Telehealth assessment of autism in preschoolers using the TELE-ASD-PEDS: A pilot clinical investigation.

PURPOSE: Appropriate early intervention is beneficial but dependent on accurate and timely diagnoses. This has been affected by long waiting lists for face-to-face clinical services, in part due to pandemic lockdowns, with telehealth introduced in many services to continue clinical services. This pilot clinical study investigated the feasibility of integrating a specially-designed telepractice autism assessment tool into a tertiary diagnostic service. METHOD: Eighteen boys (2;4-5;1) participated in the study. Assessment was undertaken as per standard practice (parent interview, questionnaires, review of reports), with an additional telepractice assessment, included in place of face-to-face assessment, to provide clinicians with an observation of the children's communication, behaviours, and interests. Ten parents provided feedback via semi-structured interviews. RESULT: The TELE-ASD-PEDS was a feasible assessment tool in terms of administration, clinical experience, and information gained through the assessment process. Parents reported mostly positive experiences of the TELE-ASD-PEDS and made suggestions for improvements for future use of this tool. CONCLUSION: It is possible to obtain useful information about a child's autism-specific behaviours using the activities in the TELE-ASD-PEDS. This information can be combined with clinical history from parents using the DSM-5 framework to provide a gold standard assessment for autism.

A systematic review of interventions for echolalia in autistic children.

INTRODUCTION: Echolalia, the repetition of others' speech, is a common observation in autistic people. Research has established that echolalia is functional and meaningful for many; however, some clinicians and researchers continue to characterise it as pathological and in need of reduction. The aim of this systematic review was to understand the range and impact of interventions for echolalia in autistic children. METHOD: A systematic search was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. A total of 15 studies met predetermined inclusion criteria. Screening, data extraction and quality rating using the Scientific Merit Rating Scale (SMRS) were performed in duplicate. RESULTS: Ten interventions across 15 papers were found. Results indicated that interventions generally decreased levels of echolalia. However, there were considerable inconsistencies in the definitions and conceptualisations of echolalia, administration, generalisation techniques and the measures used. The quality of the studies was very low. CONCLUSION: Interventions for echolalia vary widely in terms of administration and measurement. There is limited consensus on the definition of echolalia among the reviewed studies, and no evidence that echolalia is recognised as functional or meaningful to the autistic children. Further, the lack of methodological rigour makes it difficult to draw clinical conclusions about the interventions. WHAT THIS PAPER ADDS: What is already known Echolalia is the immediate or delayed repetition of others' speech and is a common observation in autistic children and in some older autistic people. While research and practice has established that echolalia is a functional and meaningful form of communication, particularly for those first developing spoken communication, some clinicians and researchers continue to characterise it as problematic and suggest that echolalia should be reduced or eliminated. What this study adds We systematically searched the literature about echolalia interventions to try to find out about the types of interventions that aim to reduce or eliminate echolalia. We found 15 studies on this topic. The way they defined echolalia was varied, and there was a range of interventions researched. None of the research papers recognised echolalia as functional or meaningful and the quality of the research was very low. What are the potential or actual clinical implications of this work? Clinicians, families and researchers should think carefully and critically about suggesting any programs or supports that aim to reduce echolalia as no recommendations can be drawn from the research we studied. Echolalia should be considered functional, and efforts made to understand the meaning and purpose of echolalic speech.

A Survey of Orthopedic Surgical Management of Pressure Ulcer-Related Pelvic Osteomyelitis.

Pressure-ulcer related pelvic osteomyelitis is managed with little high-quality evidence. We undertook an international survey of orthopedic surgical management, covering diagnostic parameters, multidisciplinary input, and surgical approaches (indications, timing, wound closure, and adjunctive therapies). This identified areas of consensus and disagreement, representing a starting point for future discussion and research.

Lenacapavir and the novel HIV-1 capsid inhibitors: an emerging therapy in the management of multidrug-resistant HIV-1 virus.

