Common Patient-reported Outcome Measures Research Articles

Assessing Correlations and Demographic Interactions Between PROMIS25 and SRS30 in Pediatric Patients With Spinal Deformity.

Historically, patient-reported outcome measures (PROMs) have been measured using anatomy-specific instruments. However, these instruments may be influenced by the presence of concomitant illnesses not associated with the orthopaedic condition. As such, standardized PROM tool, such as PROMIS25, have been developed to assess patient outcomes. In this study, we aim to compare the correlation and association between 2 common PROMs used for pediatric patients with spinal deformity. This study included patients younger than 21 years who were indicated for spinal deformity surgery at our institution. All patients were invited to complete SRS-30 and PROMIS-25 instruments through an automated, electronic patient-reported outcome platform before surgery. Patient demographics were recorded and Spearman correlations were calculated between the various PROMIS and SRS domains. Correlations were compared between different baseline characteristics and demographics using a rho-to-z transformation method. Ceiling and floor effects were also investigated. A total of 207 patients were enrolled in this study. The majority of PROMIS and SRS domains had moderate to strong correlations, with higher correlations observed when each instrument tried to capture the same construct. For example, there was strong correlation between PROMIS raw pain and SRS pain (ρ=-0.86, P <0.01), and PROMIS Depression and SRS Mental Health (ρ=-0.76, P <0.01). Ceiling effects ranged from 1.0 to 16.9% in SRS and 0.5 to 28.5% is PROMIS. Floor effects ranged from 0.5 to 1.5% in SRS and 0.5 to 29.0% in PROMIS. There were significant differences in the correlation between SRS Mental Health and PROMIS Depression when comparing between different sexes (male: ρ=-0.74, female: ρ=-0.59, P =0.04). In addition, there were significant differences in the correlation between SRS Mental Health and PROMIS Anxiety when comparing between different insurance payors (commercial: ρ=-0.86, female: ρ=-0.75, P =0.03). There is strong correlation between SRS and PROMIS domains in pediatric patients with spinal deformity. These correlations can differ by baseline characteristics and demographics. Providers should consider these differences when interpreting PROMs in diverse patient populations. Level III; Retrospective comparative study.

Use of Minimal Important Difference for Patient-Reported Outcome Measures in Plastic Surgery: A Systematic Review.

The minimal important difference (MID) is vital to consider when interpreting the clinical importance of observed changes from surgical interventions assessed by patient-reported outcome measures (PROMs). There is no gold-standard for how to calculate MIDs, and uptake in plastic surgery literature is currently unknown, leading to methodological and interpretation issues. Medline and Embase were searched to identify all plastic surgery randomized controlled trials (RCTs) employing PROMs as outcomes, and MID estimation studies for PROMs used by RCTs. Included studies were assessed for uptake and application of MIDs, and MID estimation methodology and values were categorized. A total of 554 RCTs employing PROMs as outcomes were identified. Of these, 419 RCTs had the possibility of incorporating a previously published MID. Uptake rate of MIDs was 11.5% (n=48/419). The most common ways MIDs were applied was to calculate sample size (37.5%) or to determine whether results were clinically important (35.4%). A total of 99 studies estimating MID values for the most common PROMs in plastic surgery, based on our review, were analyzed. The most common estimation methodologies were receiver-operator curve analysis (49%), change difference (31%), and standard deviation (25%). Our review highlights limited uptake and application of MIDs in plastic surgery. We propose four major barriers: 1) there existed no repository of published MIDs for PROMs used in plastic surgery; 2) available MIDs are not specific to plastic surgery populations; 3) high heterogeneity in MID estimation methodology; 4) wide ranges in MID values with no superior choice.

Poster 193: Long-Term Outcomes of Partial Proximal Hamstring Avulsion Repair: Average 10-Year Follow-Up

