Systemic adverse events from inhaled corticosteroids self-reported by asthma patients: A “real-life” cross sectional study

Abstract Background: Inhalation therapy is the backbone of asthma and COPD control. However, inhaler adherence and device mishandling continue to be a problem in real life. Some studies have shown that using a patient-preferred inhaler may reduce device handling errors and improve adherence to prescribed chronic inhaler drug therapy. The aim of this study was to compare the preferences for commonly used inhaler devices in Germany in patients with chronic obstructive respiratory disease. We also pursued the question which properties of an inhaler device are particularly important to the user and what effects age, gender and type of disease (asthma or COPD) may have on device preference and handling errors.Methods: Prospective, open-label cross-sectional study in which 105 patients with asthma (58%) or COPD (42%) participated. Validated checklists were used to objectively assess inhaler technique and errors with 10 different placebo devices. For each device, patients were asked to test the handling, to assess the device properties and to name the device that they would most or least prefer.Results:Across the 10 placebo inhaler devices tested, patients needed an average of 1.22 attempts to error-free use. The device with the lowest mean number of attempts was the Turbohaler® (1.02), followed by the Nexthaler® (1.04), the Diskus® (1.07) and the Spiromax® (1.10). Patients over 60 years vs. younger age (p=0.002) and COPD vs. asthma patients (p=0.016) required more attempts to ensure correct use. 41% of the study participants chose one of the devices they already used as the most preferred inhaler. Overall, 20% opted for the Spiromax®, 15% for the Nexthaler® and 14% for the Turbohaler® or a pMDI. The least preferred device was the Elpenhaler® (0%). From a selection of 7 predefined inhaler attributes, patients stated easy handling as the most important for them. This was followed by short inhalation time and low inhalation resistance. Conclusions: Patient preference may vary between inhaler devices. The lowest number of attempts to error-free use was reported for the Turbohaler® and the Nexthaler®. The Spiromax® and the Nexthaler® achieved the best overall ratings and were the devices most preferred by patients.

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Asthma control and quality of life in a real-life setting: a cross-sectional study of adult asthma patients in Japan (ACQUIRE-2)

Journal of Asthma ◽

10.1080/02770903.2018.1514628 ◽

2018 ◽

Vol 56 (9) ◽

pp. 1016-1025 ◽

Cited By ~ 3

Author(s):

Mitsuru Adachi ◽

Soichiro Hozawa ◽

Masanori Nishikawa ◽

Atsushi Yoshida ◽

Tatsunori Jinnai ◽

...

Keyword(s):

Quality Of Life ◽

Asthma Control ◽

Real Life ◽

Cross Sectional Study ◽

Sectional Study ◽

Cross Sectional ◽

Adult Asthma ◽

Real Life Setting ◽

Asthma Patients

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Inhaler devices in asthma and COPD patients – A prospective cross-sectional study on inhaler preferences and error rates

10.21203/rs.3.rs-29319/v2 ◽

2020 ◽

Author(s):

Jens Schreiber ◽

Tina Sonnenburg ◽

Eva Luecke

Keyword(s):

Real Life ◽

Cross Sectional Study ◽

Error Rates ◽

Inhalation Therapy ◽

Chronic Obstructive ◽

Sectional Study ◽

Open Label ◽

Cross Sectional ◽

Asthma Patients ◽

Inhaler Devices

Abstract Background: Inhalation therapy is the backbone of asthma and COPD control. However, inhaler adherence and device mishandling continue to be a problem in real life. Some studies have shown that using a patient-preferred inhaler may reduce device handling errors and improve adherence to prescribed chronic inhaler drug therapy. The aim of this study was to compare the preferences for commonly used inhaler devices in Germany in patients with chronic obstructive respiratory disease. We also pursued the question which properties of an inhaler device are particularly important to the user and what effects age, gender and type of disease (asthma or COPD) may have on device preference and handling errors.Methods: Prospective, open-label cross-sectional study in which 105 patients with asthma (58%) or COPD (42%) participated. Validated checklists were used to objectively assess inhaler technique and errors with 10 different placebo devices. For each device, patients were asked to test the handling, to assess the device properties and to name the device that they would most or least prefer.Results: Across the 10 placebo inhaler devices tested, patients needed an average of 1.22 attempts to error-free use. The device with the lowest mean number of attempts was the Turbohaler® (1.02), followed by the Nexthaler® (1.04), the Diskus® (1.07) and the Spiromax® (1.10). Patients over 60 years vs. younger age (p=0.002) and COPD vs. asthma patients (p=0.016) required more attempts to ensure correct use. 41% of the study participants chose one of the devices they already used as the most preferred inhaler. Overall, 20% opted for the Spiromax®, 15% for the Nexthaler® and 14% for the Turbohaler® or a pMDI. The least preferred device was the Elpenhaler® (0%). From a selection of 7 predefined inhaler attributes, patients stated easy handling as the most important for them. This was followed by short inhalation time and low inhalation resistance.Conclusions: Patient preference may vary between inhaler devices. The lowest number of attempts to error-free use was reported for the Turbohaler® and the Nexthaler®. The Spiromax® and the Nexthaler® achieved the best overall ratings and were the devices most preferred by patients.

