Proceedings of Patient Reported Outcome Measure’s (PROMs) Conference Oxford 2017: Advances in Patient Reported Outcomes Research

Abstract Background Randomized trials can provide evidence to inform decision-making but this may be limited if the outcomes of importance to patients and clinicians are omitted or reported inconsistently. We aimed to assess the scope and heterogeneity of outcomes reported in trials in peritoneal dialysis (PD). Methods We searched the Cochrane Kidney and Transplant Specialized Register for randomized trials in PD. We extracted all reported outcome domains and measurements and analyzed their frequency and characteristics. Results From 128 reports of 120 included trials, 80 different outcome domains were reported. Overall, 39 (49%) domains were surrogate, 23 (29%) patient-reported and 18 (22%) clinical. The five most commonly reported domains were PD-related infection [59 (49%) trials], dialysis solute clearance [51 (42%)], kidney function [45 (38%)], protein metabolism [44 (37%)] and inflammatory markers/oxidative stress [42 (35%)]. Quality of life was reported infrequently (4% of trials). Only 14 (12%) trials included a patient-reported outcome as a primary outcome. The median number of outcome measures (defined as a different measurement, aggregation and metric) was 22 (interquartile range 13–37) per trial. PD-related infection was the most frequently reported clinical outcome as well as the most frequently stated primary outcome. A total of 383 different measures for infection were used, with 66 used more than once. Conclusions Trials in PD include important clinical outcomes such as infection, but these are measured and reported inconsistently. Patient-reported outcomes are infrequently reported and nearly half of the domains were surrogate. Standardized outcomes for PD trials are required to improve efficiency and relevance.

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Strain Elastography and Tendon Response to an Exercise Program in Patients With Supraspinatus Tendinopathy: An Exploratory Study

Orthopaedic Journal of Sports Medicine ◽

10.1177/2325967120965185 ◽

2020 ◽

Vol 8 (12) ◽

pp. 232596712096518

Author(s):

Karen Brage ◽

Birgit Juul-Kristensen ◽

John Hjarbaek ◽

Eleanor Boyle ◽

Per Kjaer ◽

...

Keyword(s):

Patient Reported Outcomes ◽

Structural Changes ◽

Supraspinatus Tendon ◽

Patient Reported Outcome ◽

Minimal Detectable Change ◽

Detectable Change ◽

Tendon Stiffness ◽

Patient Reported ◽

Tendon Thickness

Background: Shoulder pain is common, with a lifetime prevalence of up to 67%. Evidence is conflicting in relation to imaging findings and pain in the shoulder. Sonoelastography can be used to estimate tissue stiffness and may be a clinically relevant technique for diagnosing and monitoring tendon healing. Purpose: To evaluate changes in supraspinatus tendon stiffness using strain elastography (SEL) and associations with changes in patient-reported outcomes, supraspinatus tendon thickness, and grade of tendinopathy after 12 weeks of unilateral shoulder exercises in patients with supraspinatus tendinopathy. Study Design: Controlled laboratory study. Methods: A total of 23 patients with unilateral clinical supraspinatus tendinopathy performed 12 weeks of “standard care” exercises. At baseline and follow-up, supraspinatus tendon stiffness was measured bilaterally using SEL and compared with tendinopathy grading on magnetic resonance imaging scans and tendon thickness measured using conventional ultrasound. Patient-reported outcome measures included physical function and symptoms from the Disabilities of the Arm, Shoulder and Hand questionnaire and pain rating (visual analog scale). Results: No significant changes in SEL within or between groups (asymptomatic vs symptomatic tendon) were seen. All patient-reported outcomes showed significant improvement from baseline to follow-up, but with no change in tendinopathy grading and tendon thickness. No significant differences in the proportion of patients changing above the minimal detectable change in SEL and PROM were seen, except for discomfort while sleeping. Conclusion: Despite no significant within-group or between-group changes in SEL, significant improvements were found in patient-reported outcomes. An acceptable agreement between patients changing above the minimal detectable change in SEL and patient-reported outcome measure was seen. Further studies should explore the use of SEL to detect changes after tendon repair and long-term training potentially in subgroups of different tendinopathy phases. Clinical Relevance: In the short term, structural changes in supraspinatus tendons could not be visualized using SEL, indicating that a longer time span should be expected in order to observe structural changes, which should be considered before return to sports. Subgrouping based on stage of tendinopathy may also be important in order to evaluate changes over time with SEL among patients with supraspinatus tendinopathy. Registration: NCT03425357 ( ClinicalTrials.gov identifier).

