Showing papers by "Gordon H. Guyatt published in 1991"

Development and testing of a new measure of health status for clinical trials in rhinoconjunctivitis.

Abstract: The objective of this study was to develop and test a health-related quality of life questionnaire for clinical trials in rhinoconjunctivitis. The Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) was developed by asking patients to identify areas of their lives affected by rhinoconjunctivitis. The resultant RQLQ was tested for reproducibility, responsiveness and validity in a randomized, double-blind trial of regular versus 'as required' aqueous beclomethasone dipropionate (BDP) nasal spray in ragweed pollen-induced rhinoconjunctivitis. Eighty-five patients from previous rhinoconjunctivitis studies participated in the developmental survey. Sixty ragweed-sensitive patients, from previous trials and media notices, were enrolled in the clinical trial. Aqueous BDP (800 micrograms) nasal spray was administered regularly or 'as required' throughout the ragweed pollen season. The survey revealed that, in addition to local symptoms of rhinoconjunctivitis, patients experienced impairment of quality of life through systemic symptoms, sleep disturbance, practical problems, activity limitations and emotional problems. The RQLQ includes 28 questions related to these dimensions. Repeated administration of the RQLQ demonstrated good reproducibility. During the clinical trial, the RQLQ proved responsive in its ability to distinguish between regular and 'as required' medication use. Validity was shown by moderate to strong relations between changes in symptom diary scores and changes in RQLQ scores. In conclusion the RQLQ is likely to prove useful as a measure of health-related quality of life in clinical trials in both rhinoconjunctivitis and rhinitis.

Effects on quality of life with comprehensive rehabilitation after acute myocardial infarction.

Abstract: This investigation was designed to determine the impact of a brief period of cardiac rehabilitation, initiated within 6 weeks of acute myocardial infarction (AMI), on both disease-specific and generic health-related quality of life, exercise tolerance and return to work after AMI. With a stratified, parallel group design, 201 low-risk patients with evidence of depression or anxiety, or both, after AMI, were randomized to either an 8-week program of exercise conditioning and behavioral counseling or to conventional care. Although the differences were small, significantly greater improvement was seen in rehabilitation group patients at 8 weeks in the emotions dimension of a new disease-specific, health-related Quality of Life Questionnaire, in their state of anxiety and in exercise tolerance. All measures of health-related quality of life in both groups improved significantly over the 12-month follow-up period. However, the 95% confidence intervals around differences between groups at the 12-month follow-up effectively excluded sustained, clinically important benefits of rehabilitation in disease-specific (limitations, -2.70, 1.40; emotions, -4.86, 1.10, where negative values favor conventional care and positive values favor rehabilitation) and generic health-related quality of life (time trade-off, -0.062, 0.052; quality of well-being, -0.042, 0.035) or in exercise tolerance (-38.5, 52.1 kpm/min); also, return to work was similar in the 2 groups (relative risk, 0.93; confidence interval, 0.71, 1.64).(ABSTRACT TRUNCATED AT 250 WORDS)

A randomized control trial of right-heart catheterization in critically ill patients. Ontario Intensive Care Study Group.

Abstract: We investigated the impact of right-heart catheterization (RHC) on physiological status and stay in the intensive care unit. Thirty three of 148 potentially eligible patients were randomized. Fifty...

Evaluation of the burden of illness for pediatric asthmatic patients and their parents.

Abstract: To examine the quality-of-life burden of asthma in a pediatric population, we systematically surveyed 100 patients with moderate asthma and one parent of each patient to determine the impact of the disease on day-to-day life. We found that perceptions of burden of illness varied by viewpoint. For patients, the symptoms of asthma form the largest component of the burden of the disease; in addition, more than half of the sample listed various emotional function items that were of at least moderate bother to them. Parents cited worry and concern about the disease and the medications used to treat it and their inability to relieve their child's symptoms as the major components of the burden of the disease. We conclude that although pediatric patients with moderate asthma find the respiratory symptoms of the disease troublesome, few children perceive that their asthma poses a major disruption of their lives. For the parents of these patients, strategies could be implemented by clinicians to ease the common worries and concerns surrounding the child's asthma.

