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PubMed2004

The 'effectiveness' scale--therapeutic outcome of pharmacologic therapies for ED: an international consensus panel report.

Despite availability of outcome measures and scales for assessing erectile dysfunction (ED) treatment efficacy, guidelines are not available for assessing broader therapeutic outcomes or defining treatment failure in ED. An International Consensus Advisory Panel was convened to develop guidelines, definitions and a new algorithm for evaluating treatment effectiveness in ED. These new guidelines are recommended for use in both research and clinical practice. A multidisciplinary, international panel, consisting of 11 senior researchers and clinicians, was convened to address pertinent issues concerning therapeutic outcome assessment for ED. The panel utilized a modified Delphi method of consensus development and proposed a new model for outcomes assessment. This model is inherently testable, using existing instruments and current methods of assessment. Following a comprehensive literature review and discussion, the Panel recommended adoption of a new treatment effectiveness conceptual framework or theoretical model for assessing therapeutic outcomes in ED. Treatment effectiveness is presumed to be a combined function of two other factors, treatment response and treatment satisfaction. Treatment response is based on the combined assessment of efficacy and tolerability, and treatment satisfaction on the combined assessment of patient and partner satisfaction. Taken together, these two domains define an overall domain of treatment effectiveness. This therapeutic index would be derived by independently assessing treatment efficacy and satisfaction by means of event logs, questionnaires or the more typical patient interview methods. In conclusion, the Ad Hoc Advisory Consensus Panel recommends adoption of a new framework or conceptual model for conducting ED outcome trials or clinical research. The concept of 'treatment effectiveness' is proposed as a new 'umbrella concept' or distal outcome to be evaluated.

Consensus Statements as Topic↗

PubMed2005

Long-term weight loss after diet and exercise: a systematic review.

OBJECTIVE: To assess the effectiveness of dietary interventions and exercise in long-term weight loss in overweight and obese people. DESIGN: A systematic review with meta-analysis. SUBJECTS: Overweight and obese adults-18 years old or older with body mass index (calculated as weight divided by the square of height in meters)>25. DATA SOURCE: Medline, Cochrane Library and Lilacs databases up to March 2003. Also, published reviews and all relevant studies and their reference lists were reviewed in search for other pertinent publications. No language restrictions were imposed. STUDY SELECTION: Randomised clinical trials comparing diet and exercise interventions vs diet alone. All trials included a follow-up of 1 y after intervention. DATA EXTRACTION: Two reviewers independently abstracted data and evaluated the studies' quality with criteria adapted from the Jadad Scale and the Delphi list. DATA SYNTHESIS: The estimate of the intervention's effect size was based on the differences between the comparison groups, and then the overall effect was calculated. A chi-squared test was used to assess statistical heterogeneity. RESULTS: A total of 33 trials evaluating diet, exercise or diet and exercise were found. Only 6 studies directly comparing diet and exercise vs diet alone were included (3 additional studies reporting repeated observations were excluded). The active intervention period ranged between 10 and 52 weeks across studies. Diet associated with exercise produced a 20% greater initial weight loss. (13 kg vs 9.9 kg; z=1.86-p=0.063, 95%CI). The combined intervention also resulted in a 20% greater sustained weight loss after 1 y (6.7 kg vs 4.5 kg; z=1.89-p=0.058, 95%CI) than diet alone. In both groups, almost half of the initial weight loss was regained after 1 y. CONCLUSION: Diet associated with exercise results in significant and clinically meaningful initial weight loss. This is partially sustained after 1 y.

Adult↗

PubMed2000

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↗

PubMed2001

Evaluation of a new digital panoramic system: a comparison with film.

OBJECTIVES: To evaluate the diagnostic efficacy of the Orthophos DS digital panoramic system (Sirona, Bensheim, Germany) for the detection of dento-alveolar disease in comparison with film. METHODS: Five patients selected for admission to the School of Dentistry had a panoramic radiograph obtained with the Orthophos Plus (Sirona, Bensheim, Germany) system, a digital panoramic image obtained with the Orthophos DS (Sirona, Bensheim, Germany) system and a full mouth series. The ground truth was determined from the full mouth series by a panel of board certified oral and maxillofacial radiologists using the Delphi method. Four observers scored both the film and digital panoramic images for the presence of caries and marginal periodontitis. Results were statistically analysed using ROC analysis and ANOVA. RESULTS: There was no significant difference (P=0.704) between the two modalities for the detection of caries but there was a significant difference (P=0.015) for the detection of periodontal disease where conventional panoramic film performed better than the digital image. CONCLUSIONS: Though the conventional film was better than the digital image for the detection of periodontal disease, further studies are needed to determine the clinical significance of this result in relation to the potential advantages of digital technology.

