Mindy Liang

Patient preferences for research access to administrative data in Ontario.

144 Background: Clinical trials collect outcome data until the trial ends. Subsequent health data is often available in government or health care administrative databases, yet this information is often not made available to researchers. We assessed patient preferences of long-term linkage of such administrative databases to clinical trials databases. METHODS A self-reported questionnaire was administered to outpatients in clinics of academic and community cancer centres. Cancer patients were presented with a hypothetical scenario of a clinical trial and asked about their willingness to allow confidential research access to their personal health information contained in administrative databases. RESULTS Of 524 patients, 54% were females, median age was 60 (range 19-93), 81% were Caucasian, and 61% had post-secondary education. Of cancer sites, 20% had breast cancer, 17% GI, 14% GU, 13% hematology, 12% thoracic, 12% head/neck and 11% gynecologic cancers. One-third (33%) had participated in a clinical trial. An overwhelming 93% allowed confidential access to health information in administrative databases (59% always, 34% depending on circumstances) including access to initials and birth dates, to be used to match information across databases (70% always, 23% depending on circumstances). Only 3% were unwilling to release their information under any circumstances. When asked about other identifiable information, such as name and address, more than 74% allowed the secure storage of this information at the central study coordinating center. In a new cohort of 103 patients, 84% preferred long-term data to be continually available to researchers after the clinical trial has ended; only 9% did not want this option. Results were similar across all sociodemographic subgroups studied including patients who had prior participation in clinical trials, although older patients were even more likely to allow access than younger patients (p = 0.02). CONCLUSIONS The vast majority of patients were willing to have their long-term outcome data collected through government and health care administrative databases made available to clinical trial researchers, to improve our understanding of long-term outcomes of trial procedures and drugs.

Development and prospective evaluation of CAPLET, a cancer ambulatory patient physical function longitudinal evaluation tool for routine clinical practice

PurposeA patient’s physical function is a critical outcome variable for measuring and improving chronic care management. However, patient-reported outcome measures of physical function are not routinely assessed in cancer outpatients, in part due to limitations of tools available. This study presents the development and evaluation of the Cancer Ambulatory Patient Physical Function Longitudinal Evaluation Tool (CAPLET) as an adaptive response tool for routinely screening for physical dysfunction in oncology clinical practice.MethodsIn phase 1, 407 adult outpatients at Princess Margaret Cancer Centre completed the World Health Organization Disability Assessment Schedule (WHODAS) 2.0, Health Assessment Questionnaire Disability Index (HAQ-DI), EuroQuol-5D-3L ( EQ-5D-3L), and patient-reported outcome (PRO)-Eastern Cooperative Oncology Group (ECOG). CAPLET was developed based on a branching logic algorithm navigating patients to appropriate domains of HAQ-DI/WHOAS using their responses to the PRO-ECOG/EQ-5D-3L as screeners. Sensitivity/specificity of CAPLET screeners for HAQ-DI/WHODAS items were reported. In phase 2, CAPLET vs the WHODAS/HAQ-DI were alternatively administrated to 318 adult outpatients in a two-arm trial comparing time to completion and acceptability between the tools.ResultsUsing a patient’s ECOG status and the sum of the mobility, self-care, and usual activity dimensions of the EQ-5D-3L to dichotomize patients as with or without difficulty, CAPLET achieved a sensitivity > 90% against recommended WHODAS and HAQ-DI cutoffs for significant dysfunction. Sensitivity of screeners for capturing dysfunction in individual WHODAS/HAQ-DI items ranged from 85 to 100%. Compared to the HAQ-DI/WHODAS, CAPLET was associated with a 50% reduction in administration times and improved patient acceptability, while reducing question burden by 84% for half the sample population.ConclusionsCAPLET improves the feasibility of capturing detailed assessments of patient-reported physical function in cancer outpatients.

Development and evaluation of screening dysphagia tools for observational studies and routine care in cancer patients

Dysphagia can be associated with significant morbidity in cancer patients. We aimed to develop and evaluate dysphagia screener tools for use in observational studies (phase 1) and for routine symptom monitoring in clinical care (phase 2).

Identifying tools for capturing the overall experience of dyspnea in a lung cancer population: The patient’s perspective.