Clinical usefulness of amitriptyline in fibromyalgia: the results of 23 N-of-1 randomized controlled trials.

Abstract: Twenty-three double blind, randomized, multiple crossover trials (N-of-1 RCT) of amitriptyline were conducted in patients with fibromyalgia. The benefit of amitriptyline was assessed using a symptom questionnaire and count of tender points. To assess the usefulness of the method, the proportion of trials that provided a definite answer was examined. Completing the trial resulted in reaching a high degree of confidence in the final management decision in 74% of trials. In 35% of trials, results led to discontinuation of the drug which otherwise would have been continued indefinitely. The drug benefit, if present, was evident within first 2 weeks of therapy. We concluded that these results support the feasibility and usefulness of N-of-1 RCT in rheumatology practice.

Factors affecting physicians' decisions on caring for an incompetent elderly patient: an international study

Abstract: OBJECTIVES: To determine what treatment decisions physicians will make when faced with a hypothetical incompetent elderly patient with life-threatening gastrointestinal bleeding and to examine the relative importance of physician characteristics and factors (legal and ethical concerns, hospital costs, level of dementia, patient9s age, physician9s religion, patient9s wishes and family9s wishes) in making those decisions. DESIGN: Survey. SETTING: Family practice, medical and geriatrics rounds in academic medical centres and community hospitals in seven countries. PARTICIPANTS: Physicians who regularly cared for incompetent elderly patients. MAIN OUTCOME MEASURES: A self-administered questionnaire describing the elderly patient. Respondents were asked to choose one of four levels of care and to identify the level of importance factors had in making that decision. Older physicians, those less concerned about litigation, those for whom the level of dementia was important and those for whom the patient9s age was important were expected to give less aggressive care than the other physicians. MAIN RESULTS: Supportive care was chosen by 8.1% of the respondents, limited therapeutic care by 41.5%, maximum therapeutic care without admission to the intensive care unit (ICU) by 32.2% and maximum care with admission to the ICU by 18.2%. The patient9s wishes were reported by 91.0% as being extremely or very important in choosing the treatment. Stepwise logistic regression analysis revealed that the following variables independently predicted the level of treatment: level of dementia, country of residence, duration of practice, legal concerns, patient9s age and ethical concerns. These factors were significantly correlated with the physicians9 treatment choices (p less than 0.05). CONCLUSIONS: The importance that the physicians placed on the level of dementia was the strongest predictor of the level of care that would be provided. A societal consensus on the influence of cognitive function on the appropriate level of care as well as training of physicians in ethical issues are required.

Incidence of Clinically Important Bleeding in Mechanically Ventilated Patients

Abstract: The purpose of this study was to determine the incidence of clinically important gastrointestinal hemorrhage in mechanically ventilated patients, and to determine the risk factors for overt bleeding in this population. One hundred consecutive critically ill medical and surgical patients requiring mechanical ventilation for more than 48 hours were prospectively evaluated in a university-based tertiary care, medical/surgical intensive care unit. Seventyfour patients received stress ulcer prophylaxis. Overt bleeding occurred in nine paticnts (9.0%; 95% confidence interval [CI], 3.4-14.6%); eight of the nine patients had a coagulopathy. Clinically important bleeding occurred in two additional patients (2.0%; 95% CI, 0-6.2%). Multiple logistical regression analysis revcaled that only the presence of a coagulopathy (odds ratio 12.5; 95% CI, 3.4-46.5) and the presence of occult bleeding for six or more days (odds ratio 5.5; 95% CI, 1.2-25.4) were independently predictive of overt gastrointestinal hemorrhage. Six...

Validity and reliability of the Dysfunctional Behaviour Rating Instrument.

