Development Of Patient-reported Outcome Measures Research Articles

A multi-phase approach for developing a conceptual model and preliminary content for patient-reported outcome measurement in TKA patients: from a Chinese perspective.

Patient-reported outcome measures (PROMs) are being used more frequently in total knee arthroplasty (TKA). By utilizing high-quality scales, surgeons can achieve a more comprehensive and accurate evaluation of the effectiveness of TKA surgery. Currently, there is no widely accepted conceptual model for TKA PROMs. The objective of this study is to fill this gap by developing a conceptual model and preliminary content for a PROM that is specifically designed for TKA patients in mainland China. The study design consisted of three stages: (1) a targeted literature review followed by the formation of a conceptual model pool; (2) qualitative data collection involving experts and patients, leading to the development of the preliminary Chinese TKA PROM (CTP); and (3) review of the CTP by experts using the Delphi method, along with cognitive debriefing interviews with patients. 64 patients and 28 experts took part in this study. The conceptual model focused on six key concepts: pain, symptom, function, quality of life, expectation, and satisfaction. To match the model, the authors developed a total of 35 items. A conceptual model and preliminary content for CTP was developed with substantial participation from patients and a multidisciplinary group of experts. The integration of patient and clinical perspectives ensured a comprehensive representation of all relevant disease experiences and the focus of clinical practice. With further refinement through psychometric testing, the CTP is positioned to provide a standardized, comprehensive measure for research specific to Chinese TKA patients.

A systematic review and mapping exercise to assess the content validity of patient-reported outcome measures for adults having reconstructive surgery of the lower limb.

Lower limb reconstruction (LLR) has a profound impact on patients, affecting multiple areas of their lives. Many patient-reported outcome measures (PROMs) are employed to assess these impacts; however, there are concerns that they do not adequately capture all outcomes important to patients, and may lack content validity in this context. This review explored whether PROMs used with adults requiring, undergoing, or after undergoing LLR exhibited content validity and adequately captured outcomes considered relevant and important to patients. A total of 37 PROMs were identified. Systematic searches were performed to retrieve content validity studies in the adult LLR population, and hand-searches used to find PROM development studies. Content validity assessments for each measure were performed following Consensus-based Standards for the selection of health measurement Instruments (COSMIN) guidelines. A mapping exercise compared all PROMs to a conceptual framework previously developed by the study team ('the PROLLIT framework') to explore whether each PROM covered important and relevant concepts. The systematic searches found 13 studies, while hand searches found 50 PROM development studies, and copies of all 37 measures. Although several studies discussed content validity, none were found which formally assessed this measurement property in the adult LLR population. Development of many PROMs was rated as inadequate, no PROM had sufficient content validity in the study population, and none covered all areas of the PROLLIT framework. The LIMB-Q was the most promising and comprehensive measure assessed, although further validation in a wider sample of LLR patients was recommended. Current PROMs used in adults requiring, undergoing, or after undergoing LLR lack content validity and do not assess all important and relevant outcomes. There is an urgent need for improved outcome measurement in this population. This can be achieved through development of a new PROM, or through validation of existing measures in representative samples.

Patient-Reported Outcome Measures for Mohs Reconstruction: A Systematic Review.

Mohs micrographic surgery (MMS) and subsequent reconstructive procedures for the treatment of facial nonmelanoma skin cancers (NMSCs) significantly impact quality of life (QoL). A validated patient-reported outcome measure (PROM) for patients who undergo Mohs reconstruction is not yet established. This study aims to systematically assess the quality of existing PROMs to determine their effectiveness in capturing the challenges faced after Mohs reconstruction for facial NMSC. A systematic review following established Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines was performed. Medline, PubMed, Scopus, and Cochrane databases were searched using keywords relevant to MMS, NMSC, facial reconstruction, QoL, and PROMs. Inclusion and exclusion criteria were used to compile eligible PROMs. Methodological quality and psychometric properties of PROMs were evaluated using COnsensus-based Standards for the Selection of Health Measurement Instruments (COSMIN) criteria. Of 2997 articles, 78 met the inclusion criteria. Of these, 45 studies utilized a PROM as an outcome measure, and 33 reported PROM development or validation. COSMIN assessment demonstrated that the FACE-Q Skin Cancer Module and Facial Skin Cancer Index have the strongest validation. The Mohs Reconstruction Questionnaire-12 (MRQ-12) was the only PROM specific to this population of interest; however, it has not undergone psychometric property assessment. Various PROMs have been utilized to assess QoL for patients undergoing facial reconstructive surgery after MMS. A clinically validated PROM specific to this patient population is required to gain deeper insight into these emotional impacts. Further validation and psychometric testing of the MRQ-12 may be beneficial.

