Abstract
Introduction
Percutaneous kidney biopsy is the gold standard method to reach a precise diagnosis in most medical kidney diseases, which positively impacts patient care by personalizing the treatment. Accurate diagnosis in the pathology report for medical kidney diseases requires clinicopathological correlation, and clinical data is not always reachable to the nephropathologist. This study aimed to create a standardized, paperless requisition form compatible with medical renal biopsies.
Methods
An initial form was prepared for native and allograft renal biopsies according to the current classification of medical kidney diseases. We invited 33 nephropathologists working in Canadian healthcare institutions to answer survey questions about the need to include a particular aspect of clinical information. According to the responses, we modified the experimental form. Eighty nephrologists were asked to complete a clinical data-collecting form given out as PDF files. The time for completing the form and clinicians’ satisfaction were assessed.
Results
The experimental form survey was answered by 20 out of 33 nephropathologists (61%) from 14 Canadian healthcare centers. The agreement rate on the questions was from 38.89% to 100.00% (average 83.33% and 77.14% for the native and the allograft section, respectively). Seventeen out of 80 nephrologists and their assistants (21%) responded by completing 22 PDF forms. The time required to finish a PDF form was 10.4 min on average. Nephrologists considered the form time-consuming and suggested making it more clinically relevant. Only seven nephrologists responded to the satisfaction survey; four (57%) were satisfied.
Conclusions
Medical information is critical in renal pathology diagnoses. A uniform paperless clinical data requisition form was evolved through an agreement by Canadian nephropathologists.
Keyword(s): Clinical data, Effective, Electronic, Quality improvement, Collecting form, Renal biopsy
1. Introduction
The history of medical renal pathology starts with Malpighi describing the microanatomy of the kidney in 1666 using a newly developed microscope [1], with remarkable progress in the identification and classification of medical renal diseases by the introduction of percutaneous renal biopsy in 1951 and the development of electron microscopy and immunofluorescence [2].
Renal pathology is a subspecialty of surgical pathology that involves the pathogenesis, classification and diagnosis of medical renal diseases using light, immunofluorescence and electron microscopy. Without a clinical correlation, the final diagnosis would only be a descriptive form of injury. The nephropathologist works closely with the nephrologist, who uses the renal biopsy report to make a clinicopathologic correlation that guides optimal patient management. Since clinical information is essential to make an accurate pathologic diagnosis in many cases, close collaboration between the nephropathologist and nephrologist is crucial.
Clinical information in the hospital information system is not always easily accessible to the pathologist when assessing a renal biopsy. We thus aimed to create a standardized, efficient, and environmentally friendly electronic clinical data form that would be easy to use for the nephrologist. The importance of clinical information in surgical pathology [3] and the benefits of standardization of the surgical pathology report and structured clinical templates [[4], [5], [6]] have been documented in the literature. However, to our knowledge, a standardized electronic clinical data form has not yet been proposed to assess medical renal biopsies.
2. Material and methods
The Quality Improvement Review Committee (QIRC) approved this study at University Health Network (QID 20–0073), which waived the Research Ethics Board approval.
Phase 1: One nephrology fellow, two nephropathology fellows, and a nephropathologist brainstormed to create two clinical data collection forms that could be used in clinical practice for patients undergoing medical renal biopsies; one form designed for renal biopsies from native kidneys and another for allograft renal biopsies. The forms comprised items on critical clinical features of medical kidney diseases and were divided into six categories: 1) healthcare institution information, 2) patient information, 3) kidney biopsy procedure information, 4) clinical history, 5) management, and 6) laboratory investigations. The survey comprised 161 questions (73 for native renal biopsies and 88 for allograft renal biopsies); Table 1, Table 2. In brief, the authors had a summit to prepare a consensus on the clinical information that would be considered critical for the best clinicopathological correlation. The questionnaire wrapped the primary renal disease entities and the secondary involvement of the kidney by a systemic disease, which includes glomerulonephritis (immune-complex mediated, pauci-immune, anti-glomerular basement membrane, monoclonal immunoglobulin, and C3 glomerulopathy), podocytopathies, structural abnormalities of the basement membrane, metabolic diseases, thrombotic microangiopathies, organized deposition, tubulointerstitial diseases, vascular diseases, aging, inherited diseases and renal transplant pathology.
