National Health Service Centre Research Articles

Insulin Glargine in a Brazilian State: Should the Government Disinvest? An Assessment Based on a Systematic Review

The costs of the insulin analogue (insulin glargine) have been growing appreciably in the State of Minas Gerais in Brazil, averaging 291% per year in recent years. This growth has been driven by an increasing number of successful law suits and a 536% price difference between insulin glargine and neutral protamine Hagedorn (NPH) insulin. One potential way to address this is to undertake a systematic review assessing the efficacy and safety of insulin glargine analogue compared with NPH insulin in patients with type 1 diabetes mellitus (T1DM), and, as a result, provide published data to support future recommended activities by the State of Minas Gerais. These could include maintaining it on the list of the Public Health System (SUS) provided there is a price reduction. Alternatively, the review could provide potential arguments to defend against future law suits should the authorities decide to delist insulin glargine. A systematic review of published studies researching the effectiveness of insulin glargine in patients with T1DM between January 1970 and July 2009 in MEDLINE (PubMed), the Latin American and Caribbean Centre on Health Sciences Information, the Cochrane Controlled Trials Databases and the National Health Service Centre for Reviews and Dissemination. Inclusion criteria included insulin glargine on its own or combined with other insulin formulations. Only randomised controlled clinical trials were included. Initially, the titles of all studies were assessed by two independent reviewers before being potentially discarded, with the quality of papers assessed using a modified Jadad scale. The outcome measures included blood levels of glycated haemoglobin, episodes of hypoglycaemia, adverse effects and the reduction of microvascular and macrovascular end-organ complications of T1DM. Out of 803 studies found in the selected databases, only eight trials met the inclusion criteria. Most of the studies were of poor methodological quality or had a high risk of bias, with a mean score of 2.125 on the Jadad scale. No study could be classified as double-blind, and only one study documented the increased efficacy of insulin glargine in relation to both glycaemic control and hypoglycaemic episodes. Typically, there was no significant difference between insulin glargine and NPH insulins. This systematic review showed no therapeutic benefit of insulin glargine over other insulin formulations studied when analysing together glycaemic control and the frequency and severity of hypoglycaemia. We therefore recommend to the State Authority to delist insulin glargine or renegotiate a price reduction with the manufacturer. This systematic review provides support for this decision as well as documentation to combat potential law suits if discussions are unsatisfactory.

Care pathways: challenges and opportunities for restorative dentistry

In the future, dental care in England, both in the primary and secondary sectors, will be delivered increasingly via care pathways. A care pathway describes in detail a patient’s journey from referral to treatment, review and subsequent recall if required. It provides for the right person treating the right patients at the right time for the right condition in the right situation. It is the intention at a central National Health Service (NHS) level that these pathways will operate in managed clinical networks that will be consultant and/or specialist led. There are already several successful pilots running in England. A good example is the periodontic and endodontic service provided by three enhanced practitioners in the Bradford and Airedale primary care trust (PCT).

Building the Genetic Counsellor Profession in the United Kingdom: Two Decades of Growth and Development

Building the Genetic Counsellor Profession in the United Kingdom: Two Decades of Growth and Development

Radiation exposure from CT scans in childhood and subsequent risk of leukaemia and brain tumours: a retrospective cohort study

