Continuous adaptation of conversation aids for uterine fibroids treatment options in a four-year multi-center implementation project.

BACKGROUND: Fibroids are non-cancerous uterine growths that can cause symptoms impacting quality of life. The breadth of treatment options allows for patient-centered preference. While conversation aids are known to facilitate shared decision making, the implementation of these aids for uterine fibroids treatments is limited. We aimed to develop two end-user-acceptable uterine fibroids conversation aids for an implementation project. Our second aim was to outline the adaptations that were made to the conversation aids as implementation occurred. METHODS: We used a multi-phase user-centered participatory approach to develop a text-based and picture-enhanced conversation aid for uterine fibroids. We conducted a focus group with project stakeholders and user-testing interviews with eligible individuals with symptomatic uterine fibroids. We analyzed the results of the user-testing interviews using Morville's Honeycomb framework. Spanish translations of the conversation aids occurred in parallel with the English iterations. We documented the continuous adaptations of the conversation aids that occurred during the project using an expanded framework for reporting adaptations and modifications to evidence-based interventions (FRAME). RESULTS: The first iteration of the conversation aids was developed in December 2018. Focus group participants (n = 6) appreciated the brevity of the tools and suggested changes to the bar graphs and illustrations used in the picture-enhanced version. User-testing with interview participants (n = 9) found that both conversation aids were satisfactory, with minor changes suggested. However, during implementation, significant changes were suggested by patients, other stakeholders, and participating clinicians when they reviewed the content. The most significant changes required the addition or deletion of information about treatment options as newer research was published or as novel interventions were introduced into clinical practice. CONCLUSIONS: This multi-year project revealed the necessity of continuously adapting the uterine fibroids conversation aids so they remain acceptable in an implementation and sustainability context. Therefore, it is important to seek regular user feedback and plan for the need to undertake updates and revisions to conversation aids if they are going to be acceptable for clinical use.

Patient perspectives on climate friendly healthcare: an exploratory study in obstetrics and gynaecology.

OBJECTIVE: To investigate patient perspectives on climate change and climate change mitigation strategies in healthcare. METHODS: A cross-sectional survey among gynaecological patients from two Dutch outpatient clinics. Main outcomes included patients' climate-related knowledge and worry, climate friendly healthcare perspectives and willingness to opt for climate friendly treatment alternatives. Multivariable linear regression analyses were performed to explore patient characteristics associated with climate friendly healthcare perspectives. RESULTS: 274 surveys were included. Most patients (79 %) were worried about climate change. Although almost all (91 %) found it important to contribute to climate protection, patients showed hesitance regarding healthcare measures that would impinge on individual choices. 62 % was willing to opt for climate friendly treatments, but this proportion varied by medical condition. Climate-related knowledge and worry were both positively associated with climate friendly healthcare perspectives. CONCLUSION: Gynaecological patients are concerned about climate change and possess substantial self-reported climate-related knowledge. Patients vary in their support of climate action that involves individual patient care, but the majority is open to choose climate friendly treatment alternatives for certain medical conditions. PRACTICE IMPLICATIONS: This exploratory study holds implications for the feasibility of integrating climate impact into clinical decision-making and provides a foundation for normative evidence for decarbonizing healthcare.

Patients' preferences, experiences and expectations with wait time until surgery in gynaecological oncology: a mixed-methods study in two gynaecological oncological centres in the Netherlands.