Table 1.
The proposed clinical data elements for the native kidney biopsy requisition form and the response rate of the nephropathologists.
| Question | Yes | No | Skipped | Agreement % |
|---|---|---|---|---|
| 1. Referring Hospital | 19 | 0 | 1 | 100 |
| 2. Referring Physician/Pathologist | 19 | 0 | 1 | 100 |
| 3. Address | 14 | 5 | 1 | 73.68 |
| 4. Phone number | 18 | 1 | 1 | 94.74 |
| 5. Fax number | 16 | 3 | 1 | 84.21 |
| 6. Email address | 15 | 4 | 1 | 78.95 |
| 7. Last Name | 19 | 0 | 1 | 100 |
| 8. First Name | 19 | 0 | 1 | 100 |
| 9. Middle Name/Initials | 17 | 2 | 1 | 89.47 |
| 10. Date of Birth | 19 | 0 | 1 | 100 |
| 11. Age | 19 | 0 | 1 | 100 |
| 12. Ethnicity | 14 | 5 | 1 | 73.68 |
| 13. Date of Biopsy | 19 | 0 | 1 | 100 |
| 14. In-patient/Out-patient | 15 | 4 | 1 | 78.95 |
| 15. Chief Complaint | 19 | 0 | 1 | 100 |
| 16. Diabetes | 17 | 2 | 1 | 89.47 |
| 17. HA1C | 15 | 4 | 1 | 78.95 |
| 18. Random Blood Sugar | 10 | 9 | 1 | 52.63 |
| 19. Obesity | 15 | 4 | 1 | 78.95 |
| 20. BMI/height/weight | 15 | 4 | 1 | 73.68 |
| 21. Malignancy | 17 | 2 | 1 | 89.47 |
| 22. Hypertension | 18 | 1 | 1 | 94.74 |
| 23. Average Blood Pressure | 13 | 6 | 1 | 68.42 |
| 24. Family history of renal disease | 18 | 1 | 1 | 94.74 |
| 25. History of recent infection | 16 | 3 | 1 | 84.21 |
| 26. History of alcohol abuse | 11 | 8 | 1 | 57.89 |
| 27. History of smoking | 16 | 3 | 1 | 84.21 |
| 28. History of drug abuse | 17 | 2 | 1 | 89.47 |
| 29. History of chemical exposure | 16 | 3 | 1 | 84.21 |
| 30. Nephrotic Syndrome | 16 | 2 | 2 | 88.89 |
| 31. Acute Nephrotic syndrome | 14 | 4 | 2 | 77.78 |
| 32. Acute Renal failure | 16 | 2 | 2 | 88.89 |
| 33. RPGN | 14 | 4 | 2 | 77.78 |
| 34. Isolated Hematuria (Micro/Macroscopic) | 16 | 2 | 2 | 88.89 |
| 35. Isolated Proteinuria | 16 | 2 | 2 | 88.89 |
| 36. Chronic kidney disease | 16 | 2 | 2 | 88.89 |
| 37. Other (Please indicate) | 13 | 5 | 2 | 72.22 |
| 38. Antibiotics | 15 | 3 | 2 | 83.33 |
| 39. Antihypertensive | 13 | 5 | 2 | 72.22 |
| 40. NSAID | 15 | 3 | 2 | 83.33 |
| 41. Immunosuppression | 15 | 3 | 2 | 83.33 |
| 42. Immunotherapy | 15 | 3 | 2 | 83.33 |
| 43. Chemotherapy | 15 | 3 | 2 | 83.33 |
| 44. Serum Creatinine (μmol/L) | 17 | 1 | 2 | 94.44 |