73 Background: Efficient methods of tracking dyspnea can improve quality of care. We asked lung cancer patients to assess five validated patient-reported outcome (PRO) tools and determine whether these tools captured different domains of their dyspnea experience. METHODS This cross-sectional study of adult lung cancer outpatients of all stages utilized touch screen tablets to administer five dyspnea tools (Borg severity (B), Reduced Cancer Dyspnea (R), Breathlessness intensity (I), breathlessness distress (D), and MRC breathlessness (M) scales) that focused on the severity, experience, intensity, extent, and functional impairment of dyspnea, respectively. Patients were then asked whether each tool captured their dyspnea experience. RESULTS Of 226 lung cancer patients, 120 reported some level of dyspnea, and their responses were analyzed. Median age (range) was 67 (30-97) years; 53% were males; 37% were stage I-II; 56%, were stage III-IV. All the tools except B were completed by over 90% of patients (R 95%, I 93%, D 91%, M 91%). 71% of patients thought that M captured functional impairment well, while 58-62% of patients thought that R, S, A captured experience, intensity and distress well. B had the lowest completion rate (83%) and the lowest patient perception that is captured severity of dyspnea well (49%). Qualitative analysis suggests that most dyspnea is activity-related in this population, which would be consistent with patients favoring M (functional assessment) over B (dyspnea at present in clinic). I+D+M takes under 5 minutes to complete, whilst R takes 5+ minutes alone to complete. CONCLUSIONS In a sample of cancer patients with high prevalence of dyspnea, patients felt four of five tools were useful in capturing various domains of their dyspnea experience. The majority of patients felt that the questions were relevant to their circumstances. I, D, M are appropriate screening tools, whilst R may be useful under specific circumstances. Our next step is the application and evaluation of self management tools in the dyspnea setting using these four tools.

Implementation of a new patient health questionnaire into standard practice in outpatient cancer clinics to improve patient care and quality of treatment.

214 Background: Patient socio-demographic, lifestyle, and risk factor information at the Princess Margaret Cancer Centre (PM) is routinely collected for clinical purposes. The only standardized patient information presently being gathered in the outpatient cancer clinics at the PM is symptom management data, which is linked directly into the electronic medical records. Collecting and recording additional data can improve the quality of patient care, help identify risk factors, and guide treatment options. Our aim was to determine the feasibility of collecting this additional information in a clinical setting. METHODS This pilot cohort study was implemented in the thoracic outpatient oncology clinic at the PM. It involved developing a questionnaire utilizing literature sources, expert review, and pilot testing. Adult cancer patients completed the questionnaire and a complementary acceptability survey during their first clinic visit. RESULTS 170 patients with thoracic tumours, primarily lung cancer, took part in the feasibility study. Of these, 51% were female, 67% were Caucasian, and the median age was 65 (range 32 to 88) years old. The acceptability survey demonstrated that: 76% of respondents found that the questionnaire did not make their clinic visit more difficult, 68% found that it asked the right questions, 79% thought the questionnaire contained pertinent information for their doctor and other healthcare providers to know, and 51% found that it was time consuming to complete. CONCLUSIONS This study determined that it is feasible to implement a standardized questionnaire that gathers patient socio-demographic, lifestyle, and risk factor information in routine clinical cancer care. Since half of the study population found the questionnaire time consuming to complete it should be administered prior to patient visits, in an electronic format, and with greater explanation/education. The next phase is converting the questionnaire into an electronic version, which aligns with the preferences of study participants and will allow the information to be more easily accessible by clinicians/researchers.

Are palliative patients less accepting to self-report symptom measures for clinical management than curative patients?

79 Background: Patient reported outcome measures (PROMs) are a tool used for collecting patient symptom data in the clinic, prior to the patients appointment. Patients being treated with a palliative intent are often assumed to find completing PROM surveys more burdensome than patients being treated with a curative intent. We compared patient acceptability of palliative versus curative patients to complete PROM surveys. METHODS 202 cancer out-patients (120 curative and 82 palliative) at the Princess Margaret Cancer Centre completed a PROM survey using a touchscreen tablet regarding their symptoms of pain. Ten questions assessed patient acceptance of completing PROM surveys. RESULTS The median age was 60 (range 21-86) and 48% were female. There were no clinically relevant demographic differences between the palliative and curative patients; however there were a higher proportion of palliative patients than curative patients with gynecological (8.3% palliative, 16% curative), lung (5.8% palliative, 10% curative), and gastrointestinal (14% palliative, 28% curative) cancers. There were no significant differences in acceptability between palliative and curative patients (p>0.05, all 10 comparisons). Only 3.6% of palliative patients and 3.3% of curative patients reported that completing the survey made their clinic visit more difficult; 16% of palliative patients and 11% of curative patients found the survey to be time consuming; no palliative patients and only 0.83% of curative patients found the questions upsetting or distressful. 93% of palliative patients and 92% of curative patients were happy to complete the surveys on a touchscreen tablet. Overall 62% of patients surveyed were willing to complete surveys at every visit (56% palliative and 67% curative, p>0.05). CONCLUSIONS Palliative and curative patients appear to have an equally high level of acceptance of PROM surveys, though a significant minority would have problems with completing them at every visit. Further research using mixed-methods analysis will be done to better understand the factors limiting the overall willingness of both palliative and curative patients to complete the survey on a regular basis.