Six-month and 12-month patient outcomes based on inflammatory subphenotypes in sepsis-associated ARDS: secondary analysis of SAILS-ALTOS trial

Thorax ◽  
2021 ◽  
pp. thoraxjnl-2020-216613
Author(s):  
Mohamed D Hashem ◽  
Ramona O Hopkins ◽  
Elizabeth Colantuoni ◽  
Victor D Dinglas ◽  
Pratik Sinha ◽  
...  
Keyword(s):  
Mental Health ◽  
Patient Reported Outcomes ◽  
Secondary Analysis ◽  
Cognitive Outcomes ◽  
Short Term ◽  
Sf 36 ◽  
Significant Difference ◽  
Patient Reported ◽  
Sepsis Trial

BackgroundPrior acute respiratory distress syndrome (ARDS) trials have identified hypoinflammatory and hyperinflammatory subphenotypes, with distinct differences in short-term outcomes. It is unknown if such differences extend beyond 90 days or are associated with physical, mental health or cognitive outcomes.Methods568 patients in the multicentre Statins for Acutely Injured Lungs from Sepsis trial of rosuvastatin versus placebo were included and assigned a subphenotype. Among 6-month and 12-month survivors (N=232 and 219, respectively, representing 243 unique survivors), subphenotype status was evaluated for association with a range of patient-reported outcomes (eg, mental health symptoms, quality of life). Patient subsets also were evaluated with performance-based tests of physical function (eg, 6 min walk test) and cognition.FindingsThe hyperinflammatory versus hypoinflammatory subphenotype had lower overall 12-month cumulative survival (58% vs 72%, p<0.01); however, there was no significant difference in survival beyond 90 days (86% vs 89%, p=0.70). Most survivors had impairment across the range of outcomes, with little difference between subphenotypes at 6-month and 12-month assessments. For instance, at 6 months, in comparing the hypoinflammatory versus hyperinflammatory subphenotypes, respectively, the median (IQR) patient-reported SF-36 mental health domain score was 47 (33–56) vs 44 (35–56) (p=0.99), and the per cent predicted 6 min walk distance was 66% (48%, 80%) vs 66% (49%, 79%) (p=0.76).InterpretationComparing the hyperinflammatory versus hypoinflammatory ARDS subphenotype, there was no significant difference in survival beyond 90 days and no consistent findings of important differences in 6-month or 12-month physical, cognitive and mental health outcomes. These findings, when considered with prior results, suggest that inflammatory subphenotypes largely reflect the acute phase of illness and its short-term impact.

Understanding quality of life and treatment history of patients with Bertolotti syndrome compared with lumbosacral radiculopathy

2019 ◽  
Vol 31 (2) ◽  
pp. 222-228 ◽  
Author(s):  
Joshua L. Golubovsky ◽  
Arbaz Momin ◽  
Nicolas R. Thompson ◽  
Michael P. Steinmetz
Keyword(s):  
Quality Of Life ◽  
Mental Health ◽  
Propensity Score ◽  
Disc Herniation ◽  
Symptom Onset ◽  
Patient Reported Outcomes ◽  
Lumbosacral Radiculopathy ◽  
Patient Reported ◽  
Age And Sex

