A protocol for a prospective, multicentre observational study to determine if nonanaemic iron deficiency worsens postoperative outcome in patients undergoing elective surgery for resection of colorectal cancer: The NATO study.

BACKGROUND: Preoperative absolute and functional iron deficiency anaemia is associated with poor postoperative outcomes in patients undergoing surgery for colorectal cancer. It is biologically plausible that "early", or "nonanaemic" iron deficiency may also be associated with worse postoperative outcomes in similar cohorts, albeit at lesser severity than that seen for anaemia. The evidence supporting this assertion is of low quality. METHODS: We have designed a prospective, observational study to delineate associations between preoperative non-anaemic iron deficiency and postoperative outcomes after surgery for colorectal cancer. Patients without anaemia, undergoing elective surgery for colorectal cancer will be allocated to an iron replete or an iron deficient group based on preoperative transferrin saturation. The primary outcome is days alive and at home on postoperative day 90. Secondary outcomes include days alive and at home on postoperative day 30, length of hospital stay, readmission to acute care, postoperative complications, health-related quality of life scores, quality of postoperative recovery, and requirement for allogeneic blood transfusion. The planned sample size is 422 patients, which has 80% power to detect a two-day difference in the primary outcome. The study commenced in May 2019. CONCLUSION: The results of this study will provide patients and clinicians with high-quality evidence concerning associations between nonanaemic iron deficiency and patient-centred outcomes after surgery for colorectal cancer. The study will be conducted in multiple urban and rural centres across Australia and New Zealand. The results will be highly generalisable to contemporary surgical practice and should be rapidly translated.

The epidemiology of rapid response team activation amongst patients undergoing major gastrointestinal surgery.

BACKGROUND: Clinical deterioration requiring rapid response team (RRT) review is associated with increased morbidity amongst hospitalised patients. The frequency of and association with RRT calls in patients undergoing major gastrointestinal surgery is unknown. Understanding the epidemiology of RRT calls might identify areas for quality improvement in this cohort. OBJECTIVES: The objective of this study is to identify perioperative risks and outcome associations with RRT review following major gastrointestinal surgery. METHODS: We conducted a retrospective cohort study using electronic databases at a large Australian university hospital. We included adult patients admitted for major gastrointestinal surgery between 1 January 2015 and 31 March 2018. RESULTS: Of 7158 patients, 514 (7.4%) required RRT activation postoperatively. After adjustment, variables associated with RRT activation included the following: hemiplegia/paraplegia (odds ratio [OR]: 8.0, 95% confidence interval [CI]: 2.3 to 27.8, p = 0.001), heart failure (OR: 6.9, 95% CI: 3.3 to 14.6, p < 0.001), peripheral vascular disease (OR: 5.3, 95% CI: 2.7 to 10.4, p < 0.001), peptic ulcer disease (OR: 4.2, 95% CI: 2.2 to 8.0, p < 0.001), chronic obstructive pulmonary disease (OR: 4.0, 95% CI: 2.2 to 7.2, p < 0.001), and emergency admission status (OR: 2.6, 95% CI: 2.1 to 3.3, p < 0.001). Following the index operation, 46% of first RRT activations occurred within 24 h of surgery and 61% had occurred within 48 h. The most common triggers for RRT activation were tachycardia, hypotension, and tachypnoea. Postoperative RRT activation was associated with in-hospital mortality (OR: 6.7, 95% CI: 3.8 to 11.8, p < 0.001), critical care admission (incidence rate ratio: 8.18, 95% CI: 5.23 to 12.77, p < 0.001), and longer median length of hospital stay (12 days vs. 2 days, p < 0.001) compared to no RRT activation. CONCLUSION: After major gastrointestinal surgery, one in 14 patients had an RRT activation, almost half within 24 h of surgery. Such activation was independently associated with increased morbidity and mortality. Identified associations may guide more pre-emptive management for those at an increased risk of RRT activation.

Inclusion, characteristics, and outcomes of male and female participants in large international perioperative studies.

