scholarly journals Implementing an automated monitoring process in a digital, longitudinal observational cohort study

2021 ◽  
Vol 23 (1) ◽  
Author(s):  
Lisa Lindner ◽  
Anja Weiß ◽  
Andreas Reich ◽  
Siegfried Kindler ◽  
Frank Behrens ◽  
...  
Keyword(s):  
Cohort Studies ◽  
Data Quality ◽  
Missing Values ◽  
Randomized Clinical Trials ◽  
Cost Effective ◽  
Observational Research ◽  
Research Centre ◽  
Automated Monitoring ◽  
Monitoring Process ◽  
Observational Cohort

Abstract Background Clinical data collection requires correct and complete data sets in order to perform correct statistical analysis and draw valid conclusions. While in randomized clinical trials much effort concentrates on data monitoring, this is rarely the case in observational studies- due to high numbers of cases and often-restricted resources. We have developed a valid and cost-effective monitoring tool, which can substantially contribute to an increased data quality in observational research. Methods An automated digital monitoring system for cohort studies developed by the German Rheumatism Research Centre (DRFZ) was tested within the disease register RABBIT-SpA, a longitudinal observational study including patients with axial spondyloarthritis and psoriatic arthritis. Physicians and patients complete electronic case report forms (eCRF) twice a year for up to 10 years. Automatic plausibility checks were implemented to verify all data after entry into the eCRF. To identify conflicts that cannot be found by this approach, all possible conflicts were compiled into a catalog. This “conflict catalog” was used to create queries, which are displayed as part of the eCRF. The proportion of queried eCRFs and responses were analyzed by descriptive methods. For the analysis of responses, the type of conflict was assigned to either a single conflict only (affecting individual items) or a conflict that required the entire eCRF to be queried. Results Data from 1883 patients was analyzed. A total of n = 3145 eCRFs submitted between baseline (T0) and T3 (12 months) had conflicts (40–64%). Fifty-six to 100% of the queries regarding eCRFs that were completely missing were answered. A mean of 1.4 to 2.4 single conflicts occurred per eCRF, of which 59–69% were answered. The most common missing values were CRP, ESR, Schober’s test, data on systemic glucocorticoid therapy, and presence of enthesitis. Conclusion Providing high data quality in large observational cohort studies is a major challenge, which requires careful monitoring. An automated monitoring process was successfully implemented and well accepted by the study centers. Two thirds of the queries were answered with new data. While conventional manual monitoring is resource-intensive and may itself create new sources of errors, automated processes are a convenient way to augment data quality.

scholarly journals Implementing an Automated Monitoring Process in a Digital, Longitudinal Observational Cohort Study

2021 ◽  
Author(s):  
Lisa Lindner ◽  
Anja Weiß ◽  
Andreas Reich ◽  
Siegfried Kindler ◽  
Frank Behrens ◽  
...  
Keyword(s):  
Cohort Studies ◽  
Data Quality ◽  
Missing Values ◽  
Randomized Clinical Trials ◽  
Cost Effective ◽  
Observational Research ◽  
Research Centre ◽  
Automated Monitoring ◽  
Monitoring Process ◽  
Observational Cohort

Abstract Background Clinical data collection requires, correct and complete data sets in order not to perform wrong statistical analysis and avoid false conclusions. While in randomized clinical trials much effort concentrates on data monitoring, this is rarely the case in observational studies- due to high numbers of cases and often restricted resources. We have developed a valid and cost-effective monitoring tool, which can substantially contribute to an increased data quality in observational research. Methods An automated digital monitoring system for cohort studies developed by the German Rheumatism Research Centre (DRFZ) was tested within the disease register RABBIT-SpA, a longitudinal observational study including patients with axial spondyloarthritis and psoriatic arthritis. Physicians and patients complete electronic case report forms (eCRF) twice a year for up to ten years. Automatic plausibility checks were implemented to verify all data after entry into the eCRF. To identify conflicts that cannot be found by this approach, all possible conflicts were compiled into a catalog. This ‘conflict catalog’ was used to create queries, which are displayed as part of the eCRF. The proportion of queried eCRFs and responses were analyzed by descriptive methods. For the analysis of responses, the type of conflict was assigned to either a single conflict only (affecting individual items) or a conflict that required the entire eCRF to be queried. Results Data from 1883 patients was analyzed. A total of n = 3145 eCRFs submitted between baseline (T0) and T3 (12 months) had conflicts (40–64%). 56–100% of the queries regarding eCRFs that were completely missing were answered. A mean of 1.4 to 2.4 single conflicts occurred per eCRF, of which 59–69% were answered. The most common missing values were CRP, ESR, Schober’s test, data on systemic glucocorticoid therapy and presence of enthesitis. Conclusion Providing high data quality in large observational cohort studies is a major challenge, which requires careful monitoring. An automated monitoring process was successfully implemented and well accepted by the study centers. Two-thirds of the queries were answered with new data. While conventional manual monitoring is resource-intensive and may itself create new sources of errors, automated processes are a convenient way to augment data quality.

