Patient-reported Outcome Measurement Tools Research Articles

Early Results of a Novel Treatment Technique with Autologous Blood for Chronic Lateral Epicondylitis

Background: Chronic lateral epicondylitis can be a severe disabling condition. There is still lack of consensus on best treatment, as no single intervention has been proven to be superior regarding pain relief and improvement of function. Due to the self-limiting nature of this elbow condition, we are looking for a fast and safe treatment method to break through this pattern of pain and loss of elbow function. Autologous blood injection therapy by means of an automatic injection system, can be a promising new treatment option for this group of patients suffering from chronic lateral epicondylitis. In this study, we evaluated the short-term results of autologous blood injection therapy in a standardized way by using an automatic injection system (=ITEC device) for the treatment of chronic lateral epicondylitis. Methods: A total of 141 patients with chronic lateral epicondylitis (88 female, 53 male) were enrolled in this clinical treatment evaluation being treated with the ITEC device. The mean age of the patients was 50.0 years (19 years-73 years). Numeric rating scale (NRS) and a patient reported outcome measurement tool (Oxford Elbow Score (OES)) were measured at baseline, six weeks and three months follow-up. Results: Pain (NRS, OES) and elbow function / quality of life (OES) were significantly improved within 6 weeks after ITEC treatment. This improvement in NRS and OES sustained during the 3 months follow-up period. Conclusion: Autologous blood injection therapy by means of a new automatic injection system (ITEC device) is a safe and effective treatment method for patients with chronic lateral epicondylitis. More research is necessary to see if this effectiveness sustains in the long-term follow-up.

Impact of Expanded Hemodialysis Using Medium Cut-off Dialyzer on Quality of Life: Application of Dynamic Patient-Reported Outcome Measurement Tool

Rationale & ObjectiveCurrent hemodialysis (HD) treatments have limited ability to clear larger-molecular-weight uremic toxins. Retention is associated with increased symptom burden, low health-related quality of life (HRQoL), and high mortality. Improved clearance, using novel medium cut-off dialyzers, termed expanded HD (HDx), may be associated with improved subjective experience. We have previously developed a dynamic patient-reported outcome measure (PROM) instrument to allow iterative recording to better appreciate the overall burden of disease and assess the impact of therapy changes.Study DesignSingle-center interventional pilot study.Setting & Participants28 patients established on maintenance HD, London, Ontario, Canada.InterventionInitial study consisting of 2-week observation (baseline-conventional high-flux HD) followed by 12 weeks of HDx. HRQoL was assessed using the dynamic PROM instrument thrice weekly (enabled in a dedicated app as the London Evaluation of Illness [LEVIL]). Extension phase; 2-week baseline with 24 weeks of HDx and 8-week washout.OutcomesPrincipal aim was to establish whether HDx therapy was associated with improved HRQoL, evidence of dose-dependant response, and whether effects were durable over time, using LEVIL.ResultsPatients with lower LEVIL scores (<70/100) at baseline showed improvement in overall HRQoL after 8 weeks of therapy with similar carryover effect. General well-being, energy, and sleep quality were improved significantly as a consequence of HDx therapy. There were no detrimental effects of HDx detected in patients with higher baseline HRQoL.LimitationsSmall nonrandomized sample size. The coronavirus disease 2019 pandemic interfered with the extension phase.ConclusionsDynamic PROM assessment effectively identified patients with lower HRQoL and higher symptom burden, demonstrating durable time/dose-dependent improvements across a range of symptom domains. The use of this instrument may allow targeted selection of patients most likely to benefit from HDx therapy and assist in monitoring response and defining effect size and treatment duration to allow optimal design of further definitive randomized controlled trials of this newly introduced technology.FundingBaxter Healthcare Canada.Trial RegistrationClinicalTrials.gov ID: NCT03640858.

Reporting guideline for interventional trials of primary and incisional ventral hernia repair.