OBJECTIVES: Patient-centredness of care during wait time before surgery can be improved. In this study we aimed to assess (1) patients' experiences with and preferences regarding wait time before surgery; (2) the impact of wait time on quality of life (QoL) and (3) which factors influence patients' wait time experience. DESIGN, SETTING, PARTICIPANTS: We performed an exploratory sequential mixed-methods study among women with gynaecological cancer in two tertiary hospitals. We conducted semistructured interviews and identified aspects of QoL and factors that influenced wait time acceptability through thematic analysis. We developed a questionnaire from this thematic analysis which was completed by 97 women. Descriptive statistics and univariate and multivariate regression analyses were performed. RESULTS: Average ideal wait time was 3.5 weeks (±1.7 weeks), minimum and maximum acceptable wait times were 2.2 and 5.6 weeks. Many patients scored above the threshold of the Hospital Anxiety and Depression Scale for anxiety (48%) or depression (34%), had sleeping problems (56%) or experienced pain (54%). A number of factors were more common in patients who indicated that their wait time had been too long: low education level (OR 7.4, 95% CI 0.5 to 5.0, p=0.007), time to surgery >4 weeks (OR 7.0, 95% CI 0.8 to 4.4, p=0.002) and experienced sleep disturbance (OR 3.27, 95% CI 0.0 to 3.1, p=0.05). If patients expectation of wait time was >4 weeks (OR 0.20, 95% CI -4.0 to -0.5 p=0008) or if patients experienced pain (OR 0.26, 95% CI -3.6 to -0.3, p=0.03), they less frequently indicated that wait time had been too long. CONCLUSION: To improve patient-centredness of care, healthcare providers should aim to reduce wait time to 3-4 weeks and ensure that patients are well informed about the length of wait time and are aware of high levels of anxiety, depression and pain during this time. Future studies should evaluate what interventions can improve QoL during wait time.

Preferences and considerations for interval cytoreductive surgery in advanced ovarian cancer: The patient's perspective.

OBJECTIVE: Treatment of advanced-stage ovarian cancer contains cytoreductive surgery (CRS) and chemotherapy. Achieving successful CRS (≤ 1 cm residual disease) is prognostically important, but may not be feasible peri-operatively while still risking complications. Therefore, patients' treatment expectations are important to discuss. We investigated patient considerations for interval CRS. METHODS: Patients with advanced-stage ovarian cancer planned for interval CRS completed a questionnaire about the impact of chance of successful CRS, survival benefit and becoming care-dependent on decision-making regarding CRS. The questionnaire included a vignette study, in which patients repeatedly chose between two treatment scenarios with varying levels for chance of successful CRS, survival benefit and risk of complications including stoma. Patient preferences were analyzed, including differences between patients aged < 70 and ≥ 70 years. RESULTS: Among 85 included patients, 31 (37%) patients considered interval CRS worthwhile irrespective of survival benefit and 33 (39%) irrespective of chance of successful surgery. However, 34 patients (41%) considered interval CRS only worthwhile if survival benefit was > 12 months, while 41 (49%) thought so if chance of successful surgery was ≥ 25%. Older patients considered these factors more important. Overall, 27% considered becoming permanently dependent of home care unacceptable. In the vignette study (n = 72) risk of complications and stoma were considered less important than chance of successful CRS and survival benefit. CONCLUSION: Survival benefit, chance of successful surgery and becoming care-dependent are important factors in patient's decision for interval CRS, while risk of complications and stoma are less important. Our results are useful in shared decision-making for interval CRS in ovarian cancer.

Explorative observational study of Dutch patient-clinician interactions: operationalisation of personal perspective elicitation as part of shared decision-making in real-life audio-recorded consultations.

OBJECTIVES: Patients' preferences, values and contexts are important elements of the shared decision-making (SDM) process. We captured those elements into the concept of 'personal perspective elicitation' (PPE), which reflects the need to elicit patients' preferences, values and contexts in patient-clinician conversations. We defined PPE as: 'the disclosure (either elicited by the clinician or spontaneously expressed by the patient) of information related to the patient's personal preferences, values and/or contexts potentially relevant to decision-making'. Our goal was to operationalise the concept of PPE through the evaluation of preferences, values and contexts and explore how PPE occurs in clinical encounters. DESIGN: Cross-sectional study: observational coding based on a novel coding scheme of audio-recorded outpatient clinical encounters where encounter patient decision aids were applied. SETTING: We audio-recorded patient-clinician interactions at three Dutch outpatient clinics. PPE was analysed using a novel observational coding scheme, distinguishing preferences, contexts and four Armstrong taxonomy value types (global, decisional, external and situational). We measured SDM using the Observer OPTION5. PARTICIPANTS: Twenty patients who suffered from psoriasis or ovarian cysts; four clinicians. RESULTS: We included 20 audio-recordings. The mean Observer OPTION5 score was 57.5 (SD:10.1). The audio-recordings gave a rich illustration of preferences, values and contexts that were discussed in the patient-clinician interactions. Examples of identified global values: appearance, beliefs, personality traits. Decisional values were related to the process of decision-making. External values related to asking advice from for example, the clinician or significant others. An identified situational value: a new job ahead. Contexts related to how the illness impacted the life (eg, sexuality, family, sports, work life) of patients. CONCLUSIONS: The operationalisation of PPE, an important aspect of SDM, explores which preferences, values and contexts were discussed during patient-clinician interactions where an ePDA was used. The coding scheme appeared feasible to apply but needs further refinement.

