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Article ; Online: Artificial intelligence as a diagnostic aid in cross-sectional radiological imaging of surgical pathology in the abdominopelvic cavity

Natalie S Blencowe / Rhiannon Macefield / Neil J Smart / George E Fowler / Conor Hardacre / Mark P Callaway

BMJ Open, Vol 13, Iss

a systematic review

2023 Volume 3

Abstract: Objectives There is emerging use of artificial intelligence (AI) models to aid diagnostic imaging. This review examined and critically appraised the application of AI models to identify surgical pathology from radiological images of the abdominopelvic ... ...

Abstract	Objectives There is emerging use of artificial intelligence (AI) models to aid diagnostic imaging. This review examined and critically appraised the application of AI models to identify surgical pathology from radiological images of the abdominopelvic cavity, to identify current limitations and inform future research.Design Systematic review.Data sources Systematic database searches (Medline, EMBASE, Cochrane Central Register of Controlled Trials) were performed. Date limitations (January 2012 to July 2021) were applied.Eligibility criteria Primary research studies were considered for eligibility using the PIRT (participants, index test(s), reference standard and target condition) framework. Only publications in the English language were eligible for inclusion in the review.Data extraction and synthesis Study characteristics, descriptions of AI models and outcomes assessing diagnostic performance were extracted by independent reviewers. A narrative synthesis was performed in accordance with the Synthesis Without Meta-analysis guidelines. Risk of bias was assessed (Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2)).Results Fifteen retrospective studies were included. Studies were diverse in surgical specialty, the intention of the AI applications and the models used. AI training and test sets comprised a median of 130 (range: 5–2440) and 37 (range: 10–1045) patients, respectively. Diagnostic performance of models varied (range: 70%–95% sensitivity, 53%–98% specificity). Only four studies compared the AI model with human performance. Reporting of studies was unstandardised and often lacking in detail. Most studies (n=14) were judged as having overall high risk of bias with concerns regarding applicability.Conclusions AI application in this field is diverse. Adherence to reporting guidelines is warranted. With finite healthcare resources, future endeavours may benefit from targeting areas where radiological expertise is in high demand to provide greater efficiency in clinical care. Translation to ...
Keywords	Medicine ; R
Subject code	610
Language	English
Publishing date	2023-03-01T00:00:00Z
Publisher	BMJ Publishing Group
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Understanding stage of innovation of invasive procedures and devices

Jane M Blazeby / Natalie S Blencowe / Sian Cousins / Daisy Elliott / Kerry NL Avery / Darren L Scroggie

BMJ Open, Vol 12, Iss

protocol for a systematic review and thematic analysis

2022 Volume 2

Keywords	Medicine ; R
Language	English
Publishing date	2022-02-01T00:00:00Z
Publisher	BMJ Publishing Group
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Novel device for assisted vaginal birth

Natalie S Blencowe / Emily J Hotton / Erik Lenguerrand / Julia Wade / Joanna F Crofts / Tim J Draycott / Nichola Bale

BMJ Open, Vol 12, Iss

using integrated qualitative case study methodology to optimise Odon Device use within a feasibility study in a maternity unit in the Southwest of England

2022 Volume 8

Abstract: Objective When novel devices are used ‘in human’ for the first time, their optimal use is uncertain because clinicians only have experience from preclinical studies. This study aimed to investigate factors that might optimise use of the Odon Device for ... ...

Abstract	Objective When novel devices are used ‘in human’ for the first time, their optimal use is uncertain because clinicians only have experience from preclinical studies. This study aimed to investigate factors that might optimise use of the Odon Device for assisted vaginal birth.Design We undertook qualitative case studies within the ASSIST Study, a feasibility study of the Odon Device. Each ‘case’ was defined as one use of the device and included at least one of the following: observation of the attempted assisted birth, and an interview with the obstetrician, midwife or woman. Data collection and thematic analysis ran iteratively and in parallel.Setting Tertiary referral National Health Service maternity unit in the Southwest of England.Participants Women requiring a clinically indicated assisted vaginal birth.Intervention The Odon Device, an innovative device for assisted vaginal birth.Primary and secondary outcome measures Determining the optimal device technique, device design and defining clinical parameters for use.Results Thirty-nine cases involving an attempted Odon-assisted birth were included in this study, of which 19 resulted in a successful birth with the device. Factors that improved use included optimisation of device technique, device design and clinical parameters for use. Technique adaptations included: applying the device during, rather than between, contractions; having a flexible approach to the application angle; and deflating the air cuff sooner than originally proposed. Three design modifications were proposed involving the deflation button and sleeve. Although use of the device was found to be appropriate in all fetal positions, it was considered contraindicated when the fetal station was at the ischial spines.Conclusions Case study methodology facilitated the acquisition of rapid insights into device function in clinical practice, providing key insights regarding use, design and key clinical parameters for success. This methodology should be considered whenever innovative devices are ...
Keywords	Medicine ; R
Subject code	600
Language	English
Publishing date	2022-08-01T00:00:00Z
Publisher	BMJ Publishing Group
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Systematic review of the introduction, early phase study and evaluation of pyrocarbon proximal interphalangeal joint arthroplasty.

