Systematic development and feasibility testing of a multibehavioural digital prehabilitation intervention for patients approaching major surgery (iPREPWELL): A study protocol.

Improving outcomes for people undergoing major surgery, specifically reducing perioperative morbidity and mortality remains a global health challenge. Prehabilitation involves the active preparation of patients prior to surgery, including support to tackle risk behaviours that mediate and undermine physical and mental health and wellbeing. The majority of prehabilitation interventions are delivered in person, however many patients express a preference for remotely-delivered interventions that provide them with tailored support and the flexibility. Digital prehabilitation interventions offer scalability and have the potential to benefit perioperative healthcare systems, however there is a lack of robustly developed and evaluated digital programmes for use in routine clinical care. We aim to systematically develop and test the feasibility of an evidence and theory-informed multibehavioural digital prehabilitation intervention 'iPREPWELL' designed to prepare patients for major surgery. The intervention will be developed with reference to the Behaviour Change Wheel, COM-B model, and the Theoretical Domains Framework. Codesign methodology will be used to develop a patient intervention and accompanying training intervention for healthcare professionals. Training will be designed to enable healthcare professionals to promote, support and facilitate delivery of the intervention as part of routine clinical care. Patients preparing for major surgery and healthcare professionals involved with their clinical care from two UK National Health Service centres will be recruited to stage 1 (systematic development) and stage 2 (feasibility testing of the intervention). Participants recruited at stage 1 will be asked to complete a COM-B questionnaire and to take part in a qualitative interview study and co-design workshops. Participants recruited at stage 2 (up to twenty healthcare professionals and forty participants) will be asked to take part in a single group intervention study where the primary outcomes will include feasibility, acceptability, and fidelity of intervention delivery, receipt, and enactment. Healthcare professionals will be trained to promote and support use of the intervention by patients, and the training intervention will be evaluated qualitatively and quantitatively. The multifaceted and systematically developed intervention will be the first of its kind and will provide a foundation for further refinement prior to formal efficacy testing.

Fit4Surgery for cancer patients during covid-19 lockdown - A systematic review and meta-analysis.

BACKGROUND: Prehabilitation is a promising method to enhance postoperative recovery, especially in patients suffering from cancer. Particularly during times of social distancing, providing home-based programmes may have become a suitable solution to increase compliance and effectiveness. METHODS: In line with the PRISMA guidelines, a systematic review was conducted including trials that investigated the effect of home-based prehabilitation (HBP) in patients undergoing surgery for cancer. The primary outcome was postoperative functional capacity (6 min walk test, 6MWT). Secondary outcomes were postoperative complications and compliance. RESULTS: Five randomized controlled trials were included with 351 patients undergoing surgery for colorectal cancer, oesophagogastric cancer, bladder cancer and non-small cell lung cancer. Three studies presented results of significant progress after eight weeks. The meta-analysis showed a significant improvement of the 6MWT in the prehabilitation group compared to the control group preoperatively (MD 35.06; 95% CI 11.58 to 58.54; p = .003) and eight weeks postoperatively (MD 44.91; 95% CI 6.04 to 83.79; p = .02) compared to baseline. Compliance rate varied from 63% to 83% with no significant difference between prehabilitation and control groups. These data must be interpreted with caution because of a high amount of heterogeneity and small sample sizes. DISCUSSION: In conclusion, HBP may enhance overall functional capacity of patients receiving oncological surgery compared to standard of care. This could be a promising alternative to hospital-based prehabilitation regarding the current pandemic and further digitalization in the future. In order to increase accessibility and effectiveness of prehabilitation, home-based solutions should be further investigated.

Peri-operative COVID-19 infection in urgent elective surgery during a pandemic surge period: a retrospective observational cohort study.

