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.

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.

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.

Team-Based Care for Improving Hypertension Management: A Pragmatic Randomized Controlled Trial.

Objective: We evaluated the effect on long term blood pressure (BP) of an interprofessional team-based care (TBC) intervention, involving nurses, pharmacists, and physicians, compared to usual care. Methods: We conducted a pragmatic randomized controlled study in ambulatory clinics and community pharmacies in Switzerland (ClinicalTrials.gov: NCT02511093). Uncontrolled treated hypertensive patients were randomized to TBC or usual care (UC). In the TBC group, nurses and pharmacists met patients every 6 weeks to measure BP, assess lifestyle, support medication adherence, and provide health education for 6 months. After each visit, they wrote a report to the physician who could adjust antihypertensive therapy. The outcome was the intention-to-treat difference in mean daytime ambulatory blood pressure measurement (ABPM) and control (<135/85 mmHg) at 6 and 12 months. Results: Eighty-nine patients (60 men/29 women; mean (SD) age: 61(12) year) were randomized to TBC (n = 43) or UC (n = 46). At baseline, mean (SD) BP was 144(10)/90(8) mmHg and 147(12)/87(11) mmHg in the TBC and UC groups. At 6 months, the between-groups difference in daytime systolic ABPM was-3 mmHg [95% confidence interval (CI):-10 to +4; p = 0.45]; at 12 months, this difference was-7 mmHg [95% CI:-13 to-2; p = 0.01]. At 6 months, the between-groups difference in daytime diastolic ABPM was +2 mmHg [95% CI:-1 to +6; p = 0.20]; at 12 months, this difference was-2 mmHg [95% CI:-5 to +2; 0.42]. Upon adjustment for baseline covariates including baseline BP, the between-groups differences at 6 and 12 months were maintained. At 6 months, there was no difference in BP control. At 12 months, the TBC group tended to have a better control in systolic BP (p = 0.07) but not in diastolic BP (p = 0.33). Conclusion: While there was not significant effect on BP at 6 months of follow-up, the TBC intervention can help decrease long-term systolic BP among uncontrolled hypertensive patients.

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.

Knowledge, perception and practice of Québec nurses for ambulatory and clinic blood pressure measurement methods: are we there yet?

BACKGROUND: Guidelines regarding blood pressure measurement (BPM) methods, namely home (HBPM), ambulatory (ABPM), office (OBPM) and automated (AOBP) are published by Hypertension Canada and rely on accurate measurement technique. Nurses commonly perform BPM but their knowledge, perception and practice considering all methods is understudied. This study is the first to establish the picture of Québec nurses working in primary care settings concerning the four BPM methods. METHODS: All nurses licensed to practice in primary care in Québec were targeted in our survey. Data were collected using a validated and pretested investigator-initiated questionnaire in English and French. A personalized e-mail invitation, and two reminders, including a link to a secured platform was sent in December 2019. A certificate of ethics was issued by UQTR. RESULTS: A total of 453 nurses participated in the study. Median age was 40 ±â€Š11 years, and 92% were women. The overall score on BPM methods knowledge was slightly below 50% (46% ±â€Š23). The perception was mostly positive, with an overall score above 50% (73% ±â€Š8). In practice, HBPM was recommended by 47% of nurses, and ABPM by 18%. Although AOBP is the preferred method in Canada, only 25% of the nurses use it, including the 57% that use an oscillometric device and 11% that use manual auscultation. CONCLUSION: Nurses working in primary care play a central role in BPM. Our results highlight that overall knowledge and practice are suboptimal. Resources should, therefore, be allocated to ensure that initial training and continuing education are addressed.

Associations Between Systolic Interarm Differences in Blood Pressure and Cardiovascular Disease Outcomes and Mortality: Individual Participant Data Meta-Analysis, Development and Validation of a Prognostic Algorithm: The INTERPRESS-IPD Collaboration.

