© The Author 2006. Published by Oxford University Press.
ARTICLE |
Development of Quality Indicators for Patients Undergoing Colorectal Cancer Surgery
Affiliations of authors: Center for Surgical Outcomes and Quality, Department of Surgery, David Geffen School of Medicine, University of California, Los Angeles, CA (MLM, CYK); Departments of Medicine (PGS) and Surgery (CYK), VA Greater Los Angeles Healthcare System, Los Angeles, CA
Correspondence to: Marcia L. McGory, MD, Department of Surgery, David Geffen School of Medicine, University of California, Los Angeles, 10833 Le Conte Ave., 72-215 Center for Health Sciences, Box 956904, Los Angeles, CA 90095-6904 (e-mail: mmcgory{at}mednet.ucla.edu).
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ABSTRACT |
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Background: Colorectal cancer is the second most common cancer type among new cancer diagnoses in the United States. Attention to the quality of surgical care for colorectal cancer is of particular importance given the increasing numbers of colorectal cancer resections performed in the aging population. A National Cancer Institute–sponsored consensus panel produced guidelines for colorectal cancer surgery in 2000. We have updated and extended that work by using a formal process to identify and rate quality indicators as valid for care during the preoperative, intraoperative, and postoperative periods. Methods: Using a modification of the RAND/UCLA Appropriateness Methodology, we carried out structured interviews with leaders in the field of colorectal cancer surgery and systematic reviews of the literature to identify candidate quality indicators addressing perioperative care for patients undergoing surgery for colorectal cancer. A panel of 14 colorectal surgeons, general surgeons, and surgical oncologists then evaluated and formally rated the indicators using the modified Delphi method to identify valid indicators. Results: A total of 142 candidate indicators were identified in six broad domains: privileging (which addresses surgical credentials), preoperative evaluation, patient–provider discussions, medication use, intraoperative care, and postoperative management. The expert panel rated 92 indicators as valid. These indicators address all domains of perioperative care for patients undergoing surgery for colorectal cancer. Conclusions: The RAND/UCLA Appropriateness Methodology can be used to identify and rate indicators of high-quality perioperative care for patients undergoing surgery for colorectal cancer. The indicators can be used as quality performance measures and for quality-improvement programs.
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INTRODUCTION |
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Measures of the quality of care for diseases other than cancer are being developed and employed by numerous groups and agencies, including the Centers for Medicare and Medicaid Services (CMS) (1), the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) (2), and the National Quality Forum (NQF) (3). Quality measures are also being used as tools in pay-for-performance demonstration projects, such as the CMS's Hospital Quality Initiative, which requires all eligible hospitals to submit data on adherence to an initial set of 10 quality indicators for the conditions of acute myocardial infarction (five indicators), heart failure (two indicators), and pneumonia (three indicators) (4). Measures and indicators of the quality of care will be needed for evaluating and improving the quality of cancer care as well.
Colorectal cancer is the second most common cancer type among both estimated new cancer cases and cancer deaths in 2005 in the United States (5). The importance of quality care for cancer patients, including those with colorectal cancer, was highlighted by the Institute of Medicine (IOM) report on Ensuring Quality Cancer Care (6), which recommended that the quality of cancer care be monitored and measured using a core set of quality measures. However, the IOM report also noted that specific quality measures for cancer care require further development and testing.
Although regulatory agencies have not yet adopted quality measures for colorectal cancer surgery, quality measures for colorectal cancer care have been recently identified by the NQF (3) and the American Society of Clinical Oncologists/National Comprehensive Cancer Network (NCCN) (7). Although these groups used different methodologies, they developed similar groups of three to four measures each. The identification of these measures raises a number of issues. Can these measures be used for detailed programmatic quality improvement? Is this number of quality measures sufficient or representative for the topic of colorectal cancer surgery? If not, there are potential sources for additional quality indicators including clinical practice guidelines for colorectal cancer surgery, developed by the NCCN (8), the Standards Practice Task Force of the American Society of Colon & Rectal Surgeons (ASCRS) (9,10), and a prior National Cancer Institute (NCI)–sponsored consensus panel (11). This panel developed guidelines for colon and rectal surgery and addressed important issues such as anatomic definitions (e.g., colon versus rectum), staging, surgical techniques, and surgical documentation (11). Since these NCI-sponsored guidelines were developed, however, advances in colorectal cancer treatment (e.g., laparoscopic colectomy) have occurred. In addition, it is important to note that the intended conceptual and clinical purposes of guidelines differ from those of quality measures. Whereas clinical practice guidelines are useful for internal improvement and are open to clinical judgment, quality measures represent the most basic level of quality and thus are useful for both internal improvement and external reporting; they also provide specific indicators of the quality of care (12).