scholarly journals Difference in surgical outcomes of rectal cancer by study design: meta-analyses of randomized clinical trials, case-matched studies, and cohort studies

BJS Open ◽  
2021 ◽  
Vol 5 (2) ◽  
Author(s):  
N Hoshino ◽  
T Sakamoto ◽  
K Hida ◽  
Y Takahashi ◽  
H Okada ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Laparoscopic Surgery ◽  
Robotic Surgery ◽  
Cohort Studies ◽  
Anastomotic Leakage ◽  
Study Design ◽  
Randomized Clinical Trials ◽  
Postoperative Mortality ◽  
Resection Margins ◽  
Meta Analyses

Abstract Background RCTs are considered the standard in surgical research, whereas case-matched studies and propensity score matching studies are conducted as an alternative option. Both study designs have been used to investigate the potential superiority of robotic surgery over laparoscopic surgery for rectal cancer. However, no conclusion has been reached regarding whether there are differences in findings according to study design. This study aimed to examine similarities and differences in findings relating to robotic surgery for rectal cancer by study design. Methods A comprehensive literature search was conducted using PubMed, Scopus, and Cochrane CENTRAL to identify RCTs, case-matched studies, and cohort studies that compared robotic versus laparoscopic surgery for rectal cancer. Primary outcomes were incidence of postoperative overall complications, incidence of anastomotic leakage, and postoperative mortality. Meta-analyses were performed for each study design using a random-effects model. Results Fifty-nine articles were identified and reviewed. No differences were observed in incidence of anastomotic leakage, mortality, rate of positive circumferential resection margins, conversion rate, and duration of operation by study design. With respect to the incidence of postoperative overall complications and duration of hospital stay, the superiority of robotic surgery was most evident in cohort studies (risk ratio (RR) 0.83, 95 per cent c.i. 0.74 to 0.92, P < 0.001; mean difference (MD) –1.11 (95 per cent c.i. –1.86 to –0.36) days, P = 0.004; respectively), and least evident in RCTs (RR 1.12, 0.91 to 1.38, P = 0.27; MD –0.28 (–1.44 to 0.88) days, P = 0.64; respectively). Conclusion Results of case-matched studies were often similar to those of RCTs in terms of outcomes of robotic surgery for rectal cancer. However, case-matched studies occasionally overestimated the effects of interventions compared with RCTs.

scholarly journals Decision-making in Surgery or Active Surveillance for Low Risk Papillary Thyroid Cancer During the COVID-19 Pandemic

Cancers ◽  
2021 ◽  
Vol 13 (3) ◽  
pp. 371
Author(s):  
Anna Sawka ◽  
Sangeet Ghai ◽  
Ogemdi Ihekire ◽  
Jennifer Jones ◽  
Amiram Gafni ◽  
...  
Keyword(s):  
Thyroid Cancer ◽  
Papillary Thyroid Cancer ◽  
Active Surveillance ◽  
Low Risk ◽  
Observational Research ◽  
Papillary Thyroid ◽  
Missed Appointments ◽  
Physician Visits ◽  
Observational Cohort ◽  
Study Participants

