Introduction Of New Interventions Research Articles

Extended compartmental model for modeling COVID-19 epidemic in Slovenia

In the absence of a systematic approach to epidemiological modeling in Slovenia, various isolated mathematical epidemiological models emerged shortly after the outbreak of the COVID-19 epidemic. We present an epidemiological model adapted to the COVID-19 situation in Slovenia. The standard SEIR model was extended to distinguish between age groups, symptomatic or asymptomatic disease progression, and vaccinated or unvaccinated populations. Evaluation of the model forecasts for 2021 showed the expected behavior of epidemiological modeling: our model adequately predicts the situation up to 4 weeks in advance; the changes in epidemiologic dynamics due to the emergence of a new viral variant in the population or the introduction of new interventions cannot be predicted by the model, but when the new situation is incorporated into the model, the forecasts are again reliable. Comparison with ensemble forecasts for 2022 within the European Covid-19 Forecast Hub showed better performance of our model, which can be explained by a model architecture better adapted to the situation in Slovenia, in particular a refined structure for vaccination, and better parameter tuning enabled by the more comprehensive data for Slovenia. Our model proved to be flexible, agile, and, despite the limitations of its compartmental structure, heterogeneous enough to provide reasonable and prompt short-term forecasts and possible scenarios for various public health strategies. The model has been fully operational on a daily basis since April 2020, served as one of the models for decision-making during the COVID-19 epidemic in Slovenia, and is part of the European Covid-19 Forecast Hub.

Economic Evaluation of Cost and Time Required for a Platform Trial vs Conventional Trials

Platform trial design allows the introduction of new interventions after the trial is initiated and offers efficiencies to clinical research. However, limited guidance exists on the economic resources required to establish and maintain platform trials. To compare cost (US dollars) and time requirements of conducting a platform trial vs a series of conventional (nonplatform) trials using a real-life example. For this economic evaluation, an online survey was administered to a group of international experts (146 participants) with publication records of platform trials to elicit their opinions on cost and time to set up and conduct platform, multigroup, and 2-group trials. Using the reported entry dates of 10 interventions into Systemic Therapy in Advancing Metastatic Prostate Cancer: Evaluation of Drug Efficacy, the longest ongoing platform trial, 3 scenarios were designed involving a single platform trial (scenario 1), 1 multigroup followed by 5 2-group trials (scenario 2), and a series of 10 2-group trials (scenario 3). All scenarios started with 5 interventions, then 5 more interventions were either added to the platform or evaluated independently. Simulations with the survey results as inputs were used to compare the platform vs conventional trial designs. Data were analyzed from July to September 2021. Platform trial design. Total trial setup and conduct cost and cumulative duration. Although setup time and cost requirements of a single trial were highest for the platform trial, cumulative requirements of setting up a series of multiple trials in scenarios 2 and 3 were larger. Compared with the platform trial, there was a median (IQR) increase of 216.7% (202.2%-242.5%) in cumulative setup costs for scenario 2 and 391.1% (365.3%-437.9%) for scenario 3. In terms of total cost, there was a median (IQR) increase of 17.4% (12.1%-22.5%) for scenario 2 and 57.5% (43.1%-69.9%) for scenario 3. There was a median (IQR) increase in cumulative trial duration of 171.1% (158.3%-184.3%) for scenario 2 and 311.9% (282.0%-349.1%) for scenario 3. Cost and time reductions in the platform trial were observed in both the initial and subsequently evaluated interventions. Although setting up platform trials can take longer and be costly, the findings of this study suggest that having a single infrastructure can improve efficiencies with respect to costs and efforts.

Disparities in Neonatal Intensive Care: Context Matters.

