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BACKGROUND: Few studies have examined long-term outcomes following oral immunotherapy (OIT); none have examined long-term risks and benefits associated with distinct clinical outcomes (desensitization, remission). METHODS: Participants completing the probiotic and peanut oral immunotherapy (PPOIT) -003 randomized trial were enrolled in a follow-on study, PPOIT-003LT. Peanut ingestion, reactions, and health-related quality of life (HRQOL) were monitored prospectively. Outcomes at 1-year and 2-years post-treatment were examined by treatment group and by post-OIT clinical outcome (remission, desensitization without remission [DWR], allergic). RESULTS: 86% (151/176) of eligible children enrolled. Post-treatment peanut ingestion at 2-years post-treatment were similar for PPOIT (86.7%) and OIT (78.7%) groups, both higher than placebo (10.3%). Reactions reduced over time for all treatment and clinical outcome groups (PPOIT 31.7% to 23.3%, OIT 37.7% to 19.7%, placebo 13.8% to 6.9%; remission 27.5% to 15.9%; DWR 57.9% to 36.8%; allergic 11.6% to 7%). At 2-years post-treatment, similar proportions of remission and allergic participants reported reactions (RD 0.09 (95%CI -0.03, 0.20), p = .127), whereas more DWR participants reported reactions than remission (remission vs DWR: RD -0.21 (95%CI -0.39; -0.03), p = .02) and allergic (DWR vs allergic: RD 0.30 (95%CI 0.13, 0.47), p = .001) participants. At 2-years post-treatment, 0% remission versus 5.3% DWR versus 2.3% allergic participants reported adrenaline injector usage. Remission participants had significantly greater HRQOL improvement (adjusted for baseline) compared with both DWR (MD -0.54 (95%CI -0.99, -0.10), p = .017) and allergic (MD -0.82 (95%CI -1.25, -0.38), p < .001). CONCLUSION: By 2-years post-treatment, remission participants reported fewer reactions, less severe reactions and greater HRQOL improvement compared with DWR and allergic participants, indicating that remission is the patient-preferred treatment outcome over desensitization or remaining allergic.
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BACKGROUND: Gluteal tendinopathy (GT) is found in 20 to 25% of patients undergoing total hip arthroplasty (THA). Despite this, there is a scarcity of literature assessing the association between GT and THA outcomes. The aim of this study was to evaluate whether intraoperative diagnosis of GT negatively affected postoperative outcomes. METHODS: Consecutive patients undergoing primary THA for osteoarthritis via a posterior approach over 5 years were recruited in a prospective study. Gluteal tendinopathy was assessed and graded at the time of surgery, but not repaired. A total of 1,538 (93%) completed the patient-reported outcome measures (PROMs) at 1 year after surgery and were included in the analysis. The PROMs included the Oxford Hip Score (OHS), Hip Disability and Osteoarthritis Outcome Score Joint Replacement (HOOS JR), and EuroQol 5-Dimension, and were collected preoperatively and one year after THA. RESULTS: The gluteal tendons were graded as 4 distinct grades: normal (n = 1,023, 66%), tendinopathy but no tear (n = 337, 22%), partial thickness tear (n = 131, 9%), and full thickness tear (n = 47, 3%). The occurrence of GT was associated with age, body mass index, and sex. There was no significant difference in baseline OHS or HOOS JR scores according to GT grade. As GT grade increased, lower median 1-year OHS (P = .001) and HOOS JR (P = .016) were observed. This association was confirmed by linear regression analysis with 1-year OHS (B = 0.5, 95% CI = -0.9 to -0.1, P = .011) when controlled for age and sex. CONCLUSIONS: Gluteal tendinopathy was commonly observed and was associated with inferior 1-year PROMs in patients undergoing THA via posterior approach. Increasing degree of tendinopathy was a negative prognostic factor for outcomes and patient satisfaction. LEVEL OF EVIDENCE: Level 2 (High quality prospective cohort study).
