Screening and Intervention to Prevent Falls and Fractures in Older People.

BACKGROUND: Community screening and therapeutic prevention strategies may reduce the incidence of falls in older people. The effects of these measures on the incidence of fractures, the use of health resources, and health-related quality of life are unknown. METHODS: In a pragmatic, three-group, cluster-randomized, controlled trial, we estimated the effect of advice sent by mail, risk screening for falls, and targeted interventions (multifactorial fall prevention or exercise for people at increased risk for falls) as compared with advice by mail only. The primary outcome was the rate of fractures per 100 person-years over 18 months. Secondary outcomes were falls, health-related quality of life, frailty, and a parallel economic evaluation. RESULTS: We randomly selected 9803 persons 70 years of age or older from 63 general practices across England: 3223 were assigned to advice by mail alone, 3279 to falls-risk screening and targeted exercise in addition to advice by mail, and 3301 to falls-risk screening and targeted multifactorial fall prevention in addition to advice by mail. A falls-risk screening questionnaire was sent to persons assigned to the exercise and multifactorial fall-prevention groups. Completed screening questionnaires were returned by 2925 of the 3279 participants (89%) in the exercise group and by 2854 of the 3301 participants (87%) in the multifactorial fall-prevention group. Of the 5779 participants from both these groups who returned questionnaires, 2153 (37%) were considered to be at increased risk for falls and were invited to receive the intervention. Fracture data were available for 9802 of the 9803 participants. Screening and targeted intervention did not result in lower fracture rates; the rate ratio for fracture with exercise as compared with advice by mail was 1.20 (95% confidence interval [CI], 0.91 to 1.59), and the rate ratio with multifactorial fall prevention as compared with advice by mail was 1.30 (95% CI, 0.99 to 1.71). The exercise strategy was associated with small gains in health-related quality of life and the lowest overall costs. There were three adverse events (one episode of angina, one fall during a multifactorial fall-prevention assessment, and one hip fracture) during the trial period. CONCLUSIONS: Advice by mail, screening for fall risk, and a targeted exercise or multifactorial intervention to prevent falls did not result in fewer fractures than advice by mail alone. (Funded by the National Institute of Health Research; ISRCTN number, ISRCTN71002650.).

Characteristics of L-PRP preparations for treating Achilles tendon rupture within the PATH-2 study.

Platelet-rich plasma (PRP) is an autologous preparation that has been claimed to improve healing and mechanobiological properties of tendons both in vitro and in vivo. In this sub-study from the PATH-2 (PRP in Achilles Tendon Healing-2) trial, we report the cellular and growth factor content and quality of the Leukocyte-rich PRP (L-PRP) (N = 103) prepared using a standardized commercial preparation method across 19 different UK centers. Baseline whole blood cell counts (red cells, leukocyte and platelets) demonstrated that the two groups were well-matched. L-PRP analysis gave a mean platelet count of 852.6 x 109/L (SD 438.96), a mean leukocyte cell count of 15.13 x 109/L (SD 10.28) and a mean red blood cell count of 0.91 x 1012/L (SD 1.49). The activation status of the L-PRP gave either low or high expression levels of the degranulation marker CD62p before and after ex-vivo platelet activation respectively. TGF-ß, VEGF, PDGF, IGF and FGFb mean concentrations were 131.92 ng/ml, 0.98 ng/ml, 55.34 ng/ml, 78.2 ng/ml and 111.0 pg/ml respectively with expected correlations with both platelet and leukocyte counts. While PATH-2 results demonstrated that there was no evidence L-PRP is effective for improving clinical outcomes at 24 weeks after Achilles tendon rupture, our findings support that the majority of L-PRP properties were within the method specification and performance.

Effect of platelet-rich plasma on healing tissues in acute ruptured Achilles tendon: a human immunohistochemistry study.

