- Email: [email protected]
Protocol for the development of a core outcome set for autologous fat grafting to the breast
Accepted Manuscript Protocol for the Development of a Core Outcome Set for Autologous Fat Grafting to the Breast Mr Riaz A. Agha, MBBS MRCS FRSPH, Alexander J. Fowler, MBBS BSc, Thomas E. Pidgeon, BMedSc MBChB, MRCS, Georgina Wellstead, BSc, Dennis P. Orgill, MD PhD PII:
S1743-9191(16)30154-6
DOI:
10.1016/j.ijsu.2016.05.067
Reference:
IJSU 2836
To appear in:
International Journal of Surgery
Received Date: 16 April 2016 Revised Date:
3 May 2016
Accepted Date: 25 May 2016
Please cite this article as: Agha RA, Fowler AJ, Pidgeon TE, Wellstead G, Orgill DP, on behalf of the VOGUE Steering Group, Protocol for the Development of a Core Outcome Set for Autologous Fat Grafting to the Breast, International Journal of Surgery (2016), doi: 10.1016/j.ijsu.2016.05.067. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT
Protocol for the Development of a Core Outcome Set for Autologous Fat Grafting to the Breast Riaz A Agha MBBS MRCS FRSPH1, Alexander J Fowler MBBS BSc2, Thomas E Pidgeon BMedSc MBChB, MRCS3, Georgina Wellstead BSc4, Dennis P Orgill MD
RI PT
PhD5 on behalf of the VOGUE Steering Group.
1. Department of Plastic Surgery, Guy's and St. Thomas' NHS Foundation Trust, London, UK
SC
2. Department of Acute Medicine, Guy's and St. Thomas' NHS Foundation Trust, London, UK
M AN U
3. Mid-Essex Hospitals NHS Trust, Chelmsford, Essex
4. Centre for Surgical Research, School of Social and Community Medicine, University of Bristol
5. Division of Plastic Surgery, Brigham and Women’s Hospital, Boston, MA 02115,
TE D
USA
Corresponding author contact information: Mr Riaz Agha, Department of Plastic Surgery, Guy’s and St. Thomas’ NHS
EP
Foundation Trust, Westminster Bridge Road, London SE1 7EH [email protected]
AC C
Conflicts of Interest and Sources of Funding: Funding – None received Financial interests – None declared. None of the authors has a financial interest in any of the products, devices or drugs mentioned in this manuscript. Conflicts of interest – None declared. The authors have no financial, consultative, institutional, and other relationships that might lead to bias or conflict of interest Ethical approval – Not applicable
ACCEPTED MANUSCRIPT Author contributions: RAA: Concept and design of study, drafting, revision, approval of final manuscript AJF: Revision, approval of final manuscript TEP: Revision, approval of final manuscript GW: Revision, approval of final manuscript
AC C
EP
TE D
M AN U
SC
RI PT
DPO: Revision, approval of final manuscript
ACCEPTED MANUSCRIPT
Protocol for the Development of a Core Outcome Set for Autologous Fat Grafting to the Breast Abstract Introduction
RI PT
One in eight women will develop breast cancer in their lifetime. Reconstruction is routinely offered to patients and can be autologous and/or implant based. One area of growing interest in autologous fat grafting (AFG). Our group recently published a systematic review and meta-analysis of this topic which showed 51 different
SC
outcomes were being utilized in the published literature, with substantial
M AN U
heterogeneity in their definitions.
Methods and analysis
A Delphi consensus exercise amongst key stakeholders will be conducted using the long list of 51 outcomes generated through our previous work. We will fist group these according to the six domains previously identified; oncological, clinical, aesthetic and functional, patient-reported, process and radiological.
Through
TE D
sequential rounds of voting, the long list of outcomes will be narrowed down using predefined rules of agreement.
