Role Of Patient-reported Outcome Measures Research Articles

Patient-Reported Outcomes Following Periprosthetic Joint Infection of the Hip and Knee: A Longitudinal, Prospective Observational Study.

The role of patient-reported outcome measures (PROMs) as tools for monitoring the impact and outcomes of periprosthetic joint infection (PJI) is not well described. This study analyzed the Oxford Hip Score (OHS) or Oxford Knee Score (OKS) in a prospective observational cohort of patients with hip or knee PJI. The PIANO (Prosthetic joint Infection in Australia and New Zealand, Observational study) cohort prospectively enrolled patients with newly diagnosed PJI from multiple centers. The OHS and OKS were evaluated at PJI diagnosis (baseline) and at 3, 12, and 24 months. Scores and score changes were examined according to PJI type, patient characteristics, and management. A successful functional outcome at 12 months was defined as an OHS of >38 or OHS of >36 and/or an improvement from baseline of >12 or >9, respectively. Of the 741 participants, PROMs were available at 12 months for 233 with hip and 342 with knee PJI. Significant improvements (p < 0.0001) were seen at 12 months for both the OHS (24.5 to 36) and OKS (25 to 34), with no further improvement at 24 months. Patients with late-acute PJI had a higher median baseline OHS (35; interquartile range [22 to 46]) and OKS (30 [18 to 41]) than those with early PJI (OHS: 19 [15 to 29]; OKS: 22 [16 to 29.5]) or chronic PJI (OHS: 23 [14 to 34]; OKS 22 [14 to 28]). Logistic regression showed that a clinical cure (adjusted odds ratio [aOR] = 1.88, 95% confidence interval [CI] = 1.28 to 2.76, p = 0.001) and early PJI (aOR = 2.56, 95% CI = 1.64 to 4.07, p < 0.0001) independently predicted a successful functional outcome. Chronic renal impairment (aOR = 0.31, 95% CI = 0.13 to 0.71, p = 0.007), congestive cardiac failure (aOR = 0.41, 95% CI = 0.17 to 0.95, p = 0.04), and clinical signs of inflammation (aOR = 0.53, 95% CI = 0.33 to 0.85, p = 0.009) at diagnosis independently predicted failure to achieve a successful functional outcome. The OHS and OKS varied significantly at baseline and 12 months according to PJI type, emphasizing the need to consider the PJI type when evaluating treatment success. This study highlights superior functional outcomes associated with early PJI and with achievement of a clinical cure. Therapeutic Level II . See Instructions for Authors for a complete description of levels of evidence.

Role of patient-reported outcome measures in the management of chronic urticaria and angioedema

Due to the lack of reliable biomarkers, patient-reported outcome measures (PROMs) have a crucial role in assessing and monitoring the progression of chronic urticaria (CU) and angioedema (AE). PROMs are described as “any report coming directly from subjects without interpretation of the physician or others about how they function overall or feel in relation to a condition and its therapy.” There are four urticaria-specific PROMs, namely, urticaria activity score (UAS), urticaria control test (UCT), CU quality of life (QoL) questionnaire, and urticaria severity score. UAS7 is the most widely used, simple, and validated scoring system to estimate disease activity in chronic spontaneous urticaria cases. UCT on the other hand is a retrospective assessment of the current control of the disease after initiation of the treatment. The current EAACI/GA2LEN/EuroGuiDerm/APAAACI international urticaria guidelines suggest the use of UCT for stepping up or stepping down in the treatment of urticaria. Similarly, the severity and control of AE can be assessed by two PROMs, namely, AE activity score and AE QoL questionnaire.

Research Trends of Patient-Reported Outcome Measures in Orthopedic Medical Practices: A Bibliometric and Visualized Study.