BACKGROUND: Platelet-rich plasma (PRP), an autologous derivative of whole blood that contains a supraphysiological concentration of platelets, is thought to invoke an earlier and improved tissue healing response. This notion has been supported by in-vitro and animal studies in bone, cartilage, tendon, and muscle. To our knowledge no published study exists of the effects of PRP in human tissues in vivo. The aim of our study was to investigate the response of ruptured Achilles tendon treated with PRP. METHODS: Tendon tissue biopsy samples were obtained from 20 patients with ruptured Achilles tendon by means of ultrasound-guided needle biopsies from the healing area of the Achilles tendon 6 weeks after treatment with PRP or placebo controls (10 patients each). All samples were embedded in paraffin wax, sectioned, and stained with haematoxylin and eosin and alcian blue. Immunohistochemistry markers were used to identify collagen I and III, lymphocytes (CD45), proliferation (KI67), and blood vessels (CD34). All images were masked and analysed with Image J software. FINDINGS: Cellularity and glycosaminoglycans content were significantly higher in PRP-treated tendons than in controls (p=0·01 and p<0·001, respectively). Fibre structure of the tissue was significantly better in the PRP group than in the control tissue (p<0·001). Although both groups showed high collagen I staining, content of collagen I was significantly higher in PRP-treated tendons than in control tendons (p=0·0079), whereas collagen III content was not different (p=1·0). The ratio of collagen III to collagen I was significantly lower in PRP samples (p=0·007). There was no significant difference in CD45 expression (p=0·33). However, PRP samples had fewer blood vessels than did control samples (p=0·023). The overall modified Bonar score was significantly lower in PRP samples, which indicates improved early tendon healing. INTERPRETATION: This is the first study, to our knowledge, to report the immunohistochemical response of ruptured human Achilles tendon to PRP. The findings reveal that locally applied PRP enhanced the maturity of the healing tendon tissues by promoting better collagen I deposition, decreased cellularity, less vascularity, and higher glycosaminoglycan content when compared with control samples. Further work is required to determine the longer term effects of the use of PRP in musculoskeletal diseases. FUNDING: National Institute for Health Research.

Close Contact Casting vs Surgery for Initial Treatment of Unstable Ankle Fractures in Older Adults: A Randomized Clinical Trial.

Importance: Ankle fractures cause substantial morbidity in older persons. Surgical fixation is the contemporary intervention but is associated with infection and other healing complications. Objective: To determine whether initial fracture treatment with close contact casting, a molded below-knee cast with minimal padding, offers outcome equivalent to that with immediate surgery, with fewer complications and less health resource use. Design, Setting, and Participants: This was a pragmatic, equivalence, randomized clinical trial with blinded outcome assessors. A pilot study commenced in May 2004, followed by multicenter recruitment from July 2010 to November 2013; follow-up was completed May 2014. Recruitment was from 24 UK major trauma centers and general hospitals. Participants were 620 adults older than 60 years with acute, overtly unstable ankle fracture. Exclusions were serious limb or concomitant disease or substantial cognitive impairment. Interventions: Participants were randomly assigned to surgery (n = 309) or casting (n = 311). Casts were applied in the operating room under general or spinal anesthesia by a trained surgeon. Main Outcomes and Measures: The primary 6-month, per-protocol outcome was the Olerud-Molander Ankle Score at 6 months (OMAS; range, 0-100; higher scores indicate better outcomes and fewer symptoms), equivalence prespecified as ±6 points. Secondary outcomes were quality of life, pain, ankle motion, mobility, complications, health resource use, and patient satisfaction. Results: Among 620 adults (mean age, 71 years; 460 [74%] women) who were randomized, 593 (96%) completed the study. Nearly all participants (579/620; 93%) received allocated treatment; 52 of 275 (19%) who initially received casting later converted to surgery, which was allowable in the casting treatment pathway to manage early loss of fracture reduction. At 6 months, casting resulted in ankle function equivalent to that with surgery (OMAS score, 66.0 [95% CI, 63.6-68.5] for surgery vs 64.5 [95% CI, 61.8-67.2] for casting; mean difference, -0.6 [95% CI, -3.9 to 2.6]; P for equivalence = .001). Infection and wound breakdown were more common with surgery (29/298 [10%] vs 4/275 [1%]; odds ratio [OR], 7.3 [95% CI, 2.6-20.2]), as were additional operating room procedures (18/298 [6%] for surgery and 3/275 [1%] for casting; OR, 5.8 [95% CI, 1.8-18.7]). Radiologic malunion was more common in the casting group (38/249 [15%] vs 8/274 [3%] for surgery; OR, 6.0 [95% CI, 2.8-12.9]). Casting required less operating room time compared with surgery (mean difference [minutes/participant], -54 [95% CI, -58 to -50]). There were no significant differences in other secondary outcomes: quality of life, pain, ankle motion, mobility, and patient satisfaction. Conclusions and Relevance: Among older adults with unstable ankle fracture, the use of close contact casting compared with surgery resulted in similar functional outcomes at 6 months. Close contact casting may be an appropriate treatment for such patients. Trial Registration: isrctn.com Identifier: ISRCTN04180738.

Tranexamic acid use in severely injured civilian patients and the effects on outcomes: a prospective cohort study.

