Facilitators and Barriers in the Implementation and Adoption of Patient-Reported Outcomes Measurements in Daily Practice.

OBJECTIVES: At the Erasmus Medical Center, patient-reported outcomes measures (PROMs) are implemented on a hospital-wide scale. However, less than half of the patients and healthcare professionals (HCPs) use these PROMs. Therefore, this study aimed to investigate facilitators and barriers for adoption of PROMs to develop guidance around implementation. METHODS: A mixed-methods study with a combination of interviews and focus groups and questionnaires was conducted, involving patients, both PROM nonresponders and PROM responders, HCPs, and medicine students and nurse specialists in training (hereafter "students"). Interview transcripts were subjected to thematic content analysis. Subsequently, questionnaires were developed and presented to all stakeholders to validate the findings. Finally, identified themes and implementation recommendations were presented in a final questionnaire to the Value-Based Healthcare Erasmus Medical Center expert group to prioritize findings. RESULTS: Interviews were conducted with 15 patients, 14 HCPs and 4 students, and 2 focus groups with 5 students. The questionnaire was completed by 370 of 999 responders (37.0%), 173 of 1395 nonresponders (12.5%), and 44 of 194 HCPs (22.7%), and 40 students were reached via an open link. The identified facilitators and barriers were grouped into 4 overarching themes: training on PROMs at different levels in the education of (future) HCPs, motivate and reduce the burden for the HCP, implement generic and disease-specific PROMs simultaneously, and motivate, activate, and reduce the patient burden. CONCLUSIONS: Providing end users with digital tools, implementation support, and a clear hospital-wide vision is important, yet this does not guarantee successful adoption of PROMs. Successful adoption necessitates ongoing efforts to engage, motivate, and train end users.

Sexual well-being in patients with early-stage breast cancer at 1- and 2-year follow-up.

BACKGROUND: Sexual well-being (SWB) is an important aspect of overall quality of life and should therefore be considered when measuring the effect of breast cancer on daily life. AIM: To identify positive and negative predictive factors associated with change in SWB 1 year after diagnosis (T12; hereafter, ∆SWB) and whether SWB changes the year after. METHODS: All data were derived from an online patient-reported outcome measure that included patients aged >18 years who were treated for breast cancer between October 2015 and March 2022 at the Erasmus University Medical Center. Multivariable linear regression was used to analyze the association between demographic- and disease-specific variables and change in SWB between time of diagnoses (T0) and one year after (T12) (∆SWB). For defining the clinical relevance of ∆SWB, patients were divided into 3 groups based on their SWB score at T12: decreased, stable, and improved. Wilcoxon signed rank test was used to test the difference in SWB between T12 and T24 (2 years after diagnosis) in all 3 groups. OUTCOMES: Outcomes included the associations between demographic- and disease-specific variables and ∆SWB (T0 vs T12) and change in SWB the year after (T12 vs T24). RESULTS: An overall 204 patients were included, with a mean age of 51.7 years (SD, 12.8) and a mean SWB score of 64.3 (SD, 20.9) at T0. Body mass index >30 kg/m2 at T0 had a significant negative association (ß = -8.369, P = .019) with ∆SWB. Reconstruction (ß = 20.136, P < .001) and mastectomy (ß = 11.157, P < .001) had a significant positive association with ∆SWB vs lumpectomy. Change in psychological well-being had a significant positive relation to ∆SWB (ß = 0.349, P < .001). Patients with decreased SWB at T12 did not improve the year after (P = .376). CLINICAL IMPLICATIONS: By identifying the variables that are associated with decreased SWB during the trajectory of breast cancer treatment and by defining the clinical relevance of decreased SWB, patient groups can be targeted and offered extra support. STRENGTHS AND LIMITATIONS: This study is one of the first to analyze the development of SWB, instead of sexual function, over time in patients with breast cancer, and it uses data over a longer period. However, only one-third of the patients responded to the SWB domains at both time points. CONCLUSION: Type of operation, body mass index >30, and change in psychological well-being were associated with ∆SWB. Patients with decreased SWB 1 year after diagnosis tended not to improve or normalize the year after, indicating that intervention is needed to restore SWB in this specific group.

