Methods for estimation of disparities in medication use in an observational cohort study: results from the Multi-Ethnic Study of Atherosclerosis

IntroductionDespite the significant disease burden of bronchiectasis in Korea, no large-scale, representative prospective cohort studies have been conducted to evaluate the clinical characteristics of Korean patients with bronchiectasis, indicating an urgent need for cohort studies on bronchiectasis.Methods and analysisThe Korean Multicenter Bronchiectasis Audit and Research Collaboration (KMBARC) is a prospective, non-interventional observational cohort study on bronchiectasis in Korea. The inclusion criteria of this registry are as follows: (1) adult patients (aged ≥18 years) with or without respiratory symptoms (cough, chronic sputum and/or recurrent respiratory infection) and chest computed tomography revealing bronchiectasis affecting one or more lobes and (2) stable status at the time of registration: patients with bronchiectasis who were admitted for a respiratory aetiology can be enrolled at least 4 weeks after hospital discharge. The exclusion criteria are as follows: (1) bronchiectasis due to cystic fibrosis; (2) traction bronchiectasis associated with interstitial lung disease; (3) patients actively being treated for pneumonia, pulmonary tuberculosis or non-tuberculous mycobacterial infection; (4) patients who are unable or unwilling to provide informed consent; and (5) pregnant patients. Although the KMBARC questionnaires for baseline and annual follow-up data are similar to the European Multicentre Bronchiectasis Audit and Research Collaboration questionnaires, KMBARC has distinctive features such as use of Bronchiectasis Health Questionnaires, measurement with fatigue and depression scales, blood tests, use of consensus definition of exacerbations and information on emergency room or hospitalisation.We aim to recruit at least 1200 patients over the study period from more than 26 hospitals in South Korea. Patients will undergo a detailed baseline and yearly assessment for up to 5 years. The study objectives of the KMBARC registry are as follows: (1) uncovering the natural course of bronchiectasis; (2) aiding in establishing evidence-based bronchiectasis guidelines in Korea; and (3) encouraging and facilitating studies on bronchiectasis in Korea.Ethics and disseminationThis study received necessary approval from the Institutional Review Boards of all participating institutions. The Asan Medical Center Institutional Review Board gave overall approval for the study. Results will be disseminated via peer-reviewed publications and conference presentations.Trial registration numberKCT0003088.

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Complicated Odontogenic Infections at 2 District Hospitals in Tonkolili District, Sierra Leone: Protocol for a Prospective Observational Cohort Study (DELAY) (Preprint)

10.2196/preprints.33677 ◽

2021 ◽

Author(s):

Hanna M J L Hazenberg ◽

Jan Henk Dubbink ◽

Issa Sesay ◽

Tom Versteege ◽

Hassan Bangura ◽

...

Keyword(s):