SummaryBackgroundAlthough CT scans are very useful clinically, potential cancer risks exist from associated ionising radiation, in particular for children who are more radiosensitive than adults. We aimed to assess the excess risk of leukaemia and brain tumours after CT scans in a cohort of children and young adults.MethodsIn our retrospective cohort study, we included patients without previous cancer diagnoses who were first examined with CT in National Health Service (NHS) centres in England, Wales, or Scotland (Great Britain) between 1985 and 2002, when they were younger than 22 years of age. We obtained data for cancer incidence, mortality, and loss to follow-up from the NHS Central Registry from Jan 1, 1985, to Dec 31, 2008. We estimated absorbed brain and red bone marrow doses per CT scan in mGy and assessed excess incidence of leukaemia and brain tumours cancer with Poisson relative risk models. To avoid inclusion of CT scans related to cancer diagnosis, follow-up for leukaemia began 2 years after the first CT and for brain tumours 5 years after the first CT.FindingsDuring follow-up, 74 of 178 604 patients were diagnosed with leukaemia and 135 of 176 587 patients were diagnosed with brain tumours. We noted a positive association between radiation dose from CT scans and leukaemia (excess relative risk [ERR] per mGy 0·036, 95% CI 0·005–0·120; p=0·0097) and brain tumours (0·023, 0·010–0·049; p<0·0001). Compared with patients who received a dose of less than 5 mGy, the relative risk of leukaemia for patients who received a cumulative dose of at least 30 mGy (mean dose 51·13 mGy) was 3·18 (95% CI 1·46–6·94) and the relative risk of brain cancer for patients who received a cumulative dose of 50–74 mGy (mean dose 60·42 mGy) was 2·82 (1·33–6·03).InterpretationUse of CT scans in children to deliver cumulative doses of about 50 mGy might almost triple the risk of leukaemia and doses of about 60 mGy might triple the risk of brain cancer. Because these cancers are relatively rare, the cumulative absolute risks are small: in the 10 years after the first scan for patients younger than 10 years, one excess case of leukaemia and one excess case of brain tumour per 10 000 head CT scans is estimated to occur. Nevertheless, although clinical benefits should outweigh the small absolute risks, radiation doses from CT scans ought to be kept as low as possible and alternative procedures, which do not involve ionising radiation, should be considered if appropriate.FundingUS National Cancer Institute and UK Department of Health.

Evaluation of Face-to-Face Courses in Behavioural Support for Stop Smoking Practitioners

Introduction: In English National Health Service (NHS) Stop Smoking Services, stop smoking practitioners provide behavioural support and medication to support smokers wanting to quit. There is a need to develop an evidence base for the training of such practitioners. This study evaluated a national face-to-face skills training course in behavioural support for practitioners. Methods: Data were gathered from 169 trainees attending the NHS Centre for Smoking Cessation and Training (NCSCT) courses between October 2010 and August 2011. They provided confidence in competence ratings for 16 core competences before, immediately following and 3 months after training. At 3-month follow-up, they also described what they believed were the most important learning outcomes. Trainees also provided course evaluations in the form of ratings (n = 386, courses not yet followed up included). Results: Confidence ratings increased overall by 40% immediately after the course and the higher level of confidence was maintained at 3-month follow-up; 92% agreed or strongly agreed that the course was very useful and very interesting; 90% that it was very enjoyable; 88% that it improved their skills and 87% that they would recommend it. The learning outcomes rated as most important reflected the relevant behaviour change techniques. Conclusion: The NCSCT skills training course appears to result in a substantial improvement in confidence in ability to deliver smoking cessation support and trainees evaluate it highly. The next step is to assess improvements in observed practice and success rates.

Patient and provider barriers to effective management of gout in general practice: a qualitative study

ObjectivesTo explore patient and provider illness perceptions and barriers to effective management of gout in general practice.Design and settingA qualitative study involving semistructured face-to-face interviews with patients and health professionals...

Effectiveness of an Online Knowledge Training and Assessment Program for Stop Smoking Practitioners

In English National Health Service (NHS) stop smoking services, stop smoking practitioners (SSPs) provide behavioral support and medication to support smokers wanting to quit. This study aimed to evaluate an evidence-based national online knowledge training program for SSPs developed by the NHS Centre for Smoking Cessation and Training (NCSCT). Knowledge required to deliver effective stop smoking interventions was assessed using 25 multiple-choice questions drawn randomly from a common larger pool at baseline and after use of the training program in 778 consecutive users. Change in knowledge and association of this change with time spent on the training were assessed. Baseline and change in knowledge of SSPs with different amounts of experience, prior training, and time dedicated to smoking cessation were compared. Knowledge improved from 64.4% correct to 77.7% (p < .001). Time spent on the training predicted improvement. Pretraining knowledge scores differed with experience, prior training, and time practicing. Training improved even the highest performing SSPs and minimized differences between groups. Knowledge required to deliver effective stop smoking intervention is improved efficiently by using the NCSCT online training program for English smoking cessation practitioners. SSPs with all levels of prior knowledge benefit.

Is pre-employment health screening by questionnaire effective?