We describe our experience conducting a prospective observational cohort study on the management of small, low risk papillary thyroid cancer during the COVID-19 pandemic. Our study participants are given the choice of active surveillance (AS) or surgery, and those in the AS arm are followed at the study center, whereas surgical patients undergo usual care. During the pandemic we have transitioned from in-person research patient visits to largely virtual care of patients under AS. As of 30 October 2020, we had enrolled 181 patients enrolled in our study (including 25 during the pandemic), of which 92.3% (167/181) consented to telephone communication and 79.0% (143/181) consented to secure videoconferencing communication. Prior to the pandemic, 74.5% (117/157) of our patients chose AS over surgery, whereas during the pandemic, 96.0% (24/25) chose AS. Of the 133 study patients who were under AS within the timeframe from 12 March 2020, to 30 October 2020, the percentage of patients who missed appointments was 8.3% (11/133, for neck ultrasound and physician visits, respectively) and delayed appointments was 23.3% (31/133). This preliminary data suggests that prospective observational research on AS of thyroid cancer can safely continue during the pandemic.

scholarly journals Non-operative orthobiologic use for rotator cuff disorders and glenohumeral osteoarthritis: A systematic review

2020 ◽  
pp. 1-16
Author(s):  
David M. Robinson ◽  
Christine Eng ◽  
Steven Makovitch ◽  
Joshua B. Rothenberg ◽  
Stephanie DeLuca ◽  
...  
Keyword(s):  
Systematic Review ◽  
Rotator Cuff ◽  
Cohort Studies ◽  
Randomized Clinical Trials ◽  
Platelet Rich Plasma ◽  
Inclusion Criteria ◽  
Serious Adverse Events ◽  
Bias Risk ◽  
Glenohumeral Osteoarthritis ◽  
Functional Outcome Measures

BACKGROUND: Shoulder pain from rotator cuff pathology and glenohumeral osteoarthritis is a common entity encountered in musculoskeletal practices. Orthobiologic agents are being increasingly used as a treatment option and understanding their safety and efficacy is necessary. OBJECTIVE: To systematically evaluate the available evidence for orthobiologic use in rotator cuff and glenohumeral pathology. METHODS: A systematic review was undertaken following PRISMA guidelines. Randomized clinical trials (RCTs) and prospective cohort studies evaluating non-operative treatment with prolotherapy, platelet-rich plasma (PRP), or medicinal signaling cells (MSCs) for rotator cuff pathology and glenohumeral osteoarthritis were included. Bias risk assessments used were the Cochrane tool and Newcastle-Ottawa score. RESULTS: The search yielded 852 potential articles, of which 20 met the inclusion criteria with a breakdown of 5 prolotherapy, 13 PRP, and 2 MSC. Sixteen studies were RCTs and 4 were cohort studies. Six studies were deemed “low risk of bias or good quality”. Efficacy results were mixed, and no serious adverse events were reported from orthobiologic treatment. CONCLUSIONS: Orthobiologics offer a relatively safe management option with inconclusive evidence for or against its use for rotator cuff pathology. No studies on glenohumeral osteoarthritis met the inclusion criteria. Adoption of standardized preparation reporting and consistent use of functional outcome measures is imperative for future studies to consider.

Potential impact of observational cohort studies in Japan on rheumatoid arthritis research and practice

2006 ◽  
Vol 16 (2) ◽  
pp. 75-76 ◽  
Author(s):  
Hisashi Yamanaka ◽  
Shigeto Tohma
Keyword(s):  
Rheumatoid Arthritis ◽  
Cohort Studies ◽  
Research And Practice ◽  
Observational Cohort ◽  
Potential Impact

scholarly journals The effect of renin-angiotensin-aldosterone blockers on SARS-CoV-2 infection in adults: a systematic review of studies and meta-analyzes

2021 ◽  
pp. 26-33
Author(s):  
М. V. Leonova
Keyword(s):  
Cohort Studies ◽  
Randomized Clinical Trials ◽  
Ace Inhibitor ◽  
Scientific Evidence ◽  
Renin Angiotensin ◽  
Risk Of Death ◽  
Risk Of Mortality ◽  
Duration Of Hospitalization ◽  
Severity Of The Disease

