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Table 2 Summary Table with Key Elements of Included Studies

From: Exploring the implementation of patient-reported outcome measures in cancer care: need for more real-world evidence results in the peer reviewed literature

Citation (author, year, title) Patient/ Type of Cancer Research Design Study Goal PRO Used Member of medical team receiving feedback PRO score interpretation Plans for addressing issues identified by PRO Study Results
Álvarez-Maestroa, M. 2014 [60] Adults with metastatic prostate cancer Cohort study Feasibility PROSQoLI, Perceived health status Physician Score information provided No instructions given, only usual best practice guidelines • % Physicians finding useful:
o 66.1% clinical decision making
o 71.3% questionnaire characteristics
o 73.4% doctor---patient communication.
Basch, E. 2016 [61] Adults with any cancer type RCT Intervention EQ-5D and CTCAE Oncologist, nurse Score information provided No instructions given, only usual best practice guidelines • EQ-5D (p < .001)
 • ER Visits (p < .02)
 • 1 year survival (p = .05)1
 • # of Nursing calls (p = .93)
Basch, E. et al. 2007 [62] Adults with any cancer type Cohort study Feasibility/ Intervention EQ-5D and CTCAE Clinicians Score information provided Standard AE reporting procedures • 85% of participants logged in during clinical visits
 • 66% logged in from home
 • 57 Grade 3 or 4 Toxicity reported
Berry, D. 2014 [63] Adults with any cancer type Cluster RCT Intervention ESRA-C and SDS Clinicians Score information provided Questions for patient to ask clinician • ESRA Intervention group had a significant reduction (p < .05)
Berry, D. 2015 [64] Adults with any cancer type RCT Intervention ESRA-C and SDS Patient Graphical data display Questions for patient to ask clinician • Significant reductions of symptom distress in ESRA-C intervention group (p < .01)
Berry, L., et al., 2011 [65] Adults with any cancer type RCT Intervention ESRA-C and SDS Clinicians Score information provided No instructions given, only usual best practice guidelines • Significant interaction effect for reporting of symptom/QoL issues (p = .032).
 • More discussion in intervention group if SQoLs reported as problems.
 • 50–60% of clinicians found PRO report useful
 • No difference in study length
Blum, D. 2014 [66] Adults with advanced cancer Cohort study Feasibility E-MOSAIC Physician Graphical data display Discussion of PRO results • % Clinicians agreeing:
 • 77% Useful monitoring system
 • 38–95% Better symptom control
Boyes, A., et al. 2006 [67] Adults with any cancer type RCT Intervention Symptoms, HADS, Care needs Oncologist Score information provided No instructions given, only usual best practice guidelines • No significant differences between groups in HADS outcomes
 • Majority of patients founds the survey easy to complete, good way to communicate with doctors, willing to complete again.
Chiang., A. 2015 [68] Adults with any cancer type Cohort study Intervention for quality Improvement NCCN-EDT Clinical team None Referral to social worker • EMR documentation increased from 19% to 34% over 6mo before and after intervention
 • Barriers:
 • Insufficient time with patients, lack of social work resources, lack of privacy and space to discuss, and patient discomfort in discussing.
Compaci, G., 2015 [69] Adults with lymphoma Cohort study Feasibility HADS, PTSD-CL, SF-36, eCRF Oncologist, nurse or GP Score information provided Phone follow-up, clinic consultations • Time for whole intervention 55 min per quarter
 • Anxiety decrease 20% to 14% baseline to 12 months
 • Depression decrease 10% to 6.5% baseline to 12 months
 • PTSD 14.8% to 17.6%
Cox, A., et al., 2011 [70] Adults with lung cancer Qualitative interviews and Cross-sectional study Feasibility ESAS and EQ-5D Clinicians Score information provided Questions for patient to ask clinician • Clinicians found PRO beneficial, but only considered them complementary.
Engelen, V., et al., 2012 [71] Children with any cancer type Cohort study Intervention QLIC-ON, PEDSQL, TAPQoL Oncologist Not reported Discussion of PRO results • HRQoL domains discussed more in intervention group (p < .05)
 • Significantly more emotional and cognitive problems were identified in the intervention group compared to the control group.
 • Better HRQoL outcomes in intervention group for children 5–7 old, but not other age groups.
