Aids to improve understanding of statistical risk in patients consenting for surgery and interventional procedures: A systematic review.

BACKGROUND: Informed consent is an essential process in clinical decision-making, through which healthcare providers educate patients about benefits, risks, and alternatives of a procedure. Statistical risk information is difficult to communicate and the effectiveness of aids aimed at supporting this type of communication is uncertain. This systematic review aims to study the impact of risk communication adjuncts on patients' understanding of statistical risk in surgery and interventional procedures. METHODS: A systematic search was performed across Medline, Embase, PsycINFO, Scopus, and Web of Science until July 2021 with a repeated search in September 2022. RCTs and observational studies examining risk communication tools (e.g., information leaflets and audio-video) in adult (age >16) patients undergoing a surgical or interventional procedure were included. Primary outcomes included the objective assessment of statistical risk recall. Secondary outcomes included patient attitudes with respect to statistical information. Due to the study heterogeneity, a narrative synthesis was performed. RESULTS: A total of 4348 articles were identified, and following abstract and full-text screening 14 articles, including 9 RCTs, were included. The total number of adult patients was 1513. The most common risk communication tool used was written information (n = 7). Most RCTs (7/9, 77.8%) showed statistically significant improvements in patient understanding of statistical risk in the intervention group. Quality assessment found some concerns with all RCTs. CONCLUSION: Risk communication tools appear to improve recall of statistical risk. Additional prospective trials comparing various aids simultaneously are warranted to determine the most effective method of improving understanding.

Improving risk communication: a proof-of-concept randomised control trial assessing the impact of visual aids for neurosurgical consent.

Introduction: Informed consent is a fundamental component in the work-up for surgical procedures. Statistical risk information pertaining to a procedure is by nature probabilistic and challenging to communicate, especially to those with poor numerical literacy. Visual aids and audio/video tools have previously been shown to improve patients' understanding of statistical information. In this study, we aimed to explore the impact of different methods of risk communication in healthy participants randomized to either undergo the consent process with visual aids or the standard consent process for lumbar puncture. Material and methods: Healthy individuals above 18 years old were eligible. The exclusion criteria were prior experience of the procedure or relevant medical knowledge, lack of capacity to consent, underlying cognitive impairment and hospitalised individuals. After randomisation, both groups received identical medical information about the procedure of a lumbar puncture in a hypothetical clinical scenario via different means of consent. The control group underwent the standard consent process in current clinical practice (Consent Form 1 without any illustrative examples), whereas the intervention group received additional anatomy diagrams, the Paling Palette and the Paling perspective scale. Anonymised questionnaires were received to evaluate their perception of the procedure and its associated risks. Results: Fifty-two individuals were eligible without statistically significant differences in age, sex, professional status and the familiarity of the procedure. Visual aids were noted to improve the confidence of participants to describe the risks by themselves (p = 0.009) and participants in the intervention group felt significantly less overwhelmed with medical information (p = 0.028). The enhanced consent process was found to be significantly more acceptable by participants (p = 0.03). There was a trend towards greater appropriateness (p = 0.06) and it appeared to have "good" usability (median SUS = 76.4), although this also did not reach statistical significance (p = 0.06). Conclusion: Visual aids could be an appropriate alternative method for medical consent without being inferior regarding the understanding of the procedure, its risks and its benefits. Future studies could possibly compare or incorporate multiple interventions to determine the most effective tools in a larger scale of population including patients as well as healthy individuals.

Updates on the Global Prevalence and Etiology of Constrictive Pericarditis: A Systematic Review.

Constrictive pericarditis is a rare disease with poorly understood epidemiology. A systematic literature search was adopted to assess the region- and period-specific traits of constrictive pericarditis through Pubmed, EMBASE, and Scopus. Case reports and studies including less than 20 patients were excluded. The risk of bias was assessed through the Study Quality Assessment Tools developed by the National Heart Lung Blood Institute by 4 reviewers. Patient demographics, disease etiology, and mortality were the primary assessed outcomes. One hundred thirty studies with 11,325 patients have been included in this systematic review and meta-analysis. The age at diagnosis of constrictive pericarditis has markedly increased after 1990. Patients from Africa and Asia are considerably younger compared with those from Europe and North America. Moreover, there are differences in etiology, as tuberculosis remains the dominant cause of constrictive pericarditis in Africa and Asia but has been surpassed by history of previous chest surgery in North America and Europe. The human immunodeficiency virus affects 29.1% of patients from Africa diagnosed with constrictive pericarditis, a feature that is not observed on any other continent. The early mortality rate after hospitalization has improved. The variances of age at diagnosis and etiology of constrictive pericarditis should be considered by the clinician during the work-up of cardiac and pericardial diseases. An underlying human immunodeficiency virus infection complicates a significant portion of constrictive pericarditis cases in Africa. Early mortality has improved across the world but remains high.

Effectiveness of pharmacologic interventions for prevention of cerebral hyperperfusion syndrome following bypass surgery.