Subject(s)
Arthroplasty, Replacement, Hip , Osteoarthritis, Hip , Patient Reported Outcome Measures , Tendinopathy , Humans , Male , Female , Tendinopathy/surgery , Tendinopathy/etiology , Prospective Studies , Aged , Middle Aged , Buttocks/surgery , Osteoarthritis, Hip/surgery , Aged, 80 and over , Treatment OutcomeABSTRACT
BACKGROUND: Immobile patients with cerebral palsy can suffer with painful dislocated hips. Decision-making and surgical management can prove challenging in this cohort of patients, with hips that cannot be reconstructed. METHODS: We conduced a retrospective chart review of all patients who underwent prosthetic femoral interposition arthroplasty (PFIA) by two surgeons from 2013 to 2021, for unreconstructable hips. We compared pain and range of motion in preoperative period to the postoperative period. Caregiver reported outcomes were used to assess satisfaction post operatively. During the follow up, radiographs of the PFIA were obtained to assess for proximal migration, heterotopic ossification and loosening of implants. RESULTS: Eleven index surgeries, which met the inclusion criteria, were included in this study. These were performed in eleven patients with an average follow up of 45 months. Regarding pain and range of motion post-operatively an excellent or good result was seen in nine cases. Two patients were classified as having a fair result with none having a poor result. Most caregivers reported being satisfied or very satisfied with the post-operative outcomes. CONCLUSION: A prescriptive operative solution to the painful dislocated hip in children with spastic cerebral palsy remains elusive. In this study, we have demonstrated both clinically and radiologically satisfactory results post proximal femoral interposition arthroplasty, for those patients with unreconstructable hips. Patient caregiver reported outcomes, show that the majority of caregivers were satisfied or very satisfied with the outcome of the surgery.
Subject(s)
Arthroplasty, Replacement, Hip , Cerebral Palsy , Hip Dislocation , Humans , Adult , Child , Cerebral Palsy/complications , Cerebral Palsy/surgery , Treatment Outcome , Retrospective Studies , Arthroplasty/methods , Hip Dislocation/etiology , Hip Dislocation/surgery , Pain/surgery , Humerus/surgery , Follow-Up Studies , Arthroplasty, Replacement, Hip/methodsABSTRACT
BACKGROUND: Surgical Hip Dislocation (SHD) is a powerful tool in the armamentarium of any surgeon treating conditions affecting the hips of children presenting with sequelae of a number of common conditions including Legg-CalvéPerthes disease (LCPD) and slipped capital femoral epiphysis (SCFE). Risks associated with the procedure are well described. We investigated to assess if SHD is associated with significant surgical risk and if it improved clinical outcomes for patients. METHODS: We conducted a prospective cohort study. We reviewed 18 (11 males and 7 females; mean age 13.7 years (6-17) with symptomatic hip pathology, secondary to femoroacetabular impingement (FAI) between 2017 and 2021. All patients underwent a surgical hip dislocation approach and femoral head-neck osteochondroplasty, Head Split osteotomy or both. Clinical improvement was assessed using the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index. The minimum follow-up was 6 months (mean, 22 months; range, 6-42 months). RESULTS: WOMAC scores improved at final follow-up from 10 to 3 for pain, 33 to 10 for function, and 4 to 2 for the stiffness subscales. All radiographic measures improved significantly of the postoperative X-rays. No patients developed osteonecrosis, implant failure, deep infection, or nonunion. CONCLUSION: Surgical Hip Dislocation, in the short term, we found improvement in WOMAC scores and radiographic indices with a low complication rate.