OBJECTIVEBertolotti syndrome is a rare spinal condition that causes low-back pain due to a lumbosacral transitional vertebra (LSTV), which is a pseudoarticulation between the fifth lumbar transverse process and the sacral ala. Bertolotti syndrome patients are rarely studied, particularly with regard to their quality of life. This study aimed to examine the quality of life and prior treatments in patients with Bertolotti syndrome at first presentation to the authors’ center in comparison with those with lumbosacral radiculopathy.METHODSThis study was a retrospective cohort analysis of patients with Bertolotti syndrome and lumbosacral radiculopathy due to disc herniation seen at the authors’ institution’s spine center from 2005 through 2018. Diagnoses were confirmed with provider notes and imaging. Variables collected included demographics, diagnostic history, prior treatment, patient-reported quality of life metrics, and whether or not they underwent surgery at the authors’ institution. Propensity score matching by age and sex was used to match lumbosacral radiculopathy patients to Bertolotti syndrome patients. Group comparisons were made using t-tests, Fisher’s exact test, Mann-Whitney U-tests, Cox proportional hazards models, and linear regression models where variables found to be different at the univariate level were included as covariates.RESULTSThe final cohort included 22 patients with Bertolotti syndrome who had patient-reported outcomes data available and 46 propensity score–matched patients who had confirmed radiculopathy due to disc herniation. The authors found that Bertolotti syndrome patients had significantly more prior epidural steroid injections (ESIs) and a longer time from symptom onset to their first visit. Univariate analysis showed that Bertolotti syndrome patients had significantly worse Patient-Reported Outcomes Measurement Information System (PROMIS) mental health T-scores. Adjustment for prior ESIs and time from symptom onset revealed that Bertolotti syndrome patients also had significantly worse PROMIS physical health T-scores. Time to surgery and other quality of life metrics did not differ between groups.CONCLUSIONSPatients with Bertolotti syndrome undergo significantly longer workup and more ESIs and have worse physical and mental health scores than age- and sex-matched patients with lumbosacral radiculopathy. However, both groups of patients had mild depression and clinically meaningful reduction in their quality of life according to all instruments. This study shows that Bertolotti syndrome patients have a condition that affects them potentially more significantly than those with lumbosacral radiculopathy, and increased attention should be paid to these patients to improve their workup, diagnosis, and treatment.

scholarly journals POS0919 BIMEKIZUMAB SHOWS SUSTAINED LONG-TERM IMPROVEMENTS IN PATIENT-REPORTED OUTCOMES AND QUALITY OF LIFE IN ANKYLOSING SPONDYLITIS: 3-YEAR RESULTS FROM A PHASE 2B STUDY

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 720.2-721
Author(s):  
X. Baraliakos ◽  
M. Dougados ◽  
K. Gaffney ◽  
R. Sengupta ◽  
M. Magrey ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Ankylosing Spondylitis ◽  
Patient Reported Outcomes ◽  
Morning Stiffness ◽  
Spinal Pain ◽  
Research Support ◽  
Sf 36 ◽  
Patient Reported ◽  
Full Analysis

