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PubMedDate not supplied

A framework for clinical protocols.

By April 1994, all provider units should have started to develop clinical protocols. Despite some difficulties involved in their development, protocols potentially offer a variety of benefits. The author describes a framework within which clinical protocols can be devised. By using the stages of this framework, nurses can be assisted in working with the patient, collaborating with other disciplines, clarifying channels of communication, and demonstrating the value of their own contribution to care.

Clinical Nursing Research↗
PubMed2005

Development of a clinical protocol for home hospice care for Koreans.

As the Korean government's recognition of the importance of hospice service grows, the government has initiated a variety of hospice services in Korea. Each hospice organization has shown a significant difference in its health care delivery methods, constitution and care content. Developing a clinical protocol is essential for establishing standardized hospice services. A preliminary protocol was drawn up by examining the records of terminal patients (n=541) in a home hospice organization while elucidating the health problems as well as classifying them through the Home Health Care Classification (HHCC), and by reviewing the relevant nursing interventions and medical treatments in the literature concerning the clinical protocols. Korea's leading hospice specialty groups participated in four rounds of content validity verification processes in order to establish a protocol. A guideline was developed through a team approach, integrating the opinions of doctors, nurses, ministers, volunteers, patients' families, nutritionists and pharmacists. Eighteen health problems and a total of 223 interventions (173 major treatments and nursing interventions, and 50 optional interventions) were included in the final clinical protocol. This study is expected to contribute to the overall qualitative improvement of home hospice care and the subsequent shortening of documentation time. Evaluation tools and a regulatory feedback system need to be developed in order to maintain consistent evaluation procedures based on the continuous promotion and use of the protocol.

Adult↗
PubMed2002

Temporal knowledge representation for scheduling tasks in clinical trial protocols.

Clinical trial protocols include detailed temporal constraints on treatment and associated tasks. Unlike health-care guidelines, protocols are highly prescriptive. Therefore, informatics applications that enforce such temporal constraints are more directly useful with protocols than with guidelines. Although there are some temporal knowledge representation efforts for health-care guidelines, we find these to be insufficiently expressive for clinical trial protocols. In this paper, we focus on temporal knowledge representation for clinical trial protocols and the task of patient-specific scheduling in protocols. We define a temporal ontology, use it to encode clinical trial protocols, and describe a prototype tool to carry out patient-specific scheduling for the tasks in protocols. We predict that an expressive temporal knowledge representation can support a number of scheduling and management tasks for protocol-based care.

Appointments and Schedules↗
PubMed1994

Clinical protocols are key to quality health care delivery.

The use of clinical protocols allows health care providers to offer appropriate diagnostic treatment and care services to patients, variance reports to purchasers and quality training to clinical staff. Such protocols provide a locally agreed standard to which clinicians and the organization can work and against which they can be audited. By embedding protocols into patients' records and reporting by exception, the use of protocols may help to tackle a raft of other issues successfully such as the reduction in junior doctors' hours, and the facilitation of shared care. It may also bolster the medico-legal robustness of the health care delivered. If the protocols are sufficiently detailed, costing, coding and other resource usage information can flow directly from the clinical records. Such benefits may be maximized by using protocols within the framework of an electronic patient record system.

Clinical Protocols↗
PubMed2005

Implementing clinical protocols in oncology: quality gaps and the learning curve phenomenon.

BACKGROUND: The quality improvement effort in clinical practice has focused mostly on 'performance quality', i.e. on the development of comprehensive, evidence-based guidelines. This study aimed to assess the 'conformance quality', i.e. the extent to which guidelines once developed are correctly and consistently applied. It also aimed to assess the existence of quality gaps in the treatment of certain patient segments as defined by age or gender and to investigate methods to improve overall conformance quality. METHODS: A retrospective audit of clinical practice in a well-defined oncology setting was undertaken and the results compared to those obtained from prospectively applying an internally developed clinical protocol in the same setting and using specific tools to increase conformance quality. RESULTS: All indicators showed improvement after the implementation of the protocol that in many cases reached statistical significance, while in the entire cohort advanced age was associated (although not significantly) with sub-optimal delivery of care. A 'learning curve' phenomenon in the implementation of quality initiatives was detected, with all indicators improving substantially in the second part of the prospective study. CONCLUSIONS: Clinicians should pay separate attention to the implementation of chosen protocols and employ specific tools to increase conformance quality in patient care.

