Abstract
BACKGROUND:
Accurate and comprehensive surgical pathology reports are integral to the quality of cancer care. Despite guidelines from the College of American Pathologists, variations in reporting quality continue to exist.
OBJECTIVE:
The aim of this study was to evaluate the quality of rectal cancer pathology reports and to identify areas of deficiency and potential sources of reporting variations.
DESIGN:
This is a retrospective analysis of prospectively obtained pathology reports.
SETTING:
This study is based at the hospitals participating in the National Surgical Adjuvant Breast and Bowel Project Protocol R-04 study.
PATIENTS:
Patients with rectal cancer undergoing surgical resection between July 2004 and August 2010 were included.
MAIN OUTCOME MEASURES:
The primary outcomes measured were the adherence to the College of American Pathologists guidelines and the impact of synoptic reporting, academic status, rural/urban setting, and hospital bed size on reporting quality.
RESULTS:
We identified 1004 surgical pathology reports for rectal cancer surgery from 383 hospitals and 755 pathologists. The overall adherence rate to the College of American Pathologists guidelines was 73.3%. Notable reporting deficiencies were found in several key pathology characteristics, including tumor histologic grade (reporting rate 77.8%), radial margin (84.6%), distance from the closest margin (47.9%), treatment effect (47.1%), and lymphovascular (73.1%)/perineural invasions (35.4%). Synoptic reporting use and urban hospital settings were associated with better adherence rates, whereas academic status and hospital bed size had no impact. Reporting variations existed not only between institutions, but also within individual hospitals and pathologists. There was a trend for improved adherence over time (2005 = 65.7% vs 2010 = 82.3%, p < 0.001), which coincided with the increased adoption of synoptic reporting by pathologists (2005 vs 2010, 9.4% vs 25.3%, p < 0.001).
LIMITATIONS:
Data were obtained from a restricted setting (ie, hospitals participating in a randomized clinical trial).
CONCLUSIONS:
Wide variations in the quality of pathology reporting are observed for rectal cancer. The National Accreditation Program for Rectal Cancer mandates that programs meet strict quality standards for surgical pathology reporting. Further improvement is needed in this key aspect of oncology care for patients with rectal cancer. See Video Abstract at http://links.lww.com/DCR/B238.
ClinicalTrials.gov registration:
Keywords: Pathology report, Rectal cancer, Quality improvement
ANTECEDENTES:
Un informe de patología quirúrgica preciso y completo es fundamental en la calidad de atención de pacientes con cáncer. A pesar de las normas establecidas por el Colegio Americano de Patología, la variabilidad en la calidad de los informes es evidente.
OBJETIVO:
Evaluar la calidad de los informes de patología en casos de cáncer de recto para así identificar las áreas con deficiencias y las posibles fuentes variables en los mencionados informes.
DISEÑO:
Análisis retrospectivo de informes de patología quirúrgica obtenidos prospectivamente.
AJUSTE:
Hospitales que participan del Protocolo del Estudio Nacional R-04 como Adyuvantes Quirúrgicos de Mama e Intestino.
PACIENTES:
Todos aquellos pacientes con cáncer de recto sometidos a resección quirúrgica entre Julio 2004 y Agosto 2010.
PRINCIPALES MEDIDAS DE RESULTADO:
Cumplimiento de las normas del Colegio Americano de Patología, del impacto de los informes sinópticos, del estado académico, del entorno rural / urbano y el número de camas hospitalarias en en la calidad de los informes.