Primary and incisional ventral hernia trials collect unstandardized inconsistent data, limiting data interpretation and comparison. This study aimed to create two minimum data sets for primary and incisional ventral hernia interventional trials to standardize data collection and improve trial comparison. To support these data sets, standardized patient-reported outcome measures and trial methodology criteria were created. To construct these data sets, nominal group technique methodology was employed, involving 15 internationally recognized abdominal wall surgeons and two patient representatives. Initially a maximum data set was created from previous systematic and panellist reviews. Thereafter, three stages of voting took place: stage 1, selection of the number of variables for data set inclusion; stage 2, selection of variables to be included; and stage 3, selection of variable definitions and detection methods. A steering committee interpreted and analysed the data. The maximum data set contained 245 variables. The three stages of voting commenced in October 2019 and had been completed by July 2020. The final primary ventral hernia data set included 32 variables, the incisional ventral hernia data set included 40 variables, the patient-reported outcome measures tool contained 25 questions, and 40 methodological criteria were chosen. The best known variable definitions were selected for accurate variable description. CT was selected as the optimal preoperative descriptor of hernia morphology. Standardized follow-up at 30 days, 1 year, and 5 years was selected. These minimum data sets, patient-reported outcome measures, and methodological criteria have allowed creation of a manual for investigators aiming to undertake primary ventral hernia or incisional ventral hernia interventional trials. Adopting these data sets will improve trial methods and comparisons.

Measuring functional outcomes in major trauma: can we do better?

There is relatively limited large scale, long-term unified evidence to describe how quality of life (QoL) and functional outcomes are affected after polytrauma. The aim of this study is to review validated measures available to assess QoL and functional outcomes and make recommendations on how best to assess patents after major trauma. PubMed and EMBASE databases were interrogated to identify suitable patient-reported outcome measures (PROMs) for use in major trauma, and current practice in their use globally. Overall, 81 papers met the criteria for inclusion and evaluation. Data from these were synthesised. A full set of validated PROMs tools were identified for patients with polytrauma, as well as critique of current tools available, allowing us to evaluate practice and recommend specific outcome measures for patients following polytrauma, and system changes needed to embed this in routine practice moving forward. To achieve optimal outcomes for patients with polytrauma, we will need to focus on what matters most to them, including their needs (and unmet needs). The use of appropriate PROMs allows evaluation and improvement in the care we can offer. Transformative effects have been noted in cases where they have been used to guide treatment, and if embedded as part of the wider system, it should lead to better overall outcomes. Accordingly, we have made recommendations to this effect. It is time to seize the day, bring these measures even further into our routine practice, and be part of shaping the future.

Patient reported outcome measures in a cohort of patients at high risk of breast cancer treated by bilateral risk reducing mastectomy and breast reconstruction

<h2>Summary</h2><h3>Background</h3> Many women with increased lifetime risk of developing breast cancer, due to pathogenic gene variants or family history, choose to undergo bilateral risk reducing mastectomies (BRRM). Patient reported outcome measures (PROMS) are an increasingly important part of informed consent but are little studied in women undergoing BRRM. <h3>Methods</h3> We used a validated PROMS tool for breast reconstruction (BREAST-Q) in 297 women who had BRRM and breast reconstruction, 81% of whom had no malignancy (Benign Group, BG) and 19% in whom a perioperative breast cancer was diagnosed (Cancer Group, CG). 128 women also completed a Hospital Anxiety & Depression Score (HADS) questionnaire to test if preoperative HADS score could predict PROMS outcomes. <h3>Results</h3> Women in the CG had lower PROMS scores for satisfaction with their breasts, nipple reconstruction and sexual wellbeing. Both groups reported equal satisfaction with BRRM outcome and psychosocial well-being. Physical well-being PROMS of the abdomen and chest were high in women in both groups as were scores for satisfaction with the care they received. The CG group reported suboptimal quality of patient information. A higher presurgical HADS anxiety score predicted less favourable postoperative psychosocial well-being despite similar levels of satisfaction with aesthetic outcome. <h3>Conclusion</h3> We show a high degree of patient reported satisfaction by woman undergoing BRRM and reconstruction. There was a negative association with a cancer diagnosis on quality of life PROMS and higher preoperative anxiety levels negatively affected postoperative psychosocial well-being. These important findings should be part of the informed consent process during preoperative counselling.

The Development of a Digital Patient-Reported Outcome Measurement for Adults With Chronic Disease (The Parsley Symptom Index): Prospective Cohort Study.

