scholarly journals ASSERT (Acute Sacral inSufficiEncy fractuRe augmenTation) randomised controlled, feasibility in older people trial: a study protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (7) ◽  
pp. e032111 ◽  
Author(s):  
Dawn van Berkel ◽  
Terence Ong ◽  
Avril Drummond ◽  
Paul Hendrick ◽  
Paul Leighton ◽  
...  
Keyword(s):  
Older People ◽  
Surgical Management ◽  
Pain Control ◽  
Insufficiency Fracture ◽  
Safety Data ◽  
Fragility Fractures ◽  
Feasibility Trial ◽  
Sacral Insufficiency Fracture ◽  
Qualitative Interview Study ◽  
Randomised Controlled

IntroductionPelvic fragility fractures (PFF) are common in older people and associated with a significant burden of mortality and morbidity. This is related to the challenges of appropriate pain control and early mobilisation. The current standard for treatment of PFF is non-surgical management. Minimally invasive surgical techniques for sacral fracture stabilisation have been shown to improve outcomes in terms of pain control and mobility, and they are safe. Randomised controlled trials are required before recommendations can be made for surgical management of PFF to become the new standard of care. This feasibility study will explore several uncertainties around conducting such a trial.Methods and analysisASSERT (Acute Sacral inSufficiEncy fractuRe augmenTation) is a single-site randomised controlled, parallel-arm, feasibility trial of surgical stabilisation versus non-surgical management of acute sacral fragility fractures in people aged 70 years and over. Patients will be randomised to either surgical or non-surgical group on a 1:1 ratio. Follow-up of participants will occur at 2, 4 and 12 weeks with safety data collected at 52 weeks. Primary objectives are to determine feasibility and design of a future trial, including outcomes on recruitment, adherence to randomisation and safety. This will be supplemented with a qualitative interview study of participants and clinicians. Secondary objectives will inform study design procedures to determine clinical and economic outcomes between groups, including scored questionnaires, analgesia requirements, resource use and quality of life data. Data analysis will be largely descriptive to inform outcomes and future sample size.Ethics and disseminationEthical approval was granted by the North East Newcastle and North Tyneside 2 Research Ethics Committee (reference 18/NE/0212). ASSERT was approved and sponsored by Nottingham University Hospitals NHS Trust (reference 18HC001) and the Health Research Authority (reference IRAS 232791). Recruitment is ongoing. Results will be presented at relevant conferences and submitted to appropriate journals on study completion.Trial registration numberISRCTN16719542; Pre-results.

scholarly journals Investigation of ward fidelity to a multicomponent delirium prevention intervention during a multicentre, pragmatic, cluster randomised, controlled feasibility trial

2020 ◽  
Vol 49 (4) ◽  
pp. 648-655 ◽  
Author(s):  
Jane Smith ◽  
John Green ◽  
Najma Siddiqi ◽  
Sharon K Inouye ◽  
Michelle Collinson ◽  
...  
Keyword(s):  
Older People ◽  
Health Care Professionals ◽  
Routine Care ◽  
Feasibility Trial ◽  
Maximum Score ◽  
Intervention Delivery ◽  
Cluster Randomised ◽  
Delirium Prevention ◽  
Randomised Controlled ◽  
Multicomponent Interventions

Abstract Background delirium is a frequent complication of hospital admission for older people and can be reduced by multicomponent interventions, but implementation and delivery of such interventions is challenging. Objective to investigate fidelity to the prevention of delirium system of care within a multicentre, pragmatic, cluster randomised, controlled feasibility trial. Setting five care of older people and three orthopaedic trauma wards in eight hospitals in England and Wales. Data collection research nurse observations of ward practice; case note reviews and examination of documentation. Assessment 10 health care professionals with experience in older people’s care assessed the fidelity to 21 essential implementation components within four domains: intervention installation (five items; maximum score = 5); intervention delivery (12 items; maximum score = 48); intervention coverage (three items; maximum score = 16); and duration of delivery (one item; maximum score = 1). Results the mean score (range) for each domain was: installation 4.5 (3.5–5); delivery 32.6 (range 27.3–38.3); coverage 7.9 (range 4.2–10.1); and duration 0.38 (0–1). Of the 10 delirium risk factors, infection, nutrition, hypoxia and pain were the most and cognitive impairment, sensory impairment and multiple medications the least consistently addressed. Overall fidelity to the intervention was assessed as high (≥80%) in two wards, medium (51–79%) in five wards and low (≤50%) in one ward. Conclusion the trial was designed as a pragmatic evaluation, and the findings of medium intervention fidelity are likely to be generalisable to delirium prevention in routine care and provide an important context to interpret the trial outcomes.

scholarly journals ASSERT (Acute Sacral inSufficiEncy fractuRe augmenTation): Perceptions in the Assessment and Treatment of Pubic Rami and Sacral Fragility Fractures Amongst Healthcare Professionals in Geriatric Medicine and Surgery.