Abstract: The objective of this study was to examine the reliability and validity of the Dysfunctional Behaviour Rating Instrument (DBRI) in cognitively impaired older adults living in the community. A total of 184 adults with suspected cognitive impairment received a standardized history, physical examination and work-up that included the Standardized Mini-Mental State Examination. Caregivers scored a DBRI Behaviour Problem Checklist (BPC) and Lawton Scale for each patient. The reliability of the DBRI, measured by an intraclass correlation coefficient, was 0.75. The correlation coefficient between the DBRI and the BPC total score was 0.71. The correlations between the DBRI and the cognitive, activities of daily living and self-care domain scores of the BPC were lower (0.66, 0.38 and 0.26 respectively). The DBRI is a specific, reliable and valid caregiver-reported measure of dysfunctional behaviour in cognitively impaired elderly living in the community.

Effectiveness of a geriatric day hospital

Abstract: OBJECTIVE To determine whether there is a difference in the quality of life between elderly patients managed in a day hospital and those receiving conventional care. DESIGN Randomized controlled trial; assessment upon entry to study and at 3, 6 and 12 months afterward. SETTING Geriatrician referral-based secondary care. PATIENTS A total of 113 consecutively referred elderly patients with deteriorating functional status believed to have rehabilitation potential; 55 were assessed and treated by an interdisciplinary team in a day hospital (treatment group), and 58 were assessed in an inpatient unit or an outpatient clinic or were discharged early with appropriate community services (control group). OUTCOME MEASURES Barthel Index, Rand Questionnaire, Global Health Question and Geriatric Quality of Life Questionnaire (GQLQ). MAIN RESULTS Eight study subjects and four control subjects died; the difference was insignificant. Functional status deteriorated over time in the two groups; although the difference was not significant there was less deterioration in the control group. The GQLQ scores indicated no significant difference between the two groups in the ability to perform daily living activities and in the alleviation of symptoms over time but did show a trend favouring the control group. The GQLQ scores did indicate a significant difference in favour of the control group in the effect of treatment on emotions (p = 0.009). CONCLUSION The care received at the day hospital did not improve functional status or quality of life of elderly patients as compared with the otherwise excellent geriatric outpatient care.

Evaluation of Graduating Neonatal Nurse Practitioners

Abstract: To compare the knowledge and problem-solving, communication, and clinical skills of graduating neonatal nurse practitioners (NNPs) and pediatric residents, a cohort study was conducted in a 33-bed tertiary-level neonatal intensive care unit in a 400-bed teaching hospital affiliated with a faculty of health sciences. Participants were all (n = 10) NNP graduates from the first 3 years of the educational program and 13 (87%) of 15 second-year pediatric residents. One hundred multiple-choice questions and 20 radiographic slides were used to test knowledge; a semistructured oral examination tested problem-solving skills; three simulated interactions with parents tested communication skills; and seven simulated procedures tested clinical skills. Graduating NNPs scored similarly to the pediatric residents on the multiple-choice questions (difference –3.4%; 95% confidence interval [CI] around difference –9.7, 2.9), radiographs (difference –1.4%; 95% CI –11.5, 8.7), oral examination (difference 2.8%; 95% CI –11.1, 16.7), communication skills (simulated parents assessment: difference 0.8%; 95% CI –4.2, 5.7; expert observer assessment: difference 5.8%; 95% CI –2.8, 14.3), and clinical skills (difference 7.4%; 95% CI –5.5, 20.2). The NNPs about to graduate from their educational program showed knowledge and problem-solving, communication, and clinical skills equivalent to those of second-year pediatric residents and are thus likely to deliver comparable care in the clinical setting. The results support the adoption of the NNP role.

