An Analysis of Incident Reports Related to Electronic Medication Management: How They Change Over Time.

OBJECTIVE: Electronic medication management (EMM) systems have been shown to introduce new patient safety risks that were not possible, or unlikely to occur, with the use of paper charts. Our aim was to examine the factors that contribute to EMM-related incidents and how these incidents change over time with ongoing EMM use. METHODS: Incidents reported at 3 hospitals between January 1, 2010, and December 31, 2019, were extracted using a keyword search and then screened to identify EMM-related reports. Data contained in EMM-related incident reports were then classified as unsafe acts made by users and the latent conditions contributing to each incident. RESULTS: In our sample, 444 incident reports were determined to be EMM related. Commission errors were the most frequent unsafe act reported by users (n = 298), whereas workarounds were reported in only 13 reports. User latent conditions (n = 207) were described in the highest number of incident reports, followed by conditions related to the organization (n = 200) and EMM design (n = 184). Over time, user unfamiliarity with the system remained a key contributor to reported incidents. Although fewer articles to electronic transfer errors were reported over time, incident reports related to the transfer of information between different computerized systems increased as hospitals adopted more clinical information systems. CONCLUSIONS: Electronic medication management-related incidents continue to occur years after EMM implementation and are driven by design, user, and organizational conditions. Although factors contribute to reported incidents in varying degrees over time, some factors are persistent and highlight the importance of continuously improving the EMM system and its use.

The impact of management option on out-of-pocket costs and perceived financial burden among men with localised prostate cancer in Australia within 6 months of diagnosis.

Objective This study aimed to quantify the out-of-pocket (OOP) costs and perceived financial burden among Australian men with localised prostate cancer in the first 6 months after diagnosis, by primary management option. Methods This cost-analysis quantified OOP costs using administrative claims data and self-reported survey data. Financial burden was assessed using the COmprehensive Score for financial Toxicity-Functional Assessment of Chronic Illness Therapy (COST-FACIT) tool. Participants were recruited into a randomised control trial from public or private treatment centres in Victoria and Queensland. Generalised linear models were used to predict OOP costs and COST-FACIT scores. Results Median total OOP costs within 6 months of diagnosis for 256 Australian patients with localised prostate cancer was A$1172 (A$343-2548). Up to 50% of the sample reported A$0 costs for most medical services. Compared with those managed with active surveillance, men having active treatment had 6.4 (95% CI: 3.2-12.7) times greater total OOP costs. Management option, higher Gleason score at diagnosis and having multiple comorbidities were significant predictors of higher OOP costs. Overall high scores on the COST-FACIT indicated low levels of financial burden for the entire sample. Conclusion Largely attributable to being managed with active surveillance, Australian men diagnosed with localised prostate cancer reported relatively low OOP costs and financial burden in the first 6 months post-diagnosis. Together with clinical outcomes, clinicians can use this up to date evidence on costs and perceived financial burdens to assist localised prostate cancer patients and their families make informed decisions about their preferred management option.

Psychometric assessment of the Concerns about Late Effects in Oncology Questionnaire (CLEO) among female breast cancer survivors.

OBJECTIVE: The Concerns about Late Effects in Oncology (CLEO) questionnaire was developed to measure concerns cancer survivors may have about late effects. The current study sought to assess the Concerns about Late Effects in Oncology's (CLEO) psychometric properties - factor structure, construct validity, discriminatory power, and internal consistency. METHODS: 147 breast cancer survivors completed a survey. Factor structure was determined by exploratory factor analysis (EFA). Construct validity was assessed against fear of cancer recurrence, anxiety, depression, quality of life, and neuroticism. Discriminatory power was assessed against participants' age and clinical characteristics. RESULTS: The EFA confirmed a 4-factor structure; health professionals' support, psychological impacts, adapting, and daily functional impacts. There was only partial support for construct validity and discriminatory power. The CLEO demonstrated excellent internal consistency, with an overall Cronbach's α = 0.87 (health professionals' support: α = 0.89, psychological impacts: α = 0.93, adapting: α = 0.82, and daily functional impacts: α = 0.89). CONCLUSION: The findings suggest further development of the CLEO should focus on the psychological and functional impacts of late effects. PRACTICE IMPLICATIONS: Use of the CLEO may enhance communication about the impact of late effects, ensuring earlier identification and management of late effects in this population.

Electronic Medication Management Systems: Analysis of Enhancements to Reduce Errors and Improve Workflow.

