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Objectives Our recent systematic review determined that remote patient monitoring (RPM) interventions can reduce acute care use. However, effectiveness varied within and between populations. Clinicians, researchers, and policymakers require more than evidence of effect; they need guidance on how best to design and implement RPM interventions. Therefore, this study aimed to explore these results further to (1) identify factors of RPM interventions that relate to increased and decreased acute care use and (2) develop recommendations for future RPM interventions.Design Realist review—a qualitative systematic review method which aims to identify and explain why intervention results vary in different situations. We analysed secondarily 91 studies included in our previous systematic review that reported on RPM interventions and the impact on acute care use. Online databases PubMed, EMBASE and CINAHL were searched in October 2020. Included studies were published in English during 2015–2020 and used RPM to monitor an individual’s biometric data (eg, heart rate, blood pressure) from a distance.Primary and secondary outcome measures Contextual factors and potential mechanisms that led to variation in acute care use (hospitalisations, length of stay or emergency department presentations).Results Across a range of RPM interventions 31 factors emerged that impact the effectiveness of RPM innovations on acute care use. These were synthesised into six theories of intervention success: (1) targeting populations at high risk; (2) accurately detecting a decline in health; (3) providing responsive and timely care; (4) personalising care; (5) enhancing self-management, and (6) ensuring collaborative and coordinated care.Conclusion While RPM interventions are complex, if they are designed with patients, providers and the implementation setting in mind and incorporate the key variables identified within this review, it is more likely that they will be effective at reducing acute hospital events.PROSPERO registration number CRD42020142523.

Objective Chronic diseases are associated with increased unplanned acute hospital use. Remote patient monitoring (RPM) can detect disease exacerbations and facilitate proactive management, possibly reducing expensive acute hospital usage. Current evidence examining RPM and acute care use mainly involves heart failure and omits automated invasive monitoring. This study aimed to determine if RPM reduces acute hospital use.Methods A systematic literature review of PubMed, Embase and CINAHL electronic databases was undertaken in July 2019 and updated in October 2020 for studies published from January 2015 to October 2020 reporting RPM and effect on hospitalisations, length of stay or emergency department presentations. All populations and disease conditions were included. Two independent reviewers screened articles. Quality analysis was performed using the Joanna Briggs Institute checklist. Findings were stratified by outcome variable. Subgroup analysis was undertaken on disease condition and RPM technology.Results From 2050 identified records, 91 studies were included. Studies were medium-to-high quality. RPM for all disease conditions was reported to reduce admissions, length of stay and emergency department presentations in 49% (n=44/90), 49% (n=23/47) and 41% (n=13/32) of studies reporting each measure, respectively. Remaining studies largely reported no change. Four studies reported RPM increased acute care use. RPM of chronic obstructive pulmonary disease (COPD) was more effective at reducing emergency presentation than RPM of other disease conditions. Similarly, invasive monitoring of cardiovascular disease was more effective at reducing hospital admissions versus other disease conditions and non-invasive monitoring.Conclusion RPM can reduce acute care use for patients with cardiovascular disease and COPD. However, effectiveness varies within and between populations. RPM’s effect on other conditions is inconclusive due to limited studies. Further analysis is required to understand underlying mechanisms causing variation in RPM interventions. These findings should be considered alongside other benefits of RPM, including increased quality of life for patients.PROSPERO registration number CRD42020142523.

