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Gordon Guyatt

Publications and source records attributed to Gordon Guyatt.

At least 55 records · Page 3Linked to original sources
PubMed2004

Interaction of St John's wort with conventional drugs: systematic review of clinical trials.

OBJECTIVE: To determine the methodological quality of clinical trials that examined possible interactions of St John's wort with conventional drugs, and to examine the results of these trials. DESIGN: Systematic review. DATA SOURCES: Electronic databases from inception to April 2004, reference lists from published reports, and experts in the field. STUDY SELECTION: Eligible studies were prospective clinical trials evaluating the pharmacokinetic effect of St John's wort on the metabolism of conventional drugs. DATA EXTRACTION: Two reviewers selected studies for inclusion and independently extracted data. DATA SYNTHESIS: 22 pharmacokinetic trials studied an average of 12 (SD 5) participants; 17 trials studied healthy volunteers and five studied patients. Most (17) studies used a "before and after" design; four studies used control groups other than the active group. Three studies randomised the sequence of administration or the participants to study arms or periods; three studies blinded participants or investigators. In 15 trials, investigators independently assayed the herb. Of 19 trials with available plasma data, three found no important interaction (change in area under the curve < 20%) and 17 found a decrease in systemic bioavailability of the conventional drug; in seven studies the 95% confidence interval excluded a decrease of < 20%. CONCLUSION: Clinicians and patients should beware of possible decreases in the systemic bioavailability of conventional drugs when taken concomitantly with St John's wort.

Area Under Curve↗
PubMed2004

Clinician discomfort with life support plans for mechanically ventilated patients.

OBJECTIVE: To examine the incidence and predictors of clinician discomfort with life support plans for ICU patients. DESIGN AND SETTING: Prospective cohort in 13 medical-surgical ICUs in four countries. PATIENTS: 657 mechanically ventilated adults expected to stay in ICU at least 72 h. MEASUREMENTS AND RESULTS: Daily we documented the life support plan for mechanical ventilation, inotropes and dialysis, and clinician comfort with these plans. If uncomfortable, clinicians stated whether the plan was too technologically intense (the provision of too many life support modalities or the provision of any modality for too long) or not intense enough, and why. At least one clinician was uncomfortable at least once for 283 (43.1%) patients, primarily because plans were too technologically intense rather than not intense enough (93.9% vs. 6.1%). Predictors of discomfort because plans were too intense were: patient age, medical admission, APACHE II score, poor prior functional status, organ dysfunction, dialysis in ICU, plan to withhold dialysis, plan to withhold mechanical ventilation, first week in the ICU, clinician, and city. CONCLUSIONS: Clinician discomfort with life support perceived as too technologically intense is common, experienced mostly by nurses, variable across centers, and is more likely for older, severely ill medical patients, those with acute renal failure, and patients lacking plans to forgo reintubation and ventilation. Acknowledging the sources of discomfort could improve communication and decision making.

APACHE↗
PubMed2004

Clinically important deep vein thrombosis in the intensive care unit: a survey of intensivists.

INTRODUCTION: Outside the intensive care unit (ICU), clinically important deep vein thrombosis (DVT) is usually defined as a symptomatic event that leads to objective radiologic confirmation and subsequent treatment. The objective of the present survey is to identify the patient factors and radiologic features of lower limb DVT that intensivists consider more or less likely to make a DVT clinically important in ICU patients. METHODS: Our definition of clinically important DVT was a DVT likely to result in short-term or long-term morbidity or mortality if left untreated, as opposed to a DVT that is unlikely to have important consequences. We asked respondents to indicate the likelihood that patient factors and ultrasonographic features make a DVT clinically important using a five-point scale (from 1 = much less likely to 5 = much more likely). RESULTS: Of the 71 Canadian intensivists who responded, 70 (99%) rated three patient factors as most likely to make a DVT clinically important: clinical suspicion of pulmonary embolism (mean score 4.6), acute or chronic cardiopulmonary morbidity that might limit a patient's ability to tolerate pulmonary embolism (score 4.5), and leg symptoms (score 4.2). Of the ultrasound features, proximal (score 4.7), large (score 4.2), and totally occlusive (score 3.9) thrombi were considered the three most important. CONCLUSION: When labeling a DVT as clinically important, intensivists rely on different patient specific factors and thrombus characteristics than are used to assess the clinical importance of DVT outside the ICU. The clinical importance of DVT is influenced by unique factors such as cardiopulmonary reserve among mechanically ventilated patients.

