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INTRODUCTION: Type 2 diabetes is a major public health issue in Mexico due to its high prevalence and its projection for the coming years for this disease. Findings on multidisciplinary care related to chronic diseases have proven effective, based on measurement of patient-centered outcomes, The Center of Comprehensive Care for Patients with Diabetes (CAIPaDi) is a multidisciplinary program focused on reducing diabetes complications. This case study aims to illustrate the results of implementing health outcomes measurements and demonstrate the beneficial effects of establishing a comprehensive model of care through a patient-centered approach. METHODS: A descriptive analysis of the comprehensive care indicators of patients with type 2 diabetes treated in the CAIPaDi program between 2013 and 2023 was conducted. The results were structured according to the standard set of outcomes for diabetes proposed by the International Consortium for Health Outcomes Measurements (ICHOM). RESULTS: The baseline and prospective registration of consultations was completed for five years, complying with 25 of the 26 indicators of the ICHOM set. In diabetes control, 56.5% of patients had A1c ≤ 7%, 87.9% had BP ≤ 130/80 mmHg, 60.9% had LDL-cholesterol < 100 mg/dl, and obesity rates decreased from 42.19% to 30.6% during annual consultations. Fewer years of diagnosis before the first visit is key to overall improvement in program adherence (P = 0.02). In acute events, a hyperglycemic crisis occurred in only two cases and severe hypoglycemia episodes in 8 patients. For chronic complications, no lower limb amputations occurred. Cardiovascular outcomes occurred in < 1%. Periodontal disease was analyzed, and periodontitis decreased from 82.9% to 78.7%. Mortality reports were low, with COVID-19 being the main cause of death. Patient-reported outcomes demonstrated reductions in anxiety, depression, and diabetes distress during follow-up. CONCLUSION: Registering quality-of-care indicators is feasible in a comprehensive care program. It allows improving the medical, mental health, and lifestyle outcomes of patients with type 2 diabetes and provides relevant data for planning health programs. A quick diagnosis before program adherence is crucial for overall improvement in patients.

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BACKGROUND: Prostate cancer (PC) is the most common cancer in men in 112 countries, and accounts for 15% of cancers. Because it cannot be prevented, the rise in cases is inevitable, and improvements in diagnostic pathways and treatments are needed, as there is still a shortage of cost-effective diagnostics and widespread oncologically safe treatment options with measurable quality. As part of the implementation of a Full Cycle of Care, instruments have been developed to achieve value-based medicine, such as consistent commitment to measurability. One of these instruments is the Balanced Scorecard (BSC). Here, we propose the first BSC for prostate cancer (PC) treatment. METHODS: BSCs are used to assess performance in healthcare organizations across four dimensions: financial, patient and referrer, process, and learning and development. This study aimed to identify Key Performance Indicators (KPIs) for each perspective. A systematic literature search was conducted according to PRISMA guidelines using multiple databases and specific search terms to identify KPIs for PC care, excluding case reports and conference abstracts. In total, 44 reports were included in analyses and development of the PC-specific BSC. RESULTS: In the present study, a PC-specific BSC and KPIs were defined for the four classic perspectives, as well as for a newly developed PC-Specific Disease and Outcome perspective, including patient-related parameters from the German Cancer Society and the International Consortium for Health Outcomes Measurement. In addition, the Process perspective includes KPIs of fulfillment of continuing education of residents and the metrics of structured training of the radical prostatectomy procedure in the Learning and Development perspective. CONCLUSIONS: The developed BSC provides a comprehensive set of perspectives for an Integrated Practice Unit or center in PC care, ensuring that the indicators remain manageable and applicable. The BSC facilitates value creation in line with Porter's Full Cycle of Care by systematically collecting and providing economic, personnel, and medical results, actions, and indicators. In particular, this BSC includes KPIs of structured training of practitioners and metrics of the German Cancer Society, that recently proved to improve PC patients outcomes.

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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.

