Valid Patient-reported Outcome Measure Research Articles

Minimally Invasive Surgery for Severe Hallux Valgus with 2 Year Minimum Follow Up in 106 Feet

Category:Bunion; Lesser Toes; Midfoot/ForefootIntroduction/Purpose:There is widespread variation in the optimal procedure for correction of severe hallux valgus deformity. Severe hallux valgus (defined as hallux valgus angle (HVA) (>=40°) and/or 1-2 intermetatarsal angle (IMA) (>=20°)) is associated with increased complication rates including recurrence, delayed or non-union and metatarsal shortening with transfer metatarsalgia. There is limited evidence investigating the clinical or radiological outcomes following treatment of severe hallux valgus deformity with third-generation minimally invasive chevron and akin osteotomies (MICA). Objective: The primary aim was to investigate clinical patient reported outcome measures (PROMs) two years following surgery and the radiographic deformity correction for patients undergoing third-generation MICA for severe hallux valgus deformity.Methods:Prospective observational single surgeon series of consecutive patients who underwent primary third-generation MICA with screw fixation for severe hallux valgus. The primary outcome was a validated patient reported outcome measure, the Manchester-Oxford Foot Questionnaire (MOXFQ), assessed minimum 2 years following MICA. Secondary outcomes were radiographic deformity correction, complication rates and other quality of life PROMs (EQ-5D and Visual Analogue Pain Scale).Results:Between September 2014 and May 2018, 106 consecutive feet (n=78 patients; 73 female, 5 male) met the inclusion criteria. Prospectively collected pre-operative and 2 year PROM MOXFQ data was available for 86 feet (81.1%). At two years following surgery, the MOXFQ score significantly improved for the Pain, Walking and Standing and Social Interaction domains from 39.2 to 7.5, 38.2 to 5.9 and 48.6 to 5.5, respectively (p<0.001). Pre- and post-operative radiographic data was available for all 106 feet. Mean IMA following surgery improved from 18.2° to 6.3° (p<0.001) whilst mean HVA improved from 45.3° to 10.9° (p<0.001).Conclusion:This study has demonstrated third-generation MICA for the treatment of severe hallux valgus deformity can achieve significant improvements in clinical PROMs and radiographic deformity correction.

Structural validity and reliability of the patient experience measure: A new approach to assessing psychosocial experience of upper limb prosthesis users.

Recent advances in upper limb prosthetics include sensory restoration techniques and osseointegration technology that introduce additional risks, higher costs, and longer periods of rehabilitation. To inform regulatory and clinical decision making, validated patient reported outcome measures are required to understand the relative benefits of these interventions. The Patient Experience Measure (PEM) was developed to quantify psychosocial outcomes for research studies on sensory-enabled upper limb prostheses. While the PEM was responsive to changes in prosthesis experience in prior studies, its psychometric properties had not been assessed. Here, the PEM was examined for structural validity and reliability across a large sample of people with upper limb loss (n = 677). The PEM was modified and tested in three phases: initial refinement and cognitive testing, pilot testing, and field testing. Exploratory factor analysis (EFA) was used to discover the underlying factor structure of the PEM items and confirmatory factor analysis (CFA) verified the structure. Rasch partial credit modeling evaluated monotonicity, fit, and magnitude of differential item functioning by age, sex, and prosthesis use for all scales. EFA resulted in a seven-factor solution that was reduced to the following six scales after CFA: social interaction, self-efficacy, embodiment, intuitiveness, wellbeing, and self-consciousness. After removal of two items during Rasch analyses, the overall model fit was acceptable (CFI = 0.973, TLI = 0.979, RMSEA = 0.038). The social interaction, self-efficacy and embodiment scales had strong person reliability (0.81, 0.80 and 0.77), Cronbach's alpha (0.90, 0.80 and 0.71), and intraclass correlation coefficients (0.82, 0.85 and 0.74), respectively. The large sample size and use of contemporary measurement methods enabled identification of unidimensional constructs, differential item functioning by participant characteristics, and the rank ordering of the difficulty of each item in the scales. The PEM enables quantification of critical psychosocial impacts of advanced prosthetic technologies and provides a rigorous foundation for future studies of clinical and prosthetic interventions.

Patient-Reported Outcome Measures in Symptomatic, Non-Limb-Threatening Peripheral Artery Disease: A State-of-the-Art Review.

Patient-reported outcome measures (PROMs) are health outcomes directly reported by the patient that can be used to measure the effect of disease and treatments on patient perceived well-being. This review summarizes current evidence regarding the validation of PROMs in people with symptomatic, nonlimb-threatening peripheral artery disease. A literature search was conducted to identify studies of symptomatic peripheral artery disease without limb-threatening ischemia that included PROMs and had sample sizes ≥25. PROMs were summarized along a continuum of validation using classical test theory framework and according to whether they fulfilled defined criteria for (1) content validity; (2) psychometric validation; and (3) further validation evidence base expansion. Of 2198 articles identified, 157 (7.1%) met inclusion criteria. Twenty-four PROMs in patients with symptomatic peripheral artery disease were reviewed. Among disease-specific PROMs, 8 of 15 had excellent reliability as measured by a Cronbach alpha ≥0.80. Based on established criteria for PROM responsiveness, 6 of 15 disease-specific PROMs demonstrated excellent sensitivity to change. Of these, the disease-specific peripheral artery questionnaire, vascular quality of life questionnaire, and walking impairment questionnaire met criteria for validation at each stage of the continuum. For generic (nondisease specific) PROMs, the European Quality of Life 5-Dimension and SF-36 had the most extensive evidence of validation. Evidence from this review can inform selection of PROMs aligned with scientific and clinical goals, given the variable degree of validation and potential complementary nature of the measures.

