Phil Alderson

National Institute for Health and Clinical Excellence, Londinium, England, United Kingdom

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Publications (12)43.36 Total impact

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    Health technology assessment (Winchester, England) 04/2015; 19(8). DOI:10.3310/hta19280 · 5.12 Impact Factor
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    Tanya Graham, Phil Alderson, Tim Stokes
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    ABSTRACT: Background There is international concern that conflicts of interest (COI) may bias clinical guideline development and render it untrustworthy. Guideline COI policies exist with the aim of reducing this bias but it is not known how such policies are interpreted and used by guideline producing organisations. This study sought to determine how conflicts of interest (COIs) are disclosed and managed by a national clinical guideline developer (NICE: the UK National Institute for Health and Care Excellence). Methods Qualitative study using semi-structured telephone interviews with 14 key informants: 8 senior staff of NICE’s guideline development centres and 6 chairs of guideline development groups (GDGs). We conducted a thematic analysis. Results Participants regard the NICE COI policy as comprehensive leading to transparent and independent guidance. The application of the NICE COI policy is, however, not straightforward and clarity could be improved. Disclosure of COI relies on self reporting and guideline developers have to take “on trust” the information they receive, certain types of COI (non-financial) are difficult to categorise and manage and disclosed COI can impact on the ability to recruit clinical experts to GDGs. Participants considered it both disruptive and stressful to exclude members from GDG meetings when required by the COI policy. Nonetheless the impact of this disruption can be minimised with good group chairing skills. Conclusions We consider that the successful implementation of a COI policy in clinical guideline development requires clear policies and procedures, appropriate training of GDG chairs and an evaluation of how the policy is used in practice.
    PLoS ONE 03/2015; 10(3):e0122313. DOI:10.1371/journal.pone.0122313 · 3.53 Impact Factor
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    ABSTRACT: Background There has been a growing emphasis on evidence-informed decision-making in health care. Systematic reviews, such as those produced by the Cochrane Collaboration, have been a key component of this movement. The UK National Institute for Health Research (NIHR) Systematic Review Programme currently supports 20 Cochrane Review Groups (CRGs). The aim of this study was to identify the impacts of Cochrane reviews published by NIHR-funded CRGs during the years 2007–2011. Methods We sent questionnaires to CRGs and review authors, interviewed guideline developers and used bibliometrics and documentary review to get an overview of CRG impact and to evaluate the impact of a sample of 60 Cochrane reviews. We used a framework with four categories (knowledge production, research targeting, informing policy development and impact on practice/services). Results A total of 1,502 new and updated reviews were produced by the 20 NIHR-funded CRGs between 2007 and 2011. The clearest impacts were on policy with a total of 483 systematic reviews cited in 247 sets of guidance: 62 were international, 175 national (87 from the UK) and 10 local. Review authors and CRGs provided some examples of impact on practice or services, for example, safer use of medication, the identification of new effective drugs or treatments and potential economic benefits through the reduction in the use of unproven or unnecessary procedures. However, such impacts are difficult to objectively document, and the majority of reviewers were unsure if their review had produced specific impacts. Qualitative data suggested that Cochrane reviews often play an instrumental role in informing guidance, although a poor fit with guideline scope or methods, reviews being out of date and a lack of communication between CRGs and guideline developers were barriers to their use. Conclusions Health and economic impacts of research are generally difficult to measure. We found that to be the case with this evaluation. Impacts on knowledge production and clinical guidance were easier to identify and substantiate than those on clinical practice. Questions remain about how we define and measure impact, and more work is needed to develop suitable methods for impact analysis.
