Survival and recovery after hip fracture surgery, overall and by timing of mobilisation

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Objective for processing

[2 paragraphs unchanged] Early mobilisation after hip fracture surgery is defined as getting out of bed within 36-hours of the procedure. Proponents of early mobilisation argue that longer waits affect recovery through rapid loss of muscle strength induced by bedrest. The average patient with hip fracture is 83 years old, frail, and has at least one comorbidity. For these patients, maintaining the strength required to get out of bed could mean the difference between returning home and admission to long-term care. Further, longer waits may lead to potentially-fatal complications such as pulmonary embolism, or pneumonia. The most effective rehabilitation after hip fracture is unclear. Discrepancy in findings may results from differences in care delivery or, differences between patients with hip fracture. King's College London (KCL) propose to determine the association between early mobilisation (as a care delivery related factor) on outcomes, as well as to identify patients with different risk of poor outcomes (as patient related factors). Care delivery factor: Early mobilisation after hip fracture surgery is defined as getting out of bed within 36-hours of the procedure. Proponents of early mobilisation argue that longer waits affect recovery through rapid loss of muscle strength induced by bed rest. The average patient with hip fracture is 83 years old, frail, and has at least one comorbidity. For these patients, maintaining the strength required to get out of bed could mean the difference between returning home and admission to long-term care. Further, longer waits may lead to potentially-fatal complications such as pulmonary embolism, or pneumonia. [1 paragraph unchanged] One obstacle in studying the effects of delayed mobilisation has been a lack of information about rehabilitation and recovery in hospitalisation records. Therefore, King's College propose to examine available records from the National Hip Fracture Database (NHFD). This registry assembles data on the timing of mobilisation, and functional status before and 30-days post-fracture for patients hospitalised with hip fracture in England, Wales and Northern Ireland. Patient factors: Previous rehabilitation trials attempted to account for differences between patients by targeting homogenous subgroups such as patients with cognitive impairment, women, or patients admitted from nursing homes. It is difficult to determine how these interventions may be implemented due to limited National Health Service (NHS) resources. Stratified rehabilitation considers an entire population accessing limited resources to identify subgroups of patients with different risk of poor outcomes. Subgroups are then matched to rehabilitation tailored to their needs to optimise outcomes across the entire population. Hip fracture survivors recently described this tailored approach as key to successful recovery. Further, a stratified approach is regarded central to the progress of healthcare according to the NHS. The purpose and aims are justified under Article 6 (1) (e). This project will address an evidence gap with a view to complete analysis performed in the public interest of informing quality improvement in rehabilitative care for patients with hip fracture. This project will also help to reduce unwarranted variation in current rehabilitative care to ensure high standards of quality and safety of rehabilitative health care (Article 9 (2) (i)). One obstacle in studying the effects of care delivery and patient factors has been a lack of information about rehabilitation and recovery in hospitalisation records. Therefore, King's College propose to examine available records from the National Hip Fracture Database (NHFD). This registry assembles data on the timing of mobilisation, and functional status before and 30-days post-fracture for patients hospitalised with hip fracture in England, Wales and Northern Ireland. [1 paragraph unchanged] Kings College London made an application to the Scientific and Publications Committee of the NHFD for access to data to identify patients with different risks of poor outcome, and to provide robust estimates of the effect of early mobilization (one of [9 words unchanged] was approved as it deemed to support the objectives of the NHFD. [4 paragraphs unchanged] This research will use the NHFD linked to HES to determine whether early mobilisation is associated with survival and recovery after hip fracture surgery. surgery, and whether these outcomes vary across patient groups overall and by mobilisation timing. More specifically, the objectives are: 1) To determine whether mobilisation within 36 hours of surgery is associated with the cumulative incidence of survival on discharge; 1) To identify patient groups with different risk of survival on discharge, and survival or recovery at 30-days post-fracture; 2) To determine whether mobilisation within 36 hours of surgery is associated with the cumulative incidence of survival and recovery at 30-days post-fracture; and on discharge; 3) To determine whether these putative associations vary across subgroups defined by characteristics of patients, their injury and care delivery. 3) To determine whether mobilisation within 36 hours of surgery is associated with survival and recovery at 30-days post-fracture; and 4) To determine whether these putative associations vary across subgroups defined by characteristics of patients, their injury and care delivery. The data subjects will consist of all patients 60 years of age or older who underwent hip fracture surgery in England or Wales between January 1st 2011 and December 31st 2016. KCL require HES Admitted Patient Care data for the years 2009/10 to 2016/17 linked to this cohort. KCL also require the fact of death status at 30 days post discharge from care. This data is required to address the research question posed by the amendment to enable us to accurately identify multifactorial subgroups with different risk of survival on discharge, and survival or recovery at 30-day post-fracture (with appropriate adjustment for potential confounding). The requested data will provide essential outcome data (survival at 30-days) as well as rich information on ethnic category, deprivation, comorbidities and complications for regression adjustment and subgroups in the proposed analyses. King’s College London require pseudonymised data to address the aims of this project which allows ‘the processing of personal data in such a way that the data can no longer be attributed to a specific data subject without the use of additional information’ (GDPR 2018). The additional information required to identify an individual will not be available at King’s College London. The NHFD collected relevant data for patients admitted with hip fracture to address the aims between January 1st 2011 and December 31st 2016. KCL require data from 2010/11 to 2016/17 to capture the care spell related to hip fracture and any death within 30-days of discharge from the care spell. KCL also require data for care spells in the year prior to the hip fracture care spell (2009/2010 to 2016/17) to identify comorbidities not coded in the hip fracture care spell for regression adjustment and subgroup. King’s College London require data for England and Wales. King’s College London require this geographical spread to capture patients who underwent surgery at a NHFD site participating in data collection related to mobilisation timing which is required to address the study aims. King’s College London confirm there are no alternative, less intrusive ways of achieving the purpose. The data is minimised to the cohort of patients whose care spell related to hip fracture between January 1st 2011 and December 31st, 2016, and care spells in the year prior to the care spell related to hip fracture. This data is required to address the research question posed by the amendment to enable King’s College London to accurately identify multifactorial subgroups with different risk of survival on discharge, and survival or recovery at 30-day post-fracture (with appropriate adjustment for potential confounding). Fact of death at 30-days is only required from the civil registration mortality dataset. Kings College London is the data controller and also processes the data for this study. No other organisations process the data for this purpose. There are no funders/commissioners involved in this research. [1 paragraph unchanged]