Telehealth for outpatient spine consultation: What do the patients think?

ObjectivesWe aimed to identify patient specific characteristics associated with a favourable telehealth experience in patients undergoing outpatient spine consultation. MethodsWe enrolled consecutive patients undergoing telehealth spine consultation during the initial months of the COVID 19 pandemic. We used an online, patient reported survey that collected demographic and disease specific information, as well as validated patient reported outcome measures. Survey items also assessed patients’ perspective of their telehealth experience. We performed univariate analysis to assess for any relationship between patient satisfaction and demographic and disease specific factors, and also collected qualitative responses regarding telehealth. Results170 unique responses were collected. 35.8% of patients were satisfied with telehealth. When stratified into satisfied (n = 61) and unsatisfied (n = 109), female patients were exclusively unsatisfied with their experience (100% unsatisfied vs male patients 30% unsatisfied, p < 0.01). The groups were similar in terms of age, travel burden, and disease severity. Qualitative responses focussed on the patients’ concerns being able to adequately express their symptoms and functional limitations. ConclusionsPatients attending outpatient spinal consultation via telehealth reported a satisfaction rate of 35.8%. Female patients were less likely to be satisfied with telehealth. Patients described concerns being able to express themselves via telehealth. This may be amenable to further study and intervention as telehealth becomes a more prominent part of spinal care.

Prospective Cohort Validation Study of a Novel Foot Offloading Device

Summary:Pressure offloading is often considered a crucial factor affecting healing after a foot injury. We have devised a novel foot offloading device (PopSole) which allows for immediate customization of the area where there is foot pain and allows for adjustable arch support and metatarsal pad height while maintaining patient stability. We hypothesize that pain and function outcomes will improve significantly after use of the device over a 1-month period. Ten participants with foot pain for longer than 6 months completed five validated outcome questionnaires during three visits (initial screening, at 2 weeks, and at 4 weeks). Devices were deflated in areas of pain specific for each patient. Validated patient reported outcomes measures showed significant improvement in pain and function from baseline to week two (r = 0.644, P < 0.05), (r = 0.43, P < 0.05), and (r = 0.552, P < 0.05), respectively, and the Foot & Ankle Ability Measure (FAAM) showed improved ability in activities of daily living (r = 0.58, P < 0.05) and sports (r = 0.69, P < 0.05). All 10 patients reported pain relief during at least one visit and/or an ability to return to standing-based activities that they previously were unable to do. PopSole rapidly improved pain and function, with sustained relief through 4 weeks. Current studies are in progress to assess long-term durability of the device and potential modifications to be made before future randomized studies to assess pressure and gait assessment, shear forces, and diabetic foot ulcer mitigation.

Patient-reported outcome measures for masticatory function in adults: a systematic review

ObjectiveThe aim of this systematic review was to critically evaluate the Patient-Reported Outcome Measures (PROMs) for masticatory function in adults.MethodsFive electronic databases (Medline, Embase, Web of Science Core Collection, CINAHL Plus and APA PsycINFO) were searched up to March 2021. Studies reporting development or validation of PROMs for masticatory function on adults were identified. Methodological quality of the included studies was evaluated using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) risk of bias checklist. Psychometric properties of the PROM in each included study were rated against the criteria for good measurement properties based on the COSMIN guideline.ResultsTwenty-three studies investigating 19 PROMs were included. Methodological qualities of these studies were diverse. Four types of PROMs were identified: questions using food items to assess masticatory function (13 PROMs), questions on chewing problems (3 PROMs), questions using both food items and chewing problems (2 PROMs) and a global question (1 PROM). Only a few of these PROMs, namely chewing function questionnaire-Chinese, Croatian or Albanian, food intake questionnaire-Japanese, new food intake questionnaire-Japanese, screening for masticatory disorders in older adults and perceived difficulty of chewing-Tanzania demonstrated high or moderate level of evidence in several psychometric properties.ConclusionsCurrently, there is no PROM for masticatory function in adults with high-level evidence for all psychometric properties. There are variations in the psychometric properties among the different reported PROMs.Trial Registration PROSPERO (CRD42020171591).

