Outcome Measures Other than Morbidity and Mortality for Patients with Incurable Cancer and Gastrointestinal Obstruction

Abstract

Objective:

To prospectively evaluate outcome measures of patients undergoing palliative surgical evaluation for gastrointestinal obstruction.

Methods:

Patients with an incurable malignancy undergoing consultation for gastrointestinal obstruction were prospectively enrolled from November 2009 to July 2012. We evaluated two patient-reported outcome measures of quality of life (Functional Assessment of Cancer Therapy-General [FACT-G]) and treatment satisfaction (Functional Assessment of Chronic Illness Therapy-Treatment Satisfaction-General Version 1 [FACIT-TS-G]) and five observational outcome measures (symptom improvement, 30 “good days,” ability to tolerate diet at discharge, discharge home, and death within 90 days).

Results:

Of 53 patients enrolled, 13 had gastric outlet obstruction, 22 had small bowel obstruction, and 18 had large bowel obstruction. Patient-reported measures could not be analyzed because only 19 patients (36%) completed the FACT-G and FACIT-TS-G survey at 1-month follow-up. However, we were able to obtain results for the 5 clinical observational outcomes in all patients. Symptom improvement was obtained in 41 (77%) patients, 30 “good days” in 40 (75%), ability to tolerate diet at discharge in 45 (85%), discharge to home in 46 (87%), and 18 (34%) of patients died within 90 days of evaluation. Large bowel obstruction was associated with symptom improvement, and noncolorectal cancer histology and carcinomatosis were negatively associated with having 30 “good days.” The ability to tolerate oral intake at discharge was associated with Eastern Cooperative Oncology Group performance status and no recent chemotherapy administration. Death within 90 days was independently associated with noncolorectal cancer histology, ascites, and nonsurgical treatment.

Conclusions:

Observational outcome measures can provide follow-up data and the identification of variables associated with outcome for patients who are unable to respond to outpatient surveys.

Introduction

The collection and documentation of surgical outcomes is becoming standard of care for board-certified surgeons in the United States.¹ Traditional surgical outcome measures include morbidity, mortality, disease recurrence, and survival.² Comparison of outcomes has led to the recognition of the increased risk of surgery in patients with advanced malignancy.³ However, traditional outcome measures do not sufficiently capture the results of palliative surgery, whose purpose is to provide relief from symptoms attributable to an incurable malignancy. Morbidity and survival, although important, are not the only factors to consider in a risk-benefit analysis of palliative surgery. The identification of variables that must be considered during consultation is warranted as palliative surgical evaluation is a frequent occurrence at cancer centers and remains a critical component of multidisciplinary cancer care.^4–6

The most common indication for palliative surgical consultation is gastrointestinal obstruction.^6,7 Gastrointestinal obstruction in patients with advanced malignancy is a challenging clinical scenario with dismal median survival rates.⁸ Relatively few studies have focused on outcomes other than morbidity and survival in these patients, and most outcome measures of symptom improvement in these patients are based on retrospective review of the medical record.⁹ Thus, the optimal outcome measure for patients who have incurable cancer and gastrointestinal obstruction has not been defined. In addition, although patient-reported outcome measures are becoming increasingly important in an effort to give patients a better understanding of the treatment and care options available, few studies have investigated their use as markers of palliative surgery success.¹⁰ Therefore, the purpose of this pilot study was to prospectively evaluate patient-reported outcomes and observational outcome measures of patients who underwent palliative surgical evaluation for gastrointestinal obstruction. In addition, we sought to identify the clinical and demographic variables associated with those outcomes.

Patients and Methods

Patients

The study cohort was identified from patients evaluated in the outpatient clinics of The Winthrop P. Rockefeller Cancer Institute and inpatients hospitalized at The University of Arkansas for Medical Sciences Hospital from November 2009 to July 2012. Patients with an incurable malignancy referred for surgical consultation for gastrointestinal obstruction were prospectively enrolled. Patients were cared for in accordance with their desires with input from the surgical consultation service and attending surgeon. Only patients undergoing evaluation for surgery with palliative intent, defined as a consultation for a procedure with the primary intention of improving quality of life or relieving symptoms, were eligible for the study. Patients undergoing evaluation for potentially curative surgery, patients undergoing consultation for postsurgical or postprocedural complications, and patients less than 18 years of age or with mental status alterations preventing them from answering questionnaires were excluded. Patients' written informed consent to be included in the study was obtained at the time of their enrollment. The study was approved by The University of Arkansas for Medical Sciences Institutional Review Board.