Maintaining safe elective surgical activity during the global coronavirus disease 2019 (COVID-19) pandemic is challenging and it is not clear how COVID-19 may impact peri-operative morbidity and mortality in this population. Therefore, adaptations to normal care pathways are required. Here, we establish if implementation of a bespoke peri-operative care bundle for urgent elective surgery during a pandemic surge period can deliver a low COVID-19-associated complication profile. We present a single-centre retrospective cohort study from a tertiary care hospital of patients planned for urgent elective surgery during the initial COVID-19 surge in the UK between 29 March and 12 June 2020. Patients asymptomatic for COVID-19 were screened by oronasal swab and chest imaging (chest X-ray or computed tomography if aged ≥ 18 years), proceeding to surgery if negative. COVID-19 positive patients at screening were delayed. Postoperatively, patients transitioning to COVID-19 positive status by reverse transcriptase polymerase chain reaction testing were identified by an in-house tracking system and monitored for complications and death within 30 days of surgery. Out of 557 patients referred for surgery (230 (41.3%) women; median (IQR [range]) age 61 (48-72 [1-89])), 535 patients (96%) had COVID-19 screening, of which 13 were positive (2.4%, 95%CI 1.4-4.1%). Out of 512 patients subsequently undergoing surgery, 7 (1.4%) developed COVID-19 positive status (1.4%, 95%CI 0.7-2.8%) with one COVID-19-related death (0.2%, 95%CI 0.0-1.1%) within 30 days. Out of these seven patients, four developed pneumonia, of which two required invasive ventilation including one patient with acute respiratory distress syndrome. Low rates of COVID-19 infection and mortality in the elective surgical population can be achieved within a targeted care bundle. This should provide reassurance that elective surgery can continue, where possible, despite high community rates of COVID-19.

A cohort study investigating the relationship between patient reported outcome measures and pre-operative frailty in patients with operable, non-palliative colorectal cancer.

BACKGROUND: Frailty refers to the reduction in homeostatic reserve resulting from an accumulation of physiological deficits over a lifetime. Frailty is common in older patients undergoing surgery and is an independent risk factor for post-operative mortality, morbidity and increased length of hospital stay. In frail individuals, stressors, such as surgery, can precipitate an acute deterioration in health, manifesting as delirium, falls, reduction in mobility or continence, rendering these individuals at an increased risk of adverse perioperative outcomes. However, little is known about how frailty affects the patient experience, functional ability and quality of life (QoL) after surgery. In addition, the distribution of frailty in this population is unknown. METHODS: We will conduct a multi-centre observational trial to investigate the relationship between patient reported outcome measures and preoperative frailty. We aim to recruit approximately two-hundred patients with operable, potentially curative colorectal cancer. Eligible patients will be identified at three hospital sites. QoL and functional ability (measured using EORTC QLQ-C30 and WHO-DAS 2.0 respectively) will be recorded at the pre-operative assessment clinic, and at 6 and 12 weeks postoperatively. Frailty scores including the Edmonton Frail Scale (EFS) and Rockwood clinical frailty scale (CFS) will be calculated both preoperatively, and at 12 weeks post-operatively. Secondary outcome measures including post-operative morbidity and mortality will be measured using Clavien Dindo classification and 90-day mortality. DISCUSSION: This observational feasibility study seeks to define the prevalence of frailty in older (> 65 years) colorectal cancer patients and understand how frailty impacts on patient reported outcome measures. This information will help to inform larger studies relating to treatment decision algorithms and promote shared decision making in this population.

Exploring patient attitudes to behaviour change before surgery to reduce peri-operative risk: preferences for short- vs. long-term behaviour change.

