Tolerability of the Oscar 2 ambulatory blood pressure monitor among research participants: a cross-sectional repeated measures study

<p>Abstract</p> <p>Background</p> <p>Ambulatory blood pressure monitoring (ABPM) is increasingly used to measure blood pressure (BP) in research studies. We examined ease of use, comfort, degree of disturbance, reported adverse effects, factors associated with poor tolerability, and association of poor tolerability with data acquisition of 24-hour ABPM using the Oscar 2 monitor in the research setting.</p> <p>Methods</p> <p>Sixty adults participating in a research study of people with a history of borderline clinic BP reported on their experience with ABPM on two occasions one week apart. Poor tolerability was operationalized as an overall score at or above the 75th percentile using responses to questions adapted from a previously developed questionnaire. In addition to descriptive statistics (means for responses to Likert-scaled "0 to 10" questions and proportions for Yes/No questions), we examined reproducibility of poor tolerability as well as associations with poor tolerability and whether poor tolerability was associated with removal of the monitor or inadequate number of BP measurements.</p> <p>Results</p> <p>The mean ambulatory BP of participants by an initial ABPM session was 148/87 mm Hg. After wearing the monitor the first time, the degree to which the monitor was felt to be cumbersome ranged from a mean of 3.0 to 3.8, depending on whether at work, home, driving, or other times. The most bother was interference with normal sleeping pattern (mean 4.2). Wearers found the monitor straightforward to use (mean 7.5). Nearly 67% reported that the monitor woke them after falling asleep, and 8.6% removed it at some point during the night. Reported adverse effects included pain (32%), skin irritation (37%), and bruising (7%). Those categorized as having poor tolerability (kappa = 0.5 between sessions, p = 0.0003) were more likely to report being in fair/poor health (75% vs 22%, p = 0.01) and have elevated 24-hour BP average (systolic: 28% vs 17%, p = 0.56; diastolic: 30% vs 17%, p = 0.37). They were also more likely to remove the monitor and have inadequate numbers of measurements.</p> <p>Conclusions</p> <p>The Oscar 2 ABPM device is straightforward to use but can interfere with sleep. Commonly reported adverse effects include pain, skin irritation, and bruising. Those who tolerate the monitor poorly are more likely to report being in fair or poor health and to remove it, particularly at night.</p

Withdrawal of antihypertensive therapy in people with dementia: feasibility study

Background: This study explored the feasibility of a randomised controlled withdrawal trial of antihypertensive medication in normotensive people with dementia. Feasibility aspects included response, recruitment, exclusion and drop-out rates, suitability of outcome measures, acceptability of study procedures and an indicative economic evaluation for a randomised controlled trial. Methods: A cohort study attempting the withdrawal of antihypertensive drugs where appropriate and a feasibility study of home-based blood pressure monitoring, in people with dementia treated for hypertension, was undertaken. Interviews with participants and carers and an indicative economic evaluation were also undertaken. Results: Three hundred and sixty-two primary care practices in the East Midlands were contacted of which only 41 (11% (95%CI 8–15%)) agreed to support the study. These 41 practices posted 940 letters to potential participants. Thirty participants were enrolled in the cohort study of whom 9 were eligible for the antihypertensive withdrawal programme, 20 participated in a home blood pressure monitoring sub-group analysis and 12 took part in an interview study. Twenty-two of those enrolled in the cohort study were followed up at 6 months. The withdrawal programme was acceptable to participants and general practitioners (GPs). The study procedures including assessments and home blood pressure monitoring were acceptable to the participants and their carers. The economic evaluation was not possible. Conclusion: A withdrawal trial of antihypertensive medication in normotensive people with dementia may not be feasible in the UK because of low recruitment rates

Internet-based guided self-help for glioma patients with depressive symptoms: design of a randomized controlled trial

Background: Among glioma patients, depression is estimated to be more prevalent than in both the general population and the cancer patient population. This can have negative consequences for both patients and their primary informal caregivers (e.g., a spouse, family member or close friend). At present, there is no evidence from randomized controlled trials for the effectiveness of psychological treatment for depression in glioma patients. Furthermore, the possibility of delivering mental health care through the internet has not yet been explored in this population. Therefore, a randomized controlled trial is warranted to evaluate the effects of an internet-based, guided self-help intervention for depressive symptoms in glioma patients. Methods/design: The intervention is based on problem-solving therapy. An existing 5-week course is adapted for use by adult glioma patients with mild to moderate depressive symptoms (Center for Epidemiology Studies Depression Scale score ≥12). Sample size calculations yield 126 glioma patients to be included, who are randomly assigned to either the intervention group or a waiting list control group. In addition, we aim to include 63 patients with haematological cancer in a non-central nervous system malignancy control group. Assessments take place at baseline, after 6 and 12 weeks, and after 6 and 12 months. Primary outcome measure is the change in depressive symptoms. Secondary outcome measures include health-related quality of life, fatigue, costs and patient satisfaction. In addition, all patients are asked to assign a primary informal caregiver, who does not participate in the intervention but who is asked to complete similar assessments. Their mood, health-related quality of life and fatigue is evaluated as well. Discussion: This is the first study to evaluate the effects of problem-solving therapy delivered through the internet as treatment for depressive symptoms in glioma patients. If proven effective, this treatment will contribute to the mental health care of glioma patients in clinical practice. Trial registration: Netherlands Trial Register NTR322

MEASURING QUALITY-OF-LIFE WITH THE SICKNESS IMPACT PROFILE - A PILOT-STUDY

A pilot-study was done to investigate the applicability of the sickness impact profile (SIP) in ex-ICU patients. For this study 221 consecutively admitted patients were reviewed retrospectively after excluding children, deceased patients and readmissions. SIP was assessed in these patients by either interview or questionnaire. These were divided into three groups: i) Patients interviewed at home (n = 26). ii) Patients receiving the SIP-questionnaire by mail (n = 93). iii) As for group ii, but after receiving a telephone invitation to participate (n = 102). Highest mean SIP-score was found in group i (16.3). Groups ii and iii scored 10.2 and 7.9 respectively. Analysis of variance demonstrated overall SIP-scores of these groups to be significantly different. The response in group iii (77%) was significantly higher compared to group ii (56%). Data collection in Group i appeared to be most expensive costing $13.20 per patient, followed by group iii ($3.79) and group ii ($2.56). It is concluded that the self-administered SIP is suitable for measuring outcome in ICU-patients and is much cheaper than the direct interview technique. The 3 different approaches should be considered as independent methods of which individual results cannot be compared. The response can be improved significantly by calling the patients before sending the questionnaire