scholarly journals Acute ACL reconstruction shows superior clinical results and can be performed safely without an increased risk of developing arthrofibrosis

2019 ◽  
Vol 28 (7) ◽  
pp. 2036-2043 ◽  
Author(s):  
Christoffer von Essen ◽  
Karl Eriksson ◽  
Björn Barenius
Keyword(s):  
Range Of Motion ◽  
Acl Reconstruction ◽  
Patient Reported Outcomes ◽  
Activity Level ◽  
Knee Ligament ◽  
Acute Group ◽  
Increased Risk ◽  
Significant Difference ◽  
Patient Reported ◽  
Delayed Group

Abstract Purpose To compare acute ACL reconstruction (ACLR) within 8 days of injury with delayed reconstruction after normalized range of motion (ROM), 6–10 weeks after injury. It was hypothesized that acute ACL reconstruction with modern techniques is safe and can be beneficial in terms of patient-reported outcomes and range of motion. Methods The effect of acute and delayed ACLR was randomized studied on 70 patients with high recreational activity level, Tegner level 6 or more, between 2006 and 2013. Patient-reported outcomes, objective IKDC, KOOS, and manual stability measurements were documented during the 24-month follow-up period. Results The acute ACLR group did not result in increased stiffness and showed superior outcome regarding strength and how the patient felt their knee functioning at 24 months. In addition, the acute group was not inferior to the delayed group in any assessment. Regarding patient-related outcomes in KOOS, both groups showed significant improvements in all subscales, but no difference was found between the groups. Functional return (FR) rate was almost double compared to the Swedish knee ligament register and treatment failure (TF) rate was reduced by half, no significant difference between the groups. No difference regarding cyclops removal, re-injury of ACL or meniscus was found between the two surgical timing groups. Conclusion Acute ACLR within 8 days of injury does not appear to adversely affect ROM or result in increased stiffness in the knee joint and was not inferior to the delayed group in any assessment when compared to delayed surgery. Level of evidence I.

scholarly journals Platelet-Rich Plasma Augmentation for Isolated Arthroscopic Meniscal Repairs Leads to Significantly Lower Failure Rates: A Systematic Review of Comparative Studies

2020 ◽  
Vol 8 (11) ◽  
pp. 232596712096453
Author(s):  
Kyle R. Sochacki ◽  
Marc R. Safran ◽  
Geoffrey D. Abrams ◽  
Joseph Donahue ◽  
Constance Chu ◽  
...  
Keyword(s):  
Systematic Review ◽  
Odds Ratio ◽  
Patient Reported Outcomes ◽  
Platelet Rich Plasma ◽  
Meniscal Repair ◽  
Activity Level ◽  
Failure Rates ◽  
Significant Difference ◽  
Patient Reported ◽  
Variable Data

Background: Studies have reported relatively high failure rates of isolated meniscal repairs. Platelet-rich plasma (PRP) has been suggested as a way to increase growth factors that enhance healing. Purpose: To compare (1) meniscal repair failures and (2) patient-reported outcomes after isolated arthroscopic meniscal repair augmented with and without PRP. Study Design: Systematic review; Level of evidence, 3. Methods: A systematic review was performed using the PRISMA (Preferred Reporting Items for Systematic Meta-Analyses) guidelines. Multiple databases were searched for studies that compared outcomes of isolated arthroscopic meniscal repair augmented with PRP versus without PRP in human patients. Failures and patient-reported outcome scores were reported for each study and compared between groups. Study heterogeneity was assessed using I 2 for each outcome measure before meta-analysis. Study methodological quality was analyzed. Continuous variable data were reported as mean and standard deviation from the mean. Categorical variable data were reported as frequency with percentage. All P values were reported with significance set at P < .05. Results: Five articles were analyzed (274 patients [110 with PRP and 164 without PRP]; 65.8% male; mean age, 29.1 ± 4.6 years; mean follow-up, 29.2 ± 22.1 months). The risk of meniscal repair failure ranged from 4.4% to 26.7% for PRP-augmented repairs and 13.3% to 50.0% for repairs without PRP. Meniscal repairs augmented with PRP had significantly lower failure rates than repairs without PRP (odds ratio, 0.32; 95% CI, 0.12-0.90; P = .03). One of the 5 studies reported significantly higher outcomes in the PRP-augmented group versus the no-PRP group for the International Knee Documentation Committee (IKDC), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and Knee injury and Osteoarthritis Outcome Score (KOOS) ( P < .05 for all). The remaining 4 studies reported no significant difference between groups with regard to outcomes for the IKDC, Lysholm knee scale, visual analog scale for pain, or Tegner activity level. Conclusion: Although the studies were of mostly of low quality, isolated arthroscopic meniscal repairs augmented with PRP led to significantly lower failure rates (10.8% vs 27.0%; odds ratio, 0.32; P = .03) as compared with repairs without PRP. However, most studies reported no significant differences in patient-reported outcomes.