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Acceptability of no-test medical abortion provided via telemedicine: analysis of patient-reported outcomes

BMJ Sexual & Reproductive Health ◽

10.1136/bmjsrh-2020-200954 ◽

2021 ◽

pp. bmjsrh-2020-200954

Author(s):

Chelsey Porter Erlank ◽

Jonathan Lord ◽

Kathryn Church

Keyword(s):

Patient Reported Outcomes ◽

Medical Abortion ◽

Patient Reported Outcome Measures ◽

Patient Reported Outcome ◽

Post Procedure ◽

High Satisfaction ◽

First Choice ◽

Patient Reported ◽

At Home

IntroductionThe English government approved both stages of early medical abortion (EMA), using mifepristone and misoprostol under 10 weeks’ gestation, for at-home use on 30 March 2020. MSI Reproductive Choices UK (MSUK), one of the largest providers of abortion services in England, launched a no-test telemedicine EMA pathway on 6 April 2020. The objectives of this study were to report key patient-reported outcome measures and to assess whether our sample was representative of the whole population receiving no-test telemedicine EMA.MethodsA sample of all MSUK’s telemedicine EMA patients between April and August 2020 were invited to opt in to a follow-up call to answer clinical and satisfaction questions. A total of 1243 (13.7% of all telemedicine EMAs) were successfully followed-up, on average within 5 days post-procedure.ResultsPatients reported high confidence in telemedicine EMA and high satisfaction with the convenience, privacy and ease of managing their abortion at home. The sample responding were broadly equivalent to the whole population receiving telemedicine. No patient reported that they were unable to consult privately. The majority (1035, 83%) of patients reported preferring the telemedicine pathway, with 824 (66%) indicating that they would choose telemedicine again if COVID-19 were no longer an issue.ConclusionsTelemedicine EMA is a valued, private, convenient and more accessible option that is highly acceptable for patients seeking an abortion, especially those for whom in-clinic visits are logistically or emotionally challenging. Evidence that this pathway would be a first choice again in future for most patients supports the case to make telemedicine EMA permanent.

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PROsetta: An R Package for Linking Patient-Reported Outcome Measures

Applied Psychological Measurement ◽

10.1177/01466216211013106 ◽

2021 ◽

pp. 014662162110131

Author(s):

S. W. Choi ◽

S. Lim ◽

B. D. Schalet ◽

A. J. Kaat ◽

D. Cella

Keyword(s):

Patient Reported Outcomes ◽

R Package ◽

Patient Reported Outcome Measures ◽

Patient Reported Outcome ◽

Measurement Information ◽

Short History ◽

Rosetta Stone ◽

Patient Reported ◽

R Packages ◽

Measurement Information System

A common problem when using a variety of patient-reported outcomes (PROs) for diverse populations and subgroups is establishing a harmonized scale for the incommensurate outcomes. The lack of comparability in metrics (e.g., raw summed scores vs. scaled scores) among different PROs poses practical challenges in studies comparing effects across studies and samples. Linking has long been used for practical benefit in educational testing. Applying various linking techniques to PRO data has a relatively short history; however, in recent years, there has been a surge of published studies on linking PROs and other health outcomes, owing in part to concerted efforts such as the Patient-Reported Outcomes Measurement Information System (PROMIS®) project and the PRO Rosetta Stone (PROsetta Stone®) project ( www.prosettastone.org ). Many R packages have been developed for linking in educational settings; however, they are not tailored for linking PROs where harmonization of data across clinical studies or settings serves as the main objective. We created the PROsetta package to fill this gap and disseminate a protocol that has been established as a standard practice for linking PROs.

