A feasibility study using motivational interviewing and a smartphone application to promote physical activity (+Stay-Active) for women with gestational diabetes.

BACKGROUND: Physical activity (PA) interventions have an encouraging role in gestational diabetes mellitus (GDM) management. Digital technologies can potentially be used at scale to support PA. The aim of this study was to assess the feasibility and acceptability of + Stay-Active: a complex intervention which combines motivational interviewing with a smartphone application to promote PA levels in women with GDM. METHODS: This non-randomised feasibility study used a mixed methods approach. Participants were recruited from the GDM antenatal clinic at Oxford University Hospitals. Following baseline assessments (visit 1) including self-reported and device determined PA measurements (wrist worn accelerometer), women participated in an online motivational interview, and then downloaded (visit 2) and used the Stay-Active app (Android or iOS). Women had access to Stay-Active until 36 weeks' gestation, when acceptability and PA levels were reassessed (visit 3). The primary outcome measures were recruitment and retention rates, participant engagement, and acceptability and fidelity of the intervention. Secondary outcome measures included PA levels, app usage, blood glucose and perinatal outcomes. Descriptive statistics were performed for assessments at study visits. Statistics software package Stata 14 and R were used. RESULTS: Over the recruitment period (46 weeks), 114 of 285 women met inclusion criteria and 67 (58%) enrolled in the study. Mean recruitment rate of 1.5 participants/clinic with 2.5 women/clinic meeting inclusion criteria. Fifty-six (83%) received the intervention at visit 2 and 53 (79%) completed the study. Compliance to accelerometer measurement protocols were sufficient in 78% of participants (52/67); wearing the device for more than 10 h on 5 or more days at baseline and 61% (41/67) at 36 weeks. There was high engagement with Stay-Active; 82% (55/67) of participants set goals on Stay-Active. Sustained engagement was evident, participants regularly accessed and logged multiples activities on Stay-Active. The intervention was deemed acceptable; 85% of women rated their care was satisfactory or above, supported by written feedback. CONCLUSIONS: This combined intervention was feasible and accepted. Recruitment rates were lower than expected. However, retention rates remained satisfactory and participant compliance with PA measurements and engagement was a high. Future work will explore the intervention's efficacy to increase PA and impact on clinical outcomes. TRIAL REGISTRATION: The study has received a favourable opinion from South Central-Hampshire B Research Ethics Committee; REC reference: 20/SC/0342. ISRCTN11366562.

Cardiac Remodeling After Hypertensive Pregnancy Following Physician-Optimized Blood Pressure Self-Management: The POP-HT Randomized Clinical Trial Imaging Substudy.

BACKGROUND: Hypertensive pregnancy disorders are associated with adverse cardiac remodeling, which can fail to reverse in the postpartum period in some women. The Physician-Optimized Postpartum Hypertension Treatment trial demonstrated that improved blood pressure control while the cardiovascular system recovers postpartum associates with persistently reduced blood pressure. We now report the effect on cardiac remodeling. METHODS: In this prospective, randomized, open-label, blinded end point trial, in a single UK hospital, 220 women were randomly assigned 1:1 to self-monitoring with research physician-optimized antihypertensive titration or usual postnatal care from a primary care physician and midwife. Participants were 18 years of age or older, with preeclampsia or gestational hypertension, requiring antihypertensives on hospital discharge postnatally. Prespecified secondary cardiac imaging outcomes were recorded by echocardiography around delivery, and again at blood pressure primary outcome assessment, around 9 months postpartum, when cardiovascular magnetic resonance was also performed. RESULTS: A total of 187 women (101 intervention; 86 usual care) underwent echocardiography at baseline and follow-up, at a mean 258±14.6 days postpartum, of which 174 (93 intervention; 81 usual care) also had cardiovascular magnetic resonance at follow-up. Relative wall thickness by echocardiography was 0.06 (95% CI, 0.07-0.05; P<0.001) lower in the intervention group between baseline and follow-up, and cardiovascular magnetic resonance at follow-up demonstrated a lower left ventricular mass (-6.37 g/m2; 95% CI, -7.99 to -4.74; P<0.001), end-diastolic volume (-3.87 mL/m2; 95% CI, -6.77 to -0.98; P=0.009), and end-systolic volume (-3.25 mL/m2; 95% CI, 4.87 to -1.63; P<0.001) and higher left and right ventricular ejection fraction by 2.6% (95% CI, 1.3-3.9; P<0.001) and 2.8% (95% CI, 1.4-4.1; P<0.001), respectively. Echocardiography-assessed left ventricular diastolic function demonstrated a mean difference in average E/E' of 0.52 (95% CI, -0.97 to -0.07; P=0.024) and a reduction in left atrial volumes of -4.33 mL/m2 (95% CI, -5.52 to -3.21; P<0.001) between baseline and follow-up when adjusted for baseline differences in measures. CONCLUSIONS: Short-term postnatal optimization of blood pressure control after hypertensive pregnancy, through self-monitoring and physician-guided antihypertensive titration, associates with long-term changes in cardiovascular structure and function, in a pattern associated with more favorable cardiovascular outcomes. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04273854.

Using a novel ambulatory monitoring system to support patient safety on an acute infectious disease ward during an unfolding pandemic.

