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The Tommy's Clinical Decision Tool, a device for reducing the clinical impact of placental dysfunction and preterm birth: protocol for a mixed-methods early implementation evaluation study.
BACKGROUND: Disparities in stillbirth and preterm birth persist even after correction for ethnicity and social deprivation, demonstrating that there is wide geographical variation in the quality of care. To address this inequity, Tommy's National Centre for Maternity Improvement developed the Tommy's Clinical Decision Tool, which aims to support the provision of "the right care at the right time", personalising risk assessment and care according to best evidence. This web-based clinical decision tool assesses the risk of preterm birth and placental dysfunction more accurately than current methods, and recommends best evidenced-based care pathways in a format accessible to both women and healthcare professionals. It also provides links to reliable sources of pregnancy information for women. The aim of this study is to evaluate implementation of Tommy's Clinical Decision Tool in four early-adopter UK maternity services, to inform wider scale-up. METHODS: The Tommy's Clinical Decision Tool has been developed involving maternity service users and healthcare professionals in partnership. This mixed-methods study will evaluate: maternity service user and provider acceptability and experience; barriers and facilitators to implementation; reach (whether particular groups are excluded and why), fidelity (degree to which the intervention is delivered as intended), and unintended consequences. Data will be gathered over 25 months through interviews, focus groups, questionnaires and through the Tommy's Clinical Decision Tool itself. The NASSS framework (Non-adoption or Abandonment of technology by individuals and difficulties achieving Scale-up, Spread and Sustainability) will inform data analysis. DISCUSSION: This paper describes the intervention, Tommy's Clinical Decision Tool, according to TiDIER guidelines, and the protocol for the early adopter implementation evaluation study. Findings will inform future scale up. TRIAL REGISTRATION: This study was prospectively registered on the ISRCTN registry no. 13498237 , on 31st January 2022.
Predictors of returning home after hip fracture: a prospective cohort study using the UK National Hip Fracture Database (NHFD).
INTRODUCTION: our objective was to describe trends in returning home after hospitalisation for hip fracture and identify predictive factors of this important patient-focussed outcome. METHODS: a cohort of hip fracture patients from England and Wales (2018-2019) resident in their own home pre-admission were analysed to identify patient and service factors associated with returning home after hospital discharge, and with living in their own home at 120 days. Geographical variation was also analysed. RESULTS: analysis of returning home at discharge included 87,797 patients; 57,104 (65%) were discharged home. Patient factors associated with lower likelihood of discharge home included cognitive impairment (odds ratio (OR) 0.60 [95% CI: 0.57, 0.62]), malnutrition (OR 0.81 [0.76, 0.86]), being at risk of malnutrition (OR 0.81 [0.78, 0.85]) and experiencing delay to surgery due to reversal of anti-coagulant medication (OR 0.84 [0.77, 0.92]). Corresponding service factors included surgery delay due to hospital logistical reasons (OR 0.91 [0.87, 0.95]) and early morning admission between 4:00 and 7:59 am (OR 0.83 [0.78, 0.89]). Nerve block prior to arrival at the operating theatre was associated with higher likelihood of discharge home (OR 1.07 [1.03, 1.11]). Most of these associations were stronger when analysing the outcome 'living in their own home at 120 days', in which two out of 11 geographic regions were found to have significantly more patients returning home. CONCLUSION: we identify numerous modifiable factors associated with short-term and medium-term return to own home after hip fracture, in addition to significant geographical variation. These findings should support improvements to care and inform future research.
The synergistic effects of lysophosphatidic acid receptor agonists and calcitriol on MG63 osteoblast maturation at titanium and hydroxyapatite surfaces
Successful osseointegration stems from the provision of a mechanically competent mineralised matrix at the implant site. Mature osteoblasts are the cells responsible for achieving this and a key factor for ensuring healthy bone tissue is associated with prosthetic materials will be 1α,25 dihydroxy vitamin D3 (calcitriol). However it is known that calcitriol per se does not promote osteoblast maturation, rather the osteoblasts need to be in receipt of calcitriol in combination with selected growth factors in order to undergo a robust maturation response. Herein we report how agonists of the lysophosphatidic acid (LPA) receptor, LPA and (2S)-OMPT, synergistically co-operate with calcitriol to secure osteoblast maturation for cells grown upon two widely used bone biomaterials, titanium and hydroxyapatite. Efforts could now be focussed on functionalising these materials with LPA receptor agonists to support in vivo calcitriol-induced osseointegration via heightened osteoblast maturation responses. © 2009 Elsevier Ltd. All rights reserved.
