The magnetic effect: sustainability of patient centric outcomes, time and cost saving following 5 years of Magseed experience (2024)

Type of publication:
Conference abstract

Author(s):
*Lake B.; *Wilson M.; *Deane L.; *Cielecki L.; *Thomas G.; *Usman T.

Citation:
European Journal of Surgical Oncology. Conference: ESSO 42 2023. Florence Italy. 50(2) (no pagination), 2024. Article Number: 107333. Date of Publication: February 2024.

Abstract:
Background: Magseed has transformed the conventional guided procedures for impalpable breast cancer. In an initial service evaluation, we described "the triple effect of Magseed": reducing re-excision rates, reducing costs, and providing high patient satisfaction, with our cost saving analysis described in NICE guidance MIB236. Our change of practice service evaluation demonstrated that Magseed localisation for breast cancer promotes a patient-centric approach by reducing need for further surgery and ensuring high patient satisfaction. Other advantages are improved patient flow, as placement can occur prior to surgery, and cost saving in theatre and radiology. The aim of this study was to see if this described triple effect is sustainable in terms of patient outcomes and cost saving after 500 Magseeds and following 5 years of experience. Material(s) and Method(s): A 5-year service evaluation was conducted at Shrewsbury and Telford Hospital of all patients who had image-guided wide local excision for impalpable breast cancer from July 2017 to June 2022. Outcomes recorded included re-excision rate, theatre cost-saving analysis, radiology time and patient satisfaction. Result(s): 907 cases were performed, 501 Magseed guided procedures, and 406 coventional guided procedures. Significantly lower re-excision rates were maintained post-Magseed compared to pre-Magseed of 12.9% v 22.4% (chi2=11.1377 P<0.000846). Cost was saved in terms of surgery and radiology time. 94,321 was saved per year, with 58.6% fewer further operations, with an overall saving of 471,605. Significantly less radiology time with Magseed insertion average of 36 minutes, compared to wire insertion of 52 min (t-value =-2.24215, p-value<0.01854.) High patient satisfaction was maintained with the Magseed service described as "completely comfortable" and "quick and straightforward". Conclusion(s): Magseed continues to be the technique of choice for the detection of impalpable breast cancer, and its benefits of reducing re-excision rates, cost saving in surgery and radiology and high patient satisfaction are sustainable: the magnetic effect.

The additive effect of Magtrace: improved theatre efficiency, operative capacity and patient experience (2024)

Type of publication:
Conference abstract

Author(s):
Lake B.; Wilson M.; Appleton D.

Citation:
European Journal of Surgical Oncology. Conference: ESSO 42 2023. Florence Italy. 50(2) (no pagination), 2024. Article Number: 107518. Date of Publication: February 2024.

Abstract:
Background: Magtrace is a non-radioactive magnetic tracer designed specifically for Sentinel Lymph Node biopsy, with multiple benefits including a flexible injection window up to 30 days prior to surgery, no requirement for nuclear medicine and has been statistically proven non-inferior to Technetium and Blue Dye, the current gold standard. The "conventional" patient pathway at the Shrewsbury and Telford Hospital involved the patient travelling to the Nuclear Medicine Department at the Royal Shrewsbury Hospital the day before or morning of surgery for Technetium injection. Surgery takes place at Princess Royal Hospital, necessitating two journeys for the patient. NICE Guidance GID-MT568 recommends Magtrace as an option to locate sentinel lymph nodes for breast cancer in hospitals with limited or no access to radio-pharmacy and thus eliminates patient travel and nuclear medicine resources. Magtrace can be injected either in outpatients or on the day of surgery. Magtrace also has the potential to reduce cost as described by NICE MTG72, with an expectation that its usage would lead to an additional sentinel node biopsy per week due to improved theatre utilisation. The aim of this study was to evaluate the use of Magtrace and its impact on theatre efficiency and patient experience. Material(s) and Method(s): A 4-month trial of Magtrace for sentinel node biopsy was conducted at the Shrewsbury & Telford NHS Trust from November 2022 to March 2023. Outcomes recorded were theatre utilisation, numbers of sentinel node biopsies performed per week and patient satisfaction. Result(s): 62 patients had Magtrace as the technique for SLNB combined either wide local excision or mastectomy during the trial period. Theatre utilisation improved from 77% to 85%, due to reduction in theatre delays due to waiting for patients to have radioisotope and improved theatre flow. Significantly more sentinel node biopsies were performed per week, increasing from 6.48 per week (Pre Magtrace 2022) to 8.52 per week (Post Magtrace November 22 to March 23) (t-value = -3.03541 p-value <0.00208), with a resultant net increase of 2 patients per week. High patient satisfaction was found with 100% finding injection more convenient on day of surgery and 100% would recommend technique if needed to friend or relative. Conclusion(s): Magtrace for sentinel node biopsy gives an "additive effect" by improving theatre utilisation, increasing the number of sentinel node biopsies per week and improving patient experience.

