scholarly journals Validation of a German translation of the CARE questionnaire and its implementation as electronic PROM to assess patient-reported postoperative convalescence and recovery after major urological surgery

Author(s):  
Frederik Wessels ◽  
Maximilian Lenhart ◽  
Manuel Neuberger ◽  
Julia Mühlbauer ◽  
Johannes Huber ◽  
...  

Abstract Purpose To validate a German translation of the convalescence and recovery evaluation (CARE) as an electronic patient-reported outcome measure (ePROM) and use it to assess recovery after major urological surgery. Methods The CARE questionnaire was provided to patients scheduled for major urological surgery preoperatively, at discharge and 6 weeks postoperatively, using an ePROM system. Cronbach’s alpha, inter-scale correlations and confirmatory factor analysis (CFA) were used to validate the translation. Mixed linear regression models were used to identify factors influencing CARE results, and a multivariable logistic regression analysis was done to determine the predictive value of CARE results on quality of life (QoL). Results A total of 283 patients undergoing prostatectomy (n = 146, 51%), partial/radical nephrectomy (n = 70, 25%) or cystectomy (n = 67, 24%) responded to the survey. Internal consistency was high (α = 0.649–0.920) and the CFA showed a factor loading > 0.5 in 17/27 items. Significant main effects were found for the time of survey and type of surgery, while a time by type interaction was only found for the gastrointestinal subscale ($$\chi_{(4)}^{2}$$ χ ( 4 ) 2  = 30.37, p < 0.0001) and the total CARE score (TCS) ($$\chi_{(4)}^{2}$$ χ ( 4 ) 2  = 13.47, p = 0.009) for cystectomy patients, meaning a greater score decrease at discharge and lower level of recovery at follow-up. Complications demonstrated a significant negative effect on the TCS ($$\chi_{(2)}^{2}$$ χ ( 2 ) 2  = 8.61, p = 0.014). A high TCS at discharge was an independent predictor of a high QLQ-C30 QoL score at follow-up (OR = 5.26, 95%-CI 1.42–19.37, p = 0.013). Conclusion This German translation of the CARE can serve as a valid ePROM to measure recovery and predict QoL after major urological surgery.

Hand ◽  
2020 ◽  
pp. 155894472092848
Author(s):  
Joseph A. Gil ◽  
Justin Kleiner ◽  
Thomas J. McQuillan ◽  
Deborah Kenney ◽  
Amy L. Ladd ◽  
...  

Background There is a paucity of literature that examines how patient-reported outcomes correspond to early radiographic progression of thumb carpometacarpal (CMC) osteoarthritis (OA). This study examines how Australian/Canadian Osteoarthritis Hand Index (AUSCAN) and Patient-Rated Hand and Wrist Evaluation (PRWHE) scores change over 36 months in subjects with early CMC OA. Methods Ninety-one subjects with symptomatic early thumb CMC OA were enrolled. Differences in AUSCAN and PRWHE scores were measured between subjects at baseline and at 18-month follow-up, and between the subjects at baseline and at 36-month follow-up. Radiographic progression was defined as an increase in modified Eaton Stage. Differences in AUSCAN and PRWHE scores were compared between these 2 groups in order to determine if radiographic progression was associated with a greater change in AUSCAN and PRWHE at 18- and 36-month follow-up. Results At 18- and 36-month follow-up visits, there were no significant differences in AUSCAN or PRWHE compared to baseline. Multivariable logistic regression analysis did not reveal any significant differences between subjects with radiographic progression to subjects without radiographic progression at 18-month follow-up. At 36-month follow-up, this analysis did demonstrate that subjects with evidence of radiographic progression had a significant increase in the PRWHE pain subscale. Conclusion AUSCAN and PRWHE scores were not found to significantly progress at 18-month and 36-month follow-up. However, when comparing the subset of subjects with and without radiographic OA, subjects with early CMC OA who had 1 stage of radiographic progression were found to have a significantly higher intensity of pain on the PRWHE pain subscale at 36-month follow-up.


Author(s):  
Cristina Dauder Gallego ◽  
Irene Blanca Moreno Fenoll ◽  
José Luis Patiño Contreras ◽  
Francisco Javier Moreno Coronas ◽  
María del Carmen Torrejón de la Cal ◽  
...  

