Assessment Of Patient-reported Outcome Measures Research Articles

Use of Patient-Reported Outcome Measures to Assess the Effectiveness of Hybrid Psychiatric Visits.

Little empirical evidence exists to support the effectiveness of hybrid psychiatric care, defined as care delivered through a combination of telephone, videoconferencing, and in-person visits. The authors aimed to investigate the effectiveness of hybrid psychiatric care compared with outpatient waitlist groups, assessed with patient-reported outcome measures (PROMs). Participants were recruited from an adult psychiatry clinic waitlist on which the most common primary diagnoses were unipolar depression, generalized anxiety disorder, and bipolar disorder. Patients (N=148) were randomly assigned to one of two waitlist groups that completed PROMs once or monthly before treatment initiation. PROMs were used to assess symptoms of depression (Patient Health Questionnaire-9 [PHQ-9]), anxiety (Generalized Anxiety Disorder-7 [GAD-7]), and daily psychological functioning (Brief Adjustment Scale-6 [BASE-6]). Patient measures were summarized descriptively with means, medians, and SDs and then compared by using the Kruskal-Wallis test; associated effect sizes were calculated. PROM scores for patients who received hybrid psychiatric treatment during a different period (N=272) were compared with scores of the waitlist groups. PROM assessments of patients who engaged in hybrid care indicated significant improvements in symptom severity compared with the waitlist groups, regardless of the number of PROMs completed while patients were on the waitlist. Between the hybrid care and waitlist groups, the effect size for the PHQ-9 score was moderate (d=0.66); effect sizes were small for the GAD-7 (d=0.46) and BASE-6 (d=0.45) scores. The findings indicate the clinical effectiveness of hybrid care and that PROMs can be used to assess this effectiveness.

Linking QuickDASH and PROMIS Upper-Extremity Computer-Adaptive Test Scores in Hand Surgery: A Crosswalk Study

Assessment of patient-reported outcome measures (PROMs) for hand and upper-extremity surgery patients using measures such as the Quick Disabilities of the Arm, Shoulder, and Hand (qDASH), as well as general measures including the Patient-Reported Outcomes Measurement Information System Upper Extremity Physical Function domain via a Computer-Adaptive Test (PROMIS UE CAT), has become commonplace. The aim of this study was to link, for crosswalking, the qDASH measure to both versions of the PROMIS UE CAT (v1.2 and v2.0). We included 18,944 hand and upper-extremity patients who completed both versions of the PROMIS UE CAT and the qDASH at the same clinical encounter. Shoulder pathology was excluded. Score linkage was performed using the R package equate, and multiple equating models (linear regression, identity, mean, linear, equipercentile, and circle-arc models) were used to establish crosswalk tables. Mean qDASH and PROMIS UE CAT v1.2 scores were 38.2 (SD= 23.1) and 36.6 (SD= 9.8), respectively. Mean qDASH and PROMIS UE CAT v2.0 scores were 37.3 (SD= 21.8) and 38.3 (SD= 10.4), respectively. Pearson correlations had very strong linear relationships between the qDASH and the PROMIS UE CAT v1.2 and PROMIS UE CAT v2.0 (r=-0.83 [-0.84,-0.92] and r=-0.80 [-0.81,-0.80], respectively). For the equipercentile equating models, the intraclass correlation coefficient (ICC) had very strong positive relationships to linking measures with ICC= 0.85 (0.84, 0.86) for the qDASH-UE CAT v1.2 crosswalk and ICC= 0.83 (0.82, 0.84) for the qDASH-UE CAT v2.0 crosswalk. The linkages establish crosswalk tables using equipercentile equating models to convert the PROMIS UE CAT v1.2 and v2.0 scores to the qDASH and vice versa. This study provides crosswalk tables for commonly collected PROMs in hand surgery, increasing the comparability of results between centers using different PROMs to study the same conditions or treatments.

Systematic reviews and quality assessment of patient-reported outcome measures for physical function in comparative effectiveness studies regarding acute postoperative pain after total knee arthroplasty-Do we need to start all over again?