RESULTADOS:
Identificamos 1,004 informes de patología quirúrgica en casos de cirugía en cáncer de recto en 383 hospitales y 755 patólogos. La tasa general de adherencia a las directivas del Colegio Americano de Patología fue del 73.3%. Se encontraron deficiencias notables en los informes en varias características patológicas clave incluidos, el grado histológico del tumor (tasa de informe 77.8%), margenes radiales (84.6%), distancia del margen más cercano (47.9%), efecto del tratamiento (47.1%) invasión linfovascular (73.1 %) / invasion perineural (35.4%). El uso de informes sinópticos y los entornos hospitalarios urbanos se asociaron con mejores tasas de adherencia, mientras que el estado académico y el número de camas hospitalarias no tuvieron ningún impacto. Hubo variaciones en los informes no solo entre instituciones, sino también dentro de hospitales y patólogos individuales. Hubo una tendencia a una mejor adherencia a lo largo del tiempo (2005 = 65.7% v 2010 = 82.3%, p < 0.001), que coincidió con la mayor adopción de informes sinópticos por parte de los patólogos (2005 v 2010, 9.4% v 25.3%, p < 0.001)
LIMITACIONES:
Datos obtenidos de un entorno restringido (es decir, hospitales que participan en un ensayo clínico aleatorizado).
CONCLUSIONES:
Se observaron grandes variaciones en la calidad de los informes de patología quirúrgica en casos de cáncer de recto. El Programa Nacional de Acreditación para Cáncer de Recto exige que los programas cumplan con estrictos estándares de calidad para los informes de patología quirúrgica. Se necesita una mejoría adicional en este aspecto clave de la atención oncológica para pacientes con cáncer de recto. Video Resumen en http://links.lww.com/DCR/B238. (Traducción—Dr. Xavier Delgadillo)
Registro de Clinical Trials.gov:
The quality of surgical pathology reporting is crucial to the provision of effective cancer care.1 Pathologic evaluation of a resected cancer specimen provides anatomic and prognostic information that influences clinicians’ therapeutic decisions for patients with cancer.2,3 As options for cancer treatment diversify, pathology reports must document sufficient details that affect the increasingly nuanced therapy choices. In an effort to promote comprehensive and standardized pathology reporting, the College of American Pathologists (CAP) has devised reporting guidelines for over 50 types of resected cancer specimens.
Appropriate management of patients who have rectal cancer relies on a multitude of tumor-related factors that are found exclusively in a pathology report. Strict adherence to the CAP guidelines for rectal cancer pathology reporting provides key prognostic information (eg, radial margin, completeness of mesorectum), which is pivotal to the delivery of optimal care to these patients.4 Previous research has described notable variations in the reporting adequacy of rectal cancer pathology reports, and room for improvement clearly exists in this key aspect of oncology care.4–6 However, little is known regarding the underlying cause of the variation in reporting quality, and at what level (ie, hospital vs pathologist) these variations arise. In addition, a large-scale multi-institutional audit of rectal cancer pathology reporting with regard to the institutions’ adherence to the CAP guidelines has not been described in recent years.
The aim of the current study was to assess the adherence of rectal cancer pathology reporting to the CAP guidelines requirements, including system- and hospital-level factors influencing any variation. To this end, we evaluated the quality of surgical pathology reports of patients who have rectal cancer enrolled in the National Surgical Adjuvant Breast and Bowel Project (NSABP) Protocol R04, a randomized controlled trial utilizing 4 different chemoradiotherapy regimens in patients with locally advanced rectal cancer.
MATERIALS AND METHODS
Study Patients
The NSABP R-04 study was a clinical trial comparing neo-adjuvant chemoradiotherapy regimens in the treatment of patients undergoing rectal cancer surgery (within 12 cm of the anal verge) that enrolled patients from July 2004 to August 2010. The NSABP R-04 study was approved by institutional review boards, and written informed consent was required. Enrolled patients were stratified based on sex, clinical stage (eg, II or III), and intended surgery (eg, sphincter-sparing surgery vs abdominoperineal resection), then randomly assigned to 4 different chemoradiation treatment arms. All available surgical pathology reports for patients enrolled in the study were reviewed. Surgical pathology reports were deidentified by the NSABP before data abstraction.