| 45. If serum creatinine raised, is it sudden or gradual? | 16 | 2 | 2 | 88.89 |
| 46. If serum creatinine raised, indicate the last 3 readings | 10 | 8 | 2 | 55.56 |
| 47. Baseline Serum Creatinine | 15 | 3 | 2 | 83.33 |
| 48. Creatinine clearance (ml/min) | 11 | 7 | 2 | 61.11 |
| 49. ACR (mg/mmol) | 12 | 6 | 2 | 66.67 |
| 50. PCR (mg/mmol) | 12 | 6 | 2 | 66.67 |
| 51. Urine protein (g/24 h) | 17 | 1 | 2 | 94.44 |
| 52. Urine culture (if applicable) | 15 | 3 | 2 | 83.33 |
| 53. Urine Sediment (RBC, WBC, Casts, Crystals) | 17 | 1 | 2 | 94.44 |
| 54. ANA (+/-) | 17 | 1 | 2 | 94.44 |
| 55. ANA titer | 15 | 3 | 2 | 83.33 |
| 56. Anti-dsDNA (+/-) | 17 | 1 | 2 | 94.44 |
| 57. Anti-dsDNA titer | 12 | 6 | 2 | 66.67 |
| 58. P-ANCA (+/-) | 16 | 2 | 2 | 88.89 |
| 59. P-ANCA titer | 12 | 6 | 2 | 66.67 |
| 60. C-ANCA (+/-) | 12 | 2 | 2 | 88.89 |
| 61. C-ANCA titer | 12 | 6 | 2 | 66.67 |
| 62. RF (+/-) | 16 | 2 | 2 | 88.89 |
| 63. RF titer | 13 | 5 | 2 | 72.22 |
| 64. Anti-GBM (+/-) | 17 | 1 | 2 | 94.44 |
| 65. Anti-GBM titer | 12 | 5 | 3 | 70.59 |
| 66. Complement (C3,C4) | 17 | 1 | 2 | 94.44 |
| 67. SPEP/UPEP | 17 | 1 | 2 | 94.44 |
| 68. ASO | 16 | 2 | 2 | 88.89 |
| 69. Cryoglobulins | 17 | 1 | 2 | 94.44 |
| 70. HIV (+/-) | 16 | 2 | 2 | 88.89 |
| 71. Hepatitis B virus (+/-) | 16 | 2 | 2 | 88.89 |
| 72. Hepatitis C virus (+/-) | 16 | 2 | 2 | 88.89 |
| 73. Other related information | 15 | 3 | 2 | 83.33 |
Abbreviations: HA1C; hemoglobin A1C. BMI; body mass index. RPGN; rapidly progressive glomerulonephritis. NSAID; nonsteroidal anti-inflammatory drug. ACR; albumin creatinine ratio. PCR; protein creatinine ratio. RBC; red blood cell. WBC; white blood cell. ANA; anti-nuclear antibody. Anti-dsDNA; anti-double-stranded DNA. P-ANCA; perinuclear antineutrophil cytoplasmic antibody. C-ANCA; cytoplasmic antineutrophil cytoplasmic antibody. RF; rheumatoid factor. Anti-GBM; anti-glomerular basement membrane. SPEP; serum protein electrophoresis. UPEP; urine protein electrophoresis. ASO; antistreptolysin O. HIV; human immunodeficiency virus.
Table 2.
The proposed clinical data elements for the allograft kidney biopsy requisition form and the response rate of the nephropathologists.