Background and Objectives: Patient-reported outcome measures (PROMs), also known as self-report measures, are critical tools for evaluating health outcomes by gathering information directly from patients without external interpretation. There has been a growing trend in the number of publications focusing on PROMs in orthopedic-related research. This study aims to identify the most valuable publications, influential journals, leading researchers, and core countries in this field using bibliometric analysis, providing researchers with an understanding of the current state and future trends of PROMs in orthopedic research. Materials and Methods: All PROMs in orthopedic-related publications from 1991 to 2022 were obtained from the WoSCC database. R software (version 4.2.2), VOSviewer (version 1.6.17), and Microsoft Excel (version 2303) were used for the bibliometric and visual analysis. Results: A total of 2273 publication records were found from 1991 to 2022. The results indicated that the United States (US) has made significant contributions to orthopedic-related PROMs. The majority of active research institutions are located in the US. J ORTHOP RES has published the most articles. J BONE JOINT SURG AM has the highest total citations. Conclusions: Our study provides a valuable reference for further exploration of the application of PROMs in orthopedics. PROMs have emerged as an increasingly popular area of research within the field of orthopedics, both in clinical practice and academic research. We conducted a bibliometric analysis in terms of journals, authors, countries, and institutions in this field. Additionally, we analyzed the potentialities and advantages of using PROMs in orthopedic research. There is an increasing trend towards using network-based or short message service (SMS)-based electronic patient-reported outcome measures (ePROMs) in orthopedic medical practices. It is anticipated that the role of PROMs in psychological and mental health research and telemedicine will continue to grow in importance.

The role of patient-reported outcome measures in trials of artificial intelligence health technologies: a systematic evaluation of ClinicalTrials.gov records (1997-2022).

The extent to which patient-reported outcome measures (PROMs) are used in clinical trials for artificial intelligence (AI) technologies is unknown. In this systematic evaluation, we aim to establish how PROMs are being used to assess AI health technologies. We searched ClinicalTrials.gov for interventional trials registered from inception to Sept 20, 2022, and included trials that tested an AI health technology. We excluded observational studies, patient registries, and expanded access reports. We extracted data regarding the form, function, and intended use population of the AI health technology, in addition to the PROMs used and whether PROMs were incorporated as an input or output in the AI model. The search identified 2958 trials, of which 627 were included in the analysis. 152 (24%) of the included trials used one or more PROM, visual analogue scale, patient-reported experience measure, or usability measure as a trial endpoint. The type of AI health technologies used by these trials included AI-enabled smart devices, clinical decision support systems, and chatbots. The number of clinical trials of AI health technologies registered on ClinicalTrials.gov and the proportion of trials that used PROMs increased from registry inception to 2022. The most common clinical areas AI health technologies were designed for were digestive system health for non-PROM trials and musculoskeletal health (followed by mental and behavioural health) for PROM trials, with PROMs commonly used in clinical areas for which assessment of health-related quality of life and symptom burden is particularly important. Additionally, AI-enabled smart devices were the most common applications tested in trials that used at least one PROM. 24 trials tested AI models that captured PROM data as an input for the AI model. PROM use in clinical trials of AI health technologies falls behind PROM use in all clinical trials. Trial records having inadequate detail regarding the PROMs used or the type of AI health technology tested was a limitation of this systematic evaluation and might have contributed to inaccuracies in the data synthesised. Overall, the use of PROMs in the function and assessment of AI health technologies is not only possible, but is a powerful way of showing that, even in the most technologically advanced health-care systems, patients' perspectives remain central.

Not an awkward high school dance! Highlighting the growing importance of patient-reported outcome measures (PROMs) in chronic limb-threatening ischemia

Not an awkward high school dance! Highlighting the growing importance of patient-reported outcome measures (PROMs) in chronic limb-threatening ischemia

Value-Based Mental Health Services for Youth and Families: The Role of Patient-Reported Outcome Measures in Youth Mental Health Services

Value-Based Mental Health Services for Youth and Families: The Role of Patient-Reported Outcome Measures in Youth Mental Health Services

Value-Based Mental Health Services for Youth and Families: The Role of Patient-Reported Outcome Measures in Youth Mental Health Services