Pre-operative intervention to improve general health and readiness for surgery is known as prehabilitation. Modification of risk factors such as physical inactivity, smoking, hazardous alcohol consumption and an unhealthy weight can reduce the risk of peri-operative morbidity and improve patient outcomes. Interventions may need to target multiple risk behaviours. The acceptability to patients is unclear. We explored motivation, confidence and priority for changing health behaviours before surgery for short-term peri-operative health benefits in comparison with long-term general health benefits. A total of 299 participants at three UK hospital Trusts completed a structured questionnaire. We analysed participant baseline characteristics and risk behaviour profiles using independent sample t-tests and odds ratios. Ratings of motivation, confidence and priority were analysed using paired sample t-tests. We identified a substantial prevalence of risk behaviours in this surgical population, and clustering of multiple behaviours in 42.1% of participants. Levels of motivation, confidence and priority for increasing physical activity, weight management and reducing alcohol consumption were higher for peri-operative vs. longer term benefits. There was no difference for smoking cessation, and participants reported lower confidence for achieving this compared with other behaviours. Participants were also more confident than motivated in reducing their alcohol consumption pre-operatively. Overall, confidence ratings were lower than motivation levels in both the short- and long-term. This study identifies both substantial patient desire to modify behaviours for peri-operative benefit and the need for structured pre-operative support. These results provide objective evidence in support of a 'pre-operative teachable moment', and of patients' desire to change behaviours for health benefits in the short term.

Reliability of repeated arm-crank cardiopulmonary exercise tests in patients with small abdominal aortic aneurysm.

Arm-crank ergometry may be useful in patients unable to pedal, for instance due to peripheral arterial disease. Twenty participants with small abdominal aortic aneurysm undertook two serial arm-crank tests and then a pedal test, four of whom had indeterminate anaerobic thresholds, precluding analysis. The mean (SD) peak arm and leg oxygen consumptions in 16 participants were 13.71 (2.62) ml.kg-1 .min-1 and 16.82 (4.44) ml.kg-1 .min-1 , with mean (SD) individual differences of 3.11 (2.48) ml.kg-1 .min-1 , p = 0.0001. The respective values at the anaerobic thresholds were 7.83 (1.58) ml O2 .kg-1 .min-1 and 10.09 (3.15) ml O2 .kg-1 .min-1 , with mean (SD) individual differences of 2.26 (2.34) ml O2 .kg-1 .min-1 , p = 0.0001. The correlation coefficients (95%CI) for peak oxygen consumption and anaerobic threshold were 0.88 (0.62-1.0) and 0.70 (0.32-1.0). There were no significant differences in serial arm-crank tests, with intracluster correlations (95%CI) of 0.87 (0.86-0.88) and 0.65 (0.61-0.69) for peak oxygen consumption and anaerobic threshold, respectively.

Perioperative cardiopulmonary exercise testing (CPET): consensus clinical guidelines on indications, organization, conduct, and physiological interpretation.

The use of perioperative cardiopulmonary exercise testing (CPET) to evaluate the risk of adverse perioperative events and inform the perioperative management of patients undergoing surgery has increased over the last decade. CPET provides an objective assessment of exercise capacity preoperatively and identifies the causes of exercise limitation. This information may be used to assist clinicians and patients in decisions about the most appropriate surgical and non-surgical management during the perioperative period. Information gained from CPET can be used to estimate the likelihood of perioperative morbidity and mortality, to inform the processes of multidisciplinary collaborative decision making and consent, to triage patients for perioperative care (ward vs critical care), to direct preoperative interventions and optimization, to identify new comorbidities, to evaluate the effects of neoadjuvant cancer therapies, to guide prehabilitation and rehabilitation, and to guide intraoperative anaesthetic practice. With the rapid uptake of CPET, standardization is key to ensure valid, reproducible results that can inform clinical decision making. Recently, an international Perioperative Exercise Testing and Training Society has been established (POETTS www.poetts.co.uk) promoting the highest standards of care for patients undergoing exercise testing, training, or both in the perioperative setting. These clinical cardiopulmonary exercise testing guidelines have been developed by consensus by the Perioperative Exercise Testing and Training Society after systematic literature review. The guidelines have been endorsed by the Association of Respiratory Technology and Physiology (ARTP).

Clinical guideline and recommendations on pre-operative exercise training in patients awaiting major non-cardiac surgery.

