Days at Home after Surgery: An Integrated and Efficient Outcome Measure for Clinical Trials and Quality Assurance
Max Bell, Lars I Eriksson, Tobias Svensson, Linn Hallqvist, Fredrik Granath, Jennifer Reilly, Paul S Myles, Max Bell, Lars I Eriksson, Tobias Svensson, Linn Hallqvist, Fredrik Granath, Jennifer Reilly, Paul S Myles
Abstract
Background: Surgical audit, sometimes including public reporting, is an important foundation of high quality health care. We aimed to assess the validity of a novel outcome metric, days at home up to 30 days after surgery, as a surgical outcome measure in clinical trials and quality assurance.
Methods: This was a multicentre, registry-based cohort study. We used prospectively collected hospital and national healthcare registry data obtained from patients aged 18 years or older undergoing a broad range of surgeries in Sweden over a 10-year period. The association between days at home up to 30 days after surgery and patient (older age, poorer physical status, comorbidity) and surgical (elective or non-elective, complexity, duration) risk factors, process of care outcomes (re-admissions, discharge destination), clinical outcomes (major complications, 30-day mortality) and death up to 1 year after surgery were measured.
Findings: From January, 2005, to December, 2014, we obtained demographic and perioperative data on 636,885 patients from 21 Swedish hospitals. Mortality at 30 days and one year was 1.8% and 7.3%, respectively. The median (IQR) days at home up to 30 days after surgery was 27 (23-29), being significantly lower among high-risk patients, those recovering from more complex surgical procedures, and suffering serious postoperative complications (all p < 0.0001). Patients with 8 days or less at home up to 30 days after surgery had a nearly 7-fold higher risk of death up to 1 year postoperatively when compared with those with 29 or 30 days at home (adjusted HR 6.78 [95% CI: 6.44-7.13]).
Interpretation: Days at home up to 30 days after surgery is a valid, easy to measure patient-centred outcome metric. It is highly sensitive to changes in surgical risk and impact of complications, and has prognostic importance; it is therefore a valuable endpoint for perioperative clinical trials and quality assurance.
Funding: Swedish National Research Council Medicine and Stockholm County Council ALF-project grant (LE), and the Australian National Health and Medical Research Council (PM).
Keywords: Anaesthesia; Audit; Patient-reported outcome measures; Postoperative complications; Surgery; Survival.
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References
- Lynn J., McKethan A., Jha A.K. Value-based payments require valuing what matters to patients. JAMA. 2015;314(14):1445–1446.
- Lavallee D.C., Chenok K.E., Love R.M. Incorporating patient-reported outcomes into health care to engage patients and enhance care. Health Aff (Millwood) 2016;35(4):575–582.
- Porter M.E. What is value in health care? N Engl J Med. 2010;363(26):2477–2481.
- Hinami K., Bilimoria K.Y., Kallas P.G., Simons Y.M., Christensen N.P., Williams M.V. Patient experiences after hospitalizations for elective surgery. Am J Surg. 2014;207(6):855–862.
- Birkmeyer J.D., Gust C., Dimick J.B., Birkmeyer N.J., Skinner J.S. Hospital quality and the cost of inpatient surgery in the United States. Ann Surg. 2012;255(1):1–5.
- Berwick D.M., Nolan T.W., Whittington J. The triple aim: care, health, and cost. Health Aff (Millwood) 2008;27(3):759–769.
- Horton R. Surgical research or comic opera: questions, but few answers. Lancet. 1996;347(9007):984–985.
- Bruce J., Russell E.M., Mollison J., Krukowski Z.H. The measurement and monitoring of surgical adverse events. Health Technol Assess. 2001;5(22):1–194.
- Austin J.M., McGlynn E.A., Pronovost P.J. Fostering transparency in outcomes, quality, safety, and costs. JAMA. 2016;316(16):1661–1662.
- Macleod M.R., Michie S., Roberts I. Biomedical research: increasing value, reducing waste. Lancet. 2014;383(9912):101–104.
- Nashef S.A.M., Powell S., Jenkins D.P., Fynn S., Hall R. Crying wolf: the misuse of hospital data. Lancet. 2017;390(10091):227–228.
- Ghaferi A.A., Birkmeyer J.D., Dimick J.B. Variation in hospital mortality associated with inpatient surgery. N Engl J Med. 2009;361(14):1368–1375.