Medical innovation in the care of premature and high-risk newborns has contributed to substantial declines in infant mortality in the United States over the past several decades; however, racial and ethnic disparities, particularly for African American and American Indian and/or Alaskan native infants persist.1,2 For many, it has been assumed that care in the NICU is consistently of high quality and is delivered equitably.3 In this issue of Pediatrics, researchers challenge the long-held assumption that NICU care is the great equalizer for improving infant health.In a systematic review of the literature on various components of NICU care, Sigurdson et al4 assessed publications for racial and/or ethnic disparities in structural (eg, setting), process (eg, patient referral), and outcome (morbidity and mortality) quality measures. In general, the authors found differential receipt of or access to various aspects of care. Infants born to African American mothers are more likely to be delivered in hospitals that are of poorer quality, that serve a higher proportion of African American infants, and that experience significantly higher patient-to-nurse ratios. Disparities in process measures included lower rates of high-risk early-intervention referral and differential reports in receipt of compassionate and respectful parental communication. The introduction of new interventions, such as surfactant use, was more rapidly diffused among white infants, increasing the gap in infant survival rates. Outcome quality measures were also generally poorer among African American infants and were influenced by pathways of care (eg, timely transplant). Yet these findings are not surprising given that clinical care operates in a social context of structural racism and implicit bias.5 In fact, many of these same disparities are echoed in the delivery of maternal care.6The evidence in this review supports the idea that these disparities are amenable to quality-improvement efforts. Some studies revealed that when care is received in facilities with comparable levels of care and quality, infant survival for those of color is equal to that for white infants, and in some cases is higher.4 A few key actions may advance the improvement of NICU care for all infants, including for traditionally vulnerable groups.It is important to consider the implementation of quality-improvement efforts to ensure that they do not increase disparities.10 Stratification of outcomes by race and/or ethnicity or other demographic factors is important to demonstrate improvements among groups at the highest risk for poor outcomes. Quality improvement for adult patient care has revealed, when implemented with a specific eye on “closing the gap,” that disparities can be reduced.11,12 We owe the infants of this country consistent high-quality care, no matter their skin color, and this article documents that there is work to be done.We thank Ms Martha Boisseau and Ms Sarah Foster for their review of the article.

The role of perceptions and knowledge of leprosy in the elimination of leprosy: A baseline study in Fatehpur district, northern India.

BackgroundWith the introduction of new interventions to prevent leprosy, such as post-exposure prophylaxis (PEP) given to contacts of leprosy patients, it is necessary to update our understanding of knowledge and perception of leprosy among the populations where these interventions will be introduced, in order to tailor communication optimally to the current situation. This study is a baseline study of the PEP++ project and aimed to assess the knowledge, attitudes and practices regarding leprosy in Fatehpur, India.MethodologyThe study used a community-based cross-sectional design with a mixed-methods approach. We assessed knowledge, attitudes, and practices with the KAP measure, and stigma with the Explanatory Model Interview Catalogue community stigma scale (EMIC-CSS) and the Social Distance Scale (SDS). In addition, semi-structured interviews and focus group discussions were conducted with all participant groups. The quantitative data were analysed using stepwise multivariate regression. The qualitative data were analysed using open, inductive coding and content analysis.FindingsA total of 446 participants were included in the study: 100 persons affected by leprosy, 111 close contacts, 185 community members and 50 health care workers. In addition, 24 in-depth interviews were conducted and 35 people were included in focus group discussions. 12.5% of the participants had adequate knowledge of leprosy, while 22% had poor knowledge. Knowledge on cause (answered correctly by 10% of the participants), mode of transmission (5%) and symptoms of leprosy (16%) was especially poor. The mean EMIC-CSS score was 15.3 (95%CI 14.6–16.0) and mean SDS score 7.2 (95%CI 6.6–7.8). Better knowledge of leprosy was associated with lower levels of social distance towards persons affected by leprosy.ConclusionThis study revealed poor knowledge regarding leprosy and high levels of stigma and fear and desire to keep social distance towards persons affected by leprosy. Community education that takes cultural beliefs, knowledge gaps and fears into consideration could improve knowledge, reduce misconceptions and positively influence the perception of leprosy.

Family-based therapy for anorexia nervosa: results from a 7-year longitudinal Singapore study.

