Jones 2010.

Methods	Design: RCT
Participants	Setting: 6 general district hospitals and 6 university hospitals in 6 European countries. Type of trauma exposure: ICU patients with an ICU stay > 72 hours Inclusion criteria: patients who had been admitted to the ICU and ventilated. Exclusion criteria: patients stayed in the ICU for < 72 hours; ventilated for < 24 hours; were too confused to give informed consent (including severe traumatic brain injury) and had pre‐existing psychotic illness such as schizophrenia and manic depression (a confounding factor for psychological recovery) or diagnosed PTSD. Sample size: 1164 people screened for inclusion and 352 were randomised. Mean age: intensive care diaries: 60 (SD 15.6) years; delayed intensive care diaries: 59 (SD 16) years. Gender: 227 (64.5%) men; 125 (35.5%) women Ethnicity: not reported Country: Denmark, Italy, Norway, Portugal, Sweden, UK
Interventions	Group 1: intensive care diaries: n = 177 All patients had an ICU diary written for them while they were in critical care, which the healthcare staff wrote and the family contributed to if they considered they could. Diary was a daily record of the patients' ICU stay, written in everyday language and accompanied by photographs. Memories of the ICU were assessed at 1‐week post‐ICU. Patients received their diary as soon as they wanted following randomisation at 1‐month postdischarge. 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. Most of the discussions took place in an outpatient setting in a hospital but a small number were in the patients' own homes. In units where the travelling distance was too great for the patient to return to the hospital the discussion of the diary took place over the telephone. Group 2: delayed access to ICU diary: n = 175 Control patients received their diaries after they completed the final follow‐up questionnaires at 3 months.
Outcomes	PTSD: PDS administered as a diagnostic interview Other: PTSS‐14, a 14‐item questionnaire that has been validated with ICU patients Follow‐up: 3 months following discharge from ICU
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Patients were assigned to treatment or control group at 1 month using a closed, non‐transparent envelope technique, randomised in blocks of 6 through computerised random number generation.
Allocation concealment (selection bias)	Low risk	Patients were assigned to treatment or control group at 1 month using a closed, non‐transparent envelope technique, randomised in blocks of 6 through computerised random number generation.
Blinding of outcome assessment (detection bias) All outcomes	High risk	It was considered impractical to guarantee blinding of the allocation of the diary as patients would volunteer their use. In order to reduce bias and ensure blinding of the diagnosis of PTSD at the 3‐month follow‐up, the researchers were only trained to interview and administer the PDS but were not made aware of the scoring calculation or in what way each question contributed to the score and final diagnosis.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Outcomes based on available data at 3‐month follow‐up. Dropout from both groups was balanced and low.
Selective reporting (reporting bias)	Unclear risk	Study protocol registered after completion of study. It would make sense to report PTSD severity outcomes (e.g. on the PDS) but these were not reported.
Other bias	High risk	The PTSS‐14 has only been subject to preliminary validation in a small UK‐only sample. PTSD diagnosis was based on assessor administration of the PDS. Although the PDS can be used to generate a provisional PTSD diagnosis it is not intended to replace a structured diagnostic interview. A number of participants were excluded retrospectively based on identification of PTSD with onset prior to admission at the 3‐month follow‐up point.