Work Status, Missed Time at Work, Work Performance, and Quality of Life in Adult Survivors of Hematopoietic Cell Transplant in Childhood

Background: Post-allogeneic hematopoietic cell transplant (HCT) work status is an important indicator of survivors' health recovery and social and economic well-being. However, current literature lacks data on work status, missed time at work, work performance, and quality of life (QOL) of long-term survivors of childhood HCT.Methods: A cross-sectional web-based survey study of ≥1-year survivors of childhood allogeneic HCT (performed between 1985-2010 at Children's Wisconsin, Milwaukee, WI) who were <18 years of age at HCT and ≥18 years of age at their most recent assessment. Eligible survivors were identified using the Center for International Blood and Marrow Transplant Research database and contacted by email and/or mail. Validated patient reported outcomes measures, the World Health Organization Health and Work Performance Questionnaire (HPQ) and the National Institutes of Health Patient Reported Outcomes Measurement Information System (PROMIS) were used to capture work and QOL data, respectively. Using HPQ responses, working survivors' work absenteeism and presenteeism scores were calculated. Absenteeism scores were also calculated for the survivors who reported to be students. Absolute absenteeism was defined as 4*(no. of hours expected at work or school) - no. of hours actually worked or attended school. Relative absenteeism was defined as absolute absenteeism score/ 4*(no. of hours expected at work or school). Absolute presenteeism was defined as 10*(self-reported work performance in last 4 weeks). Relative presenteeism was defined as self-reported work performance in last 4 weeks / self-reported performance of co-workers. Higher absenteeism and presenteeism scores indicated higher missed time at work or school and better work performance, respectively. PROMIS domains were scored on a T-score metric with a mean score of reference population at 50 and standard deviation of 10. The primary outcome was individual PROMIS domain score as a continuous variable. Univariate linear regression was performed to study factors associated with increase in PROMIS domain scores. For negatively worded domains (anxiety, depression, fatigue, sleep disturbance, cognitive concerns, pain interference), higher score was considered worse and for positively worded domains (physical function, satisfaction with social roles and activities), lower score was considered worse. Student survivors were considered employed in the analysis. P-value <0.05 was considered statistically significant.Results: Out of 99 allogeneic HCT recipients who met the selection criteria, 47 initiated the survey and 44 completed it (44% response rate). At the time of survey, 73% (n=32) of the respondents were working, 23% (n=10) were unemployed, and 4% (n=2) were students. Median age at HCT and survey were 11.1 years (interquartile range [IQR] 7.0-13.5) and 30.0 years (IQR 26.5-34.0), respectively. Median follow-up from HCT was 22 years (range 9-32). Fifty two percent were females and 75% received HCT for malignant diseases (acute lymphoblastic leukemia 45%). Compared to unemployed survivors, employed survivors reported less pain interference and sleep disturbance (Figure 1). History of acute graft vs. host disease (GVHD) was associated with worse physical function. Median absolute absenteeism and presenteeism scores were 0 hours (IQR [-1.5]-16) and 83 (IQR 73-92), respectively. Higher absolute presenteeism was associated with less pain interference and more satisfaction with social roles and activities and physical function. Higher relative presenteeism was associated with less cognitive concerns. Higher absolute absenteeism was associated with less depression and higher relative absenteeism with less fatigue (Table 1).Conclusions: Nearly a quarter of the survivors reported being unemployed at the time of the survey. Significant associations between survivors' work status, work performance, and QOL were identified. Our findings provide an important insight on the implications of work outcomes on HCT survivors' physical, mental, and social health and emphasizes the importance of routine longitudinal assessment of work status, performance and QOL in this population. These results also have the potential to help develop effective communication strategies with employers to balance work expectations of survivors in order to achieve better work productivity and in turn, good QOL. [Display omitted] DisclosuresBhatt: Johnson & Johnson: Divested equity in a private or publicly-traded company in the past 24 months; Moderna, Inc.: Divested equity in a private or publicly-traded company in the past 24 months; Pfizer Inc.: Divested equity in a private or publicly-traded company in the past 24 months; Rite Aid Corporation: Divested equity in a private or publicly-traded company in the past 24 months. Phelan: Amgen Pharmaceuticals: Research Funding. Shaw: mallinkrodt: Other: payments; Orca bio: Consultancy.

A Phase 2/3 Randomized, Placebo-Controlled, Open-Label, Multi-Center Trial of Lenzilumab to Improve the Safety and Efficacy of CAR-T Cell Therapy in Adults with Relapsed or Refractory Large B-Cell Lymphoma (The SHIELD Study)

