Abstract
Objectives:
Many patients diagnosed with oropharyngeal squamous cell carcinoma (OPSCC) have the option of radiation- or surgery-based therapy, and would benefit from a treatment decision aid (DA) to make decisions congruent with their personal values. Our objective was to develop a patient-centered DA for patients with OPSCC that is comprehensible, usable, acceptable, and well-designed.
Materials and Methods:
Decisional needs from a pilot study of OPSCC survivors and treating physicians were used to inform a web-based prototype DA. A multidisciplinary steering group developed and iteratively revised the DA. Feasibility testing was conducted in two cycles to assess perspectives of stakeholders (medical, radiation and surgical oncologists, patient education experts, and OPSCC survivors). Survey data and open-ended responses were used to evaluate and refine the DA.
Results:
16 physicians, 4 patient education experts, and 6 survivors of OPSCC evaluated a web-based DA prototype in two cycles of testing. Participant feedback was used to revise the DA content and design between cycles. The majority of participants across both cycles indicated that the DA was comprehensible (97%), usable (86%), acceptable (78%), and well-designed (93%). Approximately three quarters of respondents indicated that they would use or share the DA in clinical practice.
Conclusion:
We developed the first patient-centered treatment decision aid (DA) designed for patients with OPSCC, to our knowledge. The DA was perceived favorably by stakeholders, with more than three quarters of respondents indicating they would use it in clinical practice. This tool may improve clinical practice as an adjunct to shared decision-making for OPSCC.
Keywords: Head and neck cancer, Oropharyngeal cancer, decision-making, qualitative, patient-centered care, communication
Introduction
The incidence of oropharyngeal squamous cell carcinoma is rising due to human papillomavirus (HPV).1 The markedly improved prognosis for this disease compared with other types of head and neck squamous cell carcinoma has spurred investigation into new treatment options, and patients are often presented with treatment choices that can feel complex or overwhelming.2
Despite changing treatment regimens, informational support for patients making treatment decisions remains an underdeveloped area. Patients diagnosed with OPSCC who are surgical candidates have the option to undergo primary radiotherapy or primary surgical therapy.3 These treatment options are understood to have similar results in terms of survival, however they have distinct side effect profiles.4 Shortly after their cancer diagnosis, many patients make difficult decisions which will have lasting sequelae on their speech, swallow and other functions.
Burgeoning support for patient-centered care and a growing understanding that shared decision-making improves outcomes5 have led to the development of decision aids (DAs, tools designed to assist patients making treatment decisions) in many disease processes. A Cochrane review of more than 100 randomized controlled trials across several decisional contexts found that, compared to usual care, patients who were presented with DAs felt better informed, had improved clarity in their values, and perhaps felt more involved in the decision-making process, without any adverse effects on patient satisfaction or outcomes.6,7 These findings have been demonstrated using treatment DAs developed for other cancers8 such as breast,9 colon10 and prostate.11 Patients with these cancers face treatment options characterized by clinical equipoise—that is, with similar oncologic outcomes. A recent call was made for DAs in otolaryngology, however a paucity exists to date.12
We previously reviewed existing literature and described treatment preferences among patients with OPSCC.13 Apart from the desire for cure and survival, patient preferences are not predictable and vary widely among individuals.14,15 We have also demonstrated that priorities at diagnosis compared with after treatment are largely conserved.16 A qualitative decision needs assessment among pre-treatment and post-treatment survivors found strong themes of alarm at diagnosis, a sense of personal responsibility for treatment decision-making, and a need for patient-centered information with the inclusion of survivor perspectives.2 Furthermore, this analysis uncovered decisional conflict, defined as personal perceptions of uncertainty in decision-making.17 These findings, along with the high levels of anxiety among these patients14,18 describe a population that would strongly benefit from decisional support.
This study describes the development and feasibility testing of a novel, web-based, patient-centered decision aid for patients with OPSCC making decisions about primary treatment, designed for use either independently or in the presence of a healthcare provider.
