Follow-up services for improving long-term outcomes in intensive care unit (ICU) survivors

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: Our main objective is to assess the effectiveness of follow-up services for ICU survivors that aim to identify and address unmet health needs related to the ICU period. We aim to assess the effectiveness in relation to health-related quality of life, mortality, depression and anxiety, post-traumatic stress disorder, physical function, cognitive function, ability to return to work or education and adverse events. Our secondary objectives are, in general, to examine both the various ways that follow-up services are provided and any major influencing factors. Specifically, we aim to explore: the effectiveness of service organisation (physician versus nurse led, face to face versus remote, timing of follow-up service); possible differences in services related to country (developed versus developing country); and whether participants had delirium within the ICU setting

Follow-up services for improving long-term outcomes in intensive care unit (ICU) survivors

Background: The intensive care unit (ICU) stay has been linked with a number of physical and psychological sequelae, known collectively as post‐intensive care syndrome (PICS). Specific ICU follow‐up services are relatively recent developments in health systems, and may have the potential to address PICS through targeting unmet health needs arising from the experience of the ICU stay. There is currently no single accepted model of follow‐up service and current aftercare programmes encompass a variety of interventions and materials. There is uncertain evidence about whether follow‐up services effectively address PICS, and this review assesses this. Objectives: Our main objective was to assess the effectiveness of follow‐up services for ICU survivors that aim to identify and address unmet health needs related to the ICU period. We aimed to assess effectiveness in relation to health‐related quality of life (HRQoL), mortality, depression and anxiety, post‐traumatic stress disorder (PTSD), physical function, cognitive function, ability to return to work or education and adverse effects. Our secondary objectives were to examine different models of follow‐up services. We aimed to explore: the effectiveness of service organisation (physician‐ versus nurse‐led, face‐to‐face versus remote, timing of follow‐up service); differences related to country (high‐income versus low‐ and middle‐income countries); and effect of delirium, which can subsequently affect cognitive function, and the effect of follow‐up services may differ for these participants. Search methods: We searched CENTRAL, MEDLINE, Embase and CINAHL on 7 November 2017. We searched clinical trials registers for ongoing studies, and conducted backward and forward citation searching of relevant articles. Selection criteria: We included randomised and non‐randomised studies with adult participants, who had been discharged from hospital following an ICU stay. We included studies that compared an ICU follow‐up service using a structured programme and co‐ordinated by a healthcare professional versus no follow‐up service or standard care. Data collection and analysis: Two review authors independently assessed studies for inclusion, extracted data, assessed risk of bias, and synthesised findings. We used the GRADE approach to assess the certainty of the evidence. Main results: We included five studies (four randomised studies; one non‐randomised study), for a total of 1707 participants who were ICU survivors with a range of illness severities and conditions. Follow‐up services were led by nurses in four studies or a multidisciplinary team in one study. They included face‐to‐face consultations at home or in a clinic, or telephone consultations or both. Each study included at least one consultation (weekly, monthly, or six‐monthly), and two studies had up to eight consultations. Although the design of follow‐up service consultations differed in each study, we noted that each service included assessment of participants' needs with referrals to specialist support if required. It was not feasible to blind healthcare professionals or participants to the intervention and we did not know whether this may have introduced performance bias. We noted baseline differences (two studies), and services included additional resources (two studies), which may have influenced results, and one non‐randomised study had high risk of selection bias. We did not combine data from randomised studies with data from one non‐randomised study. Follow‐up services for improving long‐term outcomes in ICU survivors may make little or no difference to HRQoL at 12 months (standardised mean difference (SMD) ‐0.0, 95% confidence interval (CI) ‐0.1 to 0.1; 1 study; 286 participants; low‐certainty evidence). We found moderate‐certainty evidence from five studies that they probably also make little or no difference to all‐cause mortality up to 12 months after ICU discharge (RR 0.96, 95% CI 0.76 to 1.22; 4 studies; 1289 participants; and in one non‐randomised study 79/259 deaths in the intervention group, and 46/151 in the control group) and low‐certainty evidence from four studies that they may make little or no difference to PTSD (SMD ‐0.05, 95% CI ‐0.19 to 0.10, 703 participants, 3 studies; and one non‐randomised study reported less chance of PTSD when a follow‐up service was used). It is uncertain whether using a follow‐up service reduces depression and anxiety (3 studies; 843 participants), physical function (4 studies; 1297 participants), cognitive function (4 studies; 1297 participants), or increases the ability to return to work or education (1 study; 386 participants), because the certainty of this evidence is very low. No studies measured adverse effects. We could not assess our secondary objectives because we found insufficient studies to justify subgroup analysis. Authors' conclusions: We found insufficient evidence, from a limited number of studies, to determine whether ICU follow‐up services are effective in identifying and addressing the unmet health needs of ICU survivors. We found five ongoing studies which are not included in this review; these ongoing studies may increase our certainty in the effect in future updates. Because of limited data, we were unable to explore whether one design of follow‐up service is preferable to another, or whether a service is more effective for some people than others, and we anticipate that future studies may also vary in design. We propose that future studies are designed with robust methods (for example randomised studies are preferable) and consider only one variable (the follow‐up service) compared to standard care; this would increase confidence that the effect is due to the follow‐up service rather than concomitant therapies

