Papageorgiou 2002.

Methods	Allocation: randomised, stratified according to number of times sectioned, using sealed envelopes. Blindness: not blinded. Duration: 12 months.
Participants	Diagnosis: "inpatients receiving compulsory psychiatric treatment under sections 2, 3,or 4 of the Mental Health Act 1983 for England and Wales" (no diagnostic criteria reported). N=161. Age: mean age 36 years. Sex: 93 M, 63 F. Inclusion criteria: inpatients receiving compulsory psychiatric treatment (under sections 2, 3, or 4 of the Mental Health Act 1983 for England and Wales), age 18 years and over, able to read English. Exclusion criteria: patients under other specialised sections, those about to be transferred to other orders or other hospitals, and those with organic brain disease. Setting: in‐patients, Inner London.
Interventions	Intervention: participants provided with a booklet containing seven statements concerning preferences for future treatment; patients were encouraged to complete and sign the booklets, or dictate their preferences to the researcher; copies were provided to the key worker, general practitioner, and filed with the hospital and general practice records; all patients received standard community psychiatric care (planned and provided by a multidisciplinary community psychiatric team). N=80. Control: usual care, consisting of standard community psychiatric treatment (as above). N=81.
Outcomes	Primary outcome: number of people compulsorily re‐admitted under the Mental Health Act during follow‐up. 12‐month follow‐up: Basis‐32. self‐report questionnaire designed for patients with mental illness. Hospital Service Satisfaction Scale. Questions on the use of the advance directive. Questions for consultant psychiatrists and key workers on their awareness of the directive, its use, and whether it could be improved. Prescribing data (from case notes).
Notes	Data regarding voluntary and involuntary admissions collected from hospital records for the 5 years before baseline and 12 months of follow‐up. Due to the nature of the intervention, it was impossible to mask research assistants to patients' allocation. However, primary outcome of admission was not likely affected by systematic bias.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Random allocation using block design in blocks of 12 (6 experimental, 6 control), stratified by first ever or subsequent sectioning. Block randomisation in known block sizes allows for identification of allocation of at least the 12th participant per block if block size is known to investigators.
Allocation concealment (selection bias)	Unclear risk	Allocation provided in sealed envelopes. Independent colleague selected next envelope. As above, is possible to identify allocation of at least the 12th participant per block.
Blinding (performance bias and detection bias) All outcomes	High risk	"It was impossible to mask the research assistants to the patients' allocation as they were required to assist patients to make a directive in those allocated to the intervention group. However, systematic bias was unlikely as the primary outcome concerned compulsory hospital admission and was not based on any later assessment by the researcher." Bias possible for secondary outcome measures.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Intention‐to‐treat analysis, with exception of 5 (1 intervention, 4 control) patients not discharged from hospital.
Selective reporting (reporting bias)	Low risk	Reported all data.
Other bias	High risk	In both arms, fewer than expected patients were compulsorily re‐admitted, leading to lower statistical power than anticipated. Potential for lack of sustained awareness of directives throughout the 12 months of follow‐up. Key workers in one of the two psychiatric services were often not allocated before patients were discharged, potentially reducing the effect of the directives.