AIM: To gain staff feedback on the implementation and impact of a novel ambulatory monitoring system to support coronavirus patient management on an isolation ward. DESIGN: Qualitative service evaluation. METHODS: Semi-structured interviews were conducted with 15 multidisciplinary isolation ward staff in the United Kingdom between July 2020 and May 2021. Interviews were audio-recorded, transcribed and analysed using thematic analysis. FINDINGS: Adopting Innovation to Assist Patient Safety was identified as the overriding theme. Three interlinked sub-themes represent facets of how the system supported patient safety. Patient Selection was developed throughout the pandemic, as clinical staff became more confident in choosing which patients would benefit most. Trust In the System described how nurses coped with discrepancies between the ambulatory system and ward observation machines. Finally, Resource Management examined how, once trust was built, staff perceived the ambulatory system assisted with caseload management. This supported efficient personal protective equipment resource use by reducing the number of isolation room entries. Despite these reported benefits, face-to-face contact was still highly valued, despite the risk of coronavirus exposure. CONCLUSION: Hospital wards should consider using ambulatory monitoring systems to support caseload management and patient safety. Patients in isolation rooms or at high risk of deterioration may particularly benefit from this additional monitoring. However, these systems should be seen as an adjunct to nursing care, not a replacement. IMPLICATIONS FOR THE PROFESSION AND/OR PATIENT CARE: Nurses valued ambulatory monitoring as a means of ensuring the safety of patients at risk of deterioration and prioritizing their workload. IMPACT: The findings of this research will be useful to all those developing or considering implementation of ambulatory monitoring systems in hospital wards. REPORTING METHOD: This manuscript follows the Consolidated criteria for Reporting Qualitative Research (COREQ) guidelines with inclusion of relevant SQUIRE guidelines for reporting quality improvement. PATIENT OR PUBLIC CONTRIBUTION: No Patient or Public Contribution.

Long-Term Blood Pressure Control After Hypertensive Pregnancy Following Physician-Optimized Self-Management: The POP-HT Randomized Clinical Trial.

Importance: Pregnancy hypertension results in adverse cardiac remodeling and higher incidence of hypertension and cardiovascular diseases in later life. Objective: To evaluate whether an intervention designed to achieve better blood pressure control in the postnatal period is associated with lower blood pressure than usual outpatient care during the first 9 months postpartum. Design, Setting, and Participants: Randomized, open-label, blinded, end point trial set in a single hospital in the UK. Eligible participants were aged 18 years or older, following pregnancy complicated by preeclampsia or gestational hypertension, requiring antihypertensive medication postnatally when discharged. The first enrollment occurred on February 21, 2020, and the last follow-up, November 2, 2021. The follow-up period was approximately 9 months. Interventions: Participants were randomly assigned 1:1 to self-monitoring along with physician-optimized antihypertensive titration or usual postnatal care. Main Outcomes and Measures: The primary outcome was 24-hour mean diastolic blood pressure at 9 months postpartum, adjusted for baseline postnatal blood pressure. Results: Two hundred twenty participants were randomly assigned to either the intervention group (n = 112) or the control group (n = 108). The mean (SD) age of participants was 32.6 (5.0) years, 40% had gestational hypertension, and 60% had preeclampsia. Two hundred participants (91%) were included in the primary analysis. The 24-hour mean (SD) diastolic blood pressure, measured at 249 (16) days postpartum, was 5.8 mm Hg lower in the intervention group (71.2 [5.6] mm Hg) than in the control group (76.6 [5.7] mm Hg). The between-group difference was -5.80 mm Hg (95% CI, -7.40 to -4.20; P < .001). Similarly, the 24-hour mean (SD) systolic blood pressure was 6.5 mm Hg lower in the intervention group (114.0 [7.7] mm Hg) than in the control group (120.3 [9.1] mm Hg). The between-group difference was -6.51 mm Hg (95% CI, -8.80 to -4.22; P < .001). Conclusions and Relevance: In this single-center trial, self-monitoring and physician-guided titration of antihypertensive medications was associated with lower blood pressure during the first 9 months postpartum than usual postnatal outpatient care in the UK. Trial Registration: ClinicalTrials.gov Identifier: NCT04273854.

Towards an Integrated Blood Pressure Self-Monitoring SolutIoN for Stroke/TIA in Ireland: a mixed methods feasibility study for the TASMIN5S IRL randomised controlled trial.

BACKGROUND: Optimising Blood Pressure (BP) control is one of the most important modifiable risk factors in preventing subsequent stroke where the risk increases by one-third for every 10 mmHg rise in systolic BP. The aim of this study was to evaluate the feasibility and effects of BP self-monitoring in patients with a previous stroke or TIA in Ireland. METHODS: Patients with a history of stroke or TIA and sub-optimal BP control were identified from practice electronic medical records and invited to take part in the pilot study. Those with systolic BP >130 mmHg were randomised to a self-monitoring or usual care group. Self-monitoring involved monitoring BP twice a day for 3 days within a 7-day period every month, following text message reminders. Patients sent their BP readings by free-text to a digital platform. The monthly average BP was sent to the patient (traffic light system) and to the patient's GP after each monitoring period. Treatment escalation was subsequently agreed by the patient and GP. RESULTS: Of those identified, 47% (32/68) attended for assessment. Of those assessed, 15 were eligible for recruitment and were consented and randomised to the intervention or control group on a 2:1 basis. Of those randomised, 93% (14/15) completed the study with no adverse events. Systolic BP was lower in the intervention group at 12 weeks. CONCLUSIONS: TASMIN5S, an integrated blood pressure self-monitoring intervention in patients with a previous stroke or TIA, is feasible and safe to deliver in primary care. A pre-agreed three step medication titration plan was easily implemented, increased patient involvement in their care, and had no adverse effects.