2021 ◽  
Author(s):  
Opinder Sahota ◽  
Paul Leighton ◽  
Maribel Cameron ◽  
Rachael Taylor ◽  
Terence Ong ◽  
...  
Keyword(s):  
Fragility Fracture ◽  
Healthcare Professionals ◽  
Surgical Intervention ◽  
Geriatric Medicine ◽  
Insufficiency Fracture ◽  
Fragility Fractures ◽  
High Association ◽  
Sacral Insufficiency Fracture ◽  
Pubic Rami ◽  
Assessment And Treatment

Abstract Background: Pubic rami fragility fractures are common in older people and result in significant morbidity and increased mortality. Co-existing fractures of the sacrum are common, but routinely missed. The aim of the study was to explore the perceptions in the assessment and treatment of pubic rami and sacral fragility fractures amongst healthcare professionals. Methods: We interviewed 14 participants about their experience in the assessment and treatment of patients presenting with pubic rami fragility fractures. Data was analysed using an inductive thematic approach.Results: The majority of patients presenting with a pubic rami fragility fracture were managed by geriatricians. However, many of the geriatricians were not aware that these fractures have a high association with co-existing sacral fragility fractures. Furthermore, they were not aware of the limitations of standard x-ray imaging, nor of the potential benefits of surgical intervention for sacral fragility fractures. Spinal surgeons recommended that early, more specialist imaging in patients with public rami fragility fractures failing to mobilise, would change clinical management, if found to have a coexisting sacral fragility fracture, amenable to surgical intervention. Conclusions: The awareness, assessment and management of sacral fragility fractures in patients presenting with pubic rami fragility fractures is poor amongst healthcare professional in geriatric medicine. Spinal surgeons in this study advocate early further imaging and surgical intervention in patients confirmed to have a concomitant sacral fragility fracture who are failing to mobilise.

scholarly journals ASSERT (Acute Sacral inSufficiEncy fractuRe augmenTation): Perceptions in the Assessment and Treatment of Pubic Rami and Sacral Fragility Fractures Amongst Healthcare Professionals in Geriatric Medicine and Surgery—A Qualitative Study

2021 ◽  
Vol 12 ◽  
pp. 215145932110267
Author(s):  
Opinder Sahota ◽  
Paul Leighton ◽  
Maribel Cameron ◽  
Rachael Taylor ◽  
Terence Ong ◽  
...  
Keyword(s):  
Fragility Fracture ◽  
Healthcare Professionals ◽  
Surgical Intervention ◽  
Geriatric Medicine ◽  
Insufficiency Fracture ◽  
Fragility Fractures ◽  
High Association ◽  
Sacral Insufficiency Fracture ◽  
Pubic Rami ◽  
Assessment And Treatment

Background: Pubic rami fragility fractures are common in older people and result in significant morbidity and increased mortality. Co-existing fractures of the sacrum are common, but routinely missed. The aim of the study was to explore the perceptions in the assessment and treatment of pubic rami and sacral fragility fractures amongst healthcare professionals. Methods: We interviewed 14 participants about their experience in the assessment and treatment of patients presenting with pubic rami fragility fractures. Data was analyzed using an inductive thematic approach. Results: The majority of patients presenting with a pubic rami fragility fracture were managed by geriatricians. However, many of the geriatricians were not aware that these fractures have a high association with co-existing sacral fragility fractures. Furthermore, they were not aware of the limitations of standard x-ray imaging, nor of the potential benefits of surgical intervention for sacral fragility fractures. Spinal surgeons recommended that early, more specialist imaging in patients with pubic rami fragility fractures failing to mobilize, would change clinical management, if found to have a coexisting sacral fragility fracture, amenable to surgical intervention. Conclusions: The awareness, assessment and management of sacral fragility fractures in patients presenting with pubic rami fragility fractures is poor amongst healthcare professionals in geriatric medicine. Spinal surgeons in this study advocate early further imaging and surgical intervention in patients confirmed to have a concomitant sacral fragility fracture who are failing to mobilize.

scholarly journals Prevention of delirium (POD) for older people in hospital: study protocol for a randomised controlled feasibility trial

Trials ◽  
2015 ◽  
Vol 16 (1) ◽  
Author(s):  
John Young ◽  
Francine Cheater ◽  
Michelle Collinson ◽  
Marie Fletcher ◽  
Anne Forster ◽  
...  
Keyword(s):  
Older People ◽  
Study Protocol ◽  
Feasibility Trial ◽  
Randomised Controlled ◽  
Hospital Study

scholarly journals 71 Ultrasound directed reduction of Colles’ type distal radial fractures in ED (UDiReCT): a feasibility randomized controlled trial