Incidence and quality of care for open fractures in England between 2008 and 2019 : a cohort study using data collected by the Trauma Audit and Research Network.
AIMS: This study estimated trends in incidence of open fractures and the adherence to clinical standards for open fracture care in England. METHODS: Longitudinal data collected by the Trauma Audit and Research Network were used to identify 38,347 patients with open fractures, and a subgroup of 12,170 with severe open fractures of the tibia, between 2008 and 2019 in England. Incidence rates per 100,000 person-years and 95% confidence intervals were calculated. Clinical care was compared with the British Orthopaedic Association Standards for Trauma and National Major Trauma Centre audit standards. RESULTS: In total, 60% of all open fractures occurred in males; the median age was 48 years (interquartile range (IQR) 29 to 68). Between 2012 and 2019, the overall incidence in England was 6.94 per 100,000 person-years. In males, the highest incidence observed was in those aged 20 to 29 years (11.50 per 100,000 person-years); in females, incidence increased with age, peaking at 32.11/100,000 person-years at 90 years of age and over. Among those with severe open fractures of the tibia, there was a bimodal distribution in males, peaking at 20 to 29 years (3.71/100,000 person-years) and greater than 90 years of age (2.84/100,000 person-years) respectively; among females, incidence increased with age to a peak of 9.91/100,000 person years at 90 years of age and over. There has been variable improvement with time in the clinical care standards for patients with severe open fractures of the tibia. The median time to debridement was 13.0 hours (IQR 6.4 to 20.9); almost two-thirds of patients underwent definitive soft-tissue coverage within 72 hours from 2016 to 2019. CONCLUSION: This is the first time the incidence of all open fractures has been studied using data from a national audit in England. While most open fractures occurred in young males, the incidence increased with age in females to a much greater level than observed in older males. The degree of missing data in the national audit is startling, and limits the certainty of inferences drawn concerning open fracture care. Cite this article: Bone Joint J 2022;104-B(6):736-746.
Minimal clinically important difference of the Four Square Step Test in people with degenerative spinal conditions.
OBJECTIVE: To identify the minimal clinically important difference (MCID) in the Four Square Step Test (FSST) for patients with degenerative spinal conditions before and after a six-week group-based physiotherapy programme. DESIGN: Secondary analysis of a longitudinal cohort study. SETTING: Physiotherapy department within a specialised orthopaedic hospital in the UK. PARTICIPANTS: Men and women with degenerative spinal conditions. INTERVENTIONS: All participants had a routine care package of up to six group-based physiotherapy led exercise and education sessions. MAIN OUTCOME MEASURES: An anchor-based approach using a self-report outcome measure (Activities-specific Balance Confidence [ABC] Scale) was utilised as a comparator to determine the MCID of the FSST. The MCID for the FSST was calculated as the difference in mean change scores from those who improved on the ABC Scale against those who did not improve (based on the standard error of measurement of the ABC Scale). RESULTS: Twenty-eight participants with degenerative spinal conditions (19 female) had a mean age of 73 years (SD 7.7). The mean ABC Scale scores for the whole sample were 61% (SD 19.1) at baseline and 66% (SD 18.3) post-physiotherapy. The mean FSST scores for the whole sample were 19.1seconds (SD 9.8) at baseline and 13.9seconds (SD 6.3) post-physiotherapy. The MCID for the FSST was 3.6seconds. CONCLUSIONS: The MCID for improvement in balance was 3.6seconds, indicating people with degenerative spinal conditions are likely to perceive an improvement of ≥3.6seconds in their FSST score as an important change in their balance performance and confidence.
The challenges and gains of delivering a home-exercise intervention: a qualitative study of physiotherapists and physiotherapy assistants.