The demographic and clinicopathologic variables obtained at the time of patients' enrollment into the study included age, gender, marital status, race, education, and work status. Clinical and cancer-related variables included malignancy type, site of obstruction (gastric outlet, small bowel, or large bowel), presence of multifocal obstruction, Eastern Cooperative Oncology Group (ECOG) performance status, baseline quality of life score, bed status (inpatient or clinic patient), and chemotherapy administration within 6 weeks.^11,12 A multifocal obstruction was defined as an obstruction with more than one point of transition or obstruction demonstrated on imaging. Laboratory parameters included white blood cell count, hemoglobin level, platelet count, albumin level, and prealbumin level. The extent of disease on imaging included the presence of an intact primary or recurrent tumor, abdominal visceral metastases, abdominal/chest lymphadenopathy, ascites, bone metastases, brain metastases, lung metastases, carcinomatosis/sarcomatosis, and subcutaneous/soft tissue metastases. Treatment was categorized as nonoperative/nonprocedural, procedural (endoscopic or interventional radiology procedures), and surgical. Patients who initially received nonoperative/nonprocedural care but required procedural/surgical therapy within 4 weeks were categorized as procedural/surgical patients for purposes of outcomes measures.

Outcome measures

Outcome measures included patient-reported measures of quality of life and treatment satisfaction. The Functional Assessment of Cancer Therapy-General (FACT-G), a 27-item validated questionnaire designed to assess the severity and impact of symptoms on daily functioning for patients with symptoms due to cancer and cancer treatment, was used to assess quality of life.¹² Subscales of the FACT-G include physical, social/family, emotional, and functional well-being. The recall time is 7 days. We administered the questionnaire through interviews conducted in person or over the phone.¹² The Functional Assessment of Chronic Illness Therapy-Treatment Satisfaction-General Version 1 (FACIT-TS-G) questionnaire, an 8-item instrument, was used to assess treatment satisfaction.

Five observational outcomes were also assessed: (1) symptom improvement for bowel obstruction, (2) 30 “good days,” (3) ability to tolerate oral intake, (4) discharge status, and (5) death within 90 days. Symptom improvement for bowel obstruction was defined as the lack of a need for a nasogastric tube and the ability to tolerate some oral intake, similar to previous reports.^5,7 This definition allowed for the addition of supplementary tube feeding as long as the patient was able to tolerate oral intake; however, a requirement for total parenteral nutrition was considered a lack of improvement. The number of “good days” was defined as the number of days out of the hospital.¹³ The ability to achieve 30 “good days” was calculated from the date of consultation for patients who received nonoperative/nonprocedural treatment, surgery, and procedural treatment. The ability to tolerate oral intake at discharge was defined as the intake of a regular or full liquid diet. The ability to tolerate a clear liquid diet only was classified as not being able to tolerate oral intake at discharge. An additional outcome variable was discharge status to home. Discharge status allowed for the inclusion of home nursing, home physical therapy, and home hospice services. The last clinical observational outcome measure was death within 90 days of consultation. All 5 clinical observational outcomes were binary measures.

Follow-up

Patients were followed for recurrent symptoms. Follow-up questionnaires and stamped return envelopes addressed to the study coordinator were mailed to patients 1 month after evaluation. At the time of their initial evaluation, patients received instructions about completing surveys and were told to expect the follow-up questionnaires at the appropriate follow-up periods. Telephone contact was used to remind patients to respond to the surveys and to answer any additional questions. In addition, attempts were also made to obtain follow-up survey results at surgical follow-up appointments and appointments with other services. During the last 6 months of the study, we provided gift card incentives for study participation.

Statistical analysis

Univariate analyses were performed to test the significance of each variable in relation to the outcomes using the χ² test or Fisher's exact test for categorical variables.¹⁴ Multivariate logistic regression analysis was used to assess the relationship between patients' demographic and clinical characteristics and outcomes.¹⁵ We used the SAS software program version 9.2 (SAS Institute Inc., Cary, NC) and S-Plus software program version 8.04 (TIBCO Software Inc., Palo Alto, CA) to perform all analyses.

