Moore 2002.
Methods | RCT; Unit of allocation: Patient; Stratified by: Hospital and treatment intent | |
Participants | Patients with lung cancer having completed their initial treatment and expected to survive for at least 3 months. Setting / country: Specialist cancer hospital and three local cancer units in south‐eastern England / UK Type of cancer: Lung Phase of care: Surveillance, palliative care Sample size at randomisation: 203 |
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Interventions | Nurse‐led follow‐up: Patients were allocated to one of two clinical nurse specialists in lung cancer and were assessed monthly by protocol over the telephone or in a nurse‐led clinic to identify signs of disease progression, symptoms warranting intervention, or serious complication. Additional contacts were made as necessary: patients had access to the clinical nurse specialists in the nurse‐led clinic or by telephone without an appointment. Nurses role was to provide information and support, coordinate input from other agencies or services. The clinical nurse specialist was responsible for the entire care of patients unless the patient needed further treatment. The emphasis was on rapid and comprehensive communication with general practitioner and primary healthcare team by telephone, fax, or letter, as appropriate. Regular discussion was made with and referral to medical team on detection of any new symptom or rapid worsening of condition. Also, documentation from nurse‐led clinic was held in notes and sent to general practitioner, home care team or hospice, if applicable, and consultant in charge of patient. Medical consultants gave regular clinical supervision sessions for the clinical nurse specialist. Control: Conventional medical follow up: routine outpatient appointments (one post‐treatment appointment, then appointments at two or three month intervals) for medical assessment and investigations to monitor disease progression. Patients were also seen on the basis of need. |
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Outcomes | Patient: QoL, satisfaction, survival, symptom‐free survival, progression‐free survival Process: Use of hospital services, place of death |
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Notes | Length of follow‐up: 12 months | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "For randomisation, patients were stratified according to hospital and treatment intent." Comment: No details are provided regarding sequence generation. |
Allocation concealment (selection bias) | Low risk | Quote: "An independent trials office was responsible for randomisation of patients to either conventional medical follow up or nurse led follow up." |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | No details on the way the outcomes were measure are provided in the article. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: Proportions of attrition and reasons for attrition are generally similar between treatment group, with slight difference at 6 months for the proportion of of non‐compliant (13% vs 3%) and at 12 months for the number of deaths (29% vs 17%). No imputation was used. Because numbers of participants presented in the tables differed for the flow chart numbers, we could not verify if missing data had an impact on the observed effect size. |
Selective reporting (reporting bias) | Low risk | All outcomes described in Methods are reported in Results. |
Other bias | Low risk | No evidence of other bias |
Baseline outcomes similar? | Low risk | Quote: "The clinical characteristics at baseline were similar between groups (table 1), as were scores for quality of life and patient satisfaction at baseline." |
Baseline characteristics similar? | Low risk | See quote from item G. |
Protected against contamination? | Low risk | Nurse specialists from three local cancer units were responsible for patients in the intervention group whereas physician in an outpatient unit of the hospital were responsible for control group participants. The use of different settings and specialists prevents contamination. |