Comparing Continuous with Periodic Vital Sign Scoring for Clinical Deterioration Using a Patient Data Model.

To evaluate a minute-by-minute monitoring algorithm against a periodic early warning score (EWS) in detecting clinical deterioration and workload. Periodic EWSs suffer from large measurement intervals, causing late detection of deterioration. This might be prevented by continuous vital sign monitoring with a real-time algorithm such as the Visensia Safety Index (VSI). This prospective comparative data modeling cohort study (NCT04189653) compares continuous algorithmic alerts against periodic EWS in continuous monitored medical and surgical inpatients. We evaluated sensitivity, frequency, number of warnings needed to evaluate (NNE) and time of initial alert till escalation of care (EOC): Rapid Response Team activation, unplanned ICU admission, emergency surgery, or death. Also, the percentage of VSI alerting minutes was compared between patients with or without EOC. In 1529 admissions continuous VSI warned for 55% of EOC (95% CI: 45-64%) versus 51% (95% CI: 41-61%) by periodic EWS. NNE for VSI was 152 alerts per detected EOC (95% CI: 114-190) compared to 21 (95% CI: 17-28). It generated 0.99 warnings per day per patient compared to 0.13. Time from detection score till escalation was 8.3 hours (IQR: 2.6-24.8) with VSI versus 5.2 (IQR: 2.7-12.3) hours with EWS (P=0.074). The percentage of warning VSI minutes was higher in patients with EOC than in stable patients (2.36% vs 0.81%, P<0.001). Although sensitivity of detection was not significantly improved continuous vital sign monitoring shows potential for earlier alerts for deterioration compared to periodic EWS. A higher percentage of alerting minutes may indicate risk for deterioration.

The Effect of Continuous Versus Periodic Vital Sign Monitoring on Disease Severity of Patients with an Unplanned ICU Transfer.

Continuous vital sign monitoring (CM) may detect ward patient's deterioration earlier than periodic monitoring. This could result in timely ICU transfers or in a transfer delay due to misperceived higher level of care on the ward. The primary objective of this study was to compare patient's disease severity upon unplanned ICU transfer, before and after CM implementation. We included a one-year period before and after CM implementation between August 1, 2017 - July 31, 2019. Before implementation, surgical and internal medicine patients' vital signs were periodically monitored, compared to continuous monitoring with wireless linkage to hospital systems after implementation. In both periods the same early warning score (EWS) protocol was in place. Primary outcome was disease severity scores upon ICU transfer. Secondary outcomes were ICU and hospital length of stay, incidence of mechanical ventilation and ICU mortality. In the two one-year periods 93 and 59 unplanned ICU transfer episodes were included, respectively. Median SOFA (3 (2-6) vs 4 (2-7), p = .574), APACHE II (17 (14-20) vs 16 (14-21), p = .824) and APACHE IV (59 (46-67) vs 50 (36-65), p = .187) were comparable between both periods, as were the median ICU LOS (3.0 (1.7-5.8) vs 3.1 (1.6-6.1), p.962), hospital LOS (23.6 (11.5-38.0) vs 19 (13.9-39.2), p = .880), incidence of mechanical ventilation (28 (47%) vs 22 (54%), p.490), and ICU mortality (11 (13%) vs 10 (19%), p.420). This study shows no difference in disease severity upon unplanned ICU transfer after CM implementation for patients who have deteriorated on the ward.

The Influencing Contexts and Potential Mechanisms Behind the Use of Web-Based Self-management Support Interventions: Realistic Evaluation.