Review on the Burden of Episodic Migraine and Utilization of Patient Reported Outcome Measures.

Migraine affects a large portion of the world's population. Migraine encompasses a broad range of symptoms, with broad reaching ramifications in the form of Health-Related Quality of Life (HRQoL) factors. In our review we sought to understand the aspects encompassing the burden of disease on both an individual and population level. Furthermore, we reviewed the development and incorporation of Patient Reported Outcome Measures (PROM), questionnaires that assess HRQoL in real time, in how they have been incorporated in clinical research up to now and how they can be utilized in clinical practice moving forward. It has been shown that there is much heterogeneity within the field in PROM development processes as well as their utilization in episodic migraine (EM) clinical trials. Furthermore, they are inconsistently used in clinical practice. Among the most commonly used PROMs, the MSQv2.1 is among the most valid and reliable. Beyond that, it also shows promise to help in guidance of clinical management of migraine.

Development and validation of MyCommunication-Adults, a self-report communicative participation measure.

People with communication problems experience challenges in participation. Optimizing communicative participation for this population is an important outcome of speech and language therapy. Participation experiences are best assessed from the patient's perspective, using a patient-reported outcome measure (PROM). The Communicative Participation Item Bank (CPIB) has been developed to identify perceived problems in communicative participation. However, previous research has shown that the item bank does not cover all domains and concepts of communicative participation, contains general communication items, and is not suitable for all people with communication problems. To develop a comprehensive PROM aimed at measuring communicative participation for all adults with communication problems and test its content validity. An initial pool of 242 items was based on three sources: relevant content from an earlier literature review and concept elicitation study, and the translation of the items of the CPIB. This item pool was pilot-tested for comprehensibility and comprehensiveness using cognitive debriefing interviews in adults with different communication problems (speech, language, voice, hearing and cognitive communication disorders). This resulted in a second version of the item bank. The content validity of this version was tested in a group of professionals. The last (third) version of 133 items was tested for content validity in a second, new group of adults with various communication problems. The initial pool of 242 items was developed and pilot-tested in 27 adults with different communication problems. After modifications, 161 items remained, which were tested in a content validity study with 25 people with different communication problems and five professionals (in the field of speech and language therapy and speech and language research). The professionals considered 91.9% of the item bank relevant and comprehensible, and comprehensive by adding two items. The item bank was then considered relevant, comprehensible and comprehensive by the group of adults with communication problems. A total of 133 items remained in the item bank, related to the International Classification of Functioning, Disability and Health (ICF) Activities and Participation domains 'mobility', 'self-care', 'domestic life', 'interpersonal interactions and relationships', 'major life areas' and 'community, social and civic life'. MyCommunication-Adults is an item bank for measuring communicative participation in adults with communication difficulties. The next step is to test the psychometric properties of the item bank, in order to establish a final item bank. The refined description of the construct of communicative participation can already be used for participation-focused goal-setting between individuals with communication problems and speech and language therapists. What is already known on the subject The CPIB was developed to measure communicative participation in community-dwelling adults with communication problems. The item bank does not cover all domains and concepts of communicative participation, contains general communication items and not all questions seem to be relevant for specific target groups (e.g., hearing population). What this paper adds to the existing knowledge This study presents a refined description of the construct of communicative participation and the development of a new comprehensive PROM aimed at measuring this construct for all adults with communication difficulties. The development of the PROM is based on a previously conducted literature review and concept elicitation study. This study describes the development process of this new PROM, called MyCommunication-Adults, and the assessment of its content validity. What are the potential or actual clinical implications of this work? The refined description of the construct of communicative participation can be used for participation-focused goal-setting between individuals with communication problems and speech and language therapists.

