Family Practice Advance Access originally published online on January 20, 2006
Family Practice 2006 23(2):203-209; doi:10.1093/fampra/cmi107
Helicobacter pylori test & treat strategy for dyspepsia: a qualitative study exploring the barriers and how to overcome them
a Health Protection Agency Primary Care Unit, Gloucester, UK, b Gloucestershire Research & Development Support Unit, Gloucestershire Hospitals NHS Foundation Trust, Gloucester, UK and c University of Birmingham, Department of Primary Care and General Practice, Birmingham, UK.
Correspondence to Dr Cliodna McNulty, Health Protection Agency Primary Care Unit, Microbiology Department, Gloucestershire Royal Hospital, Great Western Road, Gloucester, GL1 3NN, UK; Email: jill.whiting{at}hpa.org.uk
Received 27 April 2005; Accepted 9 December 2005.
McNulty C, Freeman E and Delaney B. Helicobacter pylori test & treat strategy for dyspepsia: a qualitative study exploring the barriers and how to overcome them. Family Practice 2006; 23: 203–209.
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Abstract |
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Background. The National Institute of Clinical Excellence (NICE) has issued guidance that recommends that all dyspeptic patients without alarm symptoms, irrespective of age, that relapse after one month's proton pump inhibitor, should be offered test and treat for Helicobacter pylori.
Objective. To explore the views of primary care about introducing the helicobacter test and treat NICE dyspepsia guidance.
Methods. In 15 urban and rural general practices in Central England, primary health care staff involved in the management of dyspepsia took part in qualitative focus groups to discuss the draft NICE guidance and how it might be implemented.
Results. Practices expressed concern that test and treat may not be cost-effective in younger patients and that they may miss malignancy, in older patients and in patients who relapse after triple treatment, without a further helicobacter test or endoscopy. The greatest practical barriers to test and treat were the considerable impact on nurses' and doctors' time to explain, undertake tests and report results to patients, and practice budgets from urea breath test and triple treatment costs. Staff preferred stool tests to breath tests, as they impacted less on practice budget and time. GPs did not favour prescribing the three components of the triple treatment separately.
Conclusions. GPs will need reassurance that test and treat will not lead to missed malignancies. The financial costs and staffing implications of NICE dyspepsia guidance will need to be discussed locally by Primary Care Trusts, microbiology laboratories, gastroenterologists and pharmacy advisors and implemented with local guidance, increased communication and education.
Keywords. Diagnostic tests, Helicobacter pylori, implementation, NICE guidance, qualitative.
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Introduction |
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Dyspepsia is a very common condition which, when broadly defined to include patients with recurrent epigastric pain, heartburn or acid regurgitation with or without bloating, nausea or vomiting, occurs in 40% of the population annually.1,2 As it is a chronic relapsing condition it commonly leads to GP consultation and 1% of the population are referred for endoscopy annually. The most common causes of dyspepsia are gastroeosophageal reflux, peptic ulcer and non-ulcer dyspepsia. Eradication of Helicobacter pylori leads to ulcer healing and cure and may reduce the long-term associated risk of developing gastric neoplasia.3,4
After reviewing the evidence, the National Institute for Clinical Excellence (NICE) has issued a guideline that recommends that all dyspeptic patients without alarm symptoms, irrespective of age, should be managed initially with full-dose proton pump inhibitor (PPI) therapy for 1 month. If patients relapse, NICE suggests that they should be offered test and treat for H. pylori. Test and treat is more effective than antacids at reducing dyspeptic symptoms, cures those patients with peptic ulceration and reduces the need for endoscopy, providing significant cost savings without increasing the risk of missing neoplasia.2,5 NICE guidelines recommend that GPs use the more expensive but more accurate non-invasive breath and stool antigen tests over blood serology.2,6
The aim of this qualitative study was to explore, with a range of general practices, health care staffs' views about introducing the NICE guidance for H. pylori test and treat for dyspeptic patients of all ages with recurrent dyspepsia.
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Methods |
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Participants and recruitment
We recruited inner-city, urban and rural general practices served by the microbiology laboratories at University Hospital Birmingham and County Hospital Hereford. As we anticipated their views to NICE test and treat guidelines may differ, we wished to undertake focus groups in individual practices with high and low helicobacter serology testing. Laboratory data and general practice population data from 1 April 2002 to 31 March 2003 were used to order practices by the number of requests per 1000 patients for H. pylori serology testing. Irrespective of practice size, practices in the highest and lowest quintiles were randomised and approached in order from these lists.
