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Evaluation of Anthropological, Socio-cultural and Psychological Factors of Surgeons Practising in Oncology Which Condition Brakes in the Evaluation of Surgical Innovations
Bories P, Lamy S, Simand C, Bertoli S, Delpierre C, Malak S, Fornecker L, Moreau S, Recher C, Nebout A. Physician uncertainty aversion impacts medical decision making for older patients with acute myeloid leukemia: results of a national survey. Haematologica. 2018 Dec;103(12):2040-2048. doi: 10.3324/haematol.2018.192468. Epub 2018 Jul 13.
Brandberg Y, Malm M, Blomqvist L. A prospective and randomized study, "SVEA," comparing effects of three methods for delayed breast reconstruction on quality of life, patient-defined problem areas of life, and cosmetic result. Plast Reconstr Surg. 2000 Jan;105(1):66-74; discussion 75-6. doi: 10.1097/00006534-200001000-00011.
Castel P, Negrier S, Boissel JP; Plateforme d'Aide a la Recherche Clinique en Cancerologie de la region Rhone-Alpes. Why don't cancer patients enter clinical trials? A review. Eur J Cancer. 2006 Aug;42(12):1744-8. doi: 10.1016/j.ejca.2005.10.033. Epub 2006 Jun 14.
Concato J, Peduzzi P, Holford TR, Feinstein AR. Importance of events per independent variable in proportional hazards analysis. I. Background, goals, and general strategy. J Clin Epidemiol. 1995 Dec;48(12):1495-501. doi: 10.1016/0895-4356(95)00510-2.
Cook JA. The challenges faced in the design, conduct and analysis of surgical randomised controlled trials. Trials. 2009 Feb 6;10:9. doi: 10.1186/1745-6215-10-9.
Crocker JC, Farrar N, Cook JA, Treweek S, Woolfall K, Chant A, Bostock J, Locock L, Rees S, Olszowski S, Bulbulia R. Recruitment and retention of participants in UK surgical trials: survey of key issues reported by trial staff. BJS Open. 2020 Oct 4;4(6):1238-45. doi: 10.1002/bjs5.50345. Online ahead of print.
Cros F, Lamy S, Grosclaude P, Nebout A, Chabrillac E, Vergez S, Bories P, Dupret-Bories A. Physician practice variation in head and neck cancer therapy: Results of a national survey. Oral Oncol. 2021 Jun;117:105293. doi: 10.1016/j.oraloncology.2021.105293. Epub 2021 Apr 14.
Elliott D, Hamdy FC, Leslie TA, Rosario D, Dudderidge T, Hindley R, Emberton M, Brewster S, Sooriakumaran P, Catto JWF, Emara A, Ahmed H, Whybrow P, le Conte S, Donovan JL. Overcoming difficulties with equipoise to enable recruitment to a randomised controlled trial of partial ablation vs radical prostatectomy for unilateral localised prostate cancer. BJU Int. 2018 Dec;122(6):970-977. doi: 10.1111/bju.14432. Epub 2018 Aug 15.
Evrard S, McKelvie-Sebileau P, van de Velde C, Nordlinger B, Poston G. What can we learn from oncology surgical trials? Nat Rev Clin Oncol. 2016 Jan;13(1):55-62. doi: 10.1038/nrclinonc.2015.176. Epub 2015 Oct 20.
Filleron T, Bonnetain F, Mancini J, Martinez A, Roche H, Dalenc F. Prospective construction and validation of a prognostic score to identify patients who benefit from third-line chemotherapy for metastatic breast cancer in terms of overall survival: the METAL3 Study. Contemp Clin Trials. 2015 Jan;40:1-8. doi: 10.1016/j.cct.2014.11.005. Epub 2014 Nov 8.
Filleron T, Lusque A, Dalenc F, Ferron G, Roche H, Martinez A, Jouve E. Alternative methodological approach to randomized trial for surgical procedures routinely used. Contemp Clin Trials. 2018 May;68:109-115. doi: 10.1016/j.cct.2018.03.016. Epub 2018 Mar 30.