Background: Diffuse large B-cell lymphoma (DLBCL) is the most common aggressive sub-type of non-Hodgkin's lymphoma(Liu, et al. Am J Hematol 2019). All three approved CD19-directed CAR-T therapies (axicabtagene ciloleucel, tisagenlecleucel, lisocabtagene maraleucel) are associated with toxicities, including cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) that can be severe, resulting in non-relapse mortality, ICU admission, and significant non-drug related health resource utilization which represent barriers to access and adoption (Nabhan, et al. J Clin. Pathway 2017). Studies have shown that early elevation of granulocyte-macrophage colony-stimulating factor (GM-CSF) levels 1-day post CAR-T infusion correlates with severe ICANS (Rossi, et al. EMA Workshop 2016), which is a negative prognostic factor for overall survival (Karschnia, et al. Blood 2019). It has been proposed that upon contact with the tumor, CAR-Ts produce GM-CSF, which serves as a communication conduit between the specific immune response of CAR-T and the off-target inflammatory cascade produced by myeloid lineage cells, causing myeloid cells to expand and promote the production of other downstream proinflammatory chemokines (MCP-1, IL-8, IP-10), cytokines (IL-1, IL-6), and other markers of systemic inflammation (CRP, Ferritin) (Sterner, et al. Blood 2019). Moreover, IL-6 is predominately released by tumor cells in a contact-independent manner (Barrett et al. Blood 2016), which helps explain why the prophylactic administration of tocilizumab is not effective in reducing the overall incidence of CRS or ICANS, as this cytokine is downstream in the inflammatory cascade. Further, the prophylactic use of tocilizumab has been shown to increase the incidence of all-grades and grade >3 ICANS (Locke, et al. Blood 2017). Lenzilumab is a novel Humaneered ® monoclonal antibody that neutralizes GM-CSF and has demonstrated potential to reduce the hyper-immune mediated cytokine storm induced by SARS-CoV-2 infection and significantly improve the likelihood of survival without ventilation in hospitalized COVID-19 patients, as reported in the LIVE-AIR phase 3 study (Temesgen, et al. medRxiv 2021). Methods: Eligible patients are adults (≥ 18 y) with relapsed or refractory DLBCL or are chemorefractory. Prior therapy must have included an anti-CD20 monoclonal antibody and an anthracycline-containing regimen. Patients will undergo leukapheresis and may receive optional corticosteroid bridging therapy. Patients will then receive lymphodepleting chemotherapy on Days ‒3 to ‒5 followed by infusion of lenzilumab on Day 0, 6-hrs prior to CAR-T infusion. Approximately 40 accredited sites across the U.S. certified to administer the three commercially available CAR-Ts have been engaged to participate in this 2-part study. In Part 1, all patients will receive lenzilumab 1800mg via a single 2-hour infusion prior to CAR-T administration. The objective of Part 1 is to evaluate the optimal regimen and assess whether a second dose of lenzilumab post-CAR-T infusion is required. A translational assessment of GM-CSF axis suppression, levels of CAR-T cells in blood, other inflammatory markers and lenzilumab PK/PD will be evaluated, along with the incidence and severity of CRS and ICANS, objective response rates (ORR) and rates of complete response (CR) by Day 28 to select the optimal regimen to carry forward into Part 2. The objective of Part 2 is to confirm whether lenzilumab can improve the toxicity and tolerance of CAR-T while maintaining or improving efficacy and durability of response. Up to 250 patients will be randomized 1:1 to receive lenzilumab or placebo with CAR-T per standard of care. The primary endpoint of the study is incidence of grade >2 CRS and/or ICANS by Day 28, with a key secondary endpoint of CR at 6-months in patients without grade ≥ 2 CRS and/or ICANS at Day 28 (Toxicity-free CR). This design and sample size yields 90% power to detect a 50% reduction in the primary outcome measure. Secondary endpoints include incidence of all grades and grade >3 CRS and/or ICANS, respectively; ORR and CR at 1, 3, 6, 12 months; durability of CR; progression-free survival, overall survival and health related quality of life using validated patient reported outcome measures. In addition, the study will explore the CRS and ICANS grading criteria that have been utilized with each of the approved CAR-Ts. DisclosuresKenderian: Humanigen, Inc.: Consultancy, Honoraria, Research Funding. Durrant: Humanigen, Inc.: Current Employment, Current equity holder in publicly-traded company, Divested equity in a private or publicly-traded company in the past 24 months. Chappell: Humanigen Inc.: Current Employment, Current equity holder in publicly-traded company, Divested equity in a private or publicly-traded company in the past 24 months. Ahmed: Humanigen Inc.: Current Employment, Current equity holder in publicly-traded company. Kilcoyne: Humanigen, Inc.: Current Employment, Current equity holder in publicly-traded company.

Satisfaction and experience with colorectal cancer screening: a systematic review of validated patient reported outcome measures

BackgroundPatient satisfaction or experience with colorectal cancer screening can determine adherence to screening programs. An evaluation of validated patient reported outcome measures (PROMs) for measuring experience or satisfaction with colorectal cancer screening does not exist. Our objective was to identify and critically appraise validated questionnaires for measuring patient satisfaction or experience with colorectal cancer screening.MethodsWe conducted a systematic review following the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology. We conducted searches on MEDLINE, EMBASE, PsychINFO, CINAHL and BiblioPRO and assessed the methodological quality of studies and measurement properties of questionnaires according to the COSMIN guidelines for systematic reviews of PROMs. PROSPERO registration number: CRD42019118527.ResultsWe included 80 studies that used 75 questionnaires, of which only 5 were validated. Four questionnaires measured satisfaction with endoscopy: two in the context of colorectal cancer screening (for colonoscopy and sigmoidoscopy) and two for non-screening endoscopy. One questionnaire measured satisfaction with bowel preparation. The methodological quality of studies was variable. The questionnaires with evidence for sufficient content validity and internal consistency were: the CSSQP questionnaire, which measures safety and satisfaction with screening colonoscopy, and the Post-Procedure questionnaire which measures satisfaction with non-screening endoscopic procedures.ConclusionsThis systematic review shows that a minority of existing PROMs for measuring patient satisfaction with colorectal cancer screening are validated. We identified two questionnaires with high potential for further use (CSSQP and the Post-Procedure questionnaire).

