Unanticipated Problems Research Articles

Evolving through multiple, co-existing pressures to change: a case study of self-organization in primary care during the COVID-19 pandemic in Canada

BackgroundPrimary care is often described as slow to change. But conceptualized through complexity theory, primary care is continually changing in unpredictable, non-linear ways through self-organization processes. Self-organization has proven hard to study directly. We aimed to develop a methodology to study self-organization and describe how a primary care clinic self-organizes over time.MethodologyWe completed a virtual case study of an urban primary care clinic from May-Nov 2021, applying methodological insights from actor-network theory to examine the complexity theory concept of self-organization. We chose to focus our attention on self-organization activities that alter organizational routines. Data included fieldnotes of observed team meetings, document collection, interviews with clinic members, and notes from brief weekly discussions to detect actions to change clinical and administrative routines. Adapting schema analysis, we described changes to different organizational routines chronologically, then explored intersecting changes. We sought feedback on results from the participating clinic.FindingsRe-establishing equilibrium remained challenging well into the COVID-19 pandemic. The primary care clinic continued to self-organize in response to changing health policies, unintended consequences of earlier adaptations, staff changes, and clinical care initiatives. Physical space, technologies, external and internal policies, guidelines, and clinic members all influenced self-organization. Changing one created ripple effects, sometimes generating new, unanticipated problems. Member checking confirmed we captured most of the changes to organizational routines during the case study period.ConclusionsThrough insights from actor-network theory, applied to studying actions taken that alter organizational routines, it is possible to operationalize the theoretical construct of self-organization. Our methodology illuminates the primary care clinic as a continually changing entity with co-existing and intersecting processes of self-organization in response to varied change pressures.

Integrating and Adopting AI in the Radiology Workflow: A Primer for Standards and Integrating the Healthcare Enterprise (IHE) Profiles.

The deployment of artificial intelligence (AI) solutions in radiology practice creates new demands on existing imaging workflow. Accommodating custom integrations creates a substantial operational and maintenance burden. These custom integrations also increase the likelihood of unanticipated problems. Standards-based interoperability facilitates AI integration with systems from different vendors into a single environment by enabling seamless exchange between information systems in the radiology workflow. Integrating the Healthcare Enterprise (IHE) is an initiative to improve how computer systems share information across health care domains, including radiology. IHE integrates existing standards-such as Digital Imaging and Communications in Medicine, Health Level Seven, and health care lexicons and ontologies (ie, LOINC, RadLex, SNOMED Clinical Terms)-by mapping data elements from one standard to another. IHE Radiology manages profiles (standards-based implementation guides) for departmental workflow and information sharing across care sites, including profiles for scaling AI processing traffic and integrating AI results. This review focuses on the need for standards-based interoperability to scale AI integration in radiology, including a brief review of recent IHE profiles that provide a framework for AI integration. This review also discusses challenges and additional considerations for AI integration, including technical, clinical, and policy perspectives.

Automated closed-loop insulin delivery for the management of type 1 diabetes during pregnancy: the AiDAPT RCT