Here we report the results of our effort to both update and expand on the NCI-sponsored work through the use of a formal, non–consensus-based rating methodology that combined expert opinion with a formal systematic review of the best evidence in the literature of what constitutes high-quality care for colorectal cancer surgery. We also expanded the scope beyond operative measures to measures that encompass the entire perioperative time period. Our goal was to develop a set of process-based quality indicators for colorectal cancer surgery that are applicable to the health care system, to the hospital, or to the teams of providers caring for patients undergoing colorectal cancer surgery. This is the first time, to our knowledge, that formal, independently rated (i.e., non-consensus) quality indicators have been developed that identify ways to improve care across the preoperative, intraoperative, and postoperative time periods for patients undergoing colorectal cancer surgery.
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METHODS |
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Identification of Candidate Quality Indicators
A process-based quality indicator is a process that, if performed, results in or signifies higher quality. Conceptually, quality indicators represent the basic level of care, and they set a standard that, if not met, identifies poor quality of care (13). We initially identified candidate quality indicators for colorectal cancer surgery through literature reviews and semistructured interviews with nationally recognized leaders in the fields of colorectal surgery, general surgery, and surgical oncology. During the semistructured interviews, candidate process indicators were identified that were viewed as indicating high-quality care for patients undergoing colorectal cancer surgery.
Systematic Literature Review
For each of the identified candidate indicators, we performed a systematic literature review to identify the highest level of evidence supporting the validity of that quality indicator. As part of this review, we accessed the Web sites of relevant professional societies (e.g., ASCRS), cancer networks (e.g., NCCN), and organizations and associations that monitor quality of medical care (e.g., NQF) to identify currently available clinical practice guidelines and quality measures relating to each of the indicators. In addition, we searched the Medline database for articles published from January 1966 through November 2004 using combinations of search terms relevant to each quality indicator. For example, to identify articles relevant to the quality indicator that addresses pretreatment carcinoembryonic antigen level, we used the search algorithm "colorectal cancer" AND "carcinoembryonic antigen" AND "preoperative." The reference lists of the included articles were also examined to identify any additional articles that had not been identified in the Medline search.
For candidate indicators that concern effectiveness of treatment (e.g., laparoscopic colorectal cancer resection), the highest level of evidence is the randomized controlled trial, whereas for candidate indicators concerning risk or prognosis (e.g., performance of preoperative carcinoembryonic antigen level), the highest level of evidence is generally considered to be the prospective cohort study. If evidence at the highest level were limited or absent, then lower levels of evidence were evaluated. For example, if data were not available from randomized controlled trials, then data from controlled clinical trials, cohort or case–control studies, case series, and expert opinion or clinical guidelines were reviewed. A list of definitions for all terms used in the candidate indicators (Table 1) was also developed to standardize terminology.
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RAND/UCLA Appropriateness Methodology—First- and Second-Round Ratings
We assessed the validity of the candidate indicators using a modification of the RAND/UCLA Appropriateness Methodology, which is a modified Delphi method (14). In brief, the method entails two rounds of independent ratings by a group of panelists, with a face-to-face group discussion between rounds. Each panelist has equal weight in determining the final ratings. The RAND/UCLA Appropriateness Methodology includes an explicit synthesis of findings from the literature and iterative panel ratings and has been shown to produce appropriateness criteria and quality indicators that have face, construct, and predictive validity (15–20). The list of candidate indicators, a summary of the supporting literature from the systematic review, and definitions of terms were sent to all 14 members of a panel that included seven colorectal surgeons, five surgical oncologists, and two general surgeons. The 14 panelists individually rated the validity of each candidate indicator on a 1–9 validity scale, defined as follows: 1 = definitely not valid, 5 = of uncertain or equivocal validity, and 9 = definitely valid. In general, when using the RAND/UCLA Appropriateness Methodology, ratings of 1–3 signify that the indicator is not a valid criterion of good quality, ratings of 4–6 signify uncertain or equivocal validity, and ratings of 7–9 signify that the indicator is clearly valid (14,21). Panelists were instructed to consider the following definition of validity when rating the candidate indicators. An indicator would be defined as valid if the following two conditions were met: adequate scientific evidence or professional consensus exists to support a link between the performance of care specified by the indicator and the accrual of health benefits to the patient and a physician or facility with higher rates of adherence to the indicator would be considered a higher quality provider (and those with lower rates of adherence would be considered poorer quality providers) (21).
