Accepted Article
Received Date : 14-Apr-2014 Revised Date : 19-Jun-2014 Accepted Date : 27-Jun-2014 Article type : Systematic Review 219-2014.R1 Systematic Review
A systematic review of patient preference elicitation methods in the treatment of colorectal cancer.
Andrew Currie MRCS1, Alan Askari MRCS1, Subramanian Nachiappan MRCS1 Nick Sevdalis PhD2,3, Omar Faiz MS, FRCS1,2 and Robin Kennedy MS, FRCS1,2
1. St Mark’s Hospital and Academic Institute, Harrow, Middlesex, UK 2. Department of Surgery and Cancer, Imperial College London, UK 3. Centre for Patient Safety and Service Quality, Imperial College London, UK
Study conception and design: AC & RHK Acquisition of data: AC, AA & SN Analysis and interpretation of data: AC, AA, SN, RHK Writing manuscript: AC, NS, ODF, RHK
Corresponding author: Professor Robin Kennedy, Consultant Colorectal Surgeon St. Mark’s Hospital, Watford Rd, Harrow, Middlesex HA1 3UJ, UK Tel: +44(0)20 8235 4108 Fax: +44(0)20 8235 4039 Email: [email protected]
This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process which may lead to differences between this version and the Version of Record. Please cite this article as an 'Accepted Article', doi: 10.1111/codi.12754 This article is protected by copyright. All rights reserved.
Accepted Article
Running Head: Patient preferences in colorectal cancer treatment Conflicts of Interest: None Sources of Funding: Nick Sevdalis is affiliated with the Imperial Centre for Patient Safety and Service Quality (www.cpssq.org), which is funded by the National Institute for Health Research
Abstract Aim: This systematic review aimed to assess the use of patient preference in colorectal cancer treatment. Background: Eliciting patient preference is important for shared decision-making in colorectal cancer treatment. The introduction of newer treatments, which balance quality of life and overall survival, make this an important future focus. Method: A systematic search strategy of MEDLINE, EMBASE, PsycINFO, CINAHL and the Cochrane Database for Systematic Reviews was undertaken to obtain relevant articles. Information regarding the type of patients included, preference instruments, study settings, outcomes and limitations was extracted. Results: The eight articles comprising this review described an empirical study using a validated instrument to define patient preference for an aspect of colorectal cancer treatment. The evidence suggests that patients are prepared to trade significant reductions in life expectancy to avoid certain complications of colorectal surgery, particularly stoma formation. In the adjuvant setting, patients are prepared to risk significant treatment side effects to gain small potential increases in life expectancy and chance of survival. Where neoadjuvant or adjuvant treatment risks worsening function, however, patients generally forego any potential increase in survival to improve bowel function and therefore quality of life. The only predictors of preference were tertiary education and previous cancer treatment. Conclusion: Most patients judge a moderate survival benefit to be sufficient to make adjuvant therapy for colorectal cancer worthwhile, but they are willing to trade a
This article is protected by copyright. All rights reserved.
Accepted Article
potential reduction in life expectancy and survival to avoid certain unwanted surgical sequelae. What does this this study add to the literature? This review summarises the patient preference literature across the whole colorectal cancer treatment pathway and finds that quality of life drives patients’ surgical treatment decisions. INTRODUCTION Decision-making is fundamental for the successful management of malignancy. In colorectal cancer, matters such as mortality, morbidity, quality of life (QoL), stoma formation and cure rates from surgical and adjuvant interventions are relevant to patients during the consultation with the surgeon [1, 2]. The decisions patients need to take during the colorectal cancer treatment pathway are complex and require appraisal of risk and benefit, the balance depending on the patients’ circumstances. Several studies have demonstrated that surgeons, oncologists and patients frequently place different emphasis on the end points of treatment including the side effects [3, 4], and that patients’ views are often not considered adequately when treatment is discussed at the multidisciplinary cancer meeting [5, 6]. The increasing emphasis on patient autonomy and shared decision-making between patients and their physicians has resulted in a more explicit assessment of patients’ preferences and opinions regarding treatment [7]. Preferences can be elicited by means of various methods, such as standard gamble, a time trade-off method and health economic techniques, such as discrete choice experiments [8]. All these methods present patients with descriptive and probabilistic information about the benefits and side effects associated with two or more treatment options. Determining the patient’s willingness to accept side effects of a treatment or forego benefits of an alternative treatment, can assess the relative strength of preference for that intervention.