Fisher B, Montague E, Redmond C, Barton B, Borland D, Fisher ER, Deutsch M, Schwarz G, Margolese R, Donegan W, Volk H, Konvolinka C, Gardner B, Cohn I Jr, Lesnick G, Cruz AB, Lawrence W, Nealon T, Butcher H, Lawton R. Comparison of radical mastectomy with alternative treatments for primary breast cancer. A first report of results from a prospective randomized clinical trial. Cancer. 1977 Jun;39(6 Suppl):2827-39. doi: 10.1002/1097-0142(197706)39:63.0.co;2-i. No abstract available.
Ford E, Jenkins V, Fallowfield L, Stuart N, Farewell D, Farewell V. Clinicians' attitudes towards clinical trials of cancer therapy. Br J Cancer. 2011 May 10;104(10):1535-43. doi: 10.1038/bjc.2011.119. Epub 2011 Apr 12.
Giuliano AE, McCall L, Beitsch P, Whitworth PW, Blumencranz P, Leitch AM, Saha S, Hunt KK, Morrow M, Ballman K. Locoregional recurrence after sentinel lymph node dissection with or without axillary dissection in patients with sentinel lymph node metastases: the American College of Surgeons Oncology Group Z0011 randomized trial. Ann Surg. 2010 Sep;252(3):426-32; discussion 432-3. doi: 10.1097/SLA.0b013e3181f08f32.
Goyal A, Dodwell D. POSNOC: A Randomised Trial Looking at Axillary Treatment in Women with One or Two Sentinel Nodes with Macrometastases. Clin Oncol (R Coll Radiol). 2015 Dec;27(12):692-5. doi: 10.1016/j.clon.2015.07.005. Epub 2015 Aug 5. No abstract available.
Goyal A, Mann GB, Fallowfield L, Duley L, Reed M, Dodwell D, Coleman RE, Fakis A, Newcombe R, Jenkins V, Whitham D, Childs M, Whynes D, Keeley V, Ellis I, Fairbrother P, Sadiq S, Monson K, Montgomery A, Tan W, Vale L, Homer T, Badger H, Haines RH, Lewis M, Megias D, Nabi Z, Singh P, Caraman A, Miles E; POSNOC Trialists. POSNOC-POsitive Sentinel NOde: adjuvant therapy alone versus adjuvant therapy plus Clearance or axillary radiotherapy: a randomised controlled trial of axillary treatment in women with early-stage breast cancer who have metastases in one or two sentinel nodes. BMJ Open. 2021 Dec 2;11(12):e054365. doi: 10.1136/bmjopen-2021-054365.
Gray S, Price C. Barriers to participation in randomised controlled trials. J Clin Epidemiol. 2001 Mar;54(3):323-4. doi: 10.1016/s0895-4356(00)00279-1. No abstract available.
Halsted WS. I. A Clinical and Histological Study of certain Adenocarcinomata of the Breast: and a Brief Consideration of the Supraclavicular Operation and of the Results of Operations for Cancer of the Breast from 1889 to 1898 at the Johns Hopkins Hospital. Ann Surg. 1898 Nov;28(5):557-76. No abstract available.
Hirst A, Agha RA, Rosin D, McCulloch P. How can we improve surgical research andinnovation ?: the IDEAL framework for action. Int J Surg. 2013;11(10):1038-42. doi: 10.1016/j.ijsu.2013.09.016. Epub 2013 Oct 7. No abstract available.
Jones RP, Are C, Hugh TJ, Grunhagen DJ, Xu J, Balch CM, Poston GJ. Reshaping the critical role of surgeons in oncology research. Nat Rev Clin Oncol. 2019 May;16(5):327-332. doi: 10.1038/s41571-018-0149-1.
