An official ATS statement: grading the quality of evidence and strength of recommendations in ATS guidelines and recommendations.
Explore the source record for details and available documents.
Evidence-Based Medicine↗
Biomedical subjects
Gordon Guyatt
Publications and source records attributed to Gordon Guyatt.
Patients undergoing knee surgery provided accurate ratings of preoperative quality of life and function 2 weeks after surgery.
OBJECTIVE: To evaluate patients' ability to recall their preoperative self-reported quality of life, function, and general health 2 weeks postoperatively. STUDY DESIGN AND SETTING: We randomized consecutive patients undergoing arthroscopic knee surgery to group I (assessments at 4 weeks preoperatively, on the day of surgery, and 2 weeks and 12 months postoperatively) or group II (assessments at 2 weeks and 12 months postoperatively). At each visit patients completed disease-specific, knee-specific, and generic health rating scales. At a median of 2 weeks postoperative (range, 0.6 to 14 weeks), patients completed questionnaires according to their recollection of their health 2 weeks before surgery. RESULTS: Agreement between actual and recalled data was excellent for disease-specific (ICC(WOMET)=0.88 (95% CI 0.82-0.91), ICC(ACL-QOL)=0.86 (95% CI 0.75-0.91)), knee-specific (ICC(IKDC)=0.92 (95% CI 0.90-0.94), ICC(KOOS)=0.93 (95% CI 0.91 to 0.95), and general physical health (ICC(SF-36(PCS))=0.81 (95% CI 0.75-0.86)) instruments. Agreement for general mental health was moderate (ICC(SF-36(MCS))=0.67 (95% CI 0.58-0.75). Greater error associated with recalled ratings contributed to small increases in sample size requirements or small decreases in power to detect differences between groups. CONCLUSION: Patients recalled their preoperative quality of life, function, and general health at 2 weeks postoperative with sufficiently high accuracy to warrant substituting prospectively collected baseline data with recalled ratings.
Adult↗
The clinical significance of quality of life assessments in oncology: a summary for clinicians.
BACKGROUND: A series of six manuscripts with an introduction appeared in the Mayo Clinic Proceedings, based upon the collective effort of 30 individuals with an interest and expertise in assessing the clinical significance of quality of life (QOL) assessments. The series of manuscripts described the state of the science of QOL assessments in oncology clinical research and practice and included extensive literature and theoretical justification for the continued inclusion of QOL in oncology clinical research and practice. OBJECTIVES: The purpose of this paper is to produce a summary of these articles and to supplement these works with additional information that was gleaned from subsequent meetings and discussions of this material. The primary aim of this paper is to present a cogent and concise description for clinicians to facilitate the incorporation of QOL assessments into oncology clinical research and practice. The theoretical discussion is supplemented with an example of how the various ideas can be operationalized in an oncology clinical trial.
Clinical Competence↗
Syndromic approach for treatment of STIs: time for a change.
Explore the source record for details and available documents.
Asia↗
A new preference-based analysis for randomized trials can estimate treatment acceptability and effect in compliant patients.
BACKGROUND AND OBJECTIVES: Development of a new method of analysis to evaluate the acceptability of (or preferences for) the treatments in a randomized trial, and the benefit of treatment among compliers. MATERIALS AND METHODS: We characterize trial participants through the groups who would: accept either treatment if offered (compliers); refuse one treatment but accept the other if it is offered to them (two groups of preferers); or prefer one treatment and insist on it if it is not offered to them initially (two groups of insisters). RESULTS: We show that in our framework, one can always estimate the proportions of patients in these five preference groups. However, constraints are required to estimate the corresponding outcome rates, and thus estimate the treatment effect in the compliers. We propose two possible sets of constraints and illustrate them by numerical examples. CONCLUSIONS: The traditional intention-to-treat analysis avoids biases associated with the alternative per-protocol or as-treated approaches, but it provides imperfect information about the expected treatment effect among patients who are committed to taking the treatment. Many physicians and patients want to know the expected benefit if they adhere to the therapy. Our preference-based analysis provides an estimate of treatment benefit among such patients.
Carotid Stenosis↗
Qualiveen: a urinary disorder-specific instrument for use in clinical trials in multiple sclerosis.
