INDOX Breast Pathology Reporting Study

Study investigators:

Principal investigator:

Dr Toral Gathani

Co-principal investigators:

Dr Radha Ananthakrishan

Dr Raghib Ali


The surgical pathological findings of breast specimens determine the subsequent treatment course for a patient. Therefore it is important to be confident in the accuracy of the information provided on a surgical pathological report. Quality assurance studies to determine the consistency of the reporting of breast pathology are well established in the more developed world. Studies of this nature are limited in India and would be of benefit.

The INDOX cancer research network collaboration is a partnership established between the University of Oxford and leading cancer centres in India. Currently a multicentre case-control study is underway to examine the risk factors for breast cancer within the Indian population. There is an opportunity to conduct a national study to investigate the consistency of reporting of breast pathology within the INDOX framework as an adjunct to the breast cancer case control study.

Background and Justification:

The quality of breast healthcare and the ultimate clinical outcomes of patients with breast cancer are directly related to the quality of breast pathology practice. The initial diagnosis of breast cancer consists of triple assessment of clinical examination, radiological imaging and tissue diagnosis. Treatment modalities for breast cancer include surgery, radiotherapy, chemotherapy, hormonal and biological treatments. The subsequent management of the disease following surgery depends on accurate reporting of surgical pathological specimens. The size and grade of the tumour together with information on the predictive tumour markers such as ER status determine the adjuvant treatment that a patient receives.

The key issues pertaining to pathology in the Indian subcontinent are resources, quality control and education. In India there is a wide variation in the training of pathologists, with no overarching body overseeing and regulating the quality of training programmes. Furthermore, few national guidelines exist on to inform pathologists of the minimum standards required for the reporting of cancer specimens. However in recent times, some of the larger corporate laboratories have been accredited by the American College of Pathologists.

External quality assurance programmes for pathology reporting of breast specimens are well established in high resource income countries and have been shown to improve the standard of reporting by pathologists. Furthermore the use of standardised reporting proformas encourages reporting consistency.

Within India, studies relating to the quality and accuracy of pathology reporting are limited. To our knowledge, no national study has been conducted in India to investigate the consistency of agreement of breast pathology reporting among different providers in the country. In a low income country such as India it is important that the information provided on pathology reports is accurate so as to avoid unnecessary and expensive treatments for patients and to ensure that limited resources are used in the most useful manner.

There are multiple processes that determine the quality and accuracy of a final histopathology report including surgical techniques employed to obtain specimens, transfer times to laboratories and the handling of specimens within the pathology laboratory itself. Therefore, quality assurance in pathology should relate to both the processes and outcomes.

There is limited information in India on the consistency of breast pathology reporting between different centres. There is scope to conduct such a study through the INDOX cancer research network collaboration in parallel with a current case-control study to examine the risk factors for breast cancer in the Indian population.

It is not within the scope of this study to evaluate the processes employed within the pathology laboratories. If as a result of this study a significant inconsistency in the reporting of breast pathology is observed among the INDOX collaborating centres then further studies will need to be conducted to investigate the processes employed in the preparation of specimens.


The primary aim of this study is to assess the consistency of reporting of breast pathology specimens among the participating INDOX collaborating centres


The coordinating centre for this study is G Kuppaswamy Memorial Hospital in Coimbatore, India.  The study design is based on the External Quality Assurance programme within the National Health Service Breast Screening Programme, with slides and blocks being distributed for anonymous reporting to the INDOX participating centres.


The study commenced Spring 2012 and results are expected by Spring 2013.