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PubMed2003

Customizing fetal biometric charts.

OBJECTIVE: To study the effects of maternal and pregnancy characteristics on fetal biometric size using longitudinal ultrasound measurements and to construct customized models for fetal biometric size charts. METHODS: A cohort of 533 healthy pregnant women with normal singleton pregnancies were recruited for regular ultrasound examination for fetal biometry between 24 and 40 weeks' gestation. Multilevel modeling was used to construct models of fetal head size, femur length and abdominal circumference. Variables of maternal and pregnancy characteristics including booking weight and height, age, parity and fetal sex were included in the construction of the customized fetal biometric size charts. RESULTS: Increased fetal head size and abdominal circumference were significantly associated with extremes of maternal age. Maternal height had a statistically significant influence on biparietal diameter. Maternal booking weight had an influence on fetal abdominal circumference and femur length. Fetal sex was found to have a statistically significant influence on the final regression models of biparietal diameter, head circumference and femur length. Parity had an influence on fetal head circumference and abdominal circumference. CONCLUSIONS: Maternal and pregnancy characteristics have a significant influence on in-utero fetal biometry. We produced models to construct customized fetal biometric size charts. Further validation studies are necessary to evaluate the clinical usefulness of such customized fetal biometric size charts.

Adult↗
PubMed2004

Patient trust: is it related to patient-centered behavior of primary care physicians?

BACKGROUND: Patients' trust in their health care providers may affect their satisfaction and health outcomes. Despite the potential importance of trust, there are few studies of its correlates using objective measures of physician behavior during encounters with patients. METHODS: We assessed physician behavior and length of visit using audio tapes of encounters of 2 unannounced standardized patients (SPs) with 100 community-based primary care physicians participating in a large managed care organization. Physician behavior was assessed via 3 components of the Measure of Patient-Centered Communication (MPCC) scale. The Primary Care Assessment Survey (PCAS) trust subscale was administered to 50 patients from each physician's practice and to SPs. We used multilevel modeling to examine the associations between physicians' Patient-Centered Communication during the SP visits and ratings of trust by both patients and SPs. RESULTS: Component 1 of the MPCC, which explored the patient's experience of the disease and illness, was independently associated with patient's rating of trust in their physician. A I SD increase in this score was associated with 0.08 SD increase in trust (95% confidence interval 0.02-0.14). Each additional minute spent in SP visits was also independently associated with 0.01 SD increase in patient trust. (95% confidence interval 0.0001-0.02). Component 1 and visit length were also positively associated with SP trust ratings. CONCLUSIONS: Physician verbal behavior during an SP encounter is associated with trust reported by SPs and patients. Research is needed to determine whether interventions designed to enhance physicians' exploration patients' experiences of disease and illness improves trust. Key Words: physician-patient relationship, patient-centered care, trust, physician behavior

Adult↗
PubMed2005

Urban area disadvantage and physical activity: a multilevel study in Melbourne, Australia.

OBJECTIVE: To estimate variation between small areas in the levels of walking, cycling, jogging, and swimming and overall physical activity and the importance of area level socioeconomic disadvantage in predicting physical activity participation. METHODS: All census collector districts (CCDs) in the 20 innermost local government areas in metropolitan Melbourne, Australia, were identified and ranked by the percentage of low income households (<400 dollars/week) living in the CCD. Fifty CCDs were randomly selected from the least, middle, and most disadvantaged septiles of the ranked CCDs and 2349 residents (58.7% participation rate) participated in a cross sectional postal survey about physical activity. Multilevel logistic regression (adjusted for extrabinomial variation) was used to estimate area level variation in walking, cycling, jogging, and swimming and in overall physical activity participation, and the importance of area level socioeconomic disadvantage in predicting physical activity participation. RESULTS: There were significant variations between CCDs in all activities and in overall physical participation in age and sex adjusted models; however, after adjustment for individual SES (income, occupation, education) and area level socioeconomic disadvantage, significant differences remained only for walking (p = 0.004), cycling (p = 0.003), and swimming (p = 0.024). Living in the most socioeconomically disadvantaged areas was associated with a decreased likelihood of jogging and of having overall physical activity levels that were sufficiently active for health; these effects remained after adjustment for individual socioeconomic status (sufficiently active: OR 0.70, 95% CI 0.55 to 0.90 and jogging: OR = 0.69, 95% CI 0.51 to 0.94). CONCLUSION: These research findings support the need to focus on improving local environments to increase physical activity participation.

