Marie-Anne Durand

Assessing the Quality of Decision Support Technologies Using the International Patient Decision Aid Standards instrument (IPDASi)

Objectives To describe the development, validation and inter-rater reliability of an instrument to measure the quality of patient decision support technologies (decision aids). Design Scale development study, involving construct, item and scale development, validation and reliability testing. Setting There has been increasing use of decision support technologies – adjuncts to the discussions clinicians have with patients about difficult decisions. A global interest in developing these interventions exists among both for-profit and not-for-profit organisations. It is therefore essential to have internationally accepted standards to assess the quality of their development, process, content, potential bias and method of field testing and evaluation. Methods Scale development study, involving construct, item and scale development, validation and reliability testing. Participants Twenty-five researcher-members of the International Patient Decision Aid Standards Collaboration worked together to develop the instrument (IPDASi). In the fourth Stage (reliability study), eight raters assessed thirty randomly selected decision support technologies. Results IPDASi measures quality in 10 dimensions, using 47 items, and provides an overall quality score (scaled from 0 to 100) for each intervention. Overall IPDASi scores ranged from 33 to 82 across the decision support technologies sampled (n = 30), enabling discrimination. The inter-rater intraclass correlation for the overall quality score was 0.80. Correlations of dimension scores with the overall score were all positive (0.31 to 0.68). Cronbachs alpha values for the 8 raters ranged from 0.72 to 0.93. Cronbachs alphas based on the dimension means ranged from 0.50 to 0.81, indicating that the dimensions, although well correlated, measure different aspects of decision support technology quality. A short version (19 items) was also developed that had very similar mean scores to IPDASi and high correlation between short score and overall score 0.87 (CI 0.79 to 0.92). Conclusions This work demonstrates that IPDASi has the ability to assess the quality of decision support technologies. The existing IPDASi provides an assessment of the quality of a DSTs components and will be used as a tool to provide formative advice to DSTs developers and summative assessments for those who want to compare their tools against an existing benchmark.

Salzburg statement on shared decision making

Patients have seldom been encouraged to fully realise their role in health care decisions and clinicians often fail to recognise that patients wish to understand the nature of their health problems, be informed about the best way to manage them and be supported to take part in treatment decisions that take account of their preferences and personal circumstances. Many patients and their families face barriers that make it difficult for them to participate in health care decisions, including low health literacy and difficulty in finding clear, comprehensible information.

Toward Minimum Standards for Certifying Patient Decision Aids A Modified Delphi Consensus Process

Objective. The IPDAS Collaboration has developed a checklist and an instrument (IPDASi v3.0) to assess the quality of patient decision aids (PDAs) in terms of their development process and shared decision-making design components. Certification of PDAs is of growing interest in the US and elsewhere. We report a modified Delphi consensus process to agree on IPDASi (v3.0) items that should be considered as minimum standards for PDA certification, for inclusion in the refined IPDASi (v4.0). Methods. A 2-stage Delphi voting process considered the inclusion of IPDASi (v3.0) items as minimum standards. Item scores and qualitative comments were analyzed, followed by expert group discussion. Results. One hundred and one people voted in round 1; 87 in round 2. Forty-seven items were reduced to 44 items across 3 new categories: 1) qualifying criteria, which are required in order for an intervention to be considered a decision aid (6 items); 2) certification criteria, without which a decision aid is judged to have a high risk of harmful bias (10 items); and 3) quality criteria, believed to strengthen a decision aid but whose omission does not present a high risk of harmful bias (28 items). Conclusions. This study provides preliminary certification criteria for PDAs. Scoring and rating processes need to be tested and finalized. However, the process of appraising the quality of the clinical evidence reported by the PDA should be used to complement these criteria; the proposed standards are designed to rate the quality of the development process and shared decision-making design elements, not the quality of the PDA’s clinical content.

Where is the theory? Evaluating the theoretical frameworks described in decision support technologies

OBJECTIVE To identify and describe the extent to which theory or theoretical frameworks informed the development and evaluation of decision support technologies (DSTs). METHODS The analysis was based on the decision technologies used in studies included in the Cochrane systematic review of patient decision aids for people facing health screening or treatment decisions. The assumption was made that DSTs evaluated by randomized controlled trials, and therefore included in the updated Cochrane review have been the most rigorously developed. RESULTS Of the 50 DSTs evaluated only 17 (34%) were based on a theoretical framework. Amongst these, 11 decision-making theories were described but the extent to which theory informed the development, field-testing and evaluation of these interventions was highly variable between DSTs. The majority of the 17 DSTs that relied on a theory was not explicit about how theory had guided their design and evaluation. Many had superficial descriptions of the theory or theories involved. Furthermore, based on the analysis of those 17 DSTs, none had reported field-testing prior to evaluation. CONCLUSION The use of decision-making theory in DST development is rare and poorly described. The lack of theoretical underpinning to the design and development of DSTs most likely reflects the early development stage of the DST field. PRACTICE IMPLICATIONS The findings clearly indicate the need to give more attention to how the most important decision-making theories could be better used to guide the design of key decision support components and their modes of action.