Patient-reported outcome measures (PROMs) to personalise follow-up care of ovarian cancer: what do patients think? A qualitative interview study.

PURPOSE: The purpose of this study was to explore ovarian cancer patients' preferences regarding follow-up care and, in particular, the use of patient-reported outcome measures (PROMs) as an approach to personalise follow-up care. METHODS: Between May and June 2021, semi-structured interviews were conducted with ovarian cancer patients, who had finished their primary treatment at least 6 months prior and were receiving follow-up care at our centre. Interviews were transcribed verbatim and analysed using an inductive thematic approach. A thematic flow chart was created describing interacting themes. RESULTS: Seventeen patients were interviewed, of which 11 were familiar with PROMs. Two key themes emerged from the data: the need for reassurance and the wish for personalised care. A follow-up scheme using PROMs was identified as a separate theme with the potential to personalise care. Several barriers and facilitators of PROMs were mentioned. CONCLUSIONS: Ovarian cancer patients have a desire for personalised follow-up care and seek reassurance. PROMs may be able to support both of these needs. Future research is needed to determine the most effective, patient-centred way to implement them. IMPLICATIONS FOR CANCER SURVIVORS: By understanding what patients' preferences are regarding follow-up care, more initiatives can be set up to personalise follow-up care, through which patient anxiety and dissatisfaction can be reduced.

Disentangling trust of patients with rare cancer in their healthcare professionals and the healthcare system: a qualitative interview study.

PURPOSE: Patients with a rare cancer face challenges, e.g., delayed diagnosis, that may affect trust in the healthcare system and the healthcare professionals (HCPs) involved. This study aimed to explore trust of patients with a rare cancer in their HCPs and the healthcare system. METHODS: Semi-structured interviews were conducted with 20 purposively sampled patients with a rare cancer. The interview guide included topics related to trust, including level, development, barriers and facilitators, importance, and trust dimensions. Thematic analysis was conducted with use of Atlas.ti. RESULTS: The mean age of patients was 50 years, 60% were female, and 70% were highly educated. Three themes were constructed: (1) "Confirmed expertise is a prerequisite of trust." Patients need confirmation of their HCPs' expertise, as it could not be assumed due to the rarity of their cancer; (2) "Trust depends on the adequacy of information and how it is provided." Limited information about rare cancer reduced patients' trust in health care, whereas interpersonal trust was mainly affected by how HCPs provided information; and (3) "Trust is built on properly coordinated and supportive care." Proper organization and cooperation within and between hospitals, and integration of supportive care, enhanced trust. CONCLUSION: Patients with a rare cancer experience challenges that influence trust in HCPs and the healthcare system. Further research should examine trust among subgroups of patients with a rare cancer, to enable development of tailored interventions. IMPLICATIONS FOR CANCER SURVIVORS: HCPs may improve trust by focusing on expertise, effective information provision, proper coordination of care, and provision of adequate supportive care.

Can late lymphoscintigraphy be omitted in the sentinel node procedure in early-stage vulvar cancer?

