BACKGROUND: Automated virtual reality therapies are being developed to increase access to psychological interventions. We assessed the experience with one such therapy of patients diagnosed with psychosis, including satisfaction, side effects, and positive experiences of access to the technology. We tested whether side effects affected therapy. METHODS: In a clinical trial 122 patients diagnosed with psychosis completed baseline measures of psychiatric symptoms, received gameChange VR therapy, and then completed a satisfaction questionnaire, the Oxford-VR Side Effects Checklist, and outcome measures. RESULTS: 79 (65.8%) patients were very satisfied with VR therapy, 37 (30.8%) were mostly satisfied, 3 (2.5%) were indifferent/mildly dissatisfied, and 1 (0.8%) person was quite dissatisfied. The most common side effects were: difficulties concentrating because of thinking about what might be happening in the room (n = 17, 14.2%); lasting headache (n = 10, 8.3%); and the headset causing feelings of panic (n = 9, 7.4%). Side effects formed three factors: difficulties concentrating when wearing a headset, feelings of panic using VR, and worries following VR. The occurrence of side effects was not associated with number of VR sessions, therapy outcomes, or psychiatric symptoms. Difficulties concentrating in VR were associated with slightly lower satisfaction. VR therapy provision and engagement made patients feel: proud (n = 99, 81.8%); valued (n = 97, 80.2%); and optimistic (n = 96, 79.3%). CONCLUSIONS: Patients with psychosis were generally very positive towards the VR therapy, valued having the opportunity to try the technology, and experienced few adverse effects. Side effects did not significantly impact VR therapy. Patient experience of VR is likely to facilitate widespread adoption.
\n \n\n \n \nOBJECTIVES: To characterise the quality of life, healthcare use and costs associated with early antibiotic treatment of influenza-like illness (ILI) in 'at-risk' children. DESIGN: Economic analysis of a two-arm double-blind parallel group pragmatic randomised controlled trial. SETTING: Children were recruited from community-based healthcare settings, including general practices, walk-in centres and hospital ambulatory care. PARTICIPANTS: Children with risk factors for influenza-related complications, including respiratory, cardiac and neurological conditions, who presented within the first 5\u2009days of an ILI. INTERVENTIONS: Co-amoxiclav 400/57 suspension or placebo. OUTCOME MEASURES: This economic analysis focused on quality of life measured by the EQ-5D-Y, symptoms assessed by the Canadian Acute Respiratory Infection and Flu Scale (CARIFS), healthcare use and costs including medication, hospital visits and admissions, general practitioner and nurse contacts. Outcomes were assessed for up to 28 days post randomisation. RESULTS: Information on resource use, EQ-5D-Y (day 28) and CARIFS (day 7) was available for 265 (98%), 72 (27%) and 123 (45%) out of 271 participants, respectively. Average costs in the co-amoxiclav group were \u00a325 lower (95% CI -\u00a3113 to \u00a365), but this difference was not statistically significant (p=0.566). The difference in EQ-5D-Y scores between groups was also not statistically significant (-0.014 (95% CI -0.124 to 0.096), p=0.798). However, day 7 CARIFS scores were 3.5 points lower in the co-amoxiclav arm (95%\u2009CI -6.9 to -0.1, p=0.044). CONCLUSIONS: Our findings did not show evidence that early co-amoxiclav treatment improves quality of life or reduces healthcare use and costs in 'at-risk' children with ILI, but may reduce symptom severity though confirmation from further research would be important. Reliable data collection from children's parents/carers was challenging, and resulted in high levels of missing data, which is common in pragmatic trials involving children with acute respiratory tract infections. TRIAL REGISTRATION NUMBER: ISRCTN70714783; EudraCT 2013-002822-21.
