Development of a standardized, comprehensive "ideal drug detail".

OBJECTIVES: To develop a standardized, comprehensive ideal drug detail for use in face-to-face education about individual drugs. METHODS: A random sample of 603 physicians and pharmacists was selected and stratified to include input from each of the following specialties: family practice, internal medicine, surgery, pediatrics, psychiatry, obstetrics/gynecology, geriatric medicine and clinical pharmacology. Thirty-one potential items were generated by the investigators from a preliminary survey of a local convenience sample of physicians and pharmacists. A modified Delphi consensus process was used in the large sample to determine which items should be included in the ideal drug detail. In each round of the Delphi process, respondents rated each item on a seven-point scale of importance and were then given feedback of the cumulative ratings for each item. Rounds were continued until consensus was obtained on all items. RESULTS: The response rate to the first round was 55.3%; 85.5% of these respondents responded to the second round. Response rates varied between specialties from 44% to 70%. Attempts to contact nonresponders to measure potential nonrespondent bias were unsuccessful. Consensus was obtained on 19 items after the first round, and on the remaining 12 items after the second round. Four items were dropped because they were unimportant. There was variation in modal response between specialties on eight items. CONCLUSIONS: Consensus was obtained among a sizable and interested sample of Canadian physicians and pharmacists on the items of information needed to prescribe a drug appropriately. Subsequent work will refine this list into a usable template to develop ideal drug details for specific drugs, to develop an assessment process to measure quality of information, and to assess the impact of this program on prescribing and patient outcomes.

Interrater reliability of the Clinical Dementia Rating in a multicenter trial.

OBJECTIVE: To test the interrater reliability of the Clinical Dementia Rating (CDR) in a multicenter clinical trial. DESIGN: Observational study. SETTING: Training session for a multicenter trial of milameline, a direct muscarinic agonist, in the treatment of Alzheimer's disease. PARTICIPANTS: Twenty-four raters (physicians and nurses) familiar with drug trials and expert in the care of patients with Alzheimer's disease. METHODS: Independent scoring of the CDR using four videotaped CDR interviews. OUTCOME MEASURE: Interrater reliability, as tested by the Kappa statistic RESULTS: The overall interrater reliability was 0.62. Within the CDR domains, the global kappas ranged from 0.33 +/- 0.06 to 0.88 +/- 0.06. CONCLUSIONS: The data support moderate to high overall interrater reliability but show important difficulties in the reliable assessment of early dementia.

Systematic implementation of an advance directive program in nursing homes: a randomized controlled trial.

CONTEXT: Although advance directives are commonly used in the community, little is known about the effects of their systematic implementation. OBJECTIVES: To examine the effect of systematically implementing an advance directive in nursing homes on patient and family satisfaction with involvement in decision making and on health care costs. DESIGN: Randomized controlled trial conducted June 1, 1994, to August 31, 1998. SETTING AND PARTICIPANTS: A total of 1292 residents in 6 Ontario nursing homes with more than 100 residents each. INTERVENTION: The Let Me Decide advance directive program included educating staff in local hospitals and nursing homes, residents, and families about advance directives and offering competent residents or next-of-kin of mentally incompetent residents an advance directive that provided a range of health care choices for life-threatening illness, cardiac arrest, and nutrition. The 6 nursing homes were pair-matched on key characteristics, and 1 home per pair was randomized to take part in the program. Control nursing homes continued with prior policies concerning advance directives. MAIN OUTCOME MEASURES: Residents' and families' satisfaction with health care and health care services utilization over 18 months, compared between intervention and control nursing homes. RESULTS: Of 527 participating residents in intervention nursing homes, 49% of competent residents and 78% of families of incompetent residents completed advance directives. Satisfaction was not significantly different in intervention and control nursing homes. The mean difference (scale, 1-7) between intervention and control homes was -0.16 (95 % confidence interval [CI], -0.41 to 0.10) for competent residents and 0.07 (95% CI, -0.08 to 0.23) for families of incompetent residents. Intervention nursing homes reported fewer hospitalizations per resident (mean, 0.27 vs 0.48; P = .001) and less resource use (average total cost per patient, Can $3490 vs Can $5239; P = .01) than control nursing homes. Proportion of deaths in intervention (24%) and control (28%) nursing homes were similar (P = .20). CONCLUSION: Our data suggest that systematic implementation of a program to increase use of advance directives reduces health care services utilization without affecting satisfaction or mortality.