Data Abstraction
Each pathology report was examined for its documentation of variables outlined in the CAP guidelines (see section on Colon and Rectum: Resection, Including Trans-anal Disk Excision of Rectal Neoplasms).7 Specific reporting elements reviewed are noted in Table 1. The presence or absence of these reporting elements within a pathology report was determined. Of note, the 2013 version of the CAP guidelines was applied to all reports, whereas the rectal cancer surgical pathology reports included in the current study were obtained between the years 2004 and 2010. Comparisons among the 2000, 2008, 2009, and 2013 guidelines show minor differences in their recommended documentation requirements. It is important to note that the “required” elements are essentially the same across all 4 versions, with the exception of the “treatment effect” and “tumor deposit” elements that were not present in the 2000 version. A detailed comparison among the 4 versions of the CAP guidelines (2013 vs 2009 vs 2008 vs 2000) is shown in Supplemental Table 1 (Supplemental Digital Content, http://links.lww.com/DCR/B239). Two independent reviewers were involved in the assessment of the pathology reports for adherence to the CAP guidelines. A random 10% sample was reabstracted and interrater reliability was assessed between the 2 evaluators with the κ statistic, which was ˃0.8 for all pathology elements.
TABLE 1.
List of required and optional reporting elements for colon and rectum surgical specimens in 2013 CAP guideline
| COLON AND RECTUM: Surgical Pathology Cancer Case Summary in 2013 CAP reporting categories |
|---|
| Required categories |
| Specimen |
| Procedure |
| Tumor site |
| Tumor size |
| Macroscopic tumor perforation |
| Histologic type |
| Histologic grade |
| Microscopic tumor extension |
| Margins |
| Treatment effect |
| Lymphovascular invasion |
| Perineural invasion |
| Tumor deposits (discontinuous extramural extension) |
| Pathologic staging |
| Optional categories: |
| Specimen length |
| Tumor location |
| Macroscopic intactness of mesorectum |
| Histologic features suggestive of MSI |
| Type of polyp in which invasive carcinoma arose |
CAP = College of American Pathology; MSI = microsatellite instability.
In addition to the content of the pathology report, we also abstracted the hospital name and pathologist name associated with each pathology report. The hospital name was then used to determine hospital-level characteristics using the American Hospital Association data viewer web-site.8 Hospital-level characteristics examined included: teaching status of the hospital (teaching hospital-affiliated vs nonteaching status), hospital setting (urban vs rural), and hospital bed size (>400 vs ≤400 beds).
The reporting format (synoptic reporting vs nonsyn-optic reporting) of individual pathology reports was also examined. Synoptic reporting (SR) refers to the use of a structured checklist for documentation. Determination of reporting format was done by examining for the mention of either “synoptic reporting” or “checklist” in the heading of each pathology report.
Determining Adherence to the CAP Guidelines
Each pathology report was reviewed for the documentation of both required and optional elements as listed in Table 1. The adherence rate for each element was calculated.
Reporting elements with an adherence rate of <85% were defined as “inconsistently reported.” Furthermore, an “adherence score” was calculated for each individual pathology report, based on the number of CAP-required elements documented within a report over the total number of CAP-required elements in the guidelines (ie, adherence rate = 1, all of required elements were documented; adherence rate = 0.5, half of required elements were documented).
Analysis of Factors Contributing to Adherence to the CAP Guideline
Adherence to the CAP guidelines was evaluated with respect to the hospital-level characteristics (teaching vs non-teaching, urban vs rural, hospital bed size >400 vs ≤400) and the reporting format (SR vs non-SR). The adherence rate was also calculated at the level of the hospital and the pathologist. The adherence score and the rate of SR format use were calculated for each year from 2005 to 2010. The year 2004 was omitted, because only 3 pathology reports were available from that year. The χ2 test was used to evaluate categorical data, and the Student t test was used for continuous variables; p < 0.05 was considered statistically significant. All statistical analyses were performed using the R program (v2.12.0: www.r-project.org).
