The impact of minimum unit pricing on traumatic brain injury in Scotland: a retrospective cohort study of routine national data.

BACKGROUND: Traumatic brain injury (TBI) is a common cause of disability and mortality and is associated with alcohol consumption. On 1st May 2018, the Scottish Government introduced Minimum Unit Pricing (MUP) legislation which set the floor price at which alcohol can be sold to 50 pence per unit. While MUP has led to a 7.6% decrease in off trade alcohol purchases, there are limited studies investigating the clinical impact of this legislation. This study aims to explore the impact of MUP on traumatic brain injury in Scotland. METHODS: Retrospective cohort study using routinely collected national data collated by the Scottish Trauma Audit Group. Data were requested for all TBI incidents from 1st May to 31st December for both 2017 and 2018. Primary outcome was alcohol-related TBI. Secondary outcomes were injury mechanism, injury severity, clinical course, and short-term mortality. Analysis was conducted using multiple regression models adjusted for age, sex, season, and deprivation. RESULTS: A total of 1166 patients (66% male, and 46% in the 60-79-year bracket) were identified. Alcohol-related TBI was evident in 184 of 509 (36%) patients before MUP and in 239 of 657 (36%) patients injured after its implementation (p = 0.638). Further, there was no change in injury mechanism, injury severity, hospital course and short-term mortality of TBI after MUP. CONCLUSIONS: MUP has not resulted in a change in alcohol-related TBI nor in the mechanism and severity of TBI. Limitations in two-point analysis mean that findings should be interpreted with caution and further studies investigating the clinical outcomes of MUP must be conducted.

Preparation, relationship and reflection: Lessons for international medical electives.

BACKGROUND: International medical electives (IMEs) provide opportunities for global health education within undergraduate medical curricula; however, ethical and practical preparations vary. METHODS: Single-centre, prospective, mixed-methods study, utilising online questionnaires with students and host supervisors, contemporaneous reflective diaries and focus groups, to explore the preparedness and experiences of final-year UK medical students undertaking IMEs. RESULTS: Students experienced communication challenges and felt underprepared prior to IME. Students undervalued cultural preparation, whereas host supervisors primarily desired humility and cultural sensitivity. Visitors to high-income countries underpredicted cultural differences with reflective practice supporting understanding of global health inequalities. Burden on hosts and ethical dilemmas related to acting beyond competence remained significant concerns. CONCLUSION: International medical electives provide experiential learning, and with authentic reflection facilitate professional development. Enhanced culturally competent preparation and debriefing is however essential for collaborative and responsible student learning. Acting beyond competency persists, requiring concerted reform during the pandemic-mandated hiatus of IMEs.

Biomarkers for assessing acute kidney injury for people who are being considered for admission to critical care: a systematic review and cost-effectiveness analysis.