Ambulatory blood pressure monitoring using telemedicine: proof-of-concept cohort and failure modes and effects analyses.

Background: The COVID-19 pandemic has accelerated adoption of remote consulting in healthcare. Despite opportunities posed by telemedicine, most hypertension services in Europe have suspended ambulatory blood pressure monitoring (ABPM). Methods: We examined the process and performance of remotely delivered ABPM using two methodologies: firstly, a Failure Modes and Effects Analysis (FMEA) and secondly, a quantitative analysis comparing ABPM data from a subgroup of 65 participants of the Screening for Hypertension in the INpatient Environment (SHINE) diagnostic accuracy study. The FMEA was performed over seven sessions from February to March 2021, with a multidisciplinary team comprising a patient representative, a research coordinator with technical expertise and four research clinicians. Results: The FMEA identified a single high-risk step in the remote ABPM process. This was cleaning of monitoring equipment in the context of the COVID-19 pandemic, unrelated to the remote setting. A total of 14 participants were scheduled for face-to-face ABPM appointments, before the UK March 2020 COVID-19 lockdown; 62 were scheduled for remote ABPM appointments since emergence of the COVID-19 pandemic between November 2020 and August 2021. A total of 65 (88%) participants completed ABPMs; all obtained sufficient successful measurements for interpretation. For the 10 participants who completed face-to-face ABPM, there were 402 attempted ABPM measurements and 361 (89%) were successful. For the 55 participants who completed remote ABPM, there were 2516 attempted measurements and 2214 (88%) were successful. There was no significant difference in the mean per-participant error rate between face-to-face (0.100, SD 0.009) and remote (0.143, SD 0.132) cohorts (95% CI for the difference -0.125 to 0.045 and two-tailed P-value 0.353). Conclusions: We have demonstrated that ABPM can be safely and appropriately provided in the community remotely and without face-to-face contact, using video technology for remote fitting appointments, alongside courier services for delivery of equipment to participants.

Predicting Isolated Nocturnal Hypertension Using Dawn and Dusk Home Blood Pressure Monitoring.

Hypertension is a major global cause of morbidity and mortality. Home Blood Pressure Monitoring (HBPM) has the potential to help diagnose patients experiencing isolated nocturnal hypertension who may otherwise be missed. This paper investigates potential diagnostic thresholds for diagnosing isolated nocturnal hypertension using dawn and dusk HBPM measurements in the BP-Eth ambulatory blood pressure monitoring (ABPM) database. Depending on whether European or American diagnostic guidelines for hypertension were used, incidence of isolated nocturnal hypertension in the BP-Eth database was 17.1% or 16.8%, respectively. Using averaged dawn and dusk HBPM measurements to diagnose isolated nocturnal hypertension yielded an AUROC of 0.79 (European guidelines) or 0.84 (American guidelines). The SBP and DBP diagnostic thresholds required to detect 80% of cases of isolated nocturnal hypertension were found to be 125.4 mmHg and 75.7 mmHg, respectively (European guidelines) or 117.6 mmHg and 74.3 mmHg, respectively (American guidelines). These thresholds corresponded to a sensitivity of 80% and specificity of 63% (European guidelines) or sensitivity of 83% and specificity of 65% (American guidelines). These results demonstrate the potential for HBPM to function as an intermediate step in screening patients, determining which patients require more intensive ABPM monitoring for detection of isolated nocturnal hypertension. Clinical Relevance - This study investigates the incidence of isolated nocturnal hypertension, and the possibility of using home blood pressure monitoring (HBPM) to screen for it. Isolated nocturnal hypertension is otherwise only detectable using more expensive and burdensome ambulatory blood pressure monitoring (ABPM).

Study protocol: use of a smartphone application to support the implementation of a complex physical activity intervention (+Stay Active) in women with gestational diabetes mellitus-protocol for a non-randomised feasibility study.