| Question | Yes | No | Skipped | Agreement % |
|---|---|---|---|---|
| 1. Referring Hospital | 18 | 0 | 2 | 100 |
| 2. Referring Physician/Pathologist | 18 | 0 | 2 | 100 |
| 3. Address | 14 | 4 | 2 | 77.78 |
| 4. Phone number | 16 | 2 | 2 | 88.89 |
| 5. Fax number | 14 | 4 | 2 | 77.78 |
| 6. Email address | 14 | 4 | 2 | 77.78 |
| 7. Date of Biopsy | 18 | 0 | 2 | 100 |
| 8. In-patient/Out-patient | 15 | 3 | 2 | 83.33 |
| 9. Last Name | 18 | 0 | 2 | 100 |
| 10. First Name | 18 | 0 | 2 | 100 |
| 11. Middle Name/Initials | 16 | 2 | 2 | 88.89 |
| 12. Date of Birth | 18 | 0 | 2 | 100 |
| 13. Age | 18 | 0 | 2 | 100 |
| 14. Ethnicity | 13 | 5 | 2 | 72.22 |
| 15. Chief Complaint | 17 | 1 | 2 | 94.44 |
| 16. Living donor or deceased donor | 17 | 1 | 2 | 94.44 |
| 17. Date of transplant | 17 | 1 | 2 | 94.44 |
| 18. Indication for transplant | 17 | 1 | 2 | 94.44 |
| 19. Time 0 biopsy findings | 14 | 4 | 2 | 77.78 |
| 20. Previous biopsy findings including C4d (if applicable) | 15 | 3 | 2 | 83.33 |
| 21. History of BK viremia | 17 | 1 | 2 | 94.44 |
| 22. Presensitization | 16 | 2 | 2 | 88.89 |
| 23. Diabetes | 16 | 2 | 2 | 88.89 |
| 24. HA1C | 13 | 5 | 2 | 72.22 |
| 25. Random Blood Sugar | 7 | 11 | 2 | 38.89 |
| 26. Obesity | 13 | 5 | 2 | 72.22 |
| 27. BMI/height/weight | 12 | 6 | 2 | 66.67 |
| 28. Malignancy | 15 | 3 | 2 | 83.33 |
| 29. Hypertension | 15 | 3 | 2 | 83.33 |
| 30. Average Blood Pressure | 10 | 8 | 2 | 55.56 |
| 31. Family history of renal disease | 13 | 5 | 2 | 72.22 |
| 32. Recent infection | 15 | 3 | 2 | 83.33 |
| 33. Recurrent UTI | 15 | 3 | 2 | 83.33 |
| 34. Posttransplant hematoma | 9 | 9 | 2 | 50 |
| 35. History of alcohol abuse | 9 | 9 | 2 | 50 |
| 36. History of smoking | 13 | 5 | 2 | 72.22 |
| 37. History of drug abuse | 14 | 4 | 2 | 77.78 |
| 38. Chemical exposure | 14 | 4 | 2 | 77.78 |
| 39. Nephrotic Syndrome | 16 | 2 | 2 | 88.89 |
| 40. Acute Nephrotic syndrome | 14 | 4 | 2 | 77.78 |
| 41. Acute renal failure | 16 | 2 | 2 | 88.89 |
| 42. RPGN | 13 | 5 | 2 | 72.22 |
| 43. Isolated Hematuria (Micro/Macro) | 16 | 2 | 2 | 88.89 |
| 44. Isolated Proteinuria | 17 | 1 | 2 | 94.44 |
| 45. Chronic kidney disease | 15 | 3 | 2 | 83.33 |
| 46. Delayed graft function | 15 | 3 | 2 | 83.33 |
| 47. Other (Please indicate) | 14 | 4 | 2 | 77.78 |
| 48. Antibiotics | 14 | 4 | 2 | 77.78 |
| 49. Antihypertensive | 12 | 6 | 2 | 66.67 |
| 50. NSAID | 15 | 3 | 2 | 83.33 |
| 51. Immunosuppression | 17 | 1 | 2 | 94.44 |
| 52. Immunotherapy | 15 | 3 | 2 | 83.33 |
| 53. Chemotherapy | 15 | 3 | 2 | 83.33 |
| 54. CNI | 17 | 1 | 2 | 94.44 |
| 55. Blood level of CNI | 14 | 4 | 2 | 77.78 |
| 56. Serum Creatinine (μmol/L) | 16 | 2 | 2 | 88.89 |
| 57. If serum creatinine raised, is it sudden or gradual? | 15 | 3 | 2 | 83.33 |
| 58. If serum creatinine raised, indicate the last 3 readings | 12 | 6 | 2 | 66.67 |
| 59. Baseline Serum Creatinine | 14 | 4 | 2 | 77.78 |
| 60. Creatinine clearance (ml/min) | 10 | 8 | 2 | 55.56 |
| 61. Current DSA | 16 | 2 | 2 | 88.89 |
| 62. Previous DSA | 16 | 2 | 2 | 88.89 |
| 63. ABO incompatibility | 16 | 2 | 2 | 88.89 |
