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30-day morbidity and mortality of sleeve gastrectomy, Roux-en-Y gastric bypass and one anastomosis gastric bypass: a propensity score-matched analysis of the GENEVA data (2021)

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Type of publication:Journal article

Author(s):Singhal R.; Wiggins T.; Cardoso V.R.; Gkoutos G.V.; Super J.; Ludwig C.; Mahawar K.; Pedziwiatr M.; Major P.; Zarzycki P.; Pantelis A.; Lapatsanis D.P.; Stravodimos G.; Matthys C.; Focquet M.; Vleeschouwers W.; Spaventa A.G.; Zerrweck C.; Vitiello A.; Berardi G.; Musella M.; Sanchez-Meza A.; Cantu F.J.; Mora F.; Cantu M.A.; Katakwar A.; Reddy D.N.; Elmaleh H.; Hassan M.; Elghandour A.; Elbanna M.; Osman A.; Khan A.; layani L.; Kiran N.; Velikorechin A.; Solovyeva M.; Melali H.; Shahabi S.; Agrawal A.; Shrivastava A.; Sharma A.; Narwaria B.; Narwaria M.; Raziel A.; Sakran N.; Susmallian S.; Karagoz L.; Akbaba M.; Piskin S.Z.; Balta A.Z.; Senol Z.; Manno E.; Iovino M.G.; Qassem M.; Arana-Garza S.; Povoas H.P.; Vilas-Boas M.L.; Naumann D.; Li A.; Ammori B.J.; Balamoun H.; Salman M.; Nasta A.M.; Goel R.; Sanchez-Aguilar H.; Herrera M.F.; Abou-mrad A.; Cloix L.; Mazzini G.S.; Kristem L.; Lazaro A.; Campos J.; Bernardo J.; Gonzalez J.; Trindade C.; Viveiros O.; Ribeiro R.; Goitein D.; Hazzan D.; Segev L.; Beck T.; Reyes H.; Monterrubio J.; Garcia P.; Benois M.; Kassir R.; Contine A.; Elshafei M.; Aktas S.; Weiner S.; Heidsieck T.; Level L.; Pinango S.; Ortega P.M.; Moncada R.; Valenti V.; Vlahovic I.; Boras Z.; Liagre A.; Martini F.; Juglard G.; Motwani M.; Saggu S.S.; Momani H.A.; Lopez L.A.A.; Cortez M.A.C.; Zavala R.A.; D'Haese RN C.; Kempeneers I.; Himpens J.; Lazzati A.; Paolino L.; Bathaei S.; Bedirli A.; Yavuz A.; Buyukkasap C.; Ozaydin S.; Kwiatkowski A.; Bartosiak K.; Waledziak M.; Santonicola A.; Angrisani L.; Iovino P.; Palma R.; Iossa A.; Boru C.E.; De Angelis F.; Silecchia G.; Hussain A.; Balchandra S.; Coltell I.B.; Perez J.L.; Bohra A.; Awan A.K.; Madhok B.; Leeder P.C.; Awad S.; Al-Khyatt W.; Shoma A.; Elghadban H.; Ghareeb S.; Mathews B.; Kurian M.; Larentzakis A.; Vrakopoulou G.Z.; Albanopoulos K.; Bozdag A.; Lale A.; Kirkil C.; Dincer M.; Bashir A.; Haddad A.; Hijleh L.A.; Zilberstein B.; de Marchi D.D.; Souza W.P.; Broden C.M.; Gislason H.; Shah K.; Ambrosi A.; Pavone G.; Tartaglia N.; Kona S.L.K.; Kalyan K.; Perez C.E.G.; Botero M.A.F.; Covic A.; Timofte D.; Maxim M.; Faraj D.; Tseng L.; Liem R.; Oren G.; Dilektasli E.; Yalcin I.; AlMukhtar H.; Hadad M.A.; Mohan R.; Arora N.; Bedi D.; Rives-Lange C.; Chevallier J.