Automated monitoring for the early detection of sepsis in critically ill patients

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: To evaluate whether automated systems for the early detection of sepsis can reduce the time to appropriate treatment and improve clinical outcomes in critically ill patients in the ICU

Intravenous versus inhalational maintenance of anaesthesia for postoperative cognitive outcomes in elderly surgical patients

This is the protocol for a review and there is no abstract. The objectives are as follows: To compare maintenance of general anaesthesia for elderly surgical patients using total intravenous anaesthesia (TIVA) or inhalational anaesthesia on postoperative cognitive function, mortality, risk of hypotension, length of stay in the postanaesthetic care unit (PACU), and hospital stay

Colloids versus crystalloids for fluid resuscitation in critically ill people

Background Critically ill people may lose fluid because of serious conditions, infections (e.g. sepsis), trauma, or burns, and need additional fluids urgently to prevent dehydration or kidney failure. Colloid or crystalloid solutions may be used for this purpose. Crystalloids have small molecules, are cheap, easy to use, and provide immediate fluid resuscitation, but may increase oedema. Colloids have larger molecules, cost more, and may provide swifter volume expansion in the intravascular space, but may induce allergic reactions, blood clotting disorders, and kidney failure. This is an update of a Cochrane Review last published in 2013. Objectives To assess the effect of using colloids versus crystalloids in critically ill people requiring fluid volume replacement on mortality, need for blood transfusion or renal replacement therapy (RRT), and adverse events (specifically: allergic reactions, itching, rashes). Search methods We searched CENTRAL, MEDLINE, Embase and two other databases on 23 February 2018. We also searched clinical trials registers. Selection criteria We included randomised controlled trials (RCTs) and quasi‐RCTs of critically ill people who required fluid volume replacement in hospital or emergency out‐of‐hospital settings. Participants had trauma, burns, or medical conditions such as sepsis. We excluded neonates, elective surgery and caesarean section. We compared a colloid (suspended in any crystalloid solution) versus a crystalloid (isotonic or hypertonic). Data collection and analysis Independently, two review authors assessed studies for inclusion, extracted data, assessed risk of bias, and synthesised findings. We assessed the certainty of evidence with GRADE. Main results We included 69 studies (65 RCTs, 4 quasi‐RCTs) with 30,020 participants. Twenty‐eight studied starch solutions, 20 dextrans, seven gelatins, and 22 albumin or fresh frozen plasma (FFP); each type of colloid was compared to crystalloids. Participants had a range of conditions typical of critical illness. Ten studies were in out‐of‐hospital settings. We noted risk of selection bias in some studies, and, as most studies were not prospectively registered, risk of selective outcome reporting. Fourteen studies included participants in the crystalloid group who received or may have received colloids, which might have influenced results. We compared four types of colloid (i.e. starches; dextrans; gelatins; and albumin or FFP) versus crystalloids. Starches versus crystalloids We found moderate‐certainty evidence that there is probably little or no difference between using starches or crystalloids in mortality at: end of follow‐up (risk ratio (RR) 0.97, 95% confidence interval (CI) 0.86 to 1.09; 11,177 participants; 24 studies); within 90 days (RR 1.01, 95% CI 0.90 to 1.14; 10,415 participants; 15 studies); or within 30 days (RR 0.99, 95% CI 0.90 to 1.09; 10,135 participants; 11 studies). We found moderate‐certainty evidence that starches probably slightly increase the need for blood transfusion (RR 1.19, 95% CI 1.02 to 1.39; 1917 participants; 8 studies), and RRT (RR 1.30, 95% CI 1.14 to 1.48; 8527 participants; 9 studies). Very low‐certainty evidence means we are uncertain whether either fluid affected adverse events: we found little or no difference in allergic reactions (RR 2.59, 95% CI 0.27 to 24.91; 7757 participants; 3 studies), fewer incidences of itching with crystalloids (RR 1.38, 95% CI 1.05 to 1.82; 6946 participants; 2 studies), and fewer incidences of rashes with crystalloids (RR 1.61, 95% CI 0.90 to 2.89; 7007 participants; 2 studies). Dextrans versus crystalloids We found moderate‐certainty evidence that there is probably little or no difference between using dextrans or crystalloids in mortality at: end of follow‐up (RR 0.99, 95% CI 0.88 to 1.11; 4736 participants; 19 studies); or within 90 days or 30 days (RR 0.99, 95% CI 0.87 to 1.12; 3353 participants; 10 studies). We are uncertain whether dextrans or crystalloids reduce the need for blood transfusion, as we found little or no difference in blood transfusions (RR 0.92, 95% CI 0.77 to 1.10; 1272 participants, 3 studies; very low‐certainty evidence). We found little or no difference in allergic reactions (RR 6.00, 95% CI 0.25 to 144.93; 739 participants; 4 studies; very low‐certainty evidence). No studies measured RRT. Gelatins versus crystalloids We found low‐certainty evidence that there may be little or no difference between gelatins or crystalloids in mortality: at end of follow‐up (RR 0.89, 95% CI 0.74 to 1.08; 1698 participants; 6 studies); within 90 days (RR 0.89, 95% CI 0.73 to 1.09; 1388 participants; 1 study); or within 30 days (RR 0.92, 95% CI 0.74 to 1.16; 1388 participants; 1 study). Evidence for blood transfusion was very low certainty (3 studies), with a low event rate or data not reported by intervention. Data for RRT were not reported separately for gelatins (1 study). We found little or no difference between groups in allergic reactions (very low‐certainty evidence). Albumin or FFP versus crystalloids We found moderate‐certainty evidence that there is probably little or no difference between using albumin or FFP or using crystalloids in mortality at: end of follow‐up (RR 0.98, 95% CI 0.92 to 1.06; 13,047 participants; 20 studies); within 90 days (RR 0.98, 95% CI 0.92 to 1.04; 12,492 participants; 10 studies); or within 30 days (RR 0.99, 95% CI 0.93 to 1.06; 12,506 participants; 10 studies). We are uncertain whether either fluid type reduces need for blood transfusion (RR 1.31, 95% CI 0.95 to 1.80; 290 participants; 3 studies; very low‐certainty evidence). Using albumin or FFP versus crystalloids may make little or no difference to the need for RRT (RR 1.11, 95% CI 0.96 to 1.27; 3028 participants; 2 studies; very low‐certainty evidence), or in allergic reactions (RR 0.75, 95% CI 0.17 to 3.33; 2097 participants, 1 study; very low‐certainty evidence). Authors' conclusions Using starches, dextrans, albumin or FFP (moderate‐certainty evidence), or gelatins (low‐certainty evidence), versus crystalloids probably makes little or no difference to mortality. Starches probably slightly increase the need for blood transfusion and RRT (moderate‐certainty evidence), and albumin or FFP may make little or no difference to the need for renal replacement therapy (low‐certainty evidence). Evidence for blood transfusions for dextrans, and albumin or FFP, is uncertain. Similarly, evidence for adverse events is uncertain. Certainty of evidence may improve with inclusion of three ongoing studies and seven studies awaiting classification, in future updates