| 64. ACR (mg/mmol) | 13 | 5 | 2 | 72.22 |
| 65. PCR (mg/mmol) | 14 | 4 | 2 | 77.78 |
| 66. Urine protein (g/24 h) | 15 | 3 | 2 | 83.33 |
| 67. Urine culture (if applicable) | 14 | 4 | 2 | 77.78 |
| 68. Urine Sediment (RBC, WBC, Casts, Crystals) | 15 | 3 | 2 | 83.33 |
| 69. ANA (+/-) | 12 | 6 | 2 | 66.67 |
| 70. ANA titer | 10 | 8 | 2 | 55.56 |
| 71. Anti-dsDNA (+/-) | 12 | 6 | 2 | 66.67 |
| 72. Anti-dsDNA titer | 9 | 9 | 2 | 50 |
| 73. P-ANCA (+/-) | 11 | 7 | 2 | 61.11 |
| 74. P-ANCA titer | 10 | 8 | 2 | 55.56 |
| 75. C-ANCA (+/-) | 11 | 7 | 2 | 61.11 |
| 76. C-ANCA titer | 10 | 8 | 2 | 55.56 |
| 77. RF (+/-) | 10 | 8 | 2 | 55.56 |
| 78. RF titer | 8 | 10 | 2 | 44.44 |
| 79. Anti-GBM (+/-) | 12 | 6 | 2 | 66.67 |
| 80. Anti-GBM titer | 9 | 9 | 2 | 50 |
| 81. Complement (C3,C4) | 12 | 6 | 2 | 66.67 |
| 82. SPEP/UPEP | 12 | 6 | 2 | 66.67 |
| 83. ASO | 11 | 7 | 2 | 61.11 |
| 84. Cryoglobulins | 11 | 7 | 2 | 61.11 |
| 85. HIV (+/-) | 12 | 6 | 2 | 66.67 |
| 86. Hep B (+/-) | 12 | 6 | 2 | 66.67 |
| 87. Hep C (+/-) | 12 | 6 | 2 | 66.67 |
| 88. Other related information | 14 | 4 | 2 | 77.78 |
Abbreviations: HA1C; hemoglobin A1C. BMI; body mass index. RPGN; rapidly progressive glomerulonephritis. NSAID; nonsteroidal anti-inflammatory drug. CNI; calcineurin inhibitors. DSA; donor-specific antibody. ACR; albumin creatinine ratio. PCR; protein creatinine ratio. RBC; red blood cell. WBC; white blood cell. ANA; anti-nuclear antibody. Anti-dsDNA; anti-double-stranded DNA. P-ANCA; perinuclear antineutrophil cytoplasmic antibody. C-ANCA; cytoplasmic antineutrophil cytoplasmic antibody. RF; rheumatoid factor. Anti-GBM; anti-glomerular basement membrane. SPEP; serum protein electrophoresis. UPEP; urine protein electrophoresis. ASO; antistreptolysin O. HIV; human immunodeficiency virus.
Phase 2: To assess the clinical collection forms, we invited 33 nephropathologists to respond to a survey sent individually by e-mail. The participating nephropathologists had various levels of experience in Canadian healthcare institutions. All of them were members of the Nephropathology National Specialty Network (NSN) of the Canadian Association of Pathologists (CAP-ACP). The survey was distributed as a PDF file with a questionnaire divided into two parts: native and transplant renal biopsies. The survey inquired about the necessity of each data element, and the participants were allowed to add comments.
Phase 3: Based on the responses from the nephropathologists, modified forms that could only be completed electronically were distributed as PDF files by e-mail to 80 nephrologists who were asked to complete these forms using hypothetical clinical information as requested by the QIRC to avoid breaching confidentiality. Starting and finishing times were recorded. We encouraged the nephrologists to complete the forms without interruption to better estimate the time needed for completion. However, in case of interruption, the estimated time for completion was recorded. Nephrologists could also comment on the forms. A short survey to assess nephrologists’ user satisfaction was also sent.
