Incidence of severe infection in patients with rheumatoid arthritis taking biologic agents: a systematic review.

OBJECTIVE: The objective of this review was to estimate the population-based incidence and determine the types of severe infection and deaths experienced by patients with rheumatoid arthritis taking biologic agents. INTRODUCTION: Since the late 1990s, various biologic and synthetic drugs have been developed to treat rheumatoid arthritis. In recent years, the incidence of severe infection in patients with rheumatoid arthritis in Western nations has been determined by observational studies; however, no systematic review has been conducted on this topic. INCLUSION CRITERIA: The following inclusion criteria were considered: i) observational studies on patients with rheumatoid arthritis treated with biologic agents; ii) studies reporting the number of severe infections requiring hospitalization for treatment; iii) studies reporting person-years of observation data; and iv) studies based on rheumatoid arthritis registries, medical records from rheumatology centers, or insurance claim databases. METHODS: PubMed, CINAHL, Embase, and Web of Science were searched to identify published studies. The reference lists of all studies selected for critical appraisal were screened for additional studies. Unpublished studies were searched on MedNar and OpenGrey databases. All the searches were updated on December 6, 2021. After removing the duplicates, 2 independent reviewers screened titles and abstracts against the inclusion criteria and then assessed full texts against the criteria. Two reviewers independently appraised the study and outcome levels for methodological quality using the critical appraisal instrument for cohort studies from JBI. Two reviewers extracted the relevant information related to severe infection and drugs. RESULTS: Fifty-two studies from 21 countries reported severe infection rates associated with using 8 biologic agents, plus nonbiologic disease-modifying antirheumatic drugs. In total, 18,428 infections with 395,065 person-years of biologic drug exposure were included in the analysis. Thirty-five studies included infections in outpatients receiving intravenous antibiotic therapy. Fifteen studies reported the first episode of infection, and the remaining studies did not specify either the first or all of the episodes of infection. Inclusion of viral infection and/or opportunistic infection varied among studies. Fifteen studies reported the site of infection; respiratory, skin/soft tissue, urinary tract, and sepsis/bacteremia were commonly reported. Ten studies reported the case fatality rates, ranging from 2.5% to 22.2%. Meta-analysis was conducted for 8 biologic agents and conventional disease-modifying antirheumatic drugs. The infection rate varied from 0.9 to 18.1/100 person-years. The meta-analysis revealed an infection rate of 5.0/100 person-years (95% CI 3.8-6.7) among patients receiving tumor necrosis factor inhibitors (heterogeneity 98.2%). The meta-analysis for the other 3 biologic agents revealed a point estimate of 5.5 to 8.7/100 person-years with high heterogeneity. Sensitivity analysis indicated that registry-based studies were less likely to have very low or very high infection rates compared with other data sources. The definition of infection, the patient composition of the cohorts, and the type of databases appeared to be the primary sources of clinical and methodological heterogeneity. CONCLUSIONS: Due to high statistical heterogeneity, the meta-analysis was not suited to estimating a summary measure of the infection rate. Developing standardized data collection is necessary to compare infection rates across studies. SYSTEMATIC REVIEW REGISTRATION NUMBER: PROSPERO CRD42020175137.

Severe infection risk in patients treated with biologics for rheumatoid arthritis: a systematic review protocol.

OBJECTIVE: The objective of this review is to estimate the population-based incidence and to determine the types of severe infection experienced by patients with rheumatoid arthritis who are taking biological agents. INTRODUCTION: Since the late 1990s, a variety of biological and synthetic drugs have been developed to treat rheumatoid arthritis. In recent years, the incidence of severe infection in patients with rheumatoid arthritis in Western nations has been reported by observational studies; however, no systematic review has been conducted on this topic. INCLUSION CRITERIA: The following criteria will be considered for inclusion: i) observational studies on patients with rheumatoid arthritis who are taking biological agents; ii) studies reporting the number of severe infections requiring hospitalization for treatment; and iii) studies with person-years of observational data. METHODS: MEDLINE, CINAHL, Embase, and Web of Science will be searched to identify published studies. The reference lists of all studies that are selected for critical appraisal will be screened for additional studies. The search for unpublished studies will include MedNar and OpenGrey. Only studies published in English from 1999 to the present will be included. Screening of studies, assessment of methodological quality, and data extraction will be performed by two independent reviewers. If possible, studies will be pooled in statistical meta-analysis. SYSTEMATIC REVIEW REGISTRATION NUMBER: PROSPERO CRD42020175137.

