Determinants of Implementation of a Critical Care Registry in Asia: Lessons From a Qualitative Study.

BACKGROUND: The Collaboration for Research, Implementation, and Training in Critical Care in Asia (CCA) is implementing a critical care registry to capture real-time data to facilitate service evaluation, quality improvement, and clinical studies. OBJECTIVE: The purpose of this study is to examine stakeholder perspectives on the determinants of implementation of the registry by examining the processes of diffusion, dissemination, and sustainability. METHODS: This study is a qualitative phenomenological inquiry using semistructured interviews with stakeholders involved in registry design, implementation, and use in 4 South Asian countries. The conceptual model of diffusion, dissemination, and sustainability of innovations in health service delivery guided interviews and analysis. Interviews were coded using the Rapid Identification of Themes from Audio recordings procedure and were analyzed based on the constant comparison approach. RESULTS: A total of 32 stakeholders were interviewed. Analysis of stakeholder accounts identified 3 key themes: innovation-system fit; influence of champions; and access to resources and expertise. Determinants of implementation included data sharing, research experience, system resilience, communication and networks, and relative advantage and adaptability. CONCLUSIONS: The implementation of the registry has been possible due to efforts to increase the innovation-system fit, influence of motivated champions, and the support offered by access to resources and expertise. The reliance on individuals and the priorities of other health care actors pose a risk to sustainability.

How well are biologic and conventional DMARDs tolerated in psoriatic arthritis: A real world study.

OBJECTIVE: Even though disease-modifying antirheumatic drugs (DMARDs) are well established in rou- tine clinical practice, longitudinal real-world data for their retention and tolerability are sparse, espe- cially in psoriatic arthritis (PsA) patients. Our objective was to describe the characteristics of our large PsA cohort including the comorbidities and evaluate real-world DMARD tolerability and discontinua- tion rates with reasons for stopping treatment. METHODS: We retrospectively interrogated the electronic, multipurpose, live setting database at our uni- versity hospital to identify 335 patients diagnosed with PsA who had received conventional DMARDs (cDMARDs) and/or biologic DMARDs (bDMARDs) between 1994 up to and including April 2019. RESULTS: In total, 170 (50.7%) patients had discontinued one or more cDMARDs prior with a mean dura- tion before discontinuation of 9.9 months. In contrast, only 28 (24.8%) patients had stopped a course of bDMARDs at some point. The mean duration before biologic therapy was discontinued was 18.2 months. CONCLUSION: To our knowledge, this is the first dedicated retrospective review of a large real-world PsA cohort addressing drug survival and tolerability of DMARDs over a 20-year period. Our study shows that in reality, cDMARDs are not well tolerated. This should encourage review of international guid- ance allowing earlier employment of biologics in the treatment paradigm.

A scoping review of registry captured indicators for evaluating quality of critical care in ICU.

BACKGROUND: Excess morbidity and mortality following critical illness is increasingly attributed to potentially avoidable complications occurring as a result of complex ICU management (Berenholtz et al., J Crit Care 17:1-2, 2002; De Vos et al., J Crit Care 22:267-74, 2007; Zimmerman J Crit Care 1:12-5, 2002). Routine measurement of quality indicators (QIs) through an Electronic Health Record (EHR) or registries are increasingly used to benchmark care and evaluate improvement interventions. However, existing indicators of quality for intensive care are derived almost exclusively from relatively narrow subsets of ICU patients from high-income healthcare systems. The aim of this scoping review is to systematically review the literature on QIs for evaluating critical care, identify QIs, map their definitions, evidence base, and describe the variances in measurement, and both the reported advantages and challenges of implementation. METHOD: We searched MEDLINE, EMBASE, CINAHL, and the Cochrane libraries from the earliest available date through to January 2019. To increase the sensitivity of the search, grey literature and reference lists were reviewed. Minimum inclusion criteria were a description of one or more QIs designed to evaluate care for patients in ICU captured through a registry platform or EHR adapted for quality of care surveillance. RESULTS: The search identified 4780 citations. Review of abstracts led to retrieval of 276 full-text articles, of which 123 articles were accepted. Fifty-one unique QIs in ICU were classified using the three components of health care quality proposed by the High Quality Health Systems (HQSS) framework. Adverse events including hospital acquired infections (13.7%), hospital processes (54.9%), and outcomes (31.4%) were the most common QIs identified. Patient reported outcome QIs accounted for less than 6%. Barriers to the implementation of QIs were described in 35.7% of articles and divided into operational barriers (51%) and acceptability barriers (49%). CONCLUSIONS: Despite the complexity and risk associated with ICU care, there are only a small number of operational indicators used. Future selection of QIs would benefit from a stakeholder-driven approach, whereby the values of patients and communities and the priorities for actionable improvement as perceived by healthcare providers are prioritized and include greater focus on measuring discriminable processes of care.