Background There are over 2000 pregnancies annually in women with type 1 diabetes in the UK. Despite recent improvements in diabetes technology, most women cannot achieve and maintain the recommended pregnancy glucose targets. Thus, one in two babies experience complications requiring neonatal care unit admission. Recent studies demonstrate that hybrid closed-loop therapy, in which algorithms adjust insulin delivery according to continuous glucose measurements, is effective for managing type 1 diabetes outside of pregnancy, but efficacy during pregnancy is unclear. Objective To examine the clinical efficacy of hybrid closed-loop compared to standard insulin therapy in pregnant women with type 1 diabetes. Design A multicentre, parallel-group, open-label, randomised, controlled trial in pregnant women with type 1 diabetes. Setting Nine antenatal diabetes clinics in England, Scotland and Northern Ireland. Participants Pregnant women with type 1 diabetes and above-target glucose levels, defined as glycated haemoglobin A1c of ≥ 48 mmol/mol (6.5%) in early pregnancy. Interventions A hybrid closed-loop system compared to standard insulin delivery (via insulin pump or multiple daily injections) with continuous glucose monitoring. Outcome measures The primary outcome is the difference between the intervention and control groups in percentage time spent in the pregnancy glucose target range (3.5–7.8 mmol/l) as measured by continuous glucose monitoring from 16 weeks’ gestation until delivery. Secondary outcomes include overnight time in range, time above range (> 7.8 mmol/l), glycated haemoglobin A1c, safety outcomes (diabetic ketoacidosis, severe hypoglycaemia, adverse device events), psychosocial functioning obstetric and neonatal outcomes. Results The percentage of time that maternal glucose levels were within target range was higher with closed-loop than standard insulin therapy: 68.2 ± 10.5 in closed-loop and 55.6 ± 12.5 in the control group (mean‑adjusted difference 10.5 percentage points, 95% confidence interval 7.0 to 14.0; p < 0.001). Results were consistent in secondary outcomes, with less time above range (−10.2%, 95% confidence interval −13.8 to −6.6%; p < 0.001), higher overnight time in range (12.3%, 95% confidence interval 8.3 to 16.2%; p < 0.001) and lower glycated haemoglobin A1c (−0.31%, 95% confidence interval −0.50 to −0.12%; p < 0.002) all favouring closed-loop. The treatment effect was apparent from early pregnancy and consistent across clinical sites, maternal glycated haemoglobin A1c categories and previous insulin regimen. Maternal glucose improvements were achieved with 3.7 kg less gestational weight gain and without additional hypoglycaemia or total daily insulin dose. There were no unanticipated safety problems (six vs. five severe hypoglycaemia cases, one diabetic ketoacidosis per group) and seven device-related adverse events associated with closed-loop. There were no between-group differences in patient-reported outcomes. There was one shoulder dystocia in the closed-loop group and four serious birth injuries, including one neonatal death in the standard care group. Limitations Our results cannot be extrapolated to closed-loop systems with higher glucose targets, and our sample size did not provide definitive data on maternal and neonatal outcomes. Conclusions Hybrid closed-loop therapy significantly improved maternal glycaemia during type 1 diabetes pregnancy. Our results support National Institute for Health and Care Excellence guideline recommendations that hybrid closed-loop therapy should be offered to all pregnant women with type 1 diabetes. Future work Future trials should examine the effectiveness of hybrid closed-loop started before pregnancy, or as soon as possible after pregnancy confirmation. Trial registration This trial is registered as ISRCTN56898625. Funding This award was funded by the National Institute of Health and Care Research (NIHR) Efficacy and Mechanism Evaluation (EME) programme (NIHR award ref: 16/35/01) and is published in full in Efficacy and Mechanism Evaluation; Vol. 11, No. 7. See the NIHR Funding and Awards website for further award information. Dexcom supplied the continuous glucose monitoring systems used by AiDAPT intervention- and control-arm participants at reduced cost.

Cautious hope: Prospects and perils of communitarian governance in a Web3 environment

In the context of extreme societal polarization, activists have mobilized to protest injustices and claim their rights, yet such efforts often fall short of goals because demands normally are directed to government or firms that offer superficial responses. Communitarianism, which broadly strives for autonomy from established institutions, promises the development of self-provisioning communities based on cooperative networks and participatory, democratic governance that prioritizes use over exchange value and redistribution over profitable activity for individuals. The emergence of Web3 and blockchain technology has ushered in new affordances such as scaling a communitarian enterprise and exchange of value independent of banks or other institutions. Whereas market-based organizations use Web 3 affordances for accounting purposes for profit, communitarian organizations aim to link accounting with designs to inject capital into a commons to support self-governing communities in community-based peer production (CBPP). To exemplify the broad range of approaches to the multifaceted goals of CBPP, I focus on FairCoop and Sensorica. Despite considerable differences, these organizations nonetheless share problems and generally are illustrative of longstanding challenges to communitarian enterprises – digitalized and non-digitalized alike. Perennial problems such as the fraught capitalist/postcapitalist relation, self-interest, uneven power relations, lack of diversity, and the challenge of responding adequately to societal needs combine with effects of automated governance and associated effects of technocracy that can dissolve founding values to threaten the integrity of a communitarian collective. CBPP as well as its non-digitalized counterparts are important contributions to humanity, but goals and actual practices can diverge. CBPP requires vigilant designs that complement rather than replace human decision making with algorithmic governance and pay attention to reflexivity and positionality, continual re-design to engage unanticipated problems, and distancing actually existing projects from discourses that reify patterns such as decentralization with the consequence of missing crucial contextual knowledges.