Recently, a consensus process specified a core outcome set (COS) of domains to be assessed in each comparative effectiveness research and clinical practice related to acute postoperative pain. Physical function (PF) was one of these domains. The aim of this review was to investigate which patient-reported outcome measures (PROMs) are used to assess PF after total knee arthroplasty (TKA) in clinical trials and if they fulfil basic requirements for a COS of PROMs based on their psychometric properties. A systematic review of randomized controlled trials and observational studies based on a search in MEDLINE, EMBASE and CENTRAL was undertaken. PROMs and performance measures were extracted and investigated, including evaluation of psychometric properties of PROMs based on COSMIN recommendations. From initially 2896 identified records, 479 studies were included in the qualitative synthesis. Only 87 of these trials (18%) assessed PF using PROMs, whereas especially performance outcome measures were used in 470 studies (98%). Application of the 'COSMIN Risk-of-Bias-Box1' to 13 of the 14 identified PROMs resulted in insufficient content validity of the included PROMs regarding the target population based on the inauguration or development articles. Our data indicate that a patient-centred postoperative assessment of PF in pain-related clinical trials early after TKA is not common, even though patient-reported assessment is widely recommended. In addition, none of the applied PROMs shows content validity based on their inauguration or development articles for the assessment of postoperative pain-related PF after TKA. A systematic search for patient-reported outcome measures assessing postoperative, pain-related physical function after total knee arthroplasty in clinical trials and assessment of their content validity revealed none that fulfilled requirements based on COSMIN recommendations.

Hip-specific and generic patient-reported outcome measure scores after primary hip replacement are associated with early revision surgery: a national registry study

BackgroundThe ability to efficiently identify patients at higher risk of poor outcomes after joint replacement would enable limited resources for post-operative follow-up to be directed to those with the greatest clinical need. This is particularly important as joint replacement rates continue to grow internationally, stretching health system capabilities. Patient-reported outcome measures (PROMs) are routinely administered in many settings and offer an opportunity to detect suboptimal patient outcomes early. This study aimed to determine whether hip-specific and generic PROM scores are associated with early revision hip replacement within six to 24 months after the primary procedure.MethodsPre-operative and six-month post-operative PROM scores for patients undergoing primary total hip replacement (THR) were obtained from the Australian Orthopaedic Association National Joint Replacement Registry and Arthroplasty Clinical Outcomes Registry National and linked to revision surgery data. Clinically important improvement was defined using anchor-based thresholds. Associations between PROM scores (hip pain, Oxford Hip Score, HOOS-12, EQ-5D-5L, EQ VAS, patient-perceived change, satisfaction) and revision surgery were evaluated using t-tests, chi-square tests and regression models.ResultsData were analysed for 21,236 primary THR procedures between 2013 and 2022. Eighty-eight revision procedures were performed at six to 24 months. Patients who were revised had more back pain and worse HOOS-12 scores pre-operatively but between-group differences were small. Worse post-operative PROM scores (hip pain, Oxford, HOOS-12, EQ-5D-5L, EQ VAS) were associated with early revision, after adjusting for age and sex (p < 0.001 for all analyses). Patient dissatisfaction (relative risk (RR) 10.18, 95%CI 6.01–17.25) and patient-perceived worsening (RR 19.62, 95%CI 11.33–33.98) were also associated with a higher likelihood of revision. Patients who did not achieve clinically important improvement in hip pain, function, or quality of life had a higher revision risk (RRs 2.54–5.64), compared with those who did (reference).ConclusionSix-month hip-specific and generic PROM scores can identify patients at higher risk of early revision surgery. Our data highlight the utility of routine post-operative PROM assessment for signaling suboptimal surgical outcomes.

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.

Challenging the Status Quo: Debunking the Necessity of 5-Year to 10-Year Patient-Reported Outcome Measures in Total Hip and Knee Arthroplasties

BackgroundIn the current shift toward value-based healthcare, patient-reported outcome measures (PROMs) have become essential to assess the effectiveness of medical interventions. However, elucidation of the optimal timeframe for PROMs evaluation remains crucial. This study aimed to (1) determine the proportion of patients who experienced clinically meaningful improvements in PROMs scores at each follow-up visit after total hip arthroplasty (THA) and total knee arthroplasty (TKA) and (2) calculate and apply the clinical relevance ratio (CRR) for these long-term PROM collections postoperatively. MethodsA total of 12 independent studies reporting THA (n = 8 studies) and TKA (n = 4 studies) postoperative PROM data with up to 10 years of follow-up in Europe or the United States were aggregated. A distribution-based minimal clinically important difference threshold and CRR were used to determine which patients had clinically meaningful improvements in PROMs at 1, 5, and 10 years. ResultsThe proportion of patients who had clinically meaningful improvements in PROM scores stabilized after 1 year following both THA and TKA. Overall, the CRR decreased over time for all PROMs, with the CRR beginning to decrease at 1-year follow-up, bringing into question the robustness and clinical relevance of long-term PROMs data. ConclusionsThe present study challenges the utility of requiring PROMs with a minimum follow-up of 2 years for THA and TKA. Research efforts should be focused on registries evaluating implant survivorship at longer-term follow-up, while PROMs should be better assessed up to 1-year follow-up. Reconsidering the long-term PROMs assessment would lead to more efficient and cost-effective research in orthopedic outcomes, without compromising data quality.