Subject(s)
Femoracetabular Impingement , Hip Dislocation , Slipped Capital Femoral Epiphyses , Male , Child , Female , Humans , Adolescent , Hip Dislocation/diagnostic imaging , Hip Dislocation/surgery , Hip Dislocation/complications , Prospective Studies , Treatment Outcome , Femoracetabular Impingement/diagnostic imaging , Femoracetabular Impingement/surgery , Femoracetabular Impingement/etiology , Radiography , Slipped Capital Femoral Epiphyses/diagnostic imaging , Slipped Capital Femoral Epiphyses/surgery , Retrospective StudiesABSTRACT
BACKGROUND: This study assessed change in sleep patterns before and after total hip arthroplasty (THA) and total knee arthroplasty (TKA) and its relationship to patient-reported outcome measures (PROMs). METHODS: Between July 2016 and June 2018, surgical data and PROMs were collected on 780 subjects before and 12 months after THA or TKA. PROMs included Knee Injury and Osteoarthritis Outcome Score, Hip Disability and Osteoarthritis Outcome Score, patient satisfaction, and 2 questions from the Pittsburgh Sleep Quality Index. RESULTS: Before surgery, 35% (270 of 780) reported poor quality sleep. Sleep quality and duration were worse in females over males, and in THA patients (39%) over TKA patients (30%; P = .011). Of those reporting bad sleep, 74% (201 of 270) were improved after arthroplasty. Satisfaction was higher in subjects reporting good sleep quality (626 of 676; 93%) compared with those reporting bad sleep quality (67 of 86; 78%) (P = .001). Sleep was positively correlated with better Hip Disability and Osteoarthritis Outcome Score/Knee Injury and Osteoarthritis Outcome Score (r = 0.2-0.3). CONCLUSION: Improvement in sleep quality and duration can be expected after THA and TKA and is associated with better outcome scores and satisfaction.
Subject(s)
Arthroplasty, Replacement, Hip , Arthroplasty, Replacement, Knee , Osteoarthritis, Knee , Arthroplasty, Replacement, Hip/adverse effects , Arthroplasty, Replacement, Knee/adverse effects , Female , Humans , Male , Osteoarthritis, Knee/surgery , Patient Reported Outcome Measures , Prospective Studies , Sleep , Treatment OutcomeABSTRACT
BACKGROUND: The aim was to describe the introduction and operation of a virtual developmental dysplasia of the hip (DDH) clinic. Our secondary objectives were to provide an overview of DDH referral reasons, treatment outcomes, and adverse events associated with it. METHODS: A prospective observational study involving all patients referred to the virtual DDH clinic was conducted. The clinic consultant delivered with 2 DDH clinical nurse specialists (CNS). The outcomes following virtual review include further virtual review, CNS review, consultant review or discharge. Treatment options include surveillance, brace therapy, or surgery. Efficiency and cost analysis were assessed. RESULTS: Over the 3.5-year study period, 1002 patients were reviewed, of which 743 (74.2%) were female. The median age at time of referral was 7 months, (interquartile range of 5 to 11) with a median time to treatment decision of 9 days. Median waiting times from referral to treatment decision was reduced by over 70%. There were 639 virtual reviews, 186 CNS reviews, and 144 consultant reviews. The direct discharge rate was 24%. One hundred one patients (10%) had dislocated or subluxed hips at initial visit while 26.3% had radiographically normal hips. Over the study period 704 face to face (F2F) visits were avoided. Cost reductions of 170 were achieved per patient, with 588,804 achieved in total. Eighteen parents (1.8%) opted for F2F instead of virtual review. There were no unscheduled rereferrals or recorded adverse events. CONCLUSION: We report the outcomes of the first prospective virtual DDH clinic. This clinic has demonstrated efficiency and cost-effectiveness, without reported adverse outcomes to date. It is an option to provide consultant delivered DDH care, while reducing F2F consults. LEVEL OF EVIDENCE: Level III.
