Development and testing of the Outcome Prioritization Tool adjusted to older patients with cancer: A pilot study

In older patients with cancer, the balance between harms and benefits of treatment is delicate. There is a higher risk of adverse outcomes of cancer treatment due to comorbidity and geriatric impairments, while clinical benefit is uncertain due to their frequent exclusion in clinical trials [[1]Hurria A. Togawa K. Mohile S.G. Owusu C. Klepin H.D. Gross C.P. et al.Predicting chemotherapy toxicity in older adults with cancer: a prospective multicenter study.J Clin Oncol. 2011; 29: 3457-3465https://doi.org/10.1200/JCO.2011.34.7625Crossref PubMed Scopus (1237) Google Scholar,[2]DuMontier C. Loh K.P. Soto-Perez-de-Celis E. Dale W. Decision making in older adults with Cancer.J Clin Oncol. 2021; 39: 2164-2174https://doi.org/10.1200/jco.21.00165Crossref PubMed Scopus (0) Google Scholar]. Potential benefits of treatment (for example, increased survival) may come at a cost (for example, increased treatment side-effects or loss of function). As a result, treatment decisions are often preference sensitive, which means that the optimal treatment choice depends on a patient's personal values and priorities [[3]O’Connor A.M. Légaré F. Stacey D. Risk communication in practice: the contribution of decision aids.Br Med J. 2003; 327: 736-740https://doi.org/10.1136/bmj.327.7417.736Crossref PubMed Scopus (287) Google Scholar]. These values and priorities need to be explicitly discussed. There is no single outcome that all (older) patients give highest priority to and physicians are often unable to correctly estimate what matters most to their patients [4Mulley A. Trimble C. Elwyn G. Stop the silent misdiagnosis: patients’ preferences matter.Med J Aust. 2012; 345: 23-26Google Scholar, 5Festen S. Stegmann M.E. Prins A. van Munster B.C. van Leeuwen B.L. Halmos G.B. et al.How well do healthcare professionals know of the priorities of their older patients regarding treatment outcomes?.Patient Educ Couns. 2021; 104: 2358-2363https://doi.org/10.1016/j.pec.2021.02.044Crossref PubMed Scopus (3) Google Scholar, 6Seghers P.A.L. Nelleke Wiersma A. Festen S. Stegmann M.E. Soubeyran P. Rostoft S. et al.Patient preferences for treatment outcomes in oncology with a focus on the older patient;a systematic review.Cancers (Basel). 2022; 14https://doi.org/10.3390/cancers14051147Crossref Scopus (12) Google Scholar]. Currently, less than half of the patients with cancer perceive that their values and priorities are discussed [[4]Mulley A. Trimble C. Elwyn G. Stop the silent misdiagnosis: patients’ preferences matter.Med J Aust. 2012; 345: 23-26Google Scholar,[5]Festen S. Stegmann M.E. Prins A. van Munster B.C. van Leeuwen B.L. Halmos G.B. et al.How well do healthcare professionals know of the priorities of their older patients regarding treatment outcomes?.Patient Educ Couns. 2021; 104: 2358-2363https://doi.org/10.1016/j.pec.2021.02.044Crossref PubMed Scopus (3) Google Scholar,[7]Kuijpers M.M.T. Veenendaal H. Engelen V. Visserman E. Noteboom E.A. Stiggelbout A.M. et al.Shared decision making in cancer treatment: a dutch national survey on patients’ preferences and perceptions.Eur J Cancer Care (Engl). 2021; e13534https://doi.org/10.1111/ecc.13534Crossref PubMed Scopus (7) Google Scholar]. Knowing what is important for the patient aids the healthcare professional in tailoring treatment to the patient's values and priorities, which may prevent decision regret. This conversation may be facilitated by using a conversation tool. Various methods exist to elicit patient priorities for health outcomes, mostly developed for research [[8]Hazlewood G.S. Measuring patient preferences: an overview of methods with a focus on discrete choice experiments.Rheum Dis Clin N Am. 2018; 44: 337-347https://doi.org/10.1016/j.rdc.2018.01.009Abstract Full Text Full Text PDF PubMed Scopus (18) Google Scholar]. A method that is widely studied, and that is already used in clinical practice, is the Outcome Prioritization Tool (OPT) [[9]Stegmann M.E. Festen S. Brandenbarg D. Schuling J. van Leeuwen B. de Graeff P. et al.Using the outcome prioritization tool (OPT) to assess the preferences of older patients in clinical decision-making: a review.Maturitas. 2019; 128: 49-52https://doi.org/10.1016/j.maturitas.2019.07.022Abstract Full Text Full Text PDF PubMed Scopus (37) Google Scholar]. The OPT is a conversation tool that uses four universal health outcomes and is neither disease nor treatment specific, which makes it suitable for older patients with multiple diseases [[10]Fried T.R. Tinetti M. Agostini J. Iannone L. Towle V. Health outcome prioritization to elicit preferences of older persons with multiple health conditions.Patient Educ Couns. 