‘I enjoyed it because … you could do whatever you wanted and be creative’: three principles for participatory research and pedagogy

The complexity of many children’s lives can result in their ideas being neither understood nor included in mainstream opportunities for learning, particularly children who are living with disadvantage. With a focus on developing ethical and inclusive principles for participatory research and pedagogy, this paper reports on a pilot project where we worked with young, hard-to-reach individuals across four sites in England to enable them to design and carry out research about their experiences and views of disadvantage. Here, we present snapshots of the young participants’ choices of research topics and methods, which reflected their own lives and interests, and led to powerful visualizations of the complexity of child and youth disadvantage. Reflecting back on the project, we discuss effective ways to initiate and sustain participatory research that can enable young researchers to be involved as active and empowered agents at every stage of the research process. We also consider the implications for developing participatory pedagogy, with researchers working alongside educators to create school cultures that foster belonging and genuinely support all students’ expertise and ways of knowing by looking beyond the school buildings and into their lives in the wider community

Turning evidence into recommendations: Protocol of a study guideline development groups

<p>Abstract</p> <p>Background</p> <p>Health care practice based on research evidence requires that evidence is synthesised, and that recommendations based on this evidence are implemented. It also requires an intermediate step: translating synthesised evidence into practice recommendations. There is considerable literature on evidence synthesis and implementation, but little on how guideline development groups (GDGs) produce recommendations. This is a complex process, with many influences on communication and decision-making, <it>e.g</it>., the quality of evidence, methods of presentation, practical/resource constraints, individual values, professional and scientific interests, social and psychological processes. To make this process more transparent and potentially effective, we need to understand these influences. Psychological theories of decision-making and social influence provide a framework for this understanding.</p> <p>Objectives</p> <p>This study aims to investigate the processes by which GDGs formulate recommendations, drawing on psychological theories of decision-making and social influence. The findings will potentially inform the further evolution of GDG methods, such as choice of members and procedures for presenting evidence, conducting discussion and formulating recommendations.</p> <p>Methods</p> <p>Longitudinal observation of the meetings of three National Institute of Health and Clinical Excellence (NICE) GDGs, one from each of acute, mental health and public health, will be tape recorded and transcribed. Interviews with a sample of GDG members at the beginning, middle, and end of the GDG's work will be recorded and transcribed. Site documents including relevant e-mail interchanges, GDG meeting minutes, and stakeholders' responses to the drafts of the recommendations will be collected. Data will be selected for analysis if they refer to either evidence or recommendations; the focus is on "hot spots", <it>e.g</it>., dilemmas, conflicts, and uncertainty. Data will be analysed thematically and by content analysis, drawing on psychological theories of decision-making and social influence.</p

The development and validation of a scoring tool to predict the operative duration of elective laparoscopic cholecystectomy