INTRODUCTION: In the Netherlands, the sentinel lymph node procedure protocol consists of preoperative lymphoscintigraphy combined with intraoperative blue dye for identifying sentinel lymph nodes in early vulvar squamous cell carcinoma. This study aimed at investigating the role of early and late lymphoscintigraphy. MATERIAL AND METHODS: From January 2015 to January 2019, early and late lymphoscintigraphies of 52 women were retrospectively analyzed. Lymphoscintigraphy was performed 30 minutes (early) and 2.5-4 hours (late) after vulvar injection of 99m Tc-labeled nanocolloid. We calculated the concordance correlation coefficient (CCC) between number of sentinel lymph nodes detected on both images using the Lins concordance coefficient and correlated with clinicopathological data. RESULTS: Thirty-four women had a midline tumor and 18 had a lateral tumor. Detection rates with early and late scintigraphy were 88.5% and 98.1%, respectively. Median number of detected nodes was 1.0 (0-7) and 2.0 (0-7). Good statistical correlation between number of sentinel lymph nodes detected on early and late imaging was found (CCC = 0.76) in most patients. In 18 women (35%) a mismatch occurred: a higher number of nodes was detected on late imaging. In 11 of 18 women re-injection was performed because no sentinel lymph nodes were visualized on early images. Late imaging and intraoperative detection showed a good statistical correlation (CCC = 0.61). One woman showed an isolated groin recurrence despite negative sentinel lymph nodes. CONCLUSIONS: This study showed good statistical correlations between early and late scintigraphy in most patients. However, in 35% of women late scintigraphy detected more nodes. In case of poor visualization after the first scintigraphy, re-injection should be considered. Late scintigraphy is probably helpful in confirming successful re-injection and in showing deviating lymph flow in women with failed mapping after the first injection and successful re-injection. Because missing metastatic sentinel lymph nodes often leads to a poor prognosis, we prefer optimal correlations between imaging and intraoperative identification. Hence, late scintigraphy cannot be safely omitted.

Bringing personal perspective elicitation to the heart of shared decision-making: A scoping review.

OBJECTIVES: Proponents of shared decision-making (SDM) advocate the elicitation of the patient's perspective. This scoping review explores if, and to what extent, the personal perspectives of patients are elicited during a clinical encounter, as part of a SDM process. We define personal perspective elicitation (PPE) as: the disclosure (either elicited by the clinician or spontaneously expressed by the patient) of information related to the patient's personal preferences, values and/or context. METHODS: A search was conducted in five literature databases from inception dates up to July 2020, to identify empirical studies about SDM (with/without SDM instrument). RESULTS: The search identified 4562 abstracts; 263 articles were read in full text, resulting in 99 included studies. Studies reported low levels of PPE. Integration of personal perspectives into the conversation or a future care plan was largely absent. The majority of the discussed content related to physical health, while social and psychological topics were mostly unaddressed. CONCLUSIONS: PPE occurs on a very low level in efforts to achieve SDM according to evaluation studies. PRACTICE IMPLICATIONS: PPE is advocated but rarely achieved in SDM evaluation studies. Causes should be identified, followed by designing interventions to improve this aspect of SDM.

Development of an adjective-selection measure evaluating clinicians' attitudes towards using patient decision aids: The ADOPT measure.

BACKGROUND: The implementation of shared decision-making and patient decision aids (PDAs) is impeded by clinicians' attitudes. OBJECTIVE: To develop a measure of clinician attitude towards PDAs. METHODS: To develop the ADOPT measure, we used four stages, culminating in measure responses by medically qualified clinicians, 25 from each of the following specialties: emergency medicine, family medicine, oncology, obstetrics and gynaecology, orthopaedics, and psychiatry. To assess validity, we also posed three questions to assess the participants' attitudinal and behavioural endorsement of PDAs. Allocating a point per adjective, we calculated the sum as well as positive and negative scores. We used univariate logistic regression to determine associations between the scores and attitudinal or behavioural endorsements. RESULTS: 152 clinicians completed the measure. 'Time-saving' (39%) and 'easy' (34%) were the most frequently selected adjectives. 'Time-consuming' and 'unfamiliar' were the most frequently selected negative adjectives (both 19%). The sum scores were significantly associated with behavioural endorsement of PDAs. DISCUSSION: Clinicians were able to respond to adjective-selection methods and the ADOPT measure could help assess clinician attitudes to PDAs. Validation will require further research. PRACTICE IMPLICATIONS: The ADOPT measure could help identify the extent and source of attitudinal resistance.

Comparison of the CollaboRATE and SDM-Q-9 questionnaires to appreciate the patient-reported level of shared decision-making.