Analysis of Variance↗

PubMed1999

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↗

PubMed2000

Improving the quality of reports of meta-analyses of randomised controlled trials: the QUOROM statement. QUOROM Group.

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.

Data Collection↗

PubMed1996

The study of biology as a cause of anxiety in student nurses undertaking the common foundation programme.

The subject of biology was identified as a cause of anxiety amongst student nurses on the common foundation programme (CFP), both verbally and in each of the written course evaluations, at a college of nursing and midwifery in the South of England. The aim of this study was to identify the major causes of anxiety and identify methods of reducing this anxiety in the present students, as well as minimizing anxiety in those students commencing their nurse education. Action research was considered the most appropriate design for this study. Student nurse participation was encouraged throughout the study (n = 66). A modified Delphi technique was used to identify and prioritize the causes of anxiety and a student quality circles group was formed for the purpose of problem solving by the students. This stimulated some of the biology teachers to form biology sub-groups to consider the students' proposals. Many changes were implemented. A focus group data collection method was used to evaluate the effectiveness of the relevant changes for the present students. The meeting was recorded and the tape examined for relevant data. The data indicated that although the students perceive biology as a subject that causes anxiety they did acknowledge that many of the changes made by the teachers were a positive step towards reducing the anxiety. Although the results were encouraging, it is noted that to gain a true understanding of the effect of the changes, further evaluation would need to be completed. The use of triangulation may be considered more appropriate to enhance the quality of the data obtained.

Anxiety↗

PubMed1997

A study of the educational and research priorities of registered nurses in rural Australia.

This study set out to identify the educational and research priorities of registered nurses practising in rural and remote areas of Australia. It included two groups of participants, one which identified as rural and another which identified as remote. The findings for the rural cohort in the study are presented in this article. Research participants represented a national sample. The Delphi method was used to obtain the most reliable consensus of the nurse participants. In the final phase of the study, 13 high priorities were identified. Study findings highlight perceived needs for clinical nursing research and continuing education for nurses practising in rural Australia.

Australia↗

PubMed1997

Psychometric evaluation of a questionnaire to document side-effects of chemotherapy.

This paper reports the psychometric testing of the Worthing Chemotherapy Questionnaire (WCQ). The WCQ is a patient self-report instrument to document side-effects of chemotherapy. Literature review of relevant studies shows that psychometric testing of similar instruments is rarely rigorous. Content validity for the WCQ was established in five ways: literature review, Delphi review among oncology staff, pre-pilot unstructured interviews, pilot study and amendment of the instrument and items for spontaneous reporting of problems on the questionnaire. A three-stage approach to construct validity was used. The hypothesis adopted was that as certain cytotoxic agents cause stomatitis, incidence and severity of stomatitis will decrease following cessation of treatment. Stage 1: factor analysis confirmed the presence of a sole factor, with an eigenvalue of 5.3, for mouth problems which explained 65.5% of the variance. Stage 2: the hypothesis was confirmed using research findings. Stage 3: the Wilcoxon test showed highly significant results for during and post chemotherapy stomatitis scores. Reliability of the questionnaire was assessed using the test-retest method. Weighted kappa was chosen as the test statistic. A median value of wk = 0.87 was obtained. The results indicate that the WCQ is a reliable and valid instrument.

Antineoplastic Agents↗

PubMed1998

Successive surveys of an expert panel: research in decision-making with health visitors.

A United Kingdom expert panel was consulted to develop a self-completion instrument for research on decision making in health visiting practice. The use of a Delphi-type technique demonstrated how a stand-alone postal survey was an insufficient measure for health visitors, requiring a supplementary follow-up method to study types of casework. A review of literature raised questions about the significance of intuitive thinking and reasoning in health visitor practice, in relation to measuring professional service and individual performance.

Decision Making↗

PubMed2000

Developing a model for quality evaluation in residential care for people with intellectual disability.

The present article describes the development of a general model for the evaluation, enhancement and assurance of quality of care processes in residential facilities for children and adults with intellectual disability. The framework is based on current theories regarding quality of life and quality evaluation, on a consensus between several participants in Delphi discussion-rounds, and on a questionnaire for care providers and clients in all Flemish residential facilities. The model describes 13 quality standards and a list of indicators concerning organization and support interventions. Facilities may use this set of criteria and indicators in several ways within a continuous and dynamic system of internal quality assurance. Finally, the prospects of and conditions for the implementation of this model are discussed.

