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Effects of pre-operative isolation on postoperative pulmonary complications after elective surgery: an international prospective cohort study (2022)

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Type of publication:
Journal article

Author(s):
COVIDSurg Collaborative; GlobalSurg Collaborative (COVIDSurg Collaborative includes *Yen Nee Jenny Bo, *Mohammad Iqbal, *Aarti Lakhiani, *Guleed Mohamed, *William Parry-Smith, *Banchhita Sahu of Shrewsbury and Telford Hospital NHS Trust)

Citation:
Anaesthesia. November 2021 Nov, Volume 76, Issue 11, Pages 1454-1464.

Abstract:
We aimed to determine the impact of pre-operative isolation on postoperative pulmonary complications after elective surgery during the global SARS-CoV-2 pandemic. We performed an international prospective cohort study including patients undergoing elective surgery in October 2020. Isolation was defined as the period before surgery during which patients did not leave their house or receive visitors from outside their household. The primary outcome was postoperative pulmonary complications, adjusted in multivariable models for measured confounders. Pre-defined sub-group analyses were performed for the primary outcome. A total of 96,454 patients from 114 countries were included and overall, 26,948 (27.9%) patients isolated before surgery. Postoperative pulmonary complications were recorded in 1947 (2.0%) patients of which 227 (11.7%) were associated with SARS-CoV-2 infection. Patients who isolated pre-operatively were older, had more respiratory comorbidities and were more commonly from areas of high SARS-CoV-2 incidence and high-income countries. Although the overall rates of postoperative pulmonary complications were similar in those that isolated and those that did not (2.1% vs 2.0%, respectively), isolation was associated with higher rates of postoperative pulmonary complications after adjustment (adjusted OR 1.20, 95%CI 1.05–1.36, p = 0.005). Sensitivity analyses revealed no further differences when patients were categorised by: pre-operative testing; use of COVID-19-free pathways; or community SARS-CoV-2 prevalence. The rate of postoperative pulmonary complications increased with periods of isolation longer than 3 days, with an OR (95%CI) at 4–7 days or ≥ 8 days of 1.25 (1.04–1.48), p = 0.015 and 1.31 (1.11–1.55), p = 0.001, respectively. Isolation before elective surgery might be associated with a small but clinically important increased risk of postoperative pulmonary complications. Longer periods of isolation showed no reduction in the risk of postoperative pulmonary complications. These findings have significant implications for global provision of elective surgical care.

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SARS-CoV-2 infection and venous thromboembolism after surgery (2022)

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Type of publication:
Journal article

Author(s):
COVIDSurg Collaborative; GlobalSurg Collaborative. (COVIDSurg Collaborative involves *Yen Nee Jenny Bo, *Mohammad Iqbal, *Aarti Lakhiani, *Guleed Mohamed, *William Parry-Smith, and *Banchhita Sahu of Shrewsbury and Telford Hospitals NHS Trust)

Citation:
Anaesthesia, Jan 2022, Volume77, Issue1, Pages 28-39

Abstract:
SARS-CoV-2 has been associated with an increased rate of venous thromboembolism in critically ill patients. Since surgical patients are already at higher risk of venous thromboembolism than general populations, this study aimed to determine if patients with peri-operative or prior SARS-CoV-2 were at further increased risk of venous thromboembolism. We conducted a planned sub-study and analysis from an international, multicentre, prospective cohort study of elective and emergency patients undergoing surgery during October 2020. Patients from all surgical specialties were included. The primary outcome measure was venous thromboembolism (pulmonary embolism or deep vein thrombosis) within 30 days of surgery. SARS-CoV-2 diagnosis was defined as peri-operative (7 days before to 30 days after surgery); recent (1–6 weeks before surgery); previous (≥7 weeks before surgery); or none. Information on prophylaxis regimens or pre-operative anti-coagulation for baseline comorbidities was not available. Postoperative venous thromboembolism rate was 0.5% (666/123,591) in patients without SARS-CoV-2; 2.2% (50/2317) in patients with peri-operative SARS-CoV-2; 1.6% (15/953) in patients with recent SARS-CoV-2; and 1.0% (11/1148) in patients with previous SARS-CoV-2. After adjustment for confounding factors, patients with peri-operative (adjusted odds ratio 1.5 (95%CI 1.1–2.0)) and recent SARS-CoV-2 (1.9 (95%CI 1.2–3.3)) remained at higher risk of venous thromboembolism, with a borderline finding in previous SARS-CoV-2 (1.7 (95%CI 0.9–3.0)). Overall, venous thromboembolism was independently associated with 30-day mortality (5.4 (95%CI 4.3–6.7)). In patients with SARS-CoV-2, mortality without venous thromboembolism was 7.4% (319/4342) and with venous thromboembolism was 40.8% (31/76). Patients undergoing surgery with peri-operative or recent SARS-CoV-2 appear to be at increased risk of postoperative venous thromboembolism compared with patients with no history of SARS-CoV-2 infection. Optimal venous thromboembolism prophylaxis and treatment are unknown in this cohort of patients, and these data should be interpreted accordingly.