Background:Bimekizumab (BKZ), a monoclonal antibody that selectively inhibits interleukin (IL)-17A and IL-17F, has demonstrated clinical efficacy and safety in patients with ankylosing spondylitis (AS) treated over a period up to 96 weeks.1,2Objectives:To report 3-year interim patient-reported outcomes (PROs) in patients with active AS treated with BKZ in a phase 2b dose-ranging study (BE AGILE; NCT02963506) and its open-label extension (OLE; NCT03355573).Methods:BE AGILE study design has been described previously.1 Patients treated with BKZ 160 mg or 320 mg every 4 weeks (Q4W) at Week 48 in BE AGILE were eligible for OLE entry. All OLE patients received BKZ 160 mg Q4W. Outcome measures are reported for the OLE full analysis set (patients who entered the OLE and had ≥1 dose of BKZ and ≥1 valid efficacy variable measurement in the OLE), and include: BASDAI, BASDAI50 responder rate, BASFI, fatigue (BASDAI Q1), morning stiffness (mean of BASDAI Q5 + 6), total spinal pain (numeric rating scale [NRS]), SF-36 PCS and MCS, and ASQoL. Missing data were imputed using multiple imputation (MI; based on the missing at random assumption) for continuous variables and non-responder imputation (NRI) for dichotomous variables.Results:262/303 (86%) patients randomised at BE AGILE study baseline (BL) completed Week 48 on BKZ 160 mg or 320 mg, of whom 255/262 (97%) entered the OLE (full analysis set: 254). From baseline to Week 48 in BE AGILE, BKZ-treated patients showed clinically relevant improvements in disease activity (BASDAI, BASDAI50), physical function (BASFI), fatigue, morning stiffness, spinal pain, and quality of life (SF-36 PCS and MCS, ASQoL) (Figure 1). Group-level improvements in all reported continuous efficacy measures exceeded published minimally important difference (MID), minimum clinically important improvement (MCII), and/or minimum clinically important difference (MCID) thresholds (Figure 1).3,4 Efficacy in all reported outcome measures was maintained or continued to improve from Week 48 to Week 144 or 156 (Figure 1).Conclusion:BKZ treatment was associated with sustained and consistent efficacy in patients with active AS over 3 years, including patient-reported disease activity, physical function, fatigue, morning stiffness, spinal pain, and quality of life.References:[1]van der Heijde D. Ann Rheum Dis 2020;79:595–604.[2]Baraliakos X. Arthritis Rheumatol 2020;72 (suppl 10).[3]Ogdie A. Arthritis Care Res 2020;72 (S10):47–71.[4]Maruish ME. User’s manual for the SF-36v2 Health Survey (3rd ed). 2011; Lincoln, RI: QualityMetric Incorporated.Acknowledgements:This study was funded by UCB Pharma. Editorial services were provided by Costello Medical.Disclosure of Interests:Xenofon Baraliakos Speakers bureau: AbbVie, BMS, Chugai, Eli Lilly, Galapagos, Gilead, MSD, Novartis, Pfizer, UCB Pharma, Paid instructor for: AbbVie, BMS, Chugai, Eli Lilly, Galapagos, Gilead, MSD, Novartis, Pfizer, UCB Pharma, Consultant of: AbbVie, BMS, Chugai, Eli Lilly, Galapagos, Gilead, MSD, Novartis, Pfizer, UCB Pharma, Maxime Dougados Consultant of: AbbVie, Eli Lilly, Novartis, Pfizer and UCB Pharma, Grant/research support from: AbbVie, Eli Lilly, Novartis, Pfizer and UCB Pharma, Karl Gaffney Speakers bureau: AbbVie, Eli Lilly, Novartis, UCB Pharma, Consultant of: AbbVie, Eli Lilly, Novartis, UCB Pharma, Grant/research support from: AbbVie, Gilead, Eli Lilly, Novartis, UCB Pharma, Raj Sengupta Speakers bureau: AbbVie, Biogen, Celgene, MSD, Novartis, UCB Pharma, Consultant of: AbbVie, Biogen, Celgene, Eli Lilly, MSD, Novartis, UCB Pharma, Grant/research support from: AbbVie, Celgene, UCB Pharma, Marina Magrey Consultant of: AbbVie, Eli Lilly, Novartis, Pfizer, UCB Pharma, Grant/research support from: AbbVie, UCB Pharma, Natasha de Peyrecave Employee of: UCB Pharma, Marga Oortgiesen Employee of: UCB Pharma, Thomas Vaux Employee of: UCB Pharma, Carmen Fleurinck Employee of: UCB Pharma, Valerie Ciaravino Employee of: UCB Pharma, Atul Deodhar Speakers bureau: Janssen, Novartis, Pfizer, Consultant of: AbbVie, Amgen, BMS, Boehringer Ingelheim, Celgene, Eli Lilly, Gilead, GSK, Janssen, Novartis, Pfizer, UCB Pharma, Grant/research support from: AbbVie, Eli Lilly, GSK, Novartis, Pfizer, UCB Pharma

scholarly journals Particulate Juvenile Articular Cartilage vs Osteochondral Allograft for Patellar Cartilage Defects: A Matched Cohort Analysis