BACKGROUND: Self-management can increase self-efficacy and quality of life and improve disease outcomes. Effective self-management may also help reduce the pressure on health care systems. However, patients need support in dealing with their disease and in developing skills to manage the consequences and changes associated with their condition. Web-based self-management support programs have helped patients with cardiovascular disease (CVD) and rheumatoid arthritis (RA), but program use has been low. OBJECTIVE: This study aimed to identify the patient, disease, and program characteristics that determine whether patients use web-based self-management support programs or not. METHODS: A realistic evaluation methodology was used to provide a comprehensive overview of context (patient and disease characteristics), mechanism (program characteristics), and outcome (program use). Secondary data of adult patients with CVD (n=101) and those with RA (n=77) were included in the study. The relationship between context (sex, age, education, employment status, living situation, self-management [measured using Patient Activation Measure-13], quality of life [measured using RAND 36-item health survey], interaction efficacy [measured using the 5-item perceived efficacy in patient-physician interactions], diagnosis, physical comorbidity, and time since diagnosis) and outcome (program use) was analyzed using logistic regression analyses. The relationship between mechanism (program design, implementation strategies, and behavior change techniques [BCTs]) and outcome was analyzed through a qualitative interview study. RESULTS: This study included 68 nonusers and 111 users of web-based self-management support programs, of which 56.4% (101/179) were diagnosed with CVD and 43.6% (78/179) with RA. Younger age and a lower level of education were associated with program use. An interaction effect was found between program use and diagnosis and 4 quality of life subscales (social functioning, physical role limitations, vitality, and bodily pain). Patients with CVD with higher self-management and quality of life scores were less likely to use the program, whereas patients with RA with higher self-management and quality of life scores were more likely to use the program. Interviews with 10 nonusers, 10 low users, and 18 high users were analyzed to provide insight into the relationship between mechanisms and outcome. Program use was encouraged by an easy-to-use, clear, and transparent design and by recommendations from professionals and email reminders. A total of 5 BCTs were identified as potential mechanisms to promote program use: tailored information, self-reporting behavior, delayed feedback, providing information on peer behavior, and modeling. CONCLUSIONS: This realistic evaluation showed that certain patient, disease, and program characteristics (age, education, diagnosis, program design, type of reminder, and BCTs) are associated with the use of web-based self-management support programs. These results represent the first step in improving the tailoring of web-based self-management support programs. Future research on the interaction between patient and program characteristics should be conducted to improve the tailoring of participants to program components.

Effect of continuous wireless vital sign monitoring on unplanned ICU admissions and rapid response team calls: a before-and-after study.

BACKGROUND: Continuous vital sign monitoring may potentially be improved through the use of wearable monitors linked wirelessly to hospital electronic patient records. By improving early detection of physiological deterioration this approach may save lives. METHODS: We performed a single-centre before-and-after study including surgical and medical patients at a university hospital in The Netherlands. The study intervention was continuous vital sign monitoring using wearable monitors linked wirelessly to hospital systems. The co-primary outcomes were unplanned ICU admission and rapid response team calls. Secondary outcomes were length of hospital stay and in-patient death. RESULTS: Our baseline cohort included 2466 admissions and our intervention cohort included 2303 admissions recruited from August 2017 to July 2019. Patients in the intervention cohort experienced fewer unplanned ICU admissions (84 [3.4%] vs 54 [2.3%]; P=0.03) and fewer rapid response team calls (107 [4.3%] vs 71 [3.1%]; P=0.02). The number of rapid response team calls that did not result in ICU admission also declined (70 [2.8%] vs 45 [2.0%]; P=0.05). The number of rapid response team calls that did result in ICU admission was not significantly different (52 [2.1%] vs 36 [1.6%]; P=0.16). There were no differences in hospital stay or in-patient deaths between the two study periods. CONCLUSIONS: Continuous monitoring of patient vital signs using wearable monitoring technology linked wirelessly to hospital systems was associated with a reduction in unplanned ICU admissions and rapid response team calls. Further research is necessary to confirm the impact of this approach on patient survival.

Effect of Hypoglycemia on Heart Rate Variability in People with Type 1 Diabetes and Impaired Awareness of Hypoglycemia.