Processing activities

[1 paragraph unchanged] All patients 60 years of age or older who underwent hip fracture surgery in England, Wales, or Northern Ireland Wales between 2011 and 2016 (n = 225,000). ~225,000). [1 paragraph unchanged] King's College will retrieve received data on the characteristics of patients, their injury, and care delivery, survival [14 words unchanged] Hospital Episode Statistics linked to Civil Registration (mortality) data. A separate application will be was made to the Patient Episode Database for access to Welsh data. [1 paragraph unchanged] King's College will calculate the cumulative incidence of live discharge as a function of postoperative day, with in-hospital death being a competing event, overall and by timing of mobilisation. King's College will use regression with weighting by inverse propensity score to compare the ratio of live discharge, survival and recovery at 30-days, for patient subgroups overall, and by timing of mobilisation. Analyses will be adjusted for factors associated with poor survival and recovery after hip fracture surgery. Subgroup For each subgroup, KCL will estimate outcome probabilities. KCL will assess the extent to which a model predicts a higher probability of having an event among patients who will vs those who will not have an event (discrimination). They will also assess the accuracy of absolute risk estimates (calibration). KCL will then define cut points for low/medium and medium/high risk of poor outcome to enable identification of low, medium and high risk groups. Further subgroup and interaction analyses will be conducted to determine whether there is variation in the effect of mobilisation timing across patient subgroups. [1 paragraph unchanged] This study will determine whether early mobilisation is associated with survival and [11 words unchanged] most from early mobilisation, as optimal timing may vary across patient subgroups. The study will identify those at low, medium and high risk of poor outcome after hip fracture. [1 paragraph unchanged] Crown Informatics send sent NHS Number, Date of Birth, Forename and Surname, Full postcode, Study ID and date of admission to NHS Digital. NHS Digital provide provided Kings College London with HES pseudo non sensitive product data (inclusive of fact of death at 30 days) and Study ID. Kings College London will store the data electronically in a file that is only accessible by [17 words unchanged] and will only be used for the purposes outlined in this agreement. Kings College London will link linked by study ID the product data to pseudonymised NHFD data from Crown [17 words unchanged] Population Health and Environmental Sciences at King's College London. The team are are all substantive employees of King's College London or graduate students enrolled at King's College London and are subject to King's College London's policies, procedures and sanctions. The data will be held as an encrypted file on Kings College London’s secure network drive. The encrypted file will be held in an access-controlled area of the network drive and the data will be accessible to authorised study personnel only (who are substantive employees or graduate students, and have completed training), by means of a password or a recovery key. All users have their own username and password, and these will never be shared. Access to the data for the study will be cancelled as soon as a user leaves the study, Kings College London, or if they are absent for a long period. [1 paragraph unchanged] There will be no requirement/attempt to re-identify individuals. [1 paragraph unchanged]

