Validation of days at home as an outcome measure after surgery: a prospective cohort study in Australia

Paul S Myles, Mark A Shulman, Stephane Heritier, Sophie Wallace, David R McIlroy, Stuart McCluskey, Isabella Sillar, Andrew Forbes, Paul S Myles, Mark A Shulman, Stephane Heritier, Sophie Wallace, David R McIlroy, Stuart McCluskey, Isabella Sillar, Andrew Forbes

Abstract

Objective: To evaluate 'days at home up to 30 days after surgery' (DAH30) as a patient-centred outcome measure.

Design: Prospective cohort study.

Data source: Using clinical trial data (seven trials, 2109 patients) we calculated DAH30 from length of stay, readmission, discharge destination and death up to 30 days after surgery.

Main outcome: The association between DAH30 and serious complications after surgery.

Results: One or more complications occurred in 263 of 1846 (14.2%) patients, including 19 (1.0%) deaths within 30 days of surgery; 245 (11.6%) patients were discharged to a rehabilitation facility and 150 (7.1%) were readmitted to hospital within 30 days of surgery. The median DAH30 was significantly less in older patients (p<0.001), those with poorer physical functioning (p<0.001) and in those undergoing longer operations (p<0.001). Patients with serious complications had less days at home than patients without serious complications (20.5 (95% CI 19.1 to 21.9) vs 23.9 (95% CI 23.8 to 23.9) p<0.001), and had higher rates of readmission (16.0% vs 5.9%; p<0.001). After adjusting for patient age, sex, physical status and duration of surgery, the occurrence of postoperative complications was associated with fewer days at home after surgery (difference 3.0(95% CI 2.1 to 4.0) days; p<0.001).

Conclusions: DAH30 has construct validity and is a readily obtainable generic patient-centred outcome measure. It is a pragmatic outcome measure for perioperative clinical trials.

Keywords: clinical trials; outcome; perioperative medicine.

Conflict of interest statement

Competing interests: None declared.

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Figures

Figure 1
Figure 1
Frequency distribution of days alive and at home (DAAH) up to 30 days after surgery (n=2109). The smoothing line (kernel) is a non-parametric estimate of the probability density function.

