Multicenter Cooperative Collaborative Action Research Study
in the Philippines

(MCCCARS)
2002

Reynaldo O. Joson, MD, MHA, MHPEd, MS Surg
Program Director
Email: rjoson@maniladoctors.com.ph

Final Paper

October, 2002

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Draft of Proposal/Paper

Title:

Reducing the discrepancy of clinical and pathological tumor and nodal evaluation in patients with breast cancer

A Preliminary Report

Authors:

Members of MCCCARS who ACTIVELY participated in the study will be cited as authors.

Members of MCCCARS who contributed opinions in the study will be acknowledged.

The centers will be acknowledged.

Multicenter Cooperative Collaborative Action Research Study (MCCCARS) Group

Centers:

Ospital ng Maynila Medical Center (OMMC), Manila Doctors Hospital (MDH), Zamboanga City Medical Center (ZCMC); Batangas Regional Hospital (BRH); Davao Regional Hospital (DRH), Philippine General Hospital (PGH); Region I Medical Center; Palawan Provincial Hospital (PPH)

MCCCARS Members

Reynaldo Joson, MD; Alex Cerrillo, MD; Alex Palines, MD; Alex Tan, MD; Manuel Francisco Roxas, MD; Noneng Monroy, MD; Roberto Valenzuela, MD; Dionisio Cruz, MD; Roehl Salvador, MD; Ricky Torres, MD

OMMC Residents: Nolim't Jay Raquel, MD; Miguel Galvez, MD; Rube Ann Claire Chan, MD; Oliver Leyson, MD; Danilo Querijero MD

MDH Resident: Malou Bastan, MD

Introduction:

Literature has shown a significant discrepancy rate between clinical and pathological TNM (Tumor, Node, Metastasis) staging in patients with breast cancer. In a German experience, the pretherapeutically and histologically measured size of the tumor was compared in 2511 cases of breast carcinomas. Breast tumors up to 2 cm in size revealed a correspondence in the histologically and clinically measured tumor size in only 13.6% (1). In a report from the Yorkshire Breast Cancer Group, in 348 patients with operable breast cancer, surgeons, radiologists, and pathologists varied considerably in measuring tumor size (T), with surgeons and radiologists agreeing in only 39% of cases, surgeons and pathologists in 54%, and radiologists and pathologists in 59%. Surgeons and pathologists agreed on the state of the regional lymph nodes (N) in 68% of cases (2).

In the Philippines, there are no published statistics on the discrepancy rate between clinical and pathological TNM staging in patients with breast cancer. However, discrepancy definitely exists as it has been observed by the authors. The junior authors who are surgical residents have observed it in their institution of training. The senior authors have observed it in various institutions with surgical residency training program and have personally experienced it in their practice.

Discrepancy between clinical and pathological TNM staging in patients with breast cancer certainly has a negative impact in management, particularly in the choice of primary treatment as well as in the advice of patients on extent of cancer prior to treatment. Different clinical stages of breast cancer have corresponding different primary treatment approaches. A patient with an actual clinical stage II who is erroneously categorized as clinical stage III will be erroneously treated as one with clinical stage III rather as one with clinical stage II. Nowadays, with the extensive public health information in trimedia and Internet, patients with breast cancer and their relatives would usually ask what stage they are in prior to treatment. An erroneous clinical staging may be a cause of unnecessary alarm in those with overstaging; a source of unwarranted rejoice in those with understaging, and definitely, a potential factor for patient’s dissatisfaction and complaint.

Realizing the importance of discrepancy in the clinical-pathological staging in the management of patients with breast cancer and experiencing the existence of such discrepancy, the authors decided to conduct an action research study on this topic with the goal of reducing the discrepancy and, therefore, improving patient care.

Objectives:

The general objective of the study is to reduce the discrepancy of the clinical and pathological tumor (T) and node (N) evaluation in patients with breast cancer.

The specific objectives of the study are:

1. To determine the extent of discrepancy of clinical-pathological TN staging in patients with breast cancer in the focal institution.
2. To determine the root causes of the discrepancy, if discrepancy is present and needed to be diminished further.
3. To formulate strategies to reduce the discrepancy based on identified root causes.
4. To implement and then evaluate the strategies.
5. To recommend post-evaluation improvement measures on the strategies for purposes of institutionalization and utility in other institutions where the same problem may exist.