EP
Ethics and dissemination
No patients will be involved in this study and ethical approval is not required. The research will be published in a peer-reviewed journal. It will also be presented at
AC C
national and international conferences in the fields of plastic, reconstructive and aesthetic surgery as well as breast surgery and at more general surgical and methodological conferences. It will be disseminated electronically and in print. Brief reports of the review findings will be disseminated directly to the appropriate audiences of surgeons and societies through email and other modes of communication.
Introduction Breast cancer is the most common cancer in the UK and is by far the most common
1
ACCEPTED MANUSCRIPT cancer among women, where it accounts for 31% of all new cancer cases with a lifetime incidence of 1 in 8 (1). Approximately 50,000 women are diagnosed with breast cancer each year, 16,000 of whom undergo mastectomy and there are approximately 12,000 deaths from the disease (1). In the USA, the National Cancer Institute predicts over 230,000 new cases and approximately 40,000 deaths from
RI PT
breast cancer each year with over 96 000 undergoing breast reconstruction following surgery (2).
The loss of a breast can have significant physical and psychosocial sequalae and in
SC
the UK and many other countries, reconstructive breast surgery (RBS) is routinely offered to improve cosmetic outcomes and health-related quality of life (HRQL) (3). Options for reconstruction can be autologous or implant based and decision making
M AN U
can be complex with a holistic and patient-centred approach necessary. There is growing interest in the use of autologous fat grafting (AFG) for breast reconstruction. It is a highly active research front (see figure 1) and recent national meetings are dedicating significant time to it. Indeed, Rohrich et al have classed it as number three in the list of top innovations in plastic surgery (4).
Our group
TE D
recently published a systematic review and meta-analysis of this topic and demonstrated the utility of this technique as assessed across six outcome domains; oncological, clinical, aesthetic and functional, patient-reported, process and
AC C
EP
radiological (5).
2
160 140 120 100
RI PT
80 60 40
SC
20 0
M AN U
1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014
Number of Articles Published
ACCEPTED MANUSCRIPT
Year
Figure 1. The rising trend in publications about “fat grafting”, as shown by a search
TE D
in the SCOPUS® database.
Whilst conducting the review we noticed significant heterogeneity in the outcomes used by the various study authors. Further analysis of the 35 studies in follow-up work identified that there were a total of 51 different outcomes reported (6). These
EP
studies each reported a median of five separate outcomes (range 2-14), of which a median of three outcomes were defined (range 0-14). A median of two outcomes
AC C
per paper were pre-specified in the study methods (range 0-12) and a median of only two outcomes per paper (range 0-12) were both defined and pre-specified. The most commonly reported outcome in studies of AFG was that of “Operative details”, reported by 26 studies, and 8 different outcome definitions were used. “Cancer recurrence” was reported by 20 studies, with the use of 10 different outcome definitions (6). One method for addressing non-uniform outcome definitions and reporting is the development of core outcome sets (COS). These are a set of agreed outcomes that are reported as a minimum in all trials of a particular condition. The Outcome
3
ACCEPTED MANUSCRIPT Measures in Rheumatoid Arthritis in Clinical Trials (OMERACT) initiative were among the first to recognise this and developed a series of COS for use in rheumatology studies 20 years ago (7,8). The COMET (Core Outcome Measures in Effectiveness Trials) Initiative was established to guide the development of core outcome sets in other areas and to improve methodological techniques for these
RI PT
processes (9). More recently, Potter et al have developed a COS for RBS (10). Core outcomes sets developed in alternative fields of medicine have been shown to reduce reporting bias, create homogeneity in outcome reporting and improve metaanalysis (11,12). It is therefore hypothesised that a core outcome set for AFG would
SC
result in similar improvements in the conduct and reporting of AFG research and help to minimise outcome and reporting bias, standardise end-points, boost transparency, increase reproducibility and external validity, aid evidence synthesis
M AN U
and help guide clinical decision-making going forward (13–15). Our objective is to develop a core outcome set (COS) for AFG to the breast.
