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The quality of reporting in randomised controlled trials in plastic surgery
PLASTIC SURGERY III consists of a 23-item checklist and flow diagram. Our aim was to assess the compliance of recent RCTs in Plastic Surgery with the CONSORT statement.
Involvement of regulatory t-cells in tolerance towards vascularized and non-vascularized skin allograft transplants Jeff Chang, MS, MD, Billana Hwang, MPH, Tiffany Butts, BA, Scott S Graves, PhD, Rainer Storb, MD, David W Mathes, MD, FACS University of Washington, Seattle, WA, Fred Hutchinson Cancer Research Center, Seattle, WA
METHODS: Medline was searched by an information specialist from 1 January 2009 to 30 June 2011 for the MESH heading “Surgery, Plastic” with limitations for English language, human studies and randomised controlled trials. Results were then manually searched for relevant RCTs involving surgical techniques. The papers were scored against the 23 item CONSORT checklist. Secondary scoring was then performed and discrepancies resolved by consensus.
INTRODUCTION: Transplantation of a vascularized composite allograft (VCA) such as hand or face is now a clinical reality. All VCA recipients experience rejection despite immunosuppression, likely due to the high antigenicity of transplanted skin. Previous large animal studies induce tolerance towards VCA but not non-vascularized skin allografts (NVSA). This suggests different tolerance mechanisms between vascularized and non-vascularized grafts. We established a large animal chimeric model to study tolerance towards VCA and NVSA transplants, specifically mediated by donor cell chimerism and regulatory T-cells (T-regs).
RESULTS: 57 papers involving 3,878 patients met the inclusion criteria from a manual search of 254 papers retrieved from Medline. The average CONSORT score was 11.5 out of 23 items (50%, range 5.3-21.0) with a median score of 12.9. Compliance was poorest with items related to intervention/comparator details (7%), randomisation implementation (11%) and blinding (26%). There was no link between journal 2010 ISI impact factor and CONSORT score (R⫽0.25). Only 61% declared conflicts of interest and 75% had permission from an ethics review committee.
METHODS: Five dog VCA transplants were performed across a minor mismatched barrier after receiving two Gy radiation and donor marrow followed by a short course of post-graft immunosuppression. One year post-transplant, NVSAs from marrow donors and third parties were placed on the recipients. Chimerism was followed in the blood. Biopsies of transplanted skin were stained for FoxP3 to assess for T-regs.
CONCLUSIONS: The reporting quality of RCTs in Plastic Surgery is poor and significant work is now needed to address this issue.
Comparison of prosthetic and autogenous breast reconstruction: A multi-instituional analysis of postoperative complications Geoffrey Chow, MD, Philip J Hanwright, BA, Colton H McNichols, BSc(Hons), Caitlin M Connor, BA, BA, Kevin P Bethke, MD, Karl Bilimoria, MD, MS, John YS Kim, MD, FACS Northwestern Memorial Hospital, Chicago, IL, Feinberg School of Medicine Chicago IL, Northwestern Memorial Faculty Foundation, Chicago, IL
RESULTS: All five dogs demonstrated tolerance towards the VCA and NVSA. One dog received a VCA transplant after induction of mixed chimerism yet still exhibited tolerance. Another dog rejected donor marrow but not the VCA or NVSA. T-regs were significantly higher in VCA and NVSA versus normal or rejecting tissues. CONCLUSIONS: This study suggests that maintenance of tolerance towards both VCA and NVSA are dependent on peripheral than central mechanisms. Presentation of skin antigens during tolerance induction is not required for tolerance, and that after establishing tolerance, donor cell chimerism is not necessary for maintenance of tolerance towards skin. Likely, maintenance of tolerance is due to T-regs infiltrating the allograft.