References

    1. Austin JM, McGlynn EA, Pronovost PJ. Fostering transparency in outcomes, quality, safety, and costs. JAMA 2016;316:1661–2. 10.1001/jama.2016.14039
    1. Lynn J, McKethan A, Jha AK. Value-based payments require valuing what matters to patients. JAMA 2015;314:1445–6. 10.1001/jama.2015.8909
    1. Porter ME. What is value in health care? N Engl J Med 2010;363:2477–81. 10.1056/NEJMp1011024
    1. Lavallee DC, Chenok KE, Love RM, et al. . Incorporating patient-reported outcomes into health care to engage patients and enhance care. Health Aff 2016;35:575–82. 10.1377/hlthaff.2015.1362
    1. Berian JR, Mohanty S, Ko CY, et al. . Association of loss of independence with readmission and death after discharge in older patients after surgical procedures. JAMA Surg 2016;151:e161689 10.1001/jamasurg.2016.1689
    1. Fried TR, Bradley EH, Towle VR, et al. . Understanding the treatment preferences of seriously ill patients. N Engl J Med 2002;346:1061–6. 10.1056/NEJMsa012528
    1. Goldfarb M, Drudi L, Almohammadi M, et al. . Outcome reporting in cardiac surgery trials: systematic review and critical appraisal. J Am Heart Assoc 2015;4:e002204 10.1161/JAHA.115.002204
    1. Chalmers I, Clarke M. Outcomes that matter to patients in tombstone trials. Lancet 2001;358:1649 10.1016/S0140-6736(01)06689-2
    1. Ariti CA, Cleland JG, Pocock SJ, et al. . Days alive and out of hospital and the patient journey in patients with heart failure: insights from the candesartan in heart failure: assessment of reduction in mortality and morbidity (CHARM) program. Am Heart J 2011;162:900–6. 10.1016/j.ahj.2011.08.003
    1. Wasywich CA, Gamble GD, Whalley GA, et al. . Understanding changing patterns of survival and hospitalization for heart failure over two decades in New Zealand: utility of 'days alive and out of hospital' from epidemiological data. Eur J Heart Fail 2010;12:462–8. 10.1093/eurjhf/hfq027
    1. Xian Y, Wu J, O'Brien EC, et al. . Real world effectiveness of warfarin among ischemic stroke patients with atrial fibrillation: observational analysis from patient-centered research into outcomes stroke patients prefer and effectiveness research (PROSPER) study. BMJ 2015;351:h3786 10.1136/bmj.h3786
    1. Ellis G, Whitehead MA, Robinson D, et al. . Comprehensive geriatric assessment for older adults admitted to hospital: meta-analysis of randomised controlled trials. BMJ 2011;343:d6553 10.1136/bmj.d6553
    1. Hyder JA, Hirschberg RE, Nguyen LL. Home discharge as a performance metric for surgery. JAMA Surg 2015;150:96–7. 10.1001/jamasurg.2014.1725
    1. Hyder JA, Wakeam E, Habermann EB, et al. . Derivation and validation of a simple calculator to predict home discharge after surgery. J Am Coll Surg 2014;218:226–36. 10.1016/j.jamcollsurg.2013.11.002
    1. Merkow RP, Ju MH, Chung JW, et al. . Underlying reasons associated with hospital readmission following surgery in the United States. JAMA 2015;313:483–95. 10.1001/jama.2014.18614
    1. Boney O, Bell M, Bell N, et al. . Identifying research priorities in anaesthesia and perioperative care: final report of the joint National Institute of Academic Anaesthesia/James Lind Alliance Research Priority Setting Partnership. BMJ Open 2015;5:e010006 10.1136/bmjopen-2015-010006
    1. Hinami K, Bilimoria KY, Kallas PG, et al. . Patient experiences after hospitalizations for elective surgery. Am J Surg 2014;207:855–62. 10.1016/j.amjsurg.2013.04.014
    1. Burns KE, Jacob SK, Aguirre V, et al. . Stakeholder engagement in trial design: survey of visitors to critically Ill patients regarding preferences for outcomes and treatment options during weaning from mechanical ventilation. Ann Am Thorac Soc 2016;13:1962–8. 10.1513/AnnalsATS.201606-445OC
    1. Hannah D, Lindholm B, Maisch L. Certain uncertainty: life after stroke from the patient's perspective. Circ Cardiovasc Qual Outcomes 2014;7:968–9. 10.1161/CIRCOUTCOMES.114.001315
    1. Xian Y, O'Brien EC, Fonarow GC, et al. . Patient-centered research into outcomes stroke patients prefer and Effectiveness Research: implementing the patient-driven research paradigm to aid decision making in stroke care. Am Heart J 2015;170:36–45. 10.1016/j.ahj.2015.04.008
    1. von Elm E, Altman DG, Egger M, et al. . The strengthening the reporting of observational studies in epidemiology (STROBE) statement: guidelines for reporting observational studies. Lancet 2007;370:1453–7. 10.1016/S0140-6736(07)61602-X
    1. Myles PS, Leslie K, Chan MT, et al. . The safety of addition of nitrous oxide to general anaesthesia in at-risk patients having major non-cardiac surgery (ENIGMA-II): a randomised, single-blind trial. Lancet 2014;384:1446–54. 10.1016/S0140-6736(14)60893-X
    1. Myles PS, Smith JA, Forbes A, et al. . Stopping vs. continuing aspirin before coronary artery surgery. N Engl J Med 2016;374:728–37. 10.1056/NEJMoa1507688
    1. Myles PS, Smith JA, Forbes A, et al. . Tranexamic acid in coronary artery surgery. N Engl J Med 2017;2017:136–48.
    1. Thompson EG, Gower ST, Beilby DS, et al. . Enhanced recovery after surgery program for elective abdominal surgery at three victorian hospitals. Anaesth Intensive Care 2012;40:450–9.
    1. Christelis N, Wallace S, Sage CE, et al. . An enhanced recovery after surgery program for hip and knee arthroplasty. Med J Aust 2015;202:363–8. 10.5694/mja14.00601
    1. Glassford NJ, Myles P, Bellomo R. The Australian approach to peri-operative fluid balance. Curr Opin Anaesthesiol 2012;25:102–10. 10.1097/ACO.0b013e32834decd7