2020 ◽  
Vol 8 (7_suppl6) ◽  
pp. 2325967120S0051
Author(s):  
Niv Marom ◽  
Francesca Coxe ◽  
Dean Wang ◽  
Riley Williams ◽  
Gabriella Ode
Keyword(s):  
Patient Reported Outcomes ◽  
Cohort Analysis ◽  
Osteochondral Allograft ◽  
Cartilage Defects ◽  
Matched Cohort ◽  
Chondral Defects ◽  
Sf 36 ◽  
Cartilage Restoration ◽  
Significant Difference ◽  
Patient Reported

Objectives: Management of full-thickness cartilage defects of the patella remains a significant clinical challenge. Osteochondral allograft transplantation (OCA) is a reliable cartilage restoration procedure for large chondral defects of the knee. OCA reports good long-term outcomes for condylar defects but limited literature on outcomes of patellar defects. Since 2007, particulated juvenile articular cartilage (PJAC) has been used as an alternative method of cartilage restoration. PJAC has demonstrated promising early clinical outcomes, however, no studies have directly compared the clinical and patient reported outcomes of PJAC and OCA for management of full thickness chondral defects of the patella. Methods: Prospective data was collected for patients within our institutional cartilage registry who underwent OCA or PJAC using DeNovo NT (Zimmer-Biomet) for management of grade 4 cartilage defects of the patella. OCA patients were matched to PJAC patients by age, sex and BMI. Patient characteristics and minimum 2-year patient reported outcomes (PROMs) (Knee Outcome Survey-Activities of Daily Living (KOS-ADL) score, International Knee Documentation Committee (IKDC) score, Short Form 36 (SF-36) pain rating, and Marx Activity Rating Scale) and self-reported general overall knee condition were reported. Results: There were 28 patients eligible for analysis (14 OCA, 14 PJAC). Demographics of the two groups are outlined in Table 1. The mean age of the entire cohort was 38.4 +/- 11.4 years with a mean BMI of 24.6 +/- 3.1. One patient in each group had bipolar transplantation (patella and trochlea). OCA patients had more previous surgeries (1.4 vs 0.4) (p<0.01) and significantly larger chondral defects (4.6 cm2 vs. 2.5 cm2) (p<0.01) than PJAC patients. Patient reported outcomes are reported in Figure 1. IKDC, KOS-ADL and SF-36-Pain scores improved by 17, 16 and 14 points for OCA compared to 17, 11, and 23 points for PJAC at last follow-up (average 3.5 years) (p>0.05). Both groups met the published MCID for IKDC (17 pts) and KOS-ADL (10 pts) for osteochondral grafts. There was no significant difference between OCA and PJAC for all postoperative PROMs. The reoperation rate for OCA and PJAC was 36% and 50% respectively (p>0.05). There were 4 graft failures in the PJAC group (29%) and 1 failure in the OCA group (6%) (p>0.05). The failed OCA underwent manipulation and lysis of adhesions for post-operative stiffness at 7 months and arthroscopic synovectomy for synovitis at 8 months after OCA. The four failed PJAC patients underwent revision to OCA (at 8 months), chondroplasty of the graft (at 10 and 26 months), and revision to TKA (at 78 months). Reoperations are further described in Table 2. Conclusion: In a matched cohort analysis, both PJAC and OCA demonstrated significant clinical improvement in patient reported outcomes with no significant difference between the two groups at mean 3.5 years. Larger investigational studies are needed to determine optimal indications for use of PJAC versus OCA for management of focal cartilage defects of the patella. [Table: see text][Table: see text]

scholarly journals Comparison of Patient-Reported Outcomes at 1 Year After Injury Between Limb Salvage and Amputation: A Prospective Cohort Study

2021 ◽  
Author(s):  
Taketo Kurozumi ◽  
Takahiro Inui ◽  
Yuhei Nakayama ◽  
Akifumi Honda ◽  
Kentaro Matsui ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Mental Health ◽  
Cohort Study ◽  
Limb Salvage ◽  
Lower Limb ◽  
Prospective Cohort ◽  
Patient Reported Outcomes ◽  
Early Recovery ◽  
Patient Reported

