Magnitude of change in the placebo arm of surgical trials (by outcome type).

PUBLICATIONS
  1. Hohenschurz-Schmidt D, Vase L, Scott W, Annoni M, Ajayi OK, Barth J, Bennell K, Berna C, Bialosky J, Braithwaite F, Finnerup NB, Williams ACC, Carlino E, Cerritelli F, Chaibi A, Cherkin D, Colloca L, Cote P, Darnall BD, Evans R, Fabre L, Faria V, French S, Gerger H, Hauser W, Hinman RS, Ho D, Janssens T, Jensen K, Johnston C, Juhl Lunde S, Keefe F, Kerns RD, Koechlin H, Kongsted A, Michener LA, Moerman DE, Musial F, Newell D, Nicholas M, Palermo TM, Palermo S, Peerdeman KJ, Pogatzki-Zahn EM, Puhl AA, Roberts L, Rossettini G, Tomczak Matthiesen S, Underwood M, Vaucher P, Vollert J, Wartolowska KA, Weimer K, Werner CP, Rice ASC, Draper-Rodi J. Recommendations for the development, implementation, and reporting of control interventions in efficacy and mechanistic trials of physical, psychological, and self-management therapies: the CoPPS Statement. BMJ 2023;381:e072108.
  2. Wartolowska KA, Hohenschurz-Schmidt D, Vase L, Aronson JK. The importance of using placebo controls in non-pharmacological randomised trials (invited topical review). PAIN 2023;164(5):921-925.
  3. Wartolowska K, Colloca L, Amanzio M. Editorial: The nocebo effect and its consequences for clinical trials and clinical practice. Frontiers in Psychology 2023;13:1111324.
  4. Sweeney OJ, Parepalli SA, Mirtorabi N, Loo Yong Kee K, Feakins BG, Aronson JK, Wartolowska KA. Placebo's invisible brother: a restricted scoping review of the biomedical literature on the nocebo effect. PAIN 2023;163:2103-2111
  5. Bernstein MH, Rosenfield MN, Blease C, Magill M, Terek RM, Savulescu J, Beaudoin FL, Rich JD, Wartolowska K. How do US orthopaedic surgeons view placebo-controlled surgical trials? A pilot online survey study. Journal of Medical Ethics 2022;medethics-2022-108221.
  6. Bernstein M, Rosenfield M, Fuchs N, Magill M, Blease C, Beaudoin F, Rich J, Wartolowska K, Terek R. How orthopedic surgeons view open label placebo pills – a pilot study: ethical and effective, but opposed to personal use. Journal of Psychosomatic Research 2021;151:110638.
  7. Kjær SW, Rice ASC, Wartolowska K, Vase L. Neuromodulation: more than a placebo effect? Pain 2020;161(3):491-495
  8. Vase L, Wartolowska K. Pain, placebo, and test of treatment efficacy: a narrative review. British Journal of Anaesthesia 2019;123:e254–e262
  9. Wartolowska K, Irving F, DeVito N, Feakins B, Curtis H, Bacon S, Smeeth L, Heneghan C, Goldacre B. RetractoBot: a protocol for a randomised controlled trial to assess the impact of notifying authors that they have cited a retracted paper - study protocol - peer-reviewed and preregistered at BMC Medicine. The date of in-principle acceptance: 25/01/2019.
  10. Wartolowska K. The nocebo effect as a source of bias in the assessment of treatment effects. F1000Research Latest published: 11 Mar 2019, 8:5
  11. Wartolowska K, Beard D, Carr A. Blinding in trials of interventional procedures is possible and worthwhile. F1000Research 2017;6:1663 [revised Jan 2018]
  12. Wartolowska K, Beard DJ, Carr AJ. The use of placebos in controlled trials of surgical interventions: a brief history. Journal of the Royal Society of Medicine 2018;111:177-182
  13. Bulte D, Wartolowska K Monitoring Cardiac and Respiratory Physiology During FMRI. Neuroimage 2017;154:81-91.
  14. Wartolowska K, Gerry S, Feakins BG, Collins GS, Cook J, Judge A, Carr AJ. A meta-analysis of temporal changes of response in the placebo arm of surgical randomized controlled trials: an update. Trials 2017;18:323
  15. Wartolowska KA , Feakins BG, Collins GS, Cook J, Judge A, Rombach I, Dean BJF, Smith JA, Carr AJ. The magnitude and temporal changes of response in the placebo arm of surgical randomized controlled trials: a systematic review and meta-analysis. Trials 2016;17:589
  16. Hopewell S, Boutron I, Altman DG, Barbour G, Moher D, Montori V, Schriger D, Cook J, Gerry S, Omar O, Dutton P, Roberts C, Frangou E, Clifton L, Chiocchia V, Rombach I, Wartolowska K, Ravaud P. Impact of a web-based tool (WebCONSORT) to improve the reporting of randomised trials: results of a randomised controlled trial. BMC Medicine 2016;14(1):199
  17. Savulescu J, Wartolowska K (joint first author), Carr AJ. Randomised placebo-controlled trials of surgery: ethical analysis and guidelines. Journal of Medical Ethics 2016; 42:776-783
  18. Wartolowska K , Collins GS, Hopewell S, Judge A, Dean BJ, Rombach I, Beard DJ, Carr AJ. Feasibility of surgical randomised controlled trials with a placebo arm: a systematic review. BMJ Open 2016;6:e010194
  19. George AJT, Collett C, Carr AJ, Holm S, Bale C, Burton S, Campbell M, Coles A, Gottlieb G, Muir K, Parroy S, Price J, Rice ASC, Sinden J, Stephenson C, Wartolowska K , Whittall H. When should placebo surgery as a control in clinical trials be carried out? Bulletin of The Royal College of Surgeons of England 2016;98:75-79
  20. Baldwin MJ, Wartolowska K (joint first author), Carr AJ. A survey on beliefs and attitudes of trainee surgeons towards placebo. BMC Surgery 2016;16:27
  22. Wartolowska K , Judge A, Hopewell S, Collins GS, Dean BJ, Rombach I, Brindley D, Savulescu J, Beard DJ, Carr AJ. Use of placebo controls in the evaluation of surgery: systematic review. BMJ 2014;348:g3253.
INVITED TALKS AND LECTURES
  1. "Ethical and Practical Considerations for and Against Placebo Control in the Assessment of the Effectiveness of Physical and Surgical Analgesic Interventions - topical workshop with Prof Luana Colloca and Prof Lene Vase. 17th IASP World Congress on Pain. Boston, USA. 2018.
  2. "Fake surgeries and dummy pills - control for bias and study design in trials on treatment efficacy in chronic pain" - an invited lecture. 'Introduction to Study Design and Research Methods' teaching module, Oxford, UK. 2018.
  3. "A placebo control group in surgical randomised controlled trials - when is it useful, ethical and necessary?" - an invited lecture The Wounds Research Network (WReN) 2018 Scientific Meeting, Newcastle, UK. 2018.
  4. ”Can and should placebo control be used in randomised controlled trials of surgical, physical and neuromodulation interventions?” – a workshop 6th International Congress on Neuropathic Pain (NeuPSIG), Gothenburg, Sweden. 2017.
  5. "Placebo controls in surgery" – a lecture at the BAPRAS Winter Scientific Meeting London, UK. 2016.
  6. "Ethical issues of sham surgery for orthopaedic surgery" Bioethics/HRA workshop on the use of sham surgery Nuffield Council on Bioethics, Bedford Place, London 2015.

