Improving Data Infrastructure for Person-Centered Outcomes Research on Intellectual and Developmental Disabilities.

Individuals with intellectual and developmental disabilities (IDD) continue to experience disparities in health and well-being despite improved provisions of person-centered care. Patient-centered outcomes research (PCOR) translates evidence into practice for meaningful outcomes. This piece describes findings from an environmental scan and stakeholder outreach to identify and prioritize opportunities to enhance IDD PCOR data infrastructure. These opportunities include developing a standardized research definition; advancing data standards for service systems; improving capture of IDD at point of care; developing standardized outcome measures; and encouraging Medicaid data use for IDD research. Within this piece, we discuss the implications of addressing data gaps for enhanced research. While the identified activities provide a path towards advancing IDD PCOR data infrastructure, collaborative efforts between government, researchers, and others are paramount.

Active Support Measure: a multilevel exploratory factor analysis.

BACKGROUND: Active Support is a person-centred practice that enables people with intellectual disabilities (IDs) to engage in meaningful activities and social interactions. The Active Support Measure (ASM) is an observational tool designed to measure the quality of support that people with IDs living in supported accommodation services receive from staff. The aim of the study was to explore the underlying constructs of the ASM. METHODS: Multilevel exploratory factor analysis was conducted on ASM data (n = 884 people with IDs across 236 accommodation services) collected during a longitudinal study of Active Support in Australian accommodation services. RESULTS: Multilevel exploratory factor analysis indicated that 12 of the ASM's 15 items loaded on two factors, named Supporting Engagement in Activities and Interacting with the Person. CONCLUSIONS: The 12-item ASM measures two dimensions of the quality of staff support. Both technical and interpersonal skills comprise good Active Support.

Systematic review of service improvements for home enteral tube feeding in adults.

BACKGROUND: Patients receiving home enteral tube feeding (HETF) have a high risk of complications and readmission to hospital. This study aims to evaluate effectiveness of staff- and/or patient-focused service-improvement strategies on clinical, patient-reported, and economic outcomes for patients receiving HETF across adult settings. METHODS: The search was conducted using MEDLINE, EMBASE, and CINAHL databases. Quality of studies were appraised using the Cochrane Collaboration Risk of Bias tool and Grading of Recommendations Assessment, Development, and Evaluation (GRADE) assessment. RESULTS: Eleven studies met the inclusion criteria. Pooled data found targeted HETF education with patients, carers, and staff significantly improved knowledge immediately after education and was sustained at 3-6 months. Multimodal interventions, including the formation of specialist HETF teams, significantly reduced complications such as infection, gastrostomy blockage, tube displacement, and feed intolerance but do not significantly reduce unplanned hospital encounters (outpatient clinic visits, hospitalizations, and emergency presentations). Owing to the high risk of bias in the included studies, there is low-quality evidence to support staff training, patient education, and dedicated HETF teams. CONCLUSION: This review highlights the need for further quality research to allow higher-level evidence for determining the usefulness of interventions aimed at improving outcomes for patients receiving HETF. Future research needs to include greater assessment of quality of life, quantification of the value of interventions in economic terms, and use of translational research frameworks. However, effective staff and patient education programs, along with comprehensive multidisciplinary care, should be considered standard care until a larger research base is developed.

VA/DoD clinical practice guideline for the management of headache

The VA and DoD Evidence-Based Practice Work Group (EBPWG) was established and first chartered in 2004, with a mission to advise the VA/DoD Health Executive Committee "on the use of clinical and epidemiological evidence to improve the health of the population . . ." across the Veterans Health Administration (VHA) and Defense Health Agency (DHA), by facilitating the development of CPGs for the VA and DoD populations. Development and update of VA/DoD CPGs is funded by VA Evidence Based Practice, Office of Quality and Patient Safety. The system-wide goal of evidencebased CPGs is to improve patient health and wellbeing. In July 2020, the VA and DoD published a CPG for The Primary Care Management of Headache (2020 VA/DoD Headache CPG), which was based on evidence reviewed through March 2019. Since the release of that CPG, the evidence base on Headache has expanded. Consequently, the EBPWG initiated the update of the 2020 VA/DoD Headache CPG in 2023. This updated CPG's use of Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach reflects a more rigorous application of the methodology than previous iterations.(2) Therefore, the strength of some recommendations may have been modified due to the confidence in the quality of the supporting evidence (see Evidence Quality and Recommendation Strength). This CPG provides an evidence-based framework for evaluating and managing care for individuals living with Headache toward improving clinical outcomes. Successful implementation of this CPG will: • Assess the patient's condition and collaborate with the patient, family, and caregivers to determine optimal management of patient care; • Emphasize the use of patient-centered care and shared decision making; • Minimize preventable complications and morbidity; and • Optimize individual health outcomes and quality of life (QoL).

