To assess how long the UK's National Institute for Health and Clinical Excellence's (NICE) Technology Appraisal Programme has taken to produce guidance and to determine independent predictors of time to guidance.
Retrospective time to event (survival) analysis.
Technology Appraisal guidance produced by NICE.
All appraisals referred to NICE by February 2010 were included, except those referred prior to 2001 and a number that were suspended.
Duration from the start of an appraisal (when the scope document was released) until publication of guidance.
Single Technology Appraisals (STAs) were published significantly faster than Multiple Technology Appraisals (MTAs) with median durations of 48.0 (IQR; 44.3–75.4) and 74.0 (IQR; 60.9–114.0) weeks, respectively (p <0.0001). Median time to publication exceeded published process timelines, even after adjusting for appeals. Results from the modelling suggest that STAs published guidance significantly faster than MTAs after adjusting for other covariates (by 36.2 weeks (95% CI −46.05 to −26.42 weeks)) and that appeals against provisional guidance significantly increased the time to publication (by 42.83 weeks (95% CI 35.50 to 50.17 weeks)). There was no evidence that STAs of cancer-related technologies took longer to complete compared with STAs of other technologies after adjusting for potentially confounding variables and only weak evidence suggesting that the time to produce guidance is increasing each year (by 1.40 weeks (95% CI −0.35 to 2.94 weeks)).
The results from this study suggest that the STA process has resulted in significantly faster guidance compared with the MTA process irrespective of the topic, but that these gains are lost if appeals are made against provisional guidance. While NICE processes continue to evolve over time, a trade-off might be that decisions take longer but at present there is no evidence of a significant increase in duration.
Health Economics; Public Health; Statistics & Research Methods
As part of the National Institute for Health and Clinical Excellence (NICE) Single Technology Appraisal (STA) process, manufacturers present submissions outlining the clinical and cost-effectiveness of new technologies. These submissions are critically appraised by Evidence Review Groups (ERGs), who produce a report, which forms part of the evidence considered by the NICE Appraisal Committees. The purpose of this research was first to identify common issues and concerns identified by the ERGs in their analyses of manufacturers' submissions (MS). The aim was then to use these as a basis to develop feedback for manufacturers.
A qualitative study using a content analysis approach to examine two sources of evidence, the first 30 ERG reports and 21 clarification letters associated with these STAs.
UK HTA programme.
Primary and secondary outcome measures
Common issues and concerns in MS.
There were positive comments regarding the quality of the MS, many of which were clearly written. The majority, however, were generally of poor quality and issues and concerns identified across the ERG reports and clarification letters included: criticisms related to the data being used especially data employed in the cost-effectiveness model, failure to perform a necessary analysis and poor reporting of processes used in the MS. Aspects of the decision problem were also often poorly or inadequately addressed by manufacturers. The majority of points raised for clarification related to the economic data analysis. Internal inconsistencies between the clinical and economic sections of the submission were frequently highlighted. These were used as the basis for the development of 12 suggestions for manufacturers.
Much can be done to improve the quality of MS in the NICE STA process. Suggestions include the need for clear and transparent reporting of methods and analyses.
As part of the NICE STA process, ERGs critically appraise manufacturer submissions in their reports and write clarification letters requesting more information from manufacturers. Two sources of evidence, ERG reports and the clarification letters associated with these STAs were analysed using a content analysis approach. The aim of this study was to identify issues and concerns identified by the ERGs in their analyses of submissions and use these to develop feedback to manufacturers.
A qualitative analysis of 30 ERG reports and 21 clarification letters was undertaken to identify recurring issues and concerns in manufacturers' submissions. The issues and concerns identified in this analysis were used to inform the development of a set of 12 suggestions to manufacturers to improve the quality of future submissions to NICE.
Strengths and limitations of this study
The research study applied validated methods and used multiple reviewers to check and verify data and analyses. Only the first 30 completed ERG reports and 21 associated clarification letters were examined in this analysis. There may be some misinterpretations in these analyses as documentary analysis was the only method used.
