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PubMed2000

[Prevention of venous thromboembolism in a non-surgical medical ward. Proposed indications for low molecular weight heparin].

OBJECTIVE: The efficiency of venous thromboembolism prophylaxis with low molecular weight heparins (LMWH) has not been established in non surgical patients, so their official preventive use has been limited in France since 1995 to surgery. However, a survey conducted in 5 university hospitals in non surgical patients showed that 21-29% of patients still received a LMWH prescription. It seemed necessary to define the medical conditions for which the practical use of these heparins would be justified. We contacted external experts to obtain a consensus by using the Delphi method. METHODS: The Delphi method, created by the "Rand Corporation" in the USA and used in medicine since the nineteen seventies, is based on a light logistic, with questionnaires been sent by mail with a feed-back report A total of 48 experts were chosen by local staff teams in the 5 hospitals. For the 3 rounds, from March to October 1998, questions were devised by a multicentred staff team. RESULTS: Among the 48 experts contacted, 32 completed the 3 questionnaires, 7 of them did for 2, and 43 did for at least one questionnaire. The experts first defined a list of 12 risk or high risk situations and 11 aggravating factors. For any high risk situation, prescription is justified. For other cases, 2 risk situations are required, or one risk situation with at least 2 aggravating factors, to justify a prescription. If no risk situation is present, prescription is, according to experts, usually not justified. CONCLUSION: The maximal agreement defines the situations in which one use of low molecular weight heparins is proposed to prevent deep venous thrombosis in non surgical inpatients, in most current hospital situations and for more than 24 hours of hospitalization. Clinical trials are needed, to validate their effectiveness and define the optimal dose in these indications. To date, epidemiological studies should be conducted to evaluate the experts proposals by estimating risk factors for deep venous thrombosis.

Double-Blind Method↗

PubMed2000

[Conception and testing of a regional practice guideline using bronchial asthma as an example].

Frequently, there is a gap between publication and implementation of guidelines into clinical practice. To improve adherence with guidelines, experts recommend among other things local adaptation of guidelines. The goal of the present study was to conceptualize and test such an adaptation in the region of Neckar-Alb in Germany by using asthma guidelines as an example. We conceptualized a three-step approach for regional guideline adaptation: 1) Compilation of existing national and international asthma guidelines by regional experts to develop a draft for regional asthma guideline; 2) regional consensus conference to discuss the draft with local physicians; 3) modified Delphi procedure using regional physicians as "experts" to get consent for the regional asthma guideline. We defined consensus as reaching at least a 2/3 consent for each of the statements. As starting point for the process of guideline adaptation, the regional experts developed a first draft of the regional asthma guideline including 132 recommendations. 60 out of 500 regional general practitioners (GP), internists and asthma specialists participated in the consensus process. After the preparations of the regional experts and the regional consensus conference, only four recommendations had to be changed considerably during the Delphi procedure to reach the consensus criterion. If the recommendations remained unchanged, the whole guideline might be disapproved because they were considered to affect the role of GPs by shifting responsibilities from GPs to asthma specialists. As the result of the adaptation, the first regionally adapted asthma guideline for the Neckar-Alb region fosters the principal responsibility of regional GPs in asthma care, thereby surmounting resistance for implementation that former specialist-centered guidelines provoked. Hence, the new guideline meets the requirements for successfully implementing the recommendations into clinical practice.

Asthma↗

PubMed2002

[Recommendations of EULAR on treatment of gonarthrosis. Report of a committee of the "Standing Committee for International Clinical Studies Including Therapeutic Trials (ESCIST)"].

