Moving from development to implementation of digital innovations within the NHS: myHealthE, a remote monitoring system for tracking patient outcomes in child and adolescent mental health services.

Objective: This paper aims to report our experience of developing, implementing, and evaluating myHealthE (MHE), a digital innovation for Child and Adolescents Mental Health Services (CAMHS), which automates the remote collection and reporting of Patient-Reported Outcome Measures (PROMs) into National Health Services (NHS) electronic healthcare records. Methods: We describe the logistical and governance issues encountered in developing the MHE interface with patient-identifiable information, and the steps taken to overcome these development barriers. We describe the application's architecture and hosting environment to enable its operability within the NHS, as well as the capabilities needed within the technical team to bridge the gap between academic development and NHS operational teams. Results: We present evidence on the feasibility and acceptability of this system within clinical services and the process of iterative development, highlighting additional functions that were incorporated to increase system utility. Conclusion: This article provides a framework with which to plan, develop, and implement automated PROM collection from remote devices back to NHS infrastructure. The challenges and solutions described in this paper will be pertinent to other digital health innovation researchers aspiring to deploy interoperable systems within NHS clinical systems.

Clinical recommendations for posttransplant assessment of anti-HLA (Human Leukocyte Antigen) donor-specific antibodies: A Sensitization in Transplantation: Assessment of Risk consensus document.

Although anti-HLA (Human Leukocyte Antigen) donor-specific antibodies (DSAs) are commonly measured in clinical practice and their relationship with transplant outcome is well established, clinical recommendations for anti-HLA antibody assessment are sparse. Supported by a careful and critical review of the current literature performed by the Sensitization in Transplantation: Assessment of Risk 2022 working group, this consensus report provides clinical practice recommendations in kidney, heart, lung, and liver transplantation based on expert assessment of quality and strength of evidence. The recommendations address 3 major clinical problems in transplantation and include guidance regarding posttransplant DSA assessment and application to diagnostics, prognostics, and therapeutics: (1) the clinical implications of positive posttransplant DSA detection according to DSA status (ie, preformed or de novo), (2) the relevance of posttransplant DSA assessment for precision diagnosis of antibody-mediated rejection and for treatment management, and (3) the relevance of posttransplant DSA for allograft prognosis and risk stratification. This consensus report also highlights gaps in current knowledge and provides directions for clinical investigations and trials in the future that will further refine the clinical utility of posttransplant DSA assessment, leading to improved transplant management and patient care.

Sensitization in transplantation: Assessment of Risk 2022 Working Group Meeting Report.

The Sensitization in Transplantation: Assessment of Risk workgroup is a collaborative effort of the American Society of Transplantation and the American Society of Histocompatibility and Immunogenetics that aims at providing recommendations for clinical testing, highlights gaps in current knowledge, and proposes areas for further research to enhance histocompatibility testing in support of solid organ transplantation. This report provides updates on topics discussed by the previous Sensitization in Transplantation: Assessment of Risk working groups and introduces 2 areas of exploration: non-human leukocyte antigen antibodies and utilization of human leukocyte antigen antibody testing measurement to evaluate the efficacy of antibody-removal therapies.

The feasibility of a strategy for the remote recruitment, consenting and assessment of recent referrals: a protocol for phase 1 of the On-Line Parent Training for the Initial Management of ADHD referrals (OPTIMA).