Clinical Usefulness of n-of-1 Randomized Controlled Trials in Patients with Nonreversible Chronic Airflow Limitation

Abstract: To determine if n-of-1 randomized controlled trials (n-of-1 RCT) are useful in the care of patients with nonreversible chronic airflow limitation (CAL). Individual trials had a double-blind, randomized, multiple crossover design. Patients with CAL were recruited from several respirology practices. For each individual trial the main outcome measure was a symptom questionnaire; peak flow measurements were used as a secondary measure. Physicians' plans of management (before and after trials) and confidence in the plans were determined. The proportion of trials that provided a definite clinical or statistical answer was established. Patients were followed, and long-term adherence to decisions based on n-of-1 RCT was examined. A total of 26 n-of-1 RCT in patients with CAL were attempted; 18 of these (69%) were completed. After 17 (94%) of the completed trials clinicians expressed a high degree of confidence in their management plans, confidence that was not, in any case, present before the trial. After 8 n-of-1 RCT (44% of all completed, or 31% of all trials) clinicians decided to stop the drug, which would otherwise have been continued indefinitely. In all 17 of the clinically definite n-of-1 RCT, the management decision that followed the trial was still being adhered to 40 months (on average) after completion of the trial. The results support the feasibility and usefulness of n-of-1 RCT in respirology practice.

Clinical significance of primitive reflexes in Alzheimer's disease.

Abstract: Study Objective: To establish the relationship between cognition, behavior, function, and clinical characteristics on the one hand, and the presence of primitive reflexes (PR) (pout, snout, palmomental and grasp) in patients with Alzheimer's disease (AD). Design: Cross-sectional survey. Setting: Secondary care geriatric practice specializing in the assessment of cognitive impairment. Subjects: 136 consecutive patients presenting with AD. Measurements: PR were assessed in standardized fashion by a single clinician. Cognitive function was measured using the Standardized Mini-Mental Status Examination, activities of daily living (ADL) and instrumental activities of daily living (IADL) were measured using the Lawton scale, and behavior was measured using the Behavioural Problem Checklist. Results: There was no difference in age or duration of dementia in those with and without PR, nor was there any difference in cognitive function. Despite this, patients with PR showed a greater degree of functional limitation and dysfunctional behavior. There was also a higher incidence of rigidity, gait abnormalities, and apraxia in patients with PR. Conclusions: Patients with primitive reflexes had more severe impairment in ADL function and dysfunctional behavior for an equal level of cognitive function.

Iron deficiency anemia in the elderly: the diagnostic process.

Abstract: OBJECTIVE: To determine the effectiveness of physician probability estimates calculated on the basis of findings from history-taking and physical examination in the diagnosis of iron deficiency anemia in elderly patients. DESIGN: Prospective study. SETTING: Two community hospitals offering secondary and tertiary care. PATIENTS: A total of 259 patients over 65 years of age found to have previously undiagnosed anemia. MEASURES: Physician estimates of the likelihood of iron deficiency before (pretest probability) and after (post-test probability) the laboratory test results were available. The hemogram was available to the physicians when they made their pretest probability estimates. Because the serum ferritin level proved to be the most powerful of the laboratory test results studied, the likelihood ratios associated with the post-test estimates were compared with the ratios associated with the serum ferritin level. MAIN RESULTS: The post-test probability estimates were influenced by the serum ferritin level and the pretest estimates. The post-test estimates derived from the findings obtained through history-taking and physical examination and the laboratory test results (including the serum ferritin level) were slightly less accurate in predicting iron deficiency than the serum ferritin level alone. Nevertheless, a model in which the pretest estimates were used in addition to the serum ferritin level to predict iron deficiency proved to be more powerful than the serum ferritin level alone (p = 0.006). This indicated that the limitations of the post-test estimates were due to a misinterpretation of the serum ferritin level and that the findings from history-taking and physical examination added important diagnostic information. CONCLUSIONS: Physicians must be aware of test properties to provide optimal care to their patients. If test results are properly interpreted, pretest probabilities derived from findings obtained through history-taking and physical examination can add useful information that will lead to more accurate diagnoses.