Objectives: While a growing body of literature supports the benefit of surgical repair of complete proximal hamstring avulsions involving all 3 tendons, the optimal treatment for partial proximal hamstring avulsions remains uncertain. Initial nonoperative management of partial proximal hamstring avulsions is typically recommended, but several recent studies have shown improved pain and function at short- and mid-term follow-up. However, the durability of surgical repair at long-term follow-up is unknown. The purpose of this study was to report the long-term outcomes of partial proximal hamstring avulsion repair compared to outcomes at midterm follow-up. It was hypothesized that hamstring function and patient satisfaction would remain stable over time. Methods: All patients who underwent surgical repair of a partial proximal hamstring avulsion by a single surgeon between 2006 and 2018 with a minimum 5-year follow-up were included. Institutional review board approval was obtained prior to study initiation, and all patients signed informed consent. Exclusion criteria were complete avulsions involving all 3 hamstring tendons, retraction &gt; 2 cm, or magnetic resonance imaging (MRI) findings of isolated tendinopathy. All patients had first attempted nonoperative treatment, including nonsteroidal anti-inflammatory drugs and physical therapy. Patient characteristics were collected including age, sex, injury, laterality, sports played, level of participation, length of time from injury to intervention, and length of follow-up. Patients completed a HIPPA-compliant online questionnaire (REDCap) containing the patient-reported outcomes scores of the Lower Extremity Functional Score (LEFS), Marx Activity Rating Scale, custom LEFS (%), and custom Marx (%). A Total Proximal Hamstring Score was calculated by averaging the custom Marx score and the custom LEFS. Patient satisfaction with surgical outcome (yes/no) was also determined. A portion of the included patients had the same outcome measures available from a previous study entailing a minimum 2-year follow-up, with an average follow-up of 6.2 years. Paired comparisons of current outcome scores with earlier scores were performed using a paired Mann-Whitney U test for continuous variables and Fisher exact test for categorical variables. Results: Fifty-three patients (57 hamstrings) with a mean age at surgery of 47.4 years were included at an average follow-up time of 10.1 years. Of the 53 patients, 4 had bilateral injuries and 4 underwent revision surgery. The right (n = 29) and left (n = 28) hamstrings were equally affected with a predominance of female patients (41 female, 16 male). Running was the most common sport at the time of injury (Table 1). Excellent functional outcomes were seen at average 10.1 years (Table 2). 91.2% of patients were satisfied with the results of surgery and were able to return to their desired sport at an average of 10.9 months after surgery. Nearly 88% of hamstrings considered their strength to be &gt;75% strength of the contralateral side, with approximately 58% of hamstrings reporting equal (100%) strength. When comparing the 44 partial hamstring repairs with outcome scores available at both midterm (6.2 years) and long-term follow-up (10.7 years), only the Marx and custom Marx scores were found to decline with time. Scores for LEFS, custom LEFS, Total Proximal Hamstring, satisfaction, and subjective strength were unchanged between midterm and long-term follow-up (Table 3). Conclusions: Excellent patient-reported outcomes and high levels of satisfaction were found at 10-year follow-up following partial proximal hamstring avulsion repair. Notably, the LEFS and custom LEFS, which are the most common patient-reported outcome measures used to assess hamstring function following injury, remained high at midterm and long-term follow-up. The Marx (12.5 vs. 8.5) and custom Marx scores (100% vs. 94%) did achieve statistically significant differences between time points, with lower scores at long-term follow-up possibly in part due to self-determined reduction in strenuous activities with aging. Patient-reported satisfaction and subjective strength remained high at long-term follow-up. Surgical repair of partial proximal hamstring avulsions remains a successful and durable treatment strategy in active patients who have failed nonoperative measures at an average follow-up exceeding 10 years.

Psychometric evaluation of the Japanese neck disability index by exploratory factor analysis in preoperative patients with cervical spondylotic myelopathy: impact of pain and numbness

BACKGROUND CONTEXTThe Neck Disability Index (NDI), a common Patient-Reported Outcome Measure (PROM) for neck pain, lacks sufficient study on its psychometric properties in preoperative patients with cervical spondylotic myelopathy (CSM). PURPOSEThis study aims to address these gaps by conducting an exploratory factor analysis of the Japanese NDI. The objectives are 2-fold: (1) to scrutinize the psychometric properties and internal consistency of the Japanese NDI, and (2) to explore the specific regions of pain and numbness influencing the NDI. STUDY DESIGN/SETTINGA single-center observational study. PATIENT SAMPLEA total of 100 preoperative patients with CSM. OUTCOME MEASURESThe NDI and Numerical Rating Scale (NRS) were employed to assess preoperative neck disability and pain and numbness in various body regions. METHODSDemographic and clinical characteristics were collected, encompassing age, sex, body mass index, American Society of Anesthesiologists classification, smoking status, comorbidities, pain and numbness at various sites using the NRS, and NDI. For evaluating the psychometric properties and internal consistency of the NDI, exploratory factor analysis (EFA) and Cronbach's α coefficient were utilized. Furthermore, the impact of pain and numbness on NDI factors was examined through multivariable regression analysis. RESULTSEFA identified 2 factors—Physical and Mental—highlighting the dual nature of neck-related disability. Physical factors (std.β=0.724, p<.001) exerted a stronger impact on NDI scores compared to Mental factors (std.β=0.409, p<.001). Cronbach's α coefficient was 0.831 for physical factors and 0.723 for mental factors, indicating a high level of internal consistency. Numbness in the hand (std.β=0.338, p<.001) and pain in the neck (std.β=0.202, p=.035) were significant variables influencing Physical factor, while numbness in the hand (std.β=0.485, p<.001) and pain in the head (std.β=0.374, p<.001) impacted Mental factor. CONCLUSIONThis study contributes valuable insights into the psychometric properties of the NDI in preoperative patients with CSM. The identified factors emphasize the importance of addressing both physical and sensory symptoms in preoperative care.

