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ICF Core Sets for osteoarthritis.

OBJECTIVE: To report on the results of the consensus process integrating evidence from preliminary studies to develop the first version of a Comprehensive ICF Core Set and a Brief ICF Core Set for osteoarthritis. METHODS: A formal decision-making and consensus process integrating evidence gathered from preliminary studies was followed. Preliminary studies included a Delphi exercise, a systematic review, and an empirical data collection. After training in the ICF and based on these preliminary studies relevant ICF categories were identified in a formal consensus process by international experts from different backgrounds. RESULTS: The preliminary studies identified a set of 388 ICF categories at the second, third, and fourth ICF levels with 144 categories on body functions, 49 on body structures; 165 on activities and participation, and 43 on environmental factors. Seventeen experts from 7 different countries attended the consensus conference on osteoarthritis. Altogether 55 second-level categories were included in the Comprehensive ICF Core Set with 13 categories from the component body functions, 6 from body structures, 19 from activities and participation, and 17 from environmental factors. The Brief ICF Core Set included a total of 13 second-level categories (3 on body functions, 3 on body structures, 3 on activities and participation, and 4 on environmental factors). CONCLUSION: A formal consensus process integrating evidence and expert opinion based on the ICF framework and classification led to the definition of ICF Core Sets for osteoarthritis. Both the Comprehensive ICF Core Set and the Brief ICF Core Set were defined.

Activities of Daily Living↗

ICF Core Sets for osteoporosis.

OBJECTIVE: To report on the results of the consensus process integrating evidence from preliminary studies to develop the first version of a Comprehensive International Classification of Functioning, Disability and Health (ICF) Core Set and a Brief ICF Core Set for osteoporosis. METHODS: A formal decision-making and consensus process integrating evidence gathered from preliminary studies was followed. Preliminary studies included a Delphi exercise, a systematic review, and an empirical data collection. After training in the ICF and based on these preliminary studies, relevant ICF categories were identified in a formal consensus process by international experts from different backgrounds. RESULTS: The preliminary studies identified a set of 239 ICF categories at the second, third and fourth ICF levels with 72 categories on body functions, 41 on body structures, 81 on activities and participation, and 45 on environmental factors. Fifteen experts from 7 different countries attended the consensus conference on osteoporosis. Altogether 67 second-level and 2 third-level categories were included in the Comprehensive ICF Core Set with 15 categories from the component body functions, 7 from body structures, 21 from activities and participation, and 26 from environmental factors. The Brief ICF Core Set included a total of 22 second-level categories with 5 on body functions, 4 on body structures, 6 on activities and participation, and 7 on environmental factors. CONCLUSION: A formal consensus process integrating evidence and expert opinion based on the ICF framework and classification led to the definition of ICF Core Sets for osteoporosis. Both the Comprehensive ICF Core Set and the Brief ICF Core Set were defined.

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ICF Core Sets for low back pain.

OBJECTIVE: To report on the results of the consensus process integrating evidence from preliminary studies to develop the first version of a Comprehensive ICF Core Set and a Brief ICF Core Set for low back pain. METHODS: A formal decision-making and consensus process integrating evidence gathered from preliminary studies was followed. Preliminary studies included a Delphi exercise, a systematic review and an empirical data collection. After training in the ICF and based on these preliminary studies, relevant ICF categories were identified in a formal consensus process by international experts from different backgrounds. RESULTS: The preliminary studies identified a set of 503 ICF categories at the second, third and fourth ICF levels with 211 categories on body functions, 47 on body structures, 190 on activities and participation and 55 on environmental factors. Eighteen experts from 15 different countries attended the consensus conference on low back pain. Altogether 78 second-level categories were included in the Comprehensive ICF Core Set with 19 categories from the component body functions, 5 from body structures, 29 from activities and participation and 25 from environmental factors. The Brief ICF Core Set included a total of 35 second-level categories with 10 on body functions, 3 on body structures, 12 on activities and participation and 10 on environmental factors. CONCLUSION: A formal consensus process integrating evidence and expert opinion based on the ICF framework and classification led to the definition of ICF Core Sets for low back pain. Both the Comprehensive ICF Core Set and the Brief ICF Core Set were defined.

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ICF Core Sets for chronic widespread pain.

