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The BC Community Pharmacy Asthma Study: a study of clinical, economic and holistic outcomes influenced by an asthma care protocol provided by specially trained community pharmacists in British Columbia |
McLean W, Gillis J, Waller R |
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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 Patients whose asthma was seen as uncontrolled were given enhanced pharmaceutical care (EPC) by specially trained community pharmacists. This consisted of an initial interview to complete a symptom, drug utilisation and knowledge assessment. The patient was taught the proper inhaler technique and the pharmacist answered any questions they had. The patients were taught asthma self-management, as outlined in the Health Outcome Pharmacists (HOP) Asthma Care Module (see Other Publications of Related Interest), and had to complete a monthly asthma diary. The patients were seen by the pharmacists for about an hour every 2 to 3 weeks for at least three appointments, and then had follow-up appointments every 3 months. The comparator group of patients were given usual care (UC) by the pharmacists. This was identical to EPC, except that asthma self-management was not taught. The patients only saw the pharmacist when they needed a prescription refill.
Type of intervention Treatment and management care.
Economic study type Cost-effectiveness analysis.
Study population The study population comprised asthma patients attending one of 27 HOP cooperatives. The pharmacies tried to recruit patients whose asthma was uncontrolled.
Setting The setting was community pharmacies and secondary care. The economic study was carried out in British Columbia (BC), Canada.
Dates to which data relate The effectiveness evidence related to 1999 to 2000. The dates to which the resource evidence related were unclear, but it is likely that evidence on the quantities was also from 1999 to 2000. No price year was given.
Source of effectiveness data The effectiveness data were derived from a single study.
Link between effectiveness and cost data The same patients provided both the effectiveness and cost data. It was unclear whether the costing was carried out prospectively or retrospectively.
Study sample No power calculations were reported. A total of 707 patients were initially recruited into the study and 631 completed the consent process. The study allowed for some patients to be allocated to "a control category", which meant that they did not have any special intervention. This was because some pharmacies (with experience of asthma education) could give both EPC and UC, whereas others could give either EPC and "controls" or UC and "controls". Those patients in the control group were identified for purposes of the study, but were not included in the analysis.
Initially, there were 191 patients in the EPC group and 44 of the UC patients crossed over to EPC. Of these 235 patients, 119 were available to study. The remainder dropped out (n=88) or provided insufficient data (n=27). Initially, there were 214 patients in the UC group, of which 105 were available for study. The remainder dropped out (n=95) or had insufficient data (n=14). Of the 224 available patients, 37% were male and the average age was 48 years (range: 7 - 84).
Study design This was a randomised controlled trial (RCT) in which the patients were randomised to EPC versus UC, EPC versus "control", or UC versus "control", depending on their pharmacy. The patients were followed up for 12 months. From the initial 191 EPC patients, 119 were followed up with sufficient data. From the initial 214 UC patients, 105 were followed up with sufficient data.
Analysis of effectiveness The analysis was conducted on the basis of treatment completers only. The health outcomes measured were the peak expiratory flow rate (PEFR), symptom scores, knowledge of asthma scores, daily use of beta-agonists and corticosteroids, and asthma quality of life (QoL) scores.
Symptom scores were measured on 0 to 3 scale. The total score and component scores for cough, wheeze, shortness of breath, chest tightness, phlegm production, heartburn, nocturnal awakenings, and nasal symptoms were measured.
For knowledge of asthma, the total score (out of 21) and component scores for the effect of asthma on the lungs (out of 2), medications (out of 10), asthma control (out of 7), and peak flow monitoring (out of 2) were measured.
Asthma QoL was assessed using the Juniper questionnaire on a 1 to 5 scale. The total score and component scores for activity limitation, symptoms, emotional function, and environment factors were measured.
With the exception of age and gender, the comparability of the groups at baseline was not assessed for demographic characteristics.
Effectiveness results The PEFR went from 344.1 to 351.9 L/minute in the UC group, and from 349.4 to 383.4 L/minute in the EPC group, (p=0.0002).
The total symptom score went from 1.058 to 0.928 in the UC group, and from 1.081 to 0.531 in the EPC group, (p<0.0001).
The knowledge assessment scores went from 8.697 to 14.602 in the UC group, and from 9.125 to 19.649 in the EPC group, (p<0.0001).
The use of beta-agonists went from 3.576 to 2.884 doses/day in the UC group, and from 3.962 to 1.944 doses/day in the EPC group (p=0.0082). The use of corticosteroids went from 2.503 to 2.400 doses/day in the UC group, and from 2.428 to 2.367 doses/day in the EPC group, (p=0.6309).
The QoL scores went from 4.234 to 4.400 in the UC group, and from 4.294 to 5.133 in the EPC group, (p=0.0001)
Clinical conclusions The authors concluded that the health outcomes for EPC patients were better than those for UC patients.