PURPOSE OF REVIEW: The aim of this study was to summarize current evidence regarding lenacapavir, a first in class HIV-1 capsid inhibitor, and its role as an emergent therapy for the treatment of HIV-1 infection. RECENT FINDINGS: HIV-1 capsid inhibitors (of which lenacapavir is the first in class) has been postulated to have activity against multidrug resistant HIV-1 viral isolates. Initial results from the phase 3 trial CAPELLA (combining oral and subcutaneous lenacapavir alongside failing drug therapies) suggest that there may be a role for these novel agents in a cohort of patients living with HIV-1 infection (PLWH) for whom multidrug resistance has previously been a barrier to effective therapy. Despite emergent lenacapavir resistance mutations detected in some study participants, virological suppression was still potentially attainable, offering some hope to PLWH with limited antiviral regimens available. Initial results from the CALIBRATE trial show promise for the role of lenacapavir-containing regimens in a treatment-naive cohort as well. SUMMARY: Lenacapavir may prove to be an adjunctive agent in the management of PLWH with significant HIV-1 drug resistance.

Spoken Language Change in Children on the Autism Spectrum Receiving Community-Based Interventions.

We assessed the spoken language of 73 preschool aged children on the autism spectrum receiving community-based early intervention at two time points, approximately 7 months apart. Using the Spoken Language Benchmarks, there was a small non-significant change in the proportion of children transitioning from below, to at or above, Phase 3 (word combinations). Using binomial regression, a model comprising seven of nine clinician-proposed child-related predictors explained 64% of the variance. None of the predictors were individually significant, although a large effect size (OR = 16.71) was observed for children's baseline rate of communicative acts. The findings point to substantial unmet clinical need in children with minimal verbal language, but also the relevance of clinician-proposed predictors of their spoken language outcomes.

The Benefits, Challenges and Impacts of Telehealth Student Clinical Placements for Accredited Health Programs During the COVID-19 Pandemic.

Introduction: Despite the advantages of telehealth, there has been a reluctance in its widespread adoption. During the COVID-19 pandemic, telehealth services and related placements increased internationally. Yet, there is currently limited research on the use of telehealth for student clinical placements. Aim: To explore the perceived benefits, challenges, and impacts of telehealth placements for key stakeholders (clients, students, clinical educators, and placement co-ordinators) in allied health courses. Methods: Stakeholder experiences with telehealth placements, undertaken within an Australian Allied Health University Clinic, were explored in virtual focus groups held between November 2020 and March 2021. These discussions used semi-structured interview questions, were audiotaped and transcribed verbatim. They were then thematically analyzed independently by two researchers, then cross-checked for consistency, using a qualitative descriptive approach, with reflexivity applied. Results: Twenty-six stakeholders from six allied health disciplines participated in seven homogeneous focus groups. Three themes were identified: (1) telehealth placements support competency development and graduate employability; (2) telehealth placements enable students to provide person centered-care; and (3) telehealth placements enabled innovation. Conclusion: Telehealth placements can make a valuable contribution as part of an overall placement program within accredited health courses and offer distinct advantages to student learning outcomes.

Can You See My Screen? Virtual Assessment in Speech and Language.

PURPOSE: This introduction presents the LSHSS Forum: Can You See My Screen? Virtual Assessment in Speech and Language. The goals of the forum are to document reliability and validity of assessment results conducted virtually, identify characteristics of measures that are suitable for online assessment, and provide clinical and research guidance for interpreting diagnostic results obtained in virtual settings. METHOD: In this introduction, we provide an overview of the research completed by nine teams, who submitted research articles and notes on a variety of topics pertinent to the theme of telehealth assessments. Of these, seven teams investigated the validity and reliability of 14 different assessment tools, while two teams described training and experience issues. CONCLUSION: The nine studies presented in this forum will provide speech-language pathologists with insight into a range of issues regarding telehealth assessment, including the breadth of suitable assessment tools; practical strategies for assessing children with a diverse range of ages, languages, skills, and abilities; and the unexpected challenges and opportunities of conducting clinical work and research during a global pandemic.

Barriers and facilitators: Clinicians' opinions and experiences of telehealth before and after their use of a telehealth platform for child language assessment.

