Even preoperative carbohydrate loading is too hard? Why RCT’s should not be considered the gold standard for nutrition research in acute hip fracture: results of a feasibility study
Keywords:Clinical trial, Hip fracture, Malnutrition, Research design, Carbohydrate loading, NOF
Background: Malnutrition is a high-risk co-morbidity in acute hip fracture patients. Pre-operative carbohydrate loading may improve nutritional status and therefore patient outcomes. The feasibility of nutrition focused randomised control trial designs in hip fracture is at best questionable. This study was designed to undertake efficacy testing of pre-operative carbohydrate loading and explore the broader feasibility of conducting randomised controlled trials in acute hip fracture.
Methods: This two arm randomised controlled feasibility study recruited patients previously living in the community who had fractured their hip undergoing surgery at our institution. Patients in the intervention arm received a 400 mL (50g) carbohydrate load 2 hours prior to surgery. Information was collected regarding the fidelity of pre-operative carbohydrate provision and consumption as well as patient demographic and admission details.
Results: Thirty-two patients consented to participate, 60% of the eligible patient cohort. Results demonstrated evenly matched intervention and control groups in terms of demographic details and pre-surgical morbidity and mortality risk. However, of the 17 patients allocated to the intervention arm less than half (41%) completed the carbohydrate loading intervention and even fewer 23.5% (n=4) completed all follow up due to a number of patient and system related factors.
Conclusions: Evaluating the clinical effectiveness of providing pre-operative carbohydrate loading in hip fracture and the associated outcomes is not feasible using a randomised control trial methodology. It is recommended that researchers consider a ‘silver standard’ of research and practice such as pragmatic, registry-based cluster randomised trials to ensure feasibility, relevancy and applicability when evaluating nutritional interventions in this cohort.
Bell JJ, Pulle RC, Crouch AM, Kuys SS, Ferrier RL, Whitehouse SL. Impact of malnutrition on 12-month mortality following acute hip fracture. ANZ J. Surg. 2016;86(3):157-161.
Nikkel LE, Fox EJ, Black KP, Davis C, Andersen L, Hollenbeak CS. Impact of Comorbidities on Hospitalization Costs Following Hip Fracture. The Journal of Bone & Joint Surgery. 2012;94(1):9-17.
Bell J, Bauer J, Capra S, Pulle CR. Barriers to nutritional intake in patients with acute hip fracture: time to treat malnutrition as a disease and food as a medicine? Can. J. Physiol. Pharmacol. 2013;91(6):489-495.
Australian Commission on Safety and Quality in Health Care. Hip Fracture Care Clinical Care Standard. In: Clinical Care Standards, ed. Sydney: ACSQHC; 2016.
Avenell A, Smith T, Curtain J, Mak J, Myint P. Nutritional supplementation for hip fracture aftercare in older people. Cochrane Database Syst Rev. 2016(11).
Wang ZG, Wang Q, Wang WJ, Qin HL. Randomized clinical trial to compare the effects of preoperative oral carbohydrate versus placebo on insulin resistance after colorectal surgery. Br. J. Surg. 2010;97(3):317-327.
Yuill KA, Richardson RA, Davidson HIM, Garden OJ, Parks RW. The administration of an oral carbohydrate-containing fluid prior to major elective upper-gastrointestinal surgery preserves skeletal muscle mass postoperatively—a randomised clinical trial. Clin. Nutr. 2005;24(1):32-37.
Svanfeldt M, Thorell A, Hausel J, Soop M, Nygren J, Ljungqvist O. Effect of “preoperative” oral carbohydrate treatment on insulin action—a randomised cross-over unblinded study in healthy subjects. Clin. Nutr. 2005;24(5):815-821.
Hellström PM, Samuelsson B, Al-Ani AN, Hedström M. Normal gastric emptying time of a carbohydrate-rich drink in elderly patients with acute hip fracture: a pilot study. BMC Anesthesiology. 2017;17(1):23-23.
Yagci G, Can MF, Ozturk E, et al. Effects of preoperative carbohydrate loading on glucose metabolism and gastric contents in patients undergoing moderate surgery: A randomized, controlled trial. Nutrition. 2008;24(3):212-216.
Hausel J, Nygren J, Lagerkranser M, et al. A carbohydrate-rich drink reduces preoperative discomfort in elective surgery patients. Anesth. Analg. 2001;93(5):1344-1350.
Smith MD, McCall J, Plank L, Herbison GP, Soop M, Nygren J. Preoperative carbohydrate treatment for enhancing recovery after elective surgery. The Cochrane Library. 2014.
Eneroth M, Olsson U-B, Thorngren K-G. Insufficient fluid and energy intake in hospitalised patients with hip fracture. A prospective randomised study of 80 patients. Clin. Nutr. 2005;24(2):297-303.
Lloyd BD, Williamson DA, Singh NA, et al. Recurrent and Injurious Falls in the Year Following Hip Fracture: A Prospective Study of Incidence and Risk Factors From the Sarcopenia and Hip Fracture Study. The Journals of Gerontology Series A: Biological Sciences and Medical Sciences. 2009;64A(5):599-609.
Coburn M, Sanders RD, Maze M, Rossaint R. The Hip Fracture Surgery in Elderly Patients (HIPELD) study: protocol for a randomized, multicenter controlled trial evaluating the effect of xenon on postoperative delirium in older patients undergoing hip fracture surgery. Trials. 2012;13:180-180.
