A Narrative Literature Review of Bias in Collecting Patient Reported Outcomes Measures (PROMs)

Zini, Michela Luciana Luisa; Banfi, Giuseppe

doi:10.3390/ijerph182312445

Cited by 53 publications

(29 citation statements)

References 30 publications

(29 reference statements)

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“…Although there are several advantages to electronic versions of PROs (e.g., real-time data recording, immediate scoring, and reduction of human error), the implementation of traditional paper-based methods avoids the exclusion of certain patients who are less comfortable using electronic devices. Several studies have reported no significant differences between the two modes [ 39 ]. In addition, high compliance rates for completion of the EORTC QLQ-C30 and the FACIT-F were observed with very few dropouts across both treatment groups.…”

Section: Discussionmentioning

confidence: 99%

Changes in hemoglobin and clinical outcomes drive improvements in fatigue, quality of life, and physical function in patients with paroxysmal nocturnal hemoglobinuria: post hoc analyses from the phase III PEGASUS study

et al. 2022

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Paroxysmal nocturnal hemoglobinuria (PNH) is a rare, chronic, acquired, hematologic, life-threatening disease characterized by thrombosis, impaired bone marrow function, and complement-mediated hemolysis. The PEGASUS phase III clinical trial demonstrated superiority of pegcetacoplan over eculizumab regarding improvements in hemoglobin levels in patients with suboptimal response to prior eculizumab treatment. The objective of this post hoc analysis was to compare the patient-reported outcome (PRO) response rates observed among PEGASUS participants and the relationships between their PRO scores with clinical and hematological parameters. Data from the 16-week randomized, controlled (1:1 to pegcetacoplan or eculizumab) period of the PEGASUS trial included comparisons of weekly PRO measurements taken using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) scales. A clinically meaningful FACIT-F response was defined as an increase from baseline of ≥5 points. Convergent validity was assessed using conventional threshold correlations between FACIT-F, EORTC QLQ-C30, and laboratory parameters. A clinically meaningful improvement in FACIT-F score was seen in 72.2% of pegcetacoplan-treated patients compared to 22.9% of eculizumab-treated patients. At week 16, the FACIT-F total score correlated with hemoglobin levels (r=0.47, p< 0.0001), absolute reticulocyte count (r=−0.37, p<0.01), and indirect bilirubin levels (r=−0.25, p<0.05). Clinically meaningful improvements in pegcetacoplan-treated patients were also observed for multiple EORTC scales. Fatigue and other self-reported outcomes were correlated with clinically meaningful improvements in clinical and hematological parameters. Clinical trial registration: NCT03500549

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Section: Discussionmentioning

confidence: 99%

Changes in hemoglobin and clinical outcomes drive improvements in fatigue, quality of life, and physical function in patients with paroxysmal nocturnal hemoglobinuria: post hoc analyses from the phase III PEGASUS study

et al. 2022

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“…As a retrospective analysis of prospectively collected data, it is impacted by recall bias. 35 Our mean follow-up of 13 months reports short-term outcomes and future studies looking at mid- and long-term outcomes could potentially be useful. Further, the relatively small number of patients in the study could mean that we were underpowered to find significant differences across all domains, and a power analysis was not performed.…”

Section: Discussionmentioning

confidence: 93%

Does the Canadian Orthopaedic Foot and Ankle Society Postoperative COFAS End-Stage Ankle Arthritis Classification System Correlate With Pre- and Postoperative PROMIS Scores for Total Ankle Arthroplasty?

Shlykov

Savage-Elliott

Lonergan³

et al. 2022

Foot & Ankle Orthopaedics

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Background: Recently, the Canadian Orthopaedic Foot and Ankle Society (COFAS) proposed a classification system addressing adjunct procedures in the treatment for end-stage ankle arthritis. We reviewed Patient-Reported Outcome Measures Information System (PROMIS) data to determine if outcomes of total ankle arthroplasty (TAA) correlated with postoperative COFAS classification. We hypothesize that as COFAS classification increases, patients will demonstrate greater improvement in the change between pre- and postoperative PROMIS scores. Methods: From June 2015 to December 2018, a total of 127 patients underwent 132 TAA. Demographic factors and preoperative and most recent postoperative PROMIS scores were collected. Univariate, multivariate and post hoc analyses with a significance threshold of P <.05 were performed. Results: Eighty-seven patients with a mean follow-up of 13.6±7.3 months and complete PROMIS scores were classified into COFAS types 1-4. Significant differences were identified in the PROMIS Pain Interference domain comparing COFAS types 2 and 4 and COFAS types 3 and 4. These results demonstrate that more complex ankles with a higher COFAS score had worse interval improvement in PROMIS scores. Additionally, multivariate linear regression showed that age and BMI were associated with worse physical function and depression, whereas diabetes and a history of prior surgeries were associated with improved postoperative function. Conclusion: The COFAS postoperative classification system is useful for categorizing end-stage ankle arthritis. Further research into the ideal timing of surgery and higher-level studies to better determine TAA efficacy with different classification systems is warranted. This information can be helpful with preoperative counseling about treatment outcomes. Level of Evidence: Level IV, retrospective analysis of prospectively collected data.