2020 ◽  
Vol 8 (12) ◽  
pp. 232596712096518
Author(s):  
Karen Brage ◽  
Birgit Juul-Kristensen ◽  
John Hjarbaek ◽  
Eleanor Boyle ◽  
Per Kjaer ◽  
...  

Background: Shoulder pain is common, with a lifetime prevalence of up to 67%. Evidence is conflicting in relation to imaging findings and pain in the shoulder. Sonoelastography can be used to estimate tissue stiffness and may be a clinically relevant technique for diagnosing and monitoring tendon healing. Purpose: To evaluate changes in supraspinatus tendon stiffness using strain elastography (SEL) and associations with changes in patient-reported outcomes, supraspinatus tendon thickness, and grade of tendinopathy after 12 weeks of unilateral shoulder exercises in patients with supraspinatus tendinopathy. Study Design: Controlled laboratory study. Methods: A total of 23 patients with unilateral clinical supraspinatus tendinopathy performed 12 weeks of “standard care” exercises. At baseline and follow-up, supraspinatus tendon stiffness was measured bilaterally using SEL and compared with tendinopathy grading on magnetic resonance imaging scans and tendon thickness measured using conventional ultrasound. Patient-reported outcome measures included physical function and symptoms from the Disabilities of the Arm, Shoulder and Hand questionnaire and pain rating (visual analog scale). Results: No significant changes in SEL within or between groups (asymptomatic vs symptomatic tendon) were seen. All patient-reported outcomes showed significant improvement from baseline to follow-up, but with no change in tendinopathy grading and tendon thickness. No significant differences in the proportion of patients changing above the minimal detectable change in SEL and PROM were seen, except for discomfort while sleeping. Conclusion: Despite no significant within-group or between-group changes in SEL, significant improvements were found in patient-reported outcomes. An acceptable agreement between patients changing above the minimal detectable change in SEL and patient-reported outcome measure was seen. Further studies should explore the use of SEL to detect changes after tendon repair and long-term training potentially in subgroups of different tendinopathy phases. Clinical Relevance: In the short term, structural changes in supraspinatus tendons could not be visualized using SEL, indicating that a longer time span should be expected in order to observe structural changes, which should be considered before return to sports. Subgrouping based on stage of tendinopathy may also be important in order to evaluate changes over time with SEL among patients with supraspinatus tendinopathy. Registration: NCT03425357 ( ClinicalTrials.gov identifier).


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
A Salzwedel ◽  
I Koran ◽  
E Langheim ◽  
A Schlitt ◽  
J Nothroff ◽  
...  

Abstract Introduction Comprehensive cardiac rehabilitation (CR) programs based on the bio-psycho-social approach of the international classification of functioning and disease are carried out to achieve improved prognosis, superior health-related quality of life (HRQL) and social integration. We aimed to identify predictors of returning to work (RTW) and HRQL among cardiovascular risk factors and physical performance as well as patient-reported outcome measures (PROMs) modifiable during CR. Methods We designed a prospective observational multi-center study and enrolled 1,586 patients (2017/18) in 12 German rehabilitation centers regardless of their primary allocation diagnoses (e.g. acute myocardial infarction (AMI), coronary artery bypass grafting (CABG), coronary artery disease (CAD), valvular disease). Besides general data (e.g. age, gender, diagnoses), parameters of risk factor management (e.g. smoking, lipid profile, hypertension, lifestyle change motivation), physical performance (e.g. maximum exercise capacity, endurance training load, 6-min walking distance), and PROMs (e.g. depression, heart-focused anxiety, HRQL, subjective well-being, somatic and mental health, pain, general self-efficacy, pension desire as well as self-assessment of occupational prognosis using several questionnaires) were documented at CR admission and discharge. 6 months after discharge, status of RTW and HRQL (SF-12) were captured by a follow-up (FU) survey and analyzed in multivariable regression models with multiple imputation of missing values. Results Out of the study participants, 1,262 patients (54±7 years, 77% men) responded to the follow-up survey and could be analyzed regarding the outcome parameters. Most of them were assigned to CR primarily due to AMI (40%) or CAD without myocardial infarction (18%), followed by heart valve diseases in 12% of patients and CABG (8%). 864 patients (69%) returned to work within the follow-up period. Pension desire, negative self-assessed occupational prognosis, heart-focussed anxiety, major life events, smoking and heart failure were negatively associated with RTW, while higher endurance training load, HRQL and work stress were positively associated (Figure 1). HRQL after 6 months was determined more by PROMs (e.g. pension desire, heart-focused anxiety, physical/mental HRQL in SF-12, physical/mental health in indicators of rehab-status questionnaire (IRES-24), stress, well-being in the World Health Organization well-being index and self-efficacy expectations) than by clinical parameters or physical performance. Conclusions Patient-reported outcome measures predominantly influenced RTW and HRQL in heart-disease patients, whereas patients' pension desire and heart-focussed anxiety had a dominant impact on all investigated endpoints. Therefore, the multi-component CR approach focussing on psychosocial support is crucial for subjective health prognosis and occupational resumption. Figure 1. Predictors of returning to work Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): German pension insurance