scholarly journals Current Return to Sport Criteria after ACL Reconstruction Fail to Identify Increased Risk of Second ACL Injury in Young Athletes

2018 ◽  
Vol 6 (7_suppl4) ◽  
pp. 2325967118S0006 ◽  
Author(s):  
Mark V. Paterno ◽  
Mitchell Rauh ◽  
Staci Thomas ◽  
Timothy E. Hewett ◽  
Laura Schmitt
Keyword(s):  
Acl Reconstruction ◽  
Group Analysis ◽  
Return To Sport ◽  
Acl Injury ◽  
Quadriceps Strength ◽  
Patient Reported Outcome ◽  
Young Athletes ◽  
Increased Risk ◽  
Significant Difference ◽  
Patient Reported

Objectives: The incidence of 2nd anterior cruciate ligament (ACL) injury after ACL reconstruction (ACLR) and return to sport (RTS) ranges from 25%-33% in young, active populations; with the greatest risk in the first 12 months after RTS. Recent data indicate that failure to successfully meet traditional RTS criteria, inclusive of strength, functional hop testing and patient reported outcome scores, may identify athletes at increased risk of future injury after ACLR. However, these studies have focused on adult populations and it is unknown if similar RTS criteria apply to young, adolescent, pivoting/cutting athletes. The purpose of this study was to determine if meeting all current, standard RTS criteria would identify young athletes at risk for future ACL injury after primary ACLR and RTS. The tested hypothesis was the likelihood of 2nd ACL injury in the first 2 years after RTS would be lower in patients who met all RTS criteria prior to initiation of pivoting and cutting activity compared to patients who failed to meet all RTS criteria prior to RTS. Methods: One hundred fifty-nine subjects (112 female, 47 male) with a mean age of 17.2±2.6 years old (range: 13-25 y.o.) underwent ACLR and were released to return to pivoting/cutting sport. These patients were enrolled in a prospective, observational cohort study, completed a RTS assessment and were then tracked for occurrence of 2nd ACL after ACLR for 24 months. The RTS assessment included 6 tests: isometric quadriceps strength, 4 functional hop tests and the International Knee Documentation Committee (IKDC) patient reported outcome survey. Limb symmetry index (LSI) was calculated for strength and hop test assessments [(involved/uninvolved)*100]. The IKDC was reported on a 0-100 scale with 100 representing a perfect score. Subjects were classified into groups that successfully passed all 6 RTS tests at a level of 90 and again at 95 compared to those that failed to meet all 6 criteria. Chi Square tests were used to determine if successfully passing all 6 RTS measures at various levels of symmetry resulted in a reduced risk of 2nd ACL injury in the first 24 months after RTS. Results: Thirty-five (22.0%) patients suffered a 2nd ACL injury, with 26 occurring in the first 12 months after RTS. At the time of RTS, 42 patients (26%) achieved LSI values of 90 or greater on all testing as well as an IKDC value of 90 or greater. The remaining 117 subjects (74%) scored below 90 on at least 1 of the 6 assessments. At this level, there was no difference in 2nd ACL injury prevalence between patients who passed all RTS criteria (12/42; 28.6%) and those who failed at least 1 criteria (23/117; 19.7%) (p=0.23). When the passing criteria was elevated to 95 on all RTS testing, only 15 subjects (9%) successfully passed all 6 tests. There was no significant difference in 2nd ACL injury prevalence between patients who passed all RTS criteria (5/15; 33%) and those who failed at least 1 test (30/144; 20.8%) (p=0.32). Sub-group analysis which evaluated the group by graft type, also indicated no significant differences between groups (p>0.05). Conclusion: Current criteria to evaluate readiness to return young athletes to pivoting and cutting sports, using quadriceps strength symmetry, functional hop performance symmetry and patient reported outcomes, may not identify young, active patients at high risk for 2nd ACL injury. Future work must identify more appropriate criteria to assess readiness to RTS in the young, athletic population and incorporate these findings into practice.