A mixed methods evaluation of medication reconciliation in the primary care setting.

OBJECTIVES: To understand the extent to which behaviors consistent with high quality medication reconciliation occurred in primary care settings and explore barriers to high quality medication reconciliation. DESIGN: Fully mixed sequential equal status design including ethnographic observations, semi-structured interviews, and surveys. SETTING: Primary care practices within an integrated healthcare delivery system in the United States. PARTICIPANTS: We conducted 170 observations of patient encounters across 15 primary care clinics, 48 semi-structured interviews with staff, and 10 semi-structured interviews with patients. We also sent out surveys to 2,541 eligible staff with 616 responses (24% response rate) and to 5,132 eligible patients with 577 responses (11% response rate). RESULTS: Inconsistency emerged as a major barrier to effective medication reconciliation. This inconsistency was present across a variety of factors such as the lack of standardized workflows for conducting medication reconciliation, a lack of knowledge about medication and the process of medication reconciliation, varying levels of importance ascribed to medication reconciliation, and inadequate integration of medication reconciliation into clinical workflows. Findings were generally consistent across all data collection methods. CONCLUSION: We have identified several barriers which impact the process of medication reconciliation in primary care settings. Our key finding is that the process of medication reconciliation is plagued by inconsistencies which contribute to inaccurate medication lists. These inconsistencies can be broken down into several categories (standardization, knowledge, importance, and inadequate integration) which can be targets for future studies and interventions.

Midwives' perspectives on person-centred maternity care in public hospitals in South-east Nigeria: A mixed-method study.

BACKGROUND: Person-centred maternity care (PCMC) is acknowledged as essential for achieving improved quality of care during labour and childbirth. Yet, evidence of healthcare providers' perspectives of person-centred maternity care is scarce in Nigeria. This study, therefore, examined the perceptions of midwives on person-centred maternity care (PCMC) in Enugu State, South-east Nigeria. MATERIALS AND METHODS: This study was conducted in seven public hospitals in Enugu metropolis, Enugu State, South-east Nigeria. A mixed-methods design, involving a cross-sectional survey and focus group discussions (FGDs) was used. All midwives (n = 201) working in the maternity sections of the selected hospitals were sampled. Data were collected from February to May 2019 using a self-administered, validated PCMC questionnaire. A sub-set of midwives (n = 56), purposively selected using maximum variation sampling, participated in the FGDs (n = 7). Quantitative data were entered, cleaned, and analysed with SPSS version 20 using descriptive and bivariate statistics and multivariate regression. Statistical significance was set at alpha 0.05 level. Qualitative data were analysed thematically. RESULTS: The mean age of midwives was 41.8 years ±9.6 years. About 53% of midwives have worked for ≥10 years, while 60% are junior midwives. Overall, the prevalence of low, medium, and high PCMC among midwives were 26%, 49% and 25%. The mean PCMC score was 54.06 (10.99). High perception of PCMC subscales ranged from 6.5% (dignity and respect) to 19% (supportive care). Midwives' perceived PCMC was not significantly related to any socio-demographic characteristics. Respectful care, empathetic caregiving, prompt initiation of care, paying attention to women, psychosocial support, trust, and altruism enhanced PCMC. In contrast, verbal and physical abuses were common but normalised. Midwives' weakest components of autonomy and communication were low involvement of women in decision about their care and choice of birthing position. Supportive care was constrained by restrictive policy on birth companion, poor working conditions, and cost of childbirth care. CONCLUSION: PCMC is inadequate in public hospitals as seen from midwives' perspectives. Demographic characteristics of midwives do not seem to play a significant role in midwives' delivery of PCMC. The study identified areas where midwives must build competencies to deliver PCMC.

An exploration of potential output measures to assess efficiency and productivity for labour and birth in Australia.