To determine the effectiveness of Family-Based Therapy (FBT) as a treatment for Anorexia Nervosa (AN) in adolescents in a Singaporean cohort. FBT has proven effective in studies in the West, but no such study has been done in Asia. This is a retrospective analysis of a hospital-based cohort, which included all paediatric patients (≤ 18-years) with AN treated at a tertiary hospital in Singapore between 2011 and 2017 (n = 119). The patients either received manualised FBT (n = 42) or individualized adolescent focussed therapy (non-FBT) (n = 77). Patient characteristics and time to remission were abstracted from patient records. Survival analysis was used to determine median time to remission and remission-free survival rates. Hazard ratios for remission were obtained by cox regression. Patients in the non-FBT group had a significantly longer time to remission compared with the FBT group after adjustment for age, gender, BMI, psychiatric comorbidity, and ethnicity (p = 0.003, HR = 2.523, 95% CI 1.37-4.64). In the FBT group, the median time to remission was 5.0months (95% CI 3.4-6.6months); 11months shorter than the non-FBT group (p < 0.001, 95% CI 7.9-14.1months). FBT group remission rates were 69% and 90% at 1 and 2years, respectively. Non-FBT group remission rates were 30% and 57% at 1 and 2years, respectively. This study confirms that FBT is an effective treatment strategy for AN in adolescents in the Asian context. FBT can shorten the illness duration, which reduces disruption to schooling and family life at this critical life stage. Level IV, evidence obtained from retrospective review of data before and after the introduction of new intervention.

Noncardiac chest pain: diagnosis and management.

Noncardiac chest pain (NCCP) has been defined as recurrent chest pain that is indistinguishable from ischemic heart pain after excluding a cardiac cause. NCCP is a common and highly challenging clinical problem in Gastrointestinal practice that requires targeted diagnostic assessment to identify the underlying cause of the symptoms. Treatment is tailored according to the cause of NCCP: gastroesophageal reflux disease (GERD), esophageal dysmotility or functional chest pain. The purpose of this review is to discuss the current diagnosis and treatment of NCCP. Utilization of new diagnostic techniques such as pH-impedance and high-resolution esophageal manometry, and the introduction of a new definition for functional chest pain have helped to better diagnose the underlying mechanisms of NCCP. A better therapeutic approach toward GERD-related NCCP, the introduction of new interventions for symptoms due to esophageal spastic motor disorders and the expansion of the neuromodulator armamentarium for functional chest pain have changed the treatment landscape of NCCP. GERD is the most common esophageal cause of NCCP, followed by functional chest pain and esophageal dysmotility. The proton pump inhibitor test, upper endoscopy, wireless pH capsule and pH-impedance are used to identify GERD-induced NCCP. High-resolution esophageal manometry is the main tool to identify esophageal motor disorder in non-GERD-related NCCP. Negative diagnostic assessment suggests functional chest pain. Potent antireflux treatment is offered to patients with GERD-related NCCP; medical, endoscopic or surgical interventions are considered in esophageal dysmotility; and neuromodulators are prescribed for functional chest pain. Assessment and treatment of psychological comorbidity should be considered in all NCCP patients.

Re-focusing HIV prevention messages: a qualitative study in rural Uganda.

BackgroundAfter 30 years, the human immunodeficiency virus (HIV) remains an epidemic of global concern. To support the increasing emphasis on biomedical interventions for prevention requires a renewed and reframed focus on HIV prevention messages to motivate engagement in risk-reduction activities. This paper examines youth and adult perceptions of HIV prevention messages and HIV risk assessment in a generalized HIV epidemic context in Uganda.MethodsWe conducted 24 focus group discussions and 24 in-depth interviews with 15–45 year olds (n = 218) from three communities in the Rakai district of Uganda in 2012.ResultsWe found generational differences in the how people viewed HIV, skepticism around introduction of new interventions, continued misconceptions and fears about condoms, and gender differences in content and salience of HIV prevention messages.ConclusionsShifts in HIV education are needed to address gaps in HIV messaging to foster engagement in risk reduction strategies and adoption of newer biomedical approaches to HIV prevention.