A National audit of the care of patients with acute kidney injury in England and Wales in 2019 and the association with patient outcomes (2024)

Type of publication:
Journal article

Author(s):
Graham-Brown M.P.M.; Casula A.; Savino M.; Humphrey T.; Pyart R.; Amaran M.; Williams J.; Crowe K.; Medcalf J.F.; Lee D.K.; Dan Cooper; Carr D.E.; Marthi D.A.; Swift D.O.; Hull D.K.; Nimmo D.A.; Liewm D.H.; Tariq D.B.; Whitehead D.J.; Edney D.N.; Whitbread D.D.; Mohamed D.M.; Duffy D.S.; Edwards D.G.; Czajka D.R.; Ahmad D.S.H.; Joslin D.J.; Yong D.E.S.T.; Chaudry D.S.; McGuinness D.D.; Defreitas D.S.; Nosseir D.H.; Seal D.K.; Amaran D.M.; Gulati D.K.; Azam D.M.J.; Williams D.J.; Smith-Jackson; Yin D.B.-S.; Shuaib D.R.; Akter D.M.; Arimoto D.R.; Oluyombo D.R.; Davies D.M.; Patel D.P.; Best-Trent T.; Handra D.H.; Mackie S.; Wright K.; Rahman D.M.; Cheema D.H.; Sardar D.A.; Harvard D.L.; Brook D.M.; *Elphic D.E.; Ahmed D.M.; Ammar D.K.; Harbe D.M.; Corke D.E.; Stacey D.H.; Yousif D.M.; Mohamed D.D.; Soe D.L.T.; Sherna D.A.; Soutter D.L.; Davari D.M.; Abburu D.S.; Wells D.J.; Winterbottom D.C.; Bottomley D.M.; Morris D.H.; Sadiq D.A.; Youssouf D.S.

Citation:
Clinical Medicine, Journal of the Royal College of Physicians of London. 24(2) (no pagination), 2024. Article Number: 100028. Date of Publication: March 2024.

Abstract:
Background: Acute kidney injury (AKI) is a common complication of hospitalisations. This national audit assessed the care received by patients with AKI in hospital Trusts in England and Wales. Method(s): Twenty four hospital Trusts across England and Wales took part. Patients with AKI stage2/3 were identified using the UK Renal Registry AKI master patient index. Data was returned through a secure portal with linkage to hospital episode statistic mortality and hospitalisation data. Completion rates of AKI care standards and regional variations in care were established. Result(s): 989 AKI episodes were included in the analyses. In-hospital 30-day mortality was 31-33.1% (AKI 2/3). Standard AKI interventions were completed in >80% of episodes. Significant inter-hospital variation remained in attainment of AKI care standards after adjustment for age and sex. Recording of urinalysis (41.9%) and timely imaging (37.2%) were low. Information on discharge summaries relating to medication changes/re-commencement and follow-up blood tests associated with reduced mortality. No quality indicators relating to clinical management associated with mortality. Better communication on discharge summaries associated with reduced mortality. Conclusion(s): Outcomes for patients with AKI in hospital remain poor. Regional variation in care exists. Work is needed to assess whether improving and standardising care improves patient outcomes.