Adolescent↗
PubMed2003

The burdens of cancer therapy. Clinical and economic outcomes of chemotherapy-induced mucositis.

BACKGROUND: Mucositis is a common but poorly studied problem among patients with solid tumors. The authors examined the clinical and economic outcomes of oral and gastrointestinal (GI) mucositis among patients receiving myelosuppressive chemotherapy. METHODS: A retrospective, random sample of 599 patients who developed chemotherapy-induced myelosuppression was followed for development of oral or GI mucositis and for development of subsequent episodes of bleeding or infection. Multilevel regression models of the risk of bleeding and infection were fit with chemotherapy cycles nested within patients. RESULTS: Mucositis developed during 37% of 1236 cycles of chemotherapy. Episodes of bleeding were significantly more common during cycles with GI mucositis than during cycles without GI mucositis (13% vs. 8%; P = 0.04). Episodes of infection were significantly more common during cycles with mucositis (especially GI mucositis) than during cycles without mucositis (73% vs. 36%; P < 0.0001). The mean durations of hospitalization were 4 days, 6 days, and 12 days during cycles with no mucositis, oral mucositis, and GI mucositis, respectively. After accounting for the depth and duration of myelosuppression and for other predictive factors, GI mucositis was associated with both bleeding (odds ratio [OR], 2.0; P = 0.01) and infection (OR, 2.24; P < 0.0001), whereas oral mucositis was associated with infection only (OR, 2.4; P < 0.0001). CONCLUSIONS: Mucositis was clinically and economically significant among patients with solid tumors who were receiving myelosuppressive chemotherapy. New preventive and therapeutic agents are needed.

Adult↗
PubMedDate not supplied

Influence of anatomic distribution of atherosclerosis on the outcome of revascularization with iliac stent placement.

PURPOSE: To determine the influence of clinical and angiographic variables, including the anatomic disease pattern, on the outcome of iliac stent placement. PATIENTS AND METHODS: The 455 patients of the study population were divided in three groups according to the anatomic distribution of their peripheral atherosclerosis lesions. Pattern type 1 (focal aortoiliac and/or common iliac lesion) included 180 patients (39.6%), type 2 (external iliac lesion) comprised 58 patients (12.8%), and type 3 (multilevel lesions) included 217 patients (47.7%). RESULTS: Complete relief of symptoms immediately after revascularization was observed in 88.3% and 85.4% of patients with pattern type 1 and 2, respectively, compared to 60.1% with type 3 (P < .05). The persistence of clinical benefit at 36-month follow-up was 91.6%, 97.9%, and 60.8% in disease patterns 1, 2, and 3, respectively. The overall 1-year mortality rate was 3% with type 1 lesions, 5.7% with type 2, and 9.7% with type 3. On multivariate logistic regression, the presence of a disease pattern type 3 was the most powerful indicator (P < .001) of early unsatisfactory clinical outcome in iliac stent placement. Unexpectedly, female gender was predictive of unsatisfactory clinical outcome (P < .01) and higher periprocedural complications (P < .001) following iliac stent revascularization. CONCLUSIONS: Pattern type classification helps identify patients at higher risk for cardiovascular morbidity and mortality. Ideal candidates for iliac stent placement are patients with pattern type 1 or 2 disease.

Adult↗
PubMed2006

Weight and place: a multilevel cross-sectional survey of area-level social disadvantage and overweight/obesity in Australia.