Adult↗
PubMed2004

The MacNew Heart Disease health-related quality of life instrument: a summary.

BACKGROUND: The measurement of health, the effects of disease, and the impact of health care include not only an indication of changes in disease frequency and severity but also an estimate of patients' perception of health status before and after treatment. One of the more important developments in health care in the past decade may be the recognition that the patient's perspective is as legitimate and valid as the clinician's in monitoring health care outcomes. This has lead to the development of instruments to quantify the patients' perception of their health status before and after treatment. METHODS: We review evidence supporting the measurement properties of the MacNew Heart Disease Health-related Quality of Life [MacNew] Questionnaire which was designed to evaluate how daily activities and physical, emotional, and social functioning are affected by coronary heart disease and its treatment. RESULTS: Reliability was demonstrated by using internal consistency and the intraclass correlation coefficients for the three domains in the Dutch, English, Farsi, German, and Spanish versions of the MacNew. With internal consistency and intraclass correlation coefficients =>0.73, reliability is high. Validity of the MacNew was examined with factor analysis and three core underlying factors, physical, emotional, and social, were identified, explaining 63.0 - 66.5% of the observed variance and replicated in the translations with psychometric data. Construct validity of the MacNew was further demonstrated by extensive substantiation of the logical relationships, defined a priori, between items and other comparison tools. The MacNew is responsive and sensitive to changes in HRQL following various interventions for patients with heart disease with 11 of 13 effect size statistics >0.80. Taking an average of 10 minutes or less to complete, the respondent-burden for the MacNew is low and its acceptability is demonstrated by response rates of over 90%. Normative data are available for patients with myocardial infarction, angina, and heart failure in the English version. CONCLUSION: The MacNew may be a valuable tool for assessing and evaluating health related quality of life in patients with heart disease.

Attitude to Health↗
PubMed2004

Measuring quality of life in multiple sclerosis patients with urinary disorders using the Qualiveen questionnaire.

OBJECTIVES: To assess the impact of urinary disorders on multiple sclerosis (MS) patients' health-related quality of life and to examine the cross-sectional construct validity of Qualiveen, a questionnaire originally developed for spinal cord injury patients with urinary disorders, in patients with MS. DESIGN: Cohort study. SETTING: Neurourodynamic units in 3 French university hospitals. PARTICIPANTS: Patients with MS (N=197). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: We tested predictions about the relationships among clinical features, the French version of the Multiple Sclerosis Quality of Life questionnaire (SEP-59), the Expanded Disability Status Scale (EDSS), and the 4 domains of the 30-item Qualiveen. RESULTS: Cross-sectional correlations among the 4 Qualiveen domains and type (range, .36-.54), number of symptoms (range, .23-.50), and severity of incontinence (.39-.68) were generally moderate to strong. The SEP-59 bowel and bladder function domain showed moderate to strong relationships with the Qualiveen (range, .39-.59). Relationships with other SEP-59 domains were generally weak (range, .22-.35), and with the EDSS they were very weak. Predictions proved generally accurate (weighted kappa=.61). CONCLUSIONS: Our data supported the Qualiveen's validity as a discriminative instrument for use with patients with MS. Further studies should explore the Qualiveen's longitudinal validity and responsiveness.

Activities of Daily Living↗
PubMed2004

Health-related quality of life in women with polycystic ovary syndrome, a self-administered questionnaire, was validated.