The final form was created based on the responses of the nephropathologists and nephrologists to be used on actual patients undergoing renal biopsy for non-neoplastic kidney diseases.
3. Results
Phase 1: Twenty out of 33 (61%) nephropathologists representing 14 Canadian academic medical centers responded to the survey (Table 1, Table 2). Seventeen responses were complete (51.51%), and three were partial (48.5%). They agreed on 98.75% of the data elements (159/161 questions). The agreement rate on the survey questions ranged from 38.89% to 100.00%, averaging 83.33% for the native and 77.14% for the transplant section (Fig. 1). The agreement response was <50% in only two questions within the transplant section. The nephropathologists commented on 84 questions; either by emphasizing the importance of that piece of clinical data, by arguing against the inclusion of a specific question, asking to add more relative information, adding if applicable or if relevant to certain questions, or by considering one form for both native and transplant biopsies.
Fig. 1.
Agreement rate regarding the survey questions, divided into four categories: 1) 0–25%, 2) 26–50%, 3) 51–75%, and 4) 76–100%.
Phase 2: In response, we modified the forms by adding the following items: name of referring nephrologist; health care provider contact information in case of urgent communication needed; the gender; diabetes duration; type and duration of malignancy; type of familial renal disease; systemic symptoms; Bence-Jones proteinuria; and clinical impression. We expanded the list of viruses by adding cytomegalovirus, BK virus, parvovirus (B19), Epstein-Barr virus and COVID-19; and added anti-neutrophil cytoplasmic antibodies specificities (i.e., anti-PR3 and anti-MPO), SSA and SSB antibodies. We received feedback regarding the inclusion of antibody titers, especially in the transplant form, and we agreed that this should be an optional field. Regarding the transplant form, we added the type of kidney allograft biopsy (protocol or indication); medication compliance; coexistence of another solid organ transplant; glomerular syndromes, such as nephrotic syndrome, either recurrent or de novo, isolated proteinuria, and isolated hematuria; history of post-transplant lymphoproliferative disorder; imaging findings; current levels and trends of calcineurin inhibitor. We removed the questions regarding the previous biopsy findings, as the pathologist may have more access to the previous report than the clinician, especially for the in-house cases.
Phase 3: Seventeen out of 80 (21%) nephrologists responded. Twenty-two modified PDF forms (15 native and 7-transplant) were completed (Table 3) on hypothetical patients by 16 staff clinicians/fellows and one nurse from 12 different centers. The starting and finishing times, or time needed for completion, were not recorded in three forms, and the time required to complete a form ranged from 5 to 20 min, with an average of 10.4 min. Eight nephrologists provided comments to express feedback or to require adding or removing specific questions. They suggested adding questions on serum albumin, hemodialysis, and serum light chains and using the estimated glomerular filtration rate instead of creatinine clearance.
Table 3.
The time recorded by the nephrologists or their assistants to complete the form on hypothetical patients.
| Number of responders | Time needed (native)/minute | Time needed (allograft)/minute |
|---|---|---|
| 1 | 15 | NA |
| 2 | 20 | NA |
| 3 | NA | Not recorded |
| 4 | 12 | NA |
| 5 | 10 | 10 |
| 6 | 10 | 10 |
| 7 | 6 | 6 |
| 8 | NA | 10 |
| 9 | 5 | NA |
| 10 | 7 | 8 |
| 11 | Not recorded | Not recorded |
| 12 | 8 | NA |
| 13 | 8 | NA |
| 14 | 11 | NA |
| 15 | 15 | NA |
| 16 | 16 | NA |
| 17 | 11 | NA |
NA: Not available because the form was not completed.
Furthermore, they suggested removing the email address question for the in-house cases. Most nephrologists considered the form time-consuming; however, they supported standardizing data collection to attain a meaningful diagnosis. Regarding responders for the satisfaction survey, only seven nephrologists responded; four (57%) were satisfied with using these forms and would recommend them to their colleagues.