- Schuster M.A., Onorato S.E., Meltzer D.O. Measuring the cost of quality measurement: a missing link in quality strategy. Jama. 2017;318(13):1219–1220.
- Chernew M.E., Landrum M.B. Targeted supplemental data collection — addressing the quality-measurement conundrum. N Engl J Med. 2018;378(11):979–981.
- Hyder J.A., Hirschberg R.E., Nguyen L.L. Home discharge as a performance metric for surgery. JAMA Surg. 2015;150(2):96–97.
- Glance L.G., Kellermann A.L., Osler T.M. Hospital readmission after noncardiac surgery: the role of major complications. JAMA Surg. 2014;149(5):439–445.
- Gupta A., Allen L.A., Bhatt D.L. Association of the hospital readmissions reduction program implementation with readmission and mortality outcomes in heart failure. JAMA Cardiol. 2018;3(1):44–53.
- Berian J.R., Mohanty S., Ko C.Y., Rosenthal R.A., Robinson T.N. Association of loss of independence with readmission and death after discharge in older patients after surgical procedures. JAMA Surg. 2016;151(9)
- Fried T.R., Bradley E.H., Towle V.R., Allore H. Understanding the treatment preferences of seriously ill patients. N Engl J Med. 2002;346(14):1061–1066.
- Boney O., Bell M., Bell N. 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(12)
- Burns K.E., Jacob S.K., Aguirre V., Gomes J., Mehta S., Rizvi L. 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(11):1962–1968.
- Hannah D., Lindholm B., Maisch L. Certain uncertainty: life after stroke from the patient's perspective. Circ Cardiovasc Qual Outcomes. 2014;7(6):968–969.
- Xian Y., O'Brien E.C., Fonarow G.C. 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(1):36–45. [.e1-11]
- Barnett M.L., Grabowski D.C., Mehrotra A. Home-to-home time — measuring what matters to patients and payers. N Engl J Med. 2017;377(1):4–6.
- Ariti C.A., Cleland J.G., Pocock S.J. 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(5):900–906.
- Wasywich C.A., Gamble G.D., Whalley G.A., Doughty R.N. 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(5):462–468.
- Xian Y., Wu J., O'Brien E.C. 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
- Ellis G., Whitehead M.A., Robinson D., O'Neill D., Langhorne P. Comprehensive geriatric assessment for older adults admitted to hospital: meta-analysis of randomised controlled trials. Bmj. 2011;343:d6553.
- Myles P.S., Shulman M.A., Heritier S. Validation of days at home as an outcome measure after surgery: a prospective cohort study in Australia. BMJ Open. 2017;7(8)
- Lunde A.S., Lundeborg S., Lettenstrom G.S., Thygesen L., Huebner J. vol. 84. 1980. The person-number systems of Sweden, Norway, Denmark, and Israel; pp. 1–59. (Vital and health statistics series 2, data evaluation and methods research).
- Johansson L.A., Bjorkenstam C., Westerling R. Unexplained differences between hospital and mortality data indicated mistakes in death certification: an investigation of 1,094 deaths in Sweden during 1995. J Clin Epidemiol. 2009;62(11):1202–1209.
- Charlson M.E., Pompei P., Ales K.L., MacKenzie C.R. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373–383.
- Ludvigsson J.F., Andersson E., Ekbom A. External review and validation of the Swedish national inpatient register. BMC Public Health. 2011;11:450.
- ASA House of Delegates ASA physical status classification system. 2014.
- Powell J.T., Sweeting M.J., Ulug P. Meta-analysis of individual-patient data from EVAR-1, DREAM, OVER and ACE trials comparing outcomes of endovascular or open repair for abdominal aortic aneurysm OVER 5 years. Br J Surg. 2017;104(3):166–178.
- Lovegrove R.E., Javid M., Magee T.R., Galland R.B. A meta-analysis of 21,178 patients undergoing open or endovascular repair of abdominal aortic aneurysm. Br J Surg. 2008;95(6):677–684.
- Greenhalgh R.M., Brown L.C., Kwong G.P., Powell J.T., Thompson S.G. Comparison of endovascular aneurysm repair with open repair in patients with abdominal aortic aneurysm (EVAR trial 1), 30-day operative mortality results: randomised controlled trial. Lancet. 2004;364(9437):843–848.
