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Biomedical subjects

G Guyatt

Publications and source records attributed to G Guyatt.

At least 55 records · Page 3Linked to original sources

Evaluating the performance of academic medical education administrators.

Educators have devoted little attention to formal evaluation of educational administrative personnel. The authors surveyed the educational administrators working in McMaster University's Department of Medicine residency program and found they felt they were receiving little useful feedback. The authors also surveyed the colleagues, residents, and administrative staff with whom the administrators worked and found they felt they had inadequate input into the administrators' evaluation. In response to these results, a measurement instrument was developed based on existing job descriptions and feedback was obtained on administrators' performance from relevant individuals. After three yearly evaluations, administrators and evaluators acknowledged much broader input into evaluation but saw little evaluation-related improvement in performance. Of the administrators, 85% felt the process should continue as did 91% of the evaluators. An evaluation process may not alter perceived performance when it is already good but there may be other benefits to rigorous evaluation.

Attitude of Health Personnel↗

Evidence-based medicine in everyday practice.

The evidence-based medicine method of answering clinical questions involves searching the literature for relevant studies, assessing study quality, interpreting the findings, and applying them in light of patients' preferences and societal values. In this article, evidence-based methods are used to solve questions posed by two patients.

Aged↗

The ineffectiveness of immunosuppressive therapy in lymphocytic myocarditis: an overview.

BACKGROUND: The use of immunosuppressive therapy for myocarditis is controversial. PURPOSE: To review the literature on the effectiveness of immunosuppressive therapy in biopsy-proven lymphocytic myocarditis. DATA SOURCES: Two authors independently searched MEDLINE and other medical databases from 1980 to 26 June 1997. STUDY SELECTION: Randomized, controlled trials; matched-cohort studies; and case-control studies of patients with biopsy-proven myocarditis (Dallas criteria or a mean of > or = 2.5 lymphocytes per high-power field) for which any form of immunosuppressive treatment was used. The outcomes of interest were mortality and change in left ventricular ejection fraction. DATA EXTRACTION: 6 of 374 studies satisfied the selection criteria. DATA SYNTHESIS: In survivors, left ventricular function in myocarditis improved approximately 10% over 6 months without immunosuppressive treatment. Prednisone alone did not improve survival (P >0.2) or left ventricular function (P >0.11). Prednisone combined with azathioprine or cyclosporine did not improve survival (P >0.2) or left ventricular function (P >0.2) in three studies. However, one small matched-cohort study showed improvement in children (P <0.01). Neither interferon nor thymic hormone improved survival or left ventricular function. CONCLUSIONS: Immunosuppressive therapy is ineffective in lymphocytic myocarditis. Current therapy in lymphocytic myocarditis seems to be limited to supportive measures or transplantation.

Clinical Trials as Topic↗

A comparison of sucralfate and ranitidine for the prevention of upper gastrointestinal bleeding in patients requiring mechanical ventilation. Canadian Critical Care Trials Group.

BACKGROUND: Critically ill patients who require mechanical ventilation are at increased risk for gastrointestinal bleeding from stress ulcers. There are conflicting data on the effect of histamine H2-receptor antagonists and the cytoprotective agent sucralfate on rates of gastrointestinal bleeding, ventilator-associated pneumonia, and mortality. METHODS: In a multicenter, randomized, blinded, placebo-controlled trial, we compared sucralfate with the H2-receptor antagonist ranitidine for the prevention of upper gastrointestinal bleeding in 1200 patients who required mechanical ventilation. Patients received either nasogastric sucralfate suspension (1 g every six hours) and an intravenous placebo or intravenous ranitidine (50 mg every eight hours) and a nasogastric placebo. RESULTS: The patients in the two groups had similar base-line characteristics. Clinically important gastrointestinal bleeding developed in 10 of 596 (1.7 percent) of the patients receiving ranitidine, as compared with 23 of 604 (3.8 percent) of those receiving sucralfate (relative risk, 0.44; 95 percent confidence interval, 0.21 to 0.92; P=0.02). In the ranitidine group, 114 of 596 patients (19.1 percent) had ventilator-associated pneumonia, as compared with 98 of 604 (16.2 percent) in the sucralfate group (relative risk, 1.18; 95 percent confidence interval, 0.92 to 1.51; P=0.19). There was no significant difference between the groups in mortality in the intensive care unit (ICU) (23.5 percent in the ranitidine group and 22.9 percent in the sucralfate group) or the duration of the stay in the ICU (median, nine days in both groups). CONCLUSIONS: Among critically ill patients requiring mechanical ventilation, those receiving ranitidine had a significantly lower rate of clinically important gastrointestinal bleeding than those treated with sucralfate. There were no significant differences in the rates of ventilator-associated pneumonia, the duration of the stay in the ICU, or mortality.