Results

Patients' baseline demographic and clinical variables are given in Table 1. Of the 53 patients (29 men and 24 women) enrolled in the present study, 13 (25%) had gastric outlet obstruction, 22 (42%) had small bowel obstruction, and 18 (34%) had large bowel obstruction. Approximately 50% of the patients had colorectal malignancies; only 25% of the patients had multifocal bowel obstruction. Most patients (53%) had an ECOG score of 2; only 15% of patients had an ECOG score of 3 or 4. Patients' median baseline FACT-G score was 72 (range, 30–101). Imaging studies revealed an intact primary or recurrent tumor, abdominal visceral metastases, ascites, and carcinomatosis/sarcomatosis in 75%, 57%, 28%, and 38% of patients, respectively. Most patients (59%) had ≥3 sites of disease identified on preevaluation imaging. Fifteen percent, 10%, and 75% of patients received nonoperative/nonprocedural, procedural, or surgical treatment, respectively.

Table 1.

Demographic and Clinical Variables of Fifty-Three Patients with Incurable Cancer and Gastrointestinal Obstruction

Variable	No. of patients (%)
Median age, years (range)	57 (36–86)
Gender
Female	24 (45)
Male	29 (55)
Marital status
Married	24 (45)
Widowed	5 (9)
Divorced/separated	17 (33)
Single	7 (13)
Race
White	38 (72)
Black	14 (26)
Asian	1 (2)
Education
Middle school	3 (6)
Some high school	8 (15)
High school diploma/GED	23 (43)
Some college	15 (28)
College degree	1 (2)
Graduate/professional degree	3 (6)
Work status
Working full time	4 (8)
Working part time	4 (8)
Able to work but unemployed	2 (4)
Unable to work	28 (53)
Retired	15 (28)
Malignancy type
Colorectal cancer	26 (49)
Other	27 (51)
Obstruction site
Gastric outlet	13 (25)
Small bowel	22 (42)
Large bowel	18 (34)
Multifocal bowel obstruction
No	40 (75)
Yes	13 (25)
ECOG performance status
0	2 (4)
1	15 (28)
2	28 (53)
3	7 (13)
4	1 (2)
Median baseline FACT-G score (range)	72 (30–101)
Inpatient status
Clinic patient	10 (19)
Inpatient	43 (81)
Chemotherapy ≤6 weeks
No	44 (83)
Yes	9 (17)
WBC count
<3,000/μL	0
3,000-12,000/μL	42 (79)
>12,000/μL	11 (21)
Median hemoglobin level, g/dL (range)	10.1 (6.6–14.6)
Median platelet count,×10³/μL (range)	274 (75–795)
Median albumin level, g/dL (range)	2.3 (1.2–3.7)
Median prealbumin level, mg/dL (range)	9.6 (3–31.3)
Extent of disease on imaging studies
Intact primary/recurrent tumor	40 (75)
Abdominal visceral metastases	30 (57)
Abdominal/chest lymphadenopathy	18 (34)
Ascites	15 (28)
Bone metastases	4 (8)
Brain metastases	2 (4)
Lung metastases	16 (30)
Carcinomatosis/sarcomatosis	20 (38)
Subcutaneous/soft tissue metastases	3 (6)
No. of disease sites on imaging studies
1	8 (15)
2	14 (26)
≥3	31 (59)
Treatment
Nonoperative/nonprocedural	8 (15)
Procedural	5 (10)
Surgical	40 (75)

GED, General Equivalency Degree; ECOG, Eastern Cooperative Oncology Group; FACT-G, Functional Assessment of Cancer Therapy–General.

Only 19 patients (36%) completed both the FACT-G and FACIT-TS-G surveys at 1-month follow-up. The median FACT-G score was 68 (standard deviation, 15.8) while the median Treatment Satisfaction score was 81 (standard deviation, 31) at 1-month follow-up. Limited response therefore excluded quality of life and treatment satisfaction as outcome variables in the univariate analysis. Thus, only the outcome measures of (1) symptom improvement, (2) 30 “good days,” (3) oral intake at discharge, (4) discharge to home, and (5) death within 90 days were included in the analysis. Forty-one patients (77%) experienced symptom improvement; of these patients, 5 (12%) experienced recurrence within 90 days. Forty patients (75%) had 30 “good days.” Forty-five patients (85%) tolerated an oral diet at discharge and 46 patients (87%) were discharged home. The 10 patients initially evaluated on an outpatient basis were all treated with surgery and therefore included in the analysis for discharge home after surgery. Eighteen patients (34%) died within 90 days.