RESULTS
Surgical Pathology Reports
We identified 1004 surgical pathology reports for patients enrolled in NSABP R-04 who underwent rectal cancer surgery between July 2004 and August 2010. The analysis included 383 hospitals with 755 different pathologists performing the specimen evaluation and documentation. The number of reports per hospital ranged from 1 to 22, with the median of 1 report per hospital. The number of reports per pathologist ranged from 1 to 6, with the median of 1 per pathologist. The distribution of the number of pathology reports provided per hospital/pathologist are described in Supplemental Table 2 (Supplemental Digital Content, http://links.lww.com/DCR/B240). Detailed information on hospital characteristics was available for 302 of the 383 hospitals, affecting 824 of the 1004 path reports The reasons hospital characteristics were not available for the remaining 81 hospitals were the following: hospital had closed/merged or hospital was not located in the United States (eg, Canada, Puerto Rico). Surgical pathology reports were obtained from diverse hospital types with respect to their teaching status (teaching hospital-affiliated: 679 (82.4%) vs nonteaching status: 145 (17.6%)), setting (urban: 787 (95.5%) vs rural: 37 (4.5%)), and bed size (>400 beds: 381 (46.2%) vs ≤400: 443 (53.8%)).
Adherence to the CAP Guidelines Within NSABP R-04
Rectal cancer surgical pathology reports were evaluated for their adherence to the required elements of the 2013 CAP guidelines. The mean adherence score (percentage of CAP-required reporting elements documented in a given surgical pathology report) for all 1004 reports was 73.3%. Of note, “tumor deposit” and “treatment effects” were new reporting required elements introduced in 2009 and 2008, which were only optional by previous versions. Excluding these elements, the overall adherence score increased to 77.9%. Table 2 summarizes the adherence rate to individual reporting elements outlined in the CAP guidelines. Factors relevant to cancer staging were reported at a high frequency, including the number of lymph nodes examined (98.9%), number of lymph nodes involved (98.6%), and microscopic tumor extension (95.1%). In contrast, reporting of several important prognostic factors remained inconsistent despite the CAP guidelines mandating their documentation (ie, radial margin (84.6%), lymphovascular invasion (73.1%), and distance of invasive carcinoma from closest margin (47.9%).
TABLE 2.
Documentation of specific 2013 CAP elements in rectal cancer surgical pathology reports
| Checklist item | All report (1004) | Synoptic report (175) | No synoptic report (829) | p value | Urban (783) | Rural (37) | p value | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Required categories | ||||||||||||
| Specimen | 1002 | (99.80) | 174 | (99.4) | 828 | (99.9) | 0.224 | 785 | (99.7) | 37 | (100) | 0.947 |
| Procedure | 659 | (65.64) | 139 | (79.4) | 520 | (62.7) | <0.001 | 531 | (67.4) | 22 | (59.5) | 0.311 |
| Tumor site | 957 | (95.32) | 174 | (99.4) | 783 | (94.5) | 0.005 | 750 | (95.3) | 33 | (89.2) | 0.095 |