Following a job offer, many employers require the chosen candidate to undergo health screening by questionnaire before the applicant commences work. Despite their widespread use, the effectiveness of such questionnaires remains uncertain. To systematically review the evidence for the effectiveness of pre-employment health questionnaires in predicting health and employment outcomes. We used a sensitive search strategy to search electronic databases from 1985 to September 2009. The search included dissertations for Membership of the UK Faculty of Occupational Medicine (MFOM). The authors independently selected abstracts and papers for critical appraisal and inclusion in the review using methods based on guidelines produced by the National Health Service Centre for Reviews and Dissemination, University of York. Five hundred and three abstracts were identified; nine papers and two MFOM dissertations were critically appraised. Seven papers and two MFOM dissertations were included in the final review. Six studies explored pre-employment predictors of respiratory symptoms, one explored predictors of back pain in nurses, and two dissertations explored work outcomes including sickness absence and ill-health retirement. No papers addressing mental health outcomes met our inclusion criteria. Included studies either failed to identify pre-employment predictors of health and work outcomes or found very weak predictors. Pre-employment health screening (PEHS) by questionnaire has a low predictive value in detecting future adverse health and occupational outcomes. Where PEHS takes place, the health standards required and criteria for rejection of applicants should be based on a full risk assessment of the prospective post.

PAYMENT BY RESULTS IN SMOKING CESSATION

In response to my commentary on payment by results in smoking cessation services 1, Steven Wyatt's letter 2 describes a system set up in a region of England, the West Midlands which, it is hoped, has in place the safeguards needed to avoid the problems to which I referred. It is very useful to have this case from which others can learn. There are three points made in the letter that I would like to take up. First, the letter argues that paying only for success above a threshold (to pay for quitters who would not have quit anyway) would drive up transaction costs, but I do not think that is the case. The same system for payment would obtain as currently, but only counting numbers above the threshold. The West Midlands system, that only specifies a minimum threshold, incentivizes providers to just beat the threshold rather than to do their best for every smoker. Moreover, penalizing providers after they have failed to achieve some target is highly problematic administratively, and does not help the smokers who were let down by the poor performance. Secondly, the issue of accreditation can often consist of a very bureaucratic paper exercise which does not necessarily address the important issues. In practice the process can be very streamlined, involving a brief self-assessment questionnaire and submission of key supporting documentation. Unfortunately, commissioning organizations are often not incentivized to keep things focused and simple. It would be useful to have a repository of such procedures being used by different commissioners, along with comments from providers who have engaged with them to work towards maximum efficiency in this. The third point is possibly the most important. The big question that did not appear to be addressed directly in the letter is: what independent checks are carried out on claims of successes? Those checks need to be undertaken by an agency that is independent of both commissioner and provider because both have an interest is showing that everything is fine. It is imperative not to rely upon data provided by providers, however detailed it may be. A procedure is being piloted by the National Health Service (NHS) Centre for Smoking Cessation and Training (http://www.ncsct.co.uk) that is simple and inexpensive: one takes a sample of 50 claimed successes and contacts the clients to ask a few simple questions. If doubts arise over more than 10% of these one expands the sample by a further 50. If 10% still show a discrepancy then an investigation is triggered. There need be no ‘data protection’ or confidentiality issues if a few simple procedures are put into place at the start. Robert West undertakes research and consultancy for companies that develop and manufacture smoking cessation medications. He has a share of a patent on a novel nicotine delivery device. His research is funded primarily by Cancer Research UK and the English Department of Health and he is a trustee of the charity QUIT. He is also a co-director of the NHS Centre for Smoking Cessation and Training.