Methods:

General Methods:

The concept and methodology of an action research was utilized (3,4), namely: analysis of the problems, research designs on how to solve the problems; implementation of action plan; and evaluation of results of implementation. Multicenter cooperation and collaboration was tapped for data gathering, patient accrual, and validity testing of proposed solutions. Tools for data gathering included literature search using evidence-based approach, focused group discussion among the members of the multicenter cooperative collaborative action research study (MCCCARS) group, retrospective chart reviews, and prospective data accrual. Focused group discussion done mainly through email was the tool used for consensus gathering for problem-solving and decision-making. Appropriate statistics, both descriptive and analytical, were used as needed.

Specific Methods for Each Objective:

Objective 1:

To determine the extent of discrepancy of clinical-pathological TN staging in patients with breast cancer in the focal institution.

Methods:

1. Retrospective chart and record review
2. All breast cancer patients with clinical and pathological TN determination. (Excluded are patients with post-excision-section-biopsy status.) Thus, these included only patients who have undergone total mastectomy and axillary dissection (usually modified radical mastectomy).
3. Delimitations / limitations:
   1. M staging is not included as this is difficult to document and validate. (Delimitation)
   2. Cannot standardize examiners and pathologists because of retrospective nature of study (limitation)
   3. Data in charts may not be accurate and complete because of retrospective nature of study (limitation)

The retrospective chart and record review was done only in OMMC. The other centers and members of the MCCCARS group had difficulty gathering data on baseline discrepancy rate because of chart and record problems.

Objectives 2 and 3:

To determine the root causes of the discrepancy, if discrepancy is present and needed to be diminished further .

To formulate strategies to reduce the discrepancy based on identified root causes.

1. Focused group discussion among members of MCCCARS group.
2. Dialogue with pathologists of focal institution.

Objective 4:

To implement and then evaluate the strategies.

1. Implementation of strategies.
2. Prospective study to validate effectiveness of implemented strategies.

Objective 5:

To recommend post-evaluation improvement measures on the strategies for purposes of institutionalization and utility in other institutions where the same problem may exist.

1. Focused group discussion among members of MCCCARS Group and dialogue with pathologists of focal institution.
2. Formulation of clinical practice protocols for institutionalization of effective strategies.

Results:

Objective 1:

To determine the extent of discrepancy of clinical-pathological TN staging in patients with breast cancer in the focal institution.

A total of 82 charts of breast cancer patients who have undergone total mastectomy and axillary dissection in OMMC from January 1997 to June 2001 were reviewed. The age of the patients included in the review ranged from 24 to 49 with a mean of 49. All the patients were female. The clinical-pathological T discrepancy rate was 17%, while the N discrepancy was 52 %. The overall T and N discrepancy rate was 70%. See tables.

Table 1. Clinical-Pathological T Staging

Clinical Staging		Pathological Staging
cT	No.	Discrepancy # (%)	Upstaged # (%)	Downstaged # (%)
T1	7	2(29%)	2(100%)	0
T2	38	4(11%)	3(75%)	1(25%)
T3	27	7(26%)	1(14%)	6(86%)
T4	10	1(10%)	0	1(100%)

 

Table 2. Clinical-Pathological N Staging

Clinical Staging		Pathological Staging
cN	No.	Discrepancy # (%)	Upstaged # (%)	Downstaged # (%)
N(-)	47	26(55%)	26(55%)	0
N(+)	35	17(49%)	9(53%)	8(47%)

 

Table 3. Overall Clinical-Pathological TN Staging Discrepancy

Clinical Staging		Pathological Staging
cTN	No.	Discrepancy # (%)	Upstaged # (%)	Downstaged # (%)
cT	82	14(17%)	6(43%)	8(57%)
cN	82	43(52%)	35(81%)	8(19%)

Objective 2:

To determine the root causes of the discrepancy, if discrepancy is present and needed to be diminished further.

During the focused group discussion of members of MCCCARS group, the consensus was that the discrepancy rate in OMMC is most probably true in other centers and that the discrepancy rate need to be diminished.