BackgroundThe monitoring and management of chronic illness has always been a challenge. Patient-reported outcome measures (PROMs) can be powerful tools for monitoring symptoms and guiding treatment of chronic diseases, but the available PROM tools are either too broad or too disease specific for the needs of a primary care practice focused on longitudinal care.ObjectiveIn this study we describe the development and preliminary validation of the Parsley Symptom Index (PSI).MethodsThis prospective cohort study took place from January 5, 2018, to June 05, 2020, among a sample of 4621 adult patients at Parsley Health. After a review of literature, followed by binning and winnowing of potential items, a 45-item PROM that also served as a review of systems (ROS) was developed. The PSI was deployed and completed by patients via an online portal. Construct and face validity was performed by clinicians, tested on patients, and feasibility was measured by response rate, completion rate, and percentage of missing data.ResultsThe response rate for 12,175 collected PSIs was 93.72% (4331/4621) with a 100% item completion rate. A confirmatory factor analysis confirmed the model structure was satisfactory by a Comparative Fit Index of 0.943, Tucker–Lewis index of 0.938, and root mean square error of approximation of 0.028.ConclusionsA 45-item ROS-style PROM designed to capture chronic disease symptoms was developed, and preliminary validation suggests that the PSI can be deployed, completed, and helpful to both patients and clinicians.

Quality of life, anxiety and depression patient-reported outcome measures in testicular cancer: A systematic review.

Several patient-reported outcome measures (PROMs) are available for the assessment of quality of life (QoL), anxiety and depression for testicular cancer (TCa); however, these PROMs have uncertain validation of their psychometric properties for TCa-only cohorts. This systematic review aims to critically analyse and evaluate the psychometric properties of these QoL, anxiety and depression PROMs. PubMed, EMBASE and PsycInfo were searched by two independent reviewers from inception to August 2020. Evaluative studies that assessed measurement properties of PROM(s) tools used for measuring QoL, anxiety and depression in TCa patients were included. The COnsensus-based Standards for the selection of health status Measurement Instruments (COSMIN) updated criteria for good measurement properties were used in the evaluation of PROM psychometric quality. This systematic review was registered on the PROSPERO database (CRD42020160232). Of 4,305 abstracts screened, a final eight full-text articles were included in this review. Five general and two TCa-specific PROMs were identified (depression, n=1; anxiety and depression, n=2; QoL, n=4). All studies were incomplete in the validation of nine measurement properties and the modal methodological quality was 'indeterminate'. The European Organisation for Research and Treatment of Cancer Quality -Testicular Cancer 26 questionnaire and CAYA-T had the highest psychometric validation with three out of nine measurement properties being 'sufficient'. This systematic review identifies a paucity of PROM-validation studies assessing anxiety, depression and QoL in TCa-only cohorts. We recommend further comprehensive and standardised psychometric validation studies of QoL, anxiety and depression PROMs in TCa-only study populations.

Patient-reported Outcome Measures for Angioedema: A Literature Review.

Angioedema and hereditary angioedema are characterized by swelling of the subcutaneous and/or submucosal tissue, resulting in localized oedema. The rarity, but also the diverse clinical presentation, of these conditions can be challenging regarding diagnosis, treatment, and management. Patient-reported outcome measures (PROMs) are data received directly from the patient, providing the patient’s perspective on various subjects regarding health and well-being. PROMs can be helpful tools to optimize treatment and long-term management of conditions. A major challenge regarding the consistent use of PROMs in clinical settings in Scandinavia is language availability; many of the validated PROMs for hereditary angioedema and angioedema lack translations into the Nordic languages. The litterature search yielded 9 different PROM tools for angioedema and hereditary angioedema. Five were found suitable for use in clinical practice in Europe. Even though several PROMs exist they are not used consistent. Accessible electronic PROMs and careful planning is required to implement PROMs optimally in routine care processes.

Psychometric Testing of the Premenstrual Symptoms Questionnaire and the Association Between Perceived Injustice and Premenstrual Symptoms: A Cross-Sectional Study Among Japanese High School Students.

