Causality assessment of adverse drug reaction: A narrative review to find the most exhaustive and easy-to-use tool in post-authorization settings.

BACKGROUND: The core motive of pharmacovigilance is the detection and prevention of adverse drug reactions (ADRs), to improve the risk-benefit balance of the drug. However, the causality assessment of ADRs remains a major challenge among clinicians, and none of the available tools of causality assessment used for assessing ADRs have been universally accepted. OBJECTIVE: To provide an up-to-date overview of the different causality assessment tools. METHODS: We conducted electronic searches in MEDLINE, EMBASE, and the Cochrane database. The eligibility of each tool was screened by three reviewers. Each eligible tool was then scrutinized for its domains (the reported specific set of questions/areas used for calculating the likelihood of cause-and-effect relation of an ADR) to discover the most comprehensive tool. Finally, we subjectively assessed the tool's ease-of-use in a Canadian, Indian, Hungarian, and Brazilian clinical context. RESULTS: Twenty-one eligible causality assessment tools were retrieved. Naranjo's tool and De Boer's tool appeared the most comprehensive among all the tools, covering 10 domains each. Regarding "ease-of-use" in a clinical setting, we judged that many tools were hard to implement in a clinical context because of their complexity and/or lengthiness. Naranjo's tool, Jones's tool, Danan and Benichou's tool, and Hsu and Stoll's tool appeared to be the easiest to implement into various clinical contexts. CONCLUSION: Among the many tools identified, 1981 Naranjo's scale remains the most comprehensive and easy to use for performing causality assessment of ADRs. Upcoming analysis should compare the performance of each ADR tool in clinical settings.

Team-based care for improving hypertension management among outpatients (TBC-HTA): study protocol for a pragmatic randomized controlled trial.

BACKGROUND: Blood pressure (BP) is poorly controlled among a large proportion of hypertensive outpatients. Innovative models of care are therefore needed to improve BP control. The Team-Based Care for improving Hypertension management (TBC-HTA) study aims to evaluate the effect of a team-based care (TBC) interprofessional intervention, involving nurses, community pharmacists and physicians, on BP control of hypertensive outpatients compared to usual care in routine clinical practice. METHODS/DESIGN: The TBC-HTA study is a pragmatic randomized controlled study with a 6-month follow-up which tests a TBC interprofessionnal intervention conducted among uncontrolled treated hypertensive outpatients in two ambulatory clinics and among seven nearby community pharmacies in Lausanne and Geneva, Switzerland. A total of 110 patients are being recruited and randomized to TBC (TBC: N = 55) or usual care group (UC: N = 55). Patients allocated to the TBC group receive the TBC intervention conducted by an interprofessional team, involving an ambulatory clinic nurse, a community pharmacist and a physician. A nurse and a community pharmacist meet patients every 6 weeks to measure BP, to assess lifestyle, to estimate medication adherence, and to provide education to the patient about disease, treatment and lifestyle. After each visit, the nurse and pharmacist write a summary report with recommendations related to medication adherence, lifestyle, and changes in therapy. The physician then adjusts antihypertensive therapy accordingly. Patients in the UC group receive usual routine care without sessions with a nurse and a pharmacist. The primary outcome is the difference in daytime ambulatory BP between TBC and UC patients at 6-month of follow-up. Secondary outcomes include patients' and healthcare professionals' satisfaction with the TBC intervention and BP control at 12 months (6 months after the end of the intervention). DISCUSSION: This ongoing study aims to evaluate the effect of a newly developed team-based care intervention engaging different healthcare professionals on BP control in a primary care setting in Switzerland. The results will inform policymakers on implementable strategies for routine clinical practice. TRIAL REGISTRATION: ClinicalTrials.gov registration: NCT02511093 . Retrospectively registered on 28 July 2015.

MEthods of ASsessing blood pressUre: identifying thReshold and target valuEs (MeasureBP): a review & study protocol.

Despite progress in automated blood pressure measurement (BPM) technology, there is limited research linking hard outcomes to automated office BPM (OBPM) treatment targets and thresholds. Equivalences for automated BPM devices have been estimated from approximations of standardized manual measurements of 140/90 mmHg. Until outcome-driven targets and thresholds become available for automated measurement methods, deriving evidence-based equivalences between automated methods and standardized manual OBPM is the next best solution. The MeasureBP study group was initiated by the Canadian Hypertension Education Program to close this critical knowledge gap. MeasureBP aims to define evidence-based equivalent values between standardized manual OBPM and automated BPM methods by synthesizing available evidence using a systematic review and individual subject-level data meta-analyses. This manuscript provides a review of the literature and MeasureBP study protocol. These results will lay the evidenced-based foundation to resolve uncertainties within blood pressure guidelines which, in turn, will improve the management of hypertension.