BACKGROUND: We compared baseline characteristics and outcomes and evaluated the subgroup effects of randomised interventions by sex in males and females in large international perioperative trials. METHODS: Nine randomised trials and two cohort studies recruiting adult patients, conducted between 1995 and 2020, were included. Baseline characteristics and outcomes common to six or more studies were evaluated. Regression models included terms for sex, study, and an interaction between the two. Comparing outcomes without adjustment for baseline characteristics represents the 'total effect' of sex on the outcome. RESULTS: Of 54 626 participants, 58% were male and 42% were female. Females were less likely to have ASA physical status ≥3 (56% vs 64%), to smoke (15% vs 23%), have coronary artery disease (21% vs 32%), or undergo vascular surgery (10% vs 23%). The pooled incidence of death was 1.6% in females and 1.8% in males (risk ratio [RR] 0.92; 95% confidence interval [CI]: 0.81-1.05; P=0.20), of myocardial infarction was 4.2% vs 4.5% (RR 0.92; 95% CI: 0.81-1.03; P=0.10), of stroke was 0.5% vs 0.6% (RR 1.03; 95% CI: 0.79-1.35; P=0.81), and of surgical site infection was 8.6% vs 8.3% (RR 1.03; 95% CI: 0.79-1.35; P=0.70). Treatment effects of three interventions demonstrated statistically significant effect modification by sex. CONCLUSIONS: Females were in the minority in all included studies. They were healthier than males, but outcomes were comparable. Further research is needed to understand the reasons for this discrepancy. CLINICAL TRIAL REGISTRATION: International Registry of Meta-Research (UID: IRMR_000011; 5 January 2021).

Postoperative anaemia and patient-centred outcomes after major abdominal surgery: a retrospective cohort study.

BACKGROUND: Compared with anaemia before surgery, the underlying pathogenesis and implications of postoperative anaemia are largely unknown. METHODS: This retrospective cohort study analysed prospective data obtained from 2983 adult patients across 47 centres enrolled in a clinical trial evaluating restrictive and liberal intravenous fluids. The primary endpoint was persistent disability or death up to 90 days after surgery. Secondary endpoints included major septic complications, hospital stay, and patient quality of recovery using a 15-item quality of recovery (QoR-15) score, hospital re-admissions, and disability-free survival up to 12 months after surgery. Anaemia and disability were defined according to the WHO definitions. Multivariable regression was used to adjust for baseline risk and surgery. RESULTS: A total of 2983 patients met inclusion criteria for this study, of which 78.5% (95% confidence interval [CI], 76.7-80.1%) had postoperative anaemia. Patients with postoperative anaemia had a higher adjusted risk of death or disability up to 90 days after surgery when compared with those without anaemia: 18.2% vs 9.2% (risk ratio [RR]=1.51; 95% CI, 1.10-2.07, P=0.011); lower QoR-15 scores on Day 3 and Day 30, 105 (95% CI, 87-119) vs 114 (95% CI, 99-128; P<0.001), and 130 (95% CI, 112-140) vs 139 (95% CI, 121-144; P<0.011), respectively; higher adjusted risk of a composite of mortality/septic complications, 2.01 (95% CI, 1.55-42.67; P<0.001); unplanned admission to ICU (RR=2.65; 95% CI, 1.65-4.23; P<0.001); and longer median (inter-quartile range [IQR]) hospital stays, 6.6 (4.4-12.4) vs 3.7 (2.5-6.5) days (P<0.001). CONCLUSIONS: Postoperative anaemia is common and is independently associated with poor outcomes after surgery. Optimal prevention and treatment strategies need to be investigated. CLINICAL TRIAL REGISTRATION: NCT04978285 (ClinicalTrials.gov).

Accuracy of the Clinical Frailty Scale for perioperative frailty screening: a prospective observational study.

