The use of outcome information in shared decision-making about surveillance after breast cancer
Jet Ankersmid-Matos Miguel is a PhD student in the department Health Technology and Services Research. (Co)Promotors are dr. S. Siesling and dr. C.H.C. Drossaert from the faculty BMS and dr. L.J.A. Strobbe from Canisius Wilhelmina Hospital and dr. C.F. van Uden-Kraan from Santeon.
Thanks to major advances in early detection and treatment, the survival of people with breast cancer has significantly increased in recent decades. In addition, the incidence of breast cancer is rising. These developments mean an increasing number of people who have had breast cancer (prevalence) and that make use of follow-up care after curative treatment. Follow-up after breast cancer consists of aftercare and post-treatment surveillance. Aftercare includes providing information, guidance, detecting immediate or late effects of disease and treatment, addressing these complaints and symptoms, and attention for social consequences. Post-treatment surveillance focuses on detecting new manifestations of the treated breast cancer or new associated malignancies. Until now, the surveillance for all breast cancer patients was ‘one-size-fits-all’: annual imaging (mammography or MRI) and a physical examination for at least five years after surgery. However, research shows that the risks of breast cancer recurrence differ per patient and that there are possibilities for personalising surveillance since the intensity of surveillance can safely be decreased for patients with low risks for recurrences.
The process of shared decision-making (SDM) can support the delivery of value-based health care (VBHC) as it can strengthen the position of patients by tailoring information to patient needs and by improving engagement and outcomes, whilst reducing costs and health care burden by avoiding unnecessary treatments or care procedures that do not align with patients’ goals and values. SDM can be supported using patient decision aids (PtDAs) that provide structured information and help patients to consider and prioritise their preferences and choices. PtDAs can be even more valuable when they contain personalised information about outcomes of care (so-called 'outcome information'). For SDM about personalised surveillance after breast cancer it may be beneficial to develop a PtDA which contains outcome information regarding the individual risks for recurrences. These risks can be estimated using the INFLUENCE 2.0-nomogram.
The aim of the research in this thesis was three-fold. Firstly, we aimed to assess current follow-up practices, recurrence risk perceptions, and needs and preferences regarding SDM supported by outcome information about surveillance after breast cancer. Secondly, we focussed on the development of a PtDA, which includes outcome information, to support SDM about surveillance after breast cancer. Thirdly, we aimed to evaluate the implementation and effectiveness of the developed PtDA in clinical practice.
In Chapter 2 the results of an assessment of the current organisation of follow-up care (aftercare and surveillance) for breast cancer patients are reported. Semi-structured group interviews were conducted with 16 health care professionals (HCPs) and two patient advocates. Results showed variation in the organisation of aftercare, particularly in timing, frequency, and disciplines of involved HCPs. Less variation was observed for surveillance, which was mostly guided by the national guideline and not personalised. According to HCPs, best practices centred on case management and collaboration between HCPs of different disciplines. Opportunities for improvement included structured monitoring of patient needs and a comprehensive guideline for (personalised) aftercare organisation and content. In Chapters 3 and 4, the recurrence risk perceptions of patients and HCPs were examined. Findings of a cross-sectional survey among 258 breast cancer survivors (Chapter 3) showed that respondents’ recurrence risk estimations were fairly accurate when compared to objective risk estimations from the INFLUENCE 2.0-nomogram. Interestingly, respondents’ recurrence risk estimations (expressed in odds) and their risk appraisals (expressed in high versus low) were only moderately positively correlated, indicating that these are two distinct concepts. Both were associated with FCR. Chapter 4 addresses the risk perceptions of HCPs. A cross-sectional survey was conducted among 60 hospital HCPs and 25 general practitioners in which they were asked to estimate the five-year locoregional risk for recurrences for 11 realistic patient cases. The HCPs’ estimations were then compared with objective estimations from the INFLUENCE-nomogram. The results revealed that HCPs tended to overestimate the five-year locoregional risk for recurrences for all 11 presented cases, with overestimations ranging from 5% to 26%. The degree of overestimation varied between HCP specialties, with general practitioners having the highest overestimation and medical oncologists having the lowest. Chapters 5 and 6 provide us with insights about needs and preferences of patients and HCPs regarding SDM about post-treatment surveillance. Results of semi-structured interviews with 22 breast cancer survivors in the post-treatment surveillance trajectory are reported in Chapter 5. Although most of the participants in this study desired SDM about post-treatment surveillance, they did not experience SDM. Information provision was mostly limited to practical information only. Participants were open for using risk information in decision-making, but hesitant towards less intensive surveillance. Perceived advantages of less intensive surveillance were fewer distressing moments, leaving the patient role behind, and lower burden for the hospital and for the patient (practically, psychologically and financially). Perceived disadvantages were fewer moments for reassurance, fear of missing recurrences, and less attention for aftercare due to less contact moments. Semi-structured interviews with 21 HCPs (Chapter 6) revealed that most HCPs were positive about less intensive surveillance for women with a low risk for recurrences. However, they highlighted the need for clearly defined surveillance schedules based on risk categories and cut-off values, information provision and communication support for patients and HCPs. Furthermore, they emphasised the need for clear visualisation and explanation of risk information and attention for FCR. Most HCPs supported SDM about surveillance and were positive about using estimations of patients' personal risks for recurrences in decision-making.