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Aims: Diabetes is a pressing global health issue, demanding innovative strategies for improved treatment. However, traditional care often falls short of patient goals. To address this, digital health solutions, including smartphone apps and remote monitoring, have emerged as crucial in diabetes management. This study aims to assess a comprehensive intervention, combining remote continuous data monitoring (RCDM) with in-clinic care, for enhancing diabetes-related outcomes. Additionally, it seeks to evaluate the effectiveness of the digital RCDM component by comparing adherent and non-adherent patients. Methods: Conducted in the United Arab Emirates, a retrospective study involved 89 patients primarily on anti-diabetic medications. They were split into two groups based on adherence to RCDM. Over time, significant improvements were observed across various parameters. Results: Notably, patients exhibited weight loss (-4.0 ± 5.3, p < 0.001), reduced waist circumference (-4.74 ± 7.8, p < 0.001), lowered HbA1c levels (-1.00 ± 1.3, p < 0.001), decreased systolic BP (-3.1 ± 13.1, p = 0.035), and diminished diastolic BP (-3.4 ± 9.9, p = 0.002) annually. Furthermore, patients adhering to the GluCare model demonstrated substantial HbA1c reductions (-1.53 ± 1.5, p < 0.001), improved lipid profiles, notably decreased total Cholesterol (-16.6 ± 50.3, p = 0.034), and lowered LDL levels (-18.65 ± 42.6, p = 0.006). Conclusions: The intervention model effectively managed T2D patients through a comprehensive approach, yielding notable improvements in HbA1c levels and other outcomes within a year. The study underscores the limitations of traditional care and reliance simply on pharmacotherapy, and emphasizes the need for a hyper-personalized, and continuous approach for T2D management.

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INTRODUCTION: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

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BACKGROUND: Systematically 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. METHODS: Semi-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. RESULTS: 22 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. CONCLUSION: ICHOM-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.

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BACKGROUND: Patient-reported outcome measures (PROMs) are questionnaires that measure patient outcomes related to quality of life, health, and functioning, and are increasingly used to assess important outcomes from the patient's perspective. For PROMs to contribute to better health and better care, it is vital that their content validity be adequate. This requires patient involvement in various steps of PROM development. PROM developers not only recognize the benefits of patient involvement but also report difficulties in recruiting patients and experience patient involvement as time-consuming, logistically challenging, and expensive. OBJECTIVE: This study seeks to explore different strategies for disclosing the experiential knowledge of patients, namely through analyzing patient stories on the web and social media. The research questions are as follows: (1) how do bloggers living with a disease experience their health-related quality of life? (2) How are these experiences reflected in the domains and items of PROMs related to their disease? METHODS: First, a qualitative analysis of blogs written by patients was performed. Second, subthemes and underlying codes resulting from this qualitative analysis were systematically compared with the domains and items in PROMs for the respective diseases that the bloggers write about. Blogs were identified via the Google search engine between December 2019 and May 2021. RESULTS: Bloggers describe a wide range of experiences regarding their physical functioning and health; mental well-being; social network and support; daily life, education, work, and leisure; coping; and self-management. Bloggers also write about their positive and negative experiences with health care delivery, the organization of health care, and health care professionals. In general, patients' experiences as described in blogs were reflected in the domains and items of the PROMs related to their disease. However, except for diabetes mellitus, in all the sets of PROMs, potentially missing topics could be identified. Similarly, with the exception of Parkinson disease, all PROMs address issues that patients did not write about in their blogs and that might therefore be redundant. CONCLUSIONS: Web-based patient stories in the form of blogs reveal how people living with a certain disease experience their health-related quality of life. These stories enable analyses of patients' experiences that can be used to assess the content validity of PROMs. This can be a useful step for researchers who are looking for sets of measuring instruments that match their purposes.

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BACKGROUND: Patient-reported outcome measures [PROMs] are key to documenting outcomes that matter most to patients and are increasingly important to commissioners of health care seeking value. We report the first series of the ICHOM Standard Set for Inflammatory Bowel Disease [IBD]. METHODS: Patients treated for ulcerative colitis [UC] or Crohn's disease [CD] in our centre were offered enrolment into the web-based TrueColours-IBD programme. Through this programme, e-mail prompts linking to validated questionnaires were sent for symptoms, quality of life, and ICHOM IBD outcomes. RESULTS: The first 1299 consecutive patients enrolled [779 UC, 520 CD] were studied with median 270 days of follow-up (interquartile range [IQR] 116, 504). 671 [52%] were female, mean age 42 years (standard deviation [sd] 16), mean body mass index [BMI] 26 [sd 5.3]. At registration, 483 [37%] were using advanced therapies. Median adherence to fortnightly quality of life reporting and quarterly outcomes was 100% [IQR 48, 100%] and 100% [IQR 75, 100%], respectively. In the previous 12 months, prednisolone use was reported by 229 [29%] patients with UC vs 81 [16%] with CD, p <0.001; 202 [16%] for <3 months; and 108 [8%] for >3 months. An IBD-related intervention was reported by 174 [13%] patients, and 80 [6%] reported an unplanned hospital admission. There were high rates of fatigue [50%] and mood disturbance [23%]. CONCLUSIONS: Outcomes reported by patients illustrate the scale of the therapeutic deficit in current care. Proof of principle is demonstrated that PROM data can be collected continuously with little burden on health care professionals. This may become a metric for quality improvement programmes or to compare outcomes.