BACKGROUND: Despite emerging evidence of validity and reliability, speech and language therapists' (SLT) uptake of telehealth has been limited and barriers remain to the effective and confident use of this service model. The COVID-19 pandemic has caused significant disruption to essential health services, including speech and language therapy assessment and intervention, meaning that telehealth must now be considered as part of the suite of service delivery options for all clinicians. AIMS: To explore the perceived barriers and facilitators of telehealth among community paediatric SLTs before and after their use of a telehealth platform with an embedded standardised assessment tool. METHODS & PROCEDURES: Mixed-methods questionnaires were developed for this study and completed by SLTs before and after the 3-month trial of the telehealth platform. A total of 38 SLTs completed the pre-trial questionnaire and training in the use of telehealth platform (Coviu), including instruction in using a standardised, norm referenced language test as an integrated tool within the Coviu platform. A total of 27 SLTs went on to use the telehealth platform, and 25 of these completed the post-trial questionnaire on which subsequent qualitative and quantitative analysis was completed. OUTCOMES & RESULTS: Prior to using the platform, perceived barriers included technology issues, limited clinician experience and concerns around parent acceptance of the service. Potential facilitators included access to appropriate platforms, tools and resources as well as increased clinician confidence with telehealth. Following the trial, barriers to telehealth use continued to include technology barriers, particularly internet stability, and client issues, including suitability for telehealth services. Facilitators for future telehealth use included access to appropriate platforms for telehealth, stable and appropriate internet connectivity, and more extensive telehealth resources for both assessment and intervention for this mode of service delivery. CONCLUSIONS & IMPLICATIONS: This study provides insights into the perceptions of the barriers and facilitating factors for telehealth use among community-based SLTs. This information will be useful in developing strategies to promote uptake and effective and confident use of telehealth as a mode of service delivery beyond the pandemic. WHAT THIS PAPER ADDS: What is already known on the subject Research about telehealth has shown that it is a reliable and valid way of delivering speech pathology services, yet many clinicians have been wary of its use and uptake of telehealth prior to COVID-19 had been limited. We wanted to know what SLTs thought about using telehealth before and after participating in a 3-month trial of a telehealth platform with an embedded formal language assessment. What this study adds to existing knowledge This study indicates that technology issues including internet stability are a barrier to effective telehealth services, but that appropriate telehealth platforms, resources and experience are facilitators of uptake and successful use of telehealth. What are the potential or actual clinical implications of this work? This information will be useful in developing strategies to promote uptake and effective and confident use of telehealth as a mode of service delivery for children during and beyond the pandemic, including those isolated by geographical or transport barriers.

Expect the unexpected - Implications for next phase of COVID-19 response.

A case report of a 66 year old male patient with COVID 19 who presented late in the clinical course and subsequently developed respiratory failure requiring intubation, after initially experiencing diarrhoea.

Clinician experiences using standardised language assessments via telehealth.

Purpose: Telehealth is rapidly becoming an essential part of speech-language pathologists' core business, and yet the experiences and opinions of community-based therapists in using telehealth remain relatively unknown. This paper describes a recent study in which speech-language pathologists were provided with access to a formal language assessment within a telehealth platform and asked to provide feedback about their experiences.Method: Twenty-seven speech-language pathologists in paediatric practice were recruited via callouts on social media, community contacts and professional networks. The participants were provided access to a telehealth platform with a built-in formal language assessment and asked to use the assessment with their own caseload as clinically indicated and provide feedback after each assessment. Questionnaire data was collected via an online survey system and contained questions about each assessment including the most enjoyable and most difficult aspects of the assessment and their overall experience of the platform.Result: More than 100 assessments were completed during the 3-month trial, with clinicians reporting that on most occasions, video and audio quality was adequate or more than adequate, and that interactions with their child clients were effective. Qualitative data indicated that technical difficulties were a drawback to the assessments, but that ease of use of the assessment, the added functionality of using the assessment within the telehealth platform and factors including general benefits of telehealth, particularly that of being able to continue to provide services when face-to-face work was not possible were seen as positive elements.Conclusion: This study adds clinicians' voices to the research into telehealth, indicating that the assessment within the telehealth platform was generally easy to use, and provided an unexpected depth of insight and connection for clinicians and their clients. Future research may consider the voices of other stakeholders in telehealth interactions, including parents and child clients.

Predictors of adaptive functioning in preschool aged children with autism spectrum disorder.

