Study Patient-reported Outcome Measures Research Articles

Current trends in patient-reported outcome measures for clavicle fractures: a focused systematic review of 11 influential orthopaedic journals.

Many patient-reported outcome measures (PROMs) have been used to follow clavicle fractures, providing an objective means to track outcomes. However, lack of standardization of PROM usage makes cross-study comparison difficult. Therefore, we reviewed articles on clavicle fractures from 11 of the most influential orthopedic journals to assess trends in PROM usage over time and based on geographic location. A focused systematic review of 11 of the most influential orthopedic journals was performed using PubMed. All articles published between 1981 and 2020 with greater than 9 patients reporting clinical outcomes of clavicle fractures were included. For each article, patient demographics, treatment modality, geographic location, and outcome measures used were recorded. Temporal trends were identified using the Cochran-Armitage test for trend and linear regression. Pearson chi-square and Kruskal-Wallis tests were used to compare between journals, geographic location, study type, and fracture classification. From the initial literature search of 623 articles, 151 studies reporting on 15,853 primary clavicle fractures were included. Fractures of the middle one-third of the clavicle were most studied in the included literature (71%). Seventeen different PROMs were used, with an average of 1.6 outcome measures per study, and there was a significant increase in the number of PROMs used per article over time (P < .001). The Constant-Murley score was the most-reported outcome measure (44%) followed by the Disabilities of the Arm, Shoulder, and Hand score (27%), visual analog scale for pain (23%), and American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES; 14%). There was a significant difference between the measures used based on geography (P = .002), the most notable being that North American authors use the ASES score more frequently. The use of PROMs in studies evaluating clavicle fracture treatment outcomes has increased over time, with recent studies reporting more PROMs than older studies, and there are notable differences in usage of the various scores based on geography and journal. Although there is no consensus on the most reliable PROM for assessing clavicle fractures, we recommend the use of at least 2 of the commonly reported PROMs in future studies to facilitate cross-study comparisons.

General Patient-Reported Outcome Measure Tools Non-Reflective of AL Amyloidosis Quality of Life (QoL): A Systematic Literature Review

Background: Systemic AL Amyloidosis is characterized by deposition by amyloid fibrils of light chains produced by clonal plasma cells. New combination therapies have substantially prolonged the life expectancy of patients with AL Amyloidosis . Still the prognosis of the disease in the majority of the patients is dismal and Quality of Life (QoL) issues should be included in clinicians' primary objectives. Nowadays, patient-reported outcome measures (PROMs) are considered one of the most responsive tools that can guide personalized interventions to optimize QoL in parallel with therapeutic interventions. The aim of this metanalysis was to establish which PROMs have been utilized in studies on AL Amyloidosis and evaluate their validity.Methods: Two independent investigators (S.B.; C.K.) systemically reviewed PubMed, Medline and EMBASE databases for publications up to May 2021 on PROMs employed to report QoL outcomes in AL Amyloidosis. The identified PROMs were subsequently assessed for their validity in this context against COSMIN (Consensus-based Standards for the selection of health Measurement Instruments) quality criteria.Results:Of the 246 publications originally retrieved, only 57 were further analysed as 92 were duplicates, 11 were irrelevant to AL Amyloidosis, 56 did nor refer to QOL and 13 reported QOL without using QOLQs, 13 were case-reports and 4 were review articles. These included 47 observational studies and 10 prospective clinical trials. In these, thirteen different PROMs were used on occasion to report QOL outcomes (SF-36; EQ-5D-3L; FACT-G; PROMIS-GH); HPRSS; DT; EORTC QLQ-C30; KCCQ-12; GAF; SWLS; STAI; CESD; MDASI) with SF-36 being the most popular (35/ 58 publications). All of them are traditionally validated in similar to AL Amyloidosis diseases (e.g. Multiple Myeloma) or in its complications (e.g. Congestive Heart Failure). In the absence of face-validity studies, the content validity of these PROMs was assessed against QOL aspects identified in literature by open questionnaires (Table 1). The outcome of the intensive analysis of these studies showed that the QoLQ fail to cover the broad spectrum of disease symptoms and current therapy-related toxicity. Furthermore, there is limited if any evidence for the validation of these tools in this context (Table 2). COSMIN criteria were met only for SF-36 and PROMIS-GH as regards internal consistency (Cronbach's a>70).Conclusions: This literature review reveals that commonly applied PROMs in studies on AL Amyloidosis do not represent the impact of this complex disease and its treatment on QoL issues. Thus, there is a need to develop a new, well-validated, disease-specific PROM that can facilitate the approval of new treatments and the adjustment of therapy-intensity according to its toxicity and QoL. [Display omitted] DisclosuresNo relevant conflicts of interest to declare.