Operationalisation of the Randomized Embedded Multifactorial Adaptive Platform for COVID-19 trials in a low and lower-middle income critical care learning health system.

The Randomized Embedded Multifactorial Adaptive Platform (REMAP-CAP) adapted for COVID-19) trial is a global adaptive platform trial of hospitalised patients with COVID-19. We describe implementation in three countries under the umbrella of the Wellcome supported Low and Middle Income Country (LMIC) critical  care network: Collaboration for Research, Implementation and Training in Asia (CCA). The collaboration sought to overcome known barriers to multi centre-clinical trials in resource-limited settings. Methods described focused on six aspects of implementation: i, Strengthening an existing community of practice; ii, Remote study site recruitment, training and support; iii, Harmonising the REMAP CAP- COVID trial with existing care processes; iv, Embedding REMAP CAP- COVID case report form into the existing CCA registry platform, v, Context specific adaptation and data management; vi, Alignment with existing pandemic and critical care research in the CCA. Methods described here may enable other LMIC sites to participate as equal partners in international critical care trials of urgent public health importance, both during this pandemic and beyond.

Implementing an intensive care registry in India: preliminary results of the case-mix program and an opportunity for quality improvement and research.

Background: The epidemiology of critical illness in India is distinct from high-income countries. However, limited data exist on resource availability, staffing patterns, case-mix and outcomes from critical illness. Critical care registries, by enabling a continual evaluation of service provision, epidemiology, resource availability and quality, can bridge these gaps in information. In January 2019, we established the Indian Registry of IntenSive care to map capacity and describe case-mix and outcomes. In this report, we describe the implementation process, preliminary results, opportunities for improvement, challenges and future directions. Methods: All adult and paediatric ICUs in India were eligible to join if they committed to entering data for ICU admissions. Data are collected by a designated representative through the electronic data collection platform of the registry. IRIS hosts data on a secure cloud-based server and access to the data is restricted to designated personnel and is protected with standard firewall and a valid secure socket layer (SSL) certificate. Each participating ICU owns and has access to its own data. All participating units have access to de-identified network-wide aggregate data which enables benchmarking and comparison. Results: The registry currently includes 14 adult and 1 paediatric ICU in the network (232 adult ICU beds and 9 paediatric ICU beds). There have been 8721 patient encounters with a mean age of 56.9 (SD 18.9); 61.4% of patients were male and admissions to participating ICUs were predominantly unplanned (87.5%). At admission, most patients (61.5%) received antibiotics, 17.3% needed vasopressors, and 23.7% were mechanically ventilated. Mortality for the entire cohort was 9%.  Data availability for demographics, clinical parameters, and indicators of admission severity was greater than 95%. Conclusions: IRIS represents a successful model for the continual evaluation of critical illness epidemiology in India and provides a framework for the deployment of multi-centre quality improvement and context-relevant clinical research.

Effectiveness and safety of vedolizumab in inflammatory bowel disease patients aged 60 and over: an observational multicenter UK experience.

BACKGROUND: The GEMINI trials established the efficacy of vedolizumab in moderate-to-severe inflammatory bowel disease (IBD) and demonstrated a favorable safety profile, suggesting it may be advantageous in older patients at greater risk of treatment-related complications. However, there is a paucity of data exploring the outcomes of vedolizumab in this group. Our objective was to determine the clinical effectiveness and safety of vedolizumab in older IBD patients within a real-world multicenter UK cohort. METHODS: A retrospective review of electronic records across 6 UK hospitals was undertaken to evaluate the clinical effectiveness and safety outcomes of vedolizumab in IBD patients aged ≥60 at start of therapy. Rates of clinical response, remission and corticosteroid-free remission were assessed at weeks 14 and 52, using validated clinical indices, and were compared to historical controls from real-world vedolizumab-treated cohorts unstratified by age. RESULTS: Of 74 patients aged 60 years or above (median 66 years), 48 were included in our effectiveness analysis (29 ulcerative colitis, 19 Crohn's disease). Rates of clinical response, remission and corticosteroid-free remission at week 14 were 64%, 48% and 30%, respectively. By week 52, the rates of clinical response, remission, and corticosteroid-free remission were 52%, 38%, and 32%, respectively. Six (8%) patients experienced adverse effects. Effectiveness and safety outcomes were comparable to those of age-unstratified vedolizumab-treated cohorts. CONCLUSION: Our 1-year outcome data suggests that vedolizumab is safe and effective in older IBD patients and broadly comparable to cohorts unselected by age.