PurposePremenstrual symptoms comprise a wide range of mood, behavioral, and physical symptoms occurring during the luteal phase. Perceived injustice is a belief linked to unfairness (ie, unnecessary suffering caused by illness). This study aimed to assess the validity and reliability of the Premenstrual Symptoms Questionnaire (PSQ), a patient-reported outcome measurement tool, and to examine the association between perceived injustice/perception of menstruation and premenstrual symptoms, as measured by the PSQ.Materials and MethodsOf 1388 female students, we analyzed 879 students with regular menstrual cycles who completed the PSQ, the premenstrual dysphoric disorder (PMDD) scale, the Somatic Symptom Scale-8 (SSS-8), and the Injustice Experience Questionnaire-chronic (IEQ-chr). First, the PSQ was examined for evidence of reliability and validity. Next, we used multiple regression and multivariate logistic regression to investigate the association between perceived injustice and premenstrual symptoms, using PSQ score as both a continuous variable and a dichotomous variable (premenstrual disorders or not). Moreover, the association between PSQ score and perceived menstruation was tested using student’s t-test and analysis of variance.ResultsIn terms of reliability, Cronbach’s α for PSQ score was 0.93. To assess structural validity, we used confirmatory factor analysis, which showed that the one-factor model and the two-factor model were a good fit. The PSQ showed good agreement with the PMDD scale. In terms of concurrent validity, PSQ total score correlated strongly with PMDD scale score, SSS-8 score, and IEQ-chr score (r = 0.88, 0.69, 0.57, respectively). IEQ-chr score predicted PSQ score (standardized regression coefficient = 0.53; P < 0.0001) and higher prevalence of premenstrual disorders (odds ratio: 1.15; 95% confidence interval: 1.12–1.19). Negative perception of menstruation was associated with premenstrual symptoms.ConclusionThe PSQ showed sound psychometric properties among the adolescents in our sample. Perceived injustice and negative perception of menstruation were associated with premenstrual symptoms.

Patient-Reported Outcomes Measurement Information System Physical Function Has a Lower Effect Size and is Less Responsive Than Legacy Hip Specific Patient Reported Outcome Measures Following Arthroscopic Hip Surgery

To compare the use and responsiveness of Patient Reported Outcomes Measurement Information System (PROMIS) to legacy patient-reported outcome measures (PROMs) in patients undergoing hip arthroscopy for femoroacetabular impingement syndrome (FAIS) at 6-month follow-up. Data from patients who underwent primary hip arthroscopy with routine capsular closure between August 2018 and January 2019 for the treatment of FAIS were analyzed. Preoperative outcomes, 6-month postoperative outcomes, and demographics were recorded. Primary outcome measures included PROMIS Physical Function (PROMIS-PF), PROMIS Pain Interference (PROMIS-PI), and PROMIS Depression. The legacy PROMs included Hip Outcome Score Activities of Daily Living (HOS-ADL), Hip Outcome Score Sport Subscale (HOS-SS), and the international hip outcome tool 12 questions (iHOT-12). Floor and ceiling effects along with the responsiveness and Cohen's d effect size of each PROM tool were calculated. Ninety-six patients with an average age and body mass index of 32.4 ± 11.9 years and 25.9 ± 6.1 kg/m2, respectively, were included in the final analysis. All outcomes were significantly higher at 6 months compared with the preoperative level (P < .001) except for PROMIS Depression (P= .873). PROMIS-PF demonstrated excellent correlation with HOS-SS (r= 0.81; P < .001), very good correlation with HOS-ADL (r= 0.73; P < .001), and good correlation with iHOT-12 (r= 0.68; P < .001). No floor was observed for any measure. The effect size was large for all outcomes, except PROMIS Depression (d= 0.04), but largest for iHOT12 (d= 1.87) followed by HOS-ADL (d= 1.29). The iHOT-12 was more responsive than PROMIS-PI (relative efficiency [RE]= 3.95), PROMIS-PF (RE= 4.13), HOS-ADL (RE= 2.26), and HOS-SS (RE= 3.84). HOS-SS was similarly responsive to PROMIS-PI (RE=1.03) and PROMIS-PF (RE=1.08). However, PROMIS-PF was overall the least responsive. In patients at 6 months postoperatively from hip arthroscopy for FAIS, iHOT-12 was the most responsive and had the largest effect size. In contrast, PROMIS-PF had a lower effect size compared with legacy hip-specific PROMs. Additionally, PROMIS-PF did not correlate as well with iHOT-12 compared with HOS-SS. Level IV, case series.

Validation of the Dutch version of the Edmonton Symptom Assessment System.