OBJECTIVE: To compare CollaboRATE and SDM-Q-9 questionnaires when appreciating patient-perceived level of shared decision-making (SDM) in doctor-patient consultations. METHODS: Data were harvested from five separate studies on SDM, conducted in three university and one large community hospital in the Netherlands, using Dutch versions of both questionnaires. CollaboRATE and SDM-Q-9 scores were expressed as percentages. Correlation was assessed using Spearman's Rho coefficient. Bland&Altman analysis was used to assess the degree of agreement. Top scores were calculated to assess possible ceiling effects. RESULTS: The five studies included 442 patients. Median CollaboRATE scores (88.9%, IQR 81.5-100%) were significantly higher (p < 0.001) than SDM-Q-9 scores (80.0%, IQR 64.4-100%). Correlation was moderate (Rho=0.53, p < 0.001). A systematic, 12.5-point higher score was found across the range of scores when using CollaboRATE. Top scores for CollaboRATE and SDM-Q-9 were present in 37.5% and 17% of questionnaires, respectively. CONCLUSIONS: Overall, CollaboRATE and SDM-Q-9 questionnaires showed a high level of patient-perceived SDM. However, CollaboRATE only moderately correlated with SDM-Q-9 and had a stronger ceiling effect. PRACTICE IMPLICATIONS: When choosing a SDM-measurement tool, its benefits and limitations should be weighed. These metrics should be combined with objective scores of SDM, as these may differ from the patients' subjective interpretation.

Potential impact of encounter patient decision aids on the patient-clinician dialogue: a qualitative study on Dutch and American medical specialists' experiences.

OBJECTIVES: To examine the experiences among Dutch and American clinicians on the impact of using encounter patient decision aids (ePDAs) on their clinical practice, and subsequently to formulate recommendations for sustained ePDA use in clinical practice. DESIGN: Qualitative study using semi-structured interviews with clinicians who used 11 different ePDAs (applicable to their specialty) for 3 months after a short training. The verbatim transcribed interviews were coded with thematic analysis by six researchers via ATLAS.ti. SETTING: Nine hospitals in the Netherlands and two hospitals in the USA. PARTICIPANTS: Twenty-five clinicians were interviewed: 16 Dutch medical specialists from four different disciplines (gynaecologists, ear-nose-throat specialists, neurologists and orthopaedic surgeon), 5 American gynaecologists and 4 American gynaecology medical trainees. RESULTS: The interviews showed that the ePDA potentially impacted the patient-clinician dialogue in several ways. We identified six themes that illustrate this: that is, (1) communication style, for example, structuring the conversation; (2) the patient's role, for example, encouraging patients to ask more questions; (3) the clinician's role, for example, prompting clinicians to discuss more information; (4) workflow, for example, familiarity with the ePDA's content helped to integrate it into practice; (5) shared decision-making (SDM), for example, mixed experiences whether the ePDA contributed to SDM; and (6) content of the ePDA. Recommendations to possibly improve ePDA use based on the clinician's experiences: (1) add pictorial health information to the ePDA instead of text only and (2) instruct clinicians how to use the ePDA in a flexible (depending on their discipline and setting) and personalised way adapting the ePDA to the patients' needs (e.g., mark off irrelevant options). CONCLUSIONS: ePDAs contributed to the patient-clinician dialogue in several ways according to medical specialists. A flexible and personalised approach appeared appropriate to integrate the use of ePDAs into the clinician's workflow, and customise their use to individual patients' needs.

The Tell me tool: The development and feasibility of a tool for person-centred infertility care.

