Regional versus General Anesthesia for Promoting Independence after Hip Fracture (REGAIN): Protocol for a pragmatic, international multicentre trial

BMJ Open

Volumn 6, Issue 11, 2016, Pages

  Neuman, Mark D ^a,b   Ellenberg, Susan S ^a   Sieber, Frederick E ^c   Magaziner, Jay S ^d   Feng, Rui ^a   Carson, Jeffrey L ^e  

^a UNIVERSITY OF PENNSYLVANIA   (United States)

^b UNIVERSITY OF PENNSYLVANIA   (United States)

^c JOHNS HOPKINS BAYVIEW MEDICAL CENTER   (United States)

^d UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE   (United States)

^e ROBERT WOOD JOHNSON MEDICAL SCHOOL   (United States)

Author keywords

Anaesthetics; geriatric medicine

Indexed keywords

ARTICLE; BRIEF PAIN INVENTORY; COGNITION; COGNITIVE DEFECT; DISEASE FREE SURVIVAL; GENERAL ANESTHESIA; HIP FRACTURE; HIP SURGERY; HUMAN; MORTALITY; MULTICENTER STUDY (TOPIC); PATIENT SATISFACTION; POSTOPERATIVE DELIRIUM; POSTOPERATIVE PAIN; RANDOMIZED CONTROLLED TRIAL (TOPIC); SPINAL ANESTHESIA; TELEPHONE INTERVIEW; TREATMENT FAILURE; TREATMENT OUTCOME; WALKING; AGED; CLINICAL PROTOCOL; CLINICAL TRIAL; FEMALE; LENGTH OF STAY; MALE; MIDDLE AGED; MULTICENTER STUDY; PENNSYLVANIA; POSTOPERATIVE COMPLICATION; STATISTICS AND NUMERICAL DATA; VERY ELDERLY;

AGED; AGED, 80 AND OVER; ANESTHESIA, GENERAL; ANESTHESIA, SPINAL; CLINICAL PROTOCOLS; FEMALE; HIP FRACTURES; HUMANS; LENGTH OF STAY; MALE; MIDDLE AGED; PENNSYLVANIA; POSTOPERATIVE COMPLICATIONS;

EID: 84996868014     PISSN: None     EISSN: 20446055     Source Type: Journal    
DOI: 10.1136/bmjopen-2016-013473     Document Type: Article

References (46)

