Phil Alderson

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

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Publications (25)121.47 Total impact

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    ABSTRACT: Shivering after general anaesthesia is common. It is unpleasant but can also have adverse physiological effects. Alpha-2 (α-2) adrenergic agonist receptors, which can lead to reduced sympathetic activity and central regulation of vasoconstrictor tone, are a group of drugs that have been used to try to prevent postoperative shivering. To assess the following: the effects of α-2 agonists on the prevention of shivering and subsequent complications after general anaesthesia in people undergoing surgery; the effects of α-2 agonists on the risk of inadvertent perioperative hypothermia; and whether any adverse effects are associated with these interventions. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and EMBASE on 13 June 2014. Our search terms were relevant to the review question and limited to studies that assessed shivering or hypothermia. We also carried out searches of clinical trials registers, and forward and backward citation tracking. We considered all randomized controlled trials, quasi-randomized studies, and cluster-randomized studies with adult participants undergoing surgery with general anaesthesia in which an α-2 agonist was compared with another α-2 agonist or a placebo for the prevention of shivering. Two review authors independently assessed trial quality and extracted data, consulting a third review author in the case of disagreements. We used standard Cochrane methodological procedures, including an assessment of risk of bias and use of GRADEpro software to interpret findings. We included 20 studies with 1401 surgical participants comparing an α-2 agonist against a control. Thirteen studies compared clonidine with a control, whilst seven compared dexmedetomidine with a control. The doses, methods, and time of administration varied between studies: three studies gave the drug orally or as an intravenous bolus preoperatively and nine intraoperatively; one study gave the drug as an infusion starting preoperatively and seven started at varying points from anaesthetic induction to the end of surgery. Whilst all the studies were described as randomized, many provided insufficient detail on methods used. We had anticipated that attempts would be made to reduce performance bias by blinding of personnel and participants, however this was detailed in only six of the papers. Similarly, in some studies detail was lacking on methods to reduce the risk of detection bias. We therefore downgraded the quality of evidence in our 'Summary of findings' table by one level for risk of bias using the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) approach.All 20 included studies presented outcome data for postoperative shivering, and in meta-analysis α-2 agonists were shown to significantly reduce the risk of shivering (Mantel-Haenszel risk ratio 0.28, 95% confidence interval 0.18 to 0.43, P value < 0.0001). We found significant evidence of heterogeneity (I(2) = 80%) for this result that was not explained by sensitivity or subgroup analysis; we therefore downgraded the inconsistency of the evidence by one level. Although we did not feel that there were concerns with imprecision or indirectness of the data, we downgraded the quality of the evidence for the risk of publication bias following visual analysis of a funnel plot. Using GRADEpro, we rated the overall quality of the data for shivering as very low. Only one study reported the incidence of core hypothermia, whilst 12 studies measured core temperature. However, as the results for core temperature were reported in different styles, pooling the results was inappropriate. We found no studies with participant-reported outcomes such as experience of shivering or participant satisfaction. We found limited data for the outcomes of length of stay in the postanaesthetic care unit (three studies, 200 participants) and the following adverse effects: sedation (nine studies, 875 participants), bradycardia (eight studies, 716 participants), and hypotension (seven studies, 688 participants). Unpooled analysis suggested that sedation and bradycardia were significantly more common with dexmedetomidine than placebo, with all seven dexmedetomidine studies and none of the clonidine studies reporting statistically significantly higher levels of sedation as an adverse effect. There is evidence that clonidine and dexmedetomidine can reduce postoperative shivering, but patients given dexmedetomidine may be more sedated. However, our assessment of the quality of this evidence is very low.