| Tumor size | 965 | (96.12) | 173 | (98.9) | 792 | (95.5) | 0.039 | 760 | (96.6) | 34 | (91.9) | 0.138 |
| Macroscopic tumor perforation | 238 | (23.7) | 76 | (43.4) | 162 | (19.5) | <0.001 | 166 | (21.2) | 8 | (21.6) | 0.939 |
| Histologictype | 986 | (98.21) | 175 | (100) | 811 | (97.8) | 0.392 | 775 | (98.5) | 34 | (91.9) | 0.003 |
| Histologic grade | 781 | (77.79) | 172 | (98.3) | 609 | (73.5) | <0.001 | 617 | (78.3) | 23 | (62.2) | 0.020 |
| Microscopic tumor extension | 955 | (95.12) | 172 | (98.3) | 783 | (94.5) | 0.032 | 753 | (95.7) | 34 | (91.9) | 0.277 |
| Margins: Proximal | 878 | (87.4) | 172 | (98.3) | 706 | (85.2) | <0.001 | 696 | (88.4) | 29 | (78.4) | 0.66 |
| Margins: Distal | 938 | (93.4) | 172 | (98.3) | 766 | (92.4) | 0.004 | 740 | (94.0) | 31 | (83.8) | 0.013 |
| Margins: Radial | 849 | (84.6) | 166 | (97.9) | 683 | (82.4) | <0.001 | 677 | (86.0) | 22 | (59.5) | <0.001 |
| Distance of invasive carcinoma from closest margin | 471 | (47.91) | 107 | (61.1) | 364 | (43.9) | <0.001 | 375 | (47.6) | 9 | (24.3) | 0.005 |
| Treatment effect | 473 | (47.11) | 94 | (53.7) | 379 | (45.7) | 0.054 | 374 | (47.5) | 10 | (27.0) | 0.015 |
| Lymphovascular invasion | 734 | (73.11) | 173 | (98.9) | 561 | (67.7) | <0.001 | 581 | (73.8) | 24 | (64.9) | 0.228 |
| Perineural invasion | 355 | (35.36) | 129 | (73.7) | 226 | (27.3) | <0.001 | 259 | (32.9) | 15 | (40.5) | 0.336 |
| Tumor deposits | 163 | (16.21) | 58 | (33.1) | 105 | (12.7) | <0.001 | 121 | (15.4) | 3 | (8.11) | 0.227 |
| TNM descriptorsa | 288 | (28.69) | 79 | (45.1) | 209 | (25.2) | <0.001 | 241 | (30.6) | 5 | (13.5) | 0.026 |
| T stage | 767 | (76.39) | 170 | (97.1) | 597 | (72.0) | <0.001 | 607 | (77.1) | 25 | (67.6) | 0.179 |
| N stage | 755 | (75.20) | 166 | (94.9) | 589 | (71.0) | <0.001 | 602 | (76.5) | 25 | (67.6) | 0.214 |
| # of lymph nodes involved | 990 | (98.60) | 174 | (99.4) | 816 | (98.4) | 0.31 | 776 | (98.6) | 36 | (97.3) | 0.517 |
| # of lymph nodes examined | 993 | (98.90) | 175 | (100) | 818 | (98.7) | 0.51 | 777 | (98.7) | 37 | (100) | 0.879 |
| Optional categories | ||||||||||||
| Specimen length | 962 | (95.82) | 161 | (92.0) | 801 | (96.6) | 0.006 | 750 | (95.3) | 37 | (100) | 0.160 |
| Tumor location above or below peritoneal reflection | 60 | (5.98) | 2 | (1.14) | 58 | (7.00) | 0.003 | 53 | (6.73) | 2 | (5.41) | 0.752 |
| Macroscopic intactness of mesorectum | 141 | (14.0) | 56 | (32.0) | 85 | (10.3) | <0.001 | 110 | (14.0) | 4 | (10.8) | 0.586 |
| Histologic features suggestive of MSI | 220 | (21.91) | 88 | (50.3) | 132 | (15.9) | <0.001 | 175 | (22.2) | 8 | (21.6) | 0.930 |
| Type of polyp in which invasive carcinoma arose | 47 | (4.68) | 13 | (7.43) | 34 | (4.10) | 0.058 | 36 | (4.57) | 1 | (2.70) | 0.591 |
| Overall adherence to CAP guidelines | ||||||||||||
| Adherence score (%), mean (SD) | 73.3% | (16.0) | 85.2% | (16.0) | 70.8% | (16.0) | <0.001 | 73.6% | (15.9) | 65.8% | (15.9) | 0.003 |
Components of the CAP guidelines for rectal cancer pathology report (n (%)). CAP-required elements with <85% overall reporting rate (ie, inconsistently reported components) are displayed in bold.