OBJECTIVES: The paper presents insights from the Community based Rehabilitation after Knee Arthroplasty (CORKA) trial. We aimed to explore physiotherapists and physiotherapy assistants' experiences of delivering a home-base exercise intervention following knee replacement surgery. We were particularly interested in the feasibility, potential benefits and barriers of a community-based exercise programme from the perspective of physiotherapists and physiotherapy assistants and to understand any constraints or training needs that arose. DESIGN: Qualitative thematic analysis of semi-structured interviews. SETTING: The Community based Rehabilitation after Knee Arthroplasty (CORKA) trial. PARTICIPANTS: Five physiotherapists and six physiotherapy assistants with a range of clinical experience. METHODS: Interviews were digitally recorded and transcribed verbatim. We used the stages of reflexive thematic analysis suggested by Braun and Clarke. One researcher conducted the interviewers whilst three researchers with experience in qualitative research methods contributed to the coding and analysis of data. RESULTS: We developed seven themes that help to understand the benefits and challenges of delivering treatment interventions in a person's home: seeing the person in their own world; thinking outside the cubicle;developing people skills; enjoying the above and beyond; treading a fine line between patient and friend; feeling outside my comfort zone; needing a support network. CONCLUSIONS: Treating people in their own homes facilitates a holistic approach. Our findings highlight areas for clinical education: (1) how do we help clinicians to tread the fine line between friend and professional (2) how do we balance the need to provide support and structure with the freedom to work creatively and independently?
IMI2-PainCare-BioPain-RCT2 protocol: a randomized, double-blind, placebo-controlled, crossover, multicenter trial in healthy subjects to investigate the effects of lacosamide, pregabalin, and tapentadol on biomarkers of pain processing observed by non-invasive neurophysiological measurements of human spinal cord and brainstem activity.
BACKGROUND: IMI2-PainCare-BioPain-RCT2 is one of four similarly designed clinical studies aiming at profiling a set of functional biomarkers of drug effects on specific compartments of the nociceptive system that could serve to accelerate the future development of analgesics. IMI2-PainCare-BioPain-RCT2 will focus on human spinal cord and brainstem activity using biomarkers derived from non-invasive neurophysiological measurements. METHODS: This is a multisite, single-dose, double-blind, randomized, placebo-controlled, 4-period, 4-way crossover, pharmacodynamic (PD) and pharmacokinetic (PK) study in healthy subjects. Neurophysiological biomarkers of spinal and brainstem activity (the RIII flexion reflex, the N13 component of somatosensory evoked potentials (SEP) and the R2 component of the blink reflex) will be recorded before and at three distinct time points after administration of three medications known to act on the nociceptive system (lacosamide, pregabalin, tapentadol), and placebo, given as a single oral dose in separate study periods. Medication effects on neurophysiological measures will be assessed in a clinically relevant hyperalgesic condition (high-frequency electrical stimulation of the skin), and in a non-sensitized normal condition. Patient-reported outcome measures (pain ratings and predictive psychological traits) will also be collected; and blood samples will be taken for pharmacokinetic modelling. A sequentially rejective multiple testing approach will be used with overall alpha error of the primary analysis split between the two primary endpoints, namely the percentage amplitude changes of the RIII area and N13 amplitude under tapentadol. Remaining treatment arm effects on RIII, N13 and R2 recovery cycle are key secondary confirmatory analyses. Complex statistical analyses and PK-PD modelling are exploratory. DISCUSSION: The RIII component of the flexion reflex is a pure nociceptive spinal reflex widely used for investigating pain processing at the spinal level. It is sensitive to different experimental pain models and to the antinociceptive activity of drugs. The N13 is mediated by large myelinated non-nociceptive fibers and reflects segmental postsynaptic response of wide dynamic range dorsal horn neurons at the level of cervical spinal cord, and it could be therefore sensitive to the action of drugs specifically targeting the dorsal horn. The R2 reflex is mediated by large myelinated non-nociceptive fibers, its circuit consists of a polysynaptic chain lying in the reticular formation of the pons and medulla. The recovery cycle of R2 is widely used for assessing brainstem excitability. For these reasons, IMI2-PainCare-BioPain-RCT2 hypothesizes that spinal and brainstem neurophysiological measures can serve as biomarkers of target engagement of analgesic drugs for future Phase 1 clinical trials. Phase 2 and 3 clinical trials could also benefit from these tools for patient stratification. TRIAL REGISTRATION: This trial was registered on 02 February 2019 in EudraCT ( 2019-000755-14 ).
Randomised controlled trial comparing intraoperative cell salvage and autotransfusion with standard care in the treatment of hip fractures: a protocol for the WHITE 9 study.