Piloting Rasch model scoring of the National Eye Institute Visual Function Questionnaire in uveitis

IntroductionThe National Eye Institute Visual Function Questionnaire (NEI VFQ) is a common patient-reported outcome measure (PROM) in uveitis trials. Its psychometric properties using state-of-the-art scoring based on Rasch models, a latent trait model that improves accuracy of PROMs assessment, has not yet been investigated.MethodsThe study participants were recruited online from uveitis patient organizations, where individuals self-reported their uveitis diagnosis and visual acuity level. These participants then completed the NEI VFQ-25. The visual function (VF) and socioemotional (SE) subscales were psychometrically analysed in terms of item fit, targeting, internal consistency, dimensionality, and differential item functioning (DIF), using Rasch models. Criterion validity was examined based on associations between NEI VFQ person measures and recent visual acuity (VA) levels.ResultsNinety-nine participants recruited online from uveitis patient organizations (68 women, 31 men; mean age 50 ± 15 years; 46.5% self-reported receiving systematic therapy for uveitis, 0.6% NEI VFQ-25 missing data) were included. The mean difficulty of items was lower than the average person ability. None of the items demonstrated misfit to an extent that would induce noise into the measurement. The consistency metrics person reliability and person separation index of the subscales were 0.85 and 2.34 (NEI VFQ-VF), 0.86 and 2.52 (NEI VFQ-SE), respectively. There was no evidence of multidimensionality and none of the items showed DIF by gender. The differences between item and person measures were 1.44 (NEI VFQ-VF) and 1.03 (NEI VFQ-SE). NEI VFQ-25 person measures were significantly lower in participants with visual impairment (all p values ≤ 0.007).ConclusionRasch model-based scoring of the re-engineered NEI VFQ-25 demonstrates acceptable internal consistency, item fit and construct validity for assessing two key domains of quality of life in individuals self-reporting uveitis. The PROM was targeted at a higher level of difficulty than present in our heterogeneous sample.

A Qualitative Concept Elicitation Study to Understand Patient-Reported Symptoms and Impacts of Neisseria gonorrhoeae Infections in the United States.

Gonorrhea is the second most common bacterial sexually transmitted infection in the United States, with rising rates. Emerging antimicrobial resistance threatens public health, and vaccines are in development. This study documents patient-reported gonorrhea symptoms and health-related quality-of-life (HRQoL) impact in women who have sex with men (WSM), men who have sex with women (MSW), and men who have sex with men (MSM). Semistructured qualitative interviews were conducted (April 2021-March 2022) among US adults with recent (≤6 months) confirmed gonorrhea. Concept saturation was achieved, confirming adequate participant numbers to meet objectives. Elicited symptom and HRQoL impacts were used to develop a conceptual disease model. Common patient-reported outcome measure (PROM) items were compared with elicited concepts. Thirty-two participants (15 WSM, 8 MSW, and 9 MSM) were included. Eight were asymptomatic, 6 had repeat infections, and 5 women and 4 men had complications (i.e., infertility or pelvic inflammatory disease, and urethritis, respectively).The most frequently reported symptoms were vaginal discharge (n = 11 of 12), dysuria (n = 10 of 12), and abdominal/vaginal pain (n = 9 of 12) for symptomatic WSM; dysuria (n = 5 of 6) and penile discharge (n = 4 of 6) for symptomatic MSW; and throat, testicular, or rectal pain (n = 4 of 6) for symptomatic MSM. All (symptomatic and asymptomatic) participants reported HRQoL impacts including negative emotional experiences (n = 31 of 32), and interference with sexual activity (n = 30 of 32), relationships (n = 24 of 32), and social life (n = 17 of 32). Concepts were poorly represented in existing PROMs. Participants reported a diverse range of symptoms and HRQoL impacts, to help inform the value of new treatment and prevention options. More research is needed to quantify patient burden and develop PROMs.

Variability of MCID, SCB, and PASS Thresholds in Studies Assessing Patient-Reported Outcomes After Rotator Cuff Repair: A Systematic Review

Background: An increasing reliance on patient-reported outcomes has led to greater emphasis on minimal clinically important difference (MCID), substantial clinical benefit (SCB), and Patient Acceptable Symptom State (PASS) thresholds in assessing rotator cuff repairs. Purpose: To review the MCID, SCB, and PASS thresholds reported for patient-reported outcome measures (PROMs) after rotator cuff repair. Study Design: Systematic review; Level of evidence, 4. Methods: The PubMed, Embase, Ovid, Cochrane, and Google Scholar databases were queried for full-text journal articles in English published between January 1, 2000, and May 31, 2022. Studies with MCID, SCB, and PASS thresholds reported for patients with rotator cuff repair and a minimum of 12 months of follow-up were included. Reported MCID, SCB, and PASS thresholds and associated calculation methods were extracted. Results: There were 41 unique studies (6331 shoulders) that met the inclusion criteria. Of these, 37 (90%) reported MCID; 16 (39%), PASS; and 11 (27%), SCB values. The most common PROMs were the American Shoulder and Elbow Surgeons score and the Constant-Murley score. In total, 71% (29/41) of these studies referenced values in the literature, usually studies of patients undergoing rotator cuff repair (21/29). Twelve studies calculated MCID, SCB, or PASS thresholds using anchor-based approaches, whereas 6 studies also calculated thresholds using distribution-based methods. The use of MCID, SCB, and PASS in the rotator cuff repair literature is increasing, with half of the included studies published within the final 17 months of the studied period. Conclusion: Significant variability was seen in the reporting of MCID, SCB, and PASS threshold values after rotator cuff repair. Researchers should prioritize studies that report clinical outcome thresholds calculated using anchor-based methods and should critically review both the anchor question and its response choices. Standardization of MCID, SCB, and PASS values and calculation methods will allow for a more reliable assessment of PROMs in rotator cuff repair moving forward.