OBJECTIVE: We examined the measurement properties of a questionnaire (PCOSQ) measuring health-related quality of life (HRQOL) in women with the polycystic ovary syndrome (PCOS). STUDY DESIGN: This multicenter prospective randomized placebo-controlled blinded study enrolled 393 patients with PCOS at tertiary care sites. Participants were randomized to placebo or troglitazone (150 mg/d, 300 mg/d, or 600 mg/d). At baseline (n=393) and after 44 weeks of treatment (n=284) the proportion of normal menstrual cycles, the free testosterone (T) level, four objective measures of facial hair growth (hair density and hair growth rate by photography, and hair diameter and hair growth rate using plucked hairs), and a subjective assessment of the degree of hirsutism, the modified Ferriman-Gallwey (F-G) score, were determined. At both visits, patients also completed the PCOSQ. Since the trial was conducted, troglitazone has been removed from the market because of toxic effects. The PCOSQ includes 26 questions (items) that address five areas of concern (domains), including emotions, body hair, body weight, fertility, and menstruation rated on a seven-point scales in which lower scores denote higher degrees of patient concern and a lower HRQOL. RESULTS: Cronbach's alpha was >0.7 for four of five domains. Factor analysis provided moderate to strong support for the five-domain structure of the PCOSQ. Cross-sectional correlations were weak with all measures but the F-G score and hair growth (r=-.46, P < .01). The change in the F-G score showed a statistically significant (P < .01) correlation with changes in PCOSQ hair growth (r=-.22), weight (r=-.17), infertility (r=-.20), and menstruation (r=-.20). Changes in the proportion of normal menstrual cycles correlated with change in the infertility domain (r=.14, P < .03) and with the change in the menstruation domain (r=.31, P < .001). The PCOSQ proved as responsive as the F-G, and more responsive than the objective measures of hair growth, to effects of troglitazone. CONCLUSIONS: Our data provides some support for the discriminative and longitudinal validity, and appreciable support for the responsiveness, of the PCOSQ.

Adult↗
PubMed2004

Clinician predictions of intensive care unit mortality.

OBJECTIVE: Predicting outcomes for critically ill patients is an important aspect of discussions with families in the intensive care unit. Our objective was to evaluate clinical intensive care unit survival predictions and their consequences for mechanically ventilated patients. DESIGN: Prospective cohort study. SETTING: Fifteen tertiary care centers. PATIENTS: Consecutive mechanically ventilated patients > or = 18 yrs of age with expected intensive care unit stay > or = 72 hrs. INTERVENTIONS: We recorded baseline characteristics at intensive care unit admission. Daily we measured multiple organ dysfunction score (MODS), use of advanced life support, patient preferences for life support, and intensivist and bedside intensive care unit nurse estimated probability of intensive care unit survival. MEASUREMENTS AND MAIN RESULTS: The 851 patients were aged 61.2 (+/- 17.6, mean + SD) yrs with an Acute Physiology and Chronic Health Evaluation (APACHE) II score of 21.7 (+/- 8.6). Three hundred and four patients (35.7%) died in the intensive care unit, and 341 (40.1%) were assessed by a physician at least once to have a < 10% intensive care unit survival probability. Independent predictors of intensive care unit mortality were baseline APACHE II score (hazard ratio, 1.16; 95% confidence interval, 1.08-1.24, for a 5-point increase) and daily factors such as MODS (hazard ratio, 2.50; 95% confidence interval, 2.06-3.04, for a 5-point increase), use of inotropes or vasopressors (hazard ratio, 2.14; 95% confidence interval, 1.66-2.77), dialysis (hazard ratio, 0.51; 95% confidence interval, 0.35-0.75), patient preference to limit life support (hazard ratio, 10.22; 95% confidence interval, 7.38-14.16), and physician but not nurse prediction of < 10% survival. The impact of physician estimates of < 10% intensive care unit survival was greater for patients without vs. those with preferences to limit life support (p < .001) and for patients with less vs. more severe organ dysfunction (p < .001). Mechanical ventilation, inotropes or vasopressors, and dialysis were withdrawn more often when physicians predicted < 10% probability of intensive care unit survival (all ps < .001). CONCLUSIONS: Physician estimates of intensive care unit survival < 10% are associated with subsequent life support limitation and more powerfully predict intensive care unit mortality than illness severity, evolving or resolving organ dysfunction, and use of inotropes or vasopressors.

APACHE↗
PubMed2004

Determining the reporting quality of RCTs in clinical pharmacology.