Difficulties in adaptive functioning are common in autism spectrum disorder (ASD) and contribute to negative outcomes across the lifespan. Research indicates that cognitive ability is related to degree of adaptive functioning impairments, particularly in young children with ASD. However, the extent to which other factors, such as socioeconomic status (SES) and ASD symptom severity, predict impairments in adaptive functioning remains unclear. The goal of this study was to determine the extent to which SES, ASD symptom severity, and cognitive ability contribute to variability in domain-specific and global components of adaptive functioning in preschool-aged children with ASD. Participants were 99 preschool-aged children (2-6 years) with ASD who attended a tertiary diagnostic service. Results demonstrate that cognitive ability accounted for a significant proportion of variance in domain-specific and global components of adaptive functioning, with higher cognitive ability predicting better adaptive functioning. Results also demonstrate that SES accounted for some variability in domain-specific communication skills and global adaptive functioning when compared to basic demographic factors alone (age and gender). By contrast, ASD symptom severity did not predict variability in domain-specific or global components of adaptive functioning. These findings provide support for a relationship between cognitive ability and adaptive functioning in preschool-aged children with ASD and help to explain specific contributions of verbal and nonverbal ability to adaptive functioning; from this, we can better understand which children are likely to show the greatest degree of impairments across components of adaptive functioning early in development. LAY SUMMARY: People with autism often have difficulties with everyday communication, daily living, and social skills, which are also called adaptive functioning skills. This study investigated factors that might be related to these difficulties in preschoolers with autism. We found that better cognitive ability, but not autism symptoms, were associated with better adaptive functioning. This suggests that interventions for young children with autism should take into account cognitive ability to better understand which children are likely to have difficulties with adaptive functioning.

The Acceptability and Efficacy of Electronic Data Collection in a Hospital Neurodevelopmental Clinic: Pilot Questionnaire Study.

BACKGROUND: There is a growing need for cost-efficient and patient-centered approaches to support families in hospital- and community-based neurodevelopmental services. For such purposes, electronic data collection (EDC) may hold advantages over paper-based data collection. Such EDC approaches enable automated data collection for scoring and interpretation, saving time for clinicians and services and promoting more efficient service delivery. OBJECTIVE: This pilot study evaluated the efficacy of EDC for the Child Development Unit, a hospital-based diagnostic assessment clinic in the Sydney Children's Hospital Network. Caregiver response rates and preference for EDC or paper-based methods were evaluated as well as the moderating role of demographic characteristics such as age, level of education, and ethnic background. METHODS: Families were sent either a paper-based questionnaire via post or an electronic mail link for completion before attending their first on-site clinic appointment for assessment. A total of 62 families were provided a paper version of the questionnaire, while 184 families were provided the online version of the same questionnaire. RESULTS: Completion rates of the questionnaire before the first appointment were significantly higher for EDC (164/184, 89.1%) in comparison to paper-based methods (24/62, 39%; P<.001). Within the EDC group, a vast majority of respondents indicated a preference for completing the questionnaire online (151/173, 87.3%), compared to paper completion (22/173, 12.7%; P<.001). Of the caregiver demographic characteristics, only the respondent's level of education was associated with modality preference, such that those with a higher level of education reported a greater preference for EDC (P=.04). CONCLUSIONS: These results show that EDC is feasible in hospital-based clinics and has the potential to offer substantial benefits in terms of centralized data collation, time and cost savings, efficiency of service, and resource allocation. The results of this study therefore support the continued use of electronic methods to improve family-centered care in clinical practices.

Clinician Proposed Predictors of Spoken Language Outcomes for Minimally Verbal Children with Autism Spectrum Disorder.

Our aim was to explore insights from clinical practice that may inform efforts to understand and account for factors that predict spoken language outcomes for children with Autism Spectrum Disorder who use minimal verbal language. We used a qualitative design involving three focus groups with 14 speech pathologists to explore their views and experiences. Using the Framework Method of analysis, we identified 9 themes accounting for 183 different participant references to potential factors. Participants highlighted the relevance of clusters of fine-grained social, communication, and learning behaviours, including novel insights into prelinguistic vocal behaviours. The participants suggested the potential value of dynamic assessment in predicting spoken language outcomes. The findings can inform efforts to developing clinically relevant methods for predicting children's communication outcomes.

Outcomes, Microbiology and Antimicrobial Usage in Pressure Ulcer-Related Pelvic Osteomyelitis: Messages for Clinical Practice.

