Standard Set Of Outcome Measures Research Articles

CHARACTERIZATION OF BASELINE SYMPTOMS AND FUNCTIONAL IMPAIRMENTS IN A LARGE COHORT OF OUTPATIENTS ATTENDING A LONG COVID REHABILITATION CLINIC IN THE UNITED KINGDOM.

In response to the high prevalence and morbidity associated with long COVID (LC), outpatient rehabilitation programmes were created across jurisdictions. We aimed to characterize baseline symptoms and impairments of patients attending outpatient LC rehabilitation. This study was a retrospective quality-improvement analysis. Patients attending outpatient LC rehabilitation at the Oxfordshire Post-Covid Service. Data included age/sex and 6 questionnaires performed at baseline: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Dyspnoea-12 (D12), Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder Assessment-7 (GAD-7), Visual Analogue Scale (VAS) of self-rated health, and the Work And Social Adjustment Scale (WSAS). All scores were dichotomized (indicating presence/absence of clinically significant pathology). Potential differences between age (</≥ 50 years) and sex were assessed using χ2 tests. A total of 422 patients were included (mean/standard deviation [SD] age = 47.1/13.2;132/31.3% male). A total of 76% had significant fatigue (FACIT-F), 69% had breathlessness (D12), 55% had depression (PHQ-9), 34% had anxiety (GAD-7), 41% self-reported poor health (VAS), and 57% had work/social life dysfunction (WSAS). D12 scores differed between age groups (older > younger, χ2 = 3.19/p = 0.048), with no differences observed on other scales. In this preliminary study, a high proportion of LC outpatients had significant impairments across domains. The findings of this study reaffirm the need for high-quality, multidisciplinary LC rehabilitation, and may be used to help build a standardized set of outcome measures moving forward.

Sarcopenia interventions in long-term care facilities targeting sedentary behaviour and physical inactivity: A systematic review.

Sedentary behaviour and physical inactivity are independent risk factors for sarcopenia for long-term care facility residents. Understanding the components, mechanisms and context of interventions that target change in these risk factors can help optimize sarcopenia management approaches. This study aimed to identify, appraise and synthesize the interventions targeting sedentary behaviour and physical inactivity, construct a Theory of Change logic model, inform complex sarcopenia intervention development and identify areas for improvement. Eight electronic databases, including Embase and Web of Science, were searched for eligible interventional studies from inception until February 2024. Narrative synthesis was used. The Theory of Change was applied to develop a logic model presenting the synthesized results. A Cochrane risk of bias assessment tool was used for quality appraisal. The study included 21 articles involving 1014 participants, with mean ages ranging from 72.5 to 90.4years. The proportion of female participants ranged from 8.0% to 100.0%. The applied sarcopenia diagnosis criteria varied, including those of the Asian Working Group for Sarcopenia and the European Working Group on Sarcopenia in Older People. The overall risk of bias in the included studies was moderate. Interventions primarily targeted physical inactivity, with resistance training being the most common intervention type. The reporting of intervention adherence was insufficient (only 11 out of 21 included studies provided adherence reports), and adherence overall and by intervention type was not possible to discern due to inconsistent criteria for high adherence across these studies. Four categories of intervention input were identified: educational resources; exercise equipment and accessories; monitoring and tailoring tools; and motivational strategies. Intervention activities fell into five categories: determining the intervention plan; educating; tailoring; organizing, supervising, assisting and motivating; and monitoring. While sarcopenia-related indicators were commonly used as desired outcomes, intermediate outcomes (i.e., sedentary time and physical activity level) and other long-term outcomes (i.e., economic outcomes) were less considered. Contextual factors affecting intervention use included participant characteristics (i.e., medical condition and education level) and intervention provider characteristics (i.e., trustworthiness). The findings led to the development of a novel logic model detailing essential components for interventions aimed at managing sarcopenia in long-term care facilities, with a focus on addressing sedentary behaviour and physical inactivity. Future sarcopenia interventions in long-term care facilities should fully attend to sedentary behaviour, enhance adherence to interventions through improved education, monitoring, tailoring and motivation and establish an agreed standard set of outcome measures.