-M.; Poghosyan T.; Sebbag H.; Zinai L.; Khaldi S.; Mauchien C.; Mazza D.; Dinescu G.; Rea B.; Perez-Galaz F.; Zavala L.; Besa A.; Curell A.; Balibrea J.M.; Vaz C.; Galindo L.; Silva N.; Caballero J.L.E.; Sebastian S.O.; Marchesini J.C.D.; da Fonseca Pereira R.A.; Sobottka W.H.; Fiolo F.E.; Turchi M.; Coelho A.C.J.; Zacaron A.L.; Barbosa A.; Quinino R.; Menaldi G.; Paleari N.; Martinez-Duartez P.; de Esparza G.M.A.R.; Esteban V.S.; Torres A.; Garcia-Galocha J.L.; Josa M.; Pacheco-Garcia J.M.; Mayo-Ossorio M.A.; Chowbey P.; Soni V.; de Vasconcelos Cunha H.A.; Castilho M.V.; Ferreira R.M.A.; Barreiro T.A.; Charalabopoulos A.; Sdralis E.; Davakis S.; Bomans B.; Dapri G.; Van Belle K.; Takieddine M.; Vaneukem P.; Karaca E.S.A.; Karaca F.C.; Sumer A.; Peksen C.; Savas O.A.; Chousleb E.; Elmokayed F.; Fakhereldin I.; Aboshanab H.M.; Swelium T.; Gudal A.; Gamloo L.; Ugale A.; Ugale S.; Boeker C.; Reetz C.; Hakami I.A.; Mall J.; Alexandrou A.; Baili E.; Bodnar Z.; Maleckas A.; Gudaityte R.; Guldogan C.E.; Gundogdu E.; Ozmen M.M.; Thakkar D.; Dukkipati N.; Shah P.S.; Shah S.S.; Adil M.T.; Jambulingam P.; Mamidanna R.; Whitelaw D.; Jain V.; Veetil D.K.; Wadhawan R.; Torres M.; Tinoco T.; Leclercq W.; Romeijn M.; van de Pas K.; Alkhazraji A.K.; Taha S.A.; Ustun M.; Yigit T.; Inam A.; Burhanulhaq M.; Pazouki A.; Eghbali F.; Kermansaravi M.; Jazi A.H.D.; Mahmoudieh M.; Mogharehabed N.; Tsiotos G.; Stamou K.; Rodriguez F.J.B.; Navarro M.A.R.; Torres O.M.; Martinez S.L.; Tamez E.R.M.; Cornejo G.A.M.; Flores J.E.G.; Mohammed D.A.; Elfawal M.H.; Shabbir A.; Guowei K.; So J.B.; Kaplan E.T.; Kaplan M.; Kaplan T.; Pham D.T.; Rana G.; Kappus M.; Gadani R.; Kahitan M.; Pokharel K.; Osborne A.; Pournaras D.; Hewes J.; Napolitano E.; Chiappetta S.; Bottino V.; Dorado E.; Schoettler A.; Gaertner D.; Fedtke K.; Aguilar-Espinosa F.; Aceves-Lozano S.; Balani A.; Nagliati C.; Pennisi D.; Rizzi A.; Frattini F.; Foschi D.; Benuzzi L.; Parikh C.; Shah H.; Pinotti E.; Montuori M.; Borrelli V.; Dargent J.; Copaescu C.A.; Hutopila I.; Smeu B.; Witteman B.; Hazebroek E.; Deden L.; Heusschen L.; Okkema S.; Aufenacker T.; den Hengst W.; Vening W.; van der Burgh Y.; Ghazal A.; Ibrahim H.; Niazi M.; Alkhaffaf B.; Altarawni M.; Cesana G.C.; Anselmino M.; Uccelli M.; Olmi S.; Stier C.; Akmanlar T.; Sonnenberg T.; Schieferbein U.; Marcolini A.; Awruch D.; Vicentin M.; de Souza Bastos E.L.; Gregorio S.A.; Ahuja A.; Mittal T.; Bolckmans R.; Baratte C.; Wisnewsky J.A.; Genser L.; Chong L.; Taylor L.; Ward S.; Hi M.W.; Heneghan H.; Fearon N.; Geoghegan J.; Ng K.C.; Plamper A.; Rheinwalt K.; Kaseja K.; Kotowski M.; Samarkandy T.A.; Leyva-Alvizo A.; Corzo-Culebro L.; Wang C.; Yang W.; Dong Z.; *Riera M.; *Jain R.; Hamed H.; Said M.; Zarzar K.; Garcia M.; Turkcapar A.G.; Sen O.; Baldini E.; Conti L.; Wietzycoski C.; Lopes E.; Pintar T.; Salobir J.; Aydin C.; Atici S.D.; Ergin A.; Ciyiltepe H.; Bozkurt M.A.; Kizilkaya M.C.; Onalan N.B.D.; Zuber M.N.B.A.; Wong W.J.; Garcia A.; Vidal L.; Beisani M.; Pasquier J.; Vilallonga R.; Sharma S.; Parmar C.; Lee L.; Sufi P.; Sinan H.; Saydam M.

