International Consortium For Health Outcomes Measurement Research Articles

Development of an International Standard Set of Outcomes and Measurement Methods for Routine Practice for Adults with Epilepsy: The International Consortium for Health Outcomes Measurement Consensus Recommendations.

At present, there is no internationally accepted set of core outcomes or measurement methods for epilepsy clinical practice. Therefore, the International Consortium for Health Outcomes Measurement (ICHOM) convened an international working group of experts in epilepsy, people with epilepsy and their representatives to develop minimum sets of standardized outcomes and outcomes measurement methods for clinical practice that support patient-clinician decision-making and quality improvement. Consensus methods identified 20 core outcomes. Measurement tools were recommended based on their evidence of strong clinical measurement properties, feasibility, and cross-cultural applicability. The essential outcomes included many non-seizure outcomes: anxiety, depression, suicidality, memory and attention, sleep quality, functional status, and the social impact of epilepsy. The proposed set will facilitate the implementation of the use of patient-centered outcomes in daily practice, ensuring holistic care. They also encourage harmonization of outcome measurement, and if widely implemented should reduce the heterogeneity of outcome measurement, accelerate comparative research, and facilitate quality improvement efforts.

An International, Multidisciplinary Consensus Set of Patient-Centered Outcome Measures for Substance-Related and Addictive Disorders.

Background: In 1990, the United States' Institute of Medicine promoted the principles of outcomes monitoring in the alcohol and other drugs treatment field to improve the evidence synthesis and quality of research. While various national outcome measures have been developed and employed, no global consensus on standard measurement has been agreed for addiction. It is thus timely to build an international consensus. Convened by the International Consortium for Health Outcomes Measurement (ICHOM), an international, multi-disciplinary working group reviewed the existing literature and reached consensus for a globally applicable minimum set of outcome measures for people who seek treatment for addiction. Methods: To this end, 26 addiction experts from 11 countries and 5 continents, including people with lived experience (n = 5; 19%), convened over 16 months (December 2018-March 2020) to develop recommendations for a minimum set of outcome measures. A structured, consensus-building, modified Delphi process was employed. Evidence-based proposals for the minimum set of measures were generated and discussed across eight videoconferences and in a subsequent structured online consultation. The resulting set was reviewed by 123 professionals and 34 people with lived experience internationally. Results: The final consensus-based recommendation includes alcohol, substance, and tobacco use disorders, as well as gambling and gaming disorders in people aged 12 years and older. Recommended outcome domains are frequency and quantity of addictive disorders, symptom burden, health-related quality of life, global functioning, psychosocial functioning, and overall physical and mental health and wellbeing. Standard case-mix (moderator) variables and measurement time points are also recommended. Conclusions: Use of consistent and meaningful outcome measurement facilitates carer-patient relations, shared decision-making, service improvement, benchmarking, and evidence synthesis for the evaluation of addiction treatment services and the dissemination of best practices. The consensus set of recommended outcomes is freely available for adoption in healthcare settings globally.

Translation and cross-cultural adaptation of seventeen widely-used assessment instruments for child and adolescent mental health in Greece