Evaluation of the test–retest and inter-mode comparability of the Impact of Vision Impairment questionnaire in people with chronic eye diseases

PurposeThe main objective of this study is to assess the test–retest and inter-administration mode reliability of the Impact of Vision Impairment profile (IVI), a common patient-reported outcome measure (PROM) for people with chronic eye diseases.MethodsThe IVI was administered to adult patients with stable, chronic eye diseases two to four times per participant (average intervals between administrations 12 to 20 days; maximum two phone interviews, paper administration, electronic administration) by two trained interviewers. Rasch models were fit to the data. Intra-class correlation coefficients (ICCs), mean differences and Cronbach’s alpha between test–retest administrations (two phone interviews) and inter-mode comparisons were calculated.ResultsTwo hundred-sixteen patients (mean age 67 ± 12 years, 40% male) were included in the study. The IVI met all psychometric requirements of the Rasch model, and the division into the domains of functional items (IVI_F) and emotional items (IVI_E) corresponded to the German validation study. ICCs (all for IVI_F and IVI_E, respectively) for the retest administrations were 0.938 and 0.912, and 0.853 and 0.893 for inter-mode comparisons phone/paper, 0.939 and 0.930 for phone/electronic, and 0.937 and 0.920 for paper/electronic (all p < 0.01). Mean differences (all for IVI_F and IVI_E, respectively) for the retest administrations were 2.8% and 0.7% and ranged from 2.0% to 6.2% and from 0.4 % to 4.9% between administration modes. Cronbach’s alpha ranged from 0.886 to 0.944 for retest and inter-mode comparisons.ConclusionDue to the high test–retest reliability and the almost equally high comparability of different modes of administration of the IVI, the study endorses its use as a robust PROM to capture vision-related quality of life. Our results further support the use of the IVI as an endpoint in clinical trials and may simplify implementing it in both clinical trials or real-world evidence generation by offering multiple administration modes with high reliability.

Genetic Variability in VEGFA Gene Influences the Effectiveness of Tennis Elbow Therapy with PRP: A Two-Year Prospective Cohort Study.

Vascular endothelial growth factor (VEGF) is implicated in both the etiology of tendinopathy and its healing process. Polymorphic variants of the VEGFA gene exhibit varied expression, which can influence the phenotype and treatment effectiveness. The aim of the present study was to analyze the influence of VEGFA gene variants on the effectiveness of tennis elbow therapy using platelet-rich plasma (PRP), measured through common patient-reported outcome measures (PROMs). A cohort of 107 patients (132 elbows) with tennis elbow was prospectively analyzed, with a two-year follow-up (at weeks 2, 4, 8, 12, 24, 52, and 104 after PRP injection). PROMs values were compared between variants of five VEGFA gene polymorphisms (rs699947 A>C, rs2010963 C>G, rs1413711 C>T, rs3024998 C>T and rs3025021 C>T) at each follow-up point. Patients with genotypes GG (rs2010963) and CC (rs3024998) had better response to PRP therapy (significantly fewer symptoms and limitations in the upper limb compared to carriers of alleles C and T, respectively). Polymorphisms influenced also selected hematological parameters. VEGFA gene polymorphisms (rs2010963 and rs3024998) appear to be significant treatment modifiers for tendinopathy, and their genotyping may serve as an effective tool for personalized patient selection for PRP therapy.

Equipercentile equating of scores from common patient-reported outcome measures of physical function in patients with cancer

ObjectiveTo provide equipercentile equating of physical function (PF) scores from frequently used patient-reported outcome measures (PROMs) in cancer patients to facilitate data pooling and comparisons. Study Design and SettingAdult cancer patients from five European countries completed the European Organization for Research and Treatment of Cancer (EORTC) computer adaptive test (CAT) Core, EORTC Quality of Life Questionnaire Version 3.0 (QLQ-C30), Functional Assessment of Cancer Therapy - General (FACT-G), 36-item Short Form Health Survey (SF-36), and the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function 20a short form. The R package “equate” was used to establish conversion tables of PF scores on those measures with a bivariate rank correlation of at least 0.75. ResultsIn total, 953 patients with cancer (mean age 58.9 years, 54.7% men) participated. Bivariate rank correlations between PF scores from the EORTC CAT Core, EORTC QLQ-C30, SF-36, and PROMIS were all above 0.85, but below 0.69 for the FACT-G. Conversion tables were established for all measures but the FACT-G. These tables indicate which score from one PROM best matches the score from another PROM and provide standard errors of converted scores. ConclusionOur analysis indicates that linking of PF scores from both EORTC measures (CAT and QLQ-C30) with PROMIS and SF-36 is possible, whereas the physical domain of the FACT-G seems to be different. The established conversion tables may be used for comparing results or pooling data from clinical studies using different PROMs.

Communicative participation outcomes in individuals with Parkinson's disease receiving standard care speech-language therapy services in community settings.