Cohort Study ◽

Data Collection ◽

Sierra Leone ◽

Observational Cohort Study ◽

Full Blood Count ◽

Prospective Observational Cohort Study ◽

Odontogenic Infections ◽

District Hospitals ◽

Study Results ◽

Observational Cohort

BACKGROUND Deficits in global oral health care are paramount, and complications of odontogenic infections constitute a considerable global health problem, particularly in low-income countries. A high mortality rate has been observed for patients who have been admitted with complicated odontogenic infections to our facilities in Tonkolili District, Sierra Leone, although exact data have not been published yet. Data regarding who in this region is at risk and why are lacking. OBJECTIVE The Dental Abscess Study (DELAY) aims to prospectively investigate morbidity and mortality from complicated dental abscesses and to analyze patients’ characteristics and microbial findings to examine predisposing factors for poor outcomes. In particular, the incidence and the clinical and microbial characteristics of complicated odontogenic infections, as well as the sociodemographic data and comorbidities of affected patients, will be studied to develop improved management algorithms based on circumstance-specific factors. METHODS Patients who present with complicated dental infections requiring hospital admission in Masanga Hospital or Lion Heart Medical Centre will be consecutively selected for possible inclusion in the study (starting on September 4, 2021) over a study period of 1 year, and individual routine follow-ups will be conducted at least 3 months after discharge. The results of standardized questionnaires will be obtained, and clinical measurements as well as medical photos will be taken. Standard laboratory tests (eg, full blood count and HIV status tests) will be performed, and pus specimens will be examined. Local treatment guidelines will be adhered to, and data on medical and surgical treatment as well as data on outcomes will be collected. The study results will be reported according to the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) criteria. Routine follow-ups will take place at 1 and 3 months postdischarge. RESULTS The DELAY protocol was endorsed by the Masanga Medical Research Unit’s Scientific Review Committee on June 16, 2021, and ethical approval was granted on July 5, 2021, by the Sierra Leone National Ethics Committee. The funding of the budgeted study costs was approved by Dental Health International Netherlands in August 2021. The projected start date of data collection was September 4, 2021, and the study period will most likely last for 1 year. As such, data collection is expected to be complete in November 2022. CONCLUSIONS The aim of our prospective observational cohort study is to gain more knowledge about complicated odontogenic infections in Tonkolili District, Sierra Leone, to further improve treatment strategies. INTERNATIONAL REGISTERED REPORT DERR1-10.2196/33677

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Bevacizumab in first-line treatment of elderly patients with metastatic colorectal cancer: German community-based observational cohort study results

BMC Cancer ◽

10.1186/1471-2407-14-761 ◽

2014 ◽

Vol 14 (1) ◽

Cited By ~ 8

Author(s):

Ralf Hofheinz ◽

Volker Petersen ◽

Manfred Kindler ◽

Mathias Schulze ◽

Joerg Seraphin ◽

...

Keyword(s):

Colorectal Cancer ◽

Cohort Study ◽

Elderly Patients ◽

Observational Cohort Study ◽

Line Treatment ◽

First Line ◽

Community Based ◽

Study Results ◽

Observational Cohort ◽

First Line Treatment

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Patient-reported gout attack frequency and allopurinol use in general practice in the Netherlands: a prospective observational cohort study protocol

BMJ Open ◽

10.1136/bmjopen-2018-024335 ◽

2018 ◽

Vol 8 (11) ◽

pp. e024335

Author(s):

Kevin D B van Leeuwen ◽

Arthur M Bohnen ◽

Marloes L Jacobs ◽

Johan van Der Lei ◽

Hein J E M Janssens ◽

...

Keyword(s):

General Practice ◽

Uric Acid ◽

Cohort Study ◽

Medication Use ◽

Density Lipoprotein ◽

Observational Cohort Study ◽

Prospective Observational Cohort Study ◽

Attack Frequency ◽

Observational Cohort

IntroductionGout is the most common inflammatory arthritis in the Dutch general practice population and is often managed with long-term uric acid lowering treatment. The clinical relevance of this treatment in preventing gout attacks is unclear.Primary research questionWhat is the frequency of self-reported gout attacks and what is the effect of allopurinol use in patients diagnosed with gout in general practice?Methods and analysisAdult patients with a diagnostic consultation code for gout in the year 2013, 2014 or 2015 will be invited to participate in this prospective observational cohort study. Patients with a limited life expectancy will be excluded. Baseline measurements will include blood pressure, body mass index and a blood sample (estimated glomerular filtration rate, serum uric acid, cholesterol (low-density lipoprotein (LDL) and high-density lipoprotein), glucose (fasting)). At the 2-year follow-up, patients will receive questionnaires every 3 months. The questionnaires at baseline, 12 months and 24 months assess the frequency of gout attacks, the presence of tophi, comorbidity, medication use, quality of life, diet and lifestyle. The questionnaires in between only assess the frequency of gout attacks and medication use for gout. Descriptive statistics will be used to calculate the mean frequency of self-reported gout attacks during the 2-year follow-up. The propensity score for each patient being offered allopurinol is estimated and used to match patients with and without allopurinol treatment. We will compare the frequency of gout attacks in these groups using multilevel Poisson regression analyses. With this type of analysis, we can calculate the corrected estimated effect of allopurinol on gout attack frequency.Ethics and disseminationThe research protocol was approved by the Medical Ethical Committee of the Erasmus Medical Centre in Rotterdam. The knowledge generated by this study will be transferred to the Dutch College of General Practitioners, conferences and to (inter)national peer-reviewed journals.Trial registration numberNTR6329; Pre-results.