The rating sheets were returned by mail and tabulated, and the results of the first-round ratings were used to guide a subsequent face-to-face meeting of all panelists. At the face-to-face meeting, each panelist was provided with a confidential reminder of his or her own first-round ratings as well as the median and range of scores from the other panelists (each individual panelist's ratings were kept confidential). Each candidate indicator was discussed to identify areas of disagreement, highlight evidence not cited in the systematic review, and clarify specific definitions or wording of the indicators. In addition, panelists could revise existing indicators to better fit their clinical judgment as well as propose new indicators. During the meeting, each panelist then rerated all the indicators on the 1–9 validity scale.
The validity scores from the second round of ratings were used to generate a median score and standard error for each indicator. For each indicator, the extent of agreement in scores among the panelists (i.e., agreement, disagreement, and indeterminate) was determined based on the spread of ratings between panelists in a manner equivalent to that used in other expert panels utilizing the RAND/UCLA Appropriateness Methodology (14,22,23). Specifically, we examined how many ratings for an indicator were within the same three-point region (i.e., 1–3, 4–6, or 7–9) as the observed median. If no more than two ratings were outside the three-point range that included the median, then scores were said to be in agreement. If three or more ratings for an indicator were in the 1–3 region and three or more ratings were in the 7–9 region, the scores for that indicator were said to be in disagreement. All other score distributions were defined as indeterminate. An indicator was described as "valid" if it had a median score of at least 7.0 without disagreement in the second-round ratings. An indicator was described as showing movement toward agreement between the first- and second-round ratings if it changed from indeterminate to agreement or from disagreement to indeterminate or agreement.
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RESULTS |
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Candidate Quality Indicators
A total of 142 candidate indicators for colorectal cancer surgery were identified through literature reviews and interviews with leading specialists in colorectal surgery, general surgery, and surgical oncology. These candidate indicators fell into six domains that spanned the entire perioperative period: privileging (i.e., surgical credentialing) for laparoscopic colorectal cancer surgery (six candidate indicators); preoperative evaluation, including evaluating comorbidities and staging (38 candidate indicators); patient–provider discussions, including treatment options and advance directives (nine candidate indicators); medication use, including antibiotics, beta blockade, and deep venous thrombosis prophylaxis (16 candidate indicators); intraoperative care, including criteria for intraoperative staging and oncologic resection (50 candidate indicators); and postoperative management, including infection prevention and referral for adjuvant therapy (23 candidate indicators). Each domain relates to one of the periods of care for patients undergoing colorectal cancer surgery—the preoperative, intraoperative, or postoperative period (Fig. 1). (The entire list of candidate indicators with supporting references from the systematic literature review are provided in the Supplementary Data, available at: http://jncicancerspectrum.oxfordjournals.org/jnci/content/vol98/issue22).
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Definitions
During the systematic literature review and identification of candidate indicators, an explicit list of definitions of terms related to colorectal cancer surgery was generated (Table 1). The definitions of terms used in the candidate indicators were discussed and revised at the face-to-face panel meeting. The purpose of these definitions was to provide the expert panelists with a common ground to understand the terms used in each of the candidate indicators. For example, the term "colorectal cancer surgery" is used in each of the candidate indicators and determines the scope of colorectal cancer operations to which the quality indicators are applicable. For the purposes of this project, colorectal cancer surgery was defined as an elective operation that includes major resections of colon or rectal cancers (open or laparoscopic), including hemicolectomy, low anterior resection/sphincter-preserving cancer operations, abdominal perineal resection, and procedures where an ostomy is used in conjunction with resection. The definition excludes intestinal bypass, use of diverting ostomy only, and emergent operations.