INTRODUCTION: Physical activity (PA) interventions have a promising role in the management of gestational diabetes mellitus (GDM). Digital technologies can support PA at scale and remotely. The protocol describes a study designed to determine the feasibility and acceptability of a complex intervention; known as +Stay Active. +Stay Active combines motivational interviewing with a bespoke behaviour change informed smartphone application (Stay-Active) to augment PA levels in women with GDM. METHODS AND ANALYSIS: This is a non-randomised feasibility study using a mixed methods approach. Participants will be recruited from the GDM antenatal clinic at the Women Centre, John Radcliffe Hospital, Oxford. Following baseline assessments (visit 1) including self-reported and device determined PA assessment (wearing a wrist accelerometer), women will be invited to participate in an online motivational interview, then download and use the Stay-Active app (Android or iOS) (visit 2). Women will have access to Stay-Active until 36 weeks gestation, when engagement and PA levels will be reassessed (visit 3). The target sample size is 60 women. Primary outcomes are recruitment and retention rates, compliance and assessment of participant engagement and acceptability with the intervention. Secondary outcomes are assessment of blood glucose control, self-reported and device determined assessment of PA, usage and structured feedback of participant's attitudes to +Stay Active, assessment of health costs and description of maternal and neonatal outcomes. This study will provide key insights into this complex intervention regarding engagement in smartphone technology and the wearing of accelerometers. These data will inform the development of a randomised controlled trial with refinements to intervention implementation. ETHICS AND DISSEMINATION: The study has received a favourable opinion from South Central-Hampshire B Research Ethics Committee; REC reference: 20/SC/0342. Written informed consent will be obtained from all participants. Findings will be disseminated through peer-reviewed journals, conferences and seminar presentations. TRIAL REGISTRATION NUMBER: ISRCTN11366562.

Postpartum blood pressure self-management following hypertensive pregnancy: protocol of the Physician Optimised Post-partum Hypertension Treatment (POP-HT) trial.

INTRODUCTION: New-onset hypertension affects approximately 10% of pregnancies and is associated with a significant increase in risk of cardiovascular disease in later life, with blood pressure measured 6 weeks postpartum predictive of blood pressure 5-10 years later. A pilot trial has demonstrated that improved blood pressure control, achevied via self-management during the puerperium, was associated with lower blood pressure 3-4 years postpartum. Physician Optimised Post-partum Hypertension Treatment (POP-HT) will formally evaluate whether improved blood pressure control in the puerperium results in lower blood pressure at 6 months post partum, and improvements in cardiovascular and cerebrovascular phenotypes. METHODS AND ANALYSIS: POP-HT is an open-label, parallel arm, randomised controlled trial involving 200 women aged 18 years or over, with a diagnosis of pre-eclampsia or gestational hypertension, and requiring antihypertensive medication at discharge. Women are recruited by open recruitment and direct invitation around time of delivery and randomised 1:1 to, either an intervention comprising physician-optimised self-management of postpartum blood pressure or, usual care. Women in the intervention group upload blood pressure readings to a 'smartphone' app that provides algorithm-driven individualised medication-titration. Medication changes are approved by physicians, who review blood pressure readings remotely. Women in the control arm follow assessment and medication adjustment by their usual healthcare team. The primary outcome is 24-hour average ambulatory diastolic blood pressure at 6-9 months post partum. Secondary outcomes include: additional blood pressure parameters at baseline, week 1 and week 6; multimodal cardiovascular assessments (CMR and echocardiography); parameters derived from multiorgan MRI including brain and kidneys; peripheral macrovascular and microvascular measures; angiogenic profile measures taken from blood samples and levels of endothelial circulating and cellular biomarkers; and objective physical activity monitoring and exercise assessment. An additional 20 women will be recruited after a normotensive pregnancy as a comparator group for endothelial cellular biomarkers. ETHICS AND DISSEMINATION: IRAS PROJECT ID 273353. This trial has received a favourable opinion from the London-Surrey Research Ethics Committee and HRA (REC Reference 19/LO/1901). The investigator will ensure that this trial is conducted in accordance with the principles of the Declaration of Helsinki and follow good clinical practice guidelines. The investigators will be involved in reviewing drafts of the manuscripts, abstracts, press releases and any other publications arising from the study. Authors will acknowledge that the study was funded by the British Heart Foundation Clinical Research Training Fellowship (BHF Grant number FS/19/7/34148). Authorship will be determined in accordance with the ICMJE guidelines and other contributors will be acknowledged. TRIAL REGISTRATION NUMBER: NCT04273854.

The Use of Wearable Pulse Oximeters in the Prompt Detection of Hypoxemia and During Movement: Diagnostic Accuracy Study.

BACKGROUND: Commercially available wearable (ambulatory) pulse oximeters have been recommended as a method for managing patients at risk of physiological deterioration, such as active patients with COVID-19 disease receiving care in hospital isolation rooms; however, their reliability in usual hospital settings is not known. OBJECTIVE: We report the performance of wearable pulse oximeters in a simulated clinical setting when challenged by motion and low levels of arterial blood oxygen saturation (SaO2). METHODS: The performance of 1 wrist-worn (Wavelet) and 3 finger-worn (CheckMe O2+, AP-20, and WristOx2 3150) wearable, wireless transmission-mode pulse oximeters was evaluated. For this, 7 motion tasks were performed: at rest, sit-to-stand, tapping, rubbing, drinking, turning pages, and using a tablet. Hypoxia exposure followed, in which inspired gases were adjusted to achieve decreasing SaO2 levels at 100%, 95%, 90%, 87%, 85%, 83%, and 80%. Peripheral oxygen saturation (SpO2) estimates were compared with simultaneous SaO2 samples to calculate the root-mean-square error (RMSE). The area under the receiver operating characteristic curve was used to analyze the detection of hypoxemia (ie, SaO2<90%). RESULTS: SpO2 estimates matching 215 SaO2 samples in both study phases, from 33 participants, were analyzed. Tapping, rubbing, turning pages, and using a tablet degraded SpO2 estimation (RMSE>4% for at least 1 device). All finger-worn pulse oximeters detected hypoxemia, with an overall sensitivity of ≥0.87 and specificity of ≥0.80, comparable to that of the Philips MX450 pulse oximeter. CONCLUSIONS: The SpO2 accuracy of wearable finger-worn pulse oximeters was within that required by the International Organization for Standardization guidelines. Performance was degraded by motion, but all pulse oximeters could detect hypoxemia. Our findings support the use of wearable, wireless transmission-mode pulse oximeters to detect the onset of clinical deterioration in hospital settings. TRIAL REGISTRATION: ISRCTN Registry 61535692; http://www.isrctn.com/ISRCTN61535692. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2019-034404.