This article is protected by copyright. All rights reserved.
Accepted Article
With the advent of less invasive surgical procedures, such as endoscopic resection [9]
and
transanal
endoscopic
microsurgery
(TEMS)[10],
and
neoadjuvant
chemoradiotherapy [11], complex decisions are becoming more prevalent in which improvements in QoL have to be balanced against possible reductions in survival. Therefore eliciting patient preferences accurately and with sensitivity is likely to become increasingly important in the management of colorectal cancer.
The aim of this systematic review was to document and compare the available evidence regarding patient preferences in colorectal cancer treatment. We reviewed patients’ preferences for different treatments options, the trade-offs that patients are willing to make between treatments depending on an anticipated treatment outcome and the different methods of assessing these preferences.
METHOD A systematic review was performed in adherence with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement[12] and the Cochrane Handbook for Systematic Reviews of Interventions[13].
Information sources The following databases were searched for articles: Allied and Complementary Medicine Database (AMED; 1985 to present), British Nursing Index (BNI; 1985 to present), Cumulative Index to Nursing and Allied Health Literature (CINAHL; 1981 to present), Embase (1980 to present), MEDLINE from PubMed (1950 to present) and PsycINFO® (American Psychological Association, Washington, DC, USA; 1806 to present). We also searched the Cochrane Database of Systematic Reviews. Articles were also sought by hand-searching the reference lists of the articles identified, if they met the inclusion criteria. The date last searched was 10th March 2014.
This article is protected by copyright. All rights reserved.
Accepted Article
Search Search terms were devised to cover colorectal cancer and the names and synonyms of existing patient preference elicitation methodologies. They included each of the terms:
“colorectal”,
“cancer”,
“malignancy”,
“surgery”,
“chemotherapy”
and
“radiotherapy” combined with the Boolean operator ‘AND’ with each of the following terms: “patient preference”, “shared decision-making”, “patient involvement”, “patient participation”, “patient satisfaction”, “physician-patient relation”, “standard gamble”, “time trade-off”, “willingness to trade”, “willingness to pay”, “decision board” and “discrete choice experiment” in the title or abstract. Article selection All published studies from peer-reviewed journals that met the inclusion criteria were included. The criteria for article inclusion were publication in a peer-reviewed journal, a description of empirical studies on colorectal cancer treatment that elicited preferences, used preferences or both. No restrictions on study design were imposed. Study participants included colorectal cancer patients of any age who participated in studies that elicited or used preferences in relation to treatment. Studies were excluded if the article was a conference abstract, editorial, letter, opinion, audit or review, or written in a non-English language. Two trained surgeon reviewers (AC, AA) blindly reviewed the articles retrieved by the search strategy and decided on article eligibility independently. Disagreements between reviewers were resolved by consensus.
Data collection and extraction process Raw data were collected and tabulated independently by two reviewers onto a data extraction
sheet (Microsoft®
Excel 2009; Microsoft Corporation, Redmond,
Washington, USA), following the Cochrane Handbook recommendations for systematic reviews[13]. A data extraction form was developed based on the Centre for Reviews and
This article is protected by copyright. All rights reserved.
Accepted Article
Dissemination (CRD) templates [14]. Data collected included information on authors, sample size, sex, mean or median age, study setting, study country, study design, publication date, treatments considered, preferences assessed, preference elicitation methods used, preference outcomes and major findings. The two surgeon reviewers (AC, AA) independently extracted the data from the included studies using the data extraction form. Disagreements in data extraction and interpretation were resolved through discussion with a third author (SN) until consensus was achieved. Synthesis of results A descriptive synthesis of the results was performed with consideration of the risk of bias and quality of the studies. Meta-analysis was not appropriate due to an absence of randomized clinical trials( RCT), and the heterogeneity in design and results.