An Effectiveness Analysis of Financial Educational Programs in Ngipik Village, Kulon Progo Yogyakarta

Financial education is part of the approach for mitigating the effects of unanticipated financial problems. Financial education is important not only for businesses, but also for households and individuals. However, research concentrating on financial education are scarce as compared to financial planning in practice, such as investment, retirement or saving references. Financial education is, ideally, a prerequisite for financial planning skill. In our scenario, for example, residents in Ngipik village are illiterate and admit to lacking financial literacy knowledge. As a result, this article seeks to assess the effectiveness of a month-long financial education program aimed primarily at children, youth, and society in general. The results show that 72% of the targeted objects are satisfied with the programs and that they are successful in improving their financial literacy, particularly financial planning. This program, however, did not teach them using an algorithm that can recommend the ideal composition of assets gathered in order to preserve their life sustainability.

Automated Insulin Delivery in Women with Pregnancy Complicated by Type 1 Diabetes

BackgroundHybrid closed-loop insulin therapy has shown promise for management of type 1 diabetes during pregnancy; however, its efficacy is unclear.MethodsIn this multicenter, controlled trial, we randomly assigned pregnant women with type 1 diabetes and a glycated hemoglobin level of at least 6.5% at nine sites in the United Kingdom to receive standard insulin therapy or hybrid closed-loop therapy, with both groups using continuous glucose monitoring. The primary outcome was the percentage of time in the pregnancy-specific target glucose range (63 to 140 mg per deciliter [3.5 to 7.8 mmol per liter]) as measured by continuous glucose monitoring from 16 weeks’ gestation until delivery. Analyses were performed according to the intention-to-treat principle. Key secondary outcomes were the percentage of time spent in a hyperglycemic state (glucose level >140 mg per deciliter), overnight time in the target range, the glycated hemoglobin level, and safety events.ResultsA total of 124 participants with a mean (±SD) age of 31.1±5.3 years and a mean baseline glycated hemoglobin level of 7.7±1.2% underwent randomization. The mean percentage of time that the maternal glucose level was in the target range was 68.2±10.5% in the closed-loop group and 55.6±12.5% in the standard-care group (mean adjusted difference, 10.5 percentage points; 95% confidence interval [CI], 7.0 to 14.0; P<0.001). Results for the secondary outcomes were consistent with those of the primary outcome; participants in the closed-loop group spent less time in a hyperglycemic state than those in the standard-care group (difference, −10.2 percentage points; 95% CI, −13.8 to −6.6); had more overnight time in the target range (difference, 12.3 percentage points; 95% CI, 8.3 to 16.2), and had lower glycated hemoglobin levels (difference, −0.31 percentage points; 95% CI, −0.50 to −0.12). Little time was spent in a hypoglycemic state. No unanticipated safety problems associated with the use of closed-loop therapy during pregnancy occurred (6 instances of severe hypoglycemia, vs. 5 in the standard-care group; 1 instance of diabetic ketoacidosis in each group; and 12 device-related adverse events in the closed-loop group, 7 related to closed-loop therapy).ConclusionsHybrid closed-loop therapy significantly improved maternal glycemic control during pregnancy complicated by type 1 diabetes. (Funded by the Efficacy and Mechanism Evaluation Program; AiDAPT ISRCTN Registry number, ISRCTN56898625.)

Primary pre-service teachers’ beliefs about developing future-ready learners: a qualitative inquiry in Hong Kong

ABSTRACT This study explores the readiness of pre-service primary school teachers in Hong Kong to develop future-ready learners. Societal advances require the education sector to continuously update curricula to prepare young people for the future. Schools must equip students with the flexibility to use technologies that have not yet been invented and solve unanticipated problems. In this qualitative study, we analysed the perceptions of 15 pre-service primary school English language teachers at a university in Hong Kong. The study focused on the knowledge and learning environment necessary for developing future-ready learners. Via semi-structured interviews, the findings revealed that the participants believed it is essential to integrate technology into classrooms to address future digital literacy needs. They also noted that students must develop critical thinking skills, problem-solving skills, and soft skills to succeed in the future. The findings also suggest that teachers need to be innovative and adaptable in their pedagogical approaches as the existing primary school curriculum is not cultivating learners’ future-readiness.