Targeting BRAF V600E in metastatic colorectal cancer: where are we today?

Colorectal cancer (CRC) is the second most frequent cause of direct cancer death worldwide. The study of the molecular state of oncogenes has predictive and prognostic value in metastatic CRC (mCRC). The B-raf proto-oncogene (BRAF) gene mutation represents the 8%-12% of all mutations in mCRC. The BRAF V600E mutation, considered the most common alteration of BRAF, corresponds to a constitutive kinase with a high activating capacity of the RAS/RAF/MEK/ERK pathway after a cascade of successive phosphorylations in the transcription of genes. BRAF V600E mutation is more prevalent in women, elderly, right-sided colon cancer and Caucasian population. Unfortunately, it is considered a poor predictive and prognosis biomarker. Patients with mCRC BRAF V600E mutated (BRAFm) are generally associated with poor response to chemotherapy and short progression-free survival and overall survival. Recently, randomised clinical trials have studied the combination of different chemotherapy regimens with angiogenic inhibitors in mCRC BRAFm. In addition, new anti-BRAF and immunotherapy agents have also been studied in this population, with positive results. The objective of this review is to acknowledge the biology and molecular pathway of BRAF, critically analyse the clinical trials and the therapy options published until today and evaluate the options of treatment according to the patient's clinical presentation.

A Real-Time Wearable System for Monitoring Vital Signs of COVID-19 Patients in a Hospital Setting.

The challenges presented by the Coronavirus disease 2019 (COVID-19) pandemic to the National Health Service (NHS) in the United Kingdom (UK) led to a rapid adaptation of infection disease protocols in-hospital. In this paper we report on the optimisation of our wearable ambulatory monitoring system (AMS) to monitor COVID-19 patients on isolation wards. A wearable chest patch (VitalPatch®, VitalConnect, United States of America, USA) and finger-worn pulse oximeter (WristOx2® 3150, Nonin, USA) were used to estimate and transmit continuous Heart Rate (HR), Respiratory Rate (RR), and peripheral blood Oxygen Saturation (SpO2) data from ambulatory patients on these isolation wards to nurse bays remote from these patients, with a view to minimising the risk of infection for nursing staff. Our virtual High-Dependency Unit (vHDU) system used a secure web-based architecture and protocols (HTTPS and encrypted WebSockets) to transmit the vital-sign data in real time from wireless Android tablet devices, operating as patient data collection devices by the bedside in the isolation rooms, into the clinician dashboard interface available remotely via any modern web-browser. Fault-tolerant software strategies were used to reconnect the wearables automatically, avoiding the need for nurses to enter the isolation ward to re-set the patient monitoring equipment. The remote dashboard also displayed the vital-sign observations recorded by the nurses, using a separate electronic observation system, allowing them to review both sources of vital-sign data in one integrated chart. System usage was found to follow the trend of the number of local COVID-19 infections during the first wave of the pandemic in the UK (March to June 2020), with almost half of the patients on the isolation ward monitored with wearables during the peak of hospital admissions in the local area. Patients were monitored for a median of 31.5 [8.8, 75.4] hours, representing 88.1 [62.5, 94.5]% of the median time they were registered in the system. This indicates the system was being used in the isolation ward during this period. An updated version of the system has now also been used throughout the second and third waves of the pandemic in the UK.

A Chest Patch for Continuous Vital Sign Monitoring: Clinical Validation Study During Movement and Controlled Hypoxia.

