Jones 2010.

Methods	Pragmatic, randomized controlled trial in six European countries, with two ICUs per country.
Participants	352 adult ICU patients randomized, 322 completed study. Inclusion criteria: Admitted to ICU for > 72 hours; ventilated for > 24 hours. Exclusion criteria: Too confused to give informed consent; pre‐existing psychotic illness (e.g. schizophrenia); diagnosed PTSD.
Interventions	ICU diary: a daily record of the patient's ICU stay, written in everyday language and accompanied by photographs. Authored by multidisciplinary healthcare staff and family. Diaries standardized via the provision of guidelines to each centre. The diary was introduced to the patient by a research nurse or doctor who ensured that they understood its contents but did not give any advice on what to do with it. This was done either face‐to‐face or over the phone. Controls: Received standard care at each setting. At several of the study sites, this involved giving patients verbal information about their illness prior to discharge from hospital. All control participants received the ICU diary after the final outcome assessment.
Outcomes	Patient ICU memory recall: assessed using ICUMT at randomization (1‐month post ICU discharge) and 3‐month follow‐up. Patient post‐traumatic stress symptomatology: assessed using post‐traumatic stress‐14 at randomization and 3‐month follow‐up. Patient PTSD: assessed using post‐traumatic diagnostic scale with a blinded clinician within a 'diagnostic' interview at the 3‐month follow‐up. Not included within this systematic review.
Notes	ICU: Intensive care unit
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Randomised in blocks of six through computerised random number generation" (p. 4)
Allocation concealment (selection bias)	Low risk	Quote: "Assigned to treatment or control at one‐month using closed, non‐transparent envelope technique" (p. 4)
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote: "Impractical to guarantee blinding of allocation of the diary as patients would volunteer their use" (p. 3).
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Quote: "In order to reduce bias and ensure blinding of the diagnosis of post traumatic stress disorder at the three‐month follow‐up, the researchers were only trained to interview and administer the post‐traumatic diagnostic scale but were not made aware of the scoring calculation or in what way each question contributed to the score and final diagnosis" (p. 3). For the outcomes included within this review, assessment was made via questionnaire by the participants, who were not blinded to the intervention. It is not known whether the researchers summarising these questionnaire results were blinded.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Less than 10% attrition. Well described reasons for participant withdrawal from the study. (p. 4)
Selective reporting (reporting bias)	Low risk	Research protocol well described, clinical trial registered. All outcomes reported. (p. 1, 3, 5)
Other bias	Low risk	Nil