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Improving the well-being of elderly patients via community pharmacy-based provision of pharmaceutical care: a multicentre study in seven European countries |
Bernsten C, Bjorkman I, Caramona M, Crealey G, Frokjaer B, Grundberger E, Gustafsson T, Henman M, Herborg H, Hughes C, McElnay J, Magner M, van Mil F, Schaeffer M, Silva S, Sondergaard B, Sturgess I, Tromp D, Vivero L, Winterstein A |
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Record Status This is a critical abstract of an economic evaluation that meets the criteria for inclusion on NHS EED. Each abstract contains a brief summary of the methods, the results and conclusions followed by a detailed critical assessment on the reliability of the study and the conclusions drawn. Health technology The health intervention examined in the study was a structured pharmaceutical care programme provided to elderly patients by community pharmacists. Trained pharmacists (at least one study day) were instructed to: educate patients about their drug regimen and their medical condition; implement compliance-improving strategies such as drug-remainder charts; and rationalise and simplify drug regimens in collaboration with the patient's general practitioner (GP).
Type of intervention Other: pharmaceutical care programme.
Economic study type Cost-effectiveness analysis.
Study population The study population comprised patients aged 65 years or over, taking four or more prescribed medications and orientated with respect to self, time, and place. They were community dwelling and regular visitors to a recruited community pharmacy. Patients were excluded if they were housebound or resident in a nursing/residential home.
Setting The setting was primary care. The economic study was carried out in seven European countries: Denmark, Germany, The Netherlands, Northern Ireland, Portugal, Republic of Ireland, and Sweden.
Dates to which data relate No dates were reported. The price year was 1999.
Source of effectiveness data The effectiveness evidence was derived from a single study.
Link between effectiveness and cost data The costing was carried out prospectively on the same patient sample as that used in the effectiveness analysis.
Study sample Power calculations indicated that the target sample size was 480 patients (half intervention and half control) per country. The selection of participating pharmacists was based on those who responded to publicity via mail shots, advertisements in pharmaceutical publications and at professional meetings. A minimum of 12 sites per county was chosen on the basis of specific criteria (population of elderly patients, staffing levels within the pharmacy, and working relationships with local GPs). Patients were identified via a personal approach by the pharmacist within the pharmacy, and those who were willing to participate were enrolled. In the intervention group there were 104 pharmacies and 1,290 patients (mean age: 74 years; 42.1% men, 37.2% living alone; mean number of prescribed drugs: 7.1) and in the control group there were 86 pharmacies and 1,164 patients (mean age: 74 years; 42.7% men, 37.7% living alone; mean number of prescribed drugs: 7.0).
Study design This was a multi-centre and multi-country, randomised, controlled, longitudinal, clinical trial. The unit of randomisation was the pharmacy, meaning that participating pharmacies (and their patients) were randomly allocated to the intervention or control groups. In order to minimise bias in data collection, assessment, whenever possible, was carried out by a member of staff other than the pharmacist. Patients were assessed at baseline, and at 6, 12, and 18 months. At six months there were 1,977 patients in the sample (1,024 intervention, 953 control), at 12 months there were 1,627 patients (863 intervention, 764 control), and at 18 months there were 1,340 patients (704 intervention, 636 control). The reasons for dropouts included patient withdrawal due to unwillingness to continue the study, patients becoming too ill to participate or moving away from the area, patient death, and pharmacy withdrawal due to lack of time or higher priority activities to be performed. Patients who dropped out were significantly older and reported poorer quality of life at baseline than those who remained in the study. The highest dropout rates were reported in Northern Ireland and The Netherlands.
