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Defining CD4 T helper and T regulatory cell endotypes of progressive and remitting pulmonary sarcoidosis (BRITE): protocol for a US-based, multicentre, longitudinal observational bronchoscopy study

Por: Koth · L. L. · Harmacek · L. D. · White · E. K. · Arger · N. K. · Powers · L. · Werner · B. R. · Magallon · R. E. · Grewal · P. · Barkes · B. Q. · Li · L. · Gillespie · M. · Collins · S. E. · Cardenas · J. · Chen · E. S. · Maier · L. A. · Leach · S. M. · OConnor · B. P. · Hamzeh · N. Y.
Introduction

Sarcoidosis is a multiorgan granulomatous disorder thought to be triggered and influenced by gene–environment interactions. Sarcoidosis affects 45–300/100 000 individuals in the USA and has an increasing mortality rate. The greatest gap in knowledge about sarcoidosis pathobiology is a lack of understanding about the underlying immunological mechanisms driving progressive pulmonary disease. The objective of this study is to define the lung-specific and blood-specific longitudinal changes in the adaptive immune response and their relationship to progressive and non-progressive pulmonary outcomes in patients with recently diagnosed sarcoidosis.

Methods and analysis

The BRonchoscopy at Initial sarcoidosis diagnosis Targeting longitudinal Endpoints study is a US-based, NIH-sponsored longitudinal blood and bronchoscopy study. Enrolment will occur over four centres with a target sample size of 80 eligible participants within 18 months of tissue diagnosis. Participants will undergo six study visits over 18 months. In addition to serial measurement of lung function, symptom surveys and chest X-rays, participants will undergo collection of blood and two bronchoscopies with bronchoalveolar lavage separated by 6 months. Freshly processed samples will be stained and flow-sorted for isolation of CD4 +T helper (Th1, Th17.0 and Th17.1) and T regulatory cell immune populations, followed by next-generation RNA sequencing. We will construct bioinformatic tools using this gene expression to define sarcoidosis endotypes that associate with progressive and non-progressive pulmonary disease outcomes and validate the tools using an independent cohort.

Ethics and dissemination

The study protocol has been approved by the Institutional Review Boards at National Jewish Hospital (IRB# HS-3118), University of Iowa (IRB# 201801750), Johns Hopkins University (IRB# 00149513) and University of California, San Francisco (IRB# 17-23432). All participants will be required to provide written informed consent. Findings will be disseminated via journal publications, scientific conferences, patient advocacy group online content and social media platforms.

Healthcare utilisation of patients with cholecystolithiasis in primary care: a multipractice comparative analysis

Por: Thunnissen · F. M. · Drager · L. D. · Braak · B. · Drenth · J. P. H. · van Laarhoven · C. J. H. M. · Schers · H. J. · de Reuver · P. R.
Objectives

To examine general practitioners’ (GP) management of cholecystolithiasis and to evaluate persisting abdominal complaints in the years after the diagnosis.

Design

Retrospective analysis of registry data and a subset of individual medical records.

Setting

Seventeen primary care practices affiliated with the Radboudumc Practice Based Research Network in the Netherlands.

Participants

633 patients with cholecystolithiasis diagnosed between 2012 and 2016.

Primary and secondary outcome measures

The primary outcome of this study was the healthcare utilisation of patients with cholecystolithiasis diagnosed by the GP in terms of referrals to secondary care, laboratory diagnostics, prescribed medication and the prevalence of concomitant abdominal-related diagnoses in a time interval of 3 years before and 3 years after diagnosis of cholecystolithiasis. For secondary outcomes, electronic medical records were studied from seven practices to assess emergency department visits, operation rates and repeat visits for persistent abdominal symptoms. We compared the non-referred group with the referred group.

Results

In 57% of patients, concomitant abdominal-related diagnoses were recorded besides the diagnosis cholecystolithiasis. In-depth analyses of 294 patients showed a referral rate of 79.3% (n=233); 62.9% (n=185) underwent cholecystectomy. After referral, 55.4% (129/233) returned to the GP for persistent abdominal symptoms. Patients returning after referral were more often treated for another abdominal-related diagnosis before cholecystolithiasis was recorded (51.9% vs 28.8%, p

Conclusions

The majority of patients in general practice with gallstones are referred and undergo cholecystectomy. Patients with concomitant abdominal-related diagnoses are likely to return to their physician. GPs should inform patients about these outcomes to improve the shared decision-making process before gallbladder surgery.

Quality standards for safe medication in nursing homes: development through a multistep approach including a Delphi consensus study

Por: Brühwiler · L. D. · Niederhauser · A. · Fischer · S. · Schwappach · D. L. B.
Objectives

The aim of the study was to develop quality standards reflecting minimal requirements for safe medication processes in nursing homes.

Design

In a first step, relevant key topics for safe medication processes were deducted from a systematic search for similar guidelines, prior work and discussions with experts. In a second step, the essential requirements for each key topic were specified and substantiated with a literature-based rationale. Subsequently, the requirements were evaluated with a piloted, two-round Delphi study.