Interventions using social networking sites to promote contraception in women of reproductive age.

BACKGROUND: Social networking sites (SNSs) have great potential as a platform for public health interventions to address the unmet need for contraception. OBJECTIVES: To evaluate the effectiveness of interventions using SNSs to promote the uptake of and adherence to contraception in reproductive-age women. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, and six other databases on January 2018. We also searched Google Scholar, key conference proceedings, checked the reference lists of included studies, and contacted study authors to identify additional studies. SELECTION CRITERIA: We considered randomised controlled trials (RCTs) and non-randomised interventional studies (NRS) in women of reproductive age. SNSs requiring a social profile within a bounded or restricted-access system of shared connections were included. We also included trials that utilised SNSs only or as an adjunct to an intervention. Studies had to have a follow-up outcome assessment of at least three months. DATA COLLECTION AND ANALYSIS: Two authors independently screened titles, abstracts and full-text studies, and extracted data from included studies. A third author was assigned to arbitrate areas of disagreement. Authors assessed risk of bias according to the Cochrane Handbook for Systematic Reviews of Interventions. We were unable to conduct a meta-analysis due to the heterogeneity of the study designs and outcome measures. MAIN RESULTS: Of the 461 unique records found, only two studies met our inclusion criteria. Both studies were conducted in the USA and were at high risk of bias. One RCT included 2284 women exposed to a web-based SNS or nothing. The groups were no different post intervention in their self-reported consistency of contraceptive use or knowledge of the relative effectiveness of different methods. There was a small but significant increase in the use of more effective methods (long-acting reversible methods) at 12 months' follow-up.The second study, a cluster RCT with 1578 women, used a closed Facebook page showing sexual health content compared to a modified Facebook news page that avoided sexual health content. They found no differences in the use of condoms at last act of sexual intercourse at six months or the intention to use condoms between the intervention and control groups. AUTHORS' CONCLUSIONS: Despite the prevalence of SNSs, we found little scientific evidence to support the use of SNSs to improve contraceptive use or adherence among women.

Unusual case of Lemierre's syndrome.

A young previously healthy patient presented with sepsis and cavitating pneumonia. Campylobacter rectus was isolated from blood cultures and subsequent CT neck showed an internal jugular vein thrombosis. Treatment was with antibiotics, anticoagulation and supportive management. Lemierre's syndrome is an infectious thrombophlebitis of the internal jugular vein. Although a rare diagnosis since the use of penicillin for treatment of acute pharyngitis, it is being reported with increasing frequency. Usually associated with Fusobacterium spp, we believe that this is the first reported case of Lemierre's caused by C. rectus-an anaerobic member of the human oral cavity flora, usually associated with localised periodontal disease. The bacillus was isolated from blood during the acute presentation.

Strengthening accountability to end preventable maternal deaths.

The present paper describes the ongoing efforts to revitalize the accountability of national governments toward preventable maternal deaths. Maternal death reviews are included in the national health policies of the majority of countries contributing 95% of global maternal deaths. However in actual practice, the extent of implementation and follow-up of recommended actions on lessons learnt from maternal death reviews is inadequate. This paper describes and discusses the role of the Maternal Death Surveillance and Response (MDSR) system in strengthening accountability and ending preventable maternal deaths. MDSR provides a surveillance tool for timely information on where, when, and why maternal deaths occur, builds on maternal death reviews, and includes the missing "response" component for improving quality of care and preventing maternal deaths.

Non-traumatic, bilateral subcapital femoral fractures postpartum.