BACKGROUND: In maternity services, as in other areas of healthcare, increasing emphasis is placed on improving "efficiency" or "productivity". The first step in any efficiency and productivity analysis is the selection of relevant input and output measures. Within healthcare quantifying what is produced (outputs) can be difficult. The aim of this paper is to identify a potential output measure, that can be used in an assessment of the efficiency and productivity of labour and birth in-hospital care in Australia and to assess the extent to which it reflects the principles of woman-centred care. METHODS: This paper will survey available perinatal and maternal datasets in Australia to identify potential output measures; map identified output variables against the principles of woman-centred care outlined in Australia's national maternity strategy; and based on this, create a preliminary composite outcome measure for use in assessing the efficiency and productivity of Australian maternity services. RESULTS: There are significant gaps in Australia's maternity data collections with regard to measuring how well a maternity service is performing against the values of respect, choice and access; however safety is well measured. Our proposed composite measure identified that of the 63,215 births in Queensland in 2014, 67% met the criteria of quality outlined in our composite measure. CONCLUSIONS: Adoption in Australia of the collection of woman-reported maternity outcomes would substantially strengthen Australia's national maternity data collections and provide a more holistic view of pregnancy and childbirth in Australia beyond traditional measure of maternal and neonate morbidity and mortality. Such measures to capture respect, choice and access could complement existing safety measures to inform the assessment of productivity and efficiency in maternity care.

Multidisciplinary aerodigestive program at a children's hospital: A protocol for a prospective observational study.

BACKGROUND: Children with complex chronic multisystemic diseases frequently require care from multiple pediatric subspecialists. The aerodigestive program is a multidisciplinary program that diagnoses and treats pediatric patients with complex multi-systematic problems affecting airway, breathing, feeding, swallowing, or growth. The aim of this study is to present the protocol of the aerodigestive program of a children's hospital. METHODS AND DESIGN: This study is a prospective study to evaluate and compare the overall improvement of patients' objective and subjective conditions before and after the AeroDigestive Team (ADT) program. Among children from 1 month to 18 years of age, patients with complex problems of the airway, breathing, feeding, swallowing, or growth meeting at least two parameters of the inclusion criteria were enrolled. The overall process included referral based on the inclusion criteria, enrollment of ADT program with informed consents, interview and questionnaire for assessing patients' medical condition, prescheduling appointment, multi-specialists' evaluation, monthly team meetings, wrap-up discussion with the patients and family, therapeutic intervention, and follow-up at 6 months with the assessment of outcome measures. The outcome was evaluated objectively and subjectively. The objective outcome measure was divided into surgical or medical intervention, assessment of changes in medical condition, and follow-up study. Both caregiver interviews and questionnaires using a scoring system were used as subjective outcome measures before and after the ADT program. Children were scheduled to be followed-up at 6 months after the interventions or ADT meeting. DISCUSSION: The aerodigestive program is expected to provide comprehensive and multidisciplinary management of children with complex airway and digestive tract disorders.

Aligning care with the personal values of patients with complex care needs.

OBJECTIVE: To identify opportunities to align care with the personal values of patients from three distinct groups with complex medical, behavioral, and social needs. DATA SOURCES/STUDY SETTING: Between June and August 2019, we conducted semi-structured interviews with individuals with complex care needs in two integrated health care delivery systems. STUDY DESIGN: Qualitative study using semi-structured interviews. DATA COLLECTION METHODS: We interviewed three groups of patients at Kaiser Permanente Washington and Kaiser Permanente Colorado representing three distinct profiles of complex care needs: Group A ("obesity, opioid prescription, and low-resourced neighborhood"), Group B ("older, high medical morbidity, emergency department, and hospital use"), and Group C ("older, mental and physical health concerns, and low-resourced neighborhood"). These profiles were identified based on prior work and prioritized by internal primary care stakeholders. Interview transcripts were analyzed using thematic analysis. PRINCIPAL FINDINGS: Twenty-four patients participated; eight from each complex needs profile. Mean age across groups was 71 (range 48-86) years. We identified five themes common across the three groups that captured patients' views regarding values-aligned care. These themes focused on the importance of care teams exploring and acknowledging a patient's values, providing access to nonphysician providers who have different perspectives on care delivery, offering values-aligned mental health care, ensuring connection to community-based resources that support values and address needs, and providing care that supports the patient plus their family and caregivers. CONCLUSIONS: Our results suggest several opportunities to improve how care is delivered to patients with different complex medical, behavioral, and social needs. Future research is needed to better understand how to incorporate these opportunities into health care.