Task-shifting in asthma and chronic obstructive pulmonary disease management: A review of the obstructive lung disease program.

Task shifting, an approach to address physician shortage through redistribution of clinical tasks, may help address the high burden of chronic respiratory diseases like asthma and COPD. We aimed to measure its utility and impact in the Obstructive Lung Disease program (OLD). A retrospective, cross-sectional study was conducted at five integrated outpatient departments of Primary Care Program within Indus Hospital & Health Network, Pakistan, from January 2018 to March 2023. After a formative evaluation, registered nurses were trained as Lung Health Nurses (LHNs) to perform spirometry, collect Patient Reported Outcome Measures (PROMs) including Asthma Control Test (ACT), modified Medical Research Council (mMRC) dyspnea score and COPD Assessment Test (CAT), counsel on inhaler use and tobacco cessation, and refer to pulmonary rehabilitation (PR). Data was collected online contemporaneously on REDCap and later analyzed using Excel and STATA 14. Pre-implementation, a monthly average of 126 asthmatics and 33 COPD patients visited primary care centers. Medical records of 147 OLD patients showed 8% received inhaler education, 3% completed ACT and 2% had mMRC documented. Implementation included capacity building of nine LHNs. Of 7427 referrals to the program, 86% underwent nurse-led assessments. LHNs performed spirometry (92%), PROMs assessments [ACT (89%), CAT (91%), mMRC (85%)], inhaler education (97%), tobacco cessation advice (85%) and made PR referrals (94%). Trained nurses can play a role in providing holistic and timely care for patients with CRDs and strengthen existing healthcare systems. Future directions may include expanding nurse clinical counselling roles through telehealth monitoring and home management.

Evaluation of hemodynamic changes and patient-reported outcome measures in surgical therapy with or without intravenous sedation: a prospective controlled clinical study.

To determine whether intravenous (IV) sedation would contribute to the stabilization of patients' hemodynamics during periodontal and oral surgical procedures, and to evaluate the patient-reported outcome measures (PROMs). Periodontal or oral surgery patients were recruited and distributed into two groups: (1) sedation group (SG): intravenous sedation plus local anesthesia; (2) control group (CG): local anesthesia only. Systolic and diastolic blood pressure (SBP, DBP), heart rate (HR), and oxygen saturation (SaO2), were monitored at 15-min intervals from sitting in the dental chair (baseline) until the end of the treatment. In addition, a subjective assessment of PROMs was obtained through a post-operative questionnaire. Forty-nine patients (25 in SG and 24 in CG) were included. The highest SBP and DBP were significantly higher in CG compared to the SG (141.1 ± 18.4 and 133.6 ± 15.1, respectively in SBP; and 85.5 ± 11.0 and 82.9 ± 10.1, respectively in DBP), but no mean significant differences were found between groups (P value of 0.85 and 0.72 for systolic and diastolic BP, respectively). HR and SaO2 did not show statistical intra- and inter-group differences. The overall patient satisfaction score was significantly higher in the SG group compared to CG. Intravenous moderate sedation seems to contribute to the stabilization of patient's hemodynamics, especially the systolic blood pressure, although small differences have been found. Intravenous sedation seems to contribute to stabilize the hemodynamic values, and enhances the patient satisfaction after periodontal and oral surgical treatment in the dental office.

Precision Anaesthesia: Advancing Patient-Centered Precision Care Through Repetitive Assessment of PROMs with the Safe Brain Initiative Approach

This article aims to introduce the Safe Brain Initiative (SBI) approach, focusing on collecting and leveraging Patient-Reported Outcome Measures (PROMs) to enhance patient-centred precision anaesthesia and prevent postoperative delirium (POD) and neurocognitive disorders (NCD). The SBI was implemented to systematically address the feedback gap in perioperative care by collecting and analysing real-world data. The initiative focuses on monitoring and preventing POD and NCD, providing effective anaesthesia care, assessing patient and team satisfaction, and evaluating environmental sustainability impact. Based on international guidelines, 18 core recommendations were established to address potential complications and challenges associated with anaesthesia. Preliminary results showed a notable reduction in POD and increased awareness among anaesthesia team members regarding PROMs. The SBI approach demonstrated significant benefits during emergency situations, such as the February 2023 earthquake in Turkey, by providing crucial support and comfort to victims requiring multiple surgical interventions. The SBI presents an innovative, cost-effective, and patient-centred approach to perioperative care. By integrating PROMs and systematic feedback mechanisms, the SBI aims to expedite the advancement of efficient, patient-centered precision perioperative care, improve patient outcomes, and elevate the quality of care. The initiative has shown promising results, and its adoption is growing globally. Collaboration among healthcare providers, researchers, and patients is crucial in shaping the future of anaesthesia practice and further improving patient outcomes. Turkish hospitals are encouraged to join the SBI to benefit from international collaborations and contribute to positive change in perioperative care standards. The SBI project significantly advances precision anaesthesia, emphasising personalised care and patient well-being.