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Analysis of adverse events following immunization in Zhejiang, China, 2019: a retrospective cross-sectional study based on the passive surveillance system

Human Vaccines & Immunotherapeutics ◽

10.1080/21645515.2021.1939621 ◽

2021 ◽

pp. 1-8

Author(s):

Xuejiao Pan ◽

Huakun Lv ◽

Fuxing Chen ◽

Ying Wang ◽

Hui Liang ◽

...

Keyword(s):

Adverse Events ◽

Surveillance System ◽

Cross Sectional Study ◽

Passive Surveillance ◽

Sectional Study ◽

Cross Sectional ◽

Passive Surveillance System

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SAT0078 SAFETY OF LOW DOSE METHOTREXATE (MTX) IN HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.2968 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 974.2-974

Author(s):

A. Gunay ◽

A. Davidson ◽

I. Colmegna ◽

D. Lacaille ◽

H. Loewen ◽

...

Keyword(s):

Human Immunodeficiency Virus ◽

Adverse Events ◽

Low Dose ◽

Opportunistic Infections ◽

Case Reports ◽

Cross Sectional Study ◽

Study Quality ◽

Sectional Study ◽

Cross Sectional ◽

Immunodeficiency Virus

Background:Increased awareness of the efficacy of MTX in rheumatic disease is leading to more MTX use in patients from HIV endemic areas. While HIV related immunosuppression may contribute to improvement of some rheumatic diseases, immune reconstitution from highly active antiretroviral therapy (HAART) may lead to exacerbation or presentation of autoimmune disorders for which MTX therapy may be warranted. Most management guidelines for rheumatic disease do not address MTX use in the context of HIV.Objectives:To systematically review the published literature on the safety of using MTX ≤30 mg per week in HIV.Methods:We searched CINAHL, Embase, Global, MEDLINE and World of Science databases (Jan 1990 to May 2018) for terms including ‘methotrexate’ and ‘human immunodeficiency virus’. We also searched citations from review articles. Titles, abstracts or full manuscripts were screened independently by 2 reviewers to identify studies reporting HIV in patients taking MTX. Study quality was assessed using the McGill Mixed Methods Appraisal Tool (MMAT). Data was extracted on MTX and HIV adverse events (MTX toxicity, HIV viral load, CD4 count). Descriptive summaries are presented for studies providing outcomes in patients taking MTX ≤30 mg per week.Results:After removing duplicates and studies not meeting criteria or not providing sufficient information, 42 of the 2714 identified reports were included (1 clinical trial, 2 cohort, 1 cross-sectional study, 38 case reports/case series). Most reports (81%) originated from USA or Europe. Study quality was generally good with most studies fulfilling 50-100% of MMAT criteria. The randomized controlled trial (USA) assessing MTX on atherosclerotic disease in HIV showed that adverse events were more common in MTX versus placebo (12.8% vs 5.6%, p non-inferiority <0.05) and included infection, transient CD4 and CD8 drop, pulmonary toxicity, and death (1 attributed to MTX/HIV, 1 unrelated). One cohort study (South Africa) reported 43 RA patients on MTX who acquired HIV. In this cohort, RA generally improved despite only 5 individuals continuing MTX. No data on MTX adverse event rates was reported. One cohort study (USA) reported 13 HIV patients with myositis. One received MTX (with other immunosuppression) without MTX adverse effects but died due to AIDS. A cross-sectional study (France) of 43 HIV pts with autoimmune disease reported one patient on MTX (and other immunosuppression) developed an adverse event (cytopenia) compared to 5/33 patients not on MTX (cytopenia). The 38 case reports/series described 54 individuals with HIV receiving MTX. Of these studies, 27 (describing 42 subjects) reported on MTX adverse events and 35 (describing 46 subjects) reported on HIV adverse events. MTX adverse events developed in 29 subjects (hematologic 13, renal/hepatic 1, opportunistic infections 10, other events 2). HIV adverse events were noted in 23 subjects (Kaposi’s sarcoma 4, CD4 decrease 16, HIV viral titer increase 4). Five deaths were reported (2 infection, 1 infection and wasting, 2 HIV related deaths). Most subjects also received corticosteroids or other immunosuppressants including biologics.Conclusion:There remains limited data on the safety of low dose MTX in HIV. Surveillance for HIV is warranted for individuals on MTX who are at risk for acquiring HIV. Caution and careful monitoring for MTX toxicity, opportunistic infections and HIV state is suggested if MTX is used in the setting of HIV particularly if combined with other immunosuppression.References:[1] Clin Infectious Disease 2019:68[2] J Rheumatology 2014:41[3] Arthritis and Rheumatism 2003:49[4] Medicine 2017:96Acknowledgments :Funding from International League Against RheumatismMcGill University Global Health Scholar AwardsDisclosure of Interests:Alize Gunay: None declared, Anna Davidson: None declared, Ines Colmegna: None declared, Diane Lacaille: None declared, Hal Loewen: None declared, Michele Meltzer: None declared, Yewondwossen Mengistu: None declared, Rosie Scuccimarri: None declared, Zenebe Yirsaw: None declared, Sasha Bernatsky: None declared, Carol Hitchon Grant/research support from: UCB Canada; Pfizer Canada