Quality Indicators Rated as Valid
Through the formal rating process (summarized in Fig. 2), a total of 92 (65%) of the 142 candidate indicators were rated as valid. This proportion is similar to what has been seen in other studies (21). The quality indicators that were rated as valid in each of the six domains are shown in Table 2. The number of quality indicators rated as valid for each of the six domains of care were as follows: privileging (three of six candidate indicators rated as valid), preoperative evaluation (29 of 38), patient–provider discussions (five of nine), medication use (nine of 16), intraoperative care (28 of 50), and postoperative management (18 of 23). Of the 92 indicators rated as valid, 61 (66%) were applicable to all patients undergoing colorectal cancer surgery. Of the rest, 19 (21%) were restricted to rectal cancer, three (3%) to colon cancer, and nine (10%) to laparoscopic surgery.
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7.0 and without disagreement among panelists during the first and second rounds of ratings*Emphasis Within Domains
Although the 92 indicators rated as valid were initially divided in only six domains of care, additional areas of emphasis within most domains emerged as a result of the expert panel rating process. The privileging domain includes only three indicators, all of which relate to credentialing for surgeons performing laparoscopic colon and rectal cancer surgery. The indicators in the preoperative evaluation domain could be further divided into those that address preoperative history, physical examination, and evaluation of preoperative comorbidities (11 indicators) and those that address preoperative diagnosis and staging (18 indicators). The indicators in the patient–provider discussions domain address issues that are unique to colorectal cancer surgery, such as genetic counseling for hereditary colorectal cancer (two indicators), and a specific type of rectal cancer treatment (transanal endoscopic microsurgery), as well as issues that are applicable to most surgical procedures, including informed consent and preoperative smoking cessation. The intraoperative care domain could be further divided into indicators addressing patient safety (three indicators), intraoperative staging (six indicators), prevention of complications such as ureteral injury or anastomotic leak (five indicators), criteria necessary for an oncologic resection (10 indicators), and issues unique to laparoscopic colorectal cancer surgery (four indicators). Finally, the postoperative management domain indicators were found to address both areas unique to colorectal cancer surgery (seven indicators) as well as standard postoperative care items (11 indicators).
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DISCUSSION |
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The goal of the current work was to develop process-based quality indicators for colorectal cancer surgery. Such indicators are needed because colorectal cancer is a common malignancy, the risk of which increases with age. Given the aging of the US population, surgeons will need to develop methods to ensure delivery of high-quality surgical care for patients with colorectal cancer. In addition, the foreseeable future in quality evaluation and improvement for health care will likely involve the use of quality indicators of processes of care by regulatory and accrediting agencies such as CMS, JCAHO, and others.
The current project represents a unique contribution to the literature for several reasons. One way in which it is unique is that we have developed quality indicators rather than practice guidelines. To date, several practice guidelines for colorectal cancer surgery have been developed, including the NCCN practice guidelines in oncology (8), the ASCRS practice parameters (9,10), and the Guidelines 2000 for colon and rectal cancer surgery (11). However, the quality indicators developed in this project differ in several ways from the existing practice guidelines for colorectal cancer surgery. First, quality indicators are measurable and define the most basic level of care that, if not performed, would indicate poor quality care. In addition, the majority of the quality indicators identified in the current project (except the three quality indicators in the privileging domain) are process measures, which reflect interpersonal, diagnostic, and therapeutic aspects of the encounter between patient and provider. Process measures are generally more specific and representative of the delivered quality of care than structural (e.g., hospital volume) or outcome (e.g., mortality) measures. In contrast, practice guidelines are generally not measurable and present a framework for optimal care in the context of complex medical decision making (13). Second, we used a formal iterative rating process, the RAND/UCLA Appropriateness Methodology, to develop the quality indicators; by contrast, the authors of the practice guidelines used consensus methodology to identify guidelines for care. Consensus panels have been criticized for the lack of a formal and transparent methodology (24), which has the potential to bias the results toward the opinions of the most senior or most vocal member of the panel. The RAND/UCLA Appropriateness Methodology has been widely used within quality-of-care research to identify valid quality measures for other types of cancer [e.g., prostate (23)], to identify appropriateness criteria for procedures including colonoscopy and rectal cancer treatment (25,26), and to evaluate the quality of health care delivered to adults in the United States (27). This formal methodology combines the opinion of experts with the available literature using a modified Delphi method, in which two separate independent ratings are performed in combination with a face-to-face expert panel meeting for discussion of each proposed quality indicator. In this context, it is interesting to note that a recent study of quality indicators developed using a process identical to the current work demonstrated a statistically significant process-to-outcome relationship for care of vulnerable elders, defined as persons 65 years old or older who are at increased risk for death or functional decline (i.e., better performance on quality measures was associated with better survival) (13,28).