    10/2014; 3(1):125. DOI:10.1186/2046-4053-3-125
  • 22nd Cochrane Colloquium, Hyderabad, India; 09/2014
  • Lucy J H Alderson, Phil Alderson, Toni Tan
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    ABSTRACT: To describe the length of time National Institute for Health and Care Excellence (NICE) clinical guidelines have remained valid. The present study is a survival analysis of a cohort of published NICE clinical guidelines. The National Health Service in England and Wales uses NICE clinical practice guidelines as a reference for treatment and care of individuals. They need to be updated as new evidence arises, to remain credible and relevant, and are currently assessed 3 years after publication. Survival analysis suggested that about 86% of guidelines are still up-to-date 3 years after their publication. The median life span was 60 months (95% confidence interval: 51, 69). These findings are similar to those in other studies of the life span of guidelines. Efficient mechanisms must be in place to detect the minority of guidelines that become outdated quickly.
    Journal of clinical epidemiology 10/2013; 67(1). DOI:10.1016/j.jclinepi.2013.07.012 · 5.48 Impact Factor
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    ABSTRACT: This article describes the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach to classifying the direction and strength of recommendations. The strength of a recommendation, separated into strong and weak, is defined as the extent to which one can be confident that the desirable effects of an intervention outweigh its undesirable effects. Alternative terms for a weak recommendation include conditional, discretionary, or qualified. The strength of a recommendation has specific implications for patients, the public, clinicians, and policy makers. Occasionally, guideline developers may choose to make "only-in-research" recommendations. Although panels may choose not to make recommendations, this choice leaves those looking for answers from guidelines without the guidance they are seeking. GRADE therefore encourages panels to, wherever possible, offer recommendations.
    Journal of clinical epidemiology 01/2013; 66(7). DOI:10.1016/j.jclinepi.2012.03.013 · 5.48 Impact Factor
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    ABSTRACT: Introduction: Professional societies, like many other organizations around the world, have recognized the need to use more rigorous processes to ensure that healthcare recommendations are informed by the best available research evidence. This is the 11th of a series of 14 articles that methodologists and researchers from around the world prepared to advise guideline developers for respiratory and other diseases on how to achieve this goal. For this article, we developed five key questions and updated a review of the literature on moving from evidence to recommendations. Methods: We addressed the following specific questions.What is the strength of a recommendation and what determines the strength? What are the implications of strong and weak recommendations for patients, clinicians, and policy makers? Should guideline panels make recommendations in the face of very low-quality evidence? Under which circumstances should guideline panels make research recommendations? How should recommendations be formulated and presented? We searched PubMed and other databases of methodological studies for existing systematic reviews and relevant methodological research. We did not conduct systematic reviews ourselves. Our conclusions are based on available evidence, consideration of what guideline developers are doing, and pre- and postworkshop discussions. Results and Discussion: The strength of a recommendation reflects the extent to which guideline developers can, across the range of patients for whom the recommendations are intended, be confident that the desirable effects of following the recommendation outweigh the undesirable effects. Four factors influence the strength of a recommendation: the quality of evidence supporting the recommendation, the balance between desirable and undesirable effects, the uncertainty or variability of patient values and preferences, and costs. Strong and weak (also called "conditional") recommendations have distinct implications for patients, clinicians, and policy makers. Adherence to strong recommendations or, in the case of weak (conditional) recommendations, documentation of discussion or shared decision making with a patient, might be used as quality measures or performance indicators. Clinicians desire guidance regardless of the quality of the underlying evidence. Very low-quality evidence should ideally result in either appropriately labeled recommendations (i.e., as based on very low-quality evidence) or a statement that the guideline panel did not reach consensus on the recommendation due to the lack of confidence in the effect estimates. However, guideline panels often have more resources, time, and information than practicing clinicians. Therefore, they may be in a position to use their best judgments to make recommendations even when there is very low-quality evidence, although some guideline developers disagree with this approach and prefer a general approach of not making recommendations in the face of very low-quality evidence. Guideline panels should consider making research recommendations when there is important uncertainty about the desirable and undesirable effects of an intervention, further research could reduce that uncertainty, and the potential benefits and savings of reducing the uncertainty outweigh the potential harms of not making the research recommendation. Recommendations for additional research should be as precise and specific as possible.