BACKGROUND: People with impaired awareness of hypoglycemia (IAH) are at elevated risk of severe, potentially hazardous, hypoglycemia and would benefit from a device alerting to hypoglycemia. Heart rate variability (HRV) changes with hypoglycemia due to sympathetic activity. Since IAH is associated with suppressed sympathetic activity, we investigated whether hypoglycemia elicits a measurable change in HRV in patients with T1D and IAH. METHOD: Eligible participants underwent a modified hyperinsulinemic euglycemic hypoglycemic clamp (glucose nadir, 43.1 ± 0.90 mg/dl), while HRV was measured by a VitalConnect HealthPatch. Measurements of HRV included Root Mean Square of the Successive Differences (RMSSD) and low to high frequency (LF:HF) ratio. Wilcoxon rank-sum test was used for testing within-subject HRV changes. RESULTS: We included 12 participants (8 female, mean age 57 ± 12 years, mean HbA1c 57 ± 5 mmol/mol (7.4 ± 0.4%)). Symptoms increased from 4.0 (1.5-7.0) at euglycemia to 7.5 (5.0-11.0) during hypoglycemia (P = .003). In response to hypoglycemia, the LF:HF ratio and RMSSD increased when normalized for data obtained during euglycemia (both P < .01). The LF:HF ratio increased in 6 participants (50%) and declined in one other participant (8%). The RMSSD decreased in 3 (25%) and increased in 4 (33%) participants. In 2 patients, no change in HRV could be detected in response to hypoglycemia. CONCLUSIONS: This study reveals that hypoglycemia-induced changes in HRV are retained in the majority of people with T1D and IAH, and that these changes can be detected by a wearable device. Real-time HRV seems usable for detection of hypoglycemia in patients with IAH.

Correction: Continuous Monitoring of Vital Signs Using Wearable Devices on the General Ward: Pilot Study.

[This corrects the article DOI: 10.2196/mhealth.7208.].

Algorithms for Prediction of Clinical Deterioration on the General Wards: A Scoping Review.

OBJECTIVE: The primary objective of this scoping review was to identify and describe state-of-the-art models that use vital sign monitoring to predict clinical deterioration on the general ward. The secondary objective was to identify facilitators, barriers, and effects of implementing these models. DATA SOURCES: PubMed, Embase, and CINAHL databases until November 2020. STUDY SELECTION: We selected studies that compared vital signs-based automated real-time predictive algorithms to current track-and-trace protocols in regard to the outcome of clinical deterioration in a general ward population. DATA EXTRACTION: Study characteristics, predictive characteristics and barriers, facilitators, and effects. RESULTS: We identified 1741 publications, 21 of which were included in our review. Two of the these were clinical trials, 2 were prospective observational studies, and the remaining 17 were retrospective studies. All of the studies focused on hospitalized adult patients. The reported area under the receiver operating characteristic curves ranged between 0.65 and 0.95 for the outcome of clinical deterioration. Positive predictive value and sensitivity ranged between 0.223 and 0.773 and from 7.2% to 84.0%, respectively. Input variables differed widely, and predicted endpoints were inconsistently defined. We identified 57 facilitators and 48 barriers to the implementation of these models. We found 68 reported effects, 57 of which were positive. CONCLUSION: Predictive algorithms can detect clinical deterioration on the general ward earlier and more accurately than conventional protocols, which in one recent study led to lower mortality. Consensus is needed on input variables, predictive time horizons, and definitions of endpoints to better facilitate comparative research.

Wearable Patch Heart Rate Variability Is an Early Marker of Systemic Inflammation During Experimental Human Endotoxemia.