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The multi-ethnic study of atherosclerosis individual response to vitamin D trial: Building a randomized clinical trial into an observational cohort study

Contemporary Clinical Trials ◽

10.1016/j.cct.2021.106318 ◽

2021 ◽

Vol 103 ◽

pp. 106318

Author(s):

Ian H. de Boer ◽

David K. Prince ◽

Kayleen Williams ◽

Norrina B. Allen ◽

Gregory L. Burke ◽

...

Keyword(s):

Clinical Trial ◽

Vitamin D ◽

Cohort Study ◽

Randomized Clinical Trial ◽

Observational Cohort Study ◽

Individual Response ◽

Ethnic Study ◽

Observational Cohort

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Complicated Odontogenic Infections at 2 District Hospitals in Tonkolili District, Sierra Leone: Protocol for a Prospective Observational Cohort Study (DELAY)

JMIR Research Protocols ◽

10.2196/33677 ◽

2021 ◽

Vol 10 (12) ◽

pp. e33677

Author(s):

Hanna M J L Hazenberg ◽

Jan Henk Dubbink ◽

Issa Sesay ◽

Tom Versteege ◽

Hassan Bangura ◽

...

Keyword(s):

Cohort Study ◽

Data Collection ◽

Sierra Leone ◽

Observational Cohort Study ◽

Full Blood Count ◽

Prospective Observational Cohort Study ◽

Odontogenic Infections ◽

District Hospitals ◽

Study Results ◽

Observational Cohort

Background Deficits in global oral health care are paramount, and complications of odontogenic infections constitute a considerable global health problem, particularly in low-income countries. A high mortality rate has been observed for patients who have been admitted with complicated odontogenic infections to our facilities in Tonkolili District, Sierra Leone, although exact data have not been published yet. Data regarding who in this region is at risk and why are lacking. Objective The Dental Abscess Study (DELAY) aims to prospectively investigate morbidity and mortality from complicated dental abscesses and to analyze patients’ characteristics and microbial findings to examine predisposing factors for poor outcomes. In particular, the incidence and the clinical and microbial characteristics of complicated odontogenic infections, as well as the sociodemographic data and comorbidities of affected patients, will be studied to develop improved management algorithms based on circumstance-specific factors. Methods Patients who present with complicated dental infections requiring hospital admission in Masanga Hospital or Lion Heart Medical Centre will be consecutively selected for possible inclusion in the study (starting on September 4, 2021) over a study period of 1 year, and individual routine follow-ups will be conducted at least 3 months after discharge. The results of standardized questionnaires will be obtained, and clinical measurements as well as medical photos will be taken. Standard laboratory tests (eg, full blood count and HIV status tests) will be performed, and pus specimens will be examined. Local treatment guidelines will be adhered to, and data on medical and surgical treatment as well as data on outcomes will be collected. The study results will be reported according to the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) criteria. Routine follow-ups will take place at 1 and 3 months postdischarge. Results The DELAY protocol was endorsed by the Masanga Medical Research Unit’s Scientific Review Committee on June 16, 2021, and ethical approval was granted on July 5, 2021, by the Sierra Leone National Ethics Committee. The funding of the budgeted study costs was approved by Dental Health International Netherlands in August 2021. The projected start date of data collection was September 4, 2021, and the study period will most likely last for 1 year. As such, data collection is expected to be complete in November 2022. Conclusions The aim of our prospective observational cohort study is to gain more knowledge about complicated odontogenic infections in Tonkolili District, Sierra Leone, to further improve treatment strategies. International Registered Report Identifier (IRRID) DERR1-10.2196/33677

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