scholarly journals Pharmacogenetic and Clinical Predictors of Ondansetron Failure in a Diverse Pediatric Oncology Population

2021 ◽  
Author(s):  
Shana Jacobs ◽  
Jeffrey S Dome ◽  
Jiaxiang Gai ◽  
Andrea Gross ◽  
Elena Postell ◽  
...  
Keyword(s):  
Pediatric Oncology ◽  
Medical Records ◽  
Patient Reported Outcomes ◽  
Clinical Predictors ◽  
Drug Metabolizing Enzyme ◽  
Increased Risk ◽  
Significant Difference ◽  
Patient Reported ◽  
Metabolizing Enzyme ◽  
Definition Of

Abstract Purpose: Chemotherapy induced nausea and vomiting (CINV) is a frequently seen burdensome adverse event of cancer therapy. The 5-HT3 receptor antagonist ondansetron has improved the rates of CINV but, unfortunately, up to 30% of patients do not obtain satisfactory control. This study examined whether genetic variations in a relevant drug metabolizing enzyme (CYP2D6), transporter (ABCB1) or receptor (5-HT3) were associated with ondansetron failure. Methods: DNA was extracted from blood and used to genotype: ABCB1 (3435C>T (rs1045642) and G2677A/T (rs2032582)), 5-HT3RB (rs3758987 T>C and rs45460698 (delAAG/dupAAG)) and CYP2D6 variants. Ondansetron failure was determined by review of the medical records and by patient-reported outcomes (PROs). Results: 129 patients were approached; 103 consented. Participants were less than 1 to 33 years (mean 6.85). 39.8% were female, 58.3% were White (22.3% Black, 19.4% other); and 24.3% were Hispanic. A majority had leukemia or lymphoma, and 41 (39.8%) met the definition of ondansetron failure. Of variants tested, rs45460698 independently showed a significant difference in risk of ondansetron failure between a mutant (any deletion) and normal allele (p=0.0281, OR 2.67). Age and BMI were both predictive of ondansetron failure (Age > 12 (OR 1.12, p=0.0012) and higher BMI (OR 1.13, p=0.0119)). In multivariate analysis, age > 12 was highly predictive of ondansetron failure (OR 7.108, p=0.0008). rs45460698 was predictive when combined with an increased nausea phenotype variant of rs1045642 (OR 3.45, p=0.0426). Conclusion: Select phenotypes of 5-HT3RB and ABCB1, age, and potentially BMI can help predict increased risk for CINV in a diverse pediatric oncology population.

scholarly journals Effect of High-Grade Preoperative Knee Laxity on 6-Year Anterior Cruciate Ligament Reconstruction Outcomes

2018 ◽  
Vol 46 (12) ◽  
pp. 2865-2872 ◽  
Author(s):  
Robert A. Magnussen ◽  
Emily K. Reinke ◽  
Laura J. Huston ◽  
Timothy E. Hewett ◽  
Kurt P. Spindler ◽  
...  
Keyword(s):  
Acl Reconstruction ◽  
Patient Reported Outcomes ◽  
Pivot Shift ◽  
Cruciate Ligament ◽  
Knee Laxity ◽  
High Grade ◽  
Anterior Drawer ◽  
Increased Risk ◽  
Patient Reported ◽  
Anterior Cruciate