Adult↗

PubMed2001

The clinician's role in meeting patient information needs: suggested learning outcomes.

BACKGROUND: Patients have always fulfilled their information needs from a variety of different sources over time. Clinician-patient consultations are one part of that process. Some patients have increasing opportunities to obtain information through new sources such as the internet, touch-screens, and patient-held records. Others remain poorly informed. OBJECTIVES: To identify learning outcomes for clinicians in meeting patient information needs and working with well-informed patients. DESIGN: Four-stage multicentre multidisciplinary qualitative study. SETTING AND SUBJECTS: (1) Semistructured interviews with 20 clinicians in Glasgow; (2) semistructured interviews with 52 clinicians in Nottingham and London; (3) testing of consensus by postal questionnaire and Delphi method amongst 37 clinicians in medicine, nursing and the professions allied to medicine, and (4) conference to discuss results. RESULTS: 46 learning outcomes were identified in the eight areas of: placing a higher priority on patient information and education; understanding the patient's information needs and environment; understanding the emotional aspects of learning; developing patient understanding; helping patients to understand about health care and health care information; learning from the patient; knowing about information sources and their use, and issues of multidisciplinary working. CONCLUSIONS: The suggested learning outcomes provide the basis for wider discussion, for possible inclusion in curricula both at undergraduate and continuing education levels, and as the basis for the development of new educational materials.

Communication↗

PubMed2001

Use of community health needs assessment for regional planning in country South Australia.

This study examined the impact of community health needs assessments used in country South Australian health service planning between 1995 and 1999. Data were collected from regional health planning officers during a Search Conference and a series of Delphi rounds. The needs assessments were found to vary from regionally to locally driven approaches. Locally driven approaches ensured local involvement but the process was slower and required more effort from the planner. It was also felt that locally driven approaches could exacerbate tension between a community's imperatives and the regional focus of regional decision-makers. In the overall regional budgets, the reallocation of health service funds according to the needs assessment findings was only small because of difficulties in refocusing from traditional clinical services in the short term. In contrast, the impact on health service thinking about population health issues was thought to have been more significant, for example, in the development of regional women's health plans. The use of community health needs assessments was useful, but for greater impact these should not now be so 'broad-brushed', but be more focused on feasible changes that health services could support. Other priority-setting techniques, such as marginal analysis, should also be used to determine where maximum health gains can be obtained.

Community Health Planning↗

PubMed2003

Academic nursing education guidelines: tool for bridging the gap between theory, research and practice.

The aim of the present study was to develop educational guidelines to be used as a tool for the integration of theory, research and practice to ensure that nursing knowledge and practical skills form the basis of academic nursing education. An additional aim was to describe the nursing competence expected of the students at four academic levels: introductory, intermediate and advanced levels I and II. Clinical nursing education plays a crucial role in assisting nursing students to integrate the theory and practice of nursing at the baccalaureate level, as well as in further specialization and in-depth nursing studies at the advanced level. A research group consisting of lecturers from the Institute of Nursing, Göteborg University, Sweden, was given the objective to formulate educational guidelines for clinical practice within nursing education. The study took the form of a literature search. In addition, the Delphi method, aimed at reaching a consensus of opinion among colleagues, was used. Based on the literature review and the collegial discussions, four core concepts emerged: professional stance, reflective processes, problem-solving processes, and practical skills, from which the educational guidelines were developed. Guidelines were formulated both in general and abstract form. They were not connected to a specific care context, specific patient group or specific nursing problems. The most important objective of academic education is that the student develops abilities and techniques necessary for life-long learning. Students will, in their professional life as nurses, continuously meet situations where they are challenged to take appropriate decisions and actions. This demands training in problem-solving, reflection, decision-making and the ability to use both deductive and inductive learning strategies. The guidelines describe what is expected of the students in terms of nursing competence and personal qualifications to ensure that they will be ready to meet the demands of their future profession.

Clinical Competence↗

PubMed2003

Development of a comprehensive scoring system to measure multifaceted nursing workloads in ICU.