OBJECTIVE: To characterize the relationship between tranexamic acid (TXA) use and patient outcomes in a severely injured civilian cohort, and to determine any differential effect between patients who presented with and without shock. BACKGROUND: TXA has demonstrated survival benefits in trauma patients in an international randomized control trial and the military setting. The uptake of TXA into civilian major hemorrhage protocols (MHPs) has been variable. The evidence gap in mature civilian trauma systems is limiting the widespread use of TXA and its potential benefits on survival. METHODS: Prospective cohort study of severely injured adult patients (Injury severity score > 15) admitted to a civilian trauma system during the adoption phase of TXA into the hospital's MHP. Outcomes measured were mortality, multiple organ failure (MOF), venous thromboembolism, infection, stroke, ventilator-free days (VFD), and length of stay. RESULTS: Patients receiving TXA (n = 160, 42%) were more severely injured, shocked, and coagulopathic on arrival. TXA was not independently associated with any change in outcome for either the overall or nonshocked cohorts. In multivariate analysis, TXA was independently associated with a reduction in MOF [odds ratio (OR) = 0.27, confidence interval (CI): 0.10-0.73, P = 0.01] and was protective for adjusted all-cause mortality (OR = 0.16 CI: 0.03-0.86, P = 0.03) in shocked patients. CONCLUSIONS: TXA as part of a major hemorrhage protocol within a mature civilian trauma system provides outcome benefits specifically for severely injured shocked patients.

Ankle Injury Management (AIM): design of a pragmatic multi-centre equivalence randomised controlled trial comparing Close Contact Casting (CCC) to Open surgical Reduction and Internal Fixation (ORIF) in the treatment of unstable ankle fractures in patients over 60 years.

BACKGROUND: Ankle fractures account for 9% of all fractures with a quarter of these occurring in adults over 60 years. The short term disability and long-term consequences of this injury can be considerable. Current opinion favours open reduction and internal fixation (ORIF) over non-operative treatment (fracture manipulation and the application of a standard moulded cast) for older people. Both techniques are associated with complications but the limited published research indicates higher complication rates of fracture malunion (poor position at healing) with casting. The aim of this study is to compare ORIF with a modification of existing casting techniques, Close Contact Casting (CCC). We propose that CCC may offer an equivalent functional outcome to ORIF and avoid the risks associated with surgery. METHODS/DESIGN: This study is a pragmatic multi-centre equivalence randomised controlled trial. 620 participants will be randomised to receive ORIF or CCC after sustaining an isolated displaced unstable ankle fracture. Participants will be recruited from a minimum of 20 National Health Service (NHS) acute hospitals throughout England and Wales. Participants will be aged over 60 years and be ambulatory prior to injury. Follow-up will be at six weeks and six months after randomisation. The primary outcome is the Olerud & Molander Ankle Score, a functional patient reported outcome measure, at 6 months. Follow-up will also include assessments of mobility, ankle range of movement, health related quality of life and complications. The six-month follow-up will be conducted face-to-face by an assessor blinded to the allocated intervention. A parallel economic evaluation will consider both a health service and a broader societal perspective including the individual and their family. In order to explore patient experience of their treatment and recovery, a purposive sample of 40 patients will also be interviewed using a semi-structured interview schedule between 6-10 weeks post treatment. DISCUSSION: This multicentre study was open to recruitment July 2010 and recruitment is due to be completed in December 2013. TRIAL REGISTRATION: Current Controlled Trials ISRCTN04180738.

Mobile phone use for contacting emergency services in life-threatening circumstances.

BACKGROUND: The potential health benefits of mobile phone use have not been widely studied, except for telemedicine-type applications. STUDY OBJECTIVES: This study seeks to determine whether initial contact with emergency services via a mobile phone in life-threatening situations is associated with potential health benefits when compared to contact via a landline. METHODS: A record-linkage study was carried out in which data from all emergency dispatches for immediately life-threatening events from a United Kingdom county ambulance service were linked to the Patient Admission System at two major local hospitals. Mortality (at the scene, at the emergency department [ED], and during hospitalization); transfer to the ED; admission (inpatient care, and intensive care unit); and length of stay were analyzed for calls classified as Code Red (immediately life-threatening) by initial exposure (mobile phone vs. landline), while controlling for potential confounding variables. RESULTS: Of 354,199 ambulances dispatched to attend emergency incidents, 66% transported patients to the hospital while 2% stood down due to death at the scene. Mobile phone compared to landline reporting of emergencies resulted in significant reductions in the risk of death at the scene (odds ratio [OR] 0.77), but not for death in the ED or during inpatient admission. The risk of being transferred to the ED and subsequent inpatient admission were significantly lower with reporting from mobile phones compared to landline (OR 0.93 and OR 0.82, respectively). CONCLUSIONS: In this study, evidence of statistical association was demonstrated between the use of mobile phones to alert ambulance services in life-threatening situations and improved outcomes for patients.

Radiological malunion after ankle fractures in older adults : definitions and new thresholds derived from clinical outcome data from the AIM trial.