A standard set of outcome measures for the comprehensive assessment of oral health and occlusion in individuals with osteogenesis imperfecta

BackgroundOsteogenesis imperfecta (OI) is a group of inherited connective tissue disorders of varying severity characterized by bone fragility. The primary objective of this international multidisciplinary collaboration initiative was to reach a consensus for a standardized set of clinician and patient-reported outcome measures, as well as associated measuring instruments for dental care of individuals with OI, based on the aspects considered important by both experts and patients. This project is a subsequent to the Key4OI project initiated by the Care4BrittleBones foundation which aims to develop a standard set of outcome measures covering a large domain of factors affecting quality of life for people with OI. An international team of experts comprising orthodontists, pediatric dentists, oral and maxillofacial surgeons, and prosthetic dentists used a modified Delphi consensus process to select clinician-reported outcome measures (CROMs) and patient-reported outcome measures (PROMs) to evaluate oral health in individuals with OI. Important domains were identified through a literature review and by professional expertise (both CROMs and PROMs). In three focus groups of individuals with OI, important and relevant issues regarding dental health were identified. The input from the focus groups was used as the basis for the final set of outcome measures: the selected issues were attributed to relevant CROMs and, when appropriate, matched with validated questionnaires to establish the final PROMs which represented best the specific oral health-related concerns of individuals with OI.ResultsConsensus was reached on selected CROMs and PROMs for a standard set of outcome measures and measuring instruments of oral health in individuals with OI.ConclusionsOur project resulted in consensus statements for standardization oral health PROMs and CROMs in individuals with OI. This outcome set can improve the standard of care by incorporating recommendations of professionals involved in dental care of individuals with OI. Further, it can facilitate research and international research co-operation. In addition, the significant contribution of the focus groups highlights the relevance of dental and oral health-related problems of individuals with OI.

The relationship between patient-reported and objective measures of physical function among cancer survivors receiving rehabilitation care: A correlation analysis.

Physical function is associated with cancer-related quality of life and survival. The correlation of patient-reported and objective measures of physical function has not been quantified previously in the cancer rehabilitation medicine setting. To correlate patient-reported physical function with objective measures of physical function. The secondary aim is to correlate fatigue and social participation levels with objective measures of physical function. Retrospective. Tertiary university cancer center. A total of 226 cancer survivors referred to an outpatient cancer rehabilitation medicine clinic. Not applicable. Correlation of Patient-Reported Outcomes Measurement Information System (PROMIS) Cancer Function Brief 3D Profile domains with objective physical function measured by the 30-second sit-to-stand and hand grip strength. Pearson correlation analysis revealed a moderate correlation between patient-reported physical function and the 30-second sit-to-stand test (r = 0.57; p <.001), and a weak correlation of patient-reported physical function and handgrip strength (r = 0.27; p <.001). Multivariable regression modeling controlling for age, gender, and receipt of systemic therapy demonstrated a significant association between patient-reported physical function and the 30-second sit-to-stand test (estimated confidence interval 0.76 [0.60, 0.92], p < .01), in addition to patient-reported function and handgrip strength (estimated 0.22 [0.10, 0.34], p < .01). Multiple myeloma but no other cancer type was inversely associated with lower physical function. Patient-reported physical function correlated moderately with the 30-second sit-to-stand test, whereas hand grip strength demonstrated a weak correlation. The 30-second sit-to-stand test is a suitable substitute for patient-reported physical function. Further work evaluating how measures relate to each other across cancer populations is needed before recommending a standardized set of outcome measures.

A prospective, observational multicenter registry of heart failure patients in Germany: preliminary results of the ongoing H2-registry