Focus group discussions
Participants were given the draft NICE summary flow chart for the management of uninvestigated dyspepsia in primary care and were asked for their opinions of the guidance and how it might be implemented.7 As the practices sampled had no experience of using breath or stool tests, we explained the procedures, cost and accuracy of these tests, which stimulated a discussion about their use and how any barriers to test and treat by stool or breath test may be overcome.
Focus groups
The focus groups were held at each participating practice's premises. All health care staff who may be involved in the management of dyspepsia and implementation of test and treat were invited. Practices were given £20 per participant. The focus groups were moderated by a researcher with extensive qualitative research experience (EF) and observed by a microbiologist (CMcN 11) or a GP with an interest in gastroenterology (BD 3). The focus group discussions were tape-recorded. To increase confidence in the validity of the findings, at the end of each focus group any points that needed clarification were confirmed by the group. The observer made extensive field notes during the focus groups and the moderator afterwards. These data were appended to the transcripts for further analysis.
Ethics
Ethical approval was obtained from the LRECs in each area (Hereford & Worcester 03/51, Birmingham 2003/149). All participants gave written informed consent to participate and for the focus groups to be tape-recorded, transcribed and analysed.
Data analysis
We adopted an iterative approach to data analysis, with analysis beginning after the first focus group, to allow emerging themes to be explored in subsequent focus groups. All the tapes were transcribed using QSR N5 software (QSR International Pty Ltd. N5 software for qualitative data analysis, Melbourne) and Microsoft Word files. The moderator (EF) validated the transcriptions against the original recordings. These transcribed data were analysed using an interpretive phenomenological approach, which developed codes categories and themes arising from the data.8,9 The transcripts were scrutinised independently (by EF and CMcN). An initial coding frame was developed that identified common categories and themes that explored the opinions about test and treat and its implementation in primary care. These were used to further analyse the transcripts. A high level of consensus was achieved between the two research team members (EF and CMcN) who interpreted the data. Saturation of data was attained in that no new material was forthcoming after conducting 14 focus groups.
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Results |
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Fifteen of 18 practices that were approached agreed to take part. Although we initially planned to do 12 focus groups, randomisation resulted in three single-handed practices, in which we conducted individual interviews. We visited the practices between September 2003 and April 2004. Seven were high testing practices and eight were low testing practices. Testing rates ranged from 0.1 to 2.7/1000 patient population in low testing practices and 8.2–59/1000 in high testing practices. Two practices with very similar testing rates, that held regular joint meetings, came together to form a single focus group. Two to ten health care staff participated. GPs participated in all focus groups, practices managers in four and a practice nurse in seven. The nursing staff were only involved in undertaking diagnostic tests and, therefore, mainly took part in the discussion about the type of diagnostic test used and barriers to introducing the stool and breath tests over blood serology. The four practice managers who participated felt they had some involvement in dyspepsia management. This was mainly the paperwork associated with the tests and staffing issues. The average duration of focus groups was 75 minutes.
Barriers to test and treat
The barriers identified by high and low testing practices were very similar, although high testing practices were much more enthusiastic and felt that implementation of the guidance would only require small changes in their testing practice. The prevalent feeling was that they would need to see the evidence before changing their management, but this was particularly so in low testing practices.
Test and treat for all age groups
The majority of practices expressed concern about introducing the test and treat policy in all age groups. Doubts were expressed about the cost-effectiveness of testing patients in younger age groups.
‘I would like to feel that the evidence is strong enough that it is worth doing that ... because [referring to test and treat in all patients with dyspepsia] you're practically population testing now.’ (High testing practice GP B02)
In addition, testing in older patients (>55 years) runs counter to previous guidance,10 which suggested GPs should be referring older patients for endoscopy because of an increased cancer risk.a
‘It's difficult to change your practice and if something has been given to you as a biblical truth that patients over the age of 55 are more likely to have cancer of the stomach and you mustn't treat them blindly and that's something you've believed for 20 years, it's very difficult to unbelieve it overnight. It will take some time to get used to it.’ (High testing practice GP B06)
There was confusion about the number of changes in advice from gastroenterologists regarding age risk factors, which they have had to assimilate.
‘Over the years we receive different guidelines. I remember many years ago there was this cut off point between those who are 50 and those who are under 50 and then these were changed. So on the whole things have become less clear cut than it used to be.’ (High testing practice GP B07)
However, several practices reported that the removal of the age cut-off for endoscopy referrals was sensible, as they could concentrate more on the patient's symptoms, rather than having what they felt was an arbitrary age cut-off. One low testing practice reported that the NICE guidelines would clarify the recent changes in guidance for management of dyspepsia.10 It could be used to justify their management of patients if things went wrong and neoplasias were missed.