Adult↗
PubMed1995

Clinical protocols: the next automation frontier. Computerized records will play a key role in the implementation of clinical guidelines.

Interest in creating clinical protocols has surged in recent years, and experts say computer-based patient records represent the most practical way to put these guidelines to use. Economic forces, particularly the growth of managed care, will push clinicians to identify the most cost-effective ways to deliver care. Electronic records will serve as a useful source of information on which to base and refine guidelines.

American Medical Association↗
PubMedDate not supplied

Rational approach to the clinical protocol design for drug combinations: a review.

Based on the median-effect equation of Chou and the combination index (CI) equation of Chou-Talalay, a computer software for automated dose-effect analysis has been developed. This method provides quantitation of synergism (CI < 1) and antagonism (CI > 1) at different dose and effect levels. Therefore, it allows the selection of the best pair (or triplet) of combination, optimal combination ratio, and the best schedule of treatment. These analyses has been shown to be useful for the clinical protocol design. (Chang et al. Cancer Res. 45: 2434-2439, 1985). The user-friendly computer program also gives dose-reduction index (DRI) which determines how many fold of dose-reduction is allowed for each drug in synergistic combinations. Dose reduction leads to reduced toxicity while maintaining the desired efficacy (Chou et al. Encyclopedia of Human Biology 2:675-683, 1997; Encyclopedia of Cancer 1:368-379, 1997). The Chou-Talalay method distincts from all other methods by the fact that it not only takes into account the "potency" but also the "shape" of dose-effect curves of each drug and their combinations (Chou & Hayball, CalcuSyn for Windows, Biosoft, Cambridge UK, 1996). This method has been applied in combination of anticancer agents, anti-HIV agents, purging leukemic cells for autologous bone marrow transplantation (Chang et al. Cancer Res. 47:119-122, 1987) and combination of immunosuppressants for organs transplants. Specific examples of the theoretical equations, the median-effect plot, the CI plot, the isobologram, and the polygonogram are illustrated.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed2002

Clinical protocol. Gene therapy of Canavan disease: AAV-2 vector for neurosurgical delivery of aspartoacylase gene (ASPA) to the human brain.

This clinical protocol describes virus-based gene transfer for Canavan disease, a childhood leukodystrophy. Canavan disease, also known as Van Bogaert-Bertrand disease, is a monogeneic, autosomal recessive disease in which the gene coding for the enzyme aspartoacylase (ASPA) is defective. The lack of functional enzyme leads to an increase in the central nervous system of the substrate molecule, N-acetyl-aspartate (NAA), which impairs normal myelination and results in spongiform degeneration of the brain. No effective treatment currently exists; however, virus-based gene transfer has the potential to arrest or reverse the course of this otherwise fatal condition. This procedure involves neurosurgical administration of approximately 900 billion genomic particles (approximately 10 billion infectious particles) of recombinant adeno-associated virus (AAV) containing the aspartoacylase gene (ASPA) directly to affected regions of the brain in each of 21 patients with Canavan disease. Pre- and post-delivery assessments include a battery of noninvasive biochemical, radiological, and neurological tests. This gene transfer study represents the first clinical use of AAV in the human brain and the first instance of viral gene transfer for a neurodegenerative disease.

Amidohydrolases↗
PubMed2000

Judging the use of clinical protocols by fellow professionals.