44069 An Assessment of Patient-Reported Outcome Measures in Pyoderma Gangrenosum

44069 An Assessment of Patient-Reported Outcome Measures in Pyoderma Gangrenosum

Nottingham Klavikula Skorunun Türk Populasyonunda Geçerliliği ve Doğrulanması

Aim: The aim of this study was to evaluate the validation and verification of the Nottingham Clavicle Score (NCS) in the Turkish population. Methods: Sixty-eight patients (12 females, 56 males; mean age: 37.1±13.3 years) who underwent surgery due to clavicle fracture or acromioclavicular separation were included in the study. The Turkish version of the NCS (NCS-Tr) was designed in accordance with the stages recommended by Beaton et al. Each patient completed the NCS-Tr twice at 7 to 10-day intervals to evaluate the test-retest reliability based on the interrater correlation coefficient, and Cronbach’s alpha was evaluated for internal consistency. Additionally, the Oxford Shoulder Score (OSS), Disabilities of the Arm, Shoulder, and Hand (DASH), Constant-Murley Score (CMS), and Short Form-36 (SF-36) Health Survey tests were completed by each participant to assess the correlation with the NCS-Tr. Results: The main score of the NCS-Tr was 79.71 ± 20.37. The other mean scores of CMS, OSS, and DASH were 84.14 ± 21.47, 38.34 ± 12.43, and 17.84 ± 22.47 respectively. The translation and adaptation of the NCS-Tr for a Turkish context required no major cultural adaptation. Internal consistency was high (Cronbach’s alpha: 0.933). Test-retest reproducibility was excellent (q=0.941, p&amp;lt;0.001). Conclusion: The NCS-Tr is a valid, reliable, shoulder-specific scale in the assessment of patient-reported outcome measures for the functional assessment of Turkish patients undergoing surgery due to clavicle fractures or acromioclavicular joint separation.

Electronic Patient-Reported Outcome Measures (ePROMs) Improve the Assessment of Underrated Physical and Psychological Symptom Burden among Oncological Inpatients.

For advanced cancer inpatients, the established standard for gathering information about symptom burden involves a daily assessment by nursing staff using validated assessments. In contrast, a systematic assessment of patient-reported outcome measures (PROMs) is required, but it is not yet systematically implemented. We hypothesized that current practice results in underrating the severity of patients' symptom burden. To explore this hypothesis, we have established systematic electronic PROMs (ePROMs) using validated instruments at a major German Comprehensive Cancer Center. In this retrospective, non-interventional study, lasting from September 2021 to February 2022, we analyzed collected data from 230 inpatients. Symptom burden obtained by nursing staff was compared to the data acquired by ePROMs. Differences were detected by performing descriptive analyses, Chi-Square tests, Fisher's exact, Phi-correlation, Wilcoxon tests, and Cohen's r. Our analyses pointed out that pain and anxiety especially were significantly underrated by nursing staff. Nursing staff ranked these symptoms as non-existent, whereas patients stated at least mild symptom burden (pain: meanNRS/epaAC = 0 (no); meanePROM = 1 (mild); p < 0.05; r = 0.46; anxiety: meanepaAC = 0 (no); meanePROM = 1 (mild); p < 0.05; r = 0.48). In conclusion, supplementing routine symptom assessment used daily by nursing staff with the systematic, e-health-enabled acquisition of PROMs may improve the quality of supportive and palliative care.