OBJECTIVE: To estimate variation between small areas in adult body mass index (BMI), and assess the importance of area level socioeconomic disadvantage in predicting BMI. METHODS: We identified all census collector districts (CCDs) in the 20 innermost Local Government Areas in metropolitan Melbourne, Australia, and ranked them by the percentage of low income households (< dollar 400/week). In all, 50 CCDs were randomly selected from the least, middle and most disadvantaged septiles of the ranked list and 4913 residents (61.4% participation rate) completed one of two surveys. Multilevel linear regression was used to estimate area level variance in BMI and the importance of area level socioeconomic disadvantage in predicting BMI. RESULTS: There were significant variations in BMI between CCDs for women, even after adjustment for individual and area SES (P = 0.012); significant area variation was not found for men. Living in the most versus least disadvantaged areas was associated with an average difference in BMI of 1.08 kg/m2 (95% CI: 0.48-1.68 kg/m2) for women, and of 0.93 kg/m2 (95% CI: 0.32-1.55 kg/m2) for men. Living in the mid versus least disadvantaged areas were associated with an average difference in BMI of 0.67 kg/m2 (95% CI: 0.09-1.26 kg/m2) for women, and 0.43 kg/m2 for men (95% CI: -0.16-1.01). CONCLUSION: These findings suggest that area disadvantage is an important predictor of adult BMI, and support the need to focus on improving local environments to reduce socioeconomic inequalities in overweight and obesity.

Adult↗
PubMed2003

Contributions of social context to inequalities in years of life lost to heart disease in Texas, USA.

Several recent articles have pointed to the effect of social context on heart disease mortality after adjusting for individual level indicators. This study investigates the contributions of individual socioeconomic factors (sex, race, and education) and social context at the neighborhood level (wealth, education, social capital, and racial/ethnic composition), and the county level (social inequality, human and social capital, economic and demographic characteristics) on premature cardiovascular mortality. Death certificate information was obtained for all those who died of heart disease in Texas, USA, in 1991. Deaths were geocoded to obtain block-group, census tract, and county social context from the census. Multilevel hierarchical models quantified the contributions of individual characteristics and block-group, tract, and county social context on years of potential life lost to heart disease. Cross-level analyses investigated the interaction between individual and contextual factors. Being female, having more education, and residing in areas with higher median house value were associated with less premature mortality. Although blacks and Hispanics lost more years of life to heart disease than whites, blacks and Hispanics living in tracts with higher own racial/ethnic group density lost fewer years of life than their peers living in less homogenous tracts. At the county level, premature mortality was negatively associated with social capital. The tract and county level variances were statistically significant indicating the importance of social context to premature heart disease mortality. Plausible mechanisms through which these effects operate are explored. Social context at the block-group, tract, and county level played an important role, though a smaller role than individual factors, in explaining years of life lost to heart disease.

Black or African American↗
PubMed2005

Using multilevel models for assessing the variability of multinational resource use and cost data.

Multinational economic evaluations often calculate a single measure of cost-effectiveness using cost data pooled across several countries. To assess the validity of pooling international cost data the reasons for cost variation across countries need to be assessed. Previously, ordinary least-squares (OLS) regression models have been used to identify factors associated with variability in resource use and total costs. However, multilevel models (MLMs), which accommodate the hierarchical structure of the data, may be more appropriate. This paper compares these different techniques using a multinational dataset comprising case-mix, resource use and cost data on 1300 stroke admissions from 13 centres in 11 European countries. OLS and MLMs were used to estimate the effect of patient and centre-level covariates on the total length of hospital stay (LOS) and total cost. MLMs with normal and gamma distributions for the data within centres were compared. The results from the OLS model showed that both patient and centre-level covariates were associated with LOS and total cost. The estimates from the MLMs showed that none of the centre-level characteristics were associated with LOS, and the level of spending on health was the centre-level variable most highly associated with total cost. We conclude that using OLS models for assessing international variation can lead to incorrect inferences, and that MLMs are more appropriate for assessing why resource use and costs vary across centres.

