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To systematically identify the latest versions of official economic evaluation guidelines (EEGs) in low- and middle-income countries (LMICs) and explore similarities and differences in their content.
We conducted a systematic search in MEDLINE (Ovid), PubMed, EconLit, Embase (Ovid), the Cochrane Library, and the gray literature. Using a predefined checklist, we extracted the key features of economic evaluation and the general characteristics of EEGs. We conducted a comparative analysis, including a summary of similarities and differences across EEGs.
Thirteen EEGs were identified, three pertaining to lower-middle-income countries (Bhutan, Egypt, and Indonesia), nine to upper-middle-income countries (Brazil, China, Colombia, Cuba, Malaysia, Mexico, Russian Federation, South Africa, and Thailand), in addition to Mercosur, and none to low-income countries. The majority (n = 12) considered cost–utility analysis and health-related quality-of-life outcome. Half of the EEGs recommended the societal perspective, whereas the other half recommended the healthcare perspective. Equity considerations were required in ten EEGs. Most EEGs (n = 11) required the incremental cost-effectiveness ratio and recommended sensitivity analysis, as well as the presentation of a budget impact analysis (n = 10). Seven of the identified EEGs were mandatory for pharmacoeconomics submission. Methodological gaps, contradictions, and heterogeneity in terminologies used were identified within the guidelines.
As the importance of health technology assessment is increasing in LMICs, this systematic review could help researchers explore key aspects of existing EEGs in LMICs and explore differences among them. It could also support international organizations in guiding LMICs to develop their own EEGs and improve the methodological framework of existing ones.
In the USA, commercial contracts often include tiered or stepped dispute resolution schemes that comprise multiple, varied mechanisms for resolving conflict. Contractual relationships are particularly suitable for tiered processes that accommodate business priorities, although critiques raise issues regarding necessity, utility and enforceability. Where courts have found contractual negotiation or mediation provisions to be valid and enforceable, the manner in which they address non-compliance under such agreements varies. When a party to a multi-step process fails or refuses to participate in contractually required negotiation or mediation prior to arbitration, there may be issues as to whether the consequences should be addressed in court or via arbitration. Despite being conventionally disfavoured in the USA, many neutrals have experience with ‘switching hats’ – ie moving from being mediator to being arbitrator, or vice versa – in the course of resolving disputes. Guidelines for the use of multi-tier processes take into account the uncertainties associated with judicial handling of stepped agreements as well as their inherent complexities, while recognising potential benefits.
Benzodiazepines (BZD) are psychotropic drugs prescribed in psychiatry for their anxiolytic, hypnotic and sedative properties. Several guidelines aimed to limit the chronic use of BZDs. However, BZDs prescribing that does not comply with international recommendations remains widespread, estimated in France at 30% for anxiolytic BZDs.
The aims of our study were to evaluate BZDs prescribing practices in the treatment of anxiety and to assess their compliance with international recommendations.
This is a cross-sectional study conducted through a Google-forms self-administered questionnaire,intended for psychiatrists and psychiatric residents, over a period of two months, from April 1 to May 31, 2019.
One hundred physicians practicing in psychiatry answered our questionnaire. The response rate was 28%. The most prescribed BZD for anxiolytic purposes was Prazepam (76.2%). Clonazepam was prescribed for anxiolytic purposes in 10.5% of cases. Of the 105 participants, 48 indicated that they prescribed BZDs for anxiolytic purposes in states of acute stress (45.7%), 28.6% prescribed them for the treatment of mild to moderate anxiety manifestations in anxiety disorders. For the treatment of anxiety without panic attacks, 20% indicated that they prefer a short half-life BZD, 80% a long half-life BZD. The maximum duration of BZDs prescription for anxiolytic purposes was 12 weeks (62%), and 6 months in 10% of cases.
BZDs are often prescribed in psychiatry for their anxiolytic property, sometimes in a way that does not comply with the recommendations of good practice, with regard to the prescribed molecules, their indications and the duration and modalities of prescription.