Assessment of patient capacity to consent to treatment.

OBJECTIVE: To compare results of a specific capacity assessment administered by the treating clinician, and a Standardized Mini-Mental Status Examination (SMMSE), with the results of expert assessments of patient capacity to consent to treatment. DESIGN: Cross-sectional study with independent comparison to expert capacity assessments. SETTING: Inpatient medical wards at an academic secondary and tertiary referral hospital. PARTICIPANTS: One hundred consecutive inpatients facing a decision about a major medical treatment or an invasive medical procedure. Participants either were refusing treatment, or were accepting treatment but were not clearly capable according to the treating clinician. MEASUREMENTS AND MAIN RESULTS: The treating clinician (medical resident or student) conducted a specific capacity assessment on each participant, using a decisional aid called the Aid to Capacity Evaluation. A specific capacity assessment is a semistructured evaluation of the participant's ability to understand relevant information and appreciate reasonably foreseeable consequences with regard to the specific treatment decision. Participants also received a SMMSE administered by a research nurse. Participants then had two independent expert assessments of capacity. If the two expert assessments disagreed, then an independent adjudication panel resolved the disagreement after reviewing videotapes of both expert assessments. Using the two expert assessments and the adjudication panel as the reference standard, we calculated areas under the receiver-operating characteristic curves and likelihood ratios. The areas under the receiver-operating characteristic curves were 0.90 for specific capacity assessment by treating clinician and 0.93 for SMMSE score (2p =.48). For the treating clinician's specific capacity assessment, likelihood ratios for detecting incapacity were as follows: definitely incapable, 20 (95% confidence interval [CI] 3. 6, 120); probably incapable, 6.1 (95% CI 2.6, 15); probably capable, 0.39 (95% CI 0.18, 0.81); and definitely capable, 0.05 (95% CI 0.01, 0.29). For the SMMSE, a score of 0 to 16 had a likelihood ratio of 15 (95% CI 5.3, 44), a score of 17 to 23 had a likelihood ratio of 0. 68 (95% CI 0.35, 1.2), and a score of 24 to 30 had a likelihood ratio of 0.05 (95% CI 0.01, 0.26). CONCLUSIONS: Specific capacity assessments by the treating clinician and SMMSE scores agree closely with results of expert assessments of capacity. Clinicians can use these practical, flexible, and evaluated measures as the initial step in the assessment of patient capacity to consent to treatment.

Predicting outcome in very low birthweight infants using an objective measure of illness severity and cranial ultrasound scanning.

AIM: To investigate the feasibility of developing an objective tool for predicting death and severe disability using routinely available data, including an objective measure of illness severity, in very low birthweight babies. METHOD: A cohort study of 297 premature babies surviving the first three days of life was made. Predictive variables considered included birthweight, gestation, 3 day cranial ultrasound appearances and 3 day CRIB (clinical risk index for babies) score. Models were developed using regression techniques and positive predictive values (PPV) and likelihood ratios (LR) were calculated. RESULTS: On univariate analysis, birthweight, gestation, 3 day CRIB score and 3 day cranial ultrasound appearances were each associated with death. On multivariate analysis, 3 day CRIB score and 3 day cranial ultrasound appearances remained independently associated. A 3 day CRIB score > 4 along with intraventricular haemorrhage (IVH) grade 3 or 4 was associated with a PPV of 64% and an LR of 9.8 (95% confidence limits 3.5, 27.9). Only 3 day CRIB score and 3 day cranial ultrasound appearances were associated with severe disability on univariate analysis. Both remained independently associated on multivariate analysis. A 3 day CRIB score > 4 along with an IVH grade of 3 or 4 was associated with a PPV of 60% and an LR of 24.2 (95% CI 4.4, 133.3). CONCLUSION: Incorporating objective measures of illness severity may improve current prediction of death and disability in premature infants.

Capacity to choose place of residence: autonomy vs beneficence?