The Communicative Participation Item Bank (CPIB) is a patient-reported outcome measure (PROM) designed to measure the extent of interference, or difficulty, experienced by adults with communication disorders participating in their day-to-day communication activities. To date, there is limited evidence regarding sensitivity of the CPIB for capturing change with intervention in people with Parkinson's disease (PwPD). The purpose of this study was to examine the following measurement properties of the CPIB in PwPD who received community-based, standard care, speech-language therapy focusing on motor speech concerns: Change over time between treatment and observation groups, comparison to patient-defined ideal and satisfactory targets, comparison of static short form to computerised adaptive testing (CAT), comparison of self to proxy-rated scores, and comparison to other common PROMs. Forty-six PwPD (20 treatment/26 observation) completed data collection upon enrolment (pre-treatment) and 6 months later. In addition to the CPIB, PROMs included the Voice Handicap Index 10-item short form (VHI-10), PROMIS Global Health-Related Quality of Life, Levels of Speech Usage, self-rated speech severity, and Patient Health Questionnaire-9 (PHQ-9). Participants also engaged in qualitative interviews. Forty-four family members completed proxy CPIB ratings. There were no significant differences between treatment and observation groups on the CPIB pre-treatment, but there were significant differences post-treatment. The differences appeared to be largely due to significant gains in the treatment group. No participants reached their ideal CPIB target, and few reached their satisfactory target. Static CPIB short form and CAT scores were not significantly different, with an average of five CAT items administered per participant. Overall group similarities between patient and proxy scores may have obscured wide variability across individual patient-proxy pairs. Associations between CPIB and VHI-10, health-related quality of life, self-reported speech severity, and depression ranged from weak to moderate. The CPIB appears to be sensitive to capturing change with intervention, and similar results are obtained with the static short form and CAT formats. One clinical caution is that even with gains observed in the treatment group, no participants obtained their ideal communicative participation goals, and few obtained a satisfactory level of communicative participation. Thus, while current interventions are beneficial, they may not meet the full range of clients' communication needs. While responding to the CPIB through a proxy rater may be feasible, caution is warranted due to concerns about maintaining the autonomy of PwPD. What is already known on this subject The communication disorders associated with Parkinson's disease (PD) can have a negative impact on quality of life and life participation as measured by patient (or person)-reported outcome measures (PROMs). The Communicative Participation Item Bank (CPIB) is one PROM available to use with adults with communication disorders. However, little is known about whether the CPIB captures changes in communicative participation as a result of standard care treatment for people with Parkinson's disease (PwPD). Use of computerised adaptive testing (CAT), proxy report and comparison to targeted participation outcomes have not been explored. What this study adds to existing knowledge As a result of this study, we know that the CPIB captured differences between treatment and observation groups after community-based, standard care speech therapy intervention focusing on motor speech production in PwPD. Static short form and CAT scores did not differ significantly, so the CAT option provides better efficiency requiring, on average, five items to administer compared to the 10-item short form. Proxy and PwPD scores did not differ as a group, but wide variability was noted. What are the potential or actual clinical implications of this work? The CPIB may be a clinically sensitive instrument for capturing changes in communicative participation after treatment. No participants met their ideal CPIB target, and few reached their satisfactory target, suggesting that while current interventions contribute to gains in communicative participation, there are still unmet needs that may call for support and interventions addressing the more complex array of factors affecting communicative participation outcomes for PwPD.

Patient Reported Outcome Measures in the Foot and Ankle Literature: A Systematic Review

Category: Other Introduction/Purpose: Optimising clinical practice requires emphasis on patient-orientated care and therefore patient reported outcome measures (PROMs) play a key role in shaping evidence-based clinical guidelines. As such, it is crucial that we use appropriate, valid and reliable PROMs to quantify outcomes in orthopaedic research. A previous systematic review evaluating evidence published between 2002-2011 identified 139 different PROMs used in the foot and ankle literature and found the most common PROM was The American Orthopaedic Foot and Ankle Society (AOFAS) score. However, in 2011, AOFAS issued a position statement outlining the lack of reliability and validity of the AOFAS score, describing it as a ‘less than ideal’ measure. This systematic review aims to provide an updated analysis of the PROMS used in the foot and ankle literature. Methods: This systematic review was performed according to PRIMSA guidelines. An electronic title/abstract screen of every article published between January 2012- December 2022 in Foot and ankle international, Clinical Orthopaedics and Related Research, Knee Surgery Sports Traumatology and Arthroscopy, The Bone and Joint Journal and The American Journal of Sports Medicine was performed by two reviewers. Articles with a foot and ankle focus were selected for full text screening and papers reporting at least one PROM were included in the final review. The following data was extracted from each article: journal of publication, month/year of publication, pathology/intervention described, PROMS reported and use of the minimally clinically important difference (MCID) to evaluate post intervention changes in PROMs. The number of studies using each individual PROM was calculated and a subgroup analysis was performed to investigate variation in PROM selection according to year of publication, journal of publication and the condition being investigated. Results: A total of 3,174 foot and ankle articles were identified, of which 1,168 (36.8%) articles reporting at least one PROM were included. The most common PROM was the AOFAS score, reported in 50.3% of studies, followed by visual analogue scale (VAS) pain score (44.4%) and 36-item short form survey (SF-36) (15.3%). Use of the AOFAS score declined across the review period. Between 2012-2016 AOFAS was the most common PROM, whilst VAS pain was most common in four of the last six years. Although some variation in PROMs according to clinical pathology exists, AOFAS score is featured in the top 3 most common PROMs for every analysed condition. Only 8/1,168 (0.7%) articles reported the number of patients achieving a minimally clinically important difference (MCID) post-intervention. Conclusion: Whilst use of the AOFAS score declined over the review period, it remains the most common PROM overall across all included journals and many conditions. There exists a lack of consensus regarding the most suitable alternative PROMs, with multiple validated instruments including FAOS, FAAM and FFI used inconsistently with relatively low frequency. There is a heavy reliance on statistical significance to evaluate and compare post-intervention PROM changes. However, it is important to quantify PROMs according to the patient perspective. Reporting the proportion of patients achieving MCID will allow clinicians to interpret PROMs and develop management guidelines in a patient-focused manner.

