CURRENT ISSUES
3
Challenges of measuring outcomes in 'real-life' DM programmes - Carlene Todd~ere
are several important problems associated with measuring 'real-life' outcomes in
~ disease management (DM) programmes, according to Dr Bert van Oekelen from Glaxo
Wellcome, The Netherlands. At PharmEcon '97 [Paris, France; June 1997], he noted that even if 'real-life' outcomes measures are obtained, researchers can still have problems gaining acceptance of their findings. At the meeting, Dr van Oekelen suggested some ways to increase the likelihood of acceptance of such outcomes data, including the participation of all healthcare players in the disease management programme. To illustrate these ideas, he outlined how Glaxo Wellcome in The Netherlands has overcome numerous challenges in implementing an asthma self-management pilot programme, and has generated some positive 'real-life' health outcomes.
Challenges of measuring outcomes If you are going to measure outcomes, it is important to keep the results as close to 'real life' as possible. Simplification of the measures is also important as there is still a lot to be learnt in the area of disease management and outcomes research. Another challenge of measuring outcomes is that fast-paced technological development means that obsolescence is an important consideration. For example, if general practitioners simply focus on the information systems of today, they will 'miss the battle' in 5 years' time because the lifecycle of these systems is quite short, noted Dr van Oekelen. Another challenge is getting 'real-life' outcomes research accepted by decision-makers.
Preparation of disease management plan The key is for a pharmaceutical company to move from conducting clinical trials to conducting 'real-life' research. With regard to the preparation of a 'real-life' case study- for example, Glaxo Wellcome's asthma self-management pilot study - it is important to keep the research as local as possible. A large project involving too many locations and networks can generate data that are not comparable between the different sites; each location has a different infrastructure, as well as individuals with different needs, skills, knowledge and outcomes. There is also a need to involve all healthcare players in the disease management plan, since they all have individual needs and goals. All healthcare providers involved in the project should understand and accept each others' roles.
Different parties have different objectives Dr van Oekelen discussed the different interests and objectives of patients, physicians, pharmacists, health i..'1.surers, gcverrLrn.ents, employers and pha_rmaceutical companies. All of these parties have different views on the benefits of disease management and outcomes research. Therefore, disease management projects are 'not a desk research subject', stated Dr van Oekelen. He suggested that pharmaceutical companies initiating the disease management programmes should always discuss the relevant issues with each of these parties before their disease management plans are put in place. Starting a project is very easy, but putting 1173-5503/97/0126-0003/$01.00c Adls International Limited 1997. All rights reserved
together an effective plan and then setting up the programme to fit into that plan is more difficult.
Conducting outcomes research In order to conduct outcomes research, the researchers must consider: • • • • •
what data should be collected? what information should be derived from these data? which measurement instruments should be used? who should collect the data? how should the information be communicated?
A common problem is that researchers are often not measuring what they think they are measuring. Therefore, a measurement plan is required for each disease management project. It is also important to remember that measurements are simply a tool, not a goal.
Implementation of the project It is very important that the developer of the disease management programme knows how to influence physician and patient behaviour. Motivations and incentives can be used over the long term during a project. The focus must be on getting the programme started. It can often take a long time to initiate the programme if numerous discussions are taking place with various parties. The longer it takes to start a programme, the greater the complexity, the more measurements required, and the less likely it is that the outcomes will represent 'real life'.
Need to persevere with programme Dr van Oekelen also emphasised the importance of persevering with the programme. The first month of the programme tends to be successful; however, it could be followed by a decrease in motivation and interest in the programme. When conducting 'real-life' outcomes research, it is difficult to keep patient and physician motivation high over a long period of time; this could have a profound influence on the results. He also cautioned against delaying the dissemination of the results of the programme. Developers of the plan should lower their expectations on the speed of plan implementation - since it often takes much longer to get started than initially anticipated - and raise their expectations on the level PharmacoEconomics & Outcomes News 23 Aug 1997 No. 126
CURRENT ISSUES
4
Measuring outcomes in 'real-life' DM programmes -continued of investment required. Dr van Oekelen advised that everything should be tested early-on in the programme.