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Baseline Expression of Immune Gene Modules in Blood is Associated With Primary Response to Anti-TNF Therapy in Crohn's Disease Patients (2024)

Type of publication:
Journal article

Author(s):
Journal of Crohn's and Colitis. 18(3) (pp 431-445), 2024. Date of Publication: 01 Mar 2024

Citation:
Reppell M.; Smaoui N.; Waring J.F.; Pivorunas V.; Guay H.; Lin S.; Chanchlani N.; Bewshea C.; Goodhand J.R.; Kennedy N.A.; Anderson C.A.; Patel V.; Mazhar Z.; Saich R.; Colleypriest B.; Tham T.C.; Iqbal T.H.; Kaushik V.; Murugesan S.; Singhi S.; Weaver S.; Preston C.; Butt A.; Smith M.; Basude D.; Beale A.; Langlands S.; Direkze N.; Parkes M.; Torrente F.; De La Revella Negro J.; MacDonald C.E.; Evans S.M.; Gunasekera A.V.J.; Thakur A.; Elphick D.; Shenoy A.; Nwokolo C.U.; Dhar A.; Cole A.T.; Agrawal A.; Bridger S.; Doherty J.; Cooper S.C.; de Silva S.; Mowat C.; Mayhead P.; Lees C.; Jones G.; Hart J.W.; Gaya D.R.; Russell R.K.; Gervais L.; Dunckley P.; Mahmood T.; Banim P.J.R.; Sonwalkar S.; Ghosh D.; Phillips R.H.; Azaz A.; Sebastian S.; Shenderey R.; Armstrong L.; Bell C.; Hariraj R.; Matthews H.; Jafferbhoy H.; Selinger C.P.; Zamvar V.; De Caestecker J.S.; Willmott A.; Miller R.; Babu P.S.; Tzivinikos C.; Bloom S.L.; Chung-Faye G.; Croft N.M.; Fell J.M.E.; Harbord M.; Hart A.; Hope B.; Irving P.M.; Lindsay J.O.; Mawdsley J.E.; McNair A.; Monahan K.J.; Murray C.D.; Orchard T.; Paul T.; Pollok R.; Shah N.; Bouri S.; Johnson M.W.; Modi A.; Kabiru K.D.; Baburajan B.K.; Bhaduri B.; Fagbemi A.A.; Levison S.; Limdi J.K.; Watts G.; Foley S.; Ramadas A.; MacFaul G.; Mansfield J.; Grellier L.; Morris M.-A.; Tremelling M.; Hawkey C.; Kirkham S.; Charlton C.P.J.; Rodrigues A.; Simmons A.; Lewis S.J.; Snook J.; Tighe M.; Goggin P.M.; De Silva A.N.; Lal S.; Smith M.S.; Panter S.; Cummings F.; Dharmisari S.; Carter M.; Watts D.; Mahmood Z.; McLain B.; Sen S.; Pigott A.J.; Hobday D.; Wesley E.; Johnston R.; Edwards C.; Beckly J.; Vani D.; Ramakrishnan S.; Chaudhary R.; Trudgill N.J.; Cooney R.; Bell A.; Prasad N.; Gordon J.N.; Brookes M.J.; Li A.; Gore S.; Bai B.Y.H.; Ahmad T.;