BACKGROUND: Osteoarthritis (OA) is the most common joint disease encountered throughout Europe. A task force for the EULAR standing committee for clinical trials met in 1998 to determine the methodological and logistical approach required for the development of evidence-based guidelines for treatment of knee OA. The guidelines were restricted to cover all currently available therapies for knee OA diagnosed either clinically and/or radiographically affecting any compartment of the knee. METHODS: The first stage was the selection of treatment modalities to be considered. The second stage comprised a search of the electronic databases Medline and Embase using a combination of subject headings and key words. All European language publications in the form of systematic reviews, meta-analyses, randomized-controlled trials, controlled trials and observational studies were included. During stage three all of the relevant studies were quality scored. The summary statistics for validated outcome measures, when available, were recorded and where practical the numbers needed to treat (NNT) and the effect size (ES) for each therapy was calculated. The fourth stage involved determination of key clinical propositions by expert consensus employing a Delphi approach. The final stage involved ranking of these propositions according to the available evidence. A second set of propositions relating to a future research agenda was determined by expert consensus using a Delphi approach. RESULTS: Over 2400 English language publications and 400 non-English language publications were identified. Seven hundred and forty four studies presented outcome data of the effects of specific treatments on knee OA. Quantitative analysis of treatment effect was possible in only 61 studies. Recommendations for the management of knee OA based on currently available data and expert opinion are presented. Proposals for a future research agenda are highlighted. CONCLUSIONS: These are the first clinical guidelines on knee OA to combine an evidence-based approach and a consensus approach across a wide range of treatment modalities. It is apparent that only certain clinical propositions are supported by substantial research-based evidence, while others are not. There is thus an urgent need for future well designed trials to address key clinical questions.

English Abstract↗

PubMed2004

The development of a short instrument to identify common unmet needs in older people in general practice.

BACKGROUND: No structured needs assessment tool exists that is appropriate for older people and also suitable for use in routine consultations in general practice. AIMS: To engage older people in the development of a brief, valid, practical, and acceptable instrument to help identify common unmet needs suitable for use in routine clinical practice in primary care. DESIGN OF STUDY: User involvement in a multi-stages approach to heuristic development. SETTING: General practices, voluntary groups, and community organisations in north and central London. METHOD: Subjects included patients aged 65 years and over in purposively selected practices, voluntary organisations for older people in the same localities, community organisations involving older people, general practitioners and community nurses. Data were collected through mixed methodology interviews using a structured assessment tool (Camberwell Assessment of Need for the Elderly), a postal questionnaire, and focus groups. Synthesis and interpretation of results was done through a consensus conference followed by a Delphi process involving primary care professionals. RESULTS: Five domains of unmet need were identified as priority areas by all three data collection methods, the consensus conference, and the Delphi process: senses (vision and hearing), physical ability (mobility and falls), incontinence, cognition, and emotional distress (depression and anxiety) (SPICE). CONCLUSIONS: Public involvement in the design of clinical tools allowed the development of a brief assessment instrument that could potentially identify common, important, and tractable unmet needs in older people.

Aged↗

PubMed2004

Development of Standards and Criteria for the Selection, Training, and Evaluation of Athletic Training Approved Clinical Instructors.

OBJECTIVE: To develop standards and associated criteria for the selection, training, and evaluation of athletic training approved clinical instructors (ACIs). DESIGN AND SETTING: A previously developed set of 7 physical therapy clinical instructor standards/criteria and 2 additional standards/criteria developed through a review of the literature were systematically adapted, judged, and revised through a Delphi technique. SUBJECTS: Athletic training education experts currently employed as program directors for entry-level Commission on Accreditation of Allied Health Education Programs-accredited athletic training educational programs and who had the following: a doctoral degree, at least 5 years of supervising athletic training students, and familiarity/experience with clinical instruction in various athletic training clinical education settings. MEASUREMENTS: We used panelists' critiques and ratings to make sequential revisions in a series of 3 Delphi rounds. Standards were rated as to whether they were clear, necessary, and appropriate. We rated criteria for the associated standard as to whether they were useful, helpful, clear, specific, and consistent. RESULTS: We developed a final set of 7 standards and 50 associated criteria to measure these standards. The accepted standards include the following: legal and ethical behavior, communication skills, interpersonal relationships, instructional skills, supervisory and administrative skills, evaluation of performance, and clinical skills and knowledge. CONCLUSIONS: The 7 standards and associated criteria developed in this research project could be used not only for selecting, training, and evaluating an ACI but also for developing an understanding of the requirements of clinical education in general. Further research should include validating these standards/criteria among athletic training ACIs representing different types of clinical settings.

Journal Article↗

PubMed2006

Factors affecting the implementation of telenursing in Korea.

The purpose of this study is to deduce and prioritize the factors affecting the implementation of telenursing in Korea. For this study, Delphi methods were used. Thirty professors and specialists in the field of nursing informatics and telemedicine contributed to two rounds of Delphi survey. The factors necessary for the introduction of telenursing were divided into systematic, economical, societal and technical aspects. The critical factors of each aspect were prioritized to produce a guide to support the feasible implementation plan for telenursing. They are: Governmental support to control the regulatory issues, verification of telenursing as a cost-effective health care delivery system, value verification of telenursing versus on-site consultation, social trust building, and development of characteristic telenursing content which consumers willingly pay for. The results of this study will enable health professionals to understand the prospect and necessity of telenursing implementation. In addition, they will be used efficiently in a variety of e-health milieus as a practical strategy for the improvement of health care in Korea.

