Lyons, J.C.

Quach, C.

Reeve, B.B.

Sanoff, H.K.

Williams, G.R.

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A94  VA L U E  I N  H E A LT H  1 7  ( 2 0 1 4 )  A 1 - A 2 9 5  
PCN151
PatieNt RePoRted outComes iN CastRatioN-ResistaNt PRostate 
CaNCeR
Aggarwal S., Segal J.
Novel Health Strategies, Bethesda, MD, USA
Objectives: Patient reported outcomes (PRO) are becoming useful tools for col-
lecting and generating evidence for new medical products to show improvements 
in health-related quality of life (HRQoL). Castration-Resistant Prostate Cancer 
(CRPC) is a chronic disease with high importance for patient HRQoL. The objective 
of this study was to review, analyze, and understand trends in the PRO instruments 
used in patients with CRPC. MethOds: A systematic literature search for CRPC 
randomized controlled trials (RCTs) with PROs endpoints was undertaken for the 
databases Pubmed, Embase, Biosis, Google Scholar, and Cochrane. Data was col-
lected for the study size, interventions, year, PRO instrument, and results for PROs. 
Analysis was conducted to identify trends in commonly used PRO instruments 
and categorize results as positive, neutral or negative. Results: Ten RCTs with 
a total of 5,797 patients were identified. In these studies there were thirteen dif-
ferent PROs instruments were identified that were FACT-P, FACT-G, BPI-SF, EQC30, 
EQPR25, FLIC, SDS, SUF, PDA, IPDA, PROSQOLI, SF-36, and QOLM-P14. The most 
commonly used instrument were FACT-P (used in 4,297 patients) and EQC-30 (used 
in 1,091 patients). Six studies reported positive results with improvement in qual-
ity of life symptoms (QoL) versus comparator treatments. Fours studies reported 
results with deterioration in (QOL). Three studies reported improvement in pain 
scores. cOnclusiOns: Patients with CRPC have relatively longer survival and 
hence QoL is an important consideration for these patients. PRO instruments such 
as FACT-P and EQC-30 have been commonly used to generate evidence to show 
which therapies improve patient QoL.
PCN152
imPaCt of ColoReCtal CaNCeR oN aCtivities of daily liviNg aNd 
dePRessioN Risk amoNg oldeR ameRiCaNs
Quach C., Sanoff H.K., Williams G.R., Lyons J.C., Reeve B.B.
University of North Carolina at Chapel Hill, Chapel Hill, NC, USA
Objectives: 1) Estimate change in activities of daily living (ADL) and risk for major 
depressive disorder (MDD) among older Americans > 64 years following diagnosis 
and treatment of colorectal cancer (CRC); 2) Compare change in ADL function and 
MDD risk among CRC patients to matched controls without cancer. MethOds: 
This population-based study used the Surveillance, Epidemiology, and End Results-
Medicare Health Outcomes Survey (SEER-MHOS) dataset (1998-2007). Medicare 
managed care beneficiaries diagnosed with CRC between completion of baseline 
and follow-up MHOS (n= 349) were matched to non-cancer controls (n= 1,745) using 
propensity scores. Analysis of covariance models estimated change in ability to 
perform six ADLs: bathing, dressing, eating, getting in or out of chairs, walking, 
using the toilet. Logistic regression was used to estimate MDD risk. Covariates 
included socio-demographic, clinical and survey characteristics. Results: Mean 
time from diagnosis to MHOS follow-up was 12.3 months (SD 9.8) for CRC patients 
(n= 103 Stage I, 122 Stage II, 95 Stage III, 29 Stage IV). Though patients and controls 
reported similar ADL impairment at baseline (.97 vs. .92; p= 0.06), CRC patients 
had greater impairment at follow-up (mean 2.21 vs. .92; p< 0.01). Mean increase 
in ADL impairment was 1.02 for Stage I, 1.25 for Stage II, 1.53 for Stage III, and 1.67 
for Stage IV patients (each p< 0.01). Compared to controls, CRC patients suffered 
greater impairment with respect to bathing (p= 0.01), getting in/out of chairs (p= 0.01) 
and walking (p< 0.01). CRC patients and controls had similar MDD risk at baseline 
(odds ratio [OR] 1.22 [95% confidence interval .94–1.58]) and at follow-up (OR 3.18 
[0.65–15.69]). cOnclusiOns: CRC has adverse effects on ADL functioning among 
older Americans—even in the early, curable stages. This study informs clinicians 
and caregivers of the need to identify opportunities to provide supportive care for 
patients’ basic needs of self-care.
PCN154
the Real imPaCt of Quality of life (Qol) eNdPoiNts oN maRket aCCess 
deCisioNs aCRoss maRkets – a Case study of oNCology PRoduCts
