Basch 2016.
Study characteristics | ||
Methods | Randomised trial, USA | |
Participants | 766 patients initiating chemotherapy at Memorial Sloan Kettering Cancer Center (MSK) in New York for metastatic breast, genitourinary, gynaecological, or lung cancers. | |
Interventions | Nonblinded, randomised, controlled trial of web‐based self‐reporting of symptoms, compared with usual care. Intervention features Multiple simple feedback (one PROM at multiple times) PROM(s) used as intervention: STAR (Symptom Tracking and Reporting) Constructs measured: Health related Quality of Life, Symptoms Instrument categories/domains: Generic, Domain/Disease specific (cancer) Administration features Where PROMs administered: Clinical setting (e.g. waiting room, office, etc) and non‐clinical setting How administered: Self‐administered Format of PROMs questionnaire(s): Electronic Feedback features Format of PROMs feedback: Electronic and paper (clinicians received symptom printouts, nurses received email alerts when patient symptoms worsening) How often information fed back: At each clinic visit Who information fed back to: Clinicians Information fed back: Scores, Previous scores, Interpretation guidance |
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Outcomes | Main outcome: change in HRQL at 6 months from baseline Other outcomes: survival at 1 year, quality‐adjusted survival |
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Notes | Funded by the Conquer Cancer Foundation of the American Society of Clinical Oncology. The study ran from March 2014 until January 2017. Two authors reported receiving funding from pharmaceutical companies (MGK; HIS). | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer generation random. |
Allocation concealment (selection bias) | Low risk | Allocations conducted by different service. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not possible due to study design (crossed design; study looking at feedback). |
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 variables were well balanced between groups. |
Baseline characteristics similar | Low risk | All baseline characteristics relatively balanced between sub groups within intervention and usual care. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Multiple sensitivity imputation analysis conducted for incomplete data past baseline measurements. |
Was study protected against contamination | Low risk | Controls did not do intervention or had access to intervention system. |
Selective reporting (reporting bias) | Low risk | All outcome measurements mentioned in methods section was reported in results. |