Intra-operative blood salvage in total hip and knee arthroplasty

Purpose To review records of 371 patients who underwent total hip or knee arthroplasty (THA or TKA) with intra-operative blood salvage to determine the allogeneic blood transfusion rate and the predictors for allogeneic blood transfusion. Methods Records of 155 male and 216 female consecutive patients aged 17 to 95 (mean, 70) years who underwent primary THA or TKA by a single surgeon with the use of intra-operative blood salvage were reviewed. Results The preoperative haemoglobin level was &lt;120 g/dl in 15% of THA patients and 5% of TKA patients; the allogeneic transfusion rate was 24% in THA patients and 12% in TKA patients. Despite routine use of intra-operative blood salvage, only 59% of THA patients and 63% of TKA patients actually received salvaged blood, as a minimum of 200 ml blood loss was required to activate blood salvage. In multivariable analysis, predictors for allogeneic blood transfusion were female gender (adjusted odds ratio [OR]=2.8, p=0.02), age &gt;75 years (adjusted OR=5.9, p&lt;0.001), and preoperative haemoglobin level &lt;120 g/l (adjusted OR=30.1, p&lt;0.001), despite the use of intra-operative blood salvage. Patients who received allogeneic blood transfusion had a longer hospital stay and greater complication rate. Conclusion Intra-operative blood salvage is not effective in preventing allogeneic blood transfusion in patients with a preoperative haemoglobin level &lt;120 g/l. It should be combined with preoperative optimisation of the haemoglobin level or use of tranexamic acid. </jats:sec

Focus on sharing individual patient data distracts from other ways of improving trial transparency

The International Committee of Medical Journal Editors (ICMJE) recently reiterated its commitment to improving trial transparency by sharing individual patient data from randomised trials.1 2 But, although sharing individual patient data contributes to transparency, it is not sufficient by itself. Trial transparency requires a data sharing package, which begins with trial registration and contains other elements such as protocols, summary results, and other trial materials. Valuable as sharing individual patient data can be,3 discussion about it has hijacked the broader conversation about data sharing and trial transparency.4-6 For example, we identified 76 articles published in the six leading general medical journals that had “data” and “sharing” in their title and were about clinical trials. In 64 (84%) articles, the content was focused on individual patient data and did not mention any of the other components of trial transparency (see appendix on bmj.com). Much of the discussion has focused on the complexities and practical problems associated with sharing individual patient data and on the processes and systems needed for responsible data sharing.6-9 However, many of the data sharing activities that are needed for trial transparency are not complex. We believe that trying to solve the complex issues around availability of individual patient data should not eclipse or distract from a more pressing problem: the unavailability of even summary data and protocols from all controlled trials. Current estimates are that around 85% of research is avoidably “wasted” because of design flaws, poor conduct, non-publication, and poor reporting.10 Focusing efforts and attention on making individual patient data accessible might paradoxically exacerbate this waste in research. We argue that simpler and more cost efficient activities should be prioritised.</p

Prescribable mHealth apps identified from an overview of systematic reviews

AbstractMobile health apps aimed towards patients are an emerging field of mHealth. Their potential for improving self-management of chronic conditions is significant. Here, we propose a concept of “prescribable” mHealth apps, defined as apps that are currently available, proven effective, and preferably stand-alone, i.e., that do not require dedicated central servers and continuous monitoring by medical professionals. Our objectives were to conduct an overview of systematic reviews to identify such apps, assess the evidence of their effectiveness, and to determine the gaps and limitations in mHealth app research. We searched four databases from 2008 onwards and the Journal of Medical Internet Research for systematic reviews of randomized controlled trials (RCTs) of stand-alone health apps. We identified 6 systematic reviews including 23 RCTs evaluating 22 available apps that mostly addressed diabetes, mental health and obesity. Most trials were pilots with small sample size and of short duration. Risk of bias of the included reviews and trials was high. Eleven of the 23 trials showed a meaningful effect on health or surrogate outcomes attributable to apps. In conclusion, we identified only a small number of currently available stand-alone apps that have been evaluated in RCTs. The overall low quality of the evidence of effectiveness greatly limits the prescribability of health apps. mHealth apps need to be evaluated by more robust RCTs that report between-group differences before becoming prescribable. Systematic reviews should incorporate sensitivity analysis of trials with high risk of bias to better summarize the evidence, and should adhere to the relevant reporting guideline.</jats:p

Reference bias: presentation of extreme health states prior to eq-vas improves health-related quality of life scores. a randomised cross-over trial