BackgroundIn the context of Greece, many instruments measuring constructs pertinent to child and adolescent mental health lacked a locally-validated, freely-available version. As part of a nationwide survey, we translated and cross-culturally adapted a collection of seventeen brief, largely-employed assessment tools that can be used at scale.MethodsThis study is part of the Child and Adolescent Mental Health Initiative in Greece (CAMHI), a capacity-building program focusing on enhancing mental health care for children and adolescents living in Greece. We conducted a nationwide survey assessing mental health symptoms, parenting practices, service availability and quality, mental health literacy and stigma, and professional practices within the country. As part of this process, we selected outcomes and instruments after consulting the International Consortium for Health Outcomes Measurement (ICHOM) and the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN). From our selection, we identified 17 instruments that did not have a Greek-validated version available for use. These instruments were translated and cross-culturally adapted following a structured procedure, including independent back-and-forth translations, synthesis of versions, expert revision, and pilot testing. Some instruments were slightly modified to meet CAMHI survey purposes.ResultsA cross-culturally adapted version in Greek was made available for the following instruments: Pediatric Symptoms Checklist (PSC); Deliberate Self Harm Inventory (DSH) (modified); Child and Adolescent Trauma Screen-2 (CATS-2); ABCD Screen Use (modified); Swanson, Nolan, and Pelham-IV (SNAP-IV); Parent Behavior Inventory (PBI); Mental Health Literacy Scale (MHLS)—(modified); Australian Mental Health Vignettes; Reported and Intended Behavior Scale (RIBS); Barriers to Access to Care (BACE) (modified); Experience of Service Questionnaire (ESQ) (modified); and Multitheoretical List of Therapeutic Interventions (MULTI-30) (modified).ConclusionA collection of these widely-used assessment tools is now adapted for the local context and freely accessible at [https://osf.io/crz6h/]. Researchers and health professionals in Greece can utilize this resource to screen, evaluate, and monitor various constructs related to mental health in accordance with the most effective practices.

Protocol for the development of a Core Outcome Set (COS) for Adolescents and Young Adults (AYAs) with cancer

BackgroundAdolescents and young adults (AYAs) with cancer, defined as individuals aged 15–39 years at initial cancer diagnosis, form a unique population; they face age-specific issues as they transition to adulthood. This paper presents the protocol for the development of a core outcome set (COS) for AYAs with cancer.MethodsThe methodological standards from the Core Outcome Measures in Effectiveness Trials (COMET) and the International Consortium for Health Outcomes Measurement (ICHOM) for COS development will guide the development of the COS for AYAs with cancer. The project will consist of the following phases: (1) define the scope of the COS; (2) establish the need for a COS in this field (3) assemble an international, multi-stakeholder working group; (4) develop a detailed protocol; (5) determine “what to measure” (i.e., outcomes); (6) determine “how to measure” (i.e., measures); and (7) determine “case-mix” variables.ConclusionsThe development of a COS for AYAs with cancer will facilitate the implementation of efficient and relevant standards for data collection, both for clinical trials and in routine healthcare, thereby increasing the usefulness of these data to improve the value of the care given to these underserved young cancer patients.

Healthcare use and direct medical costs in a cleft lip and palate population: an analysis of observed and protocolized care and costs

This study was performed to describe observed healthcare utilization and medical costs for patients with a cleft, compare these costs to the expected costs based on the treatment protocol, and explore the additional costs of implementing the International Consortium for Health Outcomes Measurement (ICHOM) Standard Set for Cleft Lip and Palate (CL/P). Forty patients with unilateral CL/P between 0 and 24 years of age, treated between 2012 and 2019 at Erasmus University Medical Center, were included. Healthcare services (consultations, diagnostic and surgical procedures) were counted and costs were calculated. Expected costs based on the treatment protocol were calculated by multiplying healthcare products by the product prices. Correspondingly, the additional expected costs after implementing the ICHOM Standard Set (protocol + ICHOM) were calculated. Observed costs were compared with protocol costs, and the additional expected protocol + ICHOM costs were described. The total mean costs were highest in the first year after birth (€5596), mainly due to surgeries. The mean observed total costs (€40,859) for the complete treatment (0–24 years) were 1.6 times the expected protocol costs (€25,198) due to optional, non-protocolized procedures. Hospital admissions including surgery were the main cost drivers, accounting for 42% of observed costs and 70% of expected protocol costs. Implementing the ICHOM Standard Set increased protocol-based costs by 7%.

Translation and cross-cultural adaptation of the ICHOM standard set for stroke: the Dutch version.