Citation:International Journal of Obesity; 2021 [epub ahead of print]

Abstract:Background: There is a paucity of data comparing 30-day morbidity and mortality of sleeve gastrectomy (SG), Roux-en-Y gastric bypass (RYGB), and one anastomosis gastric bypass (OAGB). This study aimed to compare the 30-day safety of SG, RYGB, and OAGB in propensity score-matched cohorts. Material(s) and Method(s): This analysis utilised data collected from the GENEVA study which was a multicentre observational cohort study of bariatric and metabolic surgery (BMS) in 185 centres across 42 countries between 01/05/2022 and 31/10/2020 during the Coronavirus Disease-2019 (COVID-19) pandemic. 30-day complications were categorised according to the Clavien-Dindo classification. Patients receiving SG, RYGB, or OAGB were propensity-matched according to baseline characteristics and 30-day complications were compared between groups. Result(s): In total, 6770 patients (SG 3983; OAGB 702; RYGB 2085) were included in this analysis. Prior to matching, RYGB was associated with highest 30-day complication rate (SG 5.8%; OAGB 7.5%; RYGB 8.0% (p = 0.006)). On multivariate regression modelling, Insulin-dependent type 2 diabetes mellitus and hypercholesterolaemia were associated with increased 30-day complications. Being a non-smoker was associated with reduced complication rates. When compared to SG as a reference category, RYGB, but not OAGB, was associated with an increased rate of 30-day complications. A total of 702 pairs of SG and OAGB were propensity score-matched. The complication rate in the SG group was 7.3% (n = 51) as compared to 7.5% (n = 53) in the OAGB group (p = 0.68). Similarly, 2085 pairs of SG and RYGB were propensity score-matched. The complication rate in the SG group was 6.1% (n = 127) as compared to 7.9% (n = 166) in the RYGB group (p = 0.09). And, 702 pairs of OAGB and RYGB were matched. The complication rate in both groups was the same at 7.5 % (n = 53; p = 0.07). Conclusion(s): This global study found no significant difference in the 30-day morbidity and mortality of SG, RYGB, and OAGB in propensity score-matched cohorts.

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Machine learning risk prediction of mortality for patients undergoing surgery with perioperative SARS-CoV-2: The COVIDSurg mortality score (2021)

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Type of publication:Journal article

Author(s):COVIDSurg Collaborative (includes Blair, J of Shrewsbury and Telford Hospital NHS Trust)

Citation:British Journal of Surgery; 2021; vol. 19 (no. 4) p.1-19

Abstract:Since the beginning of the COVID-19 pandemic tens of millions of operations have been cancelled as a result of excessive postoperative pulmonary complications (51.2 per cent) and mortality rates (23.8 per cent) in patients with perioperative SARS-CoV-2 infection. There is an urgent need to restart surgery safely in order to minimize the impact of untreated non-communicable disease. As rates of SARS-CoV-2 infection in elective surgery patients range from 1–9 per cent, vaccination is expected to take years to implement globally9 and preoperative screening is likely to lead to increasing numbers of SARS-CoV-2-positive patients, perioperative SARS-CoV-2 infection will remain a challenge for theforeseeable future. In order to inform consent and shared decision making, a robust, globally applicable score is needed to predict individualized mortality risk for patients with perioperative SARS-CoV-2 infection. The authors aimed to develop and validate a machine learning-based risk score to predict postoperative mortality risk in patients with perioperative SARS-CoV-2 infection.

