Standard set of patient-reported outcomes for personality disorder

Abstract 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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Appraisal of Candidate Instruments for Assessment of the Physical Function Domain in Patients with Psoriatic Arthritis

The Journal of Rheumatology ◽

10.3899/jrheum.191119 ◽

2020 ◽

Vol 48 (1) ◽

pp. 58-66 ◽

Cited By ~ 1

Author(s):

Ying Ying Leung ◽

Ana-Maria Orbai ◽

Alexis Ogdie ◽

Pil Hojgaard ◽

Richard Holland ◽

...

Keyword(s):

Psoriatic Arthritis ◽

Physical Function ◽

Outcome Measures ◽

Physical Functioning ◽

Working Group ◽

Short Form ◽

Outcome Measurement ◽

Patient Reported Outcome Measures ◽

Measurement Information ◽

Patient Reported

Objective.Numerous patient-reported outcome measures (PROM) exist for the measurement of physical function for psoriatic arthritis (PsA), but only a few are validated comprehensively. The objective of this project was to prioritize PROM for measuring physical function for potential incorporation into a standardized outcome measurement set for PsA.Methods.A working group of 13 members including 2 patient research partners was formed. PROM measuring physical function in PsA were identified through a systematic literature review and recommendations by the working group. The rationale for inclusion and exclusion from the original list of existing PROM was thoroughly discussed and 2 rounds of Delphi exercises were conducted to achieve consensus.Results.Twelve PROM were reviewed and discussed. Six PROM were prioritized: Health Assessment Questionnaire (HAQ) and 4 modifications (HAQ-Disability Index, HAQ-Spondyloarthritis, modified HAQ, multidimensional HAQ), Medical Outcomes Study 36-item Short Form survey physical functioning domain, and the Patient-Reported Outcomes Measurement Information System (PROMIS) physical functioning module.Conclusion.Through discussion and Delphi exercises, we achieved consensus to prioritize 6 physical function PROM for PsA. These 6 PROM will undergo further appraisal using the Outcome Measures in Rheumatology (OMERACT) Filter 2.1.

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Graphical representations of patient tolerability data: Recommendations from the National Cancer Institute (NCI) Cancer Moonshot Standardization Working Group.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.e18612 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. e18612-e18612

Author(s):

Gillian Gresham ◽

Gina L. Mazza ◽

Blake Langlais ◽

Bellinda King-Kallimanis ◽

Lauren J. Rogak ◽

...

Keyword(s):

Working Group ◽

Best Practice ◽

Clinical Decision Making ◽

Clinical Decision ◽

Section 508 ◽

Graphical Displays ◽

Patient Reported ◽

Tolerability Data ◽

Survey Results ◽

Data Incorporate

e18612 Background: Effective communication of treatment tolerability data is essential for clinical decision making and improved patient outcomes, yet standardized approaches to the analysis and visualization of tolerability data in cancer clinical trials are currently limited. To address this need, the Standardization Working Group (SWG) was established within the NCI Cancer Moonshot Tolerability Consortium. This abstract describes the SWG’s initiative to develop a publicly accessible online toolkit with a comprehensive set of guidelines, references, and resources for graphical displays of tolerability data. Methods: A multidisciplinary group of PRO researchers including biostatisticians, clinicians, epidemiologists, and representatives from the NCI and FDA convened monthly to discuss toolkit development and content. Considerations for standardization of graphical displays of tolerability data included (1) types of graphical displays, (2) incorporation of missing data, (3) labeling and color schemes, and (4) software to produce graphical displays. For consistency, considerations of tolerability relied on the Patient-Reported Outcomes version of the CTCAE (PRO-CTCAE), which includes 124 items assessing the frequency, severity, interference, and/or presence of 78 symptomatic adverse events. Graphical displays were generated using simulated PRO-CTCAE data and summarized by composite score (range 0-3).Color schemes that were Section 508 compliant and color blindness accessible were created. Surveys were distributed to 68 consortium members to assess preferences and interpretability of the graphical displays. Results: The SWG created graphical displays for PRO-CTCAE data, including bar charts, butterfly plots, and Sankey diagrams and compiled SAS macros and R functions to do so. Graphical displays made available in the toolkit maximize the use of PRO-CTCAE data, incorporate missingness, support between-arm comparisons, and present data longitudinally over treatment cycles or study timepoints. Survey results for labeling and color schemes were summarized and informed a list of short labels for PRO-CTCAE items (e.g., “radiation burns” for “skin burns from radiation”) and standardized color schemes for use in graphical displays. Survey results were also summarized to provide insight into PRO researchers’ ability to accurately interpret the graphical displays. Conclusions: Standardizinggraphical displays is important for improving the communication and interpretation of tolerability data. The type of graphical display used depends on the purpose of the analysis and should be tailored to the intended audience, including patients. This toolkit will provide a comprehensive resource with best practice recommendations.

