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The standardization of radiation skin care in British Columbia: a collaborative approach.

PURPOSE/OBJECTIVES: To develop evidence-based practice guidelines for and standardize the care of radiation skin reactions. DATA SOURCES: Peer-reviewed scientific journals and texts and a survey of the guidelines in use at leading cancer treatment facilities in Canada, the United States, the United Kingdom, and Australia. DATA SYNTHESIS: A formal reference document with recommended guidelines was developed. Consensus was obtained from all relevant disciplines, and the guidelines were implemented successfully into practice. CONCLUSIONS: The document introduced a major change in practice from the maintenance of a dry radiation treatment area to the promotion of skin cleanliness and hydration, as well as the adoption of the principles of moist wound healing. Annual review indicated that dissemination of (94%) and compliance with (78%) the guidelines were good. IMPLICATIONS FOR NURSING: The process to develop, obtain consensus for, and implement evidence-based practice guidelines was an exemplary demonstration of teamwork and interdisciplinary collaboration.

British Columbia↗

ICF core sets: how to specify impairment and function in systemic lupus erythematosus.

The World Health Organization's International Classification of Function (ICF) is a tool to characterize and illuminate better the full of array of problems a patient faces when affected by disease. Specifying these problems is a particular challenge in a disease like systemic lupus erythematosus (SLE) because of the wide variety in organ systems involved, its variable activity and severity, and considerable ethnic and local differences. The authors of this manuscript believe, however, that a broader understanding will prove essential for optimal patient care, and that there is sufficient experience now in defining ICF Core Sets to successfully complete core sets for SLE. Therefore, we will embark on an international project for developing ICF Core Sets for SLE, which we here delineate. This development will include two versions: 1) The Brief ICF Core Set for SLE will be a very focused list of categories essential for SLE clinical trials; and 2) The Comprehensive ICF Core Set will be much broader and useful for guiding multidisciplinary assessment in patients with SLE. Both Core Sets will be developed in a formal decision-making and consensus process of health professionals integrating evidence gathered from preliminary studies. The final definition of the Core Sets will occur at a consensus conference which will integrate: i) a systematic review of the literature regarding the outcome measures used in clinical trials and selected observational studies; ii) focus groups or semi-structured interviews with SLE patients; iii) a Delphi exercise with world wide involvement of experts; and iv) the evidence from empirical studies. The development of these SLE ICF Core Sets is designed to be an inclusive, open, worldwide process. We therefore invite both SLE clinical experts and SLE patients to participate actively.

Consensus Statements as Topic↗

Researchers' understanding of the federal guidelines for waiver of and exception from informed consent.

The survival of patients who present to the emergency department with severe injury or illness is dismal. Resuscitation researchers are interested in advancing the science of resuscitation, and clinical studies must be conducted to determine the best treatment protocols. These studies must reflect good science and must balance individual patient autonomy and safety with scientific progress that benefits society as a whole. Researchers find the present federal guidelines on waiver of and exception from informed consent to be time consuming and expensive. They see variability in the requirements as interpreted by institutional review boards. There is confusion regarding the requirements for public notification and response to community consultation. They believe that the majority of the public, as well as health care professionals, want resuscitation research to progress, but a minority of people and governmental regulators are uncomfortable with waiver of and exception from informed consent for research studies. There is concern and some evidence that the federal guidelines have impeded the advancement of resuscitation science. Several strategies have been suggested to improve the situation. These include 1) better education of resuscitation researchers regarding the federal guidelines, 2) a toolbox for resuscitation researchers clarifying the guidelines, 3) advocacy for the advancement of resuscitation science as a public good, and 4) a national research advisory board that provides unbiased reviews of clinical studies and guidelines for local institutional review boards regarding risks, benefits, and communication strategies for waiver of and exception from consent proposals.

Community-Institutional Relations↗

Confronting the Ethical Conduct of Resuscitation Research: a consensus opinion.