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Effect of COVID-19 pandemic lockdowns on planned cancer surgery for 15 tumour types in 61 countries: an international, prospective, cohort study (2021)

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Type of publication:
Journal article

Author(s):
COVIDSurg Collaborative (includes *Blair J, *Lakhiani A, *Parry-Smith W, *Sahu B)

Citation:
The Lancet Oncology; 5th October 2021 [epub ahead of print]

Abstract:
Background: Surgery is the main modality of cure for solid cancers and was prioritised to continue during COVID-19 outbreaks. This study aimed to identify immediate areas for system strengthening by comparing the delivery of elective cancer surgery during the COVID-19 pandemic in periods of lockdown versus light restriction.
Methods; This international, prospective, cohort study enrolled 20 006 adult (≥18 years) patients from 466 hospitals in 61 countries with 15 cancer types, who had a decision for curative surgery during the COVID-19 pandemic and were followed up until the point of surgery or cessation of follow-up (Aug 31, 2020). Average national Oxford COVID-19 Stringency Index scores were calculated to define the government response to COVID-19 for each patient for the period they awaited surgery, and classified into light restrictions (index <20), moderate lockdowns (20–60), and full lockdowns (>60). The primary outcome was the non-operation rate (defined as the proportion of patients who did not undergo planned surgery). Cox proportional-hazards regression models were used to explore the associations between lockdowns and non-operation. Intervals from diagnosis to surgery were compared across COVID-19 government response index groups. This study was registered at ClinicalTrials.gov, NCT04384926.
Findings; Of eligible patients awaiting surgery, 2003 (10·0%) of 20 006 did not receive surgery after a median follow-up of 23 weeks (IQR 16–30), all of whom had a COVID-19-related reason given for non-operation. Light restrictions were associated with a 0·6% non-operation rate (26 of 4521), moderate lockdowns with a 5·5% rate (201 of 3646; adjusted hazard ratio [HR] 0·81, 95% CI 0·77–0·84; p<0·0001), and full lockdowns with a 15·0% rate (1775 of 11 827; HR 0·51, 0·50–0·53; p<0·0001). In sensitivity analyses, including adjustment for SARS-CoV-2 case notification rates, moderate lockdowns (HR 0·84, 95% CI 0·80–0·88; p<0·001), and full lockdowns (0·57, 0·54–0·60; p<0·001), remained independently associated with non-operation. Surgery beyond 12 weeks from diagnosis in patients without neoadjuvant therapy increased during lockdowns (374 [9·1%] of 4521 in light restrictions, 317 [10·4%] of 3646 in moderate lockdowns, 2001 [23·8%] of 11 827 in full lockdowns), although there were no differences in resectability rates observed with longer delays.
Interpretation: Cancer surgery systems worldwide were fragile to lockdowns, with one in seven patients who were in regions with full lockdowns not undergoing planned surgery and experiencing longer preoperative delays. Although short-term oncological outcomes were not compromised in those selected for surgery, delays and non-operations might lead to long-term reductions in survival. During current and future periods of societal restriction, the resilience of elective surgery systems requires strengthening, which might include protected elective surgical pathways and long-term investment in surge capacity for acute care during public health emergencies to protect elective staff and services.

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DOI: https://doi.org/10.1016/S1470-2045(21)00493-9

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Optimising frontline learning and engagement between consultant-led neonatal teams in the West Midlands: a survey on the utility of an augmented simulation training technique (2021)

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Type of publication:
Journal article

Author(s):
Pillay, Thillagavathie; Clarke, Lynsey; Abbott, Lee; Surana, Pinki; Shenvi, Asha; *Deshpande, Sanjeev; Cookson, Joanne; Nash, Matthew; Fawke, Joe; Rasiah, Vishna; Cusack, Jonathan