Methods
The study schema is displayed in Figure 1. This study was approved by the Johns Hopkins University School of Medicine Institutional Review Board. The DA was developed using schema outlined by the International Patient Decision Aids Standards (IPDAS) Collaboration. The IPDAS is a group of researchers, practitioners and stakeholders that has developed criteria for improving the quality and effectiveness of patient decision aids.19
Figure 1.
Decision aid development and feasibility testing flow diagram.
At Johns Hopkins Sidney Kimmel Cancer Center, a National Comprehensive Cancer Network-designated cancer center, patients with OPSCC receive either primary surgical resection or primary radiotherapy, with or without chemotherapy. Primary surgery is most often transoral robotic surgery (TORS) with a neck dissection. If the patient is at high-risk for recurrence because of extranodal extension, positive or close margins, late stage, multiple involved lymph nodes, or perineural, vascular or lymphatic invasion,20 patients receive a planned 60–66 Gy of adjuvant radiation with or without chemotherapy. Primary radiation involves a planned 70 Gy of radiation with or without concurrent chemotherapy depending upon extent of disease. At the time of initial diagnosis, patients undergo consultation with a head and neck surgical oncologist, a radiation oncologist, and a medical oncologist.
The scope of the DA was determined by the principal investigators and study investigators on the basis of prior investigation,13,16,14 clinical experience and literature review. The decision aid target audience was patients with incident OPSCC making decisions about primary curative therapy. The purpose of the DA was to improve understanding and reduce decisional conflict with an instrument that is comprehensible, usable, acceptable, and well-designed.
Stakeholder Needs Assessment
The treatment decision-making experiences of 11 recently diagnosed patients with OPSCC (pre-treatment survivors) and 15 post-treatment survivors was conducted using qualitative methods March 2018- September 2019 as previously described.2 Attitudes toward and suggestions regarding content and format of the proposed DA were also collected from this patient population in the context of the semi-structured interview. Qualitative methods revealed highly positive attitudes toward the utility of the proposed DA among all OPSCC survivors included (n=26). Desired characteristics of the tool included the presentation of information regarding side effects from all modalities of treatment, pros and cons of each treatment, perspective of survivors, use of layman’s terms, a web-based format with graphics and visual aids, an acknowledgement of personal values, and a listing of where to access additional information. The questions used to elicit the attitudes, content and format are available in the Appendix.
In addition to the patient perspectives previously described, oncologists treating patients with OPSCC at Johns Hopkins and other National Comprehensive Cancer Network-designated cancer centers were recruited with peer networking and enrolled with oral consent to comment on patient decisional needs as understood by physicians. This group included 4 head and neck surgical oncologists, 4 radiation oncologists, and 1 medical oncologist. Semi-structured interviews eliciting attitudes and suggestions for the DA were conducted (Appendix). The proposed DA was seen as useful by all treating physicians interviewed.
Desired characteristics of the proposed DA by stakeholders are collated and summarized in the Appendix.
Steering Group
A multidisciplinary steering group was assembled with representation from the following disciplines: cancer epidemiology (GD), otolaryngology-head and neck surgery (EB, MJW, CF), radiation oncology (TS), medical oncology (APK), patient and family education, and risk management. This group reviewed the preliminary content for the decision aid and provided guidance where needed throughout the process of DA development and feasibility testing.
Prototype content development
Building on the needs assessment, the investigators drafted a mockup of a patient-centered DA website meeting all qualifying criteria from the IPDASi v4.0.21 The informational content regarding OPSCC diagnosis and treatment was adapted from the patient versions of the National Cancer Institute Physician Data Query Cancer Information Summaries, a comprehensive source of cancer information.22 Paraphrased quotes with advice from survivors who participated in the decisional needs assessment were also included. Given the emphasis on the value of survivor perspectives elucidated in the needs assessment,2 post-treatment survivor stories were also included in the DA design. Survivors of OPSCC who had received a variety of primary treatment regimens were recruited by purposive sampling and physician referral, and enrolled with written consent to record video testimonials. Videos featuring these survivors were recorded in a professional studio. A video prompt script developed by the investigators and followed by an off-camera interviewer is included in the Appendix. These videos were edited with the input of the investigator team, and approval for use was obtained from the patients after they had viewed the final versions.