BACKGROUND: An important-and often missing-element of person-centred care is the inclusion of individual patients' values and preferences. This is challenging but especially important for high-burden fertility treatments. We describe the development of a clinical tool that aims to facilitate the delivery of person-centred fertility care by giving insight into the patients' values and preferences. METHODS: We developed the Tell me tool following the three principles of user-centred design: (1) early and continual focus on users; (2) iterative design; (3) measurement of user behaviour. Accordingly, our methods consisted of three phases: (1) conducting semi-structured interviews with 18 couples undergoing fertility treatment, followed by a consensus meeting with relevant stakeholders; (2) performing seven iterative improvement rounds; (3) testing the feasibility of the tool in 10 couples. RESULTS: The Tell me tool consists of a ranking assignment of 13 themes and two open-ended questions. These themes relate to the couples' wellbeing and experience of the treatment, such as mental health and shared decision making. The open-ended questions ask them to write down what matters most to them. The field test showed variation between the individual patients' answers. The tool proved to highlight what is important to the individual patient and gives insight into patients' personal contexts. CONCLUSIONS: We developed a tool that gives insight into the values and preferences of the individual patient. The tool seems feasible for facilitating person-centred fertility care. PATIENT OR PUBLIC CONTRIBUTION: The tool was developed with a user-centred design that strongly involved patients.

Structurally collecting patient feedback on trainee skills: A pilot study in Obstetrics and Gynaecology.

OBJECTIVE: This pilot study tested a tool that collects patient feedback on trainees' skills in shared decision-making (SDM) and general consultation. It also examined trainees' views on SDM and patient feedback, exploring potential skills improvement through reflexive practice. METHODS: Patients were asked to rate trainees after consultation in a six-itemed questionnaire. The questionnaire included 'CollaboRATE' (a validated tool to test SDM), the 'Net Promoter Score' and two open-ended questions. Questionnaire results were described quantitatively and tested for differences. Results were presented to trainees at three intervals. Trainees were interviewed afterwards. Interview transcripts were thematically analysed. RESULTS: Eleven trainees in Obstetrics and Gynaecology participated. Out of 1651 sent questionnaires 399 were returned (response rate 24%). Questionnaire results showed no differences when comparing trainees or group scores over time. Interview results were thematically analysed using the reflexivity framework. Trainees were able to reflect on their SDM skills. They valued receiving patient feedback, yet were able to formulate few learning points from it. CONCLUSION: Although skills improvement was not evident, patient feedback still has potential benefits. PRACTICE IMPLICATIONS: Patient feedback should be combined with facilitated reflections at timely intervals to reinforce behaviour change. Supervisors play an important role in facilitating reflections with trainees.

Implementation and sustainability factors of two early-stage breast cancer conversation aids in diverse practices.

BACKGROUND: Conversation aids can facilitate shared decision-making and improve patient-centered outcomes. However, few examples exist of sustained use of conversation aids in routine care due to numerous barriers at clinical and organizational levels. We explored factors that will promote the sustained use of two early-stage breast cancer conversation aids. We examined differences in opinions between the two conversation aids and across socioeconomic strata. METHODS: We nested this study within a randomized controlled trial that demonstrated the effectiveness of two early-stage breast cancer surgery conversation aids, one text-based and one picture-based. These conversation aids facilitated more shared decision-making and improved the decision process, among other outcomes, across four health systems with socioeconomically diverse patient populations. We conducted semi-structured interviews with a purposive sample of patient participants across conversation aid assignment and socioeconomic status (SES) and collected observations and field notes. We interviewed trial surgeons and other stakeholders. Two independent coders conducted framework analysis using the NOrmalization MeAsure Development through Normalization Process Theory. We also conducted an inductive analysis. We conducted additional sub-analyses based on conversation aid assignment and patient SES. RESULTS: We conducted 73 semi-structured interviews with 43 patients, 16 surgeons, and 14 stakeholders like nurses, cancer center directors, and electronic health record (EHR) experts. Patients and surgeons felt the conversation aids should be used in breast cancer care in the future and were open to various methods of giving and receiving the conversation aid (EHR, email, patient portal, before consultation). Patients of higher SES were more likely to note the conversation aids influenced their treatment discussion, while patients of lower SES noted more influence on their decision-making. Intervention surgeons reported using the conversation aids did not lengthen their typical consultation time. Most intervention surgeons felt using the conversation aids enhanced their usual care after using it a few times, and most patients felt it appeared part of their normal routine. CONCLUSIONS: Key factors that will guide the future sustained implementation of the conversation aids include adapting to existing clinical workflows, flexibility of use, patient characteristics, and communication preferences. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03136367 , registered on May 2, 2017.