Subject(s)
Ambulatory Care/methods , Hip Dislocation, Congenital/diagnostic imaging , Hip Dislocation, Congenital/therapy , Telemedicine/statistics & numerical data , Ambulatory Care/economics , Ambulatory Care/organization & administration , Braces , Cost Savings/statistics & numerical data , Female , Health Care Costs/statistics & numerical data , Humans , Infant , Male , Nurse Clinicians/organization & administration , Office Visits/economics , Office Visits/statistics & numerical data , Patient Discharge/statistics & numerical data , Prospective Studies , Referral and Consultation/statistics & numerical data , Telemedicine/economics , Telemedicine/organization & administration , Time-to-Treatment , Treatment Outcome , Watchful WaitingABSTRACT
BACKGROUND: Virtual fracture clinics are an alternative to the traditional model of fracture care. Since their introduction in 2011, they have become increasingly used in the United Kingdom and Ireland. The coronavirus disease 2019 (COVID-19) health crisis has driven institutions to examine such innovative solutions to manage patient care. The current controversies include quantifying safety outcomes, such as potential delayed or missed injuries, inadequate treatment, and medicolegal claims. Questions also exist regarding the potential for cost reductions and efficiencies that may be achieved. Physical distancing has limited the number of face-to-face consultations, so this review was conducted to determine if virtual fracture clinics can provide an acceptable alternative in these challenging times. QUESTIONS/PURPOSES: The aim of this systematic review was to describe (1) adverse outcomes, (2) cost reductions, and (3) efficiencies associated with the virtual fracture clinic model. METHODS: A systematic review of the PubMed, MEDLINE, and Embase databases was conducted from database inception to March 2020. The keywords "virtual" or "telemedicine" or "telehealth" or "remote" or "electronic" AND "fracture" or "trauma" or "triage" AND "clinic" or "consultation" were entered, using the preferred reporting items for systematic reviews and meta-analyses. Inclusion criteria included adults and children treated for injuries by a virtual clinic model at the initial review. Eligible injuries included injuries deemed to not need surgical intervention, and those able to be treated remotely using defined protocols. Exclusion criteria consisted of patients reviewed by telemedicine using video links or in person at the initial review. Initially, 1065 articles were identified, with 665 excluded as they did not relate to virtual fracture clinics. In all, 400 articles were screened for eligibility, and 27 full-text reviews were conducted on 18 studies (30,512 virtual fracture clinic encounters). Three subdomains focusing on adverse outcomes, cost reductions, and efficiencies were recorded. The term adverse outcomes was used to describe any complications, further surgeries, re-referrals back to the clinic, or deviations from the protocols. Efficiency described the number of patients reviewed and discharged using the model, savings in clinic slots, reduced waiting times, or a reduction in consumption of resources such as radiographs. All studies were observational and the quality was assessed using Newcastle-Ottawa tool, which demonstrated a median score of 6 ± 1.8, indicating moderate quality. RESULTS: Six studies reported adverse outcomes in detail, with events ranging from inappropriate splinting, deviations from protocols, and one patient underwent an osteotomy for a malunion. Efficiency varied from direct discharge proportions of 18% in early studies to 100% once the virtual fracture clinic model was more established. Cost reductions compared with estimates derived from conventional fracture clinics varied from USD 53 to USD 297 and USD 39,125 to USD 305876 compared with traditional fracture clinic visits. CONCLUSIONS: Virtual fracture clinics may provide a means to treat patients remotely, using agreed-upon protocols. They have an important role in the current COVID-19 pandemic, due to the possibility to provide ongoing care in an otherwise challenging setting. More robust studies looking at this model of care will be needed to assess its long-term effects on patients, institutions, and health care systems. LEVEL OF EVIDENCE: Level IV, therapeutic study.
Subject(s)
Ambulatory Care Facilities , Coronavirus Infections/prevention & control , Fractures, Bone/therapy , Orthopedics/methods , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Telemedicine/methods , Adult , Betacoronavirus , COVID-19 , Child , Female , Humans , Ireland/epidemiology , Male , Orthopedics/standards , Quality of Health Care , SARS-CoV-2 , Telemedicine/standards , United Kingdom/epidemiologyABSTRACT