Re-focusing HIV Prevention Messages: A Qualitative Study in Rural Uganda

After 30 years, the human immunodeficiency virus (HIV) remains an epidemic of global concern. To support the increasing emphasis on biomedical interventions for prevention requires a renewed and reframed focus on HIV prevention messages to motivate engagement in risk-reduction activities. This paper examines youth and adult perceptions of HIV prevention messages and HIV risk assessment in a generalized HIV epidemic context in Uganda. We conducted 24 focus group discussions and 24 in-depth interviews with 15–45 year olds (n = 218) from three communities in the Rakai district of Uganda in 2012. We found generational differences in the how people viewed HIV, skepticism around introduction of new interventions, continued misconceptions and fears about condoms, and gender differences in content and salience of HIV prevention messages. Shifts in HIV education are needed to address gaps in HIV messaging to foster engagement in risk reduction strategies and adoption of newer biomedical approaches to HIV prevention.

"Health system approach" for improving immunization program performance.

Immunization programs are one of the most well-recognized and successful public health programs across the world. The immunization programs have achieved significant successes in a number of countries; however, the coverage with available vaccines remains sub-optimal in many low- and middle-income countries (LMICs). This article, based upon extensive review of literature and using universal immunization program (UIP) in India as a case study, summarizes the latest developments and initiatives in the area of vaccination and immunization in the last few years. The article analyzes initiatives under UIP in India from the “health system approach” and argues that it is possible to increase coverage with available vaccines and overall program performance by focused attention on various functions of health systems. It also discusses the emerging evidence that health systems could be strengthened prior to the introduction of new interventions (vaccines included) and the introduction of new interventions (including vaccines) could be planned in a way to strengthen the health systems. It concludes that immunization programs could be one of the entry points for strengthening health systems in the countries and lessons from vaccine introduction could pave pathway for scaling up other health interventions and therefore, could contribute to advancing Universal Health Coverage (UHC).

Malaria Control in India: Strategies, Progress and Challenges

Malaria continues to be one of India's leading public health problems. About 95% population in the country resides in malaria endemic areas consisting of high burden states the North-Eastern (NE) states, Chhatisgarh, Jharkhand, Gujrat, Rajasthan, West Bengal and Karnataka. In 2013 alone total 881730 malaria cases (463846 cases were falciparum malaria) and 440 deaths were reported. In India, malaria control comes under NVBDCP (National Vector Borne Disease Control Programme) under National Rural Health Mission. The National strategy on malaria control has undergone a paradigm shift with the introduction of new interventions for case management and vector control.

Introducing a dengue vaccine to Mexico: development of a system for evidence-based public policy recommendations.

The incidence of dengue fever (DF) is steadily increasing in Mexico [1], [2], as it is in the rest of Latin America [3], burdening health systems with the consequent morbidity and mortality [4]–[6]. The incidence of DF in Mexico has increased from 1.7 cases per 100,000 inhabitants in 2000 to 43.03 cases per 100,000 inhabitants in 2012 (Table 1) [1], [2]. Growing urbanization, human migration, climate change, and ecological disruption have facilitated the expansion of dengue's vectors, Aedes aegypti and A. albopictus [3], [4]. This increase, which could be solely attributed to an improvement in epidemiological surveillance, in reality has a much more complex explanation. According to reports from the Mexican Secretariat of Health, DF in Mexico follows a cyclical pattern of approximately five years per cycle, characterized by a sudden and dramatic rise in cases subsequently followed by a period of decrement that ultimately results in years with a low number of cases. This pattern seems to have its origin in the introduction/reintroduction of new serotypes among the population [2]. Table 1 Evolution of the incidence of dengue fever cases in Mexico between 2000 and 2012. Globally, an estimated 2,500,000,000 to 3,000,000,000 individuals are at risk of infection. Each year 50 million people fall ill, and 20,000 people die as a result of dengue [5]–[7]. These trends will continue to worsen in the foreseeable future [3], [7]. Even at its current level, dengue overloads healthcare systems, particularly in developing countries in which resources are scarce [4]. The direct and indirect costs of dengue are high and impose a considerable financial burden on those affected [2], [8]. The most commonly used dengue control measure—vector control programs—have had poor effects on dengue incidence and are difficult to implement in a sustainable fashion [9]–[11]. Also, these programs are costly and have limited effect because of the difficulty of destroying all mosquitoes in an area [9]. Additionally, there are no effective antivirals available to treat the disease. However, as a result of much progress in research and development over the last decade [12], there is a prospect of a safe and effective preventive vaccine becoming available soon [13]–[16]. In 2012, Sanofi-Pasteur (SP) published the results of a Phase IIB clinical trial carried out in Thailand to test the efficacy of its recombinant, live-attenuated, tetravalent dengue vaccine. The authors reported that although the vaccine showed less efficacy than projected, this was not significant, and the vaccine resulted immunogenic for the four dengue serotypes and protected against serotypes 1, 3, and 4 [17]. Irregardless of the results, the authors of the present report consider that this exercise has been successful and a step forward in the process towards obtaining a much-needed dengue vaccine. Nevertheless, it will be important to assess further data, particularly from the ongoing Phase III studies in Latin America and Asia, in which Mexico is participating with several clinical sites [18]. A dengue vaccine would change the paradigm of dengue control by providing invaluable support to currently available prevention and control measures. Importantly, as a disease most prevalent in developing regions, a dengue vaccine would be primarily aimed at low- and middle-income countries (LMICs) [2], [16], a reversal of the traditional situation. Historically, LMICs wait for vaccines to become available and licensed in developed countries before adopting it themselves once an evidence base is generated and prices have come down to affordable levels [19], [20]. The prospect of a dengue vaccine presents LMICs, like Mexico, with an opportunity to strengthen their decision-making capacity in order to make timely and well-informed decisions about the introduction of new interventions for disease prevention and control. Improving the decision-making process will help LMICs become early adopters of public health interventions [21] and help close the time gap between innovation and access to new vaccines in such countries [22]. For early access to the dengue vaccine, countries will need to be proactive, since early access entails the timely development of adoption plans with active involvement of all sectors of society, including academic institutions, nonprofit organizations, ministries of health and finance, and health service providers [21]. Consequently, LMICs will need to prepare early and engage with all stakeholders to accelerate the process of making the vaccine available to their populations.