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Adaptação transcultural dos Bancos de Itens de Ansiedade e Depressão do Patient-Reported Outcomes Measurement Information System (PROMIS) para língua portuguesa

Cadernos de Saúde Pública ◽

10.1590/0102-311x00096113 ◽

2014 ◽

Vol 30 (4) ◽

pp. 879-884 ◽

Cited By ~ 2

Author(s):

Natália Fontes Caputo de Castro ◽

Carlos Henrique Alves de Rezende ◽

Tânia Maria da Silva Mendonça ◽

Carlos Henrique Martins da Silva ◽

Rogério de Melo Costa Pinto

Keyword(s):

Information System ◽

Patient Reported Outcomes ◽

Outcome Measurement ◽

Patient Reported Outcome ◽

Measurement Information ◽

Outcomes Measurement ◽

Patient Reported ◽

Measurement Information System

O Patient-Reported Outcome Measurement Information System (PROMIS), estruturado em domínios físicos e psicossociais, superou lacunas ao propor nova ferramenta de avaliação de resultados aplicáveis às doenças crônicas com base em técnicas avançadas de estatística (TRI) e testes adaptativos computadorizados (CAT). O objetivo do estudo foi adaptar culturalmente os Bancos de Itens de Ansiedade e Depressão do PROMIS para a língua portuguesa. O processo seguiu rigorosas recomendações do FACIT por meio da tradução avançada, reconciliação, retrotradução, revisão do FACIT, revisores independentes, finalização das etapas pelo FACIT, pré-teste e incorporação dos resultados do pré- teste. A versão traduzida foi pré-testada em dez pacientes, sendo necessária a modificação nos itens 3, 46 e 53 de Ansiedade e no item 46 de Depressão. As alterações alcançaram a equivalência de significado e a versão final foi compatível com as habilidades linguísticas e culturais da população brasileira. Concluiu-se que a versão traduzida é semântica e conceitualmente equivalente aos originais.

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Patient-reported outcomes in obsessive-compulsive disorder

Dialogues in Clinical Neuroscience ◽

10.31887/dcns.2014.16.2/msubramaniam ◽

2014 ◽

Vol 16 (2) ◽

pp. 239-254 ◽

Cited By ~ 2

Keyword(s):

Obsessive Compulsive Disorder ◽

Patient Reported Outcomes ◽

Functional Disability ◽

Psychometric Evaluation ◽

Patient Reported Outcome Measures ◽

Patient Reported Outcome ◽

Future Research ◽

Obsessive Compulsive ◽

Compulsive Disorder ◽

Patient Reported

The purpose of the article was to provide an overview of patient-reported outcomes (PROs) and related measures that have been examined in the context of obsessive-compulsive disorder (OCD). The current review focused on patient-reported outcome measures (PROMs) that evaluated three broad outcome domains: functioning, health-related quality of life (HRQoL), and OCD-related symptoms. The present review ultimately included a total of 155 unique articles and 22 PROMs. An examination of the PROs revealed that OCD patients tend to suffer from significant functional disability, and report lower HRQoL than controls. OCD patients report greater symptom severity than patients with other mental disorders and evidence indicates that PROMs are sensitive to change and may be even better than clinician-rated measures at predicting treatment outcomes. Nonetheless, it should be noted that the measures reviewed lacked patient input in their development. Future research on PROMs must involve patient perspectives and include rigorous psychometric evaluation of these measures.

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Patient-Reported Outcomes Measures: An Introduction for Clinicians

Perspectives of the ASHA Special Interest Groups ◽

10.1044/2018_pers-st-2018-0001 ◽

2019 ◽

Vol 4 (1) ◽

pp. 8-15 ◽

Cited By ~ 3

Author(s):

Kathryn Yorkston ◽

Carolyn Baylor

Keyword(s):

Instrument Development ◽

Patient Reported Outcomes ◽

Outcome Measurement ◽

Communication Disorders ◽

Patient Reported Outcome Measures ◽

Patient Reported Outcome ◽

Patient Centered ◽

Outcomes Measures ◽

Patient Reported ◽

Measurement Tools

Patient-reported outcome measures contain information that comes directly from the patient without interpretation by anyone else. These measures are an important part of a clinicians' arsenal of assessment approaches and are critical in the development of patient-centered approaches to intervention. In this introduction to patient-reported outcome measurement tools, a history is provided of this approach to measurement and its place within the context of clinical research and practice. The process of instrument development and application will be reviewed, along with examples of measurement tools from the field of neurological communication disorders. This introduction is supplemented by references that provide interested readers with more detailed information.