To propose a set of internationally harmonized procedures and methods for assessing neurocognitive functions, smell, taste, mental, and psychosocial health, and other factors in adults formally diagnosed with COVID-19 (confirmed as SARS-CoV-2 + WHO definition).
We formed an international and cross-disciplinary NeuroCOVID Neuropsychology Taskforce in April 2020. Seven criteria were used to guide the selection of the recommendations’ methods and procedures: (i) Relevance to all COVID-19 illness stages and longitudinal study design; (ii) Standard, cross-culturally valid or widely available instruments; (iii) Coverage of both direct and indirect causes of COVID-19-associated neurological and psychiatric symptoms; (iv) Control of factors specifically pertinent to COVID-19 that may affect neuropsychological performance; (v) Flexibility of administration (telehealth, computerized, remote/online, face to face); (vi) Harmonization for facilitating international research; (vii) Ease of translation to clinical practice.
The three proposed levels of harmonization include a screening strategy with telehealth option, a medium-size computerized assessment with an online/remote option, and a comprehensive evaluation with flexible administration. The context in which each harmonization level might be used is described. Issues of assessment timelines, guidance for home/remote assessment to support data fidelity and telehealth considerations, cross-cultural adequacy, norms, and impairment definitions are also described.
The proposed recommendations provide rationale and methodological guidance for neuropsychological research studies and clinical assessment in adults with COVID-19. We expect that the use of the recommendations will facilitate data harmonization and global research. Research implementing the recommendations will be crucial to determine their acceptability, usability, and validity.
Cetacean watching is an increasingly popular economic activity in Ecuador for tourism operators. Despite government regulations, cetacean watching can have a negative impact on observed animal populations. To enhance good dolphin-watching practices, a course was carried out in Puerto El Morro, Ecuador about sensitisation activities promoting empathy towards and knowledge about bottlenose dolphins, local avifauna and mangrove ecosystems. The course provided tourism operator staff with theoretical and practical knowledge on dolphin physiology and ecology, with a focus on empathy towards the species and on regulations to be respected during the watching tours. The course included interactive workshops, didactic materials, advice, video screening and structured conversations. Two innovative questionnaires were implemented on the boat during 68 dolphin-watching tours to evaluate whether the training course had improved the regulation compliance and on-tour guiding quality of the tour guides and boat drivers. The results showed a statistically significant improvement in dolphin-watching practices in compliance with the “Regulations for the Whale and Dolphin Watching of Ecuador” (p = .0002) and in guidance quality (p = .0004) after the training course. Boat drivers were identified as influential actors in compliance with regulations and should also be included in the environmental awareness training courses. The study showed that empathy-based sensitisation and knowledge reinforcement positively affect policy compliance and can generate new sustainable approaches for future dolphin-watching activities.
In this chapter I consider some important implications of adopting rules, principles and supplementary guidance-based approaches to the regulation and governance of health research. This is a topic that has not yet received sufficient attention given how impactful different regulatory approaches can be on health research. I suggest that each approach has strengths and limitations to be factored in when considering how we shape health research practices. I argue that while principles-based approaches can be well-suited to typically complex health research landscapes, additional guidance is often required. I explore why this is so, highlighting in particular the added value of best practice and noting that incorporating additional guidance within regulatory approaches demands its own important considerations, which are laid out in the final section.