Epstein, R., 2017 [72] Adults with any cancer type Cluster RCT Intervention McGill QoL scale single item, McGill Psychological Well-Being subscale, McGill Existential Well-Being subscale, FACT-G Physical Functioning subscale, and FACT-G Social Functioning subscale. Clinicians None Coaching session, follow-up phone calls, list of follow-up questions • Significant intervention effect for the composite of patient centered communication measure reported (p < .02)
Erharter, A., et al., 2010 [73] Adults with primary brain tumor Cohort study Feasibility EORTC-QLQ-C30, EORTC-BN20 Physician Score information provided No instructions given, only usual best practice guidelines • Time for completion decreased from 10 to 5 min over the course of the study.
 • Majority of patients and physicians found the PRO acceptable.
Hilarius, D., et al., 2008 [74] Adults with any cancer type Cohort study Intevention EORTC QLQ-C30, EORTC QLQ-CR38, EORTC QLQ-LC13, EORTC QLQ-BR23 Nurse Score information provided No instructions given, only usual best practice guidelines • HRQoL-related topics discussed significantly more often in the intervention group (p = .009)
• Awareness of HRQoL issues significantly better in intervention group at visit 4 (p = .05)
 • Significantly more HRQoL chart notations in intervention group (p < .001)
 • No significant differences in patient satisfaction
• No significant differences in patient HRQoL at visit 4.
 • Evaluation of
 • Intervention: All nurses reported: the summary provided useful information, facilitated communication, resulted in a more efficient use of their time with the patients, a desire to continue using the HRQoL summary profiles in their daily practice.
• Patients
o 89% reported the
HRQoL summary profile provided an accurate picture of their HRQoL, 69% reported it was used explicitly during treatment 89% believed that the summary enhanced their nurses’ awareness of their health problems, and 99% believed that it would be useful to introduce the intervention as a standard part of the outpatient clinic procedure.
Izard, J. 2014 [75] Adults with prostate cancer Cohort study Feasibility REALM-SD, SNS, Graphic Literacy Scale Researcher Graphical data display Not reported • Pictograph was the least preferred format
 • Patients favored the bar chart (mean rank, 1.8 [P = .12] vs line graph [P < .01] vs table and pictograph);
 • Providers favored bar (34%), and line (34% and Table (30%) formats.
Kallen, M., et a., 2012 [76] Adults with any cancer type Qualitative interviews and Cross-sectional study Feasibility ELVIS and ESAS Providers, patients and caregivers Graphical data display Not reported • Provider interview themes: Improved communication, Barriers to implementation
 • Patient interview themes: improved comprehension, improved communication, and improved patient peace-of-mind
• Usability: physicians, nurses, patients, and caregivers endorsed the usability of the system (SUS score 83.9)
Mooney, K. 2014 [77] Adults with any cancer type RCT Intervention Symptoms Oncologist, nurse, preferred provider Cut-offs/Thresholds Structured interview • There were a total of 6509 calls into the system by 223 patients. The overall daily call adherence was 65.0% of expected days.
 • No significant intervention effect
Nicklasson, M., et al., 2013 [78] Adults with lung cancer or mesothelioma RCT Intervention EORTC QLQ-C30, EORTC LC13 Physician Interpretation of PRO score reports No instructions given, only usual best practice guidelines • Only emotional functioning was more frequently discussed in the intervention group both by doctors (p = 0.018) and by doctors or patients taken together (p = 0.015).
 • More interventions aimed at emotional and social issues and dyspnea in intervention group (p < .05
Rogers, S.N. 2016 [79] Adults with any cancer type Cohort study Intervention UWQoLv4, PCI Physician Not reported Not reported • Median number of concerns 3 (range 1–6)
 • Significant association with number of dysfunction scores (p < .005)
Rosenbloom, S., 2007 [80] Adults with advanced breast, lung or colorectal cancer RCT Intervention FACT-G, FLIC, PSQ-III, POMS-17 Nurse Score information provided Structured interview • No significant differences between groups on study outcomes
Ruland, C., 2010 [81] Adults with acute myelogenous leukemia (AML), lymphatic leukemia (ALL), multiple myeloma, Hodgkin disease, or non-Hodgkin lymphoma, RCT Intervention SF-36, CES-D, MOS-SS Patient, clinicians Patient importance or bothersome ranking No instructions given, only usual best practice guidelines • Significantly more symptoms and problems address in intervention group (p < .0001)
 • Positive intervention
 • Effect for discomfort, eating/drinking, sleep/rest, and sexuality.