AIMS: The rationale for exacting restoration of skeletal anatomy after unstable ankle fracture is to improve outcomes by reducing complications from malunion; however, current definitions of malunion lack confirmatory clinical evidence. METHODS: Radiological (absolute radiological measurements aided by computer software) and clinical (clinical interpretation of radiographs) definitions of malunion were compared within the Ankle Injury Management (AIM) trial cohort, including people aged ≥ 60 years with an unstable ankle fracture. Linear regressions were used to explore the relationship between radiological malunion (RM) at six months and changes in function at three years. Function was assessed with the Olerud-Molander Ankle Score (OMAS), with a minimal clinically important difference set as six points, as per the AIM trial. Piecewise linear models were used to investigate new radiological thresholds which better explain symptom impact on ankle function. RESULTS: Previously described measures of RM and surgeon opinion of clinically significant malunion (CSM) were shown to be related but with important differences. CSM was more strongly related to outcome (-13.9 points on the OMAS; 95% confidence interval (CI) -21.9 to -5.4) than RM (-5.5 points; 95% CI -9.8 to -1.2). Existing malunion thresholds for talar tilt and tibiofibular clear space were shown to be slightly conservative; new thresholds which better explain function were identified (talar tilt > 2.4°; tibiofibular clear space > 6 mm). Based on this new definition the presence of RM had an impact on function, which was statistically significant, but the clinical significance was uncertain (-9.1 points; 95% CI -13.8 to -4.4). In subsequent analysis, RM of a posterior malleolar fracture was shown to have a statistically significant impact on OMAS change scores, but the clinical significance was uncertain (-11.6 points; 95% CI -21.9 to -0.6). CONCLUSION: These results provide clinical evidence which supports the previously accepted definitions. Further research to investigate more conservative clinical thresholds for malunion is indicated.Cite this article: Bone Jt Open 2022;3(10):841-849.

Platelet-rich plasma injection for acute Achilles tendon rupture : two-year follow-up of the PATH-2 randomized, placebo-controlled, superiority trial.

AIMS: To determine whether platelet-rich plasma (PRP) injection improves outcomes two years after acute Achilles tendon rupture. METHODS: A randomized multicentre two-arm parallel-group, participant- and assessor-blinded superiority trial was undertaken. Recruitment commenced on 28 July 2015 and two-year follow-up was completed in 21 October 2019. Participants were 230 adults aged 18 years and over, with acute Achilles tendon rupture managed with non-surgical treatment from 19 UK hospitals. Exclusions were insertion or musculotendinous junction injuries, major leg injury or deformity, diabetes, platelet or haematological disorder, medication with systemic corticosteroids, anticoagulation therapy treatment, and other contraindicating conditions. Participants were randomized via a central online system 1:1 to PRP or placebo injection. The main outcome measure was Achilles Tendon Rupture Score (ATRS) at two years via postal questionnaire. Other outcomes were pain, recovery goal attainment, and quality of life. Analysis was by intention-to-treat. RESULTS: A total of 230 participants were randomized, 114 to PRP and 116 to placebo. Two-year questionnaires were sent to 216 participants who completed a six-month questionnaire. Overall, 182/216 participants (84%) completed the two-year questionnaire. Participants were aged a mean of 46 years (SD 13.0) and 25% were female (57/230). The majority of participants received the allocated intervention (219/229, 96%). Mean ATRS scores at two years were 82.2 (SD 18.3) in the PRP group (n = 85) and 83.8 (SD 16.0) in the placebo group (n = 92). There was no evidence of a difference in the ATRS at two years (adjusted mean difference -0.752, 95% confidence interval -5.523 to 4.020; p = 0.757) or in other secondary outcomes, and there were no re-ruptures between 24 weeks and two years. CONCLUSION: PRP injection did not improve patient-reported function or quality of life two years after acute Achilles tendon rupture compared with placebo. The evidence from this study indicates that PRP offers no patient benefit in the longer term for patients with acute Achilles tendon rupture.Cite this article: Bone Joint J 2022;104-B(11):1256-1265.

Progressive exercise versus best practice advice for adults aged 50 years or over after ankle fracture: the AFTER pilot randomised controlled trial.