BACKGROUND: One of the aims of the National Institute for Clinical Excellence (NICE) is to promote faster access to the best treatments. However, there is no published research on the impact that NICE guidance has had on prescribing decisions. AIMS: To explore the attitudes of general practitioners (GPs) to NICE guidance and to investigate any changes in prescribing patterns. DESIGN: Descriptive cross-sectional study. SETTING: North Devon Primary Care Trust. METHOD: Five technology appraisals most likely to impact on GP prescribing were investigated. Prescribing analysis and cost (PACT) data were analysed for changes in prescribing patterns before and after the publication of each technology appraisal. A postal questionnaire, developed from semi-structured interviews, was sent to all GPs within a single primary care trust (PCT) to explore factors that were encouraging or discouraging adherence to NICE guidance. RESULTS: PACT data showed that there was an increase in the prescribing of the drugs studied immediately after NICE guidance, with the exception of zanamivir (Relenza [GlaxoSmithKline]); only one zanamivir inhaler was prescribed during the study period. Although there was an increase in the prescribing of maintenance doses of proton pump inhibitors, there was also an increase in treatment doses. Eighty-one (82.7%) questionnaires were completed and returned. In general, there was a balance between the factors that encouraged and those that discouraged adherence. The main exception was zanamivir, where factors that discouraged adherence greatly exceeded factors that encouraged adherence. CONCLUSIONS: This study showed that NICE guidance in isolation had little impact on GP prescribing. Where the guidance coincided with information from other sources, or personal experience, there was some evidence that technology appraisals triggered an increase in prescribing, but that this was not always sustained. The recommendations of NICE concerning zanamivir were universally rejected and there was evidence that this had undermined confidence in NICE recommendations in general.
The National Institute for Health and Care Excellence (NICE) Technology Appraisal Guidance on spinal cord stimulation (SCS) was published in 2008 and updated in 2012 with no change. This guidance recommends SCS as a cost-effective treatment for patients with neuropathic pain.
To assess the impact of NICE guidance by comparing SCS uptake in England pre-NICE (2008–2009) and post-NICE (2009–2012) guidance. We also compared the English SCS uptake rate with that of Belgium, the Netherlands, France and Germany.
SCS implant data for England was obtained from the Hospital Episode Statistics (HES) database and compared with other European countries where comparable data were available.
The HES data showed small increases in SCS implantation and replacement/revision procedures, and a large increase in SCS trials between 2008 and 2012. The increase in the total number of SCS procedures per million of population in England is driven primarily by revision/replacements and increased trial activity. Marked variability in SCS uptake at both health regions and primary care trust level was observed.
Despite the positive NICE recommendation for the routine use of SCS, we found no evidence of a significant impact on SCS uptake in England. Rates of SCS implantation in England are lower than many other European countries.
Objective To assess the association between different types of organisation and the results from economic evaluations.
Design Retrospective pairwise comparison of evidence submitted to the technology appraisal programme of the National Institute for Clinical Excellence (NICE) by manufacturers of the relevant healthcare technologies and by contracted university based assessment groups.
Data sources Data from the first 62 appraisals.
Main outcome measure Incremental cost effectiveness ratios.
Results Data from 27 of the 62 appraisals could be compared. The analysis of 54 pairwise comparisons showed that manufacturers' estimates of incremental cost effectiveness ratios were lower (suggesting a more cost effective use of resources) than those produced by the assessment groups (25 were lower, 29 were the same, none were higher, P < 0.01). Restriction of this dataset to include only one pairwise comparison per appraisal (27 pairs) produced a similar result (21 were lower, two were the same, four were higher, P < 0.001).
Conclusions The estimated incremental cost effectiveness ratios submitted by manufacturers were on average significantly lower than those submitted by the assessment groups. These results show that an important role of NICE's appraisal committee, and of decision makers in general, is to determine which economic evaluations, or parts of evaluations, should be given more credence.
