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Clinical practice guidelines: from methodological to practical issues.

The main goal of clinical practice guidelines is to help clinical decision by practitioners, who can not integrate in their daily practice all the published data concerning new technologies and knowledge. Guidelines also have growing applications in the ethical, legal, socio-economic, public policy and health care funding fields. This article describes the various methodologies that have been proposed to develop guidelines. These methods rely to varying degrees on formal methods of analysis of scientific evidence and expert opinions. Then a step by step process is described, that should ensure a rigorous, feasible and explicit guideline development and lead to valid and applicable recommendations. In order for guidelines to be used, they have to be efficiently implemented. Respective efficiency and justification of educational and coercive methods of implementation are discussed.

Clinical Competence↗

[Need for professional expertise in institutions and public health services in 4 cantons and Tessin. Hypothesis--objectives--implementation].

This survey consists in a process of "collaborative reflection" between consultants from a university department of public health and health authorities in five cantons. The goal of this effort is to identify, within a common framework, known and suspected health problems, risk factors, preventive measures as well as priority research needs in these areas. This information is used to determine the need for an increased access to public health experts at the level of the cantons and gives some indication as to the characteristics required of such experts. Since participants in the survey are also responsible for promotion and implementation of concrete actions for prevention, it is anticipated that this project will result in a number of initiatives focused on the problem which have been identified. The methodology used was inspired by methods previously described for problem identification and program planning, such as the Delphi technique, but was adapted in an original way to the particular needs of this survey. In the first phase, interviews with persons responsible for key health administrations and institutions in each canton are conducted in order to identify the maximum number of salient facts, problems and unresolved questions. In a second phase results and problem statements are consolidated, fed back to all participants and, through repeated contacts, completed, redefined and ranked in order of importance. Although the survey is still ongoing, it has already led to the identification of a number of health problems, possible risk factors and research priorities which had hitherto not been formally identified, and to one concrete program aimed at improving preventive intervention.(ABSTRACT TRUNCATED AT 250 WORDS)

Health Planning↗

A new international classification of childhood vasculitis.

There has been, for many years, a need for an acceptable classification of childhood vasculitis as well as criteria for classifying specific sub-categories of vasculitic disease affecting the young. Hitherto, there has been, with certain exceptions, much reliance on adult classification systems and criteria that have not proved entirely satisfactory. A recent International Consensus Conference held in Vienna in June 2005 attempted to rectify this state of affairs. It resulted in a new proposal for childhood vasculitis classification and proposals of classification criteria for several important categories of childhood vasculitis including Henoch-Schonlein purpura, Kawasaki disease, polyarteritis nodosa (with additionally definitions for cutaneous and microscopic polyarteritis), Wegener granulomatosis and Takayasu arteritis. The process involved the Delphi technique to gather a wide spectrum of opinion from pediatric rheumatologists and nephrologists followed by the Consensus Conference attended by a group of pediatricians with extensive vasculitis experience where nominal group techniques were utilized to agree on a general classification and classification criteria for individual childhood vasculitides. The consensus that was reached will hopefully provide pediatricians with a valuable tool in the study of childhood vasculitides but will require appropriate validation using patient and control groups.

Child↗

Validating the certification process for infection control practice.

Approximately 5 years ago a task analysis was conducted by the Certification Board of Infection Control (CBIC) to describe infection control practice. This task analysis served as the basis for development of the certification examination. This article describes the process used to update and revalidate the original task analysis to ensure the continued validity and job relatedness of the certification process. Using a modified Delphi technique, several panels of representative expert infection control practitioners (ICPs), a total of 29 persons, participated in an iterative process to define the practice dimensions of infection control and to link these practice dimensions to the certification examination. In general, there was a high level of congruence between respondents on the original task analysis and the expert panels, although a few differences in practice were identified among ICPs in extended care facilities and a few new tasks were identified. In addition, a revised content outline for the examination was created by placing clusters of knowledge statements together around common themes.

Certification↗

Methodology for the development of the ESPEN Guidelines on Enteral Nutrition.