Ready to innovate during a crisis? Innovation governance during the first wave of COVID-19 infections in Iceland

ABSTRACT Previous studies on innovation governance have focused on the governance of science, technology, and innovation from a long-term perspective. In this article we focus on the short term by exploring the generation and use of new scientific and technical knowledge to address an urgent societal crisis. We empirically analyse the emergency response during the first wave of COVID-19 infections in Iceland using a conceptual framework based on three theoretical components, namely, emergency management, innovation governance, and the innovation process as a problem-solving process. The empirical analysis is built on a systematic analysis of secondary data. Based on the results, we conclude that improvisation processes using existing knowledge and capabilities and triggered by unanticipated problems during a crisis are in some cases sources of successful innovation. In these cases initial problem-solving processes characterized by improvisation can be interpreted as blind variations that are retained and diffused through a series of complementary problem-solving processes that generate and use new scientific and technical knowledge. Furthermore, we extend the concept of innovation governance readiness to include both the readiness to exploit technological opportunities and the readiness to address unanticipated problems during a crisis and propose that our extension is useful for integrating long-term and short-term aspects of innovation governance.

Self-Help Group Therapy as Community Nursing Intervention to Reduce Stress Response and Increase Self-Efficacy in High-Risk Pregnant Women

Background: Unexpected and unanticipated obstetric problems that can have a direct or indirect impact on the well-being of mothers and babies are considered high-risk pregnancies. Uncertainty in health conditions is felt as a life-threatening event that can threaten the lives of mothers and babies. This condition will trigger various stress responses felt by the mother. Moderate to severe stress during pregnancy greatly increases the risk of developing postpartum depression. One of the important coping sources to deal with stress is self-efficacy. Personal abilities are all aspects of an individual that can be utilized to solve problems. One of the interventions that can be used to improve coping mechanisms is self-help groups. Self Help group is a group approach to help its members solve their problems. Purpose: This study aims to determine the impact of self-help groups as therapy in the community to reduce stress responses and increase self-efficacy in high-risk pregnant women. Methods: The research design used was a quasi-experimental one-group pre-test post-test design. 15 respondents were given intervention in 3 sessions for 90 minutes in each session. Stress response and self-efficacy were measured before and after the intervention. Data analysis was carried out using the paired sample T-test. Results: This study shows that the average assessment stress response and self-efficacy score of mothers before the self-help group therapy is 128 and 35. After the therapy, the average response stress and self-efficacy score of mothers was 86 and 53. The study shows the effect of self-help group therapy on stress response (?-value = 0,012) and self-efficacy (?-value = 0,021). Conclusion: It was concluded that self-help group therapy was effective in decreasing stress respons and improving self-efficacy for high-risk pregnant women.

An Efficient Utilization and Comparative Analysis of Blackboard Learn and Collaborate in Higher Education Institution

The COVID-19 pandemic has enforced higher education institutions to adopt emergency remote teaching (ERT) as a substitution for traditional face-to-face (F2F) classes. A lot of concerns have been raised among education institutions, faculty, and students regarding the effectiveness of this sudden shift to online learning. Various digital platforms and ICT initiatives are accessed by academic authorities, teachers, and researchers around the clock. The Learning Management System (LMS) has emerged as a crucial resource for all institutions of higher learning during the current crisis and has taken center stage in web-based learning. Jazan University switches to an online learning environment after normal classes were suspended. This study aims to statistically investigate the academic activities, utilization, and satisfaction of Blackboard Learn and Collaborate of pre, during, and post-COVID-19 pandemic amongst the faculty members and students at Jazan University, Saudi Arabia. The study’s primary findings are a contribution to the online execution of educational information, providing students with the appropriate support from faculty members and teaching assistants, as well as having a backup plan in place for unanticipated problems with the online educational system.

Varicella Vaccine: a Molecular Variant That May Contribute to Attenuation.

Varicella was troublesome when varicella vaccine (vOka) was licensed in the United States. Varicella's yearly death toll was ~100, indirect costs were massive, and varicella threatened immunocompromised children. Since licensure, varicella has almost disappeared; nevertheless, vOka attenuation has lacked a molecular explanation. Sadaoka et al. (T. Sadaoka, D. P. Depledge, L. Rajbhandari, J. Breuer, et al., mBio 13:e0186422, 2022, https://doi.org/10.1128/mbio.01864-22), however, have now identified 6 core single nucleotide polymorphisms (SNPs), which singly or in combination may contribute to VOka attenuation; moreover, they found a predominant variant allele of vOka encoding the viral glycoprotein gB that results in glutamine instead of arginine at amino acid 699. This change impairs fusion activity and the ability of varicella-zoster virus (VZV) to infect human neurons from axon terminals. Molecular virological studies of vOka are reassuring in suggesting that reversion to virulence is unlikely and should also help assuage current fears about VZV vaccination and alleviate unanticipated future problems. The impressive work of Sadaoka et al. thus represents an auspicious advance in knowledge.