Brain tumours account for <2% of all primary neoplasms but are responsible for 7% of the years of life lost from cancer before age 70 years. The latest survival trends for patients with CNS malignancies have remained largely static. The objective of this study was to evaluate the change in practice as a result of implementing the Improving Outcomes Guidance from the UK National Institute for Health and Clinical Excellence (NICE).
Patients were identified from the local cancer registry and hospital databases. We compared time from diagnosis to treatment, proportion of patients discussed at multidisciplinary team (MDT) meetings, treatment received, length of inpatient stay and survival. Inpatient and imaging costs were also estimated.
Service reconfiguration and implementation of NICE guidance resulted in significantly more patients being discussed by the MDT—increased from 66 to 87%, reduced emergency admission in favour of elective surgery, reduced median hospital stay from 8 to 4.5 days, increased use of post-operative MRI from 17 to 91% facilitating early discharge and treatment planning, and reduced cost of inpatient stay from £2096 in 2006 to £1316 in 2009. Patients treated with optimal surgery followed by radiotherapy with concomitant and adjuvant temozolomide achieved outcomes comparable to those reported in clinical trials: median overall survival 18 months (2-year survival 35%).
Advancing the management of neuro-oncology patients by moving from an emergency-based system of patient referral and management to a more planned elective outpatient-based pattern of care improves patient experience and has the potential to deliver better outcomes and research opportunities.
glioblastoma; management; surgery; radiotherapy; chemotherapy; NICE guidance
Objective To quantify the change in prescribing of antibiotic prophylaxis before invasive dental procedures for patients at risk of infective endocarditis, and any concurrent change in the incidence of infective endocarditis, following introduction of a clinical guideline from the National Institute for Health and Clinical Excellence (NICE) in March 2008 recommending the cessation of antibiotic prophylaxis in the United Kingdom.
Design Before and after study.
Population All patients admitted to hospital in England with a primary or secondary discharge diagnosis of acute or subacute infective endocarditis.
Main outcome measures Monthly number of prescriptions for antibiotic prophylaxis consisting of a single 3 g oral dose of amoxicillin or a single 600 mg oral dose of clindamycin, and monthly number of cases of infective endocarditis, infective endocarditis related deaths in hospital, or cases of infective endocarditis with a possible oral origin for streptococci.
Results After the introduction of the NICE guideline there was a highly significant 78.6% reduction (P<0.001) in prescribing of antibiotic prophylaxis, from a mean 10 277 (SD 1068) prescriptions per month to 2292 (SD 176). Evidence that the general upward trend in cases of infective endocarditis before the guideline was significantly altered after the guideline was lacking (P=0.61). Using a non-inferiority test, an increase in the number of cases of 9.3% or more could be excluded after the introduction of the guideline. Similarly an increase in infective endocarditis related deaths in hospital of 12.3% or more could also be excluded.
Conclusion Despite a 78.6% reduction in prescribing of antibiotic prophylaxis after the introduction of the NICE guideline, this study excluded any large increase in the incidence of cases of or deaths from infective endocarditis in the two years after the guideline. Although this lends support to the guideline, ongoing data monitoring is needed to confirm this, and further clinical trials should determine if antibiotic prophylaxis still has a role in protecting some patients at particularly high risk.
Health technology assessments (HTAs) by the National Institute for Health and Clinical Excellence (NICE) enjoy high levels of international attention. The present analysis addresses NICE's appraisal of methylphenidate, atomoxetine and dexamphetamine for attention-deficit/hyperactivity disorder (ADHD) in children and adolescents, published in March 2006.
A qualitative study of NICE Technology Appraisal No. 98 was done focusing on the >600-page technology assessment report, which aimed at evaluating ADHD treatment strategies by a clinical effectiveness review and an economic analysis using meta-analytical techniques and a cost-effectiveness model.