Gardiner R.B.1, Sealey S.1, Edathodu A.1, Mukku S.R.2
1Access Partnership, London, UK, 2The Access Partnership, London, UK
Objectives: Recent approvals of targeted oncology therapies have resulted in 
increased patient survival, and potential comorbidities. Subsequently, a greater 
emphasis has been placed on QoL, and PRO endpoints. However, the impact of QoL 
instruments on market access of new oncology products remains unclear. This 
research aims at understanding the true relevance of QoL endpoints in payer deci-
sion making MethOds: The research was conducted through in-depth secondary 
research and interviews with payers in 6 countries including the US, Germany, 
France, Spain, Italy, and Sweden. Results: In the markets studied, QoL data is a 
requirement to be submitted for reimbursement; however, it is not a key determi-
nant of reimbursement or pricing decisions at a national level. Some countries like 
Italy and Spain view QoL data as being important at a regional and local level for 
inclusion in formularies and guidelines. Furthermore, payers suggest that QoL is 
considered only in a qualitative sense based on the safety profile of a drug, and do 
not consider the instruments used to measure it. For example, in France, although 
the expectation is that a disease-specific QoL instrument is submitted for review 
by the Transparency Commission, this data will not contribute towards an ASMR 
determination. Meanwhile, in Sweden, the TLV requires the use of only generic 
instruments such as EQ-5D that are validated to be used in cost/QALY calculations, 
unlike disease specific instruments. cOnclusiOns: Contrary to the increasing aca-
demic interest in QoL and PRO endpoints, these have not yet translated into playing 
a significant role in payer decision making for new oncology products. Currently, 
QoL instruments are used in oncology clinical trials as standard protocol. However, 
differentiating one drug over another through an improvement demonstrated using 
QoL instruments does not yet directly translate to an advantage from a market 
access point of view for that drug.
site and access to patients who are home bound or located in remote geographic 
locations. This novel approach did not seem to alter the participant’s ability to 
participate in a qualitative study.
PCN148
ideNtifyiNg symPtoms aNd imPaCts exPeRieNCed by meN with NoN-
metastatiC CastRatioN ResistaNt PRostate CaNCeR
Moïse P.1, Tomaszewski E.L.2, Krupnick R.3, Baskin-Bey E.4, Meyer M.3, Holmstrom S.5
1Quintiles Consulting Europe, Levallois-Perret, France, 2Quintiles, Cambridge, MA, USA, 
3Quintiles Consulting, Cambridge, MA, USA, 4Astellas Pharma Global Development, Leiden, The 
Netherlands, 5Astellas Pharma Europe, Leiderdorp, The Netherlands
Objectives: We sought to identify the most relevant and important symptoms and 
impacts of non metastatic (M0) castration resistant prostate cancer (CRPC) from 
the patient’s perspective. MethOds: First, a literature review was performed that 
focused on symptoms related to living with M0 CRPC. Then, individual interviews 
with five clinicians experienced in treating PC were conducted to understand the 
clinical perspective of treating M0 CRPC. Finally, individual interviews with 17 M0 
CRPC patients were conducted following a semi-structured interview guide. Patients 
were asked about symptoms, impacts of living with M0 CRPC, and interference of 
symptoms with daily living and impacts on a scale of 0-10. Results: 35 unique 
symptoms were mentioned by patients: 15 patients mentioned erectile issues, 13 
loss of sexual desire, 11 urge to urinate, and 11 incontinence. No patient rated the 
interference of symptoms higher than a six on the impact scale. The most common 
impacts mentioned included: need to plan for urinary frequency (n= 9), interference 
with daily activities (n= 8), and anxiety (n= 7) or frustration (n= 7) over the diagnosis, 
symptoms, or treatment. Clinicians confirmed the symptoms expressed by patients 
and noted that many could be attributed to prior and/or current treatments for 
PC and not the PC itself, a finding observed consistently in the published litera-
ture. cOnclusiOns: The most relevant and important symptoms (erectile dys-
function, urinary symptoms, anxiety, and emotional impacts) expressed by patients 
aligned with those mentioned by clinicians and the literature. This data provides 
valuable insight into patients’ experience with M0 CRPC illustrating that the most 