INTRODUCTION: Early diagnosis and treatment can reduce the risk of organ failure and mortality in systemic inflammatory conditions. Heart rate variability (HRV) has potential for early identification of the onset of systemic inflammation, as it may detect changes in sympathetic nervous system activity resulting from the developing inflammatory response before clinical signs appear. With the use of new methodologies, we investigated the onset and kinetics of HRV changes as well as several inflammatory parameters and symptoms during experimental human endotoxemia, a model of systemic inflammation in humans in vivo. PATIENTS AND METHODS: Healthy volunteers were intravenously administered LPS (n = 15) or placebo (n = 15). HRV was determined using a wireless wearable device, and parameters low to high frequency (LF:HF) ratio, root mean square of the successive differences (RMSSD), and standard deviation of normal-to-normal R-R intervals (SDNN)were calculated through 1-min-rolling 6-min windows. Plasma cytokine levels and flu-like symptoms and vital signs were serially assessed. RESULTS: The increase in LF:HF ratio, reflecting sympathetic predominance, was more pronounced in the LPS group compared to the placebo group, with the difference becoming statistically significant 65 min following LPS administration (1.63 [1.42-1.83] vs. 1.28 [1.11-1.44], P = 0.005). Significant between-group differences in RMSSD and SDNN were observed from 127 to 140 min post-LPS administration onwards, respectively. Plasma cytokine levels showed significant between-group differences staring 60 min post-LPS. For symptom score, heart rate, temperature, and diastolic blood pressure, significant differences compared with the placebo group were observed at 90, 118, 120, and 124 min post-LPS, respectively. CONCLUSION: In a controlled human model of systemic inflammation, elevations in the LF:HF ratio followed very shortly after elevations in plasma cytokine levels and preceded onset of flu-like symptoms and alterations in vital signs. HRV may represent a promising non-invasive tool for early detection of a developing systemic inflammatory response.

Low compliance to a vital sign safety protocol on general hospital wards: A retrospective cohort study.

BACKGROUND: Periodic vital sign monitoring is commonly used to detect clinical deterioration. Incomplete assessment of Early Warning Score (EWS) and poor protocol compliance may negatively impact nurses' responsiveness to critical situations. OBJECTIVE: This study assesses the quality of recorded EWSs and the degree of overall protocol compliance and protocol compliance in adverse event patients, in a centre that is an early adopter of an EWS safety protocol. DESIGN: Retrospective single-centre cohort study. SETTING: General hospital wards of a tertiary referral university medical centre. PARTICIPANTS: 48,864 patients admitted to general wards between 2015 and 2018. METHODS: Vital sign and Modified EWS (MEWS) data were collected from the electronic health record. MEWS completeness was evaluated by determining the proportion of missing values for each vital sign. To evaluate protocol compliance, we assessed whether the elapsed time between consecutive MEWSs was within the protocollary time as dictated by the MEWS protocol. Outcome measures were overall MEWS completeness, and both overall protocol compliance and protocol compliance specifically in the 24 h before adverse events. RESULTS: All required items to calculate a MEWS were present in 76 percent of the 1,663,743 vital sign measurements. Overall protocol compliance was 62 percent. For the low, mid-range and high MEWS groups, protocol compliances were 67, 47 and 30 percent, respectively. Time-to-next-MEWS exceeded protocol-recommended timing by up to 9 h for a substantial amount of MEWSs in the mid- and high-range MEWS groups. In patients with adverse events, compliance to the MEWS protocol during the 24 h prior to the events was 66 percent in aggregate, ranging from 80% in low MEWS groups, 74% in the mid-range, and 49% in the high MEWS groups. In the high MEWS group, improvements in protocol compliance were primarily noted in five hours immediately preceding the event. CONCLUSIONS: EWS assessments were incomplete in one-quarter of measurements. Compliance to a MEWS safety protocol was generally low, specifically when the protocol mandated more frequent MEWS assessments. Although more MEWSs were recorded in patients with adverse events, the increase in vital sign measurements' frequency mostly occurred shortly before the event manifested. This finding suggests missed opportunities to detect clinical deterioration.

Identification of Cardiovascular Patient Groups at Risk for Poor Medication Adherence: A Cluster Analysis.

