Drawing Tool for Remembering for Hepatobiliary and Pancreatic Tumors

Abstract

This study's intent was to develop and validate a symptom indicant derived from the Functional Assessment of Cancer the Crab Therapy-Hepatobiliary, a questionnaire measuring gross and hepatobiliary disease specific aspects of quality of life. The item pool was narrowed to 26 questions that valuate symptoms and function. For each one of 95 hepatobiliary genus Cancer experts narrowed the heel to 5 of the well-nig important to attend to when treating advanced hepatobiliary disease. Eight symptoms were endorsed by Thomas More than 20% of the experts (3 pain, 2 fatigue, nausea, weight loss, jaundice) and were called the FACT-Hepatobiliary Symptom Index-8 (FHSI-8). Among 51 hepatobiliary cancer patients, the FHSI-8 showed good internal consistency (0.79), trial run-retest reliability (r = 0.86), strong tie-u with mood (r = −0.56), and patient differentiation by ECOG Carrying out Condition Rating ( P < 0.0001) and treatment status ( P = 0.057). Symptom scaling in diseases such as hepatobiliary cancer is feasible and may provide an cost-efficient, clinically-relevant end point for undermentioned groups over time.

Keywords

• Lineament of life
• cancer
• symptoms
• hepatobiliary cancer

Introduction

Hepatobiliary cancers occur with limited relative frequency in the Federated States just with increasing prevalence worldwide.

In Asia and Africa, liver cancer is one of the most common malignancies, and duct gland Cancer has hyperbolic four-fold in Japan and three-fold in Asia over the last 50 old age.

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Although the incidence of some hepatobiliary cancers in the Consolidated States is relatively low, they often carry a engrave medical prognosis. This is overdue, in part, to the general and non-special symptoms associated with these cancers, which often result to diagnosis in an advanced stage.

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• Beazley R.M.
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Tumors of the pancreas, gallbladder, and extrahepatic bile ducts.

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Thus, symptom palliation is frequently the most good therapy that can be offered to these patients.

The moderate theory of curative treatments has implications not only for survival simply also quality of life (QOL).

The QOL of people with ripe hepatobiliary cancer is adversely stilted away symptoms of disease and treatment.

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• Beazley R.M.
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Tumors of the pancreas, gallbladder, and extrahepatic bile ducts.

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Some surgical and chemotherapeutic interventions receive been shown to bring home the bacon symptomatic relief and improved QOL in hepatobiliary cancer patients.

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Experts in the field of oncology have freshly identified a take for adapted, specially tailored QOL assessment in diseases so much equally hepatobiliary cancers, which are extremely symptomatic and wholly too often involve speedy deterioration of health status.

Clinical and restrictive interest in a symptom-adjusted approach path to QOL assessment, whereby the disease symptoms measured by multi-magnitude QOL questionnaires are aggregate in a clinically relevant and psychometrically unexceptionable style, has increased. Despite a proliferation of cured-proved, sure, and valid instruments to measure QOL in oncology,

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wellness care experts have voiced concerns about the ease of interpreting scores on these multi-item, multi-magnitude instruments.

Clinical researchers and practicing oncologists report uncertainty about how to interpret and derive clinical meaning from scores

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and how to translate the QOL information into discussion decisions.

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More or less physicians have also been resistant to incorporating QOL appraisal into clinical trials.

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Hardheaded barriers admit time and resource constraints and the sensed deficiency of a suitable questionnaire.

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A brief, clinically substantive set of symptoms age-related hepatobiliary malignant neoplastic disease could improve the willingness of researchers and clinicians to obtain these enduring-reported outcomes.

Regulatory agencies likewise are interested in valid patient-reported outcomes that bear some relationship to QOL. For lesson, since 1985, there has been an explicit recognition from the U.S. Food and Drug Administration (Food and Drug Administration) that, along with survival, benefit to QOL is one of two elementary endpoints that could be considered for approval of new anti-cancer drugs.

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Since then, it has been challenging to review data submitted in support of QOL claims.

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The Food and Drug Administration has stated that austere standards for QOL claims may be needed to guard against "arrogate expansiveness" in which a promotional claim goes beyond the data bearing the call.

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Quality of spirit ad claims should be specific, FDA-sponsored physician focus groups say; ad variance direction cautions against QOL "claim expansiveness." FDC Rep. 1994;56(4):8–9.

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Terms much as "clinical benefit" and "patient according outcomes" take surfaced newly, reflecting a preference among clinical and regulatory reviewers of QOL information for tumor-taxon symptom assessment with a focus on happening a curative palliative target. Some primordial work, convergent on a single-item symptom assessment, has contributed to regulatory approval in oncology.

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Withal, these approaches fail to take advantage of Recent measurement advances in symptom and QOL appraisal. Most recently-validated measures of Cancer the Crab-specific QOL incorporate an assessment of certain prevalent symptoms (e.g., pain and fatigue) inside the larger context of multidimensional assessment.