BACKGROUND: Acute kidney injury is a serious complication that occurs in the context of an acute critical illness or during a postoperative period. Earlier detection of acute kidney injury may facilitate strategies to preserve renal function, prevent further disease progression and reduce mortality. Acute kidney injury diagnosis relies on a rise in serum creatinine levels and/or fall in urine output; however, creatinine is an imperfect marker of kidney function. There is interest in the performance of novel biomarkers used in conjunction with existing clinical assessment, such as NephroCheck® (Astute Medical, Inc., San Diego, CA, USA), ARCHITECT® urine neutrophil gelatinase-associated lipocalin (NGAL) (Abbott Laboratories, Abbott Park, IL, USA), and urine and plasma BioPorto NGAL (BioPorto Diagnostics A/S, Hellerup, Denmark) immunoassays. If reliable, these biomarkers may enable earlier identification of acute kidney injury and enhance management of those with a modifiable disease course. OBJECTIVE: The objective was to evaluate the role of biomarkers for assessing acute kidney injury in critically ill patients who are considered for admission to critical care. DATA SOURCES: Major electronic databases, conference abstracts and ongoing studies were searched up to June 2019, with no date restrictions. MEDLINE, EMBASE, Health Technology Assessment Database, Cumulative Index to Nursing and Allied Health Literature, Cochrane Central Register of Controlled Trials, Web of Science, World Health Organization Global Index Medicus, EU Clinical Trials Register, International Clinical Trials Registry Platform and ClinicalTrials.gov were searched. REVIEW METHODS: A systematic review and meta-analysis were conducted to evaluate the performance of novel biomarkers for the detection of acute kidney injury and prediction of other relevant clinical outcomes. Random-effects models were adopted to combine evidence. A decision tree was developed to evaluate costs and quality-adjusted life-years accrued as a result of changes in short-term outcomes (up to 90 days), and a Markov model was used to extrapolate results over a lifetime time horizon. RESULTS: A total of 56 studies (17,967 participants), mainly prospective cohort studies, were selected for inclusion. No studies addressing the clinical impact of the use of biomarkers on patient outcomes, compared with standard care, were identified. The main sources of bias across studies were a lack of information on blinding and the optimal threshold for NGAL. For prediction studies, the reporting of statistical details was limited. Although the meta-analyses results showed the potential ability of these biomarkers to detect and predict acute kidney injury, there were limited data to establish any causal link with longer-term health outcomes and there were considerable clinical differences across studies. Cost-effectiveness results were highly uncertain, largely speculative and should be interpreted with caution in the light of the limited evidence base. To illustrate the current uncertainty, 15 scenario analyses were undertaken. Incremental quality-adjusted life-years were very low across all scenarios, ranging from positive to negative increments. Incremental costs were also small, in general, with some scenarios generating cost savings with tests dominant over standard care (cost savings with quality-adjusted life-year gains). However, other scenarios generated results whereby the candidate tests were more costly with fewer quality-adjusted life-years, and were thus dominated by standard care. Therefore, it was not possible to determine a plausible base-case incremental cost-effectiveness ratio for the tests, compared with standard care. LIMITATIONS: Clinical effectiveness and cost-effectiveness results were hampered by the considerable heterogeneity across identified studies. Economic model predictions should also be interpreted cautiously because of the unknown impact of NGAL-guided treatment, and uncertain causal links between changes in acute kidney injury status and changes in health outcomes. CONCLUSIONS: Current evidence is insufficient to make a full appraisal of the role and economic value of these biomarkers and to determine whether or not they provide cost-effective improvements in the clinical outcomes of acute kidney injury patients. FUTURE WORK: Future studies should evaluate the targeted use of biomarkers among specific patient populations and the clinical impact of their routine use on patient outcomes and management. STUDY REGISTRATION: This study is registered as PROSPERO CRD42019147039. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Evidence Synthesis programme and will be published in full in Health Technology Assessment; Vol. 26, No. 7. See the NIHR Journals Library website for further project information.

Among people who are very ill or have undergone surgery, the kidneys may suddenly stop working properly. This is known as acute kidney injury. Acute kidney injury can progress to serious kidney problems and can be fatal. Currently, to decide whether or not acute kidney injury is present, doctors use the level of creatinine (a waste product filtered by the kidneys) in the blood or urine. However, creatinine levels are not a precise indicator and they can take hours or days to rise; this may lead to delays in acute kidney injury recognition. Novel biomarkers may help doctors to recognise the presence of acute kidney injury earlier and treat patients promptly. This work evaluates current evidence on the use of biomarkers for acute kidney injury with respect to clinical usefulness and costs. We reviewed the current evidence on the use of biomarkers for assessing the risk of acute kidney injury among people who are very ill, and assessed whether or not the evidence was of good value for the NHS. We assessed the ARCHITECT^® urine neutrophil gelatinase-associated lipocalin (NGAL) (Abbott Laboratories, Abbott Park, IL, USA), urine and plasma BioPorto NGAL (BioPorto Diagnostics A/S, Hellerup, Denmark) and urine NephroCheck^® (Astute Medical, Inc., San Diego, CA, USA) biomarkers. We checked studies published up to June 2019 and found 56 relevant studies (17,967 patients). Most studies were conducted outside the UK and investigated people already admitted to critical care. We combined the results of the studies and found that NephroCheck and NGAL biomarkers might be useful in identifying acute kidney injury or pre-empting acute kidney injury in some circumstances. However, studies differed in patient characteristics, clinical setting and the way in which biomarkers were used. This could explain why the number of people correctly identified and missed by the biomarkers varied across studies. Hence, we do not completely trust the pooled results. We also found that acute kidney injury is associated with substantial costs for the NHS, but there was insufficient good-quality evidence to decide which biomarker (if any) offered the best value for money.

Cost-effectiveness and value of information analysis of NephroCheck and NGAL tests compared to standard care for the diagnosis of acute kidney injury.