Background: The ability to accurately predict operative duration has the potential to optimise theatre efficiency and utilisation, thus reducing costs and increasing staff and patient satisfaction. With laparoscopic cholecystectomy being one of the most commonly performed procedures worldwide, a tool to predict operative duration could be extremely beneficial to healthcare organisations. Methods: Data collected from the CholeS study on patients undergoing cholecystectomy in UK and Irish hospitals between 04/2014 and 05/2014 were used to study operative duration. A multivariable binary logistic regression model was produced in order to identify significant independent predictors of long (> 90 min) operations. The resulting model was converted to a risk score, which was subsequently validated on second cohort of patients using ROC curves. Results: After exclusions, data were available for 7227 patients in the derivation (CholeS) cohort. The median operative duration was 60 min (interquartile range 45–85), with 17.7% of operations lasting longer than 90 min. Ten factors were found to be significant independent predictors of operative durations > 90 min, including ASA, age, previous surgical admissions, BMI, gallbladder wall thickness and CBD diameter. A risk score was then produced from these factors, and applied to a cohort of 2405 patients from a tertiary centre for external validation. This returned an area under the ROC curve of 0.708 (SE = 0.013, p  90 min increasing more than eightfold from 5.1 to 41.8% in the extremes of the score. Conclusion: The scoring tool produced in this study was found to be significantly predictive of long operative durations on validation in an external cohort. As such, the tool may have the potential to enable organisations to better organise theatre lists and deliver greater efficiencies in care

The Changing Landscape for Stroke\ua0Prevention in AF: Findings From the GLORIA-AF Registry Phase 2

Background GLORIA-AF (Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation) is a prospective, global registry program describing antithrombotic treatment patterns in patients with newly diagnosed nonvalvular atrial fibrillation at risk of stroke. Phase 2 began when dabigatran, the first non\u2013vitamin K antagonist oral anticoagulant (NOAC), became available. Objectives This study sought to describe phase 2 baseline data and compare these with the pre-NOAC era collected during phase&nbsp;1. Methods During phase 2, 15,641 consenting patients were enrolled (November 2011 to December 2014); 15,092 were eligible. This pre-specified cross-sectional analysis describes eligible patients\u2019 baseline characteristics. Atrial fibrillation&nbsp;disease characteristics, medical outcomes, and concomitant diseases and medications were collected. Data were analyzed using descriptive statistics. Results Of the total patients, 45.5% were female; median age was 71 (interquartile range: 64, 78) years. Patients were from Europe (47.1%), North America (22.5%), Asia (20.3%), Latin America (6.0%), and the Middle East/Africa (4.0%). Most had high stroke risk (CHA2DS2-VASc [Congestive heart failure, Hypertension, Age&nbsp; 6575 years, Diabetes mellitus, previous Stroke, Vascular disease, Age 65 to 74 years, Sex category] score&nbsp; 652; 86.1%); 13.9% had moderate risk (CHA2DS2-VASc&nbsp;= 1). Overall, 79.9% received oral anticoagulants, of whom 47.6% received NOAC and 32.3% vitamin K antagonists (VKA); 12.1% received antiplatelet agents; 7.8% received no antithrombotic treatment. For comparison, the proportion of phase 1 patients (of N&nbsp;= 1,063 all eligible) prescribed VKA was 32.8%, acetylsalicylic acid 41.7%, and no therapy 20.2%. In Europe in phase 2, treatment with NOAC was more common than VKA (52.3% and 37.8%, respectively); 6.0% of patients received antiplatelet treatment; and 3.8% received no antithrombotic treatment. In North America, 52.1%, 26.2%, and 14.0% of patients received NOAC, VKA, and antiplatelet drugs, respectively; 7.5% received no antithrombotic treatment. NOAC use was less common in Asia (27.7%), where 27.5% of patients received VKA, 25.0% antiplatelet drugs, and 19.8% no antithrombotic treatment. Conclusions The baseline data from GLORIA-AF phase 2 demonstrate that in newly diagnosed nonvalvular atrial fibrillation patients, NOAC have been highly adopted into practice, becoming more frequently prescribed than VKA in&nbsp;Europe and North America. Worldwide, however, a large proportion of patients remain undertreated, particularly in&nbsp;Asia&nbsp;and North America. (Global Registry on Long-Term Oral Antithrombotic Treatment in Patients With Atrial Fibrillation [GLORIA-AF]; NCT01468701