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• Aaronson N.K.
• Ahmedzai S.
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Cancer-unique QOL questionnaires much as the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30

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and the Utilitarian Judgment of Cancer Therapy-General (FACT-G)

measure few common cancer symptoms and add more elaborated, site-specific symptom assessment to the "core" full general questionnaire. E.g., in hepatobiliary Cancer the Crab, 18 questions are added to the FACT-G to assess limited concerns related to hepatobiliary disease and is known as the FACT-Hepatobiliary (FACT-Informed).

³¹

• Heffernan N.
• Fong Y.
• Jarnagin W.
• et aluminium.

Measure health-correlated quality of life with the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT- Hep) Questionnaire.

• Crossref
• PubMed
• Scopus (173)
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Thus, while there are galore questionnaires that have been developed and tested to assess cancer-specific symptoms, many of them have been nested within larger three-dimensional QOL questionnaires. This creates an chance to infer clinically appropriate and precise valuation of symptomatology in specific cancer populations.

This consider is an attempt to set about to address the concerns of the clinical and regulative communities around the interpretability and relevance of multi-item, multi-dimensional QOL instruments and the more recent requests for a more targeted, symptom-adjusted set about to QOL judgment. In this article, we describe the growing of a symptom index derived from a fit-established multidimensional QOL measuring system, the Functional Appraisal of Cancer Therapy.

Methods

Study Design and Overview

The development and proof of an index finger of hepatobiliary cancer symptoms was part of a larger study involving the developing and validation of the FACT-Hep QOL questionnaire.

³¹

• Heffernan N.
• Fong Y.
• Jarnagin W.
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Measurement health-related quality of life with the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT- Hep) Questionnaire.

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The destination of the study was to determine if a subset of symptoms and concerns derived from the FACT-Hep could Be demonstrated to have adequate psychological science properties to serve as a stand-alone brief index of hepatobiliary symptoms. This FACT Hepatobiliary Symptom Index (FHSI) was formulated and validated in 3 phases. First of all, the FACT-Hip to was developed and administered along with unusual measures to a try of hepatobiliary cancer patients to leave aggregation of data for reliability and validity of the candidate FHSI items.

³¹

• Heffernan N.
• Fong Y.
• Jarnagin W.
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Measuring wellness-related quality of life with the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT- Hep) Questionnaire.

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Second, the FHSI items were selected away presentation of a list of symptoms and concerns from the FACT-Hip to to an transnational sample of experts in treating hepatobiliary cancer patients WHO were asked to select the 5 virtually important symptoms/concerns to address in treating patients with these types of cancer. Third, FHSI psychometric performance was compared to FACT-Hep performance.

Participants

Patient Sample

The validation sample consisted of an initial puddle of 59 patients recruited through the outpatient clinics at Commemoration Sloan-Kettering Cancer Center. Inclusion criteria were: 1) 18 years of age or older; 2) diagnosis of cancer of the liver, pancreas, gallbladder, or bile duct; and 3) ability to speak, learn, and write English. Four patients refused, and one patient was excluded overdue to a psychiatric history. Reasons for refusal included wear and concern about active in research. Of the 54 patients enrolled, 51 patients (94%) completed the study. A complete verbal description of the sociology and clinical characteristics of the validation sample is presented in Mesa 1.

Table 1 Synchronic Statistics of Patient Validation Sample (n = 51)

Characteristic	n (%)
Age
Mean (SD)	61.5 (9.6)
Range	40 –80
Sex
Male	26 (51%)
Female	25 (49%)
Marital status Status
Married	39 (76%)
Single	4 (8%)
Separated/Single	5 (10%)
Widowed	3 (6%)
Ethnicity
White, non-American	45 (88%)
Black, non-Hispanic	1 (2%)
Hispanic	2 (4%)
Asian	3 (6%)
Education
8 years Oregon little	3 (6%)
9 –12 years	28 (39%)
13 –16 years	(35%)
17 –25 years	(20%)
Employment Status
Employed	15 (29%)
Woman of the house	2 (4%)
Handicapped/unemployed	9 (18%)
Retired	25 (49%)
Disease Locate
Colon w/liver metastases	19 (38%)
Hepatocellular	10 (20%)
Pancreatic	5 (10%)
Gallbladder	5 (10%)
Other	9 (22%)
Extent of disease
NED	29 (56%)
Local disease	6 (12%)
Liver disease	8 (16%)
Nodal metastases	1 (2%)
Other	7 (14%)
ECOG Performance Status
0	16 (31%)
1	12 (24%)
2 /3	23 (45%)
4 /5	0 (0%)

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Physician Sample

The item selection stage of the study complex administering a survey of pre-selected symptoms to an international sample of 180 physicians WHO are experts in treating hepatobiliary cancers. The experts practice in 11 different countries, including the United States, Canada, Western Europe, India, and Russia. Ninety-five experts responded, giving up a answer rate of 53%.

Measures

As the present study was part of a larger study on the QOL of hepatobiliary cancer patients, lonesome a subset of the instruments in the stamp battery of questionnaires administered to patients will be according on here, including the FACT-G plus Hepatobiliary subscale (FACT-Hip to), the Profile of Mood States (POMS),

and the Eastern Cooperative Oncology Aggroup (ECOG) Functioning Position Valuation (PSR).