BACKGROUND: Oral immunotherapy is effective at inducing desensitisation to allergens and induces sustained unresponsiveness (ie, clinical remission) in a subset of patients, but causes frequent reactions. We aimed to investigate whether addition of a probiotic adjuvant improved the efficacy or safety of peanut oral immunotherapy. METHODS: PPOIT-003, a multicentre, randomised, phase 2b trial, was conducted in three tertiary hospitals in Australia (Adelaide [SA], Melbourne [VIC], and Perth [WA]) in children aged 1-10 years, weighing more than 7 kg, with peanut allergy confirmed by a double-blind placebo-controlled food challenge (cumulative 4950 mg dose of peanut protein) and positive peanut skin prick test (≥3 mm) or peanut-specific IgE (≥0·35 kU/L). Children were randomly assigned (2:2:1) to receive probiotic and peanut oral immunotherapy (PPOIT), placebo probiotic and peanut oral immunotherapy (OIT), or placebo probiotic and placebo OIT (placebo) for 18 months, and were followed up until 12 months after completion of treatment. Oral immunotherapy consisted of increasing doses of peanut protein (commercially available food-grade 12% defatted peanut flour [50% peanut protein]) until a 2000 mg daily maintenance dose was reached. The probiotic adjuvant was a daily dose of 2 × 1010 colony-forming units of the probiotic Lactobacillus rhamnosus ATCC 53103. Placebo immunotherapy comprised maltodextrin, brown food colouring, and peanut essence, and placebo probiotic was maltodextrin. Dual primary outcomes were 8-week sustained unresponsiveness, defined as no reaction to a cumulative dose of 4950 mg peanut protein at treatment completion and 8 weeks after treatment completion, in the PPOIT versus placebo groups and the PPOIT versus OIT groups, analysed by intention to treat. Safety endpoints were adverse events during the treatment phase, and peanut ingestion and reactions in the 12-month post-treatment period. This study is registered with the Australian New Zealand Clinical Trials Registry, 12616000322437. FINDINGS: Between July 4, 2016, and Sept 21, 2020, 201 participants were enrolled and included in the intention-to-treat analysis. 36 (46%) of 79 children in the PPOIT group and 42 (51%) of 83 children in the OIT group achieved sustained unresponsiveness compared with two (5%) of 39 children in the placebo group (risk difference 40·44% [95% CI 27·46 to 53·42] for PPOIT vs placebo, p<0·0001), with no difference between PPOIT and OIT (-5·03% [-20·40 to 10·34], p=0·52). Treatment-related adverse events were reported in 72 (91%) of 79 children in the PPOIT group, 73 (88%) of 83 children in the OIT group, and 28 (72%) of 39 children in the placebo group. Exposure-adjusted incidence of adverse events was 10·58 in the PPOIT group, 11·36 in the OIT, and 2·09 in the placebo group (ratio 0·92 [95% CI 0·85 to 0·99] for PPOIT vs OIT, p=0·042; 4·98 [4·11-6·03] for PPOIT vs placebo, p<0·0001; 5·42 [4·48-6·56] for OIT vs placebo, p<0·0001), with differences seen primarily in gastrointestinal symptoms and in children aged 1-5 years. During the 12-month post-treatment period, 60 (85%) of 71 participants in the PPOIT group, 60 (86%) of 70 participants in the OIT group, and six (18%) of 34 participants in the placebo group were eating peanut; rescue epinephrine use was infrequent (two [3%] of 71 in the PPOIT group, four [6%] of 70 in the OIT group, and none in the placebo group). INTERPRETATION: Both PPOIT and OIT were effective at inducing sustained unresponsiveness. Addition of a probiotic did not improve efficacy of OIT, but might offer a safety benefit compared with OIT alone, particularly in preschool children. FUNDING: National Health and Medical Research Council Australia and Prota Therapeutics.
Subject(s)
Allergens/administration & dosage , Arachis/immunology , Desensitization, Immunologic/methods , Immunologic Factors/administration & dosage , Lacticaseibacillus rhamnosus/immunology , Peanut Hypersensitivity/therapy , Probiotics/administration & dosage , Administration, Oral , Australia , Child , Child, Preschool , Dietary Proteins/administration & dosage , Double-Blind Method , Female , Humans , Infant , Male , Quality of Life , Tertiary Care Centers , Treatment OutcomeABSTRACT
OBJECTIVE: The possibility exists that the vehicle for 17-alpha-hydroxyprogesterone caproate, castor oil, exerts an effect on human uterine contractility. The aim of this study was to evaluate its effects on contractility of myometrial preparations that were obtained during pregnancy. STUDY DESIGN: Myometrial strips were suspended under isometric conditions. Contractility was induced with oxytocin. Strips were incubated in castor oil or physiologic salt solution and suspended for a further oxytocin challenge. Contractile integrals were compared between both groups. RESULTS: Strips that were exposed to castor oil demonstrated increased contractile activity that was elicited by oxytocin (mean contractility value, 165.53%+/-17.03%; n=8; P=.004), compared with control strips (mean contractility value, 72.57%+/-7.48%; n=8; P=.003). There was a significant increase in contractile activity of the castor oil-exposed strips, compared with those that were exposed to physiologic salt solution (n=8; P<.001). CONCLUSION: Exposure of human myometrial preparations to castor oil results in enhanced oxytocin-induced contractility.