Age Factors↗
PubMed2004

Clinicians' assessments of practice guidelines in oncology: the CAPGO survey.

OBJECTIVES: Promoting the adoption of clinical practice guidelines is a challenging task. Research shows that adopters' beliefs about guidelines and the process of their development are important predictors of guideline use. Our objective is to report on the development and refinement of an instrument designed to measure oncologists' assessments of guidelines in oncology. METHOD: A theoretically derived instrument was drafted. Oncologists were asked to complete a questionnaire for each draft guideline they were asked to review. Factor analyses and multilevel modeling techniques were undertaken to explore the properties of the instrument and refine it. RESULTS: A total of 488 Ontario clinicians were sent 1494 new questionnaires regarding 34 clinical practice guidelines produced between 1999 and 2002. A refined eighteen-item questionnaire with four stable factors that predicted 60 percent of the variance emerged. The factors are interpreted as guideline quality, applicability, acceptability, and comparative value. The four factors predicted oncologists' endorsements of draft guidelines and, with the exception of quality, predicted their intentions to use the guidelines. As expected, variation in the factor scores could be attributed more to the differences among the oncologist who completed the survey than to the differences among the guidelines themselves. CONCLUSIONS: An instrument composed of four stable and theoretically relevant factors emerged. The findings support the hypothesis that beliefs about guideline attributes and development attributes relate to oncologists' endorsement of and intentions to use guidelines. Our next step is to link the responses of the survey with actual clinical behavior.

Attitude of Health Personnel↗
PubMed2006

Early sexual maturity in male hamadryas baboons (Papio hamadryas hamadryas) and its reproductive implications.

We present data on sexual maturity in young hamadryas baboon males (Papio hamadryas hamadryas) and its reproductive consequences in a large captive baboon colony. Hamadryas baboons live in a multilevel social system, with one-male units (OMUs) as the smallest social entity. Male leaders of OMUs are believed to monopolize matings within their OMUs; hence mating is believed to be polygynous and monandrous. In a captive colony of hamadryas baboons, we found evidence that young males less than 4 years old fathered at least 2.5% of 121 offspring born subsequent to vasectomy of all adult males, and males aged 4-5 years fathered at least 16.5% of the offspring. Additional evidence that these young males are able to sire offspring came from a morphological comparison of sperm from hamadryas males of different ages. The sperm of a 48-month-old hamadryas baboon were morphologically indistinguishable from viable sperm from adult males, whereas sperm from a 45-month-old male showed some aberrations. If successful copulations by adolescent males constitute a regular pattern even in free-ranging hamadryas baboons, a hamadryas male's chances to reproduce would not be limited to his role as an OMU leader as previously assumed, and a male's reproductive career would consist of two phases: the adolescent phase, and the OMU leader male phase.

Animals↗
PubMed2006

Day-to-day dynamics of experience--cortisol associations in a population-based sample of older adults.

In 156 older adults, day-to-day variations in cortisol diurnal rhythms were predicted from both prior-day and same-day experiences, to examine the temporal ordering of experience-cortisol associations in naturalistic environments. Diary reports of daily psychosocial, emotional, and physical states were completed at bedtime on each of three consecutive days. Salivary cortisol levels were measured at wakeup, 30 min after awakening, and at bedtime each day. Multilevel growth curve modeling was used to estimate diurnal cortisol profiles for each person each day. The parameters defining those profiles (wakeup level, diurnal slope, and cortisol awakening response) were predicted simultaneously from day-before and same-day experiences. Prior-day feelings of loneliness, sadness, threat, and lack of control were associated with a higher cortisol awakening response the next day, but morning awakening responses did not predict experiences of these states later the same day. Same-day, but not prior-day, feelings of tension and anger were associated with flatter diurnal cortisol rhythms, primarily because of their association with higher same-day evening cortisol levels. Although wakeup cortisol levels were not predicted by prior-day levels of fatigue and physical symptoms, low wakeup cortisol predicted higher levels of fatigue and physical symptoms later that day. Results are consistent with a dynamic and transactional function of cortisol as both a transducer of psychosocial and emotional experience into physiological activation and an influence on feelings of energy and physical well-being.

