scholarly journals Opportunities for the use of routinely collected data for the generation of large randomized evidence in Colombia

2021 ◽  
Vol 6 ◽  
pp. 182
Author(s):  
Jonny Alejandro Garcia Luna ◽  
Eduardo López-Medina ◽  
Norman Danilo Maldonado-Vargas ◽  
Adrian D. Smith

Randomized clinical trials are the cornerstone design for the evaluation of the safety and efficacy of health interventions. Furthermore, morbidity and mortality rates could be reduced if evidence of better interventions is sought and used to inform medical practice. However, only small to moderate, yet worthwhile, effects can be expected from such interventions. Therefore, moderate random error and moderate biases must be avoided during the design, conduct and analysis of trials. Routinely collected data, such as vital statistics, hospital episode statistics and surveillance data, could be used to enhance recruitment and follow-up a large number of patients, reducing both random error and moderate biases. Here, we discuss the opportunities and challenges for the use of these data for clinical studies in Colombia.

Stroke ◽  
2021 ◽  
Vol 52 (Suppl_1) ◽  
Author(s):  
Mahmoud Mohammaden ◽  
Raul G Nogueira ◽  
WONDWOSSEN TEKLE ◽  
farhan siddiq ◽  
Diogo C Haussen ◽  
...  

Introduction: Intracranial atherosclerotic disease (ICAD) is a common cause of refractory stroke. Randomized clinical trials failed to prove the safety and efficacy of the endovascular treatment options of symptomatic ICAD (sICAD). However, there are many concerns regarding inclusion criteria in these trials which made them less effective than standard medical management. Herein, we aim to study the safety and efficacy of drug-eluting balloon mounted stents (DES) in the treatment of sICAD. Methods: A retrospective review of endovascular database from 10 comprehensive stroke centers inside and outside the USA from January 2017 to January 2020 was reviewed. Patients were included if they had symptomatic intracranial stenosis ≥70% in the target vessel, failed best medical management, and underwent intracranial stenting with DES. The primary outcome was the occurrence of ischemic stroke, hemorrhage, or mortality within 72 hours of the procedure. Secondary outcomes included rates of symptomatic and angiographic recurrence within 6 months of the procedure. Results: There was a total of 129 patients, the median age was 65 [58-72] years, 40 (31%) were females. The intracranial stenotic lesions were located in anterior circulation in 74 (57.4%) of cases [24 (18.6%) supraclinoid ICA, 5 (3.9%) cavernous ICA, 17 (13.2%) petrous ICA, 5 (19.4%) MCA-M1, and 3 (2.3%) M2] and in posterior circulation in 55 (42.6%) of cases [36 (27.9) vertebral artery V4 segment, 18 (14%) basilar and 1 (0.7%) PCA]. Recurrent stroke was the qualifying event in 101 (78.3%) while transient ischemic attacks (TIA) were identified in 28 (21.7%) of cases. The median time from the qualifying event to stenting was 6 [2-24] days. Strokes were reported within 72 hours of the procedure; 2 (1.6%) ischemic, 2 (1.6%) hemorrhagic strokes and 2 (1.6%) patients suffered inpatient mortality. The median follow-up time was 6 [3-6.75] months. Among 99 patients who had clinical follow up 2 (2%) had TIA and 6 (6.1%) had strokes. Fifty-one patients had follow-up imaging of whom symptomatic ISR was reported in 8 (15.7%). Conclusion: Our study has shown that in appropriately selected patients with sICAD, endovascular treatment using DES is safe and effective. Prospective randomized clinical trials are warranted.


2020 ◽  
Vol 16 (6) ◽  
pp. 1031-1038
Author(s):  
T. V. Pavlova

Anticoagulant therapy in elderly patients with atrial fibrillation and concomitant diseases is often the challenge for clinicians. The high risk of stroke is inherent in atrial fibrillation, and it increases when combined with coronary heart disease and chronic kidney disease. On the other hand, the comorbidity increases the risk of bleeding. Older age is also the risk factor of thrombotic and hemorrhagic complications. As a consequence, the choice of specific anticoagulant should be based on a solid evidences, obtained both from randomized clinical trials and from daily clinical practice. In the ROCKET AF trail the direct oral anticoagulant rivaroxaban showed a tendency to reduce the risk of thromboembolism by 20% compared with warfarin in the patients aged 75 years and older. The safety of rivaroxaban has been evaluated in the XANTUS POOLED program. According to the follow-up results for 12 months, more than 96% of patients didn't have any adverse event, and the number of patients with major bleeding was 1.5%. Several meta-analyzes reported a reduction of cardiovascular complications in patients treated by rivaroxaban. In the ROCKET AF trail, a “renal” dose of rivaroxaban (15 mg OD) was studied in patients with chronic kidney disease. The efficacy and safety of rivaroxaban were validated in this patients, and a simple algorithm for selecting the dose of this drug in patients with chronic kidney disease was provided. 


