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. 2012 Jul 11;2012(7):CD007672. doi: 10.1002/14651858.CD007672.pub2

King 2009.

Methods RCT; Unit of allocation: Patient
Participants Patients having breast, lung or colorectal cancer and having reached the end of first treatment.
Setting / country: Breast, lung and colorectal cancer services at 4 North London NHS Trusts; North London Marie Curie Hospice / UK
Type of cancer: Breast, lung, colorectal
Phase of care: Treatment, discharge, surveillance
Sample size at randomisation: 93
Interventions (1) FULL INTERVENTION: Usual care + continuity assessment + feedback to the clinical nurse specialist (CNS). The patient completed a 17‐item continuity assessment. After each item, patients ticked a box if they wished to discuss the issue further with a clinical team member. Four boxes were given at the end of the questionnaire in which participants could also write any additional information they wanted to give on up to four items. Patients responses were fed back to CNS who were expected to take action as necessary in any areas highlighted by patients for further attention. This could involve discussion with patients and/or discussion between members of the team. How or when actions should be taken was not indicated, but was rather left to the CNSs expertise. Nurses were asked to complete a clinical feedback form briefly detailing any action they had taken in response.
(2) PARTIAL INTERVENTION: Usual care + continuity assessment (partial intervention).
Control: Usual care
Outcomes Patient: Perceived needs
Process: Patient experience of continuity
Notes Length of follow‐up: 1.5 months
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote from ref #2: "An independent statistician used a blocked randomised design to achieve equal numbers in each trial arm. Researchers telephoned the trial centre to receive each participants allocation from an administrator independent of the trial."
Allocation concealment (selection bias) Low risk See quote first item.
Blinding (performance bias and detection bias) 
 All outcomes High risk Quote from ref #1: "Patients in all three arms completed the continuity assessment (primary outcome), and the needs assessment and satisfaction rating (secondary outcomes) by post after 6 weeks." 
 
 Comment: Patients filled the self‐report instruments, so they were the assessors and could not be blinded to treatment allocation.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Quote from reference #1: "Attrition was highest in the 32 patients randomised to the partial intervention arm only (arm 2, Figures 1 and 2). Most (81%) of those lost to follow‐up were patients who failed to respond. A small number died, and two refused to complete the follow‐up questionnaires. Patients in the intervention groups were significantly more likely to drop out than those in arm 1 (arm 2: OR: 6.25, P < 0.004, arm 3: OR: 3.75, P < 0.042)." 
 
 Comment: There was a less important proportion of missing data in arm 1 (14%) than in arm 2 (50%) or arm 3 (38%). Reasons for dropping out are not explained. No imputation was used for missing data.
Selective reporting (reporting bias) Low risk All outcomes described in Methods are reported in Results.
Other bias Low risk No evidence of other sources of bias were found.
Baseline outcomes similar? Unclear risk Quotes from ref #1: "Patients in trial arm 1 completed no assessments at baseline. Patients in trial arms 2 and 3 completed a need assessment (the supportive care needs survey, (SCNS), which covers psychological, physical, sexuality, patient care and health system domains (Bonevski et al, 2000). They also completed the same visual analogue scales to measure satisfaction that we had used in our earlier cohort study (King et al, 2008)."
Comment: Results of the baseline outcome assessment are lacking for one of the trial arms and are not presented in the publication for the 2 other trial arms. However, results were adjusted for the covariates for these 2 arms. Lack of baseline assessment in one of the trial arms justifies the evaluation made of this item.
Baseline characteristics similar? Low risk Quote from reference #1: "There were no significant differences in patient characteristics between the three arms of the trial."
Quote from reference #3: "There were no demographic differences between patients in the five treatment phases at baseline (Table 1)."
Protected against contamination? High risk Comment: Patients were the one randomised and randomisation was not stratified according to providers. Since there were 29 clinics and 93 participants, then contamination was possible.