The needs assessment revealed patients’ desire for the description of side effects and for visual aids (Appendix). Side effects of each treatment modality (surgery, radiotherapy, chemotherapy) were sourced from a literature review with guidance from a systematic review of transoral robotic surgery and radiotherapy published in 2014.4 Lists and frequencies of treatment side effects were reviewed by clinical members of the multidisciplinary steering group for accuracy and consensus. A decision tool eliciting the personal importance of various decisional factors. For visual cohesion throughout the DA, a medical illustrator was contracted to develop icons for several concepts on the website: surgery, radiotherapy, chemotherapy, icon arrays for side effect frequencies, quotation marks for survivor quotes, preference scale (“not very important”/“extremely important”). Additional images featured in the DA were either open source or used according to paid license agreement. A web designer was contracted to build the website. Multiple rounds of editing and proofing were conducted to the satisfaction of the investigator team. The prototype website was housed on the Johns Hopkins server and password-protected during alpha testing.
Alpha testing
The DA development and feasibility testing schema are depicted in Figure 1. After prototype development, the alpha testing aimed to determine comprehensibility, usability, acceptability, and design of the decision aid. Survivors of OPSCC, physicians who treat patients with OPSCC from our institution and other cancer centers, and patient education experts were recruited by purposive sampling and enrolled with oral consent to participate in testing. Participants were asked to view the website and complete an online questionnaire. Questions used in the survey were partly adapted from a feasibility study of a DA for contralateral prophylactic mastectomy.23 Additional questions collected details on the study participant and open-ended comments. In the open-ended comment section, respondents were invited to state their likes, dislikes, and what alterations may be needed. These responses were then analyzed thematically and summarized.
Alpha testing was conducted in two cycles with a representative mix of participant types in each cycle (Figure 1). After cycle 1, results and feedback were compiled and reviewed by the steering group and used to revise the DA prior to commencing the second cycle. Similarly, the results from cycle 2 were reviewed by the steering group and used to make additional changes to the DA.
Results
Prototype description
The DA prototype was drafted to address the items identified in the needs assessment2 in accordance with IPDAS criteria.19 The DA was comprised of a narrated slideshow providing an overview of OPSCC and treatment; quotations with advice from survivors; videos of survivors describing their experiences; an interactive treatment timeline calendar; side-by-side comparisons of treatment advantages, disadvantages, and side effects; and an interactive printable worksheet querying patients’ personal values designed to catalyze conversations with the treating oncology team. In accordance with the desired content elicited during the needs assessment (Appendix), a listing of web links was included where patients could learn more about OPSCC.
Participant characteristics
26 individuals participated in alpha testing (n=13 in each cycle), including 16 physicians, 4 patient education experts, and 6 OPSCC survivors (Supplemental Table 1). Physician participants included head and neck surgeons (n=6, 23%), radiation oncologists (n=7, 27%), and medical oncologists (n=3, 12%). Number of years in practice ranged from two to 33 (mean of 10 years). Patient education experts included individuals with expertise in health literacy and patient teaching material development as well as individuals with expertise in head and neck surgical nursing and patient education. The 6 OPSCC survivors (n=5 male) who participated were all diagnosed at least 6 months prior to study enrollment and had completed their primary oncologic treatment. Two received surgery-based therapy with adjuvant treatment, and 4 radiation-based therapy. Participants in cycle 1 of alpha testing included 9 physicians, 1 patient education expert, and 3 survivors; cycle 2 included 7 physicians, 3 patient education experts, and 3 survivors.
Decision Aid comprehensibility and usability
When asked to rate the comprehensibility of each content section of the DA, 97% of respondents (both alpha testing cycles combined) indicated that the DA was extremely easy or somewhat easy to understand (Table 1). The majority (86%) of respondents also agreed with the DA’s usability in aiding patient decision-making (Table 2). In cycle 1, agreement with the 8 usability statements ranged from 62–85%, and this increased to 77–100% in cycle 2.