ORGANISED WORKSHOPS
  1. We need to talk about nocebo - one of three talks at a workshop "Is Nocebo Placebo's Evil Twin?" (Chair: K Wartolowska; organisers: K Wartolowska, L Colloca, M Amanzio). IASP Virutal Series on Pain & Expo. (virtual due to COVID) .
  2. Placebo-controlled non-pharmacological trials on pain conditions (Chair: K Wartolowska; organisers: K Wartolowska, L Vase, I Harris, N O'Connell, S Eldabe), International Association for the Study of Pain conference virtual due to COVID).

CONFERENCE PRESENTATIONS
  1. Hohenschurz-Schmidt D, Vase L, Annoni WSM, Barth J, Bennell K, Berna Renella C, Bialosky J, Braithwaite F, Finnerup NB, de C Williams AC, Carlino E, Cerritelli F, Chaibi A, Cherkin D, Colloca L, Côte P, Darnall DB, Evans R, Fabre L, Faria V, French S, Gerger H, Häuser W, Hinman RS, Ho D, Janssens T, Jensen K, Juhl Lunde S, Keefe F, Kerns RD, Koechlin H, Kongsted A, Michener LA, Moerman D, Musial F, Newell D, Nicholas M, Palermo TM, Palermo S, Pashko S, Peerdeman KJ, Pogatzki-Zahn EM, Puhl AA, Roberts L, Rossettini G, Johnston C, Tomczak Matthiesen S, Underwood M, Vaucher P, Wartolowska K, Weimer K, Werner CP, Rice ASC, Draper-Rodi J. Recommendations for the development, implementation, and reporting of (sham) control interventions in efficacy trials of physical, psychological, and self-management therapies: CoPPS statement. The Society for Back Pain Research (SBPR) Annual General Meeting. Coventry, UK. 2022.
  2. Parepalli S, Sweeney O, Mirtorabi N, Loo Yong Kee K, Feakins BG, Aronson JK, Wartolowska K. Placebo’s invisible brother – a restricted scoping review of biomedical literature on the nocebo effect (a poster). World Congress on Pain. Virtual due to COVID.
  3. Wartolowska K, Gerry S, Feakins BG, Collins GS, Cook J, Judge A, Carr AJ Temporal characteristics of effect size in the placebo arm of surgical randomised controlled trials: a meta-analysis – at talk Evidence Live Oxford, UK. 2017.
  4. Wartolowska K, Judge A, Dean B Rombach I, Savulescu J, Beard D, Carr A The use of placebo in randomised surgical clinical trials (a poster) The 2nd Clinical Trials Methodology Conference: Methodology Matters Edinburgh, UK. 2013.
  5. Wartolowska K, Judge A, Dean B, Rombach I, Savulescu J, Beard D, Carr A Benefits and harms of placebo in surgical randomised clinical trials: a systematic review (a poster) The 2nd Clinical Trials Methodology Conference: Methodology Matters, Edinburgh, UK. 2013.

BLOGS
  1. Fake surgeries and dummy pills - bias control and study design in trials of treatment efficacy. Evidence-based Health Care podcasts, University of Oxford. 2018.
  2. Unreported trial of the week: ketorolac vs nepafenac after cataract surgery (NCT02752646). 2018. The BMJ Opinion. 2018.
  3. Electrical shavers and splashed saline – how blinding has been achieved in surgical placebo-controlled trials. F1000 blognetwork. 2017.
  4. Randomised Placebo-Controlled Trials of Surgery: Ethical Analysis and Guidelines. Journal of Medical Ethics Forum. 2016.
  5. Use of placebo controls in the evaluation of surgery: a systematic review. Oxford Clinical Trials Research Unit. 2014.


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