Diagnosing hypertension: Evidence supporting the 2015 recommendations of the Canadian Hypertension Education Program.

OBJECTIVE: To highlight the 2015 Canadian Hypertension Education Program (CHEP) recommendations for the diagnosis and assessment of hypertension. QUALITY OF EVIDENCE: A systematic search was performed current to August 2014 by a Cochrane Collaboration librarian using the MEDLINE and PubMed databases. The search results were critically appraised by the CHEP subcommittee on blood pressure (BP) measurement and diagnosis, and evidence-based recommendations were presented to the CHEP Central Review Committee for independent review and grading. Finally, the findings and recommendations were presented to the Recommendations Task Force for discussion, debate, approval, and voting. The main recommendations are based on level II evidence. MAIN MESSAGE: Based on the most recent evidence, CHEP has made 4 recommendations in 2 broad categories for 2015 to improve BP measurement and the way hypertension is diagnosed. A strong recommendation is made to use electronic BP measurement in the office setting to replace auscultatory BP measurement. For patients with elevated office readings, CHEP is recommending early use of out-of-office BP measurement, preferably ambulatory BP measurement, in order to identify early in the process those patients with white-coat hypertension. CONCLUSION: Improvements in diagnostic accuracy are critical to optimizing hypertension management in Canada. The annual updates provided by CHEP ensure that practitioners have up-to-date evidence-based information to inform practice.

[The experience of men with hypertension]. / L'expérience des hommes atteints d'hypertension artérielle.

Many studies show that men make specific lifestyle choices. However, regarding high blood pressure (HBP), guidelines are without distinction for gender. The purpose of this project is to explore the men's experience with HBP. Using a phenomenological design, semi-structured interviews were conducted with ten men living with HBP to explore beliefs and perceptions of men living with HBP. The main framework used is the health belief model. Two themes emerged: the meaning given to HBP (an unavoidable disease, the trivialization of HBP et HBP as synonymous of stress) and the management of this illness (the notion of control, the paradox of knowing about what to do and implementation of healthy lifestyle, relationship with health professionals). These results bring a better understanding of the experience of men with hypertension.

Beta-blockers are associated with increased risk of first cardiovascular events in non-diabetic hypertensive elderly patients.

PURPOSE: Although treatment should be considered for elderly patients with hypertension (HTN), the effectiveness of beta-blockers (BBs) compared with other medications is less clear. This study's objective is to assess the relative effectiveness of BBs in elderly primary prevention patients with uncomplicated HTN. METHODS: This is a population-based nested case-control study. The cohort is composed of 94,844 elderly patients followed through 2009 and diagnosed with HTN between 2000 and 2004, without recent antecedents of diabetes, renal disease, or cardiovascular disease (CVD). Individuals with a CVD outcome were considered cases, and controls were matched to cases according to age, sex, date of cohort entry, and comorbidity index. Patients whose treatment included a BB were compared with patients on other HTN drug(s). RESULTS: The BB use by patients was associated with an increased risk for CVD events (odds ratio (OR) = 1.36, 95%CI: 1.31-1.40) compared with patients using antihypertensive therapies without BBs. Sensitivity analyses suggest that this increased risk is not due to differences in prescription patterns on the basis of perceived disease severity. CONCLUSIONS: In real-world settings, antihypertensive therapies that include BBs are associated with less effective prevention of adverse outcomes in elderly hypertensive patients in primary prevention compared with antihypertensive therapies without BBs. Pending further studies, we recommend caution when prescribing BBs in primary prevention except when otherwise indicated.

Recommendations on screening for high blood pressure in Canadian adults.

OBJECTIVE: To provide recommendations on screening for hypertension in adults aged 18 years and older without previously diagnosed hypertension. QUALITY OF EVIDENCE: Evidence was found through a systematic search of MEDLINE, EMBASE, and the Cochrane Database of Systematic Reviews (EBM Reviews), from January 1985 to September 2011. Study types were limited to randomized controlled trials, systematic reviews, and observational studies with control groups. MAIN MESSAGE: Three strong recommendations were made based on moderate-quality evidence. It is recommended that blood pressure measurement occur at all appropriate primary care visits, according to the current techniques described in the Canadian Hypertension Education Program recommendations for office and ambulatory blood pressure measurement. The Canadian Hypertension Education Program criteria for assessment and diagnosis of hypertension should be applied for people found to have elevated blood pressure. CONCLUSION: After review of the most recent evidence, the Canadian Task Force on Preventive Health Care continues to recommend blood pressure measurement during regular physician visits.