The technology assessment was unable to differentiate between the various drugs in terms of efficacy, and its economic model was ultimately driven by cost differences. While the assessment concluded that the economic model "clearly identified an optimal treatment strategy" with first-line dexamphetamine, the NICE appraisal committee subsequently found it impossible to distinguish between the different strategies on grounds of cost-effectiveness. Analyzing the assessment reveals gaps and inconsistencies concerning data selection (ultimately relying on a small number of short-term studies only), data synthesis (pooling of heterogeneous study designs and clinical endpoints), and economic model structure (identifying double-counting of nonresponders as a likely source of bias, alongside further methodological anomalies).
Many conclusions of the NICE technology assessment rest on shaky grounds. There remains a need for a new, state-of-the-art systematic review of ADHD treatment strategies including economic evaluation, which ideally should address outcomes beyond children's health-related quality of life, such as long-term sequelae of the disorder and caregiver burden.
In England and Wales, the National Institute for Health and Clinical Excellence (NICE) has provided guidance [technology appraisals (TAs) 130, 186, 195, 198 and 225] on the use of biologic drugs for the treatment of RA. This is based on an analysis of efficacy, safety and cost-effectiveness, and has resulted in a complex management pathway that restricts freedom to prescribe biologics according to their licensed indications. Specifically, TNF antagonists are the only class of biologics that can be used first line in DMARD-inadequate responders, and only in patients with a persistent 28-joint DAS score of ≥5.1. Alternative biologic agents are denied to those with contraindications to anti-TNF drugs and are also not supported following intolerance to TNF antagonists. Rituximab is the only class of biologic permitted after TNF antagonist inefficacy, in the absence of a contraindication to its use, whereas abatacept and tocilizumab are licensed and may be a more efficacious choice at this stage in some patient groups. Furthermore, for patients who demonstrate sequential inadequate responses, treatment is restricted to one TNF antagonist, rituximab and tocilizumab, whereas abatacept is only a permitted choice when rituximab is contraindicated or has been withdrawn because of an adverse event. In this review, we discuss the treatment algorithm published by NICE, and suggest alternatives where perceived deficiencies exist.
rheumatoid arthritis; biologic agents; guidelines; TNF antagonists; adalimumab; etanercept; certolizumab pegol; rituximab; abatacept; tocilizumab
Background. Multidisciplinary team (MDT) working in oncology aims to improve outcomes for patients with cancer. One role is to ensure the implementation of best practice and National Institute for Health and Clinical Excellence (NICE) guidance. In this study, we have assessed the role of MDT in implementing the TA121 appraisal of the use of carmustine wafers in high grade gliomas. Methods. 296 patients with high-grade glioma suitable for maximal resection were recruited from 17 Neurosurgical Centres. The number of patients treated with carmustine wafers and reasons for not using this were recorded. Complications at 48 hours post-operatively and at 6 weeks post-radiotherapy were recorded. Results. 94/296 (32%) of suitable patients received carmustine wafers. In 55% of cases carmustine was not used due to either surgeon preference or a lack of an MDT decision. There was no increased complication rate with carmustine use at either 48 hours post-surgery or at 6 weeks post radiotherapy. Use of carmustine wafers did not decrease access to and use of chemoradiotherapy. Conclusions. One third of patients suitable for carmustine wafers received them. Their use was neither associated with more frequent complications, nor decreased use of chemoradiotherapy. Implementation of NICE TA121 Guidance is extremely variable in different MDTs across the United Kingdom.
Brain neoplasms; implementing NICE guidance; carmustine wafers; improving outcomes guidance
Objectives To assess the extent and pattern of implementation of guidance issued by the National Institute for Clinical Excellence (NICE).
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.