McCulloch P, Altman DG, Campbell WB, Flum DR, Glasziou P, Marshall JC, Nicholl J; Balliol Collaboration; Aronson JK, Barkun JS, Blazeby JM, Boutron IC, Campbell WB, Clavien PA, Cook JA, Ergina PL, Feldman LS, Flum DR, Maddern GJ, Nicholl J, Reeves BC, Seiler CM, Strasberg SM, Meakins JL, Ashby D, Black N, Bunker J, Burton M, Campbell M, Chalkidou K, Chalmers I, de Leval M, Deeks J, Ergina PL, Grant A, Gray M, Greenhalgh R, Jenicek M, Kehoe S, Lilford R, Littlejohns P, Loke Y, Madhock R, McPherson K, Meakins J, Rothwell P, Summerskill B, Taggart D, Tekkis P, Thompson M, Treasure T, Trohler U, Vandenbroucke J. No surgicalinnovation without evaluation: the IDEAL recommendations. Lancet. 2009 Sep 26;374(9695):1105-12. doi: 10.1016/S0140-6736(09)61116-8.
McLeod RS. Issues in surgical randomized controlled trials. World J Surg. 1999 Dec;23(12):1210-4. doi: 10.1007/s002689900649.
Mishra-Kalyani PS, Amiri Kordestani L, Rivera DR, Singh H, Ibrahim A, DeClaro RA, Shen Y, Tang S, Sridhara R, Kluetz PG, Concato J, Pazdur R, Beaver JA. External control arms in oncology: current use and future directions. Ann Oncol. 2022 Apr;33(4):376-383. doi: 10.1016/j.annonc.2021.12.015. Epub 2022 Jan 10.
Moons KG, Altman DG, Reitsma JB, Ioannidis JP, Macaskill P, Steyerberg EW, Vickers AJ, Ransohoff DF, Collins GS. Transparent Reporting of a multivariable prediction model for Individual Prognosis or Diagnosis (TRIPOD): explanation and elaboration. Ann Intern Med. 2015 Jan 6;162(1):W1-73. doi: 10.7326/M14-0698.
Nakamura S. Axillary lymph node dissection in sentinel node positive breast cancer: is it necessary? Curr Opin Obstet Gynecol. 2013 Feb 19. doi: 10.1097/GCO.0b013e32834f3608. Online ahead of print.
Potter S, Mills N, Cawthorn SJ, Donovan J, Blazeby JM. Time to be BRAVE: is educating surgeons the key to unlocking the potential of randomised clinical trials in surgery? A qualitative study. Trials. 2014 Mar 14;15:80. doi: 10.1186/1745-6215-15-80.
Ross S, Grant A, Counsell C, Gillespie W, Russell I, Prescott R. Barriers to participation in randomised controlled trials: a systematic review. J Clin Epidemiol. 1999 Dec;52(12):1143-56. doi: 10.1016/s0895-4356(99)00141-9.
Schroen AT, Brenin DR. Breast cancer treatment beliefs and influences among surgeons in areas of scientific uncertainty. Am J Surg. 2010 Apr;199(4):491-9. doi: 10.1016/j.amjsurg.2009.04.005.
Spillane AJ, Mann GB. Surgeon knows best versus breast cancer surgical clinical trial equipoise: a plea for the sake of future trials. ANZ J Surg. 2017 Mar;87(3):111-112. doi: 10.1111/ans.13831. No abstract available.
Taylor KM, Margolese RG, Soskolne CL. Physicians' reasons for not entering eligible patients in a randomized clinical trial of surgery for breast cancer. N Engl J Med. 1984 May 24;310(21):1363-7. doi: 10.1056/NEJM198405243102106.
Tibau A, Molto C, Borrell M, Del Paggio JC, Barnadas A, Booth CM, Amir E. Magnitude of Clinical Benefit of Cancer Drugs Approved by the US Food and Drug Administration Based on Single-Arm Trials. JAMA Oncol. 2018 Nov 1;4(11):1610-1611. doi: 10.1001/jamaoncol.2018.4300.
Tolaney SM, Barry WT, Dang CT, Yardley DA, Moy B, Marcom PK, Albain KS, Rugo HS, Ellis M, Shapira I, Wolff AC, Carey LA, Overmoyer BA, Partridge AH, Guo H, Hudis CA, Krop IE, Burstein HJ, Winer EP. Adjuvant paclitaxel and trastuzumab for node-negative, HER2-positive breast cancer. N Engl J Med. 2015 Jan 8;372(2):134-41. doi: 10.1056/NEJMoa1406281.