Dutch normative data of the sexual distress scale and the body image scale.

PURPOSE: Sexual health is an important contributing factor for health-related quality of life, but research in this domain is scarce. Moreover, normative data are needed to interpret patient-reported outcome measures on sexual health. The aim of this study was to collect and describe normative scores of the Female Sexual Distress Scale (FSDS) and the Body Image Scale (BIS) from the Dutch population and assess the effect of important demographic and clinical variables on the outcome. As the FSDS is also validated in men, we refer to it as SDS. METHOD: Dutch respondents completed the SDS and BIS between May and August 2022. Sexual distress was defined as a SDS score > 15. Descriptive statistics were calculated to present normative data per age group per gender after post-stratification weighting was applied. Multiple logistic and linear regression analyses were conducted to assess the effect of age, gender, education, relationship status, history of cancer and (psychological) comorbidities on SDS and BIS. RESULTS: For the SDS 768 respondents were included with a weighted mean score of 14.41 (SD 10.98). Being female (OR 1.77, 95% CI [1.32; 2.39]), having a low educational level (OR 2.02, CI [1.37; 2.39]) and psychological comorbidities (OR: 4.86, 95% CI [2.17; 10.88]) were associated with sexual distress. For the BIS, 696 respondents were included. Female gender (ß: 2.63, 95% CI [2.13; 3.13]), psychological comorbidities (ß: 2.45, 95% CI [1.43; 3.47]), higher age (ß: -0.07, 95% CI [-0.09; -0.05]), and a high educational level (ß:-1.21, CI: -1.79 to -0.64) were associated with the non-disease related questions of the Body Image Scale. CONCLUSION: This study provides age- and gender-dependent normative values for the SDS and the non-disease related questions of the BIS. Sexual distress and body image are influenced by gender, education level, relationship status and psychological comorbidities. Moreover, age is positively associated with Body Image.

Let's talk about sex! Why should healthcare professionals address sexual distress in breast cancer patients and survivors?

PURPOSE: Sexual distress impacts the quality of life (QoL) of breast cancer patients but is often overlooked in standard care pathways. This study evaluated the prevalence and factors of sexual distress among Dutch breast cancer patients, compared them to the general population, and explored how sexual distress is discussed in clinical settings from the perspectives of patients and healthcare professionals (HCPs). METHODS: Questionnaires containing the Female Sexual Distress Scale (FSDS) and demographic variables were distributed to women with breast cancer. The effect of breast cancer on sexual distress was assessed with a Mann-Whitney U test. Multivariable linear regression was used to analyze variables associated with FSDS. The Sexuality Attitudes and Beliefs Survey (SABS) was sent to HCPs. RESULTS: Breast cancer patients reported significantly higher sexual distress compared to a Dutch non-breast cancer cohort, respectively 16.38 (SD 11.81) and 23.35 (SD 11.39). Factors associated with higher sexual distress were psychological comorbidities, the body image scale, and being diagnosed >10 years ago. Sexual distress was not discussed as often as patients needed. Barriers to addressing sexual distress were time constraints, HCPs' confidence in their ability to address sexual distress, and uncertainty about who is responsible for initiation. CONCLUSIONS: Breast cancer patients showed significantly higher sexual distress compared to the Dutch population. However, it was not frequently addressed in the consultation room. While some barriers have been identified, this study highlights the importance of further exploring obstacles to integrating discussions about sexual distress into routine care to improve QoL of breast cancer patients.

Internal Responsiveness of EQ-5D-5L and EORTC QLQ-C30 in Dutch Breast Cancer Patients during the First Year Post-Surgery: A Longitudinal Cohort Study.