Patient-reported outcome measures for acute rhinosinusitis in adults and children: a systematic review of the quality of existing instruments

BackgroundAcute rhinosinusitis (ARS) is a self-limiting inflammation of the nose and sinuses caused by viral or bacterial infections that requires primarily symptomatic treatment. Patient-reported outcome measures (PROMs) are suitable tools for the assessment of the effectiveness of remedies for ARS from the patient’s perspective in clinical trials and real-world studies. Data regarding the quality of existing PROMs for ARS are limited.PurposeTo conduct a systematic review of the quality of existing disease-specific PROMs for use in adults and children with ARS according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology, and to derive recommendations for use of the identified instruments in future clinical studies.MethodsWe systematically searched PubMed, Web of Science and Embase for studies reporting on the development and/or validation of PROMs for ARS. We assessed the methodological quality of each included study, evaluated the quality of measurement properties per PROM and study, and graded the evidence. Based on the overall evidence, we derived recommendations for use of the instruments.ResultsWe identified four studies on three PROMs measuring symptoms of ARS and quality of life in adults (Sinonasal Outcome Test-16, SNOT-16; Measurement of Acute Rhinosinusitis, MARS; Rhinosinusitis Quality-of-Life Assessment, RhinoQoL). For ARS in children, we identified two studies on two PROMs measuring symptoms of ARS (Pediatric Rhinosinusitis Symptom Scale, PRSS; Sinus Symptom Questionnaire, S5). Our assessment of measurement properties indicates that all instruments require further validation before they can be unrestrictedly recommended for use in future research (COSMIN category B). In particular, there were no content validity studies for any of the identified instruments, but also data on other important measurement properties, e.g., structural validity, are lacking.ConclusionCurrently, no PROM for ARS in adults and children can be unrestrictedly recommended based on the evaluation of their quality. Further validation is required for all identified PROMs. Content validation involving patients and experts should be given priority.Systematic review registrationOSF (https://doi.org/10.17605/OSF.IO/VAP8U).

Patient-reported outcome measures for medication treatment satisfaction: a systematic review of measure development and measurement properties

BackgroundMedication Treatment Satisfaction (M-TS) from the patients’ perspective is important for comprehensively evaluating the effect of medicines. The extent to which current patient-reported outcome measures (PROMs) for M-TS are valid, reliable, responsive, and interpretable remains unclear. To assess the measurement properties of existing PROMs for M-TS and to highlight research gaps.MethodsUsing PubMed, Embase (Ovid), Cochrane library (Ovid), IPA (Ovid), PsycINFO, Patient-Reported Outcome and Quality of Life Questionnaires biomedical databases, and four Chinese databases, we performed a systematic search for studies addressing the development and validation of PROMs for M-TS. Based on the Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) guideline, pairs of reviewers independently assessed the measurement properties of the PROMs and rated the quality of evidence on the measurement properties of each PROM. (The Open Science Framework registration: https://doi.org/10.17605/OSF.IO/8S5ZM).ResultsThis review identified 69 PROMs for M-TS in 114 studies (four generic, 32 disease-specific, and 33 drug-specific) of which 60 were intended for adults. All provided limited or no information regarding interpretability. Most demonstrated appropriate construct validity including convergent validity (39/69) and discriminative or known-groups validity (40/69) (high to moderate quality of evidence). Only a few provided evidence of sufficient content validity (8/69), structural validity (13/69), and internal consistency (11/69). Of 38 PROMs reporting test–retest reliability, results in 24 provided evidence of satisfactory test–retest reliability (18 with high to moderate, 6 with low to very low quality of evidence). Few PROMs reported responsiveness (16/69). Two generic PROMs (Treatment Satisfaction Questionnaire for Medication initial Version 1.4, TSQM-1.4; Treatment Satisfaction with Medicines Questionnaire, SATMED-Q) and one drug-specific PROM (Insulin Treatment Satisfaction Questionnaire, ITSQ) demonstrated both satisfactory validity and reliability.ConclusionsMost existing PROMs for M-TS require further exploration of measurement properties. Reporting guidelines are needed to enhance the reporting quality of the development and validation of PROMs for M-TS.