Methods
TE D
A Delphi consensus exercise amongst key stakeholders will be conducted using the long list of 51 outcomes generated through our previous work. We will fist group these according to the six domains previously identified; oncological, clinical,
AC C
EP
aesthetic and functional, patient-reported, process and radiological.
Delphi Process
The list will be operationalised to produce the round one Delphi questionnaire which will be administered via SurveyMonkey (www.surveymonkey.com) and conducted using standard Delphi Methodology (16). It is planned that the same questionnaire will be completed by all participants throughout the process. In each round, the participants will rate the importance of reporting each outcome on a nine-point Likert scale as proposed by the GRADE group (16). In the first round, they will have the opportunity to suggest new items/outcomes not already included. In this scale 1 to 3 signifies an outcome of limited importance, 4 to 6 important but not critical and 7 to 9
4
ACCEPTED MANUSCRIPT critical. If 70% or more of respondents score an item 7 to 9 and fewer than 15% score it 1 to 3, then that item should proceed into the COS. Similarly, consensus that an outcome should not be included would be 70% or more scoring it 1 to 3 and 15% or less scoring it 7 to 9. Sequential rounds and questionnaire administration and completion will take place until a final set of outcomes with agreed definitions are
RI PT
achieved. The entire process will be conducted electronically and there is no predetermined number of Delphi rounds, although the expectation is that at least three will be needed.
SC
Participant Selection
Surgeons with significant experience in fat grafting to the breast will be invited to They will be drawn from both the specialties of breast and plastic
surgery.
Ethics and Dissemination
M AN U
participate.
TE D
No ethical approval is necessary since this is a professional COS with no patient input. The research will be published in a peer-reviewed journal. It will also be presented at national and international conferences in the fields of plastic, reconstructive and aesthetic surgery as well as breast surgery and at more general
EP
surgical and methodological conferences. It will be disseminated electronically and in print. Brief reports of the review findings will be disseminated directly to the
AC C
appropriate audiences of surgeons and societies through email and other modes of communication.
References 1.
Breast cancer statistics | Cancer Research UK [Internet]. [cited 2015 Nov 20]. Available from: http://www.cancerresearchuk.org/health-professional/cancerstatistics/statistics-by-cancer-type/breast-cancer
2.
Breast Cancer - National Cancer Institute [Internet]. [cited 2015 Nov 20]. 5
ACCEPTED MANUSCRIPT
Harcourt D, Rumsey N. Psychological aspects of breast reconstruction: a review of the literature. J Adv Nurs. 2001 Aug;35(4):477–87.
4.
Rohrich RJ, Rosen J, Longaker MT. So you want to be an innovator? Plast Reconstr Surg. 2010 Sep;126(3):1107–9.
5.
Agha RA, Fowler AJ, Herlin C, Goodacre TEE, Orgill DP. Use of autologous fat grafting for breast reconstruction: a systematic review with meta-analysis of oncological outcomes. J Plast Reconstr Aesthet Surg. 2015 Feb;68(2):143–61.
6.
Agha RA, Fowler AJ, Pidgeon TE, Wellstead G, Orgill DP. The Need for Core Outcome Reporting in Autologous Fat Grafting for Breast Reconstruction. Ann Plast Surg. 2015 Nov 5;
7.
Boers M, Kirwan JR, Wells G, Beaton D, Gossec L, d’Agostino M-A, et al. Developing Core Outcome Measurement Sets for Clinical Trials: OMERACT Filter 2.0. J Clin Epidemiol. 2014 Jul;67(7):745–53.
8.
Boers M, Brooks P, Strand C V, Tugwell P. The OMERACT filter for Outcome Measures in Rheumatology. J Rheumatol. 1998 Feb;25(2):198–9.
9.
Home :: Core Outcome Measures in Effectiveness Trials Initiative (COMET) [Internet]. [cited 2015 Nov 20]. Available from: http://www.comet-initiative.org/
10.