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Objective: To systematically describe the use and outcomes of Patient-Reported Outcomes Measurement Information System (PROMIS) measures in clinical studies in populations with stroke. Data Sources: A systematic search on the use of PROMIS measures in clinical stroke studies in 9 electronic databases. Study Selection: Studies had to be original, reporting on outcome data using PROMIS measures in populations with stroke (ischemic and/or hemorrhagic), from January 1st, 2007. Initially, 174 unique studies met the inclusion criteria. In 2 steps, titles, abstracts and full-text articles were screened for eligibility (2 authors independently). Data Extraction: From the selected articles, study characteristics, type of PROMIS measures, and its outcomes were extracted by 2 authors independently. The authors discussed their views to achieve consensus. A third author was consulted if necessary. Data Synthesis: In total, 27 studies (24,366 patients) were included, predominantly from the United States (22); most study populations were hospital-based (20); the number of patients ranged from 30-3283. In general, patients had no or mild symptoms (median modified Rankin scale 1). Two different generic PROMIS measures were reported (PROMIS Global Health, PROMIS 29) and 9 PROMIS measures focusing on specific domains (sleep, pain, physical functioning, self-efficacy, satisfaction with social roles, depression, anxiety, cognition, fatigue). These match the International Classification of Functioning, Disability, and Health (ICF) domains mentioned in the Core Set for Stroke. The measures were administered 1-55 months after stroke. Outcome data are provided. Pooling of data was not achieved because of a large variety in study characteristics (inclusion criteria, follow-up moments, data processing). Conclusions: The PROMIS measures in this review could be relevant from a patient's perspective, covering ICF core set domains for patients with stroke. The large variety in study characteristics hampers comparisons across populations. Many different outcome measures are used to report results of stroke rehabilitation studies.

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This commentary proposes that Rasch Measurement Theory (RMT) is an innovative method for assessments of patient-centric therapy response in hemophilia A and B, as they are in other disease states or target patient populations. RMT is a necessary and sufficient approach to moving from ordinal observations to interval measurement, which has arithmetic properties. This applies across the board in hemophilia and other disease states for clinical value claims, patient centric or subjective value claims as well as those for anticipated drug utilization and other medical care resources. The purpose of this commentary is to point out limitations regarding current methods for making claims regarding hemophilia response and to propose a new start in hemophilia studies to identify core claims that meet required measurement standards. This applies to both the development of new patient reported outcome instruments as well as the evaluation of existing instruments, with a focus on polytomous instruments and their sub-domains, to evaluate their possible application as measures that approximate RMT requirements.

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BACKGROUND: We aimed to identify groups of patients with similar health status after stroke, assessed by patient reported outcome measures (PROMs), to improve initial risk stratification. METHODS: In a prospective study, inpatients were recruited during acute stroke treatment. Demographics, history, and cardio-vascular risk factors were assessed at baseline. Self-reported functional status, physical and mental health as well as anxiety and depressive symptoms were assessed 3 and 12 months after stroke and used to identify latent classes. The association of patient characteristics with latent class membership was investigated with multinomial logistic regression. RESULTS: Of the 650 patients included with a mean age of 75 years and 48% female, 70% had ischemic, 6% hemorrhagic strokes, and 24% transient ischemic attacks. Median NIHSS on admission was 2 (IQR:0,5). Values of PROMs remained comparable at 3 and 12 months. A three-class model was developed, differentiating between patients with mildly (75%), moderately (17%), and severely (8%) impaired self-reported health status. Adjusted for univariately significant baseline characteristics, initial NIHSS distinguished mild- from moderate-, and moderate- from severe-class-membership (p < 0.001). Length of inpatient stay (p < 0.001;OR = 1.1), diabetes (p = 0.021;OR = 1.91), and atrial fibrillation (p = 0.004;OR = 2.20) predicted allocation to the moderately vs. mildly affected class. CONCLUSIONS: Grading stroke patients by a standard set of PROMs up to 1 year after stroke allows to distinguish the diverse impact of baseline characteristics on differently affected groups. In addition to initial stroke severity, longer inpatient stay, presence of diabetes and atrial fibrillation correlate with greater impairment of self-reported health in the less affected groups. TRIAL REGISTRATION: http://www.ClinicalTrials.gov ; Unique identifier: NCT03795948 .