‘There are various views on what you should do and what you tend to do is what the last lecturer told you about. So [NICE will] virtually bring it all together to do something which is cost effective and safe if things go wrong you've someone [to] justify why you did what you did, so it makes life much easier for us really.’ (Low testing practice GP B08)
Patients with recurrent symptoms
NICE guidance recommends that patients who relapse after helicobacter treatment should not be retested or offered endoscopy, but should be treated as functional dyspepsia, with PPIs, unless they have alarm symptoms.2 This led to expressions of concern, particularly about the risks of prescribing PPIs long-term without a further helicobacter test or definitive diagnosis, usually through endoscopy or gastroenterologist referral.
‘I think it's going to be a fairly brave person who doesn't go on to refer these patients who haven't been scoped and they're getting symptoms and they are 50 odd perhaps and they are even without alarm symptoms.’ (Low testing practice GP H06).
Time
The greatest practical barrier to introducing a test and treat policy was the impact on practice nurses' and doctors' time. Those high testing practices that already undertook much helicobacter testing explained that, although the guidance would not greatly increase their testing rate, it was time-consuming but essential to explain to the patient the reason for the test, then reconsult with and treat those with a positive helicobacter result.
‘I mean after we tell the patient that the test is positive they think oh my God I've got cancer. They don't listen any more. So you need to counsel them to make sure that they understand what we're doing, so usually when we do a H. pylori test we see them afterwards and explain.’ (High testing practice GP B07)
The GPs and nurses reported a shortage of practice nursing staff, especially in the inner city Birmingham area which had low testing. Nurses were stretched by their extended role and by chronic disease monitoring. GPs reported that they were being bombarded by the Department of Health (DH) and NICE with one initiative after another.11 Moreover, the pace and volume of change, which GPs had to assimilate, was considerable.
‘I think blood tests are increasing here and we're getting more and more monitoring and we're faced with the problem of not having enough staff, the practice nurse situation is horribly bad.’ (Low testing practice GP B05)
None of the practices had experience of using practice-based urea breath tests (UBTs) and none were keen to take on the additional workload of testing in their practice.
‘You want the patient to come and have the capsules and wait 20 minutes ... . you need somebody who is available here to do that. You need practice time. Now believe me practice time at the moment is very difficult.’ (High testing practice GP B03)
All the practices stated that if there was a significant increase in their helicobacter testing then the staffing implications would need to be funded by the Primary Care Trusts (PCTs).
Some practices suggested that, instead of each individual practice training and providing staff to undertake UBTs, the PCTs should fund a central satellite testing centre similar to some of the centralised ECG testing that is currently performed.12
‘If there is a facility available at [the] hospital ---- [rather than] creating all these small clinics with urea breath tests in each and every practice....’ GP3
‘Like a satellite clinic. Like we send our ECG patients to a local practice... . and then the results would come back to us.’ GP4 (High testing practice 2 GPs B09)
Practices stated they would prefer to use a laboratory-based stool antigen test rather than the breath test, as this impacted less on nursing staff time and was as accurate as the UBT.
Practice budget
Many practices were concerned that the NICE dyspepsia test and treat guidance had a cost saving motive.
‘NICE guidance—a lot of it looks like it's money saving, you know Government induced—we do listen to NICE but we don't take the recommendations uncritically.’ (Low testing practice GP H06)
‘I don't want to become the agent of rationing of expensive healthcare services [referring to endoscopy], this is the least of my priorities. But I'll do it [test and treat] when it seems sensible to do so, but I'm not taking it to extreme lengths.’ (High testing practice GP B06)
Participants expressed dismay that a diagnostic test should incur a prescription charge to the patient, as patients do not usually have to pay for diagnostic tests.
‘What are the patients going to say if you're asking them to pay for the diagnostic test, [they] don't have to pay for the diagnostic test normally.’ GP2 (Low testing practice B08)
The test costs would also impact on their drug budget. These were expressed by all practices as a significant barrier to its use. All practices stated they were under continuous pressure from PCTs to reduce their drug budget, particularly for PPI prescribing. Introducing test and treat using prescribed UBTs would have major consequences for the practice budget, PCT prescribing leads and contracting laboratory services.
‘Regarding the cost of all this sort of thing, I can imagine that it would actually be the transferral of the cost from secondary care to primary care. We end up prescribing more eradication therapy probably and we're in this unfortunate situation of having the pressure of providing decent care and decent treatment of people but also at the same time being told we've got to cut our drug budgets’. (Low testing practice GP H05)
Patient acceptance of tests
All participants thought the stool test would be less popular with patients than a blood test and may have less compliance.