Abstract:
Background and Aims: Anti-tumour necrosis factor [anti-TNF] therapy is widely used for the treatment of inflammatory bowel disease, yet many patients are primary non-responders, failing to respond to induction therapy. We aimed to identify blood gene expression differences between primary responders and primary non-responders to anti-TNF monoclonal antibodies [infliximab and adalimumab], and to predict response status from blood gene expression and clinical data. Method(s): The Personalised Anti-TNF Therapy in Crohn's Disease [PANTS] study is a UK-wide prospective observational cohort study of anti-TNF therapy outcome in anti-TNF-naive Crohn's disease patients [ClinicalTrials.gov identifier: NCT03088449]. Blood gene expression in 324 unique patients was measured by RNA-sequencing at baseline [week 0], and at weeks 14, 30, and 54 after treatment initiation [total sample size = 814]. Result(s): After adjusting for clinical covariates and estimated blood cell composition, baseline expression of major histocompatibility complex, antigen presentation, myeloid cell enriched receptor, and other innate immune gene modules was significantly higher in anti-TNF responders vs non-responders. Expression changes from baseline to week 14 were generally of consistent direction but greater magnitude [i.e. amplified] in responders, but interferon-related genes were upregulated uniquely in non-responders. Expression differences between responders and non-responders observed at week 14 were maintained at weeks 30 and 54. Prediction of response status from baseline clinical data, cell composition, and module expression was poor. Conclusion(s): Baseline gene module expression was associated with primary response to anti-TNF therapy in PANTS patients. However, these baseline expression differences did not predict response with sufficient sensitivity for clinical use.

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Best practice for embryology staffing in HFEA licensed assisted conception centres-guidance from Association of Reproductive & Clinical Scientists (2024)

Type of publication:
Journal article

Author(s):
*Kasraie, Jason; Kennedy, Hannah

Citation:
Human Fertility. 27(1):2322729, 2024 Dec.

Abstract:
The Association of Reproductive and Clinical Scientists (ARCS) has long promoted the importance of externally accredited training and assessment of scientific staff within assisted conception centres to ensure professional registration and relevant training at all levels. This not only gives scientific staff the opportunity to empower themselves but also acts to ensure assisted conception centres maintain the highest standards of care and quality for patients whilst meeting HFEA requirements for staffing and training. It also provides assurance to patients that treatment is being delivered by highly trained and competent staff. Clinical embryology practice requires intense concentration, with increasingly complex treatment plans and options coupled with the ever-present consequences of clinical error at the forefront of practitioners' minds, exhaustion and burn out are very real risks. Overloading embryology teams is likely to lead to increased error rates and serious incidents. This guideline aims to bring the sector in line with other Clinical Science specialities to optimise patient care, increase safety, reduce risk (including the risk of legal action against centres and individuals), ensure the use of recognised job titles with appropriate levels of remuneration, and provide centres with a template to work towards for appropriate levels of scientific staffing.

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A genome-wide meta-analysis of palmoplantar pustulosis implicates Th2 responses and cigarette smoking in disease pathogenesis (2024)

Type of publication:
Journal article

Author(s):
Hernandez-Cordero A.; Thomas L.; Smail A.; Lim Z.Q.; Saklatvala J.R.; Chung R.; Curtis C.J.; Baum P.; Visvanathan S.; Burden A.D.; Cooper H.L.; Dunnill G.; Griffiths C.E.M.; Levell N.J.; Parslew R.; Reynolds N.J.; Wahie S.; Warren R.B.; Wright A.; Simpson M.; Hveem K.; Barker J.N.; Dand N.; Loset M.; Smith C.H.; Capon F.; Abraham T.; Ali M.; August S.; Baudry D.; Becher G.; Bewley A.; Brown V.; Cornelius V.; Ghaffar S.; Ingram J.; Kavakleiva S.; *Kelly S.; Khorshid M.; Lachmann H.; Ladoyanni E.; McAteer H.; McKenna J.; Meynell F.; Patel P.; Pink A.; Powell K.; Pushparajah A.; Sinclair C.; Wachsmuth R.;

Citation:
Journal of Allergy and Clinical Immunology. 2024 May 28:S0091-6749(24)00553-0 [epub ahead of print]