\n \n\n \n \nImportance: Inadequate management of elevated blood pressure is a significant contributing factor to maternal deaths. The role of blood pressure self-monitoring in pregnancy in improving clinical outcomes for the pregnant individual and infant is unclear. Objective: To evaluate the effect of blood pressure self-monitoring, compared with usual care alone, on blood pressure control and other related maternal and infant outcomes, in individuals with pregnancy hypertension. Design, Setting, and Participants: Unblinded, randomized clinical trial that recruited between November 2018 and September 2019 in 15 hospital maternity units in England. Individuals with chronic hypertension (enrolled up to 37 weeks' gestation) or with gestational hypertension (enrolled between 20 and 37 weeks' gestation). Final follow-up was in May 2020. Interventions: Participants were randomized to either blood pressure self-monitoring using a validated monitor and a secure telemonitoring system in addition to usual care (n\u2009=\u2009430) or to usual care alone (n\u2009=\u2009420). Usual care comprised blood pressure measured by health care professionals at regular antenatal clinics. Main Outcomes and Measures: The primary maternal outcome was the difference in mean systolic blood pressure recorded by health care professionals between randomization and birth. Results: Among 454 participants with chronic hypertension (mean age, 36 years; mean gestation at entry, 20 weeks) and 396 with gestational hypertension (mean age, 34 years; mean gestation at entry, 33 weeks) who were randomized, primary outcome data were available from 444 (97.8%) and 377 (95.2%), respectively. In the chronic hypertension cohort, there was no statistically significant difference in mean systolic blood pressure for the self-monitoring groups vs the usual care group (133.8 mm Hg vs 133.6 mm Hg, respectively; adjusted mean difference, 0.03 mm Hg [95% CI, -1.73 to 1.79]). In the gestational hypertension cohort, there was also no significant difference in mean systolic blood pressure (137.6 mm Hg compared with 137.2 mm Hg; adjusted mean difference, -0.03 mm Hg [95% CI, -2.29 to 2.24]). There were 8 serious adverse events in the self-monitoring group (4 in each cohort) and 3 in the usual care group (2 in the chronic hypertension cohort and 1 in the gestational hypertension cohort). Conclusions and Relevance: Among pregnant individuals with chronic or gestational hypertension, blood pressure self-monitoring with telemonitoring, compared with usual care, did not lead to significantly improved clinic-based blood pressure control. Trial Registration: ClinicalTrials.gov Identifier: NCT03334149.
\n \n\n \n \nImportance: Inadequate management of elevated blood pressure (BP) is a significant contributing factor to maternal deaths. Self-monitoring of BP in the general population has been shown to improve the diagnosis and management of hypertension; however, little is known about its use in pregnancy. Objective: To determine whether self-monitoring of BP in higher-risk pregnancies leads to earlier detection of pregnancy hypertension. Design, Setting, and Participants: Unblinded, randomized clinical trial that included 2441 pregnant individuals at higher risk of preeclampsia and recruited at a mean of 20 weeks' gestation from 15 hospital maternity units in England between November 2018 and October 2019. Final follow-up was completed in April 2020. Interventions: Participating individuals were randomized to either BP self-monitoring with telemonitoring (n\u2009=\u20091223) plus usual care or usual antenatal care alone (n\u2009=\u20091218) without access to telemonitored BP. Main Outcomes and Measures: The primary outcome was time to first recorded hypertension measured by a health care professional. Results: Among 2441 participants who were randomized (mean [SD] age, 33 [5.6] years; mean gestation, 20 [1.6] weeks), 2346 (96%) completed the trial. The time from randomization to clinic recording of hypertension was not significantly different between individuals in the self-monitoring group (mean [SD], 104.3 [32.6] days) vs in the usual care group (mean [SD], 106.2 [32.0] days) (mean difference, -1.6 days [95% CI, -8.1 to 4.9]; P\u2009=\u2009.64). Eighteen serious adverse events were reported during the trial with none judged as related to the intervention (12 [1%] in the self-monitoring group vs 6 [0.5%] in the usual care group). Conclusions and Relevance: Among pregnant individuals at higher risk of preeclampsia, blood pressure self-monitoring with telemonitoring, compared with usual care, did not lead to significantly earlier clinic-based detection of hypertension. Trial Registration: ClinicalTrials.gov Identifier: NCT03334149.