Objective: To explore and model factors affecting antibiotic prescribing decision-making early in the pandemic., Design: Semistructured qualitative interview study., Setting: National Health Service (NHS) trusts/health boards in England and Wales., Participants: Clinicians from NHS trusts/health boards in England and Wales., Method: Individual semistructured interviews were conducted with clinicians in six NHS trusts/health boards in England and Wales as part of the Procalcitonin Evaluation of Antibiotic use in COVID-19 Hospitalised patients study, a wider study that included statistical analysis of procalcitonin (PCT) use in hospitals during the first wave of the pandemic. Thematic analysis was used to identify key factors influencing antibiotic prescribing decisions for patients with COVID-19 pneumonia during the first wave of the pandemic (March to May 2020), including how much influence PCT test results had on these decisions., Results: During the first wave of the pandemic, recommendations to prescribe antibiotics for patients with COVID-19 pneumonia were based on concerns about secondary bacterial infections. However, as clinicians gained more experience with COVID-19, they reported increasing confidence in their ability to distinguish between symptoms and signs caused by SARS-CoV-2 viral infection alone, and secondary bacterial infections. Antibiotic prescribing decisions were influenced by factors such as clinician experience, confidence, senior support, situational factors and organisational influences. A decision-making model was developed., Conclusion: This study provides insight into the decision-making process around antibiotic prescribing for patients with COVID-19 pneumonia during the first wave of the pandemic. The importance of clinician experience and of senior review of decisions as factors in optimising antibiotic stewardship is highlighted. In addition, situational and organisational factors were identified that could be optimised. The model presented in the study can be used as a tool to aid understanding of the complexity of the decision-making process around antibiotic prescribing and planning antimicrobial stewardship support in the context of a pandemic., Trial Registration Number: ISRCTN66682918., Competing Interests: Competing interests: All authors (with the exception of RH) and members of the PEACH consortium received funding from NIHR COVID Learning and Recovery Call programme (NIHR132254) for the PEACH Study and for the delivery of this manuscript. ET-J, JE, LB-H, PP and WM (main authors) and ST (consortium) all received funding from NIHR-HTA programme for delivery of the PRONTO trial (NIHR17/136/13). EC, ET-J, PP and LB-H received funding from NIHR for the BATCH trial (15/188/42). EC, ET-J and PP received funding from MRC-NIHR EME for contribution to the PRECISE study (NIHR129960). PH received funding from Abbot Laboratories for attending the European Network for Antimicrobial Stewardship in Point of Care. PH has also previously held post as Vice Chancellor for British Society for Antimicrobial Chemotherapy (BSAC) and is currently a committee member., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Sepsis is a common, potentially life-threatening complication of infection. The optimal treatment for sepsis includes prompt antibiotics and intravenous fluids, facilitated by its early and accurate recognition. Currently, clinicians identify and assess severity of suspected sepsis using validated clinical scoring systems. In England, the National Early Warning Score 2 (NEWS2) has been mandated across all National Health Service (NHS) trusts and ambulance organisations. Like many clinical scoring systems, NEWS2 should not be used without clinical judgement to determine either the level of acuity or a diagnosis. Despite this, there is a tendency to overemphasise the score in isolation in patients with suspected infection, leading to the overprescription of antibiotics and potentially treatment-related complications and rising antimicrobial resistance. The biomarker procalcitonin (PCT) has been shown to be useful in specific circumstances to support appropriate antibiotics prescribing by identifying bacterial infection. PCT is not routinely used in the care of undifferentiated patients presenting to emergency departments (EDs), and the evidence base of its optimal usage is poor. The PROcalcitonin and NEWS2 evaluation for Timely identification of sepsis and Optimal (PRONTO) study is a randomised controlled trial (RCT) in adults with suspected sepsis presenting to the ED to compare standard clinical management based on NEWS2 scoring plus PCT-guided risk assessment with standard clinical management based on NEWS2 scoring alone and compare if this approach reduces prescriptions of antibiotics without increasing mortality., Methods and Analysis: PRONTO is a parallel two-arm open-label individually RCT set in up to 20 NHS EDs in the UK with a target sample size of 7676 participants. Participants will be randomised in a ratio of 1:1 to standard clinical management based on NEWS2 scoring or standard clinical management based on NEWS2 scoring plus PCT-guided risk assessment. We will compare whether the addition of PCT measurement to NEWS2 scoring can lead to a reduction in intravenous antibiotic initiation in ED patients managed as suspected sepsis, with at least no increase in 28-day mortality compared with NEWS2 scoring alone (in conjunction with local standard care pathways). PRONTO has two coprimary endpoints: initiation of intravenous antibiotics at 3 hours (superiority comparison) and 28-day mortality (non-inferiority comparison). The study has an internal pilot phase and group-sequential stopping rules for effectiveness and futility/safety, as well as a qualitative substudy and a health economic