Univariate analysis

The results of the univariate analysis for factors associated with the outcome measures of symptom improvement, 30 “good days,” and the ability to tolerate oral intake at discharge are shown in Table 2. Ability to work and site of obstruction classified as large bowel were associated with symptom improvement. Colorectal cancer histology, small bowel or large bowel obstruction, and lack of carcinomatosis on imaging were associated with 30 “good days.” Education and work status, small bowel or large bowel obstruction, lack of recent chemotherapy, and the finding of no ascites or carcinomatosis on imaging were associated with the ability to tolerate a diet at discharge.

Table 2.

Univariate Analysis for Association of Patient Variables with the Observational Outcome Measures Symptom Improvement, Thirty Good Days, and Ability to Tolerate Oral Intake at Discharge

	Improved			30 Good days			Oral intake at discharge
Variable	Yes (n=41)	No (n=12)	p	Yes (n=40)	No (n=13)	p	Yes (n=45)	No (n=8)	p
Age, years
<65	32	8	0.46	31	9	0.71	34	6	1
≥65	9	4		9	4		11	2
Gender
Female	18	6	0.71	17	7	0.48	19	5	0.44
Male	23	6		23	6		26	3
Marital status
Not married	21	8	0.51	22	7	0.94	23	6	0.27
Married	20	4		18	6		22	2
Race
Other	14	1	0.14	10	5	0.48	14	1	0.42
White	27	11		30	8		31	7
Education
<High school degree	7	4	0.24	8	3	1	7	4	0.05
≥High school degree	34	8		32	10		38	4
Work status
Unable to work	18	10	0.02	20	8	0.54	21	7	0.05
Working/retired	23	2		20	5		24	1
Malignancy type
Other	18	9	0.10	16	11	0.01	21	6	0.25
Colorectal	23	3		24	2		24	2
Gastric outlet obstruction
No	32	8	0.46	31	9	0.71	34	6	1
Yes	9	4		9	4		11	2
Small bowel obstruction
No	26	5	0.20	27	4	0.03	29	2	0.05
Yes	15	7		13	9		16	6
Large bowel obstruction
No	24	11	0.04	22	13	<0.01	27	8	0.04
Yes	17	1		18	0		18	0
Multifocal bowel obstruction
No	31	9	1	32	8	0.27	35	5	0.39
Yes	10	3		8	5		10	3
ECOG performance status
≤2	37	8	0.07	35	10	0.39	40	5	0.09
>2	4	4		5	3		5	3
Baseline quality of life score
≤70	18	5	1	16	7	0.38	19	4	0.72
>70	23	7		24	6		26	4
Inpatient status
Outpatient	9	1	0.42	10	0	0.1	10	0	0.33
Inpatient	32	11		30	13		35	8
Chemotherapy ≤6 weeks
No	36	8	0.18	34	10	0.67	40	4	0.02
Yes	5	4		6	3		5	4
WBC count
≤12,000/μL	32	10	1	31	11	0.71	35	7	1
>12,000/μL	9	2		9	2		10	1
Albumin level, g/dL
≤2	8	4	0.43	10	2	0.71	9	3	0.36
>2	33	8		30	11		36	5
Intact primary/recurrent tumor
No	9	4	0.46	9	4	0.71	10	3	0.39
Yes	32	8		31	9		35	5
Abdominal visceral metastases
No	17	6	0.60	17	6	0.82	18	5	0.27
Yes	24	6		23	7		27	3
Abdominal/chest lymphadenopathy
No	27	8	1	29	6	0.08	31	4	0.42
Yes	14	4		11	7		14	4
Ascites
No	31	7	0.29	31	7	0.10	35	3	0.03
Yes	10	5		9	6		10	5
Bone metastases
No	38	11	1	37	12	1	42	7	0.49
Yes	3	1		3	1		3	1
Lung metastases
No	27	10	0.31	26	11	0.30	30	7	0.41
Yes	14	2		14	2		15	1
Carcinomatosis/sarcomatosis
No	27	6	0.32	28	5	0.05	31	2	0.04
Yes	14	6		12	8		14	6
Subcutaneous/soft tissue metastases
No	39	11	0.55	39	11	0.15	43	7	0.39
Yes	2	1		1	2		2	1
No. of disease sites on imaging studies
<3	16	6	0.50	18	4	0.52	19	3	1
≥3	25	6		22	9		26	5
Treatment
Nonsurgical	8	5	0.14	8	5	0.27	9	4	0.09
Surgical	33	7		32	8		36	4

ECOG, Eastern Cooperative Oncology Group; WBC, white blood cell.