‘I think some of them might not do it [stool specimen] and won't come back. A blood test you can get an assistant to do it there and then. So they're getting it done before they leave.’ (High testing practice, GP B02)
However, this could be overcome with appropriate explanation about the benefits of the test.
‘Patient information, very clear guidance of why you are doing this, what the consequences of the test are ... basic details of how accurate it is, what may occur if it's positive or negative ... just as with the information given with the ECG—that's a good example of good practice.’ (High testing practice GP B09)
It was thought that compliance with stool test would be better in dyspeptic patients than screening for occult blood in asymptomatic populations.13 One GP felt strongly that the great symptomatic relief provided by PPIs would make some patients very reluctant to stop taking them for the required wash-out 2 week period prior to a UBT or stool test.
‘They would never accept that. I can assure you they will make a lot of fuss, they will make a lot of noise and they will be very aggressive ... we have a lot of experience with these patients and we know they cannot tolerate any kind of thing [symptoms].’ (High testing practice GP B03)
Participants agreed that if patients' follow-up appointments were appropriately spaced this problem could be minimised.
Compliance with treatment regimen recommended by NICE
We asked GPs what they thought of the first line eradication regimens recommended by NICE.2 Nearly all GPs prescribed HeliClear® (Wyeth Laboratories, Huntercombe Lane South, Taplow, Maidenhead, Berks) for H. pylori treatment, as they thought that the packaging was much easier for the patient and, therefore, increased compliance.
‘I don't know whether they're much more expensive but I think its very nice for the patient and I think it probably helps the compliance and it makes it feel sort of not so scary taking three different tablets. A whole load of them you just think oh my God is this right whereas if you have it in a nice little box and you've got a little packet for each day.’ (High testing practice GP B02)
None were enthusiastic about prescribing the three components of the triple treatment separately.
‘HeliClear's easier, it's just literally a 5 second job, if you prescribe them separately....there are 10 different choices, the different antibiotics. Different doses, so I think it's just impractical.’ (High testing practice GP B09)
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Discussion |
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Summary of main findings
High testing practices were more enthusiastic about implementing the guidance. The primary care health staff in this study reported that the major barrier to the introduction of NICE test and treat guidance for all patients with dyspepsia was the time taken to give patients information and details of testing, test results and treatment and the impact on practice nurse time. GPs felt that, with appropriate explanation, patients would comply with producing a stool specimen but practices were not keen to commit practice nurse time and budget to the urea breath tests. Most GPs were anxious about missing malignancy if they did not endoscope older patients or patients who relapse after helicobacter treatment. GPs reported that prescribing HeliClear or Helimet® (Wyeth Laboratories) was easier and quicker for them and would improve patient compliance in completing their course of treatment.
The strengths and the limitations of this study
The randomly selected practices in this study were served by two different microbiology laboratories in a rural and urban setting. They are probably typical of inner city, urban, and rural practices found in other areas of the UK and should be transferable to general practices across the UK. Because we sampled practices with a wide range of testing rates, we were able to obtain the most and least enthusiastic viewpoints about the introduction of test and treat for dyspepsia. The testing range is similar to that seen across four laboratories in the south west of England surveyed in 2004 (0–19.7/1000 population; mean range 4–6.3) (Cliodna McNulty, personal communication).Therefore, the barriers raised will probably be encountered in most PCTs when they implement the NICE dyspepsia guidance.
During the focus groups, the open questioning style revealed individual variations that we may have been unable to explore. Nevertheless, we were able to elicit attitudes to the test and treat policy and explore their concerns, which would not have been possible through a postal questionnaire. The moderator was careful not to influence the opinions of the participants. She had no previous experience in gastroenterology or microbiology, and therefore was able to approach the work with no preconceptions. The observers were both experts in the field of dyspepsia and were concerned that they may influence the discussion. Therefore, at the beginning of the focus groups, the observers explained that they would not be taking part in the discussion and were only there to clarify points of fact and to present and discuss the NICE draft guidance with the focus group members.7 There was no evidence that the participants were influenced by the observers, as they voiced their opinions very openly.
Thirteen of the 15 practices were seen as individual practices. The advantage of this is that the individual practice participants were not influenced by behaviours and opinions of other practices. However, if we had held more joint focus groups we may have been able to stimulate more discussion. In general, however, we believe that our approach was appropriate, especially for staff from low testing practices who may have been embarrassed to express their reservations about national guidance in the presence of staff from another practice.