    Proceedings of the American Thoracic Society 12/2012; 9(5):282-292. DOI:10.1513/pats.201208-064ST
  • Phil Alderson, Toni Tan
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    ABSTRACT: The National Institute for Health and Clinical Excellence (NICE) produces clinical guidelines for the National Health Service (NHS) in England and Wales. These guidelines are developed by groups that combine people with expertise in conducting systematic reviews and health economic analyses, with those with expertise in the clinical area (from healthcare professionals and patients). During guideline development, the group poses about 20 to 25 clinical questions, which are then addressed by systematic reviews. As described in the NICE Guidelines Manual, groups routinely search for existing relevant systematic reviews. The NHS funds NICE and makes substantial contributions to The Cochrane Collaboration, so there is a common interest in making the best use of Cochrane Reviews for informing guidelines. One way of assessing the extent to which systematic reviews are used in guidelines is to look at the number of citations of reviews in each guideline. In a recent piece of work, we aimed to find out the extent of citation of Cochrane Reviews in NICE guidelines.For all NICE guidelines published before the end of February 2011 we used full-text searching of the full version of the guideline (and appendices) to identify the word 'Cochrane'. Where the occurrence of 'Cochrane' was a citation of a Cochrane Review, we looked for the current version of the Cochrane Review (or the record of a withdrawn Cochrane Review) in the Cochrane Database of Systematic Reviews (CDSR); we then identified and assigned the name of the Cochrane Review Group (CRG) developing the Cochrane Review to each citation.We tried to examine the context of the use of the Cochrane Review, and decide whether it was used as a source of evidence or as a background document (for example, a review describing how an intervention has been used for a completely different condition).By the end of February 2011 NICE had published 116 clinical guidelines. Ten of these had been replaced by a more up-to-date version, leaving 106 guidelines in the sample. There were 731 citations of Cochrane Reviews in the 106 guidelines, ranging from no citations to 44 citations, with a mean of 6.90 (standard deviation 9.23). Some Cochrane Reviews were cited more than once in different guidelines; therefore, the figures do not represent the number of Cochrane Reviews cited. There were 23 citations that we judged to be for background use rather than directly used to address guideline questions, but we have included these in the data below, as it was difficult at times to be sure of this coding. Table shows the frequency of citations in guidelines.Of the 52 currently registered CRGs, 46 had Cochrane Reviews cited. The maximum number of citations for any CRG was 192. Summary frequencies of citations for the CRGs are shown in Table .In the absence of any established systems for tracking the use of Cochrane Reviews in NICE guidelines, this project required laborious free-text searching. Cochrane Reviews may have been missed by error if the citation in the guideline was incorrect and did not include the word 'Cochrane', or if a Cochrane Review was not cited and should have been.The coding of Cochrane Reviews by CRG used the CRG listed in the latest version of the CDSR; if the Cochrane Review cited in the guideline was not in the latest version, we used the Cochrane Review with the most similar title to the citation. The citations in guidelines may be several years old, authors and titles of Cochrane Reviews change, and some Cochrane Reviews are allocated to new CRGs. Therefore, there may be some errors in these data, but it is likely these are only a small percentage.The data show that some CRGs do not have any Cochrane Reviews cited in NICE guidelines, which may be because they do not map clearly on to the topics covered to date in NICE clinical guidelines. More recently established CRGs would also have had less chance to both develop Cochrane Reviews and have them cited. Even with these limitations, the data show the extensive use of Cochrane Reviews in the development of NICE clinical guidelines. Preliminary work in analysing the types of questions posed in NICE guidelines suggests that around half of the questions concern interventions of the type addressed by most Cochrane Reviews, with a mean of about 14 intervention questions per guideline.Although the data show an impressive level of use of Cochrane Reviews in NICE clinical guidelines, there is no doubt that we could do more to make efficient use of Cochrane Reviews, and work together for mutual benefit in a number of ways. We could make better use of the knowledge contained in CRGs when we draw up the scope for guidelines, and encourage more involvement from Cochrane Review