Standards for evaluating patient-reported outcome (PRO)-based performance measures.

2012 ◽  
Vol 30 (34_suppl) ◽  
pp. 45-45
Author(s):  
Ethan M. Basch ◽  
Christine Goertz ◽  
Keri Christenson ◽  
Amaris Crawford ◽  
R. Adams Dudley ◽  
...  
Keyword(s):  
Performance Improvement ◽  
Performance Measures ◽  
Patient Reported Outcomes ◽  
Patient Perspective ◽  
Patient Reported Outcome ◽  
Lessons Learned ◽  
Use Cases ◽  
Use Case ◽  
Patient Reported ◽  
Measurement Strategies

45 Background: There is growing interest to use performance measures that integrate patient-reported outcomes (PROs), but there are no existing methodological standards for developing, implementing, or analyzing such measures in this context. Methods: To develop standards for evaluating PRO-based performance measures submitted to or developed by the American Medical Association-convened Physician Consortium for Performance Improvement, a multi-disciplinary expert technical panel was assembled. A systematic literature review and landscape overview were conducted to identify use cases and existing PRO standards in related contexts. Lessons learned from use cases and existing standards guided development of discrete methodological standards. Results: The systematic review identified only one use case, whereas the landscape overview identified eight. Five purposes were identified for which PROs might be measured to assess performance, including one categorized as process and four as outcome. Eight discrete methodological standards were developed which will be detailed at the meeting. Conclusions: The patient perspective is an essential but missing component of performance evaluation. When appropriately elicited, data from patients can be informative. Lack of adherence to good practices and inadequate patient input when developing measurement strategies are potential pitfalls to be avoided.

Patient Perspective Workshop: Moving Towards OMERACT Guidelines for Choosing or Developing Instruments to Measure Patient-Reported Outcomes

2011 ◽  
Vol 38 (8) ◽  
pp. 1711-1715 ◽  
Author(s):  
JOHN R. KIRWAN ◽  
JAMES F. FRIES ◽  
SARAH E. HEWLETT ◽  
RICHARD H. OSBORNE ◽  
STANTON NEWMAN ◽  
...  
Keyword(s):  
Instrument Development ◽  
Research Agenda ◽  
Patient Reported Outcomes ◽  
Patient Perspective ◽  
Patient Reported Outcome ◽  
Discussion Groups ◽  
Reading Material ◽  
Complex Process ◽  
Patient Reported ◽  
New Instruments

The workshop Choosing or Developing Instruments held at the Outcome Measures in Rheumatology (OMERACT) 10 meeting was designed to help participants think about the underlying methods of instrument development. Conference pre-reading material and 3 brief introductory presentations elaborated the issues, and participants broke into discussion groups before reconvening to share insights, engage in a more general discussion of the issues, and vote on recommendations. Tradeoffs between using current imperfect measures and the long and complex process of developing new instruments were considered, together with the need for rigor in patient-reported outcome (PRO) instrument development. The main considerations for PRO instrument development were listed and a research agenda for action produced. As part of the agenda for action, it is recommended that researchers and patient partners work together to tackle these issues, and that OMERACT bring forward proposals for acceptable instrument development protocols that would meet an enhanced “Truth” statement in the OMERACT Filter.

Optimizing electronic capture of patient-reported outcome measures in oncology clinical trials: lessons learned from a qualitative study

2020 ◽  
Vol 9 (17) ◽  
pp. 1195-1204
Author(s):  
Florence D Mowlem ◽  
Brad Sanderson ◽  
Jill V Platko ◽  
Bill Byrom
Keyword(s):  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Lessons Learned ◽  
Structured Interviews ◽  
Patient Reported ◽  
Oncology Clinical Trials ◽  
Anticancer Treatment ◽  
Fit For Purpose ◽  
The Impact ◽  
Electronic Implementation

Aim: To understand the impact of anticancer treatment on oncology patients’ ability to use electronic solutions for completing patient-reported outcomes (ePRO). Materials & methods: Semi-structured interviews were conducted with seven individuals who had experienced a cancer diagnosis and treatment. Results: Participants reported that the following would impact the ability to interact with an ePRO solution: peripheral neuropathy of the hands (4/7), fatigue and/or concentration and memory issues (6/7), where they are in a treatment cycle (5/7). Approaches to improve usability included: larger, well-spaced buttons to deal with finger numbness, the ability to pause a survey and complete at a later point and presenting the recall period with every question to reduce reliance on memory. Conclusion: Symptoms associated with cancers and anticancer treatments can impact the use of technologies. The recommendations for optimizing the electronic implementation of patient-reported outcome instruments in this population provides the potential to improve data quality in oncology trials and places patient needs at the forefront to ensure ‘fit-for-purpose’ solutions.

scholarly journals Scope and heterogeneity of outcomes reported in randomized trials in patients receiving peritoneal dialysis

2020 ◽  
Author(s):  
Karine E Manera ◽  
David W Johnson ◽  
Yeoungjee Cho ◽  
Benedicte Sautenet ◽  
Jenny Shen ◽  
...  
Keyword(s):  
Peritoneal Dialysis ◽  
Patient Reported Outcomes ◽  
Randomized Trials ◽  
Primary Outcome ◽  
Median Number ◽  
Patient Reported Outcome ◽  
Patient Reported ◽  
Inform Decision Making ◽  
Solute Clearance

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.

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

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).

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

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.

scholarly journals SP-0146: Patient perspective of quality. patient-reported outcomes vs physician reported outcomes

2015 ◽  
Vol 115 ◽  
pp. S70-S71
Author(s):  
K. Kirchheiner ◽  
R.A. Nout ◽  
K. Tanderup ◽  
J.C. Lindegaard ◽  
W. Dörr ◽  
...  
Keyword(s):  
Patient Reported Outcomes ◽  
Patient Perspective ◽  
Patient Reported

Overview of the Patient Perspective at OMERACT 10 — Conceptualizing Methods for Developing Patient-Reported Outcomes

2011 ◽  
Vol 38 (8) ◽  
pp. 1699-1701 ◽  
Author(s):  
JOHN R. KIRWAN ◽  
PETER S. TUGWELL
Keyword(s):  
Clinical Trials ◽  
Experimental Work ◽  
Patient Reported Outcomes ◽  
Patient Perspective ◽  
Methodological Issues ◽  
Instrument Selection ◽  
Patient Reported ◽  
The Impact ◽  
Choice Of Instruments ◽  
The Way

This overview draws out the main conclusions from the 4 workshops focused on incorporating the patient perspective into outcome assessment at the 10th Outcome Measures in Rheumatology (OMERACT 10) conference. They raised methodological issues about the choice of outcome domains to include in clinical trials, the development or choice of instruments to measure these domains, and the way these instruments might capture the impact of a disease and its treatment. The need to develop a more rigorous conceptual model of quantifying the way conditions affect health, and the need to ensure patients are directly involved in the decisions about domains and instruments, emerged clearly. The OMERACT participants voted to develop guidelines for domain and instrument selection, and conceptual and experimental work will be brought forward to revise and upgrade the OMERACT Filter.

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

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.

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

2014 ◽  
Vol 30 (4) ◽  
pp. 879-884 ◽  
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.

scholarly journals Patient-reported outcomes in obsessive-compulsive disorder

2014 ◽  
Vol 16 (2) ◽  
pp. 239-254 ◽  
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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