Background: Knee laxity in the setting of anterior cruciate ligament (ACL) injury is often assessed through physical examination using the Lachman, pivot shift, and anterior drawer tests. The degree of laxity noted on these examinations may influence treatment decisions and prognosis. Hypothesis: Increased preoperative knee laxity is associated with increased risk of revision ACL reconstruction, increased risk of contralateral ACL reconstruction, and poorer patient-reported outcomes at 6 years postoperatively. Study Design: Cohort study; Level of evidence, 2. Methods: 2333 patients who underwent primary isolated ACL reconstruction without additional ligament injury were identified. Patients reported by the operating surgeons to have an International Knee Documentation Committee (IKDC) grade D Lachman, anterior drawer, or pivot shift examination were classified as having a high-grade laxity. Multiple logistic regression models were used to evaluate whether having high-grade preoperative laxity was predictive of increased odds of undergoing subsequent revision or contralateral ACL reconstruction within 6 years of the index procedure, controlling for patient age, sex, body mass index, Marx activity level, sport, graft type, medial meniscal treatment, and lateral meniscal treatment. Multiple linear regression modeling was used to evaluate whether having high-grade preoperative laxity was predictive of poorer IKDC or Knee injury and Osteoarthritis Outcome Score Knee-Related Quality of Life (KOOS-QOL) scores at 6 years postoperatively, after controlling for baseline score, patient age, ethnicity, sex, body mass index, marital status, smoking status, sport participation, competition level, Marx activity rating score, graft type, and articular cartilage and meniscal status. Results: In total, 743 of 2325 patients (32.0%) were noted to have high-grade laxity on at least 1 physical examination test. High-grade Lachman was noted in 334 patients (14.4%), high-grade pivot shift was noted in 617 patients (26.5%), and high-grade anterior drawer was noted in 233 patients (10.0%). Six-year revision and contralateral ACL reconstruction data were available for 2129 patients (91.6%). High-grade prereconstruction Lachman was associated with significantly increased odds of ACL graft revision (odds ratio [OR], 1.76; 95% CI, 1.10-2.80, P = .02) and contralateral ACL reconstruction (OR, 1.68; 95% CI, 1.09-2.69; P = .019). High-grade prereconstruction pivot shift was associated with significantly increased odds of ACL graft revision (OR, 1.75; 95% CI, 1.19-2.54, P = .002) but not with significantly increased odds of contralateral ACL reconstruction (OR, 1.30; 95% CI, 0.89-1.87; P = .16). High-grade prereconstruction laxity was associated with statistically significantly lower 6-year IKDC (β = −2.26, P = .003), KOOS-QOL (β = −2.67, P = .015), and Marx activity scores (β = −0.54, P = .020), but these differences did not approach clinically relevant differences in patient-reported outcomes. Conclusion: High-grade preoperative knee laxity is predictive of increased odds of revision ACL reconstruction and contralateral ACL reconstruction 6 years after ACL reconstruction. Poorer patient-reported outcome scores in the high-grade laxity group were also noted, but the difference did not reach a level of clinical relevance.

scholarly journals Clinical and Immunological Efficacy of Mangosteen and Propolis Extracted Complex in Patients with Gingivitis: A Multi-Centered Randomized Controlled Clinical Trial

Nutrients ◽  
2021 ◽  
Vol 13 (8) ◽  
pp. 2604
Author(s):  
Jin-Young Park ◽  
Kyung-A Ko ◽  
Ji-Yeong Lee ◽  
Jae-Woon Oh ◽  
Hyun-Chang Lim ◽  
...  
Keyword(s):  
Patient Reported Outcomes ◽  
Daily Intake ◽  
Test Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Control Groups ◽  
Immunological Parameters ◽  
Significant Difference ◽  
Patient Reported ◽  
And Control

Background: Mangosteen and propolis extracts (MAEC) have been potential therapeutic agents known to exhibit powerful antioxidant and anti-inflammatory properties. The aim of the current study was to evaluate the clinical and immunological efficacy of MAEC as well as safety and patient-reported outcomes (PROMs) on gingivitis and incipient periodontitis. Methods: This study was performed on 104 patients diagnosed with gingivitis or incipient periodontitis. At baseline, the participants were randomly allocated to either the test group, with daily intake of a single capsule containing 194 mg of MAEC for eight weeks, or control group, with placebo. Clinical periodontal evaluation and immunological parameters from saliva and gingival sulcular fluid were assessed at baseline, four, and eight weeks. Individual PROMs were assessed by OHIP-14 questionnaires. Results: There was a significant difference of modified gingival index at four and eight weeks between the test and control groups. In the test group, crevicular interleukin (IL)-6 was reduced, and the salivary matrix metalloproteinase (MMP)-9 was increased after eight weeks. PROMs were improved up to four weeks compared to placebo. Conclusion: Oral administration of MAEC would have a potential to reduce gingival inflammation clinically and immunologically in the patients with gingivitis and incipient periodontitis.