P110 Challenges of meeting NICE guidance for rheumatoid arthritis in the modern era: a service audit

Abstract Background/Aims NICE guidance for patients with rheumatoid arthritis (RA) (NG100) states all patients should receive an annual review appointment. This should encompass assessment of disease activity metrics, co-morbidity review and appropriate onward referral to other healthcare professionals. A preliminary snapshot service review in 2020 had suggested that our department’s adherence to NICE RA guidance was inconsistent. This assessed small patient numbers, so a larger audit was devised enabling us to better understand current practice and inform areas for future development. Methods NG100 was fully reviewed, and relevant audit standards devised. JE and BM created metrics demonstrating compliance with guidance; areas requiring clarification were discussed with AA. 3400 adult RA patients were identified under the care of the department. The records of 340 patients were selected for review using convenience sampling. All clinic encounters were reviewed for 12 months prior to an identified appointment in January 2019. Data was collected by HC, reviewed by JE, and analysis completed by HC, JE and AA. Results Female to male ratio was 2.33:1, mean age was 65.9 (SD = 12.3), median DAS28 score was 2.94 (IQR=2.01), median VAS score was 40.0 (IQR=63.5). 74% (n = 251/340) of patients were reviewed more than once in 12 months. 41% (n = 141/340) of appointments were with nurses, 35% (n = 118/340) with consultants, 10% (n = 34/340) with SHOs, 14% (n = 47/340) with registrars. DAS28 was documented for 74.4% (n = 253/340) of patients. Presence or absence of erosions was documented for 42% (n = 144/340) of patients. Blood pressure was documented in 33% (n = 113/340) of patients, 18% (n = 60/340) patients were known to have hypertension, 6% (n = 20/340) of patients had ischemic heart disease. Assessment for metrics relating to audit standards: mental health screen 7.9% (n = 27/340), neck pain 14% (n = 46/340), respiratory symptoms 21% (n = 72/340), eye symptoms 21% (n = 70/340), bone health 27.9% (n = 95/340). There was documented consideration of referral to allied health professionals in 38% (n = 128/340) and to surgical teams in 18% (n = 61/340). Quantitative assessment of patient-reported outcome measures (PROMs) included: VAS 73% (n = 248/340), HAQ 22% (n = 76/340). Conclusion There is variation amongst clinicians in documenting NICE guidance annual review targets for RA; this may reflect time pressure in clinics, incomplete documentation, and unclear delineation of primary and secondary care roles. Secondary care should be aware of the quality framework targets for primary care relating to RA monitoring to encourage collaboration and optimise use of resources. Developing virtual assessments and PROM tools provides new opportunities for shared responsibility of care between clinicians and patients; this could improve patient outcomes. We are developing a digital RA annual review tool incorporating PROMs to simplify documentation and reduce pressures on clinic times; this may improve patient and clinician experience. Disclosure H. Cooney: None. J. Ellis: None. B. Mulhearn: None. A. Allard: None.

UNICOMPARTMENTAL KNEE ARTHROPLASTY VERSUS HIGH TIBIAL OSTEOTOMY: AN ANALYSIS OF PATIENT-REPORTED HEALTH OUTCOMES

Unicompartmental knee arthroplasty (UKA) and high tibial osteotomy (HTO) are well-established operative interventions in the treatment of knee osteoarthritis (KOA). However, which of these interventions is more beneficial, to patients with KOA, is not known and remains a topic of much debate.Aims: (i) To determine whether UKA or HTO is more beneficial in the treatment of isolated medial compartment KOA, via an assessment of patient-reported outcome measures (PROMs). (ii) To investigate the relationship between PROMs and radiographic parameters of knee joint orientation/alignment.This longitudinal observational study assessed a total of 42 patients that had undergone UKA (n=23) or HTO (n=19) to treat isolated medial compartment KOA. The PROMs assessed, pre-operatively and 1-year post-operatively, consisted of the: self-administered comorbidity questionnaire; short form-12; oxford knee score; knee injury and osteoarthritis outcome score; and the EQ-5D-5L. The radiographic parameters of knee joint alignment/orientation assessed, pre-operatively and 8-weeks post-operatively, included the: hip-knee-ankle angle; mechanical axis deviation; and the angle of the Mikulicz line.Statistical analysis demonstrated an overall significant (p&lt;0.001), pre-operative to post-operative, improvement in the PROM scores of both groups. There were no significant differences in the post-operative PROM scores of the UKA and HTO group. Correlation analyses revealed that pre-operatively, a more distolaterally angled Mikulicz line was associated with worse knee function (p&lt;0.05) and overall health (p&lt;0.05); a relationship that, until now, has not been investigated nor commented upon within the literature.UKAs and HTOs are both efficacious operations that provide a comparable degree of clinical benefit to patients with isolated medial compartment KOA. To further the scientific/medical community's understanding of the factors that impact upon health-outcomes in KOA, future research should seek to investigate the mechanism underlying the relationship, between Mikulicz line and PROMs, observed within the current study.