Anbar R, Beloosesky Y, Cohen J, et al. Tight Calorie Control in geriatric patients following hip fracture decreases complications: A randomized, controlled study. Clin. Nutr. 2014;33(1):23-28.
Bruce D, Laurance I, McGuiness M, Ridley M, Goldswain P. Nutritional supplements after hip fracture: poor compliance limits effectiveness. Clin. Nutr. 2003;22(5):497-500.
Myint MWW, Wu J, Wong E, et al. Clinical benefits of oral nutritional supplementation for elderly hip fracture patients: a single blind randomised controlled trial. Age and Ageing. 2012.
Chevalley T, Hoffmeyer P, Bonjour J-P, Rizzoli R. Early serum IGF-I response to oral protein supplements in elderly women with a recent hip fracture. Clin. Nutr. 2010;29(1):78-83.
Eschbach D, Kirchbichler T, Wiesmann T, et al. Nutritional intervention in cognitively impaired geriatric trauma patients: a feasibility study. Clinical Interventions in Aging. 2016;11:1239-1246.
Eneroth M, Olsson UB, Thorngren KG. Nutritional supplementation decreases hip fracture-related complications. Clinical orthopaedics and related research. 2006;451:212-217.
Miller MD, Crotty M, Whitehead C, Bannerman E, Daniels LA. Nutritional supplementation and resistance training in nutritionally at risk older adults following lower limb fracture: a randomized controlled trial. Clin. Rehabil. 2006;20(4):311-323.
Carlsson P, Tidermark J, Ponzer S, Söderqvist A, Cederholm T. Food habits and appetite of elderly women at the time of a femoral neck fracture and after nutritional and anabolic support. J. Hum. Nutr. Diet. 2005;18(2):117-120.
Sivakumar BS, McDermott LM, Bell JJ, Pulle CR, Jayamaha S, Ottley MC. Dedicated hip fracture service: implementing a novel model of care. ANZ J. Surg. 2013;83(7-8):559-563.
Roulin D, Blanc C, Muradbegovic M, Hahnloser D, Demartines N, Hübner M. Enhanced Recovery Pathway for Urgent Colectomy. World J. Surg. 2014;38(8):2153-2159.
Wisely JC, Barclay KL. Effects of an Enhanced Recovery After Surgery programme on emergency surgical patients. ANZ J. Surg. 2016;86(11):883-888.
McMahon M, Marsh H, Rizza R. Comparison of the Pattern of Postprandial Carbohydrate Metabolism After Ingestion of a Glucose Drink or a Mixed Meal. The Journal of Clinical Endocrinology & Metabolism. 1989;68(3):647-653.
Proctor E, Silmere H, Raghavan R, et al. Outcomes for Implementation Research: Conceptual Distinctions, Measurement Challenges, and Research Agenda. Adm. Policy Ment. Health. 2011;38(2):65-76.
Australian and New Zealand College of Anaesthetists. Guidelines on pre-anaesthesia consultation and patient preparation. Vol PS072016.
Kastanis G, Topalidou A, Alpantaki K, Rosiadis M, Balalis K. Is the ASA Score in Geriatric Hip Fractures a Predictive Factor for Complications and Readmission? Scientifica. 2016;2016:7096245-7096245.
Yeoh CJC, Fazal MA. ASA Grade and Elderly Patients With Femoral Neck Fracture. Geriatric Orthopaedic Surgery & Rehabilitation. 2014;5(4):195-199.
Moher D, Hopewell S, Schulz KF, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. J. Clin. Epidemiol. 2010;63(8):e1-e37.
Bell JJ, Bauer JD, Capra S, Pulle RC. Multidisciplinary, multi-modal nutritional care in acute hip fracture inpatients – Results of a pragmatic intervention. Clin. Nutr. 2014;33(6):1101-1107.
ANZHFR. Bi-National Annual Report for Hip Fracture Care 2017. In: (ANZHFR) AaNZHFR, ed2017.
Moppett IK, Greenhaff PL, Ollivere BJ, Joachim T, Lobo DN, Rowlands M. Pre-Operative nutrition In Neck of femur Trial (POINT) - carbohydrate loading in patients with fragility hip fracture: study protocol for a randomised controlled trial. Trials. 2014;15:475.
Macfie D, Zadeh RA, Andrews M, Crowson J, Macfie J. Perioperative multimodal optimisation in patients undergoing surgery for fractured neck of femur. The Surgeon: Journal Of The Royal Colleges Of Surgeons Of Edinburgh And Ireland. 2012;10(2):90-94.
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 surgery. 2017;152(7):e171032-e171032.
Gramlich LM, Sheppard CE, Wasylak T, et al. Implementation of Enhanced Recovery After Surgery: a strategy to transform surgical care across a health system. Implementation Science. 2017;12(1):67.
Bell JJ, Rossi T, Bauer JD, Capra S. Developing and evaluating interventions that are applicable and relevant to inpatients and those who care for them; a multiphase, pragmatic action research approach. BMC Med. Res. Methodol. 2014;14:98-98.
Tim Mathes, Stefanie Buehn, Peggy Prengel, Dawid Pieper. Registry-based randomized controlled trials merged the strength of randomized controlled trails and observational studies and give rise to more pragmatic trials. J. Clin. Epidemiol. 2018;93:120-127.
Zwarenstein M, Treweek S, Gagnier JJ, et al. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ. 2008;337:2390.