Health care workers often perceive a conflict between autonomy and beneficence when dealing with clients living at risk in the community. Respect for personal freedom and the desire to help and protect vulnerable people frequently appear to demand opposite interventions. The assessment of decision-making capacity is a vital part of any process that deals with these complicated situations and can resolve some of the apparent conflict. Standardized assessment tools which are flexible enough to deal with the complexities of capacity assessment are needed. Health care workers aim to maximize the safety of people incapable of making decisions while protecting the freedom and autonomy of the capable. Some limits to autonomy must be accepted, especially where others' interests are threatened.

Measurement properties of the Clinical Risk Index for Babies--reliabilty, validity beyond the first 12 hours, and responsiveness over 7 days.

OBJECTIVES: Clinical Risk Index for Babies (CRIB) is a simple instrument used to measure clinical risk and illness severity in very low birth-weight infants. We assessed its reliability, validity beyond the first 12 hrs after birth, and responsiveness to individual change in condition after 7 days. DESIGN: Cohort study. SETTING: Three tertiary and three nontertiary UK hospitals. PATIENTS: Three hundred ninety-eight infants whose birth weight was <1501 g or who were born before a 31-wk gestation period. INTERVENTIONS: Inter- and intrarater reliability of data extraction were assessed by Pearson and intraclass correlation. To validate CRIB, we tested the correlation between clinical risk and illness severity with the risk of: a) death; b) prolonged treatment with supplemental oxygen; and c) disability at 2 yrs. Logistic regression models were fitted to assess validity and responsiveness. MEASUREMENTS AND MAIN RESULTS: Reliability coefficients ranged from 0.76 (95% confidence interval, 0.71 to 0.81) to 0.97 (0.94 to 1.00). Throughout the first week, CRIB correlated with the risk of death (p < .001), prolonged treatment with oxygen (p < .001), and disability (p < .001 to p = .033). Improved condition, represented by a reduction in CRIB within the first week, was independently associated with lower risks of each adverse outcome, p < .05. CONCLUSIONS: During the first week, CRIB was reliable, valid, and responsive. These properties support the use of CRIB in the stratification of infants by risk and illness severity in cohort studies, and they also indicate that CRIB may have the potential to be used in other ways in the future.

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.

National survey on the attitudes of Canadian physicians towards drug-detailing by pharmaceutical representatives.

OBJECTIVE: Our objective was to study the attitudes of Canadian physicians toward product presentations by pharmaceutical representatives (PRs), the use of inducements by the pharmaceutical industry, and methods to improve the quality of prescribing information provided to physicians. DESIGN: We used a mailed survey. PARTICIPANTS: A random sample of 550 Canadian physicians in all settings was chosen. OUTCOME MEASURES: The main outcome measure was the proportion of respondents agreeing with a series of statements. RESULTS: The response rate was 262 of 525 deliverable surveys (50 per cent). Respondents had a mean of 4.2 interactions per week with PRs. Of the 262 respondents (5.8 per cent of data were incomplete), 193 (80 per cent) believed that PRs overemphasize their products' effectiveness, 108 (45 per cent) thought PRs do not present fairly the drugs' negative aspects, and 223 (92 per cent) felt that PRs have production promotion as a goal. Most, 175 (70 per cent), believe that drug-detailing affects physicians' prescribing behavior. Most, 210 (86 per cent), considered drug samples acceptable, but fewer agreed that other inducements were acceptable. Of the respondents, 183 (74 per cent) agreed that PRs should be required to use guidelines for standardized, comprehensive drug-detailing, and 165 (65 per cent) agreed that face-to-face drug-detailing by PRs using standardized guidelines would be an effective way to receive information. CONCLUSIONS: There is dissatisfaction among Canadian physicians about the quality of information provided by the pharmaceutical industry. Standardized, comprehensive guidelines would be accepted by physicians as one improvement.

Measuring capacity to complete an advance directive.