Introduction: Pressure ulcer-related pelvic osteomyelitis is a relatively under-studied entity in the field of bone infection. We sought to add to the limited evidence base for managing this challenging syndrome. Methods: Cases were identified retrospectively from a surgical database and hospital discharge codes at a U.K. tertiary centre (2009-2018). Risk factors associated with outcomes were analysed by logistic regression. Results: We identified 35 patients (mean age 57.4 years), 69% managed with a combined medical and surgical approach, with mean follow-up of 3.7 years from index admission. Treatment failure (requiring further surgery or intravenous antimicrobials) occurred in 71% and eventual ulcer healing in 36%. One-year mortality was 23%. Lack of formal care support on discharge, post-traumatic (asensate) neurological deficit and index CRP (>184mg/L) were associated with treatment failure (p=0.001). Age (>59.5 years), lack of attempted soft tissue coverage, haemoglobin (<111g/L) and albumin (<25g/L) were associated with non-healing ulcers (p=0.003). Superficial wound swabs had low sensitivity and specificity compared to deep bone microbiology. Infection (based on deep bone microbiology from 46 infection episodes) was usually polymicrobial (87%), commonly involving S. aureus, Enterococci, GNB and anaerobes. Antimicrobial duration ranged from 0-103 days (mean 54) and was not associated with subsequent treatment failure. Conclusions: Attempted soft tissue coverage after surgical debridement, ensuring appropriate support for personal care after discharge and nutritional optimisation could improve outcomes. Superficial wound swabs are uninformative and deep bone sampling should be pursued. Long antimicrobial courses do not improve outcomes. Clinicians should engage patients in anticipatory care planning.

The index case of SARS-CoV-2 in Scotland.

Since its identification in December 2019, SARS-CoV-2 has infected 125,048 persons globally with cases identified in 118 countries across all continents. We report on the Scottish index case of SARS-CoV-2 infection, the virus causing COVID-19.

Brief Report: Perceived Evidence and Use of Autism Intervention Strategies in Early Intervention Providers.

Use of empirically unsupported practices is a challenge in the field of autism spectrum disorder (ASD). We explored whether attitudes and perceived evidence were linked to intended practice use in early intervention staff. Seventy-one participants completed ratings of the evidence base, current and future use of six ASD intervention practices, and reported attitudes to research and evidence-based practice. Participants reported greater use and rated the evidence base higher for the empirically supported practices. However, variability in accuracy of evidence base ratings was observed across individuals. Higher perceived evidence was linked to greater future use intentions for empirically supported and unsupported practices. The need for accurate information across practice types is highlighted. Self-report methodology limitations and future research directions are discussed.

Oral versus intravenous antibiotics for bone and joint infections: the OVIVA non-inferiority RCT.

BACKGROUND: Management of bone and joint infection commonly includes 4-6 weeks of intravenous (IV) antibiotics, but there is little evidence to suggest that oral (PO) therapy results in worse outcomes. OBJECTIVE: To determine whether or not PO antibiotics are non-inferior to IV antibiotics in treating bone and joint infection. DESIGN: Parallel-group, randomised (1 : 1), open-label, non-inferiority trial. The non-inferiority margin was 7.5%. SETTING: Twenty-six NHS hospitals. PARTICIPANTS: Adults with a clinical diagnosis of bone, joint or orthopaedic metalware-associated infection who would ordinarily receive at least 6 weeks of antibiotics, and who had received ≤ 7 days of IV therapy from definitive surgery (or start of planned curative treatment in patients managed non-operatively). INTERVENTIONS: Participants were centrally computer-randomised to PO or IV antibiotics to complete the first 6 weeks of therapy. Follow-on PO therapy was permitted in either arm. MAIN OUTCOME MEASURE: The primary outcome was the proportion of participants experiencing treatment failure within 1 year. An associated cost-effectiveness evaluation assessed health resource use and quality-of-life data. RESULTS: Out of 1054 participants (527 in each arm), end-point data were available for 1015 (96.30%) participants. Treatment failure was identified in 141 out of 1015 (13.89%) participants: 74 out of 506 (14.62%) and 67 out of 509 (13.16%) of those participants randomised to IV and PO therapy, respectively. In the intention-to-treat analysis, using multiple imputation to include all participants, the imputed risk difference between PO and IV therapy for definitive treatment failure was -1.38% (90% confidence interval -4.94% to 2.19%), thus meeting the non-inferiority criterion. A complete-case analysis, a per-protocol analysis and sensitivity analyses for missing data each confirmed this result. With the exception of IV catheter complications [49/523 (9.37%) in the IV arm vs. 5/523 (0.96%) in the PO arm)], there was no significant difference between the two arms in the incidence of serious adverse events. PO therapy was highly cost-effective, yielding a saving of £2740 per patient without any significant difference in quality-adjusted life-years between the two arms of the trial. LIMITATIONS: The OVIVA (Oral Versus IntraVenous Antibiotics) trial was an open-label trial, but bias was limited by assessing all potential end points by a blinded adjudication committee. The population was heterogenous, which facilitated generalisability but limited the statistical power of subgroup analyses. Participants were only followed up for 1 year so differences in late recurrence cannot be excluded. CONCLUSIONS: PO antibiotic therapy is non-inferior to IV therapy when used during the first 6 weeks in the treatment for bone and joint infection, as assessed by definitive treatment failure within 1 year of randomisation. These findings challenge the current standard of care and provide an opportunity to realise significant benefits for patients, antimicrobial stewardship and the health economy. FUTURE WORK: Further work is required to define the optimal total duration of therapy for bone and joint infection in the context of specific surgical interventions. Currently, wide variation in clinical practice suggests significant redundancy that likely contributes to the excess and unnecessary use of antibiotics. TRIAL REGISTRATION: Current Controlled Trials ISRCTN91566927. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 38. See the NIHR Journals Library website for further project information.