The International Consortium for Health Outcomes Measurement (ICHOM) developed a standard set of patient-centered outcome measures for use in stroke patients. In addition to the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health, it is comprised of 25 questions that are not part of a specific questionnaire. This study aimed to translate these 25 single questions into Dutch. Two native Dutch-speaking translators independently translated the original ICHOM questions into Dutch. A consensus translation was made by these translators and a third person. This translation was subsequently translated back to English independently by two native English-speaking translators. Afterwards a pre-final version was made by consensus of a committee. After field-testing among 30 stroke patients, a final version was made. The forward and backward translations led to eight cross-cultural adaptations. Based on the interviews with stroke patients, 12 questions were changed to enhance comprehensibility leading to a final Dutch translation of the 25 single questions. A Dutch translation of the 25 single questions of the ICHOM Standard Set for Stroke was developed. Now a complete ICHOM Standard Set for Stroke can be used in Dutch populations allowing comparison and improvement of stroke care.

Long-Term Observation of Patients With Cancer - an Entity-Independent Registry for Healthcare and Translational Research at the University Medicine Dresden (Cancer-Reg-VT).

Translational research is important, especially in medicine where decisions affect people's lives. Clinical registries and the studies embedded in them allow the depiction of actual care practice under routine conditions. Translating the findings of health services research back into clinical research through prospective cohort studies has the potential to drive medical innovations faster, more effectively and, above all, in a more targeted manner. These must therefore be a central component of cutting-edge oncological research. The aim of the registry is the establishment of clinical cohorts and the provision of a comprehensive, high-quality data set for oncological diseases. The registry will prospectively record all patients treated for cancer at Dresden University Hospital (UKD). In addition to the data from the hospital information systems (ORBIS, TDS, GEPADO, etc.), monitoring of health-related quality of life (HRQOL) is to be carried out at regular intervals at the beginning and during the course of treatment. In addition, individual linkage with data from clinical cancer registries and health insurance companies (including AOK PLUS) is planned for a period of five years before and after inclusion. All these data will be merged in a registry database. The selection of variables and measurement time points is closely based on the guidelines for colorectal carcinoma of the international initiative ICHOM (International Consortium for Health Outcomes Measurement). The study management software (STeVe) separates personal identification characteristics (IDAT) and medical data (MDAT) at an early stage. The independent trust centre of the TU Dresden (Treuhandstelle) ensures that no personal data enter the registry database. It is thereby also ensured that the data owners involved (UKD, biobank, health insurance company, cancer registry, patient) only receive the personal data they need for allocation. The MOSAIC software tools recommended by the TMF (Technologie- und Methodenplattform für die vernetzte medizinische Forschung e.V.) are used to manage the pseudonyms. With the registry, previously missing evidence on the effectiveness, safety and costs of diagnostic and therapeutic measures can be made, taking into account long-term and patient-reported outcomes of routine care. The data potentially allow for the identification of barriers to and facilitators of innovative promising cancer diagnostics and therapies. They also enable generation of scientifically relevant hypotheses in the field of translational and outcomes research.

Introducing standard patient-reported measures (PRMs) into routine maternity care: A pre-implementation qualitative study on women’s perspectives in Finland

BackgroundSystematically using standard patient-reported measures (PRMs) in clinical routines is trending. The International Consortium for Health Outcomes Measurement (ICHOM) has developed condition-specific standard sets of patient-centred measures, one of which is the Pregnancy and Childbirth Standard (PCB) set, where standard PRMs are included. There is limited knowledge on the use of ICHOM PCB set-included PRMs (ICHOM-PCB-PRMs) in routine care. This study investigates women’s perspectives on the future implementation of standard ICHOM-PCB-PRMs in routine maternity care in Finland.MethodsSemi-structured interviews were conducted. Pregnant and postpartum women were asked to evaluate each ICHOM-PCB-PRM in several dimensions, e.g., importance and quality of questions, and to provide their views on future implementation in terms of benefits, difficulties, and practices. With the predefined topics and themes, deductive analysis was applied. Ethical committee approval (HUS 220/880/2015) and research permissions were obtained.Results22 women participated. Participants felt that most of the ICHOM-PCB-PRMs were important, relevant, understandable, and appropriately designed, and agreed that some changes in ICHOM-PCB-PRMs were needed, e.g., adding other important measures, changing the wording, and adding open-ended questions. Women would be hesitant to answer questions honestly if follow-up actions were unclear. Most “outcome” measures could be asked repeatedly as maternal health status changes over time, and “experience” measures could be asked separately for different service providers. Disagreements regarding data collection at birth were observed. PRMs were regarded as a way for women to express their thoughts and feelings. Our participants were concerned about the possible consequences of negatively answering the PREMs questions and the availability of follow-up care. Participants expected that they could answer short and easy questions digitally before appointments, and that instructions and follow-up actions based on their answers should be available.ConclusionICHOM-PCB-PRMs could be applicable in Finnish maternity care, but some modifications may be required. Careful consideration is needed regarding how and when PRMs questions are asked for eliciting more accurate and honest answers and minimizing women feeling judged, embarrassed, or offended. Follow-ups should be available according to women’s responses and needs. This study provides insights on the adoption and implementation of standard PRMs in routine maternity care.