BACKGROUND: Early and accurate acute kidney injury (AKI) detection may improve patient outcomes and reduce health service costs. This study evaluates the diagnostic accuracy and cost-effectiveness of NephroCheck and NGAL (urine and plasma) biomarker tests used alongside standard care, compared with standard care to detect AKI in hospitalised UK adults. METHODS: A 90-day decision tree and lifetime Markov cohort model predicted costs, quality adjusted life years (QALYs) and incremental cost-effectiveness ratios (ICERs) from a UK NHS perspective. Test accuracy was informed by a meta-analysis of diagnostic accuracy studies. Clinical trial and observational data informed the link between AKI and health outcomes, health state probabilities, costs and utilities. Value of information (VOI) analysis informed future research priorities. RESULTS: Under base case assumptions, the biomarker tests were not cost-effective with ICERs of £105,965 (NephroCheck), £539,041 (NGAL urine BioPorto), £633,846 (NGAL plasma BioPorto) and £725,061 (NGAL urine ARCHITECT) per QALY gained compared to standard care. Results were uncertain, due to limited trial data, with probabilities of cost-effectiveness at £20,000 per QALY ranging from 0 to 99% and 0 to 56% for NephroCheck and NGAL tests respectively. The expected value of perfect information (EVPI) was £66 M, which demonstrated that additional research to resolve decision uncertainty is worthwhile. CONCLUSIONS: Current evidence is inadequate to support the cost-effectiveness of general use of biomarker tests. Future research evaluating the clinical and cost-effectiveness of test guided implementation of protective care bundles is necessary. Improving the evidence base around the impact of tests on AKI staging, and of AKI staging on clinical outcomes would have the greatest impact on reducing decision uncertainty.

Analysis of the UK recommendations on obesity based on a proposed implementation framework.

BACKGROUND: There is considerable expertise in the obesity field in identifying, appraising, and synthesising evidence to develop guidelines and recommendations for policy and practice. The recommendations, while based on evidence, are not formulated in a way that readily leads to implementation. This paper analyses the recent UK recommendations on obesity using a proposed implementation framework. METHODS: Two bibliographic databases (Medline and Embase) and various health related and government websites were systematically searched for obesity recommendations published between 1996 and 2007. All the documents published on recommendations for either prevention or treatment of obesity in the UK were assessed. A proposed implementation framework was developed for the purpose of this review. All the UK recommendations were critically appraised and results summarised according to the criteria used within the framework. Cross-country applicability of the proposed framework was assessed using the Swedish policy recommendations on obesity. RESULTS: Most recommendations on obesity while demonstrating their basis in evidence, fail to meet the implementation standards. They tend to be non-specific in identifying who is responsible for implementation and monitoring, and often no timescale is indicated. The costs of implementation are rarely estimated and those responsible for such funding are not specified. There are some notable exemptions to the general pattern emanating from more operational and locally based groups. The Swedish policy details 79 proposals with responsibility clearly identified and costs are presented for 20 of them. This policy satisfied most of the framework criteria but failed to give details on evaluation, monitoring and the timeframe for implementation. CONCLUSIONS: Public health has developed skills in appraising evidence and formulating recommendations based on appropriate evidence but these are often not implemented. Different skills are required to translate these recommendations into actions. Public health clearly needs to develop the implementation skills to a level comparable to the ability to synthesise evidence.

Quantitative assessment of chronic postsurgical pain using the McGill Pain Questionnaire.

OBJECTIVES: The McGill Pain Questionnaire (MPQ) provides a quantitative profile of 3 major psychologic dimensions of pain: sensory-discriminative, motivational-affective, and cognitive-evaluative. Although the MPQ is frequently used as a pain measurement tool, no studies to date have compared the characteristics of chronic post-surgical pain after different surgical procedures using a quantitative scoring method. METHODS: Three separate questionnaire surveys were administered to patients who had undergone surgery at different time points between 1990 and 2000. Surgical procedures selected were mastectomy (n = 511 patients), inguinal hernia repair (n = 351 patients), and cardiac surgery via a central chest wound with or without saphenous vein harvesting (n = 1348 patients). A standard questionnaire format with the MPQ was used for each survey. The IASP definition of chronic pain, continuously or intermittently for longer than 3 months, was used with other criteria for pain location. The type of chronic pain was compared between the surgical populations using 3 different analytical methods: the Pain Rating Intensity score using scale values, (PRI-S); the Pain Rating Intensity using weighted rank values multiplied by scale value (PRI-R); and number of words chosen (NWC). RESULTS: The prevalence of chronic pain after mastectomy, inguinal herniorrhaphy, and median sternotomy with or without saphenectomy was 43%, 30%, and 39% respectively. Chronic pain most frequently reported was sensory-discriminative in quality with similar proportions across different surgical sites. Average PRI-S values after mastectomy, hernia repair, sternotomy (without postoperative anginal symptoms), and saphenectomy were 14.06, 13.00, 12.03, and 8.06 respectively. Analysis was conducted on cardiac patients who reported anginal symptoms with chronic post-surgical pain (PRI-S value 14.28). Patients with moderate and severe pain were more likely to choose more than 10 pain descriptors, regardless of the operative site (P < 0.05). DISCUSSION: The prevalence and characteristics of chronic pain was remarkably similar across different operative groups. This study is the first to quantitatively compare chronic post-surgical pain using similar methodologies in heterogeneous post-surgical populations.