EAL

ONC: Radiation Therapy (2007)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

Review the outcome of patients with radiation enteritis treated with home parenteral nutrition (HPN)

Inclusion Criteria:

All patients with radiatiion enteritis treated with HPN at the Mayo Clinic

Exclusion Criteria:

Description of Study Protocol:

Design: Clinical data were collected retrospectively from medical records of all pateints with radiation enteritis treated with HPN.

Statistical Analysis: Descriptive statistics. Cumulative probability of survival was calculated by the Kaplan-Meier method.

Data Collection Summary:

The following information was collected from the medical records:

Demographic data
Diagnosis of primary disease
Causes of death
Morbidity and mortality related to HPN
Duration of HPN
Number of required surgical procedures

Description of Actual Data Sample:

Initial N: 54 (39 women, 15 men)

Location: May Clinic, Jacksonville FL and Rochester MN.

Demographic data

Characteristics

Age (yr)

<40

40-60

>60

HPN duration (yr)

1-3

4-5

Primary Cancer

Cancer Type	n
Ovarian	14
Colorectal	11
Lymphoma	6
Uterine	5
Cervical	5
Testicular	3
Bladder	2
Squamous cell	2
Liposarcoma	1
Phechromocytoma	1
Rectal carcinoid	1
Renal cell carcinoma	1
Cholangiocarcinoma	1
GI stromal tumor	1

Patient Outcomes

Alive

-Weaned from HPN

-Continued on HPN

Dead

-On HPN

-HPN stopped before death

-Off HPN

-Transferred care

Cause of death

-Recurrent cancer

-Other (sepsis, aspiration, heart failure)

-HPN catheter sepsis

-Unknown

Lost to long term follow-up

57% of patients required HPN for < 1 year.

Causes of intestinal failure due to radiation therapy

bowel obstruction due to radiation stricutres
short bowel syndrome
malabsorption
dysmotility
fistulae

Mean numer of intestinal operations directly related to radiation damage was 2.2/patient (range = 0-6)

HPN discontinuation was higher for patients with surgically correctable strictures and dysmotility than for patients with short bowel syndrome.

Mean number of catheter infections/1000 days of HPN was 1.56 (range = 0-14.49)

Estimated cumulative survival for patients with radiation enteritis receiving HPN was 76% at 1 year and 64% at 5 years.

Summary of Results:

Frequency and severity of radiation complications was related to the location and dose of radiation
Persistent bowl obstruction and short bowel syndrome were the principles reasons for HPN
Catheter infections were the most common HPN associated complication. One patient died as a result of catheter sepsis.
Death was due to the underlying disease

Author Conclusion:

"In conclusion, HPN offers a reasonable treatment for patients with intestinal failure as a result of radiation therapy in whom surgery is not possible."

Funding Source:

Reviewer Comments:

This report provides descriptive data only. Results are not generalizable. Provides information on which to base larger studies. Supportive of HPN in certain cases.

Quality Criteria Checklist: Primary Research
Relevance Questions
	1.	Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies)	N/A
	2.	Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about?	Yes
	3.	Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice?	Yes
	4.	Is the intervention or procedure feasible? (NA for some epidemiological studies)	Yes

Validity Questions
1.	Was the research question clearly stated?		Yes
	1.1.	Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified?	Yes
	1.2.	Was (were) the outcome(s) [dependent variable(s)] clearly indicated?	Yes
	1.3.	Were the target population and setting specified?	Yes
2.	Was the selection of study subjects/patients free from bias?		N/A
	2.1.	Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study?	Yes
	2.2.	Were criteria applied equally to all study groups?	N/A
	2.3.	Were health, demographics, and other characteristics of subjects described?	Yes
	2.4.	Were the subjects/patients a representative sample of the relevant population?	Yes
3.	Were study groups comparable?		N/A
	3.1.	Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT)	N/A
	3.2.	Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?	N/A
	3.3.	Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.)	N/A
	3.4.	If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis?	N/A
	3.5.	If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.)	N/A
	3.6.	If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")?	N/A
4.	Was method of handling withdrawals described?		N/A
	4.1.	Were follow-up methods described and the same for all groups?	N/A
	4.2.	Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.)	N/A
	4.3.	Were all enrolled subjects/patients (in the original sample) accounted for?	Yes
	4.4.	Were reasons for withdrawals similar across groups?	N/A
	4.5.	If diagnostic test, was decision to perform reference test not dependent on results of test under study?	N/A
5.	Was blinding used to prevent introduction of bias?		N/A
	5.1.	In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate?	N/A
	5.2.	Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.)	N/A
	5.3.	In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded?	N/A
	5.4.	In case control study, was case definition explicit and case ascertainment not influenced by exposure status?	N/A
	5.5.	In diagnostic study, were test results blinded to patient history and other test results?	N/A
6.	Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described?		N/A
	6.1.	In RCT or other intervention trial, were protocols described for all regimens studied?	N/A
	6.2.	In observational study, were interventions, study settings, and clinicians/provider described?	Yes
	6.3.	Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect?	Yes
	6.4.	Was the amount of exposure and, if relevant, subject/patient compliance measured?	N/A
	6.5.	Were co-interventions (e.g., ancillary treatments, other therapies) described?	N/A
	6.6.	Were extra or unplanned treatments described?	N/A
	6.7.	Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups?	N/A
	6.8.	In diagnostic study, were details of test administration and replication sufficient?	N/A
7.	Were outcomes clearly defined and the measurements valid and reliable?		Yes
	7.1.	Were primary and secondary endpoints described and relevant to the question?	Yes
	7.2.	Were nutrition measures appropriate to question and outcomes of concern?	Yes
	7.3.	Was the period of follow-up long enough for important outcome(s) to occur?	Yes
	7.4.	Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures?	Yes
	7.5.	Was the measurement of effect at an appropriate level of precision?	N/A
	7.6.	Were other factors accounted for (measured) that could affect outcomes?	N/A
	7.7.	Were the measurements conducted consistently across groups?	N/A
8.	Was the statistical analysis appropriate for the study design and type of outcome indicators?		Yes
	8.1.	Were statistical analyses adequately described and the results reported appropriately?	Yes
	8.2.	Were correct statistical tests used and assumptions of test not violated?	Yes
	8.3.	Were statistics reported with levels of significance and/or confidence intervals?	N/A
	8.4.	Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)?	N/A
	8.5.	Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)?	N/A
	8.6.	Was clinical significance as well as statistical significance reported?	Yes
	8.7.	If negative findings, was a power calculation reported to address type 2 error?	N/A
9.	Are conclusions supported by results with biases and limitations taken into consideration?		Yes
	9.1.	Is there a discussion of findings?	Yes
	9.2.	Are biases and study limitations identified and discussed?	Yes
10.	Is bias due to study's funding or sponsorship unlikely?		No
	10.1.	Were sources of funding and investigators' affiliations described?	Yes
	10.2.	Was the study free from apparent conflict of interest?	Yes