2020 ◽  
Vol 37 (12) ◽  
pp. 835.3-836
Author(s):  
Hamza Malik ◽  
Andrew Appelboam ◽  
Gordon Taylor ◽  
Daryl Wood ◽  
Karen Knapp
Keyword(s):  
Data Collection ◽  
Controlled Trial ◽  
Wrist Fracture ◽  
Recruitment Rate ◽  
Feasibility Trial ◽  
Point Of Care Ultrasound ◽  
Distal Radial Fractures ◽  
Definitive Trial ◽  
Randomised Controlled

Aims/Objectives/BackgroundWrist fractures are among the commonest injuries seen in the emergency department (ED). Around 25% of these injuries have Colles’ type fracture displacement and undergo manipulation in the ED. In the UK, these manipulations are typically done ‘blind’ without real time imaging and recent observational studies show that over 40% of the injuries go on to require surgical fixation (due to inadequate initial reduction or re-displacement). Point of care ultrasound has been used to guide and improve wrist fracture reductions but it’s effect on subsequent outcome is not established. We set up and ran the UK’s first randomised controlled feasibility trial comparing standard and ultrasound guided ED wrist fracture manipulations to test a definitive trial protocol, data collection and estimate recruitment rate towards a future definitive trial.Methods/DesignWe conducted a 1:1, single blind, parallel group, randomised controlled feasibility trial in two UK hospitals. Adults with Colles’ type distal radial fractures requiring manipulation in the ED were recruited by supervising emergency physicians supported by network research nurses. Participants were randomised to ultrasound directed fracture manipulation (intervention) or standard care with sham ultrasound (controls). The trial was run through Exeter Clinical Trials Unit and consent, randomisation and data collection conducted electronically in REDCap cloud. All participants were followed up at 6 weeks to record any surgical intervention and also underwent baseline and 3 month quality of life (EQ-5D-5L) and wrist function (Patient Rated Wrist Evaluation (PRWE) assessments.Results/ConclusionsWe recruited 47 patients in total, with 23 randomised to the interventional arm and 24 randomised to the control arm. We were able to follow up 100% of the patients for the 6 week follow up. Data analysis and results will be presented at the time of the conference.

scholarly journals Nutrigenetics-based intervention approach for adults with non-alcoholic fatty liver disease (NAFLD): study protocol for a randomised controlled feasibility trial

BMJ Open ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. e045922
Author(s):  
Laura Haigh ◽  
Stuart McPherson ◽  
John C Mathers ◽  
Quentin M Anstee
Keyword(s):  
Liver Disease ◽  
Fatty Liver ◽  
Fatty Liver Disease ◽  
Controlled Trial ◽  
Phase 1 ◽  
Feasibility Trial ◽  
Alcoholic Fatty Liver ◽  
Intervention Protocol ◽  
Randomised Controlled ◽  
Alcoholic Fatty Liver Disease

IntroductionLifestyle interventions targeting weight loss and improved dietary patterns are the recommended treatment for non-alcoholic fatty liver disease (NAFLD). However, the effectiveness of current established diet therapies is suboptimal. The patatin‐like phospholipase domain containing 3 (PNPLA3) gene modifies disease outcome and hepatic lipid handling, but the role of PNPLA3 variants in modulating responsiveness to different diet therapies is unknown.Methods and analysisThis project aims to assess the feasibility of conducting a genotype-driven randomised controlled trial (RCT) investigating the differential response to a Mediterranean diet (MD) intervention of NAFLD patients according to genotype for the rs738409 (I148M) variant of PNPLA3. A single-centre randomised controlled feasibility trial will be undertaken. We will recruit 60 adults with NAFLD from a tertiary hepatology centre in England. In a cross-over design, participants will undertake Diet 1 (MD) and Diet 2 (control) for 4 weeks, in random order (1:1 allocation), separated by a 4 weeks washout period. Participants will complete one-to-one diet and lifestyle consultations at baseline, end of diet phase 1, end of washout and end of diet phase 2. Participants will be advised to maintain baseline levels of physical activity and body weight. The primary outcome is the acceptability and feasibility of the intervention protocol. Secondary outcomes include exploratory assessment of liver fibrosis biomarkers and lipid biomarkers.Ethics and disseminationEthical approval was granted by East of Scotland Research Ethics Service REC 1 (19/ES/0112). Results will be disseminated through peer-reviewed journals and presented at local, national and international meetings and conferences. The findings of this trial will lay the foundation for a future definitive RCT by informing trial design and optimising the intervention diets, instruments and procedures.Trial registration numberISRCTN93410321.

scholarly journals An external pilot cluster randomised controlled trial of a theory-based intervention to improve appropriate polypharmacy in older people in primary care (PolyPrime): study protocol

