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BMJ 2004;329:999 (30 October), doi:10.1136/bmj.329.7473.999
Trevor A Sheldon, professor1, Nicky Cullum, professor1, Diane Dawson, senior research fellow3, Annette Lankshear, senior research fellow1, Karin Lowson, deputy director2, Ian Watt, professor1, Peter West, director2, Dianne Wright, research fellow2, John Wright, operations medical director4
1 Department of Health Sciences, University of York, York YO10 5DD, 2 York Health Economics Consortium, University of York, 3 Centre for Health Economics, University of York, 4 Bradford Royal Infirmary, Bradford, BD9 6RJ
Correspondence to: T A Sheldon tas5{at}york.ac.uk
Design Interrupted time series analysis, review of case notes, survey, and interviews.
Setting Acute and primary care trusts in England and Wales.
Participants All primary care prescribing, hospital pharmacies; a random sample of 20 acute trusts, 17 mental health trusts, and 21 primary care trusts; and senior clinicians and managers from five acute trusts.
Main outcome measures Rates of prescribing and use of procedures and medical devices relative to evidence based guidance.
Results 6308 usable patient audit forms were returned. Implementation of NICE guidance varied by trust and by topic. Prescribing of some taxanes for cancer (P < 0.002) and orlistat for obesity (P < 0.001) significantly increased in line with guidance. Prescribing of drugs for Alzheimer's disease and prophylactic extraction of wisdom teeth showed trends consistent with, but not obviously a consequence of, the guidance. Prescribing practice often did not accord with the details of the guidance. No change was apparent in the use of hearing aids, hip prostheses, implantable cardioverter defibrillators, laparoscopic hernia repair, and laparoscopic colorectal cancer surgery after NICE guidance had been issued.
Conclusions Implementation of NICE guidance has been variable. Guidance seems more likely to be adopted when there is strong professional support, a stable and convincing evidence base, and no increased or unfunded costs, in organisations that have established good systems for tracking guidance implementation and where the professionals involved are not isolated. Guidance needs to be clear and reflect the clinical context.
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The research consisted of three phases, each one using a different method of data collection to answer different but complementary questions.
Phase I
We analysed routine national or regional data and national surveys (centrally collected data; box 1) to assess the extent to which practice changed after publication of the tracer guidance. We used data from the NHS Prescription Pricing Authority, which covers all of England, to explore trends in the primary care prescribing of relevant drugs. We used hospital episode statistics data (covering England and Wales) to assess the trends in use of invasive procedures. We accessed or directly collected a range of other sources of national and regional data where these two sources did not have relevant or adequate data (box 1). Table 2 shows data sources used for each of the 12 sets of guidance.
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We used interrupted time series analysis to assess if the pattern of practice had changed after NICE guidance3 and so infer whether the intervention had an impact. We used an autoregressive integrated moving average (ARIMA) model with dummy variables to examine the impact of publication on the growth rate and the average rate of use (constant parameter) of a technology once any growth rate had been removed.4
Phase II
Most NICE guidance provides criteria for appropriate use rather than a simple recommendation to use the technology or not. To assess whether the guidance was being implemented properly requires scrutiny of patient records by using methods developed for appropriateness studies.5
6 We selected a random sample of 20 (out of 221) acute trusts and their associated mental health hospitals and 21 (out of 303) primary care trusts (within which we selected a stratified random sample of five practices), from which we reviewed 50 relevant case notes for each of eight guidance topics (table 2). The resulting trusts reflected a good cross selection of geographical spread and size.
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Local audit staff agreed to extract data from patients' records by using audit proforma. Overall usable audit forms for 6308 patients were returned (table 3). We calculated the proportion of cases conforming to the NICE guidance for each healthcare organisation in the sample at two periods of time and estimated the overall average.
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Phase III
We surveyed the chief executives, leads of clinical governance, and leads of clinical specialties of the 20 acute trusts that participated in the audit of patients' notes (65% response rate for chief executive officers (13 out of 20) and 57% overall (68 out of 120)) to assess their handling of NICE guidance. We also conducted semistructured interviews to access professional and managerial perspectives on our quantitative findings and, in particular, to explore the response to the NICE guidance.