BACKGROUND: The Consolidated Standards for Reporting Trials (CONSORT) are recommendations for improving the quality of reports of randomized controlled trials (RCTs). OBJECTIVE: To determine the extent to which clinical pharmacology journals implement specific CONSORT recommendations. DESIGN AND SETTING: Analysis of RCTs published between May 2002 and May 2003 in four clinical pharmacology journals. MAIN OUTCOME MEASURES: Proportion of RCTs that published a participant flow diagram and that reported on randomization and restriction methods, allocation concealment, blinding, intention-to-treat analysis, ethical considerations, adverse events and source of funding. RESULTS: Of 482 clinical trials, 193 were RCTs. Healthy participants were involved in 129 [66.8%, 95% confidence interval (CI) 59.9, 73.1] trials, patients who required treatment in 61 (31.6%, 95% CI 25.4, 38.4) trials and both in three (1.6%, 95% CI 0.5, 4.4) trials. The following items were infrequently reported: sequence generation (17%), allocation concealment (3%), use of restriction (16%), description of blinding (26%), and flow diagrams of study participants (2%). In contrast, the following areas were often reported: use of intention-to-treat analysis (79%), description of withdrawals (92.2%) and description of adverse events (71%), ethics review (94%) and informed consent (95%). Sources of funding were reported in 56% of studies. CONCLUSION: The use of the selected CONSORT items is limited in these journals, possibly as many items may not be relevant to the types of studies published in clinical pharmacology journals. Further efforts are required to determine the applicability of CONSORT to RCTs in clinical pharmacology.

Humans↗
PubMed2004

Methodology for guideline development for the Seventh American College of Chest Physicians Conference on Antithrombotic and Thrombolytic Therapy: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy.

This article describes the methodology for the Seventh American College of Chest Physicians (ACCP) Conference on Antithrombotic and Thrombolytic Therapy: Evidence-Based Guidelines. Guideline authors began by specifying the population, the intervention and alternative, and the outcomes for each clinical question, and defined the criteria for eligible articles, including methodological criteria, for each recommendation. Librarians, in collaboration with guideline authors and methodologists, conducted systematic searches for evidence. Guideline authors systematically evaluated the evidence, considered the full range of benefits, risks, inconvenience, and costs associated with alternative management strategies, considered patients' underlying values and preferences, and made recommendations accordingly. To increase the likelihood that the recommendations adequately represent patient values and preferences, the development process included a review of recommendations by research methodologists, practicing generalists, and specialists. Chapters are organized so that evidence is clearly linked to the relevant recommendations, and that recommendations particularly sensitive to underlying values and preferences are explicitly identified. Authors paid careful attention to the strength of the underlying evidence and to the balance between risks and benefits, which are both reflected in the grades of recommendations. Thus, improvements to the process of making recommendations for the ACCP guidelines include the explicit definition of questions, transparent eligibility criteria for including studies, and the specification of values and preferences underlying recommendations where they are particularly relevant. In combination with our previous practice of grading recommendations according to their strength, and the methodological quality of the supporting studies, these innovations establish our guidelines as, by and large, evidence based.

Bias↗
PubMed2004

Applying the grades of recommendation for antithrombotic and thrombolytic therapy: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy.

This article about the grades of recommendation for antithrombotic and thrombolytic therapy is part of the Seventh American College of Chest Physicians Conference on Antithrombotic and Thrombolytic Therapy: Evidence-Based Guidelines. Clinicians need to know whether a recommendation is strong or weak, and about the methodological quality of the evidence underlying that recommendation. We determine the strength of a recommendation by considering the trade-off between the benefits of a treatment, on the one hand, and the risks, burdens, and costs on the other. Here, as elsewhere, we assume that a recommended treatment will increase costs (we recognize this is not always the case, but for simplicity we will continue to make this assumption). If the benefits outweigh the risks, burdens, and costs, we recommend that clinicians offer a treatment to typical patients. The uncertainty associated with the trade-off between the benefits and the risks, burdens, and costs will determine the strength of the recommendations. If we are very certain that the benefits do, or do not, outweigh the risks, burdens, and costs, we make a strong recommendation (in our formulation, Grade 1). If we are less certain of the magnitude of the benefits and the risks, burdens, and costs, and thus of their relative impact, we make a weaker Grade 2 recommendation. We grade the methodological quality of a recommendation according to the following criteria. Randomized clinical trials (RCTs) with consistent results provide evidence with a low likelihood of bias, which we classify as Grade A recommendations. RCTs with inconsistent results, or with major methodological weaknesses, warrant Grade B recommendations. Grade C recommendations come from observational studies or from a generalization from one group of patients included in randomized trials to a different, but somewhat similar, group of patients who did not participate in those trials. When we find the generalization from RCTs to be secure, or the data from observational studies overwhelmingly compelling, we choose a Grade C+. When that is not the case, we designate methodological quality as Grade C.