Despite calls for the routine implementation of pre-operative exercise programmes to optimise patient fitness before elective major surgery, there is no practical guidance for providing safe and effective exercise in this specific context. The following clinical guideline was developed following a review of the evidence on the effects of pre-operative exercise interventions. We developed a series of best-practice and, where possible, evidence-based statements to advise on patient care with respect to exercise training in the peri-operative period. These statements cover: patient selection for exercise training in surgical patients; integration of exercise training into multi-modal prehabilitation programmes; and advice on exercise prescription factors and follow-up. Although we acknowledge that further research is needed to identify the optimal exercise prescription in different clinical scenarios, we urge peri-operative teams to make use of these recommendations.

Randomized feasibility trial of high-intensity interval training before elective abdominal aortic aneurysm repair.

BACKGROUND: This study assessed the feasibility of a preoperative high-intensity interval training (HIT) programme in patients awaiting elective abdominal aortic aneurysm repair. METHODS: In this feasibility trial, participants were allocated by minimization to preoperative HIT or usual care. Patients in the HIT group were offered three exercise sessions per week for 4 weeks, and weekly maintenance sessions if surgery was delayed. Feasibility and acceptability outcomes were: rates of screening, eligibility, recruitment, retention, outcome completion, adverse events and adherence to exercise. Data on exercise enjoyment (Physical Activity Enjoyment Scale, PACES), cardiorespiratory fitness (anaerobic threshold and peak oxygen uptake), quality of life, postoperative morbidity and mortality, duration of hospital stay and healthcare utilization were also collected. RESULTS: Twenty-seven patients were allocated to HIT and 26 to usual care (controls). Screening, eligibility, recruitment, retention and outcome completion rates were 100 per cent (556 of 556), 43·2 per cent (240 of 556), 22·1 per cent (53 of 240), 91 per cent (48 of 53) and 79-92 per cent respectively. The overall exercise session attendance rate was 75·8 per cent (276 of 364), and the mean(s.d.) PACES score after the programme was 98(19) ('enjoyable'); however, the intensity of exercise was generally lower than intended. The mean anaerobic threshold after exercise training (adjusted for baseline score and minimization variables) was 11·7 ml per kg per min in the exercise group and 11·4 ml per kg per min in controls (difference 0·3 (95 per cent c.i. -0·4 to 1·1) ml per kg per min). There were trivial-to-small differences in postoperative clinical and patient-reported outcomes between the exercise and control groups. CONCLUSION: Despite the intensity of exercise being generally lower than intended, the findings support the feasibility and acceptability of both preoperative HIT and the trial procedures. A definitive trial is warranted. Registration number: ISRCTN09433624 ( https://www.isrctn.com/).

Do first impressions count? Frailty judged by initial clinical impression predicts medium-term mortality in vascular surgical patients.

Recognising frailty during pre-operative assessment is important. Frail patients experience higher mortality rates and are less likely to return to baseline functional status following the physiological insult of surgery. We evaluated the association between an initial clinical impression of frailty and all-cause mortality in 392 patients attending our vascular pre-operative assessment clinic. Prevalence of frailty assessed by the initial clinical impression was 30.6% (95% CI 26.0-35.2%). There were 133 deaths in 392 patients over a median follow-up period of 4 years. Using Cox regression, adjusted for age, sex, revised cardiac risk index and surgery (yes/no), the hazard ratio for mortality for frail vs. not-frail was 2.14 (95% CI 1.51-3.05). The time to 20% mortality was 16 months in the frail group and 33 months in the not-frail group. The initial clinical impression is a useful screening tool to identify frail patients in pre-operative assessment.

Cross-sectional Association between Walking Pace and Sleep-disordered Breathing.