ABSTRACTBackgroundThe Utrecht Symptom Diary (USD) is a Dutch and adapted version of the Edmonton Symptom Assessment System, a patient‐reported outcome measurement (PROM) tool to asses and monitor symptoms in cancer patients. This study analyses the validity and responsiveness of the USD and the cutoff points to determine the clinical significance of a symptom score.MethodsObservational longitudinal cohort study including adult in‐ and outpatients treated in an academic hospital in the Netherlands who completed at least one USD as part of routine care (2012‐2019). The distress thermometer and problem checklist (DT&PC) was used as a reference PROM.Content, construct and criterion validity, responsiveness, and cutoff points are shown with prevalences, area under receiver operating characteristic (ROC) curve, Chi‐squared test, Wilcoxon signed‐rank test, and positive and negative predictive values, respectively.ResultsA total of 3913 patients completed 22 400 USDs. Content validity was confirmed for all added USD items with prevalences of ≥22%. All USD items also present on the DT&PC demonstrated a good criterion validity (ROC >0.8). Construct validity was confirmed for the USD as a whole and for the items dry mouth, dysphagia and well‐being (P < .0001). USD scores differed significantly for patients when improving or deteriorating on the DT&PC which confirmed responsiveness. Optimal cutoff points (3 or 4) differed per symptom.ConclusionThe USD is a valid 12‐item PROM for the most prevalent symptoms in cancer patients, which has content, criterion, and construct validity, and detects clinically important changes over time, in both curative and palliative phase.

Good validity and reliability of forgotten joint score-12 in total knee arthroplasty in Hindi language for Indian population.

Commonly used patient-reported outcome measurement (PROM) tools for knee joint have a ceiling effect and may not be able to differentiate between patients achieving outcomes better than the upper limit of the score. Forgotten joint score-12 (FJS-12) is said to be free of this limitation. FJS-12 has been translated and validated in different languages. This study aims to translate and validate FJS-12 in Hindi (Hindi FJS-12). Hindi FJS-12 was tested for comprehensibility in a pilot study in 20 patients. This was followed by a prospective cohort study including 140 patients of bilateral total knee arthroplasty, with a minimum follow-up of 12months. The mean age of the patients was 62.0 ± 14.5years. There were 77 (55.2%) males and remaining were females. All patients were asked to fill up questionnaires of Hindi FJS-12, WOMAC, KSS and OKS. Hindi FJS-12 was tested for validity, reliability, responsiveness, floor effect and ceiling effect. Construct validity was expressed as the Pearson correlation coefficient. Internal consistency was expressed as Cronbach's alpha and test-retest reliability as the intra-class correlation coefficient (ICC). In the pilot study, it was seen that all the questions were well answered by most of the participants. The main study showed good construct validity with Hindi FJS-12 showing moderate correlation with WOMAC, KSS and OKS (Pearson coefficients 0.45, 0.32, 0.37, respectively). Hindi FJS-12 had excellent internal consistency with Cronbach's alpha of 0.93 (95% CI 0.90, 0.97). ICC was 0.95 (95% CI 0.90, 0.99). No floor or ceiling effect was observed. Hindi FJS-12 has high validity, reliability and reproducibility for knee function after TKA. It is devoid of floor or ceiling effect. Thus, it can be successfully used for studying knee function in the Indian population. Prospective cohort study, Level II.

EUROQoL-5D as a valid patient-reported outcome measurement (PROM) tool to predict health-related quality of life (HRQoL) and survival in patients with hematological malignancies.

e19141 Background: Patient-Reported Outcome Measurement (PROM) is the way to collect not only Health-Related Quality of Life (HRQoL) but also symptoms. EUROQOL-5D is a PROM tool explored widely in patients with cancer, although is not specific for cancer patients. The primary end-point of this project is to analyse the significance of impairments in EUROQOL-5D domains in overall survival of patients with hematological malignances, and the utility to incorporate as a PROM tool in a daily clinical practice. Methods: Patients with hematologic malignancies attended at Fundacion Jimenez Diaz University Hospital were assessed with EUROQOL-5D prior to receive any therapy. Self-reported health status stated as better, equal or worse was recorded at the time of assessment. Other variables such as age, sex, diagnosis and ECOG was collected to analyze their impact in survival. Results: From January 1, 2017 to December 31, 2019, 390 consecutive patients were included. Median age was 72 years (range 18-92), 194 (49.7%) were female, with a diagnosis of lymphoma in 257 (65.9%) and myeloma in 70 (17.9%), and ECOG 0-1 in 78.2% of patients. With a median follow-up of 10.5 months (range 0-32 months), we registered 72 events for overall survival. In the univariate analysis, age &gt; 76 years (AUC 0.739, Likelyhood Ratio 3.321, p &lt; 0.0001), ECOG 2-4 (OR 11.161, 95% CI 5.276-23.610, p &lt; 0.0001), impairment in EUROQOL-5D domains such us mobility (OR 2.896, 95%CI 1.406-5.967, p = 0.003), self-care (OR 3.959, 95%CI 1.732-9.050, p = 0.001) and usual activities (OR 3.190, 95%CI 1.573-6.467, p = 0.001), but not pain/disconfort nor anxiety/depression were identified as prognostic factors for shorter survival. Self-reported health status (OR 3.975, 95%CI 1.845-8.565, p &lt; 0.0001) was also a prognostic factor for survival. Impairments in EUROQOL-5D were also prognostic in patients with ECOG 0-1 (p &lt; 0.001). In the multivariate analysis, only ECOG 2-4 and self-reported health status remained with statistical significance. Conclusions: EUROQOL-5D is a valid tool to be incorporated as a PROM tool in pacients with hematological malignancies. Impairments in mobility, self-care and usual activities will identify a poorer prognosis group that would need closer monitoring.