    No preview · Article · Aug 2015 · Cochrane database of systematic reviews (Online)
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    ABSTRACT: During surgical operations, patients may become cold as the result of a combination of factors including the action of anaesthetic drugs, the presence of uncovered skin and the administration of cold fluids into the veins or to parts of the body where surgery is taking place to wash them. Becoming cold during surgery can be unpleasant and can cause excessive shivering after the operation. It can also cause heart problems and bleeding problems and can contribute to problems with pressure sores and wound healing and longer hospital stay. This review seeks to find out whether warming the fluids given into veins or used to wash parts of the body may prevent patients from becoming cold. We searched medical databases up until February 2014 to find studies comparing warmed fluids with unwarmed fluids and other methods of warming the patient. We found 24 relevant trials with 1250 adult patients undergoing all types of surgery. We did not include studies for which it was intended that the patient would become cold (such as to facilitate heart bypass surgery). We had intended to collect data on which patients became hypothermic (when their body temperature dropped to below 36 degrees Celsius), but no trials reported this, so we collected data on patient temperatures at various time points throughout surgery. We found evidence of moderate quality showing that if patients had the fluids they were given into their veins warmed up, they were about half a degree Celsius warmer and shivered less than those who received unwarmed fluids; however, we were unable to show a significant difference in patients who received warmed fluids to wash out parts of their bodies. We have demonstrated that warming fluids does keep adult patients warmer; however it is unclear whether this alone can make a difference in the severe complications that becoming cold may cause.
    No preview · Article · Apr 2015 · Cochrane database of systematic reviews (Online)

  • No preview · Article · Apr 2015
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    ABSTRACT: The last few decades have seen a growing emphasis on evidence-informed decision-making in health care. Systematic reviews, such as those produced by Cochrane, have been a key component of this movement. The National Institute for Health Research (NIHR) Systematic Review Programme currently supports 20 Cochrane Review Groups (CRGs) in the UK and it is important that this funding represents value for money. Aims and objectives The overall aim was to identify the impacts and likely impacts on health care, patient outcomes and value for money of Cochrane Reviews published by 20 NIHR-funded CRGs during the years 2007–11. Design We sent questionnaires to CRGs and review authors, undertook interviews with guideline developers (GDs) 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. The evaluation was guided by a framework with four categories (knowledge production, research targeting, informing policy development and impact on practice/services). Results A total of 3187 new and updated reviews were published on the Cochrane Database of Systematic Reviews between 2007 and 2011, 1502 (47%) of which were produced by the 20 CRGs funded by the NIHR. We found 40 examples where reviews appeared to have influenced primary research and reviews had contributed to the creation of new knowledge and stimulated debate. Twenty-seven of the 60 reviews had 100 or more citations in Google Scholar™ (Google, CA, USA). Overall, 483 systematic reviews had been cited in 247 sets of guidance. This included 62 sets of international guidance, 175 sets of national guidance (87 from the UK) and 10 examples of local guidance. Evidence from the interviews suggested that Cochrane Reviews often play an instrumental role in informing guidance, although reviews being a poor fit with guideline scope or methods, reviews being out of date and a lack of communication between CRGs and GDs were barriers to their use. Cochrane Reviews appeared to have led to a number of benefits to the health service including safer or more appropriate use of medication or other health technologies or the identification of new effective drugs or treatments. However, whether or not these changes were directly as a result of the Cochrane Review and not the result of subsequent clinical guidance was difficult to judge. Potential benefits of Cochrane Reviews included economic benefits through budget savings or the release of funds, improvements in clinical quality, the reduction in the use of unproven or unnecessary procedures and improvements in patient and carer experiences. Conclusions This study identified a number of impacts and likely impacts of Cochrane Reviews. The clearest impacts of Cochrane Reviews are on research targeting and health-care policy, with less evidence of a direct impact on clinical practice and the organisation and delivery of NHS services. Although it is important for researchers to consider how they might increase the influence of their work, such impacts are difficult to measure. More work is required to develop suitable methods for defining and quantifying the impact of research. Funding The NIHR Health Technology Assessment programme.
    Full-text · Article · Apr 2015 · Health technology assessment (Winchester, England)
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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.