Assisted bathing of older people with dementia: a mixed methods systematic review protocol.

OBJECTIVE: The objective of this review update is to determine the best strategies for assisted bathing or showering of older people with dementia. INTRODUCTION: Bathing is a high-risk activity that can worsen agitated behavior in people with dementia, becoming a source of stress or burden for nurses and caregivers. Since a review was originally published in 2013, new studies have been conducted reporting on various interventions related to assisted bathing and showering. INCLUSION CRITERIA: The review will consider people older than 60 years with dementia, their families, nurses, and formal caregivers. The quantitative component will consider studies that examine interventions aiming to reduce agitated behaviors during assisted bathing. The qualitative component will include studies reporting on experiences of assisted bathing of older people with dementia. METHODS: This review update will follow the JBI mixed methods review approach. Published and unpublished studies will be identified from searches of the major international databases and relevant databases for gray literature. Two independent reviewers will carry out screening, critical appraisal, and data extraction. The extracted data will include details about the study characteristics, quantitative results, and qualitative findings relevant to the review. Where possible, quantitative data will be statistically pooled. Qualitative results will be synthesized using the meta-aggregation approach developed by JBI. Finally, the findings from both quantitative and qualitative components will be organized into a line of argument to produce an overall configured analysis. Where configuration is not possible, the findings will be presented in narrative form. SYSTEMATIC REVIEW REGISTRATION NUMBER: PROSPERO CRD42020208048.

Preparedness for Protecting the Health of Community-Dwelling Vulnerable Elderly People in Eastern and Western Japan in the Event of Natural Disasters.

We clarified the preparedness necessary to protect the health of community-dwelling vulnerable elderly people following natural disasters. We collected data from 304 community general support centres throughout Japan. We found the following in particular to be challenging: availability of disaster-preparedness manuals; disaster countermeasures and management systems; creation of lists of people requiring assistance following a disaster; evacuation support systems; development of plans for health management following disasters; provision of disaster-preparedness guidance and training; disaster-preparedness systems in the community; disaster information management; the preparedness of older people themselves in requiring support; and support from other community residents.

Efficient health information management systems using wireless communications technology to aid disaster victims.

Japan is an earthquake-prone country, and disasters have a devastating effect on the lives of residents in stricken areas. Shelters can be constructed in order to secure the physical safety of residents, but there are no such provisions for the shock of experiencing a disaster, losing property and friends, and transitioning to an unfamiliar life in a shelter, all of which can lead to mental disorders. Caretakers such as medical doctors and nurses who are dispatched to disaster sites also face difficulties in the disruption of communications and transportation, thus a system able to secure efficient health management in those facilities is also required. This paper proposes a health information management system that utilizes mobile phone cameras and mark-sensing cards to improve recovery conditions in disaster-stricken areas.

Development of web-based qualitative and quantitative data collection systems: study on daily symptoms and coping strategies among Japanese rheumatoid arthritis patients.

With the sharp rise in Internet access in recent years, the Internet is increasingly being used for research. We have developed two new systems using the Internet for both quantitative and qualitative data collection. One is a dynamic system for creating questionnaires and collecting responses and the other is an individual patient support follow-up system. These systems do not depend on the capacity of computers or servers and enable researchers to interact with participants privately and asynchronously. We have used these systems to collect data on daily symptoms and journal entries from 12 community-dwelling women with rheumatoid arthritis (RA) for a minimum of 1 month. The mean number of data submissions per month was 14.2 +/- 7.8, with the majority recording entries every day, and some submitting several times a day. The combination of two types of data elucidated the changes in coping and coping strategies in conjunction with changes in symptoms, even in a single day, and the coexistence of positive and negative coping. Research participants benefited from web-based symptom management and counseling resulting from 1 month of frequent interactions with the researcher. The use of the Internet for nursing research and interventions thus seems to show promising results.