Development of Sinonasal Outcome Test (SNOT-22) Domains in Chronic Rhinosinusitis With Nasal Polyps.

Objectives/HypothesisThe 22‐item Sinonasal Outcome Test (SNOT‐22) is a validated chronic rhinosinusitis health‐related quality‐of‐life outcome (HRQoL) measure; however, SNOT‐22 domains have not been validated specifically for chronic rhinosinusitis with nasal polyps (CRSwNP).Study DesignValidation of SNOT‐22 domain structure, using data from 3 randomized, placebo‐controlled, double‐blinded, multicenter clinical trials of dupilumab in adults with moderate‐to‐severe CRSwNP.MethodsPreliminary dimensional structure was derived by exploratory factor analyses of SNOT‐22 data from a phase 2 trial (NCT01920893) of dupilumab for the treatment of CRSwNP. Data from 2 phase 3 clinical trials (NCT02912468 and NCT02898454) were then used for confirmatory factor analysis, and evaluated for reliability, construct validity, and responsiveness. In all three trials, the SNOT‐22 was administered electronically on a tablet and trial participants were required to answer all items.ResultsFactor analysis supported five domains: Nasal, Ear/Facial, Sleep, Function, and Emotion. Correlations between domains were moderate to high, ranging from 0.53 (Nasal–Emotion) to 0.88 (Function–Sleep). Construct validity was mostly supported; relationships with other measures were almost always in the intended direction and magnitude. Internal consistency reliability also confirmed questionnaire structure with strong Cronbach's alpha values (all >0.80). Moderate‐to‐high correlations were observed between change in SNOT‐22 domain scores and other study patient‐reported outcome measures, along with large effect‐size estimates (≥0.7), demonstrating responsiveness of the Nasal, Sleep, and Function domains. Emotion and Ear/Facial domains had small‐to‐moderate effect sizes.ConclusionsPsychometric analyses support the validity, reliability, and responsiveness of five domains of SNOT‐22 (Nasal, Ear/Facial, Sleep, Function, and Emotion) for assessing symptoms and impact on HRQoL in patients with CRSwNP. Laryngoscope, 132:933–941, 2022

Trends in the use of patient-reported outcome measures for inguinal hernia repair: a quantitative systematic review.

To quantitatively assess the use of patient-reported outcome measures in studies involving patients undergoing inguinal hernia repair. We performed a systematic literature search in Medline and EMBASE. We included all studies published between 2000 and 2019 that involved > 5 patients receiving inguinal hernia repair and evaluated a postoperative patient-reported outcome measure. Studies were stratified in 5-year intervals. We extracted data on which patient-reported outcome measure was used, its time of administration, study design, and the size and composition of the study population. Data were presented using descriptive statistics. We included 929 studies that covered 81 different patient-reported outcome measures. Of these, the Short-Form 36 was the most commonly used generic instrument (14%), the Carolinas Comfort Scale was the most commonly used hernia-specific instrument (5%), and the Visual Analogue Scale was the most commonly used domain-specific instrument (70%). There was a proportional decrease in the use of generic instruments, from 24% of studies in 2000-2004 to only 14% of studies in 2015-2019. Conversely, there was an increase in the use of hernia-specific instruments, from 0% in 2000-2004 to 18% in 2015-2019. There is heterogeneity in the use of patient-reported outcome measures in the field of inguinal hernia research. The use of hernia-specific instruments is increasing, the use of generic instruments is decreasing, and the use of domain-specific instruments remains consistently high. This study serves as a repository of all available patient-reported outcome measures relevant to patients undergoing inguinal hernia repair.

Prevalence and Trends of Patient-Reported Outcome Measures Used in Hip Arthroscopy.