PURPOSE: Perioperative frailty increases postoperative complications, mortality, and new functional dependence. Despite this, routine perioperative frailty screening is not widespread. We aimed to assess the accuracy of the Clinical Frailty Scale (CFS) as a screening tool prior to anesthesia, and to determine which health domains are affected by frailty. METHODS: In a prospective, single-centre observational study, we enrolled 218 patients aged ≥ 65 yr undergoing elective and emergency surgery. The screening performance of the CFS was compared with the Edmonton Frail Scale, including the effect in individual frailty domains, and outcomes including discharge location and mortality. RESULTS: The median [interquartile range] age of the enrolled subjects was 74 [69-80] yr and 24% of the patients were frail. The CFS and Edmonton scales were highly correlated (Spearman correlation coefficient, 0.81; 95% confidence interval [CI], 0.77 to 0.86), and in substantial agreement (kappa coefficient, 0.76; 95% CI, 0.70 to 0.81), with an area under the receiver operating characteristic curve of 0.91 (95% CI, 0.86 to 0.94) indicating excellent discrimination for the CFS in predicting frailty status based on the Edmonton scale. Frail patients had higher 30-day mortality (odds ratio, 5.26; 95% CI, 1.28 to 21.62), and were less likely to be discharged home. Frail patients had poorer health throughout frailty domains, including functional dependence (42% of frail vs 4% of non-frail patients; P < 0.001), malnutrition (48% vs 19%, P < 0.001), and poor physical performance (47% vs 7%, P < 0.001). CONCLUSION: The CFS is a valid and accurate tool to screen for perioperative frailty, which encompasses the spectrum of health-related domains.

RéSUMé: OBJECTIF: La fragilité périopératoire augmente les complications postopératoires, la mortalité et une nouvelle dépendance fonctionnelle. Le dépistage de routine de la fragilité périopératoire n'est cependant pas une pratique répandue. Nous avions pour objectif d'évaluer la précision de l'échelle de mesure de fragilité CFS (pour Clinical Frailty Scale) comme outil de dépistage préanesthésique et de déterminer quels domaines de la santé étaient affectés par la fragilité. MéTHODE: Nous avons recruté 218 patients âgés de plus de 65 ans et subissant une chirurgie non urgente ou urgente dans notre étude observationnelle prospective et monocentrique. Les résultats du dépistage de la CFS ont été comparés à l'échelle de fragilité d'Edmonton (Edmonton Frail Scale), y compris en ce qui a trait à l'effet de la fragilité sur les domaines individuels de fragilité et aux résultats tels que la destination au congé et la mortalité. RéSULTATS: L'âge médian [écart interquartile] des patients recrutés était de 74 [69­80] ans et 24 % des patients étaient fragiles. Les échelles CFS et d'Edmonton avaient une forte corrélation (coefficient de corrélation de Spearman, 0,81; intervalle de confiance [IC] 95 %, 0,77 à 0,86) et étaient en accord substantiel (coefficient kappa, 0,76; IC 95 %, 0,70 à 0,81), avec une surface sous la courbe de fonction d'efficacité de l'observateur de 0,91 (IC 95 %, 0,86 à 0,94), indiquant une discrimination excellente de la CFS pour prédire l'état de fragilité fondé sur l'échelle d'Edmonton. Les patients fragiles souffraient d'une mortalité à 30 jours plus élevée (rapport de cotes, 5,26; IC 95 %, 1,28 à 21,62) et il était moins probable qu'ils reçoivent leur congé de l'hôpital à la maison. Les patients fragiles étaient en moins bonne santé dans tous les domaines de fragilité, notamment en dépendance fonctionnelle (42 % des patients fragiles vs 4 % des patients non fragiles; P < 0,001), en malnutrition (48 % vs 19 %, P < 0,001) et en mauvaise performance physique (47 % vs 7 %, P < 0,001). CONCLUSION: L'échelle CFS constitue un outil valable et précis pour dépister la fragilité périopératoire, qui englobe l'éventail des domaines liés à la santé.

Survey Research.