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• Zubrod C.G.
• Schneiderman M.
• Frei E.
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The FACT QOL measurement organisation began with the creation of a generic core questionnaire called the FACT-G.

The FACT-G is a 27-item compilation of general questions divided into quatern primary QOL domains: Physical Well-Being (PWB; 7 items), Social/Family Fortunate-Beingness (SFWB; 7 items), Emotional Well-Being (EWB; 6 items), and Functional Eudaimoni (FWB; 7 items) using a five-point Likert-type scale ranging from 0 ("not the least bit") to 4 ("same much and then"). Scores are obtained for each of the specific domains atomic number 3 cured arsenic a total QOL score. An extra score obtained from the FACT-G, the Trial Outcome Forefinger (TOI),

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is created by summing the PWB, FWB, and Hepatobiliary subscales and was used in this study as a agency of determinative known-groups cogency for the FHSI. The FACT-G has good test-retest reliableness (r ranging from 0.82 to 0.92), is spiritualist to change terminated time, and has been shown to own good convergent and discriminant validity.

A telephone number of subscales give birth since evolved that complement the FACT-G and address pertinent disease-, discussion-, or condition-related issues non already covered in the gross questionnaire, including the FACT-Hep. The FACT-Hep comprises the 27 core items plus an additional 18 hepatobiliary-specific items. This subscale has likewise been shown to give good internal consistency, test-retest reliability, and convergent and discriminant validity.

³¹

• Heffernan N.
• Fong Y.
• Jarnagin W.
• et Heart of Dixie.

Measuring health-attendant quality of life with the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT- Hep) Questionnaire.

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The Profile of Humor States (POMS) is a wide utilized 65-item self-composition measure of 37 prejudiced mood states.

Adjectives are rated on a 5-point rating descale ranging from 0 ("not at all") to 4 ("extremely"), and responses are summed to yield both subscale scores and a total mood disturbance score.

The Eastern Cooperative Oncology Group (ECOG) PSR

³³

• Zubrod C.G.
• Schneiderman M.
• Frei E.
• et aluminum.

Appraisal of methods for the study of chemotherapy of cancer in humanity comparative therapeutic trial of nitrogen mustard and triethylene thiophosphoramide.

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is a single-item rating of the stage to which patients are able to participate in typical activities without the deman for rest. This indicant is wide used in cancer clinical trials to value functional capability of patients as they have treatment. The PSR score ranges from 0 ("I have average activity without symptoms") to 4 ("I am unable to break of bed"). In that contemplate, the PSR was obtained from patients themselves and served arsenic a means of classifying patients for known-groups validation.

Procedure

Collection of Symptom Index Substantiation Data

Validation of the FHSI involved presentment of a package of questionnaires, including the FACT-Hep, to a sample of hepatobiliary cancer patients recruited through the outpatient clinics at Memorial Sloan-Kettering Hospital. Patients were asked to complete a retest of the FACT-Hip to at home within 3–7 days of the initial battery for purposes of test–retest reliability.

Mental synthesis of the Symptom Index

To narrow the particular pool down to a clinically relevant subset of symptoms, eight items from the FACT-G that, supported face validity, were deemed to assess Crab-related symptoms operating room function and all 18 items from the Hepatobiliary subscale were included in the 26-token symptom appraise administered to clinical experts. The survey instructions contained a two-measure request: 1) select up to 10 of the "nearly crucial symptoms to track when assessing the value of treatment for genus Cancer of the pancreas"; 2) superior up to 5 of the 10 that are the "all but clinically important symptoms to mitigate in pancreatic malignant neoplastic disease patients." While the ultimate goal is to develop a symptom index applicable to patients with all hepatobiliary cancers, this survey used pancreatic cancer as the reference because it represents a large percentage of patients with hepatobiliary Crab, and because of extensive recent nonsubjective test activity in that disease. IT was as wel believed that respondents would have an easier clock endorsing priority symptoms if a specific diagnosis (such as pancreatic Cancer the Crab) was given.

Analysis Plan

Surveys returned by the experts were tabulated by frequency with which respondents selected a particular symptom/concern Eastern Samoa one of the 5 near important. The most unremarkably endorsed items, as judged by examination of the frequency distribution, were retained for psychometric analysis as the FHSI. Two criteria for token retention were considered: 1) chance of chance second A nonpareil of the whirligig 5 symptoms/concerns; and 2) the 95% confidence interval around this probability of chance endorsement. The probability of an item being one of the 5 items selected perchance (19%) was calculated without adjusting for multiple comparisons by dividing 5 (the allowable number of "very well-nig main symptoms") by the total number of items happening the survey (26). Patient responses to these surviving items were subjected to analysis for determination of internal consistency (Cronbach's alpha), exam–retest reliability, and convergent and discriminant cogency.

To evaluate the unidimensionality and construct validity of the FHSI candidate items in greater detail, we also applied an item response theory (IRT) based come on.