CAP = College of American Pathology; NSABP = National Surgical Adjuvant Breast and Bowel Project.
TNM descriptors (m = multiple primaries, r = recurrent, y = posttherapy) are required if applicable. Because all rectal cancer cases in NSABP underwent neoadjuvant therapy, this component is considered required.
Impact of Using Synoptic Reporting Format
Of the 1004 surgical pathology reports, 175 (17.4%) were identified that mentioned the use of an SR format. These reports were found to have an improved adherence to the CAP guidelines compared to reports that did not use SR (SR vs non-SR, mean (SD); 85.2% (16.0) vs 70.8% (16.0), p < 0.001). Use of SR resulted in a notable improvement in the adherence rates for all of the inconsistently reported elements (Table 2), including reporting of radial margin (97.9% vs 82.4%), lymphovascular invasion (98.9% vs 67.7), and distance of invasive carcinoma from closest margin (61.1% vs 43.9%, p < 0.001 for all). For perineural invasion, the reporting rate differed by >2.5-fold between the SR (73.7%) and non-SR (27.3%, p < 0.001) groups.
Impact of Hospital Characteristics on the Quality of Surgical Pathology Reports
The degree of overall adherence to the CAP guidelines, as well as to the individual reporting elements, was evaluated with respect to hospital-level characteristics. Details on the characteristics of hospitals in which the pathology reports originated were available for the 820 of 1004 (81.7%) reports. Hospitals located in urban areas had a better adherence score than those from rural areas (adherence score: 73.5% (15.9) vs 66% (15.9), p = 0.0031; Table 2). At the level of individual reporting elements, notable differences were noted in the reporting of histologic grade (urban vs rural: 78.3% vs 62%, p = 0.02), radial margin (86% vs 59.5%, p < 0.001), and distance of invasive carcinoma from closest margin (47.6% vs 24.3%, p = 0.005). Academic status of the hospital (adherence score, teaching vs nonteaching status: 73.3% (15.6) vs 72.8 (16.2), p = 0.73) and hospital bed size (adherence score, >400 bed vs ≤400 beds: 73.7% (16.0) vs 72.9% (15.5), p = 0.44) had no impact on the overall adherence to the CAP guidelines or to the individual required reporting elements.
Changes in the Quality of Surgical Pathology Reports Over Time
We assessed for the changes in the adherence score of pathology reports between the years 2005 and 2010. As depicted in Figure 1A, there was a steady improvement in the quality of pathology reporting on an annual basis over the 5-year period. Comparing between 2005 and 2010, the adherence score of pathology reports improved by approximately 17% (adherence score, 2005 vs 2010: 65.7% vs 82.3%, p < 0.001). Furthermore, we also noted a concomitant rise in the use of SR over the same 5-year period (Figure 1B). Although only 9.3% of the rectal cancer surgical pathology reports used the SR format in 2005, a quarter of all pathology reports (25.3%) were documented in a SR format by 2010.
FIGURE 1.
Change over time between 2005 and 2010 in the adherence score (A) and the rate of synoptic report use (B).
Variations in the Quality of Surgical Pathology Reports
Figure 2 depicts the distribution of the adherence score across all reports. There was a widespread adherence score among all reports with a range from 20% to 100%. The median adherence score was 75% with an interquartile range of 65% to 85%
FIGURE 2.
Distribution of the adherence score across all pathology reports
There were 172 hospitals and 176 pathologists that provided ≥2 pathology reports. Notable variations in adherence to the CAP guidelines existed within hospitals and individual pathologists. More than half of the hospitals included in the current study that enrolled more than 1 patient had ≥20% difference in the adherence score within their own reports. Similarly, more than half of all pathologists with multiple reports had ≥15% difference in the adherence score within their own reports. When examining the pattern of SR format use, we identified that, of the 175 pathologists using SR, only 50% with multiple pathology reports used the SR format on a consistent basis.