RESULTS Study selection Search of the databases yielded 1011 citations and after removal of duplicates 679 articles remained. Following review of abstracts, 655 articles were excluded as they did not meet the inclusion criteria. The full text of the remaining 24 articles was examined in more detail. At the final stage of the selection process, eight articles met the inclusion criteria and were included in the review [15-22] (Figure 1). Based on these studies, the preferences of 912 patients, investigated using three preference elicitation techniques (Table 1), form the basis of the study.
Study characteristics The eight included papers were published between 2002 and 2012 (Table 2). Treatment preference instruments that were described included modified standard gamble (SG) questions [15, 21], time trade-off (TTO) techniques [16-18, 20, 21] and discrete choice experiment (DCE) methods [19, 20, 22]. Two papers described studies involving actual decision-making [18, 22]. The other studies were concerned
This article is protected by copyright. All rights reserved.
Accepted Article
with hypothetical treatment preferences. Treatment preference questions addressed colon cancer [15], rectal cancer [16-18, 20, 22] or both colon and rectal malignancy [19, 21]. Four studies evaluated preferences for surgical management [16, 18, 21, 22], five discussed the use of adjuvant chemoradiotherapy [15, 17-19, 21] and three dealt with neoadjuvant treatment [18-20]. The sample sizes ranged between 47[17] and 249[22] patients. Three studies were undertaken in Australasia [15, 18, 21], four in Europe [16, 19, 20, 22] and one in North America [17].
Synthesis of evidence Surgical management preferences The results of patient preferences for surgical decisions are summarized in Table 3. Zolciak et al [22] investigated patients’ dichotomous preferences for either abdominoperineal excision of the rectum (APR) or anterior resection (AR). Preoperatively, the majority (65%) wanted to leave the decision to the surgeon, whereas the others preferred AR (30%) more often than APR (5%). Four years postoperatively, APR patients preferred APR (46%) more often than AR (22%), whereas AR patients preferred AR (69%) more often than APR (4%). However, in this study the option to undertake AR was constructed in negative language (i.e. negative ‘framing’ of the option) compared the APR option. Using time trade-off methodology in a study of immediately postoperative colorectal cancer patients, Harrison et al [18] found that 63% of patients were willing to give up a mean of 34% of their life expectancy in order to choose AR over APR.
Bossema et al [16] found that to avoid APR, low AR patients accepted a much higher risk of incontinence than APR patients. In treatment trade-off questioning, 71% of the low AR patients chose this option even if they would suffer monthly incontinence, and 32% would still chose low AR over APR even if they would suffer daily incontinence. When time trade-off assessments were made with regard to future survival, APR
This article is protected by copyright. All rights reserved.
Accepted Article
patients would trade less remaining life expectancy not to have a permanent stoma than low AR patients would, to have improved continence.
An Australian study [21] elicited the attitudes of patients with distal rectal cancer toward local excision (therefore avoiding colostomy) versus abdominoperineal resection (requiring permanent colostomy) for rectal cancer. In this study, 52% (50/97) of patients were willing to risk increased mortality (mean increase of 20%) and 48% (43/90) were prepared to trade life expectancy (three months on average) to avoid a colostomy, and would thus choose to undergo transanal excision. Adjuvant treatment preferences The results of patient preferences for adjuvant treatment decisions are summarized in Table 4. Patient preferences for use of postoperative chemoradiotherapy (CRT) for rectal cancer treatment were investigated in three studies. Couture et al reported that 31 of 47 65%) patients with colorectal cancer would not accept postoperative CRT (post-CRT) until the 10% baseline risk of local recurrence reduced to less than 5% with treatment (i.e. equivalent to an absolute risk reduction (ARR)
Received Date : 14-Apr-2014 Revised Date : 19-Jun-2014 Accepted Date : 27-Jun-2014 Article type : Systematic Review 219-2014.R1 Systematic Review
A systematic review of patient preference elicitation methods in the treatment of colorectal cancer.