relevant symptoms and impacts thereof expressed by patients may be attributed 
to PC therapy and not to the consequences of the M0 CRPC disease state itself.
PCN149
assessmeNt of ResPoNse shift aNd tRue ChaNge usiNg stRuCtuRal 
eQuatioN modeliNg foR health–Related Quality-of-life sCoRes iN 
PatieNts with bReast CaNCeR afteR suRgeRy
Nakamura K.1, Shimozuma K.1, Suzukamo Y.2, Taira N.3, Shiroiwa T.4, Shibahara H.1, Saito S.5
1Ritsumeikan University, Kusatsu, Japan, 2Tohoku Universitiy, Seidai, Japan, 3Okayama University 
Hospital, Okayama, Japan, 4National Institute of Public Health, Saitama, Japan, 5Okayama 
University, Okayama, Japan
Objectives: Response shift can be considered measurement bias in the assessment 
of HRQOL. The purpose of this study was to detect response shifts and true change 
in health-related quality-of-life (HRQOL) scores in patients with breast cancer after 
surgery using structural equation modeling (SEM) proposed by Oort F. J. MethOds: 
The HRQOL data set was derived from published in the ‘Breast Cancer Res Treat’ in 
2011 to reveal predictors of HRQOL scores 1 and 2 years after breast cancer surgery. 
HRQOL was assessed in patients with breast cancer (N= 196) using the Functional 
Assessment of Cancer Therapy – General (FACT-G) at baseline (1 month), 6, 12, and 
24 months after surgery. We developed models using ‘four domains’ (physical well-
being [PWB], social/family well-being [SWB], emotional well-being [EWB], and func-
tional well-being [FWB] subscales of the FACT-G) and ‘higher concept’ integrating 
four domains. Analyses were performed using Oort’s SEM (Software: IBM SPSS AMOS 
20.0) approach to detect response shifts and true change. Results: The following 
response shifts were detected: between baseline and 6 months, uniform recalibra-
tion and reprioritization in SWB and non-uniform recalibration in PWB; and between 
baseline and 12 months, uniform/non-uniform recalibration and reprioritization in 
SWB. True change was detected both between baseline and 6 months and between 
baseline and 12 months for overall QOL. cOnclusiOns: The analyses using the mod-
els developed in this study based on ‘four domains’ and ‘higher concept’ yielded more 
easily interpretable results compared to previously reported models based on ‘items’ 
and ‘domains’. The results of this study will help understand possible measurement 
bias due to response shift effects on the assessment of HRQOL in a longitudinal study.
PCN150
desigN aNd validatioN of a QuestioNNaiRe foR measuRiNg PeRCeived 
Risk of skiN CaNCeR
Morales-Sánchez MA1, Peralta-Pedrero ML2
1Centro Dermatológico “Dr. Ladislao de la Pascua”, Secretaría de Salud del D.F., Distrito Federal, 
Mexico, 2Centro Dermatológico “Dr. Ladislao de la Pascua”, Secretaría de Salud del D.F., Distrito 
Federal, Mexico
Objectives: The aim of this study was to design and validate a self-administered 
questionnaire for measuring the perceived risk of skin cancer. MethOds: A self-
administered questionnaire with a visual Likert-type scale was designed based on 
the results of the analysis of the content of a survey performed in 100 patients in the 
DrLadislao de la Pascua Skin Clinic, Distrito Federal México, Mexico. Subsequently, 
the questionnaire was administered to a sample of 359 adult patients who attended 
the clinic for the first time. As no gold standard exists for measuring the perceived 
risk of skin cancer, the construct was validated through factor analysis. Results: 
The final questionnaire had 18 items. The internal consistency measured with 
Cronbach alpha was 0.824 overall. In the factor analysis, 4 factors (denoted as affec-
tive, behavioral, severity, and susceptibility) and an indicator of risk accounted for 
65.133% of the variance. cOnclusiOns: The psychometric properties of the scale 
were appropriate for measuring the perception of risk in adult patients (aged 18 
years or more) who attended the dermatology clinic. This is the first questionnaire 
in spanish to measure perceived risk of skin cancer that serves to quantify the 
response to interventions for preventing this disease.


PCN152 Impact of Colorectal Cancer on Activities of Daily Living and Depression Risk Among Older Americans 

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PCN152 Impact of Colorectal Cancer on Activities of Daily Living and Depression Risk Among Older Americans

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