Bias↗
PubMed2004

Antithrombotic and thrombolytic therapy: from evidence to application: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy.

This chapter about implementation strategies for practice guidelines is part of the 7th ACCP Conference on Antithrombotic and Thrombolytic Therapy: Evidence Based Guidelines. Grade 1 recommendations are strong and indicate that the benefits do, or do not, outweigh risks, burden, and costs. Grade 2 suggests that feasibility, acceptability and cost related to implementation strategies may lead to different choices depending on the practice setting (for a full understanding of the grading see Guyatt et al, CHEST 2004; 126:179S-187S). To encourage uptake of guidelines to reduce thrombosis, we recommend that appreciable resources be devoted to distribution of educational material (Grade 2B). We suggest that few resources be devoted to educational meetings (Grade 2B), to audit and feedback (Grade 2B), or to educational outreach visits (Grade 2B) to encourage uptake of the guidelines. We suggest that appreciable resources be devoted to computer reminders (Grade 2A) and to patient-mediated interventions (Grade 2B) to encourage uptake of the guidelines. This review suggests that there are few implementation strategies that are of unequivocal, consistent benefit, and that are clearly and consistently worth resource investment. Fully informed decisions will require additional research to identify effective guideline implementation strategies to optimize antithrombotic and thrombolytic therapy.

Education↗
PubMed2003

Withdrawal of mechanical ventilation in anticipation of death in the intensive care unit.

BACKGROUND: In critically ill patients who are receiving mechanical ventilation, the factors associated with physicians' decisions to withdraw ventilation in anticipation of death are unclear. The objective of this study was to examine the clinical determinants that were associated with the withdrawal of mechanical ventilation. METHODS: We studied adults who were receiving mechanical ventilation in 15 intensive care units, recording base-line physiological characteristics, daily Multiple Organ Dysfunction Scores, the patient's decision-making ability, the type of life support administered, the use of do-not-resuscitate orders, the physician's prediction of the patient's status, and the physician's perceptions of the patient's preferences about the use of life support. We examined the relation between these factors and withdrawal of mechanical ventilation, using Cox proportional-hazards regression analysis. RESULTS: Of 851 patients who were receiving mechanical ventilation, 539 (63.3 percent) were successfully weaned, 146 (17.2 percent) died while receiving mechanical ventilation, and 166 (19.5 percent) had mechanical ventilation withdrawn. The need for inotropes or vasopressors was associated with withdrawal of the ventilator (hazard ratio, 1.78; 95 percent confidence interval, 1.20 to 2.66; P=0.004), as were the physician's prediction that the patient's likelihood of survival in the intensive care unit was less than 10 percent (hazard ratio, 3.49; 95 percent confidence interval, 1.39 to 8.79; P=0.002), the physician's prediction that future cognitive function would be severely impaired (hazard ratio, 2.51; 95 percent confidence interval, 1.28 to 4.94; P=0.04), and the physician's perception that the patient did not want life support used (hazard ratio, 4.19; 95 percent confidence interval, 2.57 to 6.81; P<0.001). CONCLUSIONS: Rather than age or the severity of the illness and organ dysfunction, the strongest determinants of the withdrawal of ventilation in critically ill patients were the physician's perception that the patient preferred not to use life support, the physician's predictions of a low likelihood of survival in the intensive care unit and a high likelihood of poor cognitive function, and the use of inotropes or vasopressors.

Adult↗
PubMed2003

Influence of perceived functional and employment status on cardiopulmonary resuscitation directives.