We modified the form in response to the feedback from nephropathologists and nephrologists to be used on actual patients (Table 4) to a link to a PDF algorithmic format that directs the user to one of two pathways: native or transplant biopsies (https://forms.office.com/r/d7DPQiiWf8). The data elements were divided into categories, which may expand depending on responses. We also included a free text field for additional information for patients with uncommon clinical presentations. The completed forms must be returned to the nephropathologist only using a secure institutional email address to protect patient confidentiality. At the end of the form, the users would be asked about their satisfaction and any comments or suggestions that may improve it.
Table 4.
Summary of clinical history elements essential for the clinicopathological diagnosis of medical kidney diseases.
|
Clinician/Nephrologist's information: Name, email, phone number. |
|
Patient's Information: Name, age, sex, ethnicity, medical record number, location (in-patient/out-patient). |
|
Clinical Information: Original Disease, indications of biopsy, type of biopsy (native/allograft). |
|
Native renal biopsy: Clinical syndrome (nephrotic/nephritis syndrome, RPGN, etc.), hypertension, diabetes, obesity, recent infection, malignancy, smoking, drug abuse, alcohol abuse, chemical exposure, systemic symptoms, medications. Allograft renal biopsy: Type of biopsy (protocol, indication), date of transplant, donor (deceased/living), the indication of transplant, other organ transplants, compliance to medication, delayed graft function, post-transplant hematoma, presensitization (e.g. ABO incompatibility), recurrent UTI, past history of polyomavirus nephropathy, PTLD, lymphadenopathy, systemic symptoms, clinical syndrome (nephrotic/nephritis syndrome, RPGN, etc.), hypertension, diabetes, obesity, recent infection, malignancy, smoking, drug abuse, alcohol abuse, chemical exposure, medications. |
|
Laboratory Data: Serum creatinine (current, baseline, trending), 24-h urine protein, ACR, PCR, serum albumin, urine culture, urine sediment, antibody testing (ANA, anti-dsDNA, anti-MPO, anti-PR3, RF, anti-GBM, SSA, SSB, cryoglobulins, ASO), viral infection (Hepatitis B, Hepatitis C, CMV, HIV, BK, parvovirus (B19), EBV, COVID-19), Complements (C3, C4), SPEP/UPEP, light chains, Bence-Jones proteins. For allograft renal biopsy: Current/previous DSA, dd-cfDNA, rejection-associated transcripts. Genetic Data. |
| Kidney imaging finding. |
| Clinical impression/diagnosis. |
Abbreviations: RPGN; rapidly progressive glomerulonephritis. UTI; urinary tract infection. PTLD; post-transplant lymphoproliferative disorder. ACR; albumin creatinine ratio. PCR; protein creatinine ratio. ANA; anti-nuclear antibody. Anti-dsDNA; anti-double-stranded DNA. Anti-MPO; anti-myeloperoxidase. Anti-PR3; anti-proteinase 3. RF; rheumatoid factor. Anti-GBM; anti-glomerular basement membrane. SPEP; serum protein electrophoresis. UPEP; urine protein electrophoresis. DSA; donor-specific antibody. dd-cfDNA: donor-derived cell-free DNA.
4. Discussion
The medical renal biopsy is vital for optimal patient care in the era of personalized and precision medicine, and clinicopathologic correlation is essential for making an accurate integrative diagnosis to guide optimal treatment. The lack of adequate clinical information may result in a diagnosis based only on the disease pattern and failure to describe the pathogenesis, as recommended by the Consensus Report of the Renal Pathology Society [7]. The importance of adequate clinical information in surgical pathology has been addressed before [3] and is a laboratory accreditation standard [8,9].
In terms of quality assurance and improvement, adequate clinical information is a crucial part of the pre-analytical phase of the test cycle [10]. Nakhleh et al. found that clinical information in the pathology requisitions is either missed in 2.4% of the cases [11] or inadequate in 0.73% [3]. Inadequate clinical information may impact the final diagnosis, resulting in errors and an increased rate of amended reports [3,[12], [13], [14]].
Renal pathology publications have advocated for uniform reporting and emphasized the importance of adequate clinical information, including recommending a concise summary of the clinical history [15]. Some publications have mentioned the required information type [7,16,17]. However, a standardized clinical history form has not been proposed for routine use.