OBJECTIVE: To report on the results of the consensus process integrating evidence from preliminary studies to develop the first version of a Comprehensive ICF Core Set and a Brief ICF Core Set for chronic widespread pain. METHODS: A formal decision-making and consensus process integrating evidence gathered from preliminary studies was followed. Preliminary studies included a Delphi exercise, a systematic review and an empirical data collection. After training in the ICF and based on these preliminary studies relevant ICF categories were identified in a formal consensus process by international experts from different backgrounds. RESULTS: The preliminary studies identified a set of 365 ICF categories at the second, third and fourth ICF levels with 143 categories on body functions, 45 on body structures, 125 on activities and participation and 125 on environmental factors. Thirty experts attended the consensus conference on chronic widespread pain (16 physicians with at least a specialization in physical and rehabilitation medicine, 4 rheumatologists, 2 psychiatrists, 5 physical therapists, one psychologist, one occupational therapist and 1 social worker). Altogether 65 second-level and 2 third-level categories were included in the Comprehensive ICF Core Set with 23 categories from the component body functions, one from body structures, 27 from activities and participation and 16 from environmental factors. The Brief ICF Core Set included a total of 24 second-level categories and 2 third-level categories with 10 on body functions, 10 on activities and participation and 6 on environmental factors. No body structures were included in the Brief ICF Core Set. CONCLUSION: A formal consensus process integrating evidence and expert opinion based on the ICF framework and classification led to the definition of ICF Core Sets for chronic widespread pain. Both the Comprehensive ICF Core Set and the Brief ICF Core Set were defined.

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ICF Core Sets for depression.

OBJECTIVE: To report on the results of the consensus process integrating evidence from preliminary studies to develop the first version of a Comprehensive ICF Core Set and a Brief ICF Core Set for depression. METHODS: A formal decision-making and consensus process integrating evidence gathered from preliminary studies was followed. Preliminary studies included a Delphi exercise, a systematic review and an empirical data collection. After receiving training in the ICF and based on these preliminary studies, relevant ICF categories were identified in a formal consensus process by international experts from different backgrounds. RESULTS: The preliminary studies identified a set of 323 ICF categories at the second, third and fourth ICF levels with 163 categories on body functions, 22 on body structures, 91 on activities and participation and 47 on environmental factors. Twenty experts attended the consensus conference on depression. Altogether 121 categories (89 second-level and 32 third-level categories) were included in the Comprehensive ICF Core Set with 45 categories from the component body functions, 48 from activities and participation and 28 from environmental factors. The Brief ICF Core Set included a total of 31 categories with 9 on body functions, 12 on activities and participation and 10 on environmental factors. CONCLUSION: A formal consensus process integrating evidence and expert opinion based on the ICF framework and classification led to the definition of ICF Core Sets for depression. Both the Comprehensive ICF Core Set and the Brief ICF Core Set were defined.

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ICF Core Sets for obesity.

OBJECTIVE: To report on the results of the consensus process integrating evidence from preliminary studies to develop the first version of the Comprehensive ICF Core Set and the Brief ICF Core Set for obesity. METHODS: A formal decision-making and consensus process integrating evidence gathered from preliminary studies was followed. Preliminary studies included a Delphi exercise, a systematic review and an empirical data collection. After training in the ICF and based on these preliminary studies relevant ICF categories were identified in a formal consensus process by international experts from different backgrounds. RESULTS: The preliminary studies identified a set of 219 ICF categories at the second, third and fourth ICF levels with 87 categories on body functions, 34 on body structures, 53 on activities and participation and 45 on environmental factors. Twenty-one experts attended the consensus conference on obesity (18 physicians with various sub-specializations and 3 physical therapists). Altogether 109 categories (108 second-level and one third-level categories) were included in the Comprehensive ICF Core Set with 30 categories from the component body functions, 18 from body structures, 28 from activities and participation and 33 from environmental factors. The Brief ICF Core Set included a total of 9 second-level categories with 3 on body functions, 4 on activities and participation and 2 on environmental factors. No body-structures categories were included in the Brief ICF Core Set. CONCLUSION: A formal consensus process integrating evidence and expert opinion based on the ICF framework and classification led to the definition of ICF Core Sets for obesity. Both the Comprehensive ICF Core Set and the Brief ICF Core Set were defined.

Activities of Daily Living↗

ICF Core Sets for stroke.