The Role of Anterolateral Ligament Reconstruction or Lateral Extra-articular Tenodesis for Revision Anterior Cruciate Ligament Reconstruction: A Systematic Review and Meta-analysis of Comparative Clinical Studies

Background: After its success in restoring rotational stability and reducing failure rates in primary anterior cruciate ligament reconstruction (ACLR), lateral extra-articular tenodesis (LET) or anterolateral ligament reconstruction (ALLR) has been endorsed for use in revision ACLR surgery, where failure rates are historically higher. Purpose: To perform a systematic review and meta-analysis on whether the addition of a LET or ALLR results in superior clinical outcomes and stability compared with isolated revision ACLR (iACLR). Study Design: Meta-analysis; Level of evidence, 4. Methods: The Cochrane Controlled Register of Trials, PubMed, Medline, and Embase were used to perform a systematic review and meta-analysis of comparative studies using the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) criteria with the following search terms: (“extra-articular” OR “tenodesis” OR “anterolateral ligament” OR “iliotibial”) AND (“anterior cruciate ligament”) AND (“revision” OR “re-operation”). Data pertaining to all patient-reported outcome measures (PROMs), rotational stability, and postoperative complications were extracted from each study. Results: After abstract and full-text screening, 10 clinical comparative studies were included. There were 793 patients, of whom 390 had an iACLR while 403 had an ACLR augmented with a LET or an ALLR (augmented ACLR [aACLR]). The mean time for assessment of PROMs was 35 months. The aACLR group had superior International Knee Documentation Committee (IKDC) scores (standardized mean difference [SMD], 0.27; 95% CI, 0.01 to 0.54; P = .04), rotational stability (odds ratio [OR], 2.77; 95% CI, 1.91 to 4.01; P < .00001), and lower side-to-side difference (OR, −0.53; 95% CI, −0.81 to −0.24; P = .0003) than those without the augmentation. Furthermore, they were less likely to fail (OR, 0.44; 95% CI, 0.24 to 0.80; P = .007). Subgroup analysis in the higher-grade laxity cohort (grade ≥2) revealed an even greater IKDC score (SMD, 0.51; 95% CI, 0.16 to 0.86; P = .005) and an improved Lysholm score (SMD, 0.45; 95% CI, 0.24 to 0.67; P < .0001) in the aACLR group. Conclusion: Revision aACLR with a LET or an ALLR can improve subjective IKDC scores, restore rotational stability, and reduce failure rates compared with iACLR. Although controversy remains on the necessity of augmenting all revision ACLRs, the present meta-analysis advocates adding a lateral procedure, particularly in those with a higher-grade pivot shift.

Gov➔Value: How to combine reported quality experiences and patient-reported outcome measures. First results on vulvar cancer patients in an Italian Research Hospital.

Vulvar cancer (VC) accounts for <1% of cancers affecting the female gender. Clinical Pathways (CP) and Clinical Outcomes Monitoring are useful for providing high-quality care to these patients. However, it is essential to integrate them with the patient's perspective according to Value-Based Healthcare paradigms. Patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) are tools for assessing outcomes and experiences with health care from the patient's perspective. The aim of this paper is to collect and synthesize PROMs and main stakeholders' experience on the VC CP, according to a value-based approach. To select the most appropriate instrument, a review was conducted on the main databases and official websites of specific institutions and organizations. In the second phase, a 2-round Delphi survey was conducted to assess the Reported Experience Measures (REMs) tool. Questions were evaluated according to four criteria (general relevance, evidence-based, measurability, actionability) and included if strong agreement was reached. A Principal Component Analysis (PCA) was executed. Cronbach's alpha and McDonald's omega were computed. Fisher's exact test and Wilcoxon rank sum test were used to compare ratings between groups. Descriptive statistics were performed for both PROMs and REMs instruments. For PROMs assessment, EORTC QLQ-C30 questionnaire was selected and administered to 28 patients. Global Health Status/Quality of Life and Functional Scales Scores were high or very high, while symptoms scale reported low or medium scores. The final REMs consists of 22 questions for professionals and 16 for patients and caregivers. It was administered to 22 patients, 11 caregivers, 5 physicians, 2 nurses and 1 clinical senior manager. PCA identified 4 components. Scale reliability was acceptable (α = 0.75 95% CI: 0.61-0.85; ω = 0.69; 95% CI: 0.54, 0.82). A statistically significant difference between the patient/caregiver group and the professionals was found for items 8 (follow-up), 10 (perceived quality), 12 (safety), and 16 (climate) (p = 0.02; p = 0.03; p < 0.001; p < 0.001, respectively). PROMs could provide new ways of intercepting patients' needs and feedback, thus acting on them. The proposed REMs tool would allow to detect information not available elsewhere, which, through Audit and feedback strategies, could lead to enhancement of healthcare experience, according to a value-based approach.