Setting

Nursing homes in Switzerland.

Participants

Interprofessional panel of 25 experts from science and practice.

Primary and secondary outcome measures

Each requirement was rated for its relevance for a safer and resident-oriented medication on a 9-point Likert-Scale based on the RAND/UCLA method. The requirements were considered relevant if, in the second round, the median relevance rating was ≥7 and the proportion of ratings ≥7 was ≥80%.

Results

Five key topics with a total of 87 requirements were elaborated and rated in the Delphi study. After the second round (response rate in both rounds 100%), 85 requirements fulfilled the predefined criteria and were therefore included in the final set of quality standards. The five key topics are: (I) ‘The medication is reviewed regularly and in defined situations’, (II) ‘The medication is reviewed in a structured manner’, (III) ‘The medication is monitored in a structured manner’, (IV) ‘All healthcare professionals are committed to an optimal interprofessional collaboration’ and (V) ‘Residents are actively involved in medication process’.

Conclusions

We developed normative quality standards for a safer and resident-oriented medication in Swiss nursing homes. Altogether, 85 requirements define the medication processes and the behaviour of healthcare professionals. A rigorous implementation may support nursing homes in taking a step towards safer and resident-oriented medication.

Effectiveness and safety of ivermectin in the treatment of COVID-19: protocol for a systematic review and meta-analysis

Introduction

Ivermectin is a drug with antiviral properties and has been proposed as an alternative treatment for patients with COVID-19, in some countries; however, there is limited evidence to support its clinical use. Accordingly, the aim of this review and meta-analysis is to obtain superior evidence on the effectiveness and safety of ivermectin in treatment of COVID-19.

Methods and analysis

We will search in the medical databases and International Clinical Trials Registry Platform databases for randomised clinical trials and quasi-randomised trials published from December 2019. The criteria for inclusion are that infection needs to be confirmed by a real-time PCR or serology test, and the effect of ivermectin has been compared with placebo, symptomatic treatment or no treatment. We will exclude observational studies and clinical trials that involved patients with symptoms suggestive of COVID-19, but without a laboratorial diagnosis. Outcomes of interest include mortality, time to symptom resolution, time of hospitalisation, frequency of invasive mechanical ventilation and extracorporeal membrane oxygenation, incidence of severe acute respiratory syndrome, admission to intensive care unit, viral load, PCR-negative status, percentage of infection after prophylactic use, and total incidence of adverse and side effects. Study selection will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Two reviewers will independently select the studies and assess their eligibility. Two other reviewers will independently extract data from each study. Meta-analysis will then be carried out using fixed-effects or random-effects model, using the mean difference for continuous outcomes and the relative risk for dichotomous outcomes. Bias risk will be assessed using the Cochrane risk-of-bias tool. The quality of evidence for each outcome will be assessed using GRADE (Grading of Recommendations Assessment, Development and Evaluation) methodology. Review Manager V.5.3.5 will be used for synthesis and subgroup analysis.

Ethics and dissemination

Owing to the nature of the review, ethical approval is not required. The results will be disseminated through peer-reviewed publications.

PROSPERO registration number

CRD42020197395.

COVID‐19 in a state of Brazilian Northeast: Prevalence and associated factors in people with flu‐like syndrome

Abstract

Aims and objectives

To estimate the prevalence and associated factors of COVID‐19 in people with flu‐like syndrome in Ceará, Brazil.

Background

COVID‐19 is an infectious disease that has led to a worldwide public health emergency. More than 30,000 cases were confirmed in Brazil, especially in the States of São Paulo, Rio de Janeiro and Ceará. The capital of the Ceará State is the one with the highest incidence of COVID‐19 in Brazil. Estimating the prevalence of the disease and its associated factors is important to offer adequate health care.

Design

A cross‐sectional study with secondary data of people notified with flu‐like syndrome and COVID‐19 test results.

Methods

19,967 cases of flu‐like syndrome were analysed according to the result of the COVID‐19 test. Predictive variables were as follows: age range, sex, women in puerperium, presence or absence of cardiovascular diseases, diabetes, haematological illness, immunodeficiencies, neurological diseases, obesity, renal diseases and Down syndrome. Robust Poisson regression models estimated the prevalence ratios of COVID‐19. The research was reported via STROBE guidelines for cross‐sectional studies.

Results

The prevalence of COVID‐19 in the population was 10.37%. In the final model, the following variables were associated with COVID‐19: aged people, male sex, cardiovascular diseases and diabetes.

Conclusion

Among the flu‐like syndrome cases, COVID‐19 prevalence was high. In the Ceará State, clinical factors such as aged people, male sex, cardiovascular diseases and diabetes can enhance the prevalence of COVID‐19 by up to 2.57 times.

Relevance to clinical practice

The identification of factors that are associated with the enhanced prevalence of COVID‐19 facilitates early diagnosis, and adequate and prompt treatment. This knowledge may avoid an unfavourable prognosis of the disease.

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