A second unique aspect of the current work is that we addressed detailed issues in the entire perioperative period to encompass a longer duration of surgical care for a patient with colorectal cancer. Ninety-two of the candidate quality indicators were rated as valid by the expert panel. These quality indicators cover the preoperative, intraoperative, and postoperative time periods and include indicators that address the issues of surgeon credentialing for laparoscopic colorectal cancer surgery, preoperative assessment of comorbidities, preoperative staging, patient–provider discussions, medication use, and postoperative management. Like the Nelson 2000 Guidelines, which addressed intraoperative techniques (11), many of the quality indicators we identified are intraoperative quality indicators. However, additional topics such as prevention of ureteral damage as well as indicators unique to laparoscopic colorectal cancer surgery, for example, are also included in the current project.
A third unique aspect of the current work is that we emphasized noncancer quality indicators in both the preoperative and postoperative time periods. Given the aging of the population, increased attention to issues of comorbid disease, for example, are essential to ensure quality of care for all aspects of care of a patient with colorectal cancer. Although this is not a comprehensive list of measures addressing the elderly, it does encompass many of the important issues. A previous study identified a more complete list of measures addressing abdominal surgery in the elderly (29).
A fourth unique aspect of the current work is that the quality indicators may be useful to regulatory and accrediting agencies as well as to individual hospitals and providers. First, the quality indicators may be translated into quality measures for pay-for-performance initiatives by CMS, for example. Given that CMS pay-for-performance initiatives generally use only three to seven quality measures per disease topic, a similar number of colorectal cancer measures may be selected by CMS from the 92 indicators rated as valid in the current project. Second, cancer registry databases such as the National Cancer Data Base (NCDB), which is housed by the American College of Surgeons, may potentially serve as a mechanism for collection as well as feedback of data regarding the quality of surgical care for patients with colorectal cancer. Specifically, the NCDB could provide information to each individual hospital or provider regarding its adherence to any number of quality measures (e.g., the percentage of colon cancer patients whose specimen contains at least 12 lymph nodes) to identify areas for improvement in colorectal cancer care at the level of the individual hospital. Third, because it may be difficult to comprehensively improve quality of health care with the small number of quality measures used in the current CMS pay-for-performance initiatives (1), the larger list of quality indicators that we identified, along with the literature reviews performed for each candidate indicator, may also be used for teaching, comprehensive programmatic development, and standardization of care at all hospitals performing resections for colorectal cancer. Indeed, because the issue of regionalization based on hospital or surgeon volume remains controversial, an alternative approach may use the colorectal cancer surgery quality indicators identified in the current project to improve care regardless of the volume of colorectal cancer procedures performed.
In the process of developing the list of quality indicators for colorectal cancer surgery, a number of related issues and controversies arose. One controversial issue surrounds the candidate indicators in the privileging domain. The Clinical Outcomes of Surgical Therapy (COST) Study Group (30) carried out a trial comparing laparoscopically assisted with open colectomy for colon cancer and found similar rates of perioperative complications and recurrent colon cancer in the two groups. The results of this randomized controlled trial suggest that laparoscopically assisted colectomy is an acceptable alternative to open colectomy for colon cancer. Given that the COST Study Group used 20 prior laparoscopic cases as credentialing criteria for surgeons to be included in the study, the expert panelists relied heavily on this criterion when rating the privileging candidate indicators.
Another controversial issue relates to the legal implications of the quality indicators. Could quality indicators addressing the adequacy of oncologic resection (e.g., length of bowel margin during a colon resection) be grounds for legal action if a patient develops a cancer recurrence?