 • Significant reduction in 10 of 19 symptom distress categories (p < .01)
 • Symptom management: Group differences statistically significant in favor of the intervention group in 13 of 19 (68%) categories.
Schuler, M. 2016 [82] Adults with any cancer type Cohort study Feasibility PRO-Onc, EQ-5D Clinic staff Not reported Not reported • Only 4 patients refused to participate
 • 68% staff reported PRO easy to handle
 • 22% used information for care planning during hospital stay; 52% rated additional time as minimal
• HRQoL scores from admission to discharge (no control group)
Seow, H., et al., 2012 [43] Adults with lung and Breast Cancer Retrospective chart reviews Implementation ESAS Oncologist and nurse Clinically significant severity levels Not reported • ESAS score associated with increase in both documentation and actions for pain and shortness of breath
Siekkinen, M. 2015 [83] Adults with breast cancer Single-blinded, RCT Intervention FACT-Breast Cancer, STAI Oncologist, nurse Not reported Patient education materials • As ESAS severity score category increase associated with
 • Significant increase in proportion of visits with symptom documentation (pain and shortness of breath) (p < .0001)
 • Increase proportion of visits with symptom related actions (p < .0001)
Snyder, C., et al., 2010 [84] Adults with breast or prostate cancer Qualitative interviews and Cross-sectional study Feasibility None Not applicable Not applicable Not applicable • Only 2 domains that over 70% of patients reported discussing (pain and information needs), while 9 domains reported by physicians
 • Barriers to using PROs in clinical practice: (1) time constraints, (2) varying relevance of questions, (3) value of the conversational approach, (4) decreased usefulness in established relationships, and (5) respondent burden.
 • Benefits of PROs in clinical practice include (1) identifying problems, (2) serving as a reminder of topics to discuss, and (3) tracking changes over time.
Synder, C. 2014 [85] Adults with breast or prostate cancer RCT Intervention EORTC QLQ-C30, SCNS-SF34, PROMIS Clinicians Problematic scores noted No instructions given, only usual best practice guidelines • Patient feedback suggested differences in ratings for included PROs in order QLQ-C30, PROMIS, SCNS-SF34 (P < .05).
 • Clinicians did not prefer one questionnaire over the others.
Taenzer, P. 2000 [86] Adults with lung cancer Controlled trial (no randomization) Intervention EORTC QLQ-C30, PSQ, PDIS Nurse, physician Score information provided Exit Interview • No group differences in patient satisfaction
 • More QL issues identified were addressed in the experimental group (p < .001)
 • No statistical differences in charting of issues and action taken.
Takeuchi, E. et al., 2011 [87] Adults with any cancer type RCT Intervention EORTC QLQ-C30, HADS Oncologists Score information provided, graphical display No instructions given, only usual best practice guidelines • Significant intervention effect for the discussion of symptoms (p-.008)
 • Discussion of most symptom initiated by patients, no group differences.
 • Severity of symptom associated with clinical discussion. No group differences
Trautmann, F. 2016 [45] Adults with any cancer type Cohort study Implementation EORTC QLQ-C30, NCCN-DT, BPI Physician 1 SD above/below mean Physician-patient consultation using traffic light color-coded scoring • 79% of patients agreed to participate
 • 67% provided complete PRO information
 • Mean completion time 30 min
 • Rates of approaching patients to participate increased over time
Veilkova, G. 2010 [88] Adults with any cancer type RCT Intervention EORTC QLQ-C30, HADS Physician Not reported Not reported • Continuity of care communication rated better in intervention group (o < 03).