evaluation., Ethics and Dissemination: The trial protocol was approved by the Health Research Authority (HRA) and NHS Research Ethics Committee (Wales REC 2, reference 20/WA/0058). In England and Wales, the law allows the use of deferred consent in approved research situations (including ED studies) where the time dependent nature of intervention would not allow true informed consent to be obtained. PRONTO has approval for a deferred consent process to be used. Findings will be disseminated through peer-reviewed journals and presented at scientific conferences., Trial Registration Number: ISRCTN54006056., Competing Interests: Competing interests: EC is co-CI for the BATCH Trial (HTA 15/188/42) and the PEACH study (HTA Project: NIHR132254) on PCT use, and member of NICE Diagnostic advisory committee (2014–2020), and NICE Sepsis guideline development committee (2014-6). All other authors declare no competing interests., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Hidradenitis suppurativa (HS) is a chronic, painful, inflammatory skin disease with estimates of prevalence in the European population of 1%-2%. Despite being a relatively common condition, the evidence base for management of HS is limited. European and North American management guidelines rely on consensus for many aspects of treatment and within the UK variations in management of HS have been identified. The HS James Lind Alliance Priority Setting Partnership (PSP) published a top 10 list of future HS research priorities including both medical and surgical interventions. The aims of the THESEUS study are to inform the design of future HS randomised controlled trials (RCTs) and to understand how HS treatments are currently used. THESEUS incorporates several HS PSP research priorities, including investigation of oral and surgical treatments. Core outcome domains have been established by the HIdradenitis SuppuraTiva cORe outcomes set International Collaboration (HISTORIC) and THESEUS is designed to validate instruments to measure the domains., Methods and Analysis: The THESEUS study is a prospective observational cohort study. Participants, adults with active HS of any severity, will be asked to select one of five HS treatment options that is appropriate for their HS care. Participants will be allocated to their chosen treatment intervention and followed for a period of up to 12 months. Outcomes will be assessed at 3-monthly intervals using HISTORIC core outcome instruments. Video recordings of the surgical and laser operations will provide informational and training videos for future trials. Nested mixed-methods studies will characterise the interventions in clinical practice, understand facilitators and barriers to recruitment into future HS RCTs and examine patients' and clinicians' perspectives on HS treatment choices., Trial Registration Number: ISRCTN69985145., Competing Interests: Competing interests: JRI: Consultant for UCB Pharma, Novartis, Boehringer Ingelheim and ChemoCentryx; Advisory Boards for Kymera Therapeutics,Viela Bio and Insmed; Honoraria for BJD Editor-in-Chief, UpToDate HS chapter author; Copyright holder for HiSQOL, HS Patient Global Assessment, HS Investigator Global Assessment, and HS Guideline lead for British Association of Dermatologists. JR is funded by a National Institute of Health Research (NIHR) Postdoctoral Fellowship (PDF-2017-10-075). This represents independent research funded by the NIHR., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.)

Introduction: Procalcitonin (PCT) is a biomarker more specific for bacterial infection and responds quicker than other commonly used biomarkers such as C reactive protein, but is not routinely used in the National Health Service (NHS). Studies mainly in adults show that using PCT to guide clinicians may reduce antibiotic use, reduce hospital stay, with no associated adverse effects such as increased rates of hospital re-admission, incomplete treatment of infections, relapse or death. A review conducted for National Institute for Health and Care Excellence recommends further research on PCT testing to guide antibiotic use in children., Methods and Analysis: Biomarker-guided duration of Antibiotic Treatment in Children Hospitalised with confirmed or suspected bacterial infection is a multi-centre, prospective, two-arm, individually Randomised Controlled Trial (RCT) with a 28-day follow-up and internal pilot. The intervention is a PCT-guided algorithm used in conjunction with best practice. The control arm is best practice alone. We plan to recruit 1942 children, aged between 72 hours and up to 18 years old, who are admitted to the hospital and being treated with intravenous antibiotics for suspected or confirmed bacterial infection. Coprimary outcomes are duration of antibiotic use and a composite safety measure. Secondary outcomes include time to switch from broad to narrow spectrum antibiotics, time to discharge, adverse drug reactions, health utility and cost-effectiveness. We will also perform a qualitative process evaluation. Recruitment commenced in June 2018 and paused briefly between March and May 2020 due to the COVID-19 pandemic., Ethics and Dissemination: The trial protocol was approved by the HRA and NHS REC (North West Liverpool East REC reference 18/NW/0100). We will publish the results in international peer-reviewed journals and present at scientific meetings., Trial Registration Number: ISRCTN11369832., Competing Interests: Competing interests: EDC is a member of NIHR Invention for Innovation panel, member of NICE Diagnostic advisory committee April 2014–September 2020, Member of MRC DPFS panel and MRC COVID-19 Agile panel. SNF is an NIHR Senior Investigator. All other authors declare no competing interests., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.)