Aged↗

Adjudicating ventilator-associated pneumonia in a randomized trial of critically ill patients.

PURPOSE: The purpose of this study was to evaluate an adjudication strategy for diagnosing ventilator-associated pneumonia (VAP) in a randomized trial. MATERIALS AND METHODS: In a double-blind trial of sucralfate versus ranitidine, one of four pairs of adjudicators examined each case of clinically suspected VAP. Nurse and physician notes and all relevant laboratory data were allocated to each adjudication pair in groups of five patients. Each reader in the pair decided whether the patient had VAP; differences were resolved by consensus discussion. RESULTS: The overall unadjusted study odds ratio for VAP was 0.82 (P = .21) representing a trend toward less pneumonia with sucralfate compared with ranitidine. The odds ratio adjusted for adjudication pair was 0.85 (P = .27). The proportion of charts adjudicated as VAP positive among pairs ranged from 50% to 92%; crude agreement between readers in each pair varied from 50% to 82%. When adjudicators disagreed, the final consensus was split evenly between the two adjudicators' initial opinions in two pairs; in the other two pairs, the final decision reflected one dominant initial opinion. Personnel time to adjudicate all patients with a suspicion of VAP was 74 days. CONCLUSIONS: Though adjudication of outcomes such as VAP is time-consuming, consistent decision-making requires strict criteria, training, and calibration. Patients should be assigned to adjudication teams through random allocation.

Anti-Ulcer Agents↗

Methodological and statistical issues of quality of life (QoL) and economic evaluation in cancer clinical trials: report of a workshop.

In recent years, quality of life (QoL) and economic evaluations have become increasingly important as additional outcome measures in cancer clinical trials. However, both fields of research are relatively new and in need of finding solutions to a substantial number of specific methodological problems. This paper reports on the proceedings of a symposium aimed at summarising and discussing some of the most contentious methodological and statistical issues in QoL and economic evaluations. In addition, possible solutions are indicated and the most pertinent areas of research are identified. Issues specific to QoL evaluations that are addressed include clinically meaningful changes in QoL scores; how to analyse QoL data and to handle missing and censored data and integration of length of life and QoL outcomes. Issues specific to economic evaluations are the advantages and disadvantages of various outcome measures; statistical methods to analyse economic data and choice of decision criteria and analytical perspective. How to perform QoL and economic evaluations in large and simple trials and whether the gap between QoL and utility measures can be bridged are also discussed.

Clinical Trials as Topic↗

Frequency and methodologic rigor of quality-of-life assessments in the critical care literature.

OBJECTIVES: To present a framework for describing/measuring quality of life (QOL) and health-related quality of life (HRQL), and to assess the frequency and methodologic rigor of QOL studies in the adult critical care literature. DATA SOURCES: Computerized bibliographic search of published research, manual search of key intensive care unit (ICU) journals, and citation review of relevant articles. STUDY SELECTION: We manually searched Critical Care Medicine, American Journal of Respiratory and Critical Care Medicine, and Intensive Care Medicine for the period January 1992 to July 1995 to assess the frequency of published QOL studies. Combined with a computerized bibliographic search, we found 64 studies that met our criteria that reported on patient-related outcomes (other than mortality) after hospital discharge. DATA EXTRACTION: We abstracted data on the nature of each study, the instruments used to measure QOL, and the methodologic rigor of the QOL assessments. We evaluated each study using criteria we developed to assess the validity of HRQL measurements. MEASUREMENTS AND MAIN RESULTS: In our manual search, we found 1,073 articles relevant to the practice of adult critical care. Of these, 19 (1.7%)/1073 included QOL measurements. Combined with our comprehensive search strategy, we found 64 papers that evaluated QOL in ICU patients. These papers dealt primarily with issues of: prognosis (32 [50%]), resource allocation (23 [36%]), and clinical prediction (9 [14%]). We found no randomized trials that included post-ICU QOL as an outcome. With respect to the validity of the HRQL assessments, 63/64 (98%) studies evaluated aspects of patients' lives that we considered important. Thirty-three (52%) studies were limited in scope to specific aspects of HRQL, and 31 (48%) studies covered broad areas of HRQL. In these 64 studies, there were 108 different instruments used. The reliability and validity of the instruments used were reported in 7 (6%) and 15 (14%) cases, respectively. For 81 (75%) instruments, the investigators either explained the results or used informative, qualitative descriptors whose interpretation was self-evident. Overall, three (5%) of the included studies met all four methodologic criteria to assess the validity of HRQL assessments. CONCLUSIONS: QOL assessments occur infrequently in the ICU literature and are of limited methodologic quality. More studies using valid and reliable instruments are necessary to document the long-term QOL of critically ill patients, especially those at risk of a "poor" outcome.