Evaluating Comprehensibility of 157 Patient-Reported Outcome Measures (PROMs) in the Nationwide Dutch Outcome-Based Healthcare Program: More Attention for Comprehensibility of PROMs is Needed.

Patient-reported outcomes measures (PROMs) are increasingly prevalent in healthcare and used for shared decision-making and healthcare quality evaluation. However, the extent to which patients with varying health literacy levels can complete PROMs is often overlooked. This may lead to biased aggregated data and patients being excluded from studies or other PROM collection initiatives. This cross-sectional study evaluates the comprehensibility of 157 well-known and widely used PROM scales using a comprehensibility checklist. Pairs of two independent raters scored 157 PROM scales designed for adults included in the 35 sets of outcome information developed as part of the Dutch Outcome-Based Healthcare Program. The PROM scales were scored on the eight comprehensibility domains of the Pharos Checklist for Questionnaires in Healthcare (PCQH). Interrater agreement of domain ratings was assessed using Intraclass Correlation Coefficients or Cohen's kappa. Subsequently, final ratings were established through discussion and used to evaluate the domain-specific comprehensibility rating for each PROM scale. Comprehensibility of a large number of PROM scales (n = 157), which cover a wide range of diseases and conditions across Dutch medical specialist care, was assessed. While most PROM scales were written at an accessible language level, with minimal use of medical terms, instruction clarity, number of questions, and response options emerged as significant issues, affecting a substantial proportion of PROM scales. Interrater agreement was high for most domains of the PCQH. This study highlights the need for greater attention to the comprehensibility of PROMs to ensure their accessibility to all patients, including those with low health literacy. The PCQH can be a valuable tool in PROM development in addition to qualitative methods and in selection processes enabling comparison of comprehensibility between PROMs. However, the PCQH needs further development and validation for these purposes. Enhancing the comprehensibility of PROMs is essential for their effective incorporation in healthcare evaluation and decision-making processes.

Schizophrenia Quality of Life Scale and Schizophrenia Quality of Life Scale Revision 4: A Systematic Review of Measurement Properties.

Schizophrenia is a severe mental disorder that has a significant impact on quality of life (QOL). Measuring QOL can offer insights into treatment efficacy and areas of intervention, highlighting the importance of valid tools assessing QOL in people with schizophrenia. We employed the COSMIN systematic review guideline to assess the psychometric properties of the schizophrenia quality of life scale (SQLS) and its 4th revision, the schizophrenia quality of life scale revision 4 (SQLS-R4), as patient-reported outcome measures (PROMs). The search yielded 455 papers, 16 were included, 7 for the SQLS and 9 for the SQLS-R4. Both scales demonstrated good results in risk of bias assessment for internal consistency and convergent validity, the SQLS-R4 additionally for known-groups validity. For the SQLS, PROM development, structural validity, and reliability were suboptimal. The SQLS-R4 showed suboptimality regarding structural validity and reliability and inadequacy for cross-cultural validity and responsiveness. The updated criteria for good measurement properties indicated good convergent validity for the SQLS and good internal consistency, reliability, and convergent validity for the SQLS-R4. The SQLS showed suboptimal results for reliability and known-groups validity, while the SQLS-R4 demonstrated suboptimality in structural validity and known-groups validity. The SQLS had indeterminate structural validity and internal consistency; the SQLS-R4 showed indeterminate responsiveness, and insufficient cross-cultural validity. When using the updated GRADE approach of the COSMIN group, both scales received a very low grade. The SQLS and SQLS-R4 hold the potential for recommendation in rating QOL. Identified weaknesses necessitate further validations.

