Harmonized outcome measures for use in asthma patient registries and clinical practice

OBJECTIVE The development of new treatment approaches for degenerative lumbar spondylolisthesis (DLS) has introduced many questions about comparative effectiveness and long-term outcomes. Patient registries collect robust, longitudinal data that could be combined or aggregated to form a national and potentially international research data infrastructure to address these and other research questions. However, linking data across registries is challenging because registries typically define and capture different outcome measures. Variation in outcome measures occurs in clinical practice and other types of research studies as well, limiting the utility of existing data sources for addressing new research questions. The purpose of this project was to develop a minimum set of patient- and clinician-relevant standardized outcome measures that are feasible for collection in DLS registries and clinical practice. METHODS Nineteen DLS registries, observational studies, and quality improvement efforts were invited to participate and submit outcome measures. A stakeholder panel was organized that included representatives from medical specialty societies, health systems, government agencies, payers, industries, health information technology organizations, and patient advocacy groups. The panel categorized the measures using the Agency for Healthcare Research and Quality’s Outcome Measures Framework (OMF), identified a minimum set of outcome measures, and developed standardized definitions through a consensus-based process. RESULTS The panel identified and harmonized 57 outcome measures into a minimum set of 10 core outcome measure areas and 6 supplemental outcome measure areas. The measures are organized into the OMF categories of survival, clinical response, events of interest, patient-reported outcomes, and resource utilization. CONCLUSIONS This effort identified a minimum set of standardized measures that are relevant to patients and clinicians and appropriate for use in DLS registries, other research efforts, and clinical practice. Collection of these measures across registries and clinical practice is an important step for building research data infrastructure, creating learning healthcare systems, and improving patient management and outcomes in DLS.

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Harmonized Outcome Measures for Use in Depression Patient Registries and Clinical Practice

Annals of Internal Medicine ◽

10.7326/m19-3818 ◽

2020 ◽

Vol 172 (12) ◽

pp. 803-809 ◽

Cited By ~ 1

Author(s):

Richard E. Gliklich ◽

Michelle B. Leavy ◽

Lisa Cosgrove ◽

Gregory E. Simon ◽

Bradley N. Gaynes ◽

...

Keyword(s):

Clinical Practice ◽

Outcome Measures ◽

Patient Registries

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Importance of Patient-Reported Outcome Measures on Clinical Practice in Patients With Kidney Disease

Kidney Medicine ◽

10.1016/j.xkme.2021.06.001 ◽

2021 ◽

Author(s):

Rebecca Frazier ◽

John Devin Peipert

Keyword(s):

Clinical Practice ◽

Kidney Disease ◽

Outcome Measures ◽

Patient Reported Outcome Measures ◽

Patient Reported Outcome ◽

Patient Reported

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In Pursuit of an Effective Treatment: the Past, Present and Future of Clinical Trials in Inclusion Body Myositis

Current Treatment Options in Rheumatology ◽

10.1007/s40674-020-00169-4 ◽

2021 ◽

Author(s):

A. M. Snedden ◽

J. B. Lilleker ◽

H. Chinoy

Keyword(s):

Clinical Practice ◽

Effective Treatment ◽

Inclusion Body ◽

Therapeutic Effect ◽

Outcome Measures ◽

Inclusion Body Myositis ◽

Cytotoxic T Cells ◽

Treatment Options ◽

Trial Methodology ◽

Short Treatment

Abstract Purpose of review No clinical trial in sporadic inclusion body myositis (IBM) thus far has shown a clear and sustained therapeutic effect. We review previous trial methodology, explore why results have not translated into clinical practice, and suggest improvements for future IBM trials. Recent findings Early trials primarily assessed immunosuppressive medications, with no significant clinical responses observed. Many of these studies had methodological issues, including small participant numbers, nonspecific diagnostic criteria, short treatment and/or assessment periods and insensitive outcome measures. Most recent IBM trials have instead focused on nonimmunosuppressive therapies, but there is mounting evidence supporting a primary autoimmune aetiology, including the discovery of immunosuppression-resistant clones of cytotoxic T cells and anti-CN-1A autoantibodies which could potentially be used to stratify patients into different cohorts. The latest trials have had mixed results. For example, bimagrumab, a myostatin blocker, did not affect the 6-min timed walk distance, whereas sirolimus, a promotor of autophagy, did. Larger studies are planned to evaluate the efficacy of sirolimus and arimoclomol. Summary Thus far, no treatment for IBM has demonstrated a definite therapeutic effect, and effective treatment options in clinical practice are lacking. Trial design and ineffective therapies are likely to have contributed to these failures. Identification of potential therapeutic targets should be followed by future studies using a stratified approach and sensitive and relevant outcome measures.

