Table 2 Summary Table with Key Elements of Included Studies
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 |