\n \n\n \n \nObjective: We aimed to document and describe variation in a range of factors impacting on preparedness for and the management of emergencies in midwifery units in the UK. Design, setting and participants: National cross-sectional survey administered online through the UK Midwifery Study System (UKMidSS) to midwife \u2018reporters\u2019 in all 206 alongside and freestanding midwifery units in the UK, January-April 2020. Topics investigated included communication with the ambulance service in freestanding units, staff support for emergencies, training and equipment held. Findings: In total, 137 (67%) midwifery units responded, representing 75% of eligible UK maternity services. There was no evidence of differences between responding and non-responding units in terms of type of unit, annual number of births, or country/region of the UK. Overall, 10 freestanding units (20%) reported using an ordered categorical system (e.g. \u2018category 1\u2019 or \u2018code red\u2019) to communicate an emergency to the ambulance service, 17 (35%) reported using other words describing urgency (e.g. \u2018obstetric emergency\u2019), and 15 (31%) reported having no agreed word or phrase. Almost all alongside units reported that a senior midwife, paediatrician/neonatologist and obstetrician might attend in an emergency, whereas most freestanding units reported the attendance of paramedics and/or a senior midwife. The type and frequency of staff training varied, with 77% of units reporting annual skills and drills training, and lower proportions reporting annual multi-disciplinary simulation (55%), in-situ simulation (50%) and neonatal life support training (59%). The equipment kept in midwifery units varied between different types of unit. For example, 28 alongside units (32%) reported keeping ventouse in the unit and 21 (24%) kept forceps, compared with 4 (8%) and 2 (4%) freestanding units respectively. Almost half of freestanding units (47%) and around a quarter of alongside units (24%) reported having a cardiotocograph (CTG) in the unit. Conclusions: The study found wide variation in factors that impact on preparedness for and management of emergencies in UK midwifery units. Although some variation is inevitable given the varying size and location of units, this study has identified some areas where greater consistency might improve outcomes.
\n \n\n \n \nObjectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows:. To assess the evidence on the relationship between the use and availability of e-cigarettes and subsequent cigarette smoking in young people (aged 29 years or less), and whether the relationship differs by socioeconomic status, gender, or other demographic characteristics.
\n \n\n \n \nBACKGROUND: Colchicine has been proposed as a COVID-19 treatment. AIM: To determine whether colchicine reduces time to recovery and COVID-19-related admissions to hospital and/or deaths among people in the community. DESIGN AND SETTING: Prospective, multicentre, open-label, multi-arm, randomised, controlled, adaptive platform trial (PRINCIPLE). METHOD: Adults aged \u226565 years or \u226518 years with comorbidities or shortness of breath, and unwell for \u226414 days with suspected COVID-19 in the community, were randomised to usual care, usual care plus colchicine (500 \u00b5g daily for 14 days), or usual care plus other interventions. The co-primary endpoints were time to first self-reported recovery and admission to hospital/death related to COVID-19, within 28 days, analysed using Bayesian models. RESULTS: The trial opened on 2 April 2020. Randomisation to colchicine started on 4 March 2021 and stopped on 26 May 2021 because the prespecified time to recovery futility criterion was met. The primary analysis model included 2755 participants who were SARS-CoV-2 positive, randomised to colchicine (n = 156), usual care (n = 1145), and other treatments (n = 1454). Time to first self-reported recovery was similar in the colchicine group compared with usual care with an estimated hazard ratio of 0.92 (95% credible interval (CrI) = 0.72 to 1.16) and an estimated increase of 1.4 days in median time to self-reported recovery for colchicine versus usual care. The probability of meaningful benefit in time to recovery was very low at 1.8%. COVID-19-related admissions to hospital/deaths were similar in the colchicine group versus usual care, with an estimated odds ratio of 0.76 (95% CrI = 0.28 to 1.89) and an estimated difference of -0.4% (95% CrI = -2.7 to 2.4). CONCLUSION: Colchicine did not improve time to recovery in people at higher risk of complications with COVID-19 in the community.