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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 of Shrewsbury and Telford Hospital NHS Trust)

Citation:
The Lancet Oncology;  November 2021, Volume 22, Issue 22, Pages 1507-1517

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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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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Non-drug therapies for the management of chronic constipation in adults: the CapaCiTY research programme including three RCTs (2021)

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Type of publication:
Journal article

Author(s):
Knowles, Charles H; Booth, Lesley; Brown, Steve R; Cross, Samantha; Eldridge, Sandra; Emmett, Christopher; Grossi, Ugo; Jordan, Mary; *Lacy-Colson, Jon; Mason, James; McLaughlin, John; Moss-Morris, Rona; Norton, Christine; Scott, S Mark; Stevens, Natasha; Taheri, Shiva; Yiannakou, Yan.

Citation:
NIHR Journals Library. Programme Grants for Applied Research 2021 Vol 9(14).

Abstract:
BACKGROUND: Chronic constipation affects 1-2% of adults and significantly affects quality of life. Beyond the use of laxatives and other basic measures, there is uncertainty about management, including the value of specialist investigations, equipment-intensive therapies using biofeedback, transanal irrigation and surgery. OBJECTIVES: (1) To determine whether or not standardised specialist-led habit training plus pelvic floor retraining using computer-assisted direct visual biofeedback is more clinically effective than standardised specialist-led habit training alone, and whether or not outcomes of such specialist-led interventions are improved by stratification to habit training plus pelvic floor retraining using computer-assisted direct visual biofeedback or habit training alone based on prior knowledge of anorectal and colonic pathophysiology using standardised radiophysiological investigations; (2) to compare the impact of transanal irrigation initiated with low-volume and high-volume systems on patient disease-specific quality of life; and (3) to determine the clinical efficacy of laparoscopic ventral mesh rectopexy compared with controls at short-term follow-up. DESIGN: The Chronic Constipation Treatment Pathway (CapaCiTY) research programme was a programme of national recruitment with a standardised methodological framework (i.e. eligibility, baseline phenotyping and standardised outcomes) for three randomised trials: a parallel three-group trial, permitting two randomised comparisons (CapaCiTY trial 1), a parallel two-group trial (CapaCiTY trial 2) and a stepped-wedge (individual-level) three-group trial (CapaCiTY trial 3). SETTING: Specialist hospital centres across England, with a mix of urban and rural referral bases. PARTICIPANTS: The main inclusion criteria were as follows: age 18-70 years, participant self-reported problematic constipation, symptom onset > 6 months before recruitment, symptoms meeting the American College of Gastroenterology's constipation definition and constipation that failed treatment to a minimum basic standard. The main exclusion criteria were secondary constipation and previous experience of study interventions. INTERVENTIONS: CapaCiTY trial 1: group 1 – standardised specialist-led habit training alone (n = 68); group 2 – standardised specialist-led habit training plus pelvic floor retraining using computer-assisted direct visual biofeedback (n = 68); and group 3 – standardised radiophysiological investigations-guided treatment (n = 46) (allocation ratio 3 : 3 : 2, respectively). CapaCiTY trial 2: transanal irrigation initiated with low-volume (group 1, n = 30) or high-volume (group 2, n = 35) systems (allocation ratio 1 : 1). CapaCiTY trial 3: laparoscopic ventral mesh rectopexy performed immediately (n = 9) and after 12 weeks' (n = 10) and after 24 weeks' (n = 9) waiting time (allocation ratio 1 : 1 : 1, respectively). MAIN OUTCOME MEASURES: The main outcome measures were standardised outcomes for all three trials. The primary clinical outcome was mean change in Patient Assessment of Constipation Quality of Life score at the 6-month, 3-month or 24-week follow-up. The secondary clinical outcomes were a range of validated disease-specific and psychological scoring instrument scores. For cost-effectiveness, quality-adjusted life-year estimates were determined from individual participant-level cost data and EuroQol-5 Dimensions, five-level