Measure of benefits used in the economic analysis No summary measure of benefit was produced. In effect, the authors carried out a cost-consequences analysis.
Direct costs Discounting was not carried out as the costs were incurred during less than 2 years. The quantities and the costs were analysed separately for all costs apart from the drug costs and the pharmacists' fees. The costs measured were for medical visits, emergency visits, hospitalisations, prescription drugs, and pharmacist fees. The quantities were estimated on the basis of the study sample. The unit costs were derived from published data (1996) and unpublished data from the BC Ministry of Health and BC Pharmacare (1998-1999). No price year was given (probably 1998-1999) and it was unclear whether the same price year was used for all the costs.
Statistical analysis of costs No statistical analysis of the costs was carried out.
Indirect Costs No discounting was carried out as the costs were incurred during less than 2 years. The costs measured were for days off school and work, and were broken down into prices and quantities. The quantities were estimated on the basis of the study sample, while the costs were derived from published data (1998). No price year was given, but it was probably 1998.
Sensitivity analysis No sensitivity analysis was carried out.
Estimated benefits used in the economic analysis See the 'Effectiveness Results' section.
Cost results The cost per patient was $351.00 in the UC group and $150.00 in the EPC group.
The costs were calculated for one year.
The authors did not report whether the costs of adverse events were included in the analysis.
Synthesis of costs and benefits The costs and benefits were not combined as the study was, in effect, a cost-consequences analysis.
Authors' conclusions Enhanced pharmaceutical care (EPC) administered by specially trained community pharmacists improved the health and economic outcomes in asthma patients.
CRD COMMENTARY - Selection of comparators The choice of the comparator (UC) was justified by the authors as being a current practice in community pharmacies. However, their description of "control care" as normal practice means that no intervention should have been a potential baseline comparator. You should decide whether UC represents current practice in your own setting.
Validity of estimate of measure of effectiveness The effectiveness data were derived from a single study. The analysis was based on a RCT, which was suitable for the study question as well-conducted RCTs are considered the 'gold' standard study design when comparing different health interventions. However, as the patients were allowed to move from UC to EPC, this switch would underestimate the real effect of EPC. The initial study sample was representative of the study population, but there was a significant dropout rate and several patients had insufficient data. This means that the data relate to conscientious, compliant patients rather than asthma patients in general. The authors did not assess the comparability of the patient groups at baseline, although they presented health data at baseline. The fact that patients could change groups, and that outcomes were analysed for treatment completers only, represent the main drawbacks to the study.
Validity of estimate of measure of benefit The authors did not derive a summary measure of health benefit. The study was a cost-consequences analysis, therefore the health benefits are those associated with the effectiveness outcomes.
Validity of estimate of costs The perspective of the analysis was not explicitly stated, but it was consistent with that of society. As such, all the relevant categories of cost were included in the analysis. Most of the costs, but not all, were reported separately from the quantities, which will increase the generalisability of the authors' results to other settings. The resource use quantities were taken from a single study, while the prices were taken from published and unpublished sources. No statistical, sensitivity, or any other analyses of the quantities or prices were conducted. In addition, no price year was given. These facts will prevent any future reflation exercises and will limit the generalisability of the study. Discounting was not relevant, as all the costs were incurred during one year, and was not performed.
Other issues The authors made comparisons of their results with those from another study, showing that their results were better. They reported that the generalisability of the study must be treated cautiously because of the elevated level of UC. The authors did not present their results selectively, but their conclusions overestimated the strength of their data as they only had data on treatment completers. The authors were aware of the high dropout rate. They also drew attention to the fact that the patients and pharmacists recorded the outcome measurements, and that it would have been better, particularly for health service utilisation, to use data from British Columbia Health.
Implications of the study The authors suggested that the health care system should produce incentives for EPC.
Source of funding Supported by a financial contribution from the Health Transition Fund, Health Canada.
Bibliographic details McLean W, Gillis J, Waller R. The BC Community Pharmacy Asthma Study: a study of clinical, economic and holistic outcomes influenced by an asthma care protocol provided by specially trained community pharmacists in British Columbia. Canadian Respiratory Journal 2003; 10(4): 195-202 Other publications of related interest Health Outcome Pharmacies Asthma Disease State Module 1998.
Oauley TR, Magee MJ, Cury JD. Pharmacist-managed, physician-directed asthma management program reduces emergency department visits. Annals of Pharmacotherapy 1995;29:5-9.
Indexing Status Subject indexing assigned by NLM MeSH Adolescent; Adult; Aged; Aged, 80 and over; Asthma /economics /therapy; British Columbia; Child; Clinical Protocols; Cluster Analysis; Community Pharmacy Services /economics; Female; Holistic Health; Humans; Male; Middle Aged; Patient Education as Topic; Pharmacists /economics; Quality of Life; Treatment Outcome AccessionNumber 22003009802 Date bibliographic record published 31/07/2005 Date abstract record published 31/07/2005 |
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