BACKGROUND: In the UK, children with high levels of hyperactivity, impulsivity and inattention referred to clinical services with possible attention-deficit/hyperactivity disorder (ADHD) often wait a long time for specialist diagnostic assessment. Parent training (PT) has the potential to support parents during this difficult period, especially regarding the management of challenging and disruptive behaviours that often accompany ADHD. However, traditional face-to-face PT is costly and difficult to organise in a timely way. We have created a low-cost, easily accessible PT programme delivered via a phone app, Structured E-Parenting Support (STEPS), to address this problem. The overall OPTIMA programme will evaluate the efficacy and cost-effectiveness of STEPS as a way of helping parents manage their children behaviour while on the waitlist. To ensure the timely and efficient evaluation of STEPS in OPTIMA, we have worked with children's health services to implement a remote strategy for recruitment, screening and assessment of recently referred families. Part of this strategy is incorporated into routine clinical practice and part is OPTIMA specific. Here, we present the protocol for Phase 1 of OPTIMA-a study of the feasibility of this remote strategy, as a basis for a large-scale STEPS randomised controlled trial (RCT). METHODS: This is a single arm observational feasibility study. Participants will be parents of up to 100 children aged 5-11 years with high levels of hyperactivity/impulsivity, inattention and challenging behaviour who are waiting for assessment in one of five UK child and adolescent mental health or behavioural services. Recruitment, consenting and data collection will occur remotely. The primary outcome will be the rate at which the families, who meet inclusion criteria, agree in principle to take part in a full STEPS RCT. Secondary outcomes include acceptability of remote consenting and online data collection procedures; the feasibility of collecting teacher data remotely within the required timeframe, and technical difficulties with completing online questionnaires. All parents in the study will receive access to STEPS. DISCUSSION: Establishing the feasibility of our remote recruitment, consenting and assessment strategy is a pre-requisite for the full trial of OPTIMA. It can also provide a model for future trials conducted remotely.

Sociodemographic factors associated with routine outcome monitoring: a historical cohort study of 28,382 young people accessing child and adolescent mental health services.

BACKGROUND: Patient-reported outcome measures (PROMs) are important tools to inform patients, clinicians and policy-makers about clinical need and the effectiveness of any given treatment. Consistent PROM use can promote early symptom detection, help identify unexpected treatment responses and improve therapeutic engagement. Very few studies have examined associations between patient characteristics and PROM data collection. METHODS: We used the electronic mental health records for 28,382 children and young people (aged 4-17 years) accessing Child and Adolescent Mental Health Services (CAMHS) across four South London boroughs between the 1st of January 2008 to the 1st of October 2017. We examined the completion rates of the caregiver Strengths and Difficulties Questionnaire (SDQ), a ubiquitous PROM for CAMHS at baseline and 6-month follow-up. RESULTS AND CONCLUSIONS: SDQs were present for approximately 40% (n = 11,212) of the sample at baseline, and from these, only 8% (n = 928) had a follow-up SDQ. Patterns of unequal PROM collection by sociodemographic factors were identified: males were more likely (aOR 1.07, 95% CI 1.01-1.13), whilst older age (aOR 0.87, 95% CI 0.87-0.88), Black (aOR 0.79 95% CI 0.74-0.84) and Asian ethnicity (aOR 0.75 95% CI 0.66-0.86) relative to White ethnicity, and residence within the most deprived neighbourhood (aOR 0.87 95% CI 0.80-0.94) were less likely to have a record of baseline SDQ. Similar results were found in the sub-group (n = 11,212) with follow-up SDQ collection. Our findings indicate systematic differences in the currently available PROMS data and highlights which groups require increased focus if we are to gain equitable PROM collection. We need to ensure representative PROM collection for all individuals accessing treatment, regardless of ethnic or socioeconomic background; biased data have adverse ramifications for policy and service level decision-making.

Monitoring severe acute maternal morbidity across Europe: A feasibility study.

BACKGROUND: Monitoring severe acute maternal morbidity (SAMM) appears essential for optimising care and informing health care policies, especially given changes in obstetric practices and mother profiles. International comparisons can identify areas where improvement is needed, but the comparability of indicators must be evaluated. OBJECTIVE: To assess the feasibility of monitoring SAMM using common definitions from hospital discharge databases across Europe. METHODS: We used hospital discharge data in eight countries (2 826 868 deliveries) to identify women with SAMM among all hospitalisations of women of reproductive age admitted for antenatal or delivery care. Five SAMM indicators were investigated: eclampsia, septicaemia, hysterectomy, hysterectomy associated with a diagnosis of obstetric haemorrhage, and red blood cell (RBC) transfusion associated with a diagnosis of obstetric haemorrhage. Between-country variation was described, by the ratio of the highest to lowest rates, while external validation was assessed by comparing with population-based studies on maternal morbidity. RESULTS: Ratios for hysterectomy and red blood cell (RBC) transfusion in the context of obstetric haemorrhage were 1:2.1 and 1:3.5, respectively. High values of hysterectomy and low values of transfusion were both consistent with high maternal mortality from haemorrhage (France, Italy, Portugal). Ratios across countries were relatively low for eclampsia (1:3.4) but very high for septicaemia (1:22.5). Compared to population-based morbidity estimates, eclampsia was over-reported in hospital databases whereas the two indicators of severe haemorrhage had good external validity. CONCLUSIONS: In association with diagnosis codes indicating obstetric haemorrhage, hysterectomy and RBC transfusion appear to be good candidates for surveillance of maternal morbidity in Europe.