Sleep-disordered breathing is an important comorbidity for several diseases, including stroke. Initial screening tools comprise simple yes/no questions about known risk factors for sleep-disordered breathing, e.g., obesity, sex. But walking speed has not been investigated in this context. We examined the cross-sectional association between walking pace and sleep-disordered breathing in the population-level Multi-Ethnic Study of Atherosclerosis. A sample of 2912 men and 3213 women (46-87 years) reported perceived walking pace outside their homes. A walking pace<0.89 m/s was deemed "slow", with ≥ 0.89 m/s considered "average/brisk" according to validated thresholds. Sample prevalences were: sleep apnoea (3.5%), self-reported apnoeas (8.4%), loud snoring (20.5%), daytime tiredness (22.2%) and slow-walking pace (26.9%). The 95% CI risk differences (multivariable-adjusted) for slow vs. faster walking pace were; sleep apnoea (0.4-2.5%), self-reported apnoeas (0.1-3.8%), loud snoring (1.2-8.3%), and daytime tiredness (3.0-7.8%). Risk differences were similar between sexes. The multivariable-adjusted risk ratio indicated that slower walkers had 1.5 (95% CI: 1.0 to 2.1) times the risk of sleep apnoea vs. faster walkers. In conclusion, a slower walking speed was associated with a greater prevalence of sleep-disordered breathing, independently from other common screening factors. Therefore, a simple walking speed question may help consolidate screening for this disorder.

Validation of long-term survival prediction for scheduled abdominal aortic aneurysm repair with an independent calculator using only pre-operative variables.

We observed survival after scheduled repair of abdominal aortic aneurysm in 1096 patients for a median (IQR [range]) of 3.0 (1.5-5.8 [0-15]) years: 943 patients had complete data, 250 of whom died. We compared discrimination and calibration of an external model with the Kaplan-Meier model generated from the study data. Integrated Brier misclassification scores for both models at 1-5 postoperative years were 0.04, 0.08, 0.11, 0.13 and 0.16, respectively. Harrel's concordance index at 1-5 postoperative years was 0.73, 0.71, 0.68, 0.67 and 0.66, respectively. Groups with median 5-year predicted mortality of 40% (n = 251), 18% (n = 414) and 8% (n = 164) had lower observed mortality than 114 patients with 70% predicted mortality, hazard ratio (95% CI): 0.58 (0.37-0.76), p = 0.0031; 0.30 (0.19-0.48), p = 1.7 × 10(-12) and 0.19 (0.13-0.27), p = 1.3 × 10(-10) , respectively, test for trend p = 5.6 × 10(-15) . Survival predicted by the external calculator was similar to the Kaplan-Meier estimate.

Effect of supervised aerobic exercise rehabilitation on physical fitness and quality-of-life in survivors of critical illness: an exploratory minimized controlled trial (PIX study).

BACKGROUND: Evidence is limited for the effectiveness of interventions for survivors of critical illness after hospital discharge. We explored the effect of an 8-week hospital-based exercise-training programme on physical fitness and quality-of-life. METHODS: In a parallel-group minimized controlled trial, patients were recruited before hospital discharge or in the intensive care follow-up clinic and enrolled 8-16 weeks after discharge. Each week, the intervention comprised two sessions of physiotherapist-led cycle ergometer exercise (30 min, moderate intensity) plus one equivalent unsupervised exercise session. The control group received usual care. The primary outcomes were the anaerobic threshold (in ml O2 kg(-1) min(-1)) and physical function and mental health (SF-36 questionnaire v.2), measured at Weeks 9 (primary time point) and 26. Outcome assessors were blinded to group assignment. RESULTS: Thirty patients were allocated to the control and 29 to the intervention. For the anaerobic threshold outcome at Week 9, data were available for 17 control vs 13 intervention participants. There was a small benefit (vs control) for the anaerobic threshold of 1.8 (95% confidence interval, 0.4-3.2) ml O2 kg(-1) min(-1). This advantage was not sustained at Week 26. There was evidence for a possible beneficial effect of the intervention on self-reported physical function at Week 9 (3.4; -1.4 to 8.2 units) and on mental health at Week 26 (4.4; -2.4 to 11.2 units). These potential benefits should be examined robustly in any subsequent definitive trial. CONCLUSIONS: The intervention appeared to accelerate the natural recovery process and seems feasible, but the fitness benefit was only short term. CLINICAL TRIAL REGISTRATION: Current Controlled Trials ISRCTN65176374 (http://www.controlled-trials.com/ISRCTN65176374).

Prevalence and implications of a difference in systolic blood pressure between one arm and the other in vascular surgical patients.