\n \n\n \n \nBACKGROUND: Mindfulness-based smoking cessation interventions may aid smoking cessation by teaching individuals to pay attention to, and work mindfully with, negative affective states, cravings, and other symptoms of nicotine withdrawal. Types of mindfulness-based interventions include mindfulness training, which involves training in meditation; acceptance and commitment therapy (ACT); distress tolerance training; and yoga. OBJECTIVES: To assess the efficacy of mindfulness-based interventions for smoking cessation among people who smoke, and whether these interventions have an effect on mental health outcomes. SEARCH METHODS: We searched the Cochrane Tobacco Addiction Group's specialised register, CENTRAL, MEDLINE, Embase, PsycINFO, and trial registries to 15 April 2021. We also employed an automated search strategy, developed as part of the Human Behaviour Change Project, using Microsoft Academic. SELECTION CRITERIA: We included randomised controlled trials (RCTs) and cluster-RCTs that compared a mindfulness-based intervention for smoking cessation with another smoking cessation programme or no treatment, and assessed smoking cessation at six months or longer. We excluded studies that solely recruited pregnant women. DATA COLLECTION AND ANALYSIS: We followed standard Cochrane methods. We measured smoking cessation at the longest time point, using the most rigorous definition available, on an intention-to-treat basis. We calculated risk ratios (RRs) and 95% confidence intervals (CIs) for smoking cessation for each study, where possible. We grouped eligible studies according to the type of intervention and type of comparator. We carried out meta-analyses where appropriate, using Mantel-Haenszel random-effects models. We summarised mental health outcomes narratively. MAIN RESULTS: We included 21 studies, with 8186 participants. Most recruited adults from the community, and the majority (15 studies) were conducted in the USA. We judged four of the studies to be at low risk of bias, nine at unclear risk, and eight at high risk. Mindfulness-based interventions varied considerably in design and content, as did comparators, therefore, we pooled small groups of relatively comparable studies. We did not detect a clear benefit or harm of mindfulness training interventions on quit rates compared with intensity-matched smoking cessation treatment (RR 0.99, 95% CI 0.67 to 1.46; I2 = 0%;\u00a03 studies, 542 participants; low-certainty evidence), less intensive smoking cessation treatment (RR 1.19, 95% CI 0.65 to 2.19; I2 = 60%;\u00a05 studies, 813 participants; very low-certainty evidence), or no treatment (RR 0.81, 95% CI 0.43 to 1.53;\u00a01 study, 325 participants; low-certainty evidence). In each comparison, the 95% CI encompassed benefit (i.e. higher quit rates), harm (i.e. lower quit rates) and no difference. In one study of mindfulness-based relapse prevention, we did not detect a clear benefit or harm of the intervention over no treatment (RR 1.43, 95% CI 0.56 to 3.67;\u00a086 participants; very low-certainty evidence). We did not detect a clear benefit or harm of ACT on quit rates compared with less intensive behavioural treatments, including nicotine replacement therapy alone (RR 1.27, 95% CI 0.53 to 3.02;\u00a01 study, 102 participants; low-certainty evidence), brief advice (RR 1.27, 95% CI 0.59 to 2.75;\u00a01 study, 144 participants; very low-certainty evidence), or less intensive ACT (RR 1.00, 95% CI 0.50 to 2.01;\u00a01 study, 100 participants; low-certainty evidence). There was a high level of heterogeneity (I2 = 82%) across studies comparing ACT with intensity-matched smoking cessation treatments, meaning it was not appropriate to report a pooled result. We did not detect a clear benefit or harm of distress tolerance training on quit rates compared with intensity-matched smoking cessation treatment (RR 0.87, 95% CI 0.26 to 2.98;\u00a01 study, 69 participants; low-certainty evidence) or less intensive smoking cessation treatment (RR 1.63, 95% CI 0.33 to 8.08;\u00a01 study, 49 participants; low-certainty evidence). We did not detect a clear benefit or harm of yoga on quit rates compared with intensity-matched smoking cessation treatment (RR 1.44, 95% CI 0.40 to 5.16;\u00a01 study, 55 participants; very low-certainty evidence). Excluding studies at high risk of bias did not substantially alter the results, nor did using complete case data as opposed to using data from all participants randomised. Nine studies reported on changes in mental health and well-being, including depression, anxiety, perceived stress, and negative and positive affect. Variation in measures and methodological differences between studies meant we could not meta-analyse these data. One study found a greater reduction in perceived stress in participants who received a face-to-face mindfulness training programme versus an intensity-matched programme. However, the remaining eight studies found no clinically meaningful differences in mental health and well-being between participants who received mindfulness-based treatments and participants who received another treatment or no treatment (very low-certainty evidence). AUTHORS' CONCLUSIONS: We did not detect a clear benefit of mindfulness-based smoking cessation interventions for increasing smoking quit rates or changing mental health and well-being. This was the case when compared with intensity-matched smoking cessation treatment, less intensive smoking cessation treatment, or no treatment. However, the evidence was of low and very low certainty due to risk of bias, inconsistency, and imprecision, meaning future evidence may very likely change our interpretation of the results. Further RCTs of mindfulness-based interventions for smoking cessation compared with active comparators are needed. There is also a need for more consistent reporting of mental health and well-being outcomes in studies of mindfulness-based interventions for smoking cessation.