INTRODUCTION: Prosthetic and autogenous tissue reconstructions are utilized following mastectomy. There are limited multiinstitutional data directly comparing outcomes of prosthetic and autogenous breast reconstruction. METHODS: Patients from American College of Surgeons NSQIP hospitals were identified who underwent mastectomy followed by implant or autogenous tissue reconstruction from 2006-2010. The implant group consisted of tissue expander or breast prosthesis, while the autogenous group included pedicled TRAM, free TRAM, lattisimus flap, and other free flaps. Thirty day postoperative complication rates were compared for twenty complications.
The quality of reporting in randomised controlled trials in plastic surgery Riaz Ahmed Agha, MB, BS, MRCS, MRCSCEd, Christian Camm, MB, BCh, Emre Doganay, MB, BS, Eric Edison, MB, BS, Muhammed Siddiqui, MB, BS, MRCS, Dennis P Orgill, MD, PhD, FACS Queen Victoria Hospital NHS Foundation Trust, East Grinstead, United Kingdom
RESULTS: 1,525 patients underwent implant reconstruction, and 678 had autogenous tissue reconstruction. Patients undergoing implant reconstruction had a lower rate of adverse events (9.3% vs. 36.6%, p⬍0.001). Tissue reconstruction carried higher rate of superficial surgical site infection (SSI) (4.0% vs. 1.6%, p⫽0.001), deep SSI (3.4% vs. 0.9%, p⬍0.001), and wound disruption (1.8% vs. 0.5%, p⫽0.005). There was no difference in MI, cardiac arrest, stroke, and mortality; all with low incidence. Tissue reconstruction had a higher rate of reoperation (11.5% vs. 3.9%, p⬍0.001), sepsis
INTRODUCTION: Randomised controlled trials (RCTs) represent the gold standard in evaluating healthcare interventions. However, RCTs can yield biased results if they lack methodological rigour, especially where surgical techniques are involved. Readers need complete, clear and transparent information. The Consolidated Standards of Reporting Trials (CONSORT) statement for nonpharmacological interventions was developed to aid reporting and
© 2012 by the American College of Surgeons Published by Elsevier Inc.
S89
ISSN 1072-7515/12/$36.00 http://dx.doi.org/10.1016/j.jamcollsurg.2012.06.237
Involvement of regulatory t-cells in tolerance towards vascularized and non-vascularized skin allograft transplants Jeff Chang, MS, MD, Billana Hwang, MPH, Tiffany Butts, BA, Scott S Graves, PhD, Rainer Storb, MD, David W Mathes, MD, FACS University of Washington, Seattle, WA, Fred Hutchinson Cancer Research Center, Seattle, WA
METHODS: Medline was searched by an information specialist from 1 January 2009 to 30 June 2011 for the MESH heading “Surgery, Plastic” with limitations for English language, human studies and randomised controlled trials. Results were then manually searched for relevant RCTs involving surgical techniques. The papers were scored against the 23 item CONSORT checklist. Secondary scoring was then performed and discrepancies resolved by consensus.
INTRODUCTION: Transplantation of a vascularized composite allograft (VCA) such as hand or face is now a clinical reality. All VCA recipients experience rejection despite immunosuppression, likely due to the high antigenicity of transplanted skin. Previous large animal studies induce tolerance towards VCA but not non-vascularized skin allografts (NVSA). This suggests different tolerance mechanisms between vascularized and non-vascularized grafts. We established a large animal chimeric model to study tolerance towards VCA and NVSA transplants, specifically mediated by donor cell chimerism and regulatory T-cells (T-regs).
RESULTS: 57 papers involving 3,878 patients met the inclusion criteria from a manual search of 254 papers retrieved from Medline. The average CONSORT score was 11.5 out of 23 items (50%, range 5.3-21.0) with a median score of 12.9. Compliance was poorest with items related to intervention/comparator details (7%), randomisation implementation (11%) and blinding (26%). There was no link between journal 2010 ISI impact factor and CONSORT score (R⫽0.25). Only 61% declared conflicts of interest and 75% had permission from an ethics review committee.