Care of the Well Newborn.

Care of the newborn infant is a critical skill for general pediatricians and other providers in the practice of pediatric medicine. Optimal care relies on a thorough understanding of risk factors that may be present during the pregnancy and delivery, as well as the ability to recognize and address unanticipated problems in the postnatal period. This article focuses on antenatal care of the newborn, issues that present in the immediate postdelivery period, and care of the newborn after discharge. It also includes updated information on current topics in pediatric practice, such as the importance of vaccination, parental hesitancy in accepting common medical interventions, and updated guidelines related to the coronavirus disease 2019 pandemic. At the conclusion of the article, the reader should have a general understanding of antenatal risk factors that could affect the transition from the intrauterine environment and have the knowledge to address common issues that arise in the care of newborn infants.

Managing the Unpredictable: Recommendations to Improve Trainee Safety During Global Health Away Electives

Background:For institutions offering global health programs, the safety of trainees during clinical rotations at international sites is paramount. Current guidelines for global health electives recommend pre-departure training and safety-net resources, yet their advice on managing unanticipated problems is limited.Objective:This report illustrates critical safety considerations requiring additional guidance for programs and students and highlights approaches that may improve trainee safety while abroad.Methods:We present a series of five cases adapted from the experiences of students traveling to and from the Yale School of Medicine between the years of 2011–2021. These cases include instances of personal injury, mental health challenges following trauma, sexual harassment, political instability, and natural disaster. For each case, we recommend ways in which programs and their participants may approach the challenges and we highlight issues requiring additional analysis.Findings:We categorized the types of trainee safety issues into three groups: personal health emergencies, individual-level stressors, and large-scale crises.Conclusion:Ultimately, we recommend that rather than solely emphasizing a universal policy, programs and trainees should also be educated on the tools and resources available for addressing unexpected emergencies.

The Evolution of Our Understanding of Penicillin Allergy: 1942-2022

This article reviews our evolving understanding of penicillin hypersensitivity at the 80th anniversary of penicillin's clinical introduction. Penicillin breakdown products covalently bond to serum proteins, leading to classic drug hypersensitivity. Penicillin remains the most frequently reported drug "allergy." Adverse reactions were presumed, in retrospect incorrectly, to implicate a risk for anaphylaxis, and therefore skin testing for IgE became the focus. Skin test positivity may wane over time. This insight has led to the radical conclusion that penicillin hypersensitivity may not be "forever." Atopic background, other drug allergies, family history, gender, and race are apparently not risk factors for penicillin hypersensitivity. Confirmed penicillin hypersensitivity has declined since the 1960s, potentially due to "cleaner" penicillin products and lower dose oral, instead of parenteral, use. Avoiding penicillins, without evaluation, caused unanticipated problems that have been appreciated only recently including longer hospital stays, increased cost of care, suboptimal outcomes from serious infections, and greater toxicities and costs with alternative antibiotics. There are personal and public health advantages with broadly implemented penicillin allergy delabeling based on a reaction history-based risk assessment. Limited skin testing followed by an oral challenge, if negative, for higher-risk histories, and direct oral challenges in lower-risk individuals are currently the reference standard tests to confirm current tolerance.

Capability as a concept in advanced practice nursing and education: a scoping review protocol.

The objective of this scoping review is to identify and map how the concept of capability in advanced practice nursing and education is described in the literature. Advanced practice nursing and education is often described in terms of the achievement of competencies. The concept of capability has been proposed as a more accurate description of the attributes of advanced practice nursing. Definitions of capability in advanced practice nursing vary, but often focus on the integration of prior knowledge, skills, resources, judgment, and experience when solving unanticipated problems or working in new situations. This review will consider studies addressing the concept of individual capability in any setting related to advanced practice nursing education and practice. The working definition of capability in this review is a combination of knowledge, skills, experience, and competencies that enables advanced practice nurses to provide appropriate care for patients in both familiar and unfamiliar clinical settings. Advanced practice nurses will include nurses with both graduate education and an expanded scope of practice. Eight academic databases will be searched for qualitative, quantitative, and mixed methods study designs. The gray literature search will include policy and practice documents from nursing and health organization websites. Two reviewers will independently complete title and abstract screening prior to full-text review and data extraction. Articles published in English from 1975 to the present will be included. Other languages will be included if translations are available.