In Alberta, the responsibility for youth mental-health is shared among three separate government ministries, compounding the challenge of determining the value of services delivered, especially from the youth’s own perspective. As a result, Alberta’s ability to measure service quality at the systems level is limited. Yet, given the short-term and long-term effects of poor mental health on youth, families, and society, there are clinical, moral, and economic imperatives for ensuring that all services provided are of the highest value possible. Currently, Alberta is limited to estimating value mainly through quantitative measures focused on the cost of service delivery. However, value-based healthcare services are measured as quality or outcomes for persons receiving health services in relation to the costs of delivering those services. One approach is to measure outcomes of youth receiving mental-health services from their own perspective to achieve value-based measurement of youth mental-health services. Patient-reported outcome measures (PROMs) are questionnaires filled out by the persons receiving mental-health services themselves, and assess their self-reported health and well-being. PROMs have been shown to be important in evaluating the value of health-care services both at the individual and systems level. At the individual level, PROMs allow patients and health-care providers to track progress over time. At the systems level, PROMs data can be compiled to evaluate trends between different sites or different health-care services or treatments over time, to help improve quality. Policy-makers can use these comparisons to help pinpoint which services offer the most value. Given resource constraints, implementing PROMs province-wide in Alberta can improve the value of youth mental-health services at a time when they have become a matter of great urgency. Improving the quality and outcomes for youth and their families in the short term will deliver positive socioeconomic impacts in the future.

PDB32 Integration of Patient-Reported Outcome Measures in the Evaluation of Digital Health Solutions: Research in Diabetes

Although the field of Digital Health Solutions (DHS) for improving outcomes in diabetes has evolved rapidly over the last 20 years, there are still significant challenges in generating relevant evidence and demonstrating the value such solutions bring to patients and the overall health-care value chain. Research was conducted to review guidelines from national health authorities regarding patient outcomes to consider in the evaluation of DHS and to determine if existing Patient-Reported Outcome Measures (PROMs) are adequate tools for assessing the value of DHS. Guidelines for evaluating DHS from national health authorities in France (HAS), Germany (BfArM), the UK (NICE), and the US (FDA) were reviewed. Recommended patient outcomes were retrieved, as well as the role of PROMs in assessing them. In addition, a list of PROMs used in diabetes care was identified from the ProQolid database, Clinicaltrials.gov and PubMed. Each instrument was evaluated on multiple attributes, including previous use in assessing DHS, and classified by patient value domain. Five guidelines were reviewed identifying 12 domains of patient outcomes. Most guidelines focused on a particular type of DHS and there was no consensus across guidelines on patient outcomes. Nevertheless, all health authorities recognize PROMs as important tools to demonstrate the value of DHS. Overall, 62 PROMs were identified (46 diabetes-specific and 16 non-diabetes-specific) in the literature. There was a clear alignment between some of the outcomes covered in both the guidelines and PROMs, such as satisfaction, empowerment, health literacy, adherence and quality of life. However, some patient outcomes in the guidelines were poorly covered by (existing) PROMs, such as engagement, autonomy in daily life, coping strategies and reduction of efforts. It is urgent to develop frameworks aiming at integrating relevant domains of patient value in the evaluation of DHS to ensure alignment across national jurisdictions in reimbursement processes.

Optimal assessment tools in assessing breast surgery: patient reported outcome measures (PROMs) vs. objective measures.

Improving the health-related quality of life (HRQoL) of patients is the fundamental aim of aesthetic breast surgery and its importance is increasingly recognised in breast cancer-related surgery. There has been growing acceptance of the value of assessing physical, psychological and social well-being through patient reported outcome measures (PROMs). It is important to consider the role of PROMs in relation to objective measures to ensure that the optimal assessment tools are selected when assessing outcomes in breast surgery. A narrative review was conducted of published articles identified on Ovid Medline by searching the terms: patient reported outcome measures, quality of life (QoL), functional outcomes, aesthetic outcomes, complications and breast surgery. Reference lists were also examined to find relevant articles not detected through the search. Survival and mortality are outcomes of immense importance in breast surgery that are not suitable for assessment through PROMs and should be measured objectively. Post-operative complication rates and markers of their severity are most appropriately assessed using objective measures, however, patients may provide valuable insights into the impact complications have on their QoL. All current assessment tools for assessing aesthetic outcome have inherent limitations, and thus it is likely that both subjective and objective measures are required to comprehensively assess aesthetic outcomes in breast surgery. Physical dysfunction can be assessed objectively, however, PROMs may better evaluate physical well-being, reflecting the real-life implications of a change in function. Psychological and social well-being is irrefutably personal in nature and best assessed through PROMs. There is no one optimal assessment tool for assessing breast surgery outcomes. Utilising a combination of PROMs and objective measures is necessary to accurately and comprehensively evaluate the impact and effectiveness of surgical breast interventions.