The 2020 update of the Canadian Stroke Best Practice Recommendations (CSBPR) for the Secondary Prevention of Stroke includes current evidence-based recommendations and expert opinions intended for use by clinicians across a broad range of settings. They provide guidance for the prevention of ischemic stroke recurrence through the identification and management of modifiable vascular risk factors. Recommendations address triage, diagnostic testing, lifestyle behaviors, vaping, hypertension, hyperlipidemia, diabetes, atrial fibrillation, other cardiac conditions, antiplatelet and anticoagulant therapies, and carotid and vertebral artery disease. This update of the previous 2017 guideline contains several new or revised recommendations. Recommendations regarding triage and initial assessment of acute transient ischemic attack (TIA) and minor stroke have been simplified, and selected aspects of the etiological stroke workup are revised. Updated treatment recommendations based on new evidence have been made for dual antiplatelet therapy for TIA and minor stroke; anticoagulant therapy for atrial fibrillation; embolic strokes of undetermined source; low-density lipoprotein lowering; hypertriglyceridemia; diabetes treatment; and patent foramen ovale management. A new section has been added to provide practical guidance regarding temporary interruption of antithrombotic therapy for surgical procedures. Cancer-associated ischemic stroke is addressed. A section on virtual care delivery of secondary stroke prevention services in included to highlight a shifting paradigm of care delivery made more urgent by the global pandemic. In addition, where appropriate, sex differences as they pertain to treatments have been addressed. The CSBPR include supporting materials such as implementation resources to facilitate the adoption of evidence into practice and performance measures to enable monitoring of uptake and effectiveness of recommendations.
The decade of the United Nations Guiding Principles on Business and Human Rights (UNGPs) coincides with India’s National Voluntary Guidelines on businesses’ social, environmental, and economic responsibilities (NVGs) and the National Guidelines on Responsible Business Conduct (NGRBC) – an updated version of the NVGs. Human rights are one of the core principles in both guidelines and they draw upon the ‘Protect–Respect–Remedy’ framework of the UNGPs. The NVGs and NGRBC go beyond the UNGPs by requiring organizations not only to respect human rights, but also to promote them in their spheres of influence. Several factors, however, derailed the implementation of this progressive policy shift. This article explores the challenges in implementation and calls for the multiple actors involved to work together and shape a collaborative action plan for effective implementation of the NGRBC in the next decade. The authors reiterate the need for alternative lenses to frame the responsible business agenda within developing countries through positive obligations.
To prioritise and refine a set of evidence-informed statements into advice messages to promote vegetable liking in early childhood, and to determine applicability for dissemination of advice to relevant audiences.
A nominal group technique (NGT) workshop and a Delphi survey were conducted to prioritise and achieve consensus (≥70 % agreement) on thirty evidence-informed maternal (perinatal and lactation stage), infant (complementary feeding stage) and early years (family diet stage) vegetable-related advice messages. Messages were validated via triangulation analysis against the strength of evidence from an Umbrella review of strategies to increase children’s vegetable liking, and gaps in advice from a Desktop review of vegetable feeding advice.
A purposeful sample of key stakeholders (NGT workshop, n 8 experts; Delphi survey, n 23 end users).
Participant consensus identified the most highly ranked priority messages associated with the strategies of: ‘in-utero exposure’ (perinatal and lactation, n 56 points) and ‘vegetable variety’ (complementary feeding, n 97 points; family diet, n 139 points). Triangulation revealed two strategies (‘repeated exposure’ and ‘variety’) and their associated advice messages suitable for policy and practice, twelve for research and four for food industry.
Supported by national and state feeding guideline documents and resources, the advice messages relating to ‘repeated exposure’ and ‘variety’ to increase vegetable liking can be communicated to families and caregivers by healthcare practitioners. The food industry provides a vehicle for advice promotion and product development. Further research, where stronger evidence is needed, could further inform strategies for policy and practice, and food industry application.
We have seen in Chapter 9 that we have many avenues to improve medication safety in anesthesia and the perioperative period, with considerable evidence and expert consensus to support them. However, human nature, just as it leads to errors, also often drives resistance to implementing safety interventions. Complicating our efforts to improve safety are safety paradoxes that, although would seem to improve safety, actually may work against safety. Achieving improved patient safety requires a deep understanding of not just how things go wrong when error-prone human beings work within complex systems but also why changes that would have a high probability of reducing the risk of errors are so often resisted. Needed changes can be resisted by individual physicians and by entire leadership of a large healthcare system. We return to the concept of violations, and emphasize that failure to hold violators accountable will effectively undermine safety efforts. Finally, an effort to understand why we do not change is absolutely imperative, as our continued refusal to change to safer methods continues to imperil our patients.
