Are patient-reported outcomes useful in post-treatment follow-up care for women with early breast cancer? A scoping review

Figures & data

Table 1 Summary of studies reviewed

Study (author, year, country, reference)	Patients (number, mean age, breast cancer stage)	Study methods and setting	Aims and outcome	Assessments	Description of PRO tools	How PROs were used	Principal findings	Comments
Mertz et al, 2017, Denmark^Citation32	N=116, 54.8 years. Women with newly diagnosed early breast cancer	RCT+observational, 50 women in an RCT and 66 in an observational group. Patients were recruited at the surgical department	To determine the feasibility and effectiveness of an individual, nurse navigator intervention for relieving distress, anxiety, depression, and health-related quality of life	All patients (control, intervention, and observation groups) were asked to fill in questionnaires at baseline and after 6 and 12 months. Patients in the intervention group filled in three additional short screenings at 1, 9, and 18 weeks	# Distress thermometer, a numerical scale from 0 (no distress) to 10 (extreme distress) # HADS # European Organization for Research and Treatment of Cancer quality of life questionnaire Core 30	Dialogue and screening: baseline scores were used to allocate patients to observation or RCT study Symptom screening assessment at baseline, 9 weeks, 18 weeks, 6 months, and 12 months provided the basis for dialogue between the patients in the intervention group and the nurse navigator	Women in the intervention group reported significantly greater satisfaction with treatment and rehabilitation, and lower levels of distress (mean 2.7 vs 5.1, P<0.01), anxiety (mean 5.1 vs 7.8, P=0.02), and depression (mean 2.2 vs 4.4, P=0.04) after 12 months compared to the control group	No significant effects on health- related quality of life. It was a strength to this study that the intervention was restricted to patients with moderate-to- severe distress at the time of randomization, thus focusing on the patients who might gain most from professional support
Wheelock et al, 2015, USA^Citation33	N=102, 52.85 years. Stage I–III, during follow-up	RCT comparing SIS.NET with standard follow-up care	To quantify the time between symptom reporting and remote evaluation of symptoms. The secondary endpoint was to compare use of healthcare resources (breast cancer- related visits, total medical appointments, and laboratory and imaging studies) over an 18-month period	Participants in the SIS.NET arm received email invitations to complete an online health questionnaire every third month and could by email request an interim questionnaire	# Short-Form Health Survey # Patient Health Questionnaire Depression Scale # Unspecified symptom questionnaire	Dialogue and screening: completion of the online questionnaire by the patient generated a clinician report summarizing the patient’s symptoms and identifying those symptoms that met a prespecified threshold for clinical concern and generated automated referrals	74% of new or changed self-reported symptoms were reviewed within <3 days. SIS.NET patients reported more new or changed symptoms compared with standard care patients. No statistically significant difference between the SIS.NET and standard care arms with regard to oncology- related appointments, total number of physician visits, or number of medical tests was found	A relatively low questionnaire completion rate of 50% in the SIS.NET arm compared with the 62.5% completion rate of preclinical questionnaires among the patients in the standard care arm indicated some feasibility and compliance issues
Thompson et al, 2013, UK^Citation35	N=172, 63.7 years. Stage I–III, attending routine follow-up	Prospective study, patients were approached in outpatient clinics	To examine levels of psychological distress for patients approaching discharge from hospital follow-up care to community-based care	Only one assessment at least 2 years past diagnosis. Patients were provided with paper questionnaires and a prepaid envelope so measures could be self-completed and returned to the study team	# HADS # CORE # Measure Yourself Medical Outcomes Profile	Screening tool: if a patient reported scores indicative of distress, the individual was contacted by the principal investigator to assess their need for additional support and facilitate access to services	Patients reported low levels of distress in hospital-based follow-up, which were comparable or better than general population norms, although there was a significant minority of patients reporting high scores (n=27, 15.7%) on HADS or CORE	The sample in this study was highly selected with 227 patients who voluntarily agreed to participate and who were provided with questionnaires, from a cohort of 323 eligible candidates; only 172 (75%) actually completed and returned them. There was no argument whether this sample was representative for all eligible candidates
Bock et al, 2012, USA^Citation34	N=106, 56.9 years. Stage I–III, during follow-up	Retrospective analysis of symptoms reported in a questionnaire, clinic notes, or both, excluding chronic symptoms addressed previously	To investigate the impact of a web-based health questionnaire on symptom reporting, physician documentation of symptoms, and symptom management	A comprehensive questionnaire for completion before each new patient appointment and a shorter survey before follow-up appointments	# A non-specified web-based health questionnaire	Dialogue and screening tool: the clinician summary report was placed within the chart before the clinic visit containing the patient’s self-reported data	Patients reported significantly more symptoms using the online questionnaire (mean=3.8, range 0–13) than were documented by the provider in clinic notes (mean=1.8, range 0–7; P<0.001 for the difference)	This study is of sparse clinical interest, since the findings were not compared to standard procedure. It is reasonable to expect that the clinician performed a prioritized reporting of relevant symptoms and thereby failed to report as many symptoms as reported by the patient

Abbreviations: CORE, Clinical Outcomes for Routine Evaluation; HADS, Hospital Anxiety and Depression Scale; PRO, patient-reported outcome; RCT, randomized controlled trial; SIS.NET, System for Individualized Survivorship Care, based on patient self-reported data, with review by Nurse practitioners, targeted Education, and Triage.

Table 2 Assessment of risk of bias (ROBINS-I)

Study (author, reference, country of research)	Bias due to confounding	Bias in selection of participants into the study	Bias in classification of interventions	Bias due to departures from intended interventionsa	Bias due to missing data	Bias in measurement of outcomes	Bias in selection of reported results	Overall assessment of risk of bias
Mertz et al^Citation32, Denmark	Low	Moderate	Low	Moderate	Low	Moderate	Low	Moderate: selection bias, small study, but otherwise a well performed RCT
Wheelock et al^Citation33, USA	Serious	Critical	Moderate	Low	Critical	Moderate	Low	Critical: selection bias, low response rate, time-varying confounding, and confounding due to difference in TNM stages between groups
Thompson et al^Citation35, UK	Serious	Serious	Moderate	Not relevant	Low	Moderate	Low	Serious: selection bias, only the ones with motivation and willingness to participate were included. No evaluation or considerations of whether the sample was representative of the population
Bock et al^Citation34, USA	Moderate	Moderate	Moderate	Not relevant	Low	Serious	Low	Serious: lacking comparator. The clinical relevance of this study fails because data about symptoms handled in a setting without PRO are not reported

Note:

a Since the studies were heterogeneous, not all domains were relevant to all studies.

Abbreviations: PRO, patient-reported outcome; RCT, randomized controlled trial; ROBINS-I, Risk of Bias in Non-randomized Studies – of Interventions.

Figure 1 PRISMA diagram.

Abbreviation: PRO, patient-reported outcome.

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