Health Data Processes: A Framework for Analyzing and Discussing Efficient Use and Reuse of Health Data With a Focus on Patient-Reported Outcome Measures.

The collection and use of patient health data are central to any kind of activity in the health care system. These data may be produced during routine clinical processes or obtained directly from the patient using patient-reported outcome (PRO) measures. Although efficiency and other reasons justify data availability for a range of potentially relevant uses, these data are nearly always collected for a single specific purpose. The health care literature reflects this narrow scope, and there is limited literature on the joint use of health data for daily clinical use, clinical research, surveillance, and administrative purposes. The aim of this paper is to provide a framework for discussing the efficient use of health data with a specific focus on the role of PRO measures. PRO data may be used at an individual patient level to inform patient care or shared decision making and to tailor care to individual needs or group-level needs as a complement to health record data, such as that on mortality and readmission, in order to inform service delivery and measure the real-world effectiveness of treatment. PRO measures may be used either for their own sake, to provide valuable information from the patient perspective, or as a proxy for clinical data that would otherwise not be feasible to collect. We introduce a framework to analyze any health care activity that involves health data. The framework consists of four data processes (patient identification, data collection, data aggregation and data use), further structured into two dichotomous dimensions in each data process (level: group vs patient; timeframe: ad hoc vs systematic). This framework is used to analyze various health activities with respect to joint use of data, considering the technical, legal, organizational, and logistical challenges that characterize each data process. Finally, we propose a model for joint use of health data with data collected during follow-up as a base. Demands for health data will continue to increase, which will further add to the need for the concerted use and reuse of PRO data for parallel purposes. Repeated and uncoordinated PRO data collection for the same patient for different purposes results in misuse of resources for the patient and the health care system as well as reduced response rates owing to questionnaire fatigue. PRO data can be routinely collected both at the hospital (from inpatients as well as outpatients) and outside of hospital settings; in primary or social care settings; or in the patient’s home, provided the health informatics infrastructure is in place. In the future, clinical settings are likely to be a prominent source of PRO data; however, we are also likely to see increased remote collection of PRO data by patients in their own home (telePRO). Data collection for research and quality surveillance will have to adapt to this circumstance and adopt complementary data capture methods that take advantage of the utility of PRO data collected during daily clinical practice. The European Union’s regulation with respect to the protection of personal data—General Data Protection Regulation—imposes severe restrictions on the use of health data for parallel purposes, and steps should be taken to alleviate the consequences while still protecting personal data against misuse.

Quality improvement in vascular access: The role of patient-reported outcome measures.

Quality improvement initiatives should be aimed to enhance clinical outcomes, service delivery and quality of life for patients. For patients reliant on haemodialysis, vascular access is a lifeline. Survival differences relating to the type of vascular access are evident and many initiatives have focussed on increasing absolute rates of arteriovenous fistulas and/or decreasing central venous catheter use. While these have achieved some success quantitatively, the qualitative effects are less obvious. The aims of this review article are to explore the concepts of quality of care in vascular access. There is a paucity of studies into the effects of vascular access on the quality of life of dialysis patients, and where studies have been performed, generalised patient-reported outcome measures have been used. To facilitate the implementation of quality improvement programmes specifically for vascular access requires suitable tools. While existing patient-reported outcome measures may be applicable to vascular access, it is likely that these will require further evaluation, and the development of vascular access-specific patient-reported outcome measures may be required.

The Role of Patient-Reported Outcome Measures in Value-Based Payment Reform.

The U.S. health care system is currently experiencing profound change. Pressure to improve the quality of patient care and control costs have caused a rapid shift from traditional volume-driven fee-for-service reimbursement to value-based payment models. Under the 2015 Medicare Access and Children's Health Insurance Program Reauthorization Act, providers will be evaluated on the basis of quality and cost efficiency and ultimately receive adjusted reimbursement as per their performance. Although current performance metrics do not incorporate patient-reported outcome measures (PROMs), many wonder whether and how PROMs will eventually fit into value-based payment reform. On November 17, 2016, the second annual Patient-Reported Outcomes in Healthcare Conference brought together international stakeholders across all health care disciplines to discuss the potential role of PROs in value-based health care reform. The purpose of this article was to summarize the findings from this conference in the context of recent literature and guidelines to inform implementation of PROs in value-based payment models. Recommendations for evaluating key perspectives and measurement goals are made to facilitate appropriate use of PROMs to best benefit and amplify the voice of our patients.

