Purpose: IPDAS developed an instrument (IPDASi) to assess the quality of patient decision aids (PDAs). There have been calls in the US for these tools to be certified. The aims were to: (1) correlate IPDASi scores with outcome measurements in RCTs (included in Cochrane systematic review of PDAs); (2) conduct a Delphi consensus process for expert agreement on minimum standards for PDAs, based on IPDASi items.
Method: Aim 1: The PDAs were included if the RCT measured at least one of the following outcomes: knowledge, accurate risk perceptions, preference congruence with choice (attributes of decision), participation in decision-making or satisfaction with decision-making process (attributes of decision process). IPDASi quality scores were produced (two independent raters per PDA). Correlation analyses were conducted between adjusted mean global IPDASi scores and effect sizes. Aim 2: Two-stage Delphi voting process considered the inclusion of IPDASi items as minimum standards. Item mean scores and qualitative comments were analysed, followed by expert multidisciplinary group discussion.
Result: Aim 1: 31 PDAs were included in the sample, 26 were accessible for evaluation. A significant correlation was found between quality scores and accurate patient risk perceptions (rho = 0.8, p = 0.02). No other correlations were significant, but the positive direction of all but one outcome correlation provides support for the view that PDA quality scores, as judged by IPDASi, is associated with better outcomes in RCTs. Aim 2: 101 people voted in round 1; 87/101 (88%) voted in round 2. The 47 items in IPDASi v3.0 were reduced to 45 items (3 items combined) and were placed in three categories, namely: qualifying criteria (6 items); certification criteria (11 items) and quality criteria (28 items). The following operationalisation was adopted: 1) qualifying criteria would be assessed on a binary (yes or no) scale; to qualify, i.e. be considered for certification, tools should meet all these 6 criteria; 2) certification criteria would be scored on a 4-point Likert (agreement) scale and tools should score positively to meet a certification threshold (minimum standards); 3) quality criteria would be scored on a 4 point Likert (agreement) scale.
Conclusion: To ensure ‘fitness for use’ and for the protection of patients, this study provides minimum standards criteria for PDAs, standards that need to be tested and ratified.