1. Brauer CA, Coca-Perraillon M, Cutler DM, et al. Incidence and mortality of hip fractures in the United States. JAMA 2009;302:1573-9.
2. Blackman DK, Kamimoto LA, Smith SM. Overview: surveillance for selected public health indicators affecting older adults-United States. MMWR CDC Surveill Summ 1999;48:1-6.
3. Haentjens P, Autier P, Barette M, et al. Survival and functional outcome according to hip fracture type: a one-year prospective cohort study in elderly women with an intertrochanteric or femoral neck fracture. Bone 2007;41:958-64.
4. Leslie WD, O'Donnell S, Jean S, et al. Trends in hip fracture rates in Canada. JAMA 2009;302:883-9.
5. Tajeu GS, Delzell E, Smith W, et al. Death, debility, and destitution following hip fracture. J Gerontol A Biol Sci Med Sci 2014;69:346-53.
6. Nahm ES, Resnick B, Orwig D, et al. Exploration of informal caregiving following hip fracture. Geriatr Nurs 2010;31:254-62.
7. Saltz C, Zimmerman S, Tompkins C, et al. Stress among caregivers of hip fracture patients. J Gerontol Soc Work 1999;30:167-81.
8. Braithwaite RS, Col NF, Wong JB. Estimating hip fracture morbidity, mortality and costs. J Am Geriatr Soc 2003;51:364-70.
9. Burge R, Dawson-Hughes B, Solomon DH, et al. Incidence and economic burden of osteoporosis-related fractures in the United States, 2005-2025. J Bone Miner Res 2007;22:465-75.
10. Boulton C, Currie C, Griffiths R, et al. National hip fracture database: Anaesthesia sprint audit of practice. London: Royal College of Physicians, 2014.
11. Neuman MD, Rosenbaum PR, Ludwig JM, et al. Anesthesia technique, mortality, and length of stay after hip fracture surgery. JAMA 2014;311:2508-17.
12. White SM, Griffiths R, Holloway J, et al. Anaesthesia for proximal femoral fracture in the UK: first report from the NHS Hip Fracture Anaesthesia Network. Anaesthesia 2010;65:243-8.
13. Guay J, Parker MJ, Gajendragadkar PR, et al. Anaesthesia for hip fracture surgery in adults. Cochrane Database Syst Rev 2016;2: CD000521.
14. Parker MJ, Handoll HH, Griffiths R. Anaesthesia for hip fracture surgery in adults. Cochrane Database Syst Rev 2004(4):CD000521.
15. Murthy S, Hepner DL, Cooper Z, et al. Controversies in anaesthesia for noncardiac surgery in older adults. Br J Anaesth 2015;115(Suppl 2): 15-25.
16. Roberts KC, Brox WT. AAOS clinical practice guideline: management of hip fractures in the elderly. J Am Acad Orthop Surg 2015;23:138-40.
17. Luger TJ, Kammerlander C, Gosch M, et al. Neuroaxial versus general anaesthesia in geriatric patients for hip fracture surgery: does it matter Osteoporos Int 2010;21(Suppl 4):S555-72.
18. U.K. National Clinical Guideline Centre. The management of hip fracture in adults. London, UK: National Clinical Guideline Centre, 2011. http://www.ncgc.ac.uk
19. Thorpe KE, Zwarenstein M, Oxman AD, et al. A pragmaticexplanatory continuum indicator summary (PRECIS): a tool to help trial designers. J Clin Epidemiol 2009;62:464-75.
20. Ustun T, Kostanjsek N, Chatterji S. Measuring health and disability: manual for WHO disability assessment schedule (WHODAS 2.0). Geneva: World Health Organization, 2010.
21. Shulman MA, Myles PS, Chan MT, et al. Measurement of disabilityfree survival after surgery. Anesthesiology 2015;122:524-36.
22. Katzman R, Brown T, Fuld P, et al. Validation of a short orientation-memory-concentration test of cognitive impairment. Am J Psychiatry 1983;140:734-9.
23. Kawas C, Karagiozis H, Resau L, et al. Reliability of the Blessed Telephone Information-Memory-Concentration Test. J Geriatr Psychiatry Neurol 1995;8:238-42.
24. Palihnich K, Inouye SK, Marcantonio ER. The 3D CAM training manual for research. 2nd edn. Boston: Hospital Elder Life Program, 2014.
25. Marcantonio ER, Ngo LH, O'Connor M, et al. 3D-CAM: derivation and validation of a 3-minute diagnostic interview for CAM-defined delirium: a cross-sectional diagnostic test study. Ann Intern Med 2014;161:554-61.
26. Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singapore 1994;23:129-38.
27. Keller S, Bann CM, Dodd SL, et al. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004;20:309-18.
28. Smith BW, Dalen J, Wiggins K, et al. The brief resilience scale: assessing the ability to bounce back. Int J Behav Med 2008;15:194-200.
29. Chernik DA, Gillings D, Laine H, et al. Validity and reliability of the Observer's Assessment of Alertness/Sedation Scale: study with intravenous midazolam. J Clin Psychopharmacol 1990;10:244-51.
30. Carson JL, Terrin ML, Magaziner J, et al. Transfusion trigger trial for functional outcomes in cardiovascular patients undergoing surgical hip fracture repair (FOCUS). Transfusion 2006;46:2192-206.
31. Gill TM. Disentangling the disabling process: insights from the precipitating events project. Gerontologist 2014;54:533-49.
32. Juster FT, Suzman R. An overview of the health and retirement study. J Hum Res 1995;30:S7-S56.
33. Carson JL, Terrin ML, Noveck H, et al. Liberal or restrictive transfusion in high-risk patients after hip surgery. N Engl J Med 2011;365:2453-62.
34. Bauer M, Böhrer H, Aichele G, et al. Measuring patient satisfaction with anaesthesia: perioperative questionnaire versus standardised face-to-face interview. Acta Anaesthesiol Scand 2001;45:65-72.
35. Fuzier R, Bataille B, Fuzier V, et al. Spinal anesthesia failure after local anesthetic injection into cerebrospinal fluid: a multicenter prospective analysis of its incidence and related risk factors in 1214 patients. Reg Anesth Pain Med 2011;36:322-6.
36. Munhall RJ, Sukhani R, Winnie AP. Incidence and etiology of failed spinal anesthetics in a university hospital: a prospective study. Anesth Analg 1988;67:843-8.
37. Fettes PD, Jansson JR, Wildsmith JA. Failed spinal anaesthesia: mechanisms, management, and prevention. Br J Anaesth 2009;102:739-48.
38. Andrews G, Kemp A, Sunderland M, et al. Normative data for the 12 item WHO Disability Assessment Schedule 2.0. PLoS ONE 2009;4: e8343.
39. Saks EB, Dunn LB, Wimer J, et al. Proxy consent to research: the legal landscape. Yale J Health Policy Law Ethics 2008;8:37-92.
40. Matts JP, Lachin JM. Properties of permuted-block randomization in clinical-trials. Control Clin Trials 1988;9:327-44.
41. Lachin JM, Matts JP, Wei LJ. Randomization in clinical trials: conclusions and recommendations. Control Clin Trials 1988;9:365-74.
42. Breslow N, Day N. Statistical methods in medical research, : analysis of case-control studies. IARC Scientific Publications. Lyon, France: International Agency for Research on Cancer, volume 1, 1980.
43. Verbeke G, Molenberghs G, Thijs H, et al. Sensitivity analysis for nonrandom dropout: a local influence approach. Biometrics 2001;57:7-14.
44. Molenberghs G, Thijs H, Jansen I, et al. Analyzing incomplete longitudinal clinical trial data. Biostatistics 2004;5:445-64.
45. Inouye SK, van Dyck CH, Alessi CA, et al. Clarifying confusion: the confusion assessment method. A new method for detection of delirium. Ann Intern Med 1990;113:941-8.
46. U.S. Food and Drug Administration. Guidance for industry: oversight of clinical investigations-a risk-based approach to monitoring. Washington DC: US Department of Health and Human Services, 2013.