Potter S, Holcombe C, Ward JA, Blazeby JM. Development of a core outcome set for research and audit studies in reconstructive breast surgery. Br J Surg. 2015 Oct;102(11):1360–71.
11.
EP
TE D
M AN U
SC
RI PT
3.
AC C
Available from: http://www.cancer.gov/types/breast
12.
13.
Duncan PW, Jorgensen HS, Wade DT. Outcome measures in acute stroke trials: a systematic review and some recommendations to improve practice. Stroke. 2000 Jun;31(6):1429–38. Chan A-W, Altman DG. Identifying outcome reporting bias in randomised trials on PubMed: review of publications and survey of authors. BMJ. 2005 Apr 2;330(7494):753. Moher D, Glasziou P, Chalmers I, Nasser M, Bossuyt PMM, Korevaar DA, et al. Increasing value and reducing waste in biomedical research: who’s listening? Lancet. 2015 Sep 25;
6
ACCEPTED MANUSCRIPT Kirkham JJ, Gargon E, Clarke M, Williamson PR. Can a core outcome set improve the quality of systematic reviews?--a survey of the Co-ordinating Editors of Cochrane Review Groups. Trials. 2013 Jan;14:21.
15.
Williamson P, Clarke M. The COMET (Core Outcome Measures in Effectiveness Trials) Initiative: Its Role in Improving Cochrane Reviews. Cochrane database Syst Rev. 2012 Jan;5:ED000041.
16.
Sinha IP, Smyth RL, Williamson PR. Using the Delphi technique to determine which outcomes to measure in clinical trials: recommendations for the future based on a systematic review of existing studies. PLoS Med. 2011 Jan;8(1):e1000393.
AC C
EP
TE D
M AN U
SC
RI PT
14.
7
ACCEPTED MANUSCRIPT Highlights •
One in eight women will develop breast cancer in their lifetime.
•
Reconstruction can be autologous or implant based.
•
An autologous technique is autologous fat grafting, in which our group has
Here we present a protocol for a Delphi consensus exercise amongst key
EP
TE D
M AN U
SC
stakeholders.
AC C
•
RI PT
recently conducted a systematic review of safety and efficacy.
S1743-9191(16)30154-6
DOI:
10.1016/j.ijsu.2016.05.067
Reference:
IJSU 2836
To appear in:
International Journal of Surgery
Received Date: 16 April 2016 Revised Date:
3 May 2016
Accepted Date: 25 May 2016
Please cite this article as: Agha RA, Fowler AJ, Pidgeon TE, Wellstead G, Orgill DP, on behalf of the VOGUE Steering Group, Protocol for the Development of a Core Outcome Set for Autologous Fat Grafting to the Breast, International Journal of Surgery (2016), doi: 10.1016/j.ijsu.2016.05.067. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT
Protocol for the Development of a Core Outcome Set for Autologous Fat Grafting to the Breast Riaz A Agha MBBS MRCS FRSPH1, Alexander J Fowler MBBS BSc2, Thomas E Pidgeon BMedSc MBChB, MRCS3, Georgina Wellstead BSc4, Dennis P Orgill MD
RI PT
PhD5 on behalf of the VOGUE Steering Group.