OBJECTIVE: The aim of the Ankle Fracture Treatment: Enhancing Rehabilitation (AFTER) study, a multicentre external pilot parallel-group randomised controlled trial (RCT), was to assess feasibility of a definitive trial comparing rehabilitation approaches after ankle fracture. SETTING: Five UK National Health Service hospitals. PARTICIPANTS: Participants were aged 50 years and over with an ankle fracture requiring immobilisation for at least 4 weeks. INTERVENTIONS: Participants were allocated 1:1 via a central web-based randomisation system to: (1) best practice advice (one session of physiotherapy, up to two optional additional advice sessions) or (2) progressive exercise (up to six sessions of physiotherapy). PRIMARY OUTCOME MEASURES: Feasibility: (1) participation rate, (2) intervention adherence and (3) retention. RESULTS: Sixty-one of 112 (54%) eligible participants participated, exceeding progression criteria for participation of 25%. Recruitment progression criteria was 1.5 participants per site per month and 1.4 was observed. At least one intervention session was delivered for 28/30 (93%) of best practice advice and 28/31 (90%) of progressive exercise participants, exceeding the 85% progression criteria. For those providing follow-up data, the proportion of participants reporting performance of home exercises in the best practice advice and the progressive exercise groups at 3 months was 20/23 (87%) and 21/25 (84%), respectively. Mean time from injury to starting physiotherapy was 74.1 days (95% CI 53.9 to 94.1 days) for the best practice advice and 72.7 days (95% CI 54.7 to 88.9) for the progressive exercise group. Follow-up rate (6-month Olerud and Molander Ankle Score) was 28/30 (93%) for the best practice advice group and 26/31 (84%) in the progressive exercise group with an overall follow-up rate of 89%. CONCLUSIONS: This pilot RCT demonstrated that a definitive trial would be feasible. The main issues to address for a definitive trial are intervention modifications to enable earlier provision of rehabilitation and ensuring similar rates of follow-up in each group. TRIAL REGISTRATION NUMBER: ISRCTN16612336.

Outcome measures in major trauma care: a review of current international trauma registry practice.

Multiple reports over the past 20 years have criticised the care delivered to major trauma patients in England. The setting up of regional trauma networks is well underway to address these deficiencies. Outcomes currently collected in major trauma are restricted to mortality rates and process measures; however, many patients are left with long-term disabilities and reduced quality of life (QoL), which are not measured at present. Trauma systems need to develop outcome measures that capture this important information to judge the quality of care and influence the development of services. This review aimed to identify the current practice of international trauma registries with regard to outcome measurement and review the literature surrounding these measures. An internet-based search of international trauma registry websites including data dictionaries and annual reports was carried out as well as a literature review to determine what outcome measures are routinely collected by trauma registries. All registries were found to look at mortality and process measures, but only one registry routinely collected morbidity outcome measures for both adults and children. There is a considerable amount of disability and reduced QoL in survivors of major trauma that lasts for years following the injury. At present only the Victorian State Trauma Registry collects outcome measures that evaluate the extent of this. English regional trauma networks and the Trauma Audit and Research Network have the opportunity to learn from this experience and routinely start to collect measures of outcome that can drive service improvement and reduce patient morbidity.

Patient and informal carer experience of hip fracture: a qualitative study using interviews and observation in acute orthopaedic trauma.

OBJECTIVES: The time taken for older people to recover from hip fracture can be extensive. The aim of this study was to gain an understanding of patient and informal carer experience of recovery in the early stage, while in acute care. DESIGN: A phenomenological (lived experience) approach was used to guide the design of the study. Interviews and observation took place between March 2016 and December 2016 in acute care. SETTING: Trauma wards in a National Health Service Foundation Trust in the South West of England. PARTICIPANTS: A purposive sample of 25 patients were interviewed and observation taking 52 hours was undertaken with 13 patients and 12 staff. 11 patients had memory loss, 2 patients chose to take part in an interview and observation. The age range was 63-91 years (median 83), 10 were men. A purposive sample of 25 informal carers were also interviewed, the age range was 42-95 years (mean 64), 11 were men. RESULTS: The results identified how participants moved forward together after injury by sharing the journey. This was conveyed through three themes: (1) sustaining relationships while experiencing strong emotions and actively helping, (2) becoming aware of uncertainty about the future and working through possible outcomes, (3) being changed, visibly looking different, not being able to walk, and enduring indignity and pain. CONCLUSION: This study identified the experience of patients and informal carers as they shared the journey during a challenging life transition. Strategies that support well-being and enable successful negotiation of the emotional and practical challenges of acute care may help with longer term recovery. Research should focus on developing interventions that promote well-being during this transition to help provide the foundation for patients and carers to live fulfilled lives.

Fall prevention interventions in primary care to reduce fractures and falls in people aged 70 years and over: the PreFIT three-arm cluster RCT.