First Real-World, Multicenter, Post-Marketing, Retrospective Study of Dexamethasone Intraocular Suspension for Inflammation After Cataract Surgery.

PurposeTo evaluate dexamethasone intraocular suspension 9% (intraocular DXM) in real-world clinical use to manage inflammation associated with cataract surgery.SettingPatients who underwent cataract surgery and received intraocular DXM at 22 outpatient eye surgery centers in the US.DesignRetrospective, observational chart review.MethodsRecords of all patients who received intraocular DXM from March to December 2019 at participating centers were reviewed.Main Outcome MeasuresOutcomes included anterior chamber cell (ACC) grades, anterior chamber flare (ACF) grades, and visual acuity, as well as intraocular pressure (IOP) and adverse events (AEs) at postoperative days (PODs) 1, 8, 14, 30. Descriptive statistics were generated.ResultsThe study population included 527 patients (641 eyes), with glaucoma history in 66 patients (80 eyes). Among eyes with recorded ACC grades, the percentage with grade 0 increased from 40% at POD 1 to 89.7% at POD 30, with similar results in eyes with glaucoma history. Among eyes with recorded ACF grades, the percentage with grade 0 increased from 78.4% at POD 1 to 97.1% at POD 30. At POD 30, 96.6% eyes with recorded results achieved target acuity. Mean IOP was 18.6 mmHg at POD 1 but declined to ≤15.2 mmHg thereafter. Investigators reported 22 AEs in 20 patients, all reported mild or moderate, the most common: IOP increase (7 events).ConclusionPatients undergoing cataract surgery and treated with intraocular DXM showed favorable inflammatory and visual outcomes, without unanticipated safety problems, consistent with results of previous controlled clinical trials.

Evaluation of an adapted version of the Diabetes Prevention Program for low- and middle-income countries: A cluster randomized trial to evaluate "Lifestyle Africa" in South Africa.

BackgroundLow- and middle-income countries (LMICs) are experiencing major increases in diabetes and cardiovascular conditions linked to overweight and obesity. Lifestyle interventions such as the United States National Diabetes Prevention Program (DPP) developed in high-income countries require adaptation and cultural tailoring for LMICs. The objective of this study was to evaluate the efficacy of “Lifestyle Africa,” an adapted version of the DPP tailored for an underresourced community in South Africa compared to usual care.Methods and findingsParticipants were residents of a predominantly Xhosa-speaking urban township of Cape Town, South Africa characterized by high rates of poverty. Participants with body mass index (BMI) ≥ 25 kg/m2 who were members of existing social support groups or “clubs” receiving health services from local nongovernmental organizations (NGOs) were enrolled in a cluster randomized controlled trial that compared Lifestyle Africa (the intervention condition) to usual care (the control condition). The Lifestyle Africa intervention consisted of 17 video-based group sessions delivered by trained community health workers (CHWs). Clusters were randomized using a numbered list of the CHWs and their assigned clubs based on a computer-based random allocation scheme. CHWs, participants, and research team members could not be blinded to condition. Percentage weight loss (primary outcome), hemoglobin A1c (HbA1c), blood pressure, triglycerides, and low-density lipoprotein (LDL) cholesterol were assessed 7 to 9 months after enrollment. An individual-level intention-to-treat analysis was conducted adjusting for clustering within clubs and baseline values. Trial registration is at ClinicalTrials.gov (NCT03342274). Between February 2018 and May 2019, 782 individuals were screened, and 494 were enrolled. Participants were predominantly retired (57% were receiving a pension) and female (89%) with a mean age of 68 years. Participants from 28 clusters were allocated to Lifestyle Africa (15, n = 240) or usual care (13, n = 254). Fidelity assessments indicated that the intervention was generally delivered as intended. The modal number of sessions held across all clubs was 17, and the mean attendance of participants across all sessions was 61%. Outcome assessment was completed by 215 (90%) intervention and 223 (88%) control participants. Intent-to-treat analyses utilizing multilevel modeling included all randomized participants. Mean weight change (primary outcome) was −0.61% (95% confidence interval (CI) = −1.22, −0.01) in Lifestyle Africa and −0.44% (95% CI = −1.06, 0.18) in control with no significant difference (group difference = −0.17%; 95% CI = −1.04, 0.71; p = 0.71). However, HbA1c was significantly lower at follow-up in Lifestyle Africa compared to the usual care group (mean difference = −0.24, 95% CI = −0.39, −0.09, p = 0.001). None of the other secondary outcomes differed at follow-up: systolic blood pressure (group difference = −1.36; 95% CI = −6.92, 4.21; p = 0.63), diastolic blood pressure (group difference = −0.39; 95% CI = −3.25, 2.30; p = 0.78), LDL (group difference = −0.07; 95% CI = −0.19, 0.05; p = 0.26), triglycerides (group difference = −0.02; 95% CI = −0.20, 0.16; p = 0.80). There were no unanticipated problems and serious adverse events were rare, unrelated to the intervention, and similar across groups (11 in Lifestyle Africa versus 13 in usual care). Limitations of the study include the lack of a rigorous dietary intake measure and the high representation of older women.ConclusionsIn this study, we found that Lifestyle Africa was feasible for CHWs to deliver and, although it had no effect on the primary outcome of weight loss or secondary outcomes of blood pressure or triglycerides, it had an apparent small significant effect on HbA1c. The study demonstrates the potential feasibility of CHWs to deliver a program without expert involvement by utilizing video-based sessions. The intervention may hold promise for addressing cardiovascular disease (CVD) and diabetes at scale in LMICs.Trial registrationClinicalTrials.gov NCT03342274.