Patient-reported visual function outcome in cataract surgery: test-retest reliability of the Catquest-9SF questionnaire.

To study the test-retest reliability of the Catquest-9SF questionnaire in cataract surgery. A single-centre prospective non-randomized test-retest study was conducted using the Swedish National Cataract Register and the Catquest-9SF questionnaire, which is a valid patient-reported outcome measurement tool developed and used for evaluating quality and visual disability outcome in cataract surgery. Consecutive patients (n=144) scheduled for cataract surgery completed the Catquest-9SF twice before surgery, with a minimum of 7days and a maximum of 14days between the two questionnaires. A rating scale model was constructed on the basis of the questionnaires from the first measurement and used to generate scores for both the first and second measurements. The consistency was investigated by calculating intraclass correlation, Pearson correlation and a Bland-Altman plot. Internal consistency was measured using Cronbach's alpha. Analyses showed an intraclass correlation of 0.93 (95% confidence interval: 0.90-0.95), a Pearson correlation of 0.93 and Cronbach's alpha of 0.94. The results fit well in a Bland-Altman plot. The test-retest reliability of the Swedish Catquest-9SF is excellent. Along with previous knowledge, this supports continued use of the Catquest-9SF in evaluating quality and outcome in cataract surgery.

French Translation and Validation of the Victorian Institute of Sports Assessment for Gluteal Tendinopathy Questionnaire.

Developed in 2015, the Victorian Institute for Sport Assessment for Gluteal Tendinopathy (VISA-G) is the first patient-reported outcome measure tool specifically designed to measure the severity of disability associated with greater trochanteric pain syndrome. There is currently no French version of the VISA-G questionnaire. To translate the VISA-G questionnaire into French (VISA-GF) and to test its psychometric performances. Cross-sectional study, validation study. Clinics in Liège, Belgium and in France. Participants with greater trochanteric pain syndrome and control asymptomatic participants. Not applicable. French translation of the VISA-G and psychometric performances of the questionnaire tested using internal consistency, construct validity and test-retest reliability with a 7-day interval. The eight items of the VISA-G questionnaire were translated without any difficulties. The psychometric validation study included 106 participants (median age 53 [58-64] years old, 65 women [61.3%]). The questionnaire discriminates well between pathologic (n = 52) and asymptomatic participants (n = 54). Moreover, we found a good internal consistency and excellent test-retest reliability for the VISA-GF questionnaire. We also confirmed the construct validity and did not find any floor or ceiling effects. The VISA-GF has been shown to be a valid and reliable way to measure the severity of disability associated with greater trochanteric pain syndrome in French-speaking participants.

Deciding Our Future: Consensus Conference Summary Report.

There are few quality measures that allow for optimization of care for pelvic organ prolapse (POP). In coordination with the American Urogynecologic Society (AUGS), a prior group agreed upon health care provider-reported data elements that are important for large-scale quality measurement. The primary objective was to review existing patient-reported outcome (PRO) measurement tools for POP and consider where improvements are needed for inclusion in a quality measurement tool. A secondary objective was to discuss enhanced strategies to improve the quality of care for women with mesh complications. The AUGS Scientific Committee convened a 1-day meeting titled "Deciding our Future: Consensus Conference on Prolapse Outcomes and Best Practices for Mesh Complications." Speakers discussed the current state of POP outcome measurement and meaningful ways of measuring and improving quality. Furthermore, past and future work for standardization of care regarding mesh complications was discussed. Conference participants included invited speakers, representatives from AUGS and partner societies, 5 patient representatives from the AUGS Patient Advisory Committee, and 38 registered participants from academic institutions, community practices, and industry. Participants developed a roadmap for incorporating PROs into a national POP quality improvement registry. Participants also discussed important gaps in our knowledge of treatment of mesh complications and previewed proposed terminology and treatment algorithms. Using appropriate methodology, existing PRO measurement tools can be collapsed into one concise tool for POP quality measurement. Over the next year, work will continue toward this goal. Proposed updates to mesh terminology and treatment algorithms will be published separately.