The results of the univariate analysis for factors associated with the outcome measures of discharge to a skilled nursing facility and death within 90 days of consultation are shown in Table 3. No patient characteristics were associated with discharge to home. However, malignancy type (other than colorectal cancer), site of obstruction, inpatient status, presence of ascites or carcinomatosis on imaging, and non-surgical treatment were associated with death within 90 days of consultation.

Table 3.

Univariate Analysis for Association of Patient Variables with the Observational Outcome Measures Discharge Home and Death within Ninety Days

	Discharge home			Death within 90 days
Variable	Yes (n=46)	No (n=7)	p	Yes (n=18)	No (n=35)	p
Age, years
<65	36	4	0.34	13	27	0.74
≥65	10	3		5	8
Gender
Female	22	2	0.44	10	14	0.28
Male	24	5		8	21
Marital status
Not married	26	3	0.69	11	18	0.50
Married	20	4		7	17
Race
Other	11	4	0.09	4	11	0.54
White	35	3		14	24
Education
<High school degree	9	2	0.63	5	6	0.48
≥High school degree	37	5		13	29
Work status
Unable to work	25	3	0.69	10	18	0.78
Working/retired	21	4		8	17
Malignancy type
Other	22	5	0.42	14	13	0.01
Colorectal	24	2		4	22
Gastric outlet obstruction
No	36	4	0.34	11	29	0.08
Yes	10	3		7	6
Small bowel obstruction
No	27	4	1	7	24	0.04
Yes	19	3		11	11
Large bowel obstruction
No	29	6	0.40	18	17	<0.01
Yes	17	1		0	18
Multifocal bowel obstruction
No	36	4	0.34	13	27	0.74
Yes	10	3		5	8
ECOG performance status
≤2	38	7	0.58	14	31	0.42
>2	8	0		4	4
Baseline quality of life score
≤70	20	3	1	8	15	0.91
>70	26	4		10	20
Inpatient status
Outpatient	10	0	0.32	0	10	0.01
Inpatient	36	7		18	25
Chemotherapy ≤6 weeks
No	37	7	0.33	13	31	0.24
Yes	9	0		5	4
WBC count
≤12,000/μL	38	4	0.15	16	26	0.30
>12,000/μL	8	3		2	9
Albumin level, g/dL
≤2	10	2	0.65	5	7	0.73
>2	36	5		13	28
Intact primary/recurrent tumor
No	11	2	1	5	8	0.74
Yes	35	5		13	27
Abdominal visceral metastases
No	18	5	0.22	10	13	0.20
Yes	28	2		8	22
Abdominal/chest lymphadenopathy
No	32	3	0.21	10	25	0.25
Yes	14	4		8	10
Ascites
No	32	6	0.66	9	29	0.01
Yes	14	1		9	6
Bone metastases
No	42	7	1	17	32	1
Yes	4	0		1	3
Lung metastases
No	31	6	0.66	15	22	0.21
Yes	15	1		3	13
Carcinomatosis/sarcomatosis
No	29	4	1	8	25	0.05
Yes	17	3		10	10
Subcutaneous/soft tissue metastases
No	43	7	1	16	34	0.26
Yes	3	0		2	1
No. of disease sites on imaging studies
<3	18	4	0.43	7	15	0.78
≥3	28	3		11	20
Treatment
Nonsurgical	11	2	1	9	4	0.01
Surgical	35	5		9	31

ECOG, Eastern Cooperative Oncology Group; WBC, white blood cell.

Multivariate analysis

The results of the multivariate analysis for association with observational outcome measures are given in Table 4. Multivariate analysis revealed that the variables independently associated with symptom improvement included working or retired work status (odds ratio [OR], 6.58, 95% confidence interval [CI], 1.34–32.3) and large bowel obstruction (OR, 7.03; 95% CI, 1.03–48.07). Variables independently associated with 30 “good days” were colorectal cancer histology (OR, 13.86; 95% CI, 2.17–88.29) and the presence of carcinomatosis or sarcomatosis on imaging (OR, 0.14; 95% CI, 0.03–0.71). Variables adversely associated with tolerating oral intake at discharge included an ECOG performance status >2 (OR, 0.12; 95% CI, 0.02–0.9) and chemotherapy within 6 weeks of consultation (OR, 0.08; 95% CI, 0.01–0.56). No variables were independently associated with discharge to home. Variables independently associated with death within 90 days of consultation included colorectal cancer histology (OR, 0.12; 95% CI, 0.02–0.6), presence of ascites on imaging (OR, 5.56; 95% CI, 1.1–28.02), and surgical treatment (OR, 0.13; 95% CI, 0.03–0.7).