2021 ◽  
pp. 1-10
Author(s):  
Panagiotis Kerezoudis ◽  
Rohin Singh ◽  
Veronica Parisi ◽  
Gregory A. Worrell ◽  
Kai J. Miller ◽  
...  

OBJECTIVE The prevalence of epilepsy in the older adult population is increasing. While surgical intervention in younger patients is supported by level I evidence, the safety and efficacy of epilepsy surgery in older individuals is less well established. The aim of this study was to evaluate seizure freedom rates and surgical outcomes in older epilepsy patients. METHODS The authors’ institutional electronic database was queried for patients older than 50 who had undergone epilepsy surgery during 2002–2018. Cases were grouped into 50–59, 60–69, and 70+ years old. Seizure freedom at the last follow-up constituted the primary outcome of interest. The institutional analysis was supplemented by a literature review and meta-analysis (random effects model) of all published studies on this topic as well as by an analysis of complication rates, mortality rates, and cost data from a nationwide administrative database (Vizient Inc., years 2016–2019). RESULTS A total of 73 patients (n = 16 for 50–59 years, n = 47 for 60–69, and n = 10 for 70+) were treated at the authors’ institution. The median age was 63 years, and 66% of the patients were female. At a median follow-up of 24 months, seizure freedom was 73% for the overall cohort, 63% for the 50–59 group, 77% for the 60–69 group, and 70% for the 70+ group. The literature search identified 15 additional retrospective studies (474 cases). Temporal lobectomy was the most commonly performed procedure (73%), and mesial temporal sclerosis was the most common pathology (52%), followed by nonspecific gliosis (19%). The pooled mean follow-up was 39 months (range 6–114.8 months) with a pooled seizure freedom rate of 65% (95% CI 59%–72%). On multivariable meta-regression analysis, an older mean age at surgery (coefficient [coeff] 2.1, 95% CI 1.1–3.1, p < 0.001) and the presence of mesial temporal sclerosis (coeff 0.3, 95% CI 0.1–0.6, p = 0.015) were the most important predictors of seizure freedom. Finally, analysis of the Vizient database revealed mortality rates of 0.5%, 1.1%, and 9.6%; complication rates of 7.1%, 10.1%, and 17.3%; and mean hospital costs of $31,977, $34,586, and $40,153 for patients aged 50–59, 60–69, and 70+ years, respectively. CONCLUSIONS While seizure-free outcomes of epilepsy surgery are excellent, there is an expected increase in morbidity and mortality with increasing age. Findings in this study on the safety and efficacy of epilepsy surgery in the older population may serve as a useful guide during preoperative decision-making and patient counseling.


Author(s):  
Mohamed Fahmy Doheim ◽  
Ahmed Elsnhory ◽  
Mohammed Elgammal ◽  
Abdulrahman Ibrahim Hagrass ◽  
Ahmed Hanbal ◽  
...  