Encounter decision aids to facilitate shared decision-making with women experiencing heavy menstrual bleeding or symptomatic uterine fibroids: A before-after study.

OBJECTIVE: Is the level of shared decision-making (SDM) higher after introduction of a SDM package (including encounter decision aids on treatment options for heavy menstrual bleeding and training for clinicians) than before?. METHODS: This before-after study, performed in OB-GYN practice, compared consultations before and after introduction of a SDM package. The target sample size was 25 patients per group. Women seeking treatment for heavy menstrual bleeding were eligible. After their appointments, patients filled out a three-item patient-reported SDM measure. Treatment discussions were audio-recorded and rated for SDM using Observer OPTION5. Consultation transcripts in the 'after' group were checked for adherence to the steps required for intended use of decision aids. RESULTS: 16 gynaecologists participated. 25 patients participated before introduction of the decision aids and 28 after. The proportion of women reporting optimal SDM was higher after introduction (75 %) than before (50 %;p < 0.001). The mean observer-rated level of SDM was also significantly higher after than before (MD = 12.50,95 % CI 5.53-19.47). CONCLUSION: The level of SDM was higher after the introduction of the package than before. PRACTICE IMPLICATIONS: This study was conducted in a real-life setting in three clinics, both large academic and small rural, offering opportunities for implementation in different type of organizations.

Patients' and gynecologists' views on sentinel lymph node mapping in low- and intermediate-risk endometrial cancer: a Dutch vignette study.

OBJECTIVE: Sentinel lymph node (SLN) mapping in endometrial cancer is gaining ground. However, patient views on this new technique are unknown. The aim of this study was to determine factors important to patients and gynecologists when considering SLN mapping in low- and intermediate-risk endometrial cancer. METHODS: We performed a vignette study. Patients who underwent a total hysterectomy for low- or intermediate-risk endometrial cancer between 2012 and 2015 were invited. Dutch gynecologists specializing in gynecologic oncology were also invited. We based the selection for attributes in the vignettes on literature and interviews: risk of complications of SLN mapping; chance of finding a metastasis; survival gain; risk of complications after radiotherapy; operation time; and hospital of surgery (travel time). We developed a questionnaire with 18 hypothetical scenarios. Each attribute level varied and for each scenario, participants were asked how strongly they would prefer SLN on a scale from 1 to 7. The strength of preference for each scenario was analyzed using linear mixed effects models. RESULTS: A total of 38% of patients (41/108) and 33% of gynecologists (42/126) participated in the study. Overall, they had a preference for SLN. The mean preference for patients was 4.29 (95% CI 3.72 to 4.85) and 4.39 (95% CI 3.99 to 4.78) for gynecologists. Patients' preferences increased from 3.4 in the case of no survival gain to 4.9 in the case of 3-year survival gain (P<0.05) and it decreased when travel time increased to >60 min (-0.4, P=0.024), or with an increased risk of complications after adjuvant radiotherapy (-0.6, P=0.002). For gynecologists all attributes except travel time were important. CONCLUSIONS: Overall, patients and gynecologists were in favor of SLN mapping in low- and intermediate-risk endometrial cancer. Most important to patients were survival gain, travel time, and complication risk after adjuvant radiotherapy. These preferences should be taken into account when counseling about SLN mapping.

Neoadjuvant Chemotherapy Followed by Vaginal Radical Trachelectomy as Fertility-Preserving Treatment for Patients with FIGO 2018 Stage 1B2 Cervical Cancer.