Possible sources of error / discrepancy (from focused group discussion among MCCCARS members and dialogue with pathologists):

• Error lies on the clinician-examiner or surgeon-examiner
  • Error in determination of size of primary tumor
    • Wrong estimate because did not use ruler (Pathologists use ruler)
  • Error in determination of presence or absence of axillary node
• Error lies in determining clinical T and N in those with previous open biopsy
• Error lies in the surgeon during operation intended for modified radical mastectomy
  • No nodes were removed in patients with actually cN+ leading to pN0
• Error lies on the pathologist-examiner
  • Pathologist missed detection of lymph node in axillae during cutting of specimen in patients with actual cN+
• Lack of communication between surgeon and pathologist on
  • What happen before, during and after operation
    • Distortion of specimen created by surgeon during and right after the operation, such as cutting the specimen
    • Distortion of specimen when fixed in preservative solution
    • Distortion of specimen when squeezed into container to be sent to pathologist
  • No mutually agreed or standardized way of measuring T
  • No mutually agreed or standardized way of determining N

Possible root causes:

• NO structured training for surgeon-examiner that leads to wrong determination of cT and cN
  • Clinician-examiner estimates size of tumor without using ruler.
  • Clinician-examiner's technique in examining the axillae and interpreting findings.
    • Axilla not laxed during palpation
    • Too light pressure during palpation
    • Not sweeping down the chest wall
    • Not reaching the apex
    • Not covering the whole area of the axilla
    • No side to side palpation of the axilla just one
    • Not conscientious or thorough in examining axillae
    • Not knowing how to interpret finding
    • Neurovascular bundle and ribs may be mistaken for nodes
• NO mutually agreed protocol between pathologists and surgeons on the reporting of T and N.

Objective 3:

To formulate strategies to reduce the discrepancy based on identified root causes.

1. Communication and cooperation between surgeons and pathologists to come out with a mutually agreed protocol on the determination and reporting of T and N (memorandum of cooperation). See Memorandum of Cooperation in appendix.
2. Structured training for surgeons to develop accuracy in clinical determination of T and N and to implement the mutually agreed protocol with the pathologists. See Structured Training Program in appendix.

Objective 4:

To implement and then evaluate the strategies.

Results of implementation --------

The results of implementation show effectiveness of the strategy. Based on interview of stakeholders, the strategy was easy to implement.

Improvements needed -------

Easy to implement the training program

Accuracy rate of the trainees

Feedback from trainees

Awareness of importance

Habit for continual self-improvement

In terms of effectiveness and easy to accomplish.

Objective 5:

To recommend post-evaluation improvement measures on the strategies for purposes of institutionalization and utility in other institutions where the same problem may exist.

Adjustments in Memo of Cooperation with the Department of Pathology, if necessary for refinements.

Clinical practice guidelines incorporating the validated strategies and memo to staff of the departments of surgery and radiology for institutionalization.

Multicenter adoption of memo of cooperation with department of pathology and other validated stragegies.

Discussion:

This is a preliminary report awaiting for more data to come in, particularly the validation of the effectiveness of the strategies in reducing the discrepancy between the tumor and nodal evaluation of patients with breast cancers.

Short of more validation data, the

An action research on the problem of discrepancy of clinical-pathological staging was conducted.

The strategy used has shown improvement in the accuracy of clinical-pathological staging and thus, can be institutionalized in the focal hospital as well as be used as a model in other institutions.

Basically, the strategy includes a communication of pathologist on a cooperative effort as well as a training program for improvement.

More important is that trainees should be constantly aware that clinical staging is important and be constantly be on the look out for possible errors and continually improve.

The best way to learn is to prove it whether correct or wrong - pathological correlation.

The strategy is easy to implement and has been adopted by other institutions.

References:

1. Leonhardt A. Observations and problems in the TNM classification of breast cancers. Geburtshilfe Frauenheilkd 1988;48(5):318-21.

2. Anonymous. Critical assessment of the clinical TNM system in breast cancer. Report from the Yorkshire Breast Cancer Group. Br Med J 1980;281(6233):134-6.

3. Cohen L, Manion L. Research Methods in Education. London, Croom Helm, 1980.

4. Marguiles N. Managing change in health care organization. Medical Care 1977;15:693-704.

Questions to the members:

Do you consider the discrepancy of the clinical and pathological tumor and node evaluation in patients with breast cancer a significant health concern or problem in your practice and in the training of surgical residents that an action research is worth trying?

o YES

o NO

Results

5 - Yes 1 - No, I dont think it is a significant problem but I do think it is worth doing the research.