Use of patient-reported outcome measures in patients with venous thromboembolism: communication from the ISTH SSC Subcommittee on Predictive and Diagnostic Variables in Thrombotic Disease

Patient-reported outcome measures (PROMs) are patient-completed instruments that capture patient-perceived health status and well-being. PROMs measure disease impact and outcomes of care as reported by those who experience the disease. After pulmonary embolism or deep vein thrombosis, patients may face a broad spectrum of complications and long-term sequelae beyond the usual quality-of-care indicators of recurrent venous thromboembolism (VTE), bleeding complications, and survival. The full impact of VTE on individual patients can only be captured by assessing all relevant health outcomes from the patient’s perspective in addition to the traditionally recognized complications. Defining and measuring all important outcomes will help facilitate treatment tailored to the needs and preferences of patients and may improve health outcomes. The International Society on Thrombosis and Haemostasis Scientific and Standardization Committee Subcommittee on Predictive and Diagnostic Variables in Thrombotic Disease endorsed the International Consortium for Health Outcomes Measurement (ICHOM) VTE project on development of a standardized set of patient-centered outcome measures for patients with VTE. In this communication, the course and result of the project are summarized, and based on these findings, we propose recommendations for the use of PROMs during clinical follow-up of patients with VTE. We describe challenges to implementation of PROMs and explore barriers and enablers.

The importance of communication and involvement in decision-making: A study in Ireland exploring birth satisfaction using the Birth Satisfaction Scale-Revised (BSS-R).

Evaluation in healthcare services has become a priority, globally1. The Government of Ireland has highlighted the importance of stakeholder engagement to identify the needs of women in the design and delivery of high-quality health services, driven by necessity rather than financial ability2. The Birth Satisfaction Scale-Revised (BSS-R), an internationally validated tool, and recommended for measuring childbirth satisfaction by the International Consortium for Health Outcomes Measurement (ICHOM)3; however, it has yet to be considered in the Irish context. The aim of the study was to explore birth satisfaction with a sample of new mothers in Ireland. A mixed-methods study was conducted including a survey that involved collection of data from the BSS-R 10-item questionnaire from 307 mothers over an 8-week period in 2019, in one urban maternity hospital in Ireland. Quantitative and qualitative data were collected. Qualitative data from the free-text comments of the survey questions were analyzed using content analysis. Overall, women reported positive relationships with their care providers and were satisfied with the communication and support they received, as well as high levels of control and choice. Postnatal care, however, was highlighted as being less satisfactory with staffing levels described as inadequate. Understanding women's birth experiences and what is important to them could facilitate midwives and other health professionals to improve the quality of their care and develop guidelines and policies that focus on women and their families' needs. The vast majority of women rated their birthing experience as extremely positive. The main elements of care that contributed to a positive birthing experience for women were quality relationships with clinicians, choice and control, and emotional safety.

The Development, Deployment, and Evaluation of the CLEFT-Q Computerized Adaptive Test: A Multimethods Approach Contributing to Personalized, Person-Centered Health Assessments in Plastic Surgery.