We purposively selected five acute trusts7 that returned positive consent forms, to represent differing degrees of implementation of guidance (see phase II). In each trust we approached the chief executive, medical director, and lead clinicians for the guidance topic. We supplemented a common interview schedule (see appendix on bmj.com) by specific interview questions based on findings from the audit. We offered all interviewees face to face interviews but finally conducted three interviews by telephone. Where possible we recorded and transcribed interviews. Where recording proved impossible we returned notes to the interviewee for checking.
Data analysis was concurrent, and clear thematic categories and subcategories emerged.8 9 Two researchers working independently developed these categories and compared and reconciled differences by discussion. We used analytic matrices to examine differences between trusts and across sets of guidance.10
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Hip prostheses
The guidance recommended the use of prostheses with a demonstrable replacement rate of 10% or less, at 10 years, or a minimum of three years, provided that the performance of the prostheses is consistent with the 10 year benchmark. The guidance did not specify which prostheses met the benchmark and the NHS Purchasing and Supply Agency was slow to issue this information (which was subsequently withdrawn).
Use of more than 50 different prostheses was documented in the Trent and Wales register over the period 1998-2002. Of the single prostheses, 69% (3671) met the 10 year benchmark and 81% (4327) met the three year benchmark, proportions that had been declining over recent years. There is some evidence that the decline in 10 year benchmarked prostheses may have stabilised slightly after guidance (1.7 monthly increase after guidance (95% confidence interval 0.4 to 3.1) compared with a long term monthly decrease of -1.8 prostheses per month (-0.75 to -2.80)). We observed similar results from the audit of patients' notes: 66% (325), 74% (727), and 75% (734) of heads, cups, and stems, respectively, meeting the benchmarks. Interviews and the survey indicated that surgeons thought that the guidance did not acknowledge the complexity of hip surgery, and some surgeons interviewed believed that cementless prostheses would ultimately prove to offer longer service.
Taxanes for breast and ovarian cancer
We obtained usable data on taxanes from 24 hospital pharmacies (including nine cancer centres). We found a significant increase in the use of docetaxel and paclitaxel of 1112 (95% confidence interval 530 to 2222, P < 0.001) patient months and 3.7 (1.1 to 7.8, P < 0.002) patient months, respectively (fig 2), but no evidence of a change in the growth rate in the use of gemcitabine (0.5% per month, -36.2% to 37.2%) or vinorelbine (-1.0 patient months, -3.3 to1.3). This is unlikely to be due to lack of statistical power.
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Case note review showed that, of the 707 patients identified as receiving taxanes for breast cancer, all but one were receiving this appropriately (for more advanced forms of the disease or in the context of randomised controlled trials). Interviewees acknowledged that the NICE guidance had made funding easier to obtain. The picture for ovarian cancer, however, was more varied. Of the 520 women with ovarian cancer for whom we have data, only 33% (166) were recorded as having been prescribed paclitaxel. However, oncologists interviewed believed that the guidance had overstated the effectiveness of taxanes in ovarian cancer. NICE subsequently amended its guidance.
Implantable cardioverter defibrillators
Although the number of implantable cardioverter defibrillators implanted has risen, we found no evidence of a significant change after NICE guidance had been published (fig 3). Given the small data set, the power is low to detect a change as significant, but visual inspection does not indicate any structural break. This may reflect the high costs of implantable cardioverter defibrillators, at around £20 000 ($36 000;
29) per device, competition for resources with other interventional procedures in cardiology, and scarcity of skills in electrophysiology.11
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Hearing aids
The NICE guidance seems to have been received enthusiastically by audiology departments; all of those surveyed had undertaken an immediate audit of their service against the guidance requirements. However, review of case notes indicates that the range of analogue hearing aids offered does not seem to have been extended. Funding was described in the interviews as a major impediment to implementation. The guidance was issued at the same time as the Department of Health implemented a series of pilots of digital hearing aids, which cut across the guidance on analogue aids, which was subsequently withdrawn.
Laparoscopic surgery for primary inguinal hernia repair and colorectal cancer
Only 4% of primary inguinal hernia repairs in England and Wales were undertaken laparoscopically (contrary to NICE guidance), and this did not change after the guidance (0.3 monthly increase in hernia repairs, 95% confidence interval -5.48 to 6.08).