Paul Welford / Natalie S Blencowe / Emily Pardington / Conor S Jones / Jane M Blazeby / Barry G Main

PLoS ONE, Vol 16, Iss 10, p e

2021 Volume 0257497

Abstract: Background In 2002 a pyrocarbon interphalangeal joint implant was granted Food and Drug Administration approval with limited evidence of effectiveness. It is important to understand device use and outcomes since this implant entered clinical practice in ... ...

Abstract	Background In 2002 a pyrocarbon interphalangeal joint implant was granted Food and Drug Administration approval with limited evidence of effectiveness. It is important to understand device use and outcomes since this implant entered clinical practice in order to establish incremental evidence, appropriate study design and reporting. This systematic review summarised and appraised studies reporting pyrocarbon proximal interphalangeal joint arthroplasty. Methods Systematic review of MEDLINE, EMBASE, SCOPUS, Web of Science, BIOSIS, CINAHL and CENTRAL from inception to November 2020. All study designs reporting pyrocarbon proximal interphalangeal joint arthroplasty in humans were included. Data extracted included information about study characteristics, patient selection, regulatory (gaining research ethics approval) and governance issues (reporting of conflicting interests), operator and centre experience, technique description and outcome reporting. Descriptive and narrative summaries were reported. Results From 4316 abstracts, 210 full-text articles were screened. A total of 38 studies and 1434 (1-184) patients were included. These consisted of three case reports, 24 case series, 10 retrospective cohort studies and one randomised trial. Inclusion and exclusion criteria were stated in 25 (66%) studies. Most studies (n = 27, 71%) gained research ethics approval to be conducted. Six studies reported conflicting interests. Experience of operating surgeons was reported in nine (24%) and caseload volume in five studies. There was no consensus about the optimal surgical approach. Technical aspects of implant placement were reported frequently (n = 32) but the detail provided varied widely. Studies reported multiple, heterogenous outcomes. The most commonly reported outcome was range of motion (n = 37). Conclusions This systematic review identified inconsistencies in how studies describing the early use and update of an innovative procedure were reported. Incremental evidence was lacking, risking the implant being ...
Keywords	Medicine ; R ; Science ; Q
Subject code	306
Language	English
Publishing date	2021-01-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Artificial intelligence as a diagnostic aid in cross-sectional radiological imaging of the abdominopelvic cavity

Natalie S Blencowe / Neil J Smart / George E Fowler / Rhiannon C Macefield / Conor Hardacre / Mark P Callaway

BMJ Open, Vol 11, Iss

a protocol for a systematic review

2021 Volume 10

Keywords	Medicine ; R
Language	English
Publishing date	2021-10-01T00:00:00Z
Publisher	BMJ Publishing Group
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: How surgical Trainee Research Collaboratives achieve success

Graeme Maclennan / Nick Heywood / Clare Clement / Natalie S Blencowe / Jane Blazeby / Dmitri Nepogodiev / Laura Magill / Alejandro Arenas-Pinto / Tom Pinkney / J Athene Lane / James Glasbey / Victoria Hardy / Karen Coulman / Jonathan Alistair Cook / Claire Snowdon / Richard Bulbulia / Zoe Hilton

BMJ Open, Vol 13, Iss

a mixed methods study to develop trainee engagement strategies

2023 Volume 12

Abstract: Objectives This study aimed to understand the role of surgical Trainee Research Collaboratives (TRCs) in conducting randomised controlled trials and identify strategies to enhance trainee engagement in trials.Design This is a mixed methods study. We used ...