2021 ◽  
pp. bmjsrh-2020-200954
Author(s):  
Chelsey Porter Erlank ◽  
Jonathan Lord ◽  
Kathryn Church

IntroductionThe English government approved both stages of early medical abortion (EMA), using mifepristone and misoprostol under 10 weeks’ gestation, for at-home use on 30 March 2020. MSI Reproductive Choices UK (MSUK), one of the largest providers of abortion services in England, launched a no-test telemedicine EMA pathway on 6 April 2020. The objectives of this study were to report key patient-reported outcome measures and to assess whether our sample was representative of the whole population receiving no-test telemedicine EMA.MethodsA sample of all MSUK’s telemedicine EMA patients between April and August 2020 were invited to opt in to a follow-up call to answer clinical and satisfaction questions. A total of 1243 (13.7% of all telemedicine EMAs) were successfully followed-up, on average within 5 days post-procedure.ResultsPatients reported high confidence in telemedicine EMA and high satisfaction with the convenience, privacy and ease of managing their abortion at home. The sample responding were broadly equivalent to the whole population receiving telemedicine. No patient reported that they were unable to consult privately. The majority (1035, 83%) of patients reported preferring the telemedicine pathway, with 824 (66%) indicating that they would choose telemedicine again if COVID-19 were no longer an issue.ConclusionsTelemedicine EMA is a valued, private, convenient and more accessible option that is highly acceptable for patients seeking an abortion, especially those for whom in-clinic visits are logistically or emotionally challenging. Evidence that this pathway would be a first choice again in future for most patients supports the case to make telemedicine EMA permanent.


2021 ◽  
Vol 9 (1) ◽  
pp. 232596712096792
Author(s):  
James L. Cook ◽  
Kylee Rucinski ◽  
Cory R. Crecelius ◽  
Richard Ma ◽  
James P. Stannard

Background: Return to sport (RTS) after osteochondral allograft (OCA) transplantation for large unipolar femoral condyle defects has been consistent, but many athletes are affected by more severe lesions. Purpose: To examine outcomes for athletes who have undergone large single-surface, multisurface, or bipolar shell OCA transplantation in the knee. Study Design: Case series; Level of evidence, 4. Methods: Data from a prospective OCA transplantation registry were assessed for athletes who underwent knee transplantation for the first time (primary transplant) between June 2015 and March 2018 for injury or overuse-related articular defects. Inclusion criteria were preinjury Tegner level ≥5 and documented type and level of sport (or elite unit active military duty); in addition, patients were required to have a minimum of 1-year follow-up outcomes, including RTS data. Patient characteristics, surgery type, Tegner level, RTS, patient-reported outcome measures (PROMs), compliance with rehabilitation, revisions, and failures were assessed and compared for statistically significant differences. Results: There were 37 included athletes (mean age, 34 years; range, 15-69 years; mean body mass index, 26.2 kg/m2; range, 18-35 kg/m2) who underwent large single-surface (n = 17), multisurface (n = 4), or bipolar (n = 16) OCA transplantation. The highest preinjury median Tegner level was 9 (mean, 7.9 ± 1.7; range, 5-10). At the final follow-up, 25 patients (68%) had returned to sport; 17 (68%) returned to the same or higher level of sport compared with the highest preinjury level. The median time to RTS was 16 months (range, 7-26 months). Elite unit military, competitive collegiate, and competitive high school athletes returned at a significantly higher proportion ( P < .046) than did recreational athletes. For all patients, the Tegner level at the final follow-up (median, 6; mean, 6.1 ± 2.7; range, 1-10) was significantly lower than that at the highest preinjury level ( P = .007). PROMs were significantly improved at the final follow-up compared with preoperative levels and reached or exceeded clinically meaningful differences. OCA revisions were performed in 2 patients (5%), and failures requiring total knee arthroplasty occurred in 2 patients (5%), all of whom were recreational athletes. Noncompliance was documented in 4 athletes (11%) and was 15.5 times more likely ( P = .049) to be associated with failure or a need for revision than for compliant patients. Conclusion: Large single-surface, multisurface, or bipolar shell OCA knee transplantations in athletes resulted in two-thirds of these patients returning to sport at 16 to 24 months after transplantation. Combined, the revision and failure rates were 10%; thus, 90% of patients were considered to have successful 2- to 4-year outcomes with significant improvements in pain and function, even when patients did not RTS.