Assessment of reactive oxygen species generated by electronic cigarettes using acellular and cellular approaches.

Electronic cigarettes (e-cigs) have fast increased in popularity but the physico-chemical properties and toxicity of the generated emission remain unclear. Reactive oxygen species (ROS) are likely present in e-cig emission and can play an important role in e-cig toxicity. However, e-cig ROS generation is poorly documented. Here, we generated e-cig exposures using a recently developed versatile exposure platform and performed systematic ROS characterization on e-cig emissions using complementary acellular and cellular techniques: 1) a novel acellular Trolox-based mass spectrometry method for total ROS and hydrogen peroxide (H2O2) detection, 2) electron spin resonance (ESR) for hydroxyl radical detection in an acellular and cellular systems and 3) in vitro ROS detection in small airway epithelial cells (SAEC) using the dihydroethidium (DHE) assay. Findings confirm ROS generation in cellular and acellular systems and is highly dependent on the e-cig brand, flavor, puffing pattern and voltage. Trolox method detected a total of 1.2-8.9nmol H2O2eq./puff; H2O2 accounted for 12-68% of total ROS. SAEC cells exposed to e-cig emissions generated up to eight times more ROS compared to control. The dependency of e-cig emission profile on e-cig features and operational parameters should be taken into consideration in toxicological studies.

Clinical and cost effectiveness of booklet based vestibular rehabilitation for chronic dizziness in primary care: single blind, parallel group, pragmatic, randomised controlled trial.

OBJECTIVE: To determine the clinical and cost effectiveness of booklet based vestibular rehabilitation with and without telephone support for chronic dizziness, compared with routine care. DESIGN: Single blind, parallel group, pragmatic, randomised controlled trial. SETTING: 35 general practices across southern England between October 2008 and January 2011. PARTICIPANTS: Patients aged 18 years or over with chronic dizziness (mean duration >five years) not attributable to non-vestibular causes (confirmed by general practitioner) and that could be aggravated by head movement (confirmed by patient). INTERVENTIONS: Participants randomly allocated to receive routine medical care, booklet based vestibular rehabilitation only, or booklet based vestibular rehabilitation with telephone support. For the booklet approach, participants received self management booklets providing comprehensive advice on undertaking vestibular rehabilitation exercises at home daily for up to 12 weeks and using cognitive behavioural techniques to promote positive beliefs and treatment adherence. Participants receiving telephone support were offered up to three brief sessions of structured support from a vestibular therapist. MAIN OUTCOME MEASURES: Vertigo symptom scale-short form and total healthcare costs related to dizziness per quality adjusted life year (QALY). RESULTS: Of 337 randomised participants, 276 (82%) completed all clinical measures at the primary endpoint, 12 weeks, and 263 (78%) at one year follow-up. We analysed clinical effectiveness by intention to treat, using analysis of covariance to compare groups after intervention, controlling for baseline symptom scores. At 12 weeks, scores on the vertigo symptom scale in the telephone support group did not differ significantly from those in the routine care group (adjusted mean difference -1.79 (95% confidence interval -3.69 to 0.11), P=0.064). At one year, both intervention groups improved significantly relative to routine care (telephone support -2.52 (-4.52 to -0.51), P=0.014; booklet only -2.43 (-4.27 to -0.60), P=0.010). Analysis of cost effectiveness acceptability curves showed that both interventions were highly cost effective; at very low QALY values, the booklet only approach was most likely to be cost effective, but the approach with additional telephone support was most likely to be cost effective at QALY values more than £1200 (€1488; $1932). Using the booklet approach with telephone support, five (three to 12) patients would need to be treated for one patient to report subjective improvement at one year. CONCLUSIONS: Booklet based vestibular rehabilitation for chronic dizziness is a simple and cost effective means of improving patient reported outcomes in primary care. TRIAL REGISTRATION: ClinicalTrials.gov NCT00732797.