Abstract:
Background: Palmoplantar pustulosis (PPP) is an inflammatory skin disorder that mostly affects smokers and manifests with painful pustular eruptions on the palms and soles. While the disease can present with concurrent plaque psoriasis, TNF and IL-17/IL-23 inhibitors show limited efficacy. There is therefore a pressing need to uncover PPP disease drivers and therapeutic targets. Objective(s): To identify genetic determinants of PPP and investigate whether cigarette smoking contributes to disease pathogenesis. Method(s): We performed a genome-wide association meta-analysis of three North-European cohorts (n=1,456 PPP cases and 402,050 controls). We then used the scGWAS program to investigate the cell-type specificity of the resulting association signals. We undertook genetic correlation analyses to examine the similarities between PPP and other immune-mediated diseases. Finally, we applied Mendelian randomization to analyze the causal relationship between cigarette smoking and PPP. Result(s): We found that PPP is not associated with the main genetic determinants of plaque psoriasis. Conversely, we identified genome-wide significant associations with the FCGR3A/FCGR3B and CCHCR1 loci. We also observed 13 suggestive (P<5X10-6) susceptibility regions, including the IL4/IL13 interval. Accordingly, we demonstrated a significant genetic correlation between PPP and Th2-mediated diseases like atopic dermatitis and ulcerative colitis. We also found that genes mapping to PPP-associated intervals were preferentially expressed in dendritic cells and enriched for T-cell activation pathways. Finally, we undertook a Mendelian randomization analysis, which supported a causal role of cigarette smoking in PPP. Conclusion(s): The first genome-wide association study of PPP points to a pathogenic role for deregulated Th2 responses and cigarette smoking.

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The characteristics and predictors of mortality in periprosthetic fractures around the knee (2024)

Type of publication:
Journal article

Author(s):
Nasser, Ahmed A H H; Sidhu, Manpreet; Prakash, Rohan; Mahmood, Ansar; Osman, Khabab; Chauhan, Govind S; Nandra, Rajpal; Dewan, Varun; Davidson, Jerome; Al-Azzawi, Mohammed; Smith, Christian; Gawad, Mothana; Palaiologos, Ioannis; Cuthbert, Rory; Wignadasan, Warran; Banks, Daniel; Archer, James; Odeh, Abdulrahman; Moores, Thomas; Tahir, Muaaz; Brooks, Margaret; Biring, Gurdeep; Jordan, Stevan; Elahi, Zain; Shaath, Mohammed; Veettil, Manoj; De, Chiranjit; Handford, Charles; Bansal, Mohit; Bawa, Akshdeep; Mattar, Ahmed; Tandra, Varun; Daadipour, Audrina; Taha, Ahmed; Gangoo, Shafat; Srinivasan, Sriram; Tarisai, Mandishona; Budair, Basil; Subbaraman, Krishna; Khan, Farrukh; Gomindes, Austin; Samuel, Arjun; Kang, Niel; Kapur, Karan; Mainwaring, Elizabeth; Bridgwater, Hannah; Lo, Andre; *Ahmed, Usman; *Khaleeq, Tahir; El-Bakoury, Ahmed; Rashed, Ramy; Hosny, Hazem; Yarlagadda, Rathan; Keenan, Jonathan; Hamed, Ahmed; Riemer, Bryan; Qureshi, Arham; Gupta, Vatsal; Waites, Matthew; Bleibleh, Sabri; Westacott, David; Phillips, Jonathan; East, Jamie; Huntley, Daniel; Masud, Saqib; Mirza, Yusuf; Mishra, Sandeep; Dunlop, David; Khalefa, Mohamed; Balakumar, Balasubramanian; Thibbaiah, Mahesh; Payton, Olivia; Berstock, James; Deano, Krisna; Sarraf, Khaled M; Logishetty, Kartik; Lee, George; Subbiah-Ponniah, Hariharan; Shah, Nirav; Venkatesan, Aakaash; Cheseldene-Culley, James; Ayathamattam, Joseph; Tross, Samantha; Randhawa, Sukhwinder; Mohammed, Faisal; Ali, Ramla; Bird, Jonathan; Khan, Kursheed; Akhtar, Muhammad A; Brunt, Andrew; Roupakiotis, Panagiotis; Subramanian, Padmanabhan; Bua, Nelson; Hakimi, Mounir; Bitar, Samer; Al Najjar, Majed; Radhakrishnan, Ajay; Gamble, Charlie; James, Andrew; Gilmore, Catherine; Dawson, Dan; Sofat, Rajesh; Antar, Mohamed; Raghu, Aashish; Heaton, Sam; Tawfeek, Waleed; Charles, Christerlyn; Burnand, Henry; Duffy, Sean; Taylor, Luke; Magill, Laura; Perry, Rita; Pettitt, Michala; Okoth, Kelvin; Pinkney, Thomas

