Wheelock 2015.
Study characteristics | ||
Methods | Randomised trial, USA | |
Participants | 102 patients with TNM stage I to III breast cancer, average age 53yrs, average time from diagnosis 3.2 years | |
Interventions | SIS.NET (System for Individualized Survivorship Care, based on patient self‐reported data, with review by nurse practitioners, targeted Education, and Triage) vs usual care. Intervention features Multiple complex feedback (multiple PROMs at multiple times) PROM(s) used as intervention: Web based application SIS.NET (System for Individualized Survivorship Care, based on patient self‐reported data, with review by Nurse practitioners, targeted Education, and Triage) including ‐ 36‐Item Short Form Survey (SF‐36), Personal Health Questionnaire Depression Scale (PHQ‐8), (modified questions from) Memorial Symptom Assessment Scale Constructs measured: Health related Quality of Life, Symptoms, Functioning Instrument categories/domains: Generic, Domain/Disease specific (mental health, cancer) Administration features Where PROMs administered: Non‐clinical setting How administered: Self‐administered Format of PROMs questionnaire(s): Electronic Feedback features Format of PROMs feedback: Electronic, Paper How often information fed back: Patients in the SIS.NET arm were scheduled for 3 breast cancer‐related clinic visits with the providers of their choice (breast surgeon, medical oncologist, and radiation oncologist) during the 18‐month duration of the study, with additional appointments scheduled later as needed. The SIS.NET intervention also included the integration of online health questionnaires at 3‐month intervals between clinic visits evaluating symptoms that were monitored and followed by telephone as necessary by a designated nurse practitioner (NP). Who information fed back to: Clinicians, Patients Information fed back: Scores, Previous scores |
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Outcomes | Primary endpoint: time in days between symptom reporting and remote evaluation of symptoms (i.e. time elapsed between completion of questionnaire (as documented automatically by the ISS software) and the NP’s documentation of attempts to contact the patient to evaluate the symptom and make treat‐ ment recommendations). Other outcome: use of healthcare resources (breast cancer‐related visits, total medical appointments, and laboratory and imaging studies) over an 18‐month period. |
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Notes | The study was supported by the Henry J. Kaiser Family Foundation (grant). The study period was not reported. Conflicts of interest were reported as: Ms. Wheelock, Dr. Melisko, Dr. Martin, Ms. Ernest, and Ms. Bock report that the Safeway Foundation provided financial support for the Athena Breast Health Network and Survivorship Programming for work performed as part of the current study. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation occurred by block design developed by the statistician |
Allocation concealment (selection bias) | Unclear risk | Allocation was done by the research coordinator, but unclear if patients/personnel aware |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Due to nature of intervention not possible to blind patients and personnel. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Due to nature of the intervention blinding of outcomes not possible: PROM used for feedback also used to assess outcome, patients were aware they received the intervention. |
Baseline outcome measurements similar | Low risk | Baseline data on Table 1 were similar between chart and control groups |
Baseline characteristics similar | Low risk | No significant differences between the groups |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No mention of how missing data were handled |
Was study protected against contamination | Unclear risk | No mention about potential contamination |
Selective reporting (reporting bias) | Unclear risk | Unclear whether selective reporting took place |