Abstract Background Heart failure (HF) is a highly prevalent condition affecting 1-2% of the adult population in Europe. Despite pioneering improvements in HF treatment during the last two decades, hospitalization and mortality rates remain relatively high. Gathering real-world data on HF populations is crucial especially in the light of newly emerging therapeutic approaches. Purpose The H2-registry was set up in 2021 to provide up-to-date, real-world data on a contemporary cohort of hospitalized HF patients in Germany using a standardized set of outcome measures. Methods The ongoing H2-registry represents a prospective, investigator-initiated, multicenter observational registry. Inpatients ≥18 years of age with a present diagnosis of chronic or acute HF are recruited in secondary and tertiary hospitals throughout Germany. Patients are excluded if they present in any kind of shock during index hospitalization, or if they previously underwent heart transplantation or ventricular assist device therapy. Routine follow-up (FU) is conducted every 6 months. A standardized set of variables according to the International Consortium of Health Outcome Measurements (ICHOM) including a pre-defined selection of questionnaires to collect patient-reported outcome measures (PROMs) is used to objectively monitor the course of disease. Results Until the reference date 12/31/22, a total of 2,190 patients were included in ten active study centers. Mean age was 72 years, 36.8% were female, and mean left-ventricular ejection fraction (LVEF) was 43.4% (38.1% had an LVEF of ≤ 40%). In-hospital mortality at index case was 1.3%. Within the cohort with completed 6-month FU comprising of 976 patients, all-cause mortality was 11.3% (110). In addition, 24.2% (209) in the survival cohort had at least one HF-related re-hospitalization. Numbers for all-cause mortality and re-hospitalizations at 12-month FU were 21.3% (71) and 32.8% (86), respectively. Evaluations of Kansas City Cardiomyopathy Questionnaire (KCCQ-12) scores showed a significant improvement overall and in all sub-categories (p &amp;lt; 0.001) at 6- and 12-month FU. Conclusions The H2-registry currently represents the largest ongoing prospective registry of HF inpatients in Germany. Our preliminary data highlights the pronounced mortality risk and healthcare burden in this cohort. However, HF-related therapies initiated during the course of a hospitalization have the potential to significantly improve patients’ quality of life. In the near future, it its foreseeable that the actively recruiting H2-registry based on ICHOM-standards will markedly contribute to the collection of real-world data on HF patients.

Scoping review of outcome measures in cleft care used in research and reports.

Treatment outcome measures are critical in the decision making of best practices in the OFC field. OFC consortium working groups provided standardization of outcome measures based on previous treatment outcome studies. However, the implementation of such standardization in OFC centres worldwide is unknown. This study presented mapped outcome measures in cleft care using a structured review method complemented by quantitative overview of the relevant published research to provide initial guidelines for the implementation of treatment outcome standardization. A scoping review of the literature of treatment outcomes in cleft care following Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews guidelines was performed. The selected indexed paper in outcome measures mapped following the international consortium in standard set of outcome measures in cleft care. Three hundred and sixty-five articles were filtered. The most discussed domains of cleft care were dental and oral health, appearance and speech/communication. Overall, the majority of publications were produced in high-income countries. The current review indicates that there are inequalities of treatment outcome studies among the domain of cleft care. In addition, there are also inequalities of published articles from HIC versus LMIC in treatment outcomes. This information can be used to develop targeted interventions aimed at encouraging cleft centres worldwide to adapt standardized outcome measures.

Expert consensus on the surgical evaluation and management of upper extremity spasticity in adults.

In the last decade there has been incredible interest and advancement in the surgical care of adult patients with upper motor neuron (UMN) injuries. Spasticity represents a prevalent and debilitating feature of UMN syndrome, which can result from cerebral palsy, spinal cord injury, cerebrovascular accident and traumatic or anoxic brain injury. While several diagnostic tools and management strategies have been described for upper limb spasticity, evidence-based practice guidelines do not currently exist due to low patient volume and a paucity of surgeons routinely performing surgeries in UMN syndrome patients. As such, expert consensus may help provide guidance for patients, therapists and clinicians alike. In this article an expert panel was assembled, and the Delphi method was utilized to present diagnostic considerations, define operative indications, discuss surgical treatment modalities and encourage a standard set of outcome measures for patients with upper extremity spasticity.

The International Standard Set of Outcome Measures for the Assessment of Hearing in People with Osteogenesis Imperfecta.

The aim is to recommend a minimum standard set of clinician-reported outcome measures (CROMs) and patient-reported outcome measures (PROMs) on hearing for people with osteogenesis imperfecta (OI). This project is part of the larger "Key4OI" project initiated by the "Care4BrittleBones foundation" of which the goal is to improve quality of life of people with OI. Key4OI provides a standard set of outcome measures and covers a large set of domains affecting the well-being of people with OI. An international team of experts in OI, comprising specialists in audiological science, medical specialists, and an expert patient representative, used a modified Delphi consensus process to select CROMs and PROMs to evaluate hearing problems in people with OI. In addition, focus groups of people with OI identified key consequences of their hearing loss. These criteria were matched to categories of preselected questionnaires to select a PROM that matched their specific hearing-related concerns best. Consensus on PROMs for adults and CROMs for adults and children was reached. The focus of the CROMs was on specific audiological outcome measures and standardized follow-up. This project resulted in a clear consensus statement for standardization of hearing-related PROMs and CROMs and follow-up management of patients with OI. This standardization of outcome measurements will facilitate comparability of research and easier international cooperation in OI and hearing loss. Furthermore, it can improve standard of care in people with OI and hearing loss by incorporating the recommendations into care pathways.