Diffusion of Innovation↗

PubMed2006

[Guidelines for management of acute lung injury/acute respiratory distress syndrome: an evidence-based update by the Chinese Society of Critical Care Medicine (2006)].

OBJECTIVE: In 2006, Chinese critical care experts drafted management guidelines for diagnosis and therapy of acute lung injury (ALI)/acute respiratory distress syndrome (ARDS), that would be of practical use for the clinician, and this effort may serve to increase nationwide awareness and to improve the treatment result of ALI/ARDS. METHODS: The process included a modified Delphi method, a consensus conference, several subsequent smaller meetings of subgroups and key individuals, teleconferences, and electronic based discussion among subgroups and among the entire committee. The modified Delphi methodology used for grading recommendations was derived from a 2001 publication sponsored by the International Sepsis Forum. A systematic review of the literature was undertook, and the reported results were graded into five levels to create recommendation grading from A to E, with a being the highest grade. RESULTS: It is essential to control the primary disease in ALI/ARDS. Role of noninvasive positive-pressure ventilation in ALI/ARDS is undefined. Noninvasive positive-pressure ventilation can not be considered in patients with coma, shock and damage of airway clearance. Limitation of end-inspiratory plateau pressure is important in the management of ARDS and may be facilitated by permissive hypercapnia. Recruitment maneuver should be considered to open collapsed lung and improve oxygenation. A minimum amount of positive end-expiratory pressure (PEEP) should be set to prevent atelectasis at end expiration in ARDS. If it is possible, setting the level of PEEP may be guided by measurement of static pulmonary pressure-volume curve. Unless contraindicated, patients with ARDS should be maintained semi-recumbent. Prone positioning should be considered in the patients with severest ARDS. Sedation protocols should be used. Paralysis is not recommended. The limited fluid management strategy is beneficial for ARDS. Corticosteroid is not recommended for ARDS. The role of other drugs is uncertain in ARDS. CONCLUSION: Evidence-based recommendations can be made regarding many aspects of the acute management of ALI/ARDS that will hopefully translate into improved outcomes for the critically ill patient. The guidelines will be updated when some important new knowledge becomes available.

Acute Lung Injury↗

PubMed1993

AASCIN strategic plan--1993-1998.

A long-standing commitment to planned growth and development are essential for the AASCIN to be effective in influencing the direction of spinal cord injury (SCI) nursing. Recognizing these needs, a long-range planning initiative was supported by the Board of Directors in March, 1990. A task force was charged with the responsibility for outlining the future of the AASCIN through the development of a five-year strategic plan. The long-range planning initiative was divided into two segments. First, a Delphi Study was developed to obtain membership input into AASCIN's priorities. Once this data was collected, the Strategic Planning Task Force synthesized the results of the study and developed a five-year AASCIN strategic plan. The purpose of this article is to describe the process and content of the proposed AASCIN strategic plan. The report begins with a brief description of the Delphi Survey, which forms the foundation for the strategic plan. Since the strategic plan needs to be congruent with the organization's mission statement and goals, the organizational plan of AASCIN is presented. Lastly, a brief summary of how the organization proposes to use this strategic planning document is provided.

Forecasting↗

PubMed2026

Latin American consensus on the medical oncologic management of early-stage HR+/HER2- breast cancer: Addressing regional disparities in Spanish-speaking countries.

