36C10X19Q0200-017.pdf

Review of Gastrointestinal (GI) Look Back Study: Executive Summary

Background External review was conducted about the impact of a delay in evaluation and diagnosis of a potential gastrointestinal malignancy. A total of 251 cases with a pre-established delay in a GI procedure was assigned to reviewers, board certified in hematology-oncology. A “delay” in a

GI malignancy diagnosis was defined as 1) the time interval of greater than 60 days between the date of a positive fecal occult blood test (FIT/FOBT) and the date the GI endoscopy (e.g. upper endoscopy or colonoscopy) was performed; or 2) the time interval of greater than 60 days between the date of the GI consult referral and the date the GI endoscopy was performed. “No delay” in a GI malignancy diagnosis was defined as 1) the time interval of within 60 days between the date of a positive FIT/FOBT result and the date of the GI endoscopy procedure; or 2) the time interval within 60 days between the date of the

GI consult referral and the date of the GI endoscopy procedure. This report summarizes the reviewers’ findings for these 251 cases.

Methods The reviewers were provided with the following information to complete the case reviews:

Type of cancer that was diagnosed

Date of the cancer diagnosis

Date of the positive FIT/FOBT test (if available)

Date of the referral for a gastroenterology consult (if available)

Date of the endoscopy procedure (e.g. upper endoscopy, colonoscopy)

It was initially expected that all of the patients had a cancer diagnosis and a delay of at least 60 days from the date of the positive FIT/FOBT result or GI referral to the date of the performance of an endoscopy procedure; however, according to the data provided by the VA, some patients did not meet these conditions. The patient cases were thus classified into 2 groups: group 1 patients with a documented delay of at least 60 days, and group 2 patients with no documented delay.

The oncology reviewers were instructed to:

“Focus on the impact to the patient of the pre-established delay of completing the endoscopy procedure and reaching a diagnosis.”

For group 1 patients, the reviewers completed the following VA-derived questions:

1. Did the patient experience an advance in disease (malignancy) in direct relationship to the delay in diagnosis which was associated with an increase in morbidity/mortality?

2. Did the patient experience an advance in disease (malignancy) in direct relationship to the delay in diagnosis which required a more aggressive treatment (chemotherapy, surgery) with an increased risk in morbidity/mortality?

The following definitions were used in the evaluation of the impact on the patient:

Harm when the reviewer answered ‘Yes’ to question 1 and/or question 2

No Harm when the reviewer answered ‘No’ to both questions 1 and 2.

For group 2 patients, the reviewers completed the following VA-derived questions:

1. Was a GI endoscopy warranted for any reason between and ?

2. If so, was there a clinically significant delay in obtaining it?

3. If GI endoscopy was not warranted, was the patient’s management within the standard of care for investigating any presenting GI symptoms and/or screening test results?

4. If the patient refused further testing/treatment, were all appropriate steps taken to contact the patient and encourage further testing/treatment?

5. Was documentation of the refusal and discussion of the implications of the refusal within the standard of care?

Individual case report findings are provided to the VA. Each case report includes the reviewer’s responses to the appropriate questions, a synopsis of the case, and a narrative explanation for the

“harm” or “no harm” determination.

Results As shown in Table 1, a total of 251 cases were reviewed. Among these, 193 cases had a documented delay in a GI cancer diagnosis. Fifty-eight cases had no documented delay in a GI cancer diagnosis, no GI cancer diagnosis, or incomplete patient information; thus, these cases did not meet the review criteria of the patient cases having a pre-established delay in the procedure and GI malignancy and would be excluded from the “harm” or “no harm” calculated ratios.

Table 2 shows the reviewers’ assessments of “harm” with untimely diagnostic testing, the association between the delay in diagnosis and potential advancement of the disease with increased morbidity or mortality, and the association between the delay in diagnosis and the need for more aggressive treatment. Of the 193 patients with a delay in GI cancer diagnosis, 45 (23.3%) patients experienced an advance in disease (malignancy). For 37 (19.2%) patients, the delay in diagnosis resulted in the need for more aggressive treatment (e.g. chemotherapy, radiation, and/or surgery). Among 193 patients who met the review criteria, the proportion of the delay in diagnosis and an assessment of

“harm” was 23.3% (45/193), and the proportion of delay in diagnosis and an assessment of “no harm” was 76.7% (148/193).