Expected output

[2 paragraphs unchanged] 1. An interim report on the progress of the research to the funding body (National Institute for Health Research) in October 2019. [COMPLETED] 2. The final report to National Institute for Health Research: Research for Patient Benefit as condition of funding award within 14 days of the completion date in August November 2020. This will cover all findings of the study related to mobilisation timing including: the association between early mobilization, recovery, and survival overall and by subgroups defined by characteristics of the patients, their injury and care delivery. [COMPLETED] 3.Annual reports on the progress of research outputs (publications/presentations) to the funding body bodies and/ResearchFish for five years after the end of the study (National Institute for Health Research). Research, UK Research and Innovation). [1 paragraph unchanged] 4.1 Live discharge after hip fracture surgery in relation to timing of mobilisation. (target journal Osteoporosis International 2019) (Age & Ageing 2020) [completed] 4.2 30-day survival and recovery after hip fracture surgery in relation to timing of mobilisation. (target journal Age & Ageing Open Access 2019) Bone and Joint Journal 2020) [submitted] [1 paragraph unchanged] 4.4 Live discharge after hip fracture surgery in relation to timing of mobilisation by patient and care delivery factors. (target journal Medicine Injury 2020) [submitted] 4.5 30-day survival and recovery after hip fracture surgery in relation to timing of mobilisation by patient and care delivery factors. factors (target journal Osteoporosis International 2020) 5. A simplified version of the findings of each paper will be disseminated to patients and the public interested in research on hip fractures through the National Osteoporosis Society. This charity agreed disseminate this summary and findings from the project via their various media streams: updates/articles in their quarterly membership magazine Osteoporosis News (23,000 readership); their Bone Matters e-newsletter (21,000 readership); and on the research section of the charity͛s website (www.nos.org.uk/research). 4.6 Development of multivariable prognostic models for survival and recovery after hip fracture. (target journal Age and Ageing 2021) 6. For each paper published, a short presentation will be developed to summarize the findings for a range of stakeholders including healthcare professionals, policymakers, patients and their caregivers. Findings will be presented at: the Fragility Fracture Network 2019 and 2020, as well as the British Geriatric Society 2019 and 2020. 5. A simplified version of the findings of each paper will be disseminated to patients and the public interested in research on hip fractures through the National Osteoporosis Society [submitted]. This charity agreed disseminate this summary and findings from the project via their various media streams: updates/articles in their quarterly membership magazine Osteoporosis News (23,000 readership); their Bone Matters e-newsletter (21,000 readership); and on the research section of the charity͛s website (www.nos.org.uk/research). 6. For each paper published, a short presentation will be developed to summarize the findings for a range of stakeholders including healthcare professionals, policymakers, patients and their caregivers. Findings will be presented at: the Fragility Fracture Network 2019 [not completed due to maternity leave], 2021 and 2022, as well as the British Geriatric Society 2020 [completed], 2021, and 2022. KCL have presented the results at the British Orthopaedic Association annual conference, the Royal Osteoporosis Society annual conference and the British Geriatrics Society conference. The team have co-developed lay summaries with patients and their carers for completed and submitted papers. The lay summary for the completed paper is due for publication by the Royal Osteoporosis Society. [1 paragraph unchanged]