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PURPOSE: To describe the principles, process, and results of creating the International Consortium for Health Outcomes Measurement (ICHOM) standard set for hand and wrist conditions. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. CLINICAL RELEVANCE: The ICHOM standard set for hand and wrist conditions can enable clinical decision making, quality improvement, and comparisons between treatments and health care professionals.

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OBJECTIVES: Impairments after stroke may affect multiple domains of health-related quality of life (HRQoL). Patient-reported outcome measures (PROMs) have proven valuable in measuring patients' well-being. We examine the psychometric properties of a standard set of PROMs assessing global health, anxiety, and depression, and functioning in a German health care setting. METHOD: We included inpatients at the Department of Neurology at the University Medical Center Hamburg-Eppendorf, diagnosed with stroke. Following the stroke-specific standard set of the International Consortium for Health Outcome Measurement, we collected demographic and clinical information at baseline, and PROMs for global health (PROMIS-10), three items for self-reported functioning, anxiety, and depression (PHQ-4) at 90 days follow-up. We calculated confirmatory factor analyses to test factorial validity and correlation analyses to test construct validity. We further conducted item and reliability analyses. RESULTS: In a sample of 487 patients (mean age, SD: 71.1, 12.6; 47% female) with mild and moderate symptoms, model fit for the PROMIS-10 was acceptable for the two-factor and single-factor models. Factor loadings ranged from 0.52 to 0.94. The postulated single-factor model for functioning was saturated with zero degrees of freedom. Factor loadings ranged from 0.90 to 0.96. For the PHQ-4, the two-factor model showed excellent model fit. Factor loadings ranged from 0.78 to 0.87. Internal consistency was acceptable to good. Construct validity was generally confirmed. CONCLUSIONS: The PROMIS-10 is a valid and reliable instrument to measure HRQoL among German stroke patients. While the PHQ-4 was confirmed as a screening measure for mental disorders, further research is needed on items assessing self-reported functioning. Results are limited to patients showing minimal functional deficits.

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PURPOSE: The 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. METHODS: The 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. RESULTS: The 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. CONCLUSION: The 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.

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PURPOSE: To evaluate in a large sample of patients from 10 different European centers the results of cataract surgery, characterizing the relationship between patient-reported outcomes (PROMs) and clinician-reported outcome measures (CROMs). METHODS: Prospective non-interventional multicenter observational descriptive study analyzing the clinical outcomes of a total of 3799 cases undergoing cataract surgery (mean age: 72.7 years). In all cases, the cataract surgery standard developed by the International Consortium for Health Outcomes Measurements (ICHOM) was used to register the clinical data. Three-month postoperative visual acuity and refraction data were considered CROMs, whereas Rasch-calibrated item 2 (RCCQ2) and total Catquest-9SF score (CQ) were considered PROMs. RESULTS: Postoperative corrected distance visual acuity (CDVA) was 0.3 logMAR or better in 88.7% (2505/2823) of eyes. Mean differences between preoperative and postoperative RCCQ2 and CQ scores were -3.09 and -2.39, respectively. Visual function improvement with surgery was reported by 91.5% (2163/2364) of patients. Statistically significant, although weak, correlations of postoperative CDVA with postoperative refraction, PROMs, and complications were found (0.133 ≤ r ≤0.289, p < 0.001). A predictive model (R2: 0.254) of postoperative CDVA considering 10 variables was obtained, including preoperative CDVA, different ocular comorbidities, age, gender and intraoperative complications. Likewise, another predictive model (R2: 0.148) of postoperative CQ considering a total of 14 variables was obtained, including additionally preoperative CQ, target refraction and previous surgeries. CONCLUSIONS: Cataract surgery provides an improved functional vision in most of patients although this improvement can be limited by ocular comorbidities and complications. The relationship between PROMs and CROMs is multifactorial and complex.

