Chronic kidney disease (CKD), kidney failure, and kidney replacement therapies are associated with high symptom burden and impaired health-related quality of life (HRQOL). Symptoms change with ...disease progression or transition between treatment modalities and frequently go unreported and unmanaged. Tools that reliably monitor symptoms may improve the management of patients with CKD. Patient-reported outcome measures (PROMs) assess symptom severity; physical, psychological, social, and cognitive functioning; treatment-related side effects; and HRQOL. Systematic use of PROMs can improve patient–provider communication, patient satisfaction, clinical outcomes, and HRQOL. Potential barriers to their use include a lack of engagement, response burden, and limited guidance about PROM collection, score interpretation, and workflow integration. Well-defined, acceptable, and effective clinical response pathways are essential for implementing PROMs. PROMs developed by the Patient-Reported Outcomes Measurement Information System (PROMIS) address some challenges and may be suitable for clinical use among patients with CKD. PROMIS tools assess multiple patient-valued, clinically actionable symptoms and functions. They can be administered as fixed-length, customized short forms or computer adaptive tests, offering precise measurement across a range of symptom severities or function levels, tailored questions to individuals, and reduced question burden. Here we provide an overview of the potential use of PROMs in CKD care, with a focus on PROMIS.
Background
Patient‐reported outcome measures (PROMs) are questionnaires that collect health outcomes directly from the people who experience them. This review critically synthesizes information on ...generic and selected condition‐specific PROMs to describe trends and contemporary issues regarding their development, validation and application.
Methods
We reviewed academic and grey literature on validated PROMs by searching databases, prominent websites, Google Scholar and Google Search. The identification of condition‐specific PROMs was limited to common conditions and those with a high burden of disease (eg cancers, cardiovascular disorders). Trends and contemporary issues in the development, validation and application of PROMs were critically evaluated.
Results
The search yielded 315 generic and condition‐specific PROMs. The largest numbers of measures were identified for generic PROMs, musculoskeletal conditions and cancers. The earliest published PROMs were in mental health‐related conditions. The number of PROMs grew substantially between 1980s and 2000s but slowed more recently. The number of publications discussing PROMs continues to increase. Issues identified include the use of computer‐adaptive testing and increasing concerns about the appropriateness of using PROMs developed and validated for specific purposes (eg research) for other reasons (eg clinical decision making).
Conclusions
The term PROM is a relatively new designation for a range of measures that have existed since at least the 1960s. Although literature on PROMs continues to expand, challenges remain in selecting reliable and valid tools that are fit‐for‐purpose from the many existing instruments.
Patient or public contribution
Consumers were not directly involved in this review; however, its outcome will be used in programmes that engage and partner with consumers.
The objective of this study was to examine measurement properties of the Joint replacement version for Hip Disability and Osteoarthritis Outcome Score (HOOS-JR) using Rasch analysis in patients with ...osteoarthritis of hip (HOA).
Cross-sectional clinical measurement SETTING: Patient outcomes database at a tertiary care hospital PARTICIPANTS: Convenience sampling of patients with HOA scheduled for total hip arthroplasty (N=327) OUTCOME MEASURES AND ANALYSIS: The data for pre-surgery assessments for patients with HOA were extracted from an existing database. Variables extracted included HOOS-JR scores, demographic information (age, sex), health-related data, and anthropometric variables. The assumptions of Rasch model such as the test of fit, fit residuals, ordering of item thresholds, factor structure, DIF, internal consistency and Pearson separation index were examined for the HOOS-JR scores.
The HOOS-JR showed adequate overall fit to the Rasch model, logically ordered response thresholds, no floor or ceiling effects, and high internal consistency (Cronbach's alpha of 0.91). The HOOS-JR did not satisfy the assumption of unidimensionality, albeit the violation of this assumption was marginal (6.12% over 5%). Person-item threshold distribution (difference between person and item means were equal to 0.92 which was less than 1 logit unit) confirmed that the HOOS-JR scores were well targeted.
Given that the violation of unidimensionality for HOOS-JR was marginal, we recommend further studies to validate this finding. Results broadly support the use of HOOS-JR for assessing hip health in patients with HOA.
While the use of electronic methods to collect patient-reported outcome (PRO) data in clinical trials continues to increase, it remains the case that many PRO measures (PROMs) have originally been ...developed and validated on paper. Careful consideration during the move from paper PROMs to electronic (ePROM) format is required to preserve the integrity of the measure and ensure a “faithful migration”. Relevant literature has long called out the importance of following migration best practices during this process; however, such best practices are distributed across multiple documents. This article consolidates and builds upon existing ePROM implementation best practice recommendations to provide a comprehensive, up-to-date, single point of reference. It reflects the current consensus based on the significant advances in technology capabilities and knowledge gleaned from the growing evidence-base on electronic migration and implementation, to balance the need for maintaining the integrity of the measure while optimizing respondent usability. It also specifies whether the practice is rooted in evidence or expert consensus, to enable those using these best practices to make informed and considered decisions when conducting migration.