Routine use of patient-reported outcome measures (PROMs) and computerized adaptive tests (CATs) may improve care in a range of surgical conditions. However, most available CATs are neither condition-specific nor coproduced with patients and lack clinically relevant score interpretation. Recently, a PROM called the CLEFT-Q has been developed for use in the treatment of cleft lip or palate (CL/P), but the assessment burden may be limiting its uptake into clinical practice. We aimed to develop a CAT for the CLEFT-Q, which could facilitate the uptake of the CLEFT-Q PROM internationally. We aimed to conduct this work with a novel patient-centered approach and make source code available as an open-source framework for CAT development in other surgical conditions. CATs were developed with the Rasch measurement theory, using full-length CLEFT-Q responses collected during the CLEFT-Q field test (this included 2434 patients across 12 countries). These algorithms were validated in Monte Carlo simulations involving full-length CLEFT-Q responses collected from 536 patients. In these simulations, the CAT algorithms approximated full-length CLEFT-Q scores iteratively, using progressively fewer items from the full-length PROM. Agreement between full-length CLEFT-Q score and CAT score at different assessment lengths was measured using the Pearson correlation coefficient, root-mean-square error (RMSE), and 95% limits of agreement. CAT settings, including the number of items to be included in the final assessments, were determined in a multistakeholder workshop that included patients and health care professionals. A user interface was developed for the platform, and it was prospectively piloted in the United Kingdom and the Netherlands. Interviews were conducted with 6 patients and 4 clinicians to explore end-user experience. The length of all 8 CLEFT-Q scales in the International Consortium for Health Outcomes Measurement (ICHOM) Standard Set combined was reduced from 76 to 59 items, and at this length, CAT assessments reproduced full-length CLEFT-Q scores accurately (with correlations between full-length CLEFT-Q score and CAT score exceeding 0.97, and the RMSE ranging from 2 to 5 out of 100). Workshop stakeholders considered this the optimal balance between accuracy and assessment burden. The platform was perceived to improve clinical communication and facilitate shared decision-making. Our platform is likely to facilitate routine CLEFT-Q uptake, and this may have a positive impact on clinical care. Our free source code enables other researchers to rapidly and economically reproduce this work for other PROMs.

P221 Validity of the Self-administered Comorbidity Questionnaire in patients with Inflammatory Bowel Disease

Abstract Background The International Consortium for Health Outcomes Measurement (ICHOM) has defined a standard set of outcome measures for inflammatory bowel disease (IBD) to capture effectiveness of care delivery processes by systematic collection of outcomes. However, several case-mix variables can confound the outcome measures and should be adjusted for before interpreting and comparing outcomes. To account for the impact of comorbidities, the self-assessed comorbidity questionnaire (SCQ), containing 36 questions on presence, treatment and limitation of thirteen diseases, was selected by ICHOM. As the SCQ has been validated for other diseases, but not for IBD, we aimed to assess the validity of the SCQ for measuring comorbidities in a population of IBD patients. Methods Data in this study was extracted from a prospective study evaluating quality of care of IBD patients treated with a biologic or new small molecule. We assessed criterion validity by comparing patient-reported and clinician-reported presence (as noted in the electronic health record) of the thirteen diseases of the SCQ using Cohen’s kappa. Construct validity was assessed by evaluating the Spearman correlation coefficient between the SCQ and the Charlson Comorbidity Index (CCI), clinician-reported SCQ, quality of life (EQ-5D-5L), IBD-related healthcare and productivity costs and prevalence of disability. We assessed responsiveness by measuring the correlation between changes in the SCQ and changes in healthcare costs, productivity costs and quality of life after 15 months. Results A total of 642 patients were included. Median age was 49, 56% were female and 60% had Crohn’s disease. Median SCQ at baseline was 1.75 (IQR: 0.01 – 4.00) and increased to 2 (IQR: 0.26-4.00) after 15 months of follow-up. Fair agreement was found for most comorbidities, but agreement was poor for back pain, arthritis, blood diseases, stomach diseases, kidney diseases and depression (Table 1). Significant correlations were found between the SCQ and CCI, clinician-reported SCQ, quality of life, prevalence of disability and productivity costs, but not with healthcare costs (Table 2). A change in the SCQ after 15 months was negatively correlated with a change in quality of life, but not with a change in healthcare or productivity costs. Conclusion The SCQ seems a useful tool to adjust for case-mix for health-related quality of life in IBD patients, but does not relate to IBD-attributable healthcare or productivity costs. The SCQ does not always agree with the electronic health record, which may be due to inadequate capture of comorbidities in the electronic health record or because patients may confuse comorbidities and complications of IBD.

