Available here: https://journals.lww.com/annalsofsurgery/Abstract/9000/The_IDEAL_Reporting_Guidelines__A_Delphi_Consensus.94383.aspx

We are delighted to announce the completion and publication of the IDEAL Reporting Guidelines which we hope will improve the quality of surgical research by increasing awareness of the key methodological issues throughout the innovation life-cycle. We hope they will serve to assist researchers/authors in their study planning, conduct and reporting of IDEAL Stage studies. We encourage Journals to alert authors to these guidelines in their Instructions to Authors.

We would like to thank the IDEAL Reporting Guidelines Working Group for their hard work in the consensus guideline development process:

We would also like to thank the participants who participated in 2 Rounds of the Delphi Survey:

Stage Checklists available here:

Word and PDF versions for each

Stage 1 Word  IDEAL Reporting Guidelines Stage 1 checklist

Stage 1 PDF  IDEAL Reporting Guidelines Stage 1 checklist

Stage 2a Word  IDEAL Reporting Guidelines Stage 2a checklist

Stage 2a PDF  IDEAL Reporting Guidelines Stage 2a checklist

Stage 2b Word  IDEAL Reporting Guidelines Stage 2b checklist

Stage 2b PDF  IDEAL Reporting Guidelines Stage 2b checklist

For Stage 3 use: SPIRIT for RCT protocols https://www.spirit-statement.org/

and CONSORT for RCT full study reports http://www.consort-statement.org/

Stage 4 Word    IDEAL Reporting Guidelines Stage 4 checklist

Stage 4 PDF  IDEAL Reporting Guidelines Stage 4 checklist

The Independent Medicines and Medical Devices Safety Review, chaired by Baroness Julia Cumberlege, has today published its report. Titled “First Do No Harm”, it comes after a two-year review of harrowing patient testimony and a large volume of other evidence concerning three medical interventions: Primodos, sodium valproate and pelvic mesh.

“First Do No Harm” sets out nine major recommendations to bring much-needed help and support to those who have suffered as a result of these interventions, and to reduce the risk of avoidable harm from medicines and medical devices in the future.

The Review’s major recommendations include:

• That the Government immediately issues a fulsome apology on behalf of the healthcare system to the families affected by Primodos, sodium valproate and pelvic mesh.
• That a Patient Safety Commissioner is appointed. This person would be the patients’ port of call, listener and advocate, who holds the system to account, monitors trends, and demands action.
• Separate schemes should be set up for Hormone Pregnancy Tests, valproate and pelvic mesh to meet the cost of providing additional care and support to those who have experienced avoidable harm and are eligible to claim.
• A Redress Agency for those harmed by medicines and medical devices in future should be established.
• The establishment of two types of specialist centres, located regionally – for mesh, and separately for those affected by medications taken during pregnancy.
• The regulator of medicines and medical devices, the MHRA, needs to put patients at the heart of its activity, and to overhaul adverse event reporting and medical device regulation.
• That a central database should be created by collecting key details including the patient, the implanted device, and the surgeon.
• That the register of the General Medical Council (GMC) should be expanded to include a list of financial and non-pecuniary interests for all doctors, as well as doctors’ clinical interests and specialisms.
• Finally, that the Government immediately sets up a task force to implement the Review’s recommendations.

We had a very interesting meeting discussing how we should evaluate surgical and device innovations in emergency scenarios on 3rd July.

The programme is below and can be downloaded here: Final Programme_3rdJuly IDEAL Virtual meeting

Presentations now available here:

Rovers for IDEAL meeting 3 July

PeterMcCulloch IDEAL Amsterdam

Campbell – ideal-innovations-jul2020-FINAL (1)

Hutchinson – ethics of innovation in a crisis_IDEAL presentation_final

Derek Stewart video – https://t.co/AzGupI0z86?amp=1

How should we evaluate innovations in a crisis?

Free online IDEAL event – Friday 3 July 2020 (13.00 -15.30 UK time)

FINAL PROGRAMME

13:00 – 13:05  Short word of welcome by Maroeska Rovers, Professor of Evidenced-Based Surgery at Radboud University Medical Centre, Nijmegen, Netherlands

13:05 – 13:17  Recap on IDEAL and why the framework needs to be adjusted to deal with emergency scenarios – Peter McCulloch, Professor of Surgical Science and Practice, Nuffield Dept of Surgical Sciences, University of Oxford, UK

13:17 – 13:29  Innovations in disaster relief scenarios – Mamoon Rashid, Professor of Plastic Surgery, STM University & Head, Dept. of Plastic Surgery, Shifa International Hospital. Islamabad, Pakistan

13:29 – 13:37  Questions/discussion

13:37 – 13:49  How to assess innovations in a crisis – Marion Campbell, Vice Principal (Research) & Prof of Health Services Research, Health Services Research Unit, University of Aberdeen, UK

13:49 – 13:57  Questions/discussion

13:57 – 14:09  Ethical considerations  – Dr Katrina Hutchison, Research Fellow (MQRF) Department of Philosophy, Macquarie University, NSW, Australia

14:09 – 14:17  Questions/discussion

14:17 – 14:29  Public & Patient Involvement in emergency research  – Derek Stewart, PPI Lead with the MRC NIHR Trials Methodology Research Partnership

14:29 – 14:40  General discussion about all aspects

14:40 – 14:45   Grab a coffee or tea yourself 

14:45 – 15:30  Session 1: Tea corner meet people from the IDEAL collaboration to discuss more about our work

14:45 – 15:30  Session 2: Sandpit session where researchers can pitch their idea and get advice/feedback from others in that session

Best wishes

IDEAL Organising Committee: Maroeska Rovers, Peter McCulloch, Allison Hirst, Crispin Boyd

Advisory Service for designing IDEAL Stage studies

We are pleased to announce that we are piloting a service for researchers and innovators seeking guidance on planning a study and writing a protocol for their evaluation of a surgical technique or therapeutic device appropriate to any stage of the IDEAL Framework.