METHODS: Five dog VCA transplants were performed across a minor mismatched barrier after receiving two Gy radiation and donor marrow followed by a short course of post-graft immunosuppression. One year post-transplant, NVSAs from marrow donors and third parties were placed on the recipients. Chimerism was followed in the blood. Biopsies of transplanted skin were stained for FoxP3 to assess for T-regs.
CONCLUSIONS: The reporting quality of RCTs in Plastic Surgery is poor and significant work is now needed to address this issue.
Comparison of prosthetic and autogenous breast reconstruction: A multi-instituional analysis of postoperative complications Geoffrey Chow, MD, Philip J Hanwright, BA, Colton H McNichols, BSc(Hons), Caitlin M Connor, BA, BA, Kevin P Bethke, MD, Karl Bilimoria, MD, MS, John YS Kim, MD, FACS Northwestern Memorial Hospital, Chicago, IL, Feinberg School of Medicine Chicago IL, Northwestern Memorial Faculty Foundation, Chicago, IL
RESULTS: All five dogs demonstrated tolerance towards the VCA and NVSA. One dog received a VCA transplant after induction of mixed chimerism yet still exhibited tolerance. Another dog rejected donor marrow but not the VCA or NVSA. T-regs were significantly higher in VCA and NVSA versus normal or rejecting tissues. CONCLUSIONS: This study suggests that maintenance of tolerance towards both VCA and NVSA are dependent on peripheral than central mechanisms. Presentation of skin antigens during tolerance induction is not required for tolerance, and that after establishing tolerance, donor cell chimerism is not necessary for maintenance of tolerance towards skin. Likely, maintenance of tolerance is due to T-regs infiltrating the allograft.
INTRODUCTION: Prosthetic and autogenous tissue reconstructions are utilized following mastectomy. There are limited multiinstitutional data directly comparing outcomes of prosthetic and autogenous breast reconstruction. METHODS: Patients from American College of Surgeons NSQIP hospitals were identified who underwent mastectomy followed by implant or autogenous tissue reconstruction from 2006-2010. The implant group consisted of tissue expander or breast prosthesis, while the autogenous group included pedicled TRAM, free TRAM, lattisimus flap, and other free flaps. Thirty day postoperative complication rates were compared for twenty complications.
The quality of reporting in randomised controlled trials in plastic surgery Riaz Ahmed Agha, MB, BS, MRCS, MRCSCEd, Christian Camm, MB, BCh, Emre Doganay, MB, BS, Eric Edison, MB, BS, Muhammed Siddiqui, MB, BS, MRCS, Dennis P Orgill, MD, PhD, FACS Queen Victoria Hospital NHS Foundation Trust, East Grinstead, United Kingdom
RESULTS: 1,525 patients underwent implant reconstruction, and 678 had autogenous tissue reconstruction. Patients undergoing implant reconstruction had a lower rate of adverse events (9.3% vs. 36.6%, p⬍0.001). Tissue reconstruction carried higher rate of superficial surgical site infection (SSI) (4.0% vs. 1.6%, p⫽0.001), deep SSI (3.4% vs. 0.9%, p⬍0.001), and wound disruption (1.8% vs. 0.5%, p⫽0.005). There was no difference in MI, cardiac arrest, stroke, and mortality; all with low incidence. Tissue reconstruction had a higher rate of reoperation (11.5% vs. 3.9%, p⬍0.001), sepsis
INTRODUCTION: Randomised controlled trials (RCTs) represent the gold standard in evaluating healthcare interventions. However, RCTs can yield biased results if they lack methodological rigour, especially where surgical techniques are involved. Readers need complete, clear and transparent information. The Consolidated Standards of Reporting Trials (CONSORT) statement for nonpharmacological interventions was developed to aid reporting and
© 2012 by the American College of Surgeons Published by Elsevier Inc.
S89
ISSN 1072-7515/12/$36.00 http://dx.doi.org/10.1016/j.jamcollsurg.2012.06.237