    1. Vijay A, Grover A, Coulson TG, et al. . Perioperative management of patients treated with angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers: a quality improvement audit. Anaesth Intensive Care 2016;44:346–52.
    1. Shulman MA, Myles PS, Chan MT, et al. . Measurement of disability-free survival after surgery. Anesthesiology 2015;122:524–36. 10.1097/ALN.0000000000000586
    1. Mangram AJ, Horan TC, Pearson ML, et al. . Guideline for prevention of surgical site infection, 1999. Infect Control Hosp Epidemiol 1999;20:247–80. 10.1086/501620
    1. Degnim AC, Throckmorton AD, Boostrom SY, et al. . Surgical site infection after breast surgery: impact of 2010 CDC reporting guidelines. Ann Surg Oncol 2012;19:4099–103. 10.1245/s10434-012-2448-6
    1. Thygesen K, Alpert JS, Jaffe AS, et al. . Third universal definition of myocardial infarction. Circulation 2012;126:2020–35. 10.1161/CIR.0b013e31826e1058
    1. Leonardi S, Armstrong PW, Schulte PJ, et al. . Implementation of standardized assessment and reporting of myocardial infarction in contemporary randomized controlled trials: a systematic review. Eur Heart J 2013;34:894–902. 10.1093/eurheartj/eht003
    1. Koenker R, Bassett G. Regression quantiles. Econometrica 1978;46:33–50. 10.2307/1913643
    1. Jackknife WCFJ. Bootstrap and other resampling methods in regression analysis. Ann Stat 1986;14:1261–350.
    1. He X, Hu F. Markov chain marginal bootstrap. J Am Stat Assoc 2002;97:783–95. 10.1198/016214502388618591
    1. Koenker R, Machado JAF. Goodness of fit and related inference processes for quantile regression. J Am Stat Assoc 1999;94:1296–310. 10.1080/01621459.1999.10473882
    1. Gornall BF, Myles PS, Smith CL, et al. . Measurement of quality of recovery using the QoR-40: a quantitative systematic review. Br J Anaesth 2013;111:161–9. 10.1093/bja/aet014
    1. Liu VX, Rosas E, Hwang J, et al. . Enhanced recovery after surgery program implementation in 2 surgical populations in an integrated health care delivery system. JAMA Surg 2017;152:e171032 10.1001/jamasurg.2017.1032
    1. Yadla S, Ghobrial GM, Campbell PG, et al. . Identification of complications that have a significant effect on length of stay after spine surgery and predictive value of 90-day readmission rate. J Neurosurg Spine 2015;23:807–11. 10.3171/2015.3.SPINE14318
    1. Berwick DM, Nolan TW, Whittington J. The triple aim: care, health, and cost. Health Aff 2008;27:759–69. 10.1377/hlthaff.27.3.759
    1. Lee VS, Kawamoto K, Hess R, et al. . Implementation of a value-driven outcomes program to identify high variability in clinical costs and outcomes and association with reduced cost and improved quality. JAMA 2016;316:1061–72. 10.1001/jama.2016.12226
    1. Bauer M, Fitzgerald L, Haesler E, et al. . Hospital discharge planning for frail older people and their family. are we delivering best practice? a review of the evidence. J Clin Nurs 2009;18:2539–46. 10.1111/j.1365-2702.2008.02685.x
    1. Birkmeyer JD, Gust C, Dimick JB, et al. . Hospital quality and the cost of inpatient surgery in the United States. Ann Surg 2012;255:1–5. 10.1097/SLA.0b013e3182402c17
    1. Jencks SF, Williams MV, Coleman EA. Rehospitalizations among patients in the medicare fee-for-service program. N Engl J Med 2009;360:1418–28. 10.1056/NEJMsa0803563
    1. Zuckerman RB, Sheingold SH, Orav EJ, et al. . Readmissions, observation, and the hospital readmissions reduction program. N Engl J Med 2016;374:1543–51. 10.1056/NEJMsa1513024
    1. Danino JF, Taylor T, Metcalfe CW, et al. . Readmission rates and financial penalties after ear, nose and throat surgery: how can we improve? Br J Hosp Med 2015;76:655–7. 10.12968/hmed.2015.76.11.655
    1. Hannan EL, Zhong Y, Lahey SJ, et al. . 30-day readmissions after coronary artery bypass graft surgery in New York state. JACC Cardiovasc Interv 2011;4:569–76. 10.1016/j.jcin.2011.01.010
    1. Ahmed J, Khan S, Lim M, et al. . Enhanced recovery after surgery protocols - compliance and variations in practice during routine colorectal surgery. Colorectal Dis 2012;14:1045–51. 10.1111/j.1463-1318.2011.02856.x
    1. ERAS Compliance Group. The impact of Enhanced Recovery Protocol Compliance on Elective Colorectal Cancer Resection: results from an international registry. Ann Surg 2015;261:1153–9. 10.1097/SLA.0000000000001029
    1. Myles PS, Devereaux PJ. Pros and cons of composite endpoints in anesthesia trials. Anesthesiology 2010;113:776–8. 10.1097/ALN.0b013e3181ee2ceb
    1. Ferreira-Gonzalez I, Permanyer-Miralda G, Busse JW, et al. . Composite outcomes can distort the nature and magnitude of treatment benefits in clinical trials. Ann Intern Med 2009;150:566–7. 10.7326/0003-4819-150-8-200904210-00016
    1. Pogue J, Thabane L, Devereaux PJ, et al. . Testing for heterogeneity among the components of a binary composite outcome in a clinical trial. BMC Med Res Methodol 2010;10:49 10.1186/1471-2288-10-49
    1. Khuri SF, Henderson WG, DePalma RG, et al. . Determinants of long-term survival after major surgery and the adverse effect of postoperative complications. Ann Surg 2005;242:326–41. 10.1097/01.sla.0000179621.33268.83
    1. Myles PS, Peyton P, Silbert B, et al. . Perioperative epidural analgesia for major abdominal surgery for cancer and recurrence-free survival: randomised trial. BMJ 2011;342:d1491 10.1136/bmj.d1491
    1. Sheingold SH, Zuckerman R, Shartzer A. Understanding medicare hospital readmission rates and differing penalties between safety-net and other hospitals. Health Aff 2016;35:124–31. 10.1377/hlthaff.2015.0534

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