The design of patient decision support interventions: addressing the theory–practice gap

BACKGROUND Although an increasing number of decision support interventions for patients (including decision aids) are produced, few make explicit use of theory. We argue the importance of using theory to guide design. The aim of this work was to address this theory-practice gap and to examine how a range of selected decision-making theories could inform the design and evaluation of decision support interventions. METHODS We reviewed the decision-making literature and selected relevant theories. We assessed their key principles, theoretical pathways and predictions in order to determine how they could inform the design of two core components of decision support interventions, namely, information and deliberation components and to specify theory-based outcome measures. RESULTS Eight theories were selected: (1) the expected utility theory; (2) the conflict model of decision making; (3) prospect theory; (4) fuzzy-trace theory; (5) the differentiation and consolidation theory; (6) the ecological rationality theory; (7) the rational-emotional model of decision avoidance; and finally, (8) the Attend, React, Explain, Adapt model of affective forecasting. Some theories have strong relevance to the information design (e.g. prospect theory); some are more relevant to deliberation processes (conflict theory, differentiation theory and ecological validity). None of the theories in isolation was sufficient to inform the design of all the necessary components of decision support interventions. It was also clear that most work in theory-building has focused on explaining or describing how humans think rather than on how tools could be designed to help humans make good decisions. It is not surprising therefore that a large theory-practice gap exists as we consider decision support for patients. There was no relevant theory that integrated all the necessary contributions to the task of making good decisions in collaborative interactions. DISCUSSION Initiatives such as the International Patient Decision Aids Standards Collaboration influence standards for the design of decision support interventions. However, this analysis points to the need to undertake more work in providing theoretical foundations for these interventions.

Coaching and guidance with patient decision aids: A review of theoretical and empirical evidence

BackgroundCoaching and guidance are structured approaches that can be used within or alongside patient decision aids (PtDAs) to facilitate the process of decision making. Coaching is provided by an individual, and guidance is embedded within the decision support materials. The purpose of this paper is to: a) present updated definitions of the concepts “coaching” and “guidance”; b) present an updated summary of current theoretical and empirical insights into the roles played by coaching/guidance in the context of PtDAs; and c) highlight emerging issues and research opportunities in this aspect of PtDA design.MethodsWe identified literature published since 2003 on shared decision making theoretical frameworks inclusive of coaching or guidance. We also conducted a sub-analysis of randomized controlled trials included in the 2011 Cochrane Collaboration Review of PtDAs with search results updated to December 2010. The sub-analysis was conducted on the characteristics of coaching and/or guidance included in any trial of PtDAs and trials that allowed the impact of coaching and/or guidance with PtDA to be compared to another intervention or usual care.ResultsTheoretical evidence continues to justify the use of coaching and/or guidance to better support patients in the process of thinking about a decision and in communicating their values/preferences with others. In 98 randomized controlled trials of PtDAs, 11 trials (11.2%) included coaching and 63 trials (64.3%) provided guidance. Compared to usual care, coaching provided alongside a PtDA improved knowledge and decreased mean costs. The impact on some other outcomes (e.g., participation in decision making, satisfaction, option chosen) was more variable, with some trials showing positive effects and other trials reporting no differences. For values-choice agreement, decisional conflict, adherence, and anxiety there were no differences between groups. None of these outcomes were worse when patients were exposed to decision coaching alongside a PtDA. No trials evaluated the effect of guidance provided within PtDAs.ConclusionsTheoretical evidence continues to justify the use of coaching and/or guidance to better support patients to participate in decision making. However, there are few randomized controlled trials that have compared the effectiveness of coaching used alongside PtDAs to PtDAs without coaching, and no trials have compared the PtDAs with guidance to those without guidance.

Dyadic OPTION : Measuring perceptions of shared decision-making in practice

BACKGROUND Current models of the medical consultation emphasize shared decision-making (SDM), whereby the expertise of both the doctor and the patient are recognised and seen to equally contribute to the consultation. The evidence regarding the desirability and effectiveness of the SDM approach is often conflicting. It is proposed that the conflicts are due to the nature of assessment, with current assessments from the perspective of an outside observer. AIMS To empirically assess perceived involvement in the medical consultation using the dyadic OPTION instrument. METHOD 36 simulated medical consultations were organised between general practitioners and standardized- patients, using the observer OPTION and the newly developed dyadic OPTION instruments. RESULTS SDM behaviours observed in the consultations were seen to depend on both members of the doctor and patient dyad, rather than each in isolation. Thus a dyadic approach to measurement is supported. CONCLUSIONS This current study highlights the necessity for a dyadic approach to assessment and introduces a novel research instrument: the dyadic OPTION instrument.