For items coming together the more loose of the criteria described above (i.e., coming together or extraordinary take chances probability of endorsement), Andrich's

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military rating scale extension of the Rasch measurement model was used to fix whether FHSI candidate items measure the synoptical underlying construct. The WINSTEPS computer program

was used for Rasch analyses. Unweighted item fit mean square (MNSQ) values (arithmetic mean = 1.0) were also measured to place potential misfitting items or those that indicate a lack of construct homogeneity with unusual items in a scale to assure scale unidimensionality. Past convention, MNSQ = 1.3 was jell as the important rate for a misfitting item. The MNSQ value indicates the amount of error associated with the particular estimate with respect to its fit with other items in the dimension being measured. For representative, a MNSQ of 1.98 indicates 98% surplus noise in the data, suggesting the item is measuring a different property than the one it is intended to measure.

Results

FHSI Item Endorsement by Experts

Ninety-five medical experts were presented with 26 symptoms and concerns associated with hepatobiliary cancer from which they were requested to select quintuplet of the most noteworthy symptoms to measure in treating these cancers. The frequency with which these items were endorsed is displayed in Mesa 2. Among the 8 well-nig commonly selected items, pain is delineate by 3 items, and outwear/lack of energy is depicted by 2 items. Of the 26 items, 5 (tense, intestine control, change in appearance, chills, dry mouth) did non have whatsoever expert endorsements atomic number 3 important symptoms to assess.

Mesa 2 Frequency of Blurb of Checklist Symptoms/Concerns

Symptoms/Concerns	% Endorsed ("crowning 5")
Pain	68
Exercising weight passing	60
Feel for worn-out	44
Sickness	30
Jaundice	26
Binding pain	25
Stomach infliction/uncomfortableness	22
Lack of energy	20 (19% prospect probability of endorsement)
Itching	16
Feel ill	13
Stomach intumescency/cramps	12
Diarrhea	10
Spend time in bed	9
Able to do customary activities	8
Side personal effects	7
Sadness	5
Digestion	3
Appetite	3
Impairment	3
Fevers	3
Change in taste	2
Nervous	0
Gut control	0
Shift in appearance	0
Chills	0
Dry mouth	0

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To quantify the selection of items for the FHSI, two criteria were initially practical: 1) meeting or exceeding the chance of item endorsement by fortune, and 2) meeting operating theatre exceeding the 95% confidence interval limen round this chance chance. Using the more reformist criterion, 8 symptoms or concerns exceeded the verge: pain, weight loss, nausea, jaundice, back pain, stomach annoyance/discomfort, and two fatigue items (want of energy, feeling fagged). Applications programme of the more conservative criterion resulted in a scurf comprised of 4 symptoms/concerns. For purposes of validation analyses, described on a lower floor, the initial symptom indicant was considered to be unagitated of 8 items. (See Appendix for FHSI-8.)

FHSI Validation Analyses

The scores for the FACT-G, FACT-Hep, and FHSI are reported in Table 3. The scale raw scores were changed to a 0–100 scale for ease of equivalence crossways scales.

Table 3 Descriptive Statistics of Scales

Scale/Subscale	Raw Piles M (SD) (n = 51)	Transformed Scores (0–100) M (SD) (n = 51)	Cronbach's Alpha (n = 51)	Test–Retest Correlation (n = 50)	Correlational statistics with POMS (n = 50)
FACT-G Total	84.5 (13.1)	78.2 (12.1)	0.90	0.91 a p < 0.0001	−0.85 a p < 0.0001
Physical symptomless-being	22.6 (4.6)	80.6 (16.3)	0.79	0.90 a p < 0.0001	−0.63 a p < 0.0001
Social/family well-being	24.2 (3.8)	86.3 (13.7)	0.72	0.86 a p < 0.0001	−0.25
Emotional well-being	18.7 (4.1)	77.9 (17.3)	0.80	0.88 a p < 0.0001	−0.76 a p < 0.0001
Practical eudaemonia	19.1 (5.9)	68.1 (21.1)	0.84	0.86 a p < 0.0001	−0.71 a p < 0.0001
FACT-Hip Total	143.0 (20.6)	79.4 (11.5)	0.94	0.91 a p < 0.0001	−0.80 a p < 0.0001
Hepatobiliary subscale	58.5 (9.0)	81.2 (12.5)	0.83	0.82 a p < 0.0001	−0.59 a p < 0.0001
FHSI-3 (pain, weight loss, wear)	8.9 (2.5)	74.2 (20.8)	0.69	0.77 a p < 0.0001	−0.60 a p < 0.0001
FHSI-4 (annoyance, weight loss, fatigue, nausea)	12.4 (2.9)	77.7 (18.3)	0.70	0.80 a p < 0.0001	−0.61 a p < 0.0001
FHSI-6 (excluding jaundice, hindmost pain)	17.7 (4.7)	73.9 (19.7)	0.83	0.86 a p < 0.0001	−0.61 a p < 0.0001
FHSI-7a (excluding acerbity)	20.9 (5.2)	74.6 (18.5)	0.81	0.84 a p < 0.0001	−0.56 a p < 0.0001
FHSI-7b (excluding backward pain)	21.4 (5.0)	76.5 (17.9)	0.80	0.86 a p < 0.0001	−0.61 a p < 0.0001
FHSI-8	24.6 (5.38)	76.9 (16.8)	0.79	0.86 a p < 0.0001	−0.56 a p < 0.0001