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Patients and clinicians define symptom levels and meaningful change for PROMIS pain interference and fatigue in RA using bookmarking

Rheumatology ◽

10.1093/rheumatology/keab014 ◽

2021 ◽

Author(s):

Clifton O Bingham ◽

Alessandra L Butanis ◽

Ana Maria Orbai ◽

Michelle Jones ◽

Victoria Ruffing ◽

...

Keyword(s):

Clinical Decision Making ◽

Outcome Measurement ◽

Clinical Decision ◽

Patient Reported Outcome ◽

Pain Interference ◽

Measurement Information ◽

Meaningful Change ◽

External Anchor ◽

New Information ◽

Patient Reported

Abstract Objectives Using patient-reported outcomes to inform clinical decision-making depends on knowing how to interpret scores. Patient-Reported Outcome Measurement Information System® (PROMIS®) instruments are increasingly used in rheumatology research and care, but there is little information available to guide interpretation of scores. We sought to identify thresholds and meaningful change for PROMIS Pain Interference and Fatigue scores from the perspective of RA patients and clinicians. Methods We developed patient vignettes using the PROMIS item banks representing a continuum of Pain Interference and Fatigue levels. During a series of face-to-face ‘bookmarking’ sessions, patients and clinicians identified thresholds for mild, moderate and severe levels of symptoms and identified change deemed meaningful for making treatment decisions. Results In general, patients selected higher cut points to demarcate thresholds than clinicians. Patients and clinicians generally identified changes of 5–10 points as representing meaningful change. The thresholds and meaningful change scores of patients were grounded in their lived experiences having RA, approach to self-management, and the impacts on function, roles and social participation. Conclusion Results offer new information about how both patients and clinicians view RA symptoms and functional impacts. Results suggest that patients and providers may use different strategies to define and interpret RA symptoms, and select different thresholds when describing symptoms as mild, moderate or severe. The magnitude of symptom change selected by patients and clinicians as being clinically meaningful in interpreting treatment efficacy and loss of response may be greater than levels determined by external anchor and statistical methods.

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Defining a standard set of patient-centred outcomes for lung cancer

European Respiratory Journal ◽

10.1183/13993003.02049-2015 ◽

2016 ◽

Vol 48 (3) ◽

pp. 852-860 ◽

Cited By ~ 35

Author(s):

Kimberley S. Mak ◽

Annelotte C.M. van Bommel ◽

Caleb Stowell ◽

Janet L. Abrahm ◽

Matthew Baker ◽

...

Keyword(s):

Lung Cancer ◽

Cell Lung Cancer ◽

Working Group ◽

Outcome Measurement ◽

Nonsmall Cell Lung Cancer ◽

Case Mix ◽

Consensus Recommendation ◽

International Consensus ◽

Lung Cancer Patients ◽

Patient Reported

In lung cancer, outcome measurement has been mostly limited to survival. Proper assessment of the value of lung cancer treatments, and the performance of institutions delivering care, requires more comprehensive measurement of standardised outcomes.The International Consortium for Health Outcomes Measurement convened an international, multidisciplinary working group of patient representatives, medical oncologists, surgeons, radiation oncologists, pulmonologists, palliative care specialists, registry experts and specialist nurses to review existing data and practices. Using a modified Delphi method, the group developed a consensus recommendation (“the set”) on the outcomes most essential to track for patients with lung cancer, along with baseline demographic, clinical and tumour characteristics (case-mix variables) for risk adjustment.The set applies to patients diagnosed with nonsmall cell lung cancer and small cell lung cancer. Our working group recommends the collection of the following outcomes: survival, complications during or within 6 months of treatment and patient-reported domains of health-related quality of life including pain, fatigue, cough and dyspnoea. Case-mix variables were defined to improve interpretation of comparisons.We defined an international consensus recommendation of the most important outcomes for lung cancer patients, along with relevant case-mix variables, and are working to support adoption and reporting of these measures globally.

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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

European Heart Journal ◽

10.1093/eurheartj/ehz871 ◽

2020 ◽

Vol 41 (10) ◽

pp. 1132-1140 ◽

Cited By ~ 8

Author(s):

William H Seligman ◽

Zofia Das-Gupta ◽

Adedayo O Jobi-Odeneye ◽

Elena Arbelo ◽

Amitava Banerjee ◽

...