Analysis of effectiveness The analysis of the clinical study appears to have been based on treatment completers only. The primary health outcomes were health-related quality of life (measured using the SF-36 health survey), number of hospitalisations, sign and symptoms control, and patient satisfaction with the service provided (all self-reported using specific questionnaires). Several intermediate outcomes (such as patient knowledge of medicines, compliance with dosage regimens, number of contacts with GP, prescription and non-prescription drug use, number of times medication regimens were changed, acceptance by GPs of treatment recommendations made to them by the pharmacists, and professional satisfaction of pharmacists involved in the study and satisfaction of the GPs with the participation of the pharmacists in patient care) were also assessed. Study groups were statistically comparable at baseline, (p>/=0.05).
Effectiveness results The 18-months study was not completed in the Republic of Ireland or Portugal, while in The Netherlands the study lasted 24-months (and data were treated as 18-months data).
In the pooled data there were no statistically significant differences between intervention and control patients in any of the eight dimensions assessed using the SF-36 health survey. However, improvements in general health and role emotional scores were reported in the intervention group in Denmark, while reductions in physical functioning, role physical and vitality were reported in the intervention group in Northern Ireland.
Good-quality data on hospitalisations were available only from Northern Ireland, Sweden, Germany, and the Republic of Ireland: in the pooled data there was no statistical difference in the number of hospitalisations as the percentage of patients requiring one or more hospitalisations was 41.7% in the intervention group and 41.3% in the control group at baseline and the corresponding figures at 18-months were 35.6% in the intervention group and 40.4% in the control group.
The only statistically significant difference occurred in Denmark, where there were a smaller proportion of intervention patients requiring hospitalisation compared with the control patients (31.3% versus 42.3%; p=0.04).
Intervention patients had better control of their medical conditions (sign and symptoms) during the study (73% at 6-months, 71% at 12-months, and 75% at 18-months).
As regards patient satisfaction with the service provided, three dimensions were assessed: rating of services provided, overall satisfaction with services and general opinion of pharmaceutical care (the latter only for intervention patients). At baseline, 66.2% of intervention patients and 68.2% of control patients rated the services as excellent, while at 18-months these figures were 73.8% and 64.6%, respectively and the difference was statistically significant. Overall satisfaction with services was in general similar in both groups. Finally, the general opinion of pharmaceutical care was positive, with intervention patients stating that the intervention was better than the service received prior to the study (77% at 18-months).
Clinical conclusions The patients positively rated the intervention procedure. However, the intervention did not produce any statistically significant improvement in patient's quality of life.
Measure of benefits used in the economic analysis Health outcomes were left disaggregated and no summary benefit measure was used, thus a cost-consequences analysis was carried out.
Direct costs Discounting was not relevant as the time horizon of the analysis was 18-months. Unit costs and quantities of resources were not reported separately. The economic analysis comprised the costs of additional time spent by the pharmacists (estimated from pharmacist diary), contacts with GPs (estimated from patient's self-completed questionnaire), and hospitalisations and drugs (estimated from patient's self-completed questionnaire and pharmacy-held medication records). The cost resource boundary adopted was not stated. The estimation of costs and quantities was based on actual data. All costs were inflated to January 1999 using the Retail Price Index.
Statistical analysis of costs A statistical analysis of total costs was carried out to test for statistical significance of the results.
Indirect Costs Indirect costs were not included in the analysis.
Sensitivity analysis No sensitivity analysis was performed.
Estimated benefits used in the economic analysis Please refer to the effectiveness results reported earlier.
Cost results Cost-savings were achieved in most countries at each assessment period.
At the last assessment (12-18 months), total costs in the intervention and control groups were:
Intervention Euro 1,298.13 and control Euro 1,419.88 (cost savings of Euro 121.75) in Denmark;
Intervention Euro 2,995.25 and control Euro 3,167.25 (cost savings of Euro 175.00) in Germany;
Intervention Euro 735.22 and control Euro 750.01 (cost savings of Euro 14.79) in the Northern Ireland; and
Intervention Euro 1,266.76 and control Euro 1,250.34 (extra cost of Euro 16.42) in Sweden.
Between-group statistical analysis indicated that there was no statistically significant difference between total costs for control and intervention patients in any country.