Unger JM, Hershman DL, Till C, Minasian LM, Osarogiagbon RU, Fleury ME, Vaidya R. "When Offered to Participate": A Systematic Review and Meta-Analysis of Patient Agreement to Participate in Cancer Clinical Trials. J Natl Cancer Inst. 2021 Mar 1;113(3):244-257. doi: 10.1093/jnci/djaa155.
Bories P, Lamy S, Simand C, Bertoli S, Delpierre C, Malak S, Fornecker L, Moreau S, Recher C, Nebout A. Physician uncertainty aversion impacts medical decision making for older patients with acute myeloid leukemia: results of a national survey. Haematologica. 2018 Dec;103(12):2040-2048. doi: 10.3324/haematol.2018.192468. Epub 2018 Jul 13.
Brandberg Y, Malm M, Blomqvist L. A prospective and randomized study, "SVEA," comparing effects of three methods for delayed breast reconstruction on quality of life, patient-defined problem areas of life, and cosmetic result. Plast Reconstr Surg. 2000 Jan;105(1):66-74; discussion 75-6. doi: 10.1097/00006534-200001000-00011.
Castel P, Negrier S, Boissel JP; Plateforme d'Aide a la Recherche Clinique en Cancerologie de la region Rhone-Alpes. Why don't cancer patients enter clinical trials? A review. Eur J Cancer. 2006 Aug;42(12):1744-8. doi: 10.1016/j.ejca.2005.10.033. Epub 2006 Jun 14.
Concato J, Peduzzi P, Holford TR, Feinstein AR. Importance of events per independent variable in proportional hazards analysis. I. Background, goals, and general strategy. J Clin Epidemiol. 1995 Dec;48(12):1495-501. doi: 10.1016/0895-4356(95)00510-2.
Cook JA. The challenges faced in the design, conduct and analysis of surgical randomised controlled trials. Trials. 2009 Feb 6;10:9. doi: 10.1186/1745-6215-10-9.
Crocker JC, Farrar N, Cook JA, Treweek S, Woolfall K, Chant A, Bostock J, Locock L, Rees S, Olszowski S, Bulbulia R. Recruitment and retention of participants in UK surgical trials: survey of key issues reported by trial staff. BJS Open. 2020 Oct 4;4(6):1238-45. doi: 10.1002/bjs5.50345. Online ahead of print.
Cros F, Lamy S, Grosclaude P, Nebout A, Chabrillac E, Vergez S, Bories P, Dupret-Bories A. Physician practice variation in head and neck cancer therapy: Results of a national survey. Oral Oncol. 2021 Jun;117:105293. doi: 10.1016/j.oraloncology.2021.105293. Epub 2021 Apr 14.
Elliott D, Hamdy FC, Leslie TA, Rosario D, Dudderidge T, Hindley R, Emberton M, Brewster S, Sooriakumaran P, Catto JWF, Emara A, Ahmed H, Whybrow P, le Conte S, Donovan JL. Overcoming difficulties with equipoise to enable recruitment to a randomised controlled trial of partial ablation vs radical prostatectomy for unilateral localised prostate cancer. BJU Int. 2018 Dec;122(6):970-977. doi: 10.1111/bju.14432. Epub 2018 Aug 15.
Evrard S, McKelvie-Sebileau P, van de Velde C, Nordlinger B, Poston G. What can we learn from oncology surgical trials? Nat Rev Clin Oncol. 2016 Jan;13(1):55-62. doi: 10.1038/nrclinonc.2015.176. Epub 2015 Oct 20.
Filleron T, Bonnetain F, Mancini J, Martinez A, Roche H, Dalenc F. Prospective construction and validation of a prognostic score to identify patients who benefit from third-line chemotherapy for metastatic breast cancer in terms of overall survival: the METAL3 Study. Contemp Clin Trials. 2015 Jan;40:1-8. doi: 10.1016/j.cct.2014.11.005. Epub 2014 Nov 8.
Filleron T, Lusque A, Dalenc F, Ferron G, Roche H, Martinez A, Jouve E. Alternative methodological approach to randomized trial for surgical procedures routinely used. Contemp Clin Trials. 2018 May;68:109-115. doi: 10.1016/j.cct.2018.03.016. Epub 2018 Mar 30.