Understanding the patient profile and health-related quality of life in patients presenting for hand surgery.

The aim of this descriptive epidemiological study of patients, referred to and selected for surgery at a UK tertiary hand centre, was to investigate patterns of common hand disorders and their impact on those individuals. A prospective collection of patient-reported outcome scores was carried out in patients before operation using the Patient Outcomes of Surgery Hand/Arm and the Euro-Qol 5 dimension three-level measures. Patient participation was voluntary and data collected over a 4-year period are discussed. Patient-reported outcome scores were calculated using appropriate algorithms. The results show correlation between the number of comorbidities and both symptoms and activity domains of the Patient Outcomes of Surgery Hand/Arm; higher symptom scores were seen in women. There was no increase in scores for older patients or those from more deprived areas. Population-based research using recognized patient-reported outcome measurement tools could aid future health service planning. Level of evidence: IV.

A Meta-analysis of Clinical, Patient-Reported Outcomes and Cost of DIEP versus Implant-based Breast Reconstruction.

Introduction:Comparative data on clinical outcomes and cost of deep inferior epigastric perforator (DIEP) and implant-based reconstruction (IBR) are limited. We conducted a Preferred Reporting Items for Systematic Review and Meta-analysis-compliant systematic review and meta-analysis to compare clinical, patient-reported outcomes (PROs) and cost.Methods:The protocol was published a priori on PROSPERO (CRD42017072557). EMBASE, MEDLINE, Google Scholar, Cochrane Controlled Register of Trials, Science Citation Index, and ClinicalTrials.gov were searched from January 1994 to August 2018. Two independent reviewers evaluated the articles for inclusion. Study quality was assessed using Grading of Recommendations Assessment, Development, and Evaluation, and risk of bias (RoB) was assessed using Cochrane’s RoB in Nonrandomized Studies of Interventions tool.Results:Out of 6,381 articles screened, 16 were included [unilateral 782 DIEPs, 376 implants; mean age 49 years, follow-up (months): DIEP 29.9; IBR 35.5]. Mean flap loss and fat necrosis rates were 3.97% (SD 4.90) and 9.67% (SD 17.0), respectively. There was no difference in mean length of stay {standard mean difference 0.63 [confidence interval (CI) −9.17 to 10.43]; P =0.90}. The number of reoperations for complications was significantly lower in DIEP versus IBR [SMD −0.29 (CI −0.48 to −0.09); P < 0.01]. There were no randomized controlled trials. Study quality was low with high RoB. One study reported $11,941/Quality-adjusted Life Year incremental cost-effectiveness ratio for DIEP, with higher breast Quality-adjusted Life Year (DIEP 19.5; IBR 17.7) using Breast Questionnaire; 3 studies evaluated cost, favoring DIEP. Two comparative studies evaluating PROs favored DIEP.Conclusions:DIEP reconstruction maybe more cost-effective and yield superior PROs. However, poor-quality, bias-ridden studies limit the findings. Adequate reporting of core outcome measures is required to minimize reporting bias and facilitate evidence synthesis. Prospective, multicenter, cohort studies using robust patient-reported outcome measures (PROMs) tools, evaluating cost-effectiveness and contributing to national/international registries, will facilitate national-level policy and shared decision-making.