    Full-text · Article · Mar 2015 · PLoS ONE
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    ABSTRACT: Background Electrical cardioversion is a procedure by which pads on the chest aim to return the heart to a normal rhythm following disturbances. This procedure is painful and can be distressing for the patient; therefore drugs are used to make patients unaware of the procedure. We aimed to compare the safety and effectiveness of the drugs used in electrical cardioversion. Study characteristics Evidence is current to 27 March 2014. We found 23 relevant randomized controlled trials with 1250 participants undergoing cardioversion procedures. These studies compared one anaesthetic drug against one or more other drugs, including propofol, etomidate, thiopentone, sevoflurane, midazolam and diazepam. Key results Study authors considered clinical outcomes such as decreased blood pressure, interrupted breathing and whether cardioversion was successful, as well as patient relevant outcomes such as recall, nausea and vomiting, pain on injection and satisfaction with the procedures. In addition to a variety of drug comparisons between studies, differences in study methods were described, with drugs given in different doses and over different lengths of time. These differences meant that it was inappropriate to combine the results of these studies. Quality of the evidence We believe that the quality of these studies was not sufficiently high, and that it would be misleading to combine the findings of all studies within this review. Study authors had not taken enough steps to reduce the risk of differences in methods within the studies, for example, by masking doctors and assessors regarding which drug was given to each patient. Conclusions Most authors of individual studies concluded that all agents studied were adequate for making patients unaware during cardioversion. It is our opinion that at present, there is no evidence to suggest that drugs used by anaesthetists to make patients unaware of cardioversion should change.
    No preview · Article · Mar 2015 · Cochrane database of systematic reviews (Online)
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    ABSTRACT: To identify the number of drug-disease and drug-drug interactions for exemplar index conditions within National Institute of Health and Care Excellence (NICE) clinical guidelines. Systematic identification, quantification, and classification of potentially serious drug-disease and drug-drug interactions for drugs recommended by NICE clinical guidelines for type 2 diabetes, heart failure, and depression in relation to 11 other common conditions and drugs recommended by NICE guidelines for those conditions. NICE clinical guidelines for type 2 diabetes, heart failure, and depression Potentially serious drug-disease and drug-drug interactions. Following recommendations for prescription in 12 national clinical guidelines would result in several potentially serious drug interactions. There were 32 potentially serious drug-disease interactions between drugs recommended in the guideline for type 2 diabetes and the 11 other conditions compared with six for drugs recommended in the guideline for depression and 10 for drugs recommended in the guideline for heart failure. Of these drug-disease interactions, 27 (84%) in the type 2 diabetes guideline and all of those in the two other guidelines were between the recommended drug and chronic kidney disease. More potentially serious drug-drug interactions were identified between drugs recommended by guidelines for each of the three index conditions and drugs recommended by the guidelines for the 11 other conditions: 133 drug-drug interactions for drugs recommended in the type 2 diabetes guideline, 89 for depression, and 111 for heart failure. Few of these drug-disease or drug-drug interactions were highlighted in the guidelines for the three index conditions. Drug-disease interactions were relatively uncommon with the exception of interactions when a patient also has chronic kidney disease. Guideline developers could consider a more systematic approach regarding the potential for drug-disease interactions, based on epidemiological knowledge of the comorbidities of people with the disease the guideline is focused on, and should particularly consider whether chronic kidney disease is common in the target population. In contrast, potentially serious drug-drug interactions between recommended drugs for different conditions were common. The extensive number of potentially serious interactions requires innovative interactive approaches to the production and dissemination of guidelines to allow clinicians and patients with multimorbidity to make informed decisions about drug selection. © Dumbreck et al 2015.