INTRODUCTION: People who sustain a hip fracture are typically elderly, frail and require urgent surgery. Hip fracture and the urgent surgery is associated with acute blood loss, compounding patients' pre-existing comorbidities including anaemia. Approximately 30% of patients require a donor blood transfusion in the perioperative period. Donor blood transfusions are associated with increased rates of infections, allergic reactions and longer lengths of stay. Furthermore, there is a substantial cost associated with the use of donor blood. Cell salvage and autotransfusion is a technique that recovers, washes and transfuses blood lost during surgery back to the patient. The objective of this study is to determine the clinical and cost effectiveness of intraoperative cell salvage, compared with standard care, in improving health related quality-of-life of patients undergoing hip fracture surgery. METHODS AND ANALYSIS: Multicentre, parallel group, two-arm, randomised controlled trial. Patients aged 60 years and older with a hip fracture treated with surgery are eligible. Participants will be randomly allocated on a 1:1 basis to either undergo cell salvage and autotransfusion or they will follow the standard care pathway. Otherwise, all care will be in accordance with the National Institute for Health and Care Excellence guidance. A minimum of 1128 patients will be recruited to obtain 90% power to detect a 0.075-point difference in the primary endpoint: EuroQol-5D-5L HRQoL at 4 months post injury. Secondary outcomes will include complications, postoperative delirium, residential status, mobility, allogenic blood use, mortality and resource use. ETHICS AND DISSEMINATION: NHS ethical approval was provided on 14 August 2019 (19/WA/0197) and the trial registered (ISRCTN15945622). After the conclusion of this trial, a manuscript will be prepared for peer-review publication. Results will be disseminated in lay form to participants and the public. TRIAL REGISTRATION NUMBER: ISRCTN15945622.
Cemented or Uncemented Hemiarthroplasty for Intracapsular Hip Fracture.
BACKGROUND: Controversy exists over the use of bone cement in hip fractures treated with hemiarthroplasty. Only limited data on quality of life after cemented as compared with modern uncemented hemiarthroplasties are available. METHODS: We conducted a multicenter, randomized, controlled trial comparing cemented with uncemented hemiarthroplasty in patients 60 years of age or older with an intracapsular hip fracture. The primary outcome was health-related quality of life measured with the use of utility scores on the EuroQol Group 5-Dimension (EQ-5D) questionnaire at 4 months after randomization (range of scores, -0.594 to 1, with higher scores indicating better quality of life; range for minimal clinically important difference, 0.050 to 0.075). RESULTS: A total of 610 patients were assigned to undergo cemented hemiarthroplasty and 615 to undergo modern uncemented hemiarthroplasty; follow-up data were available for 71.6% of the patients at 4 months. The mean EQ-5D utility score was 0.371 in patients assigned to the cemented group and 0.315 in those assigned to the uncemented group (adjusted difference, 0.055; 95% confidence interval [CI], 0.009 to 0.101; P = 0.02). The between-group difference at 1 month was similar to that at 4 months, but the difference at 12 months was smaller than that at 4 months. Mortality at 12 months was 23.9% in the cemented group and 27.8% in the uncemented group (odds ratio for death, 0.80; 95% CI, 0.62 to 1.05). Periprosthetic fractures occurred in 0.5% and 2.1% of the patients in the respective groups (odds ratio [uncemented vs. cemented], 4.37; 95% CI, 1.19 to 24.00). The incidences of other complications were similar in the two groups. CONCLUSIONS: Among patients 60 years of age or older with an intracapsular hip fracture, cemented hemiarthroplasty resulted in a modestly but significantly better quality of life and a lower risk of periprosthetic fracture than uncemented hemiarthroplasty. (Funded by the National Institute for Health Research; WHiTE 5 ISRCTN number, ISRCTN18393176.).
Protocol for the Weight-bearing in Ankle Fractures (WAX) trial: a multicentre prospective non-inferiority trial of early versus delayed weight-bearing after operatively managed ankle fracture.