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Assessment of the surveillance system for adverse events following immunisation in the Gaza Strip: a cross-sectional study

The Lancet ◽

10.1016/s0140-6736(21)01513-0 ◽

2021 ◽

Vol 398 ◽

pp. S27

Author(s):

Jehad A Awad ◽

Majdi I Dhair ◽

Nedal I Ghuneim ◽

Khaled Abu Ali ◽

Yousef S Al-Yaqoubi ◽

...

Keyword(s):

Adverse Events ◽

Surveillance System ◽

Gaza Strip ◽

Cross Sectional Study ◽

Sectional Study ◽

Cross Sectional ◽

The Gaza Strip

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Attitudes Towards and Compliance with the WHO Surgical Safety Checklist in China: A Multicentre Cross-Sectional Study

10.21203/rs.3.rs-106310/v1 ◽

2020 ◽

Author(s):

Jie Tan ◽

James Reeves Mbori Ngwayi ◽

Zhaohan Ding ◽

Yufa Zhou ◽

Ming Li ◽

...

Keyword(s):

Patient Safety ◽

Adverse Events ◽

Operating Room ◽

Cross Sectional Study ◽

World Health ◽

Sectional Study ◽

Local Data ◽

Cross Sectional ◽

Surgical Safety Checklist ◽

Surgical Safety

Abstract Background: Ten years after the introduction of Chinese Ministry of Health (MoH) version of Surgical Safety Checklist (SSC) we wished to assess the ongoing influence of the World Health Organisation (WHO) SSC by observing all three sections during elective surgical procedures in China, as well as to survey operating room staff more widely about the WHO SSC.Methods: A questionnaire was designed to gain authentic views on the WHO SSC. We also conducted a prospective cross-sectional study at five level 3 hospitals. Local data collectors were trained to document specific item performance. Adverse events which delayed the operation were recorded as well as the professionals leading or participating in the three SSC phases.Results: A total of 846 operating room professionals from 138 hospitals representing every mainland province responded to the survey. There was widespread acceptance of the checklist and its value in improving patient safety. 860 operations were observed for SSC compliance. Overall compliance was 79.8%. The ‘time-out’ phase compliance in surgeon-dependent items reduced when it was nurse-led (p<0.0001). WHO SSC interventions which are omitted from the MoH SSC continued to be discussed over half the time. Overall adverse events rate was 2.7%. One site had near 100% compliance in association with a circulating inspection team which had power of sanction.Conclusion: The WHO SSC remains a powerful tool for patient safety in China. Changes in behaviour for nurses (assertiveness) and surgeons (teamwork) could improve compliance. Random checks of compliance may have merit.

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