DISCUSSION
In the current study, we evaluated the reporting quality of rectal cancer pathology with respect to its adherence to the CAP guidelines (see section on Colon and Rectum: Resection, Including Transanal Disk Excision of Rectal Neoplasms).
We found that the adherence rate to the CAP required reporting elements (ie, adherence score) was 73.3% on average across all reports included in the current study (N = 1004). Variations in adherence to the CAP guidelines existed across hospitals and pathologists. Use of the SR format was associated with a statistically significant improvement in adherence to the CAP guidelines (SR (SD) vs non-SR (SD), 85.2% (16.0%) vs 70.8% (16.0%), p < 0.001). Last, we noted that the adherence to the CAP guidelines had steadily improved over time between 2005 and 2010, which coincided with the rising rate of pathology reports completed in the SR format.
Our analysis indicated excellent reporting rates for microscopic tumor extension (95.1%) and the number of lymph nodes examined/involved (98.6%). These factors form the basis for decisions on adjuvant therapy in patients who have rectal cancer according to the National Comprehensive Cancer Network guidelines. However, the reporting of other important prognostic elements was often omitted at a significant rate. For example, the reporting rates for the following required, well–recognized prognostic indicators were poor: presence of lymphovascular invasion (adherence rate 73.1%), perineural invasion (adherence rate 35.4%), radial margin status (adherence rate 84.6%), histologic grade (adherence rate 77.8%), distance from margin to the closest invasive carcinoma (adherence rate 47.9%), and neoadjuvant treatment effect (adherence rate 47.1%). These findings echo the results from prior studies evaluating the quality of colorectal cancer pathology reports.4,5 Winn et al5 examined the reporting efficacy of colorectal cancer pathology reports in Victoria, Australia. Among the 116 reports examined, microscopic tumor extension and nodal status were reported in nearly 100%, whereas deficiencies in the reporting of lymphovascular invasion (79%) and radial margins (85%) were noted. Similarly, reporting of lymphovascular invasion remained at 64% in the study conducted by Wei et al,4 which evaluated the quality of colon carcinoma pathology reports in North Carolina. Our findings, as well as observations from prior studies, highlight the need for further improvement in the reporting of these key elements.
Our current analysis included pathology reports from 383 hospitals and 755 pathologists, which allowed us to evaluate the degree of variations in adherence to the CAP guidelines across a wide range of pathology reports.
We found notable variations in quality, not only across different hospitals, but also within hospitals and individual pathologists. Prior studies have described the use of standardized checklist reporting systems (ie, synoptic format) to improve the consistency in the reporting of various clinical documentations.9–13 Use of the SR format has also been shown to enhance the documentation quality of surgical pathology reports.14–18 In a study by Messenger et al,19 the use of the SR format was shown to eliminate the difference in the reporting quality of rectal cancer pathology between specialist GI pathologists and non-GI pathologists. Consistent with these findings, our analysis shows that the SR format statistically significantly improves adherence to the CAP guidelines compared to the non-SR format (85.2% vs 70.8%, p < 0.001). In addition, reporting rates for all the inconsistently reported elements improved with the use of the SR format. Despite its efficacy, however, the SR format was used in only 175 of 1004 cases (17.4%) in our current analysis, although the use of the SR format did increase throughout the study time period. It is notable that only 50% of pathologists who used the SR format did so on a consistent basis. Without a standardized process to ensure reliable reporting each and every time, variations in the quality of pathology reports will likely persist. Our observation that variations in reporting quality existed even within an individual pathologist’s reports demonstrates that a standardized, replicable process is lacking, and is, therefore, a valid and valuable target for quality improvement. Of note, the National Accreditation Program for Rectal Cancer now mandates that 95% of rectal cancer pathology reports must contain ALL required CAP elements and use a standardized synoptic format.20