Clinicians' Perspectives After Implementation of the Serious Illness Care Program: A Qualitative Study.

Importance: Discussions about goals of care with patients who are seriously ill typically occur infrequently and late in the illness trajectory, are of low quality, and focus narrowly on the patient's resuscitation preferences (ie, code status), risking provision of care that is inconsistent with patients' values. The Serious Illness Care Program (SICP) is a multifaceted communication intervention that builds capacity for clinicians to have earlier, more frequent, and more person-centered conversations. Objective: To explore clinicians' experiences with the SICP 1 year after implementation. Design, Setting, and Participants: This qualitative study was conducted at 2 tertiary care hospitals in Canada. The SICP was implemented at Hamilton General Hospital (Hamilton, Ontario) from March 1, 2017, to January 19, 2018, and at Foothills Medical Centre (Calgary, Alberta) from March 1, 2018, to December 31, 2020. A total of 45 clinicians were invited to participate in the study, and 23 clinicians (51.1%) were enrolled and interviewed. Semistructured interviews of clinicians were conducted between August 2018 and May 2019. Content analysis was used to evaluate information obtained from these interviews between May 2019 and May 2020. Exposures: The SICP includes clinician training, communication tools, and processes for system change. Main Outcomes and Measures: Clinicians' experiences with and perceptions of the SICP. Results: Among 23 clinicians interviewed, 15 (65.2%) were women. The mean (SD) number of years in practice was 14.6 (9.1) at the Hamilton site and 12.0 (6.9) at the Calgary site. Participants included 19 general internists, 3 nurse practitioners, and 1 social worker. The 3 main themes were the ways in which the SICP (1) supported changes in clinician behavior, (2) shifted the focus of goals-of-care conversations beyond discussion of code status, and (3) influenced clinicians personally and professionally. Changes in clinician behavior were supported by having a unit champion, interprofessional engagement, access to copies of the Serious Illness Conversation Guide, and documentation in the electronic medical record. Elements of the program, especially the Serious Illness Conversation Guide, shifted the focus of goals-of-care conversations beyond discussion of code status and influenced clinicians on personal and professional levels. Concerns with the program included finding time to have conversations, building transient relationships, and limiting conversation fluidity. Conclusions and Relevance: In this qualitative study, hospital clinicians described components of the SICP as supporting changes in their behavior and facilitating meaningful patient interactions that shifted the focus of goals-of-care conversations beyond discussion of code status. The perceived benefits of SICP implementation stimulated uptake within the medical units. These findings suggest that the SICP may prompt hospital culture changes in goals-of-care dialogue with patients and the care of hospitalized patients with serious illness.

Emerging models of care for individuals with multiple chronic conditions.

OBJECTIVE: To characterize emerging and current practice models to more effectively treat and support patients with multiple chronic conditions (MCC). DATA SOURCES/STUDY SETTING: We conducted a rapid literature scoping augmented by key informant interviews with clinicians knowledgeable about MCC care from a broad spectrum of US delivery systems and feedback from multidisciplinary experts at two virtual meetings. STUDY DESIGN: Literature findings were triangulated with data from semi-structured interviews with clinical experts. Reflections on early results were obtained from policy, research, clinical, advocacy, and patient representatives at two virtual meetings sponsored by the Agency for Healthcare Research and Quality. Emergent themes addressed were as follows: (1) more timely strategies for MCC care; and (2) trends not previously represented in the peer-reviewed literature. DATA COLLECTION/EXTRACTION METHODS: The rapid literature scoping relied on Ovid MEDLINE(R) and Epub Ahead of Print databases for the most recent 5-year period. Qualitative interviews were conducted by telephone. Virtual meetings provided oral and written (chat) captured inputs. PRINCIPAL FINDINGS: Although the literature scoping did not identify a specific set of evidence-based care models, key informant discussions identified eight themes reflecting emerging approaches to population-based MCC care. For example, addressing the needs of individuals with MCC through a complexity lens by assessing and addressing social risk factors; extending the care continuum with home-based care; understanding how to address ongoing patient and caregiver supports outside of clinical encounters; and engaging available community resources. CONCLUSIONS: Integrating care for MCC patient populations requires processes for determining different subpopulation needs in various settings and lived experiences. Innovation should be anchored at the nexus of payment systems, social risks, medical needs, and community-based resources. Our learnings suggest a need for an ongoing MCC care research agenda to inform new approaches to care delivery incorporating innovations in technology and home-based supports for patients and caregivers.

