The Value of Nonoperative Versus Operative Treatment of Frail Institutionalized Elderly Patients with a Proximal Femoral Fracture in the Shade of Life (FRAIL-HIP); Protocol for a Multicenter Observational Cohort Study

Overview

Journal BMC Geriatr

Publisher Biomed Central

Specialty Geriatrics

Date 2019 Nov 10

PMID 31703579

Citations 11

Authors

Pieter Joosse

Sverre A I Loggers

C L P Marc Van de Ree

Romke van Balen

Jeroen Steens

Rutger G Zuurmond

Taco Gosens

Sven H van Helden

Suzanne Polinder

Hanna C Willems

Esther M M Van Lieshout

Affiliations

Soon will be listed here.

Abstract

Background: Proximal femoral fractures are strongly associated with morbidity and mortality in elderly patients. Mortality is highest among frail institutionalized elderly with both physical and cognitive comorbidities who consequently have a limited life expectancy. Evidence based guidelines on whether or not to operate on these patients in the case of a proximal femoral fracture are lacking. Practice variation occurs, and it remains unknown if nonoperative treatment would result in at least the same quality of life as operative treatment. This study aims to determine the effect of nonoperative management versus operative management of proximal femoral fractures in a selected group of frail institutionalized elderly on the quality of life, level of pain, rate of complications, time to death, satisfaction of the patient (or proxy) and the caregiver with the management strategy, and health care consumption.

Methods: This is a multicenter, observational cohort study. Frail institutionalized elderly (70 years or older with a body mass index < 18.5, a Functional Ambulation Category of 2 or lower pre-trauma, or an American Society of Anesthesiologists score of 4 or 5), who sustained a proximal femoral fracture are eligible to participate. Patients with a pathological or periprosthetic fractures and known metastatic oncological disease will be excluded. Treatment decision will be reached following a structured shared decision process. The primary outcome is quality of life (Euro-QoL; EQ-5D-5 L). Secondary outcome measures are quality of life measured with the QUALIDEM, pain level (PACSLAC), pain medication use, treatment satisfaction of patient (or proxy) and caregivers, quality of dying (QODD), time to death, and direct medical costs. A cost-utility and cost-effectiveness analysis will be done, using the EQ-5D utility score and QUALIDEM score, respectively. Non-inferiority of nonoperative treatment is assumed with a limit of 0.15 on the EQ-5D score. Data will be acquired at 7, 14, and 30 days and at 3 and 6 months after trauma.

Discussion: The results of this study will provide insight into the true value of nonoperative treatment of proximal femoral fractures in frail elderly with a limited life expectancy. The results may be used for updating (inter)national treatment guidelines.

Trial Registration: The study is registered at the Netherlands Trial Register (NTR7245; date 10-06-2018).

Citing Articles

Strategies to improve end-of-life decision-making and palliative care following hip fracture in frail older adults: a scoping review.

Tremblay A, Pelet S, Belzile E, Boulet J, Morency C, Dion N Age Ageing. 2024; 53(7).

PMID: 38970548 PMC: 11227115. DOI: 10.1093/ageing/afae134.

The Quality of Dying in Frail Institutionalized Older Patients After Nonoperative and Operative Management of a Proximal Femoral Fracture: An In-Depth Analysis.

Loggers S, van Balen R, Willems H, Gosens T, Polinder S, Ponsen K Am J Hosp Palliat Care. 2023; 41(6):583-591.

PMID: 37403839 PMC: 11032625. DOI: 10.1177/10499091231180556.

Intercontinental validation of a clinical prediction model for predicting 90-day and 2-year mortality in an Israeli cohort of 2033 patients with a femoral neck fracture aged 65 or above.

Oosterhoff J, Karhade A, Groot O, Schwab J, Heng M, Klang E Eur J Trauma Emerg Surg. 2023; 49(3):1545-1553.

PMID: 36757419 PMC: 10229470. DOI: 10.1007/s00068-023-02237-5.

Proximal Femur Fractures in the Elderly-A Novel Modality to Predict Mortality: The Neutrophil-to-Lymphocyte Ratio.

Marom O, Paz I, Segal D, Topaz G, Abelson N, Tavdi A J Clin Med. 2023; 12(2).

PMID: 36675385 PMC: 9865272. DOI: 10.3390/jcm12020456.

Nonoperative versus operative management of frail institutionalized older patients with a proximal femoral fracture: a cost-utility analysis alongside a multicenter prospective cohort study.

Loggers S, Geraerds A, Joosse P, Willems H, Gosens T, Van Balen R Osteoporos Int. 2023; 34(3):515-525.

PMID: 36609506 PMC: 9908658. DOI: 10.1007/s00198-022-06638-x.

References

Sims A, Parsons N, Achten J, Griffin X, Costa M, Reed M . The World Hip Trauma Evaluation Study 3: Hemiarthroplasty Evaluation by Multicentre Investigation - WHITE 3: HEMI - An Abridged Protocol. Bone Joint Res. 2016; 5(1):18-25. PMC: 4756728. DOI: 10.1302/2046-3758.51.2000473. View

Downey L, Curtis J, Lafferty W, Herting J, Engelberg R . The Quality of Dying and Death Questionnaire (QODD): empirical domains and theoretical perspectives. J Pain Symptom Manage. 2009; 39(1):9-22. PMC: 2815047. DOI: 10.1016/j.jpainsymman.2009.05.012. View

Peeters C, Visser E, van de Ree C, Gosens T, Den Oudsten B, de Vries J . Quality of life after hip fracture in the elderly: A systematic literature review. Injury. 2016; 47(7):1369-82. DOI: 10.1016/j.injury.2016.04.018. View

Zwakhalen S, Hamers J, Berger M . The psychometric quality and clinical usefulness of three pain assessment tools for elderly people with dementia. Pain. 2006; 126(1-3):210-20. DOI: 10.1016/j.pain.2006.06.029. View

Charlson M, Charlson R, Briggs W, Hollenberg J . Can disease management target patients most likely to generate high costs? The impact of comorbidity. J Gen Intern Med. 2007; 22(4):464-9. PMC: 1829434. DOI: 10.1007/s11606-007-0130-7. View

Holden M, Gill K, Magliozzi M, Nathan J . Clinical gait assessment in the neurologically impaired. Reliability and meaningfulness. Phys Ther. 1984; 64(1):35-40. DOI: 10.1093/ptj/64.1.35. View

Zwakhalen S, Hamers J, Berger M . Improving the clinical usefulness of a behavioural pain scale for older people with dementia. J Adv Nurs. 2007; 58(5):493-502. DOI: 10.1111/j.1365-2648.2007.04255.x. View

Neuman M, Silber J, Magaziner J, Passarella M, Mehta S, Werner R . Survival and functional outcomes after hip fracture among nursing home residents. JAMA Intern Med. 2014; 174(8):1273-80. PMC: 4122620. DOI: 10.1001/jamainternmed.2014.2362. View

White I, Royston P, Wood A . Multiple imputation using chained equations: Issues and guidance for practice. Stat Med. 2011; 30(4):377-99. DOI: 10.1002/sim.4067. View

10.

Black W . The CE plane: a graphic representation of cost-effectiveness. Med Decis Making. 1990; 10(3):212-4. DOI: 10.1177/0272989X9001000308. View

11.

Van Balen R, Steyerberg E, Polder J, Ribbers T, Habbema J, Cools H . Hip fracture in elderly patients: outcomes for function, quality of life, and type of residence. Clin Orthop Relat Res. 2001; (390):232-43. View

12.

Shabat S, Mann G, Gepstein R, Fredman B, Folman Y, Nyska M . Operative treatment for hip fractures in patients 100 years of age and older: is it justified?. J Orthop Trauma. 2004; 18(7):431-5. DOI: 10.1097/00005131-200408000-00007. View

13.

van Beeck E, Larsen C, Lyons R, Meerding W, Mulder S, Essink-Bot M . Guidelines for the conduction of follow-up studies measuring injury-related disability. J Trauma. 2007; 62(2):534-50. DOI: 10.1097/TA.0b013e31802e70c7. View

14.

Ishimaru D, Ogawa H, Maeda M, Shimizu K . Outcomes of elderly patients with proximal femoral fractures according to positive criteria for surgical treatment. Orthopedics. 2012; 35(3):e353-8. DOI: 10.3928/01477447-20120222-21. View

15.

Jain R, Basinski A, Kreder H . Nonoperative treatment of hip fractures. Int Orthop. 2003; 27(1):11-7. PMC: 3673693. DOI: 10.1007/s00264-002-0404-y. View

16.

Ooi L, Wong T, Toh C, Wong H . Hip fractures in nonagenarians--a study on operative and non-operative management. Injury. 2004; 36(1):142-7. DOI: 10.1016/j.injury.2004.05.030. View

17.

Fuchs-Lacelle S, Hadjistavropoulos T . Development and preliminary validation of the pain assessment checklist for seniors with limited ability to communicate (PACSLAC). Pain Manag Nurs. 2004; 5(1):37-49. DOI: 10.1016/j.pmn.2003.10.001. View

18.

Arons A, Wetzels R, Zwijsen S, Verbeek H, van de Ven G, Ettema T . Structural validity and internal consistency of the Qualidem in people with severe dementia. Int Psychogeriatr. 2017; 30(1):49-59. DOI: 10.1017/S1041610217001405. View

19.

Lamers L, Stalmeier P, McDonnell J, Krabbe P, van Busschbach J . [Measuring the quality of life in economic evaluations: the Dutch EQ-5D tariff]. Ned Tijdschr Geneeskd. 2005; 149(28):1574-8. View

20.

van de Ree C, de Jongh M, Peeters C, de Munter L, Roukema J, Gosens T . Hip Fractures in Elderly People: Surgery or No Surgery? A Systematic Review and Meta-Analysis. Geriatr Orthop Surg Rehabil. 2017; 8(3):173-180. PMC: 5557195. DOI: 10.1177/2151458517713821. View