Background: Clinical practice and clinical research has made a concerted effort to move beyond the use of clinical indicators alone and embrace patient focused care through the use of patient reported outcomes such as healthrelated quality of life. However, unless patients give consistent consideration to the health states that give meaning to measurement scales used to evaluate these constructs, longitudinal comparison of these measures may be invalid. This study aimed to investigate whether patients give consideration to a standard health state rating scale (EQ-VAS) and whether consideration of good and poor health state descriptors immediately changes their selfreport. Methods: A randomised crossover trial was implemented amongst hospitalised older adults (n = 151). Patients were asked to consider descriptions of extremely good (Description-A) and poor (Description-B) health states. The EQ-VAS was administered as a self-report at baseline, after the first descriptors (A or B), then again after the remaining descriptors (B or A respectively). At baseline patients were also asked if they had considered either EQVAS anchors. Results: Overall 106/151 (70%) participants changed their self-evaluation by ≥5 points on the 100 point VAS, with a mean (SD) change of +4.5 (12) points (p < 0.001). A total of 74/151 (49%) participants did not consider the best health VAS anchor, of the 77 who did 59 (77%) thought the good health descriptors were more extreme (better) then they had previously considered. Similarly 85/151 (66%) participants did not consider the worst health anchor of the 66 who did 63 (95%) thought the poor health descriptors were more extreme (worse) then they had previously considered. Conclusions: Health state self-reports may not be well considered. An immediate significant shift in response can be elicited by exposure to a mere description of an extreme health state despite no actual change in underlying health state occurring. Caution should be exercised in research and clinical settings when interpreting subjective patient reported outcomes that are dependent on brief anchors for meaning. Trial Registration: Australian and New Zealand Clinical Trials Registry (#ACTRN12607000606482) http://www.anzctr. org.a

Blood loss in primary total knee arthroplasty-body temperature is not a significant risk factor-a prospective, consecutive, observational cohort study

BACKGROUND: Hypothermia related to anaesthesia and operating theatre environment is associated with increased blood loss in a number of surgical disciplines, including total hip arthroplasty. The influence of patient temperature on blood loss in total knee arthroplasty (TKA) has not been previously studied. METHODS: We recorded patient axillary temperature in the peri-operative period, up to 24 h post-operatively, and analysed the effect on transfusion rate and blood loss from a consecutive cohort of 101 patients undergoing primary TKA. RESULTS: No relationship between peri-operative patient temperature and blood loss was found within the recorded patient temperature range of 34.7–37.8 °C. Multivariable analysis found increasing age, surgical technique, type of anaesthesia and the use of anti-platelet and anticoagulant medications as significant factors affecting blood loss following TKA. CONCLUSION: Patient temperature within a clinically observed range does not have a significant impact on blood loss in primary TKA patients. As long as patient temperature is maintained within a reasonable range during the intra-operative and post-operative periods, strategies other than rigid temperature control above 36.5 °C may be more effective in reducing blood loss following TKA