In Chapter 7, the development of the ‘Breast Cancer Surveillance Decision Aid’ (BCS-PtDA) is described. The development involved combining the International Patient Decision Aids Standards (IPDAS) development process with a mixed methods design inspired by the development process of other PtDAs. The development process included eight steps, which involved establishing a multidisciplinary steering group consisting of patients, HCPs and other stakeholders; defining the end-users; assessing their decisional needs; defining requirements for the PtDA; determining its format and implementation strategy; prototyping; alpha testing; and beta testing. The developed BCS-PtDA consists of three components that support the SDM process: 1) a handout sheet on which personalised risks for recurrences, calculated using the INFLUENCE 2.0-nomogram, can be visualised and which contains an explanation about the decision for surveillance and a login code for a web-based deliberation tool; 2) a web-based deliberation tool, including a patient-reported outcome measure on FCR; and 3) a sheet summarising patient preferences and considerations. The BCS-PtDA was assessed as usable and acceptable during alpha testing with six patients and fourteen HCPs.
Chapter 8 presents the study protocol for the ‘Effectiveness and implementation of SHared decision-making supported by OUTcome information’ (SHOUT)-study in which the implementation and effectiveness of SDM supported by outcome information was examined in three different patient groups: patients with advanced kidney disease (SHOUT-AKD), patients who have suffered a stroke (SHOUT-STROKE), and patients who have had breast cancer (SHOUT-BC). For each patient group, a PtDA was developed containing outcome information. Furthermore, a training on SDM supported by outcome information and an accompanying implementation strategy were developed. A multiple interrupted time series (MiTS) design was used in which implementation took place stepwise. The study design consisted of three distinct phases; the pre-implementation phase in which the standard care was assessed; the transition phase in which HCPs were trained in SDM supported by outcome information (including risk communication) and in which the developed PtDA was introduced; and the post-implementation phase in which the new situation was evaluated. The primary outcome was the patient-reported level of SDM. Secondary outcomes included decisional conflict, patients’ perceived role in decision-making, knowledge, quality of life, preferred and chosen care, satisfaction with the decision-making process, and health care utilisation. Outcomes regarding implementation included the implementation rate and HCPs’ perspectives on the implementation. In Chapter 9, the results of the SHOUT-BC study regarding effectiveness and the evaluation of the BCS-PtDA are reported. A total of 507 patients (282 pre-implementation, 225 post-implementation) from eight hospitals completed a questionnaire. The results showed a significant increase in patient-reported SDM during the post-implementation phase. Furthermore, experienced decisional conflict decreased and patients had a more active role in the decision-making process along with increased knowledge. We also found a slight decrease in FCR, risk appraisal, and the intensity of surveillance schedules. Patients evaluated the BCS-PtDA highly positive. In Chapter 10, the results of a process evaluation within the SHOUT-BC study are described. Implementation and participation rates and patients’ BCS-PtDA use were calculated using hospital registry data and logdata. HCPs’ perspectives on facilitators and barriers for implementation were collected through a survey study using the MIDI framework. Observed SDM level in audio-recorded consultation transcripts was quantified using the OPTION-5 scale. Thematic analysis was performed to assess consultation content. The study showed low implementation rates (average 26%) and modest to good participation rates (average 61%); both differing over the participating hospitals. HCPs reported that the PtDA supported choice awareness. Reported barriers for implementation were an increased workload and a lack of perceived benefits (e.g. decrease in time spent on informing patients). Consultation analysis (N=64) showed patients were offered a choice, but deliberation was lacking. Risk communication was generally adequate.
Overall, this thesis represents a pioneering effort in developing, implementing and evaluating SDM about surveillance after breast cancer. The receptivity among patients and HCPs towards a more personalised approach and SDM about surveillance is encouraging. The integration of outcome information into the BCS-PtDA and SDM has proven feasible and enhances decision-making. However, moving towards less intensive post-treatment surveillance necessitates a cultural shift and managing the persistent FCR, which is high and difficult to influence. While the BCS-PtDA is positively evaluated and effective in increasing patient-reported SDM about post-treatment surveillance, its implementation remains a significant challenge that demands (even) more attention.
A digital version of the PhD dissertation is available on request via j.ankersmid@santeon.nl.