    Full-text · Article · Mar 2015 · BMJ Clinical Research
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    ABSTRACT: Inadvertent postoperative hypothermia (a drop in core body temperature to below 36°C) occurs as an effect of surgery when anaesthetic drugs and exposure of the skin for long periods of time during surgery result in interference with normal temperature regulation. Once hypothermia has occurred, it is important that patients are rewarmed promptly to minimise potential complications. Several different interventions are available for rewarming patients. To estimate the effectiveness of treating inadvertent perioperative hypothermia through postoperative interventions to decrease heat loss and apply passive and active warming systems in adult patients who have undergone surgery. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (2014, Issue 2), MEDLINE (Ovid SP) (1956 to 21 February 2014), EMBASE (Ovid SP) (1982 to 21 February 2014), the Institute for Scientific Information (ISI) Web of Science (1950 to 21 February 2014) and the Cumulative Index to Nursing and Allied Health Literature (CINAHL), EBSCO host (1980 to 21 February 2014), as well as reference lists of articles. We also searched www.controlled-trials.com and www.clincialtrials.gov. Randomized controlled trials of postoperative warming interventions aiming to reverse hypothermia compared with control or with each other. Three review authors identified studies for inclusion in this review. One review author extracted data and completed risk of bias assessments; two review authors checked the details. Meta-analysis was conducted when appropriate by using standard methodological procedures as expected by The Cochrane Collaboration. We included 11 trials with 699 participants. Ten trials provided data for analysis. Trials varied in the numbers and types of participants included and in the types of surgery performed. Most trials were at high or unclear risk of bias because of inappropriate or unclear randomization procedures, and because blinding of assessors and participants generally was not possible. This may have influenced results, but it is unclear how the results may have been influenced. Active warming was found to reduce the mean time taken to achieve normothermia by about 30 minutes in comparison with use of warmed cotton blankets (mean difference (MD) -32.13 minutes, 95% confidence interval (CI) -42.55 to -21.71; moderate-quality evidence), but no significant difference in shivering was noted. Active warming was found to reduce mean time taken to achieve normothermia by almost an hour and a half in comparison with use of unwarmed cotton blankets (MD -88.86 minutes, 95% CI -123.49 to -54.23; moderate-quality evidence), and people in the active warming group were less likely to shiver than those in the unwarmed cotton blanket group (Relative Risk=0.61 95% CI= 0.42 to 0.86; low quality evidence). There was no effect on mean temperature difference in degrees celsius at 60 minutes (MD=0.18°C, 95% CI=-0.10 to 0.46; moderate quality evidence), and no data were available in relation to major cardiovascular complications. Forced air warming was found to reduce time taken to achieve normothermia by about one hour in comparison to circulating hot water devices (MD=-54.21 minutes 95% CI= -94.95, -13.47). There was no statistically significant difference between thermal insulation and cotton blankets on mean time to achieve normothermia (MD =-0.29 minutes, 95% CI=-25.47 to 24.89; moderate quality evidence) or shivering (Relative Risk=1.36 95% CI= 0.69 to 2.67; moderate quality evidence), and no data were available for mean temperature difference or major cardiovascular complications. Insufficient evidence was available about other comparisons, adverse effects or any other secondary outcomes. Active warming, particularly forced air warming, appears to offer a clinically important reduction in mean time taken to achieve normothermia (normal body temperature between 36°C and 37.5°C) in patients with postoperative hypothermia. However, high-quality evidence on other important clinical outcomes is lacking; therefore it is unclear whether active warming offers other benefits and harms. High-quality evidence on other warming methods is also lacking; therefore it is unclear whether other rewarming methods are effective in reversing postoperative hypothermia.
    No preview · Article · Nov 2014 · Cochrane database of systematic reviews (Online)
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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.