Implications of this research for clinical practice
During implementation of NICE test and treat guidance, PCTs must be aware of the pressures on GPs and nurses who are struggling to cope with many other new initiatives and chronic disease management. Any education initiatives must stress the great benefits of test and treat to patients and GPs and provide evidence that there is no significant increased risk of missing cancers in the older patients as well as those who relapse after treatment. As practices with low helicobacter testing were more sceptical and less knowledgeable about the benefits of test and treat,14 these practices will need to be identified by analysis of laboratory use, then be offered specific invitations to attend NICE implementation education sessions, which is more effective at increasing testing than passive dissemination of guidance alone.15 In a recent study exploring the impact of other NICE guidance, Wathen et al.16 found that guidance taken in isolation had little impact on practice. Where the guidance coincided with information from other sources or personal experience there was some evidence that NICE guidance triggered a change in prescribing. GPs reported that changes in practice were often due to ‘pressure from local pharmaceutical advisors’ to make cost savings.16 Furthermore, the guidance reinforced their practice rather than changed it. This suggests that implementation of the NICE guidance will be easier in the practices that are already undertaking helicobacter testing as part of their routine management of dyspepsia14 and emphasises the need for monitoring of triple therapy prescribing by pharmaceutical advisors. Laboratory feedback to PCTs and general practices on audit of use of helicobacter diagnostic tests will also aid implementation.16 We suggest that PCTs, microbiology laboratories and gastroenterologists meet locally to discuss the implementation process. The production of educational materials by primary care, gastroenterology and microbiology societies, at a national level, would facilitate this process. These should address the barriers we have identified. Production of guidance alone has little impact on practice. Guidance needs active implementation, as a combination of outreach workshops and feedback on practice activity has greater impact on practice than either of these methods or guidance alone.17 To facilitate implementation, we suggest that NICE publish PowerPoint workshops with teaching notes in parallel with their guidance.
All practices stated that their drug budgets were audited closely by PCTs. GPs felt that the impact of prescription-based UBTs and increased use of triple treatment on their drug budgets would be a barrier to implementation unless the PCT increased their drug budgets accordingly. NICE indicates that UBT or stool antigen tests should be used in preference to serology.2 Both of these tests are more expensive than serology and, therefore, PCTs will need to determine which test they should fund and how to implement use. Practices in this study favoured stool tests over UBTs, as these required less practice nurse time and would not come out of their drug budget. The increased costs of the stool test will be outweighed by its increased specificity, leading to fewer false positives and, therefore, lower treatment costs.18 The benefits of the stool tests over serology will need to be explained at educational sessions so that GPs can advise patients appropriately.
In patients who test positive for helicobacter, compliance with triple treatment is an important determinant of successful eradication.19 Prescribing by GPs exemplified this as they reported that, to improve patient compliance, they prescribed non-generic products that had improved packaging with the three components of triple treatment in a daily blister pack format. We suggest that pharmaceutical companies should manufacture the alternative cheaper regimen recommended by NICE in the same format, as poor eradication due to non-compliance with the cheaper regimens may outweigh the cost-benefits of test and treat.
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Declarations |
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Funding: This study was funded by Public Health Laboratory Service South West.
Ethical approval: Granted by the local research ethics committees for Hereford & Worcester (03/51) and Birmingham (2004/149).
Conflicts of interests: Cliodna McNulty is responsible for the Health Protection Agency GP Microbiology Laboratory Use Group guidance and reviewed the NICE guidance. Elaine Freeman, on behalf of the Gloucestershire Research and Development Support Unit, has received sponsorship from AstraZeneca UK and Wyeth Laboratories to support RDSU local conferences. Brendan Delaney was technical lead for the NICE dyspepsia guidelines 2004. He has received speaking honoraria from AstraZeneca UK, AstraZeneca Canada, AstraZeneca Sweden, AxCanPharma Canada, Eisai, but has never held a consultancy role; he has also received research grants in dyspepsia from the Medical Research Council and is supported by an NHS R&D Primary Care Career Scientist Award. In line with journal policy this paper was managed by an associate editor double blind to the Editor's presence as an author.
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Acknowledgments |
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We wish to thank Jo Bowen for analysis of laboratory data and facilitating one of the focus groups, the practice staff for their enthusiastic participation, laboratory staff (Wally Palmer and Peter Adams) for providing laboratory use figures, Vicky Wilson and Allison Bates for transcribing the tapes and Jill Whiting for her patience with the manuscript.
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Notes |
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a Since the preparation of this paper NICE have revised the dyspepsia guideline to clarify that patients over the age of 55 with ‘unexplained’ or ‘persistent’ symptoms of recent onset should be referred for endoscopy. The original wording had been interpreted by some that patients should not be investigated at all unless they developed alarm symptoms suggestive of cancer (http://www.nice.org.uk/page.aspx?o=CG017quickrefguide).
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References |
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