Iterative qualitative approach to establishing content validation of a patient-reported outcome measure for arm lymphedema: the LYMPH-Q Upper Extremity Module

BackgroundBreast cancer-related lymphedema (BRCL) is one of the most common causes of upper extremity (UE) lymphedema in developed nations and substantially impacts health-related quality of life. To advance our understanding of the epidemiology and treatment of BRCL, rigorously developed and validated patient-reported outcome measures (PROMs) are needed. This study aimed to demonstrate the iterative content validity of a modular UE lymphedema-specific PROM called the LYMPH-Q UE module.MethodsA multi-step iterative qualitative approach was used. Semi-structured interview data from in-depth qualitative interviews with adult women (18 years and older) with BCRL were used to develop the first set of the LYMPH-Q UE scales. The content validity of these scales was demonstrated with patient and clinician feedback. Over the course of cognitive debriefing interviews, additional concepts of lymphedema worry and impact on work were identified as missing from the LYMPH-Q UE module. Subsequently, two new qualitative studies (a focus group and in-depth concept elicitation interviews with patients) were conducted, and two new scales were developed to measure lymphedema worry and impact on work life and their content validity was demonstrated.ResultsQualitative data from in-depth and cognitive interviews with 15 (age 40–74 years) and 16 (age 38–74 years) women with BRCL, respectively, and feedback from 12 clinical experts, were used to develop and demonstrate the content validity of six LYMPH-Q UE scales measuring symptoms, function, appearance, psychological, information, and arm sleeve. Additionally, data from in-depth interviews with 12 (age 35–72 years) women with UE lymphedema and four focus groups (n = 16 women; age 35–74 years) was used to develop and assess the content validity of two new LYMPH-Q UE scales measuring lymphedema worry and impact on work life. The content validity of the previously established six scales was also demonstrated in these subsequent qualitative studies.ConclusionThe LYMPH-Q UE is a modular PROM developed using international guidelines for PROM development and can be used in clinical practice, research, and quality improvement to enhance patient-centered shared decision-making. This study’s innovative and iterative approach to content validation demonstrates that the LYMPH-Q UE is a comprehensive measure that includes important concepts relevant to patients with UE lymphedema.

Guidelines for the development and validation of patient-reported outcome measures: a scoping review

ObjectiveThe objectives of this scoping review were to provide an overview of existing guidelines for the development and validation of patient-reported outcome measures (PROMs), review them for comprehensiveness and clarity...

Patient-Reported Outcome Measures in Neuromuscular Diseases: A Scoping Review.

Patient-reported outcome measures (PROMs) are valuable in comprehensively understanding patients' health experiences and informing healthcare decisions in research and clinical care without clinicians' input. Until now, no central resource containing information on all PROMS in neuromuscular diseases (NMD) is available, hindering the comparison and choice of PROMs used to monitor NMDs and appropriately reflect the patient's voice. This scoping review aimed to present a comprehensive assessment of the existing literature on using PROMs in children and adults with NMD. A scoping methodology was followed using Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) and COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines to assess the literature on PROMs in NMDs. Eligibility criteria encompassed articles describing psychometric development or evaluation of generic or disease-specific PROM-based instruments for adults and children with specific NMDs. The data charting process involved extracting measurement properties of included PROMs, comprising validity, reliability, responsiveness, and interpretability information. The review identified 190 PROMs evaluated across 247 studies in individuals with NMDs. The majority of PROMs were disease specific. The physical functioning domain was most assessed. Validity was the most frequently investigated measurement property, with a limited number of PROMs sufficiently evaluated for a range of psychometric characteristics. There is a strong need for further research on the responsiveness and interpretability of PROMs and the development of PROMs on social functioning in NMD.