An objective of the 2005 Academic Emergency Medicine Consensus Conference, "Ethical Conduct of Resuscitation Research," was to identify if consensus exists regarding application of the Food and Drug Administration (FDA) Final Rule allowing an exception from informed consent in resuscitation research. At the start of the consensus conference, 49 attendees participated in a survey containing three sections: 1) demographic questions characterizing respondents, 2) questions regarding application of the FDA Final Rule, and 3) complexities associated with seeking informed consent in an emergency setting. Consensus analysis was used to determine if a formal consensus was reached, relying on a Bayesian posterior probability of 0.99 to consider survey responses a "consensus." Respondents demonstrated consensus regarding the need to further refine and standardize application of the FDA Final Rule in resuscitation research. However, participants agreed that current regulations provide adequate and appropriate protection to safeguard patients. Complexities associated with seeking informed consent in emergency departments were prevalent among most institutions represented at the conference. There was general agreement that current efforts to safeguard human subjects are effective, but participants agreed that refinements to and standardization of the FDA Final Rule would facilitate resuscitation research and enhance patient safety.

Consensus Statements as Topic↗

Keynote address: Toward a pragmatic model for community consultation in emergency research.

Under the Final Rule enacted in 1996 by the United States Food and Drug Administration and Office of Health and Human Services, community consultation and public notification are required when emergency research is to be conducted in the absence of prior informed consent by subjects. There is a dearth of published recommendations concerning the degree to which communities must be aware of the existence and parameters of a study for which informed consent might not be obtained prior to enrollment. It is argued that effective community consultation requires empirical measurement of the dynamics of community, and that ordinary notions of community may not capture the populations at greatest risk or those who might for other reasons figure most prominently in community consultation. A pragmatic approach to community consultation would establish benchmarks for such measures, and it is argued that such an approach is possible given the correct empirical measures.

Community-Institutional Relations↗

Compliance with consensus recommendations for systemic therapy is associated with improved survival of women with node-negative breast cancer.

PURPOSE: The impact of consensus recommendations for systemic therapy on outcome of disease is unclear. We evaluated if compliance with guidelines for systemic adjuvant treatment is associated with improved survival of women with node-negative breast cancer. PATIENTS AND METHODS: The study population included women diagnosed with invasive node-negative breast cancer in Québec, Canada, in 1988 to 1989, 1991 to 1992, and 1993 to 1994. Information was collected by chart review, linkage with administrative databases, and queries to attending physicians. Guidelines from the 1992 St Gallen conference were used as standard of care. Survival was estimated by Kaplan-Meier and Cox proportional hazards analyses. RESULTS: Among 1,541 women, 358 died before December 1999. Median follow-up was 6.8 years. Seven-year event-free and overall survivals were 66% and 81%, respectively. Survival was 88%, 84%, and 74% in women at minimal, moderate, or high risk of recurrence. Virtually all women at minimal risk were treated according to the consensus (98.4% of 370). In comparison, adjusted hazard ratios of death were 1.0 (95% CI, 0.6 to 1.7) and 2.3 (95% CI, 1.3 to 4.0) among women at moderate risk treated according to the consensus or not, respectively. Among women at high risk, adjusted hazard ratios of death were 2.0 (95% CI, 1.4 to 2.8) and 2.7 (95% CI, 1.9 to 3.9), respectively. Both risk category (P <.0005) and compliance with guidelines (P <.0005) were independent significant predictors of survival. CONCLUSION: Treatment according to consensus recommendations is associated with improved survival of women with breast cancer in the community. Promoting the adoption of guidelines for treatment is an effective strategy for disease control.

Adult↗

Systematic review on the efficacy of cytoreductive surgery combined with perioperative intraperitoneal chemotherapy for peritoneal carcinomatosis from colorectal carcinoma.