[The best cuff for measuring arterial pressure]. / Le bon brassard pour mesurer la pression artérielle.

Hypertension prevention, detection, follow-up and medication adjustment depend on valid blood pressure measurement. Many factors should be taken into consideration to get accurate blood pressure readings: the blood pressure measurement method, the equipment used and the patient preparation. This column will focus on the importance of the cuff for blood pressure measurement.

[The pulse, an essential measurement]. / Le pouls, une mesure essentielle.

As has been known for a long time, the measurement of the pulse enables the patient's haemodynamic state to be assessed. Pulse, rate, rhythm and amplitude are indicators that enable monitoring of health status in different situations. Therefore, the nurse, in her daily practice, can and must use this measurement in preference to that provided by devices whose relevance is limited.

Device and nondevice-guided slow breathing to reduce blood pressure in hypertensive patients: A systematic review and meta-analysis.

Backgroud and Aims: Hypertension (HTN) is a multifactorial chronic disease. Considering the high prevalence rates of this disease, treatment of HTN is necessary, not only to reduce blood pressure (BP) levels but also to prevent the development of cardiovascular, cerebrovascular, and kidney diseases. This treatment can be through medication, which will be determined according to the BP values, obtained either in medical consultations or at home; presence of cardiovascular risk factors, and the presence of target organ damage identified during anamnesis. The aim of this systematic review and meta-analysis is to summarize the effects of device-guided slow breathing (DGSB) and nondevice-guided slow breathing (NDGSB) on BP levels of patients with HTN. Methods: This study is a systematic review and meta-analysis of randomized clinical trials, pertaining to hypertensive patients, with or without comorbidity, over 18 years old, of both sexes, and with or without hypertensive medication. The selected studies showed comparisons between groups that performed DGSB and/or NDGSB with control conditions. The primary outcome was the value of systolic blood pressure (SBP) and diastolic blood pressure (DBP) after the interventions. Results: Twenty-two studies involving 17,214 participants were included in the quantitative analysis. Considerable heterogeneity was revealed between studies. Using random effect model, it was found that DGSB did not significantly reduce SBP and DBP compared to usual care, both in terms BP values and in relation to their variations (SBP, mean difference [MD]: -2.13 mmHg, (95% confidence interval [CI]: -12.71 to 8.44), 288 individuals; I 2 = 93%, high heterogenity: DBP, MD: -0.90, 95% CI: -3.97 to 2.11, 288 individuals; I 2 = 63%, substantial heterogenity. SBP variations MD: -2.42, 95% CI: -7.24 to 2.40, 443 individuals; I 2 = 85% high heterogenity/DBP variations MD: -1.67, 95% CI: -4.57 to 1.24, 443 individuals; I 2 = 80%, high heterogenity). Conclusion: Based on these results it appears that DGSB did not reduce BP in hypertensive patients and NDGSB is a new path for the future.

Device- and Nondevice-Guided Slow Breathing to Reduce Blood Pressure in Patients with Hypertension: Protocol for a Systematic Review and Meta-analysis.

BACKGROUND: Physiotherapy can include both device-guided slow breathing (DGSB) and nondevice-guided slow breathing (NDGSB) in the treatment of systemic arterial hypertension. OBJECTIVE: The aim of this study is to summarize the effects of DGSB on blood pressure levels of patients with hypertension based on the published literature to date. METHODS: A systematic search of all published randomized controlled trials (RCTs) on the effects of device-guided and nondevice-guided slow breathing in patients with hypertension, without language restriction, was carried out up to a publication date of January 2020 in nine databases: PubMed/MEDLINE, Latin American and Caribbean Health Sciences Literature (LILACS), EMBASE, CENTRAL (Cochrane Central Register of Controlled Trials), Physiotherapy Evidence Database (PEDro), CINAHL (Cumulative Index to Nursing and Allied Health Literature), Scopus, Web of Science, and Livivo. Clinical trial records databases (ClinicalTrials.gov), and bases for the open gray literature, including Gray Literature Report and ProQuest Central (Citation, Abstract or Indexing, and Dissertations and Theses), were also searched for potentially eligible RCTs. The quality assessment of the included studies will be performed using the Cochrane Risk of Bias Tool for Randomized Trials. The overall quality of the evidence for each outcome will be assessed using the GRADE (Grading of Recommendations, Development and Evaluation) system. RESULTS: As of December 2021, the review was completed and all data from continuous variables referring to blood pressure values (mmHg) were synthesized. CONCLUSIONS: This systematic review will provide a summary of the current evidence on the effects of both DGSB and NDGSB on blood pressure levels. This information can contribute to decision-making by health professionals related to the use of these interventions in patients with hypertension. TRIAL REGISTRATION: PROSPERO (Prospective International Register of Systematic Reviews) CRD42020147554; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=147554. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/33579.