Coccygectomy for refractory coccygodynia: a systematic review and meta-analysis.

We sought to systematically assess and summarize the available literature on outcomes following coccygectomy for refractory coccygodynia. PubMed, Scopus, and Cochrane Library databases were systematically searched in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Data concerning patient demographics, validated patient reported outcome measures (PROMs) for pain relief, disability outcomes, complications, and reoperation rates were extracted and analyzed. A total of 21 studies (18 retrospective and 3 prospective) were included in the quantitative analysis. A total of 826 patients (females = 75%) received coccygectomy (720 total and 106 partial) for refractory coccygodynia. Trauma was reported as the most common etiology of coccygodynia (56%; n = 375), followed by idiopathic causes (33%; n = 221). The pooled mean difference (MD) in pain scores from baseline on a 0-10 scale was 5.03 (95% confidence interval [CI]: 4.35 to 6.86) at a 6-12month follow-up (FU); 5.02 (95% CI: 3.47 to 6.57) at > 12-36months FU; and 5.41 (95% CI: 4.33 to 6.48) at > 36months FU. The MCID threshold for pain relief was surpassed at each follow-up. Oswestry Disability Index scores significantly improved postoperatively, with a pooled MD from baseline of - 23.49 (95% CI: - 31.51 to - 15.46), surpassing the MCID threshold. The pooled incidence of complications following coccygectomy was 8% (95% CI: 5% to 12%), the most frequent of which were surgical site infections and wound dehiscence. The pooled incidence of reoperations was 3% (95% CI: 1% to 5%). Coccygectomy represents a viable treatment option in patients with refractory coccygodynia.

Minimally invasive hallux valgus correction: Is it better than open surgery?

BackgroundThe aim was to compare the minimally invasive (MIS) chevron osteotomy to the well-established open chevron osteotomy for the correction of hallux valgus deformity. MethodsTwo retrospective cohorts of patients treated with MIS or open chevron osteotomy for hallux valgus correction, matched for age and gender with a minimum follow up of six months were reviewed. Functional outcomes were evaluated using pre and post-operative Manchester Oxford Foot and Ankle Questionnaire (MOXFQ), Visual Analog Score (VAS) for pain and the Unified Elective Orthopaedic Score (UnEOS). Two independent, blinded examiners evaluated the radiographic correction of hallux valgus (HV) and intermetatarsal (IM) angle. ResultsA Total of 54 cases (27 per study group) with a mean follow-up of 25.9 months were included in the study. Pre-operatively, VAS (p = 0.76) and MOXFQ (p = 0.46) scores and HV angle (p = 0.1) were comparable in both groups. However, IM angle was significantly larger in the MIS group (p = 0.005). Post-operatively there was significant improvement in VAS and MOXFQ scores as well as significant correction of the HV and IM angles (p < 0.0001) for both groups. Comparing the two procedures, there was no significant difference between groups for VAS (p = 0.34), MOXFQ scores (p = 0.56) and HV angles (p = 0.069) but the MIS technique was significantly better in improving the IM angle (p = 0.016). The post-operative UnEOS score and the Satisfaction UnEOS domain reached excellent levels for the entire cohort with no statistical difference between the two groups (p = 0.2 and 0.28 respectively). ConclusionResults show MIS chevron osteotomy provides better radiographic correction of the IM angle but functional outcomes for all parameters were comparable to the open technique. It can therefore be considered at least equivalent to standard open surgery when compared using validated Patient Reported Outcome Measures (PROMs).

A Quantitative Evaluation of Functional Recovery after Traumatic Lower Extremity Salvage

Soft tissue reconstruction is a routine component of lower extremity trauma care and focus is increasingly being directed towards understanding functional outcomes. This study aims to quantify functional recovery and identify variables associated with functional outcomes of patients who undergo traumatic limb salvage. A retrospective review was performed of patients with lower extremity traumatic injuries requiring vascularized soft tissue reconstruction at a Level 1 trauma center between July 2007-December 2015. Postoperatively, patients were administered the 36-Item Short Form Health Survey Version 2 (SF-36v2) and the Lower Extremity Functional Scale (LEFS) questionnaires by telephone. Demographics, perioperative variables, and postoperative outcomes were analyzed by univariate and bivariate analysis. Forty-two patients with 42 flaps and a mean of 12.7 months follow up were included in the study. Limb salvage was successful in 38 patients (90.5%). Patients ≥ 40 years old had significantly worse SF-36v2 scores in physical functioning (P ≤0.01) and mental health (P ≤0.05) than their younger counterparts. Patients who had pre-existing hypertension demonstrated significantly lower physical functioning (P ≤0.01). Role limitation due to emotional health was significantly lower in patients who were female (P ≤0.01) or required revision surgery (P ≤0.01). The mean LEFS score was 37.7 ± 18.5. Patients exhibited poor functional outcomes following major limb trauma with attempted limb salvage based on two validated patient reported outcomes measures (PROMs). Patient characteristics should be considered in evaluating candidates for reconstruction to optimize outcomes and to effectively counsel patients on their functional prognosis.