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Development and Validation of a Novel Knee-Specific Patient-Reported Outcomes Measure

Journal of Sport Rehabilitation ◽

10.1123/jsr.2019-0264 ◽

2020 ◽

pp. 1-11

Author(s):

James L. Farnsworth ◽

Todd Evans ◽

Helen Binkley ◽

Minsoo Kang

Keyword(s):

Outcome Measures ◽

Patient Reported Outcomes ◽

Patient Reported Outcome Measures ◽

Patient Reported Outcome ◽

Measurement Properties ◽

Partial Credit Model ◽

Partial Credit ◽

Specific Patient ◽

Patient Reported ◽

Full Study

Context: Previous research suggests that several knee-specific patient-reported outcome measures have poor measurement properties. The patient-reported outcomes knee assessment tool (PROKAT) was created to improve assessment of knee-specific function. Examination of the measurement properties of this new measure is critical to determine its clinical value. Objective: Examine the measurement properties of the PROKAT. Design: Cross-sectional study. Setting: Clinical athletic training setting. Patients or Other Participants: The pilot study included 32 student-athletes (mean age = 20.78 [1.01], males = 56.30%). The full study included 203 student-athletes (mean age = 21.46 [4.64], males = 54.70%) from 3 separate institutions. The participants were recruited for both the pilot and full study using face-to-face and electronic (eg, email and social media sites) communications. Intervention(s): Evaluation of the measurement properties of the PROKAT occurred using the Rasch partial-credit model. Main Outcome Measures: Infit and outfit statistics, item step difficulties, person ability parameters, category function, item and test information functions, and Cronbach alpha. An independent samples t test was used to evaluate the differences in injured and noninjured athletes’ scores. Results: The Rasch partial-credit model analysis of pilot test items and qualitative participant feedback were used to modify the initial PROKAT. Evaluation of the revised PROKAT (32 items) indicated 27 items had acceptable model–data fit. The injured athletes scored significantly worse than the noninjured athletes (t188 = 12.89; P < .01). The ceiling effects for the PROKAT were minimal (3.9%). Conclusions: A major advantage of this study was the use of the Rasch measurement and the targeted population. Compared with alternative knee-specific patient-reported outcome measures (eg, Knee Injury Osteoarthritis Outcome Score, International Knee Documentation Committee Subjective Knee Form), the PROKAT has low ceiling effects in athletic populations. In addition, evidence suggests the measure may be capable of distinguishing between injured and noninjured athletes.

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Generic Patient-Reported Outcomes and Outcome Measures: A Systematic Review Study Protocol

10.1101/2021.05.28.21257980 ◽

2021 ◽

Author(s):

Yuki Seidler ◽

Erika Mosor ◽

Margaret R Andrews ◽

Carolina Watson ◽

Nick Bott ◽

...

Keyword(s):

Systematic Review ◽

Outcome Measures ◽

Systematic Reviews ◽

Patient Reported Outcomes ◽

Outcome Measurement ◽

Meta Analysis ◽

Patient Reported Outcome ◽

Cochrane Library ◽

Screening Process ◽

Patient Reported

Background: Patient-reported outcomes (PROs) are an essential part of health outcome measurement and vital to patient-centricity and valued-based care. Several international consortia have developed core outcome sets and many of them include PROs. PROs are measured by patient-reported outcome measures (PROMs). PROs and PROMs can be generic or specific to certain diseases or conditions. While the characteristics of generic PROs and PROMs are well recognised as widely relevant and applicable across different domains, diseases and conditions, there is a lack of knowledge on the types of PROs measured by generic PROMs. We also do not know in which disease areas generic PROs and PROMs are commonly used. To date, there has been no systematic review solely focusing on generic PROMs, what they measure and their areas of application. Objectives: This systematic review will identify core PROs measured by generic PROMs used in adult populations and the areas in which they are applied. Methods: We will conduct a systematic review of reviews. The screening process and the reporting will comply with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis) 2020 Statement. We will use four databases, Medline [PubMed], CINHAL [Ebsco], Cochrane [Cochrane Library], and PsycINFO [Ovid], and reports from international consortia. Inclusion criteria are systematic reviews, meta-analysis or patient-reported outcome sets developed by international consortia reporting on generic PROMs in adult populations. Articles primarily focusing on patient-reported experience measures (PREMs), children or adolescents, or those not written in English will be excluded. Risk of bias will be assessed by checking if the included articles comply with established guidelines for systematic reviews such as the PRISMA statement. We will extract generic PROMs and PROs measured by these PROMs, and the areas applied from the selected articles and reports. Extracted data and information will be quantitatively and qualitatively synthesised without statistical interference. The quality of the synthesised evidences will be assessed by clarifying the strengths, limitations and possible biases in our review.

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