BACKGROUND: Cerebral hyperperfusion syndrome (CHS) following bypass surgery is a major cause of neurological morbidity and mortality. However, data regarding its prevention have not been assorted until date. OBJECTIVE: The objective of this study was to review the literature and evaluate whether any conclusion can be drawn regarding the effectiveness of any measure on preventing bypass-related CHS. METHODS: We systematically reviewed PubMed and Cochrane Library from September 2008 to September 2018 to collect data regarding the effectiveness of pharmacologic interventions on the refers to pretreatment (PRE) of bypass-related CHS. We categorized interventions regarding their class of drugs and their combinations and calculated overall pooled estimates of proportions of CHS development through random-effects meta-analysis of proportions. RESULTS: Our search yielded 649 studies, of which 23 fulfilled inclusion criteria. Meta-analysis included 23 studies/2,041 cases. In Group A (blood pressure [BP] control), 202 out of 1,174 pretreated cases developed CHS (23.3% pooled estimate; 95% confidence interval [CI]: 9.9-39.4), Group B (BP control + free radical scavenger [FRS]) 10/263 (0.3%; 95% CI: 0.0-14.1), Group C (BP control + antiplatelet) 22/204 (10.3%; 95% CI: 5.1-16.7), and Group D (BP control + postoperative sedation) 29/400 (6.8%; 95% CI: 4.4-9.6)]. CONCLUSIONS: BP control alone has not been proven effective in preventing CHS. However, BP control along with either a FRS or an antiplatelet agent or postoperative sedation seems to reduce the incidence of CHS.

Albuminuria and Cerebral Small Vessel Disease: A Systematic Review and Meta-Analysis.

OBJECTIVES: To determine whether albuminuria, a marker of systemic endothelial dysfunction, is associated with cerebral small vessel disease (SVD). DESIGN: Systematic review following the Meta-analyses Of Observational Studies in Epidemiology guidelines; independent reviewers searched Pubmed/Medline and Scopus, data were extracted, studies were evaluated on quality, and random-effects models were implemented for meta-analysis. SETTING: Observational studies quantifying an association between albuminuria and cerebral SVD. PARTICIPANTS: Adults. MEASUREMENTS: Magnetic resonance imaging-defined markers of cerebral SVD; white matter hyperintensities (WMHs), lacunar infarcts (LIs), cerebral microbleeds (CMBs), and enlarged perivascular spaces (EPVSs). RESULTS: Of 31 eligible studies comprising 23,056 participants identified, 27 were included in quantitative synthesis. Most of the studies were cross-sectional and of varying quality. On meta-analysis, albuminuria was associated with greater risk of WMHs (odds ratio (OR) = 1.70, 95% confidence interval (CI) = 1.43-2.01; 13,548 subjects, 2,665 cases; I2  = 44%), LIs (OR = 1.86, 95% CI = 1.49-2.31; 12,857 subjects, 998 cases; I2  = 27%), CMBs (OR = 1.78, 95% CI = 1.30-2.43; 7,645 subjects; 748 cases; I2  = 39%), and EPVSs in the basal ganglia (OR = 1.78, 95% CI = 1.02-3.09; 1,388 subjects, 399 cases; I2  = 37%) and centrum semiovale (OR = 3.27, 95% CI = 1.49-7.20; 1,146 subjects, 460 cases; I2  = 66%). Sensitivity analyses for high-quality and general population studies, but also studies controlling for cardiovascular disease risk factors and renal function, confirmed the findings and resolved the moderate heterogeneity and publication bias that were evident in the overall analyses. CONCLUSION: Albuminuria is independently associated with cerebral SVD, indicating shared microvascular pathology in the kidney and the brain. The results suggest that peripheral systemic microvascular disease biomarkers could be useful in the evaluation of brain microvascular damage.

Season of birth and primary central nervous system tumors: a systematic review of the literature with critical appraisal of underlying mechanisms.

PURPOSE: Season of birth has been considered a proxy of seasonally varying exposures around perinatal period, potentially implicated in the etiology of several health outcomes, including malignancies. METHODS: Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, we have systematically reviewed published literature on the association of birth seasonality with risk of central nervous system tumors in children and adults. RESULTS: Seventeen eligible studies using various methodologies were identified, encompassing 20,523 cases. Eight of 10 studies in children versus four of eight in adults showed some statistically significant associations between birth seasonality and central nervous system tumor or tumor subtype occurrence, pointing to a clustering of births mostly in fall and winter months, albeit no consistent pattern was identified by histologic subtype. A plethora of perinatal factors might underlie or confound the associations, such as variations in birth weight, maternal diet during pregnancy, perinatal vitamin D levels, pesticides, infectious agents, immune system maturity, and epigenetic modifications. CONCLUSIONS: Inherent methodological weaknesses of to-date published individual investigations, including mainly underpowered size to explore the hypothesis by histological subtype, call for more elegant concerted actions using primary data of large datasets taking also into account the interplay between the potential underlying etiologic factors.