In the Philippines, there are no published statistics on the discrepancy,rate between clinical and pathological TNM staging in patients with breast cancer.

o TRUE (have NOT encountered any)

o FALSE (have encountered)

Results

6 - Agree (NO published data)

Discrepancy between clinical and pathological TNM staging in patients with breast cancer certainly has a negative impact in management, particularly in the choice of primary treatment as well as in the advice of patients on extent of cancer prior to treatment.

o AGREE

o DISAGREE

Results

5 - YES 1 - I do not think it significantly affects primary or adjuvant treatment but certainly has a bearing on advice given to the patient

 

Ospital ng Maynila Medical Center

 

Memorandum of Cooperation

between Department of Surgery and Department of Pathology

in an effort to reduce the discrepancy rate in the clinical and pathological tumor and node evaluation in patients with breast cancer

Whereas, there exists a significant discrepancy rate in the clinical and pathological tumor and node evaluation in patients with breast cancer which needs to and can be reduced to within acceptable limits;

Whereas, an acceptable discrepancy rate is a parameter of quality patient care;

Whereas, one of the root causes of the discrepancy is lack of communication and understanding between the staff of the Department of Surgery and that of the Department of Pathology;

Be it resolved, and hereby resolved, that a memorandum of understanding and cooperation be forged between the Department of Surgery and the Department of Pathology with the following stipulations:

I. In the clinical examination, surgeon will

A. Measure the size(s) of the primary breast tumor(s) using a stiff ruler.

B. Note down presence or absence of palpable axillary lymph nodes; if present, size of smallest and largest node palpated.

C. The clinical T and clinical N data should be noted down in the pathology request.

II. After the total mastectomy and axillary dissection, surgeon will do the following:

A. Measure the tumor (sT)

1. In tumor with no previous open biopsy or frozen section biopsy, cut the tumor along the widest diameter in one direction only and then using a stiff ruler measure the length of the widest diameter in cm. Note down size (length) of sT in pathology request.

2. In tumor with frozen section biopsy, determine the sT in its widest diameter using a stiff ruler taking into consideration the size of the specimen removed and submitted for frozen section. Note down size (length) of sT in pathology request.

B. Identify and isolate nodes in the axillary dissection specimen.

Note down in pathology request number of grossly palpable nodes isolated and their sizes in greatest diameter using stiff ruler.

III. Role of the pathologists after receiving the specimen and request:

A. Study the pathology request of surgeon.

1. Take note of the clinical and surgical T and N.

2. Verify the sTN data.

Make the necessary adjustment and corrections for sT and sN.

B. Make a histopathological report after conducting a microscopic examination of all specimens submitted.

1. Include the data submitted by surgeon in the report (cTcN and sTsN)

2. Place a pTpN report.

The pT and sT should gibe. The cT may not gibe with the sT or pT depending on the accuracy of clinical measurement of T by the surgeon. The pN and cN and sN may not gibe.

Reynaldo O. Joson, MD	Sergio Paguio, MD
Chair Department of Surgery	Chair Department of Pathology
Date:	Date:

Structured training program for surgeons to develop accuracy in clinical determination of T and N and to implement the mutually agreed protocol with the pathologists.

1. Developing accuracy in clinical determination of T and N

Training program with the following main learning strategy: Plan - Do - Check - Improve

Plan:

1. Creation of awareness of importance of accurate clinical staging

2. Structured training on physical examination of the primary breast tumor and axillae (demo-return demo on 2 patients one with and one without axillary nodes)

a. How to determine the clinical T (see details below)

b. How to do the physical examination of the axillae with emphasis on how to determine the presence and absence of lymph nodes (see details below)

3. Do - Check - Improve (with inculcation of importance of continual self-improvement):

Each surgeon do (cTcN) - check (sTsN - pTpN) - improve on at least 10 patients for and undergoing modified or classical radical mastectomy.