Treatment interruptions and inconsistent supply of anti-tuberculosis drugs in the United Kingdom

National Health Service (NHS) centres treating tuberculosis (TB) in the United Kingdom. To describe NHS TB treatment centres' experience of obtaining anti-tuberculosis drugs to treat drug-susceptible and drug-resistant TB between 2007 and 2009. In particular: 1) any difficulties experienced in obtaining different drugs; 2) resulting interruptions or alterations in the prescribed regimen; 3) availability of paediatric formulations; and 4) resources available to identify and manage drug shortages. Questionnaires were sent to pharmacists at 168 treatment centres. Of the 77 (46%) treatment centres that responded, 63% (48/77) reported difficulties in obtaining anti-tuberculosis drugs. Consequently, 27% had to interrupt the prescribed treatment regimen at least once, whilst 19% had to alter the regimen. Of 55 centres treating multidrug-resistant tuberculosis, 36% reported difficulties obtaining second-line drugs, 16% had to interrupt the prescribed treatment regimen at least once and 5% had to alter the regimen. A lack of licensed liquid formulations for children resulted in 26% of treatment centres using unlicensed, variable-strength liquids and locally prepared suspensions. Difficulties obtaining drugs to treat both drug-susceptible and drug-resistant disease are common in the UK. There are particular risks for children. Our data identify an urgent need for national strategic guidance to ensure a consistent and reliable supply of anti-tuberculosis drugs.

32 Does complete revascularisation confers a long term survival benefit in patients with chronically occluded coronary vessels?

IntroductionChronic total occlusion (CTO) of coronary vessels is a relatively common finding on diagnostic angiography. There has been increasing interest in this clinically important area with development of technologies resulting...

Oesophageal Doppler monitoring: should it be routine for high-risk surgical patients?

To determine whether sufficient evidence exists to justify routine use of oesophageal Doppler monitoring to guide perioperative haemodynamic management in high-risk surgery. Systematic reviews of the literature have been performed independently by the National Health Service Centre for Evidence-based Purchasing in the UK, and the US Agency for Healthcare-Related Quality. A before-after evaluation was also recently performed in three hospitals by the National Health Service Technology Adoption Centre. Although multicentre prospective randomized controlled trials are lacking, the evidence base for both outcome-benefit and cost-benefit is considered strong enough by the National Institute for Health and Clinical Excellence in the UK for them to recommend use of this technology in high-risk surgical patients. Whether these findings also apply to other monitoring technologies requires formal validation. Better patient outcomes can be achieved by perioperative haemodynamic optimization using oesophageal Doppler monitoring and should be considered for routine use in most types of high-risk surgery.

Utility of therapeutic drug monitoring in the management of HIV-infected pregnant women in receipt of lopinavir

The pharmacokinetics of antiretroviral drugs in pregnancy is poorly understood. We reviewed the use of therapeutic drug monitoring (TDM) in clinical settings to document plasma concentrations of lopinavir during pregnancy and investigated how clinicians acted upon TDM results. A retrospective review was carried out of all HIV-infected pregnant women taking boosted lopinavir-based highly active antiretroviral therapy (HAART) at five National Health Service (NHS) centres in the UK between May 2004 and March 2007. Seventy-three women in receipt of lopinavir were identified, of whom 89% had plasma lopinavir concentrations above the suggested minimum recommended for wild-type HIV. Initial TDM results prompted dosage change in 10% and assessment of adherence and/or pharmacist review in 11%. TDM was repeated in 29%. TDM can play an important role in the clinical management of HIV-positive pregnant women, allowing informed dose modification and an alternative measure of adherence.

Podiatric surgery: friend or foe?

Podiatric surgery within the UK remains controversial in some quarters and, despite being well established within many National Health Service (NHS) centres, myth and rumour remain. All too often individual concerns and misreporting can foster negative publicity, yet the quality and standard of practice have facilitated continued development and establishment of services. This presentation will review the common areas of confusion and overview training, regulation, interaction with government and other medical bodies. The available evidence base will be reviewed in relation to patient satisfaction and outcomes / complications. If the profession as a whole is to continue to develop, integrated care pathways will be an essential component. The relevance of podiatric surgery to the profession as a whole and methods for integrating practice will be discussed.

