Patient Experience Assessments in Advanced Gastric, Esophageal, and Gastroesophageal Junction Cancer Studies

A452

VA L U E I N H E A LT H 2 0 ( 2 0 1 7 ) A 3 9 9 – A 8 1 1

Objectives: Past research has focused on cancer’s negative consequences. Recent research has paid increasing attention to the more positive side of psychosocial adjustment to illness. The PROMIS Illness Impact (II) scale contains 46 positive II (PII) and 40 negative II (NII) items that are classified into four sub-domains: Self-Concept (SC), Social-Impact (SI), Stress-Response (SR), and Spirituality (Sp). The purpose of this study was to investigate PII and NII in cancer survivors.  Methods: Cancer survivors (n= 509; age: 59.5±1.4; 51.5% men) completed the PROMIS PII and NII items comparing current and premorbid perspectives. We calculated change scores as the discrepancy between participants’ ratings of recalled experiences before cancer diagnosis and their ratings of post-cancer experiences. Descriptive statistics and agreement (Weighted kappa (κ )) were calculated on change scores. Effect sizes (ES) provided standardized change scores. Coefficient of variation (CV) was also calculated for each item.  Results: The largest mean change scores appeared on PII-SI items and NII-SR items (absolute mean > 0.5). The CV results showed that items from PII-SC and from NII-SR and NII-SP have better discrimination power among survivors (CVs> 10). As demonstrated by ES values, participants tended to report more positive than negative impacts after cancer (mean: 0.30 vs.0.23). Across NII and PII, there were 25 of 86 (29.1%) areas where significant negative change was reported, and 32 of 86 (37.2%) areas where significant positive change was reported.  Conclusions: Cancer survivors reported more positive than negative psychosocial illness impact after diagnosis. Future research should examine how the perceived change captured by the PII and NII items correspond to reported change over time. PCN221 Moving Pro Measures from the Promise to Impact in Oncology Clinical Practice: Results from a Systematic Literature Review Anatchkova M1, Skalicky AM1, Whiteley J2, Jagun D2, McHorney CA1, Donelson S2 - Evidence, Value & Access by PPD, Bethesda, MD, USA, 2Genentech Inc., South San Francisco, CA, USA

1Evidera

Objectives: To explore existing evidence on the impact of incorporating patientreported outcomes (PRO) into routine oncology clinical care on patient outcomes and work flow using a systematic literature review (SLR).  Methods: A Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) protocol was developed and used to guide the SLR conducted in Medline and Embase databases for studies published from 2006 to 2017. An additional search was completed following the initial search to include references of identified articles and prior SLRs. A theoretical framework based on ISOQOL PRO Implementation Guidelines was used to guide data synthesis.  Results: After screening 4,417 abstracts, 36 studies met the eligibility criteria (44% from US). The majority of studies reported PRO intervention trial evaluations (n= 22, 61%) or feasibility assessments (n= 13, 36%); only three studies reported real-world PRO implementation. Of the 22 studies with an intervention component, three reported no intervention effects on study outcomes. PRO intervention effect was documented for patient centered communication (n= 8), changes in PRO score (n= 8), chart documentation (n= 3), and satisfaction with treatment (n= 3). The EORTC QLQ-C30 was most commonly-used across studies (n= 10, 28%) with an additional 38 measures also reported. Most elements of the ISOQOL PRO Implementation Guidelines were followed, with a notable gap in providing interpretation guidelines. Fewer than 20% of studies reported information on interpretation of PRO scores and 25% discussed strategies for addressing issues identified by PROs.  Conclusions: Existing evidence is mixed, but suggests that the use of PROs in clinical care may be effective for symptom monitoring, improving quality of care, and/or increasing patient-centered communication. Yet, reports of real world PRO implementation are scarce. Factors that can facilitate implementation include: 1) increased focus on interpretation guidelines for PROs; 2) addressing existing implementation barriers; 3) early engagement of diverse stakeholders and 4) systematic implementation approach. PCN222 Patient Experience Assessments in Advanced Gastric, Esophageal, and Gastroesophageal Junction Cancer Studies Morlock R1, Turnbull J2, Rhode T2, Hawryluk E2, Gwaltney C2, Paty J2, Holmstrom S3 Pharma Global Development, Inc., Northbrook, IL, USA, 2QuintilesIMS Consulting Services, New York, NY, USA, 3Astellas Pharma, B.V., Leiden, The Netherlands

1Astellas

Objectives: The objectives of this research were to identify signs, symptoms, and impacts of advanced gastric, esophageal, and gastroesophageal junction cancers (GC/EC/GEJC) and map these to the patient-reported outcomes (PRO) instruments frequently used to assess patient experience.  Methods: A structured, targeted literature and clinical trial search of HRQoL and PRO studies in English for GC/ EC/GEJC from was conducted. Results were supplemented with patient blogs and message-boards discovered through an internet search to identify and corroborate the symptoms and impacts. A preliminary conceptual model was developed, summarizing the signs, symptoms, and impacts frequently mentioned by the existing literature or patient websites.  Results: 39 concepts (24 symptoms, 15 impacts) were identified. Symptoms related to dysphagia, nausea and vomiting, pain, and satiety were most important; impacts related to weakness and weight loss were frequently mentioned. Previous gastrectomy/esophagectomy was associated with worsening symptoms. Of the PRO instruments identified, the EORTC QLQ-C30 was most frequently cited; however, it does not capture all concepts in our conceptual model and it was often supplemented by a disease-specific module (e.g., STO22, OES18, OG25). The OG25 was developed most recently and captures important concepts for GC/EC/GEJC patients; the most comprehensive capture of general and diseasespecific symptoms and impacts most important to patients is the combination of the QLQ-C30 and OG25.  Conclusions: In patients with advanced GC/EC/GEJC, the most important symptoms and impacts were disease-specific (e.g., dysphagia) and general (e.g., satiety), indicating that a general instrument supplemented by a disease-specific module can best represent patient experience. The QLQ-C30 and OG25 used together comprehensively assess the most important patient symptoms and impacts. The OG25 is validated to measure concepts in both GC/EC/GEJC, and covers more concepts. Further research through patient concept elicitation