Table 4.

Multivariate Analysis for Association of Patient Variables with Observational Outcome Measures

Variable	Odds ratio	95% CI
Symptom improvement
Work status (working/retired vs. unable to work)	7.03	1.03–48.07
Large bowel obstruction (yes vs. no)	6.58	1.34–32.30
Thirty good days
Malignancy type (colorectal cancer vs. other)	13.86	2.17–88.29
Carcinomatosis/sarcomatosis (yes vs. no)	0.14	0.03–0.71
Oral intake at discharge
ECOG performance status (>2 vs. ≤2)	0.12	0.02–0.90
Chemotherapy ≤6 weeks (yes vs. no)	0.08	0.01–0.56
Death within 90 days
Malignancy type (colorectal cancer vs. other)	0.12	0.02–0.60
Ascites (yes vs. no)	5.56	1.1–28.02
Treatment (surgical vs. nonsurgical)	0.13	0.03–0.70

CI, confidence interval; ECOG, Eastern Cooperative Oncology Group.

Discussion

In this pilot study, we evaluated observational and patient-reported outcomes of 53 patients undergoing palliative surgical consultation for gastrointestinal obstruction. Follow-up rates of clinical observational outcomes were excellent: rates of symptom improvement, 30 “good days,” oral intake at discharge, and discharge to home were all ≥75%. Approximately one-third of the patients in the present study died within 90 days of consultation. However, patient-reported outcomes could not be analyzed because only 36% of patients provided information about these outcomes at 1-month follow-up.

A common criticism of the existing palliative surgery literature is that the majority of outcomes continue to focus on morbidity and mortality.⁹ The observational outcomes evaluated in the present study were chosen on the basis of a thorough literature review. Symptom improvement, ability to tolerate diet, discharge disposition, and number of “good days” have all been utilized in other studies or suggested by established experts in palliative care.^5,13,16–18 We included discharge status because many patients desire to remain at home during their final days of life.¹⁹ A previous study of patients with recurrent gastrointestinal cancer undergoing surgery for malignant bowel obstruction found that only 4 of 15 patients with ascites and carcinomatosis were able to be discharged to home after operation and suggests that we should monitor this outcome closely to better inform patients of their anticipated discharge status prior to surgery.²⁰ Resumption of oral intake as an outcome measure has been used in several studies was therefore included in the present study.^18,20,21 We also included a survival outcome (death within 90 days of consultation) because many other studies have used survival outcomes and palliative care should not necessarily exclude the hope of longer survival.²² Although improved quality of life may lead to improved length of life, finding a nonsurgical means of palliation within the last few months of life may also be important.

Using patient-reported outcomes in palliative surgical research remains challenging. Patient-reported outcomes help provide patients with a better understanding of available treatment options and outcomes and thereby facilitate improved decision-making regarding care. In the present study, we used the FACT-G to measure patients' physical, social, emotional, and functional well-being, promote patient engagement, and include meaningful outcomes in our analysis. Similar to other reports, however, we found that disease progression and the burden of questionnaire completion resulted in poor response rates.²³

We have attempted to identify variables associated with our outcome measures. Although the primary purpose of this study was to use observational and patient-reported outcomes to gauge the success of palliative surgery in patients with incurable cancer and gastrointestinal obstruction, we also sought to identify patient variables associated with these outcome measures that could be more thoroughly evaluated in subsequent larger studies. We found that colorectal cancer histology was predictive of achieving 30 “good days” and not dying within 90 days, likely because colorectal cancer is less aggressive than other malignancies such as hepatopancreatobiliary or gastroesophageal cancer. Similarly, the rate of symptom improvement associated with large bowel obstruction was higher than that associated with gastric outlet or small bowel obstruction. Performance status and recent chemotherapy administration must be considered when determining a patient's ability to tolerate oral intake at discharge, and we continue to use these variables in preoperative discussions and to anticipate patients' needs at discharge. Although no variables were associated with discharge home, this measure might be better addressed with indicators of frailty or a comprehensive geriatric assessment, as 25% of the patients in the present study were age ≥65 years.