Abstract Background: Owing to advances in knowledge and technology, salvaging the limbs of patients with severe trauma and injuries is possible. However, severe limb injuries occasionally necessitate amputation because it allows patients to regain their social lives earlier than limb salvaging. Moreover, previous related investigations are retrospective cohort studies or meta-analyses of retrospective studies, and prospective cohort studies of patient-reported outcomes are extremely rare. This single-center, prospective cohort study aimed to compare the patient-reported outcomes at 1 year after injury between limb salvage and amputation and to elucidate whether amputation contributes to early recovery of functionality and quality of life.Methods: We included 47 limbs of 45 patients with severe open fractures of the lower limb and categorized them into limb salvage and amputation groups. They were registered in the Database of Orthopedic Trauma by the Japanese Society for Fracture Repair at our center; data on patient-reported outcomes at 1 year after injury were obtained from this database. The mean patient age was 49.6 years. Patients’ limbs were evaluated using the lower extremity functional scale (LEFS) and Short-Form 8 (SF-8). Early recovery was evaluated using functionality and quality-of-life questionnaires. Nonparametric statistical analyses were conducted.Results: Of the 47 limbs, 34 limbs of 34 patients were salvaged and 13 limbs of 11 patients were amputated. Significant differences were noted between the limb salvage and amputation groups in terms of the LEFS scores (mean: 49.5 vs 33.1, P=0.025) and scores for the mental health component (mean: 48.7 vs 38.7, P=0.003), role–physical component (mean: 42.2 vs 33.3, P=0.026), and mental component summary (mean: 48.2 vs 41.3, P=0.042) of the SF-8. The limb salvage group had better scores than the amputation group. Conclusions: In this study, limb salvage results in better functional and mental health outcomes at 1 year after severe lower limb injury than after amputation. As reconstruction technology has advanced and limb salvaging has become possible, the focus of studies should now be based on the perspective of “how the patient feels”; hence, we believe that the results of this study, which is based on patient-reported outcomes, are meaningful.

scholarly journals Assessment of patient-reported outcomes after polytrauma: protocol for a systematic review

BMJ Open ◽  
2018 ◽  
Vol 8 (3) ◽  
pp. e017571 ◽  
Author(s):  
Irmela Gnass ◽  
Michaela Ritschel ◽  
Silke Andrich ◽  
Silke Kuske ◽  
Kai Moschinski ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Systematic Review ◽  
Activities Of Daily Living ◽  
Daily Living ◽  
Patient Reported Outcomes ◽  
Short Term ◽  
Patient Reported

IntroductionSurvivors of polytrauma experience long-term and short-term burden that influences their lives. The patients’ view of relevant short-term and long-term outcomes should be captured in instruments that measure quality of life and other patient-reported outcomes (PROs) after a polytrauma. The aim of this systematic review is to (1) collect instruments that assess PROs (quality of life, social participation and activities of daily living) during follow-up after polytrauma, (2) describe the instruments’ application (eg, duration of period of follow-up) and (3) investigate other relevant PROs that are also assessed in the included studies (pain, depression, anxiety and cognitive function).Methods and analysisThe systematic review protocol is developed in line with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols statement. MEDLINE, EMBASE, Cumulative Index to Nursing and Allied Health Literature, PsycINFO, Cochrane Central Register of Controlled Trials and the trials registers ClinicalTrials.gov and WHO International Clinical Trials Registry Platform will be searched. Keywords, for example, ‘polytrauma’, ‘multiple trauma’, ‘quality of life’, ‘activities of daily living’ or ‘pain’ will be used. Publications published between January 2005 and the most recent date (currently: August 2016) will be included. In order to present the latest possible results, an update of the search is conducted before publication. The data extraction and a content analysis will be carried out systematically. A critical appraisal will be performed.Ethics and disseminationFormal ethical approval is not required as primary data will not be collected. The results will be published in a peer-reviewed publication.PROSPERO registration numberCRD42017060825.