OBJECTIVE: To examine the longitudinal construct validity and the responsiveness of the English and French versions of Qualiveen in multiple sclerosis (MS) patients with urinary disorders. DESIGN: Cohort study. SETTING: MS clinics and departments of rehabilitation in Canada and France. PARTICIPANTS: One hundred eighty English-speaking and French-speaking outpatients who, at enrollment, were classified as "stable" if they had no urinary disorders requiring change in medicine, or "anticipated improvement" if they had troubling urinary disorders that mandated intensified treatment. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: We tested predictions about the relation between changes in other questionnaires (Multiple Sclerosis Quality of Life-54 questionnaire or its French version, the SEP-59, and a global rating of change) and changes in the Qualiveen domains. A paired t test in the anticipated improvement group comparing scores before and after the intervention, and the magnitude of the standardized response mean (SRM) provided measures of responsiveness. RESULTS: Consistent with a priori predictions (weighted kappa=.71), changes in Qualiveen score correlated with changes in other questionnaires. All Qualiveen domains detected changes in patients in the anticipated improvement group (P<.001) and differentiated these patients from "stable" patients (P<.001);all SRMs were large (>.75). CONCLUSIONS: Valid and responsive, both English and French versions are useful for MS studies into urinary disorders.
Canada↗
Preparing a research protocol to improve chances for success.
Explore the source record for details and available documents.
Clinical Protocols↗
[Choosing a quality-of-life questionnaire].
UNLABELLED: Define the objective of the questionnaire: Discrimination: do you want a questionnaire to enable you to describe the quality of life of patients or to compare the quality of life between groups of patients, for example, to determine who has improved and who has gotten worse? ASSESSMENT: do you want a questionnaire to help you measure changes over time (improvement or aggravation) in your patients? Determine the properties of instruments necessary for this objective: If the objective is discrimination, analyze: construct validity, reliability. If the objective is assessment, analyze construct validity, sensitivity to changes. Choose the general category of questionnaire: generic questionnaire, specific questionnaire.
Activities of Daily Living↗
Barriers to participation in HIV drug trials: a systematic review.
The enrolling of adequate participants into HIV experimental drug trials presents an important challenge. We systematically reviewed the literature to identify barriers and concerns amongst HIV patients to participation in HIV clinical drug trials. We reviewed studies for validity and content, and generated pooled estimates of the frequency with which patients identified particular issues by pooling across studies that presented results as proportions. We included three semi-structured interview studies, two open-ended questionnaires, and nine quantitative studies. Major barriers to participation included fear of side-effects, distrust of researchers, general concerns about research design, interference in everyday life or changes in routine, and social discrimination. Results from the quantitative studies indicated that the most prevalent barriers were as follows: suspicions about the drug itself (53%, 95% CI 24-83%), patients were not informed or believed they were not eligible (38%, 25-50%), and travel or transport obstacles (39%, 21-57%). The findings of this study should aid drug trialists in developing strategies to maximise participation and cooperation in HIV clinical drug trials while adequately informing and protecting prospective participants.
Anti-HIV Agents↗
Preadmission antithrombotic treatment and stroke severity in patients with atrial fibrillation and acute ischaemic stroke: an observational study.
BACKGROUND: Vitamin K antagonists (eg, warfarin) substantially reduce the risk of ischaemic stroke in patients with atrial fibrillation. Additionally, therapeutic anticoagulation at time of acute stroke admission might reduce in-hospital mortality and disability. We assessed the association between preadmission antithrombotic treatment and initial stroke severity, neurological deterioration, major vascular events during hospital stay, and death or disability at discharge in patients with acute ischaemic stroke and atrial fibrillation. METHODS: We identified consecutive patients with acute ischaemic stroke and atrial fibrillation, admitted to 11 hospitals in Ontario, Canada, from the Registry of the Canadian Stroke Network (2003-05). Logistic regression was used to assess the association between antiplatelet treatment, subtherapeutic warfarin treatment (admission international normalised ratio [INR] < 2), therapeutic warfarin treatment (admission INR > or = 2), and clinical outcome. Stroke severity was measured using the Canadian neurological scale (CNS) and was categorised into mild (CNS > 7) and severe stroke (CNS < or = 7). Disability was measured with the modified-Rankin scale (mRS) and was categorised into strokes associated with no or mild-moderate dependency (mRS 0-3) and with severe dependency or death (mRS 4-6). RESULTS: Of 948 patients, 306 (32%) were not on antithrombotic treatment, 292 (31%) were receiving antiplatelet treatment, 238 (25%) were receiving warfarin with a subtherapeutic INR, and 112 (12%) were receiving warfarin with a therapeutic INR on admission. Compared with those not receiving antithrombotic therapy, antiplatelet therapy (odds ratio 0.7; 95% CI 0.5-0.995) and therapeutic warfarin (0.4; 0.2-0.6) were associated with a reduction in severe stroke at admission. Therapeutic warfarin was also associated with a reduction in the odds of severe disability or death at discharge (0.5; 0.3-0.9). INTERPRETATION: Therapeutic warfarin is associated with reduced severity of ischaemic stroke at presentation and reduced disability or death at discharge in patients with atrial fibrillation. Antiplatelet treatment is associated with a more modest reduction than warfarin in baseline stroke severity.