A systematic assessment of the quality of reporting for platelet transfusion studies.

BACKGROUND: As evidence-based medicine assumes increasing importance, there is a need for high-quality reporting of clinical studies. A recent review of clinical platelet (PLT) studies indicated variability in reporting. We undertook a critical analysis of PLT transfusion studies to determine the quality of reporting. STUDY DESIGN AND METHODS: A systematic MEDLINE search for clinical studies of PLT transfusion was performed to identify articles. Relevant observational studies (OBS) were critiqued using the STROBE checklist and randomized controlled clinical trials (RCTs) using the CONSORT checklist. Studies were further evaluated with a PLT-specific checklist developed by the authors. Observations were analyzed descriptively and using Pareto analysis. RESULTS: A total of 772 articles were identified by the search. Eighty-six articles (23 RCTs and 63 OBS) met eligibility criteria. All RCTs, and a similar number of OBS (24), were randomly selected for analysis. Studies reported the scientific background and rationale, key results, and outcomes. OBS frequently did not consider bias and confounders. RCTs frequently did not explain bias, interim analyses, stopping rules, success of blinding, or weaknesses of multiple analyses. The PLT-specific critique found many studies adequately reported basics of the PLT product, PLT increment, and transfusion reactions. Studies frequently failed to report specific details of PLT compatibility, details of product preparation, and use of other blood products. CONCLUSION: Recently published articles of clinical PLT transfusion share common strengths and weaknesses. The quality of reporting may be improved by providing guidelines to authors and journal editors that list the essential elements of a well-reported clinical study of PLT transfusion.

An evaluation of the cost-effectiveness of booklet-based self-management of dizziness in primary care, with and without expert telephone support.

BACKGROUND: Dizziness is a very common symptom that often leads to reduced quality of life, anxiety and emotional distress, loss of fitness, lack of confidence in balance, unsteadiness and an increased risk of falling. Most dizzy patients are managed in primary care by reassurance and medication to suppress symptoms. Trials have shown that chronic dizziness can be treated effectively in primary care using a self-help booklet to teach patients vestibular rehabilitation exercises that promote neurological adaptation and skill and confidence in balance. However, brief support from a trained nurse was provided in these trials, and this model of managing dizzy patients has not been taken up due to a lack of skills and resources in primary care. The aim of this trial is to evaluate two new alternative models of delivery that may be more feasible and cost-effective. METHODS/DESIGN: In a single blind two-centre pragmatic controlled trial, we will randomise 330 patients from 30 practices to a) self-help booklet with telephone support from a vestibular therapist, b) self-help booklet alone, c) routine medical care. Symptoms, disability, handicap and quality of life will be assessed by validated questionnaires administered by post at baseline, immediately post-treatment (3 months), and at one year follow-up. The study is powered to test our primary hypothesis, that the self-help booklet with telephone support will be more effective than routine care. We will also explore the effectiveness of the booklet without any support, and calculate the costs of treatment in each arm. DISCUSSION: If our trial indicates that patients can cost-effectively manage their dizziness in primary care, then it can be easily rolled out to relieve the symptoms of the many patients in primary care who currently have chronic, untreated, disabling dizziness. Treatment in primary care may reduce the development of psychological and physical sequelae that cause handicap and require treatment. There is also the potential to reduce the cost to the NHS of treating dizziness by reducing demand for referral to secondary care for specialist assessment and treatment. TRIAL REGISTRATION: ClinicalTrials.gov trial registration ID number: NCT00732797.