Systolic interarm differences in blood pressure have been associated with all-cause mortality and cardiovascular disease. We undertook individual participant data meta-analyses to (1) quantify independent associations of systolic interarm difference with mortality and cardiovascular events; (2) develop and validate prognostic models incorporating interarm difference, and (3) determine whether interarm difference remains associated with risk after adjustment for common cardiovascular risk scores. We searched for studies recording bilateral blood pressure and outcomes, established agreements with collaborating authors, and created a single international dataset: the Inter-arm Blood Pressure Difference - Individual Participant Data (INTERPRESS-IPD) Collaboration. Data were merged from 24 studies (53 827 participants). Systolic interarm difference was associated with all-cause and cardiovascular mortality: continuous hazard ratios 1.05 (95% CI, 1.02-1.08) and 1.06 (95% CI, 1.02-1.11), respectively, per 5 mm Hg systolic interarm difference. Hazard ratios for all-cause mortality increased with interarm difference magnitude from a ≥5 mm Hg threshold (hazard ratio, 1.07 [95% CI, 1.01-1.14]). Systolic interarm differences per 5 mm Hg were associated with cardiovascular events in people without preexisting disease, after adjustment for Atherosclerotic Cardiovascular Disease (hazard ratio, 1.04 [95% CI, 1.00-1.08]), Framingham (hazard ratio, 1.04 [95% CI, 1.01-1.08]), or QRISK cardiovascular disease risk algorithm version 2 (QRISK2) (hazard ratio, 1.12 [95% CI, 1.06-1.18]) cardiovascular risk scores. Our findings confirm that systolic interarm difference is associated with increased all-cause mortality, cardiovascular mortality, and cardiovascular events. Blood pressure should be measured in both arms during cardiovascular assessment. A systolic interarm difference of 10 mm Hg is proposed as the upper limit of normal. Registration: URL: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42015031227.

Asymptomatic carriers of COVID-19 in a confined adult community population in Quebec: A cross-sectional study.

Several countries have undertaken social distancing measures to stop SARS-CoV-2 spread. Asymptomatic carriers' prevalence is unknown and would provide essential information on hidden viral circulation. In our cross-sectional study, 1.82% of 330 asymptomatic confined individuals living in the community carried SARS-CoV-2 despite no contact with declared cases, raising concerns about unnoticed transmission.

Knowledge, perception and practice of health professionals regarding blood pressure measurement methods: a scoping review.

OBJECTIVE: Guideline-concordant performance of accurate blood pressure measurement (BPM), whether the modality is home (HBPM), ambulatory (ABPM), automated (AOBP) or office (OBPM), is dependent on proper technique. Knowledge, perception and practice of health professionals for BPM is crucial and has been partly studied, but a thorough review has never been reported. A scoping review of global studies was conducted to synthesize published data on this topic. METHODS: An Arksey and O'Malley methodological framework was used. Keywords were identified and extraction was completed to April 2019 using CINAHL and MEDLINE. Studies were classified as positive for knowledge, perception and practice if the majority (>50%) of reported responses were favourable, and negative otherwise. If specific results were not reported, the author's conclusions were used to classified. RESULTS: Seventy-two studies were identified: 25 HBPM, 14 ABPM, two AOBP, 40 OBPM. For knowledge, the percentage of negative studies were higher for HBPM (40%) and OBPM (68%) and lower for ABPM (14%) regarding BPM techniques. For perception, the number of negative studies were lower for HBPM (20%) and ABPM (7%) regarding usefulness of BPM methods in hypertension management. For practice, the number of negative studies were higher for HBPM (48%), ABPM (71%), OBPM (73%) and AOBP (50%) regarding implementation of hypertension guidelines. CONCLUSION: The results of this scoping review demonstrate adequate perception of BPM but suboptimal knowledge and practice. Education is still needed to improve knowledge and practice. Future efforts should focus on improving what we know and what we do when measuring BP.