Introduction: Deciding whether to proceed with a major lower limb amputation is life-changing and complex, and it is crucial that the right decision is made at the right time. However, medical specialists are known to poorly predict risk when assessing patients for major surgery, and there is little guidance and research regarding decisions about amputation. The process of shared decision-making between doctors and patients during surgical consultations is also little understood. Therefore, the aim of this study is to analyse in depth the communication, consent, risk prediction and decision-making process in relation to major lower limb amputation., Methods and Analysis: Consultations between patients and surgeons at which major lower limb amputation is discussed will be audio-recorded for 10-15 patients. Semi-structured follow-up interviews with patients (and relatives/carers) will then be conducted at two time points: as soon as possible/appropriate after a decision has been reached regarding surgery, and approximately 6 months later. Semi-structured interviews will also be conducted with 10-15 healthcare professionals working in the UK National Health Service (NHS) involved in amputation decision-making. This will include surgeons, anaesthetists and specialist physiotherapists at 2-4 NHS Health Boards/Trusts in Wales and England. Discourse analysis will be used to analyse the recorded consultations; interviews will be analysed thematically. Finally, workshops will be held with patients and healthcare professionals to help synthesise and interpret findings., Ethics and Dissemination: The study has been approved by Wales REC 7 (20/WA/0351). Study findings will be published in international peer-reviewed journal(s) and presented at national and international scientific meetings. Findings will also be disseminated to a wide NHS and lay audience via presentations at meetings and written summaries for key stakeholder groups., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: To explore patient experiences, understanding and perceptions of analgesia following major lower limb amputation., Design: Qualitative interview study, conducted as part of a randomised controlled feasibility trial., Setting: Participants were recruited from two general hospitals in South Wales., Participants: Interview participants were patients enrolled in PLACEMENT (Perineural Local Anaesthetic Catheter aftEr Major lowEr limb amputatioN Trial): a randomised controlled feasibility trial comparing the use of perineural catheter (PNC) versus standard care for postoperative pain relief following major lower limb amputation. PLACEMENT participants who completed 5-day postoperative follow-up, were able and willing to participate in a face-to-face interview, and had consented to be contacted, were eligible to take part in the qualitative study. A total of 20 interviews were conducted with 14 participants: 10 male and 4 female., Methods: Semi-structured, face-to-face interviews were conducted with participants over two time points: (1) up to 1 month and (2) at least 6 months following amputation. Interviews were audio-recorded, transcribed verbatim and analysed using a framework approach., Results: Interviews revealed unanticipated benefits of PNC usage for postoperative pain relief. Participants valued the localised and continuous nature of this mode of analgesia in comparison to opioids. Concerns about opioid dependence and side effects of pain relief medication were raised by participants in both treatment groups, with some reporting trying to limit their intake of analgesics., Conclusions: Findings suggest routine placement of a PNC following major lower limb amputation could reduce postoperative pain, particularly for patient groups at risk of postoperative delirium. This method of analgesic delivery also has the potential to reduce preoperative anxiety, alleviate the burden of pain management and minimise opioid use. Future research could further examine the comparison between patient-controlled analgesia and continuous analgesia in relation to patient anxiety and satisfaction with pain management., Trial Registration Number: ISRCTN: 85710690; EudraCT: 2016-003544-37., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Chronic lung disease of prematurity (CLD), also known as bronchopulmonary dysplasia (BPD), is a cause of significant respiratory morbidity in childhood and beyond. Coupled with lung immaturity, infections (especially by Ureaplasma spp) are implicated in the pathogenesis of CLD through promotion of pulmonary inflammation. Azithromycin, which is a highly effective against Ureaplasma spp also has potent anti-inflammatory properties. Thus, azithromycin therapy may improve respiratory outcomes by targeting infective and inflammatory pathways. Previous trials using macrolides have not been sufficiently powered to definitively assess CLD rates. To address this, the azithromycin therapy for chronic lung disease of prematurity (AZTEC) trial aims to determine if a 10-day early course of intravenous azithromycin improves rates of survival without CLD when compared with placebo with an appropriately powered study., Methods and Analysis: 796 infants born at less than 30 weeks' gestational age who require at least 2 hours of continuous respiratory support within the first 72 hours following birth are being enrolled by neonatal units in the UK. They are being randomised to receive a double-blind, once daily dose of intravenous azithromycin (20 mg/kg for 3 days, followed by 10 mg/kg for a further 7 days), or placebo. CLD is being assessed at 36 weeks' PMA. Whether colonisation with Ureaplasma spp prior to randomisation modifies the treatment effect of azithromycin compared with placebo will also be investigated. Secondary outcomes include necrotising enterocolitis, intraventricular/cerebral haemorrhage, retinopathy of prematurity and nosocomial infections, development of antibiotic resistance and adverse reactions will be monitored., Ethics and Dissemination: Ethics permission has been granted by Wales Research Ethics Committee 2 (Ref 18/WA/0199), and regulatory permission by the Medicines and Healthcare Products Regulatory Agency (Clinical Trials Authorisation reference 21323/0050/001-0001). The study is registered on ISRCTN (ISRCTN11650227). The study is overseen by an independent Data Monitoring Committee and an independent Trial Steering Committee. We shall disseminate our findings via national and international peer-reviewed journals, and conferences. A summary of the findings will also be posted on the trial website., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.)

Introduction: Lower urinary tract symptoms (LUTS) is a bothersome condition affecting older men which can lead to poor quality of life. General practitioners (GPs) currently have no easily available assessment tools to help effectively diagnose causes of LUTS and aid discussion of treatment with patients. Men are frequently referred to urology specialists who often recommend treatments that could have been initiated in primary care. GP access to simple, accurate tests and clinician decision tools are needed to facilitate accurate and effective patient management of LUTS in primary care., Methods and Analysis: PRImary care Management of lower Urinary tract Symptoms (PriMUS) is a prospective diagnostic accuracy study based in primary care. The study will determine which of a number of index tests used in combination best predict three urodynamic observations in men who present to their GP with LUTS. These are detrusor overactivity, bladder outlet obstruction and/or detrusor underactivity. Two cohorts of participants, one for development of the prototype diagnostic tool and other for validation, will undergo a series of simple index tests and the invasive reference standard (invasive urodynamics). We will develop and validate three diagnostic prediction models based on each condition and then combine them with management recommendations to form a clinical decision support tool., Ethics and Dissemination: Ethics approval is from the Wales Research Ethics Committee 6. Findings will be disseminated through peer-reviewed journals and conferences, and results will be of interest to professional and patient stakeholders., Trial Registration Number: ISRCTN10327305., Competing Interests: Competing interests: One of the index tests, Flowtaker, was developed by a team from Newcastle upon Tyne Hospitals (NuTH) and Newcastle University, including two individuals who are grant co-applicants, members of the study management team and co-authors (AB and MiD). In 2014, the device was licensed to MMS (Enschede, the Netherlands) and royalties from the sale of the device were paid to NuTH (not to the individuals). MMS was subsequently acquired by Laborie who removed Flowtaker from the market in January 2018., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.)