scholarly journals Lower Failure Rates and Improved Patient Outcome Due to Reconstruction of the MCL and Revision ACL Reconstruction in Chronic Medial Knee Instability

2021 ◽  
Vol 9 (3) ◽  
pp. 232596712198931
Author(s):  
Lena Alm ◽  
Tobias Claus Drenck ◽  
Jannik Frings ◽  
Matthias Krause ◽  
Alexander Korthaus ◽  
...  
Keyword(s):  
Acl Reconstruction ◽  
Lysholm Score ◽  
Knee Instability ◽  
Failure Rates ◽  
Medial Knee ◽  
Revision Acl Reconstruction ◽  
Risk Of Failure ◽  
Significant Difference ◽  
Patient Reported ◽  
Reconstruction Group

Background: Concomitant lesion of the medial collateral ligament (MCL) is associated with a greater risk of anterior cruciate ligament (ACL) graft failure. Purpose: The aim of this study was to compare two medial stabilization techniques in patients with revision ACL reconstruction (ACLR) and concomitant chronic medial knee instability. Study Design: Cohort study; Level of evidence, 3. Methods: In a retrospective study, we included 53 patients with revision ACLR and chronic grade 2 medial knee instability to compare medial surgical techniques (MCL reconstruction [n = 17] vs repair [n = 36]). Postoperative failure of the revision ACLR (primary aim) was defined as side-to-side difference in Rolimeter testing ≥5 mm or pivot-shift grade ≥2. Clinical parameters and postoperative functional scores (secondary aim) were evaluated with a mean ± SD follow-up of 28.8 ± 9 months (range, 24-69 months). Results: Revision ACLR was performed in 53 patients with additional grade 2 medial instability (men, n = 33; women, n = 20; mean age, 31.3 ± 12 years). Failure occurred in 5.9% (n = 1) in the MCL reconstruction group, whereas 36.1% (n = 13) of patients with MCL repair showed a failed revision ACLR ( P = .02). In the postoperative assessment, the anterior side-to-side difference in Rolimeter testing was significantly reduced (1.5 ± 1.9 mm vs 2.9 ± 2.3 mm; P = .037), and medial knee instability occurred significantly less (18% vs 50%; P = .025) in the MCL reconstruction group than in the MCL repair group. In the logistic regression, patients showed a 9-times elevated risk of failure when an MCL repair was performed ( P = .043). Patient-reported outcomes were increased in the MCL reconstruction group as compared with MCL repair, but only the Lysholm score showed a significant difference (Tegner, 5.6 ± 1.9 vs 5.3 ± 1.6; International Knee Documentation Committee, 80.3 ± 16.6 vs 73.6 ± 16.4; Lysholm, 82.9 ± 13.6 vs 75.1 ± 21.1 [ P = .047]). Conclusion: MCL reconstruction led to lower failure rates in patients with combined revision ACLR and chronic medial instability as compared with MCL repair. MCL reconstruction was superior to MCL repair, as lower postoperative anterior instability, an increased Lysholm score, and less medial instability were present after revision ACLR. MCL repair was associated with a 9-times greater risk of failure.

No Difference in Outcomes Following Osteochondral Allograft with Fresh Precut Cores Compared to Hemi-Condylar Allografts

Cartilage ◽  
2021 ◽  
pp. 194760352110219
Author(s):  
Danielle H. Markus ◽  
Anna M. Blaeser ◽  
Eoghan T. Hurley ◽  
Brian J. Mannino ◽  
Kirk A. Campbell ◽  
...  
Keyword(s):  
Patient Reported Outcomes ◽  
Knee Injury ◽  
Lesion Size ◽  
Osteochondral Allograft ◽  
Osteochondral Lesions ◽  
Radiographic Outcomes ◽  
Significant Difference ◽  
Patient Reported ◽  
The Mean