Current trends of breast reconstruction after mastectomy in China: a cross-sectional study

Objective: To investigate the current trends of breast reconstruction(BR) after mastectomy in China. Methods: A list of hospitals with more than 200 cases of breast cancer surgery per year nationwide was obtained, and 110 institutions were selected according to the geographical distribution. The research was conducted in the form of a questionnaire survey, and 92.3% (169/183) of the questions were single-choice questions. Information such as demographics of surgeons and hospitals, number of mastectomy and BR, type and timing of BR was included in the survey. Survey formal notification letter was issued by the China Anti-Cancer Association Breast Cancer Committee and Chinese College of Surgeons, Committee of Mammary Surgeons. Questionnaires were sent to the respondents of each center by email. The survey time range was from January 1, 2017 to December 31, 2017. All data were completely collected before September 7, 2018. Results: A total of 110 units participated in the survey. In total, 87.3% (96/110) of the hospitals have conducted BR surgery. The BR after mastectomy was 10.7% (6 534/61 099), among this, implant BR accounted for 65.7%(4 296/6 534), autologous BR accounted for 20.1% (1 312/6 534), and autologous combined implant BR accounted for 14.2% (927/6 534). Immediate reconstruction accounted for 67.6% (4 417/6 534) of BR, while delayed BR accounted for 32.4% (2 097/6 534). In 2017, 77.8% (35/45) of the plastic surgery departments cooperated with general surgery departments. General BR could be conducted after mastectomy accounted for 83.6% (92/110). The proportion of reconstruction was positively correlated with the gross domestic product (GDP) per capita (r=0.311, P=0.002). The one-step implant-based BR(IBBR) was the most preferred type in immediate BR. Two-step IBBR was the most preferred method in delayed BR. Hospitals that routinely evaluated aesthetics after BR accounted for 64.6% (62/96), while only 16.7% (16/96) of hospitals used patient-reported outcome measure (PROM). The most commonly used PROM tool was BREAST-Q. Conclusions: The overall BR in China is on upward trend, but gap between China and the developed countries still exists. Breast surgery departments should strengthen further cooperation with plastic surgery departments. Simultaneously, the aesthetics evaluation and PROM after BR should be put a high premium.

Patient-Reported Outcomes Measurement Information System (PROMIS) in Femoroacetabular Impingement (FAI)

Objectives: Patient-Reported Outcomes Measurement Information System (PROMIS) is an NIH-funded computerized adaptive test (CAT) developed to effectively assess patient outcomes in multiple domains, including physical function (PF), pain severity, and quality of life while minimizing patient burden. The purpose of this study is to validate PROMIS in patients undergoing hip arthroscopy for Femoroacetabular Impingement (FAI), including test-retest reliability and correlation with validated hip outcome measures. Methods: Patients undergoing elective hip arthroscopy for FAI were consecutively enrolled at a major academic center. Patients with chronic comorbidities, bilateral FAI with a staged approach, and lack of postoperative follow-up were excluded. Eligible patients completed the modified Hip Harris Score (mHHS), Hip Outcome Score Activities of Daily Living (HOS-ADL), International Hip Outcome Tool (iHOT-12), and PROMIS including PF, pain interference, and activity satisfaction. Questionnaires were completed preoperatively, two, and six weeks postoperatively. Ceiling effects were determined to be present if greater than 15% of patients scored the highest possible score on one of the patient reported outcome measurement tools in this study. The correlation of preoperative values with postoperative function were assessed utilizing the Pearson coefficient. Normality was evaluated using the Shapiro-Wilk test. Dependent sample t-tests were utilized to compare means in test-retest reliability. Results: There were 38 patients with a mean age of 29.3 ± 8.9 years (54% female) identified for the study. PROMIS demonstrated excellent correlation with HOS-ADL (Pearson coefficient of 0.81, Figure 1), as well as mHHS (0.80) and iHOT-12 (0.73). Patients with higher PROMIS-pain interference and pain intensity scores demonstrated a negative linear correlation with mHHS (r=-0.86, p&lt;0.05), HOS-ADL (r=-0.71, p&lt;0.05), and iHOT-12 (-0.71, p&lt;0.01). PROMIS scores exhibited significant responsiveness to hip arthroscopy. Patients with higher activity satisfaction demonstrated excellent-good correlation with mHHS scores (r=0.66, p&lt;0.05) and HOS-ADL (0.66, p&lt;0.05). PROMIS also demonstrated excellent test-retest reliability with no variability in scores, including PF (55.5 ± 8.6 vs. 54.2 ± 10.5, p=0.74). No floor or ceiling effects were exhibited by PROMIS including the physical function, pain interference, pain intensity, social participation, and role satisfaction domain scores. Conclusion: PROMIS is a valid and efficient PRO in hip arthroscopy for FAI demonstrating excellent test-retest reliability and correlation with established hip outcome measures. No floor or ceiling effects were demonstrated by PROMIS. Subdomains also exhibit excellent prognostic ability in the clinical setting.