BACKGROUND: Poor medication adherence limits the secondary prevention of cardiovascular diseases (CVDs) and leads to increased morbidity, mortality, and costs. Identifying groups of patients at risk of poor adherence behavior could enable an intervention to be developed and target patients appropriately. OBJECTIVE: The first aim of this study was to identify homogeneous subgroups of cardiovascular outpatients based on their cardiovascular risk factors. Subsequently, differences in medication adherence between these groups were examined. METHODS: In this retrospective, observational study, patients with an established CVD were included. Well-known cardiovascular risk factors such as smoking, diet, exercise, blood lipid levels, blood pressure, and body mass index were collected. To identify patient subgroups, a 2-step cluster analytic procedure was performed. Differences between the groups on medication adherence were determined on the outcome of the Modified Morisky Scale. Data collection took place between October 2011 and January 2013. RESULTS: Cardiovascular risk factors of 530 patients were included in the cluster analysis. Three groups were identified. Compared with other clusters (clusters 1 and 2), cluster 3 contained significantly fewer patients who could be classified as highly adherent and more patients classified as medium adherent (23% and 57%, respectively; P = .024). This group was characterized by a younger age (53% were <55 years old) and using a relatively low number of different medications (41% used <4 different medications). Besides, in this subgroup the most smokers (37%), unhealthy alcohol users (27%), and patients with unhealthy eating habits (14%) were present. CONCLUSION: This study showed that cardiovascular patients who are relatively young and have an unhealthy lifestyle are at risk for nonadherent behavior.

Exploring barriers to physical activity of patients at the internal medicine and surgical wards: a retrospective analysis of continuously collected data.

PURPOSE: To analyse physical activity of patients during their hospital stay and to explore the relationship between physical activity and barriers to physical activity. METHODS: This was a secondary analysis of physical activity data for patients admitted to the internal medicine and surgical wards. Physical activity data, collected with a wireless patch sensor, was operationalized as time spent lying, sitting/standing, and walking. Barriers to physical activity included patients' pain levels, the use of urinary catheters, intravenous tubing, oxygen lines, drains, and level of dependence. Regression analysis explored the relationship between physical activity and barriers to physical activity. RESULTS: Physical activity data were collected in 39 patients (aged 27-88, mean 54 years) during hospital stay. Patients were admitted for a median of 10 d (interquartile range [IQR]: 7-15 d). These patients were lying for a median of 12.1 h (7.6-17.7), sitting/standing 11.8 h (6.3-15.7), and walking 0.1 h (0-0.3) per day. Time lying during the day related to pain levels (ß = 0.4 h per unit increase in pain, p < 0.01) and drain use (ß = 3.1 h, p < 0.01). CONCLUSIONS: Patients spent the most time during the hospital stay lying in bed. Improved pain management and decreased drain use may be worth exploring to increase inpatient physical activity.Implications for rehabilitationContinuous monitoring of physical activity in patients during hospital stay is an important tool for health care professionals to improve multidisciplinary care and rehabilitation.Health care professionals should be aware of the necessity of adequate pain management and critically review the use of drains in order to improve physical activity of patients during hospital stay.Patients need extra support of health care professionals to increase physical activity during consecutive days of their hospital stay.

Evaluation of a Web-Based Self-Management Program for Patients With Cardiovascular Disease: Explorative Randomized Controlled Trial.