Table 1:
Comprehensibility of decision aid content among 26 participants by website section and testing cycle.
| Extremely or somewhat easy | Neither easy nor difficult | Somewhat or extremely difficult | Did not respond | |
|---|---|---|---|---|
| Cycle 1 | ||||
| “What is oropharyngeal cancer?” slideshow | 11 (92%) | 1 (8%) | 0 (0%) | 1 |
| “What else goes into my treatment decision?” | NA | NA | NA | -- |
| “What do survivors say?” | 11 (100%) | 0 (0%) | 0 (0%) | 2 |
| “Survivors’ stories” | 11 (100%) | 0 (0%) | 0 (0%) | 2 |
| “Expected time commitment” | 10 (91%) | 1 (9%) | 0 (0%) | 2 |
| “Compare my options” | 10 (91%) | 1 (9%) | 0 (0%) | 2 |
| “Patient preference worksheet” | 11 (92%) | 1 (8%) | 0 (0%) | 1 |
| Cycle 2 | ||||
| “What is oropharyngeal cancer?” slideshow | 13 (100%) | 0 (0%) | 0 (0%) | -- |
| “What else goes into my treatment decision?” | 13 (100%) | 0 (0%) | 0 (0%) | -- |
| “What do survivors say?” | 13 (100%) | 0 (0%) | 0 (0%) | -- |
| “Survivors’ stories” | 13 (100%) | 0 (0%) | 0 (0%) | -- |
| “Expected time commitment” | 13 (100%) | 0 (0%) | 0 (0%) | -- |
| “Compare my options” | 12 (92%) | 0 (0%) | 1 (8%) | -- |
| “Patient preference worksheet” | 12 (92%) | 1 (8%) | 0 (0%) | -- |
| Summative agreement with comprehensibility statements | ||||
| Cycle 1 | 96% | 4% | 0% | |
| Cycle 2 | 98% | 1% | 1% | |
| Overall | 97% | 3% | 0 |
Table 2:
Usability of the decision aid by testing cycle.
| Strongly or somewhat agree | Neither agree nor disagree | Somewhat or strongly disagree | |
|---|---|---|---|
|
| |||
| Cycle 1 | |||
| “The decision aid…” | |||
|
| |||
| “… fits into treatment decision-making” | 11 (85%) | 2 (15%) | 0 (0%) |
|
| |||
| “…helps patients recognize that a decision may need to be made” | 11 (85%) | 2 (15%) | 0 (0%) |
|
| |||
| “…prepares patients to make a better decision” | 10 (77%) | 3 (23%) | 0 (0%) |
|
| |||
| “…helps patients think about the pros and cons of each option” | 10 (77%) | 3 (23%) | 0 (0%) |
|
| |||
| “…helps patients think about which pros and cons are most important” | 8 (62%) | 2 (15%) | 3 (23%) |
|
| |||
| “…helps patients know that the decision depends on what matters to them” | 8 (62%) | 4 (31%) | 1 (8%) |
|
| |||
| “…helps patients organize their own thoughts about the decision” | 10 (77%) | 2 (15%) | 1 (8%) |
|
| |||
| “…helps patients prepare questions to ask their doctor” | 11 (85%) | 2 (15%) | 0 (0%) |
|
| |||
| Cycle 2 | |||
| “The decision aid…” | |||
|
| |||
| “… fits into treatment decision-making” | 13 (100%) | 0 (0%) | 0 (0%) |
|
| |||
| “…helps patients recognize that a decision may need to be made” | 13 (100%) | 0 (0%) | 0 (0%) |
|
| |||
| “…prepares patients to make a better decision” | 13 (100%) | 0 (0%) | 0 (0%) |
|
| |||
| “…helps patients think about the pros and cons of each option” | 13 (100%) | 0 (0%) | 0 (0%) |
|
| |||
| “…helps patients think about which pros and cons are most important” | 10 (77%) | 2 (15%) | 1 (8%) |
|
| |||
| “…helps patients know that the decision depends on what matters to them” | 13 (100%) | 0 (0%) | 0 (0%) |
|
| |||
|
| |||
| “…helps patients organize their own thoughts about the decision” | 12 (92%) | 1 (8%) | 0 (0%) |
|
| |||
| “…helps patients prepare questions to ask their doctor” | 13 (100%) | 0 (0%) | 0 (0%) |
|
| |||
| Summative agreement with usability statements | |||
|
| |||
| Cycle 1 | 76% | 18% | 6% |
|
| |||
| Cycle 2 | 96% | 3% | 1% |
|
| |||
| Overall | 86% | 11% | 3% |
In cycle 1, some participants expressed somewhat or strong disagreement with the following three statements: that the DA would help patients think about which pros and cons are most important (23%), would help patients know that the decision depends on what matters to them (8%), or would help patients organize their thoughts about the decision (8%). After edits were incorporated and evaluated in cycle 2, 25 of 26 participants agreed with all usability statements and 1 participant (a physician) indicated disagreement with only one statement (that the DA helps patients think about which pros and cons are most important).