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You’ve heard about outcome measures, so how do you use them? Integrating clinically relevant outcome measures in orthotic management of stroke

Prosthetics and Orthotics International ◽

10.1177/0309364612446650 ◽

2012 ◽

Vol 37 (1) ◽

pp. 30-42 ◽

Cited By ~ 4

Author(s):

Christopher Robinson ◽

Stefania Fatone

Keyword(s):

Clinical Practice ◽

Outcome Measures ◽

Careful Consideration ◽

International Classification Of Functioning ◽

Common Goal ◽

Disability And Health ◽

Healthcare Environment ◽

Relevant Outcome ◽

Selection Of

In today’s healthcare environment it is increasingly important to be able to quantify the amount of change associated with a given intervention; this can be accomplished using one or more appropriate outcome measures. However, the selection and integration of outcome measures within clinical practice requires careful consideration. This includes identification of the measure construct which can be assisted by the International Classification of Functioning, Disability, and Health; selection of outcome measures based on need, appropriateness and feasibility; and careful use in regular clinical practice including data collection, analysis and re-assessment of the process. We describe this process, focusing on orthotic management of stroke, in particular the improvement of mobility as a common goal. Clinical relevance The growing emphasis on improved documentation of patient care and outcomes requires that clinicians integrate clinically relevant outcome measures into their practice. We suggest a process to assist clinicians integrate outcome measures into clinical practice with a particular emphasis on the orthotic management of stroke.

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Optimizing management of low back pain through the pain and disability drivers management model: A feasibility trial

PLoS ONE ◽

10.1371/journal.pone.0245689 ◽

2021 ◽

Vol 16 (1) ◽

pp. e0245689

Author(s):

Christian Longtin ◽

Simon Décary ◽

Chad E. Cook ◽

Marc O. Martel ◽

Sylvie Lafrenaye ◽

...

Keyword(s):

Low Back Pain ◽

Back Pain ◽

Clinical Practice ◽

Data Collection ◽

Outcome Measures ◽

Pragmatic Trial ◽

Attrition Rate ◽

Feasibility Trial ◽

Clinical Settings ◽

Low Back

Introduction Self-reported levels of disability in individuals with low back pain (LBP) have not improved in the last decade. A broader perspective and a more comprehensive management framework may improve disability outcomes. We recently developed and validated the Low Back Pain and Disability Drivers Management (PDDM) model, which aims to identify the domains driving pain and disability to guide clinical decisions. The objectives of this study were to determine the applicability of the PDDM model to a LBP population and the feasibility of conducting a pragmatic trial, as well as to explore clinicians’ perceived acceptability of the PDDM model’s use in clinical settings. Methods This study was an one-arm prospective feasibility trial. Participants included physiotherapists working with a population suffering from LBP and their patients aged 18 years or older presenting with a primary complaint of LBP that sought a new referral and deemed fit for rehabilitation from private and public clinical settings. Clinicians participated in a one-day workshop on the integration of the PDDM model into their clinical practice, and were asked to report various LBP-related outcomes via self-reported questionnaires (i.e., impact of pain on physical function, nervous system dysfunctions, cognitive-emotional factors, work disabilities) at baseline and at six-week follow-up. Physiotherapists’ acceptability of the use of the PDDM model and appreciation of the training were assessed via semi-structured phone interviews. Analyses focused on a description of the model’s applicability to a LBP population, feasibility outcomes and acceptability measures. Results Applicablity of the PDDM model was confirmed since it successfully established the profile of patients according to the elements of each categories, and each of the 5 domains of the model was represented among the study sample. Trial was deemed feasible contingent upon few modifications as our predefined success criteria for the feasibility outcomes were met but feasibility issues pertaining to data collection were highlighted. Twenty-four (24) clinicians and 61 patients were recruited within the study’s timeframe. Patient’s attrition rate (29%) and clinicians’ compliance to the study protocol were adequate. Clinicians’ perceived acceptability of the use of the model in clinical settings and their appreciation of the training and online resources were both positive. Recommendations to improve the model’s integration in clinical practice, content of the workshop and feasibility of data collection methods were identified for future studies. A positive effect for all patients’ reported outcome measures were also observed. All outcome measures except for the PainDetect questionnaire showed a statistically significant reduction post-intervention (p<0.05). Conclusion These findings provide preliminary evidence of the potential of the PDDM model to optimize LBP management as well as conducting a future larger-scale pragmatic trial to determine its effectiveness. Trial registration Clinicaltrial.gov: NCT03949179.