Producing a preference-based quality of LIFE measure to quantify the impact of HYPOGLYCAEMIA on people living with diabetes: A mixed-methods research protocol.

Assessment of patient-reported outcome measures (PROMs), including quality of life (QoL), is essential in diabetes research and care. However, a recent review concluded that current hypoglycaemia-specific PROMs have limited evidence of validity, reliability and responsiveness for assessing the impact of hypoglycaemia on QoL in people living with diabetes. None of the PROMs identified could be used directly to inform the cost-effectiveness of treatments and interventions. There is a need for a new hypoglycaemia-specific QoL PROM, which can be used directly to inform economic evaluations. This project has three aims: (a) To develop draft PROM content for measuring the impact of hypoglycaemia on QoL in adults with diabetes. (b) To refine the draft content using cognitive debriefing interviews and psychometrics. This will result in a condition-specific PROM that can be used to quantify the impact of hypoglycaemia upon QoL. (c) To generate a preference-based measure (PBM) that will enable utility values to be calculated for economic evaluation. A mixed-methods, three-stage design is used: (a) Qualitative interviews will inform the draft PROM content. (b) Cognitive debriefing interview data will be used to refine the draft PROM content. The PROM will be administered in a large-scale survey to enable psychometric validation. Final item selection for the PROM will be informed by psychometric performance, translatability assessment and input from stakeholder groups. (c) A classification system will be generated, comprising a reduced number of items from the PROM. A valuation survey will be conducted to derive a value set for the PBM.

Knee osteoarthritis, joint laxity and PROMs following conservative management versus surgical reconstruction for ACL rupture: a meta-analysis.

Patients whose rupture of the anterior cruciate ligament (ACL) can be managed conservatively or undergo reconstruction surgery. Current scientific literature published in Web of Science, PubMed and Scopus. Several studies published by July 2022 compare surgical and conservative management following ACL rupture. The latest evidence suggests that surgical management may expose patients to an increased risk of early-onset knee osteoarthritis (OA). The state of art does not recommend a systematic ACL reconstruction to all patients who tore their ACL. After the initial trauma, surgical reconstruction may produce even greater damage to the intra-articular structures compared to conservative management. The state of art does not recommend systematic surgical reconstruction to all patients who tore their ACL. The present study compared surgical reconstruction versus conservative management for primary ACL ruptures in terms of joint laxity, patient reported outcome measures (PROMs) and rate of osteoarthritis. ACL reconstruction provides significant improvement in joint laxity compared to conservative management, but is associated with a significantly greater rate of knee osteoarthritis, despite similar results at PROM assessment.

Health-Related Quality of Life of CML Patients Under 2nd or 3rd Line Bosutinib Is Not Impaired Significantly By Gastrointestinal Toxicity (GI Tox) but Influenced By Sex - Results from a Subanalysis of the Bosutinib Dose Optimization (BODO) Study (CML-VII) Trial of the German CML Study Group