Comparison of 5-Year Patient-Reported Outcomes (PROMs) of Total Ankle Replacement (TAR) to Total Knee Replacement (TKR) and Total Hip Replacement (THR)

2020 ◽  
Vol 41 (7) ◽  
pp. 767-774
Author(s):  
Jayasree Ramaskandhan ◽  
Anjum Rashid ◽  
Simon Kometa ◽  
Malik S. Siddique
Keyword(s):  
Mental Health ◽  
Hip Replacement ◽  
Patient Reported Outcomes ◽  
Ankle Replacement ◽  
Sf 36 ◽  
Patient Reported ◽  
Total Knee ◽  
End Stage ◽  
Satisfaction Rates

Background: Total ankle replacement (TAR) is becoming a more common alternative to ankle arthrodesis for the improvement of pain and function in end-stage arthritis of the ankle. The effects of end-stage arthritis of the ankle are similar to those of end-stage hip arthritis. There is a paucity of literature on patient-reported outcome measures (PROMs) following TARs in comparison with total hip replacement (THR) or total knee replacement (TKR). We aimed to study the 1-, 3-, and 5-year outcomes of TAR in comparison with TKR and THR. Methods: PROMs data from patients who underwent a primary THR, TKR, or TAR performed between March 2008 and 2013 over a 5-year period were collected from our hospital patient registry. They were divided into 3 groups based on the type of primary joint replacement. Patient demographics and patient-reported outcomes (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC], 36-item Short-Form (SF-36) scores, and patient satisfaction scores at follow-up) were compared preoperatively and at the 1-, 3-, and 5-year follow-ups. Results: There were data available on 2672 THR, 3520 TKR, and 193 TAR patients preoperatively. Preoperatively, TAR patients reported statistically significantly higher function scores when compared with THR and TKR patients (40 vs 33; P = .001 [ P < .05] and 40 vs 36; P = .001 [ P < .05]). For SF-36 scores, there was no statistically significant difference between groups for the general health and role emotional components ( P = .171 and .064, respectively [ P > .05]); TAR patients reported similar scores to TKR patients for physical domains at the 3- and 5-year follow-ups ( P > .05), and TAR patients also reported similar scores to both THR and TKR patients for the mental domains ( P > .05). At 5 years postoperatively, TAR patients reported lower scores than THR and TKR patients for function and stiffness. For SF-36 scores, TAR patients reported similar outcomes to THR and TKR patients for mental health components ( P > .05), similar scores to TKR patients for 3 of 4 physical domains ( P < .05), but lower satisfaction rates for activities of daily living (ADL) and recreation when compared with THR ( P < .05). Conclusion: TAR patients had similar outcomes to THR and TKR patients for disease-specific and mental health domains, and lower patient satisfaction rates in terms of pain relief, ADL, and recreation. Further research is warranted including clinical outcomes along with PROMs with a long-term follow-up. Level of Evidence: Level III, retrospective comparative series.

Quality of Life and Disability in Patients with Treatment-Failure Gout

2009 ◽  
Vol 36 (5) ◽  
pp. 1041-1048 ◽  
Author(s):  
MICHAEL A. BECKER ◽  
H. RALPH SCHUMACHER ◽  
KATY L. BENJAMIN ◽  
PETER GOREVIC ◽  
MARIA GREENWALD ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Treatment Failure ◽  
Patient Reported Outcomes ◽  
Short Form ◽  
Clinical Status ◽  
Damage Index ◽  
Sf 36 ◽  
Patient Reported ◽  
Gout Flares