Cycle 1: Decision Aid design, acceptability and open-ended feedback
Results of the design and acceptability questions together with open-ended feedback provided the most opportunity for improvements to the DA, and so are presented separately by cycle.
Evaluations of the acceptability of the DA are summarized in Table 3. In cycle 1, there was near uniform agreement (92%) that the DA’s design was acceptable (including evaluations of font readability, user-friendliness, use of images and icons, color scheme and appearance, and flow of the DA) (Supplemental Table 2).The majority (69%) of respondents indicated that they would definitely or probably use and/or share the DA, while 2 respondents were neutral and 2 indicated that they would probably not use or share it. More than half of respondents felt that the amount of information (62%) and the length of time it took to view the DA (77%) were appropriate.
Table 3:
Acceptability of decision aid by testing cycle.
| Question and cycle | Response scale | |||
|---|---|---|---|---|
| Does the wording make sense? | Generally yes | About half of content | Generally no | Did not respond |
| Cycle 1 | 12 (100%) | 0 (%) | 0 (%) | 1 |
| Cycle 2 | 12 (91%) | 1 (8%) | 0 (%) | -- |
| How well does the decision aid describe treatment? * | Extremely or very accurately | Moderately accurately | Slightly or not at all accurately | Did not respond |
| Cycle 1 | 4 (44%) | 5 (56%) | 0 (0%) | -- |
| Cycle 2 | 6 (86%) | 1 (14%) | 0 (0%) | -- |
| Would you use or share the decision aid? | Definitely or probably yes | Might or might not | Definitely or probably not | Did not respond |
| Cycle 1 | 9 (69%) | 2 (15%) | 2 (15%) | -- |
| Cycle 2 | 10 (77%) | 3 (23%) | 0 (0%) | -- |
| Regarding treatment options, the decision aid is: | Slanted toward surgery | Neutral | Slanted toward radiation | Did not respond |
| Cycle 1 | 7 (58%) | 5 (42%) | 0 (0%) | 1 |
| Cycle 2 | 4 (31%) | 8 (62%) | 1 (8%) | -- |
| The amount of information in the decision aid was: | Too much | Neither too much nor too little | Too little | Did not respond |
| Cycle 1 | 1 (8%) | 8 (62%) | 4 (30%) | -- |
| Cycle 2 | 3 (23%) | 10 (77%) | 0 (0%) | -- |
| The amount of time it took to view the decision aid was: | Too much, moderately too much, slightly too much | Neither too much nor too little | Too little | Did not respond |
| Cycle 1 | 2 (15%) | 10 (77%) | 1 (8%) | -- |
| Cycle 2 | 2 (15%) | 10 (77%) | 1 (8%) | -- |
Responses elicited from physicians only.
Notably, less than half (44%, 4 out of 9 physician respondents) indicated that the initial cycle 1 DA described treatment for OPSCC extremely or very accurately. Additionally, the majority (58%) felt that the DA was slanted towards primary surgery, while the remaining participants indicated that the DA was neutral regarding treatment options.