The article discusses the role of immune dysregulation of the renin-angiotensin-aldosterone system (RAAS) in the pathogenesis of COVID-19 infection, the participation of ACE2 for the penetration of the SARS-CoV-2 coronavirus into cells and the possible role of RAAS blockers, which have a direct effect on the pathological activity of the RAAS, in the development of and the severity of the disease. It is noted that the beneficial organoprotective effects of ACE inhibitors and ARBs may protect against SARS-CoV-2 infection, and their withdrawal may lead to clinical decompensation in patients at high risk of cardiovascular risk. Since then, a number of observational cohort studies have been carried out to address the main questions: does the use of an ACE inhibitor or ARB increase the risk of contracting the novel SARS-CoV-2 coronavirus, and whether the use of RAAS blockers is associated with worse outcomes of COVID-19 disease. The article provides an overview of the scientific evidence on the relationship between the use of RASS blockers and COVID-19 infection. Several cohort studies and two meta-analyzes found no association between prior use of an ACE inhibitor/ARB and the risk of COVID-19 infection (RR 0.96–0.99). In studies on the study of clinical and laboratory features of the action of RAAS blockers in COVID-19, a significantly larger number of subpopulations of T-lymphocytes CD3+ and CD8+, lower concentrations of biomarkers (C-reactive protein, ferritin, IL-6, procalcitonin), as well as a lower viral load. In clinical outcomes, with the use of an ACE inhibitor/ARB, there was a lower incidence of severe/critical forms, and a shorter duration of hospitalization. In large cohort studies with >1000 patients, the use of an ACE inhibitor/ARB was not associated with an increase in the risk of death in patients with COVID-19 (RR < 1.0), and some studies showed a 37–67% decrease in RR. Meta-analyzes also confirmed the absence of the effect of RAAS blockers on the risk of mortality, and in the population of patients with hypertension, a significant reduction in the risk of mortality and severe course of COVID-19 was revealed. Most international associations of specialists, as well as the Russian Cardiological Society, are recommended to continue the use of RAAS blockers in patients with cardiovascular diseases and not to be canceled in case of COVID-19 disease. Further randomized clinical trials are needed to generate new evidence.

scholarly journals Laboratory parameters predicting mortality of adult in-patients with COVID-19 associated cytokine release syndrome treated with high-dose tocilizumab

2021 ◽  
Author(s):  
Botond Lakatos ◽  
Balint Gergely Szabo ◽  
Ilona Bobek ◽  
Laszlo Gopcsa ◽  
Gabriella Beko ◽  
...  
Keyword(s):  
Randomized Clinical Trials ◽  
Absolute Lymphocyte Count ◽  
Biochemical Parameter ◽  
High Dose ◽  
Cytokine Release ◽  
Cytokine Release Syndrome ◽  
Laboratory Parameters ◽  
Proven Efficacy ◽  
Observational Cohort ◽  
Intensive Care Unit Admittance

AbstractLarge randomized clinical trials in severe Coronavirus Disease 2019 (COVID-19) patients have proven efficacy of intravenous tocilizumab. Our aim was to describe the laboratory parameters predicting in-hospital mortality of patients with tocilizumab administration in COVID-19 associated cytokine release syndrome (CRS).We evaluated high-dose (8 mg/kg) intravenous tocilizumab administration in severe and critically ill COVID-19 adult patients fulfilling predefined strict CRS criteria. A single-centre, prospective, observational cohort study was carried out among consecutive adult (≥18 years of age) in-patients with COVID-19 between April 1 and December 31, 2020. The primary endpoint was 28-day all-cause mortality. The changes in laboratory parameters from baseline on day 7 and 14 after administration of tocilizumab were analysed.In total, 1801 patients were admitted to our centre during the study period. One hundred and six patients received tocilizumab, and among them 62 (58.5%) required intensive care unit admittance while 25 (23.6%) deceased. At day 7 after tocilizumab administration, inflammatory markers (CRP, IL-6, ferritin) and lactate dehydrogenase (LDH) values were significantly lower among survivors. Subsequently, at day 14, differences of IL-6 and LDH levels has become more pronounced between subgroups. Restoration of absolute lymphocyte count (ALC) by day 7 and 14 was insufficient among patients who died.In our cohort, administration of high-dose tocilizumab for COVID-19 patients with CRS demonstrated clinical and sustained biochemical parameter improvement in 76.4%. In this patient population high and increasing LDH, IL-6, and low ALC levels had a predictive role for mortality.

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