Citation:
Advances in Simulation; Aug 2021; vol. 6 (no. 1); p. 29

Abstract:
BACKGROUND In England, neonatal care is delivered in operational delivery networks, comprising a combination of the Neonatal Intensive Care (NICU), Local-Neonatal (LNU) or Special-Care Units (SCU), based on their ability to care for babies with different degrees of illness or prematurity. With the development of network care pathways, the most premature and sickest are mostly triaged for delivery in services linked to NICU. This has created anxiety for teams in LNU and SCU. Less exposure to sicker babies has resulted in limited opportunities to maintain expertise for when these babies unexpectedly deliver at their centre and thereafter require transfer for care, to NICU. Simultaneously, LNU and SCU teams develop skills in the care of the less ill and premature baby which would also be of benefit to NICU teams. A need for mutual learning through inter-unit multidirectional collaborative learning and engagement (hereafter also called neonatal networking) between teams of different designations emerged. Here, neonatal networking is defined as collaboration, shared clinical learning and developing an understanding of local systems strengths and challenges between units of different and similar designations. We describe the responses to the development of a clinical and systems focussed platform for this engagement between different teams within our neonatal ODN. METHOD An interactive 1-day programme was developed in the West Midlands, focussing on a non-hierarchical, equal partnership between neonatal teams from different unit designations. It utilised simulation around clinical scenarios, with a slant towards consultant engagement. Four groups rotating through four clinical simulation scenarios were developed. Each group participated in a clinical simulation scenario, led by a consultant and supported by nurses and doctors in training together with facilitators, with a further ~two consultants, as observers within the group. All were considered learners. Consultant candidates took turns to be participants and observers in the simulation scenarios so that at the end of the day all had led a scenario. Each simulation-clinical debrief session was lengthened by a further ~ 20 min, during which freestyle discussion with all learners occurred. This was to promote further bonding, through multidirectional sharing, and with a systems focus on understanding the strengths and challenges of practices in different units. A consultant focus was adopted to promote a long-term engagement between units around shared care. There were four time points for this neonatal networking during the course of the day. Qualitative assessment and a Likert scale were used to assess this initiative over 4 years. RESULTS One hundred fifty-five individuals involved in frontline neonatal care participated. Seventy-seven were consultants, supported by neonatal trainees, staff grade doctors, clinical fellows, advanced neonatal nurse practitioners and nurses in training. All were invited to participate in the survey. The survey response rate was 80.6%. Seventy-nine percent felt that this learning strategy was highly relevant; 96% agreed that for consultants this was appropriate adult learning. Ninety-eight percent agreed that consultant training encompassed more than bedside clinical management, including forging communication links between teams. Thematic responses suggested that this was a highly useful method for multi-directional learning around shared care between neonatal units. CONCLUSION Simulation, enhanced with systems focussed debrief, appeared to be an acceptable method of promoting multidirectional learning within neonatal teams of differing designations within the WMNODN.

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Effective implementation of an advanced clinical practitioner role in breast imaging (2021)

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Type of publication:
Conference abstract

Author(s):
*Deane L.; *Williams S.; *Cielecki L.; *Burley S.

Citation:
Breast Cancer Research 2021, 23(Suppl 1):P57

Abstract:
Background: Due to the immense pressure to provide capacity for women with breast symptoms, to be seen  within two weeks, a new innovative role has been created to provide increased capacity. Introduction: The breast services see many women with conditions that are benign and easily identified upon ultrasound. The majority of these conditions occur in women under the age of 40years. The role of an advanced clinical practitioner was created to answer a service need. This role requires a highly specialised cohort of skills combining breast image interpretation, breast ultrasound and breast biopsying alongside a range of clinical competences enabling autonomous practice within clear governance.
Method(s): A new clinic was created for under 40 aged women only requiring only a breast clinical specialist and an advanced clinical practitioner, using ultrasound for assessment. Unexpected findings suspicious upon ultrasound-would be redirected to the next consultant led clinic for full imaging assessment and biopsy.
Result(s): Increased capacity was achieved, without increased costs. Anxiety levels were reduced due to these patients seen within these clinics and more specialist skills could be directed to more complex cases in the traditional cancer clinics.
Conclusion(s): The use of this specialist role has proven to be innovative and specialised in answering capacity issues within the workforce. The ACP role is utilised as a support to all clinics working alongside consultant radiographers as well as in an autonomous role, thereby freeing up the consultants for cases requiring specialist skills. The stability of the breast service has been ensured

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Male breast ultrasound: 2019 audit results (2021)

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Type of publication:
Conference abstract

Author(s):
*Ozcan U.A.; *Williams S.; *Metelko M

Citation:
Breast Cancer Research 2021, 23(Suppl 1):O3.3

Abstract:
Background and Purpose: Male breast cancer is rare whereas gynaecomastia is very common. Only asymmetrical gynaecomastia require breast imaging and focal lumps are amenable to clinical core biopsy. So the use of ultrasound in the assessment of male breast should be limited. The aim of this study is to audit the referral indications and ultrasound outcomes in male breast US (MBUS) patients against local guidelines.
Method(s): In the last 5 years, 968 patients were referred for MBUS in our Trust. This audit includes the patients between 02/01/2019-04/12/2019. The duplicate patients and follow-ups were excluded from the study. In total, 197 patients were analysed (mean age: 58 (8-90) retrospectively. Referral diagnosis, age, US grading and clinical outcomes were noted.
Result(s): Of the 197 patients, 79% were gynecomastia (133), lipoma (21) or fat necrosis (2), and 15% (30) were normal. There was 1 chest wall lymphoma and 1 DCIS, and 9 (5%) patients had benign breast disease (fibroepithelial lesions, abscess, papilloma, sebaceous cysts, haematoma). In 122 patients (62%) clinical grade was not given, 66 had P2, 8 had P3, 1 had P5. 2 patients were scored as U4 and 4 patients as U3.
Conclusion(s): These results clearly show that 99% of the patients referred to MBUS were benign. And also 95% of the patients were clinically benign or not assessed. The excessive use of MBUS without a clinical indication leads to patient anxiety, increased waiting times and might delay the proper imaging to the patients who should have the priority in terms of clinical indication. Careful clinical assessment before ultrasound referral is mandatory for better care.