1. Department of Plastic Surgery, Guy's and St. Thomas' NHS Foundation Trust, London, UK
SC
2. Department of Acute Medicine, Guy's and St. Thomas' NHS Foundation Trust, London, UK
M AN U
3. Mid-Essex Hospitals NHS Trust, Chelmsford, Essex
4. Centre for Surgical Research, School of Social and Community Medicine, University of Bristol
5. Division of Plastic Surgery, Brigham and Women’s Hospital, Boston, MA 02115,
TE D
USA
Corresponding author contact information: Mr Riaz Agha, Department of Plastic Surgery, Guy’s and St. Thomas’ NHS
EP
Foundation Trust, Westminster Bridge Road, London SE1 7EH [email protected]
AC C
Conflicts of Interest and Sources of Funding: Funding – None received Financial interests – None declared. None of the authors has a financial interest in any of the products, devices or drugs mentioned in this manuscript. Conflicts of interest – None declared. The authors have no financial, consultative, institutional, and other relationships that might lead to bias or conflict of interest Ethical approval – Not applicable
ACCEPTED MANUSCRIPT Author contributions: RAA: Concept and design of study, drafting, revision, approval of final manuscript AJF: Revision, approval of final manuscript TEP: Revision, approval of final manuscript GW: Revision, approval of final manuscript
AC C
EP
TE D
M AN U
SC
RI PT
DPO: Revision, approval of final manuscript
ACCEPTED MANUSCRIPT
Protocol for the Development of a Core Outcome Set for Autologous Fat Grafting to the Breast Abstract Introduction
RI PT
One in eight women will develop breast cancer in their lifetime. Reconstruction is routinely offered to patients and can be autologous and/or implant based. One area of growing interest in autologous fat grafting (AFG). Our group recently published a systematic review and meta-analysis of this topic which showed 51 different
SC
outcomes were being utilized in the published literature, with substantial
M AN U
heterogeneity in their definitions.
Methods and analysis
A Delphi consensus exercise amongst key stakeholders will be conducted using the long list of 51 outcomes generated through our previous work. We will fist group these according to the six domains previously identified; oncological, clinical, aesthetic and functional, patient-reported, process and radiological.
Through
TE D
sequential rounds of voting, the long list of outcomes will be narrowed down using predefined rules of agreement.
EP
Ethics and dissemination
No patients will be involved in this study and ethical approval is not required. The research will be published in a peer-reviewed journal. It will also be presented at
AC C
national and international conferences in the fields of plastic, reconstructive and aesthetic surgery as well as breast surgery and at more general surgical and methodological conferences. It will be disseminated electronically and in print. Brief reports of the review findings will be disseminated directly to the appropriate audiences of surgeons and societies through email and other modes of communication.
Introduction Breast cancer is the most common cancer in the UK and is by far the most common
1
ACCEPTED MANUSCRIPT cancer among women, where it accounts for 31% of all new cancer cases with a lifetime incidence of 1 in 8 (1). Approximately 50,000 women are diagnosed with breast cancer each year, 16,000 of whom undergo mastectomy and there are approximately 12,000 deaths from the disease (1). In the USA, the National Cancer Institute predicts over 230,000 new cases and approximately 40,000 deaths from
RI PT
breast cancer each year with over 96 000 undergoing breast reconstruction following surgery (2).
The loss of a breast can have significant physical and psychosocial sequalae and in
SC
the UK and many other countries, reconstructive breast surgery (RBS) is routinely offered to improve cosmetic outcomes and health-related quality of life (HRQL) (3). Options for reconstruction can be autologous or implant based and decision making
M AN U
can be complex with a holistic and patient-centred approach necessary. There is growing interest in the use of autologous fat grafting (AFG) for breast reconstruction. It is a highly active research front (see figure 1) and recent national meetings are dedicating significant time to it. Indeed, Rohrich et al have classed it as number three in the list of top innovations in plastic surgery (4).
Our group
TE D
recently published a systematic review and meta-analysis of this topic and demonstrated the utility of this technique as assessed across six outcome domains; oncological, clinical, aesthetic and functional, patient-reported, process and
AC C
EP
radiological (5).
2
160 140 120 100
RI PT
80 60 40
SC
20 0
M AN U
1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014
Number of Articles Published
ACCEPTED MANUSCRIPT
Year
Figure 1. The rising trend in publications about “fat grafting”, as shown by a search
TE D
in the SCOPUS® database.