Keyword(s):

Atrial Fibrillation ◽

Health Outcomes ◽

Health Professionals ◽

Working Group ◽

Case Mix ◽

Outcomes Measurement ◽

International Consortium ◽

Patient Reported ◽

Icd Codes ◽

Standard Set

Abstract Aims As 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 results Using 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. Conclusion Implementation 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.

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Exploration, Development, and Validation of Patient-reported Outcomes in Antineutrophil Cytoplasmic Antibody–associated Vasculitis Using the OMERACT Process

The Journal of Rheumatology ◽

10.3899/jrheum.141143 ◽

2015 ◽

Vol 42 (11) ◽

pp. 2204-2209 ◽

Cited By ~ 12

Author(s):

Joanna C. Robson ◽

Nataliya Milman ◽

Gunnar Tomasson ◽

Jill Dawson ◽

Peter F. Cronholm ◽

...

Keyword(s):

Clinical Trials ◽

Outcome Measures ◽

Working Group ◽

Patient Reported Outcomes ◽

Outcome Measurement ◽

Antineutrophil Cytoplasmic Antibody ◽

International Classification Of Functioning ◽

Measurement Information ◽

Core Set ◽

Patient Reported

Objective.Antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) is a group of linked multisystem life- and organ-threatening diseases. The Outcome Measures in Rheumatology (OMERACT) vasculitis working group has been at the forefront of outcome development in the field and has achieved OMERACT endorsement of a core set of outcomes for AAV. Patients with AAV report as important some manifestations of disease not routinely collected through physician-completed outcome tools; and they rate common manifestations differently from investigators. The core set includes the domain of patient-reported outcomes (PRO). However, PRO currently used in clinical trials of AAV do not fully characterize patients’ perspectives on their burden of disease. The OMERACT vasculitis working group is addressing the unmet needs for PRO in AAV.Methods.Current activities of the working group include (1) evaluating the feasibility and construct validity of instruments within the PROMIS (Patient-Reported Outcome Measurement Information System) to record components of the disease experience among patients with AAV; (2) creating a disease-specific PRO measure for AAV; and (3) applying The International Classification of Functioning, Disability and Health to examine the scope of outcome measures used in AAV.Results.The working group has developed a comprehensive research strategy, organized an investigative team, included patient research partners, obtained peer-reviewed funding, and is using a considerable research infrastructure to complete these interrelated projects to develop evidence-based validated outcome instruments that meet the OMERACT filter of truth, discrimination, and feasibility.Conclusion.The OMERACT vasculitis working group is on schedule to achieve its goals of developing validated PRO for use in clinical trials of AAV.

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The ICHOM standard set for patient reported outcomes in diabetes

European Journal of Public Health ◽

10.1093/eurpub/ckz186.633 ◽

2019 ◽

Vol 29 (Supplement_4) ◽

Author(s):

F Carinci ◽

J Nano ◽

O Okunade ◽

S Whittaker ◽

M Walbaum ◽

...

Keyword(s):

Chronic Disease ◽

Data Collection ◽

Outcome Measures ◽

Health Professionals ◽

Patient Reported Outcomes ◽

Ad Hoc ◽

Case Mix ◽

Policy And Practice ◽

Patient Reported ◽

Standard Set

Abstract Background Between 2017-2018, the International Consortium for Health Outcomes Measurement (ICHOM) conducted a targeted study to deliver a standard set of outcome measures in diabetes, including patient reported outcomes. Compared to other conditions, the study faced the challenge of a complex data collection in a highly prevalent multifactorial chronic disease. Methods We conducted a structured systematic review of outcome measures focusing on adults with either Type 1 or Type 2 diabetes, followed by a consensus-driven modified Delphi panel including a multidisciplinary group of academics, health professionals and patient representatives. The applicability of the standard set was explored by collecting external feedback from patients and health professionals worldwide. Results The panel identified an essential set of case-mix characteristics and clinical outcomes, including factors related to diabetes control, acute events, chronic complications, health services and survival that can be regularly measured using routine data and ad hoc data collection. Three validated instruments were recommended for ad-hoc data collection of patient-reported outcomes: the “WHO-5” for psychological wellbeing, the “PAID” for diabetes distress and the “PHQ-9” for depression. The feedback received from members of the panel highlighted substantial challenges with regards to the applicability of the approach at a large scale. Conclusions The standard set recommended for use to monitor, benchmark and improve diabetes care has received strong support from stakeholders involved in the process worldwide. However, substantial challenges remain on how to organize a systematic data collection worldwide, with implications on policy and practice that can equally apply across all areas of chronic care. Prioritization of selected targets may be useful to achieve practical results in the immediate future. Key messages A standard set for the data collection of person-centred outcomes in diabetes has been successfully delivered by ICHOM, including case-mix characteristics, clinical and person reported outcomes. The feedback received from a range of stakeholders highlight implications for policy and practice in the data collection of PROMs for person-centred chronic disease monitoring.