•This article consolidates and builds upon existing electronic Patient-Reported Outcome Measure (ePROM) implementation best practices to provide a comprehensive, up-to-date, single point of reference, that reflect the significant advances in technology capabilities and knowledge gleaned from the growing evidence-base on electronic migration and implementation.•For each best practice, the rationale is provided (i.e., based on scientific evidence, regulatory guidance, or eCOA Consortium expert consensus), and it is classified depending on whether it risks impacting comparability, regulatory acceptability or optimal usability, to enable a fully informed, standardized approach to ePROM implementation.•In cases where sufficient evidence of measurement comparability exists and these best practices have been followed, as concluded by the ISPOR Task Force Good Practices Report recommendations on evidence needed to support measurement comparability among modes of data collection for patient-reported outcome measures, further testing of measurement comparability between modes of data collection is not necessary.
Patient‐reported outcomes (PRO) are collected directly from the patient and have become increasingly utilized in the clinical setting and in clinical research. In musculoskeletal oncology patients, a ...number of patient‐reported outcomes measures (PROM) have been developed and investigated to evaluate functional outcomes and health‐related quality of life in these patients. With the growing evidence for PROM in musculoskeletal oncology patients, PROM should be considered for the clinical care of these patients.
Objectives/Hypothesis
Patient‐reported outcome measures (PROMs) are communication tools to help patients convey their disease experience to medical providers and guide management decisions. However, ...the utility of healthcare outcome measures is dependent on patient literacy and readability of PROMs. If written for a more advanced literacy level, they can misestimate symptoms and add significant barriers to care, especially in the underserved. However, readability of head and neck (H&N) oncology PROMs has not been assessed. The aim of this study was to evaluate the readability of H&N oncology PROMs to assess whether they meet recommended readability levels.
Study Design
Bibliometric review.
Methods
Three readability measures: Gunning Fog, Simple Measure of Gobbledygook, and FORCAST were used to evaluate the readability level of commonly used H&N PROMs. PROMs with sixth grade readability level or lower were considered to meet the recommendations of health literacy experts.
Results
Eight H&N oncology PROMs were reviewed. None of H&N PROMs met health literacy experts' and National Institutes of Health recommended reading levels. Gunning Fog consistently estimated easiest readability and FORCAST the most difficult.
Conclusions
PROMs are important clinical tools that drive patient‐centric care in H&N oncology. All H&N PROMs are written above recommended reading levels and do not meet suggested standards. Future PROMs should be written with easier readability to accurately convey patients' H&N oncology disease experiences.
Level of Evidence
4 Laryngoscope, 2020
Objective
Outcome measures in healthcare that presume a higher level of patient health and overall literacy may inadequately estimate the disease experiences of less‐educated patients and further ...disadvantage them. Patient‐Reported Outcome Measures (PROMs) are widely used communication tools for clinical practice and are often used to evaluate and guide management for chronic rhinosinusitis (CRS) and skull base diseases. However, their readability and subsequent incomprehensibility for patients have not been assessed. The aim of this study is to evaluate the readability of commonly used PROMs for these conditions and whether they meet recommended readability levels.
Methods
Three readability measures, Gunning Fog, Simple Measure of Gobbledygook (SMOG), and FORCAST were used in the evaluation of commonly used PROMs for CRS and skull base disease. PROMs with sixth‐grade readability level or lower were considered to meet health literacy experts' recommendations.
Results
A total of 11 PROMs were reviewed (8 CRS, 3 skull base). Gunning Fog consistently estimated the easiest readability, whereas FORCAST the most difficult. One hundred percent of CRS and 67% of skull base PROMs were above National Institutes of Health and health literacy experts' recommended reading levels. PROMs developed more recently had easier readability.
Conclusion
PROMs are important clinical tools in otolaryngology that help guide management of disease for improved patient‐centered care. Like many other fields of medicine, those used in otolaryngology are beyond recommended reading levels. Development of PROMs in the future should meet recommended readability levels to fully assess the disease experience of our patients.
Level of Evidence
4 Laryngoscope, 130:2305–2310, 2020
Literature provides a moderate level of evidence for the beneficial effects of incisional negative pressure wound therapy (iNPWT) on scar quality. The purpose of this study was to establish if iNPWT ...results in improved scar outcomes in comparison to the standard of care. Therefore, a within‐patient randomised controlled, open‐label trial was conducted in transgender men undergoing gender‐affirming mastectomies. A unilateral side was randomised to receive iNPWT (PICO™, Smith&Nephew) without suction drains and contrastingly the standard dressing (Steri‐Strips™) with suction drain. Scar quality and questionnaires were bilaterally measured by means of objective assessments and patient‐reported outcome measures (PROM) at 1, 3 and 12 months. Objective scar outcomes were scar pliability (Cutometer®), colouration (DSM‐II) and scar width (3‐D imaging). PROM outcomes were related to scars (POSAS and SCAR‐Q) and body satisfaction (BODY‐Q). From 85 included patients, 80 were included for analyses. No significant difference between treatments was seen in the quantitative outcomes of scar pliability, colour, and width. For qualitative scar outcomes, several significant findings for iNPWT were found for several subscales of the POSAS, SCAR‐Q, and BODY‐Q. These effects could not be substantiated with linear mixed‐model regression, signifying no statically more favourable outcome for either treatment option. In conclusion, this study demonstrated that some PROM outcomes were more favourable for the iNPWT compared to standard treatment. In contrast, the quantitative outcomes showed no beneficial effects of iNPWT on scar outcomes. This suggests that iNPWT is of little benefit as a scar‐improving therapy.