\n \n\n \n \nObjective: To investigate childhood, teenage and young adult cancer diagnostic pathways during the first wave of the COVID-19 pandemic in England. Design: Population-based cohort study. Setting and participants: QResearch, a nationally representative primary care database, linked to hospital admission, mortality and cancer registry data, was used to identify childhood, teenage and young adult cancers (0-24 years) diagnosed between 1 January 2017 and 15 August 2020. Main outcomes: Main outcomes of interest were: (1) number of incident cancer diagnoses per month, (2) diagnostic, treatment time intervals and (3) cancer-related intensive care admissions. Results: 2607 childhood, teenage and young adult cancers were diagnosed from 1 January 2017 to 15 August 2020; 380 were diagnosed during the pandemic period. Overall, 17% (95% CI -28.0% to -4.0%) reduction in the incidence rate ratio of cancers was observed during the pandemic. Specific decreases were seen for central nervous system tumour (-38% (95% CI -52% to -21%)) and lymphoma (-28% (95% CI -45% to -5%)) diagnoses. Additionally, childhood cancers diagnosed during the pandemic were significantly more likely to have intensive care admissions (adjusted OR 2.2 (95% CI 1.33 to 3.47)). Median time-to-diagnosis did not significantly differ across periods (+4.5 days (95% CI -20.5 to +29.5)), while median time-to-treatment was shorter during the pandemic (-0.7 days (95% CI -1.1 to -0.3)). Conclusions: Collectively, our findings of a significant reduction in cancer diagnoses and increase in intensive care admissions provide initial insight into the changes that occurred to childhood, teenage and young adult cancer diagnostic pathways during the first wave of the pandemic.
\n \n\n \n \nINTRODUCTION The purpose of this study is to conduct an overview of Cochrane systematic reviews (SRs) evaluating the effects of maternal positions in childbirth in order to compile existing evidence for relevant research questions that have been addressed by more than one review, to provide a succinct summary of the up-to-date evidence and to identify areas for future research. METHODS An electronic search was conducted in the Cochrane database. Two primary outcomes were the duration of labor and birth, and operative birth. The quality of included reviews was assessed using the AMSTAR criteria, and the quality of the evidence was rated using the GRADE criteria. RESULTS We included 3 Cochrane SRs. There was a significant mean difference (MD) found in the duration of the first stage by 1 hour and 22 minutes (MD= \u22121.21; 95% CI: \u22122.35 \u2013 \u22120.07, I2=94%) and reduction in caesarean section rates (RR=0.71; 95% CI: 0.54\u20130.94, I2=0%) in the upright birth position group compared with the horizontal. Also, there was a statistically significant difference in the duration (minutes) of the second stage of labor (MD= \u22126.16; 95% CI: \u22129.74 \u2013 \u22122.59, I2=91%) and a reduction in assisted vaginal birth rates (RR=0.75, 95% CI: 0.66\u20130.86, I2=29%) in the upright group compared with the horizontal without epidural analgesia. The quality of evidence within the reviews was very low to moderate. CONCLUSIONS There is currently a limited body of evidence to clearly assess the benefits and risks of assuming upright positions during childbirth. The overview highlights the need for high-quality research studies, involving better definition and comprehensive assessment of the effects of squatting during childbirth.
\n \n\n \n \nBackground: Use of telephone, video and online consultations in general practice is increasing. This can lead to transactional consultations which make it harder for patients to describe how symptoms affect their lives, and confusion about plans for future care. The aim of this study was to test the feasibility of a randomised control trial (RCT) for a complex intervention designed to address patients\u2019 concerns more comprehensively and help them remember advice from general practitioners (GPs). Methods: The complex intervention used two technologies: a patient-completed pre-consultation form at consultation opening and a doctor-provided summary report printed or texted at consultation closure. The feasibility of the intervention was tested in a cluster-randomised framework in six practices: four randomised to intervention, and two to control. Thirty patients were recruited per practice. Quantitative data was collected via patient-reported questionnaires and health records. GPs, patients and administrators were interviewed. Analysis included a process evaluation, recruitment and follow-up rates, and data completeness to assess feasibility of a future RCT. Results:\u00a0The intervention was acceptable and useful to patients and GPs, but the process for the pre-consultation form required too much support from the researchers for a trial to be feasible. Both technologies were useful for different types of patients. Recruitment rates were high (n=194) but so was attrition, therefore criteria to progress to an RCT were not met. Conclusions: Both the pre-consultation form and the summary report showed important potential benefits. They should be considered as separate interventions and evaluated independently. The technology to send pre-consultation forms needs further development to allow integration with GP computer systems. The additional time needed to generate summary reports meant GPs preferred to use it selectively. Collecting outcome data using online questionnaires was efficient but associated with high attrition, so alternative approaches are needed before a full RCT is feasible.
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