The Coronavirus pandemic – 2022: Viruses, variants & vaccines

Since the beginning of the COVID-19 pandemic in 2019–2020, Cytokine & Growth Factor Reviews has published several Special Issues focused on the biology, pathogenesis and therapeutic options in the treatment of COVID-19 infection, including articles on the involvement of the chemokine system in the cytokine storm in COVID-19, intervention in the early stages of COVID-19 pneumonia, the therapeutic value of corticosteroid treatment, early clinical intervention with type 1 interferons, progress in vaccine development, and organ specific complications of COVID-19. By 2022, multiple highly efficacious vaccines are available and are being administered in countries around the world, therapeutic options have been clinically evaluated and approved, and SARS-CoV-2 has arguably become the most thoroughly studied virus in history. But, with progress has also come unanticipated problems – misinformation, anti-vaxxers, opposition to protective masks, and politically motivated interference disguised as knowledge. With this issue of CGFR, we continue to document the global coronavirus pandemic and provide an update on the emergence of viral variants, the global effort to administer vaccines and the impediments to progress posed by misinformation and anti-vaccine sentiment.

Myasthenia Gravis Misdiagnosed as Post-Thyroidectomy Recurrent Laryngeal Nerve Palsy: A Case Report

About 85% of patients with myasthenia gravis present with ptosis and generalised muscle weakness, but 15% may present with pure bulbar symptoms which can be misdiagnosed. We describe a 60-year old female patient with multinodular goitre who had symptom of dysphagia and was subjected to total thyroidectomy. Post-operatively she developed respiratory distress and had difficulty in phonation. Bilateral vocal cord palsy was identified and emergency tracheostomy was done. Review of the patient revealed a mass in the anterior mediastinum and the patient showed improvement with pyridostigmine. Thymoma was confirmed in the computed tomography scan. This case highlights the unanticipated problems faced due to an undiagnosed myasthenia gravis and the importance of having a high index of suspicion of myasthenia gravis in patients with subtle bulbar symptoms.

Cat and Mouse Game

This article uses findings from a field study of the world's largest guaranteed employment scheme (NREGA) in India to understand how digital technology mediates work relations and power dynamics within a bureaucracy. In this initiative, upper-level bureaucrats in the south Indian state of Andhra Pradesh built a digital network to remove local discretion at the "last mile" of an implementation of NREGA. I show how digital infrastructure affords actors at both the first and last mile opportunities to modify software to control as well as subvert certain practices. This article refers to this dialectic phenomenon as "governance by patching" and defines it as a socio-technical instantiation of a top-down process that focuses on small changes, iterative, and political process for positive change. Governance by patching is, therefore, neither a purely technical process nor an exclusively administrative one. Rather, it refers to the ability to fix unanticipated problems that arise in the implementation of governance programs by altering the socio-technical systems. The struggle for power continues, but on the new digital terrain.