Intensive care in patients with lung cancer: a multinational study

BACKGROUND Detailed information about lung cancer patients requiring admission to intensive care units (ICUs) is mostly restricted to single-center studies. Our aim was to evaluate the clinical characteristics and outcomes of lung cancer patients admitted to ICUs. PATIENTS AND METHODS Prospective multicenter study in 449 patients with lung cancer (small cell, n = 55; non-small cell, n = 394) admitted to 22 ICUs in six countries in Europe and South America during 2011. Multivariate Cox proportional hazards frailty models were built to identify characteristics associated with 30-day and 6-month mortality. RESULTS Most of the patients (71%) had newly diagnosed cancer. Cancer-related complications occurred in 56% of patients; the most common was tumoral airway involvement (26%). Ventilatory support was required in 53% of patients. Overall hospital, 30-day, and 6-month mortality rates were 39%, 41%, and 55%, respectively. After adjustment for type of admission and early treatment-limitation decisions, determinants of mortality were organ dysfunction severity, poor performance status (PS), recurrent/progressive cancer, and cancer-related complications. Mortality rates were far lower in the patient subset with nonrecurrent/progressive cancer and a good PS, even those with sepsis, multiple organ dysfunctions, and need for ventilatory support. Mortality was also lower in high-volume centers. Poor PS predicted failure to receive the initially planned cancer treatment after hospital discharge. CONCLUSIONS ICU admission was associated with meaningful survival in lung cancer patients with good PS and non-recurrent/progressive disease. Conversely, mortality rates were very high in patients not fit for anticancer treatment and poor PS. In this subgroup, palliative care may be the best option.BACKGROUND Detailed information about lung cancer patients requiring admission to intensive care units (ICUs) is mostly restricted to single-center studies. Our aim was to evaluate the clinical characteristics and outcomes of lung cancer patients admitted to ICUs. PATIENTS AND METHODS Prospective multicenter study in 449 patients with lung cancer (small cell, n = 55; non-small cell, n = 394) admitted to 22 ICUs in six countries in Europe and South America during 2011. Multivariate Cox proportional hazards frailty models were built to identify characteristics associated with 30-day and 6-month mortality. RESULTS Most of the patients (71%) had newly diagnosed cancer. Cancer-related complications occurred in 56% of patients; the most common was tumoral airway involvement (26%). Ventilatory support was required in 53% of patients. Overall hospital, 30-day, and 6-month mortality rates were 39%, 41%, and 55%, respectively. After adjustment for type of admission and early treatment-limitation decisions, determinants of mortality were organ dysfunction severity, poor performance status (PS), recurrent/progressive cancer, and cancer-related complications. Mortality rates were far lower in the patient subset with nonrecurrent/progressive cancer and a good PS, even those with sepsis, multiple organ dysfunctions, and need for ventilatory support. Mortality was also lower in high-volume centers. Poor PS predicted failure to receive the initially planned cancer treatment after hospital discharge. CONCLUSIONS ICU admission was associated with meaningful survival in lung cancer patients with good PS and non-recurrent/progressive disease. Conversely, mortality rates were very high in patients not fit for anticancer treatment and poor PS. In this subgroup, palliative care may be the best option.

Information and decision support needs of parents considering amniocentesis: interviews with pregnant women and health professionals

Objective  Our aim was to clarify and categorize information and decision support needs of pregnant women deciding about amniocentesis.

A three-talk model for shared decision making: multistage consultation process

Objectives To revise an existing three-talk model for learning how to achieve shared decision making, and to consult with relevant stakeholders to update and obtain wider engagement. Design Multistage consultation process. Setting Key informant group, communities of interest, and survey of clinical specialties. Participants 19 key informants, 153 member responses from multiple communities of interest, and 316 responses to an online survey from medically qualified clinicians from six specialties. Results After extended consultation over three iterations, we revised the three-talk model by making changes to one talk category, adding the need to elicit patient goals, providing a clear set of tasks for each talk category, and adding suggested scripts to illustrate each step. A new three-talk model of shared decision making is proposed, based on “team talk,” “option talk,” and “decision talk,” to depict a process of collaboration and deliberation. Team talk places emphasis on the need to provide support to patients when they are made aware of choices, and to elicit their goals as a means of guiding decision making processes. Option talk refers to the task of comparing alternatives, using risk communication principles. Decision talk refers to the task of arriving at decisions that reflect the informed preferences of patients, guided by the experience and expertise of health professionals. Conclusions The revised three-talk model of shared decision making depicts conversational steps, initiated by providing support when introducing options, followed by strategies to compare and discuss trade-offs, before deliberation based on informed preferences.