Rehabilitation following extra-articular proximal phalangeal fractures of the fingers in adults: a scoping review.

Proximal phalangeal fractures are common and can have a significant impact on hand function. Therefore, it is important to optimise post-operative rehabilitation. A scoping review was undertaken to map the existing evidence on rehabilitation of proximal phalangeal fractures of the fingers in adults. A comprehensive search was conducted which included database searching, reference searching, hand searching of journals, and searching for grey literature. Eight articles were included after screening for eligibility. Three studies researched surgical interventions and five studies conservative management. The immobilisation period varied between 5days to 3weeks in the surgical studies, and between 3 to 7weeks in the conservative studies. Active exercise therapy was started immediately with conservative management, while in the surgical studies time to commence exercises varied between 5days and 3weeks. All studies reported good results in mobility with a mean total active motion ranging from 240° to 258.9°. Patients reported little pain at final follow-up and grip strength recovered to 96% compared to the unaffected side. Studies reporting on function and patient satisfaction lacked transparency. All studies had a moderate to high risk of bias and the results of the included studies should therefore be interpreted with caution. More high-quality randomised controlled studies with an a priori research protocol and a standard set of outcome measures are necessary to research whether early motion, an intrinsic plus splint leaving the wrist free, and the inclusion of additional treatment modalities can result in a better and/or faster recovery.

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.

Key4OI: Development and implementation of a standard set of outcome measures for osteogenesis imperfecta

Key4OI: Development and implementation of a standard set of outcome measures for osteogenesis imperfecta

A Standard Set for Outcome Measurement in Patients With Hand and Wrist Conditions: Consensus by the International Consortium for Health Outcomes Measurement Hand and Wrist Working Group

To describe the principles, process, and results of creating the International Consortium for Health Outcomes Measurement (ICHOM) standard set for hand and wrist conditions. Following the standardized methods of ICHOM, an international working group of hand surgeons, therapists, and researchers was assembled to develop an evidence-based, patient-centered, standard set of outcome measures for patients with hand and wrist conditions. Multiple systematic reviews were performed to support our choices of outcome domains and tools for hand and wrist conditions. Fourteen video conferences were held between March 2018 and March 2020, and a modified Delphi process was used. A consensus was reached on 5 measurement tracks: the thumb, finger, wrist, nerve, and severe hand trauma tracks, with a distinction between regular and extended tracks for which specific allocation criteria applied. The standard set contains a selection of outcome tools and predefined time points for outcome measurement. Additionally, we developed a hierarchy for using the tracks when there are multiple conditions, and we selected risk-adjustment, case-mix variables. The global implementation of the ICHOM standard set for hand and wrist conditions may facilitate value-based health care for patients with hand and wrist conditions. The ICHOM standard set for hand and wrist conditions can enable clinical decision making, quality improvement, and comparisons between treatments and health care professionals.

Standard set of patient-reported outcomes for personality disorder

PurposeThe purpose of the article is to present standard set of outcomes for people with personality disorder (PD), in order to facilitate patient outcome measurement worldwide.MethodsThe International Consortium for Health Outcomes Measurement (ICHOM) gathered a multidisciplinary international working group, consisting of 16 experts, including clinicians, nurses, psychologists, methodologists and patient representatives, to develop a standard set of outcome measures for people with PD. The Delphi method was used to reach consensus on the scope of the set, outcome domains, outcome measures, case-mix variables and time points for measuring outcomes in service users. For each phase, a project team prepared materials based on systematic literature reviews and consultations with experts.ResultsThe working group decided to include PD, as defined by International Classification of Diseases 11th revision (ICD-11). Eleven core outcomes and three optional outcomes across four health domains (mental health, behaviour, functioning and recovery) were defined as those relevant for people with PD. Validated measures for the selected outcomes were selected, some covering more than one outcome. Case-mix variables were aligned to other ICHOM mental health standard sets and consisted of demographic factors and those related to the treatment that people received. The group recommended that most outcomes are measured at baseline and annually.ConclusionThe international minimum standard set of outcomes has the potential to improve clinical decision making through systematic measurement and comparability. This will be key in improving the standard of health care for people with PD across the world.