Evidence-based medicine is the conscientious, explicit and judicious use of current best evidence to make clinical decisions. Given the pace of progress in reproductive medicine, this has become an essential part of effective care. Evidence-based practice typically involves a number of steps, including asking a question, searching for evidence, critical appraisal and application of the evidence.
To explore student therapeutic radiographers’ understanding of obesity and cancer and to identify if student therapeutic radiographers believe that radiographers should have a role within weight management.
Materials and Methods:
This study used a self-completed online questionnaire (google forms) to collect data from Radiotherapy and Oncology students, studying at one Higher Education Institution, to gain an understanding of their current knowledge of weight management. A retrospective margin of error calculation was carried out, showing a 9% margin of error with a 90% confidence level.
In total 57 responses were received, n = 50 BSc students and n = 7 pre-registration MSc students. Three key barriers to openly discussing weight loss management with service users emerged from the questionnaire data; these were a lack of time, lack of clear guidelines and lack of confidence. These barriers could potentially be addressed by improving education and training, making it easier for therapeutic radiographers to openly discuss weight management with service users.
Awareness of guidelines was suboptimal, with 82% (n = 47) of respondents unaware of any guidelines. In addition to this, the majority of students identified a lack of confidence as a barrier to them providing weight management advice. Despite this, 54·4% of respondents agreed that radiographers should have a role in providing weight management advice, with 22·2% of respondents being unsure. Findings suggest that behaviour change is required amounts both students and staff members, so that healthcare professionals are more inclined to have healthy weight management discussions. Perhaps more specialist roles need to be developed, so that healthy weight management discussions can become a norm.
Traditional and complementary medicines are increasingly considered possible options for prevention and symptomatic treatment of the novel coronavirus, COVID-19. With renewed attention on these therapies from researchers and policy makers alike, the well-documented challenges of evaluating their safety and efficacy are once again of global concern. Between 2005 and 2018, the World Health Organization conducted a series of surveys, in which 88 percent of responding member states confirmed that their biggest challenge in traditional medicine was the need for technical guidance on research and evaluation. As a first step in pursuing this need, our commentary summarizes thirteen international and regional guidance documents by three broad categories on evaluating safety, efficacy, and product quality for market-based approval and distribution of these treatments. We highlight the paucity of updated international recommendations on these subjects and identify gaps that could inform the current evidence base. All available guidance note the need for evidence surrounding the efficacy of these treatments and practices but are also quick to caution against methodological difficulties in the conduct of such evaluations. Evidence suggests that improved evaluation methods on efficacy and effectiveness are crucial toward expanding future research into establishing the cost-effectiveness of these therapies, in the context of shifting acceptance, interest, and integration of traditional medicines into health systems, and as another step toward Universal Health Coverage.
To assess the adherence of economic evaluations to the recommendations on principles of economic evaluation as stated in the country-specific guidelines for three countries across different income groups, namely, Canada, South Africa, and Egypt.
Searches were undertaken in three databases to identify economic evaluations meeting predefined inclusion criteria. Methodological and reporting standards listed in the country-specific guidelines were converted into discrete binary variables to calculate mean adherence scores. Quality appraisal was done using Drummond's checklist. Stratified analysis was undertaken to identify independent variables affecting adherence.
We identified forty-four, seventy-nine, and sixteen economic evaluations for Canada, South Africa, and Egypt, respectively. The mean adherence score was the highest for Canada (71%), followed by South Africa (65%) and Egypt (60%). Adherence to guidelines was positively correlated with quality of studies, r = .72. Furthermore, the mean adherence score was significantly (p < .05) higher for studies using a cost-utility analysis design (72%), having local/national funding aid (72%), undertaken by a health economist (71%) and for pharmacoeconomic evaluations (70%).