Aged↗
PubMed2007

Television watching and frequency of family meals are predictive of overweight onset and persistence in a national sample of school-aged children.

OBJECTIVE: To identify eating and activity factors associated with school-aged children's onset of overweight and persistent overweight. DESIGN: Data were gathered at four time points between kindergarten entry and spring of third grade. Children were directly weighed and measured and categorized as not overweight (<95th percentile of body mass index) or overweight (> or =95th percentile body mass index); parents were interviewed by telephone or in person. SUBJECTS/SETTING: Subjects were participants in the Early Childhood Longitudinal Study-Kindergarten Cohort, a nationally representative sample of children who entered kindergarten during 1998-1999. Children who weighed <2,000 g at birth, received therapeutic services before kindergarten, skipped or repeated a grade, or without complete height and weight data were excluded, resulting in 8,459 participants. Children with intermittent overweight were not examined (n=459); analyses addressed 8,000 children. MAIN OUTCOME MEASURES: Three mutually exclusive groups of children were identified: never overweight, overweight onset, and persistent overweight. STATISTICAL ANALYSES PERFORMED: Multilevel, multivariate logistic regression analyses estimated the effects of eating and activity factors on the odds of overweight onset and persistent overweight above child sex, race, and family socioeconomic status. RESULTS: Children who watched more television (odds ratio [OR] 1.02) and ate fewer family meals (OR 1.08) were more likely to be overweight for the first time at spring semester of third grade. Children who watched more television (OR 1.03), ate fewer family meals (OR 1.08), and lived in neighborhoods perceived by parents as less safe for outdoor play (OR 1.32) were more likely to be persistently overweight. Child aerobic exercise and opportunities for activity were not associated with a greater likelihood of weight problems. CONCLUSIONS: This study supports theories regarding the contributions of television watching, family meals, and neighborhood safety to childhood weight status. When working with families to prevent and treat childhood weight problems, food and nutrition professionals should attend to children's time spent with screen media, the frequency of family mealtimes, and parents' perceptions of neighborhood safety for children's outdoor play.

Body Mass Index↗
PubMed2006

Increased incidence of Lyme borreliosis in southern Sweden following mild winters and during warm, humid summers.

The aim of the present study was to investigate the long-term incidence rate of Lyme borreliosis and, additionally, to determine whether a correlation exists between climatic factors and summer-season variations in the incidence of Lyme borreliosis. Climatic variability acts directly on tick population dynamics and indirectly on human exposure to Lyme borreliosis spirochetes. In this study, conducted in primary healthcare clinics in southeastern Sweden, electronic patient records from 1997-2003 were searched for those that fulfilled the criteria for erythema migrans. Using a multilevel Poisson regression model, the influence of various climatic factors on the summer-season variations in the incidence of erythema migrans were studied. The mean annual incidence rate was 464 cases of erythema migrans per 100,000 inhabitants. The incidence was significantly higher in women than in men, 505 and 423 cases per 100,000 inhabitants, respectively (p<0.001). The summer-season variations in the erythema migrans incidence rate correlated with the monthly mean summer temperatures (incidence rate ratio 1.12; p<0.001), the number of winter days with temperatures below 0 degrees C (incidence rate ratio 0.97; p<0.001), the monthly mean summer precipitation (incidence rate ratio 0.92; p<0.05), and the number of summer days with relative humidity above 86% (incidence rate ratio 1.04; p<0.05). In conclusion, Lyme borreliosis is highly endemic in southeastern Sweden. The climate in this area, which is favourable not only for human tick exposure but also for the abundance of host-seeking ticks, influences the summer-season variations in the incidence of Lyme borreliosis.

Adolescent↗
PubMed1999

Influence of hospital and clinician workload on survival from colorectal cancer: cohort study.