2011; 83: 278-282https://doi.org/10.1016/j.pec.2010.04.032Crossref PubMed Scopus (104) Google Scholar] (details in Webappendix A). However, the OPT does not contain all the priorities that a recent systematic review found to be important to patients with cancer [[6]Seghers P.A.L. Nelleke Wiersma A. Festen S. Stegmann M.E. Soubeyran P. Rostoft S. et al.Patient preferences for treatment outcomes in oncology with a focus on the older patient;a systematic review.Cancers (Basel). 2022; 14https://doi.org/10.3390/cancers14051147Crossref Scopus (12) Google Scholar]. In particular, the impact of treatments is not included. Therefore, we chose to adapt the OPT to older patients with cancer (OPT C). This paper describes the development and testing of this tool. This is a prospective study to develop the OPT-C and to pilot it. It was a collaborative effort between the University Medical Center Groningen (UMCG) and Diakonessenhuis Utrecht, the Netherlands. The study received a waiver for full ethics review from the institutional review board and was approved by the local research committee. All results were reported using descriptive data. More information about the original OPT including the rationale as to why the OPT was chosen as tool to be used can be found in Webappendix A. Webappendix B describes our adaptation process. In short, outcomes important to patients with cancer were extracted from a recently performed systematic review [[6]Seghers P.A.L. Nelleke Wiersma A. Festen S. Stegmann M.E. Soubeyran P. Rostoft S. et al.Patient preferences for treatment outcomes in oncology with a focus on the older patient;a systematic review.Cancers (Basel). 2022; 14https://doi.org/10.3390/cancers14051147Crossref Scopus (12) Google Scholar]. This review included 28 studies and 4374 patients with cancer. Additional input was provided by the GERONTE panel, which includes experts with various backgrounds, all involved in the care of older patients with cancer (n = 30; https://GERONTEproject.eu/). The selected health outcomes were approved during an online expert meeting. Subsequently, an adapted version of the original instructions developed by UMCG [[9]Stegmann M.E. Festen S. Brandenbarg D. Schuling J. van Leeuwen B. de Graeff P. et al.Using the outcome prioritization tool (OPT) to assess the preferences of older patients in clinical decision-making: a review.Maturitas. 2019; 128: 49-52https://doi.org/10.1016/j.maturitas.2019.07.022Abstract Full Text Full Text PDF PubMed Scopus (37) Google Scholar] was made with feedback from geriatricians and advanced practice nurses in oncology (Webappendix C). In the second step, patients aged over 70 years, diagnosed with cancer or treated for cancer during the last two years, tested the OPT C, either in relation to an actual treatment decision or to a hypothetical situation in which they had to make a new treatment decision. The proportion of patients that were able to complete the OPT-C in accordance with instructions was measured to look at feasibility. Patients were also asked how difficult they found the use of the OPT-C by filling out a visual analogue scale from 0 to 100 (easy-difficult). Additionally, patients were asked whether they thought the OPT-C would be helpful in their consultation with their physician. The healthcare professionals were invited to fill out a survey each time they had used the OPT-C with a patient to share their experiences. After using the OPT-C for three to five times, the healthcare professionals were asked to compare the OPT-C with the OPT. Webappendix D describes step 1 and 2 in more detail. Both the expert panel and the systematic review which provided the patient's perspective prioritized the outcomes survival and maintaining independence, but the importance of avoiding or preventing negative treatment effects was also highlighted (Webappendix E). This item was therefore selected for inclusion in the OPT-C tool. Additionally, scoping literature research on the development of conversation aids and prioritization tools revealed that patients became overwhelmed if they were asked to trade off more than four health outcomes [[10]Fried T.R. Tinetti M. Agostini J. Iannone L. Towle V. Health outcome prioritization to elicit preferences of older persons with multiple health conditions.Patient Educ Couns. 