Higher Arm Versus Lower Arm Systolic Blood Pressure and Cardiovascular Outcomes: a Meta-Analysis of Individual Participant Data From the INTERPRESS-IPD Collaboration.

BACKGROUND: Guidelines recommend measuring blood pressure (BP) in both arms, adopting the higher arm readings for diagnosis and management. Data to support this recommendation are lacking. We evaluated associations of higher and lower arm systolic BPs with diagnostic and treatment thresholds, and prognosis in hypertension, using data from the Inter-arm Blood Pressure Difference-Individual Participant Data Collaboration. METHODS: One-stage multivariable Cox regression models, stratified by study, were used to examine associations of higher or lower reading arm BPs with cardiovascular mortality, all-cause mortality, and cardiovascular events, in individual participant data meta-analyses pooled from 23 cohorts. Cardiovascular events were modelled for Framingham and atherosclerotic cardiovascular disease risk scores. Model fit was compared throughout using Akaike information criteria. Proportions reclassified across guideline recommended intervention thresholds were also compared. RESULTS: We analyzed 53 172 participants: mean age 60 years; 48% female. Higher arm BP, compared with lower arm, reclassified 12% of participants at either 130 or 140 mm Hg systolic BP thresholds (both P<0.001). Higher arm BP models fitted better for all-cause mortality, cardiovascular mortality, and cardiovascular events (all P<0.001). Higher arm BP models better predicted cardiovascular events with Framingham and atherosclerotic cardiovascular disease risk scores (both P<0.001) and reclassified 4.6% and 3.5% of participants respectively to higher risk categories compared with lower arm BPs). CONCLUSIONS: Using BP from higher instead of lower reading arms reclassified 12% of people over thresholds used to diagnose hypertension. All prediction models performed better when using the higher arm BP. Both arms should be measured for accurate diagnosis and management of hypertension. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: CRD42015031227.

[Measuring pulse oximetry at the patient's bedside]. / Mesurer l'oxymétrie de pouls au lit du malade.

Pulse oximetry, or oxygen saturation, reflects the quantity of oxygen fixed to the haemoglobin. It is commonly measured in a non invasive way, with the aid of a digital sensor oximeter. The results can be distorted by a number of parameters, it is therefore necessary to eliminate the risk of errors and to check the results against clinical data.

The feasibility of home self-assessment of vital signs and symptoms: A new key to telehealth for individuals?

OBJECTIVE: During the COVID-19 pandemic, social distancing and self-isolation called for innovative, readily implementable, and effective short-term health solutions. The objective of this study was to assess the feasibility of self-assessment of vital signs and symptoms with electronic transmission of results, by self-isolating individuals with positive SARS-CoV-2 polymerase chain reaction (PCR) test. The secondary objective was to describe the association between the presence of abnormal vital signs and severe symptoms as well as their evolution over time. METHOD: Participants with positive SARS-CoV-2 PCR test were asked to perform twice daily standardized vital signs measurements and self-assessment of symptoms for 14 consecutive days. All data were transmitted electronically through a mobile application and a web-based platform. Participants were provided with decision support tools based on the severity of their condition and a weekly nurse practitioner telephone follow-up. Abnormal values for vital signs and severe symptoms were determined. Per participant and per days, proportions of abnormal vital signs and severe symptoms were calculated. RESULTS: Data from 46 participants (mean age 54.1 ± 6.9 years, 54% male) were available for analysis. On average, participants performed the standardized self-assessment for 12.3 ± 3.4 days (89% performed at least 7 measurement days and 61% completed all 14 days). The highest proportions abnormal values for vital signs were for oximetry (20.1%) and respiratory rate (12.1%). The highest proportions of severe symptoms were for fatigue (16.9%) and myalgia. (10.2%). The combined proportion of abnormal vital signs and severe symptoms was maximal on day 1 with 20.3% of total measurements, with a linear decrease to 3.5% on day 14. CONCLUSION: Remote initiation of home measurements of vital signs and symptoms, self-management of these measures, accompanied by a decision support tool and supported by preplanned nurse follow-up are feasible. This could allow to opening up new insight for the care of sick individuals.