Whilst conducting the review we noticed significant heterogeneity in the outcomes used by the various study authors. Further analysis of the 35 studies in follow-up work identified that there were a total of 51 different outcomes reported (6). These
EP
studies each reported a median of five separate outcomes (range 2-14), of which a median of three outcomes were defined (range 0-14). A median of two outcomes
AC C
per paper were pre-specified in the study methods (range 0-12) and a median of only two outcomes per paper (range 0-12) were both defined and pre-specified. The most commonly reported outcome in studies of AFG was that of “Operative details”, reported by 26 studies, and 8 different outcome definitions were used. “Cancer recurrence” was reported by 20 studies, with the use of 10 different outcome definitions (6). One method for addressing non-uniform outcome definitions and reporting is the development of core outcome sets (COS). These are a set of agreed outcomes that are reported as a minimum in all trials of a particular condition. The Outcome
3
ACCEPTED MANUSCRIPT Measures in Rheumatoid Arthritis in Clinical Trials (OMERACT) initiative were among the first to recognise this and developed a series of COS for use in rheumatology studies 20 years ago (7,8). The COMET (Core Outcome Measures in Effectiveness Trials) Initiative was established to guide the development of core outcome sets in other areas and to improve methodological techniques for these
RI PT
processes (9). More recently, Potter et al have developed a COS for RBS (10). Core outcomes sets developed in alternative fields of medicine have been shown to reduce reporting bias, create homogeneity in outcome reporting and improve metaanalysis (11,12). It is therefore hypothesised that a core outcome set for AFG would
SC
result in similar improvements in the conduct and reporting of AFG research and help to minimise outcome and reporting bias, standardise end-points, boost transparency, increase reproducibility and external validity, aid evidence synthesis
M AN U
and help guide clinical decision-making going forward (13–15). Our objective is to develop a core outcome set (COS) for AFG to the breast.
Methods
TE D
A Delphi consensus exercise amongst key stakeholders will be conducted using the long list of 51 outcomes generated through our previous work. We will fist group these according to the six domains previously identified; oncological, clinical,
AC C
EP
aesthetic and functional, patient-reported, process and radiological.
Delphi Process
The list will be operationalised to produce the round one Delphi questionnaire which will be administered via SurveyMonkey (www.surveymonkey.com) and conducted using standard Delphi Methodology (16). It is planned that the same questionnaire will be completed by all participants throughout the process. In each round, the participants will rate the importance of reporting each outcome on a nine-point Likert scale as proposed by the GRADE group (16). In the first round, they will have the opportunity to suggest new items/outcomes not already included. In this scale 1 to 3 signifies an outcome of limited importance, 4 to 6 important but not critical and 7 to 9
4
ACCEPTED MANUSCRIPT critical. If 70% or more of respondents score an item 7 to 9 and fewer than 15% score it 1 to 3, then that item should proceed into the COS. Similarly, consensus that an outcome should not be included would be 70% or more scoring it 1 to 3 and 15% or less scoring it 7 to 9. Sequential rounds and questionnaire administration and completion will take place until a final set of outcomes with agreed definitions are
RI PT
achieved. The entire process will be conducted electronically and there is no predetermined number of Delphi rounds, although the expectation is that at least three will be needed.
SC
Participant Selection
Surgeons with significant experience in fat grafting to the breast will be invited to They will be drawn from both the specialties of breast and plastic
surgery.
Ethics and Dissemination
M AN U
participate.
TE D
No ethical approval is necessary since this is a professional COS with no patient input. The research will be published in a peer-reviewed journal. It will also be presented at national and international conferences in the fields of plastic, reconstructive and aesthetic surgery as well as breast surgery and at more general
EP
surgical and methodological conferences. It will be disseminated electronically and in print. Brief reports of the review findings will be disseminated directly to the
AC C
appropriate audiences of surgeons and societies through email and other modes of communication.
References 1.
Breast cancer statistics | Cancer Research UK [Internet]. [cited 2015 Nov 20]. Available from: http://www.cancerresearchuk.org/health-professional/cancerstatistics/statistics-by-cancer-type/breast-cancer
2.