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FACT-G and FACT-Hep

The FACT-G and FACT-Hep had favourable internal consistency (alpha = 0.90 and 0.94, respectively). The PWB, SFWB, EWB, and FWB subscales As cured arsenic the Hepatobiliary subscale too incontestable standard intragroup consistency (alpha = 0.72 to 0.84). These measures were stable over a 3–7 day interval (test–retest r = 0.86 to 0.91). The FACT-G summate make, FACT-Hep summate make, well-being subscales and Hepatobiliary subscale were every last significantly and negatively correlated with the POMS (r = −0.59 to −0.85) with the exception of the SFWB subscale, which was not significantly joint with the POMS.

FHSI Reliability Analyses

Analyses of the FHSI were conducted on various numbers and combinations of items comprising the descale: FHSI-3 (pain, weight loss, fatigue); FHSI-4 (pain, weight loss, fatigue, sickness); FHSI-6 (pain, burden loss, nausea, stomach pain/discomfort, 2 fatigue items); FHSI-7a (jaundice excluded); FHSI-7b (back pain in the ass excluded); and FHSI-8 (ail, cardinal fatigue items, weight loss, sickness, stomach anguish/discomfort, icterus, back out pain). Internal body of the various FHSI permutations ranged from 0.69 to 0.83. Mental test–retest correlations, patc slightly get down than that of the FACT-Hep total score, were still within an acceptable range (r = 0.77 to 0.86).

FHSI Convergent Validity Analyses

Complete of the various FHSI versions were importantly and negatively associated with the POMS (r = −0.56 to −0.61). Further, the FSHI-8 was significantly correlated with the FACT-G (r = 0.66, P < 0.0001), PWB (r = 0.89, P < 0.0001), EWB (r = 0.33, P < 0.05), FWB (r = 0.64, P < 0.0001), FACT-Hep tot score (r = 0.81, P < 0.0001), and Hepatobiliary subscale (r = 0.90, P < 0.0001).

Discriminant (Known-Groups) validity: Performance Status

The sample was divided into triplet groups by PSR (PSR = 0 versus 1 versus 2/3). It was expected that better public presentation condition (i.e., lower PSR) would be associated with high QOL scores and break symptom status (lower scores on FHSI). Arsenic displayed in Figure 1, PSR was indeed associated with QOL as measured by PWB (F(2,48) = 15.77, P < 0.0001), EWB (F(2,48) = 3.22, P < 0.05), FWB (F(2,48) = 17.08, P < 0.0001), FACT-G (F(2,48) = 19.70, P < 0.0001), Hepatobiliary subscale (F(2,48) = 18.22, P < 0.0001), TOI (F(2,48) = 23.64, P < 0.0001), and FHSI-8 (F(2,48) = 19.59, P < 0.0001). Stacks on SFWB were non importantly different crossways groups. Post hoc revue of subgroup differences using Tukey's HSD indicated that the TOI and Hepatobiliary subscale scores differentiated complete three PSR levels, whereas the FHSI-8, FACT-G, PWB, and FWB oodles significantly differentiated two of the three levels. Specifically, the FACT-G, PWB, and FWB subscales differentiated the PSR = 0 mathematical group from the PSR = 1 and PSR = 2/3 groups, piece the FHSI-8 specialised the PSR = 2/3 group from the PSR = 0 and PSR = 1 groups. To provide an meter reading of the clinical significance of group differences, effect sizes for group comparisons were also premeditated for all subscales, as displayed in Table 4. By convention, effect sizes of 0.20 are considered to be "small" in order of magnitude, those of 0.50 to be "moderate," and effects sizes larger than 0.80 to be "in high spirits" in magnitude.

Fig. 1 Mean FACT scale responses (± one standard error of the stingy) by Patient ECOG Carrying into action Status Paygrad (PSR). PSR groups were trichotomized into PSR = 0, PSR = 1, and PSR = 2/3. [1] indicates discrimination between (PSR = 0) v (PSR = 1 or 2/3); [2] indicates discrimination betwixt (PSR = 0) v (PSR = 1) v (PSR = 2/3); [3] indicates favouritism betwixt (PSR = 0 or 1) v (PSR = 2/3). *P < 0.05, **P < 0.0001.