A new scoring system, the comprehensive nursing intervention score (CNIS), was developed to quantify the overall workload of diverse nursing activities in the intensive care unit (ICU). A total of 88 nursing items were listed. With the cooperation of 20 skilled ICU nurses, a three-round Delphi survey was conducted to assign a four-grade workload score to each item from five aspects: number of nurses required, muscular exertion, mental stress, skill, and intensity. After the survey, 15 unnecessary items were deleted. Appropriateness of the assigned scores was confirmed by surveying 118 nurses in other ICU. Within-individual reproducibility, examined in 44 nurses, was summarized as a mean kappa-coefficient of 0.65. Time required for each job was recorded and added as the sixth aspect of the workload. Thus, final CNIS gave six subscores (0-3) plus one overall score (3-18) to each of the 73 job items. The CNIS was confirmed as truly representing overall nursing workload by applying it to the daily care of 107 patients.

Critical Care↗

PubMed2003

Prioritizing patients for elective surgery: a systematic review.

BACKGROUND: Priority scoring tools are moot as means for dealing with burgeoning elective surgical waiting lists. There is ongoing development work in New Zealand, Canada and the UK. This emerging international perspective is invaluable in determining the application of these tools and addressing any pitfalls. METHODS: A systematic electronic literature review was performed. Information was also retrieved using a search of reference lists of all papers included in the review and contact with those who were involved in the development of such criteria. RESULTS: The ethical basis of prioritization differed among priority scoring tools and in a number was not stated. The majority of tools covered criteria for specific procedures. Delphi consensus methods and regression were the predominant methods for -deter-mining -specific criteria. Authors' opinions were the main source of generic criteria. Linear and non-linear models or matrices sum-mated criteria. CONCLUSION: There is debate over the ethical basis for prioritization. It is a concern that it is not addressed in many studies. The development of generic criteria showed a dearth of consensus approaches that represents a significant gap in our knowledge. On the aspects of summation and weighting, the impact of assumptions on the prioritization of patients may not have been fully explored.

Elective Surgical Procedures↗

PubMedDate not supplied

Cost-effectiveness of enoxaparin as thromboprophylaxis in acutely ill medical patients in Spain.

OBJECTIVE: The objective of this study was to determine the cost-effectiveness of thromboprophylaxis with enoxaparin versus no thromboprophylaxis in patients with acute medical illness in Spain from the society perspective. METHODS: Markov process analysis techniques were used to model the health economic outcomes. Clinical data were derived mainly from the MEDENOX trial, while health-care utilization was derived from Delphi panels. RESULTS: An analysis over the MEDENOX trial period shows that the cost per event avoided is currency 432, while the cost per life saved is currency 1527. The cost per event includes all medical resource utilization costs associated with the event. The lifetime model, which assumes no higher risk for recurrence of venous thromboembolism (VTE) and mortality in asymptomatic patients, shows that the use of enoxaparin leads a cost per event avoided of currency 270 and cost per life-year gained of currency 71. If the lifetime model assumes a higher risk for recurrence of VTE in asymptomatic patients, enoxaparin is dominant over no thromboprophylaxis. CONCLUSION: The results showed that the favorable clinical benefit of enoxaparin as thromboprophylaxis in patients with acute medical illness, which was observed in the MEDENOX trial, results in a positive health economic benefit in both the short term and the long term in the health-care setting of Spain.

Acute Disease↗

PubMed1998

Effect of local standards on the implementation of national guidelines for asthma: primary care agreement with national asthma guidelines.

OBJECTIVE: To assess the level of modification by local primary care doctors of key aspects of the National Asthma Education Program (NAEP) Guidelines for the Diagnosis and Management of Asthma. DESIGN: A random sample of primary care physicians participating in local asthma guideline development. SETTING: Two hospital systems, one based in an urban environment, and a second in a community and rural environment. PARTICIPANTS: Primary care physicians. INTERVENTION: Design of consensus-based local asthma guidelines using a modified Delphi approach. MEASUREMENTS AND MAIN RESULTS: A total of 42 physicians participated in the local guideline development. With few exceptions, the primary care physicians modified in major ways the NAEP Guidelines regarding the role of pulmonary function testing and spirometry. Specifically, the local guidelines did not require peak flow and spirometry measurements as the basis for initiating inhaled steroids as did the national guidelines. All 42 physicians emphasized a clinical diagnosis versus one based on a pulmonary function. Peak flow monitoring was recommended by 35 (83%) of physicians in selected patients only, in contrast to the national guidelines, which emphasized monitoring for all patients routinely and during exacerbations. There was strong agreement with the national guidelines on the role and importance of patient education, and on the indications for the use of inhaled steroids. CONCLUSIONS: Disagreement by primary care doctors with parts of the NAEP guideline is a potential cause for poor compliance and lack of influence on patient care. Recognizing the need to modify or customize guidelines through field testing with local primary care physicians will improve acceptance of national guidelines.

Administration, Inhalation↗