    Full-text · Article · Oct 2014 · Systematic Reviews

  • No preview · Conference Paper · Sep 2014
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    ABSTRACT: BACKGROUND The National Institute for Health and Care Excellence (NICE) provides condition-specific recommendations based on best available evidence. An enduring challenge is how to provide recommendations for populations with multiple conditions (multimorbidity) based on robust economic evidence. OBJECTIVES To structure a model-based cost-effectiveness analysis of treatment strategies to inform a clinical guideline for a multimorbid population. METHODS Using predefined criteria, a multimorbid population living with coronary heart disease and depression (CHD/D), was selected as a pilot. Data triangulated from three sources informed an economic model-structure (i) published economic models from clinical guidelines for single conditions (ii) expert elicitation (clinicians, pharmacists, patients, guideline developers) using a structured deliberative process (iii) published recommendations on economic modelling. RESULTS A model structure (discrete event simulation) suitable to inform the development of clinical guidelines of treatment strategies for CHD/D was produced. DISCUSSION Results suggest that simply pooling cost-effectiveness evidence for single conditions is unlikely to be valid when producing guidelines for multimorbid populations undergoing numerous treatments. A key component was the need to systematically integrate quantitative risk-benefit assessment into the cost-effectiveness analysis. IMPLICATIONS FOR GUIDELINE DEVELOPERS/USERS Strictly adhering to recommendations from multiple single guidelines for multimorbid populations may lead to the promotion of care which does not clearly balance harms and benefits of treatments. Guideline developers can use the results of this study to understand how to generate useful economic evidence to inform recommendations for multimorbid populations.
    No preview · Conference Paper · Aug 2014
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    ABSTRACT: With increasing demand for surgery, pressure on healthcare providers to reduce costs, and a predicted shortfall in the number of medically qualified anaesthetists it is important to consider whether non-physician anaesthetists (NPAs), who do not have a medical qualification, are able to provide equivalent anaesthetic services to medically qualified anaesthesia providers.
    No preview · Article · Jul 2014 · Cochrane database of systematic reviews (Online)
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    ABSTRACT: Inadvertent perioperative hypothermia occurs because of interference with normal temperature regulation by anaesthetic drugs and exposure of skin for prolonged periods. A number of different interventions have been proposed to maintain body temperature by reducing heat loss. Thermal insulation, such as extra layers of insulating material or reflective blankets, should reduce heat loss through convection and radiation and potentially help avoid hypothermia.
    No preview · Article · Jun 2014 · Cochrane database of systematic reviews (Online)
  • A Nicholson · M C Lowe · J Parker · S R Lewis · P Alderson · AF Smith
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    ABSTRACT: Enhanced recovery programmes (ERPs) have been developed over the past 10 years to improve patient outcomes and to accelerate recovery after surgery. The existing literature focuses on specific specialties, mainly colorectal surgery. The aim of this review was to investigate whether the effect of ERPs on patient outcomes varies across surgical specialties or with the design of individual programmes. MEDLINE, Embase, CINAHL and the Cochrane Central Register of Controlled Trials were searched from inception to January 2013 for randomized or quasi-randomized trials comparing ERPs with standard care in adult elective surgical patients. Thirty-eight trials were included in the review, with a total of 5099 participants. Study design and quality was poor. Meta-analyses showed that ERPs reduced the primary length of stay (standardized mean difference -1·14 (95 per cent confidence interval -1·45 to -0·85)) and reduced the risk of all complications within 30 days (risk ratio (RR) 0·71, 95 per cent c.i. 0·60 to 0·86). There was no evidence of a reduction in mortality (RR 0·69, 95 per cent c.i. 0·34 to 1·39), major complications (RR 0·95, 0·69 to 1·31) or readmission rates (RR 0·96, 0·59 to 1·58). The impact of ERPs was similar across specialties and there was no consistent evidence that elements included within ERPs affected patient outcomes. ERPs are effective in reducing length of hospital stay and overall complication rates across surgical specialties. It was not possible to identify individual components that improved outcome. Qualitative synthesis may be more appropriate to investigate the determinants of success.
    No preview · Article · Feb 2014 · British Journal of Surgery
  • 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.
