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Abstract Background/purpose Lack of robust, feasible, and quantitative outcomes impedes Raynaud phenomenon (RP) clinical trials in systemic sclerosis (SSc) patients. Hyperspectral imaging (HSI) non-invasively measures oxygenated and deoxygenated hemoglobin (oxyHb and deoxyHb) concentrations and oxygen saturation (O2 sat) in the skin and depicts data as oxygenation heatmaps. This study explored the potential role of HSI in quantifying SSc-RP disease severity and activity. Methods Patients with SSc-RP (n = 13) and healthy control participants (HC; n = 12) were prospectively recruited in the clinic setting. Using a hand-held camera, bilateral hand HSI (HyperMed™, Waltham, MA) was performed in a temperature-controlled room (22 °C). OxyHb, deoxyHb, and O2 sat values were calculated for 78-mm2 regions of interest for the ventral fingertips and palm (for normalization). Subjects underwent a cold provocation challenge (gloved hand submersion in 15 °C water bath for 1 min), and repeated HSI was performed at 0, 10, and 20 min. Patients completed two patient-reported outcome (PRO) instruments: the Raynaud Condition Score (RCS) and the Cochin Hand Function Scale (CHFS) for symptom burden assessment. Statistical analyses were performed using the Mann-Whitney U test and a mixed effects model (Stata, College Station, TX). Results Ninety-two percent of participants were women in their 40s. For SSc-RP patients, 69% had limited cutaneous SSc, the mean ± SD SSc duration was 11 ± 5 years, and 38% had prior digital ulcers—none currently. Baseline deoxyHb was higher, and O2 sat was lower, in SSc patients versus HC (p < 0.05). SSc patients had a greater decline in oxyHb and O2 sat from baseline to time 0 (after cold challenge) with distinct rewarming oxyHb, O2 sat, and deoxyHb trajectories versus HCs (p < 0.01). There were no significant correlations between oxyHb, deoxyHb, and O2 sat level changes following cold challenge and RCS or CHFS scores. Conclusion Hyperspectral imaging is a feasible approach for SSc-RP quantification in the clinic setting. The RCS and CHFS values did not correlate with HSI parameters. Our data suggest that HSI technology for the assessment of SSc-RP at baseline and in response to cold provocation is a potential quantitative measure for SSc-RP severity and activity, though longitudinal studies that assess sensitivity to change are needed.

After traumatic brain injury (TBI), individuals may experience short- or long-term health burdens, often referred to as post-concussion symptoms (PCS). The Rivermead Post-Concussion Symptoms Questionnaire (RPQ) is one of the commonly used instruments to assess self-reported PCS. To date, no reference values for RPQ have been provided, although they are crucial for clinical practice when evaluating a patient's health status relative to a comparable healthy population. Therefore, the aim of this study is to provide reference values for the United Kingdom, the Netherlands, and Italy. A total of 11,759 individuals (50.3% women) from representative general population samples participated in an online survey (4646 individuals from the UK, 3564 from the Netherlands, and 3549 from Italy). The factorial structure of the RPQ was examined using confirmatory factor analysis (CFA), and results from the general population samples were compared with those from respective TBI samples recruited within the international CENTER-TBI study using multigroup CFA. Reference values were stratified by sex, health status, age, and education using percentiles. The three-factorial model outperformed the one-factorial structure. The general population samples were largely comparable to the corresponding TBI samples, except for items such as dizziness, vision, and sensory sensitivity, which can be considered more TBI-specific. Because of the significant differences between the general population samples, we provided reference values for the total score and for the somatic, emotional, and cognitive scales for each country separately. The reference values provided can now be used in clinical practice and research. Future studies should obtain stratified reference values for other countries and languages to improve accuracy in the diagnosis and treatment of symptom burden after TBI. [ABSTRACT FROM AUTHOR]