OBJECTIVE: To validate reference standards for the assessment of capacity to complete an advance directive and to develop and test three simple screening instruments. METHODS: We administered five measures of capacity to 96 older subjects from nursing homes, retirement homes, and homes for the aged. The measures included two reference standard evaluations: an assessment by a specially trained nurse in collaboration with a multidisciplinary team (Competency Clinic assessment) and geriatrician assessment using a decisional aid. Three screening instruments were also included: a Generic Instrument designed for any advance directive, a Specific Instrument designed for the "Let Me Decide" advance directive, and the Standardized Mini-Mental Status Examination (SMMSE). The screening instruments and the geriatrician's assessment were administered twice to half of the respondents to determine interrater agreement. RESULTS: The chance-corrected agreement for the assessment by two geriatricians was 0.78, and for agreement between the geriatricians and Competency Clinic assessments it was 0.82. Agreement for the Generic and Specific screening instrument assessments by two observers was 0.77 and 0.90, respectively. The areas under the Receiver Operating Characteristic curve relating the results of the three screening instruments to the Competency Clinic assessment were 0.82 for the Generic Instrument, 0.90 for the Specific Instrument, and 0.94 for the SMMSE; chance is an unlikely explanation for the difference between these three values (P < or = .01). CONCLUSIONS: Using rigorous methods, health workers can make reproducible and valid assessments of capacity to complete an advance directive. The SMMSE accurately differentiates people who can learn about and ultimately complete advance directives from those who cannot.

Improved reliability of the Standardized Alzheimer's Disease Assessment Scale (SADAS) compared with the Alzheimer's Disease Assessment Scale (ADAS).

OBJECTIVES: To compare the interrater and intrarater reliability of the Alzheimer's Disease Assessment Scale (ADAS) with the Standardized Alzheimer's Disease Assessment Scale (SADAS). DESIGN: A randomized, double blind trial. Sixteen university students were randomized to administer either version of the instrument. Subjects were randomized to three assessments, at 2-week intervals, using the ADAS or the SADAS. Each subject's first and third tests were administered by the same rater, the second by a different rater. SETTING: A geriatric outpatient clinic in a university teaching hospital. PARTICIPANTS: Fifty-four patients with possible or probable Alzheimer's disease living in the community or in a long-term care facility. MEASUREMENTS: The primary outcome was the interrater reliability of total ADAS and SADAS scores. Secondary outcomes were ADAS and SADAS cognitive scores, noncognitive scores, duration of testing, and sample size estimates. RESULTS: The interrater reliability of the SADAS total score was significantly better than that of the ADAS (interrater ICC 0.93 SADAS vs 0.83 ADAS), and the interrater standard deviation of the total SADAS score was lower than that of the ADAS (38%, P < .05). The SADAS cognitive subscale inter and intrarater reliability, although higher than the ADAS, was not significantly different when used by different raters (interrater ICC 0.91 SADAS vs 0.90 ADAS; intrarater ICC 0.88 SADAS vs 0.86 ADAS). The SADAS noncognitive subscale was significantly more reliable than the ADAS (interrater ICC 0.89 SADAS vs 0.42 ADAS; intrarater ICC 0.87 SADAS vs 0.70 ADAS; P < or = .05) and had a lower standard deviation between raters (59%; P < .01) and within raters (40%; P < .05) compared with the ADAS. CONCLUSION: The improved reliability of the SADAS total score means that investigators can now use this score as a primary outcome measure, and important behavioral symptomatology can be included as a marker for treatment efficacy in AD. The smaller standard deviation of the SADAS means that clinical trials using the SADAS as a primary outcome will demonstrate differences, if present, with smaller sample sizes than with the ADAS.

Quantitation of unintegrated HIV-1 DNA in asymptomatic patients in the presence or absence of antiretroviral therapy.

The objective of this work was to determine the amount of unintegrated human immunodeficiency virus (HIV) DNA (HIV uDNA) in asymptomatic individuals in the presence or absence of antiretroviral therapy. Twenty-one healthy seropositive individuals with no history of any opportunistic infection or previous use of nucleoside antiretrovirals, and 9 similarly asymptomatic individuals who had initiated nucleoside antiretroviral therapy within the last 24 months were studied. All patients had CD4 lymphocyte counts above 400/microliters. All subjects administered antiretrovirals received 400-600 mg of zidovudine daily for 2-24 months. Two individuals additionally received 400 mg of dideoxyinosine (ddI) daily for 4 and 5 months. Patient peripheral blood mononuclear cells (PBMCs) were examined for integrated and unintegrated HIV DNA by a quantitative PCR assay. In addition, CD4 counts were measured, and free and immune complex dissociated p24 antigen was detected in plasma by ELISA. The mean percentage of HIV uDNA in asymptomatic individuals not on therapy was 59%, with 95% confidence limits from 50 to 69%. In contrast, patients on therapy had a mean of only 13% HIV uDNA, with confidence limits from 2 to 25% (p < 0.001). These findings indicate that a significant amount of HIV DNA in infected, healthy patients not on therapy is in the unintegrated form, and that the amount of HIV uDNA in asymptomatic patients on nucleoside therapy is much less. The amount of HIV uDNA in PBMCs deserves further study as a new marker of the efficacy of antiretroviral therapy.