BACKGROUND: Perceptions about functional and employment status before admission to the intensive care unit (ICU) may influence how patients and clinicians make decisions about cardiopulmonary resuscitation. OBJECTIVE: To examine the relationship between cardiopulmonary resuscitation directives established within 24 hours of admission to the ICU and clinical perceptions of premorbid functional and employment status. DESIGN: Prospective observational study in 15 university-affiliated centers in Canada, the United States, Australia, and Sweden. PATIENTS: A total of 1,008 ICU patients aged 18 years or older expected to stay in the ICU at least 72 hours. MEASUREMENTS: By using multinomial logistic regression, we examined the relationship between functional status and employment status perceived by the ICU team 1 month before ICU admission (the independent variables) and resuscitation status (the dependent variable). Each patient had either an explicit resuscitation directive (to resuscitate or not to resuscitate), or an implicit resuscitation directive to resuscitate. RESULTS: On average, patients were 61.7 years (+/-17.4 y) old with an Acute Physiology and Chronic Health Evaluation (APACHE) II score of 21.5 (+/-8.7); 846 (83.9%) were ventilated mechanically within 48 hours and 345 (34.2%) died in the ICU. Most patients (793, 78.7%) had no explicit resuscitation directive; 98 (9.7%) had an explicit plan to resuscitate, whereas 117 (11.6%) had an explicit plan of do-not-resuscitate. Of 1,008 patients, 98 (9.7%) were severely functionally limited, 217 (21.5%) were somewhat limited, 628 (62.3%) were totally independent, and 65 (6.4%) had unknown functional status 1 month before ICU admission. Severe functional status impairment was associated moderately with an explicit plan to resuscitate (odds ratio, 2.2 relative to no explicit directive) and associated strongly with an explicit do-not-resuscitate plan (odds ratio, 6.2 relative to no explicit directive, P value on the difference =.011). This relationship was not influenced by age, sex, APACHE II score, medical or surgical status, admission diagnosis, employment status, or city. However, severe functional status was associated strongly and significantly with an explicit do-not-resuscitate directive among those who could not participate in decision making (odds ratio, 8.2; 95% confidence interval, 4.5-15.0), and more weakly associated in those who could participate (odds ratio, 1.7; 95% confidence interval, 0.3-8.6). Being unemployed was associated with an increased odds of an explicit resuscitation directive versus no explicit directive (odds ratio, 5.5; 95% confidence interval, 2.2-13.4). CONCLUSIONS: Functional status impairment perceived by the ICU team is associated clearly with do-not-resuscitate directives in patients unable to participate in decision making. However, the association appears much weaker in patients able to participate in decision making. PATIENTS' perceived employment status also may influence resuscitation decisions. Our results emphasize the challenges of ensuring that crucial resuscitation decisions are not affected adversely by patients' inability to participate in decisions, and by their functional and employment status.

APACHE↗
PubMed2003

Comparative responsiveness of generic and specific quality-of-life instruments.

We assessed the relative responsiveness of generic and specific quality of life instruments in 43 randomized controlled trials that compared head-to-head 31 generic and 84 specific instruments. Using weighted effect size as the metric of responsiveness, we assessed the impact of instrument type, disease category, and magnitude of underlying therapeutic effect on responsiveness, and assessed the responsiveness of specific instruments relative to the corresponding domains of generic measures. In studies with a nonzero therapeutic effect, specific instruments (mean = 0.57) were significantly more responsive than generic instruments (mean = 0.39, P =.01), and than the corresponding domains of generic instruments (mean = 0.40, P =.03). Studies with low, medium, and high therapeutic effects showed a corresponding gradation in responsiveness differences between specific and generic instruments. We conclude that, overall, specific instruments are more responsive than generic tools, and that investigators may come to misleading conclusions about relative instrument responsiveness if they include studies in which the magnitude of the underlying therapeutic effect is zero.

Health Status Indicators↗
PubMed2003

Agreement between mothers and children aged 11-14 years in rating child oral health-related quality of life.