Other researchers have provided many relative and some absolute contraindications for surgical intervention in malignant bowel obstruction based on survival outcome data.^21,24–27 Ascites and carcinomatosis are frequently cited as indicators of poor outcome.^20,21 Some professional associations have even attempted to develop position statements on the management of malignant bowel obstruction, with emphasis on large bowel obstruction.²⁸ In the present study, we confirmed that a few of these variables are associated with outcome and identified other variables that should be investigated in future studies. Future qualitative studies should determine whether patients with varying life expectancies elect to proceed with surgery and help identify the optimal survival outcome endpoint.

This study had several potential limitations. First is the limited quality of life and treatment satisfaction follow-up. Attrition has long been recognized as a considerable challenge in nonsurgical palliative care studies; often, fewer than half of the patients enrolled in these studies reach the end point or are able to provide follow-up data.^29,30 Although one might assume that patients who undergo surgical consultation are healthier than patients included in nonsurgical palliative care studies, our experience suggests that surgical studies need to address attrition as well.²³ In addition to patient death, disease-related fatigue and difficulty concentrating likely impact the rate of patients' questionnaire response. Our efforts at increasing follow-up extended to providing financial incentives for survey response. If survey response had increased, this would have possibly created a bias that would have been difficult to control in statistical analysis utilizing the FACT-G or FACIT-TS scores as outcome measures. In future studies, researchers may consider administering a shorter, minimally burdensome survey at the time of discharge and within a few weeks after discharge.

In conclusion, we identified several observational outcome measures that can be used to assess patients with incurable cancer and gastrointestinal obstruction who receive palliative care and the variables associated with these outcomes. While researchers continue to work to improve methods for using patient-reported outcomes to record follow-up data, observational outcome measures can provide excellent follow-up data in the setting of considerable attrition and for patients who are unable to respond to outpatient surveys. Larger observational studies that focus on specific sites of obstruction are necessary to help determine the optimal management of patients with incurable cancer and gastrointestinal obstruction.

Footnotes

Author Disclosure Statement

No competing financial interests exist.

References

The American Board of Surgery website: MOC Part 4—Practice Assessment Resources. www.absurgery.org/default.jsp?exam-mocpa (Last accessed February 13, 2013).

American College of Surgeons National Surgical Quality Improvement Program website: Data collection, analysis, and reporting. http://site.acsnsqip.org/program-specifics/data-collection-analysis-and-reporting/ (Last accessed February 13, 2013).

Tseng

, Yang

, Wang

, Martinez

, Chen

, Meyers

, Bold

, Canter

: Nomogram to predict risk of 30-day morbidity and mortality for patients with disseminated malignancy undergoing surgical intervention. Ann Surg, 2011; 254:333–338.

Krouse

, Nelson

, Farrell

, Grube

, Juarez

, Wagman

, Chu

: Surgical palliation at a cancer center: Incidence and outcomes. Arch Surg, 2001; 136:773–778.

Miner

, Brennan

, Jaques

: A prospective, symptom related, outcomes analysis of 1022 palliative procedures for advanced cancer. Ann Surg, 2004; 240:719–726; discussion 726–777.

Badgwell

, Smith

, Liu

, Bruera

, Curley

, Cormier

: Indicators of surgery and survival in oncology inpatients requiring surgical evaluation for palliation. Support Care Cancer, 2009; 17:727–734.

Badgwell

, Aloia

, Garrett

, Chedister

, Miner

, Krouse

: Indicators of symptom improvement and survival in inpatients with advanced cancer undergoing palliative surgical consultation. J Surg Oncol, 2013; 107:367–371.

Badgwell

, Contreras

, Askew

, Krouse

, Feig

, Cormier

: Radiographic and clinical factors associated with improved outcomes in advanced cancer patients with bowel obstruction. J Palliat Med, 2011; 14:990–996.

Miner

, Jaques

, Tavaf-Motamen

, Shriver

: Decision making on surgical palliation based on patient outcome data. Am J Surg, 1999; 177:150–154.

10.