Subject(s)
17-alpha-Hydroxyprogesterone/administration & dosage , Castor Oil/administration & dosage , Oxytocin/physiology , Uterine Contraction/drug effects , Uterine Contraction/physiology , Adult , Drug Synergism , Female , Humans , In Vitro Techniques , Injections, Intramuscular , Pregnancy , Pregnancy Trimester, Third/physiologyABSTRACT
BACKGROUND: The aim of this study was to compare patient-reported outcomes 6 months after hip or knee arthroplasty in subjects who were discharged to home compared to those who attended inpatient rehabilitation. METHODS: Seven hundred and forty-eight consecutive total hip or knee replacement patients were identified from a prospective database. Preoperative and 6-month post-operative patient-reported outcome measures were recorded. Forty-four patients discharged directly to home were cohort matched by age, gender, procedure and surgeon to 44 patients from the cohort who received inpatient care. Patient outcomes were compared using SPSS version 24 software. RESULTS: Both cohorts saw significant improvements from baseline at 6 months. Median length of rehabilitation for the inpatient group was 7 days (4-16 days). There was no significant difference between the groups based on patient-reported outcomes. There was a clinically significant difference (P = 0.047) in the body mass index of the Home Group (mean = 27) to Rehab Group (mean = 29). CONCLUSION: Our study has shown that inpatient rehabilitation after hip or knee arthroplasty did not positively affect 6-month patient-reported satisfaction, expectation, pain, quality of life, activities of daily living scores, when compared with subjects who were discharged direct to home. A significant average saving of $5600 per patient with the use of home discharge is a promising avenue for health cost reduction, and health resource distribution.
Subject(s)
Arthroplasty, Replacement, Hip/rehabilitation , Arthroplasty, Replacement, Knee/rehabilitation , Hospitalization/economics , Rehabilitation/methods , Activities of Daily Living/psychology , Arthroplasty, Replacement, Hip/economics , Arthroplasty, Replacement, Knee/economics , Australia/epidemiology , Female , Hospitalization/statistics & numerical data , Humans , Inpatients/statistics & numerical data , Male , Middle Aged , Patient Discharge/trends , Patient Reported Outcome Measures , Prospective Studies , Quality of Life/psychology , Rehabilitation/economics , Treatment OutcomeABSTRACT
The association of autoantibodies to cytokines with immune deficiency, autoimmunity and/or immune dysregulation is increasingly being recognized. For example, autoantibodies to interferon gamma have been found to be associated with chronic, treatment refractory infections with intracellular organisms such as mycobacteria, autoantibodies to interleukin 17 with chronic mucocutaneous candidiasis, and anti-interferon alpha autoantibodies with systemic lupus erythematosus. While low titer autoantibodies to these and other cytokines may be detected in normal individuals, patients with infectious or autoimmune manifestations tend to have high titer autoantibodies that may block or potentiate the function of the respective cytokine. Recognition of these autoantibodies is important because it may direct treatment toward a combination of adjunctive immunotherapy to modulate the autoantibody level while continuing with appropriate anti-microbial therapy. This review focuses on the anti-cytokine autoantibodies documented to date, their autoimmune, immune dysregulation and infectious disease associations, methods for detection of these antibodies and potential treatment options.
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The aim of this case report was to highlight the application of magnetic resonance imaging (MRI) in elucidating serious and occult injuries in a single case of hyperflextion injury of a patient cervical spine (C-Spine). A chart and radiology review was performed to establish the sequence of care and how the results of imaging studies influenced the clinical management in this trauma case. Plain radiographs and computed tomography (CT) imaging modalities of the C-Spine revealed bilateral C4/C5 facetal subluxation with no obvious fractures; however, the MR imaging of the C-Spine revealed a non-contiguous and occult injury to C6/C7 disc with a posterior annular tear and associated disc extrusion. This altered the operative intervention that was initially planned. MR imaging proved an invaluable diagnostic addition in this particular case of cervical trauma in a rugby player following a hyperflextion injury, by revealing a serious non-contiguous and occult injury of the C-Spine.