Objective: To develop standardised programme content for Australian phase II cardiac rehabilitation (CR) programme., Design: Using the RAND/UCLA appropriateness method (RAM), a two-phase process including a comprehensive literature review and a two round modified Delphi process was undertaken to develop and validate content of a standardised CR programmes., Participants: An invited multidisciplinary expert advisory group (EAG; n=16), including CR health professionals (nurses, allied health professionals, cardiologist), academics, policy makers, representation from the Australian Cardiovascular Health and Rehabilitation Association and consumers, provided oversight of the literature review and assisted with development of best practice statements. Twelve members of the EAG went onto participate in the modified Delphi process rating the necessity of statements in two rounds on a scale of 1 (not necessary) to 9 (essential)., Main Outcome Measure: Best practice statements that achieved a median score of ≥8 on a nine-point scale were categorised as 'essential'; statements that achieved a median score of ≥6 were categorised as 'desirable' and statements with a median score of <6 were omitted., Results: 49 best practice statements were developed from the literature across ten areas of care within four module domains (CR foundations, developing heart health knowledge, psychosocial health and life beyond CR). At the end of a two-round validation process a total of 47 best practice statements were finalised; 29 statements were rated as essential, 18 as desirable and 2 statements were omitted., Conclusions: For the first time in Australia, an evidence-based and consensus-led standardised programme content for phase II CR has been developed that can be provided to CR coordinators., Competing Interests: Competing interests: SC received financial support from a Deakin University Dean’s Postdoctoral Research Fellowship. SC has also undertaken short-term consultancy for Medibank Private, not directly related to this work. ET received financial support from a National Health and Medical Research Council postgraduate scholarship (1113920)., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: To determine the feasibility of undertaking a randomised controlled effectiveness trial evaluating the use of a perineural catheter (PNC) after major lower limb amputation with postoperative pain as the primary outcome., Design: Randomised controlled feasibility trial., Setting: Two vascular Centres in South Wales, UK., Participants: 50 patients scheduled for major lower limb amputation (below or above knee) for complications of peripheral vascular disease., Interventions: The treatment arm received a PNC placed adjacent to the sciatic or tibial nerve at the time of surgery, with continuous infusion of levobupivacaine hydrochloride 0.125% for up to 5 days. The control arm received neither local anaesthetic nor PNC. Both arms received usual perioperative anaesthesia and postoperative analgesia., Primary and Secondary Outcome Measures: The primary outcomes were the proportion of eligible patients who were randomised and the proportion of recruited patients who provided primary effectiveness outcome data. Secondary outcomes were: the proportion of recruited patients reaching 2 and 6 month follow-up and supplying pain data; identification of key cost drivers; development of an economic analysis framework for a future effectiveness trial; identification of barriers to recruitment and site set-up; and identification of the best way to measure postoperative pain., Results: Seventy-six of 103 screened patients were deemed eligible over a 10 month period. Fifty (64.5%) of these patients were randomised, with one excluded in the perioperative period. Forty-five (91.3%) of 49 recruited patients provided enough pain scores on a 4-point verbal rating scale to allow primary effectiveness outcome evaluation. Attrition rates were high; 18 patients supplied data at 6 month follow-up. Costs were dominated by length of hospital stay. Patients and healthcare professionals reported that trial processes were acceptable., Conclusions: Recruitment of patients into a trial comparing PNC use to usual care after major lower limb amputation with postoperative pain measured on a 4-point verbal rating scale is feasible. Evaluation of longer-term symptoms is difficult., Trial Registration Number: ISRCTN: 85 710 690. EudraCT: 2016-003544-37., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: To assess (1) how well validated existing paediatric track and trigger tools (PTTT) are for predicting adverse outcomes in hospitalised children, and (2) how effective broader paediatric early warning systems are at reducing adverse outcomes in hospitalised children., Design: Systematic review., Data Sources: British Nursing Index, Cumulative Index of Nursing and Allied Health Literature, Cochrane Central Register of Controlled Trials, Database of Abstracts of Reviews of Effectiveness, EMBASE, Health Management Information Centre, Medline, Medline in Process, Scopus and Web of Knowledge searched through May 2018., Eligibility Criteria: We included (1) papers reporting on the development or validation of a PTTT or (2) the implementation of a broader early warning system in paediatric units (age 0-18 years), where adverse outcome metrics were reported. Several study designs were considered., Data Extraction and Synthesis: Data extraction was conducted by two independent reviewers using template forms. Studies were quality assessed using a modified Downs and Black rating scale., Results: 36 validation studies and 30 effectiveness studies were included, with 27 unique PTTT identified. Validation studies were largely retrospective case-control studies or chart reviews, while effectiveness studies were predominantly uncontrolled before-after studies. Metrics of adverse outcomes varied considerably. Some PTTT demonstrated good diagnostic accuracy in retrospective case-control studies (primarily for predicting paediatric intensive care unit transfers), but positive predictive value was consistently low, suggesting potential for alarm fatigue. A small number of effectiveness studies reported significant decreases in mortality, arrests or code calls, but were limited by methodological concerns. Overall, there was limited evidence of paediatric early warning system interventions leading to reductions in deterioration., Conclusion: There are several fundamental methodological limitations in the PTTT literature, and the predominance of single-site studies carried out in specialist centres greatly limits generalisability. With limited evidence of effectiveness, calls to make PTTT mandatory across all paediatric units are not supported by the evidence base., Prospero Registration Number: CRD42015015326., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.)