Patient-Centered Outcomes Research Institute Mission and Vision: www.pcori.org/about/mission-and-vision/ (Last accessed February 13, 2013).

11.

Oken

, Creech

, Tormey

, Horton

, Davis

, McFadden

, Carbone

PP.

Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol, 1982; 5(6):649–55.

12.

Cella

, Tulsky

, Gray

, Sarafian

, Linn

, Bonomi

, Silberman

, Yellen

, Winicour

, Brannon

, et al. The Functional Assessment of Cancer Therapy scale: Development and validation of the general measure. J Clin Oncol, 1993; 11:570–579.

13.

Whalen

, Kutner

, Byock

, Gerard

, Stovall

, Sieverding

, Ganz

, Krouse

: Implementing palliative care studies. J Pain Symptom Manage, 2007; 34(1 Suppl):S40–48.

14.

Woolson

, Clarke

: Statistical Methods for the Analysis of Biomedical Data, 2nd ed. New York: John Wiley & Sons, 2000.

15.

Hosmer

, Lemeshow

: Applied Logistic Regression, 2nd ed. New York: Wiley, 2000.

16.

Krouse

: Surgical management of malignant bowel obstruction. Surg Oncol Clin N Am, 2004; 13(3):479–90.

17.

Podnos

, Juarez

, Pameijer

, Uman

, Ferrell

, Wagman

: Surgical palliation of advanced gastrointestinal tumors. J Palliat Med, 2007; 10:871–876.

18.

Dalal

, Gollub

, Miner

, Wong

, Gerdes

, Schattner

, Jaques

, Temple

: Management of patients with malignant bowel obstruction and stage IV colorectal cancer. J Palliat Med, 2011; 14:822–828.

19.

Higginson

, Sen-Gupta

: Place of care in advanced cancer: a qualitative systematic literature review of patient preferences. J Palliat Med, 2000; 3:287–300.

20.

Amikura

, Sakamoto

, Yatsuoka

, Kawashima

, Nishimura

, Tanaka

: Surgical management for a malignant bowel obstruction with recurrent gastrointestinal carcinoma. J Surg Oncol, 2010; 101:228–232.

21.

Blair

, Chu

, Schwarz

: Outcome of palliative operations for malignant bowel obstruction in patients with peritoneal carcinomatosis from nongynecological cancer. Ann Surg Oncol, 2001; 8:632–637.

22.

Bruera

, Yennurajalingam

: Palliative care in advanced cancer patients: How and when?. Oncologist, 2012; 17:267–273.

23.

Badgwell

, Krouse

, Cormier

, Guevara

, Klimberg

, Ferrell

: Frequent and early death limits quality of life assessment in patients with advanced malignancies evaluated for palliative surgical intervention. Ann Surg Oncol, 2012; 19:3651–3658.

24.

Ripamonti

, Twycross

, Baines

, Bozzetti

, Capri

, De Conno

, Gemlo

, Hunt

, Krebs

, Mercadante

, Schaerer

, Wilkinson

; Working Group of the European Association for Palliative Care: Clinical-practice recommendations for the management of bowel obstruction in patients with end-stage cancer. Support Care Cancer, 2001; 9:223–233.

25.

Higashi

, Shida

, Ban

, Yamagata

, Masuda

, Imanari

, Yamamoto

: Factors affecting successful palliative surgery for malignant bowel obstruction due to peritoneal dissemination from colorectal cancer. Jpn J Clin Oncol, 2003; 33:357–359.

26.

Lau

, Lorentz

TG.

Results of surgery for malignant bowel obstruction in advanced, unresectable, recurrent colorectal cancer. Dis Colon Rectum, 1993; 36:61–64.

27.

Yazdi

, Miedema

, Humphrey

LJ.

High mortality after abdominal operation in patients with large-volume malignant ascites. J Surg Oncol, 1996; 62:93–96.

28.

Finan

, Campbell

, Verma

, MacFie

, Gatt

, Parker

, Bhardwaj

, Hall

: The management of malignant large bowel obstruction: ACPGBI position statement. Colorectal Dis, 2007; 9(Suppl 4):1–17.

29.

Reymond

, Charles

, Bowman

, Treston

: The effect of dexamethasone on the longevity of syringe driver subcutaneous sites in palliative care patients. Med J Aust, 2003; 178:486–489.

30.

Grande

, Todd

: Why are trials in palliative care so difficult?. Palliat Med, 2000; 14:69–74.