group has been established to plan agendas and provide continuity. Plans call for integrating sessions on values clarification and the ethical decision-making process into the orientation program and continuing education programs for all staff.

Bioethical Issues↗