BACKGROUND: Web-based self-management programs have the potential to support patients with cardiovascular disease (CVD) in their self-management (eg, by focusing on behavior change and improving physical activity). The intervention mapping framework was used to develop a web-based program called Vascular View. The Vascular View program contained 6 modules (coping with CVD, setting boundaries, lifestyle, healthy nutrition, being physically active, interaction with health professionals) aiming to increase self-management behavior by tailoring to the perceived problems and (support) needs of patients after CVD. OBJECTIVE: The aim was to test the effectiveness of Vascular View before embarking on a full-scale randomized clinical trial (RCT) by evaluating the potential effectiveness and effect sizes of the Vascular View program and identifying outcome measures most likely to capture the potential benefits. METHODS: An explorative RCT was performed. Both control and intervention groups received care as usual and, in addition, the intervention group received 12 months of access to a web-based self-management program. Assessment occurred at baseline, 6 months, and 12 months. Outcome measures included general patient-reported outcome measurements: Illness Perception Questionnaire (IPQ), Rand-36, Patient Activation Measure, and patient self-efficacy. Module-specific patient-reported outcome measurements were Beliefs about Medicines Questionnaire, International Physical Activity Questionnaire, Dutch Healthy Diet Index, Fagerström Test for Nicotine Dependence (FTND), Alcohol Use Disorders Identification Test, and Perceived Efficacy in Patient-Physician Interaction. Linear mixed models for repeated measures using intention-to-treat and per-protocol analysis were applied to study differences between the patients in the intervention and control groups. Floor and ceiling effects were explored to give insight into the outcome measures most likely to capture the potential benefits. RESULTS: A total of 105 patients in the control group and 103 patients in the intervention group participated in the study. A positive direction of change between baseline and 12 months was shown for most outcome measurements in favor of the intervention group, of which 2 out of 10 outcomes showed a significant effect: attribution of cause of the disease to risk factors and immunity factors (IPQ) and dependency of nicotine (FTND). Floor and ceiling effects were seen in the IPQ, Rand-36, and the self-efficacy questionnaire. CONCLUSIONS: No conclusion for the efficacy of the Vascular View program or selection of outcome measurements can be taken yet. A process evaluation will be conducted to gain thorough insight into the working elements of the program, patient needs in eHealth, and the use of the program by patients. This can determine for whom web-based self-management programs will work and help to adapt the program. TRIAL REGISTRATION: Dutch Trial Register NTR5412; https://www.trialregister.nl/trial/5303. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/resprot.6352.

Continuous Monitoring of Vital Signs in the General Ward Using Wearable Devices: Randomized Controlled Trial.

BACKGROUND: Wearable devices can be used for continuous patient monitoring in the general ward, increasing patient safety. Little is known about the experiences and expectations of patients and health care professionals regarding continuous monitoring with these devices. OBJECTIVE: This study aimed to identify positive and negative effects as well as barriers and facilitators for the use of two wearable devices: ViSi Mobile (VM) and HealthPatch (HP). METHODS: In this randomized controlled trial, 90 patients admitted to the internal medicine and surgical wards of a university hospital in the Netherlands were randomly assigned to continuous vital sign monitoring using VM or HP and a control group. Users' experiences and expectations were addressed using semistructured interviews. Nurses, physician assistants, and medical doctors were also interviewed. Interviews were analyzed using thematic content analysis. Psychological distress was assessed using the State Trait Anxiety Inventory and the Pain Catastrophizing Scale. The System Usability Scale was used to assess the usability of both devices. RESULTS: A total of 60 patients, 20 nurses, 3 physician assistants, and 6 medical doctors were interviewed. We identified 47 positive and 30 negative effects and 19 facilitators and 36 barriers for the use of VM and HP. Frequently mentioned topics included earlier identification of clinical deterioration, increased feelings of safety, and VM lines and electrodes. No differences related to psychological distress and usability were found between randomization groups or devices. CONCLUSIONS: Both devices were well received by most patients and health care professionals, and the majority of them encouraged the idea of monitoring vital signs continuously in the general ward. This comprehensive overview of barriers and facilitators of using wireless devices may serve as a guide for future researchers, developers, and health care institutions that consider implementing continuous monitoring in the ward. TRIAL REGISTRATION: Clinicaltrials.gov NCT02933307; http://clinicaltrials.gov/ct2/show/NCT02933307.

Self-management support in cardiovascular consultations by advanced practice nurses trained in motivational interviewing: An observational study.

OBJECTIVE: This observational study explores advanced practice nurses' (APN) performance in secondary prevention and self-management support in patients with cardiovascular disease. METHODS: Real-life consultations in three outpatient clinics were recorded on audio and analysed. First, discussed (sub)categories were determined using five categories of self-management: symptom management, treatment, biomedical cardiovascular risk factors, psychosocial consequences, and lifestyle changes. Second, the extent in which motivational interviewing aspects were applied was determined using the Behaviour Change Counselling Index (BECCI). RESULTS: In total, 49 consultations performed by five female APNs were analysed. Physical topics were discussed in 98% and psychological subthemes in 41% of the consultations. Although not all components of motivational interviewing were applied, talking about current behaviour and behaviours that should change were discussed, and information was provided. Especially setting targets and exchanging ideas on how to reach behavioural goals were applied to a small extent. CONCLUSION: Well-trained APNs in the current study do not carry out motivational interviewing in a structural and complete manner according to BECCI and do not discuss all self-management categories. PRACTICE IMPLICATIONS: Psychological topics should be more integrated in providing self-management support by APNs and the application of motivational interviewing should be enhanced by regularly and repeated training.