Under the auspices of the European Society for Clinical Nutrition and Metabolism (ESPEN) clinical practice guidelines on enteral nutrition were systematically developed between spring 2004 and winter 2005 in a both evidence and consensus based process. A steering committee implemented 13 disease-specific working groups with a total of 88 experts in clinical nutrition from 20 countries. Evidence was gathered by conducting a structured literature search applying a defined search strategy, inclusion criteria and specified keywords. The quality and strength of the supporting evidence was then graded according to published standards. On this basis recommendations were spelled out which were not only based on the evidence levels of the studies but also on the judgement of the working groups concerning the consistency, clinical relevance and validity of the evidence. Preparation of the drafts was accomplished in interactive small group work processes. The voting of statements took place in a consensus conference and final refinements and voting were done using the Delphi technique. The ESPEN guidelines enteral nutrition reflect the current medical knowledge in the field of enteral nutrition therapy and summarize the evidence when enteral nutrition is indicated and which goals can be reached in regard to nutritional state, quality of life and outcome.

Enteral Nutrition↗

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↗

Barriers to communication regarding end-of-life care: perspectives of care providers.

OBJECTIVE: Communication regarding end-of-life care is frequently perceived as suboptimal, despite the intent of both health care providers and patients. We interviewed health care providers to determine their perspective regarding these barriers to communication. MATERIALS AND METHODS: Eleven focus groups with a total of 10 attending physicians, 24 residents, and 33 nurses were convened to explore barriers to end-of-life discussions on the Internal Medicine service at a 600-bed tertiary care hospital in Toronto, Canada. An interview schedule was designed to elicit information regarding the process of end-of-life discussions, barriers to these discussions, and possible interventions for limiting such barriers. Transcripts were qualitatively analyzed by 6 raters who independently identified "themes." Themes were refined using the Delphi technique and classified under broader "categories." RESULTS: Four main categories of barriers emerged, relating to (1) patients, (2) the health care system, (3) health care providers, and (4) the nature of this dialogue. Attending physicians and residents most frequently identified patient-related factors as barriers to discussions, followed by system, dialogue, and provider barriers (43%, 39%, 10%, and 8%, respectively, for attending physicians; 40%, 34%, 13%, and 13%, respectively, for residents). Nurses similarly identified patient-related and system barriers most frequently, but provider barriers were discussed more often than dialogue barriers (46%, 28%, 22%, and 4%, respectively). CONCLUSIONS: Attending physicians, residents, and nurses perceive the recipients of their care, and the system within which they provide this care, to be the major source of barriers to communication regarding end-of-life care. This finding may impact on the effectiveness of quality-improvement initiatives in end-of-life care.

Adult↗

Improving the quality of reports of meta-analyses of randomised controlled trials: the QUOROM statement. Quality of Reporting of Meta-analyses.

BACKGROUND: The Quality of Reporting of Meta-analyses (QUOROM) conference was convened to address standards for improving the quality of reporting of meta-analyses of clinical randomised controlled trials (RCTs). METHODS: The QUOROM group consisted of 30 clinical epidemiologists, clinicians, statisticians, editors, and researchers. In conference, the group was asked to identify items they thought should be included in a checklist of standards. Whenever possible, checklist items were guided by research evidence suggesting that failure to adhere to the item proposed could lead to biased results. A modified Delphi technique was used in assessing candidate items. FINDINGS: The conference resulted in the QUOROM statement, a checklist, and a flow diagram. The checklist describes our preferred way to present the abstract, introduction, methods, results, and discussion sections of a report of a meta-analysis. It is organised into 21 headings and subheadings regarding searches, selection, validity assessment, data abstraction, study characteristics, and quantitative data synthesis, and in the results with "trial flow", study characteristics, and quantitative data synthesis; research documentation was identified for eight of the 18 items. The flow diagram provides information about both the numbers of RCTs identified, included, and excluded and the reasons for exclusion of trials. INTERPRETATION: We hope this report will generate further thought about ways to improve the quality of reports of meta-analyses of RCTs and that interested readers, reviewers, researchers, and editors will use the QUOROM statement and generate ideas for its improvement.

Authorship↗

Practice guideline for the management of infants and children 0 to 36 months of age with fever without source. Agency for Health Care Policy and Research.