Introduction: Patient-reported outcome measures (PROMs) are an important tool to assess the impact of disease and their treatments on daily living and thereby on Health-related quality of life (HrQoL). Impact of side effects and gender-specific differences have been partly been addressed in Chronic myeloid leukemia (CML) in the past. The "Bosutinib Dose Optimization (BODO) Study" is a multicenter, open-label single arm phase II study testing tolerability and efficacy of 2nd&3rd line bosutinib step-in dosing (i.e. starting with 300 mg QD) in chronic phase CML patients (pts) intolerant and/or refractory to previous imatinib, and/or nilotinib, and/or dasatinib therapy with the ultimate goal to decrease GI toxicity rates. PROMs were assessed via the EORTC-QLQ-C30 and EORTC-CML24 questionnaires to correlate HrQoL changes with the rate and severity of GI toxicity and gender. Methods: The BODO Study (NCT02577926) had to be terminated prematurely after 57 of 127 projected pts due to delayed recruitment but included detailed analysis of PROMs reported here. Summary statistics of the HrQoL questionnaires were calculated at baseline (BL), month 3, and month 6. Depending on the observed distribution of differences of a score (component), comparisons between groups (e.g., males vs. females) were performed using methods based on the normal distribution assumption (t test) or a non-parametric test (Mann-Whitney U test or Wilcoxon signed rank test). Results: 57 pts with a median age of 51 years (median duration of pretreatment: 19.8 months) were included in the BODO trial. Even though 74%, 53% and 26% of pts suffered from any grade of GI-toxicity (e.g., diarrhea, nausea and vomiting) during the study, GI toxicity triggered treatment discontinuation in only one patient. Median duration of GI toxicity was 15 days (range: 1-1281) and was self-limiting in most pts. Median time to first onset of diarrhea was 23 days, and the median duration of any grade diarrhea was 14 days (range: 1-960). HrQoL-results were available for 51, 44 and 35 pts at baseline, end of month 3 and end of months 6 visits, respectively (for median scores over time see figure 1A-C). PROM results were analyzed according to occurrence of GI toxicity: The only symptom reported to be aggravated in the 15 pts without vs. the 42 with diarrhea during the first 6 months was the insomnia symptom scale (52 vs. 23, p=0.02). Nausea and vomiting did not significantly impact symptom burden. As most of the AEs have an early onset, the 3 month visit was assessed. Again, no significant differences in HrQoL could be detected between pts with or without GI toxicity at 3 months. At baseline, women seemed to be more affected by necessity of treatment change than males: there were statistically significant differences in physical (87 vs. 72, p=0.0055) and role functioning (82 vs. 60, p=0.0043). Higher functional scores were reported in male pts. Regarding symptoms, statistically significant differences were found for fatigue (31 vs. 51, p=0.01) and insomnia (24 vs. 42, p=0.04). Female pts reported higher symptom burden. In addition, the impact on daily life was found to be lower in male pts than in females (24 vs. 34, p=0.04). At 3 months, emotional (79 vs. 57, p=0.003) and cognitive functioning (88 vs. 68, p=0.008), insomnia (17 vs. 39, p<0.05) and symptom burden (19 vs. 26, p=0.03) differed. Male pts reported higher functional scores and lower symptom burden than female pts. At 6 months, male pts reported statistically significantly higher scores in emotional functioning (75 vs. 56, p=0.04) than female pts. Regarding the CML-24 questionnaire, symptom burden showed a statistically significant increase from BL to month 6 (25 vs. 26, p=0.02) with no statistically significant difference in any scale between month 3 and 6. Conclusion: Although the analysis is limited by relatively small number of pts in the respective subgroups and by the pre-selected time points of PROM assessment, the data suggests that HrQoL from pts with chronic phase CML treated with bosutinib within the BODO trial is not significantly impaired by the presence of GI toxicity and that there are significant differences in HrQoL and symptom burden between male and female pts which should be addressed in future trials. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Patient-Reported Outcome Measures for Acetabular Fractures Treated Operatively without a C-Arm in Ethiopia.

There is little evidence describing the open treatment of displaced acetabular fractures in low-resource environments. We endeavored to determine the results of the operative management of acetabular fractures without intraoperative C-arm use in a developing nation, through the assessment of patient-reported outcome measures. This was a prospective, single-surgeon, consecutive case series conducted in a tertiary referral hospital in Ethiopia, a high-population, low-income country. The primary author performed fixation without the use of a C-arm in 108 patients from among a total of 202 patients presenting with acetabular fracture. The modified Harris hip score (mHHS) and Short-Form Health Survey (SF)-36 at a minimum of 2 years postoperatively were used to assess the outcome. Of the 108 patients potentially available for analysis, 92 (85%) were available for 2-year follow-up (mean age of 35 years; range, 15 to 70 years). The mean duration from injury to surgery was 16 days (range, 1 to 204 days). Seventy-three (78.5%; n = 93) of the patients had associated fracture patterns. The most common fractures were associated both-column type (22%) and transverse-plus-posterior-wall type (22%). The mean mHHS was 91; 88% of the patients had a score of ≥80, and 12% had a score of ≤79. SF-36 scores were in alignment with the mHHS. The majority (approximately 90%) of our cohort returned to work. We did not find a significant difference in the mean mHHS between patients with or without anatomic reduction (p = 0.31). However, 2-year radiographic outcomes were strongly associated with the mean mHHS (p < 0.001). Predictors of a lower mHHS included older age, cartilage damage, and lack of secondary congruence. Good functional outcomes were achieved at 2 years among patients with acetabular fractures surgically treated without the use of a C-arm in a limited-resource setting. Surgical congruence of the femoral head under the acetabular roof, rather than the absolute residual gap, seems essential in determining clinical outcomes. This information can help in planning increased access to care for individuals who experience traumatic injuries in low- and middle-income countries. Therapeutic Level IV . See Instructions for Authors for a complete description of levels of evidence.