OBJECTIVE: To report on the results of the consensus process integrating evidence from preliminary studies to develop the first version of the Comprehensive ICF Core Set and the Brief ICF Core Set for stroke. METHODS: A formal decision-making and consensus process integrating evidence gathered from preliminary studies was followed. Preliminary studies included a Delphi exercise, a systematic review, and an empirical data collection. After training in the ICF and based on these preliminary studies relevant ICF categories were identified in a formal consensus process by international experts from different backgrounds. RESULTS: The preliminary studies identified a set of 448 ICF categories at the second, third and fourth ICF levels with 193 categories on body functions, 26 on body structures, 165 on activities and participation, and 64 on environmental factors. Thirty-nine experts from 12 different countries attended the consensus conference on stroke. Altogether 130 second-level categories were included in the Comprehensive ICF Core Set with 41 categories from the component body functions, 5 from body structures, 51 from activities and participation, and 33 from environmental factors. The Brief ICF Core Set included a total of 18 second-level categories (6 on body functions, 2 on body structures, 7 on activities and participation, and 3 on environmental factors). CONCLUSION: A formal consensus process integrating evidence and expert opinion based on the ICF framework and classification led to the definition of ICF Core Sets for stroke. Both the Comprehensive ICF Core Set and the Brief ICF Core Set were defined.

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ICF Core Sets for chronic ischaemic heart disease.

OBJECTIVE: To report on the results of the consensus process integrating evidence from preliminary studies to develop the first version of a Comprehensive ICF Core Set, and a Brief ICF Core Set for chronic ischaemic heart disease. METHODS: A formal decision-making and consensus process integrating evidence gathered from preliminary studies was followed. Preliminary studies included a Delphi exercise, a systematic review and an empirical data collection. After training in the ICF and based on these preliminary studies relevant ICF categories were identified in a formal consensus process by international experts from different backgrounds. RESULTS: The preliminary studies identified a set of 253 ICF categories at the second, third and fourth ICF levels with 89 categories on body functions, 25 on body structures, 82 on activities and participation and 57 on environmental factors. Sixteen experts attended the consensus conference on CIHD (11 physicians with various sub-specializations and 3 physical therapists). Altogether 61 second-level categories were included in the Comprehensive ICF Core Set with 14 categories from the component body functions, one from body structures, 17 from activities and participation and 29 from environmental factors. The Brief ICF Core Set included a total of 36 second-level categories with 10 on body functions, one on body structures, 13 on activities and participation and 12 on environmental factors. CONCLUSION: A formal consensus process integrating evidence and expert opinion based on the ICF framework and classification led to the definition of ICF Core Sets for CIHD. Both the Comprehensive ICF Core Set and the Brief ICF Core Set were defined.

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ICF Core Sets for obstructive pulmonary diseases.

OBJECTIVE: To report on the results of the consensus process integrating evidence from preliminary studies to develop the first version of the Comprehensive ICF Core Set and a Brief ICF Core Set for obstructive pulmonary diseases. METHODS: A formal decision-making and consensus process integrating evidence gathered from preliminary studies was followed. Preliminary studies included a Delphi exercise, a systematic review and an empirical data collection. After training in the ICF and based on these preliminary studies relevant ICF categories were identified in a formal consensus process by international experts from different backgrounds. RESULTS: The preliminary studies identified a set of 287 ICF categories at the second, third and fourth ICF levels with 97 categories on body functions, 33 on body structures, 104 on activities and participation, and 53 on environmental factors. Seventeen experts from 8 different countries attended the consensus conference on obstructive pulmonary diseases. Altogether 67 second-level and 4 third-level categories were included in the Comprehensive ICF Core Set with 19 categories from the component "body functions", 5 from "body structures", 24 from "activities and participation" and 23 from "environmental factors". The Brief ICF Core Set included a total of 17 second-level categories with 5 on "body functions", 3 on "body structures", 5 on "activities and participation" and 4 on "environmental factors". CONCLUSION: A formal consensus process integrating evidence and expert opinion based on the ICF framework and classification led to the definition of ICF Core Sets for obstructive pulmonary diseases. Both the Comprehensive ICF Core Set and the Brief ICF Core Set were defined.

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ICF Core Sets for diabetes mellitus.

OBJECTIVE: To report on the results of the consensus process integrating evidence from preliminary studies to develop the first version of a Comprehensive ICF Core Set and a Brief ICF Core Set for diabetes mellitus. METHODS: A formal decision-making and consensus process integrating evidence gathered from preliminary studies was followed. Preliminary studies included a Delphi exercise, a systematic review, and an empirical data collection. After training in the ICF and based on these preliminary studies relevant ICF categories were identified in a formal consensus process by international experts from different backgrounds. RESULTS: The preliminary studies identified a set of 253 ICF categories at the second, third, and fourth ICF levels with 99 categories on body functions, 40 on body structures, 55 on activities and participation, and 59 on environmental factors. Fifteen experts attended the consensus conference on diabetes mellitus (8 physicians with various sub-specializations; 5 physical therapists, one epidemiologist and one social worker). Altogether 99 categories (85 second-level and 14 third-level categories) were included in the Comprehensive ICF Core Set with 36 categories from the component body functions, 16 from body structures, 18 from activities and participation, and 29 from environmental factors. The Brief ICF Core Set included a total of 33 second-level categories with 12 on body functions, 6 on body structures, 5 on activities and participation, and 10 on environmental factors. CONCLUSION: A formal consensus process integrating evidence and expert opinion based on the ICF framework and classification led to the definition of ICF Core Sets for diabetes mellitus. Both the Comprehensive ICF Core Set and the Brief ICF Core Set were defined.