A SYSTEMATIC REVIEW OF THE CONTENT VALIDITY OF PATIENT-REPORTED OUTCOME MEASURES (PROMS) FOR ADULTS HAVING LOWER LIMB RECONSTRUCTIVE SURGERY

IntroductionThere are concerns that patient-reported outcome measures (PROMs) currently used for adults requiring, undergoing or after undergoing lower limb reconstruction (LLR) are not adequately capturing the range of experiences important to these patients. The ‘Patient-Reported Outcome Measure for Lower Limb Reconstruction’ (PROLLIT) study developed a conceptual framework of outcomes identified as important and relevant by adult LLR patients. This review explored whether existing PROMs address these outcomes, and exhibit content validity in this population.Materials & MethodsA range of key PROMs was selected (n=32). Systematic and hand-searches were employed to find studies assessing content validity of these PROMs in the adult LLR population, along with PROM content and development information. A systematic review of content validity of the measures was carried out following ‘COnsensus-based Standards for the selection of health Measurement Instruments’ (COSMIN) guidance, alongside conceptual mapping of the content of the PROMs against the PROLLIT conceptual framework.ResultsThe searches uncovered very few content validity studies assessing the PROMs when applied in adult LLR patients. The COSMIN review found that these measures lacked content validity when applied in this population. The conceptual mapping found that PROMs did not capture all concepts identified as important and relevant in the PROLLIT framework.ConclusionsExisting PROMs applied in the adult LLR population lack content validity and fail to adequately capture relevant outcomes for this patient group. There is a need for a new, dedicated PROM designed for adult LLR patients.

Validation of Biomarkers and Patient-Reported Outcome Measures to Improve the Diagnosis and Treatment of Eustachian Tube Dysfunction

Patients who suffer from Eustachian tube dysfunction (ETD) experience a significant decline in quality of life. To enhance patient outcomes, it is crucial to establish an accurate diagnosis, assess treatment effectiveness, and evaluate the severity of the condition. Substantial progress has recently been made in identifying biomarkers (BMs) and developing ETD clinical outcome assessments (COAs). This study examines the current state of BMs and COAs in ETD, including the methods evaluated historically and their potential clinical applications. The research in this area emphasizes the importance of using objective measures, such as middle ear pressure (MEP) and patient-reported outcome measures (PROMs), for diagnosing and evaluating ETD. Further, I discuss how electronic PROMs (ePROMs) and other digital health technologies can guide the development of innovative PROMs that ETD. Despite significant advances in COAs for ETD, much work remains to validate and improve them before their implementation in clinical practice. There has been less focus on vertigo as a symptom in recent assessments of ETD, suggesting that further examination of this aspect is needed. By validating BMs and COAs for ETD, we could enhance long-term patient outcomes and quality of life through improved diagnostic accuracy and evaluation of treatment efficacy.

Exploring the content validity of the Chalder Fatigue Scale using cognitive interviewing in an ME/CFS population

ABSTRACT Background The Chalder Fatigue Scale, also known as the Chalder Fatigue Questionnaire (CFQ) is a Patient Reported Outcome Measure (PROM) comprising 11 items designed to measure physical and cognitive fatigue. It is widely used with people with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). There is no published evaluation of the content validity of the CFQ. Objectives To elicit information regarding the cognitive processes undertaken by people living with ME/CFS, when completing the CFQ to allow examination of the CFQ’s content validity. Methods A qualitative study utilising semi-structured cognitive interviewing. All data were collated according to the CFQ item but some general criticisms of the content validity of the CFQ were also identified. Results The CFQ currently consists of one item clearly related to physical symptoms (1.6), four items clearly related to cognitive function (1.8, 1.9, 1.10, 1.11) and one item relating to fatigue (1.5) which could be interpreted as cognitive and/or physical fatigue. The other five items have been identified by participants as lacking clarity (1.1, 1.7), relating to behaviour not symptoms (1.2, 1.4), or relating to sleepiness not fatigue (1.3). Conclusion Participants provided a wealth of insight into the challenges related to relevance, comprehensiveness, and comprehensibility of the CFQ, indicating that revision is required. This strengthens the case for participation of people with lived experience at all stages of PROM development. There is a need for an assessment tool/PROM for clinical and research use ME/CFS which has undergone content validation involving people living with ME/CFS.