Introduction : Stroke is one of the predominant causes of permanent disability, mortality, significant cognitive, physical, and psychosocial morbidity in the world. We conducted this systematic review and meta‐analysis to assess the safety and efficacy of fluoxetine for recovery stroke patients through different time points of follow up. Methods : We searched in PubMed, Cochrane Library, Scopus, and Web of Science databases/ search engines until June 2021. Mean difference (MD) with 95% confidence interval (CI) was applied for continuous data, while risk ratio (RR) with 95% CI was used for dichotomous data. Results : Seventeen randomized clinical trials were identified which assessed the safety and efficacy of fluoxetine compared to placebo for stroke patients. Fluoxetine enhances the National Institutes of Health Stroke Scale (NIHSS) score [MD = ‐0.67, 95 % CI (‐1.19 to ‐0.15), P = 0.01] and the Fugl‐Meyer Motor Scale (FMMS) score [MD = 17.36, 95 % CI (12.12 to 22.61), P <0.00001] at three months follow up. However, the NIHSS score showed no significant difference between the two groups at two weeks [MD = ‐0.32, 95% CI (‐0.72 to 0.07), p = 0.11] or at six months [MD = ‐0.17,95% CI (‐0.47 to 0.14), p = 0.29]. Fluoxetine and placebo‐treated patients had the same overall impact on FMMS scores at one month [MD = 7.77, 95 % CI (‐10.57 to 26.11), P = 0.41]. The fluoxetine arm had a higher risk of broken bone (RR = 2.30, 95% CI [1.59, 3.32], p < 0.001) and hyponatremia (RR = 2.12, 95% CI [1.19, 3.76], p = 0.01) with lower risk of new depression (RR = 0.72, 95% CI [0.61, 0.84], p< 0.001) in comparison to the placebo arm. Conclusions : The efficacy of fluoxetine is likely to take time to emerge, and is expected to be transient. The use of fluoxetine increased the incidence of hyponatremia and bone fractures while decreasing the risk of new‐onset depression.


Author(s):  
Daniel E Forman ◽  
Samip Vasaiwala ◽  
Traecy S Silbaugh ◽  
Ann Lovett ◽  
Sharon-Lise T Normand ◽  
...  

Background: Very old (VO) adults (≥85 years) are intrinsically susceptible to coronary heart disease (CHD) and are often treated with coronary stents. While current evidence supports use of drug-eluting stents (DES), generalizability to VO remains controversial, especially given high age-associated bleeding risks from long-term dual antiplatelet therapy. Methods: We identified all VO CHD patients who received stents between April 1, 2003 and September 30, 2006 at all non-federal hospitals in Massachusetts (MA) (N=1619), and completed 2-year follow-up on the entire cohort. Patients were classified as DES-treated if stents were all drug-eluting and BMS-treated if stents were all bare-metal (those receiving DES and BMS were excluded). Mortality rates were determined from vital statistics records. New myocardial infarction (MI) and subsequent bleeding (requiring hospitalization) were determined using ICD-9 codes. Repeat target vessel revascularization (TVR) was determined from the MA database. Risk-adjusted cumulative incidence was estimated using propensity score matching based on 57 clinical, procedural, hospital, and insurance variables. Results: During the study period, 1145 and 474 VO patients received DES and BMS respectively. Unadjusted 2-year mortality rates were 23.8% vs. 35.0% (DES vs. BMS, p<0.0001). Risk-adjusted (propensity score matching [665 DES:343 BMS]) 2-year DES vs. BMS rates were 25.4% vs. 32.4% (hazard ratio [HR] 0.69, 95% confidence interval [CI] 0.51, 0.93; p=0.01) for mortality and 9.8 vs.16.9% (HR 0.51, 95% CI 0.35, 0.76; p=0.001) for MI. Risk-adjusted 2-year rates of bleeding (13.6% vs. 12.5%, HR 1.08, 95% CI 0.73, 1.59; p=0.72) and TVR (5.7% vs. 8.7%, HR 0.62, 95% CI 0.38, 1.02; p=0.06) were similar in patients treated with DES vs. BMS. Conclusions: In a large, unrestricted, state dataset of VO CHD patients with mandated follow-up, DES were associated with reduced 2-year mortality and MI compared with a matched BMS subset, without an increased hazard of bleeding.


2018 ◽  
Vol 100 (4) ◽  
pp. 316-321 ◽  
Author(s):  
N Rudarakanchana ◽  
M Hamady ◽  
S Harris ◽  
E Afify ◽  
RGJ Gibbs ◽  
...  

Objective Despite centralisation of the provision of vascular care, not all areas in England and Wales are able to offer emergency treatment for patients with acute conditions affecting the aorta proximal to the renal arteries. While cardiothoracic centres have made network arrangements to coordinate care for the repair of type A dissections, a similar plan for vascular care is lacking. This study investigates early outcomes in patients with ruptured suprarenal aortic aneurysm or dissection (rSRAD) transferred to a specialist centre. Methods Retrospective observational study over a five-year period (2009–2014) assessing outcomes of patients with ruptured sRAD diagnosed at their local hospital and then transferred to a tertiary centre capable of offering such treatment. Results Fifty-two patients (median age 73 years, 32 male) with rSRAD were transferred and a further four died during transit. The mean distance of patient transfer was 35 miles (range 4–211 miles). One patient did not undergo intervention due to frailty and two died before reaching the operating theatre. A total of 23 patients underwent endovascular repair, 9 hybrid repair and 17 open surgery. Median follow-up was 12 months (range 1–43 months). Complications included paraplegia (n = 3), stroke (n = 2), type IA endoleak (n = 4); 30-day and in-hospital mortality were 16% and 27%. For patients discharged alive from hospital, one-year survival was 67%. Conclusions Although the number of patients with rSRAD is low and those who are transferred alive are a self-selecting group, this study suggests that transfer of such patients to a specialist vascular centre is associated with acceptable mortality rates following emergency complex aortic repair.