BACKGROUND: Electronic medication management (eMM) has been shown to reduce medication errors; however, new safety risks have also been introduced that are associated with system use. No research has specifically examined the changes made to eMM systems to mitigate these risks. OBJECTIVES: To (1) identify system-related medication errors or workflow blocks that were the target of eMM system updates, including the types of medications involved, and (2) describe and classify the system enhancements made to target these risks. METHODS: In this retrospective qualitative study, documents detailing updates made from November 2014 to December 2019 to an eMM system were reviewed. Medication-related updates were classified according to "rationale for changes" and "changes made to the system." RESULTS: One hundred and seventeen updates, totaling 147 individual changes, were made to the eMM system over the 4-year period. The most frequent reasons for changes being made to the eMM were to prevent medication errors (24% of reasons), optimize workflow (22%), and support "work as done" on paper (16%). The most frequent changes made to the eMM were options added to lists (14% of all changes), extra information made available on the screen (8%), and the wording or phrasing of text modified (8%). Approximately a third of the updates (37%) related to high-risk medications. The reasons for system changes appeared to vary over time, as eMM functionality and use expanded. CONCLUSION: To our knowledge, this is the first study to systematically review and categorize system updates made to overcome new safety risks associated with eMM use. Optimization of eMM is an ongoing process, which changes over time as users become more familiar with the system and use is expanded to more sites. Continuous monitoring of the system is necessary to detect areas for improvement and capitalize on the benefits an electronic system can provide.

Assessment of the Value of Tumor Variation Profiling Perceived by Patients With Cancer.

Importance: Use of tumor molecular profiling (MP) is entering routine clinical practice; however, little is known about how much and why patients value MP. Objective: To examine the perceived value of MP to patients with advanced cancer and factors associated with perceived value. Design, Setting, and Participants: A cross-sectional survey that included willingness-to-pay trade-off scenarios was administered to participants after consent and before MP. A total of 777 participants (94% response rate) were recruited from the Molecular Screening and Therapeutics Program. Eligible patients had advanced solid cancers of any histologic type, were receiving or had completed their last line of effective therapy, had an Eastern Cooperative Oncology Group Performance Status 0 to 3, and had sufficient accessible tissue for MP. The participants were recruited between October 24, 2017, and March 12, 2019, and data analysis was conducted from March 13 to April 14, 2019. Main Outcomes and Measures: Willingness to pay for MP was assessed via hypothetical trade-off scenarios varying in the actionable return rate (1%, 20%, or 40%) and cost (A$0, A$300 [US$210], A$1000 [US $700], A$3000 [US $2100], or A$10 000 [US $7000]). Ordinal regressions were used to explore factors associated with willingness to have and pay for MP. Results: Of 777 participants (405 women [52%]; mean [SD] age, 55.47 [14.26] years), 689 patients (89%) would have MP for as little as a 1% actionable return rate. Fifty-six patients (7%) would require at least a 20% return rate and 11 patients (1%) would require at least a 40% return rate. Fifteen patients (2%) consistently chose not to have the test; 6 participants (0.8%) had missing values on this item. Participants were willing to pay a median of A$1000 if the actionable return rate was 1% and A$3000 for an actionable return rate of 20% to 40%. Of 762 individuals who agreed to testing, 482 patients (64%) were consistently unwilling to pay A$10 000, regardless of the actionable return rate. Patients born in Australia or New Zealand were more likely to want MP (eg, participants born in South Asia had an ordered odds for the tipping point of 7.74 [95% CI, 1.67-36.05; P = .009] times higher than Australian- and/or New Zealand-born participants). Patients born in Australia or New Zealand were also more willing to pay A$1000 or A$3000 (eg, participants born in Western Europe had an ordered odds for the tipping point for paying A$1000 of 1.74 [95% CI, 1.01-3.00; P = .048] times higher than Australian- and/or New Zealand-born participants). People with a medical- or science-related occupation and with more negative attitudes toward uncertainty were more likely to pay A$10 000 (eg, A$10 000 tipping point-ordered odds of participants with a medical- or science-related occupation was 0.49 [95% CI, 0.7-0.87; P = .02] times that of participants without a medical- or science-related occupation). Conclusions and Relevance: This study found apparent high interest in but lower willingness to pay for MP among patients with advanced cancer. Ability to pay may limit access to MP. Ongoing societal debate is required to establish the value of MP and whether subsidization is needed to ensure equity of access.

The development of a template for psychological assessment of women considering risk-reducing or contralateral prophylactic mastectomy: A national Delphi consensus study.

OBJECTIVE: Risk-reducing mastectomies (RRM) and contralateral prophylactic mastectomies (CPM) are increasingly prevalent strategies to reduce breast cancer risk. Given the associated physical and emotional challenges, presurgical psychological assessment is frequently recommended for this population, yet limited research exists to guide this. This study aimed to reach a consensus on the most relevant content and format of a psychological consultation prior to RRM/CPM. METHODS: A modified two-round online Delphi study was conducted Australia-wide. Expert participants (n = 25), including psychologists, surgeons, nurses, oncologists, genetic specialists, and researchers completed a round-one survey, informed by a literature review, previous qualitative study and expert clinicians' input. This required participants to rate their agreement with 36 statements regarding potential content of a psychological consultation and provide feedback on format/structure. A round-two survey comprised items that had not reached consensus and six new items suggested by participants. Parameters for statement consensus were set a priori at >75% agreement. RESULTS: Expert participants indicated agreement with the majority of statements (39/42, 92.8%), endorsing that the assessment should include (1) patient understanding of the RRM/CPM procedure/cancer risk, (2) potential physical/emotional impact of surgery, (3) informed decision-making, and (4) past/current psychological issues (anxiety and body image). A provisional assessment template and user manual is provided. CONCLUSIONS: This research culminated in a consensus-based template to guide psychological assessment of women considering RRM/CPM. This enables health professionals to assess suitability for surgery and preempt challenges within a standardised framework. Future evaluation of the acceptability and effectiveness of the template in clinical settings is warranted.