Themes of open-ended comments alongside representative reviewer comments are included in Table 4. Participant likes included the graphics and format, simplicity and user-friendliness, the survivor videos, and the information included. Dislikes and alterations requested were regarding the perceived bias toward surgical treatment, suggestions of missing information, clarification of treatment details, and some issues with formatting.
Table 4:
Themes and representative comments from open-ended responses for each testing cycle
| Endorsed [N (%)] | Representative comment | |
|---|---|---|
| Cycle 1 (N=13) | ||
| Likes | ||
| Graphics and format | 5 (38%) | “Calming color scheme, graphics, and videos” |
| Simplicity and user-friendliness | 10 (77%) | “Clear, easy to understand” |
| Survivor story videos | 3 (23%) | “Good use of videos” |
| Informative resource | 4 (31%) | “[The DA] will help patients to have something written that they can use as a resource before or after their visits” |
| Dislikes/alterations | ||
| Bias towards surgical treatment | 4 (31%) | “Consistent bias in favor of surgery, including the visuals, the selected survivor videos, and listed advantages/disadvantages” |
| Not enough information | 6 (46%) | “Lack of concrete information, including staging, survival outcomes” |
| Too complex | 2 (15%) | “Some of the information may still be too difficult for patients to understand, depending on literacy/medical literacy” |
| Clarification of wording/details needed | 5 (38%) | “Rather than stating between 1/3–2/3 of patients after surgery require radiation, it would be better to state…one number that matches the national data” |
| Format issues | 3 (23%) | “There was some font spillover” |
| Other | ||
| May not be useful for all patients | 1 (8%) | “It may be very cognitively dissonant for a patient to do this tool and have the idea that surgery is possible if they are ultimately told that it was never an option.” |
| Cycle 2 (N=13) | ||
| Likes | ||
| Simplicity and user-friendliness | 6 (46%) | “Very clear, laid out treatment options and pros/cons well” |
| Survivor story videos | 6 (46%) | “The testimonials were an excellent addition that allows a person to relate to someone that has been through the ordeal” |
| Informative resource | 6 (46%) | “Provides patients with enough information to ask educated questions of their providers” |
| Helps clarify values | 2 (15%) | “It helps the patient place value on what they want” |
| Dislikes/alterations | ||
| Lack of diverse survivor representation | 4 (31%) | “I know that the focus of this decision aid [is] for 60–70 year old Caucasian male patients but it would be great to see some diversity representation in the Survivor Story Video[s]” |
| Not enough information | 4 (31%) | “A more detailed picture of surgery would be helpful” |
| Too complex | 4 (31%) | “Some of the language is too complicated for the average [patient] to understand” |
| Clarification of wording/details needed | 4 (31%) | “It should be very clear at the top of the side effect table that patients requiring multiple modalities [will] have the combined side effects from both treatments” |
| Format issues | 3 (23%) | “the bullet [points] are not very clear on my screen” |
Cycle 1: Major changes
We analyzed all data together with participants’ open-ended comments, and these results were reviewed by the multi-disciplinary steering group. Two major areas requiring revisions were identified. The first goal for revision was to reduce the perception of bias towards surgical treatment. To this aim, multiple changes to the DA’s design, language, and other content were made, which included: replacing the icon associated with surgical treatment (a surgeon) with a different graphic more similar to the inanimate icons associated with radiation and chemotherapy (Figure 2); ensuring that each relevant section of the DA devoted equal space to each treatment and used similar syntax; and, replacing one surgical patient’s relatively optimistic video testimonial with a video from a new survivor thought to have a more representative treatment experience. The second major revision was to add a new section to the DA that was designed to give more information about how eligibility for each primary treatment modality is determined. Additionally, several revisions were made to clarify throughout the DA: for example, minor modifications to treatment timeline depictions and additional information about potential side effects.
Figure 2.