PURPOSE: Substantial disparities persist in managing early-stage hormone receptor-positive, HER2-negative (HR+/HER2-) breast cancer across Spanish-speaking Latin America, including limited access to genomic testing, systemic therapies, and fertility preservation. The Latin American Breast Cancer Association (LABCA) convened an expert panel to produce the first consensus tailored to Spanish-speaking countries. METHODS: A literature review (Embase, PubMed, Scopus, ClinicalKey, LILACS; 2014-2025), informed by ESMO/ASCO/NCCN/SEOM guidelines and registered in PROSPERO (CRD42024565706), supported statement development. A steering committee of three experts of Spanish nationality supervised the process. Twenty-one specialists from 11 countries participated in a modified Delphi process; 31 items were voted in Round 1 and 25 statements were retained within scope. Consensus was pre-defined as ≥80% agreement (or median 7-9), with a mean/outlier rule reported alongside. RESULTS: Applying the ≥80% rule, 22 of 25 statements (88%) reached full consensus; three (1.3, 2.4, 3.3; 75-76%) were near-consensus and retained with caveats. Recommendations integrated clinicopathologic and molecular factors to guide risk stratification; genomic assays were reserved for selected scenarios and discouraged in very low-risk tumors or ≥4 positive lymph nodes. Consensus also covered ovarian suppression plus endocrine therapy, fertility preservation, sexual-health and genetic evaluation, and adjuvant CDK4/6 and PARP inhibitors when accessible. Marked heterogeneity in access was documented by country and sector. CONCLUSION: This consensus provides the first region-specific, evidence-based, resource-adapted recommendations for early-stage HR+/HER2- breast cancer in Spanish-speaking Latin America, aiming to reduce disparities and strengthen equitable oncology care.

Humans↗

PubMed2025

Operationalizing the Wilson-Jungner principles for the genomics era: Consensus recommendations from the International Consortium on Newborn Sequencing.

PURPOSE: For decades, the selection of disorders included in newborn screening (NBS) programs has been guided by principles published by Wilson and Jungner in 1968. As research explores the expansion of conditions included in NBS through genomic sequencing, there is a critical need for updated recommendations to address the opportunities and complexities of genomic data. METHODS: The International Consortium on Newborn Sequencing includes leaders from over 16 research projects investigating genomic NBS across the United Kingdom, Europe, United States, and Oceania. Consortium members were invited to participate in a modified Delphi study, aggregating opinion on the selection of conditions for genomic NBS through 3 rounds of online questionnaires, with feedback provided to participants between rounds. RESULTS: In round 1, 94 participants completed the questionnaire, and 10 of 43 statements reached consensus. In round 2, 81 participants completed the questionnaire, and 14 of 27 statements reached consensus. In round 3, 68 participants completed the questionnaire, and all 10 statements reached 72% or more consensus. CONCLUSION: The 10 consensus recommendations developed in this study can guide future research and public health programs performing genomic NBS. This process also identified key areas of participant discordance, highlighting important topics for future research.

Humans↗

PubMed2006

Reporting data on homeopathic treatments (RedHot): a supplement to CONSORT*.

When homeopathy is tested in clinical trials, understanding and appraisal are likely to be improved if published reports contain details of prescribing strategies and treatments. An international Delphi panel was convened to develop consensus guidelines for reporting homeopathic methods and treatments. The panel agreed 28 treatment- and provider-specific items that supplement the CONSORT (Consolidated Standards of Reporting Trials) Statement items 2, 3, 4 and 19. The authors recommend these for adoption by authors and journals when reporting trials of homeopathy.

Delphi Technique↗

PubMedDate not supplied

Updating the Beers criteria for potentially inappropriate medication use in older adults: results of a US consensus panel of experts.

BACKGROUND: Medication toxic effects and drug-related problems can have profound medical and safety consequences for older adults and economically affect the health care system. The purpose of this initiative was to revise and update the Beers criteria for potentially inappropriate medication use in adults 65 years and older in the United States. METHODS: This study used a modified Delphi method, a set of procedures and methods for formulating a group judgment for a subject matter in which precise information is lacking. The criteria reviewed covered 2 types of statements: (1) medications or medication classes that should generally be avoided in persons 65 years or older because they are either ineffective or they pose unnecessarily high risk for older persons and a safer alternative is available and (2) medications that should not be used in older persons known to have specific medical conditions. RESULTS: This study identified 48 individual medications or classes of medications to avoid in older adults and their potential concerns and 20 diseases/conditions and medications to be avoided in older adults with these conditions. Of these potentially inappropriate drugs, 66 were considered by the panel to have adverse outcomes of high severity. CONCLUSIONS: This study is an important update of previously established criteria that have been widely used and cited. The application of the Beers criteria and other tools for identifying potentially inappropriate medication use will continue to enable providers to plan interventions for decreasing both drug-related costs and overall costs and thus minimize drug-related problems.

Aged↗

PubMed1997

A methodology to maximize resident input in improving a pediatric rotation.