Evaluation of automated specialty palliative care in the intensive care unit: A retrospective cohort study.

INTRODUCTION: Automated specialty palliative care consultation (SPC) has been proposed as an intervention to improve patient-centered care in the intensive care unit (ICU). Existing automated SPC trigger criteria are designed to identify patients at highest risk of in-hospital death. We sought to evaluate common mortality-based SPC triggers and determine whether these triggers reflect actual use of SPC consultation. We additionally aimed to characterize the population of patients who receive SPC without meeting mortality-based triggers. METHODS: We conducted a retrospective cohort study of all adult ICU admissions from 2012-2017 at an academic medical center with five subspecialty ICUs to determine the sensitivity and specificity of the five most common SPC triggers for predicting receipt of SPC. Among ICU admissions receiving SPC, we assessed differences in patients who met any SPC trigger compared to those who met none. RESULTS: Of 48,744 eligible admissions, 1,965 (4.03%) received SPC; 979 (49.82%) of consultations met at least 1 trigger. The sensitivity and specificity for any trigger predicting SPC was 49.82% and 79.61%, respectively. Patients who met no triggers but received SPC were younger (62.71 years vs 66.58 years, mean difference (MD) 3.87 years (95% confidence interval (CI) 2.44-5.30) p<0.001), had longer ICU length of stay (11.43 days vs 8.42 days, MD -3.01 days (95% CI -4.30 --1.72) p<0.001), and had a lower rate of in-hospital death (48.68% vs 58.12%, p<0.001). CONCLUSION: Mortality-based triggers for specialty palliative care poorly reflect actual use of SPC in the ICU. Reliance on such triggers may unintentionally overlook an important population of patients with clinician-identified palliative care needs.

Barriers to Care and Root Cause Analysis of LGBTQ+ Patients' Experiences: A Qualitative Study.

BACKGROUND: LGBTQ+ (lesbian, gay, bisexual, transgender, queer/questioning, and others) people face a unique set of barriers to receiving quality healthcare. Very little exists in nursing literature that addresses these barriers. OBJECTIVE: This study aimed to analyze patient experience data to better understand the context of barriers to care that LGBTQ+ patients experience, in addition to institutional responses. METHODS: Documentary analysis was employed to review four LGBTQ+ patient experiences that resulted in formal feedback provided to the Office of Patient Relations. Each case was analyzed for content, process, and outcomes. RESULTS: Through the outlined analysis, the study team found three primary themes and five secondary themes across the four cases. The overarching themes identified through the study's case review include (a) lack of provider knowledge, (b) lack of patient-centered care, and (c) lack of institutional infrastructures associated with the provision of affirming care to LGBTQ+ individuals. DISCUSSION: Findings suggest the need for a multipronged approach when addressing the care of LGBTQ+ communities. A combination of provider-level education and institutional capacity building to treat diverse patient populations is necessary for addressing the issues demonstrated within the data. Moreover, further research is needed to identify unique needs of transgender and nonbinary patients and determine efficacy of institutional efforts to build capacity for caring and studying the health needs of LGBTQ+ communities.

Oncology Medical Home: ASCO and COA Standards.

PURPOSE: To provide Standards on the basis of evidence and expert consensus for a pilot of the Oncology Medical Home (OMH) certification program. The OMH model is a system of care delivery that features coordinated, efficient, accessible, and evidence-based care and includes a process for measurement of outcomes to facilitate continuous quality improvement. The OMH pilot is intended to inform further refinement of Standards for OMH model implementation. METHODS: An Expert Panel was formed, and a systematic review of the literature on the topics of OMH, clinical pathways, and survivorship care plans was performed using PubMed and Google Scholar. Using this evidence base and an informal consensus process, the Expert Panel developed a set of OMH Standards. Public comments were solicited and considered in preparation of the final manuscript. RESULTS: Three comparative peer-reviewed studies of OMH met the inclusion criteria. In addition, the results from 16 studies of clinical pathways and one systematic review of survivorship care plans informed the evidence review. Limitations of the evidence base included the small number of studies of OMH and lack of longer-term outcomes data. More data were available to inform the specific Standards for pathways and survivorship care; however, outcomes were mixed for the latter intervention. The Expert Panel concluded that in the future, practices should be encouraged to publish the results of OMH interventions in peer-reviewed journals to improve the evidence base. STANDARDS: Standards are provided for OMH in the areas of patient engagement, availability and access to care, evidence-based medicine, equitable and comprehensive team-based care, quality improvement, goals of care, palliative and end-of-life care discussions, and chemotherapy safety. Additional information, including a Standards implementation manual, is available at www.asco.org/standards.