Aged↗
EBM user and practitioner models for graduate medical education: what do residents prefer?
The objective of the study reported in this article was to assess and explain medical residents' preferences for the evidence based medicine (EBM) practitioner versus the EBM user models. A self-administered survey and focus group of residents attending a core curriculum EBM master session were undertaken. Most residents, particularly those earlier in their training, preferred the practitioner model. Residents perceived that model as an opportunity to gain advanced EBM skills during residency, as providing the ability to choose practicing under both models, and as offering the gain of independent thinking and greater self-confidence in their critical appraisal skills. The user model had the advantage of reduced time requirements. In sum, the majority of residents preferred a curriculum that focuses on the practitioner over the user model.
Consumer Behavior↗
Beyond journal clubs. Moving toward an integrated evidence-based medicine curriculum.
Incorporating evidence-based medicine (EBM) into clinical practice is an important competency that residency training must address. Residency program directors, and the clinical educators who work with them, should develop curricula to enhance residents' capacity for independent evidence-based practice. In this article, the authors argue that residency programs must move beyond journal club formats to promote the practice of EBM by trainees. The authors highlight the limitations of journal club, and suggest additional curricular approaches for an integrated EBM curriculum. Helping residents become effective evidence users will require a sustained effort on the part of residents, faculty, and their educational institutions.
Ambulatory Care↗
Which patients to include in the analysis?
Explore the source record for details and available documents.
Data Interpretation, Statistical↗
Fiber for the treatment of hemorrhoids complications: a systematic review and meta-analysis.
OBJECTIVES: To evaluate the impact of laxatives on a wide range of symptoms in patients with symptomatic hemorrhoids. METHODS: We searched using the following sources: MEDLINE, EMBASE, CINAHL and CENTRAL, BIOSIS, AMED, Papers First and Proceedings; study authors, industry, and experts in the field. We included all published and unpublished parallel group randomized controlled trials comparing any type of laxative to placebo or no therapy in patients with symptomatic hemorrhoids. Two reviewers independently screened studies for inclusion, retrieved all potentially relevant studies, and extracted data on study population, intervention, prespecified outcomes, and methodology. RESULTS: Seven trials randomized 378 patients to fiber or a nonfiber control. Studies were of moderate quality for most outcomes. Meta-analyses using random effects models suggested that fiber has an apparent beneficial effect. The risk of not improving/persisting symptoms decreased by 47% in the fiber group (RR = 0.53, 95% CI 0.38-0.73) and the risk of bleeding by 50% (RR = 0.50, 95% CI 0.28-0.89). Studies with multiple follow-ups, usually at 6 wk and at 3 months, showed consistent results over time. Results are also compatible with large treatment effects in prolapse, pain, and itching, but even in the pooled analyses confidence intervals were wide and compatible with no effect (RR = 0.79, 95% CI 0.37-1.67; RR = 0.33, 95% CI 0.07-1.65; and RR = 0.71, 95% CI 0.24-2.10, respectively). One study suggested a decrease in recurrence. Results showed a nonsignificant trend toward increases in mild adverse events in the fiber group (RR = 6.0, 95% CI 0.57-64.8). CONCLUSIONS: Trials of fiber show a consistent beneficial effect for symptoms and bleeding in the treatment of symptomatic hemorrhoids.
Constipation↗
Grading strength of recommendations and quality of evidence in clinical guidelines: report from an american college of chest physicians task force.