 

For each patient, the surgeon fills up the form below:

	cTcN	sTsN	pTpN	Discrepancy
Pt 1 Age/sex	cT= cm	sT= cm	pT = cm
	cN= (+/-) Size = cm (<1; 1-2; >2) Location (apex/below apex)	sN= (+/-) Size = cm (<1; 1-2; >2) Location (apex/below apex)	pN = +/-
Pt 2 Age/sex	cT= cm	sT= cm	pT = cm
	cN= (+/-) Size = cm (<1; 1-2; >2) Location (apex/below apex)	sN= (+/-) Size = cm (<1; 1-2; >2) Location (apex/below apex)	pN = +/-
Pt 3 Age/sex	cT= cm	sT= cm	pT = cm
	cN= (+/-) Size = cm (<1; 1-2; >2) Location (apex/below apex)	sN= (+/-) Size = cm (<1; 1-2; >2) Location (apex/below apex)	pN = +/-
Pt 4 Age/sex	cT= cm	sT= cm	pT = cm
	cN= (+/-) Size = cm (<1; 1-2; >2) Location (apex/below apex)	sN= (+/-) Size = cm (<1; 1-2; >2) Location (apex/below apex)	pN = +/-
Pt 5 Age/sex	cT= cm	sT= cm	pT = cm
	cN= (+/-) Size = cm (<1; 1-2; >2) Location (apex/below apex)	sN= (+/-) Size = cm (<1; 1-2; >2) Location (apex/below apex)	pN = +/-
Pt 6 Age/sex	cT= cm	sT= cm	pT = cm
	cN= (+/-) Size = cm (<1; 1-2; >2) Location (apex/below apex)	sN= (+/-) Size = cm (<1; 1-2; >2) Location (apex/below apex)	pN = +/-
Pt 7 Age/sex	cT= cm	sT= cm	pT = cm
	cN= (+/-) Size = cm (<1; 1-2; >2) Location (apex/below apex)	sN= (+/-) Size = cm (<1; 1-2; >2) Location (apex/below apex)	pN = +/-
Pt 8 Age/sex	cT= cm	sT= cm	pT = cm
	cN= (+/-) Size = cm (<1; 1-2; >2) Location (apex/below apex)	sN= (+/-) Size = cm (<1; 1-2; >2) Location (apex/below apex)	pN = +/-
Pt 9 Age/sex	cT= cm	sT= cm	pT = cm
	cN= (+/-) Size = cm (<1; 1-2; >2) Location (apex/below apex)	sN= (+/-) Size = cm (<1; 1-2; >2) Location (apex/below apex)	pN = +/-
Pt 10 Age/sex	cT= cm	sT= cm	pT = cm
	cN= (+/-) Size = cm (<1; 1-2; >2) Location (apex/below apex)	sN= (+/-) Size = cm (<1; 1-2; >2) Location (apex/below apex)	pN = +/-

 

Standards:

Discrepancy rate of cT and sT (=pT)/surgeon should be 5% or less with an acceptable discrepancy of 1 cm between cT and sT.

Discrepancy rate of cN and sN/surgeon should be 30% or less.

Or there must at least be signs of definite improvement in the last 5 patients in each surgeon until he reaches a constant acceptable discrepancy rate.

The basis for considering 5% as an acceptable discrepancy rate in T determination was derived from consensus among the senior authors.

The basis for considering 30% as an acceptable discrepancy rate in N determination was derived from the literature. (wwwwhaaat)

 

2. Dissemination and implementation of memorandum of understanding between pathologists and surgeons

 

How to determine the clinical T:

• Patient in supine position
• Locate the mass by palpation
• Determination of edges of tumor for measurement (induration vs erythema)
  • use ballpen to mark the edges
  • use stiff ruler (not tape measure) to measure widest diameter in cm

 

How to determine the clinical N

• Patient in sitting position facing surgeon examiner
• Surgeon promotes laxity of axillary fold
• Palpation of axilla for nodes
  • Gentle and adequate palpating pressure (light to firm) on the lateral chest wall
  • Palpation of entire axilla up to apex and anterior and posterior parts
  • Interpretation of findings
    • Elongated structures palpated: NOT lymph nodes
    • Round or oval structures palpated in axilla (not on epidermis and dermis): lymph nodes
  • Determine size of largest node
    • < 1 cm
    • 1 - 2 cm
    • > 2 cm
  • Determine location
    • Apex
    • Way below apex
  • End-point of examination
    • Repeat and repeat until convinced of NO nodes or presence of nodes
      • If present, get data on size and location

 

All surgical residents will examine patients for modified radical mastectomy (all or some residents per patient)

At least 10 patients per residents, preferably more.

Check accuracy of clinical evaluation with operative findings.

 

Timetable: 2 months depending on prevalence of patients for modified radical mastectomy

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