authors on NICE guideline development groups. We could do more to ensure that Cochrane Reviews and guideline questions are better aligned, work harder at sharing knowledge from Cochrane Reviews and guidelines in development, and try to speed up the editorial process of turning relevant Cochrane Protocols into Cochrane Reviews, or updates of Cochrane Reviews, so that they can be considered for a clinical guideline. As guideline developers, we need to ensure that appropriate credit is given when Cochrane Reviews are used, and we could be more active in giving constructive feedback to Cochrane Review authors. It is very difficult to convert non-Cochrane Reviews into Cochrane Reviews, but perhaps we can work harder to make our different timelines and processes work together to reduce duplication of effort. Updating is a common challenge, and there must be some scope for sharing intelligence.This idea of working together is not new, and there have been a number of initiatives around particular clinical guidelines to make better use of Cochrane Reviews. Within England and Wales, there is an increasing appetite to try to make this relationship work better for mutual benefit. In September 2011, there will be a workshop between the clinical guidelines team at NICE and several people with various roles in The Cochrane Collaboration. Let's make this the start of a constructive dialogue to make sure all our efforts better inform clinical practice.How to cite: Alderson P, Tan T. Use of Cochrane Reviews in NICE clinical guidelines [editorial]. The Cochrane Library 2011 (10 Aug). http://www.thecochranelibrary.com/details/editorial/1312103/The-use-of-Cochrane-Reviews-in-NICE-clinical-guidelines.html (accessed Day Month Year).Keywords: Health systems Evidence synthesis.
    Cochrane database of systematic reviews (Online) 01/2011; DOI:10.1002/1312103.ED000032 · 5.94 Impact Factor
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    ABSTRACT: Human albumin solutions are used for a range of medical and surgical problems. Licensed indications are the emergency treatment of shock and other conditions where restoration of blood volume is urgent, such as in burns and hypoproteinaemia. Human albumin solutions are more expensive than other colloids and crystalloids. To quantify the effect on mortality of human albumin and plasma protein fraction (PPF) administration in the management of critically ill patients. We searched the Cochrane Injuries Group Specialised Register (searched 31 May 2011), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011, Issue 2), MEDLINE (Ovid) (1948 to week 3 May 2011), EMBASE (Ovid) (1980 to Week 21 2011), CINAHL (EBSCO) (1982 to May 2011), ISI Web of Science: Science Citation Index Expanded (SCI-EXPANDED) (1970 to May 2011), ISI Web of Science: Conference Proceedings Citation Index - Science (CPCI-S) (1990 to May 2011), PubMed (www.ncbi.nlm.nih.gov/sites/entrez/) (searched 10 June 2011, limit: last 60 days). Reference lists of trials and review articles were checked, and authors of identified trials were contacted. Randomised controlled trials comparing albumin or PPF with no albumin or PPF or with a crystalloid solution in critically ill patients with hypovolaemia, burns or hypoalbuminaemia. We collected data on the participants, albumin solution used, mortality at the end of follow up, and quality of allocation concealment. Analysis was stratified according to patient type. We found 38 trials meeting the inclusion criteria and reporting death as an outcome. There were 1,958 deaths among 10,842 trial participants.For hypovolaemia, the relative risk of death following albumin administration was 1.02 (95% confidence interval (CI) 0.92 to 1.13). This estimate was heavily influenced by the results of the SAFE trial, which contributed 75.2% of the information (based on the weights in the meta-analysis). For burns, the relative risk was 2.93 (95% CI 1.28 to 6.72) and for hypoalbuminaemia the relative risk was 1.26 (95% CI 0.84 to 1.88). There was no substantial heterogeneity between the trials in the various categories (Chi(2) = 26.66, df = 31, P = 0.69). The pooled relative risk of death with albumin administration was 1.05 (95% CI 0.95 to 1.16). For patients with hypovolaemia, there is no evidence that albumin reduces mortality when compared with cheaper alternatives such as saline. There is no evidence that albumin reduces mortality in critically ill patients with burns and hypoalbuminaemia. The possibility that there may be highly selected populations of critically ill patients in which albumin may be indicated remains open to question. However, in view of the absence of evidence of a mortality benefit from albumin and the increased cost of albumin compared to alternatives such as saline, it would seem reasonable that albumin should only be used within the context of well concealed and adequately powered randomised controlled trials.