Breast Cancer - National Cancer Institute [Internet]. [cited 2015 Nov 20]. 5
ACCEPTED MANUSCRIPT
Harcourt D, Rumsey N. Psychological aspects of breast reconstruction: a review of the literature. J Adv Nurs. 2001 Aug;35(4):477–87.
4.
Rohrich RJ, Rosen J, Longaker MT. So you want to be an innovator? Plast Reconstr Surg. 2010 Sep;126(3):1107–9.
5.
Agha RA, Fowler AJ, Herlin C, Goodacre TEE, Orgill DP. Use of autologous fat grafting for breast reconstruction: a systematic review with meta-analysis of oncological outcomes. J Plast Reconstr Aesthet Surg. 2015 Feb;68(2):143–61.
6.
Agha RA, Fowler AJ, Pidgeon TE, Wellstead G, Orgill DP. The Need for Core Outcome Reporting in Autologous Fat Grafting for Breast Reconstruction. Ann Plast Surg. 2015 Nov 5;
7.
Boers M, Kirwan JR, Wells G, Beaton D, Gossec L, d’Agostino M-A, et al. Developing Core Outcome Measurement Sets for Clinical Trials: OMERACT Filter 2.0. J Clin Epidemiol. 2014 Jul;67(7):745–53.
8.
Boers M, Brooks P, Strand C V, Tugwell P. The OMERACT filter for Outcome Measures in Rheumatology. J Rheumatol. 1998 Feb;25(2):198–9.
9.
Home :: Core Outcome Measures in Effectiveness Trials Initiative (COMET) [Internet]. [cited 2015 Nov 20]. Available from: http://www.comet-initiative.org/
10.
Potter S, Holcombe C, Ward JA, Blazeby JM. Development of a core outcome set for research and audit studies in reconstructive breast surgery. Br J Surg. 2015 Oct;102(11):1360–71.
11.
EP
TE D
M AN U
SC
RI PT
3.
AC C
Available from: http://www.cancer.gov/types/breast
12.
13.
Duncan PW, Jorgensen HS, Wade DT. Outcome measures in acute stroke trials: a systematic review and some recommendations to improve practice. Stroke. 2000 Jun;31(6):1429–38. Chan A-W, Altman DG. Identifying outcome reporting bias in randomised trials on PubMed: review of publications and survey of authors. BMJ. 2005 Apr 2;330(7494):753. Moher D, Glasziou P, Chalmers I, Nasser M, Bossuyt PMM, Korevaar DA, et al. Increasing value and reducing waste in biomedical research: who’s listening? Lancet. 2015 Sep 25;
6
ACCEPTED MANUSCRIPT Kirkham JJ, Gargon E, Clarke M, Williamson PR. Can a core outcome set improve the quality of systematic reviews?--a survey of the Co-ordinating Editors of Cochrane Review Groups. Trials. 2013 Jan;14:21.
15.
Williamson P, Clarke M. The COMET (Core Outcome Measures in Effectiveness Trials) Initiative: Its Role in Improving Cochrane Reviews. Cochrane database Syst Rev. 2012 Jan;5:ED000041.
16.
Sinha IP, Smyth RL, Williamson PR. Using the Delphi technique to determine which outcomes to measure in clinical trials: recommendations for the future based on a systematic review of existing studies. PLoS Med. 2011 Jan;8(1):e1000393.
AC C
EP
TE D
M AN U
SC
RI PT
14.
7
ACCEPTED MANUSCRIPT Highlights •
One in eight women will develop breast cancer in their lifetime.
•
Reconstruction can be autologous or implant based.
•
An autologous technique is autologous fat grafting, in which our group has
Here we present a protocol for a Delphi consensus exercise amongst key
EP
TE D
M AN U
SC
stakeholders.
AC C
•
RI PT
recently conducted a systematic review of safety and efficacy.