Asthma case study Glaxo Wellcome in The Netherlands has a number of challenges and experiences in its prototype asthma self-management programme. The aim of the programme was to change behaviour patterns across a broad spectrum of patients with asthma, since improvements in self-management among such patients can have a significant impact on outcomes. Glaxo Wellcome's self-management programme was conducted at 2 sites and involved around 150 patients from 3 healthcare centres. The programme assessed the impact of self-management on the use of healthcare services [see figure] . Impact of asthma self-management pilot study on patient outcomes
·--
-021
-ool.
F~uency or uttune attM:Iu (am)
F requency of asthtNI ...... (pm)
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-431 -•tl' -nl'
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-t•t -••I _.,,
l'l1yolciMvtoltl Average annullf
hMh:hcere coet. BI'MthlngclfftcuMts
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CompUence With Mlf• manaQement behaviours
- 100
-eo
- eo
-40
- 20
0
20
Percentage change in outcome· • - ..,.... ' decr'M••' and •
~
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Following the implementation of the asthma disease management programme, there was a 92% reduction in asthma-related hospitalisations and a 25% reduction in annual healthcare costs. There was a 16% rate of patient compliance with self-management behaviours. According to healthcare providers, the first priority of a disease management programme is quality, followed by cost containment. Dr van Oekelen believes that this is the right focus, since healthcare systems are looking at the influence of quality improvement on cost, rather than the influence of a decrease in investment on quality. 'The only thing left to go [in the asthma programme] is to get these results accepted', said Dr van Oekelen.
Gaining acceptance of results Dr van Oekelen highlighted the important and common dilemma of how to get 'real-life' outcomes data accepted. He recommended a number of ways for increasing the likelihood of acceptance by decisionmakers. • Involve a broad range of healthcare providers in the disease management programme. • Adapt reports to different target groups; for example, not all parties are interested in the economic findings. Physicians are more interested in quality and process improvements; therefore, reports should focus on these areas. • Translate benef~s into economic terms for healthcare payers. PharmacoEconomics & OUtcomes News 23 Aug 1997 No. 126
• Present the problems encountered during the process to the company's development groups; this is the first step towards improving the company's products and services.
Positive results in US asthma programme Glaxo Wellcome has also implemented asthma self· management programmes at 8 US sites, including corporations, managed-care organisations and specialty allergy clinics.1 The programme is aimed at individuals with mild-to-moderate asthma. To date, 137 individuals have completed the programme, which comprises 9 hours of classroom training. Training addresses the principles of self-management, the nature of antiasthmatic drugs, prevention of asthma attacks, management and the consequences of asthma, relapse prevention, and crisis management. Individuals also receive 'assertiveness training' to help improve communication with their healthcare providers. Six-month self-reported data from patients indicate that the programme is improving quality of life. Asthma· related anxiety, irritability or depression decreased from 57% prior to implementation of the programme to 25% 6 months after implementation of the programme. Also, difficulty performing indoor and outdoor tasks decreased from 68 to 38% of indMduals, respectively, while limitations with physical activity decreased from 70 to 47%. Six months after implementation of the programme, the proportion of participants reporting awakenings due to nocturnal asthma decreased from 73.0 to 58.3%. All137 individuals who completed Glaxo Wellcome's asthma self-management programme said that they would recommend it to other patients. 1. Glaxo reports stro11g six-month aslhma =Wts. Disease Management News 2: 8, 10 Aug 1997
Commitment is key Dr van Oekelen believes that providers and suppliers of healthcare commit to health outcomes by improving products and services. Payers and reimbursers commit to 'real-life' data that have been collected via a project that involves patients and providers. Consequently, payers and reimbursers are more likely to be persuaded that the products and services deserve a place in reimbursement so that patients can gain access to these programmes. The idea of an integrated approach to healthcare should not be kept on paper only, said Dr van Oekelen. He argues that there is a lot of scope for reducing 90% of all healthcare costs, with regard to integration and working together, rather than focusing on the 10% of costs that relate to drugs alone. He concluded that there is a need to not only focus on the results of disease management programmes, but also to tackle the expectations of each party participating in disease management. Dr van Oekelen introduced a formula whereby the results of a programme divided by the expectations of the participants generates a measure of satisfaction. He suggested that the developers of disease management programmes should keep this formula in mind.
1173-5503/97/0126.0004/$01.00° Adialnternational Limited 1997. All rights reserved