2021 ◽  
pp. 088506662110126
Author(s):  
Clay Small ◽  
Rebecca L. Attridge ◽  
Crystal Franco-Martinez ◽  
Jonathan Donnelly ◽  
Colleen Barthol

Background/Objective: Patients with intracranial hemorrhage (ICH) have a 30-day mortality rate up to 52%, and the risk of mortality is increased in patients with disease-induced coagulopathy such as cirrhosis. The objective of this study was to evaluate whether 4F-PCC administration mitigates hematoma expansion in ICH patients with cirrhosis not currently receiving anticoagulation therapy compared to standard of care therapies. Methods: This was a single-center, retrospective study comparing adult patients with ICH and history of cirrhosis who received 4F-PCC versus standard of care therapies. The primary outcome was rate of ICH expansion within 24 hours after admission. Results: A total of 58 patients were included with 21 who received 4FPCC vs 37 who received standard of care therapies. The 4F-PCC group had a significantly higher number of patients with Child Pugh Class C cirrhosis (85.7% vs. 48.6%, P = 0.006), higher baseline INR (1.7 vs. 1.4, P = 0.001) and more patients with a spontaneous cause of hemorrhage (61.9% vs. 29.7%, P = 0.01). Stable follow-up head CT was achieved in 68.4% of patients who received 4F-PCC versus 72.7% of patients treated with standard of care therapies ( P = 0.11). Patients who received 4F-PCC had a significantly greater change in INR within 24 hours (-0.2 vs. 0, P = 0.02) and higher rate of mortality (61.9% vs. 18.9%, P = 0.001). Baseline INR > 2 and surgical evacuation for ICH were associated with decreased odds of stable follow-up head CT in the multivariate logistic regression model. Conclusions: A single dose of 4F-PCC did not significantly improve the rate of stable head CT at 24 hours in patients with ICH and cirrhosis. Randomized clinical trials with larger patient populations are warranted to fully determine the role of 4F-PCC in this unique population.


2007 ◽  
Vol 25 (29) ◽  
pp. 4575-4580 ◽  
Author(s):  
James S. Tomlinson ◽  
William R. Jarnagin ◽  
Ronald P. DeMatteo ◽  
Yuman Fong ◽  
Peter Kornprat ◽  
...  

Purpose Resection of colorectal liver metastases (CLM) in selected patients has evolved as the standard of care during the last 20 years. In the absence of prospective randomized clinical trials, a survival benefit has been deduced relative to historical controls based on actuarial data. There is now sufficient follow-up on a significant number of patients to address the curative intent of resecting CLM. Methods Retrospective review of a prospectively maintained database was performed on patients who underwent resection of CLM from 1985 to 1994. Postoperative deaths were excluded. Disease-specific survival (DSS) was calculated from the time of hepatectomy using the Kaplan-Meier method. Results There were 612 consecutive patients identified with 10-year follow-up. Median DSS was 44 months. There were 102 actual 10-year survivors. Ninety-nine (97%) of the 102 were disease free at last follow-up. Only one patient experienced a disease-specific death after 10 years of survival. In contrast, 34% of the 5-year survivors suffered a cancer-related death. Previously identified poor prognostic factors found among the 102 actual 10-year survivors included 7% synchronous disease, 36% disease-free interval less than 12 months, 25% bilobar metastases, 50% node-positive primary, 39% more than one metastasis, and 35% tumor size more than 5 cm. Conclusion Patients who survive 10 years appear to be cured of their disease, whereas approximately one third of actual 5-year survivors succumb to a cancer-related death. In well-selected patients, there is at least a one in six chance of cure after hepatectomy for CLM. The presence of poor prognostic factors does not preclude the possibility of long-term survival and cure.