Risk factors for failure to achieve minimal clinically important difference following cervical disc replacement

BACKGROUND CONTEXTWhile cervical disc replacement (CDR) has been emerging as a reliable and efficacious treatment option for degenerative cervical spine pathology, not all patients undergoing CDR will achieve minimal clinically important difference (MCID) in patient-reported outcome measures (PROMs) postoperatively—risk factors for failure to achieve MCID in PROMs following CDR have not been established. PURPOSETo identify risk factors for failure to achieve MCID in Neck Disability Index (NDI, Visual Analog Scale (VAS) neck and arm following primary 1- or 2-level CDRs in the early and late postoperative periods. STUDY DESIGNRetrospective review of prospectively collected data. PATIENT SAMPLEPatients who had undergone primary 1- or 2-level CDR for the treatment of degenerative cervical pathology at a single institution with a minimum follow-up of 6 weeks between 2017 and 2022. OUTCOME MEASURESPatient-reported outcomes: Neck disability index (NDI), Visual analog scale (VAS) neck and arm, MCID. METHODSMinimal clinically important difference achievement rates for NDI, VAS-Neck, and VAS-Arm within early (within 3 months) and late (6 months to 2 years) postoperative periods were assessed based on previously established thresholds. Multivariate logistic regressions were performed for each PROM and evaluation period, with failure to achieve MCID assigned as the outcome variable, to establish models to identify risk factors for failure to achieve MCID and predictors for achievement of MCID. Predictor variables included in the analyses featured demographics, comorbidities, diagnoses/symptoms, and perioperative characteristics. RESULTSA total of 154 patients met the inclusion criteria. The majority of patients achieved MCID for NDI, VAS-Neck, and VAS-Arm for both early and late postoperative periods—79% achieved MCID for at least one of the PROMs in the early postoperative period, while 80% achieved MCID for at least one of the PROMs in the late postoperative period. Predominant neck pain was identified as a risk factor for failure to achieve MCID for NDI in the early (OR: 3.13 [1.10–8.87], p-value: .032) and late (OR: 5.01 [1.31–19.12], p-value: .018) postoperative periods, and VAS-Arm for the late postoperative period (OR: 36.63 [3.78–354.56], p-value: .002). Myelopathy was identified as a risk factor for failure to achieve MCID for VAS-Neck in the early postoperative period (OR: 3.40 [1.08–10.66], p-value: .036). Anxiety was identified as a risk factor for failure to achieve MCID for VAS-Neck in the late postoperative period (OR: 6.51 [1.91–22.18], p-value: .003). CDR at levels C5C7 was identified as a risk factor for failure to achieve MCID in NDI for the late postoperative period (OR: 9.74 [1.43–66.34], p-value: .020). CONCLUSIONSOur study identified several risk factors for failure to achieve MCID in common PROMs following CDR including predominant neck pain, myelopathy, anxiety, and CDR at levels C5−C7. These findings may help inform the approach to counseling patients on outcomes of CDR as the evidence suggests that those with the risk factors above may not improve as reliably after CDR.

Review of the Most Cited Patient-Reported Outcome Measure (PROM) Studies Published in the Neurospine Surgical Literature.

Patient-reported outcome measures (PROMs) are validated tools that are widely utilized in research and patient care. Their diversity, quality, and application remain matters of peak research interest. This article is a review of the PROMs that were utilized in high-impact publications in the neurospine surgical literature. The 50 most cited articles on the subject were selected and analysed. Most (42 articles) were published in spine journals and, in particular, in the journal Spine (Phila Pa 1976) (28 articles). A total of 34 PROMs were utilized, of which 24 were used only once in single studies. The four most common PROMs were Scoliosis Research Society-22 (SRS-22) (15 articles), Short Form-12 and Short Form-36 (SF-12 and SF-36) (11 articles), Ronald-Morris Disability Questionnaire (RMDQ) (nine articles), and Oswestry Disability Index (ODI) (five articles). Nineteen articles focused on validating translated versions of 11 PROMs to other languages. The languages that had the maximal number of tools translated to amongst the highly cited articles were Italian (six tools), Portuguese (four tools), German (three tools), and Japanese (three tools). The most common diagnoses and the PROMs used for them were back pain and cervical spine disorder (SF-12 and SF-36 (nine articles), RMDQ (eight articles), and ODI (five articles)), and idiopathic scoliosis (SRS-22) (14 articles)). The median (range) article citation number was 137 (78-675). The four most cited PROMs were SRS-22 (2,869), SF-12 and SF-36 (2,558), RMDQ (1,456), and ODI (852). Citation numbers were positively impacted by article age and participant number but not by tool type or clinical diagnosis. In conclusion, a wide range of PROMs was utilized in the 50 most cited publications in the neurospine surgical literature. The majority were disease-specific rather than generic and targeted particular spine pathology. Neurosurgical PROMs were under-represented amongst the most cited articles. Awareness of the PROMs used in high-impact studies may be helpful in tool selection in future research.PROMs are valuable in standardizing subjective outcomes. Their use in research and clinical settings in any validated language is highly encouraged.