OBJECTIVE: To determine whether clinician or hospital caseload affects mortality from colorectal cancer. DESIGN: Cohort study of cases ascertained between 1990 and 1994 by a region-wide colorectal cancer register. OUTCOME MEASURES: Mortality within a median follow up period of 54 months after diagnosis. RESULTS: Of the 3217 new patients registered over the period, 1512 (48%) died before 31 December 1996. Strong predictors of survival both in a logistic regression (fixed follow up) and in a Cox's proportional hazards model (variable follow up) were Duke's stage, the degree of tumour differentiation, whether the liver was deemed clear of cancer by the surgeon at operation, and the type of intervention (elective or emergency and curative or palliative intent). In a multilevel model, surgeon's caseload had no significant effect on mortality at 2 years. Hospital workload, however, had a significant impact on survival. The odds ratio for death within 2 years for cases managed in a hospital with a caseload of between 33 and 46 cases per year, 47 and 54 cases per year, and >/=55 cases per year (compared to one with </=23 cases per year) were respectively 1.48 (95% confidence interval 1.03 to 2.13), 1.52 (1.08 to 2.13), and 1.18 (0.83 to 1.68). CONCLUSIONS: There was no detectable caseload effect for surgeons managing colorectal cancer, but survival of patients treated in hospitals with caseloads above 33 cases per year was slightly worse than for those treated in hospitals with fewer caseloads. Imprecise measurement of clinician specific "events rates" and the lack of routinely collected case mix data present major challenges for clinical audit and governance in the years ahead.

Adult↗
PubMed2004

Spatial relationships among asthma prevalence, health care utilization, and pollution sources in neighborhoods of Buffalo, New York.

In this retrospective study, the authors investigate the spatial distributions of asthma cases in relation to major traffic corridors and the Peace Bridge Complex in Buffalo, New York, and assess possible contributions of other U.S. Environmental Protection Agency (U.S. EPA)--identified pollution release sources. Multiple data sources, including emergency room visits, outpatient visits, and hospital discharge databases are utilized to evaluate whether an association exists between the addresses of diagnosed asthma cases and release sources. Using a two-factor multilevel model, this study finds a statistically significant association between proximity to source and diagnosed asthma (p < .025). The authors further observe that two-thirds of the asthmatic sufferers resided between 204 and 700 meters from pollution sources and that over 40 percent who utilized health care lived within walking distance of the health care facility they patronized. Using Turnbull's method, the authors detect notable geographic asthma clusters in areas within the city of Buffalo, in North Tonawanda, along major roadways, and in the communities adjoining the Peace Bridge Complex. The authors also find local clusters in Buffalo's west side using Turnbull's method, and a significant global cluster using Besag and Newell's method. One-quarter of the case address locations were within 700 meters of identified clusters. The Score Test methods of Lawson and Waller and of Bithell also find statistically significant associations between three previously identified U.S. EPA focus sites and increased risk of asthma. Correlation of these findings with air quality assessments, especially with respect to traffic-related pollution, however, would be required for a definitive link to be made between an increased risk of asthma and identified pollution sources.

Air Pollutants↗
PubMed2006

Development of the interval endurance capacity in elite and sub-elite youth field hockey players.

OBJECTIVES: To gain more insight into the mechanisms that underlie the development of interval endurance capacity in talented youth field hockey players in the 12-19 age band. METHODS: A total of 377 measurements were taken over three years. A longitudinal model for interval endurance capacity was developed using the multilevel modelling program MLwiN. With the model, scores on the interval shuttle run test can be predicted for elite and sub-elite male and female field hockey players aged 12-19 years. RESULTS: A polynomial model of order 2 adequately represents development of the test scores over time. The fixed part of the model contains a different intercept and linear age term for boys and girls, and a common quadratic term; the random part of the model has a common level 2 variance and sex specific level 1 variances. The model was significantly improved by including differential effects of performance level for age and sex. A negative effect was found for percentage body fat, and positive effects for additional training and motivation. CONCLUSIONS: During adolescence, both male and female elite hockey players show a more promising development pattern of interval endurance capacity than sub-elite youth players. Percentage body fat, additional training hours, and motivation influence this development. However, differences between the individual players are still considerable.