2021 ◽  
Vol 15 (3) ◽  
pp. 50-56
Author(s):  
G. M. Tarasova ◽  
B. S. Belov ◽  
M. V. Cherkasova ◽  
E. A. Aseeva ◽  
T. M. Reshetnyak ◽  
...  

Objective: to study the safety and efficacy of the 23-valent polysaccharide pneumococcal vaccine (PPV-23) in patients with systemic lupus erythematosus (SLE).Patients and methods. The study included 75 patients with definite diagnosis of SLE at the age of 19–68 years, 10 (13%) of them had high SLE activity, 18 (24%) – moderate, 42 (56%) – low, in 5 (7%) patients the disease was in remission. PPV-23 was injected subcutaneously in a single dose of 0.5 ml. In 60 patients the follow-up period was ≥12 months, in 15 – from 2 to 6 months. Patients were examined before and 1, 3 and 12 months after immunization.Results and discussion. In 38 (50.7%) patients, standard local vaccination reactions of mild and moderate severity were noted, in 1 (1.3%) – a general reaction of mild severity, in 2 (2.7%) – mild diarrhea during 1 day, in 1 (1.3%) – a hyperergic reaction of the Artyus phenomenon type, the symptoms were relieved within 7 days. During 12 months of follow-up, neither exacerbations of SLE, reliably associated with vaccination, nor new autoimmune phenomena, were detected. After 1 year of observation, the number of responders to vaccination was 58%, non-responders – 42%. The duration and activity of the disease, age over 50 years, glucocorticoid therapy > 10 mg per day, did not significantly affect the vaccine response. There was a decrease in the immune response in patients on biologic DMARDs (bDMARDs) therapy compared to patients without such treatment (43 and 68% of cases, respectively), p=0.058. There was no difference between rituximab and belimumab treated subjects. There was a tendency for the prevalence of vaccination responses among patients, who received bDMARDs <1 year before immunization, as well as among patients in whom this therapy was initiated after the administration of PPV-23. There was a positive trend in decrease of pneumonia, acute and exacerbations of chronic bronchitis episodes and sinusitis.Conclusion. Sufficient immunogenicity, good tolerability and clinical efficacy of PPV-23 in patients with SLE, including those who received combined immunosuppressive therapy, have been shown. The use of bDMARDs reduces the number of patients with a vaccine response. The number of responders to vaccination increases when immunization is carried out before the initiation of therapy with bDMARDs or when this therapy is initiated <1 year before immunization. Further long-term prospective studies in large patient cohorts are required.


2019 ◽  
Vol 44 (6) ◽  
pp. 1432-1440
Author(s):  
Alejandra García-García ◽  
Pablo Demelo-Rodríguez ◽  
Lucia Ordieres-Ortega ◽  
Eva Cervilla-Muñoz ◽  
Irene García-Fernández-Bravo ◽  
...  

Background: There is limited evidence on the etiology and outcomes of renal infarction. A provoking factor is identified only in one- to two-thirds of patients. Methods: This is a retrospective observational study. The clinical characteristics and outcomes of patients with acute renal infarction were studied; the sample was divided into two groups according to the presence of at least one provoking factor at the time of diagnosis (atrial fibrillation, flutter, major thrombophilia, or renal artery malformations). Results: The study comprised 59 patients with a mean age of 63 (±16.7) years and a follow-up period of 3.1 (±2.8) years. An identifiable provoking factor was found for 59.3% of the renal infarctions at the time of diagnosis, and atrial fibrillation was the most frequent one (in 49.2% of all patients). Renal impairment was found in 49.2% of the patients at diagnosis and in 50.8% of the patients 6 months after the event (p = 0.525). When compared with the idiopathic group, the patients with provoked infarction were older (69.8 vs. 57.9 years, p = 0.014) and had a higher rate of recurrence of arterial thrombosis during follow-up (18.8 vs. 0%, p = 0.028), but there were no differences in the rest of the baseline characteristics or in mortality rates. Six patients (10.2%) in the idiopathic group were diagnosed with atrial fibrillation during follow-up. Conclusions: Atrial fibrillation, both at diagnosis and at follow-up, is the most common identifiable cause of renal infarction; however, a significant number of patients are idiopathic, and these are younger, but they have a similar burden of cardiovascular disease and a lower risk of arterial recurrence.


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