Interobserver Agreement for Noninvasive Bladder Pressure Flow Recording With Penile Cuff

We assessed variability in interpreting noninvasive measurements of bladder pressure and urine flow between experienced and novice users of the penile cuff. Urodynamicists at 6 sites were asked to use the penile cuff test as part of clinical assessment in 30 men presenting with lower urinary tract symptoms. After a short training period they measured maximum flow rate and cuff interruption pressure from penile cuff test recordings to enable categorization of bladder outlet obstruction using a nomogram. Similar measurements were then made on the same traces by 2 expert observers from the originating center. Interobserver differences were assessed. Complete agreement on obstruction categorization was seen in 77% of subjects, which increased to 86% when plots positioned on category boundary lines were allocated to the favored category. The 95% confidence limits of interobserver variability in maximum flow rate and cuff interruption pressure measurements were +/- 1.7 ml per second and +/- 13 cm H(2)O, respectively, although a small number of studies yielded discrepancies between observers that were larger than expected. They arose from complex recordings but were equally likely between experts as between expert and novice. Investigation of the causes suggested in some cases how such discrepancies may be avoided in the future. The excellent level of agreement in measurement and categorization after a short training period suggests that introducing the penile cuff test as part of assessment in men with lower urinary tract symptoms would be straightforward.

Reviewing research into attitudes towards doping in sport: Time to take stock

Introduction: Recent scandals surrounding the use of performance enhancing substances in international sport have led national and international sports organisations to consider their anti-doping strategies. The rewards that accompany success in sport are significant and reports of athletes turning to performance enhancement to achieve success are not uncommon. Therefore, understanding athletes’ attitudes and behavioural intentions towards drugs in sport is critical to informing anti-doping intervention strategies. This paper will focus on the current attitudinal research pertaining to doping in sport and the application of this evidence to guide and inform intervention programmes will be considered. Methodology: The paper will re-analyse the attitudes section of a review commissioned by the World Anti-Doping Agency, conducted in line with UK National Health Service Centre for Reviews and Dissemination guidelines. Results: The prominent research methodologies used to examine the doping attitudes of various target groups are problematic. Designs are dominated by cross-sectional samples. Data are typically based on questionnaires; few have undergone psychometric testing. Consequently, measurement tools vary considerably and capturing explicit attitudes towards doping using self-report inventories is the norm. Given the sensitive nature of this issue, responses are susceptible to considerable response bias. The USA has generated the greatest research output and, with rare exceptions, few scholars have attitudes to doping in sport as their primary research focus. Conclusion: The weak evidence base identified in the commissioned WADA review undermines strategic planning. This further limits the capacity to target appropriate and efficacious education programmes to abate doping in sport.

Metareview on Short-Term Effectiveness and Safety of Antidepressants for Depression: An Evidence-Based Approach to Inform Clinical Practice

To examine the available scientific literature for answers to clinically relevant questions regarding the effectiveness and tolerability of antidepressant drugs (ADs) for the acute phase treatment of depression and to assess the degree to which the literature supports the findings. We used several sources to identify primary reviews: MEDLINE (1955 to April 2006), EMBASE (1980 to April 2006), PsycINFO (1980 to April 2006), and the Cochrane Library 2006 Issue 1. Additional searches were also carried out on the following databases of the National Health Service Centre for Reviews and Dissemination: Abstracts of Reviews of Effects, Health Technology Assessment, and Turning Research into Practice. We also searched the National Institute of Health and Clinical Excellence guidance website. We carried out a metareview of selected high-quality systematic reviews of short-term pharmacologic interventions with ADs for major depression. To assess efficacy, we followed the hierarchy of evidence proposed by the Centre for Evidence Based Medicine (Oxford), including only reviews of randomized controlled trials. To assess tolerability, we also considered observational data when randomized evidence was not available. There was randomized evidence that ADs are efficacious in primary care settings and that there may be small, but clinically important, differences in efficacy between ADs. There was no good evidence that an AD combined with an antipsychotic is superior to AD monotherapy in cases of psychotic depression or that intravenous administration leads to more rapid response. There was evidence that monoamine oxidase inhibitors are superior to tricyclic antidepressants, but not to selective serotonin reuptake inhibitors (SSRIs), in treating atypical depression. There is some evidence of harm related to the use of SSRIs in pregnancy but not to their use when breastfeeding. There is evidence that SSRIs may increase suicidal thoughts, but not actual suicide, in early-phase therapy. We found a substantial body of evidence regarding the benefits and harms of ADs in the treatment of depressive disorder. Nonetheless, there remains considerable residual uncertainty. The evidence is inadequate for generally applicable recommendations; in most cases, the balance between risks and benefits will need to be considered for individual patients. Clinicians should also be guided by the recommendations and warnings issued by drug regulatory authorities.