BACKGROUND: Falls and fractures are a major problem. OBJECTIVES: To investigate the clinical effectiveness and cost-effectiveness of alternative falls prevention interventions. DESIGN: Three-arm, pragmatic, cluster randomised controlled trial with parallel economic analysis. The unit of randomisation was the general practice. SETTING: Primary care. PARTICIPANTS: People aged ≥ 70 years. INTERVENTIONS: All practices posted an advice leaflet to each participant. Practices randomised to active intervention arms (exercise and multifactorial falls prevention) screened participants for falls risk using a postal questionnaire. Active treatments were delivered to participants at higher risk of falling. MAIN OUTCOME MEASURES: The primary outcome was fracture rate over 18 months, captured from Hospital Episode Statistics, general practice records and self-report. Secondary outcomes were falls rate, health-related quality of life, mortality, frailty and health service resource use. Economic evaluation was expressed in terms of incremental cost per quality-adjusted life-year and incremental net monetary benefit. RESULTS: Between 2011 and 2014, we randomised 63 general practices (9803 participants): 21 practices (3223 participants) to advice only, 21 practices (3279 participants) to exercise and 21 practices (3301 participants) to multifactorial falls prevention. In the active intervention arms, 5779 out of 6580 (87.8%) participants responded to the postal fall risk screener, of whom 2153 (37.3%) were classed as being at higher risk of falling and invited for treatment. The rate of intervention uptake was 65% (697 out of 1079) in the exercise arm and 71% (762 out of 1074) in the multifactorial falls prevention arm. Overall, 379 out of 9803 (3.9%) participants sustained a fracture. There was no difference in the fracture rate between the advice and exercise arms (rate ratio 1.20, 95% confidence interval 0.91 to 1.59) or between the advice and multifactorial falls prevention arms (rate ratio 1.30, 95% confidence interval 0.99 to 1.71). There was no difference in falls rate over 18 months (exercise arm: rate ratio 0.99, 95% confidence interval 0.86 to 1.14; multifactorial falls prevention arm: rate ratio 1.13, 95% confidence interval 0.98 to 1.30). A lower rate of falls was observed in the exercise arm at 8 months (rate ratio 0.78, 95% confidence interval 0.64 to 0.96), but not at other time points. There were 289 (2.9%) deaths, with no differences by treatment arm. There was no evidence of effects in prespecified subgroup comparisons, nor in nested intention-to-treat analyses that considered only those at higher risk of falling. Exercise provided the highest expected quality-adjusted life-years (1.120), followed by advice and multifactorial falls prevention, with 1.106 and 1.114 quality-adjusted life-years, respectively. NHS costs associated with exercise (£3720) were lower than the costs of advice (£3737) or of multifactorial falls prevention (£3941). Although incremental differences between treatment arms were small, exercise dominated advice, which in turn dominated multifactorial falls prevention. The incremental net monetary benefit of exercise relative to treatment valued at £30,000 per quality-adjusted life-year is modest, at £191, and for multifactorial falls prevention is £613. Exercise is the most cost-effective treatment. No serious adverse events were reported. LIMITATIONS: The rate of fractures was lower than anticipated. CONCLUSIONS: Screen-and-treat falls prevention strategies in primary care did not reduce fractures. Exercise resulted in a short-term reduction in falls and was cost-effective. FUTURE WORK: Exercise is the most promising intervention for primary care. Work is needed to ensure adequate uptake and sustained effects. TRIAL REGISTRATION: Current Controlled Trials ISRCTN71002650. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 34. See the NIHR Journals Library website for further project information.

WHAT IS THE PROBLEM?: Falls are a major problem for older people. Current practice is to give people advice leaflets. Another approach is exercise, especially balance and strength training. A third alternative is to invite older people to attend a falls assessment with a health-care professional, either a doctor or a trained nurse. This usually involves a careful check of prescribed tablets, blood pressure, eyesight and other problems that might cause falls. WHAT DID WE DO?: We compared three strategies. We recruited 9803 people aged 70­101 years from 63 general practices across England. We randomly allocated practices in clusters into three treatment groups. The participants in one group were given a Staying Steady advice leaflet (Age UK. Staying Steady. London: Age UK; 2009). Participants in the second group received the same leaflet and were assessed to see if they were at higher risk of falling. Those participants identified as being at higher risk (about 1000 people) were invited to take part in an exercise programme, supported by an exercise therapist. These people did balance and strength training at home for up to 6 months. In the third group, we again identified participants who were at higher risk of falling (about 1000 people) and invited them for a detailed falls assessment with a trained nurse or doctor. This last group of participants were referred for other treatments if any health problems were found. In all groups we counted fractures and falls and measured changes in quality of life, frailty and the cost of the treatments over 18 months of follow-up. WHAT DID WE FIND OUT?: We found no difference in the number of fractures over 18 months between the different treatments. The exercise programme reduced falls in the short term but not over the longer term. The exercise programme was cheaper and led to a slightly better overall quality of life.

Risk of mortality: the relationship with associated injuries and fracture treatment methods in patients with unilateral or bilateral femoral shaft fractures.