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International Dermatology Outcome Measures Initiative as Applied to Psoriatic Disease Outcomes: An Update

The Journal of Rheumatology ◽

10.3899/jrheum.160114 ◽

2016 ◽

Vol 43 (5) ◽

pp. 959-960 ◽

Cited By ~ 5

Author(s):

Joseph F. Merola ◽

April W. Armstrong ◽

Ami Saraiya ◽

John Latella ◽

Amit Garg ◽

...

Keyword(s):

Clinical Trials ◽

Clinical Practice ◽

Outcome Measures ◽

Treatment Efficacy ◽

Regulatory Agencies ◽

Washington Dc ◽

Patient Centered ◽

Psoriatic Disease ◽

Disease Outcomes ◽

Dermatologic Disease

Previous publications have described the International Dermatology Outcome Measures (IDEOM) group, comprising patients, physicians, health economists, participating pharmaceutical industry partners, payers, and regulatory agencies. The goal of IDEOM is to create patient-centered, validated measures of dermatologic disease progression and treatment efficacy for use in both clinical trials and clinical practice. We provide an update of IDEOM activities as of our 2015 IDEOM meeting in Washington, DC, USA.

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Decreasing Laboratory Testing for Neonatal Jaundice Through Revision of a Clinical Practice Pathway

Hospital Pediatrics ◽

10.1542/hpeds.2021-006019 ◽

2022 ◽

Author(s):

Erin Preloger ◽

Michael Wedoff ◽

Jennifer T. Lemke ◽

Amy Pan ◽

Anika Nelson

Keyword(s):

Clinical Practice ◽

Length Of Stay ◽

Confidence Interval ◽

Outcome Measures ◽

Bilirubin Level ◽

Readmission Rate ◽

Laboratory Tests ◽

Poisson Model ◽

Median Number ◽

Neonatal Hyperbilirubinemia

OBJECTIVES: The purpose of this study was to minimize unnecessary laboratory services for hospitalized neonates with hyperbilirubinemia by revising a local clinical practice pathway (CPP). METHODS: A retrospective cohort study was performed to compare the number of laboratory tests and blood draws in patients hospitalized with neonatal hyperbilirubinemia before and after implementation of a revised CPP. The study included infants with neonatal hyperbilirubinemia <14 days old admitted after their birth hospitalization between April 2017 and October 2019. Primary outcome measures included the total number of blood draws and the number of laboratory tests obtained per patient and length of stay. Secondary outcome measures included 7-day readmission rate, charges, and discharge bilirubin level. RESULTS: The median number of blood draws per patient after implementation of the CPP decreased to 2 (interquartile range [IQR], 2–3) compared with 3 (IQR, 2–3) before implementation (Poisson model–based estimated mean difference, 1.1; 95% confidence interval, 1.0–1.3; P = .018). The median number of laboratory tests per patient after implementation decreased from 4 (IQR, 3–6) to 3 (IQR, 2–4; Poisson model–based estimated mean difference, 1.3; 95% confidence interval, 1.2–1.5; P < .0001). There was no significant change in length of stay, readmission rate, charges, or discharge bilirubin level. CONCLUSIONS: Implementation of a revised CPP was associated with a significant decrease in the number of blood draws and laboratory tests per patient for infants admitted to the hospital for neonatal hyperbilirubinemia.

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