Patient Perspectives on Value Dimensions of Lung Cancer Care: Cross-sectional Web-Based Survey.

While the lung cancer (LC) treatment landscape has rapidly evolved in recent years, easing symptom burden and treatment side effects remain central considerations in disease control. The aim of this study was to assess the relative importance of dimensions of LC care to patients, and to explore the disease burden, including socioeconomic aspects not commonly covered in patient-reported outcomes instruments. A questionnaire was sent to patients with LC and their caregivers to rate the value of a diverse set of quality of life dimensions in care, to evaluate communication between health care professionals (HCPs) and patients, and to explore the economic impact on respondents. The survey included questions on the dimensions of care covered by patient-reported outcomes instruments for quality-of-life evaluation (Functional Assessment of Cancer Therapy-Lung scale, EQ-5D, the European Organization for Research and Treatment of Cancer's Core Quality of Life questionnaire, and the European Organization for Research and Treatment of Cancer's Core Quality of Life in lung cancer 13-item questionnaire), as well as the International Consortium for Health Outcomes Measurement (ICHOM) standard set of patient-centered outcomes for LC. The survey respondents were participants on Carenity's patient community platform, living either in France, the United Kingdom, Germany, Italy, or Spain. The survey included 150 respondents (115 patients and 35 caregivers). "Physical well-being" and "end-of-life care" (median scores of 9.6, IQR 7.7-10, and 9.7, IQR 8.0-10, on a 10-point scale) were rated highest among the different value dimensions assessed. "Physical well-being and functioning" was the dimension most frequently discussed with health care professionals (82/150, 55%), while only (17/100, 17%) reported discussing "end-of-life care." After diagnosis, 43% (49/112) of patients younger than 65 years stopped working. Among respondents who indicated their monthly household income before and after diagnosis, 55% (38/69) reported a loss of income. Our results showed the relevance of a broad range of aspects of care for the quality of life of patients with LC. End-of-life care was the dimension of care rated highest by patients with LC, irrespective of stage at diagnosis; however, this aspect is least frequently discussed with HCPs. The results also highlight the considerable socioeconomic impact of the disease, despite insurance coverage of direct costs.

International development of a patient-centered core outcome set for assessing health-related quality of life in metastatic breast cancer patients

PurposeFor patients living with metastatic breast cancer (MBC), achieving best possible health-related quality of life, along with maximizing survival, is vital. Yet, we have no systemic way to determine if we achieve these goals. A Core Outcome Set (COS) that allows standardized measurement of outcomes important to patients, but also promotes discussing these outcomes during clinical encounters, is long overdue.MethodsAn international expert group (EG) of patient advocates, researchers, medical specialists, nurse specialists, and pharmaceutical industry representatives (n = 17) reviewed a list of relevant outcomes retrieved from the literature. A broader group (n = 141: patients/patient advocates (n = 45), health care professionals/researchers (n = 64), pharmaceutical industry representatives (n = 28), and health authority representatives (n = 4)) participated in a modified Delphi procedure, scoring the relevance of outcomes in two survey rounds. The EG finalized the COS in a consensus meeting.ResultsThe final MBC COS includes 101 variables about: (1) health-related quality of life (HRQoL, n = 26) and adverse events (n = 24); (2) baseline patient characteristics (n = 9); and (3) clinical variables (n = 42). Many outcome that cover aspects of HRQoL relevant to MBC patients are included, e.g. daily functioning (including ability to work), psychosocial/emotional functioning, sexual functioning, and relationship with the medical team.ConclusionThe COS developed in this study contains important administrative data, clinical records, and clinician-reported measures that captures the impact of cancer. The COS is important for standardization of clinical research and implementation in daily practice and has received accreditation by the International Consortium for Health Outcomes Measurement (ICHOM).