A standard set of outcome measures for the comprehensive assessment of osteogenesis imperfecta

BackgroundOsteogenesis Imperfecta (OI) is a genetic disorder also known as ‘brittle bone disease’. The clinical manifestation of OI shows a wide variation. Therefore, care for patients with OI requires an interdisciplinary approach. The effectiveness of particular interventions and treatment protocols of interdisciplinary teams is not clear due to a non-standardized and wide variation of patient outcomes thus making the comparison of outcome measures available in the literature difficult. It is only by agreeing on a common, standard set of outcome measures for the comprehensive appraisal of OI that comparisons across interdisciplinary treatment centers for OI will be possible in the future.MethodsThe Key4OI international interdisciplinary working group of 27 members used a consensus-driven modified Delphi approach to develop a set of global outcome measures for patients with OI. The International Classification of Functioning, Disability and Health (ICF), was used to define domains and organize the outcomes from the literature search. After reviewing the outcomes extracted from the literature, trials and registries, the working group agreed on a final selection of domains and their definition (ICF definition as well as a lay description). These domains were then presented to the focus groups who prioritized the outcome domains by taking into account the items important to the OI community. All content was collected and analyzed and final domains were determined. A consensus of appropriate measuring instruments for each domain was reached with Delphi rounds. The entire approach was in line with the International Consortium for Health Outcomes Measurement ICHOM methodology.ResultsMore than 400 different outcome measures were identified in our literature search. After three Delphi rounds, 24 domains were selected. After the focus group sessions, the number of domains were reduced to 15. A consensus was reached on the measuring instruments to cover these domains for both children and adults.ConclusionThe Key4OI project resulted in standard set of outcome measures focused on the needs and wishes of individuals with OI and their families. This outcome set will enable healthcare teams and systems to compare and to improve their care pathways and quality of care worldwide. Further studies are needed to evaluate the implementation of this standardized outcome set.

Development of an international standard set of patient-centred outcome measures for overall paediatric health: a consensus process

ObjectiveTo develop an Overall Pediatric Health Standard Set (OPH-SS) of outcome measures that captures what matters to young people and their families and recognising the biopsychosocial aspects of health for...

Immunological Outcomes of Allergen-Specific Immunotherapy in Food Allergy.

IgE-mediated food allergies are caused by adverse immunologic responses to food proteins. Allergic reactions may present locally in different tissues such as skin, gastrointestinal and respiratory tract and may result is systemic life-threatening reactions. During the last decades, the prevalence of food allergies has significantly increased throughout the world, and considerable efforts have been made to develop curative therapies. Food allergen immunotherapy is a promising therapeutic approach for food allergies that is based on the administration of increasing doses of culprit food extracts, or purified, and sometime modified food allergens. Different routes of administration for food allergen immunotherapy including oral, sublingual, epicutaneous and subcutaneous regimens are being evaluated. Although a wealth of data from clinical food allergen immunotherapy trials has been obtained, a lack of consistency in assessed clinical and immunological outcome measures presents a major hurdle for evaluating these new treatments. Coordinated efforts are needed to establish standardized outcome measures to be applied in food allergy immunotherapy studies, allowing for better harmonization of data and setting the standards for the future research. Several immunological parameters have been measured in food allergen immunotherapy, including allergen-specific immunoglobulin levels, basophil activation, cytokines, and other soluble biomarkers, T cell and B cell responses and skin prick tests. In this review we discuss different immunological parameters and assess their applicability as potential outcome measures for food allergen immunotherapy that may be included in such a standardized set of outcome measures.

First insights on value-based healthcare of elders using ICHOM older person standard set reporting