Inter-arm differences in blood pressure may confound haemodynamic management in vascular surgery. We evaluated 898 patients in the vascular pre-assessment clinic to determine the prevalence of inter-arm differences in systolic and mean arterial pressure, quantify the consequent risk of clinical error in siting monitoring peri-operatively and evaluate systolic inter-arm difference as a predictor of all-cause mortality (median follow-up 49 months). The prevalence of a systolic inter-arm difference ≥ 15 mmHg was 26% (95% CI 23-29%). The prevalence of an inter-arm mean arterial pressure difference ≥ 10 mmHg was 26% (95% CI 23-29%) and 11% (95% CI 9-13%) for a difference ≥ 15 mmHg. Monitoring could be erroneously sited in an arm reading lower for systolic pressure once in every seven to nine patients. The hazard ratio for a systolic inter-arm difference ≥ 15 mmHg vs < 15 mmHg was 1.03 (95% CI 0.78-1.36, p = 0.84). Large inter-arm blood pressure differences are common in this population, with a high potential for monitoring errors. Systolic inter-arm difference was not associated with medium-term mortality. [Correction added on 17 October 2013, after first online publication: In the Summary the sentence beginning 'We evaluated 898 patients' was corrected from (median (IQR [range]) follow-up 49 months) to read (median follow up 49 months)].

Validity of the 6 min walk test in prediction of the anaerobic threshold before major non-cardiac surgery.

BACKGROUND: For perioperative risk stratification, a robust, practical test could be used where cardiopulmonary exercise testing (CPET) is unavailable. The aim of this study was to assess the utility of the 6 min walk test (6MWT) distance to discriminate between low and high anaerobic threshold (AT) in patients awaiting major non-cardiac surgery. METHODS: In 110 participants, we obtained oxygen consumption at the AT from CPET and recorded the distance walked (in m) during a 6MWT. Receiver operating characteristic (ROC) curve analysis was used to derive two different cut-points for 6MWT distance in predicting an AT of <11 ml O(2) kg(-1) min(-1); one using the highest sum of sensitivity and specificity (conventional method) and the other adopting a 2:1 weighting in favour of sensitivity. In addition, using a novel linear regression-based technique, we obtained lower and upper cut-points for 6MWT distance that are predictive of an AT that is likely to be (P≥0.75) <11 or >11 ml O(2) kg(-1) min(-1). RESULTS: The ROC curve analysis revealed an area under the curve of 0.85 (95% confidence interval, 0.77-0.91). The optimum cut-points were <440 m (conventional method) and <502 m (sensitivity-weighted approach). The regression-based lower and upper 6MWT distance cut-points were <427 and >563 m, respectively. CONCLUSIONS: Patients walking >563 m in the 6MWT do not routinely require CPET; those walking <427 m should be referred for further evaluation. In situations of 'clinical uncertainty' (≥427 but ≤563 m), the number of clinical risk factors and magnitude of surgery should be incorporated into the decision-making process. The 6MWT is a useful clinical tool to screen and risk stratify patients in departments where CPET is unavailable.

Determination of the anaerobic threshold in the pre-operative assessment clinic: inter-observer measurement error.

The variability between observers in the interpretation of cardiopulmonary exercise tests may impact upon clinical decision making and affect the risk stratification and peri-operative management of a patient. The purpose of this study was to quantify the inter-reader variability in the determination of the anaerobic threshold (V-slope method). A series of 21 cardiopulmonary exercise tests from patients attending a surgical pre-operative assessment clinic were read independently by nine experienced clinicians regularly involved in clinical decision making. The grand mean for the anaerobic threshold was 10.5 ml O(2).kg body mass(-1).min(-1). The technical error of measurement was 8.1% (circa 0.9 ml.kg(-1).min(-1); 90% confidence interval, 7.4-8.9%). The mean absolute difference between readers was 4.5% with a typical random error of 6.5% (6.0-7.2%). We conclude that the inter-observer variability for experienced clinicians determining the anaerobic threshold from cardiopulmonary exercise tests is acceptable.