Long-term sickness absence and incapacity benefits (disability pension) rates have increased across industrialised countries. Effective measures are needed to support return to work. The recommendations of this guidance were informed by the most appropriate available evidence of effectiveness and cost-effectiveness. Public health evidence was provided by research using a variety of study designs that attempted to determine the outcome of a particular intervention by evaluating status before and after the intervention had been effected, and was not limited to randomised control trials. Where the evidence base was depleted or underdeveloped, expert witnesses were called to give their opinion on the best available evidence and emerging interventions. The process enabled challenge and contestability from stakeholder groups at different points as the guidance was developed. Forty-five heterogeneous studies were included in the review of interventions to reduce long-term sickness absence and transitions from short-term to long-term absence (mainly covering the former and also mainly examining musculoskeletal conditions). The analysis of evidence was restricted to descriptive synthesis. Three general themes emerged from an analysis of the studies that were more likely to report positive results: early interventions; multidisciplinary approaches; and interventions with a workplace component. Two further reviews were undertaken, one on interventions to reduce the re-occurrence of sickness absence, which identified seven studies on lower back pain, and concluded that early intervention and direct workplace input are important factors. The final evidence review focused on six studies of interventions for those in receipt of incapacity benefit. The evidence was that work-focused interviews coupled with access to tailored support are effective and cost-effective interventions. Practitioners should consider the impact of interventions and management options on work ability for patients of working age. Work ability should be considered a key outcome for future intervention studies.
evidence-based medicine; guideline; sick leave; sick leave, cost; work capacity evaluation
The goal of antiepileptic treatment is to achieve seizure freedom or seizure control. The aim of this paper is to review the evidence for the use of lacosamide for adjunctive treatment of refractory focal seizures with or without secondary generalization, within the scope of the 2012 update of the Clinical Guideline published by the National Institute for Health and Clinical Excellence (NICE).
Clinical evidence for the use of lacosamide and other antiepileptic drugs (AEDs) was systematically reviewed, evaluated, and presented to the Guideline Development Group. Only randomized clinical trials were included. Outcomes of clinical efficacy (seizure freedom, 50% reduction in seizure frequency, time to first seizure, time to 12-month remission, treatment withdrawal, and time to treatment withdrawal), experience of adverse events, and cognitive and quality of life outcomes were reviewed. A decision model was built to weigh the clinical benefits of each adjunctive AED, measured by seizure control and seizure reduction, compared with the harm from adverse events, as measured by withdrawals from treatment due to adverse events.
Lacosamide was included as part of the recommended AEDS to be used in tertiary epilepsy centers. The evidence review showed that more participants who received lacosamide as an adjunctive treatment had at least a 50% reduction in seizure frequency compared with those taking placebo. However, more participants on lacosamide were found to experience adverse events and withdrawal from treatment compared with those on placebo. The cost-effectiveness analysis showed that compared with placebo, the benefits gained from adjunctive lacosamide were modest and uncertain, whereas the costs were significantly high. Compared with other AEDs licensed for adjunctive therapy in focal seizures, lacosamide was associated with fewer quality-adjusted life years and higher costs. Therefore, the Guideline Development Group noted that the balance of benefit and harm needs to be carefully monitored in all patients.
focal seizures; anti-epileptic drug; adjunctive therapy; clinical guideline
Health information technology (IT) is widely endorsed as a way to improve key health care outcomes, particularly patient safety. Applying a human factors approach, this paper models more explicitly how health IT might improve or worsen outcomes. The human factors model specifies that health IT transforms the work system, which transforms the process of care, which in turn transforms the outcome of care. This study reports on transformations of the medication administration process that resulted from the implementation of one type of IT: bar coded medication administration (BCMA). Registered nurses at two large pediatric hospitals in the US participated in a survey administered before and after one of the hospitals implemented BCMA. Nurses’ perceptions of the administration process changed at the hospital that implemented BCMA, whereas perceptions of nurses at the control hospital did not. BCMA appeared to improve the safety of the processes of matching medications to the medication administration record and checking patient identification. The accuracy, usefulness, and consistency of checking patient identification improved as well. In contrast, nurses’ perceptions of the usefulness, time efficiency, and ease of the documentation process decreased post-BCMA. Discussion of survey findings is supplemented by observations and interviews at the hospital that implemented BCMA. By considering the way that IT transforms the work system and the work process a practitioner can better predict the kind of outcomes that the IT might produce. More importantly, the practitioner can achieve or prevent outcomes of interest by using design and redesign aimed at controlling work system and process transformations.