Evolution of treatment modality surgery icon. A) Initial icons developed to symbolize surgical treatment, radiation treatment, and chemotherapy. B) The icon trio after the surgical treatment icon was re-designed from a human to an inanimate icon, similar to the other two images.
Cycle 2: Design, acceptability, and open-ended feedback
Similar to cycle 1, in cycle 2 there was near uniform agreement (85%–100%) that the DA’s design was acceptable (Supplemental Table 2). Perceptions of the DA’s acceptability were generally improved compared to cycle 1 (Table 3). The majority (77%) of respondents indicated that they would be likely to use or share the DA, while the remaining participants were neutral. Most respondents indicated that the amount of information within the DA and the amount of time needed to view it were neither too much nor too little (77% for both). Importantly, 86% (6 of 7 physician respondents) felt that the DA described treatment extremely or very accurately, almost double the proportion (44%) reporting that in cycle 1. In contrast to the bias detected in cycle 1 regarding treatment options, the majority (62%) in cycle 2 felt that the DA was neutral, with the remainder detecting a slant towards surgical (31%) or radiation (8%) treatment.
Among the comments in the open-ended feedback, likes were similar to those of cycle 1 and included the DA’s user-friendliness, survivor videos, informativeness, and potential to help patients consider their treatment decision (Table 4). Dislikes and requested alterations included additional treatment information clarification, and formatting issues. About a third of respondents expressed the opinion that more information should be included, while about a third felt that the DA may be too complex. A final view shared by some respondents concerned the fact the survivor videos were all from a white, male perspective.
Cycle 2: Major changes
Again, results were shared with the steering group and additional revisions to the DA were proposed. The main resultant revision was to perform a careful language analysis to remove complex medical language and words greater than three syllables, and to plainly define absolutely necessary technical terms. Specifically, words greater than three syllables were replaced wherever an alternative wording was possible unless the word had been defined. Other minor revisions included adding information about feeding tubes and further clarifications to the treatment timeline calendar and lists of side effects. While four different treatment combinations were represented, respondents also suggested including stories from people in other demographic categories. Financial restrictions on filming and COVID-19 related restrictions prevented creation of additional videos at this stage, although additional videos from diverse perspectives are planned for the future.
Final version
Representative screen captures of the final DA website are displayed and described in Figure 3. The personal preferences worksheet is fully included in the Appendix. After additional testing in newly diagnosed patients with OPSCC, the authors anticipate the website will be freely available for public use.
Figure 3:
Representative images of the final decision aid website. A) Narrated slideshow with description of OPSCC, radiation therapy, chemotherapy, and transoral surgery with searchable dictionary of terms; B) information regarding eligibility for treatment regimens based on disease characteristics; C) quotes from survivors and feeding tube infographic; D) videos of survivors describing their treatment experiences. E) Infographic listing advantages and disadvantages of primary surgery and primary radiation-based therapy, with side effects of surgery, radiation and chemotherapy listed separately and in categories of frequency: common; somewhat common; less likely; very rare. F) Interactive treatment timeline calendar with drop-down selection of treatment regimens; G) printable personal values worksheet wherein viewers can select the personal importance of listed decisional factors. Links to learn more are included on this final page.
Discussion
In this study, we describe the development and feasibility testing of a web-based OPSCC treatment decision aid. The pilot tool was built with diligent inclusion of the perspectives of stakeholders, and determined after extensive editing to be comprehensible, usable, acceptable and well-designed. The incidence of OPSCC is rising, and clinical equipoise remains regarding radiation- and surgery-based treatments. Therefore, for newly diagnosed patients eligible for either treatment, our DA provides a framework to help patients make a treatment decision that corresponds with their personal values. Patient-centered DAs such as this offer important support in providing patient-centered care, which is considered a central component to quality care by the Institute of Medicine,24 the Affordable Care Act,25 and within the head and neck oncology community.