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A systematic review of patient-reported outcome measurement (PROM) and provider assessment in mental health: goals, implementation, setting, measurement characteristics and barriers

International Journal for Quality in Health Care ◽

10.1093/intqhc/mzz133 ◽

2020 ◽

Author(s):

Marc Gelkopf ◽

Yael Mazor ◽

David Roe

Keyword(s):

Mental Health ◽

Clinical Practice ◽

Outcome Measures ◽

Outcome Measurement ◽

Web Security ◽

Patient Reported Outcome ◽

Self Report ◽

Attrition Rate ◽

Review Of Literature ◽

Patient Reported

Abstract Purpose To review and integrate the literature on mental-health-related patient-reported outcome measures (PROMs) and routine outcome measures (ROMs), namely in the domains of goals, characteristics, implementation, settings, measurements and barriers. PROM/ROM aims mainly to ascertain treatment impact in routine clinical practice through systematic service users’ health assessment using standardized self-report, caretaker and/or provider assessment. Data sources Psych INFO and PubMed including Medline, Biomed Central, EMBASE Psychiatry and Elsevier Science’s Direct. Study selection Systemized review of literature (2000–2018) on implementation and sustainability of PROMs/ROMs in adult mental health settings (MHS). Data extraction and synthesis Systemized review of literature (2000–2018) on numerous aspects of PROM/ROM implementation and sustainability in adult MHS worldwide. Results Based on 103 articles, PROMs/ROMs were implemented mostly in outpatient settings for people with assorted mental health disorders receiving a diversity of services. Frequency of assessments and completion rates varied: one-third of projects had provider assessments; about half had both provider and self-assessments. Barriers to implementation: perceptions that PROM/ROM is intrusive to clinical practice, lack of infrastructure, fear that results may be used for cost containment and service eligibility instead of service quality improvement, difficulties with measures, ethical and confidentiality regulations and web security data management regulations. Conclusion Improving data input systems, sufficient training, regular feedback, measures to increase administrative and logistic support to improve implementation, acceptability, feasibility and sustainability, follow-up assessments and client attrition rate reduction efforts are only some measures needed to enhance PROM/ROM efficiency and efficacy.

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Transitioning towards official clinical guidelines for the diagnostics and treatment of severe behavioural problems in children across Europe: current state and future directions.

10.31234/osf.io/8hsmy ◽

2017 ◽

Author(s):

Alexandra-Raluca Gatej ◽

Audri Lamers ◽

Robert Vermeiren ◽

Lieke van Domburgh

Keyword(s):

Mental Health ◽

Clinical Guidelines ◽

Clinical Decision Making ◽

Daily Practice ◽

Clinical Decision ◽

European Guidelines ◽

Current State ◽

Assessment And Treatment ◽

Evidence Based Treatments ◽

Multifactorial Approach

Severe behaviour problems (SBPs) in early childhood include oppositional and aggressive behaviours and predict negative mental health outcomes later in life. Although effective treatments for this group are available and numerous clinical practice guidelines have been developed to facilitate the incorporation of evidence-based treatments in clinical decision-making (NICE, 2013), many children with SBPs remain unresponsive to treatment (Lahey & Waldman, 2012). At present, it is unknown how many countries in Europe possess official clinical guidelines for SBPs diagnosis and treatment and what is their perceived utility. The aim was to create an inventory of clinical guidelines (and associated critical needs) for the diagnostics and treatment of SBPs in youth mental health across Europe according to academic experts and mental health clinicians’ opinions. To investigate the aim, two separate online semi-structured questionnaires were used, one directed at academics (N=28 academic experts; 23 countries), and the other at clinicians (N=124 clinicians; 24 countries). Three key results were highlighted. First, guidelines for SBPs are perceived as beneficial by both experts and clinicians. However, their implementation needs to be reinforced and content better adapted to daily practice. Improvements may include taking a multifactorial approach to assessment and treatment, involving the systems around the child, and multidisciplinary collaboration. Second, academic experts and clinicians support the need for further developing national / European guidelines. Finally, future guidelines should address current challenges identified by clinicians to be more applicable to daily practice.

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