Factors influencing intention to undergo whole genome screening in future healthcare: a single-blind parallel-group randomised trial.

OBJECTIVE: This study investigated the effect of biased information on beliefs about, and intention to undergo, whole genome sequencing (WGS) screening; and predictors of intention. METHODS: A single-blind parallel-group randomised trial was conducted in Australia, in 2011. Using Excel, 216 participants with English proficiency and no genetic testing experience were randomly allocated (1:1): a neutral information pamphlet or a biased version omitting screening limitations. Measures included: screening intention; Protection Motivation Theory (PMT) constructs; consideration of future consequences (CFC); uncertainty avoidance (UA); anticipated regret (AR). RESULTS: Intention decreased from pre to post-manipulation (p<.001, η(2)=.07, 95% CIs [4.41, 4.86], [3.99, 4.44], respectively). Biased participants (n=106) had higher response efficacy beliefs than neutral participants (n=102) (p<.001, η(2)=.04, 95% CIs [4.80, 5.10], [4.49, 4.79] respectively), but equal intention. The model explained 36.2% of the variance in intention; response efficacy (p<.001), response costs (p<.001), self-efficacy (p=.024), and UA (p=.019) were predictors. CONCLUSION: This is the first study investigating factors influencing anticipated WGS screening uptake. Omitting screening limitations may bias beliefs about screening efficacy and benefits. Uptake may be driven by perceived benefits and costs, self-efficacy beliefs, and uncertainty avoidance. PMT appears to be an appropriate psychosocial model for this setting.

Shared decision making in Australia in 2011.

The paper describes the current position of shared decision making (SDM) within the Australian healthcare system. SDM POLICY IN AUSTRALIA: Support for SDM exists through guidelines and policy documents, and is strongly endorsed by consumer organisations; however, there is no clear overarching policy framework for SDM in Australia. TOOLS FOR SDM: There are limited tools available for SDM in clinical practice. Access to tools exists through some Australian health research and consumer organisation websites but the use of tools remains idiosyncratic. IMPLEMENTATION OF SDM: Comparatively little has been achieved in the implementation of SDM in Australia. Although there is wide recognition that consumer involvement in health decisions is important, provision of resources and infrastructure to achieve it is limited, and there is no clear strategy to support implementation within the healthcare system. SDM IN THE FUTURE: Current reforms to the healthcare system may enable a more centralised approach to implementation of SDM in the future. A new federally funded consumer health information organisation may assist by providing a central point through which SDM interventions may be made available to the Australian public and the Australian Charter of Rights has the potential to provide a national framework for consumer involvement. However, priority needs to be given to SDM by both federal and state governments with greater investment in SDM research and in activities to support implementation in clinical practice.

Sharing decisions in breast cancer care: Development of the Decision Analysis System for Oncology (DAS-O) to identify shared decision making during treatment consultations.

BACKGROUND: Shared Decision Making (SDM) is widely accepted as the preferred method for reaching treatment decisions in the oncology setting including those about clinical trial participation: however, there is some disagreement between researchers over the components of SDM. Specific standardized coding systems are needed to help overcome this difficulty. OBJECTIVE: The first objective was to describe the development of an oncology specific SDM coding system, the DAS-O. The second objective was to provide reliability and validity data supporting the DAS-O. SETTING AND PARTICIPANTS: Consultation data were available from tertiary cancer center out patient oncology clinics in: Australia, New Zealand (ANZ), Switzerland, Germany and Austria (SGA). Patients were women with a confirmed diagnosis of early stage breast cancer. Reliability data were from 18 randomly selected coded transcripts drawn from ANZ and SGA. Concurrent validity data are from 55 (ANZ) consultations. MEASUREMENT: Inter and Intra rater reliability data was evaluated using Kappa correlation statistics and correlation coefficients. Correlation coefficients were used to assess concurrent validity between the DAS-O and two other SDM coding systems, OPTION and DSAT. RESULTS: Inter and Intra rater reliability for the system were high with average Kappas of 0.58 and 0.65 respectively. Correlation coefficients between DAS-O and OPTION was 0.73 and >0.5 for DSAT. CONCLUSIONS: We have developed a reliable and valid coding system for identifying and rating the quality of SDM in breast cancer consultations.

Shared decision-making in Australia.

This paper describes the current position of shared decision-making (SDM) within the Australian health care system. Australian health care includes a mixture of public and private practice governed by both regional and national policy. Support for SDM exists through guidelines and support for interventions to increase participation. However, there is no clear overall policy framework for SDM in Australia. The result is recognition that consumer involvement is important yet there are limited resources and infrastructure, and no clear strategy to support implementation. Barriers to SDM at the macro, meso and micro levels of health care are described. Efforts to support consumer involvement to date have been targeted to the supply side of health care. There is now awareness of the need to target the demand side by educating consumers to ask for information and involvement in their health care.