While grading the strength of recommendations and the quality of underlying evidence enhances the usefulness of clinical guidelines, the profusion of guideline grading systems undermines the value of the grading exercise. An American College of Chest Physicians (ACCP) task force formulated the criteria for a grading system to be utilized in all ACCP guidelines that included simplicity and transparency, explicitness of methodology, and consistency with current methodological approaches to the grading process. The working group examined currently available systems, and ultimately modified an approach formulated by the international GRADE group. The grading scheme classifies recommendations as strong (grade 1) or weak (grade 2), according to the balance among benefits, risks, burdens, and possibly cost, and the degree of confidence in estimates of benefits, risks, and burdens. The system classifies quality of evidence as high (grade A), moderate (grade B), or low (grade C) according to factors that include the study design, the consistency of the results, and the directness of the evidence. For all future ACCP guidelines, The College has adopted a simple, transparent approach to grading recommendations that is consistent with current developments in the field. The trend toward uniformity of approaches to grading will enhance the usefulness of practice guidelines for clinicians.
Advisory Committees↗
Addressing resource allocation issues in recommendations from clinical practice guideline panels: suggestions from an American College of Chest Physicians task force.
Most panels that develop clinical practice guidelines are poorly equipped to address resource allocation or cost issues associated with management options. This risks neglect, arbitrariness, lack of transparency, and methodological flaws in consideration of resource allocation. We provide recommendations for guideline panels to promote greater transparency and rigor. We suggest focusing on resource allocation issues for only a limited number of recommendations and provide criteria for selecting those in which economic considerations are likely to influence the direction or strength of the recommendation. Panels should involve a health economist to assist with the systematic review and critical interpretation of relevant economic analyses. They should carefully define the intended audience and may consider issuing alternative recommendations when available resources vary widely across target clinical settings. Targeting a limited number of recommendations for the consideration of resource allocation issues, and ensuring methodologically high-quality review, will best serve guideline panels, and the health-care providers and patients they hope to assist.
Advisory Committees↗
How many patients? How many limbs? Analysis of patients or limbs in the orthopaedic literature: a systematic review.
BACKGROUND: Clinical studies assessing orthopaedic interventions often include data from two limbs or multiple joints within single individuals. Without appropriate design or statistical approaches to address within-individual correlations, this practice may contribute to false precision and possible bias in estimates of treatment effect. We conducted a systematic review of the orthopaedic literature to determine the frequency of inappropriate inclusion of nonindependent limb or joint observations in clinical studies. METHODS: We identified seven orthopaedic journals with high Science Citation Index impact factors and retrieved all clinical studies for 2003 for any intervention on any limb or joint. RESULTS: We identified 288 clinical studies, 143 of which involved two limbs or multiple joint observations from single individuals. These studies included nineteen randomized clinical trials (13%) fifty-eight two-group cohort studies (41%), and sixty-six one-group cohort studies (46%). Seventy-six (53%) of the 143 studies involved statistical comparisons between patient groups with use of tests of association, and an additional sixty studies (42%) presented estimates of proportions without statistical comparisons. Only sixteen of the seventy-six studies involving statistical comparisons involved the use of any technique or methodological approach to account for multiple, nonindependent observations. A median of approximately 13% of the patients in these studies contributed more than one observation. The median proportion of nonindependent observations to total observations (the unit of analysis) was approximately 23%. CONCLUSIONS: Our findings suggest that a high proportion (42%) of clinical studies in high-impact-factor orthopaedic journals involve the inappropriate use of multiple observations from single individuals, potentially biasing results. Orthopaedic researchers should attend to this issue when reporting results.
Bias↗
Levels of care in the intensive care unit: a research program.
A multidisciplinary research program on levels of care was conducted in 15 adult intensive care units in North America, Europe, and Australia. The program addressed advance directives for cardiopulmonary resuscitation, provision of advanced life support, and clinicians' discomfort with evolving treatment plans. The results indicated that the factors that determined the establishment of directives for advance life support differed from the factors that informed a decision to limit or withdraw support after admission to an intensive care unit. In addition, clinicians' prognoses were imprecise and often an underestimation of the probability of short-term survival. Finally, some degree of discomfort was common in care providers in the intensive care unit, most often because they thought interventions were excessive and not compatible with an acceptable future quality of life. The provision of advanced life support mandates explicit decision making about how life-support measures should be used.
Adult↗