Purpose
Customised individually made (CIM) total knee arthroplasty (TKA) was introduced to potentially improve patient satisfaction and other patient-reported outcome measures (PROMs). The purpose of ...this study was to compare PROMs, especially patient satisfaction, of patients with CIM and OTS TKA in a matched-pair analysis with a 2-year follow-up.
Methods
This is a prospective cohort study with a propensity score matching of 85 CIM and 85 off-the-shelf (OTS) TKA. Follow-up was at 4 months, 1 year and 2 years. The primary outcome was patient satisfaction. Secondary outcomes were as follows: overall improvement, willingness to undergo the surgery again, Knee injury and Osteoarthritis Outcome Score (KOOS), Forgotten Joint Score (FJS-12), High-Activity Arthroplasty Score (HAAS), EQ-5D-3L, EQ-VAS, Knee Society Score (KSS) and surgeon satisfaction.
Results
Patient satisfaction ranged from 86 to 90% and did not differ between CIM and OTS TKA. The EQ-VAS after 4 months and the HAAS after 1 year and 2 years were higher for CIM TKA. KOOS, FJS-12 and EQ-5D-3L were not different at follow-up. The changes in KOOS symptoms, pain and daily living were higher for OTS TKA. The KSS was higher for patients with CIM TKA. Surgeon satisfaction was high throughout both groups. Patients who were satisfied after 2 years did not differ preoperatively from those who were not satisfied. Postoperatively, all PROMs were better for satisfied patients. Patient satisfaction was not correlated with patient characteristics, implant or preoperative PROMs, and medium to strongly correlated with postoperative PROMs.
Conclusion
Patient satisfaction was high with no differences between patients with CIM and OTS TKA. Both implant systems improved function, pain and health-related quality of life. Patients with CIM TKA showed superior results in demanding activities as measured by the HAAS.
Level of evidence
II, prospective cohort study.
Posterior shoulder instability (PSI) is an increasingly recognized cause of shoulder dysfunction particularly in young active patients and certain athlete populations. When evaluating the efficacy of ...treatment for PSI, specific outcome measures for this population are essential. The aim of the current research was to describe the development and evaluation of a patient reported outcome measure (PROM) specific for PSI.
A retrospective cohort study design of patients with PSI was used to develop and evaluate the “Posterior Shoulder Instability Questionnaire (PSI-Q)”. Items for PSI-Q were generated through an expert focus group and existing questionnaires. Preliminary data analysis identified redundancy of items and resulted in the PSI-Q being refined. The final PSI-Q was evaluated on 128 patients with PSI with a structural lesion requiring surgical intervention. Participants were excluded in the absence of a posterior glenohumeral joint lesion. Internal consistency (Cronbach α and corrected item-total correlation), content validity, criterion validity, responsiveness, and test-retest reliability (intraclass correlation coefficient; ICC) were examined. Content validity, criterion validity and responsiveness were compared with the Melbourne Instability Shoulder Score (MISS) and the Western Ontario Shoulder Index (WOSI). The minimum detectable change score (MDC) was calculated.
The Cronbach α for the total scale pre and post-intervention was high (α = 0.97). All five domains (Pain, Instability/Weakness/Stiffness, Function, Occupation and Sport, and Quality of Life and Satisfaction) demonstrated acceptable internal consistency for each subsection and the overall score of the scale (α > 0.70). The corrected-item total correlation for each domain were within an acceptable range. The responsiveness of the PSI-Q questionnaire was excellent (effect size, 2.06; standard response mean, 1.34) and was higher than the MISS and WOSI. There were no relevant floor effects and one ceiling effect. Reliability was excellent (ICC (1,1) = 0.93) and the calculated MDC was 10.9 points.
This study designed and validated a questionnaire specific for measuring symptoms and function in people with structural PSI requiring surgery. The PSI-Q demonstrates good measurement properties and provides an MDC that is useful for researchers and clinicians. In structural PSI, the PSI-Q has a higher responsiveness and more accurately reflects a patient’s overall perceived shoulder status compared to current patient reported outcomes for shoulder instability. The psychometric properties of the PSI-Q are still to be determined in a non-surgical population.
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