Full-Endoscopic Lumbar Discectomy vs Standard Discectomy: A Noninferiority Study on Clinically Relevant Changes.

Surgery for lumbar disc herniation (LDH) has had a remarkable technological development during the past 20 years. Microscopic discectomy has traditionally been the gold standard method to treat symptomatic LDH before the introduction of full-endoscopic lumbar discectomy (FELD). The FELD procedure allows unsurpassed magnification and visualization and is currently the most minimally invasive surgical technique. In this study, FELD was compared with standard surgery for LDH, with a focus on medically relevant changes in patient-reported outcome measures (PROMs). The purpose of this study was to investigate whether FELD is noninferior to other surgical methods for LDH surgery in the most common PROMs, including postoperative leg pain and disability, while still reaching the necessary thresholds for relevant clinical and medical improvements. Patients undergoing a FELD procedure at the Sahlgrenska University Hospital, Gothenburg, Sweden, between 2013 to 2018 were included. A total of 80 (41 men and 39 women) patients were enrolled. The FELD patients were matched 1:5 to controls from the Swedish spine register (Swespine) who had a standard microscopic or mini-open discectomy surgery. PROMs, including the Oswestry Disability Index (ODI) and the Numerical Rating Scale (NRS), as well as the patient acceptable symptom states (PASS) and the minimal important change (MIC), were used to compare the efficacy of the 2 surgical approaches. The FELD group achieved medically relevant and significant improvements noninferior to standard surgery within the predefined thresholds of MIC and PASS. No differences could be found in disability measured by ODI FELD -28.4 (SD 19.2) vs standard surgery -28.7 (SD 18.9) or leg pain NRSLeg FELD -4.35 (SD 2.93) vs standard surgery -4.99 (SD 3.12). All intragroup score changes were significant. The FELD results are not inferior to standard surgery 1 year postoperatively after LDH surgery. There were no medically significant differences regarding MIC achieved or final PASS in any of the measured PROMs, including leg pain, back pain, or disability (ODI) between the surgical methods. The present study highlights that FELD is noninferior to standard surgery in clinically relevant PROMs.

PCR75 Assessment of Completion Time to Optimize the Administration of Common Patient-Reported Outcome Measures (PROMS) in Oncology Clinical Trials

In oncology trials, PROM endpoints provide a valuable complement to endpoints such as tumour response and are central to the patient’s understanding of treatment benefits. The burden of regular PROM completion is poorly understood, yet invaluable in informing PROM selection and scheduling strategies. We examine completion times, often seen as an indicator of burden, for commonly used PROMs in oncology to better understand how measure selection translates to patient time investment in clinical trials.

A cross-sectional study on the application of patient-reported outcome measurements in clinical trials of traditional Chinese medicine in mainland China.

Objectives: Patient-reported outcomes (PROs) provide a global perspective of patient health status which plays an enormous role in evaluating clinical efficacy. However, the application of PROs in traditional Chinese medicine (TCM) was still insufficiently studied in mainland China. Methods: This cross-sectional study was performed based on interventional clinical trials of TCM that were conducted in mainland China from 1 January 2010, to 15 July 2022. Data was retrieved from the ClinicalTrials.gov and Chinese Clinical Trial Registry. We included interventional clinical trials of TCM for which the country of the primary sponsors or recruitment settings in mainland China. For each included trial, data including clinical trial phases, study settings, participant's age, sex, diseases, and the patient-reported outcome measures (PROMs) were extracted. Trials were categorized into four categories according to 1) listed PROs as primary endpoints, 2) listed PROs as secondary endpoints, 3) listed PROs as coprimary outcomes (both primary and secondary endpoints), and 4) did not mention any PROMs. Results: Among a total of 3,797 trials, 680 (17.9%) trials listed PROs as primary endpoints, 692 (18.2%) trials listed PROs as secondary endpoints, and 760 (20.0%) trials listed PROs as coprimary endpoints. Among 675,787 participants included in the registered trials, 448,359 (66.3%) patients' data were scientifically collected by PRO instruments. Neurological diseases (11.8%), musculoskeletal symptoms (11.5%), mental health conditions (9.1%) were the most common conditions evaluated by PROMs. Disease-specific symptoms related concepts were used most frequently (51.3%), followed by health-related quality of life concepts. Visual analog scale, 36-item Short-Form Health Questionnaire, and TCM symptom score were the most common PROMs in these trials. Conclusion: In this cross-sectional study, the use of PROs increased in the past decades according to clinical trials of TCM conducted in mainland China. Considering that the application of PROs in clinical trials of TCM has some existing issues including uneven distribution and lack of normalized PROs of TCM, further study should be focused on the standardization and normalization of TCM-specific scales.