BACKGROUND: The standard of care in general wards includes periodic manual measurements, with the data entered into track-and-trigger charts, either on paper or electronically. Wearable devices may support health care staff, improve patient safety, and promote early deterioration detection in the interval between periodic measurements. However, regulatory standards for ambulatory cardiac monitors estimating heart rate (HR) and respiratory rate (RR) do not specify performance criteria during patient movement or clinical conditions in which the patient's oxygen saturation varies. Therefore, further validation is required before clinical implementation and deployment of any wearable system that provides continuous vital sign measurements. OBJECTIVE: The objective of this study is to determine the agreement between a chest-worn patch (VitalPatch) and a gold standard reference device for HR and RR measurements during movement and gradual desaturation (modeling a hypoxic episode) in a controlled environment. METHODS: After the VitalPatch and gold standard devices (Philips MX450) were applied, participants performed different movements in seven consecutive stages: at rest, sit-to-stand, tapping, rubbing, drinking, turning pages, and using a tablet. Hypoxia was then induced, and the participants' oxygen saturation gradually reduced to 80% in a controlled environment. The primary outcome measure was accuracy, defined as the mean absolute error (MAE) of the VitalPatch estimates when compared with HR and RR gold standards (3-lead electrocardiography and capnography, respectively). We defined these as clinically acceptable if the rates were within 5 beats per minute for HR and 3 respirations per minute (rpm) for RR. RESULTS: Complete data sets were acquired for 29 participants. In the movement phase, the HR estimates were within prespecified limits for all movements. For RR, estimates were also within the acceptable range, with the exception of the sit-to-stand and turning page movements, showing an MAE of 3.05 (95% CI 2.48-3.58) rpm and 3.45 (95% CI 2.71-4.11) rpm, respectively. For the hypoxia phase, both HR and RR estimates were within limits, with an overall MAE of 0.72 (95% CI 0.66-0.78) beats per minute and 1.89 (95% CI 1.75-2.03) rpm, respectively. There were no significant differences in the accuracy of HR and RR estimations between normoxia (≥90%), mild (89.9%-85%), and severe hypoxia (<85%). CONCLUSIONS: The VitalPatch was highly accurate throughout both the movement and hypoxia phases of the study, except for RR estimation during the two types of movements. This study demonstrated that VitalPatch can be safely tested in clinical environments to support earlier detection of cardiorespiratory deterioration. TRIAL REGISTRATION: ISRCTN Registry ISRCTN61535692; https://www.isrctn.com/ISRCTN61535692.

Diffusible signal factor signaling controls bioleaching activity and niche protection in the acidophilic, mineral-oxidizing leptospirilli.

Bioleaching of metal sulfide ores involves acidophilic microbes that catalyze the chemical dissolution of the metal sulfide bond that is enhanced by attached and planktonic cell mediated oxidation of iron(II)-ions and inorganic sulfur compounds. Leptospirillum spp. often predominate in sulfide mineral-containing environments, including bioheaps for copper recovery from chalcopyrite, as they are effective primary mineral colonizers and oxidize iron(II)-ions efficiently. In this study, we demonstrated a functional diffusible signal factor interspecies quorum sensing signaling mechanism in Leptospirillum ferriphilum and Leptospirillum ferrooxidans that produces (Z)-11-methyl-2-dodecenoic acid when grown with pyrite as energy source. In addition, pure diffusible signal factor and extracts from supernatants of pyrite grown Leptospirillum spp. inhibited biological iron oxidation in various species, and that pyrite grown Leptospirillum cells were less affected than iron grown cells to self inhibition. Finally, transcriptional analyses for the inhibition of iron-grown L. ferriphilum cells due to diffusible signal factor was compared with the response to exposure of cells to N- acyl-homoserine-lactone type quorum sensing signal compounds. The data suggested that Leptospirillum spp. diffusible signal factor production is a strategy for niche protection and defense against other microbes and it is proposed that this may be exploited to inhibit unwanted acidophile species.

Optimizing a digital intervention for managing blood pressure in stroke patients using a diverse sample: Integrating the person-based approach and patient and public involvement.

BACKGROUND: Having a stroke or transient ischaemic attack increases the risk of a subsequent one, especially with high blood pressure (BP). Home-based BP management can be effective at maintaining optimal BP. OBJECTIVE: To describe the optimization of a digital intervention for stroke patients and the value of participant diversity, using the person-based approach (PBA) and integral patient and public involvement (PPI). SETTING AND PARTICIPANTS: Stroke patients recruited from primary care and community settings, and health-care professionals in primary care, in England and Ireland. DESIGN: Three linked qualitative studies conducted iteratively to develop an intervention using the PBA, with integral PPI. INTERVENTION: The BP: Together intervention, adapted from existing BP self-monitoring interventions, is delivered via mobile phone or web interface to support self-monitoring of BP at home. It alerts patients and their clinicians when a change in antihypertensive medication is needed. FINDINGS: Feedback from a diverse range of participants identified potential barriers, which were addressed to improve the intervention accessibility, feasibility and persuasiveness. Easy-to-read materials were developed to improve usability for patients with aphasia and lower literacy. The importance of including family members who support patient care was also highlighted. Feedback messages regarding medication change were refined to ensure usefulness for patients and clinicians. DISCUSSION: Input from PPI alongside qualitative research with a diverse study sample allowed the creation of a simple and equitable BP management intervention for stroke patients. PATIENT INVOLVEMENT: Two PPI co-investigators contributed to design, conduct of study, data interpretation and manuscript preparation; community PPI sessions informed early planning. Study participants were stroke patients and family members.

Protocol for a prospective, controlled, cross-sectional, diagnostic accuracy study to evaluate the specificity and sensitivity of ambulatory monitoring systems in the prompt detection of hypoxia and during movement.