A main challenge during DA development was determining the amount and type of information to include. Not unexpectedly, opinions regarding content differed between physicians and patients or patient education experts. In the needs assessment2 newly diagnosed patients expressed that too much information is overwhelming, while also citing many areas in which more information was desired (mainly regarding side effects). Several physician participants called for the addition of more clinical information (prognosis and survival outcomes, cancer staging guidelines). Conversely, survivor participants expressed satisfaction with the amount of information that was included during feasibility testing, and some patient education experts cautioned that the DA may be too complex.
The inclusion of information regarding HPV was also a point of deliberation. HPV is an etiologic factor in most OPSCC,1 and prior studies have revealed unique informational needs among patients with HPV-OPSCC.18,26 At the time of writing, the NCCN guidelines stipulate treating patients similarly regardless of HPV tumor status until level 1 evidence for deintensification is reviewed.3 The investigators determined that information regarding transmission and testing for HPV, though important, was not germane to the scope of the DA, which focuses on treatment options for all OPSCC. For this reason, the investigators decided to only briefly mention this important prognostic factor and to link to websites for further information.
A third challenge was the perceived bias toward surgical treatment in cycle 1 of testing. At our institution, surgical eligibility is often viewed by the treatment team as advantageous when it is predicted to obviate the need for adjuvant therapy. However, a bias in the initial DA towards surgery was not anticipated and may be related to the fact that the lead investigators are surgeons. This bias was successfully addressed with changes proposed by multidisciplinary review, and the DA was deemed to be neutral in the second cycle. This feedback in particular demonstrates the value of multidisciplinary feasibility testing when generating educational tools for patient care.
There are limitations to this study. There is a potential for bias in participant responses, given that physicians and patient education experts were recruited through peer networking and patients were recruited by investigators affiliated with their treating physician. However, we attempted to maximize participant comfort by collecting survey data anonymously and analyzing responses in aggregate. It is important to note that treatment for OPSCC is in flux, with multiple novel approaches being investigated in clinical trials of de-escalated therapy. While these are not yet standard of care, the paradigm will continue to evolve and our DA content may need to change to stay up to date. An additional limitation is that our current survivor video stories do not represent a full range of diverse perspectives. While it is true that OPSCC predominantly affects adult white males, and the four videos testimonials reflect that population, the authors strongly acknowledge the value of including experiences of other patient groups, including women and patients of other races and ethnicities. Similarly, some respondents called for videos from survivors who underwent other treatment combinations not currently included in the DA. Given how positively these survivor story videos were received by the study participants, filming and including additional video perspectives is an important next step we are planning.
Conclusion
We have developed the first multidisciplinary web-based, patient-centered treatment decision aid for OPSCC based on stakeholder perspectives, to our knowledge. The resultant web-based, patient-centered treatment DA for patients with OPSCC is feasible for both patients and providers, with more than three quarters of oncologists indicating that they would use or share the DA in clinical scenarios. Future directions will include piloting the DA among patients with newly diagnosed OPSCC, including careful assessment of the DA’s effect on decision-making, anxiety, and other clinically relevant patient factors. We anticipate meeting nearly all of the IPDASi v4.0 certification and quality criteria.21 Ultimately, our aim is to make the DA publicly available to allow use as part of routine clinical practice as an adjunctive tool to standard oncologic consultations.
Supplementary Material
Highlights.
Patients diagnosed with oropharyngeal cancer have unique informational needs
We describe the development and feasibility testing of a web-based treatment decision aid
Multidisciplinary and stakeholder perspectives were incorporated throughout
The decision aid is comprehensible, usable, acceptable, and well-designed
Further evaluation of the tool in clinical practice is planned
Acknowledgement
We are grateful to the participants who took part in this study. We acknowledge with gratitude Dr. David Chen, who provided narration on the website, and Edward Wisniewski, the web designer. Thank you to the Milton J. Dance Endowment for awarding funding to this project.
Funding/Support:
This study was funded in part by the John Saunders, M.D. Research Award, the National Institute of Dental and Craniofacial Disorders [grant R35DE026631] and the National Institute of Deafness and Communication Disorders [grant 5T32DC000027-29].
Role of the Funding Source:
The funders had no role in the design and conduct of the study.
Footnotes
Conflict of Interest Disclosures: none
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