Abstract	Objectives This study aimed to understand the role of surgical Trainee Research Collaboratives (TRCs) in conducting randomised controlled trials and identify strategies to enhance trainee engagement in trials.Design This is a mixed methods study. We used observation of TRC meetings, semi-structured interviews and an online survey to explore trainees’ motivations for engagement in trials and TRCs, including barriers and facilitators. Interviews were analysed thematically, alongside observation field notes. Survey responses were analysed using descriptive statistics. Strategies to enhance TRCs were developed at a workshop by 13 trial methodologists, surgical trainees, consultants and research nurses.Setting This study was conducted within a secondary care setting in the UK.Participants The survey was sent to registered UK surgical trainees. TRC members and linked stakeholders across surgical specialties and UK regions were purposefully sampled for interviews.Results We observed 5 TRC meetings, conducted 32 semi-structured interviews and analysed 73 survey responses. TRCs can mobilise trainees thus gaining wider access to patients. Trainees engaged with TRCs to improve patient care, surgical evidence and to help progress their careers. Trainees valued the TRC infrastructure, research expertise and mentoring. Challenges for trainees included clinical and other priorities, limited time and confidence, and recognition, especially by authorship. Key TRC strategies were consultant support, initial simple rapid studies, transparency of involvement and recognition for trainees (including authorship policies) and working with Clinical Trials Units and research nurses. A 6 min digital story on YouTube disseminated these strategies.Conclusion Trainee surgeons are mostly motivated to engage with trials and TRCs. Trainee engagement in TRCs can be enhanced through building relationships with key stakeholders, maximising multi-disciplinary working and offering training and career development opportunities.
Keywords	Medicine ; R
Subject code	360
Language	English
Publishing date	2023-12-01T00:00:00Z
Publisher	BMJ Publishing Group
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Qualitative documentary analysis of guidance on information provision and consent for the introduction of innovative invasive procedures including surgeries within NHS organisations’ policies in England and Wales

Jane M Blazeby / Natalie S Blencowe / Sian Cousins / Daisy Elliott / Hollie Richards / Jesmond Zahra / Sangeetha Paramasivan / Nicholas Wilson / Johnny Mathews / Barry G Main / Robert Hinchliffe / Kerry N L Avery / Cynthia A Ochieng

BMJ Open, Vol 12, Iss

2022 Volume 9

Abstract: Objective To review guidance, included in written local UK National Health Service (NHS) organisation policies, on information provision and consent for the introduction of new invasive procedures- including surgeries, and devices (IPs/Ds).Design A ... ...

Abstract	Objective To review guidance, included in written local UK National Health Service (NHS) organisation policies, on information provision and consent for the introduction of new invasive procedures- including surgeries, and devices (IPs/Ds).Design A qualitative documentary analysis of data on patient information provision and consent extracted from policies for the introduction of IP/Ds from NHS organisations in England and Wales.Setting NHS trusts in England and health boards in Wales, UK.Participants Between December 2017 and July 2018, 150 acute trusts in England and 7 health boards in Wales were approached for their policies for the introduction of new IP/Ds. In total, 123 policies were received, 11 did not fit the inclusion criteria and a further policy was included from a trust website resulting in 113 policies included for review.Results From the 113 policies, 22 did not include any statements on informed consent/information provision or lacked guidance on the information to be provided to patients and were hence excluded. Consequently, 91 written local NHS policies were included in the final dataset. Within the guidance obtained, variation existed on disclosure of the procedure’s novelty, potential risks, benefits, uncertainties, alternative treatments and surgeon’s experience. Few policies stated that clinicians should discuss the existing evidence associated with a procedure. Additionally, while the majority of policies referred to patients needing written information, this was often not mandated and few policies specified the information to be included.Conclusions Nearly a fifth of all the policies lacked guidance on information to be provided to patients. There was variability in the policy documents regarding what patients should be told about innovative procedures. Further research is needed to ascertain the information and level of detail appropriate for patients when considering innovative procedures. A core information set including patients’ and clinicians’ views is required to address ...
Keywords	Medicine ; R
Subject code	360
Language	English
Publishing date	2022-09-01T00:00:00Z
Publisher	BMJ Publishing Group
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Identification of outcomes to inform the development of a core outcome set for surgical innovation

Jane M Blazeby / Angus G K McNair / Natalie S Blencowe / Nicholas Wilson / Barry G Main / Shelley Potter / Kerry N L Avery / Matthew J Edmondson / Rhiannon C Macefield / Christin Hoffmann / Rachael L Miller / Emily N Kirkham

BMJ Open, Vol 12, Iss

a targeted review of case studies of novel surgical devices

2022 Volume 4

Keywords	Medicine ; R
Language	English
Publishing date	2022-04-01T00:00:00Z
Publisher	BMJ Publishing Group
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: The Odon Device™ for assisted vaginal birth

Emily J. Hotton / Mary Alvarez / Erik Lenguerrand / Julia Wade / Natalie S. Blencowe / Tim J. Draycott / Joanna F. Crofts / The ASSIST II Study Group

Pilot and Feasibility Studies, Vol 7, Iss 1, Pp 1-

a feasibility study to investigate safety and efficacy—The ASSIST II study

2021 Volume 10

Abstract: Abstract Background The Odon Device™ is a new device for assisted vaginal birth that employs an air cuff around the fetal head for traction. Assisted vaginal birth (AVB) is a vital health intervention that can result in better outcomes for mothers and ... ...