The EuroQoL 5-Dimension 5-Level questionnaire (EQ-5D-5L) and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) are commonly used Patient-Reported Outcome Measures (PROMs) for breast cancer. This study assesses and compares the internal responsiveness of the EQ-5D-5L and EORTC QLQ-C30 in Dutch breast cancer patients during the first year post-surgery. Women diagnosed with breast cancer who completed the EQ-5D-5L and EORTC QLQ-C30 pre-operatively (T0), 6 months (T6), and 12 months post-surgery (T12) were included. Mean differences of the EQ-5D-5L and EORTC QLQ-C30 between baseline and 6 months (delta 1) and between baseline and 12 months post-surgery (delta 2) were calculated and compared against the respective minimal clinically important differences (MCIDs) of 0.08 and 5. Internal responsiveness was assessed using effect sizes (ES) and standardized response means (SRM) for both deltas. In total, 333 breast cancer patients were included. Delta 1 and delta 2 for the EQ-5D-5L index and most scales of the EORTC QLQ-C30 were below the MCID. The internal responsiveness for both PROMs was small (ES and SRM < 0.5), with greater internal responsiveness for delta 1 compared to delta 2. The EQ-5D-5L index showed greater internal responsiveness than the EORTC QLQ-C30 Global Quality of Life scale and summary score. These findings are valuable for the interpretation of both PROMs in Dutch breast cancer research and clinical care.

A Core Outcome Set for inflammatory bowel diseases: development and recommendations for implementation in clinical practice through an international multi-stakeholder consensus process.

BACKGROUND AND AIMS: Standardising health outcome measurements supports delivery of care, enables data-driven learning systems, and secondary data use for research. As part of the Health Outcomes Observatory initiative and building on existing knowledge, a core outcome set (COS) for inflammatory bowel diseases (IBD) was defined through an international modified Delphi method. METHODS: Stakeholders rated 90 variables on a 9-point importance scale twice, allowing score modification based on feedback displayed per stakeholder group. Two consecutive consensus meetings were held to discuss results and formulate recommendations for measurement in clinical practice. Variables scoring 7 or higher by ≥80% of the participants, or based on consensus meeting agreement, were included in the final set. RESULTS: In total, 136 stakeholders (45 IBD patients (advocates), 74 healthcare professionals/researchers, 13 industry representatives and 4 regulators), from 20 different countries participated. The final set includes 18 case-mix variables, 3 biomarkers (haemoglobin to detect anaemia, C-reactive protein and faecal calprotectin to detect inflammation) for completeness and 28 outcomes (including 16 patient-reported outcomes (PROs) and 1 patient-reported experience). The PRO-2 and IBD-Control questionnaires were recommended to collect disease-specific PROs at every contact with an IBD practitioner, and the Subjective Health Experience model questionnaire, PROMIS Global Health and Self-Efficacy short form to collect generic PROs annually. CONCLUSIONS: A COS for IBD, including a recommendation for use in clinical practice, was defined. Implementation of this set will start in Vienna, Berlin, Barcelona, Leuven and Rotterdam, empowering patients to better manage their care. Additional centres will follow worldwide.

Respiratory muscle activity and patient-ventilator asynchrony during different settings of noninvasive ventilation in stable hypercapnic COPD: does high inspiratory pressure lead to respiratory muscle unloading?

INTRODUCTION: High-intensity noninvasive ventilation (NIV) has been shown to improve outcomes in stable chronic obstructive pulmonary disease patients. However, there is insufficient knowledge about whether with this more controlled ventilatory mode optimal respiratory muscle unloading is provided without an increase in patient-ventilator asynchrony (PVA). PATIENTS AND METHODS: Ten chronic obstructive pulmonary disease patients on home mechanical ventilation were included. Four different ventilatory settings were investigated in each patient in random order, each for 15 min, varying the inspiratory positive airway pressure and backup breathing frequency. With surface electromyography (EMG), activities of the intercostal muscles, diaphragm, and scalene muscles were determined. Furthermore, pressure tracings were derived simultaneously in order to assess PVA. RESULTS: Compared to spontaneous breathing, the most pronounced decrease in EMG activity was achieved with the high-pressure settings. Adding a high breathing frequency did reduce EMG activity per breath, while the decrease in EMG activity over 1 min was comparable with the high-pressure, low-frequency setting. With high backup breathing frequencies less breaths were pressure supported (25% vs 97%). PVAs occurred more frequently with the low-frequency settings (P=0.017). CONCLUSION: High-intensity NIV might provide optimal unloading of respiratory muscles, without undue increases in PVA.