Clayton 2007.

Study characteristics
Methods	Aim: to determine whether the provision of a question prompt list (QPL) influences advanced cancer patients’/caregivers’ questions and discussion of topics relevant to EoL care Study design: RCT; 2 arms (intervention, usual care) Consumer involvement: development of the QPL (Clayton 2003): QPL based on focus groups and interviews with 19 patients, 24 carers, 22 palliative care health professionals. Draft QPL was reviewed by another 21 health professionals and piloted in 23 patients before being finalised with a list of 112 questions Funding source: supported by NHMRC grants; authors declared they have no potential conflicts of interest
Participants	Participants: patients with diagnosis of an advanced progressive life limiting illness, English speaking, older than 18 years of age, and able and well enough to read QPL and complete questionnaires Setting and geographic location: 9 Australian palliative care (PC) services in 2 states. Setting unclear but QPL was administered at time of consultation with physician. Almost all patients were recruited from outpatient clinics Methods of recruitment: recruitment at the clinic of 15 PC physicians from 9 PC services. Consecutive eligible patients from each participating physician were invited to participate Enrolment was within 3 consultations from initial contact with the PC physician. After obtaining written consent and baseline data, patients were randomly assigned to study groups Selection criteria for participation in study: Inclusion: PC physicians who endorsed the use of QPL patients: people with diagnosis of an advanced progressive life limiting illness, English speaking, older than 18 years of age, and able and well enough to read QPL and complete questionnaires Exclusion: criteria unclear Diagnosis of person approaching EoL: patients with diagnosis of an advanced progressive life limiting illness Target of intervention: carer accompanying patient to consultation (spouse, partner, family member or friend) Age: QPL(intervention) 65.5 years (SD 12.6); UC 64.6 years (SD 14.1) Gender: intervention 39% female; UC 40% female Ethnicity/culture/language: QPL: Australian 73%; other English speaking country 5%; non‐English speaking country 8%; unknown 14% UC: Australian 79%; other English speaking country 5%; non‐English speaking country 6%; unknown 10% Other PROGRESS aspects: non‐English speakers; those who were too unwell to attend outpatient appointments; those from non‐urban centres were all excluded from the trial Numbers of participants: see Additional Table 1
Interventions	Intervention: QPL for advanced cancer patients and their caregivers, referred for palliative care (PC) Aim of intervention: to determine whether provision of a QPL influences advanced cancer patients’/caregivers’ questions and discussion of topics relevant to EoL care during consultations with a PC physician Comparison: usual care (routine consultation with PC physician) Delivered by: physicians Setting: at clinic where consultation occurred in 9 outpatient PC clinics Materials, procedures, content: Participants received the QPL 20 to 30 minutes before their PC physician consultations The QPL is a 16‐page A5 booklet containing 112 questions grouped into 9 topics encompassing issues that may be discussed with a physician or another health professional When and how much: once. Timing in terms of number of previous consultations with PC physician was variable Tailoring: QPL purpose is to assist patients to identify questions of most importance and to raise these when in consultation with physician Modified during study: no modification reported Co‐intervention(s): not reported Fidelity assessed: not reported, unclear Theoretical base: QPL based on focus group, interviews in a range of stakeholders; prior piloting in PC population
Outcomes	Primary outcomes Total number of questions during consultation [Discussions about EoL/EoL care] Method: coding of audiotaped consultations Timing: after consultation with PC physician Scale and scoring: the QPL is a 16‐page A5 booklet containing 112 questions grouped into 9 topics encompassing issues that may be discussed with a physician or another health professional. Patient questions, concerns and items were tallied and categorised according to QPL categories. All patients’ consultations with the PC physician were audiotaped, transcribed, and coded. Question = direct request for information. Concern = patient/carer statement inviting response from physician. Items: "Items discussed (85 issues covered by questions in the QPL, whether or not prompted by a patient/caregiver question/concern), plus patient and caregiver questions/concerns were coded and tallied for each of the nine topics" (page 716) Achievement of patient information preferences [Knowledge and understanding] Method: questionnaire, 1 item Timing: 24 hours after consultation and 3 weeks after consultation Scale and scoring: Cassileth Information Styles Questionnaire (measures amount of detail preferred; 5‐point Likert scale) Achievement of patient information needs [Knowledge and understanding] Method: questionnaire Timing: 24 hours after consultation and 3 weeks after consultation Scale and scoring: totals out of 11 tallied for items not discussed, items for which they did not receive enough information, or about which they received too much information Patient satisfaction with consultation [Evaluation of the communication] Method: questionnaire, Roter and Korsch Timing: 24 hours after consultation and 3 weeks after consultation Scale and scoring: 25‐item scale, scores range from 25 to 125, higher scores reflect greater satisfaction Actual versus preferred involvement in consultation [Evaluation of the communication] Method: questionnaire Timing: 24 hours after consultation Scale and scoring: 5‐item rating scale (ranging from doctor leads decisions to patient leads decisions) Primary outcomes ‐ adverse events Patient anxiety [Evaluation of the communication] Method: questionnaire, STAI Timing: 24 hours after consultation and 3 weeks after consultation Scale and scoring: STAI, scores range 20 to 80; higher scores more anxiety Secondary outcomes Physician satisfaction with consultation [Health practitioner evaluation of communication] Method: unclear Timing: 24 hours after consultation and 3 weeks after consultation Scale and scoring: unclear Consultation length [Health systems impact]
Notes	Outcomes related to participants' views of QPL reported, alongside physician ratings of the QPL, but as these were rated only for the intervention group the data are non‐comparative and so not reported in the review Outcomes were analysed at longest follow‐up (3 weeks post‐consultation) For 'total questions during consultation' only mean total questions were extracted for the review (concerns, items were not collected but were reported by the trial)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Individually randomised and stratified by physician – random permuted blocks of 10 constructed using random number table (by research assistant not involved in recruitment)
Allocation concealment (selection bias)	Low risk	Allocations were concealed using sequentially numbered opaque sealed envelopes
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Physicians were unblinded; authors note that prior research has indicated that QPL require professional endorsement in consultations to be effective Unclear whether or not patients and carers were blinded to intervention and/or what effect this may have had on the outcomes
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Authors indicate that consultations were audiotaped, transcribed and analysed by blinded coders "Two coders were trained and blinded to group allocation. One coder coded all transcripts and recoded a random 10% to determine intrarater reliability. The second coder coded a random 10% of transcripts to determine inter‐rater reliability" (page 716)
Incomplete outcome data (attrition bias) All outcomes	Low risk	Low levels of loss to follow‐up 4/174; balanced across groups (n = 2 each), with comparable reasons
Selective reporting (reporting bias)	Unclear risk	All outcomes described in methods were reported but no protocol is available
Other bias	Unclear risk	Baseline differences between groups: authors note that groups were comparable on most characteristics but that some differences were present (> 5% differences between groups) including educational level (tertiary versus non‐tertiary (higher tertiary intervention group)); professional versus non‐professional occupation (higher professionals intervention group); carer presence (intervention group higher); timing of consultation (more seen previously intervention group)