STUDY OBJECTIVE: To develop guidelines for the care of infants and children from birth to 36 months of age with fever without source. PARTICIPANTS AND SETTING: An expert panel of senior academic faculty with expertise in pediatrics and infectious diseases or emergency medicine. DESIGN AND INTERVENTION: A comprehensive literature search was used to identify all publications pertinent to the management of the febrile child. When appropriate, meta-analysis was used to combine the results of multiple studies. One or more specific management strategies were proposed for each of the decision nodes in draft management algorithms. The draft algorithms, selected publications, and the meta-analyses were provided to the panel, which determined the final guidelines using the modified Delphi technique. RESULTS: All toxic-appearing infants and children and all febrile infants less than 28 days of age should be hospitalized for parenteral antibiotic therapy. Febrile infants 28 to 90 days of age defined at low risk by specific clinical and laboratory criteria may be managed as outpatients if close follow-up is assured. Older children with fever less than 39.0 C without source need no laboratory tests or antibiotics. Children 3 to 36 months of age with fever of 39.0 C or more and whose WBC count is 15,000/mm3 or more should have a blood culture and be treated with antibiotics pending culture results. Urine cultures should be obtained from all boys 6 months of age or less and all girls 2 years of age or less who are treated with antibiotics. CONCLUSION: These guidelines do not eliminate all risk or strictly confine antibiotic treatment to children likely to have occult bacteremia. Physicians may individualize therapy based on clinical circumstances or adopt a variation of these guidelines based on a different interpretation of the evidence.

Algorithms↗

Length-based endotracheal tube and emergency equipment in pediatrics.

HYPOTHESIS: Pediatric endotracheal (ET) tubes can be accurately selected based on body length using a specialized emergency tape. POPULATION: Derivation set: Two hundred five children undergoing elective surgery. Validation set: Two hundred thirteen children undergoing elective surgery. Each child served as his or her own control. METHODS: Derivation phase: Two hundred twenty-one children undergoing ET intubation for elective surgery had their body length and leak pressures measured. The 205 children who had leak pressures between 10 and 40 cm H2O constituted the derivation set. The body length for a given ET tube size was derived from the interquartile range of patient lengths in this derivation set. Sizes for other resuscitative equipment items were chosen by a panel of experts using a modified Delphi technique. This information was placed by length on a color-coded tape. Validation phase: The tape was validated by using it to select ET tube size in another group of 203 children undergoing elective surgery. Criteria for acceptable fit in this group included leak pressure as above and the anesthesiologists' decision to accept the tube size or to retintubate. In the validation phase, length-based ET tube selections were compared with age-based rules: (age + 16)/4, and (age + 18)/4. RESULTS: The tape selected the appropriate ET tube size by leak pressure criterion in 77% of the cases and was within +/- 0.5 mm of the "correct" size 99% of the time. This was significantly better (P less than .005) than two widely used age-based rules, which gave the correct initial size in only 47% and 9% of these cases, and were within +/- 0.5 mm for 86% and 59%. The anesthesiologists chose to continue with the tape-sized tube rather than to reintubate in 89% of cases. CONCLUSION: A system for length-based selection of emergency equipment represents a significant adjunct to emergency physicians and paramedics who must deal with critically ill children. Length-based ET tube selection is clearly superior to age-based rules, which are difficult to remember and require accurate estimation of a patient's age.

Body Height↗

[Test on knowledge about climacteric: development and validation process].

OBJECTIVE: To construct and validate a test of knowledge about the menopause. SETTING: The context for use of this test is the Autonomous Community of Andalusia. METHOD: 1. Construction of the theoretical universe through the Delphi Technique. 2. Weighting of each of the dimensions of the theoretical universe. 3. Formulation and selection of the conceptual elements to introduce into the questionnaire and formulation of the corresponding items. 4. Selection of items and analysis of their internal consistency, homogeneity, stability and equivalence after a pilot study. PARTICIPANTS: The questionnaire's pilot study was run with 150 Andalusian women, chosen through sampling by quotas of age, habitat and educational background. MEASUREMENTS AND RESULTS: A questionnaire with 56 true and false (T/F) items grouped in four dimensions was obtained: biological aspects (14 items), psychological and social aspects (14), health risks linked to the menopause (6), care and preventive and health-improvement activities at the menopause (22). Its validity and reliability were determined by the following results: internal consistency and overall homogeneity (Cronbach's alpha = 0.86); stability or absence of significant differences at the moment the questionnaire is run (Student's t = 1.09; p = 0.28); intra-class correlation coefficient (ICC) = 0.753; equivalence or absence of bias of the questioners (Student's t = 1.09; p = 0.28), ICC = 0.761. CONCLUSIONS: The results lead us to conclude that the instrument is stable, allowing for the independence of the time and questioner variables, with high internal consistency and representing well the conceptual elements that shape the theoretical universe.