Citation:
Bone & Joint Journal. 106-B(2):158-165, 2024 Feb 01

Abstract:
Aims: Periprosthetic fractures (PPFs) around the knee are challenging injuries. This study aims to describe the characteristics of knee PPFs and the impact of patient demographics, fracture types, and management modalities on in-hospital mortality. Methods: Using a multicentre study design, independent of registry data, we included adult patients sustaining a PPF around a knee arthroplasty between 1 January 2010 and 31 December 2019. Univariate, then multivariable, logistic regression analyses were performed to study the impact of patient, fracture, and treatment on mortality. Results: Out of a total of 1,667 patients in the PPF study database, 420 patients were included. The in-hospital mortality rate was 6.4%. Multivariable analyses suggested that American Society of Anesthesiologists (ASA) grade, history of peripheral vascular disease (PVD), history of rheumatic disease, fracture around a loose implant, and cerebrovascular accident (CVA) during hospital stay were each independently associated with mortality. Each point increase in ASA grade independently correlated with a four-fold greater mortality risk (odds ratio (OR) 4.1 (95% confidence interval (CI) 1.19 to 14.06); p = 0.026). Patients with PVD have a nine-fold increase in mortality risk (OR 9.1 (95% CI 1.25 to 66.47); p = 0.030) and patients with rheumatic disease have a 6.8-fold increase in mortality risk (OR 6.8 (95% CI 1.32 to 34.68); p = 0.022). Patients with a fracture around a loose implant (Unified Classification System (UCS) B2) have a 20-fold increase in mortality, compared to UCS A1 (OR 20.9 (95% CI 1.61 to 271.38); p = 0.020). Mode of management was not a significant predictor of mortality. Patients managed with revision arthroplasty had a significantly longer length of stay (median 16 days; p = 0.029) and higher rates of return to theatre, compared to patients treated nonoperatively or with fixation. Conclusion: The mortality rate in PPFs around the knee is similar to that for native distal femur and neck of femur fragility fractures. Patients with certain modifiable risk factors should be optimized. A national PPF database and standardized management guidelines are currently required to understand these complex injuries and to improve patient outcomes.

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Cardiac rehabilitation for children and young people (CardioActive): protocol for a single-blind randomised feasibility and acceptability study of a centre-based cardiac rehabilitation programme versus usual care in 11-16 years with heart conditions (2024)

Type of publication:
Journal article

Author(s):
Capobianco, Lora; Hann, Mark; McManus, Emma; Peters, Sarah; Doherty, Patrick Joseph; Ciotti, Giovanna; *Murray, Joanne; Wells, Adrian.

Citation:
BMJ Open. 14(2):e077958, 2024 Feb 24.