Social media monitoring on the perceived safety of medication use during pregnancy: A case study from the Netherlands.

AIMS: An increasing number of women trust the Internet for information about medication safety during pregnancy. This study aimed to evaluate the availability and accuracy of social media content on the perceived safety of medication use in pregnancy. METHODS: We performed a systematic search of posts related to medication safety during pregnancy in the Dutch language published on social media, blogs and forums between May 2011 and April 2016 using Coosto, a tool for social media monitoring. The perceived safety in the posts was compared with the Dutch Teratology Information Service (TIS) safety classifications. RESULTS: We included 1224 online posts, which described 1441 scenarios about medication safety in pregnancy. A total of 820 (57%) scenarios were in line with the TIS classification. Incorrect perception was higher for prescription medication compared to medication available over-the-counter (60 vs 25%). Furthermore, the safety classification of medications with a TIS classification on strict indication or second-line drugs (93%) and medications with insufficient knowledge on their safety during pregnancy (76%) was more likely to be incorrectly perceived by the public compared to medications with the TIS classification safe (24%). CONCLUSIONS: Social media monitoring may be useful for surveillance of potentially unsafe use of medications in pregnancy. Many social posts related to medication safety during pregnancy provide inaccurate information. As this information may affect women's perceptions and decisions, accurate communication between healthcare providers and pregnant women regarding the benefits and risks of medications is vital.

A nurse-based intervention for improving medication adherence in cardiovascular patients: an evaluation of a randomized controlled trial.

Background: Poor medication adherence is a limitation in the secondary prevention of cardiovascular diseases (CVDs) and leads to increased morbidity, mortality, and costs. Purpose: To examine the process and effect of a nurse-led, web-based intervention based on behavioral change strategies to improve medication adherence in patients with CVD. Patients and methods: In this single-center, prospective, controlled clinical trial, cardiovascular patients were assigned to usual care, usual care plus a personalized website, or usual care plus a personalized website and personal consultations. Primary outcome was the level of adherence to cardiovascular medication. Data collection occurred between October 2011 and January 2015. Results: In total, 419 patients were randomized. Just 77 patients logged on the website and half of the invited patients attended the group consultation. Due to the limited use of the website, we combined the results of usual care and the usual care plus website group in one group (usual care) and compared these with the results of the group which received the nurse intervention (intervention group). No significant difference in adherence between the usual care group and the intervention group was observed. The adherence level in the usual care group was 93%, compared to 89% in the intervention group (p=0.08). 29% (usual care) and 31% (intervention group) of the patients showed a low adherence according to the Modified Morisky Scale® (p-value=0.94). The mean necessity concern differential was 3.8 with no differences between the two studied groups (mean 3.8 vs mean 3.9, p-value =0.86). Conclusion: Our intervention program did not show an effect. This could indicate that structured usual care provided to all cardiovascular patients already results in high medication adherence or that shortly after a cardiovascular event adherence is high. It could also indicate that the program did not have enough impact because there was not enough compliance with the intervention protocol. Trial registration: ID number NCT01449695, approved May 2011.

Google AdWords and Facebook Ads for Recruitment of Pregnant Women into a Prospective Cohort Study With Long-Term Follow-Up.