The quality of economic evaluations improves with adherence to country-specific guidelines. Locally funded and health-economist led health technology assessments (HTAs) should be encouraged for greater adherence to the guidelines. The HTA researchers and the HTA bodies should lay emphasis on adherence to the country-specific guidelines for improving the quality of HTA evidence.
To classify, analyze, and compare published guidelines for economic evaluation within health technology assessment (HTA) in European countries and highlight differences and similarities.
We performed a literature review to identify published guidance for the conduct and assessment of economic evaluation studies that are undertaken within the context of HTA processes in European countries. Organizations and working groups were identified via the ISPOR, INAHTA, and EUnetHTA databases. Following the identification of official documents, we performed a qualitative content analysis to highlight discrepancies or common practices under the following categories: comparator, perspective on costs/benefits, time horizon, economic evaluation method, instrument used for utility measurement, outcome measure, source for efficacy, modeling, sensitivity analysis, discounting, and incremental cost-effectiveness ratio.
A total of nineteen guidance documents were identified (in English) providing data for the analysis in nineteen countries. The comparative content analysis identified common practices in most countries regarding the approaches to the choice of comparator, source of data, the preferred economic evaluation method, the option for a lifetime analytical horizon, discounting, and the choice of key outcome measure—for which, most countries recommend the use of the EQ-5D instrument. Differences were mainly found in the choice of perspective, dealing with uncertainty and sensitivity analysis, the use of end points, and the required use of modeling.
The use of economic evaluation constitutes one of the key pillars of the HTA process in Europe. Although a methodological convergence has occurred during the last few years, notable differences still remain.
In a path-breaking work, Tanya Aplin and Lionel Bently make the case that the quotation exception in Article 10 of the Berne Convention constitutes a global, mandatory, fair use provision. It is global, they argue, because of the reach of Berne qua Berne and qua TRIPS, and its mandatory nature is apparent from the clear language of Article 10 and its travaux. It relates to 'use' that is not limited by type of work, type of act, or purpose and it is 'fair' use because the work must be made available to the public, with attribution, and the use must be proportionate and consistent with fair practice. By explaining the contours of global, mandatory fair use - and thus displacing the 'three-step test' as the dominant, international copyright norm governing copyright exceptions - this book creates new insights into how national exceptions should be framed and interpreted.
Current international experience has shown the vulnerability of health-care systems of developed nations, and of developing nations such as India, to coronavirus disease 2019 (COVID-19). COVID-19 pandemic is a disaster with mass casualties. International experience has revealed that, even in the countries where mass disasters are less frequent and not involved in conflicts, they are overwhelmed with COVID-19 deaths. Although, in the current scenario with fewer deaths, India’s health-care system can handle the situation of COVID-19 but should be prepared for the worst in terms of appropriate management, and adequate infection prevention measures including handling the dead without hampering the dignity of the deceased and of the surviving family. Before any crisis overwhelms responders and resources, emergency response plans should be established and activated to ensure the reliable identification and documentation of the dead. The current review was carried out to recommend the proper management of dead bodies in the COVID-19 mass disaster with a particular focus on resource-poor countries, such as India.
Choosing Wisely Canada (CWC) is a national branch of a global campaign advocating for fewer unnecessary tests and for optimizing patient care. Professional societies representing physicians, pharmacists, and nurses participate by generating lists of recommendations meant to reduce patient harm and resource mismanagement in healthcare. The Canadian Neurological Society (CNS) plays an important role in advocating for quality patient care demonstrated by deriving specific recommendations. This process is described.
The CNS Choosing Wisely task force adapted 10 recommendations for Canadian neurology practice. These were approved by the CNS board, and subsequently ranked by CNS members.
Ten recommendations were brought forward and ranked in a survey completed by CNS members. Survey ranking is presented. The top five recommendations were selected and optimized, resulting in seven key recommendations.
The recommendations set forth by the CNS will help with resource stewardship and patient safety in the delivery of neurological care by healthcare providers in Canada.