BACKGROUND: The aim of the study was to determine the relative contributions to mortality of a unilateral or a bilateral femoral fracture in patients with or without injuries to other body regions. STUDY DESIGN: An observational cohort study of the prospectively recorded England and Wales Trauma Registry data (Trauma Audit Research Network) from 1989 to 2003. METHODS: Patients were divided into the following groups: UFi (isolated unilateral femur injury), BFi (isolated bilateral femur injury), and UFa and BFa, if an associated injury was present. Injury and treatment data were collected for each patient. Logistic regression data analysis was performed to determine variables that were associated with increased mortality. RESULTS: Patients in group BFa had an increased mortality rate (31.6% vs. 9.8%) than patients in isolated bilateral femur injury group. Group BFa patients had an increased number of associated injuries (80%) than group UFa patients. Bilateral fracture, even in isolation, significantly increased the odds of mortality by 3.07. Intramedullary nailing was the method of fracture fixation associated with the lowest patient mortality overall. When assessing patient mortality in the BFa group with an New Injury Severity Score of >40, seven other fracture fixation regimens were associated with a lower mortality. CONCLUSIONS: The increase in mortality with BFs is more closely associated with the presence of associated injuries and poor physiologic parameters than with the presence of the BF alone. The presence of BFs should alert the clinician to the very high likelihood (80%) of significant associated injuries in other body systems and their life-threatening potential. Damage control fixation options should be considered in the subgroup with a very high New Injury Severity Score.

Is it the H or the EMS in HEMS that has an impact on trauma patient mortality? A systematic review of the evidence.

BACKGROUND AND AIM: Prehospital care of trauma patients is a matter of great debate. The optimal transport method remains undecided, with conflicting data comparing helicopter and ground emergency medical transfer. This study systematically reviews the evidence comparing helicopter and ground transfer of trauma patients from the scene of injury. METHODS: A systematic literature review of all population-based studies evaluating the impact on mortality of helicopter transfer of trauma patients from the scene of injury. We searched MEDLINE, CINAHL and EMBASE from January 1980 to December 2008 and selected and reviewed potentially relevant studies. RESULTS: A search of the literature revealed 23 eligible studies. 14 of these studies demonstrated a significant improvement in trauma patient mortality when transported by helicopter from the scene. 5 of the 23 studies were of level II evidence with the remainder being of level III evidence. Data were then entered into an evidence table and reference made to transport staffing, intubation rate, time at scene and time/distance of transfer. CONCLUSIONS: The role and structure of HEMS in a modern trauma service is a debate that is likely to continue. Prehospital care design should be specific to critical incident frequency, geographical arrangements of hospital facilities and travel times within each trauma network. It is also important to consider the benefits and capabilities of the emergency medical team separately from the transport method being considered. An effective helicopter EMS will ultimately depend on effective operating procedures and tasking protocols, clinical governance, and auditing of the helicopter EMS activity.

Helicopter and ground emergency medical services transportation to hospital after major trauma in England: a comparative cohort study.

BACKGROUND: The utilization of helicopter emergency medical services (HEMS) in modern trauma systems has been a source of debate for many years. This study set to establish the true impact of HEMS in England on survival for patients with major trauma. METHODS: A comparative cohort design using prospectively recorded data from the UK Trauma Audit and Research Network registry. 279 107 patients were identified between January 2012 and March 2017. The primary outcome measure was risk adjusted in-hospital mortality within propensity score matched cohorts using logistic regression analysis. Subset analyses were performed for subjects with prehospital Glasgow Coma Scale <8, respiratory rate <10 or >29 and systolic blood pressure <90. RESULTS: The analysis was based on 61 733 adult patients directly admitted to major trauma centers: 54 185 ground emergency medical services (GEMS) and 7548 HEMS. HEMS patients were more likely male, younger, more severely injured, more likely to be victims of road traffic collisions and intubated at scene. Crude mortality was higher for HEMS patients. Logistic regression demonstrated a 15% reduction in the risk adjusted odds of death (OR=0.846; 95% CI 0.684 to 1.046) in favor of HEMS. When analyzed for patients previously noted to benefit most from HEMS, the odds of death were reduced further but remained statistically consistent with no effect. Sensitivity analysis on 5685 patients attended by a doctor on scene but transported by GEMS demonstrated a protective effect on mortality versus the standard GEMS response (OR 0.77; 95% CI 0.62 to 0.95). DISCUSSION: This prospective, level 3 cohort analysis demonstrates a non-significant survival advantage for patients transported by HEMS versus GEMS. Despite the large size of the cohort, the intrinsic mismatch in patient demographics limits the ability to statistically assess HEMS true benefit. It does, however, demonstrate an improved survival for patients attended by doctors on scene in addition to the GEMS response. Improvements in prehospital data and increased trauma unit reporting are required to accurately assess HEMS clinical and cost-effectiveness.

The Oxford Ankle Foot Questionnaire for children: responsiveness and longitudinal validity.