Objectives Several types of epidemiologic studies suffer from decreasing participation rates, resulting in potential selection bias and delay or termination of studies. We aimed to determine the feasibility of online methods for recruitment of pregnant women into a prospective cohort study. Methods In addition to traditional recruitment through prenatal care providers, we advertized participation in the PRegnancy and Infant DEvelopment (PRIDE) Study, an ongoing prospective cohort study with long-term follow-up in The Netherlands enrolling women in early pregnancy, through Google AdWords (30 days) and Facebook Ads (31 and 27 days) campaigns between September 2016 and January 2017. We calculated costs per eligible participant and compared demographics, health-related characteristics, and follow-up rates between participants recruited through online methods and prenatal care providers. Results During the study period, we recruited six women through AdWords (€54.28 per participant), 59 through Facebook (€10.17 per participant), and 327 through prenatal care providers (no valid cost estimate available). Facebook participants seemed to be younger (29.0 vs. 30.7 years), to have a higher body mass-index and/or low/intermediate education (27.0 vs. 24.0 kg/m2 and 41 vs. 25%, respectively), and to start prenatal care in secondary care more often (12 vs. 5%) than participants recruited through prenatal care providers. Item non-response and loss to follow-up rates were higher among women recruited online than among those recruited through prenatal care providers. Conclusion Google AdWords did not contribute substantially, but Facebook Ads may complement traditional recruitment methods of pregnant women into prospective cohort studies, despite challenges that may threaten internal validity.

Feasibility of a New Cuffless Device for Ambulatory Blood Pressure Measurement in Patients With Hypertension: Mixed Methods Study.

BACKGROUND: Frequent home blood pressure (BP) measurements result in a better estimation of the true BP. However, traditional cuff-based BP measurements are troublesome for patients. OBJECTIVE: This study aimed to evaluate the feasibility of a cuffless device for ambulatory systolic blood pressure (SBP) measurement. METHODS: This was a mixed method feasibility study in patients with hypertension. Performance of ambulatory SBPs with the device was analyzed quantitatively by intrauser reproducibility and comparability to a classic home BP monitor. Correct use by the patients was checked with video, and user-friendliness was assessed using a validated questionnaire, the System Usability Scale (SUS). Patient experiences were assessed using qualitative interviews. RESULTS: A total of 1020 SBP measurements were performed using the Checkme monitor in 11 patients with hypertension. Duplicate SBPs showed a high intrauser correlation (R=0.86, P<.001). SBPs measured by the Checkme monitor did not correlate well with those of the different home monitors (R=0.47, P=.007). However, the mean SBPs measured by the Checkme and home monitors over the 3-week follow-up were strongly correlated (R=0.75, P=.008). In addition, 36.4% (n=4) of the participants performed the Checkme measurements without any mistakes. The mean SUS score was 86.4 (SD 8.3). The most important facilitator was the ease of using the Checkme monitor. Most important barriers included the absence of diastolic BP and the incidental difficulties in obtaining an SBP result. CONCLUSIONS: Given the good intrauser reproducibility, user-friendliness, and patient experience, all of which facilitate patients to perform frequent measurements, cuffless BP monitoring may change the way patients measure their BP at home in the context of ambulant hypertension management.

Early Detection of Hypoglycemia in Type 1 Diabetes Using Heart Rate Variability Measured by a Wearable Device.

OBJECTIVE: Changes in heart rate variability (HRV) occur at the initiation of hypoglycemia due to sympathetic nervous system activity. We investigated the use of HRV detection by a wearable device as an early alert for hypoglycemia. RESEARCH DESIGN AND METHODS: This proof-of-principle study included 23 patients with type 1 diabetes (14 women, mean age 42 ± 11 years). Patients wore a VitalConnect HealthPatch for 5 days. Hypoglycemia was defined as glucose ≤70 mg/dL (≤3.9 mmol/L) by fingerstick measurement. HRV was analyzed in standardized periods before the hypoglycemic event. RESULTS: Sixty-six hypoglycemic events were recorded. Hypoglycemia caused a typical HRV pattern in 36 (55%) of the hypoglycemic events. Eighteen events (27%) showed an atypical pattern. Ten events were unclassified (15%), and two did not display a change in HRV (3%). CONCLUSIONS: Hypoglycemia causes early changes in HRV that can be detected by a wearable device. Measuring real-time HRV seems promising for early hypoglycemia detection.