Objective.The relationship between self-reported quality of life and disability and disease severity was evaluated in subjects with treatment-failure gout (n = 110) in a prospective, 52-week, observational study.Methods.Subjects had symptomatic crystal-proven gout of at least 2 years’ duration and intolerance or refractoriness to conventional urate-lowering therapy. Serum uric acid (sUA) concentration, swollen and tender joint counts, frequency and severity of gout flares, tophus assessments, comorbidities, and patient-reported outcomes data [Medical Outcomes Study Short Form-36 (SF-36), Health Assessment Questionnaire-Damage Index] were collected. Analyses included correlations of patient-reported outcomes with clinical variables and changes in clinical status.Results.Mean age of study subjects was 59 years. Mean scores on SF-36 physical functioning subscales were 34.2–46.8, analogous to persons aged ≥ 75 years in the general population. Subjects with more severe gout at baseline had worse health-related quality of life (HRQOL) in all areas (p < 0.02 for all measures), compared to patients with mild-moderate disease. Number of flares reported in past year, number of tender joints, swollen joints, and tophi correlated significantly with some or all HRQOL and disability measures. sUA was not significantly correlated with any HRQOL or disability measure. Subjects with comorbidities experienced worse physical, but not mental, functioning.Conclusion.Severe gout is associated with poor HRQOL and disability, especially for patients who experience more gout flares and have a greater number of involved joints. Subject perceptions of gout-related functioning and pain severity appear to be highly sensitive indicators of HRQOL and disability.

scholarly journals Feasibility, Validity, and Reliability of the 10-item Patient Reported Outcomes Measurement Information System Global Health Short Form in Outpatients with Systemic Lupus Erythematosus

2018 ◽  
Vol 45 (3) ◽  
pp. 397-404 ◽  
Author(s):  
Shanthini Kasturi ◽  
Jackie Szymonifka ◽  
Jayme C. Burket ◽  
Jessica R. Berman ◽  
Kyriakos A. Kirou ◽  
...  
Keyword(s):  
Mental Health ◽  
Lupus Erythematosus ◽  
Patient Reported Outcomes ◽  
Short Form ◽  
Measurement Information ◽  
Physical And Mental Health ◽  
Validity And Reliability ◽  
Sf 36 ◽  
Patient Reported ◽  
Health Domains

Objective.To assess the feasibility, validity, and reliability of the Patient Reported Outcomes Measurement Information System Global Health Short Form (PROMIS10) in outpatients with systemic lupus erythematosus (SLE).Methods.SLE outpatients completed PROMIS10, Medical Outcomes Study Short Form-36 (SF-36), LupusQoL-US, and selected PROMIS computerized adaptive tests (CAT) at routine visits at an SLE Center of Excellence. Construct validity was evaluated by correlating PROMIS10 physical and mental health scores with PROMIS CAT, legacy instruments, and physician-derived measures of disease activity and damage. Test-retest reliability was determined among subjects reporting stable SLE activity at 2 assessments 1 week apart using intraclass correlation coefficients (ICC).Results.A diverse cohort of 204 out of 238 patients with SLE (86%) completed survey instruments. PROMIS10 physical health scores strongly correlated with physical function, pain, and social health domains in PROMIS CAT, SF-36, and LupusQoL, while mental health scores strongly correlated with PROMIS depression CAT, SF-36, and LupusQoL mental health domains (Spearman correlations ≥ 0.70). Active arthritis, comorbid fibromyalgia (FM), and anxiety were associated with worse PROMIS10 scores, but sociodemographic factors and physician-assessed flare status were not. Test-retest reliability for PROMIS10 physical and mental health scores was high (ICC ≥ 0.85). PROMIS10 required < 2 minutes to complete.Conclusion.PROMIS10 is valid and reliable, and can efficiently screen for impaired physical function, pain, and emotional distress in outpatients with SLE. With strong correlations to LupusQoL and SF-36 but significantly reduced responder burden, PROMIS10 is a promising tool for measuring patient-reported outcomes in routine SLE clinical care and value-based healthcare initiatives.

scholarly journals Patient-Reported Outcomes following Single- and Multiple-Radius Total Knee Replacement: A Randomized, Controlled Trial