INTRODUCTION: Automated continuous ambulatory monitoring may provide an alternative to intermittent manual vital signs monitoring. This has the potential to improve frequency of measurements, timely escalation of care and patient safety. However, a major barrier to the implementation of these wearable devices in the ward environment is their uncertain reliability, efficiency and data fidelity. The purpose of this study is to test performance of selected devices in a simulated clinical setting including during movement and low levels of peripheral oxygen saturation. METHODS AND ANALYSIS: This is a single centre, prospective, controlled, cross-sectional, diagnostic accuracy study to determine the specificity and sensitivity of currently available ambulatory vital signs monitoring equipment in the detection of hypoxia and the effect of movement on data acquisition. We will recruit up to 45 healthy volunteers who will attend a single study visit; starting with a movement phase and followed by the hypoxia exposure phase where we will gradually decrease saturation levels down to 80%. We will simultaneously test one chest patch, one wrist worn only and three wrist worn with finger probe devices against 'clinical standard 'and 'gold standard' references. We will measure peripheral oxygen saturations, pulse rate, heart rate and respiratory rate continuously and arterial blood gases intermittently throughout the study. ETHICS AND DISSEMINATION: This study has received ethical approval by the East of Scotland Research Ethics Service REC 2 (19/ES/0008). The results will be broadly distributed through conference presentations and peer-reviewed publications. TRIAL REGISTRATION NUMBER: ISRCTN61535692 registered on 10/06/2019.

Screening for Hypertension in the INpatient Environment(SHINE): a protocol for a prospective study of diagnostic accuracy among adult hospital patients.

INTRODUCTION: A significant percentage of patients admitted to hospital have undiagnosed hypertension. However, present hypertension guidelines in the UK, Europe and USA do not define a blood pressure threshold at which hospital inpatients should be considered at risk of hypertension, outside of the emergency setting. The objective of this study is to identify the optimal in-hospital mean blood pressure threshold, above which patients should receive postdischarge blood pressure assessment in the community. METHODS AND ANALYSIS: Screening for Hypertension in the INpatient Environment is a prospective diagnostic accuracy study. Patients admitted to hospital whose mean average daytime blood pressure after 24 hours or longer meets the study eligibility threshold for mean daytime blood pressure (≥120/70 mm Hg) and who have no prior diagnosis of, or medication for hypertension will be eligible. At 8 weeks postdischarge, recruited participants will wear an ambulatory blood pressure monitor for 24 hours. Mean daytime ambulatory blood pressure will be calculated to assess for the presence or absence of hypertension. Diagnostic performance of in-hospital blood pressure will be assessed by constructing receiver operator characteristic curves from participants' in-hospital mean systolic and mean diastolic blood pressure (index test) versus diagnosis of hypertension determined by mean daytime ambulatory blood pressure (reference test). ETHICS AND DISSEMINATION: Ethical approval has been provided by the National Health Service Health Research Authority South Central-Oxford B Research Ethics Committee (19/SC/0026). Findings will be disseminated through national and international conferences, peer-reviewed journals and social media.

Bradicardia inducida por quimioterapia en pacientes oncológicos / Chemotherapy-induced bradycardia in oncology patients

Resumen Introducción: cada día se reportan efectos tóxicos de la quimioterapia en el corazón, entre ellos las arritmias; sin embargo, las publicaciones sobre bradicardia ocasionada por antineoplásicos son escasas. Objetivo: describir y analizar la presencia de bradicardia posquimioterapia en el paciente oncológico. Materiales y métodos: estudio no experimental, descriptivo, retrospectivo, en el que se incluyeron pacientes atendidos durante el año 2017 en un Servicio de Cardiología, a causa de bradicardia posquimioterapia. Resultados: se evaluaron 59 pacientes, 31 varones (52,5%) y 28 mujeres (47,5%), con una mediana de edad de 42 años. La mediana de la frecuencia cardiaca fue 46 latidos por minuto. La bradicardia fue más frecuente en leucemia mielocítica aguda (25,42%), seguida por leucemia linfoblástica aguda (20,34%). Fue asintomática en el 88,13% de los casos. Los fármacos quimioterápicos relacionados con bradicardia en leucemia mielocítica aguda fueron la citarabina en combinación con la daunorubicina, mientras que en leucemia linfoblástica aguda fueron la vincristina en combinación con la daunorubicina. Se presentó intervalo QTc largo en 12 casos (20,34%). El tiempo entre quimioterapia y el inicio de la bradicardia fue 24 a 48 horas en 35,6% y la recuperación de la frecuencia cardiaca fue entre 24 a 48 horas en el 61,02%. Conclusiones: la bradicardia sinusal como efecto adverso de la quimioterapia, es más frecuente en la leucemia mielocítica aguda, mientras que los medicamentos antineoplásicos relacionados con la bradicardia más comunes fueron la citarabina y la daunorubicina.