Objective: To assess, in a sample of systematic reviews of non-pharmacological interventions, the completeness of intervention reporting, identify the most frequently missing elements, and assess review authors' use of and beliefs about providing intervention information., Design: Analysis of a random sample of systematic reviews of non-pharmacological stroke interventions; online survey of review authors., Data Sources and Study Selection: The Cochrane Library and PubMed were searched for potentially eligible systematic reviews and a random sample of these assessed for eligibility until 60 (30 Cochrane, 30 non-Cochrane) eligible reviews were identified., Data Collection: In each review, the completeness of the intervention description in each eligible trial (n=568) was assessed by 2 independent raters using the Template for Intervention Description and Replication (TIDieR) checklist. All review authors (n=46) were invited to complete a survey., Results: Most reviews were missing intervention information for the majority of items. The most incompletely described items were: modifications, fidelity, materials, procedure and tailoring (missing from all interventions in 97%, 90%, 88%, 83% and 83% of reviews, respectively). Items that scored better, but were still incomplete for the majority of reviews, were: 'when and how much' (in 31% of reviews, adequate for all trials; in 57% of reviews, adequate for some trials); intervention mode (in 22% of reviews, adequate for all trials; in 38%, adequate for some trials); and location (in 19% of reviews, adequate for all trials). Of the 33 (71%) authors who responded, 58% reported having further intervention information but not including it, and 70% tried to obtain information., Conclusions: Most focus on intervention reporting has been directed at trials. Poor intervention reporting in stroke systematic reviews is prevalent, compounded by poor trial reporting. Without adequate intervention descriptions, the conduct, usability and interpretation of reviews are restricted and therefore, require action by trialists, systematic reviewers, peer reviewers and editors., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)

Objectives: To develop and validate a national set of best practice statements for use in post-stroke aphasia rehabilitation., Design: Literature review and statement validation using the RAND/UCLA Appropriateness Method (RAM)., Participants: A national Community of Practice of over 250 speech pathologists, researchers, consumers and policymakers developed a framework consisting of eight areas of care in aphasia rehabilitation. This framework provided the structure for the development of a care pathway containing aphasia rehabilitation best practice statements. Nine speech pathologists with expertise in aphasia rehabilitation participated in two rounds of RAND/UCLA appropriateness ratings of the statements. Panellists consisted of researchers, service managers, clinicians and policymakers., Main Outcome Measures: Statements that achieved a high level of agreement and an overall median score of 7-9 on a nine-point scale were rated as 'appropriate'., Results: 74 best practice statements were extracted from the literature and rated across eight areas of care (eg, receiving the right referrals, providing intervention). At the end of Round 1, 71 of the 74 statements were rated as appropriate, no statements were rated as inappropriate, and three statements were rated as uncertain. All 74 statements were then rated again in the face-to-face second round. 16 statements were added through splitting existing items or adding new statements. Seven statements were deleted leaving 83 statements. Agreement was reached for 82 of the final 83 statements., Conclusions: This national set of 82 best practice statements across eight care areas for the rehabilitation of people with aphasia is the first to be validated by an expert panel. These statements form a crucial component of the Australian Aphasia Rehabilitation Pathway (AARP) (http://www.aphasiapathway.com.au) and provide the basis for more consistent implementation of evidence-based practice in stroke rehabilitation., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)