A 28-year-old Romanian woman, presented 2 weeks postnatally with pain in her left hip. Plain radiography suggested a left intracapsular, subcapital hip fracture. A CT scan of the pelvis showed diffuse osteopaenia with bilateral subcapital fractures of both femurs. From this imaging and subsequent investigation, a diagnosis of transient osteoporosis of pregnancy was made. The patient was treated with a closed reduction and cannulated screw fixation. Rehabilitative treatment, vitamin D, calcium and bisphosphonate therapy were initiated. She remains under close follow-up from orthopaedic, rheumatological and endocrine teams. Multiple opportunities were missed to identify the source of the patient's pain and inability to weight bear. Early detection and management of this condition is crucial because of the associated morbidity, including debilitating pain, reduced mobility, fractures and avascular necrosis. Cessation of breastfeeding, adequate pain relief, early use of bisphosphonates and rehabilitative treatment are essential.

Assessing available information on the burden of sepsis: global estimates of incidence, prevalence and mortality.

OBJECTIVE: Sepsis is a complex and hard-to-define condition with many different interactions with other disorders. Presently, there are no estimates of the burden of sepsis and septicaemia at the global level and it was not included in the initial Global Burden of Disease study. Non-maternal sepsis has only recently received attention as a substantial global public health problem. The aim of this study was to assess available data on the burden of non-maternal sepsis, severe sepsis and septic shock in the community and to identify key gaps in information needed to estimate the global burden of sepsis. METHODS: Literature review of English language-based studies reporting on the incidence, prevalence, mortality or case-fatality of sepsis, severe sepsis and septic shock. The available literature was searched using the MEDLINE database of citations and abstracts of biomedical research articles published between 1980 and 2008. FINDINGS: 8 studies reported incidence of sepsis, severe sepsis or septic shock at the national level (4 from the USA and 1 from Brazil, the UK, Norway and Australia). No studies on the incidence, prevalence, mortality or case-fatality from sepsis in developing countries were found. The population sepsis incidence ranged from 22 to 240/100 000 (most plausible estimates ranged from 149 to 240/100 000); of severe sepsis from 13 to 300/100 000 (most of the estimates were between 56 and 91/100 000); and of septic shock 11/100 000. Case-fatality rate depends on the setting and severity of disease. It can reach up to 30% for sepsis, 50% for severe sepsis and 80% for septic shock. While the data were compiled using strict inclusion and exclusion criteria, a degree of uncertainty still exists regarding the reported estimates. CONCLUSION: The few national-level reports available allow only a very crude estimation of the incidence of sepsis in developed countries while there is apparent lack of data from developing countries. A clear and universal definition of sepsis as well as the development of a sound epidemiological framework to begin addressing the magnitude of this problem is urgently needed through research in developing countries.

Aetiology of community-acquired neonatal sepsis in low and middle income countries.

BACKGROUND: 99% of the approximate 1 million annual neonatal deaths from life-threatening invasive bacterial infections occur in developing countries, at least 50% of which are from home births or community settings. Data concerning aetiology of sepsis in these settings are necessary to inform targeted therapy and devise management guidelines. This review describes and analyses the bacterial aetiology of community-acquired neonatal sepsis in developing countries. METHODS: A search of Medline, Embase, Global Health and Web of Knowledge, limited to post-1980, found 27 relevant studies. Data on aetiology were extracted, tabulated and analysed along with data on incidence, risk factors, case fatality rates and antimicrobial sensitivity. RESULTS: The most prevalent pathogens overall were Staphylococcus aureus (14.9%), Escherichia coli (12.2%), and Klebsiella species (11.6%). However, variations were observed both between global regions and age-of-onset categories. Staphylococcus aureus and Streptococcus pneumoniae were most prevalent in Africa, while Klebsiella was highly prevalent in South-East Asia. A notably higher prevalence of Group B Streptococcus was present in neonates aged 7 days or less. The highest case fatality rates were recorded in South-East Asia. Klebsiella species showed highest antimicrobial resistance. CONCLUSION: Data on community-acquired neonatal sepsis in developing countries are limited. Future research should focus on areas of high disease burden with relative paucity of data. Research into maternal and neonatal vaccination strategies and improved diagnostics is also needed. All of this could contribute to the formulation of community-based care packages, the implementation of which has significant potential to lower overall neonatal mortality and hence advance progress towards the attainment of Millennium Development Goal 4.