Understanding the quality-of-life experiences of older or frail adults following a new dens fracture: Nonsurgical management in a hard collar versus early removal of collar.

INTRODUCTION: In the United Kingdom, fractures of the cervical dens process in older and/or frail patients are usually managed nonsurgically in a hard collar. However, hard collars can lead to complications and this management approach is now being questioned, with growing interest in maximising patients' short-term quality-of-life. It is vital that patients' perspectives are considered; yet, there is a dearth of literature examining the aspect. To help inform wider decision-making about use of collar/no collar management of dens fractures in older/frail people, we explored older/frail people's experience of the two management approaches and how they affected their perceived quality-of-life. METHODS: We interviewed older and/or frail adults with a recent dens fracture (aged ≥65 years or with a clinical frailty score of ≥5) or their caregiver. Participants were recruited from both arms of a clinical trial comparing management using a hard collar for 12 weeks (SM) with early removal of the collar (ERC) and were interviewed following randomisation and again, 12-16 weeks later. Data were analysed using a framework approach. RESULTS: Both participant groups (SM/ERC) reported substantial, negative quality-of-life (QoL) experiences, with the fall itself and lack of access to care services and information being frequent major contributory factors. Many negative experiences cut across both participant groups, including pain, fatigue, diminished autonomy and reduced involvement in personally meaningful activities. However, we identified some subtle, yet discernible, ways in which using SM/ERC reinforced or alleviated (negative) QoL impacts, with the perceived benefits/burdens to using SM/ERC varying between different individuals. CONCLUSION: Study findings can be used to support informed decision-making about SM/ERC management of dens fractures in older/frail patients. PATIENT OR PUBLIC CONTRIBUTION: Public and patient involvement contributors were involved in the study design, development of interview topic guides and interpretation of study findings.

Duration of External Neck Stabilisation (DENS) following odontoid fracture in older or frail adults: protocol for a randomised controlled trial of collar versus no collar.

INTRODUCTION: Fractures of the odontoid process frequently result from low impact falls in frail or older adults. These are increasing in incidence and importance as the population ages. In the UK, odontoid fractures in older adults are usually managed in hard collars to immobilise the fracture and promote bony healing. However, bony healing does not always occur in older adults, and bony healing is not associated with quality of life, functional, or pain outcomes. Further, hard collars can cause complications such as skin pressure ulcers, swallowing difficulties and difficulties with personal care. We hypothesise that management with no immobilisation may be superior to management in a hard collar for older or frail adults with odontoid fractures. METHODS AND ANALYSES: This is the protocol for the Duration of External Neck Stabilisation (DENS) trial-a non-blinded randomised controlled trial comparing management in a hard collar with management without a collar for older (≥65 years) or frail (Rockwood Clinical Frailty Scale ≥5) adults with a new odontoid fracture. 887 neurologically intact participants with any odontoid process fracture type will be randomised to continuing with a hard collar (standard care) or removal of the collar (intervention). The primary outcome is quality of life measured using the EQ-5D-5L at 12 weeks. Secondary outcomes include pain scores, neck disability index, health and social care use and costs, and mortality. ETHICS AND DISSEMINATION: Informed consent for participation will be sought from those able to provide it. We will also include those who lack capacity to ensure representativeness of frail and acutely unwell older adults. Results will be disseminated via scientific publication, lay summary, and visual abstract. The DENS trial received a favourable ethical opinion from the Scotland A Research Ethics Committee (21/SS/0036) and the Leeds West Research Ethics Committee (21/YH/0141). TRIAL REGISTRATION NUMBER: NCT04895644.