Expected measurable benefits

This study has been planned in conjunction with patients, their caregivers and treating clinicians. Support for this work: This study is also supported by the National Hip Fracture Database to meet has been planned in conjunction with patients, their demand for robust estimates of the effect of early mobilization (one of their core quality indicators) on outcomes. caregivers and treating clinicians. The Chartered Society of Physiotherapy has advocated for member engagement in quality [9 words unchanged] should therefore have direct, relevant, and measurable impact on physiotherapists across the UK. UK.This study is also supported by the National Hip Fracture Database to meet their demand for robust estimates of the effect of early mobilization (one of their core quality indicators) on outcomes. The information gained from this study will be the largest study undertaken to determine the association between a rehabilitation process measure (time to mobilisation) and patient outcomes. This will have direct implications for the way that rehabilitation care is delivered. In particular, policy makers and physiotherapy managers require this research to determine whether additional staffing is warranted to enable more patients to mobilise on the first postoperative day. Benefit to current care: This study will also indicate the potential direct cost benefit of early mobilisation. It will reflect differences in length of stay by mobilisation timing in our estimates of live discharge. Annually 75,000 patients are admitted to acute care with hip fracture. On average, these patients spend 15.5 days in hospital at £400 per day. If early mobilisation leads to one less day in hospital for half of all admissions this would reflect a cost saving of £15,000,000 each year. 1) The information gained from this study will be the largest study undertaken to determine the association between a rehabilitation process measure (time to mobilisation) and patient outcomes. This will have direct implications for the way that rehabilitation care is delivered and it's potential benefit to patients. In particular, policy makers and physiotherapy managers require this research to determine whether additional staffing is warranted to enable more patients to mobilise on the first postoperative day to maximise their opportunity for a positive outcome from their rehabilitation. The findings will also inform a future feasibility trial of stratified acute rehabilitation after hip fracture surgery (i.e. are there enough cases for subgroups, enough variation in practice to warrant trial of stratified acute rehabilitation). 2) This study will provide evidence to inform shared decision making surrounding early mobilisation after hip fracture surgery. The study will report in August 2020. 3) This study will also indicate the potential direct cost benefit of early mobilisation. It will reflect differences in length of stay by mobilisation timing in KCL's estimates of live discharge. Annually 75,000 patients are admitted to acute care with hip fracture. On average, these patients spend 15.5 days in hospital at £400 per day. If early mobilisation leads to one less day in hospital for half of all admissions this would reflect a cost saving of £15,000,000 each year which may be reallocated to other services . This project will help to inform a reduction in unwarranted variation in current rehabilitative care to ensure high standards of quality and safety of rehabilitative health care and in turn promote patient health. This will be achieved by addressing the aims outlined above which will 1) identify and report health inequities in access to early mobilisation after hip fracture and the impact of those inequities on outcomes, and 2) identify patient groups with differing risk of poor outcome after hip fracture to enable better tailored rehabilitation, and dissemination of the findings to stakeholders involved in the receipt, delivery, and organisation of rehabilitation after hip fracture, as outlined in the outputs section. It is therefore in the public interest to ensure high standards of quality and safety of rehabilitation for these people. It is appropriate for the proposed analysis to be completed and results disseminated as they will inform quality improvement initiatives to reduce unwarranted variation and improve the standards of quality and safety of rehabilitation after hip fracture. Benefit to future research: 1) The findings will inform a funded feasibility trial of stratified acute rehabilitation after hip fracture surgery. In 2017, the National Hip Fracture Database audit demonstrated marked national variation in the duration, frequency, and type of acute rehabilitation delivered by physiotherapists. This variation may be due to differences in patients and their needs receiving care. The proposed analysis will identify patient groups will different risk of poor outcome and these groups will subsequently be matched to rehabilitation better tailored to their needs. This has the potential to reduce unwarranted variation in delivery of rehabilitation. Patients and the NHS will achieve the benefit through improvements in standards of quality and safety of rehabilitative healthcare. The study will report on benefits to current care in November 2020 and inform a funded feasibility trial due to complete June 2024

Benefits reported

Yielded Benefits is not a requirement for new applications. To date, one manuscript has been accepted for publication: 1. This analysis found early mobilisation led to a two-fold increase in the adjusted odds of survival on discharge by 30-days postoperatively, accounting for the competing risk of death. Patients in the study focus group perceived early discharge as the benefit of early mobilisation. This was supported by KCL’s recent qualitative interview study where the primary patient reported goal of acute rehabilitation was to be discharged home. Yet there was no evidence for an association between mobilisation timing and discharge timing. This research provides the evidence for benefit, enabling patients to make an informed decision whether to mobilise early after hip fracture surgery. This analysis has been accepted for publication in Age and Ageing: Katie J. Sheehan, Aicha Goubar, Orouba Almilaji, Finbarr C. Martin, Chris Potter, Gareth D. Jones, Catherine Sackley, Salma Ayis. Discharge after hip fracture surgery by mobilisation timing: secondary analysis of the UK National Hip Fracture Database. Age and Ageing. 2020. In Press. 2. This analysis found, irrespective of dementia, delirium, hypotension, prefracture mobility or residence, early compared to late mobilisation increased the likelihood of hospital discharge by 30-days postoperatively. However, less patients with dementia, delirium, or hypotension, poorer prefracture mobility, or from residential care mobilised early. Research highlighted this care gap and will be used to lobby for sufficient resource and appropriate treatment techniques to enable all patients to benefit from early mobilisation. This analysis is under review at the journal Injury: Katie J. Sheehan, Aicha Goubar, Orouba Almilaji, Finbarr C. Martin, Chris Potter, Gareth D. Jones, Catherine Sackley, Salma Ayis. Discharge after hip fracture surgery in relation to mobilisation timing by patient characteristics: linked secondary analysis of the UK National Hip Fracture Database. Injury. 2020. Under review. 3. This analysis found, early mobilisation led to a 96% and 42% increase in the odds of 30-day survival and recovery respectively after admission with hip fracture when compared to late mobilisation. These increases were observed for those presenting with and without dementia, with the greatest association noted for those without dementia. These results in conjunction with those mentioned before provide evidence for a new Best Practice Tariff for early mobilisation after hip fracture surgery to enable staff to support all patients to mobilise early after the procedure. This manuscript has been submitted to the Bone and Joint Journal: Aicha Goubar, Finbarr C. Martin, Chris Potter, Gareth D. Jones, Catherine Sackley, Salma Ayis, and Katie J. Sheehan. 30-day survival and recovery after hip fracture by mobilisation timing and dementia: a UK database study. Bone and Joint Journal 2020; Submitted