Adult↗

Quality-of-life assessments and chronic liver disease.

Clinicians, researchers, and policy makers are increasingly recognizing the importance of measuring quality of life (QOL) to complement clinical, physiological and biochemical outcomes and to integrate the traditional "biomedical model" of health with the "social science or QOL model." This view is of particular importance to patients with chronic liver diseases because of the intense resource utilization and the profound impact of liver disease on patients' well-being. Although many extensively validated generic QOL instruments are available, a disease-specific instrument for chronic liver disease is not available. Generic indices allow investigators the opportunity to capture the global impact of disease on patients' well-being and to compare different programs with disparate endpoints. A disease-specific instrument may be more responsive and may capture small but clinically important changes that occur as a result of therapy or natural progression of disease. This article reviews all important issues of QOL and their relevance to patients with chronic liver diseases.

Attitude to Health↗

Development of a health-related quality-of-life questionnaire (PCOSQ) for women with polycystic ovary syndrome (PCOS).

OBJECTIVE: To develop a self-administered questionnaire for measuring health-related quality of life (HRQL) in women with polycystic ovary syndrome (PCOS). METHODS: We identified a pool of 182 items potentially relevant to women with PCOS through semistructured interviews with PCOS patients, a survey of health professionals who worked closely with PCOS women, and a literature review. One hundred women with PCOS completed a questionnaire in which they told us whether the 182 items were relevant to them and, if so, how important the issue was in their daily lives. We included items endorsed by at least 50% of women in the analysis plus additional items considered crucial by clinicians and an important subgroup of patients in a factor analysis. We chose items for the final questionnaire taking into account both item impact (the frequency and importance of the items) and the results of the factor analysis. RESULTS: Over 50% of the women with PCOS labelled 47 items as important to them. Clinicians chose 5 additional items from the infertility domain, 4 of which were identified as important by women who were younger, less educated, married, and African-American. The Cattell's Scree plot from a factor analysis of these 51 items suggested 5 factors that made intuitive sense: emotions, body hair, weight, infertility, and menstrual problems. We chose the highest impact items from these 5 domains to construct a final questionnaire, the Polycystic Ovary Syndrome Questionnaire (PCOSQ), which includes a total of 26 items and takes 10-15 minutes to complete. CONCLUSIONS: We have used established principles to construct a questionnaire that promises to be useful in measuring health-related quality of life. The questionnaire should be tested prior to, or concurrent with, its use in randomized trials of new treatment approaches.

Adult↗

Health status assessment of the elderly.

The elderly are a heterogeneous population group who range from well and completely independent individuals to a smaller proportion who are frail, require help and are high users of the healthcare system. Since health is a state of well-being which includes the domains of social, spiritual, psychological and physical function, each of these domains must be evaluated when we are measuring the health of older adults. In this article, we discuss some of the more important aspects of these domains. If we focus exclusively on the diseases which occur in older adults we will miss important aspects of their health status. We may miss the interactions of several different disease processes occurring in 1 individual, and the impact of those diseases on the individual's ability to live independently and his or her quality of life. In this article, we not only justify the measurement of function, cognition, affect and quality of life in the elderly but we also describe the necessary measurement qualities of instruments used to measure health-related quality of life in the elderly. We provide some examples of measurement approaches with which we as researchers and health workers are familiar.

Aged↗

Does treatment with L-thyroxine influence health status in middle-aged and older adults with subclinical hypothyroidism?

OBJECTIVE: To determine if health-related quality of life (HRQL) in patients of middle age and older with elevated thyroid-stimulating hormone (TSH) and normal total thyroid hormone levels-subclinical hypothyroidism-improves with L-thyroxine replacement therapy. DESIGN: Randomized, double-blind, placebo-controlled trial. SETTING: Outpatient clinic. PATIENTS: Thirty-seven patients with subclinical hypothyroidism, most with symptoms consistent with hypothyroidism, over 55 years of age. INTERVENTIONS: Placebo or L-thyroxine replacement therapy to achieve normal TSH level. MEASUREMENTS AND MAIN RESULTS: Disease-specific and general HRQL, cognitive function, bone mineral density, lipid levels. The mean daily dose of L-thyroxine replacement in the active group was 68 +/- 21 micrograms. TSH decreased by 8.6 mIU/L (95% confidence interval [CI] 4.1 to 13.1) and T4 increased by 27.9 nmol/L (95% CI 14.8 to 41.2). There was a statistically significant improvement in a composite psychometric memory score in treated versus control patients; all other outcomes showed similar findings in the two groups. Although confidence intervals for most measures did not exclude an important improvement in HRQL with thyroid replacement, no measure of symptoms or HRQL either showed clinically important trends in favor of treatment, or approached conventional levels of statistical significance. CONCLUSIONS: In middle-aged and older patients with elevated TSH and normal T4, it may not be harmful to follow biochemical and clinical status even in the presence of nonspecific symptoms potentially associated with hypothyroidism.