Fisher B, Montague E, Redmond C, Barton B, Borland D, Fisher ER, Deutsch M, Schwarz G, Margolese R, Donegan W, Volk H, Konvolinka C, Gardner B, Cohn I Jr, Lesnick G, Cruz AB, Lawrence W, Nealon T, Butcher H, Lawton R. Comparison of radical mastectomy with alternative treatments for primary breast cancer. A first report of results from a prospective randomized clinical trial. Cancer. 1977 Jun;39(6 Suppl):2827-39. doi: 10.1002/1097-0142(197706)39:63.0.co;2-i. No abstract available.
Ford E, Jenkins V, Fallowfield L, Stuart N, Farewell D, Farewell V. Clinicians' attitudes towards clinical trials of cancer therapy. Br J Cancer. 2011 May 10;104(10):1535-43. doi: 10.1038/bjc.2011.119. Epub 2011 Apr 12.
Giuliano AE, McCall L, Beitsch P, Whitworth PW, Blumencranz P, Leitch AM, Saha S, Hunt KK, Morrow M, Ballman K. Locoregional recurrence after sentinel lymph node dissection with or without axillary dissection in patients with sentinel lymph node metastases: the American College of Surgeons Oncology Group Z0011 randomized trial. Ann Surg. 2010 Sep;252(3):426-32; discussion 432-3. doi: 10.1097/SLA.0b013e3181f08f32.
Goyal A, Dodwell D. POSNOC: A Randomised Trial Looking at Axillary Treatment in Women with One or Two Sentinel Nodes with Macrometastases. Clin Oncol (R Coll Radiol). 2015 Dec;27(12):692-5. doi: 10.1016/j.clon.2015.07.005. Epub 2015 Aug 5. No abstract available.
Goyal A, Mann GB, Fallowfield L, Duley L, Reed M, Dodwell D, Coleman RE, Fakis A, Newcombe R, Jenkins V, Whitham D, Childs M, Whynes D, Keeley V, Ellis I, Fairbrother P, Sadiq S, Monson K, Montgomery A, Tan W, Vale L, Homer T, Badger H, Haines RH, Lewis M, Megias D, Nabi Z, Singh P, Caraman A, Miles E; POSNOC Trialists. POSNOC-POsitive Sentinel NOde: adjuvant therapy alone versus adjuvant therapy plus Clearance or axillary radiotherapy: a randomised controlled trial of axillary treatment in women with early-stage breast cancer who have metastases in one or two sentinel nodes. BMJ Open. 2021 Dec 2;11(12):e054365. doi: 10.1136/bmjopen-2021-054365.
Gray S, Price C. Barriers to participation in randomised controlled trials. J Clin Epidemiol. 2001 Mar;54(3):323-4. doi: 10.1016/s0895-4356(00)00279-1. No abstract available.
Halsted WS. I. A Clinical and Histological Study of certain Adenocarcinomata of the Breast: and a Brief Consideration of the Supraclavicular Operation and of the Results of Operations for Cancer of the Breast from 1889 to 1898 at the Johns Hopkins Hospital. Ann Surg. 1898 Nov;28(5):557-76. No abstract available.
Hirst A, Agha RA, Rosin D, McCulloch P. How can we improve surgical research and
Jones RP, Are C, Hugh TJ, Grunhagen DJ, Xu J, Balch CM, Poston GJ. Reshaping the critical role of surgeons in oncology research. Nat Rev Clin Oncol. 2019 May;16(5):327-332. doi: 10.1038/s41571-018-0149-1.
McCulloch P, Altman DG, Campbell WB, Flum DR, Glasziou P, Marshall JC, Nicholl J; Balliol Collaboration; Aronson JK, Barkun JS, Blazeby JM, Boutron IC, Campbell WB, Clavien PA, Cook JA, Ergina PL, Feldman LS, Flum DR, Maddern GJ, Nicholl J, Reeves BC, Seiler CM, Strasberg SM, Meakins JL, Ashby D, Black N, Bunker J, Burton M, Campbell M, Chalkidou K, Chalmers I, de Leval M, Deeks J, Ergina PL, Grant A, Gray M, Greenhalgh R, Jenicek M, Kehoe S, Lilford R, Littlejohns P, Loke Y, Madhock R, McPherson K, Meakins J, Rothwell P, Summerskill B, Taggart D, Tekkis P, Thompson M, Treasure T, Trohler U, Vandenbroucke J. No surgical
McLeod RS. Issues in surgical randomized controlled trials. World J Surg. 1999 Dec;23(12):1210-4. doi: 10.1007/s002689900649.