Balancing adaptability and standardisation: insights from 27 routinely implemented ICHOM standard sets

BackgroundHealthcare systems around the world experience increasing pressure to control future growth of healthcare expenditures. Among other initiatives, quality and value-based benchmarking has become an important field to inform clinical evaluation and reimbursement questions. The International Consortium for Health Outcomes Measurement (ICHOM) has become one of the driving forces to translate scientific evidence into standardized assessments that are routinely applicable in day-to-day care settings. These aim to provide a benchmarking tool that allows the comparison and competition of health care delivery on the basis of value-based health care principles.MethodsThis work focuses on the consolidation of the ICHOM methodology and presents insights from 27 routinely implemented Standard Sets. The analysis is based on a literature review of the ICHOM literature repository, a process document review and key informant interviews with ICHOM’s outcomes research and development team.ResultsKey findings are that the scope of ICHOM Standard Sets shifted from a more static focus on burden of disease and poorly standardized care pathways to a more dynamic approach that also takes into account questions about the setting of care, feasibility of implementing a benchmarking tool and compatibility of different Standard Sets. Although certain overlaps exist with other initiatives in the field of patient reported outcomes (PRO), their scopes differ significantly and they hence rather complement each other. ICHOM pursues a pragmatic approach to enable the benchmarking and the analysis of healthcare delivery following the principles of value-based healthcare.ConclusionThe ICHOM Standard Sets complement other initiatives in the field of patient-reported outcomes (PRO) and functional reporting by placing a particular focus on healthcare delivery, while other initiatives primarily focus on evaluation of academic endpoints. Although ICHOM promotes a pragmatic approach towards developing and devising its Standard Sets, the definition of standardized decision making processes emerged as one of the key challenges. Furthermore, the consolidation of core metrics across number of disease areas to enable the parallel implementation of different Standard Sets in the same care setting is an important goal that will enable the widespread implementation of patient-reported outcome measures (PROM).

10.3 Achieving Meaningful Health Outcome Measurement in Pediatric Care: Are Our Tools Fit for a Purpose?

Standard measurement sets are increasingly being developed and implemented to facilitate routine outcome monitoring and value-based clinical care. The International Consortium for Health Outcomes Measurement (ICHOM) recently developed a standard set to benchmark overall pediatric health outcomes in routine care, which includes measures of foundational aspects of child and youth mental health and functioning. The aim of this study was to determine if these measures have sufficient measurement property evidence to be recommended for implementation.

Development of an updated, standardized, patient-centered outcome set for lung cancer

BackgroundIn 2016, the International Consortium for Health Outcomes Measurement (ICHOM) defined an international consensus recommendation of the most important outcomes for lung cancer patients. The European Health Outcomes Observatory (H2O) initiative aimed to develop an updated patient-centered core outcome set (COS) for lung cancer, to capture the patient perspective of the impact of lung cancer and (novel) treatments using a combination of patient-reported outcome (PRO) instruments and clinical data as a means to drive value-based health-care. Material and methodsAn international, expert team of patient representatives, multidisciplinary healthcare professionals, academic researchers and pharmaceutical industry representatives (n = 17) reviewed potential outcomes generated through literature review. A broader group of patients/patient representatives (n = 31), healthcare professionals / academic researchers (n = 83), pharmaceutical industry representatives (n = 26), and health authority representatives (n = 6) participated in a Delphi study. In two survey rounds, participants scored the relevance of outcomes from a preliminary list. The threshold for consensus was defined as ≥ 70 % of participants scoring an outcome as ‘highly relevant’. In concluding consensus-meeting rounds, the expert multidisciplinary team finalized the COS. ResultsThe preliminary list defined by the core group consisted of 102 outcomes and was prioritized in the Delphi procedure to 64. The final lung cancer COS includes: 1) case-mix factors (n = 27); 2) PROs related to health-related quality of life (HRQoL) (n = 25); 3) clinical outcomes (n = 12). Patient-reported symptoms beyond domains included in the ICHOM lung cancer set in 2016 were insomnia, nausea, vomiting, anxiety, depression, lack of appetite, gastric problems, constipation, diarrhoea, dysphagia, and haemoptysis. ConclusionsWe will implement the lung cancer COS in Europe within the H2O initiative by collecting the outcomes through a combination of clinician-reported measures and PRO measures. The COS will support the adoption and reporting of lung cancer measures in a standardized way across Europe and empower patients with lung cancer to better manage their health care.