Andrew Currie MRCS1, Alan Askari MRCS1, Subramanian Nachiappan MRCS1 Nick Sevdalis PhD2,3, Omar Faiz MS, FRCS1,2 and Robin Kennedy MS, FRCS1,2
1. St Mark’s Hospital and Academic Institute, Harrow, Middlesex, UK 2. Department of Surgery and Cancer, Imperial College London, UK 3. Centre for Patient Safety and Service Quality, Imperial College London, UK
Study conception and design: AC & RHK Acquisition of data: AC, AA & SN Analysis and interpretation of data: AC, AA, SN, RHK Writing manuscript: AC, NS, ODF, RHK
Corresponding author: Professor Robin Kennedy, Consultant Colorectal Surgeon St. Mark’s Hospital, Watford Rd, Harrow, Middlesex HA1 3UJ, UK Tel: +44(0)20 8235 4108 Fax: +44(0)20 8235 4039 Email: [email protected]
This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process which may lead to differences between this version and the Version of Record. Please cite this article as an 'Accepted Article', doi: 10.1111/codi.12754 This article is protected by copyright. All rights reserved.
Accepted Article
Running Head: Patient preferences in colorectal cancer treatment Conflicts of Interest: None Sources of Funding: Nick Sevdalis is affiliated with the Imperial Centre for Patient Safety and Service Quality (www.cpssq.org), which is funded by the National Institute for Health Research
Abstract Aim: This systematic review aimed to assess the use of patient preference in colorectal cancer treatment. Background: Eliciting patient preference is important for shared decision-making in colorectal cancer treatment. The introduction of newer treatments, which balance quality of life and overall survival, make this an important future focus. Method: A systematic search strategy of MEDLINE, EMBASE, PsycINFO, CINAHL and the Cochrane Database for Systematic Reviews was undertaken to obtain relevant articles. Information regarding the type of patients included, preference instruments, study settings, outcomes and limitations was extracted. Results: The eight articles comprising this review described an empirical study using a validated instrument to define patient preference for an aspect of colorectal cancer treatment. The evidence suggests that patients are prepared to trade significant reductions in life expectancy to avoid certain complications of colorectal surgery, particularly stoma formation. In the adjuvant setting, patients are prepared to risk significant treatment side effects to gain small potential increases in life expectancy and chance of survival. Where neoadjuvant or adjuvant treatment risks worsening function, however, patients generally forego any potential increase in survival to improve bowel function and therefore quality of life. The only predictors of preference were tertiary education and previous cancer treatment. Conclusion: Most patients judge a moderate survival benefit to be sufficient to make adjuvant therapy for colorectal cancer worthwhile, but they are willing to trade a
This article is protected by copyright. All rights reserved.
Accepted Article
potential reduction in life expectancy and survival to avoid certain unwanted surgical sequelae. What does this this study add to the literature? This review summarises the patient preference literature across the whole colorectal cancer treatment pathway and finds that quality of life drives patients’ surgical treatment decisions. INTRODUCTION Decision-making is fundamental for the successful management of malignancy. In colorectal cancer, matters such as mortality, morbidity, quality of life (QoL), stoma formation and cure rates from surgical and adjuvant interventions are relevant to patients during the consultation with the surgeon [1, 2]. The decisions patients need to take during the colorectal cancer treatment pathway are complex and require appraisal of risk and benefit, the balance depending on the patients’ circumstances. Several studies have demonstrated that surgeons, oncologists and patients frequently place different emphasis on the end points of treatment including the side effects [3, 4], and that patients’ views are often not considered adequately when treatment is discussed at the multidisciplinary cancer meeting [5, 6]. The increasing emphasis on patient autonomy and shared decision-making between patients and their physicians has resulted in a more explicit assessment of patients’ preferences and opinions regarding treatment [7]. Preferences can be elicited by means of various methods, such as standard gamble, a time trade-off method and health economic techniques, such as discrete choice experiments [8]. All these methods present patients with descriptive and probabilistic information about the benefits and side effects associated with two or more treatment options. Determining the patient’s willingness to accept side effects of a treatment or forego benefits of an alternative treatment, can assess the relative strength of preference for that intervention.