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Table 4 Effect Sizes for Performance Status Evaluation (PSR) Group Comparisons

					Effect Sizes for Group Comparisons
	PSR	n	Baseline Mean	SD	0–1	1–2/3	0–2/3
Physical well-being	0	16	95	8
	1	12	80	11	1.22	0.73	1.95
	2/3	23	71	16
Sociable/family welfare	0	16	95	9
	1	12	82	17	0.99	0.23	0.76
	2/3	23	85	14
Emotional well-organism	0	16	85	16
	1	12	81	16	0.24	0.55	0.79
	2/3	23	72	17
Structural well-beingness	0	16	86	7
	1	12	69	20	1.10	0.91	2.00
	2/3	23	55	19
FACT-G	0	16	89	6
	1	12	78	11	1.23	0.78	2.00
	2/3	23	71	10
FACT-Hip to additional concerns	0	16	92	7
	1	12	83	9	0.97	1.08	2.05
	2/3	23	73	11
Test Outcome Index (TOI)	0	16	91	6
	1	12	79	10	1.24	1.04	2.28
	2/3	23	69	12
FHSI-8	0	16	90	10
	1	12	82	8	0.65	1.39	2.04
	2/3	23	65	16

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Discriminant (Known-Groups) validity: Handling Status

The sample was dichotomized into groups of patients supported treatment status (on/off treatment). It was expected that off-discussion status would be associated with bettor QOL (higher scores) and better symptoms status (lower FHSI scores). As displayed in Forecast 2, treatment condition was associated with improved PWB (t(50) = 2.8, P < 0.01), FWB (t(50) = 2.4, P < 0.05), Hepatobiliary subscale (t(51) = 2.1, P < 0.05), and the TOI (t(50) = 2.6, P < 0.05). The group differences were marginally significant for the FHSI-8 (t(50) = 1.9, P = 0.057). The SFWB, EWB, and FACT-G scores did not differ significantly past handling status. Once more, effect sizes were calculated for group differences in treatment status for each subscale, as shown in Tabular array 5.

Put over 5 Effect Sizes for Treatment Status Group Comparisons

	Discussion Status a Handling Status Groups: 0 = off-treatment, 1 = on-treatment.	n	Service line Mean	SD	Effect Size
Physical easily-being	0	18	89	14
	1	33	76	16	0.85
Social/syndicate eudaimoni	0	18	85	14
	1	33	87	14	0.14
Emotional eudaimoni	0	18	78	19
	1	33	78	16	0.00
Functional well-being	0	18	77	17
	1	33	63	22	0.69
FACT-G	0	18	82	11
	1	33	76	12	0.52
FACT-Hep additional concerns	0	18	86	12
	1	33	79	12	0.58
Trial Termination Index (TOI)	0	18	85	13
	1	33	75	14	0.73
FHSI-8	0	18	83	17
	1	33	74	16	0.55

a Treatment Status Groups: 0 = off-treatment, 1 = on-treatment.

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Point-Level Analysis of FHSI

The results of the point psychoanalysis are displayed in Table 6. Items with MNSQ values outside the 0.7–1.3 range are typically identified A possible misfitting items deserving more careful examination.

Misfit below MNSQ = 0.7 suggest "overfit" to the conception being metric, and therefore do not perturb the mensuration so very much like introduce possible redundancy. Because this is already a brief index, the two items showing modest overfit were retained. MNSQ higher up 1.3 suggests misfit to the property being measured past the assemblage of questions. Data are bestowed (Put of 3) on internal consistency variation as a function of including or excluding each of these two misfitting questions. In entirely cases—excluding both (FHSI-6), including both (FHSI-8), including one or the other (FHSI-7a and FHSI-7b)—internal consistency remained full.

Table 6 Summary of Particular Statistics for FHSI-8

a

Based on Andrich's university extension of the Rasch rating scale model.37,38

Item Content	Item Difficulty	Outfit Mean Transparent
Lack energy	1.03	0.60
Tiredness	0.86	0.62
Stick out annoyance/discomfort	0.23	0.78
Pain	0.10	0.75
Back nuisance	−0.03	1.37
Weight loss	−0.30	0.81
Nausea	−0.75	1.24
Jaundice	−1.14	1.98

a Based on Andrich's reference of the Rasch military rank scale model.^,

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Discussion

The goal of this study was to develop and evaluate an index assessing high priority concerns related with forward-looking hepatobiliary cancer by drawing items from the FACT-G¹¹and the 18-item Hepatobiliary Subscale.

³¹

• Heffernan N.
• Fong Y.
• Jarnagin W.
• et alibi.

Measuring health-related tone of life with the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT- Hep) Questionnaire.

• Crossref
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To this end, an 8-item symptom index, the FHSI-8, was constructed supported the nonsubjective importance ratings of an international sample of hepatobiliary cancer specialists. Initial patient validation of the 8 items incontestible that these items have adequate reliability and validity to assess the nigh important symptoms in this population. The 8-particular version of the FHSI demonstrated good internal consistency, test–retest reliability, and convergent validity. The FHSI-8 was significantly correlated with the FACT-G and its PWB, EWB, and FWB subscales besides atomic number 3 with the FACT-Informed and the Hepatobiliary Subscale subscale. The 8-item symptom indicator was also significantly associated with mood, such that better symptom status was associated with better temper. The FHSI-8 also successfully discriminated patients supported differences in carrying out and discourse status, and these differences were clinically evidential, as evidenced by its centrist to high burden sizes. Patients with better performance status reported better symptom status than those with poorer performance status. Similarly, patients off treatment reported better symptom status than those who were on treatment.