Objective The purpose of the current study is to evaluate the clinical and radiographic outcomes at early to midterm follow-up between fresh precut cores versus hemi-condylar osteochondral allograft (OCAs) in the treatment of symptomatic osteochondral lesions. Design A retrospective review of patients who underwent an OCA was performed. Patient matching between those with OCA harvested from an allograft condyle/patella or a fresh precut allograft core was performed to generate 2 comparable groups. The cartilage at the graft site was assessed with use of a modified Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scoring system and patient-reported outcomes were collected. Results Overall, 52 total patients who underwent OCA with either fresh precut OCA cores ( n = 26) and hemi-condylar OCA ( n = 26) were pair matched at a mean follow-up of 34.0 months (range 12 months to 99 months). The mean ages were 31.5 ± 10.7 for fresh precut cores and 30.9 ± 9.8 for hemi-condylar ( P = 0.673). Males accounted for 36.4% of the overall cohort, and the mean lesion size for fresh precut OCA core was 19.6 mm2 compared to 21.2 mm2 for whole condyle ( P = 0.178). There was no significant difference in patient-reported outcomes including Visual Analogue Scale, Knee Injury and Osteoarthritis Outcome Score for Joint Replacement, and Tegner ( P > 0.5 for each), or in MOCART score (69.2 vs. 68.3, P = 0.93). Conclusions This study found that there was no difference in patient-reported clinical outcomes or MOCART scores following OCA implantation using fresh precut OCA cores or size matched condylar grafts at early to midterm follow-up.

scholarly journals Treatment of End-Stage Hallux Rigidus and Impact of Arthrodesis versus Arthroplasty on Patient Reported Outcomes

2017 ◽  
Vol 2 (3) ◽  
pp. 2473011417S0001
Author(s):  
Monique Chambers ◽  
MaCalus Hogan ◽  
Dukens LaBaze
Keyword(s):  
Patient Reported Outcomes ◽  
Surgical Intervention ◽  
Metatarsophalangeal Joint ◽  
Hallux Rigidus ◽  
First Metatarsophalangeal Joint ◽  
Significant Difference ◽  
Patient Reported ◽  
Outcome Scores ◽  
Vas Scores ◽  
End Stage

Category: Bunion, Midfoot/Forefoot Introduction/Purpose: Hallux rigidus is a degenerative disease of the first metatarsophalangeal joint. Severe, end-stage hallux rigidus can become debilitating with surgical intervention becoming necessary once conservative measures and shoe modifications have failed. Joint salvage procedures include metatarsal phalangeal (MTP) arthrodesis and MTP arthroplasty. The purpose of this study was to assess for differences in patient reported outcomes in two cohorts who underwent fusion or joint reconstruction. Methods: This study was a retrospective review of prospectively collected data of 385 patients from an academic medical institution. Patients who underwent surgical intervention from July 2015 to November 2016 were identified based on CPT codes for MTP arthrodesis (28750) and arthroplasty (28293). We extracted outcome scores including SF12-M, SF12-P, FAAM, and VAS scores. Exclusion criteria included poly-trauma, revision procedures, and lack of pre and post-operative outcome scores. Mann- Whitney t-test was performed using GraphPad Prism version 7.0b for Mac to compare procedure groups, with significance define by a p-value of 0.05. Results: A total of eighteen patients met the inclusion criteria, with 6 who underwent arthroplasty and 12 arthrodesis. The average age was 63.7 amongst the cohort, with a total of 16 female and 2 males. Patients who underwent arthrodesis had better outcomes across all parameters. When comparing preoperative and postoperative scores, arthrodesis patients showed greater improvement of SF12-M (arthrodesis 9 vs arthroplasty -2, p=0.05), and SF12-P (9 vs -16, respectively p=0.05) scores. Arthroplasty patients were more likely to have a decrease in their SF-12 scores. VAS scores and FAAM scores showed no statistical difference between the two cohorts. Postoperative VAS scores were worse in 33% of arthroplasty patients despite surgical intervention, compared to 10% of arthrodesis patients. Conclusion: Our results suggests that both procedures provide a statistically significant difference in pain with several patients having a Global Rate of Change that is “very much better”. However, fusion of the metatarsophalangeal joint results in improved pain and functional outcomes for patients with severe hallux rigidus. These findings are consistent with current reports in the literature, which are mostly case series reports. Larger studies are needed to provide appropriate power and better support the findings of this study.

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.

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