health information technology; bar coded medication administration; process change; patient safety; human factors engineering
Mortality from coronary heart disease has been falling in the UK since the 1970s, but remains higher than in most other Western countries. Most patients receive some treatment for secondary prevention after myocardial infarction, but not all patients are offered the most effective secondary prevention package. The recently published NICE guideline for secondary prevention in patients after myocardial infarction, summarised in this article, makes clear recommendations for management of patients after myocardial infarction, based on best available evidence. The guidelines update the 2001 NICE guideline, and have expanded and emphasised the recommendations for physical activity, dietary and other lifestyle changes, and cardiac rehabilitation, and updated the recommendations for drug therapy.
Hyperglycemia is associated with increased mortality in critically ill patients. Randomized trials of intensive insulin therapy have reported inconsistent effects on mortality and increased rates of severe hypoglycemia. We conducted a meta-analysis to update the totality of evidence regarding the influence of intensive insulin therapy compared with conventional insulin therapy on mortality and severe hypoglycemia in the intensive care unit (ICU).
We conducted searches of electronic databases, abstracts from scientific conferences and bibliographies of relevant articles. We included published randomized controlled trials conducted in the ICU that directly compared intensive insulin therapy with conventional glucose management and that documented mortality. We included in our meta-analysis the data from the recent NICE-SUGAR (Normoglycemia in Intensive Care Evaluation — Survival Using Glucose Algorithm Regulation) study.
We included 26 trials involving a total of 13 567 patients in our meta-analysis. Among the 26 trials that reported mortality, the pooled relative risk (RR) of death with intensive insulin therapy compared with conventional therapy was 0.93 (95% confidence interval [CI] 0.83–1.04). Among the 14 trials that reported hypoglycemia, the pooled RR with intensive insulin therapy was 6.0 (95% CI 4.5–8.0). The ICU setting was a contributing factor, with patients in surgical ICUs appearing to benefit from intensive insulin therapy (RR 0.63, 95% CI 0.44–0.91); patients in the other ICU settings did not (medical ICU: RR 1.0, 95% CI 0.78–1.28; mixed ICU: RR 0.99, 95% CI 0.86–1.12). The different targets of intensive insulin therapy (glucose level ≤ 6.1 mmol/L v. ≤ 8.3 mmol/L) did not influence either mortality or risk of hypoglycemia.
Intensive insulin therapy significantly increased the risk of hypoglycemia and conferred no overall mortality benefit among critically ill patients. However, this therapy may be beneficial to patients admitted to a surgical ICU.
The primary aim was to use routine data to compare cancer diagnostic intervals before and after implementation of the 2005 NICE Referral Guidelines for Suspected Cancer. The secondary aim was to compare change in diagnostic intervals across different categories of presenting symptoms.
Using data from the General Practice Research Database, we analysed patients with one of 15 cancers diagnosed in either 2001–2002 or 2007–2008. Putative symptom lists for each cancer were classified into whether or not they qualified for urgent referral under NICE guidelines. Diagnostic interval (duration from first presented symptom to date of diagnosis in primary care records) was compared between the two cohorts.
In total, 37 588 patients had a new diagnosis of cancer and of these 20 535 (54.6%) had a recorded symptom in the year prior to diagnosis and were included in the analysis. The overall mean diagnostic interval fell by 5.4 days (95% CI: 2.4–8.5; P<0.001) between 2001–2002 and 2007–2008. There was evidence of significant reductions for the following cancers: (mean, 95% confidence interval) kidney (20.4 days, −0.5 to 41.5; P=0.05), head and neck (21.2 days, 0.2–41.6; P=0.04), bladder (16.4 days, 6.6–26.5; P⩽0.001), colorectal (9.0 days, 3.2–14.8; P=0.002), oesophageal (13.1 days, 3.0–24.1; P=0.006) and pancreatic (12.6 days, 0.2–24.6; P=0.04). Patients who presented with NICE-qualifying symptoms had shorter diagnostic intervals than those who did not (all cancers in both cohorts). For the 2007–2008 cohort, the cancers with the shortest median diagnostic intervals were breast (26 days) and testicular (44 days); the highest were myeloma (156 days) and lung (112 days). The values for the 90th centiles of the distributions remain very high for some cancers. Tests of interaction provided little evidence of differences in change in mean diagnostic intervals between those who did and did not present with symptoms specifically cited in the NICE Guideline as requiring urgent referral.