The aim of this review was to determine the prevalence of patient-reported outcome measures concerning outcomes of arthroscopic hip surgery. The PubMed database was comprehensively reviewed in March 2016 using the key terms "hip" and "arthroscopy." A total of 192 eligible studies were identified. The most commonly used patient-reported outcome measures were the modified Harris Hip score (61%) and the Non-arthritic Hip Score (27%). Seventy-one percent of total patient-reported outcome measures articles were published between 2011 and 2015. The modified Harris Hip score, Nonarthritic Hip Score, and Hip Outcome Score remain the most commonly used patient-reported outcome measures in studies concerning outcomes of hip arthroscopy, and this has increased in the past 5 years. [Orthopedics. 2019; 42(3):e305-e308.].

Synthesis and summary of patient‐reported outcome measures to inform the development of a core outcome set in colorectal cancer surgery

AimPatient‐reported outcome (PRO) measures (PROMs) are standard measures in the assessment of colorectal cancer (CRC) treatment, but the range and complexity of available PROMs may be hindering the synthesis of evidence. This systematic review aimed to: (i) summarize PROMs in studies of CRC surgery and (ii) categorize PRO content to inform the future development of an agreed minimum ‘core’ outcome set to be measured in all trials.MethodAll PROMs were identified from a systematic review of prospective CRC surgical studies. The type and frequency of PROMs in each study were summarized, and the number of items documented. All items were extracted and independently categorized by content by two researchers into ‘health domains’, and discrepancies were discussed with a patient and expert. Domain popularity and the distribution of items were summarized.ResultsFifty‐eight different PROMs were identified from the 104 included studies. There were 23 generic, four cancer‐specific, 11 disease‐specific and 16 symptom‐specific questionnaires, and three ad hoc measures. The most frequently used PROM was the EORTC QLQ‐C30 (50 studies), and most PROMs (n = 40, 69%) were used in only one study. Detailed examination of the 50 available measures identified 917 items, which were categorized into 51 domains. The domains comprising the most items were ‘anxiety’ (n = 85, 9.2%), ‘fatigue’ (n = 67, 7.3%) and ‘physical function’ (n = 63, 6.9%). No domains were included in all PROMs.ConclusionThere is major heterogeneity of PRO measurement and a wide variation in content assessed in the PROMs available for CRC. A core outcome set will improve PRO outcome measurement and reporting in CRC trials.

Better Patient Reported Outcome Measures: The NDI-8 and NDI-5 Assessed in 714 Patients

Introduction Patient reported outcome measures (PROM) are now a mandatory part of the assessment of clinical results in comparative effectiveness research. The 10-item neck disability index (NDI) is the most commonly used disease specific PROM in studies of patients with cervical spinal disorders. It is well known, easy to administer and score (10 items—answers added together and multiplied by 2, to provide a score). Recent studies have shown significant deficiencies in the psychometrics of the standard NDI, including poor coverage (large floor effect), multivariance, and most concerning, extremely poor raw score to measure correlation—which means using the additive score is concerning, particularly with standard statistical testing. By excluding two questions, or five questions, an NDI-8 and NDI-5 can be constructed with much-improved psychometrics and decreased clinical burden, yet this has not been evaluated in a formal spine medical practice and is not used in clinical research. The goal of this study is to clarify the psychometric properties of the standard NDI-10, in comparison with the new NDI-8 and NDI-5, in search of an improved PROM for neck patients. Material and Methods Patient demographics and the NDI were collected on 714 patients with neck ± upper extremity pain. Using Rasch analysis, the NDI-10, -8, and -5 were assessed for psychometric properties, including overall item fit, variance, coverage, and raw score to measure correlation. Results Data were assessed from 714 consecutive patients (53% males, 86% whites) with average age being 55 years, seen at a university-based spine center. The NDI-5 and NDI-8 were highly correlated at 0.95, had excellent fit, similar to the NDI-10, and less variance than the NDI-10. Like the NDI-10, coverage for the NDI-8 and -5 were poor, with very high floor effects of 39.36 and 39.22% (compared with 35.5% in the NDI-10). Ceiling effects were acceptable for both measures. Most importantly, the raw score to measure correlation of the NDI-8 and NDI-5 are very high at 0.94 each, while the NDI-10 correlation was poor, at 0.02. Conclusion While the standard 10-item NDI is of questioned value, the NDI-5 and NDI-8 show improved psychometrics, in particular the raw score to measure correlation. With fewer items the NDI-5 decreases patient and clinic burden without significantly effecting coverage, and is therefore the preferred measure. Future work should be concerned with improving coverage with the addition of items at the extremes of disability, particularly low disability items.