Evidence-based Practice in Radiology: Step 5 (Evaluate)—Caveats and Common Questions

So far, this series has described and illustrated the first four steps of the five-step evidence-based practice (EBP) process that was originally designed and taught by the medical epidemiologists of McMaster University (Hamilton, Ontario, Canada) and the National Health Service Centre for Evidence-Based Medicine (University of Oxford, Oxford, England). This article in the series first briefly considers the fifth step (evaluate). A more detailed consideration of caveats, common questions, and challenges relevant to EBP in radiology then follows. These are issues that merit some thought by those beginning or continuing work in EBP.

A dose-specific meta-analysis of lipid changes in randomized controlled trials of atorvastatin and simvastatin

Background: The available statins exhibit differences in the potency with which they alter serum lipid levels. Objective: Meta-analyses were conducted to assess the relative potency of atorvastatin arid sinivastatin (the 2 most commonly prescribed statins) across all possible dose combinations in terrrrs of changes in total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), triglycerides (TG), and high-density lipoprotein cholesterol (HDL-C). Methods: EDLINE, E BASE, the Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, National Health Service (NHS) Centre for Reviews and Dissemination database, NHS Economic Evaluation Database, and Database of Abstracts of Reviews of Effects were searched for randomized, head-to-head trials of atorvastatin and simvastatin in patients aged ≥18 years with elevated levels of serum TC arid LDL-C. Reference lists of the identified articles, letters, and editorials also were reviewed. The manufacturers of atorvastatin and simvastatin products were contacted for relevant unpublished data. All studies were reviewed and rated for quality by 2 independent reviewers. The maximum quality score was 4 points; trials with a score of <2 points were considered to be of poor quality and were excluded from analysis. Dose comparisons were abstracted in pairs from each trial. Meta-analyses were conducted on the fixed-dose pairs for each lipid parameter. Weighted mean differences in the1528 change in TC, LDL-C, TG, and HDL-C were estimated using the Der Simonian and Laird random-effects model. Results: Seventeen published trials and 1 unpublished study were included in the meta-analyses. Atorvastatin treatment was associated with significantly greater reductions in TC, LDL-C, and TG in the majority of dose comparisons with sirnvastatin. The potency of atorvastatin and sirnvastatin was comparable at dose ratios between 1:2 and 1:4. Higher doses of simvastatin were more effective in increasing HDL-C levels than atorvastatin, with no apparent dose-equivalence point. The HDL-C advantage of sirnvastatin was greatest when si invastatin 80 mg was compared with atorvastatin 80 mg (weighted mean difference, -4.35%; 95% CI, -5.64 to -3.08, P < 0.001). Conclusions: In these meta-analyses, atorvastatin was 2 to 4 times as potent as sirnvastatin in reducing TC, LDL-C, and TG, indicating that the dose equivalence of atorvastatin and sirnvastatin lay between 1:2 and 1:4. In contrast, simvastatin was more effective than atorvastatin in increasing HDL-C, but without any indication of a point of dose equivalence.

Evidence-based Radiology: Steps 1 and 2—Asking Answerable Questions and Searching for Evidence

Evidence-based medicine originated at McMaster University, Hamilton, Ontario, Canada, where it was defined as "the integration of current best evidence with clinical expertise and patient values" by the Evidence-based Medicine Working Group led by Drs Gordon Guyatt and David Sackett. From this developed the McMaster University and National Health Service Centre for Evidence-Based Medicine, University of Oxford, paradigm of evidence-based practice, which consists of five steps that can be used by ordinary practitioners: formulate answerable questions with which to search for evidence, search the literature, appraise the retrieved evidence by using explicit methods, apply results to a patient or patient group, and evaluate one's evidence-based practice and clinical performance and practice. This communication is about the first two steps of this process. Step 1 provides a framework for more effective question formulation that improves subsequent literature searches. It works equally well for questions about diagnostic and interventional radiology. A clinical scenario for a diagnostic question is used to illustrate the formulation of an answerable question. This question is then used to illustrate step 2-how and where to search for evidence.