 • Stakeholders found PRO to be useful
Wagner, L. 2015 [52] Adults with ovarian, uterine, or cervical malignancies, non-gynecologic malignancy Cohort study Implementation PROMIS CAT, NCCN- DT, NCCN-Prostate Cancer, PGA Oncologist, nurse T scores provided, severity range information No instructions given, only usual best practice guidelines • 92% of patients completed at least one assessment
 • Of multiple assessments:
o 79% Message requests read
o 37% Assessments started
o 93% Assessments completed of those started
 • Physical function generated most alerts (4% based on severe problems)
Whittle, A.K., 2016 [89] Adults with any cancer type: urological, lung,colorectal, breast, and gynecological Cohort study Feasibility/ Intervention CGA GOLD Clinical team Score information provided Questions for patient to ask clinician • Phase I Observational
o 42% consent and completion rate
o 11.7 min mean completion time
o 86.3% completed CGA-GOLD without assistance.
o 3.1% missing response rate
 • Phase II Intervention
o 39% consent and completion rate
o 89% unchanged decision after comparison of PRO results with clinical notes
Wolfe, J. 2014 [90] Children with any cancer type Cluster RCT Intervention PediQUEST (PQ): MSAS, PedsQL4.0, sickness Clinic staff, palliative care service, pain service, patient Graphical data display No instructions given, only usual best practice guidelines • PRO feedback did not have an effect on symptoms and HRQOL in the study, but effect found for children > 8 years surviving > 20 weeks.
 • Report found useful by:
o 50% of providers
o 54% of parents
o 28% of patients
Wolpin, S., 2008 [91] Adults with any cancer type RCT Feasibility/ Intervention ESRA-C and SDS Physician Not reported Not reported • Mean completion time 15.20 min 5 out of 6 acceptability questions indicated very high acceptability (mean > 4, on a 1–5 range scale)
Wright, P., et al. 2007 [92] Adults with any cancer type Qualitative interviews and Cross-sectional study Feasibility SDI, HADS, EORTC QLQ-C30 Social worker investigator Cut-offs/Thresholds Under development • Referral rates 24% for patients above PRO cutoff
  1. 1 A post-hoc analyses of the data from the same study demonstrated symptom monitoring improves overall survival by 5 months (Basch, 2017). Results were published after the completion of the current review
  2. Abbreviations: AE = adverse event, BPI = Brief Pain Inventory, CES-D = Center for Epidemiologic Studies Depression Scale; CGA GOLD = comprehensive geriatric assessment screening questionnaire, CTCAE = Common Terminology Criteria for Adverse Events, eCRF = electronic case report form, E-MOSAIC = electronic Monitoring Symptoms and Syndromes Associated with Advanced Cancer; EMR = electronic medical record, EORTC QLQ-BN20 = European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Brain Neoplasm, EORTC QLQ-BR23 = European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Breast, EORTC QLQ-C30 = European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30, EORTC QLQ-CR38 = European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal, EORTC QLQ-LC13 = European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer, EQ-5D = EuroQol Five Dimensions, ER = emergency room, ESAS = Edmonton Symptom Assessment Scale; ESRA-C = Electronic Self-Report Assessment for Cancer; FACT-G = Functional Assessment of Cancer Therapy General, GP = general practitioner, HADS = Hospital Anxiety and Depression Scale, HRQoL = health-related quality of life, MOS-SS = Medical Outcomes Study Social Support, MSAS = Memorial Symptom Assessment Scale, NCCN-DT = National Comprehensive Cancer Network Distress Thermometer, NCCN-EDT = National Comprehensive Cancer Network Emotional Distress Thermometer, PCI = patients Concerns Inventory, PDIS = patient-provider communication, PEDSQL = Pediatric Quality of Life Scale, PGA = physician’s global assessment, POMS-17 = Postoperative Morbidity Survey, PRO = patient-reported outcome, PROSQoLI = Prostate Cancer Specific Quality of Life Instrument, PSQ-III = Patient Satisfaction Questionnaire, PTSD = post-traumatic stress disorder; PTSD-CL = post-traumatic stress disorder civilian, QLIC-ON = Quality of Life in Childhood Oncology; QoL = quality of life, RCT = randomized controlled trial, REALM-SD = Rapid Estimate of Adult Literacy in Medicine;m SCNS-SF34 = Supportive Care Needs Survey Short Form, SDS = Symptom Distress Scale, SF-36 = Short-form 36, SQoL = subjective quality of life, STAI = State Trait Anxiety Inventory, TAPQoL = TNO-AZL Preschool Children Quality of Life, UWQoL = University of Washington Quality of Life