Standardized Outcome Measures for Preterm and Hospitalized Neonates: An ICHOM Standard Set

Introduction: Approximately, one in ten infants is born preterm or requires hospitalization at birth. These complications at birth have long-term consequences that can extend into childhood and adulthood. Timely detection of developmental delay through surveillance could enable tailored support for these babies and their families. However, the possibilities for follow-up are limited, especially in middle- and low-income countries, and the tools to do so are either not available or too expensive. A standardized and core set of outcomes for neonates, with feasible tools for evaluation and follow-up, could result in improving quality, enhance shared decision-making, and enable global benchmarking. Methods: The International Consortium for Health Outcomes Measurement (ICHOM) convened an international working group, which was comprised of 14 health-care professionals (HCP) and 6 patient representatives in the field of neonatal care. An outcome set was developed using a three-round modified Delphi process, and it was endorsed through a patient representative-validation survey and an HCP survey. Results: A literature review revealed 1,076 articles and 26 registries which were screened for meaningful outcomes, patient-reported outcome measures, clinical measures, and case mix variables. This resulted in a neonatal set with 21 core outcomes covering three domains (physical, social, and mental functioning) and 14 tools to assess these outcomes at three timepoints. Discussion: This set can be implemented globally and it will allow comparison of outcomes across different settings and countries. The transparent consensus-driven development process which involved stakeholders and professionals from all over the world ensures global relevance.

User-centered design and agile development of a novel mobile health application and clinician dashboard to support the collection and reporting of patient-reported outcomes for breast cancer care

ObjectivesThere is a need for advancements in health information technology that will transform how patient-reported outcomes (PRO) data are collected, reported, and used in breast cancer care. The objective of...

Bridging health technology assessment and healthcare quality improvement using international consortium of health outcomes measurement standard sets.

Although health technology assessment (HTA) and healthcare quality improvement are distinct processes, a greater level of alignment in outcome measures used may increase the quality and efficiency of data collection. This study evaluates the agreement in outcome measures used in oncology for healthcare quality improvement and HTAs, and how these align to the International Consortium for Health Outcomes Measurement (ICHOM) standard sets. We conducted a cross-sectional comparative analysis of ICHOM sets focusing on oncological indications and publicly available measures for healthcare quality and HTA reports published by the National Health Care Institute from the Netherlands and the National Institute for Health and Care Excellence from the United Kingdom. All ICHOM sets and HTAs used overall survival, whereas quality improvement used different survival estimates. Different progression estimates for cancer were used in HTAs, ICHOM sets, and quality improvement. Data on health-related quality of life (HRQoL) was recommended in all ICHOM sets and all HTAs, but selectively for quality improvement. In HTAs, generic HRQoL questionnaires were preferred, whereas, in quality improvement and ICHOM sets, disease-specific questionnaires were recommended. Unfavorable outcomes were included in all HTAs and all ICHOM sets, but not always for quality improvement. Although HTA and quality improvement use outcome measures from the same domains, a greater level of alignment seems possible. ICHOM may provide input on standardized outcome measures to support this alignment. However, residual discrepancies will remain due to the different objectives of HTA and quality improvement.