This article is protected by copyright. All rights reserved.
Accepted Article
With the advent of less invasive surgical procedures, such as endoscopic resection [9]
and
transanal
endoscopic
microsurgery
(TEMS)[10],
and
neoadjuvant
chemoradiotherapy [11], complex decisions are becoming more prevalent in which improvements in QoL have to be balanced against possible reductions in survival. Therefore eliciting patient preferences accurately and with sensitivity is likely to become increasingly important in the management of colorectal cancer.
The aim of this systematic review was to document and compare the available evidence regarding patient preferences in colorectal cancer treatment. We reviewed patients’ preferences for different treatments options, the trade-offs that patients are willing to make between treatments depending on an anticipated treatment outcome and the different methods of assessing these preferences.
METHOD A systematic review was performed in adherence with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement[12] and the Cochrane Handbook for Systematic Reviews of Interventions[13].
Information sources The following databases were searched for articles: Allied and Complementary Medicine Database (AMED; 1985 to present), British Nursing Index (BNI; 1985 to present), Cumulative Index to Nursing and Allied Health Literature (CINAHL; 1981 to present), Embase (1980 to present), MEDLINE from PubMed (1950 to present) and PsycINFO® (American Psychological Association, Washington, DC, USA; 1806 to present). We also searched the Cochrane Database of Systematic Reviews. Articles were also sought by hand-searching the reference lists of the articles identified, if they met the inclusion criteria. The date last searched was 10th March 2014.
This article is protected by copyright. All rights reserved.
Accepted Article
Search Search terms were devised to cover colorectal cancer and the names and synonyms of existing patient preference elicitation methodologies. They included each of the terms:
“colorectal”,
“cancer”,
“malignancy”,
“surgery”,
“chemotherapy”
and
“radiotherapy” combined with the Boolean operator ‘AND’ with each of the following terms: “patient preference”, “shared decision-making”, “patient involvement”, “patient participation”, “patient satisfaction”, “physician-patient relation”, “standard gamble”, “time trade-off”, “willingness to trade”, “willingness to pay”, “decision board” and “discrete choice experiment” in the title or abstract. Article selection All published studies from peer-reviewed journals that met the inclusion criteria were included. The criteria for article inclusion were publication in a peer-reviewed journal, a description of empirical studies on colorectal cancer treatment that elicited preferences, used preferences or both. No restrictions on study design were imposed. Study participants included colorectal cancer patients of any age who participated in studies that elicited or used preferences in relation to treatment. Studies were excluded if the article was a conference abstract, editorial, letter, opinion, audit or review, or written in a non-English language. Two trained surgeon reviewers (AC, AA) blindly reviewed the articles retrieved by the search strategy and decided on article eligibility independently. Disagreements between reviewers were resolved by consensus.
Data collection and extraction process Raw data were collected and tabulated independently by two reviewers onto a data extraction
sheet (Microsoft®
Excel 2009; Microsoft Corporation, Redmond,
Washington, USA), following the Cochrane Handbook recommendations for systematic reviews[13]. A data extraction form was developed based on the Centre for Reviews and
This article is protected by copyright. All rights reserved.
Accepted Article
Dissemination (CRD) templates [14]. Data collected included information on authors, sample size, sex, mean or median age, study setting, study country, study design, publication date, treatments considered, preferences assessed, preference elicitation methods used, preference outcomes and major findings. The two surgeon reviewers (AC, AA) independently extracted the data from the included studies using the data extraction form. Disagreements in data extraction and interpretation were resolved through discussion with a third author (SN) until consensus was achieved. Synthesis of results A descriptive synthesis of the results was performed with consideration of the risk of bias and quality of the studies. Meta-analysis was not appropriate due to an absence of randomized clinical trials( RCT), and the heterogeneity in design and results.