Orthodontics and oral health-related quality of life

This article presents an overview of oral health-related quality of life (OHRQoL) with particular relevance to the impact of malocclusion and hence orthodontic treatment on OHRQoL. The role of patient-reported outcome measures in assessing quality of life is explained with evidence from literature

Role of Patient-Reported Outcome Measures in the Assessment of Central Nervous System Agents

This work aimed to provide an understanding of the current use and regulatory acceptability of patient-reported outcome (PRO) measures in labeling claims for central nervous system (CNS) agents. A subset of CNS agents was identified from all New Drug Approvals and Biologic License Applications for new drugs approved in the US from January 2006 to June 2012. Clinician-reported outcomes (ClinROs) (62%) and PROs (38%) were the most widely used primary outcome measures. The PROs were frequently used in combination with ClinROs. Twelve PRO claims were granted across 41% of CNS drug approvals: 83%, symptoms; 17%, functioning. The PROs are frequently utilized as primary and secondary end points in CNS agents, and labeling claims are granted at higher levels than for non-CNS agents (41% vs 24%, respectively). These claims are granted at a lower rate than expected, given that direct patient input may lend valuable insight to treatment impacts in most CNS diseases.

PROMs in inflammatory arthritis: moving from static to dynamic

There are several advantages in using patient-reported outcome measures (PROMs) in standard clinical practice, particularly if a questionnaire is distributed to each patient at each visit as a standard in the infrastructure usual care. The patients, being the most knowledgeable persons concerning their pain and global estimate, do most of the work by completing a questionnaire. Completion of the questionnaire helps the patients prepare for their visit as well as improving doctor-patient communication. Recently, the role of PROMs has expanded from the static phase of capturing and measuring outcomes at a single point of time to a more dynamic role. This dynamic role is aiming at driving improvement not only in the quality of inflammatory arthritis care but also in the patients' reported experience. Therefore, in addition to its value in tailoring treatment targets adapted to the patient's needs, PROMs also have the potential of modifying the disease impact through improving the patients' adherence to therapy and allowing the patients to monitor the changes in their condition. Though more attention has been given to the use of PROMs in routine clinical care, little was published regarding what could be done with the plethora of data gained from PROMs and how dynamic it can be enhancing the "patient-centered care" approach and improving patients' experience. This article highlights the value of adopting PROMs for arthritic patients in standard clinical practice and its impact on long-term patients' management.

Cancer outcomes measurement

In 2001, the U.S. National Cancer Institute established the Cancer Outcomes Measurement Working Group (COMWG) to evaluate and advance the state of the science in patient-reported outcome (PRO) measurement, with a focus on health-related quality of life (HRQOL). To guide its work, the COMWG adopted the revised Medical Outcomes Trust (MOT) attributes and review criteria for evaluating health status and quality-of-life instruments. With the MOT attributes providing the organizing principle, this paper summarizes and draws inferences from key COMWG findings about the methodological soundness of HRQOL assessment in cancer and steps required to move the field forward. Across a range of cancer research applications, especially clinical trials, a variety of generic, general cancer, and cancer site-specific measures of HRQOL have demonstrated adequate reliability, validity, responsiveness, feasibility, and cultural and language adaptation. Methodological challenges remain in the interpretability of HRQOL measures, though substantial progress has been made in defining a "minimum important difference" in scale scores. Much work remains in forging a stronger link between the conceptual model and measurement model in HRQOL instrumentation. Progress along all MOT attributes will likely accelerate with the growing application of modern psychometrics, particularly item response theory modeling, which provides the underpinnings for item banking and computer-adaptive assessment of HRQOL. Future research should emphasize prospectively designed studies to evaluate PRO measures within the MOT framework and in-depth investigations of the role of PRO measures in cancer decision making at all levels.