Although the FHSI-8 performed well and met or exceeded standards for acceptableness in objective research applications, information technology did not taboo-perform existing FACT-Hep subscales. Usually, it performed comparably to the FACT PWB, FWB, Hepatobiliary subscale, and the aggregation of these, the TOI. In differentiating patients away PSR, the Hepatobiliary Subscale (18-items) and the TOI (32 items) were actually superior, separating not only patients with PSR = 1 from those with PSR = 2/3, but also from patients with PSR = 0. The only advantage of the FHSI-8 in this linguistic context, then, is its shorter length. It becomes the circumspection of the researcher as to whether to select the briefer assessment, assuming many academic degree of loss to preciseness, or the longer, much burdensome but accurate assessment. One consideration in the survival of the fittest might embody sample size projection. A projected taste size increases, acceptability of the shorter FHSI-8 would also increase. Another consideration is the relative importance of preciseness in personal diagnosis. However, as desire for true individual appraisal increases, one would be increasingly inclined to use the FACT-Hep (45 items) alternatively of the FHSI-8 due to its more favorable domestic consistence.

In plus to the 8-item version of the FHSI, results suggest that still-shorter versions may too have utility. The pick of the optimal act of items at 8 was somewhat arbitrary. An debate can be made in favou of the 6-item or one of the two 7-point indices, excluding one or both of the questions on thorniness and binding pain, as the internal consistency of these alternatives was comparable. Even the 4-point unconventional, retaining only those questions that exceeded the 95% confidence time interval for encounter probability of skillful selection, represents a feasible choice that results in a ordered series with items connected annoyance, slant loss, fatigue, and nausea. Same reward of this version is the fact that each symptom category is weighted equally, avoiding the greater weighting given to pain and outwear in the 8-item rendering. However, while the 4-item scale had an acceptable

internal consistency (alpha = 0.70), the probability of lower internal consistency in future use is high. This was a factor in our recommending a slightly longer index.

The data depicting item psychoanalysis for equip to a unidimensional model, an IRT-analogue to classical internal consistency, suggested that perhaps 6- or 7-item scales might beryllium optimal, if the only purport was to create a duplicatable, unidimensional index. All the same, symptoms of hepatobiliary disease are various naturally, and although they tend to coexist as disease-related clusters, have a competing tendency to come out somewhat independent of one and only another. This whitethorn embody more true of jaundice and back trouble than the others, and emerge as an denotation of feasible misfit. Unrivaled then must struggle with the dilemma of retaining the symptom in the index because it captures a clinically measurable problem, risking a compromise in what is ultimately plumbed, operating theatre deleting the potentially misfitting symptom, creating a more unidimensional scale but also eliminating an big clinical effect. In that case, we opted to keep on the 2 potentially misfitting items for their clinical relevancy because their effect on intimate consistency in this sample was negligible. Home consistency remained high in cases where both thorniness and back pain were excluded (FHSI-6), both were included (FHSI-8), and one or the other was included (FHSI-7a and FHSI-7b). Retention or exclusion of these items can be a clinical investigational decision based upon the scale's future applications programme.

The importance of symptom dominance in the cancer universe has been wide recognized due to the extraordinarily high prevalence of carnal and psychological symptoms also as the impact of these symptoms on patient QOL.

^,

Symptom assessment and management are integral components in the practice of medicine

and, as such, are closely attendant to areas routinely analyzed past clinicians, which may increase clinicians' comfort dismantle with conducting such an assessment.

In contrast, the application of multidimensional QOL instruments in oncology practices and clinical trials has met with underground.

²²

• Bezjak A.
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^,

^,

In addition, despite a longstanding recommendation to include QOL evaluation in the drug favourable reception process,

²⁶

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• Temple R.

Food and Drug Administration requirements for approval of new anticancer drugs.

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the FDA is confronted with the challenge of addressing the multi-dimensional nature and assessment of QOL and the consequent implications for claims of drug effectiveness. The FDA Oncology Drug Advisory Committee (ODAC) subcommittee on QOL has precocious the position that overall claims of QOL benefit cannot be made from one operating theatre two domain measurements and that claims made about "QOL" postulate to be particular to the domain that was measured.

⁴⁶

Food And Drug Administration Medicine Drugs Consultative Committee Quality of Living Subcommittee Meeting Transcript, 10 February 2000.

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Although an truncated, symptom-concentrated assessment, albeit clinically catchy and possibly maximally responsive, would not represent considered sufficient for a broadly worded QOL regulatory claim, it would lend accompaniment to the use of more appropriate claims, so much As "symptomatic relief " or "hold of onset of tumor-related symptoms."

Everyday comprehensive symptom assessment offers potential difference benefits to patients also. For patients with advanced disease, where life anticipation is reduced and on that point is no heal, relief of physical symptoms and maintenance of function become primary objectives of medical intervention.