Validation of the Dutch version of the Hip Outcome Score; validity, reliability, and responsiveness in patients with femoroacetabular impingement syndrome.

ABSTRACTDue to a lack of a validated Dutch version of the Hip Outcome Score (HOS) considering functional outcome after hip arthroscopy for femoroacetabular impingement syndrome, we validated the Dutch version of the HOS (HOS-NL) in patients with femoroacetabular impingement syndrome for reliability, internal consistency, construct- and content validity. Furthermore, the smallest detectable change (SDC) and minimal clinically important difference (MCID) were determined. All consecutive patients scheduled for an arthroscopic procedure for FAIS were selected. Five questionnaires covering groin and hip pain were filled in at three moments in time (two pre-operatively with a maximum two-week interval and 6 months postoperatively). Main endpoints were reliability (test re-test, SDC), internal consistency (Cronbach alpha), construct validity (construct validity was considered sufficient if a least 75% of a-priori made hypotheses were confirmed), content validity (floor and ceiling effects) and responsiveness (MCID). The intraclass correlation coefficient (ICC) was 0.86 for the HOS ADL-NL and 0.81 for the HOS Sports-NL. SDC for the HOS ADL-NL was 21 and for the HOS Sports-NL 29 Cronbach alpha score was 0.882 for HOS ADL-NL and 0.792 for HOS Sports-NL. Construct validity was considered sufficient since 91% of the hypotheses were confirmed. No floor effects were determined. A small ceiling effect was determined for the HOS AD-NL postoperatively. The MCID for HOS ADL-NL and HOS Sports-NL were 14 and 11.0, respectively. The HOS-NL is a reliable and valid patient reported outcome measure for measuring physical function and outcome in active and young patients with femoroacetabular impingement syndrome.

How common are complications following polypropylene mesh, biological xenograft and native tissue surgery for pelvic organ prolapse? A secondary analysis from the PROSPECT trial.

ObjectiveTo report complication rates following prolapse surgery using polypropylene mesh inlay, polypropylene mesh kit, biological collagen xenografts and native tissue repairs.DesignSecondary analysis of the PROSPECT randomised controlled trial and cohort study.SettingThirty‐five UK hospitals.PopulationA total of 2632 women undergoing anterior and/or posterior vaginal prolapse repair.MethodsEvent rates were calculated for all complications. Analysis was by treatment received.Main outcome measuresIUGA/ICS classification of complications and validated patient reported outcome measures.ResultsAt baseline, 8.4% of women had ‘generic’ pain/discomfort; at 2 years following surgery, there was an improvement in all four groups; however, 3.0% of women developed de novo extreme generic pain. At 24 months de novo vaginal tightness occurred in 1.6% of native tissue, 1.2% of biological xenograft, 0.3% of mesh inlay and 3.6% of mesh kit. Severe dyspareunia occurred in 4.8% of native tissue, 4.2% of biological xenograft, 3.4% of mesh inlay repairs and 13.0% of mesh kits. De novo severe dyspareunia occurred in 3.5% of native tissue, 3.5% of biological xenograft, 1.4% of mesh inlays and 4.8% of mesh kits. Complications requiring re‐admission to hospital, unrelated to mesh, affected 1 in 24 women; the most common reasons for re‐admission were vaginal adhesions, urinary retention, infection and constipation.ConclusionsThis is the first study to address the complications of vaginal mesh used for prolapse surgery alongside data from both native tissue and biological xenograft. It demonstrates the complexity of assessing pain and that all types of prolapse surgery have low surgical morbidity and a low rate of severe complications.Tweetable abstractA prospective study of 2362 women undergoing vaginal mesh, xenograft or native tissue repair found low surgical morbidity and low rates of severe complications.

Development and Validation of Patient-Reported Outcome Measures (PROM) and Patient-Reported Experience Measures (PREM) in Home Respiratory Therapies: Oxygen Therapy, CPAP Treatment, Mechanical Ventilation, and Aerosol Therapy

IntroductionHome respiratory therapies (HRT) are treatments aimed at diseases that are generally chronic and that have a significant impact on the biopsychosocial aspects of patients’ lives. No validated patient-reported outcome measures (PROM) and patient-reported experience measures (PREM) are available to assess the impact of these treatments on quality of life (QoL) in HRT. The objective of this work was to identify and validate PROMs and PREMs in HRT. MethodsThe process was divided into 5 stages: review of the literature, patient interviews, qualitative validation workshops, cognitive validation, and psychometric validation. For the identification of PROM and PREM, consensus techniques were used with patients, caregivers, specialist doctors, and therapists. The evaluation was based on items that were collected from questionnaires on diseases commonly treated with HRT techniques in clinical practice. The psychometric validation was analyzed by a team of psychologists trained in the methodology. ResultsFor the literature review, 20 articles met the inclusion and exclusion criteria. After patient interviews, the research team selected 40 PROM items for each treatment from the total of 51 PROM questionnaires found for respiratory diseases. For the validation workshops, the list of selected items had to be reduced to a final number of 15. After the workshops, 8 preliminary questionnaires were drawn up (4 PROMs and 4 PREMs). A second validation round was then held and the questionnaires were modified with the list of PREMs and PROMs resulting from the whole process. The psychometric validation of PROM and PREM questionnaires for each of the therapies consisted of an exploratory factor analysis (EFA) and a confirmatory factor analysis (CFA). Overall, 1299 questionnaires answered by 650 patients were obtained. ConclusionsA preliminary set of PREMs and PROMs associated with HRT with good reliability indexes was developed: Cronbach's alpha and Composite Reliability Index (CRI). These are questionnaires with a 5-point Likert scale that the patient can quickly complete and which provide excellent scores for acceptability, reliability, and validity in psychometric tests. This may offer HRT units a robust basis for better monitoring of patient outcomes and needs and improve healthcare quality and clinical outcomes.