version, data. Participant experience was investigated through interviews and qualitative analysis. RESULTS: A total of 275 participants were recruited. Baseline phenotyping demonstrated high levels of symptom burden and psychological morbidity. CapaCiTY trial 1: all interventions (standardised specialist-led habit training alone, standardised specialist-led habit training plus pelvic floor retraining using computer-assisted direct visual biofeedback and standardised radiophysiological investigations-guided habit training alone or habit training plus pelvic floor retraining using computer-assisted direct visual biofeedback) led to similar reductions in the Patient Assessment of Constipation Quality of Life score (approximately -0.8 points), with no statistically significant difference between habit training alone and habit training plus pelvic floor retraining using computer-assisted direct visual biofeedback (-0.03 points, 95% confidence interval -0.33 to 0.27 points; p = 0.8445) or between standardised radiophysiological investigations and no standardised radiophysiological investigations (0.22 points, 95% confidence interval -0.11 to 0.55 points; p = 0.1871). Secondary outcomes reflected similar levels of benefit for all interventions. There was no evidence of greater cost-effectiveness of habit training plus pelvic floor retraining using computer-assisted direct visual biofeedback or stratification by standardised radiophysiological investigations compared with habit training alone (with the probability that habit training alone is cost-effective at a willingness-to-pay threshold of 30,000 per quality-adjusted life-year gain; p = 0.83). Participants reported mixed experiences and similar satisfaction in all groups in the qualitative interviews. CapaCiTY trial 2: at 3 months, there was a modest reduction in the Patient Assessment of Constipation Quality of Life score, from a mean of 2.4 to 2.2 points (i.e. a reduction of 0.2 points), in the low-volume transanal irrigation group compared with a larger mean reduction of 0.6 points in the high-volume transanal irrigation group (difference -0.37 points, 95% confidence interval -0.89 to 0.15 points). The majority of participants preferred high-volume transanal irrigation, with substantial crossover to high-volume transanal irrigation during follow-up. Compared with low-volume transanal irrigation, high-volume transanal irrigation had similar costs (median difference -8, 95% confidence interval -240 to 221) and resulted in significantly higher quality of life (0.093 quality-adjusted life-years, 95% confidence interval 0.016 to 0.175 quality-adjusted life-years). CapaCiTY trial 3: laparoscopic ventral mesh rectopexy resulted in a substantial short-term mean reduction in the Patient Assessment of Constipation Quality of Life score (-1.09 points, 95% confidence interval -1.76 to -0.41 points) and beneficial changes in all other outcomes; however, significant increases in cost (5012, 95% confidence interval 4446 to 5322) resulted in only modest increases in quality of life (0.043 quality-adjusted life-years, 95% confidence interval -0.005 to 0.093 quality-adjusted life-years), with an incremental cost-effectiveness ratio of 115,512 per quality-adjusted life-year. CONCLUSIONS: Excluding poor recruitment and underpowering of clinical effectiveness analyses, several themes emerge: (1) all interventions studied have beneficial effects on symptoms and disease-specific quality of life in the short term; (2) a simpler, cheaper approach to nurse-led behavioural interventions appears to be at least as clinically effective as and more cost-effective than more complex and invasive approaches (including prior investigation); (3) high-volume transanal irrigation is preferred by participants and has better clinical effectiveness than low-volume transanal irrigation systems; and (4) laparoscopic ventral mesh rectopexy in highly selected participants confers a very significant short-term reduction in symptoms, with low levels of harm but little effect on general quality of life. LIMITATIONS: All three trials significantly under-recruited [CapaCiTY trial 1, n = 182 (target 394); CapaCiTY trial 2, n = 65 (target 300); and CapaCiTY trial 3, n = 28 (target 114)]. The numbers analysed were further limited by loss before primary outcome. TRIAL REGISTRATION: Current Controlled Trials ISRCTN11791740,
ISRCTN11093872 and ISRCTN11747152.

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