We suggest that the implementation of the 2005 NICE Guidelines may have contributed to this reduction in diagnostic intervals between 2001–2002 and 2007–2008. There remains considerable scope to achieve more timely cancer diagnosis, with the ultimate aim of improving cancer outcomes.
diagnostic interval; NICE guidelines; urgent referral; earlier diagnosis; database; cancer; diagnosis; symptoms; primary care; cohort
The results of the NICE-SUGAR (Normoglycaemia in Intensive Care Evaluation Survival Using Glucose Algorithm Regulation) trial were released last March. The primary outcome variable, 90-day mortality, was actually increased in patients randomly assigned to intensive insulin therapy, as compared with an intermediate target range for blood glucose. These findings, reflecting data collected in a set of more than 6,000 patients, clearly refute the external validity of tight glucose control. Future research will probably focus on several questions raised by the divergent results reported from investigations in the field of glucose control in the critically ill.
There is growing interest internationally in linking reimbursement decisions with recommendations for further research. In the UK, the National Institute for Health and Clinical Excellence (NICE) can issue guidance to approve the routine use of a health intervention, reject routine use or recommend use within a research programme. These latter recommendations have restricted use to ‘only in research’ (OIR) or have recommended further research alongside routine use (‘approval with research’ or AWR). However, it is not currently clear when such recommendations are likely to be made.
This study aims to identify NICE technology appraisals where OIR or AWR recommendations were made and to examine the key considerations that led to those decisions.
Draft and final guidance including OIR/AWR recommendations were identified. The documents were reviewed to establish the characteristics of the technology appraisal, the cost effectiveness of the technologies, the key considerations that led to the recommendations and the types of research required.
In total, 29 final and 31 draft guidance documents included OIR/AWR recommendations up to January 2010. Overall, 86 % of final guidance included OIR recommendations. Of these, the majority were for technologies considered to be cost ineffective (83 %) and the majority of final guidance (66 %) specified the need for further evidence on relative effectiveness. The use of OIR/AWR recommendations is decreasing over time and they have rarely been used in appraisals conducted through the single technology appraisal process.
NICE has used its ability to recommend technologies within research programmes, although predominantly within the multiple technology appraisal process. OIR recommendations have been most frequently issued for technologies considered cost ineffective and the most frequently cited consideration is uncertainty related to relative effectiveness. Key considerations cited for most AWR recommendations and some OIR recommendations included a need for further evidence on long-term outcomes and adverse effects of treatment.
Electronic supplementary material
The online version of this article (doi:10.1007/s40273-012-0013-6) contains supplementary material, which is available to authorized users.
One of the key roles of the English National Institute for Health and Clinical Excellence (NICE) is technology appraisal. This essentially involves evaluating the cost effectiveness of pharmaceutical products and other technologies for use within the National Health Service. Based on a content analysis of key documents which shed light on the nature of appraisals, this paper draws attention to the multiple layers of uncertainty and complexity which are latent within the appraisal process, and the often socially constructed mechanisms for tackling these. Epistemic assumptions, bounded rationality and more explicitly relational forms of managing knowledge are applied to this end. These findings are discussed in the context of the literature highlighting the inherently social process of regulation. A framework is developed which posits the various forms of uncertainty, and responses to these, as potential conduits of regulatory bias—in need of further research. That NICE’s authority is itself regulated by other actors within the regulatory regime, particularly the pharmaceutical industry, exposes it to the threat of regulatory capture. Following Lehoux, it is concluded that a more transparent and reflexive format for technological appraisals is necessary. This would enable a more robust, defensible form of decision-making and moreover enable NICE to preserve its legitimacy in the midst of pressures which threaten this.