OBJECTIVE: To develop a structured process to gain resident input into the improvement of their educational experience by (1) taking a small amount of resident time and effort, (2) fostering the generation of new ideas, (3) allowing the prioritization of ideas, (4) generating implementation plans for the ideas, and (5) offering the participants relative anonymity. DESIGN: Cross-sectional survey and group sessions. SETTING: Urban, university-based children's hospital. PARTICIPANTS: Members of the pediatric residency program in the 1993-1994 academic year. INTERVENTIONS AND RESULTS: The process was piloted for an emergency department rotation and borrows aspects of the Delphi Technique, Nominal Group Technique, and focus group methods. A survey regarding an emergency department rotation was distributed to all pediatric residents, and the 10 most commonly noted problems were compiled. These problems were brought to group sessions held for each level of training. Problems not listed were added if they were mentioned during the session; however, no problem was removed from the list. The sessions, designed to offer relative anonymity to the residents, included an initial clarification period, a round-robin prioritization of ideas, and an open discussion designed to generate solutions. Resident-generated solutions resulting from the group sessions were reviewed by the attending staff, and changes were implemented during the next year. CONCLUSION: The technique that we developed is a practical and time-efficient method of incorporating resident perspectives into the improvement of a rotation.

Attitude of Health Personnel↗

PubMed1997

Development of a quality of care measurement system for children and adolescents. Methodological considerations and comparisons with a system for adult women.

OBJECTIVES: To describe the development of a pediatric quality of care measurement system designed to cover multiple clinical topics that could be applied to enrollees in managed care organizations and to compare the development of this system with the concurrent development of a similar system for adult women. DESIGN: Indicators were developed for 21 pediatric (ages 0-18 years) clinical topics and 20 adult (ages 17-50 years) women's clinical topics. Indicators were classified by the strength of evidence supporting them. A modified Delphi method was used to obtain validity and feasibility ratings from a pediatric expert panel and an adult women's expert panel. Indicators were categorized by type of care (preventive, acute, or chronic), function (screening, diagnosis, treatment, or follow up), and modality (history, physical examination, laboratory/radiology study, medication, other intervention, or other contact). RESULTS: Of 557 pediatric and 391 adult women's proposed indicators, 453 (81%) and 340 (87%), respectively, were retained by the 2 expert panels. A lower percentage of final pediatric indicators than adult indicators were based on randomized, controlled trials and other rigorous studies (18% vs 40%, P < .001). The expert panels were more likely to retain indicators based on rigorous studies (93% retained) than on descriptive studies and expert opinion (81% retained, P < .001). A higher percentage of pediatric indicators than women's indicators were for preventive care (30% vs 11%, P < .001) and a lower percentage were for acute care (36% vs 49%, P < .001) or chronic care (34% vs 41%, P = .06). CONCLUSIONS: This study contributes to the field of pediatric quality of care assessment by providing many more indicators than have been available previously and by documenting the strength of evidence supporting these indicators. Formal consensus methods are essential for the development of pediatric quality measures because the evidence base for pediatric care is more limited than for adult care.

Adolescent↗

PubMed2000

Measuring underuse of necessary care among elderly Medicare beneficiaries using inpatient and outpatient claims.

CONTEXT: Continuing changes in the health care delivery system make it essential to monitor underuse of needed care, even for relatively well-insured populations. Traditional approaches to measuring underuse have relied on patient surveys and chart reviews, which are expensive, or simple single-condition claims-based indicators, which are not clinically convincing. OBJECTIVE: To develop a comprehensive, low-cost system for measuring underuse of necessary care among elderly patients using inpatient and outpatient Medicare claims. DESIGN: A 7-member, multispecialty expert physician panel was assembled and used a modified Delphi method to develop clinically detailed underuse indicators likely to be associated with avoidable poor outcomes for 15 common acute and chronic medical and surgical conditions. An automated system was developed to calculate the indicators using administrative data. SETTING AND SUBJECTS: A total of 345,253 randomly selected elderly US Medicare beneficiaries in 1994-1996. MAIN OUTCOME MEASURES: Proportion of beneficiaries receiving care, stratified by indicators of necessary care (n = 40, including 3 for preventive care), and avoidable outcomes (n = 6). RESULTS: For 16 of 40 necessary care indicators (including preventive care indicators), beneficiaries received the indicated care less than two thirds of the time. Of all indicators, African Americans scored significantly worse than whites on 16 and better on 2; residents of poverty areas scored significantly lower than nonresidents on 17 and higher on 1; residents of federally defined Health Professional Shortage Areas scored significantly lower than nonresidents on 16 and higher on none (P<.05 for all). CONCLUSIONS: This claims-based method detected substantial underuse problems likely to result in negative outcomes in elderly populations. Significantly more underuse problems were detected in populations known to receive less-than-average medical care. The method can serve as a reliable, valid tool for monitoring trends in underuse of needed care for older patients and for comparing care across health care plans and geographic areas based on claims data. JAMA. 2000;284:2325-2333.