PURPOSE: To evaluate how scores from the Oxford Ankle Foot Questionnaire change over time and with treatment using both distribution-based and anchor-based approaches. METHODS: Eighty children aged 5-16 and their parent or career completed questionnaires at orthopaedic or trauma outpatient clinics. They were asked to complete and return a second set of questionnaires again within 2 weeks (retest), and then mailed a third set of questionnaires to complete again after 2 months (follow-up). The follow-up questionnaires included a global rating of change 'transition' item. RESULTS: Child- and parent-reported mean domain scores (Physical, School & Play, and Emotional) were all stable at retest, whereas positive mean changes were observed at follow-up. As we hypothesised, trauma patients had poorer scores than elective patients at baseline, and showed greater improvement at follow-up. For trauma patients, mean changes in per cent scores were large (scores improved between 40 and 56 for the Physical and School & Play domains, and 17 and 21 for Emotional); all effect sizes (ES) were large (>0.8). For elective patients, the mean improvement in per cent scores were more moderate (Physical: child 10, ES = 0.4, parent 11, ES = 0.5; School & Play child 0, ES = 0, parent 9 ES = 0.4; Emotional: child 6, ES = 0.2; parents 8, ES > 0.3). Minimal detectable change (MDC(90)), an indication of measurement error, ranged from 6 to 8. Half the standard deviation of baseline scores ranged from 11 to 18. Minimal important difference could only be calculated for elective patients (9 child and 13 parent ratings), these ranged from 7 to 17. CONCLUSIONS: The findings support the responsiveness and longitudinal validity of the scales. Changes in domain scores of, or exceeding, the MDC(90) (6-8) are likely to be beyond measurement error; further work is required to refine the estimate of change that can be considered important.

Developing a spinal clearance protocol for unconscious pediatric trauma patients.

BACKGROUND: Spinal injury in pediatric trauma is associated with significant morbidity and mortality, but no current consensus exists on the safest and most effective method of clearance in the high-risk pediatric trauma patient. METHODS: A retrospective analysis was performed on the records of 115 pediatric patients who had suffered major trauma and required admission to the pediatric intensive care unit of a United Kingdom level I trauma centre during a 7-year period from January 2000 to December 2006. The spinal imaging performed, and methods of clearance for each spinal region were obtained from analysis of written and electronic medical documentation. RESULTS: In the cohort of 115 patients, there was a male predominance (63%) with motor vehicle accidents as the major mechanism of injury (63.5%). Ten patients (8.7%) were identified with spinal injuries, all of whom had sustained closed head injuries. Two of these patients had spinal cord injuries; one subsequently died. Spinal injury resulted in longer intubation times and intensive care stays, but no difference in new injury severity score or outcome. Clearance methods ranged from clinical examination to imaging with radiographs, computed tomography (CT), and dynamic screening. Magnetic resonance imaging was used as a secondary modality in two cases only, and in neither case was it used for clearance. CT demonstrated 100% specificity and sensitivity with positive and negative predictive values of 1 for all spinal regions. There were no cases of Spinal Cord Injury WithOut Radiologic Abnormality and no evidence of missed injuries. CONCLUSIONS: There is a need for an evidence-based protocol for the clearance of the spine in the obtunded and high-risk pediatric trauma patient. High-resolution CT with sagittal and coronal reconstructions should be the basis for cervical spinal clearance, in combination with the interpretation of films by an expert radiologist. All spinal regions should be imaged, and clearance should be formally documented. The role of magnetic resonance imaging in routine clearance remains controversial. Multicenter prospective studies are needed to develop consensus for an evidenced-based protocol for clearance in this high-risk group.

Implications of the Ankle Injury Management (AIM) trial: close contact casting or surgery for older adults with an unstable ankle fracture?

The Ankle Injury Management (AIM) trial was a pragmatic equivalence randomized controlled trial conducted at 24 hospitals in the United Kingdom that recruited 620 patients aged more than 60 years with an unstable ankle fracture. The trial compared the usual care pathway of early management with open reduction and internal fixation with initially attempting non-surgical management using close contact casting (CCC). CCC is a minimally padded cast applied by an orthopaedic surgeon after closed reduction in the operating theatre. The intervention groups had equivalent functional outcomes at six months and longer-term follow-up. However, potential barriers to using CCC as an initial form of treatment for these patients have been identified. In this report, the results of the AIM trial are summarized and the key issues are discussed in order to further the debate about the role of CCC. Evidence from the AIM trial supports surgeons considering conservative management by CCC as a treatment option for these patients. The longer-term follow-up emphasized that patients treated with CCC need careful monitoring in the weeks after its application to monitor maintenance of reduction. Cite this article: Bone Joint J 2019;101-B:1472-1475.