RESULTS Study selection Search of the databases yielded 1011 citations and after removal of duplicates 679 articles remained. Following review of abstracts, 655 articles were excluded as they did not meet the inclusion criteria. The full text of the remaining 24 articles was examined in more detail. At the final stage of the selection process, eight articles met the inclusion criteria and were included in the review [15-22] (Figure 1). Based on these studies, the preferences of 912 patients, investigated using three preference elicitation techniques (Table 1), form the basis of the study.
Study characteristics The eight included papers were published between 2002 and 2012 (Table 2). Treatment preference instruments that were described included modified standard gamble (SG) questions [15, 21], time trade-off (TTO) techniques [16-18, 20, 21] and discrete choice experiment (DCE) methods [19, 20, 22]. Two papers described studies involving actual decision-making [18, 22]. The other studies were concerned
This article is protected by copyright. All rights reserved.
Accepted Article
with hypothetical treatment preferences. Treatment preference questions addressed colon cancer [15], rectal cancer [16-18, 20, 22] or both colon and rectal malignancy [19, 21]. Four studies evaluated preferences for surgical management [16, 18, 21, 22], five discussed the use of adjuvant chemoradiotherapy [15, 17-19, 21] and three dealt with neoadjuvant treatment [18-20]. The sample sizes ranged between 47[17] and 249[22] patients. Three studies were undertaken in Australasia [15, 18, 21], four in Europe [16, 19, 20, 22] and one in North America [17].
Synthesis of evidence Surgical management preferences The results of patient preferences for surgical decisions are summarized in Table 3. Zolciak et al [22] investigated patients’ dichotomous preferences for either abdominoperineal excision of the rectum (APR) or anterior resection (AR). Preoperatively, the majority (65%) wanted to leave the decision to the surgeon, whereas the others preferred AR (30%) more often than APR (5%). Four years postoperatively, APR patients preferred APR (46%) more often than AR (22%), whereas AR patients preferred AR (69%) more often than APR (4%). However, in this study the option to undertake AR was constructed in negative language (i.e. negative ‘framing’ of the option) compared the APR option. Using time trade-off methodology in a study of immediately postoperative colorectal cancer patients, Harrison et al [18] found that 63% of patients were willing to give up a mean of 34% of their life expectancy in order to choose AR over APR.
Bossema et al [16] found that to avoid APR, low AR patients accepted a much higher risk of incontinence than APR patients. In treatment trade-off questioning, 71% of the low AR patients chose this option even if they would suffer monthly incontinence, and 32% would still chose low AR over APR even if they would suffer daily incontinence. When time trade-off assessments were made with regard to future survival, APR
This article is protected by copyright. All rights reserved.
Accepted Article
patients would trade less remaining life expectancy not to have a permanent stoma than low AR patients would, to have improved continence.
An Australian study [21] elicited the attitudes of patients with distal rectal cancer toward local excision (therefore avoiding colostomy) versus abdominoperineal resection (requiring permanent colostomy) for rectal cancer. In this study, 52% (50/97) of patients were willing to risk increased mortality (mean increase of 20%) and 48% (43/90) were prepared to trade life expectancy (three months on average) to avoid a colostomy, and would thus choose to undergo transanal excision. Adjuvant treatment preferences The results of patient preferences for adjuvant treatment decisions are summarized in Table 4. Patient preferences for use of postoperative chemoradiotherapy (CRT) for rectal cancer treatment were investigated in three studies. Couture et al reported that 31 of 47 65%) patients with colorectal cancer would not accept postoperative CRT (post-CRT) until the 10% baseline risk of local recurrence reduced to less than 5% with treatment (i.e. equivalent to an absolute risk reduction (ARR)