In our study, we created a clinical information form that included the most relevant clinical information required for diagnosing and classifying medical renal diseases and invited feedback from nephropathologists. In addition to providing clinical data to support an accurate diagnosis, the form's purpose was to make an efficient workflow and reduce turnaround time (TAT). According to the College of American Pathologists (CAP), TAT is “The day the specimen is accessioned in the lab to the day the final report is signed out. Business days counted only” [18]. Inadequate clinical information may delay reporting [3]. In our experience, this is more notable for external cases in which the accessibility to clinical data is limited. Similar studies in other subspecialties showed that using electronic templates or structured forms in the patients' care is advantageous as this method increases the rate of complete information, expedites data attaining and decreases the timelines [[19], [20], [21]].
The nephropathologist survey obtained a reasonable response rate (20/33, 61%). Nephropathologists agreed with most of the clinical data elements included in our form (159/161, 98.75%) and the importance of good communication between the nephropathologists and nephrologists. The response rate among questions varied, which may reflect variations in participants’ experience level, the work environment/policy, and the accessibility of the electronic health record (EHR). For example, some nephropathologists argued against the inclusion of questions regarding diabetes, hypertension and obesity because that information is available in their EHR. They suggested additional questions related to risk stratification and disease classification. For example, awareness of in-patient versus out-patient status would be helpful in terms of triaging acuity. Interpretation of C4d immunofluorescence staining can be affected by the presence or absence of a history of presensitization [22]. Nodular glomerulosclerosis is a histopathologic type of chronic glomerular injury that frequently occurs in diabetic patients; however, this injury pattern can be seen in other conditions that can be distinguished from diabetic nephropathy by immunofluorescence and electron microscopic findings. Once the possible differential diagnoses are excluded, the term idiopathic nodular glomerulosclerosis is applied; recent studies revealed that this injury could be related to smoking/hypertension, and the availability of comprehensive clinical history can guide the proper clinicopathologic diagnosis as diabetic or smoking/hypertension-related glomerulopathy [23]. Diffuse podocyte foot process effacement is a pathologic term; under which several diseases are underlay. In the absence of any other specific histopathologic findings (e.g. diabetic change, immune deposits, crescentic process, thin glomerular basement membrane), a history of nephrotic syndrome directs the pathologist to favour a diagnosis of the non-adaptive form of diffuse podocytopathy with/without segmental scarring (formerly focal segmental glomerulosclerosis/minimal change disease) [24].
Only 17 of 80 nephrologists responded to this survey. The response rate was less than expected. However, the average time to complete the form was about 10 min. Nevertheless, some participants believed it would likely be longer for actual patients. Although most participants found the form redundant and too long, they supported the standardization of clinical data-collecting form for future use on actual patients.
The final form that we proposed (https://forms.office.com/r/d7DPQiiWf8), Table 4, would be more practical as we made our effort to include the most relative clinical information needed by the nephropathologists for clinicopathological diagnosis. At the same time, the form was shortened to satisfy our clients, the nephrologists.
5. Conclusions
Clinical data is crucial for an accurate diagnosis in renal pathology, and if well-organized, easily accessible information is available to the pathologist and the quality of the service might reduce TAT. An electronic clinical data collection form designed for native and allograft renal biopsies has been developed through consensus by nephropathologists in Canada. Although focused on the kidney, the form could be used by other medical pathology subspecialties, such as lung pathology, where clinical information is needed for clinicopathological correlations. It is currently under use with actual patients improving the efficiency and TAT of the renal pathology service. The evaluation will be made after we obtain a nearly comparable number of responses from the serviced centers and nephrologists of different levels of experience. This may be achieved within one to two years. The assessment would be performed through the attending nephropathologist.
Author contributions
1 - Conceived and designed the experiments; CAC, SAQ, RF and PG.
2 - Performed the experiments; CAC, SAQ, RF and LG.
3 - Analyzed and interpreted the data; SAQ, RF and SRR.
4 - Contributed reagents, materials, analysis tools or data; SAQ and RF.
5 - Wrote the paper; SAQ, LG and CAC.
Funding
This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
Declaration of competing interest
The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
References
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