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“…These patients, as they never participated, should potentially be considered as “screening failure” instead of being categorized as “lost to follow-up”. In the future, deleting data of those patients who have not reported their preoperative assessment by a predetermined time (at which potential recollection bias may impact data quality) may be considered [ 26 ]. Nonetheless, effort should be made in order to increase the follow-up rate and decrease the rate of “screening failures”.…”

Section: Discussionmentioning

confidence: 99%

The German Arthroscopy Registry DART: what has happened after 5 years?

Hinz

Lutter

Mueller-Rath

et al. 2022

Knee Surg Sports Traumatol Arthrosc

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Purpose The German Arthroscopy Registry (DART) has been initiated in 2017 with the aim to collect real-life data of patients undergoing knee, shoulder, hip or ankle surgery. The purpose of this study was to present an overview of the current status and the collected data thus far. Methods Data entered between 11/2017 and 01/2022 were analyzed. The number of cases (each case is defined as a single operation with or without concomitant procedures) entered for each joint, follow-up rates and trends between different age groups (18–29 years, 30–44 years, 45–64 years, ≥ 65 years) and across genders, and quality of life improvement (pre- vs. 1 year postoperative EQ visual analogue scale [EQ-VAS]) for frequently performed procedures (medial meniscus repair [MMR] vs. rotator cuff repair [RCR] vs. microfracturing of the talus [MFX-T]) were investigated. Results Overall, 6651 cases were entered into DART, forming three distinct modules classified by joint (5370 knee, 1053 shoulder and 228 ankle cases). The most commonly entered procedures were: knee: partial medial meniscectomy (n = 2089), chondroplasty (n = 1389), anterior cruicate ligament reconstruction with hamstring autograft (n = 880); shoulder: sub acromial decompression (n = 631), bursectomy (n = 385), RCR (n = 359); ankle: partial synovectomy (n = 117), tibial osteophyte resection (n = 72), loose body removal (n = 48). In the knee and shoulder modules, middle-aged patients were the predominant age group, whereas in the ankle module, the youngest age group was the most frequent one. The two oldest age groups had the highest 1-year follow-up rates across all modules. In the knee and shoulder module, 1-year follow-up rates were higher in female patients, whereas follow-up rates were higher in male patients in the ankle module. From pre- to 1-year postoperative, MFX-T (EQ-VAS: 50.0 [25–75% interquartile range: 31.8–71.5] to 75.0 [54.3–84.3]; ∆ + 25.0) led to a comparably larger improvement in quality of life than did MMR (EQ-VAS: 70.0 [50.0–80.0] to 85.0 [70.0–94.0]; ∆ + 15.0) or RCR (EQ-VAS: 67.0 [50.0–80.0] to 85.0 [70.0–95.0]; ∆ + 18.0). Conclusion DART has been sufficiently established and collects high-quality patient-related data with satisfactory follow-up allowing for a comprehensive analysis of the collected data. The current focus lies on improving patient enrolment and follow-up rates as well as initiating the hip module.

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A Narrative Literature Review of Bias in Collecting Patient Reported Outcomes Measures (PROMs)

Cited by 53 publications

References 30 publications

Changes in hemoglobin and clinical outcomes drive improvements in fatigue, quality of life, and physical function in patients with paroxysmal nocturnal hemoglobinuria: post hoc analyses from the phase III PEGASUS study

Changes in hemoglobin and clinical outcomes drive improvements in fatigue, quality of life, and physical function in patients with paroxysmal nocturnal hemoglobinuria: post hoc analyses from the phase III PEGASUS study

Does the Canadian Orthopaedic Foot and Ankle Society Postoperative COFAS End-Stage Ankle Arthritis Classification System Correlate With Pre- and Postoperative PROMIS Scores for Total Ankle Arthroplasty?

The German Arthroscopy Registry DART: what has happened after 5 years?

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