Preliminary analysis of a new measure of quality of patient decision making about research participation Peter Knapp, Jonathan Graffy, Peter Bower, Jo Rick, Caroline Fairhurst, Sara Rodgers, David Torgerson, Sarah Cockayne.

Background Trial participation decisions important Decisions must be informed by information What effects of improving the quality of information? Debate about what we are measuring: Informed consent; or Valid consent; or Decision making (quality); And whether measuring an outcome or a process

Some candidate measures (NB systematic review of informed consent measures being presented by Katie Gillies at this conference!) Quality of Informed Consent (QuIC) – Joffe et al, 2001 DelibeRATE – Gillies et al, 2014 Perceived understanding of informed consent – Guarino et al, 2006 Decisional Conflict Scale – O’Connor et al, 1995 SURE -  Parayre et al, 2013. Experience of using QuIC on CASPER trial. Most appropriate for drug trials? 6.8% respondents at least 1 missing item (of 10)

Opportunity for an embedded trial REFORM study & trial Multifaceted podiatry intervention to prevent falls in older people (NIHR HTA) (1) Embedded trial of optimised participant information (within the MRC START project) (2) Would revision of the PIS impact on: Recruitment rates? Quality of decision making? (1) S Cockayne, J Adamson, A Clarke, et al. PLOS One, 2017. (2) S Cockayne, C Fairhurst, J Adamson, et al. Trials, 2017.

REFORM trial Podiatry clinic lists: aged 65+; seen in last 6 months; living independently Posted invite (n=37,000): letter + PIS (different forms) + screening form + consent form Returned expression of interest (n=3,458) If eligible: baseline measures + falls calendar + decision quality questionnaire: recruited to cohort study Some cohort study participants randomised into falls prevention RCT (n=1,010)

Decision quality measure Need for: Suitable for self-completion Brevity Potentially sensitive to information quality Drawing on: Aspects required in PIS by RECs Qualitative work on reasons for trial participation (eg Featherston & Donovan, 1998; Heaven, et al, 2006; Mills, et al, 2006): impact on treatment / care; and personal experience of the trial

REFORM questionnaire Each item scored 1-5. Overall scale scored 5-25 1) Any possible benefits of taking part were explained well. Strongly Agree Neither agree Disagree Strongly Agree nor disagree Disagree 2) Any possible disadvantages of taking part were explained well. 3) I understood what it would be like to take part in the study. 4) I understood how my treatment or care might change if I took part in the study. 5) Overall, I made an informed choice about taking part. Each item scored 1-5. Overall scale scored 5-25

Results Posted to 301 potential REFORM study participants Returned by 280 (93.0%). 277 (98.9%) completed in full Total mean 20.0 (SD 2.4; range 12-25, mode & median 20) Not affected by PIS allocation (p>.05) Item means (SD): Possible benefits: 4.03 Possible disadvantages: 3.87 What it would be like: 4.10 Change to treatment or care: 3.81 Overall informed choice: 4.24 Cronbach Alpha = 0.83 (not increased by item reduction)

Instances of disagreement Mode score 20 (ie 5 x ‘Agree’ ratings) n=100 (35.7%) Possible benefits: 3 x ‘Disagree’ Possible disadvantages: 1 x ‘Strongly Disagree’; 14 x ‘Disagree’ What it would be like: 2 x ‘Disagree’ Change to treatment/care: 1 x ‘Strongly Disagree’; 12 x ‘Disagree’ Overall informed choice: 2 x ‘Disagree’ Of 280 respondents: None endorsed 4 or 5 disagreements 3 endorsed 3 disagreements 2 endorsed 2 disagreements 21 endorsed 1 disagreement 26 (9.3%) endorsed at least 1 disagreement

Conclusions Questionnaire completed well Positive scores – selection bias? One-third endorsed ‘Agree’ to all The measure’s ability to discriminate? Should we be concerned about ‘Disagree’ endorsements: measurement of process or outcome of consent?