Another issue is whether the quality indicators rated as valid will be generalizable to different practice locations, especially those in rural areas. For example, one valid indicator for preoperative staging of rectal cancer requires radiologic imaging with transrectal ultrasound, endoscopic ultrasound, or magnetic resonance imaging—modalities that may not be readily available in some areas of the country or within smaller surgical practices. However, the rating of this indicator as "valid" was an explicit assessment of the trade-off between the importance of this process item in producing good outcomes versus the inconvenience of requiring patients to be referred to a hospital or medical center some distance away from where the patient lived. For some other proposed indicators, this trade-off was not judged to be sufficiently strong to justify rating the indicator as valid.
Finally, the relationship between documentation and measurement of quality raises questions about the amount of potential documentation that would be required to demonstrate adherence to these processes of care. The increased time required to document these items (e.g., in the progress notes or operative note) could take time away from direct patient care. However, it should be noted that the Veterans Affairs model of the National Surgical Quality Improvement Program (31) provides an example of a quality assessment program requiring documentation (including collection of preoperative, intraoperative, and 30-day outcome variables by a dedicated nurse) that has substantially reduced morbidity rates, which may justify the costs of both documentation and data collection (32). The movement toward widespread use of electronic medical records may minimize some of the documentation burden by improving access to a patient's medical records and increasing use of standardized templates for both orders and progress notes.
There are several limitations to this study. The first is the level of evidence found in the literature. For most indicators, strong evidence of their validity was not available from randomized controlled trials. However, this situation is common to many aspects of health care, and it was the very reason that the expert panel methodology was developed—specifically, to identify the processes that are most likely to be valid measures of quality when the highest level of evidence is not available. As the literature and investigations evaluate more processes of care in colorectal cancer surgery, additional process measures will be added and/or the current process measures will be redefined and revised. This methodology is an iterative process, in which the current work is merely the first version of the identification of these process indicators for patients undergoing colorectal cancer surgery. A second limitation is the focus of the quality indicators on perioperative care for patients undergoing colorectal cancer surgery. None of the quality indicators addresses screening for colorectal cancer, and issues of receipt of adjuvant therapy and postoperative surveillance are addressed on only the most basic level. Further work is needed to develop more specific quality measures that will ensure that the appropriate patients receive adjuvant chemotherapy or radiation therapy and that all colorectal cancer patients resected for cure receive timely and adequate surveillance to detect recurrence.
In summary, we have used a validated technique to develop process-based quality indicators for patients undergoing colorectal cancer surgery. These indicators identify potentially meaningful and important steps for providing high-quality cancer care among health care systems, hospitals, and providers offering surgical care to patients with colorectal cancer.
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NOTES |
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Members of the Expert Panel: Tom Anthony, MD—University of Texas Southwestern, Surgical Oncology; Stanley Ashley, MD—Brigham and Women's Hospital, General Surgery; Karen Deveney, MD—Oregon Health Sciences University, General Surgery; Julio Garcia Aguilar, MD—University of California, San Francisco, Colorectal Surgery; Neil Hyman, MD—University of Vermont, Colorectal Surgery; Elliot Prager, MD—John F. Kennedy School of Government, Harvard University, Colorectal Surgery; Miguel Rodriguez-Bigas, MD—M. D. Anderson Cancer Center, Surgical Oncology; David Shibata, MD—H. Lee Moffitt Cancer Center, Surgical Oncology; Michael Stamos—University of California, Irvine, Colorectal Surgery; Petar Vukasin, MD—University of Southern California, Colorectal Surgery; Martin Weiser, MD—Memorial Sloan Kettering, Surgical Oncology; Lynn Weston, MD—Kaiser Permanente, San Diego, Colorectal Surgery; Bruce Wolff, MD—Mayo Clinic, Colorectal Surgery; Tom Wood, MD—Kaiser Permanente, Woodland Hills, Surgical Oncology.
Funded in part by the UniHealth Foundation, Hartford Foundation and American Geriatrics Society, and the Robert Wood Johnson Clinical Scholars Program at UCLA. The study sponsors had no role in the design of the study; the collection, analysis, and interpretation of the data; the writing of the manuscript; or the decision to submit the manuscript for publication.
We acknowledge Michelle Agustin, MPH, and Lisa Lewis for project management and technical assistance.
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Manuscript received February 28, 2006; revised September 1, 2006; accepted September 22, 2006.
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