Background: The Reflux Symptom Questionnaire electronic Diary (RESQ-eD) and the Reflux Symptom Questionnaire 7-day recall (RESQ-7) are versions of a patient-reported outcome instrument that was developed and validated for measuring the frequency and intensity of symptoms in patients with gastroesophageal reflux disease (GERD) who have a partial response to proton pump inhibitor (PPI) therapy.Objective: The aim of these analyses was to assess the ability of the RESQ-7 to reproduce findings based on RESQ-eD reports of the same symptoms.Methods: These analyses are based on data from patients with GERD with a partial response to PPI (ClinicalTrials.gov identifier: NCT00703534). Participants completed the RESQ-eD twice daily for 7 days and the RESQ-7 on day 7.Results: Data from 446 patients were available for these analyses. Symptom-level analyses showed that, for intensity, mean domain scores were higher for the RESQ-7 (range 1.49-2.72) than for the RESQ-eD (range 1.45-2.57); for frequency, scores were lower for the RESQ-7 (range 2.58-4.82) than for the RESQ-eD (range 4.22-6.24). Correspondence analyses of RESQ-7 and RESQ-eD mean domain scores indicated excellent agreement for intensity (correlation-concordance coefficient 0.77-0.83) and fair agreement for frequency (correlation-concordance coefficient 0.40-0.58). Mean RESQ-eD subscale intensity scores for GERD symptoms were higher for symptoms experienced during the daytime than for those occurring at nighttime. Symptom recall was not associated with peak or recency effects.Conclusions: Patients with GERD slightly overestimated the intensity of their reflux symptoms and markedly underestimated the frequency on weekly recall compared with twice-daily reporting. [ABSTRACT FROM AUTHOR]

Patient-reported outcome instruments provide valuable insight into disease-related morbidity known only to the patient and complement more objective outcome tools in the clinical trial setting. They are of particular importance in systemic sclerosis owing to the challenges around defining disease activity, the episodic nature of many disease-specific manifestations and the paucity of validated objective surrogate outcome measures for use in clinical trials. Early clinical trials of systemic sclerosis often incorporated legacy patient-reported outcome instruments, but the last 20 years has witnessed the emergence of several scleroderma-specific instruments that are now being routinely used alongside other outcomes in systemic sclerosis clinical trials. More recently, the value of patient-reported outcomes has been highlighted by their prominence in the American College of Rheumatology Combined Response Index for Systemic Sclerosis that has been utilized as the primary endpoint of recent clinical trials of early diffuse systemic sclerosis. This review considers the role and performance of the various patient-reported outcome instruments utilized in systemic sclerosis clinical trials, the current positioning of patient-reported outcome instruments within clinical trial endpoint models across the range of systemic sclerosis disease manifestations and, where applicable, we shall highlight areas for future research., Competing Interests: Declaration of conflicting interests: J.P. has consultancy relationships with Actelion and Boehringer Ingelheim. None of the other authors declared any relevant conflicts of interest., (© The Author(s) 2019.)

Background: Lack of uniformity in reported outcomes makes comparisons between acromioclavicular joint (ACJ) injury studies challenging. Knowledge of common outcome measures and standardization will help orthopaedic surgeons report and compare outcomes more consistently., Purpose: To identify the most commonly reported outcome measures for ACJ injuries., Study Design: Systematic review., Methods: A systematic review was performed to identify all English-language original articles assessing any type of management of ACJ injuries (acute and chronic) in PubMed and Scopus from 2007 to 2017. Review articles, meta-analyses, studies with less than 5 patients, pediatric studies, technique articles, and biomechanical studies were excluded. The 100 top orthopaedic journals in the English literature were selected for review. Included studies were assessed for patient characteristics and the use of outcome variables, including range of motion (ROM), strength, patient-reported outcomes (PROs), satisfaction, return to work, return to sport, and complications., Results: A total of 605 unique articles were identified; 92 met the inclusion criteria. The average number of ACJ injuries per study was 37, with a mean weighted patient age of 36 years (range, 20.1-57.3 years). The mean follow-up was 36 months (range, 5-290 months). Acute injuries were reported in 59% of studies. ROM and strength measurements were reported in 22.8% and 5.4% of studies. Sixteen different PRO instruments were used. The most commonly reported measures were Constant score (75%), visual analog scale for pain (VAS-pain; 33%) score, American Shoulder and Elbow Surgeons (ASES) score (21%), Simple Shoulder Test (SST) score (19%), and University of California Los Angeles (UCLA; 17%) shoulder score. An average of 2.5 outcome measures per study were reported. The use of 4 or more outcome scores was associated with publication in higher-impact factor journals., Conclusion: Inconsistent reporting of multiple outcome measures is present in the ACJ injury literature. The best scoring system for assessing ACJ injury and treatment has not yet been agreed upon. Until improved scoring systems come into general use, we recommend that future literature on ACJ injuries use at least 4 outcome scores and include the commonly used outcome measures (Constant, VAS-pain, ASES, and SST scores) to enable future comparison of patient outcomes across publications., Competing Interests: One or more of the authors has declared the following potential conflict of interest or source of funding: The University of Florida Department of Orthopaedics and Rehabilitation receives research support from Exactech. B.S.S. has received educational support from Arthrex, speaking fees from DJO, royalties and consulting fees from Exectech, and hospitality payments from Zimmer Biomet. T.W.W. has received royalties from Exactech and Wolters Kluwer Health Lippincott Williams & Wilkins and consulting fees from Exactech. K.W.F. has received royalties from Arthrex and Exactech; consulting fees from Arthrex, Exactech, Flexion, and Medshape; speaking fees from CGG Medical; and honoraria from Arthrosurface. J.J.K. has received educational support from Arthrex, consulting fees from Exactech, and hospitality payments from Integra Lifesciences. AOSSM checks author disclosures against the Open Payments Database (OPD). AOSSM has not conducted an independent investigation on the OPD and disclaims any liability or responsibility relating thereto., (© The Author(s) 2020.)

