Luker 2000.
Methods | CCT; Unit of allocation: Patient; Stratified by: Week in which women attended the breast specialist unit | |
Participants | Women newly diagnosed with breast cancer. Setting / country: Hospital‐based specialist service / UK Type of cancer: Breast Phase of care: Pre‐treatment, treatment, discharge, surveillance Sample size at randomisation: 76 |
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Interventions | Services from a breast care nurse (same as control) + information cards: Eleven information cards were developed by breast specialist secondary care professionals for members of the primary healthcare team. Women with breast cancer were asked to take the information cards to their own general practitioner (GP) practice. They covered information on the rationale for a specific treatment, prognostic indicators, complications and side‐effects, suggestions for dealing with side‐effects and indicators for referral back to specialist services. Women were given cards corresponding to their treatment and the number and type of cards given to each woman was determined by the treatment received. Control: Services of a breast care nurse who offered home visits prior to admission for surgery and written patient information leaflets on a variety of treatment regimes. |
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Outcomes | Process: Number of contacts with GP and district nurse | |
Notes | Length of follow‐up: 4 months | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Quote: "Study participants were allocated to one of two study groups: intervention or non‐intervention. Allocation was determined by the week in which women attended the breast specialist unit, alternate weeks being classed as intervention or non‐intervention weeks." Comment: This is a quasi‐experimental design trial. |
Allocation concealment (selection bias) | High risk | See quote first item. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Comment: No details provided concerning the blinding of the persons who made interviews or analysis. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | The proportions of dropouts in each group are presented (11% in intervention and 2% in control) but not the reasons for dropping out. Numbers of participants reported in the tables do not concur with the text regarding attrition, so it was impossible to judge if missing data could impact the observed effect size. |
Selective reporting (reporting bias) | Low risk | All relevant outcomes (objective measures) were reported in Results. |
Other bias | Low risk | No evidence of any other bias |
Baseline outcomes similar? | Low risk | Only the proportion of patients that had a contact with breast care nurse could be compared at baseline, since the other measures could not possibly be assessed at baseline. See Table 1 for comparison of no. of contacts with breast care nurse. |
Baseline characteristics similar? | Low risk | Quote: "Patients in the intervention and non‐intervention groups appeared to be well matched on a number of demographic variables (Table 1)." |
Protected against contamination? | High risk | Quote: "13/42 practices had women in the intervention and non‐intervention groups." Comment: The same professionals were in charge of control and experimental patients, so contamination was possible. |