2011; 83: 278-282https://doi.org/10.1016/j.pec.2010.04.032Crossref PubMed Scopus (104) Google Scholar]. Therefore, in order to allow for the inclusion of the additional health outcome, the two outcomes relating to symptoms (‘reducing pain’ and ‘reducing other symptoms’) were combined into one (‘reducing pain and other symptoms’; Table 1). ‘Extending life’ and ‘maintaining independence’ were kept without any alterations. To finalize the new tool, the three primary researchers (NS, SF, MH) discussed how best to phrase the newly added item so that it would cover a broad range of negative treatment effects. In the end, we felt that ‘preventing negative treatment effects’ was the most fit for this purpose.Table 1Health outcomes of original OPT vs OPT C.Original OPTOPT-C1. Extending life1. Extending life2. Maintaining independence2. Maintaining independence3. Reducing pain3. Reducing pain and other bsymptoms4. Reducing other symptoms4. Preventing negative treatment effectsTable to illustrate the included health outcomes of the OPT and OPT C.OPT; Outcome Prioritization Tool, OPT C; OPT adapted to older patients with cancer. Open table in a new tab Table to illustrate the included health outcomes of the OPT and OPT C. OPT; Outcome Prioritization Tool, OPT C; OPT adapted to older patients with cancer. The OPT-C was used in 19 patients in a hypothetical treatment decision and in six patients during an actual treatment decision. They were included between February 2022 and May 2022. The median age was 78 years (range 71–93) and 48% were male (Webappendix E&F). Most patients were treated for lymphoma (various types; n = 6; 24%; Webappendix E&F). The OPT-C was used in accordance to instructions in 84% (n = 21; Fig. 1a ). Patients rated the difficulty of using the OPT score a median of 30/100 (with 0 being easy and 100 being difficult), with an interquartile range of 0–60. The majority (n = 16; 64%) thought the OPT-C would be helpful during their conversations with their treating oncologists. Life extension and maintaining independence were most frequently prioritized as the most important goals (Webappendix E). Seven healthcare professionals with a geriatric background were included to test the OPT C. Of the seven, six had experience with the original OPT before they participated. In total the healthcare professionals had 19 OPT-C conversations. In 89% (n = 17) of the conversations, healthcare professionals mentioned that they were able to define patient priorities using the OPT C. The healthcare professionals mentioned that the OPT-C was used by the patients in according with instructions in 79% (n = 15). Some healthcare professionals mentioned, that if it was not used in accordance with instructions, it would still provide value information. Healthcare professionals felt that the instructions were clear for 89% (n = 17) of the patients. They thought the OPT-C would contribute in the treatment decision in eight patients (42%; Fig. 1b). After trying the OPT-C three to five times, all healthcare professionals preferred the OPT-C to be used in older patients with cancer, but also mentioned that it depended on patient characteristics. In this pilot study we developed and tested an adjusted version of the OPT [ [9]Stegmann M.E. Festen S. Brandenbarg D. Schuling J. van Leeuwen B. de Graeff P. et al.Using the outcome prioritization tool (OPT) to assess the preferences of older patients in clinical decision-making: a review.Maturitas. 2019; 128: 49-52https://doi.org/10.1016/j.maturitas.2019.07.022Abstract Full Text Full Text PDF PubMed Scopus (37) Google Scholar] for patients with cancer, the OPT C. The OPT-C appears to be a feasible tool to aid the conversation on priorities of health outcomes in older patients with cancer. Most patients were able to use it in accordance with instructions and healthcare professionals were able to assess the patient priorities for health outcomes using the OPT C. Furthermore, the majority of patients perceived that using the OPT-C would aid their conversation with their healthcare professional and a substantial part of the healthcare professionals thought the OPT-C would improve the decision-making process. In previous studies, a similar percentage (9.1%- 30.6% compared to 21%in this study) of older patients with cancer were unable to use the OPT to prioritize their health outcomes [[11]Festen S. Kok M. Hopstaken J.S. van der Wal-Huisman H. van der Leest A. Reyners A.K.L. et al.How to incorporate geriatric assessment in clinical decision-making for older patients with cancer. An implementation study.J Geriatr Oncol. 