2017 ◽  
Vol 31 (01) ◽  
pp. 087-091 ◽  
Author(s):  
Nadeem Mushtaq ◽  
David Isaac ◽  
Katherine Dillow ◽  
Paul Gill ◽  
Alexander Liddle
Keyword(s):  
Total Knee Replacement ◽  
Knee Replacement ◽  
Patient Reported Outcomes ◽  
Controlled Study ◽  
Short Term ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Patient Reported ◽  
Total Knee ◽  
Single Radius

AbstractAlthough single-radius (SR) designs of total knee replacement (TKR) have theoretical benefits, the clinical advantage conferred by such designs is unknown. The aim of this randomized, controlled study was to compare the short-term clinical outcomes of the two design rationales. A total of 105 knees were randomized to receive either a single radius (Scorpio, Stryker; SR Group) or multiple radius (AGC, Zimmer Biomet; MR group) TKR. Patient-reported outcomes (Oxford Knee Score [OKS] and Knee Society Score [KSS]) were collected at 6 weeks, 6 months, and 1 year following surgery. No knees were revised. There was no difference in primary outcomes: OKS was 39.5 (95% confidence interval [CI]: 36.9–42.1) in the SR group and 38.1 (95% CI: 36.0–40.3) in the MR group (p = 0.40). KSS was 168.4 (95% CI: 159.8–177.0) in the SR group; 159.5 (95% CI 150.5–168.5) in the MR group (p = 0.16). There was a small but statistically significant difference in the degree of change of the objective subscale of the KSS, favoring the SR design (p = 0.04), but this is of uncertain clinical relevance. The reported benefits of SR designs do not provide demonstrable functional advantages in the short term.

Equivalent 10-Year Outcomes After Implantation of Autologous Bone Marrow–Derived Mesenchymal Stem Cells Versus Autologous Chondrocyte Implantation for Chondral Defects of the Knee

2019 ◽  
Vol 47 (12) ◽  
pp. 2881-2887 ◽  
Author(s):  
Alex Quok An Teo ◽  
Keng Lin Wong ◽  
Liang Shen ◽  
Jia Ying Lim ◽  
Wei Seong Toh ◽  
...  
Keyword(s):  
Patient Reported Outcomes ◽  
Tumor Formation ◽  
Chondral Defects ◽  
Sf 36 ◽  
Significant Difference ◽  
Patient Reported ◽  
Chondrocyte Implantation ◽  
Autologous Chondrocyte

Background: The use of bone marrow–derived mesenchymal stem cells (BMSCs) in cartilage repair procedures circumvents some of the limitations of autologous chondrocyte implantation (ACI), but long-term outcomes for this newer procedure are lacking. The authors previously reported comparable outcomes for the 2 procedures at 2-year follow-up. Purpose/Hypothesis: The purpose was to compare the long-term clinical outcomes of ACI versus BMSCs. It was hypothesized that there would be no significant difference between the groups in terms of patient-reported outcome scores and safety outcomes at 10-year follow-up. Study Design: Cohort study; Level of evidence, 2. Methods: Seventy-two patients who underwent either ACI or BMSC implantation—matched in terms of age and lesion site— were followed up to a median of at least 10 years. Patients were assessed with the 36-item Short Form Health Survey (SF-36), the International Knee Documentation Committee knee evaluation form, the Lysholm Knee Score, and the Tegner Activity Scale. In addition, information was obtained regarding any additional surgical procedures as well as safety data, with particular attention to infection and tumor formation. Results: There was an improvement in all patient-reported outcomes scores apart from the Mental Component Summary of the SF-36 after cartilage repair surgery. There was no significant difference in any of the patient-reported outcomes between cohorts at any time point. Six and 5 patients in the ACI and BMSC groups, respectively, underwent subsequent surgical procedures, including 1 total knee replacement in the BMSC group. None of the patients in either group developed any deep infection or tumor within the follow-up period. Conclusion: BMSC implantation used for the treatment of chondral defects of the knee appears to result in equivalent clinical outcomes to first-generation ACI at up to 10 years, with no apparent increased tumor formation risk.

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