PURPOSE: The efficacy of cytoreductive surgery combined with perioperative intraperitoneal chemotherapy for patients with peritoneal carcinomatosis from colorectal carcinoma remains to be established. METHODS: A systematic review of relevant studies before March 2006 was performed. Two reviewers independently appraised each study using a predetermined protocol. The quality of studies was assessed. Clinical effectiveness was synthesized through a narrative review with full tabulation of results of all included studies. RESULTS: Two randomized controlled trials, one comparative study, one multi-institutional registry study, and 10 most recent case-series studies were evaluated. The level of evidence was low in 13 of the 14 eligible studies. The median survival varied from 13 to 29 months, and 5-year survival rates ranged from 11% to 19%. Patients who received complete cytoreduction benefited most, with median survival varying from 28 to 60 months and 5-year survival ranging from 22% to 49%. The overall morbidity rate varied from 23% to 44%, and the mortality rate ranged from 0% to 12%. CONCLUSION: The current evidence suggests that cytoreductive surgery combined with perioperative intraperitoneal chemotherapy is associated with an improved survival, as compared with systemic chemotherapy for peritoneal carcinomatosis from colorectal carcinoma.

Antineoplastic Combined Chemotherapy Protocols↗

Prospective validation of consensus criteria for the diagnosis of dementia with Lewy bodies.

OBJECTIVE: To determine the validity of a clinical diagnosis of probable or possible dementia with Lewy bodies (DLB) made using International Consensus criteria. BACKGROUND: Validation studies based on retrospective chart reviews of autopsy-confirmed cases have suggested that diagnostic specificity for DLB is acceptable but case detection rates as low as 0.22 have been suggested. METHODS: We evaluated the first 50 cases reaching neuropathologic autopsy in a cohort to which Consensus clinical diagnostic criteria for DLB, National Institute for Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association criteria for AD, and National Institute of Neurological Disorders and Stroke-Association Internationale pour la Recherche et l'Enseignement en Neurosciences criteria for vascular dementia (VaD) had been prospectively applied. RESULTS: Twenty-six clinical diagnoses of DLB, 19 of AD, and 5 of VaD were made. At autopsy, 29 DLB cases, 15 AD, 5 VaD, and 1 progressive supranuclear palsy were identified. The sensitivity and specificity of a clinical diagnosis of probable DLB in this sample were 0.83 and 0.95. Of the five cases receiving a false-negative diagnosis of DLB, significant fluctuation was present in four but visual hallucinations and spontaneous motor features of parkinsonism were generally absent. Thirty-one percent of the DLB cases had additional vascular pathology and in two cases this contributed to a misdiagnosis of VaD. No correlations were found between the distribution of Lewy bodies and clinical features. CONCLUSION: The Consensus criteria for DLB performed as well in this prospective study as those for AD and VaD, with a diagnostic sensitivity substantially higher than that reported by previous retrospective studies. DLB occurs in the absence of extrapyramidal features and in the presence of comorbid cerebrovascular disease. Fluctuation is an important diagnostic indicator, reliable measures of which need to be developed further.

Aged↗

Assessment of benefit in tele-ophthalmology using a consensus panel.

A videoconferencing link was established from a hospital in South Africa to Moorfields Eye Hospital in London. A clinician in South Africa used a video slit-lamp and videoconferencing equipment to capture images and communicate with a specialist in London. Over 12 months, 113 cases were discussed in teleconsultations. Case-notes were subsequently obtained for 90 cases (80%). Three consultant ophthalmologists took part in the consensus process, one from the UK and two from South Africa. The consensus panel achieved on average 78-96% agreement on the items rated. In approximately half the cases, the panel judged that teleconsultation had had an effect on diagnosis. In nine cases (10%) there was potential for definite improvement in visual health as a result of tele-ophthalmology and in a further 48 cases (53%) there was potential for possible improvement in visual health. The consensus process identified 35 cases (39%) where there was potential improvement in general health as a result of tele-ophthalmology. Despite the methodological limitations of our approach, it was possible to learn a great deal about the effectiveness of the telemedicine intervention.

Adolescent↗