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Does arbitration work? (2021)

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Type of publication:
Conference abstract

Author(s):
*Williams S.; *Deane L.; *Burley S.; *Cielecki L.; *Aksoy U.; *Metelko M.

Citation:
Breast Cancer Research 2021, 23(Suppl 1):P63

Abstract:
Introduction: To improve cancer detection rates, personal performance and as part of our routine service improvement programme, an audit was undertaken of discordant cases returned directly to routine recall between 1/4/15 and 31/3/17 inclusive. These were reviewed against the results of the subsequent screening round to determine if the correct judgement had been made at the previous screening round or if there were any opportunities to learn from misinterpretation.
Method(s): All cases arbitrated and directly returned to routine screening between 2015/16 and 2016/17 were identified and crossreferenced with the results for the subsequent screening episode. All screen detected cancers previously arbitrated on the same side were reviewed by the same routine method and criteria as all interval cancers within our unit and each was given an 'interval' category. All of the screen detected cancers previously arbitrated on the same side were included in the annual interval cancer review session to discuss learn opportunities and improved outcomes.
Result(s): There were 829 cases arbitrated and returned to routine screening at the original screening episode 2015/16 or 2016/17. 11 cases were diagnosed with a same side screen detected cancer at the subsequent screening round and 2 cases presented as a same side interval cancer. Neither interval cancers detected at the case review. 1 of the 11 same side screen detected cancers classified as minimal signs.
Conclusion(s): In our unit arbitration cases returned to routine recall is the correct decision in the vast majority.

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British Society for Echocardiography and British Cardio-Oncology Society guideline for transthoracic echocardiographic assessment of adult cancer patients receiving anthracyclines and/or trastuzumab (2021)

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Type of publication:
Journal article

Author(s):
Dobson R.; Ghosh A.K.; Stanway S.; Manisty C.; Ky B.; Marwick T.; Stout M.; Pearce K.; Harkness A.; Steeds R.; Robinson S.; Oxborough D.; Adlam D.; Rana B.; *Ingram T.; Ring L.; Rosen S.; Plummer C.; Harbinson M.; Sharma V.; Lyon A.R.; Augustine D.X.

Citation:
Echo Research and Practice; Mar 2021; vol. 8 (no. 1)

Abstract:
The subspecialty of cardio-oncology aims to reduce cardiovascular morbidity and mortality in patients with cancer or following cancer treatment. Cancer therapy can lead to a variety of cardiovascular complications, including left ventricular systolic dysfunction, pericardial disease, and valvular heart disease. Echocardiography is a key diagnostic imaging tool in the diagnosis and surveillance for many of these complications. The baseline assessment and subsequent surveillance of patients undergoing treatment with anthracyclines and/or human epidermal growth factor (EGF) receptor (HER) 2-positive targeted treatment (e.g. trastuzumab and pertuzumab) form a significant proportion of cardio-oncology patients undergoing echocardiography. This guideline from the British Society of Echocardiography and British Cardio-Oncology Society outlines a protocol for baseline and surveillance echocardiography of patients undergoing treatment with anthracyclines and/or trastuzumab. The methodology for acquisition of images and the advantages and disadvantages of techniques are discussed. Echocardiographic definitions for considering cancer therapeutics-related cardiac dysfunction are also presented.