BACKGROUND: Unstable ankle fractures represent a substantial burden of disease, accounting for a mean hospital stay of nine days, a mean cost of £4,491 per patient and 20,000 operations per year. There is variation in UK practice around weight-bearing instructions after operatively managed ankle fracture. Early weight-bearing may reduce reliance on health services, time off work, and improve functional outcomes. However, concerns remain about the potential for complications such as implant failure. This is the protocol of a multicentre randomised non-inferiority clinical trial of weight-bearing following operatively treated ankle fracture. METHODS: Adults aged 18 years and over who have been managed operatively for ankle fracture will be assessed for eligibility. Baseline function (Olerud and Molander Ankle Score [OMAS]), health-related quality of life (EQ-5D-5L), and complications will be collected after informed consent has been obtained. A randomisation sequence has been prepared by a trial statistician to allow for 1:1 allocation to receive either instruction to weight-bear as pain allows from the point of randomisation, two weeks after the time of surgery ('early weight-bearing' group) or to not weight-bear for a further four weeks ('delayed weight -bearing' group). All other treatment will be as per the guidance of the treating clinician. Participants will be asked about their weight-bearing status weekly until four weeks post-randomisation. At four weeks post-randomisation complications will be collected. At six weeks, four months, and 12 months post-randomisation, the OMAS, EQ-5D-5L, complications, physiotherapy input, and resource use will be collected. The primary outcome measure is ankle function (OMAS) at four months post-randomisation. A minimum of 436 participants will be recruited to obtain 80% power to detect a non-inferiority margin of -6 points on the OMAS 4 months post-randomisation. A within-trial health economic evaluation will be conducted to estimate the cost-effectiveness of the treatment options. DISCUSSION: The results of this study will inform national guidance with regards to the most clinically and cost-effective strategy for weight-bearing after surgery for unstable ankle fractures. TRIAL REGISTRATION: ISRCTN12883981 , Registered 02 December 2019.
Facilitating trial recruitment: A qualitative study of patient and staff experiences of an orthopaedic trauma trial.
BACKGROUND: Qualitative research has been used to explore patients' and healthcare professionals' experiences of surgical randomised controlled trials (RCTs). From this research, reasons why patients accept or decline participation and barriers to engaging clinicians in trials have been identified. In a trauma setting, recruitment to surgical trials can be particularly difficult as patients may require urgent treatment and their ability to consider their options, ask questions and reach a decision may be hindered by the impact of their injury. Little research, however, has explored patients' and healthcare professionals' experiences of surgical RCTs in a trauma setting. This study aimed to understand patients' and staff's experiences of an orthopaedic trauma trial. METHODS: We carried out semi-structured interviews with 11 patients and 24 staff (10 surgeons and 14 research associates) participating in a UK multi-centre feasibility trial comparing intramedullary nails versus distal locking plates for fractures of the distal femur (TrAFFix). Interviews explored patients' experience of TrAFFix and their reason for participating and staffs' experience of recruiting to TrAFFix and trauma trials more generally. Interviews were audio recorded and transcribed verbatim. Transcripts were analysed using thematic analysis. RESULTS: Three themes were identified. These were i) navigating research with patients after orthopaedic trauma, ii) knowing that it is the right decision and iii) making it work. These themes reflect: i) how research associates supported and guided patients through the consent process enabling them to participate, ii) the difficulty in engaging surgeons in a trial when individual equipoise and experience of the interventions are low despite the presence of community equipoise and iii) the way in which research teams worked together and encouraged the development of a research culture within the clinical teams in order to facilitate recruitment. CONCLUSIONS: Our findings highlight the pivotal role of research associates (RAs) in facilitating trial recruitment. RAs supported patients to enable them to make a decision about participation and assisted in developing a research culture within the team by promoting studies and communicating research to clinical staff. Our findings also reinforce surgeons' difficulty with equipoise and suggest that accepting community equipoise could facilitate recruitment.
Operative versus non-operative treatment for closed, displaced, intra-articular fractures of the calcaneus: randomised controlled trial.