Adult↗

[Principal requirements in medical training for certification of deaths in Spain].

OBJECTIVE: To know the training need priorities in Spanish physicians in death certification. DESIGN: Study of needs by consensus technique Delphi. SETTING: Health care and medical-legal institutions in Spain. PARTICIPANTS: Physicians who ask for information in death certification, after reading an article in a medical magazine (n=38), and agree to participate (n=33). METHODS: Priorities were established by means of a list of items, based on teaching experience and professional advice. The scores obtained for each priority were hierarchized, and the participants professional profiles were described. An analysis of hierarchical clusters was done to determine profiles of training. RESULTS: The median age of the participants was 42 years, with 18 years experience in general/family, emergency or forensic medicine, which usually certified in median 8 death a year (rank from 0 to 50). The maximum training priorities were how to register a death and which doctor should make out the official documents. Intermediate priorities included the role of doctors in violent or accidental deaths. In the main three grouping needs were, in one, include certification as a degree subject and learn how different documents are made out; although in the others two, were how to register a death, which physician make out the documents, and when it should certify the family doctor and when the coroner. CONCLUSIONS: The priorities in certification training are how to register a death and who should make out the documents, pointing out that the shortcoming continues in medical training in death certification.

Adult↗

Organizational restructuring in health care: a successful approach.

The process of redesigning the internal organization structure of the Hamilton Civic Hospitals provides a successful example of this type of transformation. Based on a strategic approach to change, this multiphased process used a modified delphi technique to allow maximum participation in a total redesign of the structure during a four-month time frame. Implementation, which followed over the next year, resulted in a 40 percent reduction in management positions and the integration of the two sites of the hospital.

Efficiency, Organizational↗

Voices from practice: mental health nurses identify research priorities.

Through a collaborative research project, nurse clinicians and nurse academics identified and prioritized the most important research questions arising from the current and future practice of mental health nurses in an eastern Canadian region. Study methods included the Delphi technique and a nominal group survey approach. Nine categories of research questions emerged. The top four categories are discussed under the headings: Preparation of Helpers, the Service System, Caregiver Needs, and Clients With Major Behavior Problems. This timely study offers explicit direction for psychiatric and mental health nursing practice and research, and for the development of social policy.

Attitude of Health Personnel↗

Prehospital advanced life support provided by specially trained physicians: is there a benefit in terms of life years gained?

BACKGROUND: The benefit of prehospital advanced life support (ALS) is disputed, as is the prehospital use of specially trained, hospital-based physicians. The purpose of the study was to assess the health benefit from an anesthesiologist-manned prehospital emergency medical service (EMS), and to separate the benefit of the anesthesiologist from that of rapid transport. METHODS: The anesthesiologist-manned helicopter and rapid response car service at Rogaland Central Hospital assisted 1106 patients at the scene during the 18-month study period. Two expert panels assessed patients with a potential health benefit for life years gained (LYG) using a modified Delphi technique. The probability of survival as a result of the studied EMS was multiplied by the life expectancy of each patient. The benefit was attributed either to the anesthesiologist, the rapid transport or a combination of both. RESULTS: The expert panels estimated a benefit of 504 LYG in 74 patients (7% of the total study population), with a median age of 54 years (range 0-88). The cause of the emergency was cardiac diseases (including cardiac arrest) in 61% of the 74 patients, trauma in 19%, and cardio-respiratory failure as a result of other conditions in 20%. The LYG were equally divided between air and ground missions, and the majority (88%) were attributed solely to ALS by the anesthesiologist. CONCLUSION: The expert panels found LYG in every 14th patient assisted by this anesthesiologist-manned prehospital EMS. There was no difference in LYG between the helicopter and the rapid response car missions. The role of the anesthesiologist was crucial for health benefits.

Adolescent↗

Diagnostic and treatment strategies for erectile dysfunction: the 'Process of Care' model. [University of Medicine and Dentistry of New Jersey, Robert Wood Johnson Medical School].