Donor quality of life after living donor liver transplantation: a review of the literature.

Living donor liver transplantation (LDLT) provides a source for transplant in the setting of the deceased donor organ shortage. Seeing as living donors do not derive any medical benefit from the procedure, fully understanding the impact of donation on donor health-related quality of life (HRQOL) is essential. A systematic search of the MEDLINE database was performed from 2008–2020, using relevant Medical Subject Headings. Articles were evaluated for study design, cohort size and follow-up time and excluded if they contained significant methodological flaws. A total of 43 articles were included: 20 (47%) were cross-sectional and 23 (53%) were longitudinal. The mean number of donors per study was 142 (range:8–578) with follow-up ranging from 12–132 months. Forty-two unique HRQOL metrics were implemented across the 43 studies, the majority of which were questionnaires. Of the 31 studies that used the Medical Outcomes Study Short Form 36 questionnaire, 9.1% of donors reported physical QOL did not return to pre-LDLT levels for at least 2 years after donation. Mental QOL remained stable or improved after LDLT, with mean mental composite scores increasing from 50 to 52 at 3 months post-LDLT in one study. The predicted probability of poor sexual desire decreased at 1-year post-LDLT (male: 0.08, female: 0.26) relative to pre-LDLT (male: 0.44, female: 0.76; P<0.001) and three months post-LDLT (male: 0.35, female 0.69; P=0.001). Forty percent of donors found LDLT to be financially burdensome at 3 months and 19% at 2 years post-LDLT. Female gender and obesity were consistent predictors of worse HRQOL. Laparoscopy-assisted donor hepatectomy was associated with shorter hospitalizations than open donor hepatectomy (10.3 vs. 18.3 days, P=0.02). No studies used the National Institutes of Health Patient Reported Outcomes Measurement Information System (PROMIS) measures of HRQOL. Our review demonstrates that LDLT can have a long-lasting negative impact on physical QOL in 9.1% of donors and can cause both sexual dysfunction and significant financial strain. Future studies should consider using standardized and extensively validated patient reported outcomes measures, such as PROMIS, in order to directly compare outcomes across studies and gain further insight into the impact of LDLT on D-HRQOL.

Measuring walking impairment in patients with intermittent claudication: psychometric properties of the Walking Estimated-Limitation Calculated by History (WELCH) questionnaire.

ObjectivesPatient-reported outcome measures can facilitate the assessment of walking impairment in peripheral artery disease patients with intermittent claudication in clinical trials and practice. The aim of this study was to test the psychometric properties of the German version of the ‘Walking Estimated-Limitation Calculated by History’ (WELCH) questionnaire.MethodsThe assessed properties included feasibility, test-retest reliability, construct validity (i.e., convergent, divergent and known-groups validity) and responsiveness using classic psychometric methods. Psychometric properties were tested as part of a randomized controlled home-based exercise trial for patients with symptomatic peripheral artery disease at Fontaine stage IIA/B.ResultsAnalyses were conducted in subgroups of 1,696 patients at baseline and 1,233 patients at 12-month follow-up (i.e., post-intervention) who completed the WELCH along with a battery of other self-report measures. The WELCH did not exhibit relevant floor or ceiling effects (< 15% achieved lowest or highest possible scores), showed evidence for good test-retest reliability (ICC = .81, 95% CI [.71–.88]) and was found to be well suited for self-completion by patients (< 5% missing data per item). WELCH scores showed moderate to strong correlations with related measures of walking impairment at both time points (Walking Impairment Questionnaire: r = .56 − .74; VascuQoL-25 activity subscale: r = .61 − .66) and distinguished well among patients with poor and high quality of life when adjusting for confounders (t = 13.67, p < .001, d = .96). Adequate divergent validity was indicated by a weaker correlation between the WELCH and general anxiety at both time points (GAD-7: r = − .14 to − .22). The WELCH improved by 6.61 points (SD = 17.04, 95% CI [5.13–8.10], d = 0.39) in response to exercise treatment and was able to identify large clinically important improvements observed on the walking distance (AUC = .78, 95% CI [.71–.84]) and speed subscales (AUC = .77, 95% CI [.68–.86]) of the Walking Impairment Questionnaire.ConclusionsThe WELCH is considered a feasible, reliable and valid patient-reported outcome measure for the measurement of walking impairment in patients with peripheral artery disease. The WELCH showed evidence for responsiveness to changes in walking impairment, yet further studies are warranted to conclusively determine the WELCH’s ability to detect intervention effects.