The influence of patient-reported outcome measures on healthcare delivery: A review of methodologies and applications

Patient-Reported Outcome Measures (PROMs) have emerged as integral tools in assessing healthcare outcomes from the patient's perspective. This comprehensive review explores the methodologies employed in the development, administration, and validation of PROMs, shedding light on their applications and influence on healthcare delivery. It examines the various modes of PROMs administration, including the burgeoning role of technology through electronic platforms and mobile applications. Challenges related to patient adherence, engagement, and disparities in technological access are discussed, offering insights into potential barriers. It meticulously outlines the multifaceted applications of PROMs in healthcare. From influencing clinical decision-making and quality of care assessments to fostering patient-centered care and contributing to health policy initiatives, PROMs have permeated diverse aspects of healthcare delivery. The review also explores the role of PROMs in shaping research endeavors, serving as essential components in health policy initiatives and advancing the understanding of patient outcomes and experiences. While emphasizing the positive impact of PROMs, the paper addresses challenges and considerations associated with their use, including standardization issues, interpretation challenges, and technology-related barriers. The future directions and opportunities section examines potential advancements in personalized medicine, the integration of technology, and the empowerment of patients through increased involvement in their healthcare journey. Ethical considerations surrounding privacy, confidentiality, and informed consent in PROMs implementation are also scrutinized. This review consolidates current knowledge on PROMs methodologies and applications, offering a comprehensive understanding of their influence on healthcare delivery. The paper emphasizes the need for ongoing research, standardization efforts, and the ethical use of PROMs as they continue to shape a patient-centric and personalized approach to healthcare.

Exploring patient reported quality of life in lung cancer patients: A qualitative study of patient-reported outcome measures.

Lung cancer is the leading cause of cancer-related death globally and provides a major disease burden likely to substantially impact quality of life (QoL). Patient-reported outcome measures (PROMs) have been identified as effective methods of evaluating patient QoL. Existing lung cancer-specific PROMs however have uncertain utility and minimal patient involvement in their design and development. This qualitative study aimed to evaluate the patient perspective of existing PROMs and to explore their appropriateness for population-based descriptions of lung cancer-related QoL. A descriptive qualitative study was conducted consisting of semi-structured interviews with 14 patients recruited from the Victorian Lung Cancer Registry and Alfred Hospital using purposive sampling. Interviews first explored the factors most important to lung cancer patients QoL, and second, patient's perspectives on the appropriateness of existing PROMs. Thematic analysis was used to develop themes, and content analysis was conducted to determine PROM acceptability. Five novel themes were identified by patients as being important impacts on QoL: Personal attitude toward the disease is important for coping; independence is valued; relationships with family and friends are important; relationships with treating team are meaningful; personal and public awareness of lung cancer is limited. These patient-identified impacts are poorly covered in existing lung cancer-specific PROMs. Patients welcomed and appreciated the opportunity to complete PROMs; however, they identified problems with existing PROMs relevance, tone, and formatting. Existing lung cancer PROMs poorly reflect the five themes identified in this study as most important to lung cancer patients QoL. This study reaffirms the need to review existing PROMs to ensure utility and construct validity. Future PROM development must engage key patient-generated themes and evolve to reflect the changing management and therapeutic landscape.

First Phase Development of a Patient-reported Outcome Measure for Midface Oncology

Background: Facial cancer surgery involving the midface (comprising the lower eyelids, nose, cheeks, and upper lip) can have debilitating life-changing functional, social, and psychological impacts on the patient. Midface symptoms are inadequately captured by existing patient-reported outcome measures (PROMs). PROMs are increasingly used for individual patient care, quality improvement, and standardized reporting of treatment outcomes. This study aimed to present our findings from the first phase of the development of a midface, specifically periocular and nasal, PROM. Methods: After international guidance for PROM development, the first phase comprised identification of salient issues and item generation. Fifteen patients who had midface surgery and 10 clinicians from various specialties with more than 5 years’ experience treating these patients were recruited. Semi-structured interviews explored aesthetic, functional, social, and psychological outcomes, with specific attention to deficiencies in current PROMs. Thematic analysis was used to develop an item pool, and group interviews with clinicians were carried out to create and refine PROM scales. Results: Qualitative data from patient interviews were grouped into aesthetic, functional, and psychosocial domains for the eyelids and nose. Ninety-nine draft items were generated across these domains. Following focus group discussions, the final version of the midface-specific PROM contained 31 items (13 eye-specific, 10-nose-specific, eight general midface items). Conclusions: This midface-specific PROM is valuable in assessing and comparing patient-reported outcomes in those who have undergone complex resection and reconstruction of the midface. This PROM is currently undergoing field testing.