Brief online certification course for measuring blood pressure with an automated blood pressure device. A free new resource to support World Hypertension Day Oct 17, 2020.

Detection, diagnosis, and treatment of hypertension require accurate blood pressure assessment. However, in clinical practice, lack of training in or nonadherence to measurement recommendations, lack of patient preparation, unsuitable environments where blood pressure is measured, and inaccurate and inappropriate equipment are widespread and commonly lead to inaccurate blood pressure readings. This has led to calls to require regular training and certification for people assessing blood pressure. Hence, the Pan American Health Organization in collaboration with Resolve to Save Lives, the World Hypertension League, Lancet Commission on Hypertension Group, and Hypertension Canada has developed a free brief training and certification course in blood pressure measurement. The course is available at www. The release of the online certification course is timed to help support World Hypertension Day. This year World Hypertension Day has been delayed to October 17 due to the COVID-19 pandemic. For 2020, the World Hypertension League calls on all health care professionals, health care professional organizations, and indeed all of society, to assess the blood pressure of all adults, measure blood pressure accurately, and achieve blood pressure control in those with hypertension.

Hypertension Canada's 2020 Comprehensive Guidelines for the Prevention, Diagnosis, Risk Assessment, and Treatment of Hypertension in Adults and Children.

Hypertension Canada's 2020 guidelines for the prevention, diagnosis, risk assessment, and treatment of hypertension in adults and children provide comprehensive, evidence-based guidance for health care professionals and patients. Hypertension Canada develops the guidelines using rigourous methodology, carefully mitigating the risk of bias in our process. All draft recommendations undergo critical review by expert methodologists without conflict to ensure quality. Our guideline panel is diverse, including multiple health professional groups (nurses, pharmacy, academics, and physicians), and worked in concert with experts in primary care and implementation to ensure optimal usability. The 2020 guidelines include new guidance on the management of resistant hypertension and the management of hypertension in women planning pregnancy.

Effect of contact with podiatry in a team approach context on diabetic foot ulcer and lower extremity amputation: systematic review and meta-analysis.

Multidisciplinary team (MDT) approach has been shown to reduce diabetic foot ulcerations (DFUs) and lower extremity amputations (LEAs), but there is heterogeneity between team members and interventions. Podiatrists have been suggested as "gatekeepers" for the prevention and management of DFUs. The purpose of our study is to review the effect of podiatric interventions in MDTs on DFUs and LEAs. We conducted a systematic review of available literature. Data's heterogeneity about DFU outcomes made it impossible for us to include it in a meta-analysis, but we identified 12 studies fulfilling inclusion criteria that allowed for them to be included for LEA outcomes. With the exception of one study, all reported favourable outcomes for MDTs that include podiatry. We found statistical significance in favour of an MDT approach including podiatrists for our primary outcome (total LEAs (RR: 0.69, 95% CI 0.54-0.89, I2 = 64%, P = 0.002)) and major LEAs (RR: 0.45, 95% CI 0.23-0.90, I2 = 67%, P < 0.02). Our systematic review, with a standard search strategy, is the first to specifically address the relevant role of podiatrists and their interventions in an MDT approach for DFU management. Our observations support the literature that MDTs including podiatrists have a positive effect on patient outcomes but there is insufficient evidence that MDTs with podiatry management can reduce the risk of LEAs. Our study highlights the necessity for intervention descriptions and role definition in team approach in daily practice and in published literature.

New Antibacterial Paper Made of Silver Phosphate Cellulose Fibers: A Preliminary Study on the Elimination of Staphylococcus aureus Involved in Diabetic Foot Ulceration.