OBJECTIVE: To investigate whether surgery by open reduction and internal fixation provides benefit compared with non-operative treatment for displaced, intra-articular calcaneal fractures. DESIGN: Pragmatic, multicentre, two arm, parallel group, assessor blinded randomised controlled trial (UK Heel Fracture Trial). SETTING: 22 tertiary referral hospitals, United Kingdom. PARTICIPANTS: 151 patients with acute displaced intra-articular calcaneal fractures randomly allocated to operative (n=73) or non-operative (n=78) treatment. MAIN OUTCOME MEASURES: The primary outcome measure was patient reported Kerr-Atkins score for pain and function (scale 0-100, 100 being the best possible score) at two years after injury. Secondary outcomes were complications; hindfoot pain and function (American Orthopaedic Foot and Ankle Society score); general health (SF-36); quality of life (EQ-5D); clinical examination; walking speed; and gait symmetry. Analysis was by intention to treat. RESULTS: 95% follow-up was achieved for the primary outcome (69 in operative group and 74 in non-operative group), and a complete set of secondary outcomes were available for 75% of participants. There was no significant difference in the primary outcome (mean Kerr-Atkins score 69.8 in operative group v 65.7 in non-operative group; adjusted 95% confidence interval of difference -7.1 to 7.0) or in any of the secondary outcomes between treatment groups. Complications and reoperations were more common in those who received operative care (estimated odds ratio 7.5, 95% confidence interval 2.0 to 41.8). CONCLUSIONS: Operative treatment compared with non-operative care showed no symptomatic or functional advantage after two years in patients with typical displaced intra-articular fractures of the calcaneus, and the risk of complications was higher after surgery. Based on these findings, operative treatment by open reduction and internal fixation is not recommended for these fractures.Trial registration Current Controlled Trials ISRCTN37188541.
Five-year outcomes for patients sustaining severe fractures of the lower limb : mid-term results from the Wound management for Open Lower Limb Fracture (WOLLF) trial.
AIMS: The aim of this study was to report the outcomes of patients with severe open fractures of the lower limb in the five years after they took part in the Wound management for Open Lower Limb Fracture (WOLLF) trial. METHODS: The WOLLF trial compared standard dressings to negative pressure wound therapy (NPWT) applied at the end of the first surgical wound debridement, and patients were followed-up for 12 months. At 12 months, 170 of the original 460 participants agreed to take part in this medium-term follow-up study. Patients reported their Disability Rating Index (DRI) (0 to 100, where 100 is total disability) and health-related quality of life (HRQoL) using the EuroQol five-dimension three-level health questionnaire (EQ-5D-3L) annually by self-reported questionnaire. Further surgical interventions related to the open fracture were also recorded. RESULTS: There was no evidence of a difference in patient-reported disability, HRQoL, or the need for further surgery between patients treated with NPWT versus standard dressings at five years. Considering the combined results for all participants, there was a small but statistically significant change in DRI scores over time (1.6 units per year; p = 0.005), but no evidence that EQ-5D-3L scores changed significantly during years two to five (p = 0.551). CONCLUSION: This study shows that the high levels of disability and reduced HRQoL reported by patients 12 months after severe open fractures of the lower limb persist in the medium term, with little evidence of improvement between years two and five. Cite this article: Bone Joint J 2022;104-B(5):633-639.
Wound photography for evaluation of surgical site infection and wound healing after lower limb trauma.
AIMS: Deep surgical site infection (SSI) is common after lower limb fracture. We compared the diagnosis of deep SSI using alternative methods of data collection and examined the agreement of clinical photography and in-person clinical assessment by the Centers for Disease Control and Prevention (CDC) criteria after lower limb fracture surgery. METHODS: Data from two large, UK-based multicentre randomized controlled major trauma trials investigating SSI and wound healing after surgical repair of open lower limb fractures that could not be primarily closed (UK WOLLF), and surgical incisions for fractures that were primarily closed (UK WHiST), were examined. Trial interventions were standard wound care management and negative pressure wound therapy after initial surgical debridement. Wound outcomes were collected from 30 days to six weeks. We compared the level of agreement between wound photography and clinical assessment of CDC-defined SSI. We are also assessed the level of agreement between blinded independent assessors of the photographs. RESULTS: Rates of CDC-defined deep SSI were 7.6% (35/460) after open fracture and 6.3% (95/1519) after closed incisional repair. Photographs were obtained for 77% and 73% of WOLLF and WHiST cohorts respectively (all participants n = 1,478). Agreement between photographic-SSI and CDC-SSI was fair for open fracture wounds (83%; k = 0.27 (95% confidence interval (CI) 0.14 to 0.42)) and for closed incisional wounds (88%; k = 0.29 (95% CI 0.20 to 0.37)) although the rate of photographically detected deep SSIs was twice as high as CDC-SSI (12% vs 6%). Agreement between different assessors for photographic-SSI (WOLLF 88%, k = 0.63 (95% CI 0.52 to 0.72); WHiST 89%; k = 0.61 (95% CI 0.54 to 0.69)); and wound healing was good (WOLLF 90%; k = 0.80 (95% CI 0.73 to 0.86); WHiST 87%; k = 0.57 (95% CI 0.50 to 0.64)). CONCLUSION: Although wound photography was feasible within the research context and inter-rater assessor agreement substantial, digital photographs used in isolation overestimated deep SSI rates, when compared to CDC criteria. Wound photography should not replace clinical assessment in pragmatic trials but may be useful for screening purposes where surgical infection outcomes are paramount. Cite this article: Bone Joint J 2021;103-B(12):1802-1808.