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Cost-effectiveness of mifepristone and misoprostol versus misoprostol alone for the management of missed miscarriage: an economic evaluation based on the MifeMiso Trial (2021)

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Type of publication:
Journal article

Author(s):
Okeke Ogwulu, C B; Williams, E V; Chu, J J; Devall, A J; Beeson, L E; Hardy, P; Cheed, V; Yongzhong, S; Jones, L L; La Fontaine Papadopoulos, J H; Bender-Atik, R; Brewin, J; Hinshaw, K; Choudhary, M; Ahmed, A; Naftalin, J; Nunes, N; Oliver, A; Izzat, F; Bhatia, K; Hassan, I; Jeve, Y; Hamilton, J; Deb, S; Bottomley, C; Ross, J; Watkins, L; *Underwood, M; Cheong, Y; Kumar, C S; Gupta, P; Small, R; Pringle, S; Hodge, F S; Shahid, A; Horne, A W; Quenby, S; Gallos, I D; Coomarasamy, A; Roberts, T E

Citation:
BJOG : an international journal of obstetrics and gynaecology; May 2021 [epub ahead of print]

Abstract:
OBJECTIVE To assess the cost-effectiveness of mifepristone and misoprostol (MifeMiso) compared with misoprostol only for the medical management of a missed miscarriage. DESIGN Within-trial economic evaluation and model-based analysis to set the findings in the context of the wider economic evidence for a range of comparators. Incremental costs and outcomes were calculated using non-parametric bootstrapping and reported using cost-effectiveness acceptability curves. Analyses were performed from the NHS perspective.SETTING28 UK NHS early pregnancy units.PARTICIPANTS711 women aged 16-39 years with ultrasound evidence of a missed miscarriage. INTERVENTIONS Mifepristone and misoprostol or matched placebo and misoprostol tablets. MAIN OUTCOME MEASURES Cost per additional successfully managed miscarriage and QALYs. RESULTS For the within-trial analysis, MifeMiso intervention resulted in an absolute effect difference of 6.6% (95% CI: 0.7% to 12.5%) per successfully managed miscarriage and QALYs difference of 0.04% (95% CI: -0.01% to 0.1%). The average cost per successfully managed miscarriage was lower in the MifeMiso arm than in the placebo and misoprostol arm, with a cost-saving of £182 (95% CI: £26 to £338). Hence, MifeMiso intervention dominated the use of misoprostol alone. The model-based analysis showed that MifeMiso intervention is dominant compared to expectant management and the current medical management strategy. However, the model-based evidence suggests that the intervention is a less effective but less costly strategy than surgical management. CONCLUSIONS The within-trial analysis found that based on cost-effectiveness grounds, MifeMiso intervention is likely to be recommended by decision-makers for the medical management of women presenting with a missed miscarriage.

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Postpartum haemorrhage and risk of long-term hypertension and cardiovascular disease: an English population-based longitudinal study using linked primary and secondary care databases (2021)

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Type of publication:
Journal article

Author(s):
*Parry-Smith, William; Šumilo, Dana; Subramanian, Anuradhaa; Gokhale, Krishna; Okoth, Kelvin; Gallos, Ioannis; Coomarasamy, Arri; Nirantharakumar, Krishnarajah

Citation:
BMJ Open; May 2021; vol. 11 (no. 5); p. e041566

Abstract:
OBJECTIVE To investigate the long-term risk of developing hypertension and cardiovascular disease (CVD) among those women who suffered a postpartum haemorrhage (PPH) compared with those women who did not. DESIGN Population-based longitudinal open cohort study. SETTING English primary care (The Health Improvement Network (THIN)) and secondary care (Hospital Episode Statistics (HES)) databases. POPULATION Women exposed to PPH during the study period matched for age and date of delivery, and unexposed. METHODS We conducted an open cohort study using linked primary care THIN and HES Databases, from 1 January 1997 to 31 January 2018. A total of 42 327 women were included: 14 109 of them exposed to PPH during the study period and 28 218 matched for age and date of delivery, and unexposed to PPH. HRs for cardiovascular outcomes among women who had and did not have PPH were estimated after controlling for covariates using multivariate Cox regression models. OUTCOME MEASURES Risk of hypertensive disease, ischaemic heart disease, heart failure, stroke or transient ischaemic attack. RESULTS During a median follow-up of over 4 years, there was no significant difference in the risk of hypertensive disease after adjustment for covariates (adjusted HR (aHR): 1.03 (95% CI: 0.87 to 1.22); p=0.71). We also did not observe a statistically significant difference in the risk of composite CVD (ischaemic heart disease, heart failure, stroke or transient ischaemic attack) between the exposed and the unexposed cohort (aHR: 0.86 (95% CI: 0.52 to 1.43; p=0.57). CONCLUSION Over a median follow-up of 4 years, we did not observe an association between PPH and hypertension or CVD.

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