Adolescent↗
PubMed2000

Factors underlying the effect of organisational downsizing on health of employees: longitudinal cohort study.

OBJECTIVE: To explore the underlying mechanisms between organisational downsizing and deterioration of health of employees. DESIGN: Longitudinal cohort study. Data were assembled from before downsizing (time 1); during major downsizing affecting some job categories (time 2); and after downsizing (time 3). Contributions of changes in work, support, and health related behaviours between time 1 and time 2 to the relation between downsizing and sickness absence at time 3 were assessed by multilevel modelling. Mean length of follow up was 4.9 years. SETTING: Raisio, a town in Finland. SUBJECTS: 764 municipal employees who remained in employment after downsizing. MAIN OUTCOME MEASURES: Records of absences from work from all causes with medical certificate. RESULTS: Downsizing was associated with negative changes in work, impaired support from spouse, and increased prevalence of smoking. Sickness absence rate from all causes was 2.17 (95% confidence interval 1.54 to 3.07) times higher after major downsizing than after minor downsizing. Adjustment for changes in work (for instance, physical demands, job control, and job insecurity) diminished the relation between downsizing and sickness absence by 49%. Adjustments for impaired social support or increased smoking did not alter the relation between downsizing and sickness absence. The findings were unaffected by sex and income. CONCLUSIONS: The exploration of potential mediating factors provides new information about the possible causal pathways linking organisational downsizing and health. Downsizing results in changes in work, social relationships, and health related behaviours. The observed increase in certificated sickness absence was partially explained by concomitant increases in physical demands and job insecurity and a reduction in job control. A considerable proportion of the increase, however, remained unexplained by the factors measured.

Adult↗
PubMed2004

Long-term donepezil treatment in 565 patients with Alzheimer's disease (AD2000): randomised double-blind trial.

BACKGROUND: Cholinesterase inhibitors produce small improvements in cognitive and global assessments in Alzheimer's disease. We aimed to determine whether donepezil produces worthwhile improvements in disability, dependency, behavioural and psychological symptoms, carers' psychological wellbeing, or delay in institutionalisation. If so, which patients benefit, from what dose, and for how long? METHODS: 565 community-resident patients with mild to moderate Alzheimer's disease entered a 12-week run-in period in which they were randomly allocated donepezil (5 mg/day) or placebo. 486 who completed this period were rerandomised to either donepezil (5 or 10 mg/day) or placebo, with double-blind treatment continuing as long as judged appropriate. Primary endpoints were entry to institutional care and progression of disability, defined by loss of either two of four basic, or six of 11 instrumental, activities on the Bristol activities of daily living scale (BADLS). Outcome assessments were sought for all patients and analysed by logrank and multilevel models. FINDINGS: Cognition averaged 0.8 MMSE (mini-mental state examination) points better (95% CI 0.5-1.2; p<0.0001) and functionality 1.0 BADLS points better (0.5-1.6; p<0.0001) with donepezil over the first 2 years. No significant benefits were seen with donepezil compared with placebo in institutionalisation (42% vs 44% at 3 years; p=0.4) or progression of disability (58% vs 59% at 3 years; p=0.4). The relative risk of entering institutional care in the donepezil group compared with placebo was 0.97 (95% CI 0.72-1.30; p=0.8); the relative risk of progression of disability or entering institutional care was 0.96 (95% CI 0.74-1.24; p=0.7). Similarly, no significant differences were seen between donepezil and placebo in behavioural and psychological symptoms, carer psychopathology, formal care costs, unpaid caregiver time, adverse events or deaths, or between 5 mg and 10 mg donepezil. INTERPRETATION: Donepezil is not cost effective, with benefits below minimally relevant thresholds. More effective treatments than cholinesterase inhibitors are needed for Alzheimer's disease.

Activities of Daily Living↗