Treatment of bone and joint infection usually requires a long course of antibiotics. Doctors usually give these by injection through a vein (intravenously) for the first 4­6 weeks, rather than by mouth (orally). Although intravenous (IV) administration is more expensive and less convenient for patients, most doctors believe that it is more effective. However, there is little evidence to support this. The OVIVA (Oral Versus IntraVenous Antibiotics) trial set out to challenge this assumption. A total of 1054 patients from 26 UK hospitals were randomly allocated to receive the first 6 weeks of antibiotic therapy either intravenously or orally. Irrespective of the route of administration, the choice of antibiotic was left to an infection specialist so as to ensure that the most appropriate antibiotics were given. Patients were followed up for 1 year. Thirty-nine participants were lost to follow-up. Among the remaining 1015 participants, treatment failure occurred in 14.6% of those treated intravenously and 13.2% of those treated with PO antibiotics. This difference could easily have occurred by chance. Even if it was not by chance, the difference does not suggest that PO therapy is associated with worse outcomes than IV therapy and is too small to conclude that PO therapy is better than IV therapy. Participants in the IV group stayed in hospital longer and 10% of them had complications related to the IV line used for administering the antibiotics. In addition, their treatment was, overall, more expensive. We conclude that PO antibiotic therapy has no disadvantages for the early management of bone and joint infection. It is also cheaper and associated with fewer complications.

Oral versus Intravenous Antibiotics for Bone and Joint Infection.

BACKGROUND: The management of complex orthopedic infections usually includes a prolonged course of intravenous antibiotic agents. We investigated whether oral antibiotic therapy is noninferior to intravenous antibiotic therapy for this indication. METHODS: We enrolled adults who were being treated for bone or joint infection at 26 U.K. centers. Within 7 days after surgery (or, if the infection was being managed without surgery, within 7 days after the start of antibiotic treatment), participants were randomly assigned to receive either intravenous or oral antibiotics to complete the first 6 weeks of therapy. Follow-on oral antibiotics were permitted in both groups. The primary end point was definitive treatment failure within 1 year after randomization. In the analysis of the risk of the primary end point, the noninferiority margin was 7.5 percentage points. RESULTS: Among the 1054 participants (527 in each group), end-point data were available for 1015 (96.3%). Treatment failure occurred in 74 of 506 participants (14.6%) in the intravenous group and 67 of 509 participants (13.2%) in the oral group. Missing end-point data (39 participants, 3.7%) were imputed. The intention-to-treat analysis showed a difference in the risk of definitive treatment failure (oral group vs. intravenous group) of -1.4 percentage points (90% confidence interval [CI], -4.9 to 2.2; 95% CI, -5.6 to 2.9), indicating noninferiority. Complete-case, per-protocol, and sensitivity analyses supported this result. The between-group difference in the incidence of serious adverse events was not significant (146 of 527 participants [27.7%] in the intravenous group and 138 of 527 [26.2%] in the oral group; P=0.58). Catheter complications, analyzed as a secondary end point, were more common in the intravenous group (9.4% vs. 1.0%). CONCLUSIONS: Oral antibiotic therapy was noninferior to intravenous antibiotic therapy when used during the first 6 weeks for complex orthopedic infection, as assessed by treatment failure at 1 year. (Funded by the National Institute for Health Research; OVIVA Current Controlled Trials number, ISRCTN91566927 .).