Measurement properties of 72 movement biomarkers aiming to discriminate non‑specific chronic low back pain patients from an asymptomatic population

The identification of relevant and valid biomarkers to distinguish patients with non-specific chronic low back pain (NSCLBP) from an asymptomatic population in terms of musculoskeletal factors could contribute to patient follow-up and to evaluate therapeutic strategies. Several parameters related to movement impairments have been proposed in the literature in that respect. However, most of them were assessed in only one study, and only 8% were evaluated in terms of reliability, validity and interpretability. The aim of this study was to consolidate the current knowledge about movement biomarkers to discriminate NSCLBP patients from an asymptomatic population. For that, an experimental protocol was established to assess the reliability, validity and interpretability of a set of 72 movement biomarkers on 30 asymptomatic participants and 30 NSCLBP patients. Correlations between the biomarkers and common patient reported outcome measures were also analysed. Four biomarkers reached at least a good level in reliability (ICC ≥ 0.75) and validity (significant difference between asymptomatic participants and NSCLBP patients, p ≤ 0.01) domains and could thus be possibly considered as valuable biomarkers: maximal lumbar sagittal angle, lumbar sagittal angle range of motion, mean lumbar sagittal angular velocity, and maximal upper lumbar sagittal angle during trunk sagittal bending. These four biomarkers demonstrated typically larger values in asymptomatic participants than in NSCLBP patients. They are in general weakly correlated with patient reported outcome measures, arguing for a potential interest in including related musculoskeletal factors in the establishment of a valuable diagnosis and in guiding treatment response.

Comparison of patient preferences and responsiveness among common patient-reported outcome measures for hand/wrist injuries or disorders

BackgroundPatient-reported outcome measures (PROMs) were developed to examine patients’ perceptions of functional health. Most studies compare the responsiveness of each type of questionnaire. However, reports of patient preferences among PROMs commonly used with patients with hand/wrist injuries or disorders are limited. This study aimed to compare patient preferences, factors associated with those preferences and responsiveness among the Disability of the Arm, Shoulder, and Hand (DASH), Michigan Hand Outcomes Questionnaire (MHQ), Patient-Rated Wrist/Hand Evaluation (PRWHE) and EQ-5D in patients with hand/wrist injuries or disorders.Material and methodsThis retrospective cohort study collected data on 183 patients with hand/wrist injuries or diseases who had visited a hand/wrist outpatient clinic or were hospitalized for surgery between 2017 and 2020. Patients had to be at least 18 years old and able to complete the four questionnaires included in the study. The four PROMs (DASH, MHQ, PRWHE and EQ-5D) were administered to the patients prior to treatment. After completing the questionnaires, patients were asked to answer two open-ended questions regarding their preferences. Multinomial logistic regression was used to identify factors related to patient preferences. Results are presented as the relative risk ratio (RRR). The standardized response mean (SRM) was used to evaluate questionnaire responsiveness.ResultsOf the 183 patients, most preferred the PRWHE questionnaire (n = 74, 41%), with the main reasons cited being “specific to injuries/diseases and reflects hand/wrist function (n = 23, 31%)” and “easy to complete (n = 22, 30%).” Sex was found to be associated with patient preference after adjusting for demographic data and reasons for choosing a PROM as confounders (RRR = 0.46, P value = 0.049). The PRWHE had the highest SRM, followed by DASH (0.92 and 0.88, respectively).ConclusionsThe PRWHE is the most preferred by patients and is the most responsive questionnaire. It is recommended for use in clinical practice in situations where a clinician would like to use only one PROM for evaluating patients with various types of hand/wrist problems.Level of evidence: Prognostic III.

Outcomes and care priorities for older people living with frailty and advanced chronic kidney disease: a multi-professional scoping review.

The growing older population with advanced chronic kidney disease (ACKD stages 4-5) poses a challenge for healthcare worldwide. The high prevalence of frailty and associated adverse health outcomes highlights concerns for management and interventions specific to this population. The aim was to objectively review the evidence relating to older people (≥65years) living with frailty and ACKD. More specifically how frailty is identified, what interventions have been studied and what outcomes have been reported including outcomes important to patients, families and carers. A scoping review was undertaken following the PRISMA-Scr guidelines. Nine databases were searched and a review team of five people followed a process using defined inclusion and exclusion criteria. Data were then analysed to answer the specific questions of the review. The World Health Organization's International Classification of Functioning Disability and Health was used to map outcomes across the domains. A total of 90 studies were included. The most reported frailty measure was the frailty phenotype. The most reported outcomes were mortality, hospitalisation and healthcare utilisation. Health-related quality of life was the most common patient-reported outcome measure. There were few intervention studies and limited evidence of patient and carer perspectives. This scoping review highlights important areas for further research in older people living with frailty and ACKD. This includes a 'gold standard' measure for identifying frailty, interventions and improvements in outcome measures that matter to patients (including studies that focus on carers and carer burden) and priority setting for future research.