The new era of erectile dysfunction medicine ushered in by the availability of an effective and safe oral medication paves the evolution of the field toward a multi-disciplinary and primary care setting. There exists a paucity of guidelines regarding the assessment and management of the patient with erectile dysfunction in the primary care arena. The 'Process of Care' model for the evaluation and treatment of erectile dysfunction has been developed to advance new guidelines for the diagnosis and management of erectile dysfunction in the primary care and multi-disciplinary setting. This model was developed under the auspices of the University of Medicine and Dentistry of New Jersey (UMDNJ)-Robert Wood Johnson Medical School (chairman: R Rosen) with input from a multi-disciplinary group of experts including representation from primary care, internal medicine, endocrinology, psychiatry, psychology and urology. The methodology employed was a modified delphi-technique (RAND method). The key components of the model are: 1)a rational approach to diagnosis and treatment, 2) emphasis on clinical history-taking and a focused physical examination 3) specialized testing and referral in pre-defined situations 4) step-wise management approach with ranking of treatment options and 5)incorporation of patient and partner needs and preferences in the decision making process when possible (a goal-directed approach). The management algorithm is conceptually organized into progressive stages from Process--> Action--> Outcome. International Journal of Impotence Research (2000) 12, Suppl 4, S119-S121.

Erectile Dysfunction↗

Walking index for spinal cord injury (WISCI): an international multicenter validity and reliability study.

STUDY DESIGN: Construction of an international walking scale by a modified Delphi technique. OBJECTIVE: The purpose of the study was to develop a more precise walking scale for use in clinical trials of subjects with spinal cord injury (SCI) and to determine its validity and reliability. SETTING: Eight SCI centers in Australia, Brazil, Canada (2), Korea, Italy, the UK and the US. METHODS: Original items were constructed by experts at two SCI centers (Italy and the US) and blindly ranked in an hierarchical order (pilot data). These items were compared to the Functional Independence Measure (FIM) for concurrent validity. Subsequent independent blind rank ordering of items was completed at all eight centers (24 individuals and eight teams). Final consensus on rank ordering was reached during an international meeting (face validation). A videotape comprised of 40 clips of patients walking was forwarded to all eight centers and inter-rater reliability data collected. RESULTS: Kendall coefficient of concordance for the pilot data was significant (W=0. 843, P<0.001) indicating agreement among the experts in rank ordering of original items. FIM comparison (Spearman's rank correlation coefficient=0.765, P<0.001) showed a theoretical relationship, however a practical difference in what is measured by each scale. Kendall coefficient of concordance for the international blind hierarchical ranking showed significance (W=0.860, P<0.001) indicating agreement in rank ordering across all eight centers. Group consensus meeting resulted in a 19 item hierarchical rank ordered 'Walking Index for Spinal Cord Injury (WISCI)'. Inter-rater reliability scoring of the 40 video clips showed 100% agreement. CONCLUSIONS: This is the first time a walking scale for SCI of this complexity has been developed and judged by an international group of experts. The WISCI showed good validity and reliability, but needs to be assessed in clinical settings for responsiveness.

Australia↗

Consultant surgeons' opinion of the skills required of basic surgical trainees.

BACKGROUND: Accurate and appropriate assessment of surgical trainees requires clear determination of the skills needed for surgical competence. This study was designed to identify those skills, rank them in order of importance and translate them into behavioural terms. METHODS: A Delphi technique, using anonymous postal questionnaires, was used. All consultant surgeons in South-East Scotland were asked to identify the skills they expected of surgical trainees. Skills identified were then returned to all consultants for weighting. Differences among specialties in the importance of each item were identified using analysis of variance. RESULTS: The qualities identified fell into five domains: technical skills, clinical skills, interaction with patients and relatives, teamwork, and application of knowledge. Consultants from all specialties gave high weightings to the generic domains of clinical skills, teamwork, and interaction with patients and relatives. CONCLUSION: This study has identified the skills considered necessary by consultant surgeons in Scotland for a successful surgical career. Contrary to expectation, consultant surgeons value many generic skills more highly than technical skills, indicating that they value well rounded doctors, not just those with technical ability. The characteristics identified are being used to develop an assessment tool for use on basic surgical trainees.

Attitude of Health Personnel↗