    No preview · Article · Oct 2013 · Journal of clinical epidemiology
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    ABSTRACT: Patients undergoing vascular surgery are a high-risk population with widespread atherosclerosis, an adverse cardiovascular risk profile and often multiple co-morbidities. Postoperative cardiovascular complications, including myocardial infarct (MI), are common. Statins are the medical treatment of choice to reduce high cholesterol levels. Evidence is accumulating that patients taking statins at the time of surgery are protected against a range of perioperative complications, but the specific benefits for patients undergoing noncardiac vascular surgery are not clear. We examined whether short-term statin therapy, commenced before or on the day of noncardiac vascular surgery and continuing for at least 48 hours afterwards, improves patient outcomes including the risk of complications, pain, quality of life and length of hospital stay. We also examined whether the effect of statin therapy on these outcomes changes depending on the dose of statin received. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2012, Issue 7), MEDLINE via Ovid SP (1966 to August 2012), EMBASE via Ovid SP (1966 to August 2012), CINAHL via EBSCO host (1966 to August 2012) and ISI Web of Science (1946 to July 2012) without any language restriction. We used a combination of free text search and controlled vocabulary search. The results were limited to randomized controlled clinical trials (RCTs). We conducted forwards and backwards citation of key articles and searched two clinical trial Websites for ongoing trials (www.clinicaltrials.gov and http://www.controlled-trials.com). We included RCTs that had compared short-term statin therapy, either commenced de novo or with existing users randomly assigned to different dosages, in adult participants undergoing elective and emergency noncardiac arterial surgery, including both open and endovascular procedures. We defined short-term as commencing before or on the day of surgery and continuing for at least 48 hours afterwards. Two authors independently assessed trial quality and extracted data, including information on adverse events. We contacted study authors for additional information. We performed separate analyses for the comparisons of statin with placebo/no treatment and between different doses of statin. We presented results as pooled risk ratios (RRs) with 95% confidence intervals (CIs) based on random-effects models (inverse variance method). We employed the Chi(2) test and calculated the I(2) statistic to investigate study heterogeneity. We identified six eligible studies in total. The six Included studies were generally of high quality, but the largest eligible study was excluded because of concerns about its validity. Study populations were statin naive, which led to a considerable loss of eligible participants.Five RCTs compared statin use with placebo or standard care. We pooled results from three studies, with a total of 178 participants, for mortality and non-fatal event outcomes. In the statin group, 7/105 (6.7%) participants died within 30 days of surgery, as did 10/73 (13.7%) participants in the control group. Only one death in each group was from cardiovascular causes, with an incidence of 0.95% in statin participants and 1.4% in control participants, respectively. All deaths occurred in a single study population, and so effect estimates were derived from one study only. The risk ratio (RR) of all-cause mortality in statin users showed a non-significant decrease in risk (RR 0.73, 95% CI 0.31 to 1.75). For cardiovascular death, the risk ratio was 1.05 (95% CI 0.07 to 16.20). Non-fatal MI within 30 days of surgery was reported in three studies and occurred in 4/105 (3.8%) participants in the statin group and 8/73 (11.0%) participants receiving placebo, for a non-significant decrease in risk (RR 0.47, 95% CI 0.15 to 1.52). Several studies reported muscle enzyme levels as safety measures, but only three (with a total of 188 participants) reported explicitly on clinical muscle syndromes, with seven events reported and no significant difference found between statin users and controls (RR 0.94, 95% CI 0.24 to 3.63). The only participant-reported outcome was nausea in one small study,with no significant difference in risk between groups.Two studies compared different doses of atorvastatin, with a total of 145 participants, but reported data were not sufficient to allow us to determine the effect of higher doses on any outcome. Evidence was insufficient to allow review authors to conclude that statin use resulted in either a reduction or an increase in any of the outcomes examined. The existing body of evidence leaves questions about the benefits of perioperative use of statins for vascular surgery unanswered. Widespread use of statins in the target population means that it may now be difficult for researchers to undertake the large RCTs needed to demonstrate any effect on the incidence of postoperative cardiovascular events. However, participant-reported outcomes have been neglected and warrant further study.
    No preview · Article · Jul 2013 · Cochrane database of systematic reviews (Online)
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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.
    Full-text · Article · Jan 2013 · Journal of clinical epidemiology
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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.
    Full-text · Article · Dec 2012 · Proceedings of the American Thoracic Society
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    Full-text · Article · Oct 2012 · BMJ (online)

  • No preview · Chapter · Jun 2012