Table 3 describes the reviewer’s responses on whether 1) GI endoscopy was warranted, 2) the patient’s management was within the standard of care for investigating any presenting GI symptoms and/or screening test results, 3) appropriate steps were taken to contact the patient and encourage further testing/treatment, and 4) the refusal documentation and discussion of the implications of the refusal were within the standard of care. Of the total of 58 patient cases, 52 (89.7%) GI endoscopies were warranted for any reason between and . Twenty-three (39.7%) GI endoscopies appeared to have clinically significant delays in their completion. Six (10.3%) patients’ management was within the standard of care for investigating any presenting GI symptoms and/or screening test results. Seven (12.1%) patients refused further testing/treatment and all appropriate steps were taken to contact the patient. Six (10.3%) patient cases included documentation of the patient refusal and discussion of the implications of the refusal.

Table 1. Patient Characteristics

Characteristics Number of Cases

Delay in GI cancer diagnosis 193

No delay in GI cancer diagnosis 37

No GI cancer diagnosis 4

Incomplete patient information 17

Total 251

Table 2. Reviewer responses to the review questions for patients who had delay in gastrointestinal malignancy diagnosis

VISN

Total

Q1:

Did the patient experience an advance in disease (malignancy) in direct relationship to the delay in diagnosis which was associated with an increase in morbidity/mortality?

Q2:

Did the patient experience an advance in disease (malignancy) in direct relationship to the delay in diagnosis which required a more aggressive treatment (chemotherapy, surgery) with an increased risk in morbidity/mortality?

Harm*

No Harm**

Yes No Yes No Yes Yes

1 3 1 2 1 2 1 2

2 4 2 2 1 3 2 2

3 12 1 11 1 11 1 11

4 8 2 6 0 8 2 6

5 3 0 3 0 3 0 3

6 7 1 6 1 6 1 6

7 17 6 11 6 11 6 11

8 33 8 25 7 26 8 25

9 17 4 13 3 14 4 13

10 7 0 7 0 7 0 7

11 5 3 2 2 3 3 2

12 4 1 3 0 4 1 3

15 6 0 6 0 6 0 6

16 14 1 13 1 13 1 13

17 16 3 13 2 14 3 13

18 4 2 2 2 2 2 2

19 2 1 1 1 1 1 1

20 4 1 3 1 3 1 3

21 8 3 5 3 5 3 5

22 12 4 8 4 8 4 8

23 7 1 6 1 6 1 6

All VISNs

193 45 (23.3%)

(76.7%)

(19.2%)

(80.8%)

(23.3%)

(76.7%)

*Harm: The reviewer answered ‘Yes’ to Q1 and/or Q2 **No Harm: The reviewer answered ‘No’ to both Q1 and Q2

Table 3. Reviewer responses to the review questions for patients who had no delay in gastrointestinal malignancy diagnosis, no gastrointestinal cancer diagnosis, and incomplete patient information

Questions Total Yes (%) No (%)

Was a GI endoscopy warranted for any reason between and ?

52 (89.7) 6 (10.3)

If so, was there a clinically significant delay in obtaining it? 23 (39.7) 21 (36.2)

If GI endoscopy was not warranted, was the patient’s management within the standard of care for investigating any presenting GI symptoms and/or screening test results?

6 (10.3)

If the patient refused further testing/treatment, were all appropriate steps taken to contact the patient and encourage further testing/treatment?

7 (12.1)

3 (5.2)

Was documentation of the refusal and discussion of the implications of the refusal within the standard of care?

6 (10.3) 3 (5.2)

Conclusion This executive summary or appendix includes a descriptive analysis of 251 cases provided from the VA for external review. Of these cases reported to have had a pre-established delay in GI cancer diagnosis, 45 did have harm. There were 193 patient cases with a pre-established delay in GI cancer diagnosis.

From these cases the reviewers’ assessments were “harm” at 23.3% and “no harm” at 76.7%. The reviewers noted the delays in completion of the GI endoscopy procedures were due to patient-related factors (e.g. associated medical comorbidities that required urgent medical treatment), administrative or systems’ issues (e.g. scheduling problems), or treating practitioner-related (e.g. referral problems) factors. The reviewer assessment of “harm” in relation to the delay in the GI procedure included consideration of the history of the patient’s presenting symptoms, pathologic diagnosis of the GI malignancy, any disease advancement, and the need for more aggressive treatment.