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Standard outcome sets developed by the International Consortium for Health Outcomes Measurement (ICHOM) facilitate value-based health care in healthcare practice and have gained traction from regulators and Health Technology Assessment (HTA) agencies that regularly assess the value of new medicines. We aimed to assess the extent to which the outcomes used by regulators and HTA agencies are patient-relevant, by comparing these to ICHOM standard sets. We conducted a cross-sectional comparative analysis of ICHOM standard sets, and publicly available regulatory and HTA assessment guidelines. We focused on oncology due to many new medicines being developed, which are accompanied by substantial uncertainty regarding the relevance of these treatments for patients. A comparison of regulatory and HTA assessment guidelines, and ICHOM standard sets showed that both ICHOM and regulators stress the importance of disease-specific outcomes. On the other hand, HTA agencies have a stronger focus on generic outcomes in order to allow comparisons across disease areas. Overall, similar outcomes are relevant for market access, reimbursement, and in ICHOM standard sets. However, some differences are apparent, such as the acceptability of intermediate outcomes. These are recommended in ICHOM standard sets, but regulators are more likely to accept intermediate outcomes than HTA agencies. A greater level of alignment in outcomes accepted may enhance the efficiency of regulatory and HTA processes, and increase timely access to new medicines. ICHOM standard sets may help align these outcomes. However, some differences in outcomes used may remain due to the different purposes of regulatory and HTA decision-making.

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OBJECTIVES: The aim of this study was to evaluate the psychometric performance of the patient- and parent-reported measures in the International Consortium for Health Outcomes Measurement (ICHOM) Standard Set for Cleft Care, and to identify ways of improving concept coverage. METHODS: Data from 714 patients with cleft lip and/or palate, aged 8 to 9, 10 to 12.5, and 22 years were collected between November 2015 and April 2019 at Erasmus University Medical Center, Boston Children's Hospital, Duke Children's Hospital, and from participating sites in the CLEFT-Q Phase 3 study. The Standard Set includes 9 CLEFT-Q scales, the Nasal Obstruction Symptom Evaluation (NOSE) questionnaire, the Child Oral Health Impact Profile-Oral Symptoms Scale (COHIP-OSS), and the Intelligibility in Context Scale (ICS). Targeting, item-fit statistics, thresholds for item responses, and measurement precision (PSI) were analyzed using Rasch measurement theory. RESULTS: The proportion of the sample to score within each instruments range of measurement varied from 69% (ICS) to 92% (CLEFT-Q teeth and COHIP-OSS). Specific problems with individual items within the NOSE and COHIP-OSS questionnaires were noted, such as poor item fit to the Rasch model and disordered thresholds (6 of 10). Reliability measured with PSI was above 0.82 for the ICS and all but one CLEFT-Q scale (speech distress). PSIs were lowest for the COHIP-OSS (0.43) and NOSE questionnaire (0.35). CONCLUSION: The patient- and parent-reported components within the facial appearance, psychosocial function, and speech domains are valid measures; however, the facial function and oral health domains are not sufficiently covered by the CLEFT-Q eating and drinking, NOSE, and COHIP-OSS, and these questionnaires may not be accurate enough to stratify cleft-related outcomes.