Implementing change in physiotherapy: professions, contexts and interventions.

The purpose of this paper is to report findings from qualitative interviews with physiotherapists to demonstrate why even minor changes to clinical work resulting from the introduction of new interventions, are often difficult to implement. The paper seeks to illustrate how some of the obstacles to implementing change were managed by physiotherapists. A total of 32 qualitative interviews with participating physiotherapists were conducted, 12 interviews prior to the introduction of the new system, and 20 afterwards. The interviews were coded and analysed thematically. The findings reveal a number of perceived limitations of current management of low back pain and identify key themes around convergence with the new approach, such as willingness by physiotherapists to adopt the new approach, the perception of benefits to adopting the new approach, as well as some difficulty in adjusting to it. The authors refer to the positive and negative elements as "soft" and "hard" disruption. The adoption of the new approach is explored with reference to the "situated" dimensions of physiotherapy practice and normalisation process theory. The study raises the need to conduct future observational research to support the interview findings. The study describes the "situated" components of physiotherapy work, which have received limited research attention. The value of the study lies less in its ability to explain specifically why physiotherapists adopted or rejected the new system, but in describing the conditions and consequences of change that might be translated to other professions, contexts and interventions.

A systematic review of economic evaluation studies of tuberculosis control in high-income countries

Tuberculosis (TB) is a leading cause of death in developing countries and an important health threat in the industrialised world. Ideally, interventions in TB control are effective, acceptable and economically attractive. This review summarises all economic evaluation studies of TB control in high-income countries over the last 20 years. We provide indications on the relative economic attractiveness of TB interventions based on the reported conclusions. A total of 118 studies using different economic evaluation methodologies on a wide range of TB interventions are included. Most studies (70%) were from North America, and about half (47%) concerned interventions among the general population. Even though the large majority of studies (85%) aimed at preventing active TB disease, 44% of these ignored the prevention of secondary infections, thereby under- estimating the benefits of the intervention. Choosing a health care instead of a societal perspective (92% vs. 8%) further underestimated the benefits. Moreover, 74 studies (62%) disregarded discounting, and for 9 of them this led to overestimated future costs. In all, 66% of the studies reported conclusions favouring the evaluated intervention, which is modest given that a publishing bias towards favourable results is to be expected. In conclusion, we demonstrate that many studies in this review have put the evaluated TB intervention at a disadvantage by the choice of methodology, i. e., underestimating benefits and overestimating costs. This may have led to an overly conservative approach to the introduction of new interventions in TB control.