Surveys provide evidence on practice, attitudes, and knowledge. However, conducting good survey research is harder than it looks. The authors aim to provide guidance to both researchers and readers in conducting and interpreting survey research. Like all research, surveys should have clear research question(s) using the smallest possible number of high-quality, essential, survey questions (items) that will interest the target population. Both researchers and readers should put themselves in the position of the respondents. The survey questions should provide reproducible results (reliable), measure what they are supposed to measure (valid), and take less than 10 min to answer. Good survey research reports provide results with valid and reliable answers to the research question with an adequate response rate (at least 40%) and adequate precision (margin of error ideally 5% or less). Possible biases among those who did not respond (nonresponders) must be carefully analyzed and discussed. Quantitative results can be combined with qualitative results in mixed-methods research to provide greater insight.

Surgical nurses' perceptions and experiences of a medications and oral restrictions policy change: A focus group study.

AIMS AND OBJECTIVES: To explore the perceptions and experiences of surgical nurses before and after introducing the Medications and Oral Restrictions Policy (the Policy). BACKGROUND: The Policy was developed following extensive consultation, and evidence-based strategies were considered for its implementation. However, it is possible uptake did not meet expectations. DESIGN: Focus group interviews. METHODS: Three focus groups were conducted in November 2015 around 'what worked, what didn't and why, before and after hospital-wide implementation of the Policy.' Data were coded and analysed using an inductive-deductive thematic analysis approach. The COREQ checklist guided reporting. RESULTS: The three groups consisted of 16, 14 and six surgical nurses. Before the Policy, there was confusion, lack of clarity and guidance, and lack of experience and confidence in managing medications when patients had oral restrictions. After the Policy rollout, there was a sense of 'knowing what to do' because of improved clarity and decision support; but there were also problems with: not everyone knowing about the policy, particularly due to staff movement and turnover; and, individual interpretation of the policy including use of its signs outside of context, and decision-making processes. CONCLUSION: Exploration of nurses' perceptions of a medication-related policy change found that while the Policy provided clarity and decision support for some, it made little difference for others. Limited reach of the policy was an issue despite an effort to address this at the outset, as well as variations in interpretation of the policy and subsequent decision-making. RELEVANCE TO CLINICAL PRACTICE: How individuals interpret information and their understanding of the context behind the policy or guideline may affect implementation and should be considered alongside other barriers when implementing medication-related initiatives. Furthermore, implementation strategies that are independent of ongoing resources and/or key champions to sustain should be prioritised for all initiatives.

Agreement in hemodynamic monitoring during orthotopic liver transplantation: a comparison of FloTrac/Vigileo at two monitoring sites with pulmonary artery catheter thermodilution.

To study agreement in cardiac index (CI), systemic vascular resistance index (Systemic VRI) and stroke volume variation (SV variation) between the FloTrac/Vigileo at radial and femoral arterial cannulation sites, and pulmonary artery catheter (PAC) thermodilution, in patients undergoing orthotopic liver transplantation. A prospective observational study of 25 adult patients with liver failure. Radial and femoral arteries were cannulated with standardised FloTrac/Vigileo arterial transducer kits and a PAC was inserted. CI, SV variation and Systemic VRI were measured four times (30 min after induction of anesthesia, 30 min after portal vein clamping, 30 min after graft reperfusion, 30 min after commencement of bile duct anastomosis). The bias, precision, limits of agreement (LOA) and percentage errors were calculated using Bland-Altman statistics to compare measurements from radial and femoral arterial cannulation sites and PAC thermodilution. Neither radial nor femoral CI achieved acceptable agreement with PAC CI [radial to PAC bias (SD) 1.17 (1.49) L/min/m2, percentage error 64.40 %], [femoral to PAC bias (SD) -0.71 (1.81) L/min/m2, percentage error 74.20 %]. Agreement between radial and femoral sites for CI [mean difference (SD) -0.43 (1.51) L/min/m2, percentage error 70.40 %] and Systemic VRI [mean difference (SD) 0.03 (4.17) LOA ±8.17 mmHg min m2/L] were also unacceptable. Agreement in SV variation between radial and femoral measurement sites approached a clinically acceptable threshold [mean difference (SD) 0.68 (2.44) %), LOA ±4.78 %]. FloTrac/Vigileo CI cannot substitute for PAC thermodilution CI, regardless of measurement site. SV variation measurements may be interchangeable between radial and femoral sites for determining fluid responsiveness.