2019; 10: 951-959https://doi.org/10.1016/j.jgo.2019.04.006Abstract Full Text Full Text PDF PubMed Scopus (40) Google Scholar]. The OPT-C showed similar feasibility to the original OPT. Some of the possible explanations for some patient's inability to complete the OPT-C may be lower education level, poor health literacy, or cognitive decline. However, even when a patient was not able to prioritize their health outcomes, it was still possible to have a conversation about what matters to them with this tool. Not all patients found the tool to be helpful, and not all healthcare professionals thought the OPT-C would contribute to the final treatment decision. For instance, when priorities are already clarified or when priorities are in line with treatment options, using a tool to discuss priorities may not contribute much to the final decision and, thus, may not be considered helpful. However, even in these cases it may be good to verify that treatment decisions are in line with the patient's priorities. The OPT-C can aid in structurally discussing priorities. The OPT-C is relatively easy to implement and free to use, and, given the potential impact, we believe it is worth the extra effort. We did not directly compare the OPT-C with the OPT, but asked healthcare professionals which they preferred. They felt that for certain patient groups, the OPT-C may provide a better balance between the health outcomes, for example, in the absence of pain. However, which tool is most suitable to use in the individual patient will depend on the situation. If lasting negative treatment effects may be a likely treatment outcome, such as patients receiving chemotherapy, the OPT-C might be preferred. The original OPT on the other hand, might be more suitable for patients having a high disease-related symptom burden. Regardless of the tool used, the exact health outcomes included in the conversation tool are probably less important than the information on values and priorities that is collected during the conversation. For this, both OPT versions can be used, depending also on healthcare professionals' experience with these tools. This study has some limitations. In the development of the new OPT C, we used input from a range of clinicians and used a systematic review which described patient's outcome prioritization. Although the systematic review included data from 4374 patients, patients were not included in the final selection of the four outcomes. If patients were included they could have aided in the exact phrasing of the four outcomes, to verify that they represented their priorities well. Second, we did not have a predefined threshold for feasibility. While the information on the clinician's and patient's experience of using the instrument does provide insight in the feasibility of the tool, the lack of a clear threshold means that it is not possible to draw definitive conclusions. Additionally, the results may have been impacted by the selected patient population. Although all patients with cancer were eligible, mainly patients that were receiving chemotherapy or other systemic therapies were included. It may be that patients who need to undergo surgery, or patients that have never experienced any oncologic treatments have other priorities or have more difficulty using the OPT C. Some patients who had experience with oncologic treatments filled in the OPT-C in a hypothetical situation; other patients were inexperienced with oncologic treatments and filled out the OPT-C while making a real treatment decision. Although this may have impacted the results, it also allowed for testing in both experienced and inexperienced patients. Only physicians with a geriatric background tested the OPT C. Future research is needed to test the OPT-C with other healthcare professionals, such as oncologists, advanced practice nurses, general practitioners, or surgeons. Another focus of future research is to test validity and reliability in a larger group and in different patient categories, for example, those with cognitive impairment. Additionally, future studies could investigate the effect the OPT-C has on treatment decisions and patient outcomes. An example of a future large randomized clinical trial that will use the OPT-C is GERONTE [[12]Streamlined Geriatric and Oncological evaluation based on IC Technology (GERONTE) for holistic patient-oriented healthcare management for older multimorbid patients.https://geronteproject.eu/Google Scholar]. In conclusion, in this pilot study the OPT-C appears to be a feasible instrument to discuss values and priorities with older patients with cancer. It helps to initiate a conversation and aids the patient in expressing what health outcomes are most important to them, thereby giving them a more active role in shared decision-making. Future research should focus on testing the OPT-C in larger and different patient groups, testing it with different healthcare professionals, and evaluating the effect of the OPT-C on treatment decisions and, consequently, on outcomes like quality of life and treatment satisfaction. The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. Conception and Design: MH, SF. Data Collection: NS, MH, SF. Analysis and Interpretation of Data: NS, SF, MH. Manuscript Writing: All. Approval of Final Article: All.