Natural History of Central Retinal Vein Occlusion: An Evidence-Based Systematic Review

To describe the natural history of central retinal vein occlusion (CRVO) based on the best available evidence from the literature. Central retinal vein occlusion is a common sight-threatening retinal vascular disease. Despite the introduction of new interventions, the natural history of CRVO is unclear. Systemic review of all English language articles retrieved using a keyword search of MEDLINE, EMBASE, Current Contents, and the Cochrane Library to November 13, 2008. This was supplemented by hand-searching references of review articles published within the last 5 years. Two investigators independently identified all relevant observational studies evaluating the natural history of RVO and all clinical trials evaluating interventions for CRVO; an untreated control arm was included. Of 5966 citations retrieved, 53 studies were reviewed, providing 3271 eyes with CRVO for analysis of its natural history. Visual acuity (VA) was generally poor at baseline (<20/40) and decreased further over time. Although 6 studies reported an improvement in VA, none of these improvements resulted in VA better than 20/40. Up to 34% of eyes with nonischemic CRVO converted to ischemic CRVO over a 3-year period. In ischemic CRVO cases, neovascular glaucoma developed in at least 23% of eyes within 15 months. In nonischemic CRVO cases, macular edema resolved in approximately 30% of eyes over time, and subsequent neovascular glaucoma was rare. Untreated eyes with CRVO generally had poor VA, which declined further over time. One quarter of eyes with nonischemic CRVO converted to ischemic CRVO.

Intervention complexity--a conceptual framework to inform priority-setting in health.

Health interventions vary substantially in the degree of effort required to implement them. To some extent this is apparent in their financial cost, but the nature and availability of non-financial resources is often of similar importance. In particular, human resource requirements are frequently a major constraint. We propose a conceptual framework for the analysis of interventions according to their degree of technical complexity; this complements the notion of institutional capacity in considering the feasibility of implementing an intervention. Interventions are categorized into four dimensions: characteristics of the basic intervention; characteristics of delivery; requirements on government capacity; and usage characteristics. The analysis of intervention complexity should lead to a better understanding of supply- and demand-side constraints to scaling up, indicate priorities for further research and development, and can point to potential areas for improvement of specific aspects of each intervention to close the gap between the complexity of an intervention and the capacity to implement it. The framework is illustrated using the examples of scaling up condom social marketing programmes, and the DOTS strategy for tuberculosis control in highly resource-constrained countries. The framework could be used as a tool for policy-makers, planners and programme managers when considering the expansion of existing projects or the introduction of new interventions. Intervention complexity thus complements the considerations of burden of disease, cost-effectiveness, affordability and political feasibility in health policy decision-making. Reducing the technical complexity of interventions will be crucial to meeting the health-related Millennium Development Goals.

Do we need guidelines for the introduction of new interventions? Views from the UK, the USA, The Netherlands, and Ancient Greece

In April 2004, the Dutch Society of Obstetrics and Gynaecology issued a guideline on the introduction of new interventions in clinical practice. This initiative is discussed from an international perspective with reference to the National Institute for Clinical Excellence, launched in 1999 in the UK, the Code of Professional Ethics of the American College of Obstetricians and Gynecologists, published in September 2003, and the Hippocratic Oath, which originates from ancient Greece.

The relationship between audit, research and policy: lessons from a community paediatric audiology service.

The pace of medical change is in danger of paralysing the process of decision making, particularly in services where clinical improvements occur more slowly than the introduction of new interventions. Audit within an individual district enables staff to monitor progress towards desired goals and standards but rarely generates sufficient data to inform decision making about major policy changes. The paper describes how the findings from nine audits of a community paediatric audiology service over a 13-year period were combined with reviews of the literature, resulting in a series of changes to a children's audiological service. The interest and commitment of all the staff involved were maintained by involving them in the process and using them as a valuable source of qualitative data. Audit must be thorough and should be based on precise case definition and comprehensive casefinding if the results are to be meaningful. It is a more powerful means of achieving improvements in systems if it is combined with research evidence, and a readiness to change the system if the agreed goals are not being attained.