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

Rao 2005.

Methods RCT; Unit of allocation: Patient; Stratified by: Site (Veterans Affairs) and patient's functional status
Participants Hospitalised frail patients, 65 years of age or older, with a diagnosis of cancer.
Setting / country: Veterans Affairs medical centres / USA
Type of cancer: Any type
Phase of care: Any phase
Sample size at randomisation: 1388
Interventions Enrolled patients were randomly assigned to receive inpatient care in a geriatric evaluation and management unit (GEMU) or usual inpatient care (UCIP), followed by outpatient care in a geriatric evaluation and management clinic (GEMC) or usual outpatient care (UCOP).
Four combinations of care were thus studied:
(1) GEMU + UCOP
(2) UCIP + GEMC
(3) GEMU + GEMC
Inpatient geriatric evaluation and management unit (GEMU) or Outpatient geriatric evaluation and management clinic (GEMC): The inpatient and outpatient intervention teams, each consisting of a geriatrician, a social worker, and a nurse, followed their standard protocols for geriatric evaluation and management, with specific instructions to complete the history taking and physical examination, including screening for geriatric syndromes such as incontinence or falls (within three days for patients assigned to the geriatric evaluation and management unit); develop a list of problems; assess the patient's functional, cognitive, affective, and nutritional status; evaluate the caregiver's capabilities; and assess the patient's social situation. A plan of care was developed, and the team on the geriatric evaluation and management unit met at least twice a week to discuss the plan. Preventive and management services (e.g. dietetics, physical and occupational therapy, and clinical pharmacy) were coordinated to address the problems identified, with a general emphasis on maintaining the patients functional status.
Control: Usual inpatient (UCIP) or outpatient care (UCOP): Inpatients who were assigned to receive usual care received all appropriate hospital services except for those provided by the team on the geriatric evaluation and management unit. Outpatients assigned to receive usual care were provided with at least one follow‐up appointment in an appropriate clinic. After the initial site visits, the process of care was evaluated with the use of annual questionnaires, as well as a specific checklist for each part of the intervention, in order to ensure compliance with the study protocol.
Outcomes Patient: QoL, functional status, physical performance
Process: Use of hospital services
Notes Length of follow‐up: 12 months
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote from ref #2: "Randomisation was performed with the use of a computer program at the coordinating centre. The randomisation codes were generated according to a two‐by‐two factorial design, with stratification according to the centre and the patients functional status (high or low), with the use of permuted blocks of eight patients for the four treatment groups."
Allocation concealment (selection bias) Low risk See quote first item. 
Blinding (performance bias and detection bias) 
 All outcomes Low risk Quote: "All follow‐up data, except for PPT results, were gathered via a telephone call to the patient by a centralised research assistant, blinded to the patient’s study group status, who recorded all answers to the survey questions."... and was unaware of the treatment assignments."
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Quote: "All of these 99 cancer patients were followed successfully for 1 year or until death. Over 99% of all total potential follow‐up interviews at 6 and 12 months were obtained successfully by telephone interview."
Selective reporting (reporting bias) Low risk All outcomes described in Methods are reported in Results.
Other bias High risk Quote: "Second, we also have no information on the 99 cancer patients in terms of stage of cancer, active treatment, length of disease, and response to therapy, all factors that affect quality of life."
Baseline outcomes similar? Low risk Quote from ref #2: "None of the variables differed significantly among the 4 treatment groups."
This quote refers to baseline characteristics and outcomes presented in Table 1 (ref #2).
Quote: "Values are mean changes in scores (adjusted for length of stay) from randomisation to either discharge (D/C) or follow‐up at 12 months (12 M)."
Baseline characteristics similar? Low risk Quotes from ref#1: "There was no difference in baseline demographics of the cancer patients among the different randomisation groups."
"Of note, 15 patients carried a diagnosis of secondary cancer with bony metastasis; these patients were evenly distributed among the different treatment groups."
See quote item G.
Protected against contamination? Unclear risk Comment: Patients were the ones that were randomised. It is not clear if the same health practitioners were in charge of more than one treatment groups. It is possible since the units where the interventions took place were within the same medical centres.