Introduction: We evaluate the most common outcome measures used in distal humerus fracture studies in order to suggest standardization for future research., Materials and Methods: A systematic review identified articles assessing the outcomes of acute distal humerus fractures from 2006 to 2016 from PubMed and Web of Science databases. The inclusion criterion was studies reporting on the outcomes of treatment of acute distal humerus fractures. Review articles, meta-analyses, studies with<5 patients, technique articles, biomechanical studies, and those focusing on one complication/outcome were excluded. Patient demographics and all outcome measures were reviewed. Journal and demographic factors were then compared., Results: One-hundred-nine of 2158 articles met inclusion criteria. The median number of fractures per study was 35. Mean patient age was 55.0 years. Average follow-up was 35 months. Range-of-motion and strength measurements were reported in 90% and 17% of studies, respectively. Twenty patient-reported outcome instruments were used. The most commonly reported measures were MEPS, DASH, VAS pain, and Quick DASH scores. An average of 1.9 outcome measures were reported per study. A journal impact factor of≥1.5 was associated with more reported outcome measures. Articles including elbow arthroplasty were associated with higher impact factor journals, more outcome measures, and longer follow-up. Level of evidence was not associated with the number of reported outcome measures., Discussion: The current distal humerus fracture literature inconsistently reports outcome measures. More outcome measures were reported in higher impact journals. Future distal humerus fracture studies should include MEPS, DASH or Quick DASH, and VAS Pain scores to allow for appropriate cross-study comparison., Level of Evidence: IV, Systematic review., (Copyright © 2018 Elsevier Masson SAS. All rights reserved.)

Study Design  Literature review. Objective  To identify outcomes instruments used in spinal trauma surgery over the past decade, their frequency of use, and usage trends. Methods  Five top orthopedic journals were reviewed from 2004 to 2013 for clinical studies of surgical intervention in spinal trauma that reported patient-reported outcome instruments use or neurologic function scale use. Publication year, level of evidence (LOE), and outcome instruments were collected for each article and analyzed. Results  A total of 58 studies were identified. Among them, 26 named outcome instruments and 7 improvised questionnaires were utilized. The visual analog scale (VAS) for pain was used most frequently (43.1%), followed by the Short Form 36 (34.5%), Frankel grade scale (25.9%), Oswestry Disability Index (20.7%) and American Spinal Injury Association Impairment Scale (15.5%). LOE 4 was most common (37.9%), and eight LOE 1 studies were identified (10.3%). Conclusions  The VAS pain scale is the most common outcome instrument used in spinal trauma. The scope of this outcome instrument is limited, and it may not be sufficient for discriminating between more and less effective treatments. A wide variety of functional measures are used, reflecting the need for a disease-specific instrument that accurately measures functional limitation in spinal trauma.

In this review we discuss health measurement with a focus on psychometric methods and methodology. In particular, we examine some of the key issues currently facing the use of clinician and patient rating scales to measure the health outcomes of disease and treatment. We present three key facts and flag one crucial problem. First, the numbers generated by scales are increasingly used as the measurements of the central dependent variables upon which clinical decisions are frequently made. The rising profile of rating scales has significant implications for scale construction, evaluation, and selection, as well as for interpreting studies. Second, rating scale science is well established. Therefore, it is important to learn the lessons from those who have built and established the science over the last century. Finally, the goal of a rating scale is to measure. As such, over the last half century, developments in rating scale (psychometric) methods have caused a refocus in the way we should be measuring health. In particular, newer methods have significant clinical advantages over traditional approaches. These should be seriously considered for inclusion in everyday practice. This leads us to the central problem with health measurement, which is that we cannot currently be sure what most rating scales are measuring. This is because the methods we have in place to ensure the validity of rating scales fall short of what is actually required. We expand on this point, and provide some potential routes forward to help address this important problem.