The objective of this study was to investigate the judgements of British doctors, nurses and midwives about behaviour which complies with a protocol, violates a protocol, or constitutes an improvisation where no protocol exists. Primary data were collected on the judgments of hospital healthcare professionals (N = 310) from three specialties in each of three hospitals. Respondents were required to judge the appropriateness of the behaviour of a fellow professional in each of nine hypothetical scenarios generated on the basis of previous focus group discussions. They were also asked how likely they would be to report this professional to a senior member of staff. Within the scenarios, both behaviour with respect to the relevant clinical protocol and outcome for the patient were experimentally manipulated. Data were collected using a survey questionnaire. The three professional groups studied (doctors, nurses and midwives) were found to make significantly different judgements. Crucially, doctors judged the violation of a protocol as less inappropriate than did nurses or midwives. Midwives were disapproving of violations, even when the patient outcome was good. These differences were reflected in the ratings of reporting likelihood. The proliferation of clinical protocols likely to occur in Britain in the coming years will need to be managed with great care if the regulation of clinical behaviour is the goal. Particular care will be needed to avoid the exacerbation of professional tensions.

Anesthesiology↗
PubMed1995

Acute liver failure: results of a 5-year clinical protocol.

This investigation summarizes and evaluates the results of a clinical protocol that we designed to care for patients with acute liver failure (ALF). Adult patients with ALF were enrolled in the protocol. Grade II portal-systemic encephalopathy prompted admission to the intensive care unit (ICU). Patients who met the clinical criterion were activated for liver transplantation. Intracranial pressure (ICP) was monitored in patients with grade III encephalopathy. An increase in ICP was treated with hyperventilation, diuretics, barbiturates, or a combination thereof. Survival was considered to have occurred if the patient left the hospital alive. Our series included 25 patients. Orthotopic liver transplantation (OLT) was performed on 19 patients, 12 of whom survived. Only 2 of 6 patients who did not undergo transplantation survived. Ten of 11 patients who underwent transplantation before reaching grade IV encephalopathy survived. Only 2 of 8 patients who underwent transplantation after reaching grade IV survived (P = .006). The causes of death included cerebral edema (3 patients), disseminated aspergillosis (3 patients), and other (5 patients). ICP was monitored in 11 patients. Increased pressure was documented by seven of the monitors placed. There was one focal hemorrhage secondary to a subdural monitor. Outcome is improved if transplantation occurs before grade IV encephalopathy. ICP monitoring can be accomplished without significant risk of hemorrhage. In our series, infection with aspergillus occurred frequently and with fatal outcome.

Adolescent↗
PubMed2001

Clinical protocols.

Explore the source record for details and available documents.

Clinical Protocols↗
PubMed1989

Application of an in vitro model and a clinical protocol in the assessment of the potency of a new bisphosphonate.

The development of new bisphosphonates for clinical use requires congruence between the results of basic and clinical investigations. We have previously shown that this can be achieved with the use of an in vitro coculture mouse metacarpal resorption system sensitive to the activation of osteoclast precursors together with a clinical protocol in which the rate of decrease in urinary hydroxyproline excess with bisphosphonate treatment is assessed in patients with Paget's disease. In these studies bisphosphonates of known potencies were used. In the present study we have evaluated these approaches prospectively in the assessment of the antiresorptive potency of the new bisphosphonate (3-dimethylamino-1-hydroxypropylidene)-1,1-bisphosphonate (dimethyl-APD). A total of 42 patients with Paget's disease of bone received dimethyl-APD in doses predicted from the in vitro system. A total of 24 patients received the bisphosphonate intravenously (2, 4, and 8 mg/day) in groups of 8 patients each and 18 orally (100, 200, and 400 mg/day) in groups of 6 patients each for 10 days. Dimethyl-APD therapy was highly effective in inhibiting bone resorption. Urinary hydroxyproline excretion reached 30.9 +/- 5.6, 17.1 +/- 3.1, and 2.1 +/- 5.3% of initial excess after 10 days treatment with intravenous dimethyl-APD, 2, 4, and 8 mg/day, and 37.4 +/- 18, 10.4 +/- 8.5, and 13 +/- 4.1% with oral therapy, 100, 200, and 400 mg/day, respectively. Comparison of the antiresorptive potency of dimethyl-APD with that of APD showed that the former is roughly five times more potent, as predicted in the in vitro study.(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Oral↗