BackgroundClinical guidelines for specific conditions fragment care provision for elders. The International Consortium for Health Outcomes Measurement (ICHOM) has developed a global standard set of outcome measures for comprehensive assessment of older persons. The goal of this study was to report value-based health metrics in Taiwan using this ICHOM toolset.MethodsThe cross-sectional study of baseline data excerpted from a prospective longitudinal cohort, which recruited people ≥65 years old with ≥3 chronic medical conditions between July and December 2018. All participants received measurements of physical performance, anthropometric characteristics, health-related behaviors, Charlson Comorbidity Index, and Montreal Cognitive Assessment. The ICHOM toolset comprises three tiers: 1 includes frailty and having chosen a preferred place of death; 2 includes polypharmacy, falls, and participation in decision-making; and 3 includes loneliness, activities of daily living, pain, depression, and walking speed. These items were converted into a 0–10 point value-based healthcare score, with high value-based health status defined as ≥8/10 points.ResultsFrequencies of individual ICHOM indicators were: frail 11.7%, chose preferred place of death 14.4%, polypharmacy 31.5%, fell 17.1%, participated in decision-making 81.6%, loneliness 26.8%, limited activities of daily living 22.4%, pain 10.4%, depressed mood 13.0%, and slowness 38.5%. People with high disease burden (OR 0.40, 95% CI 0.21–0.76, p = 0.005) or cognitive impairment (OR 0.49, 95%CI 0.27–0.87, p = 0.014) were less likely to have high value-based healthcare status.ConclusionsThe ICHOM Standard Set Older Person health outcome measures provide an opportunity to shift from a disease-centric medical paradigm to whole person-focused goals. This study identified advanced age, chronic disease burden and cognitive impairment as important barriers to achieving high value-based healthcare status.

A Standard Set of Value-Based Patient-Centered Outcomes for Pancreatic Carcinoma: An International Delphi Survey.

Global health systems are shifting toward value-based health care to improve patient outcomes in the face of rising health care costs. The challenge is to identify standardized outcome measurements that allow optimal quality-of-care monitoring and comparison to optimize medical practices and patient pathways. A common outcomes definition is required, including medical results (Clinical Reported Outcomes Measurements [CROMs]) and quality-of-life components that matter most to patients (Patient-Reported Outcomes Measurements [PROMs]), which are particularly important for severe pathologies with short life expectancy such as pancreatic cancer. This study aimed to create standardized metrics that could be used for outcomes analysis of pancreatic cancer care. A multidisciplinary working group (WG) was assembled. A systematic review was performed to collect the most used outcomes in clinical studies of pancreatic cancers. The study reviewed 570 studies published in the last 10years. From these studies, 3370 outcomes, including CROMs, and PROMs, were listed and prioritized. The WG reached a consensus on key outcomes, proposed groupings for CROMs and PROMs, identified existing questionnaires that could be used for PROMs collection, and set the timeline for data collection. To refine and validate the final outcomes set, an international external committee completed a Delphi process (two rounds for both CROMS and PROMs). After the systematic literature review, the WG selected 102 outcomes (92 CROMs and 10 PROMs) for submission to the international Delphi vote committee. The committee retrained 89 outcomes (78 CROMs and 11 PROMs). For the PROMs, the WG and the international external committee chose a validated questionnaire, the Functional Assessment of Cancer Therapy-Hepatobiliary, which covers all of the 11 selected PROMs. A standardized set of outcome measures that need to be validated through international health outcome comparisons and quality-of-care assessments was built. Pilot projects are underway to test and optimize the approach in real-life conditions.

Development of an international standard set of outcome measures for patients with atrial fibrillation: a report of the International Consortium for Health Outcomes Measurement (ICHOM) atrial fibrillation working group.

AimsAs health systems around the world increasingly look to measure and improve the value of care that they provide to patients, being able to measure the outcomes that matter most to patients is vital. To support the shift towards value-based health care in atrial fibrillation (AF), the International Consortium for Health Outcomes Measurement (ICHOM) assembled an international Working Group (WG) of 30 volunteers, including health professionals and patient representatives to develop a standardized minimum set of outcomes for benchmarking care delivery in clinical settings.Methods and resultsUsing an online-modified Delphi process, outcomes important to patients and health professionals were selected and categorized into (i) long-term consequences of disease outcomes, (ii) complications of treatment outcomes, and (iii) patient-reported outcomes. The WG identified demographic and clinical variables for use as case-mix risk adjusters. These included baseline demographics, comorbidities, cognitive function, date of diagnosis, disease duration, medications prescribed and AF procedures, as well as smoking, body mass index (BMI), alcohol intake, and physical activity. Where appropriate, and for ease of implementation, standardization of outcomes and case-mix variables was achieved using ICD codes. The standard set underwent an open review process in which over 80% of patients surveyed agreed with the outcomes captured by the standard set.ConclusionImplementation of these consensus recommendations could help institutions to monitor, compare and improve the quality and delivery of chronic AF care. Their consistent definition and collection, using ICD codes where applicable, could also broaden the implementation of more patient-centric clinical outcomes research in AF.

Developing process measures in value-based healthcare: the case of aortic valve disease

BackgroundAs process measures can be means to change practices, this article presents process measures that impact on outcome measures for surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement...