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

Abstract

BackgroundProximal 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.MethodsThis 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.DiscussionThe 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 registrationThe study is registered at the Netherlands Trial Register (NTR7245; date 10-06-2018).

Shared decision-making for the treatment of proximal femoral fractures in frail institutionalised older patients: healthcare providers’ perceived barriers and facilitators

“…This cross-sectional questionnaire study followed the ‘Strengthening the Reporting of Observational studies in Epidemiology’ (STROBE) guidelines. The online questionnaire was programmed in LimeSurvey (Version 2.06lts) [ 25 ] and widely disseminated via the project team and FRAIL-HIP study group [ 26 ] to an extensive network of healthcare providers working in the departments of trauma surgery, orthopaedic surgery and in-hospital geriatrics, and to older people’s care physicians. Within Dutch healthcare, dedicated healthcare providers, named older people’s care physicians, in nursing homes are responsible for the care of frail older institutionalised patients.…”

“…The questionnaire was adapted and evaluated rigorously by the FRAIL-HIP study team until consensus was reached [ 26 ]. The pre-final version was pilot tested by six healthcare providers.…”

Orthogeriatric co-management for the care of older subjects with hip fracture: recommendations from an Italian intersociety consensus

“…It has been widely demonstrated that surgery provides better outcomes in terms of pain control, functional level, and medium-to long-term mortality in compromised individuals [50]. Surgery should, therefore, be performed in almost every instance with conservative management of HF being restricted to specific patient groups.…”

Outcome of nonoperative treatment for hip fractures in elderly patients: A systematic review of recent literature

“…A future strictly designed and adequately powered trial is essential. 36 We believe that in the event that such a study is conducted, then, our study is one of the largest analyses in the literature comparing contemporary methods of operative and nonoperative treatment and can be used as the basis for power calculations.…”