Abstract Introduction: There are daily reports of the toxic effects of chemotherapy on the heart, among them are the arrhythmias. However, there are very few publications on bradycardia caused by anti-neoplastic treatment. Objective: To describe and analyse the presence of post-chemotherapy bradycardia in the oncology patient. Materials and methods: A non-experimental, descriptive and retrospective study was conducted on patients seen during the year 2017 in a Cardiology Department due to post-chemotherapy bradycardia. Results: A total of 59 patients were evaluated, of whom 31 (52.5%) were males and 28 (47.5%) women, and with a median age of 42 years. The median heart rate was 46 beats per minute. The bradycardia was more common in acute myelocytic leukaemia (25.42%), followed by acute lymphoblastic leukaemia (20.34%). It was asymptomatic in 88.31% of cases. The chemotherapy drugs associated with bradycardia in acute myelocytic leukaemia were cytarabine in combination with daunorubicin, whilst in acute lymphoblastic leukaemia they were vincristine in combination with daunorubicin. A prolonged QTc interval was present in 12 (20.34%) of cases. The time between the chemotherapy and the onset of bradycardia was 24 to 48 hours in 35.6%, and the recovery of the heart rate was between 24 and 48 hours in 61.02%. Conclusions: Sinus bradycardia as an adverse effect of chemotherapy is more frequent in acute myelocytic leukaemia, whilst the most common anti-neoplastic drugs associated with bradycardia were cytarabine and daunorubicin.

Amiloidosis cardiaca: reporte de un caso / Cardiac amyloidosis: a case report

La amiloidosis cardiaca es una entidad clínica poco frecuente y por tanto poco conocida. Su presentación, por ser una enfermedad infiltrativa debido al depósito extracelular del amiloide en la pared cardiaca, es la de una cardiomiopatía del tipo restrictivo, que si bien puede ser sistémica, es la afección cardiaca la que determina su mal pronóstico. Se presenta el caso de un paciente de 38 años de edad, que fue hospitalizado por disnea y fatiga severa, y al que se diagnosticó mieloma múltiple IgA de cadenas ligeras lambda, estadio clínico IIIB, e inició tratamiento con ciclofosfamida, talidomida y dexametasona. El paciente abandonó el tratamiento y regresó luego de un año y 2 meses con la enfermedad avanzada y con presencia de amiloidosis. El paciente evoluciona tórpidamente y fallece.Se realiza una revisión de la literatura médica sobre los tipos de amiloidosis, la fisiopatología, los métodos diagnósticos y el tratamiento.

Cardiac amyloidosis is a rare clinical entity and, therefore, almost unknown. It shows as a restrictive cardiomyopathy, since it is an infiltrative disease caused by the extracellular deposition of amyloids in the cardiac wall. Although it may be systemic, the heart condition determines its poor prognosis. This is the case of a 38-year-old patient who was admitted for dyspnea and severe fatigue. He was diagnosed with IgA multiple myeloma, lambda light chains, clinical stage IIIB, and initiated treatment with cyclophosphamide, thalidomide and dexamethasone. The patient stopped the treatment, and returned after one year and 2 months with an advanced disease and presence of amyloidosis. The patient progressed torpidly and eventually died. A review of the medical literature is performed concerning amyloidosis types, physiopathology, diagnostic methods and treatment.

Cardiotoxicidad por quimioterapia en el Instituto Nacional de Enfermedades Neoplásicas 2012-2016 / Chemotherapy-induced cardiotoxicity at the Instituto Nacional de Enfermedades Neoplásicas 2012-2016

Objetivo: Reportar la frecuencia de los efectos adversos a nivel cardiaco (cardiotoxicidad) producida por la quimioterapia en los pacientes del Instituto Nacional de Enfermedades Neoplásicas en el período 2012-2016. Materiales y métodos: El estudio realizado fue de tipo no experimental, descriptivo y retrospectivo. La población estudiada fueron los pacientes atendidos en el Servicio de Cardiología por presentar durante la quimioterapia molestias cardiovasculares. Resultados: Se realizaron 985 evaluaciones por sintomatología cardiaca de pacientes en tratamiento antineoplásico. Entre los efectos adversos a nivel del corazón de la terapia oncológica, las arritmias cardiacas fueron las más frecuentes (41,2%), en segundo lugar estuvieron los episodios de angina de pecho con un 18,7% y la insuficiencia cardiaca tuvo una frecuencia del 4,9%. La bradicardia sinusal ha sido la arritmia más usual (55,9%), seguida por la taquicardia sinusal sintomática (17,7%) y, en tercer lugar, la fibrilación auricular (12,0%). Conclusiones: La arritmia cardiaca fue el efecto adverso más frecuente del tratamiento oncológico, siendo la bradicardia sinusal asintomática la de mayor prevalencia

objective: To report the frequency of cardiac adverse effects (cardiotoxicity) induced by chemotherapy in patients of the Instituto Nacional de Enfermedades Neoplásicas during the period 2012-2016. Materials and methods: The study had a non-experimental, descriptive and retrospective design. The study population consisted of patients treated at the Cardiology Service due to cardiovascular discomfort during chemotherapy. Results: Nine hundred eighty-five (985) evaluations were performed because of cardiac symptoms in patients undergoing antineoplastic treatment. Among the oncological treatment-related cardiovascular adverse effects, cardiac arrhythmias were the most frequent ones (41.2%), episodes of angina pectoris were in the second place with 18.7%, and heart failure had a frequency of 4.9%. The most frequent arrhythmia was sinus bradycardia (55.9%), followed by symptomatic sinus tachycardia (17.7%) and, in the third place, atrial fibrillation (12.0%). Conclusions: Cardiac arrhythmia was the most frequent adverse effect induced by oncological treatment, with asymptomatic sinus bradycardia being the most prevalent one