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OBJECTIVE: To provide comparison data on the Intelligibility in Context Scale (ICS) for a sample of 3-year-old English-speaking children born with any cleft type. DESIGN: Questionnaire data from the Cleft Collective Cohort Study were used. Descriptive and inferential statistics were carried out to determine difference according to children's cleft type and syndromic status. PARTICIPANTS: A total of 412 children born with cleft lip and/or palate whose mothers had completed the ICS when their child was 3 years old. MAIN OUTCOME MEASURE(S): Mothers' rating of their children's intelligibility using the ICS. RESULTS: The average ICS score for the total sample was 3.75 (sometimes-usually intelligible; standard deviation [SD] = 0.76, 95% CIs = 3.68-3.83) of a possible score of 5 (always intelligible). Children's speech was reported to be most intelligible to their mothers (mean = 4.33, SD = 0.61, 95% CIs = 4.27-4.39) and least intelligible to strangers (mean = 3.36, SD = 1.00, 95% CIs = 3.26-3.45). There was strong evidence (P < .001) for a difference in intelligibility between children with cleft lip only (n = 104, mean = 4.13, SD = 0.62, 95% CIs = 4.01-4.25) and children with any form of cleft palate (n = 308, mean = 3.63, SD = 0.76, 95% CIs = 3.52-3.71). Children born with cleft palate with or without cleft lip and an identified syndrome were rated as less intelligible (n = 63, mean = 3.28, SD = 0.85, 95% CIs = 3.06-3.49) compared to children who did not have a syndrome (n = 245, mean = 3.72, SD = 0.71, 95% CIs = 3.63-3.81). CONCLUSIONS: These results provide preliminary comparative data for clinical services using the outcome measures recommended by the International Consortium for Health Outcomes Measurement.

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Purpose: Lung cancer (LC) and its treatment impose a significant burden on patients' life. However, patient-centered outcomes are rarely collected during patient follow-up. Filling this gap, the International Consortium for Health Outcomes Measurement (ICHOM) developed a standard set of variables for newly diagnosed LC patients. In order to facilitate the use of this standard set, the project aims to adapt it to the Spanish setting. Methods: The variables (instrument and periodicity) to be included in Spanish standard set were selected through consensus during 4 nominal groups (13 oncologists, 14 hospital pharmacists, 4 hospital managers and 3 LC patients), under the supervision of a Scientific Committee (1 oncologist, 3 hospital pharmacists, 2 LC patients advocates). Results: The variables agreed upon included: (1) case-mix: demographic [age, sex, education and social-family support], clinical [weight loss, smoking status, comorbidities (Charlson index), pulmonary function (FEV-1)], tumor [histology, clinical, and pathological stage (TNM), EGFR, ALK, ROS-1, PD-L1] and treatment factors [intent and completion] and (2) outcomes: degree of health [performance status (ECOG) and quality-of-life (EQ-5D, LCSS)], survival [overall survival and cause of death], quality of death [place of death, end-of-life care and palliative care, death aligned with living will], treatment complications, and others [date of diagnosis and treatment initiation, productivity loss (sick leave)]. Conclusion: The adaptation of ICHOM standard set to the Spanish setting pave the way to standardize the collection of variables in LC.

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BACKGROUND AND PURPOSE: Stroke has detrimental effects in multiple health domains not captured by routine scales. The International Consortium for Health Outcome Measurement has developed a standardized set for self-reported assessment to overcome this limitation. The aim was to assess this set in acute stroke care. METHODS: Consecutive patients with acute ischaemic stroke, transient ischaemic attack or intracerebral hemorrhage were enrolled. Demographics, living situation and cardiovascular risk factors were collected from medical records and interviews. The Patient-reported Outcomes Measurement Information System 10-Question Short Form (PROMIS-10) and the Patient Health Questionnaire-4 (PHQ-4) were conducted 90 days after admission. Linear and logistic regression analyses were used to identify predictors of outcome. The study is registered at ClinicalTrials.gov, NCT03795948. RESULTS: In all, 1064 patients were enrolled; mean age was 71.6 years, 51% were female, and median National Institutes of Health Stroke Scale (NIHSS) on admission was 3. Diagnosis was acute ischaemic stroke in 74%, transient ischaemic attack in 20% and intracerebral hemorrhage in 6%. 673 patients were available for outcome evaluation at 90 days; of these 90 (13%) had died. In survivors, t scores of PROMIS-10 physical and mental health were 40.3 ± 6.17 and 44.3 ± 8.63, compared to 50 ± 10 in healthy populations. 16% reported symptoms indicating depression or anxiety on the PHQ-4. Higher NIHSS, prior stroke and requiring help pre-stroke predicted lower values in physical and mental health scores. Higher NIHSS and diabetes were associated with anxiety or depression. CONCLUSIONS: Integrated in the routine of acute stroke care, systematic assessment of patient-reported outcomes reveals impairments in physical and mental health. Main predictors are severity of stroke symptoms and comorbidities such as hypertension and diabetes.

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