Although hospital episode statistics data for the 19 trusts that returned audit forms also showed 96% compliance, our audit of 545 repairs of primary unilateral hernias indicated only 65% compliance, indicating that coding of hospital episode statistics data may be unreliable. However, both national and audit data agreed that most laparoscopic procedures were concentrated in a few trusts, and that did not change over time.
Interviews showed that some local expert surgeons had the support of managers and commissioners to continue the use of laparoscopic surgery for primary repair. It was also claimed that patients often requested laparoscopic procedures.
The percentage of cases of colorectal cancer treated with laparoscopic surgery remained unchanged, at around 0.1% from 1998 to 2001.
Zanamivir for influenza
National prescribing data show little inappropriate prescribing of zanamivir in the absence of high levels of flu; prescriptions remained very low, at 499 in 2001, 190 in 2002, and 124 in 2003.
Orlistat for obesity
We found a significant increase in the average monthly prescribing of orlistat after the guidance had been published 22 per month (0.43, 95% confidence interval 15.9 to 27.8, P < 0.001; fig 4). Health authorities increased their use of orlistat, standardised by age, in the year after NICE guidance had been issued by about eight patient months per 1000 people aged 18-75 years. The variation in use, as measured by the coefficient of variation, fell from 0.4 in 2000-1 to 0.3 in 2001-2.
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In the 689 primary care patients for whom we have a record we found evidence that the drug was not being prescribed in accordance with guidance. Only in 12% of cases (n = 83) were there data showing compliance in the three key areas of age, body mass index, and weight loss. However, data recording was poor, and data were missing in one or more fields in 80% (551) of returns, particularly in respect of weight and weight loss. In those 308 cases where patients' weight loss prior to the visit had been recorded fully, the weight loss criterion was not met in 40% (123) of cases. Of patients with recorded weight loss data, only 41% (127) and 25% (40) still being prescribed orlistat at 3 months and 6 months, respectively, had reduced their weight as advised in the NICE guidance. The rise in prescribing of orlistat therefore does not necessarily imply a rise in appropriate prescribing.
Drugs for Alzheimer's disease
Total use grew logarithmically since February 1999 (fig 5). Once this had been taken into account, the growth rate at the time of publication of guidance (-1.4% per month; 95% confidence interval -4% to 1.2%) did not increase significantly. However, the data are also compatible with a view that an increase in trend occurred shortly before the guidance was formally issued. Variability between health authorities decreased; the coefficient of variation fell from 1.1 to 0.97.
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Based on the audit data from 583 usable forms, compliance with the five recommendations in the guidance at first prescription varies between 52% and 85% for mental health organisations and 21% and 46% in primary care. Compliance with the recommendations at follow up is low, mainly because information regarding mini-mental state examination scores, follow ups, or the presence of relatives at assessment was not routinely recorded (a requirement of the guidance).
Strengths and weaknesses of the study
In a retrospective observational study we cannot fully assess the impact of NICE guidance because of the absence of the counter-factual and because NICE guidance is just one, although potentially important, factor influencing professional practice. We can only observe whether clinical practice is consistent with the guidance. This research was based on a large data gathering exercise, and although data taken from national routine hospital and primary care are complete, those obtained from hospital pharmacies were less so. Where data were recorded, the audits allowed us to assess more reliably whether the details of practice corresponded to the indications of appropriateness in the guidance compared with subjective surveys12 and analyses based simply on routine data.13 It was, however, sometimes difficult to design audits where the original wording of the NICE guidance had been complex or ambiguous. This is also likely to affect the ease with which the guidance is implemented. Our survey also offered a view of the management context into which the guidance was received, and the interviews were useful in highlighting the managerial, financial, and clinical perspectives on implementation.
Meaning of the study
The establishment of NICE as a mechanism for institutionalising evidence based health care was a unique initiative. This institutional response by itself is, however, not sufficient for the rapid and universal implementation of evidence based health care. This is unsurprising; NICE guidance is being issued at a time of great change in the NHS, with new structures, competing high level priorities, funding deficits, and staff shortages. In addition, healthcare organisations are complex, containing strong professional bureaucracies.14 Change is therefore heavily dependent on the actions of groups of professionals and individual clinicians.15 The ability to manage change in an organisation is further complicated by the increasing importance of networks that span several organisations.