Abstract	Abstract Background The Odon Device™ is a new device for assisted vaginal birth that employs an air cuff around the fetal head for traction. Assisted vaginal birth (AVB) is a vital health intervention that can result in better outcomes for mothers and their babies when complications arise in the second stage of labour. Unfortunately, instruments for AVB (forceps and ventouse) are often not used in settings where there is most clinical need often due to lack of training and resources, resulting in maternal and neonatal morbidity and mortality which could have been prevented. This is often due to a lack of trained operators as well as difficulties in the sterilisation and maintenance of AVB devices. This novel, single use device has the potential to mitigate these difficulties as it is single use and is potentially simpler to use than forceps and ventouse. All the studies of the Odon Device to date (pre-clinical, preliminary developmental and clinical) suggest that the Odon Device does not present a higher risk to mothers or babies compared to current standard care, and recruitment to intrapartum research exploring the device is feasible and acceptable to women. The first study in which the Odon Device was used in clinically indicated conditions (the ASSIST Study) reported a lower efficacy than those reported with established devices. The reasons need to be explored, specifically focussing on learning curve, the technique of the doctors using this new device and potential modifications to device design. A follow-on clinical study to further investigate the efficacy and safety of the Odon Device in its indicated use, the ASSIST II Study, is therefore being undertaken. Methods The primary feasibility outcome is study feasibility (recruitment and retention rates) whilst the primary clinical outcome successful vaginal birth completed with the Odon Device. Key secondary feasibility outcomes include participant withdrawal, compliance in data collection and acceptability of the device to women and operators. Secondary ...
Keywords	Assisted vaginal birth ; Obstetrical vacuum extraction ; Obstetrical extraction ; Odon Device ; Obstetrical forceps ; Feasibility studies ; Medicine (General) ; R5-920
Subject code	600
Language	English
Publishing date	2021-03-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Discussing surgical innovation with patients

Jane M Blazeby / Angus G K McNair / Natalie S Blencowe / Kerry Avery / Sian Cousins / Daisy Elliott / Jesmond Zahra / Sangeetha Paramasivan / Johnny Mathews / Barry G Main / Robert Hinchliffe

BMJ Open, Vol 10, Iss

a qualitative study of surgeons’ and governance representatives’ views

2020 Volume 11

Abstract: Objectives Little is known about how innovative surgical procedures are introduced and discussed with patients. This qualitative study aimed to explore perspectives on information provision and consent prior to innovative surgical procedures.Design ... ...

Abstract	Objectives Little is known about how innovative surgical procedures are introduced and discussed with patients. This qualitative study aimed to explore perspectives on information provision and consent prior to innovative surgical procedures.Design Qualitative study involving semi-structured interviews. Interviews were audio recorded, transcribed and analysed thematically.Participants 42 interviews were conducted (26 surgeons and 16 governance representatives).Setting Surgeons and governance representatives recruited from various surgical specialties and National Health Service (NHS) Trusts across England, UK.Results Participants stated that if a procedure was innovative, patients should be provided with additional information extending beyond that given during routine surgical consultations. However, difficulty defining innovation had implications for whether patients were informed about novel components of surgery and how the procedure was introduced (ie, as part of a research study, trust approval or in routine clinical practice). Furthermore, data suggest surgeons found it difficult to establish what information is essential and how much detail is sufficient, and governance surrounding written and verbal information provision differed between NHS Trusts. Generally, surgeons believed patients held a view that ‘new’ was best and reported that managing these expectations could be difficult, particularly if patient views aligned with their own.Conclusions This study highlights the challenges of information provision and obtaining informed consent in the context of innovative surgery, including establishing if and how a procedure is truly innovative, determining the key information to discuss with patients, ensuring information provision is objective and balanced, and managing patient expectations and preferences. This suggests that surgeons may require support and training to discuss novel procedures with patients. Further work should capture consultations where new procedures are discussed with patients and ...
Keywords	Medicine ; R
Subject code	360
Language	English
Publishing date	2020-11-01T00:00:00Z
Publisher	BMJ Publishing Group
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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