We acknowledge several potential limitations in our current study. First, we applied the 2013 version of the CAP guidelines to the pathology reports, although the reports included in the current study were from 2004 to 2010. However, it is important to note that the “required” elements (ie, elements used to calculate the adherence score and deemed most useful clinically) are essentially the same across all 4 versions of the CAP guidelines since 2000 (2000, 2008, 2009, and 2013), with the exception of the “treatment effect” and “tumor deposit” elements (Supplemental Table 1, Supplemental Digital Content, http://links.lww.com/DCR/B239). Furthermore, the potential for data abstraction errors in assessing the reporting of individual pathology elements cannot be excluded. However, as described in Materials and Methods, a random 10% sample of all reports was reabstracted with excellent κ statistical results (˂0.8 for all pathology elements). Second, although the pathology reports reviewed were from 2004 to 2010 and may be viewed as old data, the described variation in pathology reporting occurred within the setting of a randomized clinical trial, which likely means the global variation is even greater than described here. In addition, the mean adherence in our cohort was low, at 73%, despite the controlled environment of a randomized clinical trial, far below the goal set forth by the National Accreditation Program for Rectal Cancer as described above. Variable adherence to the CAP guidelines likely remains a relevant problem today. Last, the current analysis is subject to potential selection bias, because the pathology reports are all from hospitals enrolling patients in a clinical trial (ie, the NSABP R-04 trial) and the results may not be generalizable to other hospitals.
CONCLUSIONS
To our knowledge, the current analysis is the largest study to date evaluating the quality of rectal cancer pathology reports. The particular strength of the analysis lies in the diverse source of pathology reports that spans 383 hospitals and 755 pathologists obtained over the course of 5 years. We found that the overall adherence to the CAP guidelines for the reporting of required elements for rectal cancer specimens was 73.3%. We observed notable adherence to the reporting of findings relevant to the T and N stages, yet the reporting of several important prognostic indicators remained inadequate. Variations in reporting existed even at the level of individual pathologists. Adherence to the CAP guidelines is recognized as a key quality measure in rectal cancer care, which is now reflected in the National Accreditation Program for Rectal Cancer Standards Manual, 2017 Edition. Our findings suggest the need for further improvement in this area of oncology care, and the routine use of the SR format will be vital to achieving this goal both in rectal cancer as well as other malignancies.
Supplementary Material
ACKNOWLEDGMENTS
The authors acknowledge the contributions of: Barbara C. Good, Ph.D., Director of Scientific Publications; Christine I. Rudock, Publications and Graphics Specialist; and Wendy L. Rea, BA, Editorial Associate, all of whom are employees of NSABP. They were not compensated beyond their normal salaries for this work.
Funding/Support: This work was supported by The US National Cancer Institute at the National Institutes of Health, US Department of Health and Human Services, Public Health Service Grant numbers: U10-CA180868 (NCTN), U10-CA180822 (NRG SDMC), and UG1-CA189867 (NCORP); Sanofi-Synthelabo Inc; Roche Laboratories Inc. a full member of the Roche Group of companies; and by a Conquer Cancer Foundation of ASCO Career Development Award. Any opinions, findings, and conclusions expressed in this material are those of the author(s) and do not necessarily reflect those of the American Society of Clinical Oncology or the Conquer Cancer Foundation.
Footnotes
Financial Disclosure: Dr Yothers reports Pharmacyclics (self: fee for services, expenses, and consultant for data monitoring committee) and Mountainview Pediatrics (spouse: salary, pediatric nurse). All other authors have no conflict of interest or industry support to disclose.
Supplemental digital content is available for this article. Direct URL citations appear in the printed text, and links to the digital files are provided in the HTML and PDF versions of this article on the journal’s Web site (www.dcrjournal.com).
Podium presentation at the meeting of the American Society of Colon and Rectal Surgeons, Cleveland, OH, June 1 to 5, 2019.
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