Does digital, multimedia information increase recruitment and retention in a children's wrist fracture treatment trial, and what do people think of it? A randomised controlled Study Within A Trial (SWAT).
OBJECTIVES: To evaluate digital, multimedia information (MMI) for its effects on trial recruitment, retention, decisions about participation and acceptability by patients, compared with printed information. DESIGN: Study Within A Trial using random cluster allocation within the Forearm Fracture Recovery in Children Evaluation (FORCE) study. SETTING: Emergency departments in 23 UK hospitals. PARTICIPANTS: 1409 children aged 4-16 years attending with a torus (buckle) fracture, and their parents/guardian. Children's mean age was 9.2 years, 41.0% were female, 77.4% were ethnically White and 90.0% spoke English as a first language. INTERVENTIONS: Participants and their parents/guardian received trial information either via multimedia, including animated videos, talking head videos and text (revised for readability and age appropriateness when needed) on tablet computer (MMI group; n=681), or printed participant information sheet (PIS group; n=728). OUTCOME MEASURES: Primary outcome was recruitment rate to FORCE. Secondary outcomes were Decision-Making Questionnaire (nine Likert items, analysed summatively and individually), three 'free text' questions (deriving subjective evaluations) and trial retention. RESULTS: MMI produced a small, not statistically significant increase in recruitment: 475 (69.8%) participants were recruited from the MMI group; 484 (66.5%) from the PIS group (OR=1.35; 95% CI 0.76 to 2.40, p=0.31). A total of 324 (23.0%) questionnaires were returned and analysed. There was no difference in total Decision-Making Questionnaire scores: adjusted mean difference 0.05 (95% CI -1.23 to 1.32, p=0.94). The MMI group was more likely to report the information 'very easy' to understand (89; 57.8% vs 67; 39.4%; Z=2.60, p=0.01) and identify information that was explained well (96; 62.3% vs 71; 41.8%). Almost all FORCE recruits were retained at the 6 weeks' timepoint and there was no difference in retention rate between the information groups: MMI (473; 99.6%); PIS (481; 99.4%). CONCLUSIONS: MMI did not increase recruitment or retention in the FORCE trial, but participants rated multimedia as easier to understand and were more likely to evaluate it positively. TRIAL REGISTRATION NUMBER: ISRCTN73136092 and ISRCTN13955395.
Major trauma care at a regional trauma centre during the COVID-19 lockdown in England.
INTRODUCTION: The COVID-19 pandemic has changed the presentation of many medical and surgical conditions, including major trauma. We aimed to assess how lockdown changed the presentation, severity and management of major trauma patients at our level 1 trauma centre in England. METHODS: Data were collected retrospectively from the Trauma Audit and Research Network's database between 23 March and 28 April 2020 and compared with the same period in 2019. Collected data included patient demographics, and the mechanism, severity and management of injuries. RESULTS: We experienced a 56.4% reduction in major trauma admissions during the lockdown period when compared with 2019. In 2020, more patients arrived in haemodynamic shock (25.3% vs 12.2%, p=0.02); however, Glasgow Coma Scale and Injury Severity Score were unchanged. A higher proportion of incidents occurred at home (37.2% vs 53.5%, p=0.018), with no difference in trauma secondary to substance abuse or assault. During lockdown, patients had a significantly shorter hospital (17 vs 10 days, p=0.029) and critical care stay (2 vs 1 day, p=0.033). A higher proportion of major trauma patients were assessed by specialty trainees in the emergency department in 2020 (12.8% vs 53.1%, p=0.0001) with a lower proportion assessed by a consultant (69.8% vs 46.7%, p=0.001). CONCLUSIONS: The COVID-19 pandemic and lockdown drastically changed human behaviour, as reflected in the change in presentation of major trauma. Changes in the management of these patients reflect adaptive measures to manage the pressures generated by the worldwide pandemic.