interviews is warranted to elucidate priority symptoms of advanced GC/EC/GEJC, based on frequency and disturbance to patients. PCN223 Pro-Ctcae Impact on Payer Evaluations of Oncologic Therapies: A Qualitative Research Study Masters ET1, Kaplan H2, Smith G3, Deal LS4 Inc., New York, NY, USA, 2Red Team Associates, Horsham, PA, USA, 3Pfizer, Inc., New York, NY, USA, 4Pfizer Inc., Collegeville, PA, USA

1Pfizer

Objectives: The Patient-Reported Outcomes (PRO) version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) was developed as a companion to the standard lexicon for AE reporting utilized by clinical investigators. The objective of this research was to understand payers’ perceptions of the PRO-CTCAE tool and its potential impact on formulary and coverage decision-making for new oncologic therapies.  Methods: This double-blind qualitative research included individuals with formulary or reimbursement decision-making responsibility in the US and Europe. Respondents were provided background materials on the PRO-CTCAE. A semi-structured guide was developed to facilitate discussion during telephone interviews to elicit spontaneous reactions to the usefulness of PROs in decision making and reactions to the PRO-CTCAE in particular. The sample included 8 medical directors from the US and 2 medical/pharmacy directors each from the UK, France, Germany, Italy, and Spain with experience in evaluating oncologic therapies. Data were summarized descriptively and evaluated for geographical differences.  Results: Variables considered in evaluating a new oncologic therapy in the US and EU were similar with highest relative importance assigned to efficacy versus standard of care, followed by safety considerations, then costs. Respondents viewed the PRO-CTCAE positively, noting direct patient input as an important perspective of the patient experience. However, the combination of newness of the tool, variability in subjective ratings, lack of understanding of meaningful scale changes, and difficulty comparing responses with investigator-reported CTCAE evaluations were noted relative to potential utilization for purposes of current formulary or reimbursement decision making.  Conclusions: Payers considered the PRO-CTCAE a useful tool adding supplemental informative data on new oncologic therapies, but in the near term, until the tool and its data are better understood, it is not anticipated that these data will significantly influence current reimbursement or access decision making. PCN224 Understanding Patients’ Ability to Function in Order to Inform Clinical Benefit in Oncology Studies Karagiannis T1, Marquis P2, Petersen J1, Meyers O1, Chui SY1, Campbell AK1, Strzok S2, Pompilus F2, Piault E1 1Genentech, Inc., South San Francisco, CA, USA, 2Modus Outcomes, Newton, MA, USA

Objectives: Demonstration of clinical benefit in oncology typically focuses on the impact of treatment on survival and tumour progression. However, as survival benefit data are difficult to obtain in oncology drug development programmes, additional endpoints are needed to complement the evidence of treatment effect on the tumour. To date, little is known of the changes patients experience in day-to-day function due to cancer and/or treatment. We set out to understand the concept of ‘function’ in order to inform its assessment as a patient-relevant endpoint for clinical benefit.  Methods: Twenty semi-structured interviews were conducted to explore how cancer patients describe their daily functioning. Patient interviews and the literature were then used to develop a conceptual framework of function.  Results: Patients interviewed were diverse: eight cancer types (all solid tumours, 65% metastatic, 50% with active disease), ECOG status 0–1 (55%) and 2–3 (45%), and 35% having previously received taxanes. The term ‘function’ was not easily understood by patients and 35% did not provide a definition. When describing function, 60 unique concepts were discussed. Four categories of function emerged (mobility, cognition, activities, roles), and later a conceptual framework was developed. Impairments in function were often described as limitations in mobility and/or cognitive abilities. Patients also described 20 different concepts of ‘adaptation’ to overcome cancer or treatment-related impairment and resume their day-to-day function, including change in frequency/intensity, precaution, use of external aids or proactive behaviour changes.  Conclusions: ‘Function’ from patients’ perspective is a complex concept; further research is needed to understand the assessment of mobility, cognition, activities and roles as individual concepts for measuring function. In addition, selecting the most appropriate dimension of measurement (e.g., frequency, ability to perform, difficulties completing a task) for each concept is paramount to reliable and meaningful capture of cancer- and/or treatment-related functional impairment. PCN225 Pro Instruments Used in Studies of Skin Cancer Since 1960 Martin A Crystallise Ltd., East Tilbury, UK

Objectives: To create an evidence map of the different patient-reported outcome instruments used in studies of patients with skin cancer, the geographical settings in which these studies were conducted and the interventions assessed.  Methods: We searched the heoro.com database (www.heoro.com) for PRO studies on skin cancer published between 1960 and May 15 2017, and analysed the abstracts identified by the search to determine the different PRO instruments cited across the range of geographical locations and interventions. We presented the findings as an evidence map.  Results: We found a total of 79 abstracts that reported the use of 45 different PRO instruments. Of these, nine instruments were specific for skin cancers, four were designed for other cancers or cancer in general, 18 were general instruments used to evaluate quality of life or utilities, seven assessed the impact of treatments, and seven assessed symptoms or comorbidities of people with skin cancer. The most frequently used tool was the EORTC QLQ-C30 (12 abstracts), followed by the SF-26 (9), then Skindex, DLQI and visual anlogue scales (7 each) and Skin Cancer Index (5). Studies generally recruited patients with melanona (35 abstracts), basal