Alzheimer’s; Complexity; Hope; Polycentric regimes; Regulation; Uncertainty
This NICE technology appraisal guidance on cardiac resynchronisation therapy provides additional treatment options for some of the groups of people covered in the earlier guidance on implantable cardioverter defibrillators.
heart failure; cardiac resynchronisation therapy
This NICE technology appraisal guidance considers the clinical and cost effectiveness of the use of alteplase for acute ischaemic stroke
Healthcare spending in Canada has grown rapidly in recent years, especially for drugs. This paper discusses the causes of the problem and makes policy proposals. Conflicts of interest (COIs) are a frequent occurrence in medical research and lead to bias. Published studies, especially in the area of clinical trials on drugs, are much more likely to produce findings favourable to the drug when funded by the manufacturer. Bias can occur by various means, including inappropriate study design (such as giving a placebo to control subjects rather than an existing drug) and selective publication of results. COIs also frequently occur with clinical practice guidelines. High-priced (particularly new) drugs are often marketed by inappropriate means. Drug costs in Canada could be greatly reduced if doctors prescribed lower-cost alternatives where appropriate (therapeutic substitution). Proposals are made for changes in the regulatory agencies responsible for the approval of drugs, drug marketing and post-marketing surveillance. In addition, a new regulatory agency is proposed that would examine the value of drugs and medical devices in terms of clinical effectiveness and cost-effectiveness. Such an agency would set the rules for therapeutic substitution and would determine which medical interventions can be used based on agreed cost-effectiveness criteria.
When Newbury and Community Primary Care Trust appealed against NICE's decision on Herceptin, it was the first to do so. Jane Wells and Claire Cheong-Leen explain the process and why other trusts should make their voices heard in appraisals of new treatments
National Institute for Health and Clinical Excellence (NICE) clinical guidelines and subsequent NICE issued ‘recommendation reminders’ advocate discontinuing two fertility procedures and caesarean sections in women with hepatitis. We assess whether NICE guidance in 2004 and recommendation reminders were associated with a change in the rate of clinical procedures performed.
Routine inpatient Hospital Episode Statistics (HES) data were extracted from the HES database for 1st April 1998 to 31st March 2010 using OPCS procedure codes for varicocele operations in infertile men, endometrial biopsies in infertile women and caesarean sections in women with hepatitis B or C. We used Joinpoint regression to identify points in time when the trend in procedure rates changed markedly, to identify any influence of the release of NICE guidance.
Between 1998-2010, planned caesarean sections in women with and without hepatitis B or C increased yearly (annual percentage change (APC) 4.9%, 95% CI 2.1% to 7.7%) in women with hepatitis, compared with women without (APC 4.0% [95% CI 2.7% to 5.3%] up to 2001, APC -0.6% [95% CI -2.8% to 1.8%] up to 2004 and 1.3% [95% CI 0.8% to 1.8%] up to 2010). In infertile women under 40 years of age, endometrial biopsies for investigation of infertility increased, APC 6.0% (95% CI 3.6% to 8.4%) up to 2003, APC 1.5% (95% CI -4.3% to 7.7%) to 2007 followed by APC 12.8% (95% CI 1.0% to 26.0%) to 2010. Varicocele procedures remained relatively static between 1998 and 2010 (APC -0.5%, 95% CI -2.3% to 1.3%).
There was no decline in use of the three studied procedures, contrary to NICE guidance, and no change in uptake associated with the timing of NICE guidance or recommendation reminders. ‘Do not do’ recommendation reminders may be ineffective at improving clinical practice or achieving disinvestment.
NICE; Clinical guidelines; Fertility; Caesarean