OBJECTIVES: To assess the agreement between mothers and children concerning the child's oral health-related quality of life. METHODS: A total of 42 pairs of mothers and children aged 11-14 years with oral and orofacial conditions completed the parental (PPQ) and child (CPQ(11-4)) components of the Child Oral Health Quality of Life Questionnaire. The PPQ and CPQ(11-14) are analogous questionnaires with 31 common items. Agreement between overall and subscale scores derived from the questionnaires were assessed in comparison and in correlation analyses. The former used mean directional differences between mothers and children to assess bias and mean absolute differences to assess agreement at the group level. The latter used intraclass correlation coefficients (ICCs) to assess agreement at the level of individual mother-child pairs. RESULTS: At the group level, agreement between mothers and children was good. There was little evidence of bias in mothers' reports compared to those of their children. The mean absolute difference in overall scores constituted 9% of the possible range of scores. However, the significance of this difference is difficult to interpret. The ICC for overall scores was 0.70 indicating substantial agreement between mother and child pairs. However, the ICCs for the emotional and social well-being subscales indicated moderate agreement only. There was a suggestion that the level of agreement varied according to the characteristics of the child. CONCLUSION: Although mothers may be used as proxies for their children in some circumstances and for some purposes, the views of both should be obtained in order to fully represent child oral health-related quality of life.

Adolescent↗
PubMed2003

A guide to health measurement.

Limited healthcare dollars have resulted in insistence that the benefit of new therapies be evaluated before being approved for marketing or reimbursement under health service systems. Adequate evidence of a treatment's effectiveness includes evidence of impact on patient's health-related quality of life, including physical, mental, and emotional health. There are two types of measures of health-related quality of life. One, general health and utility measures, inquire about health in a broad sense, and can be applied and compared across many situations. The second type, specific measures, addresses narrower aspects of life related to a specific problem, function, or manifestations of an underlying disease process. Results of studies focusing on health-related quality of life only will be useful if the measurement instrument is valid and capable of detecting important change. Investigators should make a good choice of measurement instrument, and then ensure their study design will yield valid results. We offer basic guidelines for the measurement of health-related quality of life as an outcome in clinical research. This discussion addresses clinicians, who are making decisions regarding the relevance of study results, and investigators who are designing studies.

Communication↗
PubMed2003

Adaptation to the Intensive Care Environment (ATICE): development and validation of a new sedation assessment instrument.

OBJECTIVE: To develop a valid, reliable, and responsive bedside instrument assessing Adaptation to the Intensive Care Environment (ATICE) in mechanically ventilated adult intensive care unit (ICU) patients. DESIGN: Instrument development and prospective clinimetric evaluation. SETTING: University-affiliated medical ICU. PATIENTS: Consecutive patients with expected mechanical ventilation of >/=12 hrs. INTERVENTIONS: Administration of ATICE. MEASUREMENTS AND MAIN RESULTS: Item generation for the ATICE involved focus groups and literature review. The ATICE consists of five items: Awakeness and Comprehension combined in a Consciousness domain, and Calmness, Ventilator Synchrony, and Face Relaxation combined in a Tolerance domain. Clinical sensibility of the ATICE assessed by ten ICU physicians and 20 ICU nurses not involved in the development of the ATICE was rated highly (median values 5-7 on a 7-point scale). The ATICE was administered to 80 patients during a total of 152 assessments. Each assessment was performed by three raters (ICU physician, ICU nurse, research nurse), concomitantly with independent scoring of four scales (Ramsay Scale, Riker Scale, Glasgow Coma Scale, and Comfort Scale) and six visual analog scales. Internal consistency was high, as reflected by Cronbach's alpha for the Consciousness and Tolerance domains of .87 and .67, respectively. Intraclass correlation coefficients for the Consciousness and the Tolerance domains ranged from .92 to .99, indicating high interrater reliability. Cross-sectional and longitudinal validity was confirmed for the overall ATICE and the Consciousness and Tolerance domains, as reflected by strong correlations between ATICE and the relevant items or domains of the Ramsay Scale, Riker Scale, Glasgow Coma Scale, Comfort Scale, each of the visual analog scales, and the amounts of sedatives and analgesics administered. CONCLUSIONS: The ATICE measures the adaptation of mechanically ventilated patients to the ICU environment. After rigorous multidisciplinary development, we demonstrated high reliability, validity, and responsiveness of this instrument.

Adaptation, Psychological↗