Synthesis of costs and benefits Authors' conclusions The authors concluded that the structured pharmaceutical care programme provided to elderly patients by community pharmacists "had some positive effects on humanistic health outcomes such as satisfaction with treatment, and sign and symptom control, and on economic outcomes, but had less impact than anticipated on drug therapy, drug knowledge and compliance with medication". Finally, the intervention did not result in statistically significant cost-savings.
CRD COMMENTARY - Selection of comparators The rationale for the choice of the comparators was clear. No intervention was selected, as this was current practice. You, as a user of this database, should assess whether a pharmaceutical care programme is already implemented in your own setting.
Validity of estimate of measure of effectiveness The analysis of the effectiveness was based on a randomised controlled trial carried out in several countries. The study sample appears to have been representative of the study population and study groups were comparable at baseline. The unit of randomisation was reported and power calculations were performed. However, the internal validity of the analysis was adversely affected by several factors, such as the high dropout rate, the differences among dropouts in the control and intervention groups, and the smaller number of participating patients in comparison with the number scheduled in the planning phase. The authors also noted the lack of interest by some patients and pharmacists enrolled in the study. The limitation that had most effect on the study results was that the assessment of the outcomes was mainly based on self-reported instruments completed by the patients. As a consequence, caution is necessary when interpreting the study results.
Validity of estimate of measure of benefit Health outcomes were left disaggregated and no summary benefit measure was used, thus a cost-consequences analysis was carried out. It would have been interesting had a summary benefit measure including patient preferences, which were already assessed in the analysis, been adopted. However, it has to be noted that there were few statistically significant differences in the primary health outcomes.
Validity of estimate of costs Unfortunately, the perspective adopted in the study was not stated, although only direct costs related to the intervention were included in the analysis. Statistical analyses of costs were carried out to detect statistically significant differences between total costs in the study groups, the source of cost data was reported, and the price year was appropriately given. However, unit costs were not reported separately from quantities hence reducing transparency and generalisability. The authors stated that cost-savings were associated with the intervention, although differences in total costs did not reach statistical significance.
Other issues The authors made some comparisons of their findings with those from other studies. The external validity of the analysis was reduced as the issue of the generalisability of the study results to other settings was not addressed and sensitivity analyses were not carried out. The study enrolled a population of elderly patients and this was reflected in the conclusions of the analysis. The authors highlighted some limitations of the analysis, such as the difficulty in collecting good-quality data, the substantial patient withdrawal, and the lack of rigorously controlled training of participating pharmacists.
Implications of the study Aware of the limitations of their analysis, the authors point out five main recommendations for future research: improvement of patient targeting to identify patients in greatest need; encouraging the participation of patients in primary case-based projects; use of a reliable and valid outcome measure; adoption of qualitative assessment (such as a focus group on the impact of psychosocial factors on healthcare outcomes); and a multidisciplinary approach to pharmaceutical provision, enhancing collaboration between pharmacists and GPs.
Source of funding The co-ordination of the multi-centre study was funded by the European Commission under the BIOMED 2 programme for medical research.
Bibliographic details Bernsten C, Bjorkman I, Caramona M, Crealey G, Frokjaer B, Grundberger E, Gustafsson T, Henman M, Herborg H, Hughes C, McElnay J, Magner M, van Mil F, Schaeffer M, Silva S, Sondergaard B, Sturgess I, Tromp D, Vivero L, Winterstein A. Improving the well-being of elderly patients via community pharmacy-based provision of pharmaceutical care: a multicentre study in seven European countries. Drugs and Aging 2001; 18(1): 63-77 Indexing Status Subject indexing assigned by NLM MeSH Aged; Community Pharmacy Services; Europe; Female; Health Surveys; Humans; Male; Patient Satisfaction; Quality of Life AccessionNumber 22001000567 Date bibliographic record published 31/01/2003 Date abstract record published 31/01/2003 |
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