The service will be available free of charge to clinicians and scientists doing this work as part of a grant-funded research project, or as an unfunded service improvement. Contact allison.hirst@nds.ox.ac.uk

A separate Consultancy arrangement is available for commercial companies, through our associated non-profit company, IDEAL Innovation CIC.  To access this, please send initial enquiries to  idealinnovationukcic@gmail.com

If you are unsure which service is appropriate for you, please enquire to the e-mail address below in the first instance.

What do you need to do?

We ask you to contact us in the first instance to check your work is suitable – email allison.hirst@nds.ox.ac.uk

We will then ask you to identify the IDEAL stage and key purpose/question of your study using our key IDEAL papers and Flowchart to do so;

• The original IDEAL Framework 2009: McCulloch P, Altman DG, Campbell WB, et al. for the Balliol Collaboration.  No surgical innovation without evaluation: the IDEAL recommendations.  Lancet 2009; Sep 26; 374 (9695): 1105-12.
• The updated 2019 paper: Hirst A, Philippou Y, Blazeby J, Campbell B, Campbell M, Feinberg J, et al. No Surgical Innovation Without Evaluation: Evolution and Further Development of the IDEAL Framework and Recommendations. Ann Surg.2019 Feb;269(2):211-220.
• The IDEAL Stage Flowchart: http://www.ideal-collaboration.net/ideal-flowchart-and-stage-questions-for-assessing-literature/

Once we have confirmed the relevant stage with you we will allocate you an expert IDEAL Advisor to help you develop your protocol using stage-specific guidance which we will provide. Our advisors for the service include; Peter McCulloch, Art Sedrakyan, Arsenio Paez, Joel Horovitz, Angelos Kolias, Maroeska Rovers, Jane Blazeby, Fei Shan, Andrew Cook, Hani Marcus, Natalie Blencowe , Nicole Bilbro, Joshua Feinberg and Christopher Pennell.

The purpose of the service is for you to produce a clear written protocol for your study which you might consider publishing with your advisor as co-author.

Evaluation of the service  

We aim to evaluate how useful our tools and service are to researchers in order to a) improve our service and b) learn from real cases studies where the IDEAL Framework/Recommendations can be amended/updated. As soon as possible after completion of your protocol we will ask you to complete a short online survey asking for your feedback on the experience.

Thank you.

We look forward to hearing from you.

Peter McCulloch (Chair) and Allison Hirst (Project Manager) on behalf of the IDEAL Team

Due to the COVID-19 pandemic we have taken the difficult decision to postpone our international IDEAL 2020 Conference scheduled to take place on 11th-12th June 2020 in Amsterdam. We now anticipate holding the event in April 2021 in Amsterdam. Please bear with us as the Organising Committee works through the next steps and confirms the new date.

We will be sending further communications to individuals with accepted abstracts as soon as possible and more information will be posted on our websites about the future event as it becomes available:  http://www.ideal-collaboration.net/ and https://www.radboudumc.nl/en/education/events/all-events/10353-ideal-2020

Thank you all for your understanding in these uncertain times, and we wish you all the best.

We will endeavour to host a successful and enjoyable IDEAL 2021 Conference in Amsterdam in the spring.

Maroeska Rovers and Peter McCulloch, On behalf of the Organising Committee

IDEAL2020 in Amsterdam, the Netherlands: Innovation and Evaluation in Surgery

Save the date: 11th-12th June 2020

Information on the conference #IDEAL2019 is now available on our conference webpage:

IDEAL Conference 2019

Details on how to register will be available early July.

BMJ Surgery, Interventions, & Health Technologies

BMJ Surgery, Interventions, & Health Technologies is an open access journal that publishes original research on complex healthcare interventions. Intended to encourage higher standards of science and more rapid dissemination of new knowledge in the field, it provides a high-impact international platform for both early and later stage clinical studies as well as long-term assessment and surveillance studies that meet high standards of design and reporting. It actively promotes the adoption of an IDEAL-based model of an evaluation framework and encourages the submission of studies at progressive stages, with a focus on device-based surgical and invasive treatments.

Read the Editorial: Lighting a candle by Art Sedrakyan and Peter McCulloch

There has been enough cursing of the darkness engendered by inadequate evaluation of new health technology and surgical and interventional treatments. We can do better.

To submit an article read the Instructions for authors and follow the link to the manuscript submission site.

The Current Issue of the Annals of Surgery features four papers about IDEAL

February 2019 – Volume 269 – Issue 2 

The Update to the IDEAL Framework and Recommendations:

This paper incorporates additional relevant methodological principles that have developed in the surgical community since the original IDEAL papers in 2009.