Minimal Clinically Important Difference and Patient Acceptable Symptom State for the Pittsburgh Sleep Quality Index in Patients Who Underwent Rotator Cuff Tear Repair.

The Pittsburgh Sleep Quality Index (PSQI) is a valid patient-reported outcome measure developed to assess sleep quality and disturbances in clinical populations. This study aimed to calculate the minimum clinically important difference (MCID) and the patient acceptable symptom state (PASS) for the PSQI in patients who underwent rotator cuff repair (RCR). Preoperative and six-month postoperative follow-up questionnaires were completed by 50 patients (25 males and 25 females, mean age 58.7 ± 11.1 years). The MCID of the PSQI was calculated using distribution-based and anchor methods. To calculate the PSQI’s PASS, the 75th percentile approach and the receiver operating characteristic (ROC) curve were used. The MCID from preoperative to 6 months postoperative follow-up is 4.4. Patients who improved their PSQI score of 4.4 from baseline to 6 months follow-up had a clinically significant increase in their health status. The PASS is 5.5 for PSQI; therefore, a value of PSQI at least 5.5 at six months follow-up indicates that the symptom state can be considered acceptable by most patients.

Design and rationale of the ATtune Knee Outcome Study (ATKOS): multicenter prospective evaluation of a novel uncemented rotating platform knee system

BackgroundTotal Knee Arthroplasty (TKA) remains the gold standard for treatment of debilitating symptoms of knee osteoarthritis (OA). Even though providing satisfactory results for the majority of patients, some studies report dissatisfaction after TKA to be as high as 20%. Among other things, pain catastrophising and self-efficacy are thought to compromise results of TKA. Implant manufacturers keep improving upon their designs in an attempt to improve functional outcomes. One of these novel knee systems is the Attune. To our knowledge, there are no clinical follow-up studies reporting results of the uncemented version. The main objective of this multicentre prospective observational study is to evaluate revision rate, complications, radiographic outcomes (i.e. alignment and radiolucent lines) and patient reported outcomes of the uncemented Attune mobile bearing TKA. Secondary objectives are (1) to assess physical function, return to sport and return to work after TKA and (2) to evaluate the long-term effect of preoperative psychological factors on satisfaction after TKA.MethodsAll patients presenting in the participating centres with knee pathology warranting joint replacement therapy will be considered for inclusion, an absolute indication for cemented fixation is the only exclusion criterium. Evaluation of clinical and radiographic performance (e.g. radiolucent lines) is done at 6 weeks, 6 months, 1 year, 5 years and 10 years after surgery using validated patient reported outcome measures. Cumulative revision rates are calculated after 5 and 10 years using Kaplan–Meier methods. Physical function is assessed with performance based measurements before and 1 year after surgery. Return to sports is assessed using the Tegner and University of California Los Angeles (UCLA) activity rating scale before and 1 year after surgery. Return to work is evaluated by inviting patients of working age to complete a short questionnaire 1 year after surgery. Psychologic factors are assessed using questionnaires for pain catastrophising, pain self-efficacy and mental health before, 5 years and 10 years after surgery. Preoperative psychologic scores are correlated to functional outcomes.DiscussionThe current study aims to report the clinical performance of a novel implant and can help provide insight in factors that play a role in satisfaction after TKA.Trial registrationClinicalTrials.gov identifier: NCT04247672 (January 30, 2020)

A Greek Validation Study of the Multiple Sclerosis Work Difficulties Questionnaire-23.

The Multiple Sclerosis Work Difficulties Questionnaire-23 (MSWDQ-23) is a self-report instrument developed to assess barriers faced by People with Multiple Sclerosis (PwMS) in the workplace. The aim of this study was to explore the psychometric properties of the Greek version of the MSWDQ-23. The study sample consisted of 196 PwMS, all currently working in part- or full-time jobs. Participants underwent clinical examination and cognitive screening with the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) and completed self-report measures of fatigue, psychological functioning, and quality of life, along with the MSWDQ-23 questionnaire. Confirmatory Factor Analysis (CFA) was performed, and goodness-of-fit measures were used to evaluate construct validity. Convergent validity was checked by correlating MSWDQ-23 scores with study measures. Cronbach’s alpha value was produced to assess internal consistency. CFA yielded a model with a fair fit confirming the three-factor structure of the instrument. Higher work difficulties were associated with higher Expanded Disability Status Scale (EDSS) scores, poorer cognitive function, more fatigue, stress, anxiety, and depression, and poorer health status, supporting the convergent validity of MSWDQ-23. Internal consistency (Cronbach’s alpha = 0.94) and test–retest reliability (ICC = 0.996, 95%, CI = 0.990–0.998) were excellent. The Greek MSWDQ-23 can be considered a valid patient-reported outcome measure and can be used in interventions aiming to improve the vocational status of PwMS.