2017 ◽  
Vol 33 (6) ◽  
pp. 425-429 ◽  
Author(s):  
Yung-Wei Chi ◽  
Blythe Durbin-Johnson ◽  
Marlin Schul

Objective The goal of this American College of Phlebology Patient Reported Outcome Venous Registry analysis was to examine the clinical efficacy of compression stockings using short-form 6D questionnaire (SF-6D). Method SF-6D scores were modeled over time using linear mixed effects model. Changes of SF-6D score from baseline to the last encounter were examined using a paired t-test. Analysis of variance was used to compare changes from baseline in SF-6D scores between C classifications. All analyses were conducted using SAS software, version 9.4 (SAS Institute, Cary NC). Results Baseline mean SF-6D score was 0.83 and at follow-up, 0.85. Mean SF-6D change was +0.02 points (P = .001) over an average time period of 5.5 months. Patients’ SF-6D scores were estimated to increase by +0.03 points (P = .005) per year of usage of compression stockings. SF-6D score changes across C classifications did not demonstrate significant differences (P = .265). Conclusion There was an improvement of SF-6D score in the registry participants who used circular knit compression stockings.


2018 ◽  
Vol 6 (7_suppl4) ◽  
pp. 2325967118S0012
Author(s):  
Scott Thomas Watson ◽  
Amy Trammell ◽  
Stephanie Tanner ◽  
Rebecca Snider ◽  
Steven Martin ◽  
...  

Objectives: There is a general consensus that Jones fractures should be treated operatively with an intramedullary screw in high-level athletes. However, there is disagreement among team physicians, without conclusive evidence as to when the athlete should be allowed to return to play. The objective of this study is to report our experience of early return to sport in collegiate athletes after intramedullary screw fixation of Jones Fractures. Methods: All skeletally mature collegiate athletes with a true Jones fracture of the base of the fifth metatarsal that was treated by one of two orthopaedic surgeons with operative intramedullary screw fixation over a 23 year period (1994-2016) were identified and records reviewed retrospectively. All return to play and complication data was obtained from the athletic trainer database at the two universities. Fixation consisted of a single intramedullary screw (10 partially threaded cannulated screws, 13 cannulated variable pitch screws, 3 solid screws). The athletes were allowed to weight bear as tolerated in a CAM boot immediately postoperatively, and return to play with a carbon fiber insert as soon as they could tolerate activity. In 2016, patients were contacted to complete patient reported outcome scores that included the Foot and Ankle Ability Measure (FAAM) score and a brief survey specific to our study, as well as follow-up radiographs if possible. Results: 26 Jones Fractures were treated in 25 collegiate athletes. The average age was 20 years (18-23). Overall, athletes returned to play or training at an average of 3.5 weeks (1.5-6). All in-season athletes returned to play within 4.5 weeks (1.5-4.5). Off-season athletes returned to play within 4-6 weeks. There were no cases of nonunion (clinically or radiographically). Three screws were removed due to symptomatic skin irritation. There was one re-fracture following screw removal after documented radiographic and clinical fracture union. This patient was treated with repeat cannulated percutaneous screw fixation. The athlete returned to play in 2 weeks. One screw was noted to be broken on an ankle radiograph 1 year post-op, but the fracture was healed and the athlete was playing division 1 sports without symptoms, and continued professionally without symptoms. 18/25 athletes completed patient reported outcome scores at an average of 7.95 years (range 1.2-17) follow-up. The average estimated percent of normal for activities of daily living was 93.8% (70-100%, and for athletic participation was 90.3% (40-100%). Follow up radiographs were obtained on 13/26 fractures at an average of 6.48 years (range 1.2-16) with no nonunion, malunion, or additional hardware complications identified. Conclusion: Athletes with Jones fractures can safely be allowed to return to play after intramedullary screw fixation as soon as their symptoms allow without significant complications. In our experience, this is usually within 4 weeks from injury.


BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e038223
Author(s):  
Lili Tang ◽  
Ying Pang ◽  
Yi He ◽  
Qiuling Shi ◽  
Xinkun Han ◽  
...  

IntroductionAn electronic Patient-Reported Outcome (ePRO) platform is needed for implementing evidence-based symptom management in outpatients with advanced cancer. We describe the overall protocol and the methodology for measuring symptom burden, to provide critical parameters needed to implement symptom management on the ePRO platform.Methods and analysisThe study focusses on patients with advanced lung cancer, stomach cancer, oesophagus cancer, liver cancer, colorectal cancer or breast cancer. The primary outcome is the change of symptom burden. MD Anderson Symptom Inventory, and other PRO instruments (Insomnia Severity Index, Hospital Anxiety and Depression Scale, 9-item Patient Health Questionnaire and EuroQol-5 dimensions-5 levels version) were used. The secondary outcomes include feasibility of using ePRO, symptom-related quality of life, reasons for no improvement of symptoms, defining frequency of PRO assessments and cut-points, items for screening and management of comorbidity and satisfaction with ePRO platform in patients and health providers. After initial outpatient visit for baseline assessment, ePRO system will automatically send follow-up notification seven times over 4 weeks to patients. The characteristics and changing trajectory of symptoms of patients will be described. Parameters for using PROs, such as optimal time points for follow-up and cut-off point for alert will be determined. The feasibility of ePRO platform to track the changes of target symptoms in outpatients will be evaluated.Ethics and disseminationThe study protocol and related documents were approved by the Institutional Research Board (IRB) of Peking University Cancer Hospital on 13 February 2019 (2019YJZ07). The results of this study will be disseminated through academic workshops, peer-reviewed publications and conferences.Trial registration numberChiCTR1900023560.


Author(s):  
Gareth S. Turnbull ◽  
Claire Marshall ◽  
Jamie A. Nicholson ◽  
Deborah J. MacDonald ◽  
Nicholas D. Clement ◽  
...  

Abstract Introduction The Olympia femoral stem is a stainless steel, anatomically shaped, polished and three-dimensionally tapered implant designed for use in cemented total hip arthroplasty (THA). The primary aim of this study was to determine the long-term survivorship, radiographic outcome, and patient-reported outcome measures (PROMs) of the Olympia stem. Patients and methods Between May 2003 and December 2005, 239 patients (264 THAs) underwent a THA with an Olympia stem in our institution. Patient-reported outcome measures were assessed using the Oxford Hip Score (OHS), EuroQol-5 dimensions (EQ-5D) score, and patient satisfaction at mean 10 years following THA. Patient records and radiographs were then reviewed at a mean of 16.5 years (SD 0.7, 15.3–17.8) following THA to identify occurrence of complications or revision surgery for any cause following surgery. Radiographs were assessed for lucent lines and lysis according to Gruen’s zones Results Mean patient age at surgery was 68.0 years (SD 10.9, 31–93 years). There were 156 women (65%, 176 THAs). Osteoarthritis was the indication for THA in 204 patients (85%). All cause stem survivorship at 10 years was 99.2% (95% confidence interval [CI], 97.9%–100%) and at 15 years was 97.5% (94.6%–100%). The 15-year stem survival for aseptic loosening was 100%. Analysis of all-cause THA failure demonstrated a survivorship of 98.5% (96.3%–100%) at 10 years and 95.9% (92.4%–99.4%) at 15 years. There were 9 THAs with non-progressive lucent lines in a single Gruen zone and 3 had lines in two zones, and no patient demonstrated signs for lysis. At a mean of 10-year (SD 0.8, 8.7–11.3) follow-up, mean OHS was 39 (SD 10.3, range 7–48) and 94% of patients reported being very satisfied or satisfied with their THA. Conclusions The Olympia stem demonstrated excellent 10-year PROMs and very high rates of stem survivorship at final follow-up beyond 15 years.


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