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ICF Core Sets for breast cancer.

OBJECTIVE: To report on the results of the consensus process to develop the first version of both a Comprehensive ICF Core Set and a Brief ICF Core Set for breast cancer. METHODS: A formal decision-making and consensus process integrating evidence gathered from preliminary studies was realized. Preliminary studies included a Delphi exercise, a systematic review, and an empirical data collection. After training in the ICF and based on these preliminary studies, relevant ICF categories were identified in a formal consensus process by international experts from different backgrounds. RESULTS: The preliminary studies identified a set of 317 ICF categories at the second, third, and fourth ICF levels with 150 categories on body functions, 44 on body structures, 77 on activities and participation, and 46 on environmental factors. Nineteen experts attended the consensus conference on breast cancer (7 physicians with at least a specialization in physical and rehabilitation medicine, 2 with a specialization in internal medicine and one radiologist, 4 physical therapists, 2 occupational therapists, one psychologist, one epidemiologist and one nurse). Altogether 80 categories (73 second-level and 7 third-level categories) were included in the Comprehensive ICF Core Set with 26 categories from the component body functions, 9 from body structures, 22 from activities and participation, and 23 from environmental factors. The Brief ICF Core Set included a total of 40 second-level categories with 11 on body functions, 5 on body structures, 11 on activities and participation, and 13 on environmental factors. CONCLUSION: A formal consensus process integrating evidence and expert opinion based on the ICF framework and classification led to the definition of ICF Core Sets for breast cancer. Both the Comprehensive ICF Core Set and the Brief ICF Core Set were selected.

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Perspectives on switching oral acyclovir from prescription to over-the-counter status: report of a consensus panel.

The proposed switching of oral acyclovir from prescription to over-the-counter (OTC) status for the 5-day episodic treatment of genital herpes was considered by a consensus panel. It was concluded that self-diagnosis/misdiagnosis, misuse, and adverse drug effects were potential problems with the OTC use of acyclovir. While acyclovir reduces asymptomatic shedding of herpes simplex virus type 2, the reduction in transmission of virus potentially resulting from increased acyclovir use was felt to be of unknown extent but likely to be of benefit overall. The availability of acyclovir would likely be improved. There were differences in opinion as to whether widespread availability of acyclovir (prescription or OTC) may speed the development of viral resistance. However, all panel members felt that granting OTC status may set an undesirable precedent for the switch from prescription to OTC use of other systemically administered antiinfective agents. The effect of this precedent, in terms of accelerating development of multidrug-resistant bacteria, was a major concern of all panel members. The consensus was that the switch of acyclovir to OTC status could not be supported.

Acyclovir↗

Clinical trials in head injury.

Traumatic brain injury (TBI) remains a major public health problem globally. In the United States the incidence of closed head injuries admitted to hospitals is conservatively estimated to be 200 per 100,000 population, and the incidence of penetrating head injury is estimated to be 12 per 100,000, the highest of any developed country in the world. This yields an approximate number of 500,000 new cases each year, a sizeable proportion of which demonstrate significant long-term disabilities. Unfortunately, there is a paucity of proven therapies for this disease. For a variety of reasons, clinical trials for this condition have been difficult to design and perform. Despite promising pre-clinical data, most of the trials that have been performed in recent years have failed to demonstrate any significant improvement in outcomes. The reasons for these failures have not always been apparent and any insights gained were not always shared. It was therefore feared that we were running the risk of repeating our mistakes. Recognizing the importance of TBI, the National Institute of Neurological Disorders and Stroke (NINDS) sponsored a workshop that brought together experts from clinical, research, and pharmaceutical backgrounds. This workshop proved to be very informative and yielded many insights into previous and future TBI trials. This paper is an attempt to summarize the key points made at the workshop. It is hoped that these lessons will enhance the planning and design of future efforts in this important field of research.

Brain Injuries↗