AIM: To evaluate in vitro the antibacterial effect of a paper made of silver phosphate cellulose fibers (SPCF) on Staphylococcus aureus, the most common diabetic foot ulceration (DFU) pathogen when compared with other common commercial products. METHODS: The antibacterial activity of SPCF samples was evaluated through time with cell counting on agar plates. SPCF samples were then compared with commercial wound care products currently in use in DFU treatments (Silvercel™, Acticoat 7, and Aquacel Ag ExtraTM) through time on agar plates (growth inhibition zones). RESULTS: After 6 hours, there was no viable bacterial cell detected on either plate (p < 0.05). There was a net growth inhibition zone for SPCF samples but no significant difference between the two silver concentrations. Compared with common commercial products, SPCF paper provides results equal to Acticoat 7 (p < 0.05). There was a net growth inhibition zone for SPCF samples but no significant difference between the two silver concentrations. Compared with common commercial products, SPCF paper provides results equal to Acticoat 7 (p < 0.05). There was a net growth inhibition zone for SPCF samples but no significant difference between the two silver concentrations. Compared with common commercial products, SPCF paper provides results equal to Acticoat 7 (. CONCLUSIONS: These results have shown the efficiency of SPCF paper to eliminate Staphylococcus aureus in these conditions. SPCF papers are effective when compared with other common commercial products and could have an industrial potential in wound care. Infected DFU could benefit from the antibacterial effectiveness of SPCF, but more relevant experimentations related to foot ulcers are needed.Staphylococcus aureus, the most common diabetic foot ulceration (DFU) pathogen when compared with other common commercial products.

Screening for hypertension in adults during emergency department consultation: a systematic review.

A large proportion of patients affected with hypertension go undetected. A systematic review was conducted to assess the performance of a screening strategy in adults using blood pressure measurement at the time of an emergency department consultation. A systematic literature search on Embase, CINHAL and Medline was carried out. This systematic review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses-Diagnostic Test Accuracy. Intervention studies with adults including at least one blood pressure measurement for all participants were included. A repeat blood pressure assessment had to have been carried out to assess the validity of the elevated blood pressure value within the next few days after the emergency department initial visit. Out of 1030 articles identified, published between 1985 and 2018, 10 articles met the inclusion criteria. There were no randomized clinical trials. Mean age of participants was 51.6 years. A single study reports that blood pressure screening was measured according to hypertension guidelines referred to in the study. The average follow-up rate was 61.9% (95% confidence interval 45.5-78.3). For diagnostic confirmation, four studies used a blood pressure measurement method based on the reported guidelines. Half of the patients (50.2%) with elevated blood pressure during the emergency department visit had blood pressure corresponding to uncontrolled elevated blood pressure at follow-up measurement. The contribution of emergency department to the screening for hypertension, by recognizing the presence of elevated blood pressure and then making a referral for diagnostic confirmation, could provide an opportunity to detect a large number of people with hypertension.

Effect of an educational program for the knowledge and quality of blood pressure recording. / Efeito de um programa educativo no conhecimento e na qualidade dos registros da pressão arterial.

OBJECTIVE: to evaluate the effect of an educational program on blood pressure recording for nursing professionals in relation to theoretical knowledge and the quality of these records. METHOD: quasi-experimental study conducted in a hospital service located in the city of São Paulo. The theoretical knowledge of 101 professionals was measured using a validated questionnaire before and after the educational intervention; the quality of blood pressure records was evaluated using a validated form which was applied to 354 records in the pre-intervention period and 288 in the post-intervention period. The educational program was based on active teaching-learning methodologies and consisted of two strategies: expository/dialogue class and a board game. The Wilcoxon, Mann-Whitney, Fisher and Chi-Square tests were used for comparisons, adopting a level of significance of α=0.05. RESULTS: the median of the professionals' scores increased from 19 to 22 points in the post-intervention period (p<0.001). There was an improvement in the quality of the blood pressure recordings regarding the variables: cuff size (p<0.001), arm used in the procedure (p<0.001) and patient position (p<0.001). CONCLUSION: the educational program showed positive results in the promotion of knowledge among nursing professionals and in the improvement of the quality of blood pressure recording.