- Collins G.S., Jibawi A., McCulloch P. Control chart methods for monitoring surgical performance: a case study from gastro-oesophageal surgery. Eur J Surg Oncol. 2011;37(6):473–480.
- Groff A.C., Colla C.H., Lee T.H. Days spent at home - a patient-centered goal and outcome. N Engl J Med. 2017;375(17):1610–1612.
- Khuri S.F., Henderson W.G., DePalma R.G., Mosca C., Healey N.A., Kumbhani D.J. Determinants of long-term survival after major surgery and the adverse effect of postoperative complications. Ann Surg. 2005;242(3):326–341. [discussion 41-3]
- Shulman M.A., Myles P.S., Chan M.T., McIlroy D.R., Wallace S., Ponsford J. Measurement of disability-free survival after surgery. Anesthesiology. 2015;122(3):524–536.
- Myles P.S., Peyton P., Silbert B., Hunt J., Rigg J.R., Sessler D.I. Perioperative epidural analgesia for major abdominal surgery for cancer and recurrence-free survival: randomised trial. BMJ. 2011;342:d1491.
- Haynes A.B., Weiser T.G., Berry W.R. A surgical safety checklist to reduce morbidity and mortality in a global population. N Engl J Med. 2009;360(5):491–499.
- Lovegrove J., Valencia O., Treasure T., Sherlaw-Johnson C., Gallivan S. Monitoring the results of cardiac surgery by variable life-adjusted display. Lancet. 1997;350(9085):1128–1130.
- Public reporting of surgical outcomesLancet. 2011;377(9772):1126.
- Meyer G.S., Nelson E.C., Pryor D.B. More quality measures versus measuring what matters: a call for balance and parsimony. BMJ Qual Saf. 2012;21(11):964–968.
- Gan F.F., Tang X., Zhu Y., Lim P.W. Monitoring the quality of cardiac surgery based on three or more surgical outcomes using a new variable life-adjusted display. International J Qual Health Care. 2017;29(3):427–432.
- Aylin P., Alves B., Best N. Comparison of UK paediatric cardiac surgical performance by analysis of routinely collected data 1984–96: was Bristol an outlier? Lancet. 2001;358(9277):181–187.
- Carter D.J. Correcting the record: Australian prosecutions for manslaughter in the medical context. J Law Med. 2015;22(3):588–609.
- Dekker S.W., Hugh T.B. A just culture after mid Staffordshire. BMJ Qual Saf. 2014;23(5):356–358.
- Pearse R.M., Moreno R.P., Bauer P. Mortality after surgery in Europe: a 7-day cohort study. Lancet. 2012;380(9847):1059–1065.
- Stark J., Gallivan S., Lovegrove J. Mortality rates after surgery for congenital heart defects in children and surgeons' performance. Lancet. 2000;355(9208):1004–1007.
- DeLancey J.O., Softcheck J., Chung J.W., Barnard C., Dahlke A.R., Bilimoria K.Y. Associations between hospital characteristics, measure reporting, and the Centers for Medicare & Medicaid Services Overall Hospital Quality Star Ratings. JAMA. 2017;317(19):2015–2017.
- Nishikawa G., Prasad V. Diagnostic expansion in clinical trials: myocardial infarction, stroke, cancer recurrence, and metastases may not be the hard endpoints you thought they were. Bmj. 2018;362
- Terragni P.P., Antonelli M., Fumagalli R. Early vs late tracheotomy for prevention of pneumonia in mechanically ventilated adult ICU patients: a randomized controlled trial. Jama. 2010;303(15):1483–1489.
- Barnett M.L., Hsu J., McWilliams J.M. Patient characteristics and differences in hospital readmission rates. JAMA Intern Med. 2015;175(11):1803–1812.
- Ahmed J., Khan S., Lim M., Chandrasekaran T.V., MacFie J. Enhanced recovery after surgery protocols — compliance and variations in practice during routine colorectal surgery. Colorectal Dis. 2012;14(9):1045–1051.
- Group EC The impact of enhanced recovery protocol compliance on elective colorectal cancer resection: results from an international registry. Ann Surg. 2015;261(6):1153–1159.
- Sheingold S.H., Zuckerman R., Shartzer A. Understanding Medicare hospital readmission rates and differing penalties between safety-net and other hospitals. Health Aff (Millwood) 2016;35(1):124–131.
Source: PubMed