    Cochrane database of systematic reviews (Online) 01/2011; DOI:10.1002/14651858.CD001208.pub4 · 5.94 Impact Factor
  • Phil Alderson, Toni Tan
    Cochrane database of systematic reviews (Online) 01/2011; DOI:10.1002/14651858.ED000032 · 5.94 Impact Factor
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    Emma Sydenham, Ian Roberts, Phil Alderson
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    ABSTRACT: Hypothermia has been used in the treatment of head injury for many years. Encouraging results from small trials and laboratory studies led to renewed interest in the area and some larger trials. To estimate the effect of mild hypothermia for traumatic head injury on mortality and long-term functional outcome complications. We searched the Injuries Group Specialised Register, Current Controlled Trials MetaRegister of trials, Zetoc, ISI Web of Science: Science Citation Index Expanded (SCI-EXPANDED) and Conference Proceedings Citation Index-Science (CPCI-S), CENTRAL (The Cochrane Library), MEDLINE and EMBASE. We handsearched conference proceedings and checked reference lists of all relevant articles. The search was last updated in January 2009. Randomised controlled trials of hypothermia to a maximum of 35 degrees C for at least 12 consecutive hours versus control in patients with any closed traumatic head injury requiring hospitalisation. Two authors independently assessed all trials. Data on death, Glasgow Outcome Scale and pneumonia were sought and extracted, either from published material or by contacting the investigators. Odds ratios (ORs) and 95% confidence intervals (CIs) were calculated for each trial on an intention-to-treat basis. We found 23 trials with a total of 1614 randomised patients. Twenty-one trials involving 1587 patients reported deaths. There were fewer deaths in patients treated with hypothermia than in the control group (OR 0.84, 95% CI 0.67 to 1.05). Nine trials with good allocation concealment showed no decrease in the likelihood of death compared with the control group, and this result was not statistically significant (OR 1.08, 95% CI 0.79 to 1.47). Twenty-one trials involving 1587 patients reported data on unfavourable outcomes (death, vegetative state or severe disability). Patients treated with hypothermia were less likely to have an unfavourable outcome than those in the control group (OR 0.76, 95% CI 0.61 to 0.93). Nine trials with good allocation concealment showed patients treated with hypothermia were less likely to have an unfavourable outcome than those in the control group, but the reduction was small and non-significant (OR 0.91, 95% CI 0.69 to 1.20). Hypothermia treatment was associated with a slight increase in the odds of pneumonia (OR 1.31, 95% CI 0.93 to 1.86) but there was a reduction in pneumonia for trials with good allocation concealment (4 trials analysed separately, 294 patients, OR 0.79, 95% CI 0.49 to 1.27) although in both cases the results are not statistically significant. There is no evidence that hypothermia is beneficial in the treatment of head injury. Hypothermia may be effective in reducing death and unfavourable outcomes for traumatic head injured patients, but significant benefit was only found in low quality trials. Low quality trials have a tendency to overestimate the treatment effect. The high quality trials found no decrease in the likelihood of death with hypothermia, but this finding was not statistically significant and could be due to the play of chance. Hypothermia should not be used except in the context of a high quality randomised controlled trial with good allocation concealment.
    Cochrane database of systematic reviews (Online) 02/2009; DOI:10.1002/14651858.CD001048.pub4 · 5.94 Impact Factor