Aged↗

A new measure of parent satisfaction with medical care provided in the neonatal intensive care unit.

The objective of this study was to develop a valid and reliable discriminative index that measures parent satisfaction with the medical care of their infant in the NICU. We developed an initial questionnaire (Item Reduction Questionnaire) by reviewing the literature, surveying 63 NICU clinicians, and interviewing 125 parents of infants in 2 tertiary level NICUs regarding what they liked and disliked about the medical care of their infants. We administered the Item Reduction Questionnaire, which included 154 items, to 60 parents, who rated the frequency and importance of these items. We included the items identified most frequently as sources of dissatisfaction and rated most important in a second, briefer instrument, the Neonatal Index of Parent Satisfaction (NIPS). To measure reliability we administered the NIPS to 47 parents twice, separated by a 1-week interval. We assessed validity by comparing actual to predicted correlations between NIPS scores and other measures: parent's global rating of satisfaction, medical caregiver ratings of mother's satisfaction, medical caregiver ratings of father's satisfaction, and parents' perception of their infant's health status. We also compared mean NIPS scores for parents who did and who did not report incidents when errors occurred in the medical care of the infant. Of 154 items generated, we included 27 in the NIPS. The intraclass correlation between two administrations of the NIPS to the same 47 parents was 0.71. As predicted, there was a high correlation (0.61) between the NIPS score and parent global rating of satisfaction, and much lower correlations with other variables. Mean NIPS scores for parents who did and who did not report errors differed significantly (difference, 14.6; 95% CI around difference, 5.8-23.5; p < 0.001). The NIPS is likely to be a useful measure for discriminating between parents who differ in terms of their satisfaction with the medical care of their infant in the NICU.

Adult↗

A controlled trial of nurse practitioners in neonatal intensive care.

OBJECTIVE: To compare a clinical nurse specialist/neonatal practitioner (CNS/NP) team with a pediatric resident team in the delivery of neonatal intensive care. DESIGN: Randomized, controlled trial. SETTING: A 33-bed tertiary-level neonatal intensive care unit. PATIENTS: Of 821 infants admitted to the neonatal intensive care unit between September 1991 and September 1992, 414 were randomized to care by the CNS/NP team, and 407 were randomized to care by the pediatric resident team. INTERVENTION: Infants assigned to the CNS/NPs team were cared for by CNS/NPs during the day and by pediatric residents during the night. Infants assigned to the pediatric resident team were cared for by pediatric residents around the clock. Neonatologists supervised both teams. MEASURES: Outcome measures included mortality; number of neonatal complications; length of stay; quality of care, as assessed by a quantitative indicator condition approach; parent satisfaction with care, measured using the Neonatal Index of Parent Satisfaction; long-term outcomes, measured using the Minnesota Infant Development Inventory; and costs. RESULTS: There were 19 (4.6%) deaths in the CNS/NP group and 24 (5.9%) in the resident group (relative risk [RR], 0.78; confidence interval [CI], 0.43 to 1.40). In the CNS/NP group, 230 (55.6%) neonates had complications, in comparison with 220 (54.1%) in the resident group (RR, 1.03; CI 0.91 to 1.16). Mean lengths of stay were 12.5 days in the CNS/NP group and 11.7 days in the resident group (difference in means, 0.8 days; CI, -1.1 to 2.7). The performance on the indicator conditions was comparable in the two groups except for two instances, jaundice and charting, both of which favored the CNS/NP group. Mean scores on the Neonatal Index of Parent Satisfaction were 140 in the CNS/NP group and 139 in the resident group (difference in means, 1.0; CI, -3.6 to 5.6). In the CNS/NP group, 6 (2.6%) infants performed 30% or more below their age level in the Minnesota Infant Development Inventory, in comparison with 2 (0.9%) in the resident group (RR, 2.87; CI, 0.59 to 14.06) The cost per infant in the CNS/NP group was $14,245 and in the resident group $13,267 (difference in means, $978; CI, -1303.18 to 3259.05). CONCLUSIONS: CNS/NP and resident teams are similar with respect to all tested measures of performance. These results support the use of CNS/NPs as an alternative to pediatric residents in delivering care to critically ill neonates.

Female↗