Aged↗

PubMed2000

Evaluating the quality of cancer care: development of cancer quality indicators for a global quality assessment tool.

BACKGROUND: The rise of managed care has increased interest in measuring, reporting, and improving quality of care. To date, quality assessment has relied on a leading indicator approach, which may miss important variations in care. The authors developed cancer specific indicators using a novel case-based approach for a quality measurement tool designed to compare different managed care organizations. METHODS: Based on a review of the literature, quality indicators were developed for 6 types of cancer and the human immunodeficiency virus (HIV) as well as 39 general adult conditions (GAC). The validity and feasibility of these candidate indicators were evaluated using three modified Delphi expert panels. The strength of evidence, type of care (preventive, acute, or chronic), function (screening, diagnosis, treatment, and follow-up), and modality (history, physical examination, laboratory, medication, or other intervention) of the cancer/HIV quality indicators were compared with indicators developed for GAC. RESULTS: The final system included 117 of the 145 proposed cancer/HIV quality indicators (81%) and 569 of the 705 proposed GAC indicators (81%). A greater percentage of the cancer/HIV indicators were based on evidence from clinical trials compared with the GAC indicators (59% vs. 31%; P = 0.001). Cancer/HIV had significantly more indicators pertaining to chronic care than did GAC (74% vs. 56%; P = 0.001) as well as more indicators for treatment (53% vs. 39%; P = 0.004). CONCLUSIONS: Using the case-based approach, it is feasible to develop quality indicators for cancer that cover the continuum of care. Future studies will evaluate the reliability and validity of measurements made using these indicators in three managed care plans.

Adult↗

PubMed1998

Impact of training on cytotechnologists' interpretation of gynecologic thin-layer preparations.

This study determines the impact of training on the accurate interpretation of gynecologic thin-layer (TL) preparations. A workshop was developed, implemented and evaluated. Training materials were developed with the assistance of a Delphi panel. Sixty-six self-selected cytotechnologists participated. The experimental group consisted of 40 participants tested before and after an educational intervention, using gynecologic TL preparations. The 26 individuals in the comparison group were given the same pre- and post-tests as the experimental group, but the educational intervention was not offered until after the tests were administered. Data were analyzed using the t-test for independent and dependent samples, McNemar's test, point biserial correlation, and descriptive statistics. No significant difference in test scores was observed between the two groups. A correlation was observed between prior exposure to TL preparations and cytotechnologists' test scores. No correlation between experience and test scores was found.

Cell Biology↗

PubMed2005

Impact of hepatitis C on health related quality of life: a systematic review and quantitative assessment.

Hepatitis C virus (HCV) diminishes health related quality of life (HRQOL), and it is now common to measure HRQOL in clinical trials. We sought to summarize the HRQOL data in HCV, and to establish the minimally clinically important difference (MCID) in HRQOL scores in HCV. We performed a systematic review to identify relevant studies, and converted HRQOL data from each study into clinically interpretable statistics. An expert panel used a modified Delphi technique to estimate the MCID in HCV. We found that patients with HCV scored lower than controls across all scales of the SF-36. Patients achieving sustained virological response (SVR) scored higher across all scales versus patients without SVR, especially in the physical health domains. HRQOL differences did not correspond with differences in liver histology or ALT levels. Based upon the published data, the expert panel concluded that the SF-36 vitality scale was most relevant in patients with HCV, and generated a mean MCID of 4.2 points on this scale. In conclusion, patients with HCV have a clinically significant decrement in HRQOL versus controls, and physical HRQOL improves in patients achieving SVR but not in those without SVR. The data further suggest that traditional outcomes fail to capture the full spectrum of illness related to chronic HCV. A difference of 4.2 points on the SF-36 vitality scale can be used as an estimate of the MCID in HCV, and this value may be used as the basis for power calculations in clinical trials evaluating HRQOL. Supplementary material for this article can be found on the HEPATOLOGY website (http://www.interscience.wiley.com/jpages/0270-9139/suppmat/index.html).

Case-Control Studies↗