^,

⁴⁷

• Coons S.J.
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Assessing health-related quality of life application to dose therapy.

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^,

Routine judgment of symptoms Crataegus oxycantha key out a significant proportion of patients WHO postulate and would benefit from intensive symptom palliation.

⁴⁹

• Yangtze V.T.
• Hwang S.S.
• Feuerman M.
• Kasimis B.S.

Symptom and quality of life surveys of health chec oncology patients at a Veterans Affairs Medical Center on a role for symptom assessment.

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The FHSI-8 offers the additional advantage of existence a very brief instrument. In studies requiring repeated assessments, it is particularly important to minimize respondent (patient) weight down.

To the extent that symptomatology is corresponding to objective disease states, routine symptom assessment may yield additional benefits. Symptom improvement has been associated with clinical tumor regression in metastatic breast cancer patients.

⁵⁰

• Geels P.
• Eisenhauer E.
• Bezjak A.
• et alii.

Lenitive effect of chemotherapy objective tumor response is associated with symptom improvement in patients with metastatic breast cancer.

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The judgement of natural symptoms is believed to yield prognostic information incidental to survival in cancer patients, possibly even method of accounting for the predictive value of QOL scores.

In addition to those with advanced cancer, symptom assessment may also be weighty to those believed to be free of disease. A significant symmetry of patients with "no extant disease" continue to experience severe symptoms.

⁴⁹

• Chang V.T.
• Hwang S.S.
• Feuerman M.
• Kasimis B.S.

Symptom and quality of lifespan surveys of medical oncology patients at a Veterans Affairs Greco-Roman deity Substance a character for symptom assessment.

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Further, As the oncology field moves to a unified set of answer criteria for important tumors (RECIST), information technology is likely that galore tumors previously considered measurable will atomic number 102 longer be so.

Yet it will remain operative to know whether these "unmeasurable" tumors are treatable. The clinical "as credit line" is that symptomatic answer, or the delay of symptom progression, has meaning to people with cancer and their health caution providers.

Several limitations of this analyse should be acknowledged. First, clinician input was put-upon to blue-ribbon the prey symptoms, and no uncomplaining stimulus was obtained. Although patients did not participate in the choice of target symptoms, they did participate, in a 3:1 ratio, in the survival of the fittest of the original 26 items during development of the FACT-Hep. It remains to be seen, even so, if patients would select like Oregon the same 8 symptoms. Second, clinicians were asked to revolve about pancreatic cancer when responding to the survey. It is yet to make up determined the extent to which this symptom index, which has been tested happening hepatobiliary cancer patients with multifariousness of diagnoses, will work in a narrower group of any one of the subtypes of this population. Third, this sample, presenting to an outpatient ambulatory clinic and disproportionately (incomplete) free of active disease, is likely to be on the healthy side relative to the universe of hepatobiliary cancer patients. Unfortunately, laboratory information (e.g., bilirubin) were not usable on this sampling to provide additional insight into their wellness status. Still, for nonsubjective trial run purposes, where good performance status is a requirement for admission, this sample may be congressman of the patients entry trials where this issue measure would be employed. The validity of the FHSI in palliative and end-of-life like clay to represent evaluated.

This subject has provided evidence that items pertaining to symptoms and concerns of advanced hepatobiliary cancer patients can be derived from a swell-established multidimensional QOL questionnaire and aggregated in a clinically relevant and psychometrically acceptable manner. Although we continue to urge for the continued assessment of QOL across a range of biopsychosocial domains, such as those assessed with the FACT measurement system, we believe the FHSI may provide an acceptable alternative when the medical institution or research interest is symptom-focused. To date, the clinical relevance of the symptom indicator has been valid only by experts in treating these cancers. It is yet to atomic number 4 determined the extent to which FHSI is responsive to changes in symptom position over metre. Future work will validate the FHSI-8 in a patient universe as a stall-alone symptom index and determine the extent to which changes understand into meaningful advance to the patient.

Acknowledgements

Supported in part by a grant from Janssen Explore Foundation.

Appendix. FACT Hepatobiliary Symptom Index (FHSI-8)

Tabled 1

Below is a list of statements that other people with your illness have said are important. By circling one (1) numerate per line, please bespeak how lawful each statement has been for you .
		Non at all	A trifle spot	Somewhat	Quite a trifle	Very much
GP1	I get a lack of energy …	0	1	2	3	4
GP2	I have sickness …	0	1	2	3	4
GP4	I have pain …	0	1	2	3	4
C2	I am losing weight …	0	1	2	3	4
CNS7	I have pain in my back …	0	1	2	3	4
HI7	I am fatigued …	0	1	2	3	4
Hep2	I am bothered by icterus or yellow color to my skin	0	1	2	3	4
Hep8	I hold discomfort surgery pain in my stomach …	0	1	2	3	4

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Article Information

Publication History

Accepted: October 5, 2001

Recognition

Interior Department: https://doi.org/10.1016/S0885-3924(02)00422-0

Copyright

© 2002 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc.

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