Patient-Centered Education in Wound Management: Improving Outcomes and Adherence.

GENERAL PURPOSE: To educate wound care practitioners about methods of communication that can help promote patient adherence to wound healing recommendations. TARGET AUDIENCE: This continuing education activity is intended for physicians, physician assistants, nurse practitioners, and nurses with an interest in skin and wound care. LEARNING OBJECTIVES/OUTCOMES: After participating in this educational activity, the participant will:1. Distinguish the use of theoretical frameworks to promote patient adherence to prescribed wound healing recommendations.2. Synthesize the principles of motivational interviewing to best encourage patients to adhere to prescribed wound healing recommendations.3. Select the appropriate self-care strategies for patients who have nonhealing wounds.

Patients with chronic wounds make daily decisions that affect healing and treatment outcomes. Patient-centered education for effective self-management decreases episodes of care and reduces health expenditures while promoting independence. Theoretical frameworks, including the Health Belief Model, Theory of Planned Behavior, Social Cognitive Theory, and Transtheoretical Model of Behavior Change, can assist healthcare providers in identifying strategies that enhance adherence. These strategies include the use of motivational interviewing, a communication technique designed to elicit patients' perspectives regarding treatment goals, outcome expectations, anticipated barriers, and intentions to follow provider recommendations.

Using Patient-Reported Outcomes toAssess Healthcare Quality: Toward Better Measurement of Patient-Centered Care in Cardiovascular Disease.

Patient-reported outcomes (PROs) are elicited directly from patients so they can describe their overall health status, including their symptoms, function, and quality of life. While commonly used as end points in clinical trials, PROs can play an important role in routine clinical care, population health management, and as a means for quantifying the quality of patient care. In this review, we propose that PROs be used to improve patient-centered care in the treatment of cardiovascular diseases given their importance to patients and society and their ability to improve doctor- provider communication. Furthermore, given the current variability in patients' health status across different clinics and the fact that PROs can be improved by titrating therapy, we contend that PROs have a key opportunity to serve as measures of healthcare quality.

Rare use of patient-reported outcomes in childhood cancer clinical trials - a systematic review of clinical trial registries.

BACKGROUND: Patient-reported outcomes (PROs) are the gold standard to assess the patients' subjective health status. While both the Food and Drug Administration and European Medicines Agency recommend the use of PROs as end-points in paediatric clinical trials to support claims for medical product labelling, it is not known how often PROs are actually used. The aim of this study was to assess the usage of PRO instruments in childhood cancer clinical trials investigating anti-cancer medication. METHODS: In June 2020 ClinicalTrials and EudraCT were systematically searched for all trials including children and adolescents (≤21 years) with cancer registered between 2007 and 2020. The use of PRO measures and trials characteristics were analysed. To investigate which trial characteristics are associated with the use of PROs, a binary logistic regression was calculated. RESULTS: Of 4789 identified trials, 711 were included. The most frequent reason for exclusion was age limitation (age >21 years). Of all included trials, only 8.2% used PROs as end-points; .6% as the primary end-point. The most commonly used questionnaire was the PedsQL™ (32.8%), followed by the Patient-Reported Outcomes Measurement Information System scales (12.1%). No association was observed between the use of PROs and trial region, number of centres, trial phase, time period or intervention type (all p > .05). The use of PROs did not substantially increase over time. Only 20.3% of the closed studies had published their results. CONCLUSION: Despite recommendations of regulatory agencies, PRO assessment is extremely rare in paediatric oncology clinical trials. More efforts should be undertaken to facilitate implementation of PRO in paediatric trials to guarantee patient-centred research and treatments.