Abstract:
BACKGROUND: Congenital heart conditions are among the most common non-communicable diseases in children and young people (CYP), affecting 13.9 million CYP globally. While survival rates are increasing, support for young people adjusting to life with a heart condition is lacking. Furthermore, one in three CYP with heart conditions also experiences anxiety, depression or adjustment disorder, for which little support is offered. While adults are offered cardiac rehabilitation (CR) to support their mental and physical health, this is not offered for CYP.One way to overcome this is to evaluate a CR programme comprising exercise with
mental health support (CardioActive; CA) for CYP with heart conditions. The exercise and mental health components are informed by the metacognitive model, which has been shown to be effective in treating anxiety and depression in CYP and associated with improving psychological outcomes in adult CR. METHOD AND ANALYSIS: The study is a single-blind parallel randomised feasibility trial comparing a CR programme (CA) plus usual care against usual care alone with 100 CYP (50 per arm) aged 11-16 diagnosed with a heart condition. CA will include six group exercise, lifestyle and mental health modules. Usual care consists of routine outpatient management. Participants will be assessed at three time points: baseline, 3-month (post-treatment) and 6-month follow-up. Primary outcomes are feasibility and acceptability (ie, referral rates, recruitment and retention rates, attendance at the intervention, rate of return and level of completion of follow-up data). Coprimary symptom outcomes (Strength and Difficulties Questionnaire and Paediatric Quality of Life) and a range of secondary outcomes will be administered at each time point. A nested qualitative study will investigate CYP, parents and healthcare staff views of CR and its components, and staff's experience of delivering CA. Preliminary health economic data will be collected to inform future cost-effectiveness analyses. Descriptive data on study processes and clinical outcomes will be reported. Data analysis will follow intention to treat. Qualitative data will be analysed using thematic analysis and the theoretical framework of acceptability. ETHICS AND DISSEMINATION: Ethical approval was granted on 14 February 2023 by the Greater Manchester East Research Ethics Committee (22/NW/0367). The results will be disseminated through peer-reviewed journals, conference presentations and local dissemination. TRIAL REGISTRATION NUMBER: ISRCTN50031147; NCT05968521.

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The improvement and retention of skills in shoulder dystocia management with the use of high-fidelity simulation: the SAFE (SimulAtion high-FidElity) study (2024)

Type of publication:
Journal article

Author(s):
*Papoutsis, Dimitrios; Klazoglou, Paraskevi; Valasoulis, George; Tzavara, Chara.

Citation:
Women & Birth: Journal of the Australian College of Midwives. 101590, 2024 Feb 16.

Abstract:
BACKGROUND: Shoulder dystocia is a relatively uncommon but serious childbirth-related emergency. AIM: To explore the improvement and retention of skills in shoulder dystocia management through high-fidelity simulation training. METHODS: The SAFE (SimulAtion high-FidElity) study was a prospective cohort study that utilised a high-fidelity birth simulator. Registered midwives and final year midwifery students were invited to participate in a one-day workshop at 6-monthly intervals. There was a 30-minute initial assessment, a 30-minute theoretical and hands-on training, and a 30-minute post-training assessment on shoulder dystocia management. Pre-training and post-training values for the predetermined outcomes were compared. In each workshop we assessed the proportion of successful simulated births, the performance of manoeuvres to manage shoulder dystocia, the head-to-body birth time, the fetal head traction force, the quality of communication, the perception of time-to-birth, and the self-reported confidence levels. FINDINGS: The baseline workshop recruited 101 participants that demonstrated a significant increase in the proportion of successful simulated births (8.9% vs 93.1%), and a two-fold to three-fold increase in the score of manoeuvres, communication, and confidence after training. Those with low pre-training levels of competency and confidence improved the most post-training at baseline. There was a retention of manoeuvres, communication skills and confidence at 6 months. There was no reduction in fetal head traction force over time. Those being proficient before initial training retained and performed best at the 6-month follow-up. CONCLUSION: The SAFE study found a significant improvement in skills and confidence after the initial high-fidelity simulation training that were retained after 6 months.