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Audrey Rankin ◽  
◽  
Cathal A. Cadogan ◽  
Heather E. Barry ◽  
Evie Gardner ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomised Controlled Trial ◽  
Older People ◽  
Usual Care ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Online Video ◽  
Link Type ◽  
Cluster Randomised ◽  
Randomised Controlled

Abstract Background The use of multiple medications (polypharmacy) is a concern in older people (≥65 years) and is associated with negative health outcomes. For older populations with multimorbidity, polypharmacy is the reality and the key challenge is ensuring appropriate polypharmacy (as opposed to inappropriate polypharmacy). This external pilot cluster randomised controlled trial (cRCT) aims to further test a theory-based intervention to improve appropriate polypharmacy in older people in primary care in two jurisdictions, Northern Ireland (NI) and the Republic of Ireland (ROI). Methods Twelve GP practices across NI (n=6) and the six counties in the ROI that border NI will be randomised to either the intervention or usual care group. Members of the research team have developed an intervention to improve appropriate polypharmacy in older people in primary care using the Theoretical Domains Framework of behaviour change. The intervention consists of two components: (1) an online video which demonstrates how a GP may prescribe appropriate polypharmacy during a consultation with an older patient and (2) a patient recall process, whereby patients are invited to scheduled medication review consultations with GPs. Ten older patients receiving polypharmacy (≥4 medications) will be recruited per GP practice (n=120). GP practices allocated to the intervention arm will be asked to watch the online video and schedule medication reviews with patients on two occasions; an initial and a 6-month follow-up appointment. GP practices allocated to the control arm will continue to provide usual care to patients. The study will assess the feasibility of recruitment, retention and study procedures including collecting data on medication appropriateness (from GP records), quality of life and health service use (i.e. hospitalisations). An embedded process evaluation will assess intervention fidelity (i.e. was the intervention delivered as intended), acceptability of the intervention and potential mechanisms of action. Discussion This pilot cRCT will provide evidence of the feasibility of a range of study parameters such as recruitment and retention, data collection procedures and the acceptability of the intervention. Pre-specified progression criteria will also be used to determine whether or not to proceed to a definitive cRCT. Trial registration ISRCTN, ISRCTN41009897. Registered 19 November 2019. ClinicalTrials.gov, NCT04181879. Registered 02 December 2019.

Insufficiency Fractures vs. Low-Energy Pelvic Ring Fractures – Epidemiological, Diagnostic and Therapeutic Characteristics of Fragility Fractures of the Pelvic Ring

2021 ◽  
Author(s):  
Manuel Sterneder ◽  
Patricia Lang ◽  
Hans-Joachim Riesner ◽  
Carsten Hackenbroch ◽  
Benedikt Friemert ◽  
...  
Keyword(s):  
Pelvic Ring ◽  
Diagnostic Testing ◽  
Insufficiency Fracture ◽  
Fragility Fractures ◽  
Relative Increase ◽  
Trauma Centre ◽  
Low Energy ◽  
Insufficiency Fractures ◽  
Type Iv ◽  
Pelvic Ring Fractures

Abstract Background Fragility fractures of the pelvis (FFP) encompass two fracture entities: fracture after low-energy trauma and insufficiency fracture without trauma. It is unclear whether the two subgroups differ in terms of diagnosis and therapy. The aim of this retrospective study was to evaluate insufficiency fractures with regard to defined parameters and to compare specific parameters with the fractures after low-energy trauma. Patients and Methods In the period from 2008 to 2017, 203 patients with FFP were recorded at our clinic (Level 1 Trauma Centre DGU, SAV approval). Of these, 25 had an insufficiency fracture and 178 had a pelvic ring fracture after low-energy trauma. Epidemiological, diagnostic and therapeutic parameters were examined. Results There was a relative increase in the insufficiency fracture within the FFP (2008 – 2009: 5.0% vs. 2015 – 2017: 17.8%). In these patients, osteoporosis tended to be more pronounced than in patients after low-energy trauma (t-value: − 3.66 vs. − 3.13). The diagnosis of insufficiency fractures showed increased use of MRI and DECT (60.9% vs. 26.0%) and a high proportion of type IV fractures after FFP (40.0% vs. 7.9%). In terms of therapy, surgical treatment of the insufficiency fracture was sought more often (68,2% vs. 52,1%), with a tendency towards increased use of combined osteosynthesis procedures (14.3% vs. 7.6%). Conclusion We were able to show that as the number of cases increases, the insufficiency fracture becomes more important within FFP. If these patients tend to have more pronounced osteoporosis, particular attention should be paid to the diagnosis and adequate therapy of the osteoporosis, especially in the case of an insufficiency fracture. In addition to the increased diagnostic testing using MRI and DECT to detect oedema and the increased surgical therapy for this type of fracture, it is also noteworthy that the insufficiency fracture can cause higher-grade fractures after FFP.

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