The prevalence of clinically undetected occlusal dentine caries in Scottish adolescents.

During the third examination of a 3-year anti-caries dentifrice study, bitewing radiographs were read to detect occlusal, as well as approximal caries lesions in 2623 subjects aged 14-15 years. These analyses showed that 1.4% of 2107 upper molars and 7.2% of 2288 lower molars (P less than 0.001), previously scored as clinically 'sound', were carious at a radiographic Grade '3' score (dentinal involvement), and 0.2% had radiographic pulpal lesions. However, for teeth which had been deemed as having a 'suspicion' of caries clinically, but which a 0.6 mm blunted probe would not enter, 29.1% of lower molars had definite radiographic evidence of dentinal caries as compared to only 7.6% of upper molars (P less than 0.001), and a further 0.5% exhibited pulpal extension. In addition, 23.9% of lower premolars also showed dentinal involvement in this group. Overall, 12.1% of lower molars and 3.1% of upper molars showed definite radiographic evidence of occlusal caries in the absence of a firm clinical indication. Thus, the use of bitewing radiographs would appear to be a most helpful adjunct to clinical caries diagnosis, not only of approximal lesions, but also for the detection of early occlusal caries, in these days of generally available topical fluoride.

The prevalence of fissure sealants in Lanarkshire, Scotland. A 3-year study.

Fissure sealant presence was recorded at baseline and annually during a 3-year, double-blind clinical caries trial which involved 3005 children aged 12-13 years at outset. At baseline, initially, 2002 sealants were noted in 431 subjects (14.3%), a figure not dissimilar to that found for Scottish 12-year-olds in the UK National Survey completed in the same year. By the fourth examination, 400 (17.3%) children had 2209 surfaces sealed. After one year, 14%, and at 3 years, 26% of baseline sealants were missing. Overall, at the last examination, 25% of baseline unsealed surfaces were carious compared to 15% of those originally sealed (P less than 0.001), although for molars, the equivalent figures were 49% and 24% (P less than 0.001). Finally, analysis showed that at baseline, as few as 15% of sealants had been placed by general dental practitioners, and this low proportion was maintained throughout the study period. While sealant placement in the Scots' age group was low, nevertheless the prevalence recorded was greater, at least by a factor of three, than has been reported elsewhere in the UK.

[Automated evaluation and analysis of isotopic heart function tests with minimal cardiac transit times]. / Automatisierte Auswertung und Befundung der Isotopen-Herz-Funktionsuntersuchung minimaler kardialer Transitzeiten

The clinical evaluation of cardiac function by non-invasive means with the help of radioactive isotopes registering minimal cardiac transit times (MTTs) is increasingly employed in routine diagnosis. In order to economise on work load and time expenditure and for the purpose of an objective and complete evaluation of data, automatic data processing is desirable. This paper describes a program that consists of 4 sections: 1. examination 2. generation of data 3. processing of data 4. evaluation of data. The program permits a nearly total automated data generation, analysis, calculation, classification, final clinical evaluation and the automated production of a medical report. This greatly reduces the time spent per examination to approximately 5 minutes. The automated evaluation of the data is based on clinical experience with approximately 3.500 measurements in patients with the most frequent cardiac diseases. The result is an objective statement of causes of MTT changes and is highly useful for medical routine application. The control and the final inclusion of the findings into the spectrum of other clinical results remains the subject of the physician's judgement. The advantage of the method is the evaluation of all cardiac segments. This pertains to the evaluation of both atria and both ventricles, as well as of the entire central circulation with and without participation of the lung.