Measurement of compassion fatigue in animal health care professionals: a systematic review of available instruments and their content validity.

Compassion fatigue (CF) refers to emotional or physical exhaustion and emotional reactions resulting from prolonged exposure to traumatic events, commonly experienced by professionals in caregiving roles. CF is prevalent among healthcare professionals, including those in animal care. Several Patient-Reported Outcome Measures (PROMs) were developed to measure CF, but their psychometric validity was not reviewed systematically. This study aims to identify and review the content validity of CF PROMs used in animal health care professionals. Literature was searched in PubMed, PsycINFO, and EMBASE (1973-2023). We included studies conducted in animal health care professionals, using a PROM to measure CF, reporting at least one psychometric property of this PROM, and published as original research. For each identified PROM, additional literature search was conducted to identify PROM development and content validation studies. Three independent reviewers evaluated the content validity of each PROM using COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology and summarized the quality of evidence using a modified GRADE approach. The protocol was registered in PROSPERO (CRD42023433982) and results reported following PRISMA guidelines. Initially, 1709 studies were identified. After a double screening, 17 eligible studies were included. CF was measured using six different PROMs or their modified versions. Only one PROM specifically targeted animal health care professionals: the ProQOL-5 Veterinary Medicine Version. This and three other original CF PROMs were reviewed. For all PROMs, the quality of content validity was rated as insufficient due to deficiencies in the concept and items elicitation, inadequate target population representation, and inadequate details on cognitive interview procedures. The overall evidence quality was rated as low due to a limited number of PROM validation studies, poor methodological and reporting quality, and indirect result. There is a scarcity of studies examining CF within the target population, and the quality of evidence for content validity of the reviewed PROMs for CF measurement is currently low. CF definition and construct description in PROM development studies suffer from vagueness and seem inadequately reflected by the content of the reviewed PROMs. Further research with a robust methodology seems necessary to address the identified flows. Measurement of compassion fatigue in people working with animals: protocol for a systematic review. PROSPERO 2023 CRD42023433982. Available from: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42023433982.

Patient-Reported Outcomes in Venous Thromboembolism: A Systematic Review of the Literature, Current Challenges, and Ways Forward.

Venous thromboembolism (VTE) affects >1.2 million Americans annually. Although the clinical outcomes and economic burdens of VTE have been well described, the impact of VTE on patients' health status has yet to be summarized. This systematic review summarizes how patient-reported outcome measures (PROMs) have been used in VTE to date. PubMed/MEDLINE was queried for literature published through March 2023 using PROMs in a population of patients with VTE. Studies were excluded if the reference was an editorial, review, or case report, or if the study included patients with conditions other than VTE. Qualitative analyses were performed. After screening and exclusion, 136 references were identified; 5 described PROM development, 20 focused on PROM validation, and 111 used PROMs in outcomes research. The most used generic PROMs were the 36-item Short-Form Health Survey and EuroQol 5-dimensional questionnaire, and the most common disease-specific PROMs were the Venous Insufficiency Epidemiological and Economic Study-Quality of Life/Symptoms and the Pulmonary Embolism Quality of Life Questionnaire. PROMs were used to quantify the changes in health status after diagnosis, characterize the trajectory of subsequent improvement, and identify drivers of continued impairments in health status like postthrombotic syndrome and postpulmonary embolism syndrome. PROMs were also used to investigate the impact of novel treatment modalities on quality of life. This review demonstrates the many benefits of PROM use, including quantifying changes in health status with treatment, capturing patients' experiences with the treatment itself, and identifying complications of VTE. Incorporating PROMs into VTE care will be an essential component of evaluating the effectiveness of novel therapies and should lead to improved shared decision-making for patients with VTE.