BACKGROUND: Standard treatment for International Federation of Gynecology and Obstetrics (FIGO) 2018 stage 1B2 cervical cancer (i.e., tumor size between 2 and 4 cm) is a radical hysterectomy (RH) with pelvic lymph node dissection (PLND). We evaluated the oncological and fertility outcomes treatment in patients receiving a fertility-sparing alternative consisting of neoadjuvant chemotherapy (NACT) followed by vaginal radical trachelectomy (VRT). METHODS: Patients with stage 1B2 cervical cancer who wished to preserve fertility were included from September 2009 to September 2018. NACT consisted of 6-week cycles of cisplatin or carboplatin with paclitaxel. If tumor size decreased to 2 cm or smaller, NACT was followed by a robot-assisted PLND and VRT. RESULTS: Eighteen patients were included. Median follow-up time was 49.7 months (range 11.4-110.8). Median tumor size was 32 mm (range 22-40 mm). Complete remission after NACT occurred in seven women. Four women had a poor response on NACT. Three underwent RH with PLND; one received chemoradiation after PLND instead of VRT because of positive lymph nodes. The remaining 14 patients received VRT 3-4 weeks after NACT. Four recurrences occurred: three after NACT and VRT and one after NACT and RH. Median time to recurrence was 20.8 months (range 17.0-105.7). Three recurrences occurred in women with adenocarcinoma with lymph vascular space invasion (LVSI). In four women fertility could not be preserved. To date, four women had six pregnancies, including three live births born at term, two first trimester miscarriages, and one currently ongoing pregnancy. CONCLUSION: NACT and VRT in women with stage 1B2 cervical cancer showed promising results. In 78% fertility was preserved. However, patients with poor response on NACT and with adenocarcinoma and/or LVSI were possibly at risk for recurrence. Long-term results in relation to fertility and oncological outcome are needed to corroborate these findings. IMPLICATIONS FOR PRACTICE: Standard treatment for women with International Federation of Gynecology and Obstetrics (FIGO) 2018 stage 1B2 cervical cancer (tumor size 2-4 cm) is a radical hysterectomy and pelvic lymph node dissection (PLND). However, many of these women are young and wish to preserve fertility. Data on fertility-sparing treatment options are sparse, but neoadjuvant chemotherapy followed by a vaginal radical trachelectomy and PLND could be an alternative. Since 2009 we performed an observational cohort study in which 18 women opted for this treatment in our center. In 14 women fertility could be preserved. In four patients the tumor recurred. In four women six pregnancies occurred. After careful selection this treatment could be a good fertility-sparing treatment option.

Implementation of the uterine fibroids Option Grid patient decision aids across five organizational settings: a randomized stepped-wedge study protocol.

BACKGROUND: Uterine fibroids are non-cancerous overgrowths of the smooth muscle in the uterus. As they grow, some cause problems such as heavy menstrual bleeding, pelvic pain, discomfort during sexual intercourse, and rarely pregnancy complications or difficulty becoming pregnant. Multiple treatment options are available. The lack of comparative evidence demonstrating superiority of any one treatment means that choosing the best option is sensitive to individual preferences. Women with fibroids wish to consider treatment trade-offs. Tools known as patient decision aids (PDAs) are effective in increasing patient engagement in the decision-making process. However, the implementation of PDAs in routine care remains challenging. Our aim is to use a multi-component implementation strategy to implement the uterine fibroids Option Grid™ PDAs at five organizational settings in the USA. METHODS: We will conduct a randomized stepped-wedge implementation study where five sites will be randomized to implement the uterine fibroid Option Grid PDA in practice at different time points. Implementation will be guided by the Consolidated Framework for Implementation Research (CFIR) and Normalization Process Theory (NPT). There will be a 6-month pre-implementation phase, a 2-month initiation phase where participating clinicians will receive training and be introduced to the Option Grid PDAs (available in text, picture, or online formats), and a 6-month active implementation phase where clinicians will be expected to use the PDAs with patients who are assigned female sex at birth, are at least 18 years of age, speak fluent English or Spanish, and have new or recurrent symptoms of uterine fibroids. We will exclude postmenopausal patients. Our primary outcome measure is the number of eligible patients who receive the Option Grid PDAs. We will use logistic and linear regression analyses to compare binary and continuous quantitative outcome measures (including survey scores and Option Grid use) between the pre- and active implementation phases while adjusting for patient and clinician characteristics. DISCUSSION: This study may help identify the factors that impact the implementation and sustained use of a PDA in clinic workflow from various stakeholder perspectives while helping patients with uterine fibroids make treatment decisions that align with their preferences. TRIAL REGISTRATION: Clinicaltrials.gov , NCT03985449. Registered 13 July 2019, https://clinicaltrials.gov/ct2/show/NCT03985449.