Mishra-Kalyani PS, Amiri Kordestani L, Rivera DR, Singh H, Ibrahim A, DeClaro RA, Shen Y, Tang S, Sridhara R, Kluetz PG, Concato J, Pazdur R, Beaver JA. External control arms in oncology: current use and future directions. Ann Oncol. 2022 Apr;33(4):376-383. doi: 10.1016/j.annonc.2021.12.015. Epub 2022 Jan 10.
Moons KG, Altman DG, Reitsma JB, Ioannidis JP, Macaskill P, Steyerberg EW, Vickers AJ, Ransohoff DF, Collins GS. Transparent Reporting of a multivariable prediction model for Individual Prognosis or Diagnosis (TRIPOD): explanation and elaboration. Ann Intern Med. 2015 Jan 6;162(1):W1-73. doi: 10.7326/M14-0698.
Nakamura S. Axillary lymph node dissection in sentinel node positive breast cancer: is it necessary? Curr Opin Obstet Gynecol. 2013 Feb 19. doi: 10.1097/GCO.0b013e32834f3608. Online ahead of print.
Potter S, Mills N, Cawthorn SJ, Donovan J, Blazeby JM. Time to be BRAVE: is educating surgeons the key to unlocking the potential of randomised clinical trials in surgery? A qualitative study. Trials. 2014 Mar 14;15:80. doi: 10.1186/1745-6215-15-80.
Ross S, Grant A, Counsell C, Gillespie W, Russell I, Prescott R. Barriers to participation in randomised controlled trials: a systematic review. J Clin Epidemiol. 1999 Dec;52(12):1143-56. doi: 10.1016/s0895-4356(99)00141-9.
Schroen AT, Brenin DR. Breast cancer treatment beliefs and influences among surgeons in areas of scientific uncertainty. Am J Surg. 2010 Apr;199(4):491-9. doi: 10.1016/j.amjsurg.2009.04.005.
Spillane AJ, Mann GB. Surgeon knows best versus breast cancer surgical clinical trial equipoise: a plea for the sake of future trials. ANZ J Surg. 2017 Mar;87(3):111-112. doi: 10.1111/ans.13831. No abstract available.
Taylor KM, Margolese RG, Soskolne CL. Physicians' reasons for not entering eligible patients in a randomized clinical trial of surgery for breast cancer. N Engl J Med. 1984 May 24;310(21):1363-7. doi: 10.1056/NEJM198405243102106.
Tibau A, Molto C, Borrell M, Del Paggio JC, Barnadas A, Booth CM, Amir E. Magnitude of Clinical Benefit of Cancer Drugs Approved by the US Food and Drug Administration Based on Single-Arm Trials. JAMA Oncol. 2018 Nov 1;4(11):1610-1611. doi: 10.1001/jamaoncol.2018.4300.
Tolaney SM, Barry WT, Dang CT, Yardley DA, Moy B, Marcom PK, Albain KS, Rugo HS, Ellis M, Shapira I, Wolff AC, Carey LA, Overmoyer BA, Partridge AH, Guo H, Hudis CA, Krop IE, Burstein HJ, Winer EP. Adjuvant paclitaxel and trastuzumab for node-negative, HER2-positive breast cancer. N Engl J Med. 2015 Jan 8;372(2):134-41. doi: 10.1056/NEJMoa1406281.
Unger JM, Hershman DL, Till C, Minasian LM, Osarogiagbon RU, Fleury ME, Vaidya R. "When Offered to Participate": A Systematic Review and Meta-Analysis of Patient Agreement to Participate in Cancer Clinical Trials. J Natl Cancer Inst. 2021 Mar 1;113(3):244-257. doi: 10.1093/jnci/djaa155.
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