Educational interventions for the management of cancer-related fatigue in adults

Background: Cancer-related fatigue is reported as the most common and distressing symptom experienced by patients with cancer. It can exacerbate the experience of other symptoms, negatively affect mood, interfere with the ability to carry out everyday activities, and negatively impact on quality of life. Educational interventions may help people to manage this fatigue or to cope with this symptom, and reduce its overall burden. Despite the importance of education for managing cancer-related fatigue there are currently no systematic reviews examining this approach. Objectives: To determine the effectiveness of educational interventions for managing cancer-related fatigue in adults. Search methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), and MEDLINE, EMBASE, CINAHL, PsycINFO, ERIC, OTseeker and PEDro up to 1st November 2016. We also searched trials registries. Selection criteria: We included randomised controlled trials (RCTs) of educational interventions focused on cancer-related fatigue where fatigue was a primary outcome. Studies must have aimed to evaluate the effect of educational interventions designed specifically to manage cancer-related fatigue, or to evaluate educational interventions targeting a constellation of physical symptoms or quality of life where fatigue was the primary focus. The studies could have compared educational interventions with no intervention or wait list controls, usual care or attention controls, or an alternative intervention for cancer-related fatigue in adults with any type of cancer. Data collection and analysis: Two review authors independently screened studies for inclusion and extracted data. We resolved differences in opinion by discussion. Trial authors were contacted for additional information. A third independent person checked the data extraction. The main outcome considered in this review was cancer-related fatigue. We assessed the evidence using GRADE and created a 'Summary of Findings' table. Main results: We included 14 RCTs with 2213 participants across different cancer diagnoses. Four studies used only 'information-giving' educational strategies, whereas the remainder used mainly information-giving strategies coupled with some problem-solving, reinforcement, or support techniques. Interventions differed in delivery including: mode of delivery (face to face, web-based, audiotape, telephone); group or individual interventions; number of sessions provided (ranging from 2 to 12 sessions); and timing of intervention in relation to completion of cancer treatment (during or after completion). Most trials compared educational interventions to usual care and meta-analyses compared educational interventions to usual care or attention controls. Methodological issues that increased the risk of bias were evident including lack of blinding of outcome assessors, unclear allocation concealment in over half of the studies, and generally small sample sizes. Using the GRADE approach, we rated the quality of evidence as very low to moderate, downgraded mainly due to high risk of bias, unexplained heterogeneity, and imprecision. There was moderate quality evidence of a small reduction in fatigue intensity from a meta-analyses of eight studies (1524 participants; standardised mean difference (SMD) -0.28, 95% confidence interval (CI) -0.52 to -0.04) comparing educational interventions with usual care or attention control. We found low quality evidence from twelve studies (1711 participants) that educational interventions had a small effect on general/overall fatigue (SMD -0.27, 95% CI -0.51 to -0.04) compared to usual care or attention control. There was low quality evidence from three studies (622 participants) of a moderate size effect of educational interventions for reducing fatigue distress (SMD -0.57, 95% CI -1.09 to -0.05) compared to usual care, and this could be considered clinically significant. Pooled data from four studies (439 participants) found a small reduction in fatigue interference with daily life (SMD -0.35, 95% CI -0.54 to -0.16; moderate quality evidence). No clear effects on fatigue were found related to type of cancer treatment or timing of intervention in relation to completion of cancer treatment, and there were insufficient data available to determine the effect of educational interventions on fatigue by stage of disease, tumour type or group versus individual intervention. Three studies (571 participants) provided low quality evidence for a reduction in anxiety in favour of the intervention group (mean difference (MD) -1.47, 95% CI -2.76 to -0.18) which, for some, would be considered clinically significant. Two additional studies not included in the meta-analysis also reported statistically significant improvements in anxiety in favour of the educational intervention, whereas a third study did not. Compared with usual care or attention control, educational interventions showed no significant reduction in depressive symptoms (four studies, 881 participants, SMD -0.12, 95% CI -0.47 to 0.23; very low quality evidence). Three additional trials not included in the meta-analysis found no between-group differences in the symptoms of depression. No between-group difference was evident in the capacity for activities of daily living or physical function when comparing educational interventions with usual care (4 studies, 773 participants, SMD 0.33, 95% CI -0.10 to 0.75) and the quality of evidence was low. Pooled evidence of low quality from two of three studies examining the effect of educational interventions compared to usual care found an improvement in global quality of life on a 0-100 scale (MD 11.47, 95% CI 1.29 to 21.65), which would be considered clinically significant for some. No adverse events were reported in any of the studies. Authors' conclusions: Educational interventions may have a small effect on reducing fatigue intensity, fatigue's interference with daily life, and general fatigue, and could have a moderate effect on reducing fatigue distress. Educational interventions focused on fatigue may also help reduce anxiety and improve global quality of life, but it is unclear what effect they might have on capacity for activities of daily living or depressive symptoms. Additional studies undertaken in the future are likely to impact on our confidence in the conclusions. The incorporation of education for the management of fatigue as part of routine care appears reasonable. However, given the complex nature of this symptom, educational interventions on their own are unlikely to optimally reduce fatigue or help people manage its impact, and should be considered in conjunction with other interventions. Just how educational interventions are best delivered, and their content and timing to maximise outcomes, are issues that require further research

Resistance decay in individuals after antibiotic exposure in primary care: A systematic review and meta-analysis

Abstract Background Antibiotic resistance is an urgent global problem, but reversibility is poorly understood. We examined the development and decay of bacterial resistance in community patients after antibiotic use. Methods This was a systematic review and meta-analysis. PubMed, EMBASE and CENTRAL (from inception to May 2017) were searched, with forward and backward citation searches of the identified studies. We contacted authors whose data were unclear, and of abstract-only reports, for further information. We considered controlled or times-series studies of patients in the community who were given antibiotics and where the subsequent prevalence of resistant bacteria was measured. Two authors extracted risk of bias and data. The meta-analysis used a fixed-effects model. Results Of 24,492 articles screened, five controlled and 20 time-series studies (total 16,353 children and 1461 adults) were eligible. Resistance in Streptococcus pneumoniae initially increased fourfold after penicillin-class antibiotic exposure [odds ratio (OR) 4.2, 95% confidence interval (CI) 3.5–5.4], but this fell after 1 month (OR 1.7, 95% CI 1.3–2.1). After cephalosporin-class antibiotics, resistance increased (OR 2.2, 95%CI 1.7-2.9); and fell to (OR 1.6, 95% CI 1.2-2.3) at 1 month. After macrolide-class antibiotics, resistance increased (OR 3.8, 95% CI 1.9–7.6) and persisted for 1 month (OR 5.2, 95% CI 2.6–10.3) and 3 months (OR 8.1, 95% CI 4.6–14.2, from controlled studies and OR 2.3, 95% CI 0.6–9.4, from time-series studies). Resistance in Haemophilus influenzae after penicillins was not significantly increased (OR 1.3, 95% CI 0.9–1.9) initially but was at 1 month (OR 3.4, 95% CI 1.5–7.6), falling after 3 months (OR 1.0, 95% CI 0.5–2.2). Data were sparse for cephalosporins and macrolides. Resistance in Enterobacter increased post-exposure (OR 3.2, 95% CI 0.9–10.8, from controlled studies and OR 7.1, 95% CI 4.2–12, from time-series studies], but was lower after 1 month (OR 1.8, 95% CI 0.9–3.6). Conclusions Resistance generally increased soon after antibiotic use. For some antibiotic classes and bacteria, it partially diminished after 1 and 3 months, but longer-term data are lacking and urgently needed. Trial registration PROSPERO CRD42015025499