The diffusion of innovations literature indicates that the adoption of guidance would depend on several other factors (box 3; after Rogers).16 17 These also emerged in the thematic analysis of the interview data (table 4). In areas where practitioners and managers see advantages to adoption, where the value is hardly disputed (clear evidence), and where there is professional endorsement (taxanes for breast cancer, wisdom teeth extraction, and orlistat for obesity) practice has changed relatively fast. The marketing activity of the pharmaceutical industry should not be overlooked as a possible explanation for the apparent increased uptake of drugs over devices and changes in surgical behaviour.
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If the evidence has been disputed, or the costs not covered by increased income, adoption is more variable. Where practice is complex and also depends on an interaction with a practitioner's skills (such as with hip replacements or laparoscopic surgery), more formative research to understand the clinical context of practice may have helped to produce more influential guidance. Adoption may also be influenced by the degree to which decisions rest with an individual or requires team or organisational agreement. Individual surgeons are likely to have a high degree of professional autonomy, and this may partly explain the variability in techniques for hernia repair and hip replacement.
The extent to which trusts are prepared for NICE guidance and have put in place structures and processes to manage their implementation was variable.
The degree of active promotion by NICE is likely to have some impact on adoption, although probably not directly proportional to the effort invested. The greatest effect is likely when opinion leaders including the professional bodies and associations adopt and promote the guidance.
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Unanswered questions and future research
Our research covers the early period of NICE guidance; it would be interesting to see if the response to subsequent guidance is different, particularly given the recent attention that NICE is giving to implementation. More research would also be useful to understand the professional and organisational responses to evidence based guidance better and to evaluate the relative contributions of various implementation strategies to practice patterns.17
Conclusions
NICE guidance has been associated with uptake of some technologies, although this has been variable. Implementation is likely to be improved if the guidance is clear and based on an understanding of clinical practice, if the evidence is strong and relatively stable, if adequate funding is available, and if the guidance is supported and disseminated by professional bodies. Trusts should institute strong supportive internal systems for handling guidance and gathering data on implementation.
We acknowledge the support and cooperation of the NHS trusts that provided data, the audit staff and clinicians who carried out the case note audits, and the clinicians and managers who responded to the survey and participated in interviews. We thank the British Pacing and Electrophysiology Group (BPEG) for anonymised access to their register of Implantable Cardioverter Defibrillators and to the Trent and Welsh Arthroplasty Audit Groups for access to their anonymised database (TWAAG). We thank David Gibbons for advice on aspects of wisdom tooth removal and related issues and staff from the MRC Institute for Hearing Research who provided advice on the survey of audiology departments.
Contributors: NC contributed to study concept and design, study supervision, analysis and interpretation of the data, and manuscript preparation. DD contributed to the study concept and design, study supervision, analysis and interpretation of the data, and manuscript preparation. AL contributed to the design, conduct, and analysis of case note review; surveys and interviews; and manuscript preparation. KL contributed to the study concept and design, data collection, analysis and interpretation of the data, and manuscript preparation. James Mahon contributed to the statistical analysis of the data. Pauline Raynor contributed to the design and conduct of the primary care case note review. TAS contributed to study concept and design, study supervision, analysis and interpretation of the data, and manuscript preparation; he is guarantor. IW contributed to study concept and design, study supervision, analysis and interpretation of the data, and manuscript preparation. PW contributed to study concept and design, study supervision, analysis and interpretation of the data and manuscript preparation. DW contributed to the data collection and analysis. John Wilson contributed to the analysis of primary care and hospital pharmaceutical data. JW contributed to study concept and design, study supervision, analysis and interpretation of the data, and manuscript preparation.
Funding: NHS R&D National Co-ordinating Centre for Research Methodology (NCCRM).
Competing interests: NC was a member of the NICE Appraisals Committee between 1999 and 2002. KL, PW, DW, and JM work for York Health Economics Consortium, which undertakes work for a range of pharmaceutical companies, the Department of Health, and the NHS and has undertaken a cost-effectiveness study for Guidant, which manufactures implantable cardioverter defibrillators. This study was submitted to NICE as part of the assessment process.
Ethical approval: North West Multicentre Research Ethics Committee.
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